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"Morality is not correctly the doctrine of happiness : rather
it is the doctrine of how to feel worth being happy."
(Immanuel Kant)
Not every possible action is a good action.
Here is a collection of personal reflections on some particularly hot
topics (currently and probably even in future !). They all are organized
as tentatives of response to the following questions :
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| Life |
prenatal diagnosis |
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Methods of execution :
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| Freedom |
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| Health |
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| gene testing | |||
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| negative eugenics |
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| gene enhancement in somatic cells | |||
| euthanasia
: Terri Schiavo was severely brain-damaged in 1990 after an AMI. Her husband
has fought to allow her to die; her parents have opposed this on the grounds
that she shows some signs of awareness and might recover. The debate escalated
dramatically in February 2005 after a Florida judge permitted Schiavo's
feeding tube to be removed last week, prompting President George W. Bush
to sign emergency legislation ordering a review of her case. But on Tuesday
22 March, a federal judge turned down a request to have the tube reinserted. |
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therapeutical tenacity
/ overtreatment
: therapy should be practiced for the patient' sake alone and not for
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Organ trade is unlawful; organ gift is promoted on condition it is gratuitous, anonymous and spontaneous. The idea of graft and transplantation is understood differently according to culture, religion and ability of a region to supply to its needs in the field of health. The patient's eagerness can explain his quest of a donor in whatever country he is. Even those physicians who have strict ethical guidelines must pay attention not to be involved in blameable jobs. The only way to avoid rewarded organ gifts is to prohibit transplantation touring and grafting from friends, at the risk to loose true-hearted and noble donorsref. As the waiting list of patients requiring organ transplantation grows, there is a subtle but noticeable shift in society towards accepting organs as a commodity which can be paid for. Although nowhere is the organ trade legal, the commerce of organs goes on in different parts of the world, especially in developing countries such as India. This is largely due to societal and governmental failure to implement the existing "transplant laws". It is high time the medical profession ceased being an accomplice to this unscrupulous trade, which exploits the poor, deters altruism retarding the living-related and cadaver transplant programs, commercializes the human body and jeopardizes human dignityref. In the Netherlands, cross-over kidney transplantation has been introduced as an extra option in the living kidney donation programme. In cross-over transplantation, patients who cannot be given their own partner's kidney for immunological reasons are given a kidney from the partner of another patient in exchange for a kidney from their own partner. There is no difference in the medical indications and contraindications between direct and indirect living donation. There are no ethical obstacles since the net gain for the two couples is no different from that of direct living kidney donation and because the exchange takes place on the basis of equality. One should be aware that the extra possibilities may result in more psychological pressure on potential donors. It is important that the donation procedures start at the same moment and that the wishes of patients and donors for anonymity be preserved. A successful cross-over kidney transplantation programme requires a large pool of donors and patients. Therefore, this has been organised in a national programme. The Dutch Transplantation Foundation is responsible for the allocation of cross-over kidneys. Organ trade will thus be impossible. The 7 Dutch centres for kidney transplantation have developed a protocolref1, ref2, ref3. Brazil does not need to use LURD because they have not optimized their cadaver donor pool. The exploitation of LURD might be a good option for developed countries, but it is not useful for developing countriesref Web resources : Organs Watch |
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| cosy dynamics that exist between the pharmaceutical industry, drug
regulatory authorities, and the medical profession
Web resources : No Free Lunch |
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| Knowledge | informed
consent
: mental incapacity is common in acutely ill medical inpatients, and clinicians
tend not to recognise it. Screening methods for cognitive impairment could
be useful in detecting those with doubtful capacity to consent. Clinical
teams rarely identified patients who did not have mental capacity: in a
study only 24% (vs. actual 31%) were rated as lacking capacity. Factors
associated with mental incapacity were increasing age and cognitive impairmentref. |
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| education |
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| Work | |||
| Tolerance | humbleness | ||
| political intolerance | |||
| religious intolerance | |||
| war : "In accordance with the principles of double-think it does not matter if the war is not real. For when it is, victory is not possible. The war is not meant to be won, but it is meant to be continuous. Hierarchical society is only possible on the basis of poverty and ignorance. This new version is the past and no different past can ever have existed. In principle the war effort is always planned to keep society on the brink of starvation. The war is waged by the ruling group against its own subjects and its object is not the victory over either Eurasia or East Asia but to keep the very structure of society intact." (George Orwell, 1984; quoted at the end of Michael Moore's Fahrenheit 9/11) | |||
| Respect |
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| Solidarity |
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indifference | |
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tissue/organ donations |
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In China, genetic tests have increased by 20% every year. In Zhejiang and Guangdong, the growth rate can reach up to 40-50%. In 2005, the Beijing Genetic Judicial Test Center did 3,000 bio-relation tests and the result showed that 680 cases (22.6%) were labeled with "negation"ref
For the first time in the history of the United States, Congress met
in a special emergency session on Sunday, March 20, to pass legislation
aimed at the medical care of one patient — Terri Schiavo. President George
W. Bush encouraged the legislation and flew back to Washington, D.C., from
his vacation in Crawford, Texas, so that he could be on hand to sign it
immediately. In a statement issued three days earlier, he said: “The case
of Terri Schiavo raises complex issues. . . . Those who live at the mercy
of others deserve our special care and concern. It should be our goal as
a nation to build a culture of life, where all Americans are valued, welcomed,
and protected — and that culture of life must extend to individuals with
disabilities.”ref
The “culture of life” is a not-terribly-subtle reference to the antiabortion
movement in the United States, which received significant encouragement
in last year’s presidential election. The movement may now view itself
as strong enough to generate new laws to prevent human embryos from being
created for research and to require that incompetent patients be kept alive
with artificially delivered fluids and nutrition. How did the U.S. Congress
conclude that it was appropriate to attempt to reopen a case that had finally
been concluded after more than seven years of litigation involving almost
20 judges? Has the country’s culture changed so dramatically as to require
a fundamental change in the law? Or do patients who cannot continue to
live without artificially delivered fluids and nutrition pose previously
unrecognized or novel questions of law and ethics? The case of Terri Schiavo,
a Florida woman who is in a persistent vegetative state, is being played
out as a public spectacle and a tragedy for her and her husband, Michael
Schiavo. Mr. Schiavo’s private feud with his wife’s parents over the continued
use of a feeding tube has been taken to the media, the courts, the Florida
legislature, Florida Governor Jeb Bush, the U.S. Congress, and now President
Bush. Since Ms. Schiavo is in a medical and legal situation almost identical
to those of two of the most wellknown patients in medical jurisprudence,
Karen Ann Quinlan and Nancy Cruzan, there must be something about cases
like theirs that defies simple solutions, whether medical or legal. In
this sense, the case of Terri Schiavo provides an opportunity to examine
issues that most lawyers, bioethicists, and physicians believed were well
settled — if not since the 1976 New Jersey Supreme Court decision in the
case of Karen Quinlan, then at least since the 1990 U.S. Supreme Court
decision in the case of Nancy Cruzan. Before reviewing Terri Schiavo’s
case, it is well worth reviewing the legal background information that
has been ignored by Congress and the President. In 1976, the case of Karen
Quinlan made international headlines when her parents sought the assistance
of a judge to discontinue the use of a ventilator in their daughter, who
was in a persistent vegetative state.2 Ms. Quinlan’s physicians had refused
her parents’ request to remove the ventilator because, they said, they
feared that they might be held civilly or even criminally liable for her
death. The New Jersey Supreme Court ruled that competent persons have a
right to refuse life-sustaining treatment and that this right should not
be lost when a person becomes incompetent. Since the court believed that
the physicians were unwilling to withdraw the ventilator because of the
fear of legal liability, not precepts of medical ethics, it devised a mechanism
to grant the physicians prospective legal immunity for taking this action.
Specifically, the New Jersey Supreme Court ruled that after a prognosis,
confirmed by a hospital ethics committee,
that there is “no reasonable possibility of a patient returning to
a cognitive, sapient state,” life-sustaining treatment can be removed and
no one involved, including the physicians, can be held civilly or criminally
responsible for the death (In re Quinlan, 70 N.J.10, 355 A2d 647 (1976)).
The case of karen quinlan. The publicity surrounding the Quinlan case motivated
2 independent developments: it encouraged states to enact “living will”
legislation that provided legal immunity to physicians who honored patients’
written “advance directives” specifying how they would want to be treated
if they ever became incompetent; and it encouraged hospitals to establish
ethics committees that could attempt to resolve similar treatment disputes
without going to court. Although Quinlan was widely followed, the New Jersey
Supreme Court could make law only for New Jersey. When the U.S. Supreme
Court decided the case of Nancy Cruzan in 1990, it made constitutional
law for the entire country. Nancy Cruzan was a young woman in a persistent
vegetative state caused by an accident; she was in physical circumstances
essentially identical to those of Karen Quinlan, except that she was not
dependent on a ventilator but rather, like Terri Schiavo, required only
tube feeding to continue to live. 3 The Missouri Supreme Court had ruled
that the tube feeding could be discontinued on the basis of Nancy’s right
of self-determination, but that only Nancy herself should be able to make
this decision. Since she could not do so, tube feeding could be stopped
only if those speaking for her, including her parents, could produce “clear
and convincing” evidence that she would refuse tube feeding if she could
speak for herself. 4 The U.S. Supreme Court, in a 5-to-4 decision, agreed,
saying that the state of Missouri had the authority to adopt this high
standard of evidence (although no state was required to do so) because
of the finality of a decision to terminate treatment (Cruzan v. Director,
Missouri Dept. of Health, 497 U.S. 261 (1990)). In the words of the chief
justice, Missouri was entitled to “err on the side of life.” Six of the
nine justices explicitly found that no legal distinction could be made
between artificially delivered fluids and nutrition and other medical interventions,
such as ventilator support; none of the other three justices found a constitutionally
relevant distinction. This issue is not controversial as a matter of constitutional
law: Americans have (and have always had) the legal right to refuse any
medical intervention, including artificially delivered fluids and nutrition.
Supreme Court Justice Sandra Day O’Connor, in a concurring opinion (her
vote decided the case), recognized that young people (such as Karen Quinlan,
Nancy Cruzan, and now Terri Schiavo — all of whom were in their 20s at
the time of their catastrophic injuries), do not generally put explicit
treatment instructions in writing. She suggested that had Cruzan simply
said something like “if I’m not able to make medical treatment decisions
myself, I want my mother to make them,” such a statement should be a constitutionally
protected delegation of the authority to decide about her treatment. 3
O’Connor’s opinion was the reason that the Cruzan case energized a movement
— encouraging people to use the appropriate documents, such as health care
proxy forms or assignments of durable power of attorney, to designate someone
(usually called a health care proxy, or simply an agent) to make decisions
for them if they are unable to make them themselves. All states authorize
this delegation, and most states explicitly grant decision-making authority
to a close relative — almost always to the spouse above all others — if
the patient has not made a designation. Such laws are all to the good.
Terri Schiavo had a cardiac arrest, perhaps because of a potassium imbalance,
in 1990 (the year Cruzan was decided), when she was 27 years old. Since
1990, she has lived in a persistent vegetative state in nursing homes,
with constant care, being nourished and hydrated through tubes. In 1998,
Michael Schiavo petitioned the court to decide whether to discontinue the
tube feeding. Unlike Quinlan and Cruzan, however, the Schiavo case involves
a family dispute: Ms. Schiavo’s parents objected. A judge found that there
was clear and convincing evidence that Terri Schiavo was in a permanent
or persistent vegetative state and that, if she could make her own decision,
she would choose to discontinue life-prolonging procedures. An appeals
court affirmed the first judge’s decision, and the Florida Supreme Court
declined to review it. Schiavo’s parents returned to court, claiming that
they had newly discovered evidence. After an additional appeal, the parents
were permitted to challenge the original court findings on the basis of
new evidence related to a new treatment that they believed might restore
cognitive function. 5 physicians were asked to examine Ms. Schiavo — 2
chosen by the husband, two by the parents, and one by the court. On the
basis of their examinations and conclusions, the trial judge was persuaded
by the 3 experts who agreed that Schiavo was in a persistent vegetative
state. The appeals court affirmed the original decision of the trial court
judge, quoting his sympathetic conclusion: Despite the irrefutable evidence
that [Schiavo’s] cerebral cortex has sustained irreparable injuries, we
understand why a parent who had raised and nurtured a child from conception
would hold out hope that some level of cognitive function remained. If
Mrs. Schiavo were our own daughter, we could not hold to such faith. But
in the end this case is not about the aspirations that loving parents have
for their children. It is about Theresa Schiavo’s right to make her own
decision, independent of her parents and independent of her husband. .
. . It may be unfortunate that when families cannot agree, the best forum
we can offer for this private, personal decision is a public courtroom
and the best decision-maker we can provide is a judge with no prior knowledge
of the ward, but the law currently provides no better solution that adequately
protects the interests of promoting the value of life (In re Guardianship
of Schiavo, 800 So. 2d 640 (Fla. 2d Dist.Ct.App. 2001)). The Supreme Court
of Florida again refused to hear an appeal. Subsequently, the parents,
with the vocal and organized support of conservative religious organizations,
went to the state legislature seeking legislation requiring the reinsertion
of Ms. Schiavo’s feeding tube, which had been removed on the basis of the
court decisions (Goodnough A. Victory in Florida feeding case emboldens
the religious right. New York Times. October 24, 2003:A1; Kirkpatrick DD,
Stolberg SG. How family’s cause reached the halls of Congress: networks
of Christians rallied to case of Florida woman. New York Times. March 22,
2005:Al.). The legislature passed a new law (2003-418), often referred
to as “Terri’s Law,” which gave Governor Jeb Bush the authority to order
the feeding tube reinserted, and he did so. The law applied only to a patient
who met the following criteria on October 15, 2003 — in other words, only
to Terri Schiavo: (a) That patient has no written advance directive; (b)
The court has found that patient to be in a persistent vegetative state;
(c) That patient has had nutrition and hydration withheld; and (d) A member
of that patient’s family has challenged the withholding of nutrition and
hydration. The constitutionality of this law was immediately challenged.
In the fall of 2004, the Florida Supreme Court ruled that the law was unconstitutional
because it violates the separation of powers — the division of the government
into three branches (executive, legislative, and judicial), each with its
own powers and responsibilities. The doctrine states simply that no branch
may encroach on the powers of another, and no branch may delegate to another
branch its constitutionally assigned power. Specifically, the court held
that for the legislature to pass a law that permits the executive to “interfere
with the final judicial determination in a case” is “without question an
invasion of the authority of the judicial branch.” In addition, the court
found the law unconstitutional for an independent reason, because it “delegates
legislative power to the governor” by giving the governor “unbridled discretion”
to make a decision about a citizen’s constitutional rights. In the court’s
words: If the Legislature with the assent of the Governor can do what was
attempted here, the judicial branch would be subordinated to the final
directive of the other branches. Also subordinated would be the rights
of individuals, including the well established privacy right to self determination.
. . . Vested rights could be stripped away based on popular clamor (Bush
v. Schiavo, 885 So.2d 321 (Fla. 2004)). In January 2005, the U.S. Supreme
Court refused to hear an appeal brought by Governor Bush. Thereafter, the
trial court judge ordered that the feeding tube be removed in 30 days (at
1 p.m., Friday, March 18) unless a higher court again intervened. The presiding
judge, George W. Greer of the Pinellas County Circuit Court, was thereafter
picketed and threatened with death; he has had to be accompanied by armed
guards at all times. Ms. Schiavo’s parents, again with the aid of a variety
of religious fundamentalist and “right to life” organizations, sought review
in the appeals courts, a new statute in the state legislature, and finally,
congressional intervention. Both the trial judge and the appeals courts
refused to reopen the case on the basis of claims of new evidence (including
the Pope’s 2004 statement regarding fluids and nutrition (Shannon TA, Walter
JJ. Implications of the papal allocution on feeding tubes. Hastings Cent
Rep 2004;34(4):18-20)) or the failure to appoint an independent lawyer
for her at the original hearing. In Florida, the state legislature considered,
and the House passed, new legislation aimed at restoring the feeding tube,
but the Florida Senate — recognizing, I think, that this new legislation
would be unconstitutional for the same reason as the previous legislation
was — ultimately refused to approve the bill. Thereupon, an event unique
in American politics occurred: after more than a week of discussion, and
after formally declaring their Easter recess without action, Congress reconvened
two days after the feeding tube was removed to consider emergency legislation
designed to apply only to Terri Schiavo. Under rules that permitted a few
senators to act if no senator objected, the U.S. Senate adopted a bill
entitled “For the relief of the parents of Theresa Marie Schiavo” on March
20, 2005. The House, a majority of whose members had to be present to vote,
debated the same measure from 9 p.m. to midnight on the same day and passed
it by a 4-toone margin shortly after midnight on March 21. The President
then signed it into law. In substance, the new law (S. 686) provides that
“the U.S. District Court for the Middle District of Florida shall have
jurisdiction” to hear a suit “for the alleged violation of any right of
Theresa Marie Schiavo under the Constitution or laws of the United States
relating to the withholding or withdrawal of food, fluids, or medical treatment
necessary to sustain her life.” The parents have standing to bring the
lawsuit (the federal court had previously refused to hear the case on the
basis that the parents had no standing to bring it), and the court is instructed
to “determine de novo any claim of a violation of any right of Theresa
Marie Schiavo . . . notwithstanding any prior State court determination
. . . ” — that is, to pretend that no court has made any prior ruling in
the case. The act is to provide no “precedent with respect to future legislation.”
The brief debate on this bill in the House of Representatives (there were
no hearings in either chamber and no debate at all in the U.S. Senate)
was notable primarily for its uninformed and frenzied rhetoric. It was
covered live by C-SPAN. The primary sponsor of the measure, Congressman
Thomas DeLay (R-Tex.), for example, asserted that “She’s not a vegetable,
just handicapped like many millions of people walking around today. This
has nothing to do with politics, and it’s disgusting for people to say
that it does.” Others echoed the sentiments of Senate majority leader and
physician Bill Frist (R-Tenn.), who said that immediate action was imperative
because “Terri Schiavo is being denied life-saving fluids and nutrition
as we speak.” Other physician-members of the House chimed in. Congressman
Dave Weldon (R-Fla.) remarked that, on the basis of his 16 years of medical
practice, he was able to conclude that Terri Schiavo is “not in a persistent
vegetative state.” Congressman Phil Gingrey (R-Ga.) agreed, saying “she’s
very much alive.” Another physician, Congressman Joe Schwarz (R-Mich.),
who was a head and neck surgeon for 27 years, opined that “she does have
some cognitive ability” and asked, “How many other patients are there with
feeding tubes? Should they be removed too?” Another physician-congressman,
Tom Price (R-Ga.), thought the law was reasonable because there was “no
living will in place” and the family and experts disagreed. The only physician
who was troubled by Congress’s public diagnosis and treatment of Terri
Schiavo was James McDermott (D-Wash.), who chided his physician-colleagues
for the poor medical practice of making a diagnosis without examining the
patient. Although he deferred to the medical expertise of his congressional
colleagues with M.D. degrees, Congressman Barney Frank (D-Mass.) pointed
out that the chamber was not filled with physicians. Frank said of the
March 20 proceedings: “We’re not doctors, we just play them on C-SPAN.”
