About Dr. Curry
Dr. Tommy J. Curry is an Assistant Professor of Applied Ethics, Social Political Thought and Critical Race Theory in the Department of Philosophy at Texas A&M University. His research focuses on civil rights jurisprudence, ethical theory, and social justice. He teaches graduate level interdisciplinary courses in social political democratic theory, and critical jurisprudence. Dr. Curry did his post-doctoral work at Penn State University after receiving his doctorate in philosophy at Southern Illinois University Carbondale. He has a Master’s degree in Critical Theory and Post-colonial studies from DePaul University and Bachelor degrees in Philosophy and Political Science.
Dr. Curry’s research argues that the current bioethical debates occlude the true moral force of the Belmont Report by focusing on informed consent rather than reading the document as a civil rights doctrine responding to the societal oppression of individuals and groups suffering from disease. Rather than simply focusing on individuals and the paternalism of doctors, Dr. Curry insists that bioethical research must consider the complicated nexus of governmentality, corporatism, and politics in ethical deliberations concerning patients.
Q: I am concerned about academics who have appointed themselves arbiters of patient safety for adult stem cell therapy. Isn't this something that should be decided between me and my MD? They post blogs about dubious stem cell treatments at medical tourist clinics, which I appreciate. But have they gone too far, by advocating for FDA interference in legitimate IRB monitored trials, like the one that was interrupted in Texas involving adult stem cells at Celltex? The MDs enrolling patients thought it was safe, who am I to trust? What are the boundaries between academic scientists, and MDs, when it comes to ensuring patient safety in experimental clinical trials, like the Celltex trial?
Answer: As you should be. It is important to note that the relationship between academics and the medical field has never been one of absolute transparency and neutrality. Like many other professional endeavors, academics are driven by economic interest and profit as much as the entities they seek to criticize. Since its inception as a field, bioethics has been criticized for having too close of a relationship with the profit motives of the medical profession it sought to analyze. For example, Stephen Toulmin’s 1982 article “How Medicine Saved the Life of Ethics,” in Perspectives in Biology and Medicine outlines the tension between academics making formal or universal declarations about medical ethics (like one should do no harm) and the need for what Aristotle calls “practical reasoning” which starts with the specific and concrete situation at hand and develops a path of reasoning with the “good” or in the case of medical ethics the care of the patient in mind.
There are no motives free of interest, be it for academic prestige or economic gain, so for academics to claim that they are the ethical arbiters of patients and their doctors, or even more absurd, the patient and their fight against disease seems unethical and moral abhorrent, since it suggests that the intuition of those who do not suffer (the academic), who have no immediate relationship to the suffering of the individual stricken with disease is not only the best ethical proxy for the suffering patient, but has infinite insight into the suffering of all future patients so that their personal rationalizations against adult stem cell treatments specifically, but innovative therapies more generally, is the best course of (in)action.
I am of the opinion that the call for FDA interference in this area is motivated by the vulnerability of this new technology to governmental regulation and public fear. Remember these are academics who research health disparities, discrimination, malpractice, and patient dehumanization regularly. Why do none of these other medical injustices prompt a call to action, why stem cells, why now? More importantly, what allows one academic or a group of academic philosophers to overturn the call from patients for new treatments to alleviate the pain and suffering of disease? I am aware of no definite literature that suggests that aMSC are a threat to public safety. The ongoing case between the FDA and Regenerative Sciences seems to be proof of the indeterminacy that exists not only legislatively, but in the regulation of therapies that have caused no public harm, which is why it seems the bulk of the debates are about the definition of “drugs” and not the empirical effect of the past and ongoing therapies that have actually caused a public health concern.
Unfortunately, the patient is always caught between the personal interests of physicians and the corporate interests of the medical establishment. Governmental oversight while appropriate in some cases, must meet a publicized and transparent standard that justifies its intervention into these practices of medicine. Is it the case that states cannot regulate the practice of medicine in their own borders? Am I to believe that a doctor has only pure intentions when they conduct surgeries, but only ill intentions when they appeal to investigational therapies? This seems false. There are risks with both approaches, and as such I see no reason to suggest one is absolutely safer than the other purely based on the FDA’s stamp of approval. Bioethicists have appealed to “informed consent” as the guarantor of patient safety, but given the health disparities that exist amongst the vulnerable populations outlined in the Belmont Report—namely Blacks, women and the poor, I find it hard to believe that academic scientists can ethically justify allowing suffering and death to continue unabated in the interest of patient safety. In reality, to deny innovative treatments condemns those people the ethicist claims to care for to a lower quality to life and in some cases death. Experimental trials do give rise to some dangers such as exploitation or the coercion of the sick, or socially disadvantaged, but it also provides benefits to research and treatment in that it gives those sentenced by disease to potentially viable treatments for their suffering. This is actually the view of one of the drafters of the Belmont Report, Georgetown professor Patricia King, who explicitly articulates the aforementioned position in a chapter in Belmont Revisted: Ethical Principles for Research with Human Subjects entitled “Justice Beyond Belmont.”
Q: I'm a 47 yr. old woman in a wheelchair due to a 17 year struggle with multiple sclerosis. All of the MS drugs failed me, and 12 doses of Novantrone (mitoxantrone) chemo for MS caused heart damage, ongoing risk of cardiovascular disease, and a 1 in 136 chance of leukemia. This is the only FDA approved drug for secondary progressive MS, and my MS only worsened. I progressed to using a cane after I was on the drug. I was treated in May 2012 with my own adults stem cells in Texas, under an IRB monitored trial, sponsored by Celltex. I've been improving steadily for 6 months and I'm no longer shopping for a nursing home. After 40 years of adult stem cell use in medicine across many conditions, the reported risks are minimal. Specifically for MS patients, what would a bioethics professor say about the choice between a drug like Novantrone, vs Celltex adult stem cell trial?
Answer: I am happy the Celltex treatment has helped you and improved your quality of life. I want to again clarify that bioethicists do not, and certainly should not pretend to present absolute truths concerning ethical decision-making or morality. While there has historically been a tradition of academic philosophy that seeks to offer non-philosophers (T)ruth (with a capital T), the job of social political philosophers generally, and the applied ethicist specifically, is to present rational and critical arguments in support of values a democratic society aims to propagate which are negated in the concrete conditions (medical treatments, punishment for crimes, civil rights issues like racism and same-sex marriage) that give rise to moral conflicts in western societies.
