Medical Research Stakeholders Seek to Overturn Informed Consent Protections

Part 3 of 4:  Bioethicists Promote the Business of Medicine, Not the Ethics of Medicine
By Vera Sharav

A bioethicist is to ethics what a whore is to sex.”[1]  Richard J Neuhaus
“Research oversight is expensive…how much do you want to spend?”[2] John Lantos, MD, Bioethicist

This essay focuses on the ethics of bioethicists; it was prompted by the bellicose defensive response by the dominant faction in bioethics to the disclosure that researchers at 23 medical centers who conducted the government-sponsored SUPPORT study in extremely premature babies failed to comply with federal informed consent requirements.

Since we posted Part 2 (on June 30), Dr. Michael Carome[3] of Public Citizen has brought to light ADDITIONAL, previously overlooked, very serious ethical violations in the SUPPORT experimental design and consent documents.

Thirteen hundred and sixteen extremely vulnerable premature babies were subjected to two experiments conducted simultaneously: premature_infant_helmet.jpg

  1. the oxygen experiment measured the effect of two oxygen saturation target ranges—high vs. low—comparing the primary outcomes of retinopathy of prematurity (ROP) and death;

  2. the CPAP experiment measured the effect of using a continuous airway pressure mask (CPAP) vs. standard of care, comparing the primary outcome of lung disease and death.

In 2004, prior to the start of the SUPPORT trial, the investigators acknowledged:

The current dilemma is that there is an increasing interest in using early CPAP but the best available evidence indicates that intubation/early surfactant produces the best outcomes.”

The CPAP experiment used strict criteria for intubation-extubation (insertion-extraction of a tube in the babies’ windpipe) vs. “standard of care intubation and early surfactant treatment.
According to the SUPPORT investigators’ 2004 slide presentation,  babies in the CPAP group

   will be forced to early extubation attempted at higher ventilation settingsThese  criteria are more severe than have been used in any trial, and as far as we can tell, are more severe than used in most Network centers…”

Instead of minimizing risks—as medical ethics and federal regulations mandate—these babies’ safety was subordinated to protocol-dictated experimental procedures.

Every baby in the SUPPORT experiments was exposed to multiple protocol-driven, experimental procedures that deviated from “standard of care.” The babies in the combined low-oxygen-CPAP group were exposed to the most extreme combination of experimental interventions in an effort to force them off ventilators. The babies were exposed to increased serious risks, and those risks were concealed from the parents.

The Origins of Bioethics

Bioethics is not an outgrowth of medical ethics which in the Hippocratic tradition is a moral enterprise. The term bioethics was first coined in 1927,[4] pertaining to the research use of animals and plants. In the 1970s it was defined to describe the eugenic enterprise: “to help mankind toward a rational but cautious participation in the process of biological and cultural evolution.”[5] Though bioethicists self-consciously avoid using the term[6]—because of its inextricable link to Nazi ideology and its “Final Solution”—the roots of bioethics are in the American eugenics movement.

As a profession and academic discipline, bioethics stands on an extremely thin foundation. It was created by government in response to public outrage following a series of exposes about abuses in medical experiments conducted by American physicians.A Congressional mandate in 1974 required the secretary of the Department of Health, Education and Welfare (now Health and Human Services, HHS) to appoint a national commission to “identify the basic ethical principles” for the federal government to use when resolving ethical dilemmas in medical research.[7]

The National Commission for the Protection of Human Subjects formulated three ethical principles—respect for persons (dignity, autonomy), beneficence (“do no harm,” maximize benefits, minimize risks) and justice (equitable selection of subjects)—which were issued as The Belmont Report, (1979), laying the foundation for US research regulations.

Tom Beauchamp,[8] a founding father of Bioethics, and a member of that Commission, told the President’s Council on Bioethics in 2006:

“…the National Commission was very concerned throughout its work that it had become too easy in the biomedical world to use utilitarian justifications of research.  The Nazi experiments, Tuskegee, Willowbrook, and Jewish Chronic Disease Hospital case … had left a legacy of being driven by a very utilitarian view of social beneficence, that justified using human subjects on grounds of benefit to the broader public…” 

Notwithstanding Beauchamp’s rendition, the dominant faction in bioethics today is driven by utilitarian values, applying a moral calculus grounded in business ethics, applying cost-benefit calculations to public health policies. Bioethicists calculate a risk (burden) / benefit ratio from a societal viewpoint, believing that individual rights must take a back seat for the supposed “greater good.”  Implicit in utilitarian ethics is the eugenic rejection of the equality of human beings as a principle guiding government policy—individual human rights are no longer sacrosanct.

Utilitarian bioethicists rationalize overriding od individual rights, endorsing policies that determine which individuals (or groups) must bear the burden of sacrifice for the presumed societal benefits. History painfully documents how utilitarianism lends itself—and has been used—to justify coercive, discriminatory, even genocidal government policies to implement grand schemes for “improving human characteristics” and remaking society.