The mantras of the debate were that in a life-or-death decision, we should
err on the “side of life,” that action should be taken to “prevent death
by starvation” and ensure the “right to life,” and that Congress should
“protect the rights of disabled people.” The following day, U.S. District
Court Judge James D. Whittemore issued a careful opinion denying the request
of the parents for a temporary restraining order that would require the
reinsertion of the feeding tube (Schiavo ex rel. Schindler v. Schiavo,
No. 8:05-CV-530-T-27TBM (M.D. Fla. Mar. 22, 2005) (slip opinion)). The
judge concluded that the parents had failed to demonstrate “a substantial
likelihood of success on the merits” of the case — a prerequisite for a
temporary restraining order. Specifically, Judge Whittemore found that,
as to the various due-process claims made, the case had been “exhaustively
litigated”; that, throughout, all parties had been “represented by able
counsel”; and that it was not clear how having an additional lawyer “appointed
by the court [for Ms. Schiavo] would have reduced the risk of erroneous
rulings.” As to the allegation that the patient’s First Amendment rights
to practice her religion had been violated by the state, the court held
that there were no state actions involved at all, “because neither Defendant
Schiavo nor Defendant Hospice are state actors.” Whittemore’s decision
is reasonable and consistent with settled law, and it seems likely to be
upheld on appeal. The religious right and congressional Republicans may
nonetheless turn this decision to their advantage. Despite the fact that
Congress itself sent the case to federal court for determination, these
Republicans may cite the ruling as yet another example of “legislating”
by the courts. For they liken the action permitted — the withdrawal
of a feeding tube — to unfavored activities, such as abortion and same-sex
marriage, that courts have allowed to occur. All three activities, they
argue, represent attacks on the “culture of life” and necessitate that
the President appoint federal court judges who value life over liberty.
A vast majority of Americans would not want to be maintained in a persistent
vegetative state by means of a feeding tube, like Terri Schiavo and Nancy
Cruzan. The intense publicity generated by this case will cause many to
discuss this issue with their families and, I hope, to sign an advance
directive. Such a directive, in the form of a living will or the designation
of a health care proxy, would prevent court involvement in virtually all
cases — although it might not have solved the problem in the Schiavo case,
because the family members disagreed about Terri Schiavo’s medical condition
and the acceptability of removing the tube in any circumstances. Despite
the impression that may have been created by these three cases, and especially
by the grandstanding in Congress, conflicts involving medical decision
making for incompetent patients near the end of life are no longer primarily
legal in nature, if they ever were. The law has been remarkably stable
since Quinlan (which itself restated existing law): competent adults have
the right to refuse any medical treatment, including life-sustaining treatment
(which includes artificially delivered fluids and nutrition). Incompetent
adults retain an interest in self-determination. Competent adults can execute
an advance directive stating their wishes and designate a person to act
on their behalf, and physicians can honor these wishes. Physicians and
health care agents should make treatment decisions consistent with what
they believe the patient would want (the subjective standard). If the patient’s
desires cannot be ascertained, then treatment decisions should be based
on the patient’s best interests (what a reasonable person would most likely
want in the same circumstances). This has, I believe, always been the law
in the United States (Annas GJ. The rights of hospital patients. New York:
Discus Books, 1975:81-4). Of course, legal forms or formalities cannot
solve nonlegal problems. Decision making near the end of life is difficult
and can exacerbate unresolved family feuds that then are played out at
the patient’s bedside and even in the media. Nonetheless, it is reasonable
and responsible for all persons to designate health care agents to make
treatment decisions for them when they are unable to make their own. After
this recent congressional intervention, it also makes sense to specifically
state one’s wishes with respect to artificial fluids and hydration — and
that one wants no politicians, even physicianpoliticians, involved in the
process. Most Americans will agree with a resolution that was overwhelmingly
adopted by the California Medical Association on the same day that Congress
passed the Schiavo law: “Resolved: That the California Medical Association
expresses its outrage at Congress’ interference with these medical decisions.”
If there is disagreement between the physician and the family, or among
family members, the involvement of outside experts, including consultants,
ethics committees, risk managers, lawyers, and even courts, may become
inevitable — at least if the patient survives long enough to permit such
involvement. It is the long-lasting nature of the persistent vegetative
state that results in its persistence in the courtrooms of the United States.
There is (and should be) no special law regarding the refusal of treatment
that is tailored to specific diseases or prognoses, and the persistent
vegetative state is no exceptionref1,
ref2,
ref3.
“Erring on the side of life” in this context often results in violating
a person’s body and human dignity in a way few would want for themselves.
In such situations, erring on the side of liberty — specifically, the patient’s
right to decide on treatment — is more consistent with American values
and our constitutional traditions. As the Massachusetts Supreme Judicial
Court said in a 1977 case that raised the same legal question: “The constitutional
right to privacy, as we conceive it, is an expression of the sanctity of
individual free choice and self-determination as fundamental constituents
of life. The value of life as so perceived is lessened not by a decision
to refuse treatment, but by the failure to allow a competent human being
the right of choice.” (Superintendent of Belchertown State School v. Saikewicz,
373 Mass. 728, 742, 370 N.E.2d 417 (Mass. 1977). Copyright © 2005
Massachusetts Medical Society.)
The story of Terri Schiavo should be disturbing to all of us. How can
it be that medicine, ethics, law, and family can work so poorly together
in meeting the needs of this woman who was left in a persistent vegetative
state after having a cardiac arrest? Ms. Schiavo has been sustained by
artificial hydration and nutrition through a feeding tube for 15 years,
and her husband, Michael Schiavo, has been locked in a very public legal
struggle with her parents and siblings about whether such treatment should
be continued or stopped. Distortion by interest groups, media hyperbole,
and manipulative use of videotape have characterized this case and
demonstrate what can happen when a patient becomes more a precedent-setting
symbol than a unique human being. Let us begin with some medical facts.
On February 25, 1990, Terri Schiavo had a cardiac arrest, triggered by
extreme hypokalemia brought on by an eating disorder. As a result, severe
hypoxic–ischemic encephalopathy developed, and during the subsequent months,
she exhibited no evidence of higher cortical function. Computed tomographic
scans of her brain eventually showed severe atrophy of her cerebral hemispheres,
and her electroencephalograms have been flat, indicating no functional
activity of the cerebral cortex. Her neurologic examinations have been
indicative of a persistent vegetative state, which includes periods of
wakefulness alternating with sleep, some reflexive responses to light and
noise, and some basic gag and swallowing responses, but no signs of emotion,
willful activity, or cognition (Jennett B. The vegetative state: medical
facts, ethical and legal dilemmas. New York: Cambridge University Press,
2002). There is no evidence that Ms. Schiavo is suffering, since the usual
definition of this term requires conscious awareness that is impossible
in the absence of cortical activity. There have been only a few reported
cases in which minimal cognitive and motor functions were restored three
months or more after the diagnosis of a persistent vegetative state due
to hypoxic–ischemic encephalopathy; in none of these cases was there the
sort of objective evidence of severe cortical damage that is present in
this case, nor was the period of disability so longref1,
ref2.
Having viewed some of the highly edited videotaped material of Terri Schiavo
and having seen other patients in a persistent vegetative state, I am not
surprised that family members and others unfamiliar with this condition
would interpret some of her apparent alertness and movement as meaningful.
In 2002, the Florida trial court judge conducted six days of evidentiary
hearings on Ms. Schiavo’s condition, including evaluations by four neurologists,
one radiologist, and her attending physician. The two neurologists selected
by Michael Schiavo, a court-appointed “neutral” neurologist, and Ms. Schiavo’s
attending physician all agreed that her condition met the criteria for
a persistent vegetative state. The neurologist and the radiologist chosen
by the patient’s parents and siblings, the Schindler family, disagreed
and suggested that Ms. Schiavo’s condition might improve with unproven
therapies such as hyperbaric oxygen or vasodilators — but had no objective
data to support their assertions. The trial court judge ruled that the
diagnosis of a persistent vegetative state met the legal standard of “clear
and convincing” evidence, and this decision was reviewed and upheld by
the Florida Second District Court of Appeal. Subsequent appeals to the
Florida Supreme Court and the U.S. Supreme Court were denied a hearing.
So what is known about Terri Schiavo’s wishes and values? Since she unfortunately
left no written advance directive, the next step would be to meet with
her closest family members and try to understand what she would want under
these medical circumstances if she could speak for herself, drawing on
the principle of “substituted judgment.” Some families unite around this
question, especially when there is a shared vision of the patient’s views
Dr. Quill is a professor of medicine, psychiatry, and medical humanities
and the director of the Center for Palliative Care and Clinical Ethics
at the University of Rochester Medical Center, Rochester, N.Y. and values.
Other families unravel, their crisis aggravated by genuine differences
of opinion about the proper course of action or preexisting fault lines
arising from long-standing family dynamics. Here Ms. Schiavo’s story gets
more complex. Michael Schiavo was made her legal guardian under Florida
law, which designates the spouse as the decision maker above other family
members if a patient becomes irreversibly incapacitated and has not designated
a health care proxy. After three years of trying traditional and experimental
therapies, Mr. Schiavo accepted the neurologists’ diagnosis of an irreversible
persistent vegetative state. He believed that his wife would not want to
be kept alive indefinitely in her condition, recalling prior statements
that she had made, such as “I don’t want to be kept alive on a machine.”
The Schindler family, however, did not accept the diagnosis of a persistent
vegetative state, believing instead that Ms. Schiavo’s condition could
improve with additional rehabilitative treatment. The relationship between
Mr. Schiavo and the Schindler family began breaking down in 1993, around
the time that a malpractice lawsuit revolving around the events that led
to Ms. Schiavo’s cardiac arrest was settled. In 1994, Mr. Schiavo attempted
to refuse treatment for an infection his wife had, and her parents took
legal action to require treatment. Thus began wide-ranging, acrimonious
legal and public-opinion battles that now involve multiple special-interest
groups who see this case as a cause célèbre for their particular
issue. Michael Schiavo has been criticized for being motivated by financial
greed, and his loyalty to his wife has been questioned because he now lives
with another woman, with whom he has two children. The Schindlers have
been criticized for not accepting the painful reality of their daughter’s
condition and for expressing their own wishes and values rather than hers.
The right of competent patients to refuse unwanted medical treatment, including
artificial hydration and nutrition, is a settled ethical and legal issue
in this country — based on the right to bodily integrity. In the Nancy
Cruzan case, the Supreme Court affirmed that surrogate decision makers
have this right when a patient is incapacitated, but it said that states
could set their own standards of evidence about patients’ own wishesref.
Although both the Schiavo and Cruzan cases involve the potential withdrawal
of a feeding tube from a patient in a persistent vegetative state, the
family was united in believing that Nancy Cruzan would not want to be kept
alive in such a state indefinitely. Their challenge, under Missouri law,
was to prove to the court in a clear and convincing manner that this would
have been Nancy Cruzan’s own wish. The Schiavo case raises much more challenging
questions about how to define family and how to proceed if members of the
immediate family are not in agreement. The relevant Florida statute requires
“clear and convincing evidence that the decision would have been the one
the patient would have chosen had the patient been competent or, if there
is no indication of what the patient would have chosen, that the decision
is in the patient’s best interest.” Since there is no societal consensus
about whether a feeding tube is in the “best interest” of a patient in
a persistent vegetative state, the main legal question to be addressed
is that of Terri Schiavo’s wishes. In 2001, the trial court judge ruled
that clear and convincing evidence showed that Ms. Schiavo would choose
not to receive life-prolonging treatment under her current circumstances.
This ruling was also affirmed by the Florida appeals court and denied a
hearing by the Florida Supreme Court. When Terri Schiavo’s feeding tube
was removed for the second time in 2003, the Florida legislature created
“Terri’s Law” to override the court decision, and the tube was again reinserted.
This law was subsequently ruled an unconstitutional violation of the separation
of powers. On March 18, 2005, Ms. Schiavo’s feeding tube was removed for
a third time. The U.S. Congress then passed an “emergency measure” that
was signed by the President in an effort both to force federal courts to
review Ms. Schiavo’s case and to create a legal mandate to have her feeding
tube reinserted yet again. Although the U.S. District Court in Florida
denied the emergency request to reinsert the feeding tube, the final outcome
of Congress’s extraordinary maneuver is not yet clear. This sad saga reinforces
my personal belief that the courts — though their involvement is sometimes
necessary — are the last place one wants to be when working through these
complex dilemmas. Although I have not examined her, from the data I have
reviewed, I have no doubt that Terri Schiavo is in a persistent vegetative
state and that her cognitive and neurologic functions are unfortunately
not going to improve. Her life can be further prolonged with artificial
hydration and nutrition, and there is some solace in knowing that she is
not consciously suffering. I also believe that both her husband and her
family, while seeing the situation in radically different ways, are trying
to do what is right for her. If and when her feeding tube is permanently
removed, her family may be reassured that dying in this way can be a natural,
humane process (humans died in this way for thousands of years before the
advent of feeding tubes)ref.
In considering this profound decision, the central issue is not what family
members would want for themselves or what they want for their incapacitated
loved one, but rather what the patient would want for himself or herself.
The New Jersey Supreme Court that decided the case of Karen Ann Quinlan
ot the question of substituted judgment right: If the patient could wake
up for 15 minutes and understand his or her condition fully, and then had
to return to it, what would he or she tell you to do? If the data about
the patient’s wishes are not clear, then in the absence of public policy
or family consensus, we should err on the side of continued treatment even
in cases of a persistent vegetative state in which there is no hope of
recovery. But if the evidence is clear, as the courts have found in the
case of Terri Schiavo, then enforcing life-prolonging treatment against
what is agreed to be the patient’s will is both unethical and illegal.
Let us hope that future courts and legislative bodies put aside all the
special interests and distractions and listen carefully to the patient’s
voice as expressed through family members and close friends. This voice
is what counts the most, and in the Terri Schiavo case, it has been largely
drowned out by a very loud, self-interested public debate.
The media spectacle that surrounded the dying of Terri Schiavo is now 2 months past, and America's culture warriors have moved on to other battlegrounds. Much has been said about which political players won or lost and whether key voting blocs will care. But does the experience offer any useful lessons about the subject in dispute — decision making at the end of life? There is a widespread perception that the law failed Terri Schiavo, her family, and the country by not yielding a quick, clear resolution. Cultural conservatives and others who rallied to the side of Schiavo's parents condemn the courts for failing to keep her alive. Many who backed her husband's efforts to withdraw her feeding tube urge increased use of advance directives and living wills — and safeguards against challenges to the judgment of surrogate decision makers. Both sides look to the law to set clear rules, though the 2 sides differ sharply on what those rules should be. Almost forgotten in this debate, and ignored in press coverage of the Schiavo affair, is the peripheral role of law when end-of-life dilemmas arise. The law sets some limits: active killing, for example, is impermissible, and clear advance directives must be followed if they have been properly given. In most U.S. jurisdictions, suicide is unlawful, as is the assistance of physicians in self-killing. But within these bounds, end-of-life questions are almost always resolved in the private sphere, by patients, their physicians, and their family members, working with nurses, social workers, and members of the clergy. In tens of thousands of cases each year, patients and families handle catastrophic illness or injury without going to court. They do so with unsung courage, in the face of fear, anguish, and sometimes bitterness. Every loss of a loved one is, in part, a loss of hope — hope for healing of old rifts and fulfillment of thwarted possibilities. Anger and denial are common, especially when relationships were conflict-ridden beforehand. Cast-off parents, rival siblings, children who never measured up to their parents' expectations bring much to the bedside beyond their religious and philosophical leanings. Anger, denial, and other nonrational influences can lock family members into warring stances over whether to treat a devastating illness aggressively or discontinue life-sustaining measures. What is remarkable, given the intensity of the feelings at stake, is how rarely such conflicts make their way to court. It is a measure of how discreetly such squabbles are handled that we know little about how often they arise. And it is a measure of people's character under this pressure that families usually come together to make these judgments or to honor the preferences their loved ones have expressed. This is for the good: to rend families asunder at the end of a loved one's life does spiritual violence to all concerned. Within wide boundaries, we are committed to honoring patients' clearly stated wishes. This commitment not only safeguards patients' liberty and dignity; it protects against family strife when a patient's intentions are clear. When the patient's wishes are unstated and illness precludes asking about them, it is important to limit the possibilities for family conflict and lasting anger. Enabling families to mourn and move on — and discouraging them from playing out old resentments as end-of-life battles — should be a clinical and social priority. The law can help to pursue this goal by making it difficult for any one party to impose a decision when family members or others concerned disagree with it. Answers dictated by the law yield clear winners and losers, heightening long-term resentments and inviting further strife. A large literature suggests that solutions crafted by the parties to a conflict come with a sense of shared ownership that dampens discord. By making it harder to invoke a court's final say, law can encourage conversation aimed at reconciliation or, at least, mutual accommodation. The proposition that law should promise quick, clear answers is a recipe for intensified family and social strife, since we are nowhere near national consensus on what the answers should be. Some features of current law support the family-friendly resolution of agonizing end-of-life questions. The law's inquiry into what the patient would want when there is neither a clearly stated prior preference nor a designated surrogate decision maker is a legal fiction, since a person in a persistent vegetative state or a similarly incapacitated condition cannot formulate a preference. But this fiction sends the right moral message. It centers problem-solving conversation on something family members and friends have in common — their commitment to the patient's interests. This focus, in turn, encourages more mature handling of old wounds and resentments, even if they cannot be resolved. Efforts to enmesh the law in end-of-life choices through detailed advance directives and the formal selection of surrogate decision makers risk stoking conflict. Advance directives cannot anticipate all scenarios, and the law's commands can crowd out benevolent feelings. The more detailed the directive, the greater the possibilities for lawyerly argument about its application to situations that its author did not precisely foresee. Opting for a surrogate decision maker solves this problem but introduces another: selection of one person may hurt or offend others, reawakening old resentments. When conflicts seem likely, these risks are worth taking; when ties among loved ones are strong and cooperation prevails, the case for involving the law is weaker. Resort to the courts by warring family members to try to narrow the acceptable range of end-of-life choices on religious grounds is more worrisome. The clinical options at issue in the Schiavo litigation — removing the feeding tube and allowing a patient with a devastating brain injury to die or continuing tube feedings and embarking on an almost certainly futile therapeutic course — were both within the range allowed by ethics and law. To their credit, the judges who heard the case declined to narrow this range. The escalation of a family dispute through fiery religious references represented an attempt to reduce the latitude allowed by law. A Florida bishop's op-ed piece invoked "the passion of Terry Schiavo," and some insisted that, to God, stopping tube feedings is murder. The attempt failed, but the incendiary language set a new standard for family divisiveness at the end of life. What, then, are the lessons of the Schiavo affair for the management of end-of-life conflict? First, we should keep in mind that the affair represented an extraordinary exception: the overwhelming majority of such cases are handled privately, by patients, family members, and caregivers. We should take pride in this fact and not overstate the problems to be solved. Second, the overarching goal of courts, clinical caregivers, and others with a say in end-of-life disputes should be to pursue private, family-friendly accommodation within the wide limits set by law. Caregivers should, of course, defer to advance directives and to properly designated surrogate decision makers. They should, moreover, encourage patients to make their end-of-life preferences known to those closest to them, preferably through standardized means. But in so doing, caregivers should assert themselves gently: to push too hard for a living will or advance directive is to put patient trust at risk, particularly in this era of escalating worry about pressure to cut costs. In addition, caregivers should encourage conversation about end-of-life questions among patients, family members, and others who are closely involved. And when the clinical picture takes a catastrophic turn and a patient can no longer formulate preferences, caregivers should give high priority to detecting hints of discord. At the first sign of tension, physicians, nurses, and social workers should become active listeners in search of smoldering feelings that might give rise to conflict. If and when conflict erupts, end-of-life choices shouldn't be treated as purely ethical questions, divorced from the regrets and resentments involved. Psychiatric and social-work consultation should be part of the management plan, and mediation merits study as an approach. Mediators' methods of listening, exploring parties' needs, reframing problems, and proposing solutions have been well honed in work with divorcing couples, estranged business partners, and others in life-transforming crises. These skills are well suited to the work of guiding warring family members toward agreement on end-of-life choices for their loved one. At times, physicians, and even insurers, become parties to these conflicts. Financial incentives, real or perceived, can shape positions and sow distrust. Cost-control strategies that engage caregivers in covert rationing can have toxic effectsref, particularly when medical futility is at issue. Our national unwillingness to acknowledge the conflict between efforts to limit medical spending and insistence on all possibly beneficial care worsens this toxicity. Good mediation technique can help to clarify misunderstandings, soften anger, and ease irrational distrust. But it cannot finesse contradictions that, as a country, we refuse to face. For the last six years of Terri Schiavo's life, Robert Lynch, the local Catholic bishop, tried unsuccessfully to meet with her parents and husband to reach a solution through mediation. As their personal struggle became an international spectacle, Lynch broke with the Church hierarchy by refusing to side with the parents. Instead, he called on "both sides [to] step back" and to try for "a heroic moment of concern for the feelings of each other."5 In a public appeal that was ignored by all sides, he said: "The legacy of Terri's situation should not be that of those who love her the most, loathing the actions of one another."ref Schiavo's legacy has turned out to be worse than he feared. After her death, her parents and husband continued to battle — over access to her remainsref. At the time of the autopsy, her brain weighed 615 grams, about half of that of a healthy woman of her age. There was no evidence of trauma contributing her collapse, no evidence that there was any abuse or neglect, and no evidence that drugs were administered illegally while she was in the Florida hospice.