With that being said, you can better see how some ethicists that are committed to a principalist view (a position where the protection of the principle is best) of informed consent might say that, while your results in this case were desirable, they offer no way for doctors to reliably predict the same outcome for future patients, and by effect while positive, your results cannot offer future patients a reasonable verification of “informed consent” since there is no reliable prediction of the consequences or harms of such treatments. On the other hand, you can also see why bioethicists looking at your situation from a “law of bioethics,” “sociology of bioethics,” or a critical social perspective like that offered by Eric J. Cassell’s The Nature of Suffering and the Goals of Medicine (1991), would be more focused on how the innovation of stem cell therapies actually lessened your suffering and better supports the democratic choice you have as a patient over your body. Given the harm caused to your body by the traditional treatments, I think traditional bioethicists would have a hard time justifying the continuation of such medicine simply because it is “approved.” As such, the alternative seems to be (1) no treatment and the acceptance of the end result of MS, or (2) seek alternative and/or investigational therapies. Given the damage caused to your heart and the ineffectiveness of Novantrane, it would appear that CellTex best increased your health, and quality of life. This seems to be consistent with ethical ends of Belmont and Helsinki, but as you know this a major issue of contention amongst academics. The fact of the matter is that your condition improved and you are suffering less than taking FDA approved treatments which worsened your health, or doing nothing to treat the disease, which is what I fear much of the anti-stem cell advocates inevitably have to devolve towards.
Q: For MS patients earlier in the disease process who are still Relapsing/Remitting, they are not in the no-option category like progressive MS patients, but their drug treatment choices have life threatening side effects. The latest approved drug is Tysabri, which has caused 271 cases of the disabling brain disease PML, or 2 in1,000. 59 of these patients have died. Recent reports are that Tysabri has cased 17 patients to experience serious herpes simplex or varicella zoster infections. Most underwent long hospitalizations, 2 died. Comparing these risks to the risks of adult stem cell therapy, what is the ethical position on this choice?
Answer:Since I am not a M.D, I must confess that I do not know as a matter of fact whether the statements about Tysabri are true or false. That being said, as an ethicists looking at such a scenario (assuming what you state is indeed true), I would argue that aMSC would be most likely to lessen the suffering of the patient and by effect increase the patients quality of life. However, I arrive at this conclusion by some very important and contested understandings of Belmont, Helsinki and how I understand the purpose of medicine.
My work on Belmont as a civil rights doctrine takes as given that the physician has a duty to heal the patient. While this value is explicitly articulated in the Declaration of Toyko and the Declaration of Helsinki, most ethicists do not see Belmont as demanding effective treatment for illness. It is my view that a reading of Belmont that focuses on the concept of justice, rather than the routine isolation of the Belmont report’s concept of “respect for persons” which has been largely set forth as the principle of informed consent, demands that ethicists favor treatments that heal and address the suffering of the patient to be morally superior to treatments that do not.
If Tysabri does in fact inflict those types of harms upon the patient, then it seems that a stem cell treatment that at worse has no effect but could possibly heal the disease is most favorable. Now if it is the case that aMSC carry a carcinogenic threat in vivo then there is more work to be done in balancing the benefit and the likelihood of the risk involved. However, this calculus is no different than any other treatment evaluations in chronic diseases.
Q: The Declaration of Helsinki, section 35 appears to address the plight of no-option patients to make the decision with their doctors to use adult stem cell therapy.
In the treatment of a patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician's judgment it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, this intervention should be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information should be recorded and, where appropriate, made publicly available.
There are critics in the academic stem cell research field that have opined that the FDA, American Medical Association and NIH have rejected the Declaration of Helsinki, for reasons such as the perceived lack of patient protection. Do you agree that these organizations reject the Declaration? And if so, is there any organization that has put forth guidance that addresses the plight of no-option patients, that is adhered to by these medical bodies?
Answer: As this question is very similar to another question specifically asking for a response to Dr. Paul Knoepfler’s comments about the Declaration of Helsinki in the previous Ask the Doctor, I will try to address these questions all together.
Internationally, the Declaration of Helsinki is the ethical code of conduct for medical research and the doctor’s ethical duties to the patient. The Declaration of Helsinki is adopted and supported by most industrial democracies in the world, and is the primary ethical guide for research and clinical trials conducted in developing nations. There is an excellent publically available document that outlines the international support the document has historically had and the almost decade long controversy surrounding the revisions to the document led in large part by the United States and the FDA’s rejection of the Declaration in 2008 at:http://www.wma.net/en/20activities/10ethics/10helsinki/draft_historical_contemporary_perspectives.pdf.
Now Dr. Knoepfler has argued that “one concern in particular has been the perceived lack of patient protection,” but this statement is extremely vague and somewhat simplistic given the actual revisions the FDA argued for to the Declaration of Helsinki. While the FDA did argue for a “different” conceptualization of informed consent, it has for a long time been recognized that what an individualistic society like America means by informed consent differs to a great extent from how the rest of the world understands and utilizes that term in the practice of medicine and in the patient-doctor relationship. Failure to adhere to the “American concept of informed consent” does not necessarily translate into the lack of protection for the patient. Paul Root Wolpe’s 1998 work “The Triumph of Autonomy in American Medical Ethics: A Sociological View,” and the canonical piece by Linda Farber Post et. al (1996) entitled “Pain: Ethics, Culture and Informed Consent,” has shown that American views of informed consent are not only culturally determined, but peculiar in that they are formulated on western values that other western countries like Great Britain do not entirely endorse.
Secondly, other bioethicists like Dr. Staurt Rennie—an Assistant Research Professor at UNC Chapel Hill who also has a bioethics blog—adamantly disagrees with Dr. Knoepler’s assumption that the FDA’s revision was about “the perceived lack of patient protection.” Dr. Rennie argues the FDA’s insistence on GCP (Good Clinical Practices) over the Declaration of Helsinki actually translates into less patient protection. In fact Dr. Rennie specifically says that the GCP overall is less ethically demanding than the Declaration of Helsinki, and thus encourages the outsourcing of clinical trials in developing countries in a regulatory atmosphere more supportive of pharmaceutical interests than protective of research participants or communities. As some commentators have pointed out, the FDA (and the pharmaceutical companies with whom it often shares beds) was never enamoured of the section in the Declaration of Helsinki that stated that a new drug should be 'tested against the best current prophylactic, diagnostic and therapeutic method', since that would limit the possibility for placebo-controlled trials. That is why GCP is apparently more attractive to them: it does not have any such requirement. Not only that: the GCP does not (unlike the Declaration of Helsinki) contain anything about conflicts of interest, the need to publish results, or post-trial availability of the tested drug to study participants or communities. In the end, GCP is ethics-lite. (“The FDA Ditches the Declaration of Helsinki,” available at: (http://globalbioethics.blogspot.com/2008/05/fda-ditches-declaration-of-helsinki.html).
Furthermore one of the primary leaders of the challenges to the Declaration of Helsinki’s clinical guidelines was Dr. Robert Levine. He submitted a draft in 1998 that reproduced the earlier challenges of the American Medical Association and his criticisms were to a large extent incorporated into thrust of the FDA’s 2008 rejection of the Declaration of Helsinki. According to Dr. Levine in the New England Journal of Medicine (1999,v. 341 no.7) ,“the current Declaration's restrictions on placebo use, if taken literally, not only rule out the development of all new treatments other than for those diseases without a proven therapeutic treatment, but also forbid the use of a placebo when a standard therapy exists.” Levine rejected the insistence that there should be a difference between therapeutic research and non-therapeutic research, so in a world where there is research not designed to primarily help the patient, placebo controlled clinical studies become an issue—an issue that was central to the American Medical Association, the Levine draft and ultimately the FDA’s rejection of the doctrine. I find this peculiar given the recent literature suggesting this distinction is also present in Belmont.