The influence of eugenics in public health In America led to forced sterilization policies to prevent the birth of “defectives,” that cast a wide net targeting people who were perceived to be inferior. That policy was legitimized by a Supreme Court decision, Buck v Bell (1927) written by Justice Oliver Wendell Holmes justifying the policy “for the protection and health of the state.[9] The decision has never expressly been overruled.

 Whose interests does bioethics serve and what is the meaning and value of their work?

Bioethicists present themselves as a professional class of moral experts whose primary task is to advise other biomedical professionals how to conduct their work ethically. Most people expect bioethicists to have higher ethical standards; but contrary to those expectations, with very few exceptions, [10] bioethicists are NOT MORAL CRITICS who speak out to put the brakes on ethically unacceptable biomedical activities.

A notable recent exception is a letter initiated by Ruth Macklin,[11]ruth-macklin.jpg Professor of philosophy and bioethicist, Albert Einstein College of Medicine, co-signed by 45 bioethicists, physicians and legal scholars, in support of the Office for Human Research Protections (OHRP)[12] and its letter of determination that censured the SUPPORT researchers and medical centers for their failure to disclose to the parents the purpose, the nature of the experimental procedures, and the most serious foreseeable risks for the babies—i.e., death and brain damage.

Unlike traditional philosophers of ethics who criticized abuse of power, those who dominate the field and shape public policy have “aligned themselves,” as Mark Kuczewski, former president of the American Society for Bioethics and Humanities, acknowledged, “with money and power.[13]

They do not identify or support patients’ rights. Indeed, rarely, if ever, have bioethicists either criticized unethical contemporary research conduct or supported the vulnerable in society—such as people with disabilities. Neither have bioethicists supported the rare physician whose ethical action on her patients’ behalf, resulted in retaliation by a drug manufacturer and her university.  That physician, Dr. Nancy Olivieri, acted in accordance with the medical profession’s ethical responsibility; to protect her patients from serious harm that had emerged during a clinical trial.[14]

But then, unlike other professions, bioethics lacks a code of professional ethical conduct.[15]

Most, if not all other professionals, not only in medicine, but accountants, architects, engineers, financial planners, hairdressers, journalists, lawyers, nurses, psychologists, real estate agents, social workers, et al, have professional codes of ethical conduct that spell out their responsibilities and accountability. Bioethicists are a party to every facet of healthcare policy decisions—including life and death decisions at medical facilities—yet they are not held to any professional code:

There is, I think, a misunderstanding that if you set up an ethics panel there are some sorts of ground rules, like principles of accounting, and everyone knows what those rules are.  In the field of ethics, there are no ground rules…It all depends on who you pick.”[16]

Bioethicists identify themselves with powerful corporate, academic and government entities—those who set healthcare policies to promote their own intertwined financial interests. They are hired, essentially as risk managers, selling ethics—preferably as consultants to pharmaceutical and biotech companies as well as government and academic institutions. Bioethicists sign contractual confidentiality agreements and provide “ethical” guidance for developing ethics policies and redefining regulatory language for a wide range of issues beyond clinical research, including public health policies, population control, women’s issues, cloning and molecular biology. The patronage of such powerful institutions is  enormously profitable, providing large sums of money to Bioethics Centers and individual bioethicists—and is a mark of prestige within the bioethics community, earning a step up on the career ladder. Daniel Callahan,[17] founder and longtime President of The Hastings Center, described the service that bioethicists provide for their clients; they “legitimate morally controverted research”:

“bioethics and its practitioners became ‘accommodating handmaidens’ serving mainly to add ‘the imprimatur of ethical expertise’ to research that ‘somebody or other wants to do’… those who would legitimate morally controverted scientific research long ago learned how to put together commissions and panels to include sympathetic [  ] ethicists… While bioethics creates problems now and then for mainstream…it mainly serves to legitimate them, adding the imprimatur of ethical expertise to what somebody or other wants to do.

 It is hardly likely that the National Institutes of Health (NIH) Human Genome Project would have set aside 5 percent of its annual budget for the Ethical, Legal, and Social Implications program if there had been even the faintest likelihood it would turn into a source of trouble and opposition; and it indeed hasn’t.” (1996)

The “Doctors Trial” at Nuremberg revealed the unbounded capacity for evil by physicians in the service of government.  The long list of unethical, US government-supported medical experiments—such as, Tuskegee, Willowbrook, radiation experiments conducted at major medical centers and institutions for disabled children—serve as reality-checks confirming that human nature—and the proclivity of doctors in positions of power and authority to cross ethical boundaries—has not changed.