Lethal injection is the most common way people are legally put to death in the USA. To be exact, this method has been used to kill 788 of the 956 men and women who have been executed in the USA since 1976, when the death penalty was reinstated by the Supreme Court. Lethal injection is supposed to be humane, and thus not in violation of the US Constitution's Eighth Amendment proscription against "cruel and unusual" punishment. Indeed, compared with electrocution, gas, gunfire, or hanging, killing people with drugs seems almost humane. Typically, the condemned man or woman is strapped to a chair or trolley. Two intravenous lines are inserted, one as a back up. The lines are kept open with saline solution. Then, at the warden's signal, the injection team administers: first, sodium thiopental to induce anaesthesia, then pancuronium bromide to cause paralysis, and finally a bolus of potassium chloride to bring about cardiac arrest. It seems so clinical and clean. However, in a fast-track Research Letter in this week's Lancet, Leonidas Koniaris and co-workers report that these killings may not be as free from cruelty as death-penalty proponents claimref. The research team obtained information from Virginia and Texas, where since 1976 nearly half of the executions in the USA have been done. Among the facts they learned were that neither state has a record of how they developed their execution protocol, that the injection teams were made up of medical technicians or individuals from medical corps with no training in administering anaesthesia, and that there was no assessment of the depth of anaesthesia before the paralysing agent and potassium chloride were injected. The researchers also obtained toxicological reports from four other states which indicate that post-mortem thiopental concentrations in the blood of 43 of 49 executed inmates (88%) were lower than those needed for surgical anaesthesia, and 21 (43%) episodes were consistent with awareness. That is: those being executed may have been awake. Of course, because they were paralysed, no one could tell. It would be a cruel way to die: awake, paralysed, unable to move, to breathe, while potassium burned through your veins. That is why, as Koniaris and his co-authors point out, the American Veterinary Medical Association and 19 states, including Texas, prohibit the use of neuromuscular blocking agents to kill animals. The authors call for a halt to executions by lethal injection and a public review. They also argue that because "participation of doctors in protocol design and execution is ethically prohibited", a more effective, humane protocol cannot be developed. But, ethically prohibited or not, many doctors are willing to participate in putting people to death. A survey of US physicians found that although the American Medical Association (AMA) ethical guidelines forbid physicians to participate in executions, 19% said they would inject lethal drugs and 41% said they would perform at least one action prohibited by the AMA guidelines, such as starting intravenous lines. In fact, only 3% of those asked were aware that there were guidelines. Clearly, for a substantial number of physicians, the putting to death of condemned people is not considered contrary to the precept "first, do no harm". What justification can there be for capital punishment at all? The two main arguments for the death penalty are deterrence and retribution. Few experts believe that the threat of capital punishment is an effective deterrent. That leaves retribution. But to justify capital punishment, the retribution must be meted out fairly, and that is clearly not the case. In only 1% of murders do prosecutors seek the death penalty. Whether you receive the death penalty depends not on what you have done, but where you committed your crime, what colour your skin is, and how much money you have. The use of the death penalty not only varies from state to state (12 US states have no death penalty) but from jurisdiction to jurisdiction within a state. Repeated studies have shown a pattern of racial discrimination in the administration of the death penalty. Of the 205 people executed for inter-racial murders in the USA, for example, 193 were black defendants charged with killing a white person, while only 12 were white defendants charged with killing a black individual. 90% of defendants are too poor to hire their own lawyer--most rely on overworked court-appointed lawyers. Capital punishment is not only an atrocity, but also a stain on the record of the world's most powerful democracy. Doctors should not be in the job of killing. Those who do participate in this barbaric act are shameful examples of how a profession has allowed its values to be corrupted by state violenceref1, ref2. Since 1976, when the death penalty was reinstated, 959 people have been executed in the USAref. Lethal injection has eclipsed all other methods of execution because of public perception that the process is relatively humane and does not violate the Eighth Amendment prohibition against cruel and unusual punishment. US courts recognise "evolving standards of decency that mark the progress of a maturing society", and prohibit punishments that "involve the unnecessary and wanton infliction of pain", "involve torture or a lingering death", or do not accord with "the dignity of man" (Beardslee vs Woodford. 395 F.3d 1064, 1070 & n.8 (9th Cir 2005)). Lethal injection usually consists of sequential administration of sodium thiopental for anaesthesia, pancuronium bromide to induce paralysis, and finally potassium chloride to cause death (Denno D. When legislatures delegate death: the troubling paradox behind state uses of electrocution and lethal injection and what it says about us. Ohio St Law J 2002; 63: 63-261). Without anaesthesia, the condemned person would experience asphyxiation, a severe burning sensation, massive muscle cramping, and finally cardiac arrest. Thus, adequate anesthesia is necessary both to mitigate the suffering of the condemned and to preserve public opinion that lethal injection is a near-painless death. By contrast with its medical applications, however, anaesthesia in execution has not been subjected to clinical trials, governmental regulation, extensive training of practitioners, standardisation, or the supervision of peer-review and medicolegal liability. Furthermore, the American Medical Association and American Nurses Association strictly oppose participation of their members in executions. We postulated that anaesthesia methods in lethal injection might be inadequate. To assess anaesthesia methods, we sought protocol information from the states of Texas and Virginia, where 45.4% of executions are done, by a combination of statutory records requests to the Texas Department of Criminal Justice and the Virginia Department of Corrections, along with personal interviews and sworn testimony of corrections officials involved in executions. We noted that: neither state had a record of the creation of its protocol (Texas Department of Criminal Justice Assistant General Counsel, January and February, 2004; and Virginia Department of Corrections Director of Communications, December, 2003; written communications); executioners--typically one to three emergency medical technicians or medical corpsmen--had no training in anaesthesia (Virginia Department of Corrections Director of Communications, written communication; and personal interview of a former senior Texas corrections official who witnessed 219 Texas executions); after placement of one or two intravenous lines, executioners stepped behind a wall or curtain and remotely administered drugs to the conscious inmate; no direct observation, physical examination, or electronic monitoring took place for anaesthesia (Virginia Department of Corrections Senior Warden Charlie Davis; Testimony in Reid vs Johnson, Civil Action No 3:03cv1039 (Sept 1, 2004)) and there was no data collection, documentation of anaesthesia, or post-procedure peer review (Virginia Department of Corrections Director of Communications, written communication; and personal interview). No assessment of depth of anaesthesia or loss of consciousness was done; apparently anaesthesia is assumed because a relatively large quantity of thiopental is specified (usually 2 g) compared with the typical clinical induction dose of 3-5 mg/kg, immediately followed by 1-1.5 mg/kg per min for maintenance; this dose equates to 270-450 mg for induction and 90-135 mg/min maintenance for a 200 lb man. The assumption that 2 g thiopental assures anaesthesia is overly simplistic, however. First, technical difficulties or procedural errors by poorly trained executioners might hinder administration of the total dose. Second, if thiopental anaesthesia were maintained at standard infusion rates, the total dose for a 10-min procedure in a 100 kg man would be 1.3-2.0 g. Thus the dose used is not excessive for the average time from injection to death (8.4 min, SD 4.7) and might be inadequate if the process took longerref. Third, a person anticipating execution would be fearful, anxious, and hyperadrenergic, and would need a higher dose of thiopental than would a premedicated surgical patient. Fourth, inmates with histories of chronic substance misuse problems might have high tolerance to sedative hypnotics and would need increased doses of anaesthetic. Because no documentation of anaesthesia in the execution chamber existed, the only available objective data were postmortem concentrations of thiopental. Texas and Virginia refused to provide such data, but we obtained autopsy toxicology results from 49 executions in Arizona, Georgia, North Carolina, and South Carolina. Toxicology reports were generated by MedTox Laboratories (St Paul, MN) for Arizona and are available in Beardslee versus Woodford, No C-04-5381 (Northern District of California, 2004). Data from the Division of Forensic Sciences Georgia Bureau of Investigation are available in State versus Nance, Superior Court Indictment No 95-B-2461-4. North Carolina reports were obtained directly from the Office of the Chief Medical Examiner. South Carolina Law Enforcement Division Toxicology Department reports were obtained by attorney David Barron, Kentucky Department of Public Advocacy Capital Post-Conviction Unit (personal communication) and are available in Hill versus Ozmint, No 2:04-0489-18AJ (District of South Carolina, 2004). Although the protocols of all four states are similar to those of Texas and Virginia, and specify that 2 g thiopental is used, concentrations of the drug in the blood ranged from only trace amounts to 370 mg/L (median 15.5 mg/L). Thiopental concentrations did not fall with increased time between execution and blood sample collection, consistent with data showing that thiopental is quite stable in stored human plasmaref. Extrapolation of antemortem depth of anaesthesia from post-mortem blood thiopental concentrations is admittedly problematic. To estimate concentrations of thiopental in the brain from concentrations in the blood in life, details of the rate and duration of drug administration are needed. Unfortunately, such details are usually not specified in lethal injection protocols. Furthermore, no data about post-mortem distribution of thiopental are available. However, a large range of blood concentrations resulted from nearly identical protocols across and within individual states--from 8.2 mg/L to 370 mg/L in North Carolina for the same sampling site (subclavian artery) and similar collection times (same day or next day, respectively). This finding suggests substantial variations in either the autopsy or anaesthesia methods. Contrasting the expertise of state medical examiners with the relatively unskilled executioners, however, would strongly suggest that the variation is probably due to differences in drug administration in individual executions. If post-mortem thiopental concentrations are taken as a surrogate marker of concentrations in the blood during life, most of the executed inmates had concentrations that would not be expected to produce a surgical plane of anaesthesia, and 21 (43%) had concentrations consistent with consciousness. In a careful study in which actual serum thiopental concentrations were measured against clinical endpoints, the steady state serum concentration needed to produce a 50% probability of no muscle response (Cp50) after intubation was defined as 78.8 mg/L (SD 2.9)ref. The Cp50 for movement after trapezius muscle squeeze, a stimulus equivalent to skin incision, was 38.9 mg/L (3.3). Remarkably, 43 of the 49 inmates had blood thiopental concentrations below this level. Most worryingly, 21 inmates had concentrations < the Cp50 for repression of movement in response to a vocal command. In view of these data, we suggest that it is possible that some of these inmates were fully aware during their executions. We certainly cannot conclude that these inmates were unconscious and insensate. However, with no monitoring and with use of the paralytic agent, any suffering of the inmate would be undetectable. With little public dialogue about protocols for killing human beings, it is pertinent to consider recommendations from animal euthanasia protocols. The American Veterinary Medical Association (AVMA) panel on euthanasia specifically prohibits the use of pentobarbital with a neuromuscular blocking agent to kill animalsref, and 19 states, including Texas, have expressly or implicitly prohibited the use of neuromuscular blocking agents in animal euthanasia because of the risk of unrecognised consciousness (Beardslee vs Woodford. 395 F.3d 1064, 1070 & n.8 (9th Cir 2005)). Furthermore, AVMA specifies that "it is of utmost importance that personnel performing this technique are trained and knowledgeable in anaesthetic techniques, and are competent in assessing anaesthetic depth appropriate for administration of potassium chloride intravenously. Administration of potassium chloride intravenously requires animals to be in a surgical plane of anesthesia characterized by loss of consciousness, loss of reflex muscle response, and loss of response to noxious stimuli"ref. The absence of training and monitoring, and the remote administration of drugs, coupled with eyewitness reports of muscle responses during execution, suggest that the current practice of lethal injection for execution fails to meet veterinary standards (Denno D. When legislatures delegate death: the troubling paradox behind state uses of electrocution and lethal injection and what it says about us. Ohio St Law J 2002; 63: 63-261). Our data suggest that anaesthesia methods in lethal injection in the USA are flawed. Failures in protocol design, implementation, monitoring and review might have led to the unnecessary suffering of at least some of those executed. Because participation of doctors in protocol design or execution is ethically prohibited, adequate anaesthesia cannot be certain. Therefore, to prevent unnecessary cruelty and suffering, cessation and public review of lethal injections is warranted. When Socrates was executed, Plato described the action of hemlock as a slowly rising chill, beginning in the feet and ending life when it eventually reached the heart. As it did so, Socrates' last request was for an offering to thank Asclepius, patron of healers, for such an effective poison. It is an ignoble legacy that 2400 years later, medical science continues to affect the efficiency, rather than the ethos, of execution. But there is now an opportunity to redress this shortcoming, by considering evidence that demonstrates the barbarity of lethal injection.
Michael Morales was scheduled to have been executed on Feb 21 in California
for torturing, raping, and murdering a teenage girl. His attorney, Kenneth
Starr, claimed that execution by lethal injection would be a cruel and
unusual punishment, which is prohibited by the Eighth Amendment to the
US constitution. Ratified in 1789, this amendment was designed to end punishments
such as burning and disembowelling, in which death was secondary to the
infliction of pain and retribution. Afterwards, hanging became the recommended
procedure until bungled public executions caused authorities to look elsewhere.
Thomas Edison proposed that electrocution would be instantaneous. It wasn't.
Gas followed, and then lethal injection. By the 1970s a minority view of
the US Supreme Court held that execution would be cruel and unusual under
any circumstances. Similar motions before the same Californian court in
2004 and 2005 had failed. But now Starr could cite Koniaris and colleagues'
Lancet
paper, which found that despite a theoretically lethal dose of barbiturate,
21 of 49 executed US inmates had postmortem thiopental concentrations consistent
with consciousness. In addition, records from San Quentin prison revealed
that of the 13 inmates executed by lethal injection in California, 6 continued
to breathe until after pancuronium had been injected. Among those with
a lingering execution was Tookie Williams, a former gang-leader, turned
children's author in an attempt to warn youngsters away from violence.
Judge Jeremy Fogel ordered that the state could execute Morales, but must
do so without inflicting undue pain. Therefore, the state must either rely
solely on thiopental, or else have a qualified individual confirm unconsciousness
before the injection of pancuronium and potassium chloride. 2 anaesthetists
who had volunteered to observe the execution refused to accept the new
terms in which their role of monitoring vital signs would constitute active
participation; furthermore it was unclear how they should act if the plane
of anaesthesia was inadequate. This decision leaves the future of current
US lethal injection protocols in doubt. Of the 1012 executions carried
out in the US since capital punishment was re-established in 1977, 844
have been by lethal injection. Nebraska is the only state, among 38 with
death penalties, that relies on another method. New Jersey has suspended
lethal injections after concerns about the procedure, and challenges to
this method are being heard from Missouri and Florida. Meanwhile, 646 condemned
inmates wait with Michael Morales on death row in California. Despite questionnaires
showing willingness among some US physicians to participate in state executions,
such behaviour contradicts the principles of many professional organisations
in the USA, including the American Medical Association, American College
of Physicians, American Society of Anesthesiologists, American Nurses Association,
and Association of Emergency Medical Technicians. In California, the 30000-strong
state medical association is sponsoring legislation to outlaw medical participation
in executions. But why are health practitioners involved at all? Is it
to ensure outcomes, or to salve the conscience of the public by providing
a façade of compassion and clinical efficiency? This is a pivotal
point in history. A moment when individuals, like Judge Fogel, and the
anaesthetists who refused to participate, have given voice to their conscience.
They have articulated the concerns of an increasing number of Americans,
whose support for capital punishment has dropped from 80% to 64% in the
past decade. It is a voice to be heeded. As Judge Fogel noted, the Eighth
Amendment has been interpreted as prohibiting punishments that are “incompatible
with the evolving standards of decency that mark the progress of a maturing
society”. In 2004, China, Iran, Vietnam, and the USA accounted for 97%
of the world's executions. From which of these countries will a mature
society take the lead, and abolish the atrocity of state execution?ref
On April 21, 2006, Willie Brown, Jr., was executed by lethal injection
in North Carolina for the 1983 killing of a convenience-store clerk. The
execution might have received little attention if not for the fact that
Brown's electroencephalogram (EEG) was monitored during the procedure.
This apparently unprecedented monitoring was a response to concern that
some inmates have not been properly anesthetized during executions by lethal
injection and may therefore have experienced painful deaths that violated
the constitutional ban on cruel and unusual punishmentref1,
ref2.
The EEG device used during Brown's execution was a bispectral index (BIS)
monitor. Made by Aspect Medical Systems of Newton, Massachusetts, it works
by means of a proprietary algorithm that converts the raw EEG, which is
difficult to interpret in real time, into an index of hypnotic level. The
compact device is used in operating rooms and intensive care units as an
adjunct to other methods for monitoring the effects of anesthetics and
sedatives. Depending on the model, it costs $5,000 or $8,500. A single-use
sensor — a four-electrode array that is applied to the forehead to record
EEG signals — costs about $17.50. Although the BIS is a relatively new
technology, its use in North Carolina — and potentially in California and
elsewhere — merely represents the latest chapter in ongoing debates about
what methods should be used for execution and whether physicians should
participateref.
Corrections officials, under pressure to prove that their execution methods
are humane, are increasingly relying on medical expertise and technology.
However, the American Medical Association, the American Society of Anesthesiologists,
and others in the medical community consider any physician involvement
in executions unethical. There are various EEG activity monitorsref.
The BIS device records the EEG and converts it into a single number, ranging
from 0 for a flat-line, or isoelectric, tracing to 100, which is typical
for a person who is awake. The target range for a patient under general
anesthesia is 40 to 60. During an execution by means of lethal injection,
three agents are usually given: first the anesthetic sodium thiopental,
then the paralytic pancuronium bromide, and finally a fatal dose of potassium
chloride. The concept behind the monitoring is to confirm that the sodium
thiopental has rendered the inmate sufficiently unconscious that he or
she will have no awareness of the subsequent injections and their effects.