Dr. Knoepler incorrectly asserts the America rejection of the Declaration of Helsinki as optimal, but as scholars like Tatsuo Kuroyanagi have argued in a great piece, “On the 2008 Revisions to the WMA Declaration of Helsinki,” in the Journal of the Japanese Medical Association, despite the domestic political interests that demanded the changes to the document, the “DoH enjoys the recognition of international society and is held to a high standard” (312). This document is held in such regard that even nurses, for whom the Declaration of Helsinki also applies, have called the Levine revisions and American challenges “negative,” and “an undermining of patient rights and protections.” Win Tadd’s “The Helsinki Doctrine: What’s All the Fuss?” in Nursing Ethics (2000, v.7 no.5) was adamant that “by undermining the protection of individual rights, the just allocation of the burdens and benefits of research, and most ominously, the investigator’s moral duty to the research subject, the proposed revisions would substantially change the ethical boundaries of research” (448).
The historical context of the American rejection of the Declaration of Helsinki is immensely important to our interpretation of this issue. Simply suggesting that the FDA’s guidelines are more cogent and superior to the rest of the world, not only reeks of the illusion of American exceptionalism, but continues the same type of cultural imperialism that continues to undermine the democratic ethos and force of American ethical proclamations. In short, I believe Dr. Knoepfler is wrong on this issue.
Q: To what extent does the Declaration of Helsinki and the Belmont report guide decision making for ethicists and if they use these documents as foundational to their field, do these documents have any legal or legislative authority?
Answer: Applied ethicists and bioethicists interested in global or comparative (cross cultural) ethical systems would find great use in both Helsinki and Belmont, but given the various fields that bioethicists come from the extent they are influenced by these declarations will differ. I think these documents do have some legal force, but not as policy. Since these become the context of most contemporary debates, I could imagine they have some relevance in understanding the decision-making process of IRBs and other medical entities.
Q: What do you say to Paul Knoepfler's comment about the invalidity of the declaration of Helsinki?
Paul Knoepler's Answer:Notably, the FDA and NIH have rejected the Declaration of Helsinki for many years for numerous reasons. One concern in particular has been the perceived lack of patient protection. The American Medical Association has had many problems with the Declaration over the years in its different iterations as well.
I do not unconditionally support this one very isolated part (quoted above) of the Declaration of Helsinki taken out of context. I suggest that you read and study the agreement for yourself. Please note that clinics that refuse the FDA pathway are not evaluating safety and efficacy as indicated in that passage. They are making up their own rules.
Answer: I wonder in reading such a statement what then is the point of bioethics? If the bioethical endeavor is to simply justify and declare the FDA to be correct then I suppose the field is over-achieving, but if the field of bioethics is to be a very real and very tangible critical evaluation of the both the ethical successes and moral failures of governmental entities and medical institutions, then I cannot see how an allegiance to an entity like the FDA moves us towards that goal.
First, it is not clear to me that the FDA has the authority to or competence to regulate the innovations of regenerative medicine. While it is true that a lower court ruling seems to side with the FDA’s position that “stem cells=drugs,” there is not any shortage of criticism against the judicial interpretation used to reach this conclusion. To take such a literalist interpretation of government policy seems irresponsible given the external factors driving such a policy change against the practice of medicine. It is important to recognize that the argument waged by the FDA which argues that stem cells are drugs is not intuitive. Remember the practice of medicine has operated for decades without the fear that their use of blood and blood derived products like stem cells would/or could be regulated by the government. Embryologists have practiced cell cultivation in in-vitro fertilization, oncologists have used marrow derived cells for the treatment of cancers, and organizations that preserve blood and human tissue like the American Red Cross have preserved these products without federal oversight or a large scale public safety threat. In other words, the practice of medicine has conducted itself quite effectively without FDA regulation of human blood and cells as drugs without the burgeoning threat to public health the FDA claims is on the horizon.
What we are dealing with today is the attempt of a federal entity to extend its power over human bodies and the blood and blood products of those bodies under the auspices of its obligation to protect public safety. Remember the idea that stem cells could be regulated as drugs is the result of a procedural change in 21 CFR 1271 in 2006. The relevant section of that document currently states that: “[h]uman cells, tissues, or cellular or tissue-based products (HCT/Ps) means articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” Before 2006, the italicized section stated “another human recipient.” This legalese now gives the FDA an unbridled authority to regulate blood and blood/tissue products that do or could be used therapeutically in the human body.
Is it really the case that regenerative medicine clinics rejecting the FDA’s position on stem cells have really “gone rogue,” or is it more likely that some of these clinics find the FDA position illegitimate and are working on protocols and definitions in effect before the FDA policy revision?
Second, this is a policy issue not an ethical calculus. To suggest that entities or individuals who do not follow laws are by definition immoral overlooks the actual historical context of the Belmont report and other international declarations of medical morality. On need not look farther than the American civil rights movement or the Tuskegee experiment to understand why such distinctions are false.
Lastly, I fail to understand how the FDA becomes the moral arbiter for the rest of the world. Remember the Declaration of Helsinki is an INTERNATIONAL declaration and the ethical standard of the World Medical Association. Are we really comfortable arguing that American medical ethics is unique and thereby subject to different ethics and morality than the rest of the world? Helsinki provides protections to some of the most vulnerable populations of developing nations who are most at risk for exploitation. To suggest that “American individualism” and “informed consent” lacks recognition by the Declaration of Helsinki hardly proves the invalidity of the standards the rest of the world adheres to.
Q: What is your opinion on the ethics of placebo trials, specifically for adult stem cell therapy?
Answer: I am of the view that placebo trials are unethical because they deny available treatments for disease to sick and suffering patients. While the objection to this view is of course utilitarian (the good gained through medical advance for the many outweighs the suffering of the few), the violation of the liberty and personhood of the few is not and should not be tolerated for the supposed advances in medicine, especially when those advances are denied to the most disadvantaged and vulnerable segments of American society. Conducting placebo trials on people with chronic diseases like MS who are hoping they are the chosen few to receive the stem cell treatment for their disease is cruel and morally deplorable. It suggests that their lives and suffering are of no consequence when compared to the advance and profit of corporate sponsored research. Such a system is dehumanizing, since it necessitates the exploitation of sick and dying people for medical advance.
As such I would stand with my previous articulations, if aMSC offer a tangible and/or perceived to be tangible benefits to the patient, then the patient in consultation with their doctor should be able to obtain treatment.