What has changed since then is the arrival of bioethicists who provide their “ethical imprimatur” to legitimate morally controverted experiments.  The ethical legitimacy of research standards must not be left to the discretion of the medical community which has demonstrated a propensity for reconciling the wrongdoings of its fraternity.  The Maryland Court of Appeals[18] ruling in Higgins v Kennedy Krieger Institute (2001), specifically held: “It is clear to this court that the scientific and medical communities cannot be permitted to assume sole authority to determine ultimately what is right and appropriate in respect to research projects involving young children.“[p.12]

Francis Fukuyama a prominent political scientist / economist who served on the President’s Council on Bioethics (2002-2004) observed that bioethicists pandered to scientists, noting that in any discussion of controversial ethical issues, “it is usually the professional bioethicist who can be relied on to take the most permissive position of anyone in the room.”[19] He warned that the greatest danger from overreaching human genetic experimentation comes from scientists and bioethicists who “cannot be trusted to raise the alarm.” Professor Fukuyama stated that “many bioethicists have become nothing more than sophisticated and sophistic justifiers of whatever it is the scientific community wants to do.[20]

john_lantos.jpgDr. John Lantos, bioethicist at Children’s Mercy Hospital Bioethics Center, University of Kansas insists: “there was no evidence prior to the study that enrolling babies in the study would lead to an increased risk of retinopathy or blindness. And it did not….there was no evidence that enrolling in the study would lead to an increased risk of death. And it did not.”

If so, the trial lacked a purpose or clinical justification.

Dr. Lantos’ insistence is contradicted by the SUPPORT protocol and published report in the New England Journal of Medicine (NEJM) indicating that death and ROP were both components of the primary endpoint being assessed in the experiment. His claim is invalidated by the very article that he cites as the source of his conviction, “Resolving Our Uncertainty About Oxygen Therapy” (2003):

“Several hundred patients…may be sufficient to demonstrate important difference in severe ROP. However, a much larger sample… will be needed to exclude smaller important differences in outcomes such as mortality and disability to address real concerns about the safety of lower oxygen tensions.” [21]  

Erich Lowey, MD, an internationally recognized, distinguished philosopher and bioethicist who (until his death in 2011) accused the field of practicing “rich man’s bioethics” while failing to recognize systemic problems such as power disparities:  “We have made relatively little contribution to an equitable distribution of healthcare. In many respects, we have sold out.  In my view, this is an evasion of social responsibility—social responsibility being one of the hallmarks of an honest profession.”[22] “We need an ethics where we see ourselves as much as possible as part and parcel of the weak, an ethics of the weak, not of the strong.”[23]

But this humanitarian perspective fell off the radar screen from today’s reigning utilitarian bioethicists who aggressively endorse the most egregious experiments in which the safety of children was subordinated for expediency.  Babies’ lives were put at increased risk in an experimental design that is unacceptable when the subject is a human being.

Bioethicists are shown to accommodate and coordinate their positions with government officials—as was recently demonstrated in two highly controversial instances when government officials sought to “legitimate morally controverted” experiments on children who lack the capacity to refuse. The Presidential Commission for the Study of Bioethical Issues provided its “permission slip” for “Pediatric Research on Medical Countermeasures.” [24]

The ethical violations in SUPPORT disclosed in the OHRP letter of determination following a 2-year investigation, and the extensive ethical violations uncovered by Public Citizen[25] in the protocol[26] and consent documents,[27] reveal systemic failure by the research review and approval system.

The flurry of public criticism that followed,[28], [29] and the stinging denunciation of the experiment as “an ethical breakdown,”[30] alarmed the medical research establishment.  Fear about the outcome of a lawsuit that was filed (and others that may follow), and apprehension about the suspension of other neonate studies which had been approved by the NIH-Neonatal Research Network, but had not yet begun,[31] prompted the research establishment to rally in defense of this indefensible experiment.

A highly charged orchestrated campaign revealed the inextricable alignment of bioethics with the institutional medical research power structure that funds it.

Their defense of SUPPORT relies on utilitarian justifications, namely; they present a cost-benefit calculation to justify harming some babies for the benefits to be gained:

We are dismayed by the response of the OHRP and consider the SUPPORT trial a model of how to make medical progress. [32] … “Such studies are crucial for advancing medical practice, reducing risks, improving outcomes, and enhancing cost-effectiveness, particularly in the field of pediatrics.” [33]

But as often happens, the immediate beneficiaries of SUPPORT were the research stakeholders, while the claimed future benefits are speculative at best.

From their perch at the NEJM, American Academy of Pediatrics and The Hastings Center Bioethics Forum, the stakeholders who profit from clinical trials—whether or not those studies result in advancing medical progress—are demanding that they, rather than OHRP, should determine what’s ethical and what’s not; if, and when foreseeable risks should be disclosed—even risks such as death. The stakeholders seek to undercut the authority of OHRP—the federal agency charged with protecting human subjects from overreaching medical and behavioral research.

drazen.jpgThe NEJM has been serving as the launching pad for the defense of SUPPORT by the major stakeholders. The May 16, 2013 issue contained three commentaries defending SUPPORT. An editorial by Dr. Jeffrey Drazen32 stated:

the OHRP investigation has had the effect of damaging the reputation of the investigators and, even worse, casting a pall over the conduct of clinical research to answer important questions in daily practice.” A letter by SUPPORT investigators states: “Death was included in the primary outcome because it competes with retinopathy, not because a difference in mortality was expected.”[34]

david_magnus.jpgAn opinion piece by high powered bioethicists, David Magnus and Arthur Caplan,art_caplan.jpg [35] accused OHRP of focusing “unwarranted negative attention on valuable research,” admonishing OHRP to focus instead, on protecting the interest of research: “those responsible for oversight must be mindful of the value of important research…” They directed OHRP to avoid taking “measures that may impede the conduct of valuable research.” Both editorials resorted to the “strategic ignorance” defense, declaring that:

“…there is absolutely no evidence to support the claim that the infants enrolled in the [SUPPORT] study were exposed to greater risk than infants outside the study.” 35

However, their pretense of ignorance is belied by the SUPPORT report published in the NEJM[36] (2010) which confirmed previous reported findings, acknowledging that: “the safety of low target levels of oxygen saturation remains a concern.” Their finding was NOT unexpected. Drazen’s editorial contains one accurate sentence: “There was no way for you as a parent of a child in SUPPORT to know what the answer would be before your child participated.”

On June 5, 2013, the directors of NIH and NICHD[37] –the funding agency for SUPPORT—weighed in with a letter of support for SUPPORT, in concert with a letter paid for by NIH,[38] which was co-signed by 47 signatories who identified themselves as, “scholars and leaders in bioethics and pediatrics.”[33]

Both were simultaneously published in the NEJM. Additionally, the timing of OHRP’s backtracking letter[39] suspending its March 7 compliance action was posted on its website (June 4) to coincide exactly with the two letters. The 47 co-signers do indeed include “the best ethicists that money could buy.”[40]

NICHD director, Dr. Guttmacher, a co-author of the NIH letter, acknowledged that the two letters were “kind of, in some ways, partners.”[41] The thrust of their demand is that OHRP should overturn its findings and withdraw its letter of determination:

withdraw its notification to the institutions involved in the SUPPORT trial, that they failed to meet regulatory informed-consent requirements, in particular regarding reasonably foreseeable risks of enrollment in the study… failing to include specific information elements regarding risks of the study interventions in the parental permission documents… We believe that this conclusion will have adverse implications for future research.”

“Although we acknowledge that the permission forms could have been improved
Allowing the decision to stand would be unfair to the investigators and institutions involved… It would also set a precedent that would impede ongoing and future patient-centered outcomes studies. Such studies are crucial for advancing medical practice, reducing risks, improving outcomes, and enhancing cost-effectiveness, particularly in the field of pediatrics”

Of note, even as they acknowledge the “permission forms could have been improved” these bioethicists express concern only about how the rebuke might affect the investigators and institutions involved and how it “will impede other pediatric trials like it…

These “ethicists” who have set themselves up as the arbiters of what is moral and ethical have expressed absolutely no concern about the babies whose survival was put at risk; babies died as a result, and other babies suffered lasting injury in an experiment that violated ethical and scientific standards. They expressed not a word of sympathy for the parents who were deceived and deprived of their human right to protect their babies from harmful experiments. These defenders of indefensible, morally controverted research propel medical ethics on a downward spiral for utilitarian expediency, insisting that experiments such as SUPPORT—in which human beings are used as means to an end—are crucial for advancing medical practice.

But as Professor George Annas, a legal scholar and ethicist, warns,

Like the knights of old [in search of the Holy Grail], a medical researcher’s quest of the good, whether that be progress in general or a cure for AIDS or cancer specifically, can lead to the destruction of human values we hold central to a civilized life, such as dignity and liberty.[42]

Hans Jonas, an eminent philosopher whose essay, “Philosophical Reflections on Experimenting with Human Subjects,” (1969) was highly influential, identified the dilemmas posed and the threat of depersonalizing forces present in biomedical research. Unlike bioethicists, he stressed the idea that society is not threatened by a slower rate of progress.

Progress is an optional goal, not an unconditional commitment…its tempo…has nothing sacred about it.” By contrast, “society would indeed be threatened by the erosion of those moral values whose loss, possibly caused by too ruthless a pursuit of scientific progress, would make its most dazzling triumphs not worth having.”[43]

The SUPPORT experiment and its defenders demonstrate how far the profit-driven medical research enterprise has veered away from moral medical ethics.  SUPPORT defenders worked in unison to obscure the nature and purpose of this randomized trial; they are currently crafting an escape hatch to accommodate and absolve researchers from complying with Federal informed consent requirements for research that they designate as comparative effectiveness research (CER).Defenders of SUPPORT attempt to divert attention from the experiment whose strategies and experimental procedures deviated radically from standard practice, exposing the babies to multiple serious risks of harm. And they attempt to divert attention from the researchers’ failure to minimize risks. It’s time to ask these “leaders in bioethics” who condone crossing the moral line: How much is in it for you?

Five trials—US-SUPPORT, UK-BOOST II, New Zealand-BOOST II, Australia-BOOSTII, and multinational Canadian COT—using the same protocol, conducted simultaneously, failed to include precautionary safety measures such as, a current practice control group, a pooled data and safety monitoring board (DSMB) to identify and minimize risks; SUPPORT lacked even a detailed plan for unblinding the intensive care unit medical teams when the masking procedure—using intentionally miscalibrated pulse oximeters—posed a threat to the health of the babies.