The supposition is that, if necessary, someone other than an anesthesiologist
or other physician could rely on the BIS monitor to assess a prisoner's
level of consciousness and help to ensure that an execution meets constitutional
standards. Of course, there is no way to be certain that an executed prisoner
was unaware, and the concept of a humane execution could be considered
an oxymoron. An execution is not a clinical procedure, and capital punishment
is not the practice of medicine. Moreover, the role of brain-function monitors
in the prevention of intraoperative awareness is controversial (Zimmerman
R. How necessary is brain monitor in anesthesia? Wall Street Journal. October
25, 2005:B1). A monitor does not replace an anesthesiologist. Monitor readings
may be inaccurate, for instance, if the EEG signal is contaminated by artifacts.
Although intraoperative awareness is rare — with a reported incidence of
0.1 to 0.2% — a task force of the American Society of Anesthesiologists
recently concluded that "a specific number may not correlate with a specific
depth of anesthesia" and that "the general clinical applicability of these
monitors in the prevention of intraoperative awareness has not been established"ref.
The task force recommended that "intraoperative monitoring of depth of
anesthesia, for the purpose of minimizing the occurrence of awareness,
should rely on multiple modalities." Anesthesiologist Scott Kelley, a vice
president and the medical director of Aspect, said that the use of the
BIS monitor in an execution was inconsistent with its intended use in health
care facilities, as well as with his company's mission "to improve people's
lives." According to Kelley, there is no assurance that "BIS monitoring
alone would prevent an inmate from suffering during the lethal-injection
procedure." Moreover, the broader issue, said Kelley, "is the misapplication
of scientific data gathered in surgical patients under the care of an anesthesia
professional. It is not appropriate to extrapolate from the addition of
brain monitoring as a means to prevent surgical awareness to the isolated
use of BIS monitoring as described in North Carolina." He expressed concern
"that this may give a medical appearance to an execution by suggesting
that it is `performed under anesthesia.' It should not." Although Aspect
would like to prevent its monitors from being used in future executions,
it is probably powerless to do so, since > 34,000 monitors have already
been installed worldwide and can be resold: in early May, one was for sale
on eBay for $1,250. In 2005, the USA ranked fourth in the world in numbers
of executions, behind only China, Iran, and Saudi Arabia. The number of
U.S. executions peaked at 98 in 1999. In 2005, there were 60. As of May
24 of this year, there have been 20, all by lethal injection, according
to the Death Penalty Information Center. On January 1, 2006, there were
3373 death-row inmates in the USA :
Some inmates may be listed in more than one state. Data are from the
Legal Defense Fund of the National Association for the Advancement of Colored
People.
Aspect first became involved in the controversy in February 2006, when
a California corrections official sought to evaluate one of its monitors
for possible use in the execution of Michael Morales, a convicted murderer
who had challenged the state's execution procedures. Aspect refused to
sell the official a monitor. "The request did not seem appropriate," Kelley
said. After 2 anesthesiologists who had agreed to take part withdrew, the
execution was postponed and remains on hold, with a further hearing scheduled
for September 19. It remains uncertain whether California will revise its
execution procedures to incorporate the use of an EEG monitoring device
(Weinstein H. Executions unlikely for rest of year. Los Angeles Times.
April 28, 2006:B1). Like Morales, Brown had challenged his state's
lethal-injection protocol. On April 7, U.S. District Judge Malcolm Howard
ruled that his execution in North Carolina could proceed only if there
were "execution personnel with sufficient medical training to ensure that
Plaintiff is in all respects unconscious prior to and at the time of the
administration of any pancuronium bromide or potassium chloride." Subsequently,
the protocol was modified to include the BIS monitoring of Brown's level
of consciousness. The monitor was to be located in an observation room
adjacent to the execution chamber, next to an electrocardiographic monitor,
where a licensed physician and a licensed registered nurse could view them.
If the BIS reading was 60 or higher after the injection of the initial
3000 mg of sodium thiopental, then the execution team was to continue to
administer the agent until the reading fell below 60, and only then were
the subsequent injections to be given. On April 11, a North Carolina corrections
official called Aspect's toll-free telephone sales number to purchase a
monitor, which was shipped the same day. According to Aspect, the written
purchase-order request sent from North Carolina stated, "This equipment
is used to monitor vital signs and sedation scales of patients recovering
from surgery." After he became aware of the sale, Kelley described it as
"a regrettable system failure." According to an affidavit from Kelley,
the purchasers "never indicated in any way that they intended to use [the
monitor] in connection with the execution of the Plaintiff." A spokesperson
for the North Carolina Department of Correction declined to comment. After
Judge Howard accepted the modified protocol, a federal appeals court also
accepted it, in a two-to-one decision. In his blistering dissent, Judge
M. Blaine Michael wrote that "the clear weight of evidence, however, reveals
that the State's use of the BIS monitor will not adequately ensure that
Brown will remain unconscious throughout his execution." Sales of EEG monitors
to corrections facilities pose a quandary, since the devices have perfectly
acceptable uses in prison hospitals. Since 2000, Aspect has sold about
a half-dozen BIS devices to such institutions. The company now requires
that, for sales to penitentiaries, an authorized and responsible person
employed by the facility must sign and date a statement assuring that sensors
and monitors will not be used on an individual or individuals during or
as part of a lethal injection execution procedure. In May, Aspect received
another inquiry — this time from a state prison hospital in California.
As of early June, Aspect had heard nothing furtherref.
Officially, most people who are hospitalized or under therapy for mental
illness are in that treatment by choice. Part of a print from an 1880 painting
by Robert Fleury. The caption reads: "Dr. Philippe Pinel at the Saltpêtrière,
1795. The great pioneer of humanitarian reform orders the chains removed
from patients at the Paris asylum for insane women.” Pinel is credited
with having introduced rational, ethical mental health care, but debate
continues over the proper role of coercion in treating the mentally ill.
But you might well not know that if you asked them. Some recent studies
have found that many patients hospitalized for mental disorders feel they
were coerced into getting treatment, even when there was no legal order
requiring the treatment. Coercion is far from a new phenomenon in the treatment
of the mentally ill. In Western countries it started as early as the Middle
Ages, at least if you count stuffing someone naked into a dark cage as
“treatment.” The centuries since then have brought more rational, humane
therapies and a drop in the use of laws to force treatment on people, though
most agree this must remain a last resort for some cases. Yet in the past
dozen years or so, research has shed light on a different phenomenon: the
way patients who are supposedly voluntary, not subject to any legal orders,
experience coercion. Such patients sometimes perceive coercion not from
the law, as before, but from family, doctors or others, researchers have
found. One survey of such patients found that when hospitalized, two-thirds
of them either weren’t sure they were free to leave, or positively believed
they
weren’t allowed to. Another survey found that one third of studied recipients
of “electroshock” therapy—a treatment used for some difficult mental illness
cases—didn’t feel they had freely agreed to it, despite having signed consent
forms. Both these surveys, conducted in Britain, add to growing number
of studies in other countries documenting feelings of coercion among ostensibly
voluntary mental patients. The studies come from nations generally seen
as advanced, such as Norway and the United States. “Perceptions of coercion
will vary according to culture” and laws in every place, wrote Jonathan
Bindman of the Institute of Psychiatry, London, an author of both the studies,
in an email to World Science. Yet several studies have turned up similar
statistics across countries in terms of how many psychiatric patients feel
coerced. For instance, Bindman’s study on hospitalized patients, published
in the February issue of the journal Social Psychiatry and Psychiatric
Epidemiology, found that a third of them feel “highly coerced,” with a
few reporting threats or force. A similar study on Norwegian patients published
in the November 1, 2002 Nordic Journal of Psychiatry found that 32% perceived
“high levels” of coercion. In the United States, the Chicago-based MacArthur
foundation reported in February 2001, based on a series of studies, that
“a significant minority of legally ‘voluntary’ patients experience coercion.”
The opposite also occurs, the studies found: some patients who are in treatment
under orders think they are there only by free choice. One reason it has
taken some time to bring these issues to light is that coercion is hard
to measure, researchers say. “For many years coercion was equated with
legal compulsion, which had the advantage of being clearly defined and
straightforwardly measurable,” Bindman and colleagues wrote in a February,
2001 report commissioned by the U.K. Department of Health. But “the relationship
between legal restraint and coercion is not a direct one, some patients
accepting voluntary admission only after a process of persuasion (by professionals,
family, or others) in which coercive elements are clearly present.” The
problem may ironically have come to the forefront because in recent years,
industrialized countries have changed laws to sharply reduce the open,
legal use of forced treatment. The trend, called deinstitutionalization,
was part of a shift in societal attitudes towards greater tolerance and
respect for civil liberties. But critics argue that the process created
a wave of untreated, sick patients who pose a danger to themselves and
others. One treatment that stirred controversy both before and after deinstitutionalization
is electroconvulsive therapy, also known as electroshock therapy. In this
treatment, a strong electric current is passed through the brain. It is
widely considered effective for difficult cases of depression and some
other illnesses, but some advocates for the mentally ill have also decried
it as dehumanizing. One new study found that despite the dramatic rollback
of laws allowing forced treatment, electroshock therapy is still often
associated with coercion—official or not—at least in the United Kingdom.
In a paper published in the January 2005 British Journal of Psychiatry,
Bindman and colleagues found that about one-third of electroshock patients
who had participated in studies didn’t feel they had freely consented to
the therapy, despite having signed a consent form. Around half of them
also didn’t feel they had gotten enough information on the procedure and
its side effects, added the researchers, who based their findings on a
review of previously published medical literature. Neither current nor
proposed safeguards for patients are sufficient to ensure informed consent,”
the researchers wrote.Apart from the electroshock cases specifically, information
could also be a useful antidote to the feelings of coercion among patients
more generally, Bindman and colleagues wrote in their Social Psychiatry
and Psychiatric Epidemiology paper. The medical community should consider
informing all psychiatric patients “of the powers of detention which may
be used once they are admitted, and of the circumstances in which they
might be used,” the researchers wrote. Moreover, Bindman and colleagues
wrote in the 2001 report, for patients not under legal orders, mental health
professionals may have to make up their minds between two sometimes tough
choices. One is to eliminate the coercion. The other: reopen a page from
the old rulebook—make the coercion official.
British Special Operations Executive (SOE) : the ingenious gadgets of the SOE Catalogue, available to the well prepared SOE saboteur. These gadgets were used to great effect in many theatres of war. For instance, one of the most successful SOE operations of the war was Jaywick. This resulted in 30,000 tons of Japanese shipping being sunk in Singapore harbour, with all the agents returning safely. Another operation of major importance was Operation Gunnerside, which destroyed the German supplies of 'heavy water' in Norway and so hindered the German attempt to develop an atomic bomb
Stuart Newman, a professor of cell biology and anatomy at New York Medical College in Valhalla, says he opposes the patenting of living things. Newman, working with Washington, DC, activist Jeremy Rifkin, filed a patent application in 1997 for a theoretical creature he never actually made. For "tactical reasons," Newman says he eventually split his patent application into two: one involving primates and the other focused on other animals. Using what he calls the "embryo chimera technique," Newman sought to patent a creature combining human embryo cells with cells from the embryo of a monkey, ape, or other animal to create a blend of both. Other scientists have used similar methods to create a "geep" (part goat, part sheep) says Newman, adding that his chimera could be used for drug testing and as a source of organs to transplant into humans. After 7 years and several rejections and appeals, the USPTO turned down both of Newman's patent applications in August 2004, saying, among other things, that his creatures would be too close to human. Newman and Rifkin let the 6-month appeals period lapse and declared victory in February 2005. Both Rifkin and Newman say they expect the ruling to prevent scientists and biotechs from obtaining similar patents for 20 years, the time a patent is usually viable. Rifkin says crossing species boundaries is a form of animal abuse and a violation of nature and human dignity. 25 years ago, US scientist Ananda Chakrabarty, who worked for General Electric at the time, obtained the first patent on a living organism, a genetically engineered bacterium that consumes oil spills. The patent office originally denied the application, believing it could not patent living organisms, according to Brigid Quinn, USPTO spokesperson. The case landed in the US Supreme Court, which in 1980 ruled that patents could be awarded on anything that was human-made. Since then, some 436 transgenic or bioengineered animals have been patented, including 362 mice, 26 rats, 19 rabbits, 17 sheep, 24 pigs, two chickens, 20 cows, three dogs, and many more. Many say the 1980 ruling led to the birth of biotechnology in the United States. However, US law clearly prohibits the patenting of people. Irving L. Weissman, a professor of cancer biology, pathology, and developmental biology at Stanford University has created mice with brains that contain about 1% human tissue. Weissman says recent news reports that he plans to create a mouse with a 100% human brain are "inaccurate." A pioneer in the field of stem cell research, Weissman is credited as being the first scientist to identify and isolate hematopoietic stem cells from mice and humans. He says that the news reports were fueled by an academic inquiry he made to find out, in theory, what his university ethics panel thought of the idea. He says he has no current plans to create such a mouse. The Newman/Rifkin patent is "a new attempt to block science," while the "use of human-mouse chimeras is old," Weissman says. In 1988, J. Michael McCune patented the SCID-hu mouse, "a severe combined immunodeficient mouse with human organs, bones, lymphoid tissue, thymus, and liver," says Weissman, who is also director of Stanford's Institute of Cancer/Stem Cell Biology and Medicine and a cofounder of Stem-Cells and other companies. "The precedent is there, the discoveries are long published, and people's lives have been affected by those discoveries. Would they take back all those discoveries and be happy if the therapies discovered through them were taken away?" Weissman dismisses the Newman/Rifkin case as "typical Rifkin," adding that "one example doesn't hold. It doesn't invalidate the others, so it's a hollow victory. The case is not the precedent they think." Austin Smith, director of the Institute for Stem Cell Research at the University of Edinburgh, agrees. The case is "irrelevant to mainstream stem cell research and the companies interested in this area. They're not interested in creating monsters. It's absurd. The idea of using them to create body parts is just ludicrous." Smith notes that the point of much of stem cell research is to develop cells that can be transplanted into patients to cure disease. "You can only test the medication by injecting it into animal models – an already made animal, not an early embryo – which means part of the animal will be chimeric," he says. "Of necessity, it will have some human cells in it." While there is a legitimate ethical discussion concerning the mixing of very early cells from a human embryo and an animal embryo, such as a chimpanzee, it's not an application anyone is pursuing, says Smith. "Nobody's ever proposed doing that. It's like some dark fantasy. No scientist would ever think of doing that because there's no reason to do that," he says. "I can't see any business use of primary embryo chimeras," says Smith. "For late chimeras, yes, it's an important testing system to research and test therapies for degenerative diseases like Parkinson's or juvenile diabetes, so a company might want to use it, absolutely. To get it into the clinic, you need commercial involvement." Robert Lanza, medical director at Advanced Cell Technology, Worcester, Mass. says the patent case is most likely "a publicity stunt." Certain changes are acceptable, such as introducing a specific human gene into pigs to prevent transplant patients from rejecting pig organs, he says. However, he adds that it's "inhumane to create any chimeric animal that causes it distress or solely for entertainment purposes, such as glow-in-the-dark fish." In 2002, a Taiwanese company inserted DNA from jellyfish into zebrafish, creating glow-in-the-dark fish. To address ethical issues, Canada passed the Assisted Human Reproduction Act last year, which bars the transfer of a nonhuman cell into a human embryo or of human cells into a nonhuman embryo. In the United States, the National Academy of Sciences is expected in the spring to issue voluntary guidelines for researchers who work with human embryonic stem cells. Lila Feisee, director for intellectual property for the Biotechnology Industry Organization, a trade group, says companies are aiming to provide life-saving treatments, not patent people. "No one from our industry that I'm aware of has applied for a patent on a human being." McGlynn says chimeric animals, and patents, are crucial to a biotech's ability to develop cures for human diseases. To protect its investment, for example, StemCells has > 43 US patents on its stem cell technology, though none are on bioengineered mice. "If the private sector cannot receive a patent on all its work and invention," he says, "it's unlikely to engage in the work because it takes so much time and effort and money." Looking to cure a host of neurodegenerative diseases, StemCells, a Palo Alto, Calif.-based company, has transplanted human neural stem cells into the brains of thousands of mice. The mice are technically chimeras, or is a mix of two or more species. (The word "chimera" refers to the Greek mythological creature that has a lion's head, a goat's body, and a serpent's tail.) President and CEO Martin McGlynn says his biotech company is now waiting for the FDA's permission to test human neural stem cells – the ones already tested in mice – in human patients.
Direct-to-consumer advertising (DTCA) of prescription medications is controversial, with claims that it may cause overuse of unnecessary medication or prevent underuse of effective medication. In a randomized trial it was shown that patients’ requests have a profound effect on physician prescribing in major depression and adjustment disorder. Direct-to-consumer advertising may have competing effects on quality, potentially both averting underuse and promoting overuseref.
Harold Fredrick Shipman, a British general practitioner, was convicted on January 31, 2000, of murdering 15 of his patients (and of forging a will of one of them) while he was practicing in a small town in northwest England. He had killed these patients by administering lethal doses of diamorphine (diacetylmorphine). He was sentenced to 15 concurrent terms of life imprisonment but committed suicide while in custody on January 13, 2004ref.
"When a doctor does go wrong he is the first of criminals. He has nerve
and he has knowledge."
Sir Arthur Conan Doyle, "The Speckled Band"
The Netherlands' first reported case of a doctor complying with a request for assisted suicide from a patient with Alzheimer's disease was lawful. The case was reported to the Netherlands' assessment committee system, which consists of five regional committees and checks whether doctors have followed the requirements of the law. If members of the relevant committee judge that the legal requirements have been met, they do not forward the case to the public prosecution service. Committee members have defended their decision, maintaining that approval for the case did not show that the country was on a "slippery slope" towards a general acceptance of euthanasia for cases of Alzheimer's disease. The case emerged in the 2004 annual report of the five committees of doctors, lawyers, and ethicists to whom doctors must report euthanasia. The committees judged that four out of 1886 cases of euthanasia and assisted suicide in 2004 failed the legal requirements, and, as the law requires, forwarded these to the public prosecution service. But, in contrast, the case of a patient with Alzheimer's disease was considered to have met requirements as a "well-considered and voluntary request" to die. The patient was also considered to be "suffering hopelessly and unbearably," which is another of the criteria that makes euthanasia lawful. The committees' report states that, in general, patients with Alzheimer's disease could not always comply with the requirements but that "in specific circumstances" they could. The 65 year old patient had had Alzheimer's disease for three years. Since his diagnosis he had said that he did not wish to endure the full course of his illness and had in the previous year repeatedly asked for help to commit suicide. The doctor judged him to be suffering unbearably. He was conscious that he could no longer function independently and faced the future prospect of increasing dementia. A second opinion from a doctor trained through the national support and consultation with euthanasia programme, however, did not recognise such suffering. This doctor argued that the patient's awareness of his suffering would decline as the disease progressed and doubted that the patient was competent to express his wishes. Further consultations with a psychologist, a nursing home doctor, and a gerontopsychiatrist, however, all concluded that the patient was suffering unbearably because he was conscious that the disease was removing control over his life. They believed too that he remained competent.ref
Apparently heeding George Washington's call to "labor to keep alive
in your breast that little spark of celestial fire called conscience,"
physicians, nurses, and pharmacists are increasingly claiming a right to
the autonomy not only to refuse to provide services they find objectionable,
but even to refuse to refer patients to another provider and, more recently,
to inform them of the existence of legal options for care. Largely as artifacts
of the abortion wars, at least 45 states have "conscience clauses" on their
books — laws that balance a physician's conscientious objection to performing
an abortion with the profession's obligation to afford all patients nondiscriminatory
access to services. In most cases, the provision of a referral satisfies
one's professional obligations. But in recent years, with the abortion
debate increasingly at the center of wider discussions about euthanasia,
assisted suicide, reproductive technology, and embryonic stem-cell research,
nurses and pharmacists have begun demanding not only the same right of
refusal, but also — because even a referral, in their view, makes one complicit
in the objectionable act — a much broader freedom to avoid facilitating
a patient's choices. Illinois has a regulation that requires pharmacies
to fill valid contraception prescriptions in a timely manner, but a resolution
has been introduced to permit refusals. Massachusetts has a pharmacy-board
policy that requires pharmacists to fill valid prescriptions in a timely
manner. North Carolina has a pharmacy-board policy that requires pharmacists
to ensure that valid prescriptions are filled in a timely manner. Wyoming
has a bill that would permit providers to refuse to abide by advance directives
that might, in some scenarios, apply to pharmacists who refuse to fill
certain prescriptions. Adapted from a map compiled by the National Women's
Law Center.