Q: Are autologous (your own) adult stem cells more ethical to use in experimental human trials? This source is the lowest risk type of stem cells for therapeutic use, while risk increases with the other sources, allogenic (donor cells), embryonic, Induced Pluripotent (IPS). Shouldn't the lowest risk source get the greatest focus while we are still early in the research process and not let this research be outweighed or suppressed, by the profit potential of making drugs from donor sources?
Answer: I do not know if the first question dealing with the type of cells used is as much of a question of ethics as of scientific and medical expediency which might have ethical or moral consequences. Let me explain. It might be the case that autologous cells, if they have the least potential for mutation and pose the least risk to patients, would be the best choice for researchers trying to produce a safe and effect treatment for ailments, but scientists may have other goals in investigating other stem cell sources.
If this research on autologous cell research is stalled or avoided based for less effective cell cultivation, then the choice pursued by researchers on the whole has not effectively done anything to lessen the suffering of patients. The scientific community made the wrong choice or perhaps had misguided expectations in other cells which failed to produce worthwhile treatments. The consequence is that medicine has not produced anything worthwhile for patients who might have been helped had they chose differently. This is not optimal but not unethical. If the work on adult stem cells is purely based on research, then there is not an ethical mandate (at least by Belmont) to address the suffering of patients, but if this is a human trial on ailing patients I would say that there is a duty by the doctor to pursue the most promising treatment.
Now if the research on autologous stem cells is being suppressed or stalled for profit or the capitalist gains of pharmaceutical companies then this is unethical since it prevents medical innovation to treat patients, and ultimately perpetuates the suffering of those afflicted by disease.
Q: Could you articulate why you take a patient's right to stem cell therapy to be a civil rights issue? Specifically why and/or how your view differs from contemporary bioethics commenting on this issue, and what you take to be the responsibility of bioethicists dealing with this issue as academics and social activists commenting on these newly emergent therapies.
Answer: While the idea of informed consent is largely taken to be intuitive, in reality it arises as a response to the horrors of human experimentation conducted during the Tuskegee Syphilis study undertaken by the U.S. Public Health Services from 1932-1972. For 40 years, this study, funded by the government in Macon County Alabama, sought to determine the effects of untreated syphilis on Black men. These men were denied treatment, even when penicillin became readily available as treatment for the infection in the 1940’s. They were forced to endure lives of pain, impairment, and suffering through no fault of their own. The Belmont Report, the document created in 1979 as a means to guide and define the ethical parameters of medical research and treatment of human subjects, offers concepts that I believe push us to a novel understanding of treatment and the necessity for utilizing innovative treatments as a means to address social injustice, and human suffering which leads us to conclude that Belmont can be understood within the spirit of a Civil Rights doctrine. In other words, it is my belief that the Belmont Report implies a duty to address suffering and provide treatment to relieve that suffering through innovative technologies In short, it is my view that Belmont, rather than simply creating criteria to prevent the abuse of individuals by doctors, seeks to respond to the dehumanization of the victims of the Tuskegee experiment.
Since the 1960’s, oppressed racial groups in America have asserted their right to optimal health as a minimal standard of America’s democratic creed. African American civil rights leaders ranging from Dorothy Height (one of the drafters of the Belmont Report) to the Black Panthers have asserted that “health is politics by other means.” Pain and the suffering that one endures from disease is an obstacle to democratic participation and obstruct the individual’s ability to pursue life, enjoy liberty and find happiness. Alondra Nelson’s Body and Soul: The Black Panther Party and the Fight Against Medical Discrimination (2011) is a great historical illustration of how the Belmont Report was generated as a document responding to the abuses African Americans believed they suffered at the hands of government intervention into their lives for profit and unbridled experimentation. This is similar to the story of Henrietta Lacks, an African American woman whose cells were taken from her purely for research and used to establish the HeLa immortal cell line. When we do not own our bodies or control the cells within, history has shown that these denials are connected to the evils of racism and the inevitable devaluing of human life.
Contemporary bioethical scholarship altogether ignores the historical context of the Belmont Report. It is easier to speak about the abstract ideas like informed consent and how medical innovation threatens that alleged paramount value. This interpretation, however, is a gutting and watering-down of the Belmont Report’s thrust. The Belmont Report is extremely clear, “when a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research.” In other words, new treatments, insofar as they are designed with the therapeutic agenda of enhancing well-being, do not necessarily demand the authoritarian regulation of research. If we are serious about preserving the respect for persons, then it may be the case that alleviating the suffering, pain, and denial of treatment is the better way to fulfill our mission.
Q: Many bioethicists claim the FDA has the right to protect citizens from stem cell therapies under the view that the government should make sure doctors do no harm, how would you respond to this alleged duty?
Answer: I would argue that such claims are selective, and are based on the erroneous premise that “the cells in our bodies are drugs.”
If the FDA has a duty to “do no harm,” then how can we understand the multiple failures of FDA regulation to protect citizens and patients from drug manufacturers (http://www.fda.gov/drugs/drugsafety/DrugRecalls/default.htm) and faulty medical devices (http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/default.htm)? Given the impressive list of recalls on both devices and drugs just this year, why would I trust an agency that former commissioner Andrew Von Eschenbach argues, in the Wall Street Journal (April 2012) is an “agency in which science based regulations often lag behind scientific discovery…[which] forces the FDA to slow approval of new treatments and at times create acrimonious litigation between the FDA and innovators, not to mention disillusionment amongst patients.” Similarly an article by Michael Freeman and Mitchell Fuerst in the Journal of Translational Medicine has argued that FDA over-regulation of regenerative medicine is not only caused of the nascent financial crisis of regenerative medical technologies, but “threatens to smother innovation in a nascent clinical movement
that is already successfully translating promising therapies involving adult stem cells from the lab to the clinic” (1).
Suppose we grant the view proposed by bioethicists that “the FDA has the duty to do no harm” to patients. How then do we both hold this position, and allow for the harm and in some cases deaths of patients caused by FDA approved drugs and devices? Remember the bioethicists who are supporting FDA regulation are arguing that “no harm,” not “lesser harm” justifies FDA regulation of stem cells. If the FDA is supposed to prevent harm to patients but fails to do so in its approvals, then the organization’s function is ethically illegitimate since its regulation fails to protect the health and safety of the patients it has a duty towards. If the supporter of FDA regulation responds, as they are almost forced to, that “no system or agency is perfect,” then given this admission, what ethical or moral evidence exists to support their view that FDA regulation is more effective and hence ethically superior to that of states or IRB’s.
The selectivity of this argument by some bioethicists concerns me. It concedes the reality that governments, corporations, and institutions—all driven by profit and legitimacy to some extent—are responsible for the healthcare crisis in America. This crisis signals the immaturity of American medical ethics and moral thought. When compared to other western industrial democracies, the ethical consciousness of America continues to fall short. Most other western democracies have recognized one’s access to healthcare as a human right, so for American bioethicists to maintain that we have the burden of tolerating the immorality of allowing sick citizens to suffer, while excusing the physical harm and death caused by governments, hospitals, corporations, and medical practitioners, reeks of intellectual dishonest and political ideology. All the factors that culminate into patient suffering are excluded from ethical discussions, because all we are supposed to care about when we discuss the ethics of stem cell technology is FDA regulation and how our surrender of personal liberty over our health, our bodies, and our blood offers us safety in return.