According to Dr. Carome’s analysis, the false oximeters readings of the babies’ oxygen saturation resulted in harm for babies in the high-oxygen group who spent about 40-50% more time during the experiment in a range of oxygen considered generally to be toxic; and harmed babies in the low-oxygen group who spent twice as much time in a range of oxygen considered to be inadequate. “This may have been one of several factors that could have contributed to harmful outcomes for babies in both the high and low-oxygen group.” Because of the lack of a standard of care control group, we cannot know for certain the extent of harm that these trials produced.

Bioethicists in collusion with government officials are stretching the ethical boundaries defined in the Belmont Report, and are blurring the distinction between “standard routine practice” and medical research. Standard practice “is designed solely to enhance the well-being of an individual patient,” and does not require written informed consent. Whereas research—as defined in Federal regulations—“is designed to develop or contribute to generalizable knowledge” [45 CFR46.102(d) ] and requires full disclosure of the foreseeable risks and written, voluntary informed consent by the competent adult subject or parent—if the subject is a child.

By blurring that distinction they are trying to carve out a category of research that would deny some patients the protections of Federal informed consent requirements. As Tom Beauchamp acknowledged: “One of the major problems of research is the potential injustice that occurs when a benefit is generated for the well-off through a contribution to research made largely by disadvantaged members of society including [ ] many children…”8

Magnus and Caplan resort to sophistry when denying that the experiment posed any risks that needed to be disclosed to parents because, they argue, “comparative effectiveness research” poses no risk:

“The OHRP reprimand is troubling both because it has sown confusion and focused unwarranted negative attention on valuable research and because it incorrectly suggests that the risk of comparative effectiveness research involving infants, or any other group, is equivalent to the risk of research involving randomization to a novel intervention.”35

They then proceeded to denigrate the professional competence of treating physicians. These truth twisters refer to the complex clinical decisions that physicians make to meet the individual needs of each premature baby in their care, decisions that are based on their knowledge, experience and judgment—as “random physician preference.”34   SUPPORT defenders have misrepresented the clinical value of the study results: “These findings changed medical practice at many centers…The results of SUPPORT have been critical in informing treatment decisions for extremely preterm infants.”32

SUPPORT, BOOST II and COT failed to provide information on how to improve premature babies’ outcome compared to standard care—they only confirmed how to undermine these babies’ survival. premie_3.jpg

In their 2010 report in the NEJM, the SUPPORT authors recognized that their findings were tenuous and inconclusive; their recommendation: “caution should be exercised regarding a strategy of targeting levels of oxygen saturation in the low range for preterm infants, since it may lead to increased mortality.”36 And in 2012, SUPPORT researchers acknowledged the lack of generalizability seen in our results[44]thereby admitting lack of clinical and informational value.

For informed consent to be ethically valid there must be full disclosure. Any deception jeopardizes the integrity and validity of the informed consent process; it renders the research unethical. Yet, with all of its failings, its flawed design and deceptive consent documents that concealed the most serious foreseeable risks of harm for the babies, stating that the babies would receive “standard of care” and would incur no added risks—major medical research stakeholders defend it. Indeed, the editor of the NEJM proclaimed “the SUPPORT trial a model of how to make medical progress.”32

Therein lies a moral threat to society: medical progress is not an unconditional moral imperative; it is not a justification for overriding our individual right to choose whether or not to assume risk in a medical experiment.  

For medical research stakeholders the real concern about the SUPPORT trial controversy are:
1. ensuring the uninterrupted flow of public funding for “comparative effectiveness research”;
2. securing an adequate number of patient-subjects to fill their research quotas;
3. overcoming patients’ resistance to volunteering for medical research;
4. avoiding another public scandal resulting from an OHRP oversight determination that regulatory ethical requirements were violated.

francis_collins.jpgThe research establishment, led by NIH director, Dr. Francis Collins, is seeking to obtain an exemption from federal disclosure requirements for informed consent[45],[46],35 thereby evading any independent scrutiny. This fraternity of like-minded stakeholders views human rights protections as obstacles that slow or impede research. But then again, if the risks had been fully disclosed to the parents whose babies were enrolled in SUPPORT, what parent would have or could have consented to such an experiment?  In its position statement in the NEJM, NIH’s leadership indicated that:

the ramifications [of the SUPPORT debate] go well beyond this one study: the outcome of this debate could affect how we conduct and communicate about critical research on interventions that are within the standard of care for all diseases and conditions…Studies such as SUPPORT that compare two alternatives [ ] often lead to critical improvements in medical care.”37  

SUPPORT demonstrates the harm that results from research protocols that disregard the human factor—not all medical practices can be standardized. Complex conditions require individually tailored, adjusted treatment regimens. In an effort to find an expedient, one-size-fits-all oxygen treatment paradigm, babies’ lives were sacrificed. SUPPORT serves as the prototype for “comparative effectiveness research” (CER), a category of research that is being aggressively promoted by NIH and the Obama Administration.