A bill recently introduced in the Wisconsin legislature, for example,
would permit health care professionals to abstain from "participating"
in any number of activities, with "participating" defined broadly enough
to include counseling patients about their choices. The privilege of abstaining
from counseling or referring would extend to such situations as emergency
contraception for rape victims, in vitro fertilization for infertile couples,
patients' requests that painful and futile treatments be withheld or withdrawn,
and therapies developed with the use of fetal tissue or embryonic stem
cells. This last provision could mean, for example, that pediatricians
— without professional penalty or threat of malpractice claims — could
refuse to tell parents about the availability of varicella vaccine for
their children, because it was developed with the use of tissue from aborted
fetuses. This expanded notion of complicity comports well with other public
policy precedents, such as bans on federal funding for embryo research
or abortion services, in which taxpayers claim a right to avoid supporting
objectionable practices. In the debate on conscience clauses, some professionals
are now arguing that the right to practice their religion requires that
they not be made complicit in any practice to which they object on religious
grounds. Although it may be that, as Mahatma Gandhi said, "in matters of
conscience, the law of majority has no place," acts of conscience are usually
accompanied by a willingness to pay some price. Martin Luther King, Jr.,
argued, "An individual who breaks a law that conscience tells him is unjust,
and who willingly accepts the penalty of imprisonment in order to arouse
the conscience of the community over its injustice, is in reality expressing
the highest respect for law." What differentiates the latest round of battles
about conscience clauses from those fought by Gandhi and King is the claim
of entitlement to what newspaper columnist Ellen Goodman has called "conscience
without consequence." And of course, the professionals involved seek to
protect only themselves from the consequences of their actions — not their
patients. In Wisconsin, a pharmacist refused to fill an emergency-contraception
prescription for a rape victim; as a result, she became pregnant and subsequently
had to seek an abortion. In another Wisconsin case, a pharmacist who views
hormonal contraception as a form of abortion refused not only to fill a
prescription for birth-control pills but also to return the prescription
or transfer it to another pharmacy. The patient, unable to take her pills
on time, spent the next month dependent on less effective contraception.
Under Wisconsin's proposed law, such behavior by a pharmacist would be
entirely legal and acceptable. And this trend is not limited to pharmacists
and physicians; in Illinois, an emergency medical technician refused to
take a woman to an abortion clinic, claiming that her own Christian beliefs
prevented her from transporting the patient for an elective abortion. At
the heart of this growing trend are several intersecting forces. One is
the emerging norm of patient autonomy, which has contributed to the erosion
of the professional stature of medicine. Insofar as they are reduced to
mere purveyors of medical technology, doctors no longer have extraordinary
privileges, and so their notions of extraordinary duty — house calls, midnight
duties, and charity care — deteriorate as well. In addition, an emphasis
on mutual responsibilities has been gradually supplanted by an emphasis
on individual rights. With autonomy and rights as the preeminent social
values comes a devaluing of relationships and a diminution of the difference
between our personal lives and our professional duties. Finally, there
is the awesome scale and scope of the abortion wars. In the absence of
legislative options for outright prohibition, abortion opponents search
for proxy wars, using debates on research involving human embryos, the
donation of organs from anencephalic neonates, and the right of persons
in a persistent vegetative state to die as opportunities to rehearse arguments
on the value of biologic but nonsentient human existence. Conscience clauses
represent but another battle in these so-called culture wars. Most profoundly,
however, the surge in legislative activity surrounding conscience clauses
represents the latest struggle with regard to religion in America. Should
the public square be a place for the unfettered expression of religious
beliefs, even when such expression creates an oppressive atmosphere for
minority groups? Or should it be a place for religious expression only
if and when that does not in any way impinge on minority beliefs and practices?
This debate has been played out with respect to blue laws, school prayer,
Christmas crèche scenes, and workplace dress codes. Until recently,
it was accepted that the public square in this country would be dominated
by Christianity. This long-standing religious presence has made atheists,
agnostics, and members of minority religions view themselves as oppressed,
but recent efforts to purge the public square of religion have left conservative
Christians also feeling subjugated and suppressed. In this culture war,
both sides claim the mantle of victimhood — which is why health care professionals
can claim the right of conscience as necessary to the nondiscriminatory
practice of their religion, even as frustrated patients view conscience
clauses as legalizing discrimination against them when they practice their
own religion. For health care professionals, the question becomes: What
does it mean to be a professional in the United States? Does professionalism
include the rather old-fashioned notion of putting others before oneself?
Should professionals avoid exploiting their positions to pursue an agenda
separate from that of their profession? And perhaps most crucial, to what
extent do professionals have a collective duty to ensure that their profession
provides nondiscriminatory access to all professional services? Some health
care providers would counter that they distinguish between medical care
and nonmedical care that uses medical services. In this way, they justify
their willingness to bind the wounds of the criminal before sending him
back to the street or to set the bones of a battering husband that were
broken when he struck his wife. Birth control, abortion, and in vitro fertilization,
they say, are lifestyle choices, not treatments for diseases. And it is
here that licensing systems complicate the equation: such a claim would
be easier to make if the states did not give these professionals the exclusive
right to offer such services. By granting a monopoly, they turn the profession
into a kind of public utility, obligated to provide service to all who
seek it. Claiming an unfettered right to personal autonomy while holding
monopolistic control over a public good constitutes an abuse of the public
trust — all the worse if it is not in fact a personal act of conscience
but, rather, an attempt at cultural conquest. Accepting a collective obligation
does not mean that all members of the profession are forced to violate
their own consciences. It does, however, necessitate ensuring that a genuine
system for counseling and referring patients is in place, so that every
patient can act according to his or her own conscience just as readily
as the professional can. This goal is not simple to achieve, but it does
represent the best effort to accommodate everyone and is the approach taken
by virtually all the major medical, nursing, and pharmacy societies. It
is also the approach taken by the governor of Illinois, who is imposing
an obligation on pharmacies, rather than on individual pharmacists, to
ensure access to services for all patients. Conscience is a tricky business.
Some interpret its personal beacon as the guide to universal truth. But
the assumption that one's own conscience is the conscience of the world
is fraught with dangers. As C.S. Lewis wrote, "Of all tyrannies, a tyranny
sincerely exercised for the good of its victims may be the most oppressive.
It would be better to live under robber barons than under omnipotent moral
busybodies. The robber baron's cruelty may sometimes sleep, his cupidity
may at some point be satiated; but those who torment us for our own good
will torment us without end for they do so with the approval of their own
conscience" ref.
On February 17, 2005, the U.S. Senate passed bill S. 306, the Genetic Information Nondiscrimination Act of 2005, by a vote of 98 to 0. The previous day, the White House had announced that "the Administration favors enactment of legislation to prohibit the improper use of genetic information in health insurance and employment [and] supports Senate passage of S. 306." But similar legislation has been introduced in every Congress since 1995, and President George W. Bush announced his backing for a law against genetic discrimination as early as June 2001. The House of Representatives is the sticking point: knowledgeable observers consider the prospects for passage of the House equivalent of this bill to be only slightly better than they were in 2003, when the Genetic Information Nondiscrimination Act of 2003 passed the Senate by a vote of 95 to 0 but never reached the House floor. What's going on? Americans have been haunted by the fear of genetic discrimination since the beginnings of genetic testing > 30 years ago. The launch of the Human Genome Project in 1990, however, brought a whole new level of scrutiny and sophistication to the consideration of genetic information. In general, the fear has focused on health insurance, since insurers have an incentive to identify and avoid clients who will cost them more money than the average client. Similar incentives apply to employers, who not only are concerned about the effects of employees' health problems on productivity but also pay for most private health care in the USA. Published accounts of reported genetic discrimination in both life insurance and employment surfaced in the 1990sref, along with an increasing number of policy recommendations expressing concern about the potential for genetic discrimination and arguing for legislation against itref1, ref2. However, the early reports often involved allegations of discrimination on the basis of disease, rather than a genetic predisposition to disease. Subsequent studies have shown that although there is widespread concern about genetic discrimination, there are few examples of it — and no evidence that it is commonref. In retrospect, this finding is not surprising. A simple model would predict that a rational insurer or employer would discriminate on the basis of genetic information if the savings that could be expected from doing so outweighed the costs — in litigation, in employee satisfaction, in public relations, and in sheer administrative outlays. For the savings to be substantial, the genetic test would have to have strong predictive power, the costs associated with the genetic condition would have to be high, and the probability that it would occur while the person was covered by the insurer or employer would also have to be high. The apparent absence of genetic discrimination in health coverage and employment is probably the result of three factors: the structure of the health care financing system, state and federal legislation, and the limits of recent progress in human genetics. Few Americans have health coverage from organizations that pick and choose whom to cover on the basis of health, using what is called medical underwriting. > 160 million Americans receive coverage through an employer, whether their own, their spouse's or partner's, or that of another relative. Few large-scale employers ever selectively provided health coverage on the basis of an employee's medical condition; the federal Health Insurance Portability and Accountability Act of 1996 prohibited almost all employers but those in the smallest businesses from using such medical underwriting and from considering genetic risks as preexisting conditions. > 80 million Americans are covered by federal or federal–state programs — notably, Medicare and Medicaid — that do not use medical underwriting. Very few of the > 40 million Americans without health coverage lack it because of genetic discrimination; most simply do not qualify for governmental coverage and either cannot afford or choose not to pay for employer-provided or individually underwritten coverage. That leaves only about 10 to 15 million Americans who buy their own, individually underwritten coverage, along with perhaps an equal number with coverage from very small employers. Only the people in these two groups can be at risk for genetic discrimination by insurance companies. But the same health care financing system that limits the possibilities for genetic discrimination by insurers encourages such discrimination in employment. Employers have an incentive to reduce their future health insurance costs by not hiring or by firing people who have predictably high health care expenses, for genetic or other reasons. The law provides a second barrier against genetic discrimination. In the past decade or so, all but 3 states have adopted laws limiting genetic discrimination for some kinds of health insurance, and about 40 states have fairly strong rules against discrimination by small employers or companies that sell individual health insurance. > 30 states ban or limit genetic discrimination in employmentref. The coverage, definitions, and enforcement mechanisms vary enormously from state to state; none of the relevant laws appear to have been defined or tested in any reported appellate-court decisions. In addition, the federal Americans with Disabilities Act, passed in 1990, may more broadly prohibit genetic discrimination in employment, depending on whether the genetic risk is considered a disability. Another federal law, the Employee Retirement Income Security Act, prohibits an employer from discriminating against current employees on the basis of their existing or projected health care expenses. Although the exact reach of these federal laws is unclear, they — along with state laws and the prospect of more stringent legislation in the future — have largely deterred insurers and employers from practicing such discrimination. In the wake of the Human Genome Project, the third factor may strike some as surprising, but in fact there have been few recent discoveries that lend themselves to abuse in the form of genetic discrimination. Deadly, dramatic, and highly penetrant genetic diseases were identified first because they were so obvious. Fortunately (and not surprisingly, from an evolutionary perspective), such diseases are uncommon. Although many common disorders, such as asthma, type 2 diabetes mellitus, coronary artery disease, and schizophrenia, seem to have some genetic component, understanding the genetic contribution has proved to be difficult. And if a person's genetic variations contribute only a small amount to his or her risk of disease — changing it, for example, from an 8% lifetime risk to 12% or 4% — this genetic information will be too weak to prompt discrimination. The extent to which genetic contributions to common diseases will lead to strong or weak predictions of future illness remains uncertain. Although actual genetic discrimination may not be a substantial reality, several factors argue for enacting laws against it. Even if only a small fraction of the population may be at high genetic risk for serious illness and therefore for genetic discrimination that could be thought of as "rational," protecting such people may be worthwhile. Moreover, employers and insurers sometimes act foolishly: they may discriminate in ways that are irrational but that nonetheless harm people. Perhaps most important, regardless of how likely genetic discrimination may be, the fear of it is quite real. Such fears may be deadly if they prevent people who are at risk from undergoing genetic testing, and they may have broader ill effects if they keep people from participating in research that could lead to medical advances. If unreasonable fear were the only problem, one solution might be to educate the public about the small size of the actual risks. But current protections against genetic discrimination are complicated, confusing, and uncertain. A broad but careful federal law against such discrimination could provide reassurance that no combination of rational arguments and state laws can offer. Of course, all legislation has costs. Any definition of "genetic information" might end up being too broad or too narrow. Any new basis for appropriate lawsuits will inevitably provide the basis for some inappropriate claims. And the mere fact that Congress has passed legislation against genetic discrimination might have the perverse effect of convincing the public that the risk of discrimination is actually high. But although the Genetic Information Nondiscrimination Act is not perfect, the Senate has unanimously concluded correctly that it is an important step forward. A wide range of organizations have joined the White House in supporting the bill. And as the proposed legislation has evolved over the past decade, insurers have come to tolerate it, if not to welcome it. The main opposition now comes from employer groups such as the U.S. Chamber of Commerce, and even their objections focus on details of the legislation. If the bill gets to the floor of the House of Representatives, it seems likely to be approved. But there is no guarantee that it will reach the floor. The House bill has been referred to three different committees; at least two of the relevant chairs have already expressed doubts about it. But the bill should be passed. Although it is not a panacea, the Genetic Information Nondiscrimination Act would be good for medicine, for science, and for the nationref.
As the head of student government at Duke University School of Medicine
in Durham, North Carolina, Sujay Kansagra had witnessed several of his
fellow students dealing with depression. "I knew it was a big problem,"
he said. "People were feeling isolated." So Kansagra came up with an innovative
way to provide emotional support to depressed students while shielding
their identities. With the help of Caroline Haynes, Duke's associate dean
for medical education, he arranged an online forum to give students a safe
place to talk and to help them "realize they aren't alone and that there
are a lot of resources available." Students posted messages anonymously.
Although the postings were reviewed by a psychiatrist in Duke's student
counseling service, the administration was not privy to the forum, which
received more than 100 postings and more than 1000 hits during its planned
10-day existence in April 2005. According to Kansagra, people had a lot
to say about fighting with depression and feeling that medicine in general
sees mental illness as a weakness and not an actual disease. People felt
the need to hide it . . . because we are taught that we are the healers
and not the ones with problems. The pilot project led to open discussions
about mental health, and in the subsequent week, Haynes, a psychiatrist,
made two referrals for depression counseling. This was a fabulous first
step. People felt that their concerns were normalized and validated. .
. . It started a conversation that many people are hesitant to start. Medical
students are more prone to depression than their nonmedical peers. Researchers
recently surveyed first- and second-year medical students at the University
of California, San Francisco (UCSF), and found that about one fourth were
depressedref.
Others have suggested that although the rate of depression among students
entering medical school is similar to that among other people of similar
ages, the prevalence increases disproportionately over the course of medical
schoolref.
Laurie Raymond, a psychiatrist and the director of the Office of Advising
Resources at Harvard Medical School in Boston, said that she met individually
with 208 medical students — about one quarter of the student body — between
July 2003 and July 2005. 31 students (15%) presented with self-described
depression — 20 of them with transient, "reactive" depressed mood that
improved with supportive counseling or therapy and 11 who had a history
of major depression. The majority (130 students) consulted Raymond because
of concern about academic performance, but major depression was diagnosed
in 25 of them. A fourth-year medical student at Harvard estimated that
three quarters of her close friends in medical school have taken psychiatric
medications at some point during the four years. Depression not only
affects students' lives but may also have repercussions for patient care
in the long run. Many practicing physicians are afraid of being treated
for depression and thereby revealing that they have the condition. But
if people don't know how to treat their own depression, it has a negative
impact on how they treat patients. Why does being a medical student increase
the risk of depression? Students' coping strategies and personal health
deteriorate as they progress through medical school. Students see themselves
going into a very narrow tunnel. A lot of the depression we see halfway
through the first year — it's a reaction to having constricted themselves
down to studying these subjects in a very intense way. It's pretty unidimensional.
Symptoms of depression in medical students can be difficult to distinguish
from the effects of the stress inherent in student life. Students often
dismiss their feelings of despondency as a normal emotional response to
medical school, where they live from test to test and don't take time for
themselves. It's hard to ask about depression in medical students, because
you ask about sleep, and all medical students aren't sleeping : they are
overwhelmed, they are working hard, and they aren't having fun socially.
. . . Of course they are fatigued. The emotional and academic challenges
involved in becoming a physician wear on students. Their initial encounters
with illness and death may unmask psychological vulnerabilities. Such encounters
often resonate with unresolved episodes of loss or trauma in the student's
past or come as a shock to those who have had little experience with death.
The treatment of death as a part of the daily routine may appear cold and
calculating to students, who may fear becoming emotionally detached. Some
become overwhelmed by the emotional toll of caring for others. For students
who have been lifelong achievers, getting a mediocre grade on an exam often
is shocking. The transition from college to medical school is definitely
an eye-opener . . . especially if your academic performance isn't up to
par. If you get C's on your first set of tests, I can see that it would
be easy to get depressed. At the end of his second year, this student lost
15 or 20 pounds. "Retrospectively, I can say I was clinically depressed,
but at the time it was just one of those rough things. He never sought
treatment, he added, because "as a medical student, you are supposed to
just deal with it. It is unclear whether there has been a recent increase
in depression among medical students or whether greater awareness of mental
health issues has simply led to increased recognition of the phenomenon.