If these bioethicists believe it is the duty of doctors and the government (FDA) is to “do no harm” or “do lesser harm” then they should have to publically articulate 1) the actual/empirical harms that have been caused by the therapeutic use of adult mesenchymal stem cells, and 2) how specifically the FDA regulation of stem cells reduce these harms. Otherwise we are having a discussion about political beliefs and not ethics.
Q: When two ethicists disagree about what is "right" who prevails and on what basis?
Answer: Disagreement is part and parcel of the discipline of philosophy itself, and certainly evident in the bioethical literature. Remember bioethicists are arguing about everything from a patient euthanasia to homosexuality. Their disagreements reflect just as much if not more of their ideological and personal bias as any non-academic individual or professional. In 1997, Daniel Callahan published a piece entitled “Bioethics and Culture Wars,” in The Nation arguing that the idea of “who is right” is more a function of popular social consensus and ideology rather than an objective calculus that renders absolute truth. The problem arises when the academic field of bioethics, which applied ethicists know is not only fraught with disagreements and debates, but forms a very small part of the entire field of philosophy, becomes a specialized and authoritative project in the public mind that offers proclamations on ethics and morality as if those proclamations are universally accepted as true by the bioethical community.
Unfortunately, most academic bioethical research is conservative in nature. It does not aim to transform the social consciousness of society or radically alter how individuals, doctors, or medical institutions see the practice of medicine or the ethics of patient care. H.T.Engelhardt Jr. writes a brilliant chapter in Bioethics Critically Reconsidered: Having Second Thoughts entitled “Why Clinical Bioethics so Rarely Gives Morally Normative Guidance,” which argues that the advice secular bioethicists (the bioethicists who advise and consult clinically or outside the academy) offer “concerns the ethos established at law and in public policy within a particular jurisdiction…Secular clinical ethicists give guidance about an ethos established at law, including those who hire them successfully to navigate within the grey zones of that ethos, while also aiding in risk management, improved communications among patients, families, and physicians, the mediation of disputes, and risk managements, while also providing clarification about the implications of particular moral commitments” (164).
Given the function of the bioethicist you can see that what is “right” and who prevails is largely a matter of politics and institutional support rather than reason and sound moral judgment. Bioethicists largely affirm the basis of present laws as correct. In most cases, the bioethics chooses to support the status quo rather than reject outright the institutions that fund and support the prestige of professional bioethics. Being reformist in nature means that bioethicists can claim they in fact want and desire “radical” social change, but continue to support the institutions, ideologies, and popular consensus that make meaningful change slow to a snail’s pace. In the academy, who is “right” is largely a matter of who is funded more, who is cited more and who causes the most controversy in their writings and blogs. The more an academic bioethicist is recognized, even when they are disagreed with, the more they can lay claim to the correctness and impact of their work. In the academy, recognition, be it good or bad, is currency. If there are scholars you support on these issues, then you should cite and publicize their work, invite them to speak at your organizations, and support their efforts collectively. The academy is nepotistic and political so the people you see speaking on stem cells are not necessarily the most qualified or most correct.
Q: Generally do you think most ethicists would agree with the fact that patients have a "right" to their own stem cells--how much of a debate is this inside the bioethics circles?
Answer: I think most people, including bioethicists, would almost intuitively assume that a person’s blood and the cells in that blood belong to them. Unfortunately, I think that when we are talking about “stem cells” specifically, many bioethicists and academic philosophers will lean towards the already established legal interpretations of this issue to frame the philosophical interpretations about whether or not we should define stem cells as drugs.
Much to my dismay, I have not read of any contemporary debates of the “rights of individuals to their own stem cells” in American bioethical journals. Earlier this year, Bioethics published a nice and well stated piece by Tamra Lysaght and Alastair V. Campbell, “Broadening the Scope of Debates around Stem Cell Research,” which looks at the use of autologous stem cell treatment and FDA regulation of this dawning technology, but this is only one piece and does not specifically address the question of individual rights to their own cells and the boundary such a right would set on governmental, understood in this case as FDA, regulation of these blood products. Similarly, Donrich W. Jordan has raised this as a hypothetical issue in an article entitled, “Regulatory Crackdown on Stem Cell Therapy: What would the position to be in South Africa,” in the South African Medical Journal (2012), but again this article does not specifically address the ownership of one’s stem cells.
Q: Generally are bioethicists concerned with the problem of the FDA being a gatekeeper--do bioethics feel that society has a compelling need to control our healthcare decisions or do they lean more toward freedom for the patient? When does "society" have an ethical place "protecting" people if the treatment choice affects none other than the patient?
Answer: I have found that criticisms directed against the FDA from bioethicists come from news articles and popular media like blogs or online magazines. Since bioethicists range across multiple disciplines like law, sociology, public health, philosophy, and medicine, the opinions over whether “society’s duty to protect people” outweighs the “freedom of the patient” differs.
Society, which is more adequately understood as government, has a duty to protect people from medical treatments when said treatments constitute a public health concern. When a treatment solely affects the patient, I do not see a compelling case for “societal/governmental” intervention. The assumption behind such interventions, an assumption that has been explicitly stated in other ethical debates like that of euthanasia, is that the government and it citizens shoulder the burden of protecting patients suffering from disease from themselves. This concern is more political in nature (what legal and governmental powers determine an individual’s right to life) than moral, since what is best for the patient is ignored or outweighed by some larger social interests.
Q: How much of a role do you believe is played by FDA, Big Pharma and the research community in stalling the access of patients to experimental stem cell treatment? It seems rather strange that the FDA went after Celltex in what I consider record time compared to their usual glacial pace and yet many small clinics continue to operate quite openly. Were they more threatened by Celltex because of the size of the company or the people involved with it as well as Governor Perry's influence? Was pressure put on them from those that want Celltex to fail?
What is really going on in this country? I don't buy for a moment that the risk of having a doctor treat me with my own stem cells is greater than the risk of the terminal disease I have. There is no evidence of mass deaths or even life-threatening side effects except for a very few incidents and some of those are not proven to be the result of the stem cell treatment itself. Tens of thousands are being treated at offshore clinics. Quite frankly, I am disgusted reading all the articles and press releases about this scientist or this company treating rodents with tremendous success. We are told that in 5-10-15 years that
such treatment might be available for humans. Are these people insane? Most of us who are very ill will be dead by then or living like vegetables incapacitated by our disease. I actually find all this "dangling carrot" research offensive in light of the fact we are being denied our most basic civil rights in accessing our own stem cells.