Dr. Tom Koch,[47] a Canadian bioethicist, author of Thieves of Virtue: When Bioethics Stole Medicinethieves_of_virtue.jpg (2012), critiques bioethics for its “lifeboat ethics” approach to healthcare. Lifeboat ethics is a metaphor for hard choices (triage) that are demanded in critical situations of presumed insurmountable scarcity: i.e., who is to be sacrificed so that others might live?  Bioethics accepted the premise of scarcity of medical resources as a natural condition rather than the result of prior economic, political, and social choices and policies.

Bioethicists provide the ethical framework and “permission slips” to justify unfair healthcare policies that relegate the burden of sacrifice to those with the least power. Bioethics, he notes, is rooted in eugenics and its undemocratic, utilitarian value judgments that decree whose lives should be sacrificed for the (ostensible) good of many. Dr. Koch argues that the premise of dire scarcity for life-support essentials is false and avoidable through equitable public policies that would prevent such crises of scarcity.

He notes that the tragic loss of life in the Titanic (and dozens of other ships along that same route) was entirely preventable, had ship owners been required to provide lifeboats for all.  He makes the case that the idea of natural scarcity requiring ethical triage signaled a shift in ethical emphasis from patient care and the physician’s responsibility to neoliberal accountancies and the promotion of research as the preeminent good. “Lifeboat ethics is a cautionary tale about what happens when profits are put ahead of lives.”

The moral line in the sand has been drawn:

According to the Administration’s “Strategic Framework”48 the targeted patient populations for comparative effectiveness research are: “the elderly, minorities, children, and persons with disabilities.”

This is a frontal assault by medical research cowboys in government and academia who are determined to roll back medical research practices to the “good old days” when researchers were unencumbered by the Nuremberg Code, the Declaration of Helsinki, and the US Code of Federal Regulations. Bioethicists who insist they are champions of personal choice and “autonomy,” have regularly endorsed policies that restrict individual choice (as in managed care).

The SUPPORT experiment is a prototype for “Patient –Centered Comparative Effectiveness Research

Its defenders argue that research so designated should be exempt from informed consent disclosure. Bioethicists, who have no code of professional ethics, are preparing an “ethical patina” for medical experiments to be conducted without informed consent.

They will devise semantic rationalizations using utilitarian cost-benefit calculations to argue that “societal benefits” outweigh individual rights. The ever accommodating handmaidens can be counted on to provide permission slips for overriding the human right of informed consent to medical research, whenever the exercise of that right is inconvenient or stands in the way of hypothetical claimed “medical progress.”

The 47 signatories to the letter to the editor in the NEJM who signed off as “leaders in bioethics and pediatrics” defended SUPPORT on the grounds that:

Such studies are crucial for advancing medical practice, reducing risks, improving outcomes, and enhancing cost-effectiveness, particularly in the field of pediatrics.”

Dr. John Lantos, one of SUPPORT’s most bellicose defenders, encapsulates the culture of utilitarian ethics:
Some people have to be harmed for the benefit of many…Research oversight is expensive…how much do you want to spend?”[2]

And David Magnus and Art Caplan have already given their “permission” in the NEJM:   “Comparative effectiveness research has the potential to dramatically improve patient care while reducing costs… A great deal of effort is under way to make it easier and less expensive to conduct prospective, randomized comparative effectiveness research.” 35

End of Part 3 of 4

Read Part I http://www.ahrp.org/cms/content/view/925/9/

Part 2 http://www.ahrp.org/cms/content/view/927/9/


[1] Richard John Neuhaus, The Best Bioethicists That Money Can Buy, 2002 http://www.humanitas.org/resources/articles/FTbestbioethicistsmoneycanbuy.htm  ; American Babylon, 2009.

[2] John Lantos. Ethics in Pediatric Research, Children’s Mercy Hospital, Sept. 23, 2011. www.youtube.com/watch?v=6NiHDnaTyn0

[3] Michael Carome. The SUPPORT Study: Inadequate Informed Consent and Failure to Minimize Risks, Bloomberg BNA Webinar, July 17, 2013.

[4] HM Sass. Fritz Jahr’s 1927 Concept of Bioethics, Kennedy Institute of Ethics, 2007;17(4):279-95.

[5] WT. Reich. How Bioethics Got Its Name, Hastings Center Journal, 1993;23:S6-7. Cited in Tom Koch. Eugenics and the Genetic Challenge, Again: All Dressed Up and Just Everywhere to Go, Cambridge Quarterly Healthc Ethics, April, 2011 20(2):191-203. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3535762/

[6] S. Wilkinson. “’Eugenics Talk’ and the Language of Bioethics,” Journal of Medical Ethics, 2008;34(6):467-471.