Nanette Gartrell is an associate clinical professor of psychiatry at UCSF
who has treated many medical students and physicians for depression during
25 years of private practice. She said that in recent years, "[we] are
seeing more students, because we have some more efficient pharmaceutical
treatments." Students know that selective serotonin-reuptake inhibitors
(SSRIs) can make them feel better much more quickly than psychotherapy
or older classes of antidepressants could. Gartrell added that virtually
all the depressed physicians she sees have self-medicated with an SSRI
before consulting her. In addition, both Haynes and Raymond noted that
many more students than in past decades are entering college or medical
school with previous diagnoses and treatment for mental illness. When Blue
Cross asked Duke for a premium increase in their student health insurance
policy recently, Haynes and others reviewed the policy for the university
as a whole. They found that three of the top five medications that the
plan was covering were new antidepressants. Students may become depressed
at any point in medical school, but the period of greatest distress occurs
during the third and fourth years, when students rotate through the hospitals
and clinics. In the clinical years, there's just far greater commitment
of time, plus as match pressure begins to emerge, it's an extremely stressful
time for a lot of people. Students are often separated from friends and
classmates and must work with a constantly changing set of residents and
attending physicians, which contributes to their sense of isolation. Many
of the female students she sees are worried that the mounting demands of
training and clinical practice will not allow them time to find a partner,
marry, and have children. Haynes noted that the increase in sleep deprivation
during rotations may also expose mood disorders. The Harvard medical student
mentioned above recalls that her mood took a downturn during her third
year. The pressures of school were building, and medicine was not turning
out to be what she had expected. She began to think, Man, this life isn't
exactly what I imagined it would be, and now I'm stuck and have all these
debts. I don't like what I'm seeing in the hospital; that's not how I want
to practice medicine. She found herself disillusioned by the long hours,
the competition among students and doctors, and the lack of time for really
caring about, and not just for, patients. As they begin to treat sick patients,
depressed medical students usually become even more reluctant to admit
that they are not well themselves. Even though they know about depression,
students don't recognize it often in themselves. . . . That's part of the
psychology and the denial: if I'm going to be a doctor, I've got to be
well. One medical student who took antidepressants told friends that she
felt guilty about needing them. Such guilt is common among depressed medical
students, since the stigma associated with treatment is strong. One of
the problems students have in getting help . . . is a tremendous fear that
it will go on their letter" of recommendation for residency, and that there
will be professional repercussions, Tjia said. She and colleagues surveyed
University of Pennsylvania medical students and found that only one fourth
of those who were depressed had sought treatment (see bar graphs). In addition
to stigma and fear of disclosure, students cited reasons such as lack of
time and costref.
At Northwestern, Nuzzarello found that medical students were not coming
in for regular counseling appointments as often as law students — but they
had many more emergency visits. "Med students were waiting and waiting
and waiting," she said, and going in when their depression had become more
difficult to treat. Rates of Depression among Medical Students (Panel A)
and Treatment of Depressed Medical Students (Panel B) :
Data in Panel A are for 322 medical students who responded to a questionnaire;
data in Panel B are for the 49 medical students whose responses to the
questionnaire indicated that they were depressed. Treatment consisted of
counseling, antidepressants, or both. Total numbers (given in the bars)
reflect the numbers of students who replied to the relevant question.
Medical students' fear that treatment for depression will jeopardize
their careers may not be unfounded. In one study, residency directors said
they were less likely to ask a hypothetical applicant to interview if he
or she had a history of psychological counselingref.
And state medical boards ask about significant medical conditions, including
psychiatric illnesses, when certifying physicians. Candidates for medical
licensure are expected to disclose the diagnosis of or treatment for any
disorder that might impair their ability to practice. In a candidate with
a history of depression, "some states may require a consultation with a
psychiatrist or may request a report from the applicant's treating physician.
But I am unaware of any circumstance in which simply being treated for
depression would stop someone from getting a license. We are trying to
disseminate more appropriate information to residents and medical students,
to reduce some of the fear that may . . . prevent them from getting appropriate
medical treatment. Nevertheless, an anonymous forum with no administrator
looking at the responses, such as the one tested at Duke, is going to be
much more inviting to students than disclosing depression to even a sympathetic
administrator. For that reason, I think medical school administrators need
to be explicit on what will and won't be disclosed. Students need to be
reassured, she said, that problems will be reported only if they grant
permission and only to explain effects on their academic performance. Many
medical schools are looking for new ways to teach students to monitor their
own health and to persuade them to seek help when they need it. At Harvard,
a group of faculty members and students are developing workshops for first-
and second-year students to teach "mindfulness" and self-renewal skills,
based on a program pioneered by Craig Hassed of Australia's Monash University.
Administrators at Duke, discouraged by a low turnout for mental health
education programs, have decided to present a wellness program focused
on enhancing performance. Like the Harvard workshops, it will include ways
to improve eating habits, sleep hygiene, stress reduction, and mood regulation.
At UCSF, psychiatrists and psychologists with the medical school's student
well-being program lead support groups and hold "stress rounds" in which
students on clinical rotations can share their experiences and emotional
responses. Students are entitled to 10 free counseling sessions a year.
The school also conducts an annual survey to assess the mental health of
each class, said Maxine Papadakis, associate dean for student affairs.
Those data provide a longitudinal picture of students' moods, but Papadakis
declined to say whether they reveal any long-term trends. I don't know
if depression is worse now than it was 10, 20, or 30 years ago : it's certainly
a more humane environment, and people may feel better about showing their
vulnerabilitiesref.
Use of stimulants and antidepressants in college : a college student sought help at our health center because he was having social anxiety and difficulty participating in class discussion. He said he had used an antidepressant drug to combat his social fears when he was in high school but had stopped taking it because he wanted to make a fresh start in college — and because he'd noticed that the medication affected his libido. Now, however, because he was painfully aware that class participation counted for half his grade, he wanted a new prescription for his old medication. Around the same time, I saw another student who, he told me, had always been distractible, even while in his academically nonrigorous high school. When he started college, he found that he had trouble managing his time and maintaining his focus. When his roommate offered him some methylphenidate to help him study for an exam, however, he discovered that he could stay up much later than usual and concentrate on his work. He looked up the symptoms of attention deficit–hyperactivity disorder (ADHD) online, believed he had several of them, and came into the health center wanting to try medication to help him study more effectively. Like most students, these two young men were probably fed the usual clichés before they left home — among them, cherish your college years; they're the best years of your life. Unfortunately, for many college students, the reality does not live up to the promise. In fact, the current rates of depression, stress-related symptoms, insomnia, and eating disorders in U.S. colleges and universities are staggering; not surprisingly, so are the rates of substance abuse. In a recent national survey of 13,500 college students, nearly 45% reported being so depressed that they had difficulty functioning, and 94% reported feeling overwhelmed by everything they had to do (National College Health Assessment: reference group report. Baltimore: American College Health Association, 2004). Various studies have shown that about 45 percent of college students intermittently engage in binge drinkingref. Some of these students no doubt meet the criteria for therapy with effective, new psychotropic medications. The trouble is that many more of them, affected by the increased stress of college life — overextended by extracurricular activities taken on in order to build their résumés, sleeping even less than their predecessors, and worrying more than ever about financial, social, and academic pressures — are at risk for misusing or abusing these drugs, which can have serious adverse effects. The emergence of the selective serotonin-reuptake inhibitor (SSRI) antidepressants and a variety of drugs for treating ADHD has changed the landscape of prescribing for the college-age population. Unfortunately, beyond the legitimate prescription of such medications lies new territory marked by illegitimate, or at least inappropriate, uses of stimulants and antidepressants — practices that are often not even covert. Increasing numbers of students, and sometimes their families, request medication to provide an "edge," even if the students have no clinically significant impairment of functioning. They think of such drugs as safe "brain steroids" that help to maximize performance with minimal risk, and they know the symptoms to describe in order to persuade a doctor to write a prescription. Thus, the number of prescriptions has increased dramatically over the past decade; it is estimated, for example, that 25-50% of U.S. college students who are seen in counseling and at student health centers are taking antidepressants. At least in part, such consumer demand reflects our bombardment with advertisements imploring us to "ask your doctor if this pill is right for you." This type of marketing is a double-edged sword, not only raising awareness of common problems such as depression and attention deficits but also implying that there is a magic bullet for complex problems and enticing some healthy people to seek their own magical boost. The challenge for physicians is to determine which patients have a legitimate need for psychotropic medication, particularly given recent warnings about the safety of some of these compounds. It is true that late adolescence is a common time for the onset of a first episode of depression and that ADHD is the most common childhood psychiatric disorder, affecting 4 to 10 percent of young people in the United States, with as many as half of them continuing to have symptoms into adulthood. Moreover, many bright students find ways to compensate for the symptoms of ADHD in their early years, so that the disorder reveals itself only with the increased intellectual and organizational demands of college. Depression follows a parallel path, often appearing in late adolescence and worsening during the transition to college. Students with diagnosed ADHD are also three times as likely as their peers to abuse other substances, partly in an effort to ameliorate their attention problems, and students with depression may self-medicate with alcohol or other drugs. Yet more and more students with symptoms that do not clearly reach the threshold for depression or ADHD have begun seeking psychotropic drugs. When the first SSRI, fluoxetine (Prozac), was released in 1987, it heralded a new age of effective treatments for depression with far fewer side effects than with the older tricyclic drugs. But the SSRIs also quickly came to be viewed as a means of evoking an "improved self," better than the original, and they began to be prescribed for mild symptoms, to reduce social and generalized anxiety and unproductive obsessive thinking, thereby allowing students to improve their class participation and feel more comfortable in social situations (similar to the use of beta-blockers to reduce performance anxiety). More recently, stimulants have begun to be used in a similar way — to improve concentration, focus, and alertness. Many students report what they call "pharming": using stimulants for recreation and to work more efficiently (with a reduced need for sleep). They may get medications from friends or over the Internet, but many also obtain prescriptions from physicians. Some studies estimate the frequency of such abuse at 3 to 10 percent among U.S. college students, with a higher frequency among men than women. Most commonly, students use the medications in order to stay up later or study harder before tests. Some users crush the pills and snort or smoke the powder or, in extreme cases of recreational abuse, inject it intravenously to achieve a more rapid, intense effect. The goal of this approach is to get an intense "buzz," an effect heightened by the simultaneous use of alcohol or other drugs. This sensation is often the first step on the road to dependence and addiction. SSRI antidepressants and stimulants affect different neurotransmitter systems and therefore have different therapeutic and side effects. The SSRIs are thought to act, in part, by blocking the presynaptic reuptake of serotonin. Their therapeutic effects include improved mood, social functioning, energy, sleep, and concentration and (often at higher doses) reduced obsessive thinking and urges to binge on food. In most people, the side effects are minimal. They include mild nausea, headaches, odd dreams, sleep disturbance, decreased libido, and delayed orgasm. Occasionally, there are more serious side effects, especially during the first few weeks of treatment. They can induce anxiety and agitation and, albeit rarely, increase obsessive thinking about suicide. The stimulants, for their part, appear to affect both dopaminergic and noradrenergic pathways in the brain, with methylphenidate and its siblings blocking reuptake and the amphetamines increasing their availability. Common side effects include sleep problems, jitteriness, abdominal pain, anorexia, and irritability, and the drugs can, in rare cases, cause more serious side effects such as paranoia and psychosis. Stimulants are usually prescribed for ADHD, which is believed to involve impaired function of frontal or frontal–striatal networks, as well as diminished behavioral inhibition. Since the potential for abuse is high, diagnosing true ADHD requires careful history taking and collateral data from family and teachers, whenever possible, including a detailed assessment of drug and alcohol use. It is crucial to distinguish ADHD from early-onset bipolar disorder, since stimulants can markedly worsen the symptoms of the latter. If the patient is deemed to be at high risk for abusing the medication, it may be prudent to consider the use of a long-acting formulation such as Concerta (methylphenidate), which is difficult to crush and use effectively through the intranasal or intravenous route, or alternative classes of drugs; Strattera (atomoxetine), a presynaptic norepinephrine-reuptake inhibitor, and antidepressants such as Norpramin (desipramine), Effexor (venlafaxine), and Wellbutrin (bupropion) may be effective, and in patients with concomitant depression or substance abuse, they may be better choices than a stimulant. College students — and their families — tend to have polarized views about medication: either they embrace these types of drugs as a way of improving their performance or even their lives, or they shun medications as a "crutch" and fear becoming dependent on them. A student's last visit to a primary care physician before departing for college may offer an ideal opportunity to provide education about medication, warning signs of common problems, and the need for a balanced lifestyleref.
DNA from tens of thousands of suspected illegal immigrants, captives in the war on terrorism and others who have been arrested but not convicted of federal crimes could be added to a national database of convicts' DNA under a proposal the Senate is likely to vote on soon. The measure, which has drawn fire from civil libertarians, has passed the U.S. House. It would represent a dramatic expansion of the nation's DNA database, which has about 2.6 million genetic profiles. So far, database efforts have focused mostly on collecting DNA from those convicted of serious crimes, so the profiles can be compared with DNA found in blood, semen and other biological evidence from crime scenes. Virginia, Texas and Louisiana allow authorities to take DNA from arrestees, but U.S. law blocks the inclusion of such profiles in the national database until a suspect has been indicted. If an indicted suspect is not convicted, his profile is supposed to be removed.Supporters of the Senate bill say it would improve the ability of the national database — known as the Combined DNA Index System (CODIS) — to help solve crimes. Since 1991, CODIS computers have matched DNA profiles in the database to those from crime scenes in > 27,000 cases. U.S. Sen. Jon Kyl, R-Ariz., a sponsor of the bill, says collecting DNA from arrestees would help authorities catch rapists and killers who have arrest records but who go undetected by the DNA system because they have no serious convictions. Barry Steinhardt, who specializes in privacy law for the American Civil Liberties Union, says taking DNA from people who "haven't been found guilty of anything" is wrong. "We've got to ask ourselves whether this is a line we want to cross." The Senate bill would tap new DNA sources. In 2004, 235,000 suspected immigration violators were detained, the Department of Homeland Security says. The Justice Department says 124,210 people were arrested on federal charges in 2002. Since the war on terrorism began in 2001, the Defense Department says, U.S. forces have detained about 70,000. Under the Senate bill, all would be eligible for DNA testing.
On a rainy afternoon in mid-October 2005, a white bus climbed the brush-covered hills near Guantanamo Bay, Cuba, carrying a group of visitors to Camp Delta, the desolate spot on the island's southern coast where the U.S. military holds > 500 prisoners captured in the war on terror. It rolled through the detention camp's stockade-style gate and turned onto the dirt track inside the outermost of 3 high fences. Like others in the small group of civilian doctors, psychologists, and ethicists visiting that day, I peered through the bus's windows, eager for a glimpse of detainees. Since our arrival in the morning, we had spent > 2 hours in a hospital conference room on the naval base, listening to a briefing by Major General Jay W. Hood, the camp's commander, and questioning him and other officials about the interrogation and medical care of detainees, including the force-feeding of hunger strikers. At last, I thought, we were about to see the prisoners. The fences veiled the camp's interior from our curious eyes. Opaque green cloth was stretched across the chain link, obstructing our view of the buildings beyond. As we rolled slowly past Camps 3, 2, and 1, adjoining compounds with similar layouts, we caught an occasional glimpse of the military guards who sit in open doorways at the rear of each cell block, keeping a constant eye on the detainees within ("There is no place in those blocks where people can disappear and not be watched by multiple eyes," Hood said — adding, however, that guards carry no weapons: "It's the safest way to run a facility."). For a moment, I saw a prisoner's olive-skinned face peeking out at our bus through a hole in the cloth. Then, we rounded a corner and reached Camp 4, the least restrictive of the 5 currently occupied prison compounds. We saw 10 or 12 prisoners standing alone or in small groups in the exercise yard. They wore white pants and shirts. Most had long, black hair; many had untrimmed beards, and a few wore white caps. One man was chinning himself on a metal crossbar supporting an awning that shaded part of the yard. From a distance, through the layers of fence, the detainees watched silently as our military escorts hustled us into the prison hospital. We found ourselves in a long, one-story building with gray-painted metal walls and a spotless linoleum floor. Our guides led us down a hallway past physical therapy equipment, an x-ray room, a glass-windowed nurses' station, and a supply room full of surgical kits and medical equipment. We stopped outside the hospital's empty operating room. There we were greeted by members of the medical team led by a physician known to patients as Dr. O., a young military doctor with a buzz cut and a mustache. The camp's doctors, nurses, and prison guards hide their name tags from prisoners with masking tape, and officials asked us not to publish their names, to protect them and their families from terrorists. The patients — 9 in all, we were told — were invisible. They lay behind floor-to-ceiling curtains covering the bays of the 30-bed hospital. Guards standing before the curtains came to attention the moment I tried to edge closer. I had been told before the trip that we would probably be permitted to speak with patients, and I received various explanations for the change of heart: officials didn't want to give hunger-striking patients a forum for media attention; they feared that a patient who had assaulted a nurse the previous night might again become disruptive or violent; they were concerned about detainees' privacy. Had I known that I would not have access to prisoners, I might have declined the invitation to visit Guantanamo, as United Nations representatives have since done. Captain John S. Edmondson, an emergency physician and the commander of the medical group that delivers the prisoners' care, told us that 8 of the patients had been admitted for involuntary tube feeding, to treat the medical consequences of their prolonged hunger strike. We were told that 25 prisoners were on hunger strike that day (a decline from 131 on the anniversary of the September 11 attacks) and that 22 were being fed by nasogastric tube — most while in their cells. Some had continued to lose weight — as much as 30% of their original body weight — despite these tube feedings and had been admitted for monitoring, endocrinologic evaluation, and additional treatment. "They are all clinically stable" with albumin levels > 4 g/dl, said Edmondson, a dark-haired man who looked tired and careworn on the day we visited. The weight loss "does not pose a danger," he said. Although many aspects of the U.S. military's handling of detainees during the war on terror have been justly criticized, it remains a point of pride among medical workers, security staff, and military leaders at Guantanamo that there have been no deaths among Camp Delta prisoners. Clearly, Hood hopes to maintain that record. "I will not allow them to do harm to themselves," he told us. The military's policy of tube feeding prisoners on hunger strike is controversial, and military health care providers are "screened" before deployment to Guantanamo "to ensure that they do not have ethical objections to assisted feeding," Edmondson told me. The World Medical Association declared in 1975 that prisoners who refuse food and whom doctors consider capable of understanding the consequences should not be fed artificially, and British authorities allowed hunger-striking members of the Irish Republican Army to starve to death in prison in 1981. Yet civilian doctors in U.S. federal prisons are permitted to order the force-feeding of hunger strikers, and some lawyers representing Guantanamo detainees concur with the policy of "assisted feeding" (as military officials prefer to call it) if it is judged medically necessary. Ethicist Jonathan Moreno of the University of Virginia suggested in an interview that the ethical issues involved are complex. Detainees at Guantanamo, who are imprisoned in an isolated environment far from their families for an indefinite period, may not have the autonomy needed to make an informed decision to starve themselves. Moreno also noted that the military doctors, nurses, and medics responsible for the care of detainees have a strong interest in keeping them alive, which may render them unable to assess objectively the motives and decision-making process of hunger strikers. Hood and others at the prison maintain that these detainees are merely protesting their confinement and are not suicidal. Their evidence: most prisoners have submitted quietly to the insertion of nasogastric tubes and have not tried to pull them out. One prisoner threatened to fight and was put into 6-point restraints, only to swallow the nasogastric tube without incident. Edmondson said that small, soft, flexible, 10-French tubes are always