Answer: Unfortunately, the opinion I have on this matter is primarily hypothesis and speculation. However, my readings of FDA approvals and the BiDil controversy certainly lead me to conclude that economic and racial categories, profit, and corporatism are involved in the decisions of this agency. As such, I can only hypothesize what specific interests or motives the FDA had in its review and criticism of Celltex.
It is common practice for any detractor and critic of governmental authority to be labeled “a conspiracy theorist,” and while I cannot offer any “facts of the matter” that can establish the connection between the FDA, Pharma and the attack on Celltex, I believe Americans and patients would be naïve to not seriously look at the relationship between the corporatization of medicine and the role of government. These questions are usually dismissed by “popular bioethicists” on blogs and online publications, but in reality the criticisms you are waging against the FDA and the government are quite legitimate and have a long history in the bioethical literature. For example, Howard Waitzkin’s “A Critical Theory of Medical Discourse: Ideology, Social Control, and the Processing of Social Context in Medical Encounters,” appeared in the Journal of Health and Social Behavior in 1989 and argues that despite the doctors intentions they inevitable answer to and reproduce institutional regulations over health that devalue the patient. More recently, Alan Peterson published an essay entitled “Governmentality, Critical Theory and the Medical Humanities,” in the Journal of Medical Humanities (2003) demanding that the relationship between citizens and the power of the state in deciding medical treatments be made primary in research about healthcare and institutions.
Your intuitions about these institutions certainly have academic support, the problem, as is always the case when criticizing governmental practices, is the type and amount of evidence needed to convince conservative minds dedicated to the status quo.
Dr. Tommy J. Curry is an Assistant Professor of Applied Ethics, Social Political Thought and Critical Race Theory in the Department of Philosophy at Texas A&M University. His research focuses on civil rights jurisprudence, ethical theory, and social justice. He teaches graduate level interdisciplinary courses in social political democratic theory, and critical jurisprudence. Dr. Curry did his post-doctoral work at Penn State University after receiving his doctorate in philosophy at Southern Illinois University Carbondale. He has a Master’s degree in Critical Theory and Post-colonial studies from DePaul University and Bachelor degrees in Philosophy and Political Science.
Dr. Curry’s research argues that the current bioethical debates occlude the true moral force of the Belmont Report by focusing on informed consent rather than reading the document as a civil rights doctrine responding to the societal oppression of individuals and groups suffering from disease. Rather than simply focusing on individuals and the paternalism of doctors, Dr. Curry insists that bioethical research must consider the complicated nexus of governmentality, corporatism, and politics in ethical deliberations concerning patients.
Q: I am concerned about academics who have appointed themselves arbiters of patient safety for adult stem cell therapy. Isn't this something that should be decided between me and my MD? They post blogs about dubious stem cell treatments at medical tourist clinics, which I appreciate. But have they gone too far, by advocating for FDA interference in legitimate IRB monitored trials, like the one that was interrupted in Texas involving adult stem cells at Celltex? The MDs enrolling patients thought it was safe, who am I to trust? What are the boundaries between academic scientists, and MDs, when it comes to ensuring patient safety in experimental clinical trials, like the Celltex trial?
Answer: As you should be. It is important to note that the relationship between academics and the medical field has never been one of absolute transparency and neutrality. Like many other professional endeavors, academics are driven by economic interest and profit as much as the entities they seek to criticize. Since its inception as a field, bioethics has been criticized for having too close of a relationship with the profit motives of the medical profession it sought to analyze. For example, Stephen Toulmin’s 1982 article “How Medicine Saved the Life of Ethics,” in Perspectives in Biology and Medicine outlines the tension between academics making formal or universal declarations about medical ethics (like one should do no harm) and the need for what Aristotle calls “practical reasoning” which starts with the specific and concrete situation at hand and develops a path of reasoning with the “good” or in the case of medical ethics the care of the patient in mind.
There are no motives free of interest, be it for academic prestige or economic gain, so for academics to claim that they are the ethical arbiters of patients and their doctors, or even more absurd, the patient and their fight against disease seems unethical and moral abhorrent, since it suggests that the intuition of those who do not suffer (the academic), who have no immediate relationship to the suffering of the individual stricken with disease is not only the best ethical proxy for the suffering patient, but has infinite insight into the suffering of all future patients so that their personal rationalizations against adult stem cell treatments specifically, but innovative therapies more generally, is the best course of (in)action.
I am of the opinion that the call for FDA interference in this area is motivated by the vulnerability of this new technology to governmental regulation and public fear. Remember these are academics who research health disparities, discrimination, malpractice, and patient dehumanization regularly. Why do none of these other medical injustices prompt a call to action, why stem cells, why now? More importantly, what allows one academic or a group of academic philosophers to overturn the call from patients for new treatments to alleviate the pain and suffering of disease? I am aware of no definite literature that suggests that aMSC are a threat to public safety. The ongoing case between the FDA and Regenerative Sciences seems to be proof of the indeterminacy that exists not only legislatively, but in the regulation of therapies that have caused no public harm, which is why it seems the bulk of the debates are about the definition of “drugs” and not the empirical effect of the past and ongoing therapies that have actually caused a public health concern.
Unfortunately, the patient is always caught between the personal interests of physicians and the corporate interests of the medical establishment. Governmental oversight while appropriate in some cases, must meet a publicized and transparent standard that justifies its intervention into these practices of medicine. Is it the case that states cannot regulate the practice of medicine in their own borders? Am I to believe that a doctor has only pure intentions when they conduct surgeries, but only ill intentions when they appeal to investigational therapies? This seems false. There are risks with both approaches, and as such I see no reason to suggest one is absolutely safer than the other purely based on the FDA’s stamp of approval. Bioethicists have appealed to “informed consent” as the guarantor of patient safety, but given the health disparities that exist amongst the vulnerable populations outlined in the Belmont Report—namely Blacks, women and the poor, I find it hard to believe that academic scientists can ethically justify allowing suffering and death to continue unabated in the interest of patient safety. In reality, to deny innovative treatments condemns those people the ethicist claims to care for to a lower quality to life and in some cases death. Experimental trials do give rise to some dangers such as exploitation or the coercion of the sick, or socially disadvantaged, but it also provides benefits to research and treatment in that it gives those sentenced by disease to potentially viable treatments for their suffering. This is actually the view of one of the drafters of the Belmont Report, Georgetown professor Patricia King, who explicitly articulates the aforementioned position in a chapter in Belmont Revisted: Ethical Principles for Research with Human Subjects entitled “Justice Beyond Belmont.”