[7] For an excellent history of bioethics from a student at Georgetown at the time, see, Dianne Iriving PhD. The Bioethics Mess: A Critique of Bioethics As it Has Developed in north America, Crisis Magazine, May 2001 http://www.consciencelaws.org/ethics/ethics019.aspx

[8] Tom Beauchamp, PhD. Children and Clinical Research, Transcript of Meeting, April 21, 2006  http://bioethics.georgetown.edu/pcbe/transcripts/april06/session5.html

[9] Buck v. Bell. 274 U.S. 200 (1927) Justice Holmes for the majority of the Court. http://supreme.justia.com/cases/federal/us/274/200/case.html#205

[10] Carl Elliot. Deadly Corruption in Clinical Trials, Mother Jones, 2010. http://www.motherjones.com/environment/2010/09/dan-markingson-drug-trial-astrazeneca

[11] The OHRP and SUPPORT—Another View, NEJM, July 11, 2013. http://www.nejm.org/doi/full/10.1056/NEJMc1308015

[12] OHRP Letter of Determination (March 7, 2013): http://www.hhs.gov/ohrp/detrm_letrs/YR13/mar13a.pdf

[13] Tom Koch. Thieves of Virtue: When Bioethics Stole Medicine, MIT, 2012.

[14] F Baylis  The Olivieri Debacle: Where Were the Heroes of Bioethics? J Med Ethics 2004;30:44-49 http://jme.bmj.com/content/30/1/44.full?sid=fbc12167-aba7-4847-a14b-3a477848c2ac

[15] ASBH/ASLME Ethics Task Force Report, 2005. www.asbh.org/uploads/files/membership/protected/pdfs/acesrprt.pdf

[16] S Hall. Merchants of Immortality, Houghton Mifflin, 2003. Cited by Raymond De Vries and Carla Keirns. Does Money Make Bioethics Go ‘Round’? Am J Bioethics, July 17, 2009 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2712296/

[17] Daniel Callahan. Bioethics, Our Crowd, and Ideology, The Hastings Center, 1996. http://www.thefreelibrary.com/Bioethics,+our+crowd,+and+ideology.-a018995179

[18] Higgins v. Kennedy Krieger Institute, Court of Appeals of Maryland, Nos. 128, 129, Sept. Term, 2000, August 16, 2001. http://www.courts.state.md.us/opinions/coa/2001/128a00.pdf

[19] See, Carl Elliot. “Diary: The Ethics of Bioethics” in the London Review of Books (2002: 24(23): 36-7

[20] Nicholas Wade. A Dim View of ‘Posthuman Future’,” The NYT, April 2, 2002. http://www.nytimes.com/2002/04/02/science/a-dim-view-of-a-posthuman-future.html

[21] Cole et al. Resolving Our Uncertainty About Oxygen Therapy, Pediatrics, 2003;112:1415-18.

[22] Erich Loewy. Bioethics: Past, Present and Future,” Cambridge Quarterly of Healthcare Ethics, 11 (2002) cited by Jonathan Marks. Instrumental Ethics, Institutional Corruption, and the Biosciences, http://www.psu.edu/dept/liberalarts/sites/rockethics/documents/marks/marks1.pdf

[23] Obituay. Dr. Erich Loewy, 83, physician, philosopher and bioethicist, Sacramento Bee, Oct. 2011 http://www.sacbee.com/2011/11/01/4020872/obituary-dr-erich-lowey-83-physician.html

[24] Presidential Commission for the Study of Bioethical Issues released its “[ ] Pediatric Research on Medical CountermeasuresReport and recommendations, on Tuesday, March 19, 2013. http://www.ahrp.org/cms/content/view/914/9/

[25] Public Citizen’s letter (April 10, 2013) http://www.citizen.org/documents/2111.pdf; letter (May 8, 2013) http://www.citizen.org/documents/2124.pdf

[26] NICHD-Neonatal Research Network. August 28, 2004; Revised September 16, 2004; Updated March 28, 2005

http://www.nih.gov/icd/od/foia/library/Protocol.pdf

[28] Sabrina Tavernise. U.S. Says Study of Babies Failed to Disclose Risks, The New York Times, April 10, 2013 http://www.nytimes.com/2013/04/11/health/parents-of-preemies-werent-told-of-risks-in-study.html; Cait Orton. U. of Utah didn’t inform premature babies’ parents of oxygen level risks, KSL News, April 11th, 2013 http://www.ksl.com/?nid=148&sid=24748845; Laura Stark, Human Subjects Case Unfolds, Harvard Law, April 11, 2013  http://blogs.law.harvard.edu/billofhealth/2013/04/11/human-subjects-case-unfolds/; Bob Grant. Leaders of Infant Trial Will Not Yet Face Sanctions, The Scientist, June 10, 2013  http://www.the-scientist.com/?articles.view/articleNo/35918/title/Leaders-of-Infant-Trial-Will-Not-Yet-Face-Sanctions/

[29] AHRP, An Experiment Designed to Kill Babies, April 11, 2013. http://www.ahrp.org/cms/content/view/915/81/