used, with lidocaine jelly and gargle for local anesthesia. Both he and Hood strenuously denied press reports that large-gauge tubes have sometimes been inserted, without anesthetics, as a punishment. "In none of these [cases] have I ever gotten the impression that these guys want to die," Edmondson said. Nevertheless, the force-feeding has become the latest issue in an ongoing debate among medical professionals and ethicists about practices at Guantanamo — a debate that has also covered the use of psychiatrists and psychologists to monitor military interrogation of prisoners, the reported use of information from detainees' medical records to plan interrogation strategies, and other issues. Moreover, our visit came at a time of intense public, judicial, and congressional scrutiny of the Bush administration's policies regarding the legal and moral status and treatment of suspected terrorists. The Senate had recently passed an amendment by Senator John McCain (R-Ariz.) to the defense appropriations bill, prohibiting cruel, inhuman, or degrading treatment of prisoners in U.S. custody, and President Bush was threatening to veto the measure. The military's policies regarding detainees were being revised, with Defense and State department officials reportedly arguing for the incorporation of language on prisoners' rights from the Geneva Conventions and the White House vigorously opposing this change. It seemed evident that one reason for inviting us to the detention center was to try to improve Guantanamo's public image. Perhaps permitting us to talk with hunger strikers would have undermined that goal. Whatever the reason, the 8 tube-fed patients remained invisible. And the ninth patient — who was he? No one told us, but I have wondered in recent weeks whether he might have been Jumah Dossari. According to news reports published last month, Dossari, a 26-year-old prisoner captured in Pakistan who has been in U.S. custody for almost 4 years, tried to commit suicide on October 15, 4 days before our visit. His American lawyer, who had been meeting with him until a few minutes before Dossari's suicide attempt, discovered him dangling from a noose in a cell, his right arm gouged and bleeding. Dossari had reportedly complained of abuse and mistreatment at the hands of U.S. soldiers in Afghanistan and at Guantanamo and had previously attempted suicide. According to a military spokesman, as of November 1, 2005, there had been 36 suicide attempts by 22 Guantanamo detainees (White J. Guantanamo desperation seen in suicide attempts. Washington Post. November 1, 2005:A1). Allegations of abusive and inhumane interrogation techniques at Guantanamo have been widely publicized, and our group was particularly concerned about the possible involvement of health care professionals in the mistreatment of detainees. We questioned Hood and others at Camp Delta about interrogation techniques and the role of psychologists or psychiatrists serving on the Behavioral Science Consultation Teams (BSCTs), who observe interrogation sessions and advise interrogators and guards about getting detainees to cooperate. A confidential report by the International Committee of the Red Cross, received by the U.S. government in July 2004 and subsequently leaked to the media, had charged that some techniques used were "tantamount to torture" and stated that medical personnel, through BSCT members, had provided interrogators with information about prisoners' psychological vulnerabilities (Lewis NA. Red Cross finds detainee abuse in Guantánamo. New York Times. November 30, 2004:A1). The Army released a report this past July detailing incidents that had occurred at Guantanamo between 2002 and 2004 in which interrogators used such techniques as frequent sleep disruption, prolonged exposure to loud music and strobe lights, exposure to extremes of temperature, "short shackling" of detainees in a fetal position, sexual taunting by female interrogators, and the use of military working dogs for intimidationref. The U.S. Army Field Manual on intelligence interrogation specifically recommends that an interrogator "be aware of and exploit the source's psychological, moral, and sociological weaknesses" (Intelligence interrogation. Field manual 34-52. Washington, D.C. Department of the Army. September 1992:3-18). Hood and other officials acknowledged that harsh interrogation techniques had sometimes been employed but said they are not currently in use, even though techniques such as manipulating temperature and other environmental factors, trying to provoke intense feelings of fear or futility, and altering sleep patterns are among those currently permitted at Guantanamo by the Secretary of Defense. Esteban Rodriguez, a civilian responsible since mid-2003 for overseeing interrogations as director of the Joint Intelligence Group, said that of 4 controversial techniques requiring the secretary's advance approval, the only one for which approval had been requested during his tenure was isolation. (The others are attacking or insulting a detainee's ego, using a "Mutt and Jeff" team of friendly and harsh interrogators, and taking away religious items such as the Koran as a punishmentref) According to the Army report released last July, Hood discontinued the practice of sleep disruption during interrogations when he took command in early 2004. "I'm not interested in stressing anybody," Hood said. "The most valuable interrogation efforts have occurred . . . by building a rapport over time." He also told us that interrogators under his command are not given access to information from detainees' medical or psychiatric records. "Medical care has no connection to intelligence gathering," Hood said. "Zero. None." However, BSCT psychologists said that for safety reasons, they are sometimes informed if a detainee has a medical condition such as diabetes or heart disease that might cause symptoms during an interrogation session. Hood said the majority of interrogation sessions focus on > 100 detainees considered to have high intelligence value, many of whom are thought to have been mid-level operatives for Al Qaeda. Many of these detainees, as well as some of Camp Delta's most violent prisoners, are held in Camp 5, a maximum-security prison that has modern interrogation wings, electronically wired so that analysts or other observers can watch interrogation sessions remotely. Detainees are kept in single cells, apparently segregated from other prisoners to a much greater degree than in the other camps. We were not shown Camp 5. Dr. K., a military psychiatrist and internist who runs the prison's behavioral-science service, told us that someone on her staff sees each detainee in Camp 5 about every 2 weeks, "to make sure they are doing OK." We spoke with Dr. H. and Dr. D., the 2 psychologists who currently serve on Guantanamo's 3-member BSCT. The BSCT psychologists are part of the Joint Intelligence Group and do not provide mental health care to detainees. Their role is to observe interrogation sessions and provide feedback to interrogators, as well as advise guards on managing detainees' behavior. "We don't advise [interrogators] on how to up stress," said Dr. H. "Those kinds of techniques do not work; they are not effective. Rapport building . . . is really what we try to emphasize." Dr. H. said that she had undergone Survival, Evasion, Resistance, and Escape (SERE) training, a military program designed to teach trainees how to withstand abusive treatment and interrogation if they are taken prisoner. Some people familiar with the program have suggested that SERE-trained BSCT psychologists may have used the experience to help design coercive interrogation strategies. Military officials told us they had found no evidence that this has occurred. As a result of SERE training, "I now have a better appreciation of what detainees are exposed to," said Dr. H. "We are never taught any kind of techniques whatever" for harsh interrogation. But many observers remain concerned about the potential misuse of SERE training, as well as the larger ethical and medical ramifications of involving psychologists and psychiatrists in interrogations. "Empirically, it would be very easy for people with that kind of training to import their work into other arenas," said Georgetown University ethicist Nancy Sherman, an authority on military culture who was a member of the group visiting Guantanamo. "The role of a psychologist on the other side of a one-way mirror — advising, consulting, helping build rapport — is extremely slippery." In recent months, organizations for mental health professionals have been trying to set ethics guidelines for their members. This past June, a task force of the American Psychological Association concluded that "it is consistent with the APA Ethics Code for psychologists to serve in consultative roles to interrogation and information-gathering processes for national security related purposes," although they should not "support, facilitate, or offer training in torture or other cruel, inhuman, or degrading treatment." In November 2005, the assembly of the American Psychiatric Association endorsed a statement that psychiatrists should not participate in or serve as consultants for the coercive interrogation of prisoners, involving methods such as degradation, threats, isolation, imposition of fear, humiliation, sensory deprivation or excessive stimulation, sleep deprivation, exploitation of phobias, and infliction of physical pain such as prolonged stress positions. Psychiatrist Steven S. Sharfstein, the president of the American Psychiatric Association and a fellow visitor to Guantanamo, said there is consensus in his association that psychiatrists should not be involved in the interrogation of detainees at Guantanamo or in Iraq or Afghanistan. "There is great concern about when you depart from your physician role," he said. When a forensic psychiatrist examines a prisoner in a civilian jail, the psychiatrist first explains to the prisoner that the interview may not be to his benefit, and the prisoner is allowed to refuse. "With the detainee situation, there is none of that," Sharfstein said. "The process of interrogating detainees is, by its very nature, deceptive, and that's a major problem. . . . People have to interrogate, but it's really inappropriate to use psychiatrists." Department of Defense policy states that detainees in military custody should receive medical care similar to that provided to U.S. soldiers. For one Guantanamo detainee, that meant bringing in a team to perform coronary catheterization and place stents; for another, it required bringing in a thoracic surgeon to remove an anterior mediastinal thymoma. Other specialists are available at the naval hospital on the base. A prosthetist visits quarterly to care for detainees who are missing parts of limbs. The hospital has a mini-ICU and two negative-pressure laminar-flow rooms for patients with communicable diseases. Medical corpsmen screen detainees' medical problems and dispense daily medications. "We try to handle most minor medical problems on the block," Edmondson said. "It takes two guards to transport a detainee to the clinic," located in Camp 1. Some detainees are followed for chronic medical problems such as hypertension, coronary disease, diabetes, hyperlipidemia, and latent tuberculosis. As of October 19, 135 operations had been performed at Camp Delta. At first, most surgery involved treating wounds and removing shrapnel; now, operations such as hernia repairs, cholecystectomies, and appendectomies make up the bulk of the surgical caseload. Dr. O. told us that the demand for medical care has doubled in recent months, from an average of 2000 patient contacts per month last spring and early summer to an average of 4000 patient contacts per month during the late summer and fall. He added that inpatient volume had increased 10-fold (presumably because of the hunger strike) and that 4 members had been added to the medical team. With some detainees approaching the end of their fourth year at Camp Delta, mental health is an increasing concern. Adjoining the detention hospital is a new psychiatric unit containing 16 inpatient cells, recently completed at a cost of $2.65 million. Edmondson told us that 15-18% of detainees arrived with mental illness and that 6-8%are followed by mental health professionals. Dr. K., the director of the camp's behavioral services, said that there were 4 patients in the unit on the day we visited and that 40 detainees were seen regularly, for diagnoses including personality disorder, adjustment disorder, schizophrenia, and schizoaffective disorder. "The majority are appreciative of our care," she told us. "They let us know if they are having problems with sleep or depression." However, she added, fundamentalist Muslim detainees had on occasion refused to speak with her because she is a woman. "There is a lot of resistance to psychiatric care in the population we're working with," she said. Kristine Huskey, a lawyer with a Washington, D.C., firm representing 11 Kuwaiti detainees at Guantanamo, said in an interview that some of her clients had complained about their medical care. "Often, the only medical person who comes around is a corpsman," she said. "They complain that they want to see the doctor, and they don't get to. . . . I know that some of my guys have really serious health issues. I know they're not getting the care." She added that 2 of the firm's clients were debilitated by a hunger strike and were being tube fed; another had been advised by doctors at Guantanamo to have an operation but distrusted their recommendation. In other settings, "when patient–doctor issues become complicated, you get second opinions" or consult an ethics committee, Huskey said. "These guys don't have any of that." With no opportunity to see patients or speak with detainees, our group was in a position somewhat analogous to that of journalists "embedded" with U.S. military units. Although I learned much from the visit, I continue to juggle contradictory versions of the realities of Camp Delta: confident assertions by Hood and other officers that all treatment of detainees is humane, for example, contrast with statements by detainees, made through their lawyers, that it is not. Meanwhile, reports by the only objective observers with broad access to detainees — teams from the International Committee of the Red Cross that visit Guantanamo regularly — are not released to the public. As one of my fellow travelers, Georgetown's Sherman, observed the week after the trip, "I came home with cognitive dissonance." As we were preparing to board the jet at the end of our visit, Hood assured us once more that the military is trying to "do the right thing" at Guantanamo. He left us with a parting challenge: "All those who contend that what we are doing is not right should propose an alternative"ref.
Recent clinical trials of a hepatitis E vaccine in Nepal are a case in point. Run by GlaxoSmithKline and the US government Armed Forces Research Institute of Medical Sciences, the trials showed an impressive on-treatment efficacy for the experimental vaccineref. But the methodology of the trial raises questions about the ethics of clinical-trial conduct among vulnerable populations. The research team had to drop original plans to test civilian volunteers in the city of Lalitpur, after local people objected to a lack of informed consent or participation in trial design (for details of these events, see J. Andrews Am. J. Bioethics 5, W1; 2005). Instead, they gave the experimental vaccine to soldiers in the Royal Nepalese Army, who are vulnerable as members of the armed forces and as some of the poorest people in a 'least-developed' country. These ethical issues take on greater importance now that the hepatitis E vaccine may have public-health usefulness. Will the Nepalese community benefit? Or will the results be used only to develop a profitable vaccine for (mainly Western) travellers and US soldiers? We hope that GlaxoSmithKline and its collaborators make this vaccine accessible to the populations placed at risk by the trial, in line with well-intentioned humanitarianismref.
The trade in high-quality surgical instruments may be exploiting workers
in the developing world. Children as young as 7 are working to make scalpels,
scissors and other items, in sometimes unhealthy and dangerous conditions.
The problem is probably compounded by the low wages paid to workers in
Pakistan, which produces around 20% of the world's surgical instruments.
Shoppers are used to demanding that products such as coffee and bananas
are fairly traded. But healthcare institutions in the developed world should
also be striving to ensure that the products they buy do not exploit poor
workers. Some 50,000 people are involved in making stainless-steel surgical
tools in Sialkot; around 7,700 of them are childrenref.
Most start at the age of nine, although some as young as seven work in
Sialkot's many small workshops. Although complex, expensive instruments
such as endoscopes are chiefly made in Germany, many simple metal implements
are made by skilled Pakistani workers, who have inherited a tradition of
metalworking that extends back to seventeenth-century swordsmiths. A pair
of scissors that is finely crafted and machined can be made by manual labour
by someone who is appropriately trained. But although the world trade in
handheld surgical tools is worth at least $US650 million every year, poor
workers do not see much of the money. A pair of scissors might retail for
$80, but the German companies that market them typically pay the manufacturer
around $1.25. A Pakistani study in 2003 found that half of children making
surgical instruments reported injuries at work, with 95% suffering sleep
problems and 80% enduring back, neck or shoulder pain, as well as eye and
lung problems. This probably stems from the use of grinding, milling and
corrosive chemicals, and the high levels of dust and noise in workshops.
Boycotts, however, are not the answer : refusing to buy tools from these
places at all could exacerbate the poverty problem. Instead, ensuring that
adults are paid a fair wage should help to remove the need for their children
to work alongside them. The situation is similar to one encountered in
Sialkot in the manufacture of sporting goods such as hand-stitched footballs.
Sialkot and the surrounding area produces some 75% of the world's footballs,
and in 1997 sports manufacturers signed the Atlanta Agreement, which declared
that under-14s should not work stitching footballs. The big downside was
that children had to find other work. With poor families still struggling,
many of their children may have ended up making surgical tools instead.
Fair trade consists of making the whole supply chain transparent. The British
National Health Service's Purchasing and Supply Agency said that, although
they provide a list of recommended suppliers for surgical instruments,
and strive to ensure that these goods are not produced unethically, individual
healthcare trusts in Britain are free to source their goods from wherever
they like. Some of the healthcare regulations in the USA and Europe also
seem to be inadvertently fuelling the problem. In 1994, US legislation
demanded that all surgical goods conform to international quality standards.
This meant that rival companies were left producing essentially identical
products and competing only on price - leading them to increase the use
of cheap labour
Web resources:
What price a human egg? The question provokes a variety of emotions
and responses. Some will argue that an egg has no monetary value when it
is just one of those ovulated each month by billions of women and that
perishes unfertilized. Others might contend that the same egg is priceless
— because it could, if introduced to the correct sperm, form the seed of
a new person. Others still will find it morally problematic even to pose
the question, on the grounds that it treats human cells as merchandise.
But the question is being asked, nonetheless — indeed, it is at the forefront
of a vigorous debate about whether and how much to pay women for donating
their eggs for research. Some biologists are keen to use fresh human eggs
for the production of human embryonic stem cells. Yet they are anxious
to distance themselves from the path taken by disgraced South Korean researcher
Woo Suk Hwang, who lied about paying women for eggs and tainted the whole
idea of oocyte donation. In a Commentary in this week's issue, Insoo Hyun
of Case Western Reserve University in Cleveland, Ohio, who chairs a task
force exploring the issue at the International Society for Stem Cell Research,
argues that women who donate eggs should be financially compensated for
their time, discomfort and trouble. Hyun argues that institutional review
boards and other oversight bodies can select a level of remuneration that
is enough to ensure that donors are compensated for their trouble, but
not enough to blind them to the risks involved. That will be an exquisitely
fine line to draw. A sum that will be merely compensation for one woman
could be enticement for another, poorer one. And in the real world, where
questions over clinical research, informed consent and conflicts of interest
have lately enjoyed a high profile, confidence in the ability of these
review boards to ensure adequate oversight will not be universally shared.
The situation is further complicated by the health risks that may be posed
by ovarian stimulation. There are hints, but no definitive evidence, that
the drugs used to stimulate the ovaries for both in vitro fertilization
(IVF) and egg donation increase the long-term risks of cancer. How, then,
can a fair level of compensation be set for risks that are essentially
unknown? How can a fair level of compensation be set for risks that are
virtually unknown? One possible way forward lies in a practice called egg-sharing,
in which women who are already considering or undergoing IVF are asked
to contribute surplus eggs to research in return for treatment at reduced
cost. The North East England Stem Cell Institute in Newcastle Upon Tyne,
UK, will soon start offering this scheme. Proponents point out that, by
working with donors who are using ovulation-stimulating drugs anyway, this
avoids exposing otherwise healthy women to any risks associated with them.
The idea does not, however, impress those who object on ethical grounds
to any financial inducements to donors. The International Society for Stem
Cell Research is currently drafting guidelines on this issue. But they
won't overrule local laws and regulations, the uneven application of which
looks set to slow down stem-cell research. Researchers in nations that
prohibit payment for eggs, for example, may find themselves unable to work
on stem cells derived from eggs secured by collaborators elsewhere from
paid donors. In April 2005, the US National Academies issued guidelines
stating that women who donate eggs for research should receive only direct
expenses, such as travel to the clinic. If stem-cell researchers are to
suggest that payments should be more extensive, they will have to make
a more convincing case that adequate safeguards will be in place to protect
donors' rightsref.
Should women be paid for the time, discomfort and health risks involved
in donating eggs for research? The world's largest group of stem-cell scientists
is grappling with the question, and has now asked the public for its views.
Stem-cell researchers want eggs so they can work on somatic cell nuclear
transfer, or 'therapeutic cloning'. They hope to derive embryonic stem
cells matched to patients' DNA, by transferring the nucleus of one of the
patient's cells into a human egg and developing it into an embryo from
which cells can be derived. The technique has great medical potential —
but researchers are far from achieving it, and the main limiting factor
in the research is the availability of human eggs to practise on. So far,
scientists have relied on women already undergoing fertility treatment
donating their extra eggs for research. But the supply is meagre. To help
persuade them, several labs are increasingly offering financial rewards,
such as cheaper fertility treatment. Others are starting to ask healthy
women to donate — triggering a debate about how such women should be compensated.
Some ethicists argue that women should receive compensation for the discomfort
and effort involved. Others are worried that this will create an undue
incentive that will coerce women — especially poorer ones — into giving
up their eggs. The fact that so little is known about the long-term health
risks of the procedure further complicates the picture. Scientists in many
parts of Europe, Asia, the Middle East and North America ask women to donate
eggs for research, but they all treat the practice differently. Scientists
at the North East England Stem Cell Institute announced on 27 July that
they had got permission from the UK Human Fertilisation and Embryology
Authority to pay part of the cost of in vitro fertilization treatments
for women who donate eggs for researchref.
But other European countries that accept egg donation for research, such
as Sweden, prohibit payment for anything other than direct expenses. Japan
bans egg donation altogether because of the risk of complications, whereas
China, along with several other countries, does not specifically address
the question. In the United States, a National Academies panel recommended
last year that women should be reimbursed only for direct expenses. This
approach has been adopted by the California Institute for Regenerative
Medicine, and by the state of Massachusetts, home of the Harvard Stem Cell
Instituteref.