Q: I'm a 47 yr. old woman in a wheelchair due to a 17 year struggle with multiple sclerosis. All of the MS drugs failed me, and 12 doses of Novantrone (mitoxantrone) chemo for MS caused heart damage, ongoing risk of cardiovascular disease, and a 1 in 136 chance of leukemia. This is the only FDA approved drug for secondary progressive MS, and my MS only worsened. I progressed to using a cane after I was on the drug. I was treated in May 2012 with my own adults stem cells in Texas, under an IRB monitored trial, sponsored by Celltex. I've been improving steadily for 6 months and I'm no longer shopping for a nursing home. After 40 years of adult stem cell use in medicine across many conditions, the reported risks are minimal. Specifically for MS patients, what would a bioethics professor say about the choice between a drug like Novantrone, vs Celltex adult stem cell trial?
Answer: I am happy the Celltex treatment has helped you and improved your quality of life. I want to again clarify that bioethicists do not, and certainly should not pretend to present absolute truths concerning ethical decision-making or morality. While there has historically been a tradition of academic philosophy that seeks to offer non-philosophers (T)ruth (with a capital T), the job of social political philosophers generally, and the applied ethicist specifically, is to present rational and critical arguments in support of values a democratic society aims to propagate which are negated in the concrete conditions (medical treatments, punishment for crimes, civil rights issues like racism and same-sex marriage) that give rise to moral conflicts in western societies.
With that being said, you can better see how some ethicists that are committed to a principalist view (a position where the protection of the principle is best) of informed consent might say that, while your results in this case were desirable, they offer no way for doctors to reliably predict the same outcome for future patients, and by effect while positive, your results cannot offer future patients a reasonable verification of “informed consent” since there is no reliable prediction of the consequences or harms of such treatments. On the other hand, you can also see why bioethicists looking at your situation from a “law of bioethics,” “sociology of bioethics,” or a critical social perspective like that offered by Eric J. Cassell’s The Nature of Suffering and the Goals of Medicine (1991), would be more focused on how the innovation of stem cell therapies actually lessened your suffering and better supports the democratic choice you have as a patient over your body. Given the harm caused to your body by the traditional treatments, I think traditional bioethicists would have a hard time justifying the continuation of such medicine simply because it is “approved.” As such, the alternative seems to be (1) no treatment and the acceptance of the end result of MS, or (2) seek alternative and/or investigational therapies. Given the damage caused to your heart and the ineffectiveness of Novantrane, it would appear that CellTex best increased your health, and quality of life. This seems to be consistent with ethical ends of Belmont and Helsinki, but as you know this a major issue of contention amongst academics. The fact of the matter is that your condition improved and you are suffering less than taking FDA approved treatments which worsened your health, or doing nothing to treat the disease, which is what I fear much of the anti-stem cell advocates inevitably have to devolve towards.
Q: For MS patients earlier in the disease process who are still Relapsing/Remitting, they are not in the no-option category like progressive MS patients, but their drug treatment choices have life threatening side effects. The latest approved drug is Tysabri, which has caused 271 cases of the disabling brain disease PML, or 2 in1,000. 59 of these patients have died. Recent reports are that Tysabri has cased 17 patients to experience serious herpes simplex or varicella zoster infections. Most underwent long hospitalizations, 2 died. Comparing these risks to the risks of adult stem cell therapy, what is the ethical position on this choice?
Answer:Since I am not a M.D, I must confess that I do not know as a matter of fact whether the statements about Tysabri are true or false. That being said, as an ethicists looking at such a scenario (assuming what you state is indeed true), I would argue that aMSC would be most likely to lessen the suffering of the patient and by effect increase the patients quality of life. However, I arrive at this conclusion by some very important and contested understandings of Belmont, Helsinki and how I understand the purpose of medicine.
My work on Belmont as a civil rights doctrine takes as given that the physician has a duty to heal the patient. While this value is explicitly articulated in the Declaration of Toyko and the Declaration of Helsinki, most ethicists do not see Belmont as demanding effective treatment for illness. It is my view that a reading of Belmont that focuses on the concept of justice, rather than the routine isolation of the Belmont report’s concept of “respect for persons” which has been largely set forth as the principle of informed consent, demands that ethicists favor treatments that heal and address the suffering of the patient to be morally superior to treatments that do not.
If Tysabri does in fact inflict those types of harms upon the patient, then it seems that a stem cell treatment that at worse has no effect but could possibly heal the disease is most favorable. Now if it is the case that aMSC carry a carcinogenic threat in vivo then there is more work to be done in balancing the benefit and the likelihood of the risk involved. However, this calculus is no different than any other treatment evaluations in chronic diseases.
Q: The Declaration of Helsinki, section 35 appears to address the plight of no-option patients to make the decision with their doctors to use adult stem cell therapy.
In the treatment of a patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician's judgment it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, this intervention should be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information should be recorded and, where appropriate, made publicly available.
There are critics in the academic stem cell research field that have opined that the FDA, American Medical Association and NIH have rejected the Declaration of Helsinki, for reasons such as the perceived lack of patient protection. Do you agree that these organizations reject the Declaration? And if so, is there any organization that has put forth guidance that addresses the plight of no-option patients, that is adhered to by these medical bodies?
Answer: As this question is very similar to another question specifically asking for a response to Dr. Paul Knoepfler’s comments about the Declaration of Helsinki in the previous Ask the Doctor, I will try to address these questions all together.
Internationally, the Declaration of Helsinki is the ethical code of conduct for medical research and the doctor’s ethical duties to the patient. The Declaration of Helsinki is adopted and supported by most industrial democracies in the world, and is the primary ethical guide for research and clinical trials conducted in developing nations. There is an excellent publically available document that outlines the international support the document has historically had and the almost decade long controversy surrounding the revisions to the document led in large part by the United States and the FDA’s rejection of the Declaration in 2008 at:http://www.wma.net/en/20activities/10ethics/10helsinki/draft_historical_contemporary_perspectives.pdf.
Now Dr. Knoepfler has argued that “one concern in particular has been the perceived lack of patient protection,” but this statement is extremely vague and somewhat simplistic given the actual revisions the FDA argued for to the Declaration of Helsinki. While the FDA did argue for a “different” conceptualization of informed consent, it has for a long time been recognized that what an individualistic society like America means by informed consent differs to a great extent from how the rest of the world understands and utilizes that term in the practice of medicine and in the patient-doctor relationship. Failure to adhere to the “American concept of informed consent” does not necessarily translate into the lack of protection for the patient. Paul Root Wolpe’s 1998 work “The Triumph of Autonomy in American Medical Ethics: A Sociological View,” and the canonical piece by Linda Farber Post et. al (1996) entitled “Pain: Ethics, Culture and Informed Consent,” has shown that American views of informed consent are not only culturally determined, but peculiar in that they are formulated on western values that other western countries like Great Britain do not entirely endorse.