[30] “An Ethical Breakdown,” Editorial, The New York Times April 15: http://www.nytimes.com/interactive/opinion/editorialboard.html

[31] AHRP, 4,500 Neonates Sought as Guinea Pigs in Gov. Experiments, April 15, 2013. http://www.ahrp.org/cms/content/view/916/9/

[32] Jeffrey Drazen, Caren G. Solomon, and Michael F. Greene. Informed Consent and SUPPORT, New Engl J of Med, May 16, 2013 http://www.nejm.org/doi/full/10.1056/NEJMe1304996

[33] Benjamin Wilfond. The OHRP and SUPPORT, New Eng J Med, June 5, 2013

[34] WA Carlo, EF Bell, MC Walsh. Oxygen-Saturation Targets in Extremely Preterm Infants NEJM May 16, 2013; 368:1949-1950. http://www.nejm.org/doi/full/10.1056/NEJMc1304827

[35] David Magnus, and Arthur Caplan. Risk, Consent, and SUPPORT, NEJM, May 16, 2013; 368:1864-1865. http://www.nejm.org/doi/full/10.1056/NEJMp1305086

[36] SUPPORT Study Group. Target Ranges of Oxygen Saturation in Extremely Preterm Infants. N Engl J Med 2010; 362:1959-69 http://www.nejm.org/doi/full/10.1056/NEJMoa0911781

[37] Kathy L. Hudson, Ph.D., Alan E. Guttmacher,  D., and Francis S. Collins, M.D., Ph.D. In Support of SUPPORT — A View from the NIH, New Engl J of Med, June 5, 2013 http://www.nejm.org/doi/full/10.1056/NEJMp1306986

[38] Todd Neale. NIH Backs Consent Process in Preemie SUPPORT Trial, MedPage Today, June 06, 2013 http://www.citybullsheet.com/nih-backs-consent-process-in-preemie-support-trial/
Note: Some of Winford’s co-authors reported working at sites that participated in SUPPORT and had relationships with the National Center for Advancing Translational Sciences, NIH, Genzyme/Sanofi, Johns Hopkins University, Duke University, and BPCA. In fact, few, if any, of the 46 bioethicists who co-signed the letter, do not have copious financial ties to biomed companies or do not receive grants from NIH.

[39] OHRP. Determination Letter (June 4, 2013) to University of Alabama. http://www.hhs.gov/ohrp/detrm_letrs/YR13/jun13a.pdf

[40] The statement is attributed to James Watson who headed the Human Genome Project. See, Richard John Neuhaus, The Best Bioethicists That Money Can Buy, 2002 http://www.humanitas.org/resources/articles/FTbestbioethicistsmoneycanbuy.htm  ; American Babylon, 2009.

[41] Report on Research Compliance, July, 2013 http://www.reportonresearchcompliance.com/rrc-reprint-0713.pdf

[42] George Annas, “Questing for Grails: Duplicity, Betrayal and Self-Deception in Postmodern Medical Research,” Journal of Contemporary Health Law Policy 12 (1996): 297-324.

[43] Hans Jonas. “Philosophical Reflections on Experimenting with Human Subjects,” Daedalus 98 (1969): 219-247, 245. http://philosophy.tamucc.edu/readings/ethics/jonas-human-experimentation

[44] Wade Rich, Neil Finer, Marie Gantz, Nancy Newman, Angelita Hensman, Ellen Hale, Kathy Auten, Kurt Schibler, Roger Faix, Abbot Laptook, Bradley Yoder, Abhik Das, Seetha Shankaran. “Enrollment of Extremely Low Birth Weight Infants in a Clinical Research Study May Not Be Representative,” Pediatrics 129 (2012): 480-84. www.pediatrics.org/cgi/doi/10.1542/peds.2011-2121

[45] Wade Rich, Kathy Auten, Marie Gantz, Ellen Hale, Angelita Hensman, Nancy Newman, Neil Finer.  National Institute of Child Health and Human Development Neonatal Research Network. Antenatal consent in the SUPPORT trial: challenges, costs, and representative enrollment. Pediatrics. 2010;126(1). Available at: www.pediatrics.org/cgi/content/full/126/1/e215

[46] Wade Rich, Neil Finer, Marie Gantz, Nancy Newman, Angelita Hensman, Ellen Hale, Kathy Auten, Kurt Schibler, Roger Faix, Abbot Laptook, Bradley Yoder, Abhik Das, Seetha Shankaran. “Enrollment of Extremely Low Birth Weight Infants in a Clinical Research Study May Not Be Representative,” Pediatrics 129 (2012): 480-84. www.pediatrics.org/cgi/doi/10.1542/peds.2011-2121

[47] John Koch. Thieves of Virtue: When Bioethics Stole Medicine, MIT Press, 2012; Scarce Goods: Justice, Fairness, and Organ Transplantaio

[48] HHS. Draft Definition of Comparative Effectiveness Research for the Federal Coordinating Council. http://www.hhs.gov/recovery/programs/cer/draftdefinition.html