Both institutes are asking healthy women to donate eggs for research. But
even their policies differ — for instance, California law would allow paying
the travel expenses of women who come from out-of-state to donate eggs,
whereas it's not clear how Harvard will handle this question. At the moment
we're confining the search to this area. Scientists want international
guidelines so that they can share materials without worrying about how
they were derived. So a task force of the International Society for Stem
Cell Research (ISSCR) is considering the compensation question as part
of a larger effort to draw up guidelines. The task force, made up of scientists,
ethicists and lawyers from 14 countries, was convened last year after the
revelation of scientific misconduct by South Korean stem-cell researcher
Woo Suk Hwang: as well as faking evidence of 11 human ESC lines derived
by therapeutic cloning, he lied about paying hundreds of women for eggs,
and obtained eggs from his female subordinates. On 30 June, the ISSCR task
force released draft guidelines at its annual meeting in Toronto. The guidelines
embrace most of the principles proposed by the National Academies last
year. But they differ on the issue of egg donation. The task force leaves
the door open for a more liberal policy on compensation by stating simply
that stem-cell research projects should be reviewed by a local oversight
body, which must ensure there are no undue inducements or other undue influences
for the provision of human materials. What constitutes 'undue' is left
to the local oversight bodies. This is the best consensus the task force
was able to achieve, because scientists and ethicists on the task force
disagree so sharply about how egg donors should be treated. The guidelines
are seen as an important first step nonetheless, and are now open to public
comment until 1 September, when the ISSCR will finalize the document. These
are going to be seen as the rules set by scientists themselves, from the
inside out. It's very useful for scientists to show that they have thought
about these issuesref.
In 1989, a healthy 32-year-old woman offered her infertile younger sister
some of her healthy eggs, and with them the chance to have a baby. Doctors
at the Cromwell IVF and Fertility Centre in London gave the donor hormones
that made a batch of eggs in her ovary mature, and collected six eggs for
fertilization. 3 embryos were transferred to the younger sister and 2 were
frozen. One baby girl was born. 5 years later, the doctors contacted the
egg donor to ask whether to discard her frozen embryos. They discovered
that she had been diagnosed with late-stage colon cancer that spread to
her skull. She died just before her 39th birthday. Doctors don't know if
the fertility drugs caused or accelerated the woman's cancer. But the possibility
prompted Cromwell infertility specialist Kamal Ahuja to report the case
as a reminder of how little is known about the risks of donating eggsref.
It
shook us all up. Specialists in reproductive medicine say there is insufficient
information about the long-term risks of drugs used to stimulate ovulation,
a practice that has become more common in the past 25 years, with the proliferation
of in vitro fertilization (IVF) and assisted reproduction. But some
studies have suggested the drugs may be linked to the development of certain
cancers. The question is receiving renewed scrutiny now that scientists
are asking healthy women to donate their eggs for stem-cell research —
exposing them to the potential risks of ovulation stimulation without the
end result of a baby. To discuss the issue, the California Institute of
Regenerative Medicine (CIRM) in San Francisco has convened a meeting of
experts to be held next month. Britain's Human Fertilisation and Embryology
Authority (HFEA) will also tackle the issue in a forthcoming consultation
on egg donation for research. The uncertainty makes it even more difficult
to reach a consensus on whether women who donate eggs should be compensated,
and if so by how much. This discussion should emphasize long-term risk
assessment rather than money. This discussion should emphasize long-term
risk assessment rather than money. During ovulation stimulation for IVF
or egg donation, women are given drugs that encourage the ovary to ripen
several eggs simultaneously, rather than the one egg normally ovulated
each month. Doctors know that this can have side effects ranging from moodiness
to infection. The most serious is ovarian hyperstimulation syndrome, which
seriously affects about 6% of women receiving the drugs. > 30 eggs start
to develop at once and fluid leaks out of blood vessels and collects in
the abdomen, causing nausea, bloating and very occasionally kidney failure
or even death. There is little information on how frequently ovulation
stimulation has tragic side effects, says obstetrics and gynaecology professor
Didi Braat of Radboud University Medical Centre in Nijmegen, the Netherlands,
because doctors are often reluctant to report such cases and rarely have
to. But deaths are thought exceptional: in a study reported at this year's
meeting of the European Society for Human Reproduction and Embryology,
Braat and her colleagues found only six deaths clearly linked to IVF from
the medical records of some 100,000 women who underwent the procedure between
1984 and 2006. So some specialists are more worried about the long-term
risks of fertility drugs. In the 1990s, for example, studies pointed to
a link between fertility drugs and breast or ovarian cancer, although it's
not clear how cancer would be promoted. One study suggested that women
who took an ovulation-stimulating drug called clomiphene citrate for more
than a year had 11 times the risk of developing ovarian tumours compared
with the general populationref.
But these studies are controversial. It might be infertility, not fertility
drugs, that predisposes women to disease. Other aspects of women's reproductive
lives influence ovarian and breast cancer — pregnancy is thought to protect
against tumours, for example. And ovarian cancer is so rare that it's hard
to get a large enough sample to spot any connection. Louise Brinton at
the US National Cancer Institute in Bethesda, Maryland, and her colleagues
tried to control for these factors in one of the most comprehensive studies
so far. They collected the medical records of more than 12,000 women who
received ovulation-stimulating drugs between 1965 and 1988. The team did
not find statistically significant increases in breast and ovarian cancer,
but did find that the women were around 1.8 times more likely to develop
uterine cancerref.
Such studies have reassured many specialists that the risks of ovulation
stimulation are insignificant. But the picture is still incomplete. Brinton's
study involved mainly women who took clomiphene citrate, rather than the
gonadotropin hormones introduced for IVF in the 1980s. Researchers have
only had a decade or so to study significant numbers of women taking the
newer drugs, but extra cancers may not appear until the women reach 50
or 60. Researchers also don't know whether studies on infertile women can
be generalized to egg donors, who are typically younger and healthier.
Epidemiologist Mary Croughan at the University of California, San Francisco,
has unpublished data suggesting donors are at lower risk of cancer. But
"it's important to follow these women into the future. She and other experts
want more extensive studies to follow up women who have had IVF treatment
or donated eggs. There is at least one large study of the long-term effects
of ovarian stimulation under way in the Netherlands. But it's unclear who
will drive the effort, particularly when private fertility clinics may
have little interest in finding out the potential risks of the drugs they
use. Ahuja suggests that an authority such as Britain's HFEA could coordinate
such an investigation. Some argue that the researchers asking women for
eggs should help pin down the health risks. There is some kind of ethical
obligation there. The September CIRM meeting will focus on these risks
and discuss what relevant data might be collected in the course of the
institute's research. It's important for people to understand in the consent
process that we don't know as much as we should about what those risks
are. The Harvard Stem Cell Institute tells egg donors of the risks, and
that they cancel the procedure if women show signs of ovarian hyperstimulation
syndrome. If the risks aren't made clear upfront, one well-publicized tragedy
could kill efforts to find donors, adds John Buster, professor of obstetrics
and gynaecology at Baylor College of Medicine in Houston, Texas. If a woman
has a cardiac arrest while giving eggs for stem-cell research, it won't
go down too wellref.
"Who am I?" has always been a fundamental philosophical question that may require decades of reflection to answer. With the advent of DNA analysis, there is a growing public impression that the answer may be found in our genes. Various Internet sites offer descriptions of our ancestral history on the basis of our DNA, as well as testing for specific "disease genes" or general profiles that are used to recommend lifestyle changes, such as foods to be eaten or avoided. Researchers have even suggested that although the scientific evidence is speculative and at best probabilistic, many people will want to have their DNA analyzed for markers of predispositions toward certain behaviors, including risk taking, overeating, aggression, and even criminality. As these opportunities to learn about our DNA expand and affect the way we construct our personal identities, we should be alert to the risks as well as the benefits of exploring our DNA and basing an understanding of who we are on genetic testing. We should be wary of perceptions of ourselves — whether our own or others' — that are based on results of tests that have not been validated or on misinterpretations of valid tests. We should be at least as concerned that others may know more than we do about our own genetic makeup. DNA analysis, in combination with the Internet, creates an unregulated market in DNA and new opportunities for invasions of genetic privacy. Using the Internet for the marketing and purchasing of genetic tests sidesteps the doctor–patient relationship and eliminates meaningful, face-to-face genetic counseling. It also magnifies an older but unresolved danger: whenever identifiable DNA samples are collected and stored, there is a high risk that violations of genetic privacy will follow. As the evolution of DNA banking for research demonstrates, DNA donors shouldn't assume that the privacy protections they take for granted in medical care and clinical research apply. People give up more than they realize when they hand over their DNA. DNA collection and banking have already gone through two distinct stages. Initially, the people most actively involved in DNA collection (outside law enforcement and the U.S. military, both of which use DNA for identification purposes only) were researchers seeking genetic markers for a particular disease, who typically collected DNA samples from families at risk for the disease of interest and stored those samples. Consent forms typically contained a provision permitting the researchers to retain and reanalyze DNA samples in related research after the primary study was completed. In the next iteration, consent documents included much broader statements in which subjects acknowledged that their DNA samples would become the property of the researchers (or institutions), who could control the samples for their own benefit. The research subject was thereby transformed into a DNA donor. Recent years have seen the emergence of private companies, such as the Ardais Corporation and DNA Sciences, that — either at hospitals or through appeals over the Internet — collect and analyze samples and personal information for the express purpose of selling them to researchers. The National Institutes of Health also has plans to develop a national repository similar to the U.K. Biobank, a new resource for researchers that will eventually include information and blood samples from 500,000 volunteers. With such developments, DNA banking is quickly changing from an academic research activity to a governmental and commercial enterprise conducted by DNA brokers. As a result, the relationship between subjects and researchers is being severed, and along with it the associated legal rights and obligations, including obligations to reduce risks to subjects' privacy and to maintain the confidentiality of their information. The unresolved legal status of the relationships among donors, brokers, and researchers raises troubling questions about privacy and property rights. Without adequate protections for genetic privacy, autonomy to discover and use one's own genetic information for one's own purposes cannot be realized. A fundamental concern is that the possession and storage of a personally identifiable DNA sample give the possessor access to a wealth of information about the person and his or her genetic relatives. This includes information derivable from new DNA tests that were not available, or even anticipated, when the sample was relinquished. Consequently, as long as personally identifiable DNA samples are stored, there is the possibility of unauthorized access to and use of genetic information — an invasion of genetic privacy. To the extent that we see ourselves and our future as influenced by our genes, such invasions can disrupt our very sense of selfref. In response to this concern, a majority of states have begun to regulate genetic testing and fair uses of genetic information. But these laws are almost exclusively antidiscrimination statutes that target the behavior of insurers, employers, or both after the DNA has been collected and analyzed. Some states, such as New Jersey, include broader privacy protections by prohibiting unconsented-to collection and testing of DNA generally (although those statutes typically include broad exceptions for law enforcement and medical research) and by defining requirements for consent to testing. Only about half a dozen states, however, require either explicit consent for sample storage or the destruction of samples after the purpose for their collection has been achieved. It is, of course, the DNA sample itself, which can usefully be viewed as a coded probabilistic medical record, that makes genetic privacy unique and differentiates it from the privacy of medical recordsref. The absence of any meaningful property or privacy protection of DNA samples means that consumers must be extra cautious and seek specific information about the fate of the samples before sending them off for testing. Minimal information that they should obtain includes the site where the sample will be analyzed, whether and how long it will be stored, and who will have access to it and to any identifiable information linked to it. The best consumer advice, given current law, is that one should not send a DNA sample to anyone who does not guarantee to destroy it on completion of the specified test. Redefining ourselves and our futures in accordance with insights offered by our DNA is hopelessly reductionistic, if inherently fascinating. We will not learn who we are by having our DNA analyzed, but we will almost certainly give others the opportunity to learn something about us. And our DNA is not like our credit cards: we cannot simply get a new number. As long as someone has our identifiable DNA sample, he or she will be able to learn things about us we may not know, may not want to know, and certainly don't want others to know. DNA collection, banking, and analysis are expanding rapidly, and we need a federal genetic privacy law to protect people who want to know what secrets their DNA contains, as well as those who don'tref.
With a credit card and a few clicks of their computer mouse, consumers can now order a test for the BRCA1 or BRCA2 gene mutation or any of hundreds of other diagnostic assays, all without involving their physician or health insurance plan. Direct-to-consumer marketing of genetic testing and other laboratory services has arrived. Proponents argue that the companies offering these tests are bringing sophisticated diagnostic services to consumers who are interested in genetic testing and have the money to pay for it but lack access to clinical testing sites. And they laud the companies' promise of anonymity to consumers who fear discrimination by an employer or insurance company on the basis of a genetic predisposition to a disease. Critics counter that the companies exploit consumers' anxiety in order to sell them tests they don't need, without offering the counseling necessary to understand the results. At www.dnadirect.com, consumers interested in BRCA testing complete a short online questionnaire that elicits their personal and family medical history and information about their ethnic background; the site's algorithm uses this information to recommend a specific test. After paying with a credit card (DNA Direct does not accept health insurance) and speaking with a counselor on the telephone, customers receive a requisition signed by the company's medical director and a test kit to take to a phlebotomist, who will draw their blood and send it to Myriad Genetics, the only U.S. company currently performing commercial BRCA testing. Results are provided to DNA Direct, which makes them available to the customer through a secure log-in on the Web site. However, many clinicians are dubious about the quality of the genetic counseling, if any, that is provided by such companies. They question whether the counselors are appropriately trained and whether counseling conducted over the telephone is as effective as a face-to-face discussion. An ongoing study funded by the National Cancer Institute is evaluating such telephone counseling. DNA Direct, for its part, reports that genetic counselors (certified by the American Board of Genetic Counseling) conduct all counseling, which includes a telephone interview before testing and another telephone session when the results are reported. The company also provides customers with a detailed online report that contextualizes and interprets their results and makes the genetic counselor available for follow-up discussions. But not all companies build in a robust counseling feature: LabSafe, another online test provider, for instance, gives written test results but employs no genetic counselors and charges $75 for a 15-minute telephone consultation with a staff physician to review the results. One reason that many clinicians are skeptical about the counseling provided is that these companies make money only when they sell a test. "Genetic counseling is supposed to be agnostic on whether people should get tested, [so] I worry about a business model that is dependent on people being tested to make money," said Marc Schwartz, codirector of the Cancer Control Program at the Lombardi Comprehensive Cancer Center at Georgetown University. If you visited the DNA Direct Web site in mid-July 2006 and indicated that you were interested in testing for familial breast and ovarian cancers but reported no personal, family, or ethnic risk factors for either disease, the Web site would advise that full-sequence BRCA testing was the most appropriate, at a cost of $3,456. Ashkenazi Jews or consumers who have a family member with a BRCA mutation are advised to have more focused screening, costing $620 to $695. Schwartz and other critics acknowledge that these companies provide consumers who are concerned about genetic discrimination the opportunity to obtain testing and genetic counseling without the results' becoming part of their medical record. Whether fear of such discrimination is justified, however, is a matter of some debate. Examples of discrimination do exist, but many observers believe that egregious cases are rare. "I think that fears of discrimination have to date been unfounded," said Mark Barnes, a health care attorney at Ropes & Gray in New York. "One has to really search for instances in which companies or insurers have discriminated against individuals on the basis of genetic testing." Some clinicians see discrimination as the least of patients' concerns with regard to highly predictive tests for serious diseases. "Once you choose to be tested for the BRCA gene mutation, privacy is not the issue," said Judy Garber, director of the Cancer Risk and Prevention Program at the Dana–Farber Cancer Institute in Boston. "If you are negative, you don't care. If you are positive, the implications of the test to your medical care require that you communicate the results to your physician." Garber nonetheless referred a patient to DNA Direct, after genetic counseling, when the patient's concerns about privacy became an insurmountable roadblock to testing. Anonymous testing presents complex challenges to physicians and patients. Physicians who recommend that their patients be tested anonymously for a genetic predisposition to a disease may be responsible for providing follow-up care based on the results, whether or not they document their recommendation or receive the test results. Susan Smith of North Carolina was referred to DNA Direct by her hematologist after she had two mid-trimester pregnancy losses, and tests revealed that she carries the factor V Leiden gene mutation. Smith, who was pleased with the telephone counseling she received from the company, asked her hematologist to keep the result out of her medical record for fear that she would be discriminated against, posing a dilemma for the physician. Consumers may find themselves ineligible for life insurance or disability insurance if they report a genetic disposition to a disease. Or their insurance policies may be voided if they fail to disclose that they tested positive for a mutation and are later found out, according to Joy Pritts of the Health Policy Institute of Georgetown University. Furthermore, unlike physicians, hospitals, and the laboratories that do the actual testing, the companies that offer online testing services are not subject to the privacy restrictions of the Health Insurance Portability and Accountability Act (HIPAA), although most of them claim to be "HIPAA-compliant." The BRCA test is only one of a growing number of tests available directly to consumers. In addition to testing for both the relatively common factor V Leiden gene mutation and the uncommon gene for Canavan's disease, these companies provide tests as mundane as a cholesterol screening panel. But they serve only as a front end; federal regulations prohibit them from performing the tests themselves. The diagnostic laboratories they use must be certified according to the Clinical Laboratory Improvement Amendments, which specify that results must be reported to the ordering clinician — not to the consumer. So each online testing company has an arrangement with a physician whose name is used to order the tests and receive the results from the labs. There are also numerous Internet-based companies that market tests for ancestral origin or that determine whether two persons are related on the basis of polymerase-chain-reaction testing for variability in the Y chromosome or mitochondrial DNA. Some companies also market noninvasive tests for fetal sex based on the analysis of fetal DNA in the maternal circulation, although one of these companies, Acu-Gen Biolab of Massachusetts, is facing litigation stemming from testing inaccuracies. Sharon Plon, chief of the Cancer Genetics Clinic at the Baylor College of Medicine in Houston, sums up the wariness of many physicians with regard to online genetic testing: "My biggest concern," she says, "is that members of the public are getting tests that they don't understand, and their physicians may not understand, and they may be making big decisions that are ill-informed." On July 27, 2006, the Federal Trade Commission issued a consumer alert in an effort to address such concerns as well as privacy protectionref.
There is little evidence that memory can be enhanced in healthy people by taking a drug. But that may well change in the years to come as drug companies pour research money into what could be a highly lucrative market—“memoryceuticals”. Will competitors at future World Memory Championship have to provide urine samples to prove that they are not cheating? Pharmaceuticals that are licensed to treat dementia—the cholinesterase inhibitors and the N-methyl-D-aspartate blockers—have little effect on memory in healthy people. So pharmaceutical companies keen to tap in to the potentially huge market of age-related memory loss are looking to develop compounds that target the subcellular processes that underlie memory formation. In particular, they are interested in compounds that affect the initial induction of long-term potentiation or that target the later stages of memory consolidation. Importantly, however, age-related memory loss is not considered to be a medical condition—yet. Should society be worried about the medicalisation of normal physiological processes, such as forgetfulness? Is it ethically acceptable to embrace technology to make ourselves as good as we possibly can be? Competitors at the World Memory Championship have trained their brains to an astonishing extent; the current world record for memorising the order of a pack of playing cards is just 31.03 s. Advocates for memory sports say that anyone can develop a fantastic memory if they are dedicated enough. All it takes is practice and perseverance. But a safe and effective memoryceutical would certainly help. Would you be happy to pop a memory pill or would you prefer to maintain the daily routine of hunting for your car keys? You may have to choose sooner than you thinkref.
Copyright © 2001-2014 Daniele Focosi.
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