Secondly, other bioethicists like Dr. Staurt Rennie—an Assistant Research Professor at UNC Chapel Hill who also has a bioethics blog—adamantly disagrees with Dr. Knoepler’s assumption that the FDA’s revision was about “the perceived lack of patient protection.” Dr. Rennie argues the FDA’s insistence on GCP (Good Clinical Practices) over the Declaration of Helsinki actually translates into less patient protection. In fact Dr. Rennie specifically says that the GCP overall is less ethically demanding than the Declaration of Helsinki, and thus encourages the outsourcing of clinical trials in developing countries in a regulatory atmosphere more supportive of pharmaceutical interests than protective of research participants or communities. As some commentators have pointed out, the FDA (and the pharmaceutical companies with whom it often shares beds) was never enamoured of the section in the Declaration of Helsinki that stated that a new drug should be 'tested against the best current prophylactic, diagnostic and therapeutic method', since that would limit the possibility for placebo-controlled trials. That is why GCP is apparently more attractive to them: it does not have any such requirement. Not only that: the GCP does not (unlike the Declaration of Helsinki) contain anything about conflicts of interest, the need to publish results, or post-trial availability of the tested drug to study participants or communities. In the end, GCP is ethics-lite. (“The FDA Ditches the Declaration of Helsinki,” available at: (http://globalbioethics.blogspot.com/2008/05/fda-ditches-declaration-of-helsinki.html).
Furthermore one of the primary leaders of the challenges to the Declaration of Helsinki’s clinical guidelines was Dr. Robert Levine. He submitted a draft in 1998 that reproduced the earlier challenges of the American Medical Association and his criticisms were to a large extent incorporated into thrust of the FDA’s 2008 rejection of the Declaration of Helsinki. According to Dr. Levine in the New England Journal of Medicine (1999,v. 341 no.7) ,“the current Declaration's restrictions on placebo use, if taken literally, not only rule out the development of all new treatments other than for those diseases without a proven therapeutic treatment, but also forbid the use of a placebo when a standard therapy exists.” Levine rejected the insistence that there should be a difference between therapeutic research and non-therapeutic research, so in a world where there is research not designed to primarily help the patient, placebo controlled clinical studies become an issue—an issue that was central to the American Medical Association, the Levine draft and ultimately the FDA’s rejection of the doctrine. I find this peculiar given the recent literature suggesting this distinction is also present in Belmont.
Dr. Knoepler incorrectly asserts the America rejection of the Declaration of Helsinki as optimal, but as scholars like Tatsuo Kuroyanagi have argued in a great piece, “On the 2008 Revisions to the WMA Declaration of Helsinki,” in the Journal of the Japanese Medical Association, despite the domestic political interests that demanded the changes to the document, the “DoH enjoys the recognition of international society and is held to a high standard” (312). This document is held in such regard that even nurses, for whom the Declaration of Helsinki also applies, have called the Levine revisions and American challenges “negative,” and “an undermining of patient rights and protections.” Win Tadd’s “The Helsinki Doctrine: What’s All the Fuss?” in Nursing Ethics (2000, v.7 no.5) was adamant that “by undermining the protection of individual rights, the just allocation of the burdens and benefits of research, and most ominously, the investigator’s moral duty to the research subject, the proposed revisions would substantially change the ethical boundaries of research” (448).
The historical context of the American rejection of the Declaration of Helsinki is immensely important to our interpretation of this issue. Simply suggesting that the FDA’s guidelines are more cogent and superior to the rest of the world, not only reeks of the illusion of American exceptionalism, but continues the same type of cultural imperialism that continues to undermine the democratic ethos and force of American ethical proclamations. In short, I believe Dr. Knoepfler is wrong on this issue.
Q: To what extent does the Declaration of Helsinki and the Belmont report guide decision making for ethicists and if they use these documents as foundational to their field, do these documents have any legal or legislative authority?
Answer: Applied ethicists and bioethicists interested in global or comparative (cross cultural) ethical systems would find great use in both Helsinki and Belmont, but given the various fields that bioethicists come from the extent they are influenced by these declarations will differ. I think these documents do have some legal force, but not as policy. Since these become the context of most contemporary debates, I could imagine they have some relevance in understanding the decision-making process of IRBs and other medical entities.
Q: What do you say to Paul Knoepfler's comment about the invalidity of the declaration of Helsinki?
Paul Knoepler's Answer:Notably, the FDA and NIH have rejected the Declaration of Helsinki for many years for numerous reasons. One concern in particular has been the perceived lack of patient protection. The American Medical Association has had many problems with the Declaration over the years in its different iterations as well.
I do not unconditionally support this one very isolated part (quoted above) of the Declaration of Helsinki taken out of context. I suggest that you read and study the agreement for yourself. Please note that clinics that refuse the FDA pathway are not evaluating safety and efficacy as indicated in that passage. They are making up their own rules.
Answer: I wonder in reading such a statement what then is the point of bioethics? If the bioethical endeavor is to simply justify and declare the FDA to be correct then I suppose the field is over-achieving, but if the field of bioethics is to be a very real and very tangible critical evaluation of the both the ethical successes and moral failures of governmental entities and medical institutions, then I cannot see how an allegiance to an entity like the FDA moves us towards that goal.
First, it is not clear to me that the FDA has the authority to or competence to regulate the innovations of regenerative medicine. While it is true that a lower court ruling seems to side with the FDA’s position that “stem cells=drugs,” there is not any shortage of criticism against the judicial interpretation used to reach this conclusion. To take such a literalist interpretation of government policy seems irresponsible given the external factors driving such a policy change against the practice of medicine. It is important to recognize that the argument waged by the FDA which argues that stem cells are drugs is not intuitive. Remember the practice of medicine has operated for decades without the fear that their use of blood and blood derived products like stem cells would/or could be regulated by the government. Embryologists have practiced cell cultivation in in-vitro fertilization, oncologists have used marrow derived cells for the treatment of cancers, and organizations that preserve blood and human tissue like the American Red Cross have preserved these products without federal oversight or a large scale public safety threat. In other words, the practice of medicine has conducted itself quite effectively without FDA regulation of human blood and cells as drugs without the burgeoning threat to public health the FDA claims is on the horizon.
What we are dealing with today is the attempt of a federal entity to extend its power over human bodies and the blood and blood products of those bodies under the auspices of its obligation to protect public safety. Remember the idea that stem cells could be regulated as drugs is the result of a procedural change in 21 CFR 1271 in 2006. The relevant section of that document currently states that: “[h]uman cells, tissues, or cellular or tissue-based products (HCT/Ps) means articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” Before 2006, the italicized section stated “another human recipient.” This legalese now gives the FDA an unbridled authority to regulate blood and blood/tissue products that do or could be used therapeutically in the human body.
Is it really the case that regenerative medicine clinics rejecting the FDA’s position on stem cells have really “gone rogue,” or is it more likely that some of these clinics find the FDA position illegitimate and are working on protocols and definitions in effect before the FDA policy revision?
Second, this is a policy issue not an ethical calculus. To suggest that entities or individuals who do not follow laws are by definition immoral overlooks the actual historical context of the Belmont report and other international declarations of medical morality. On need not look farther than the American civil rights movement or the Tuskegee experiment to understand why such distinctions are false.
Lastly, I fail to understand how the FDA becomes the moral arbiter for the rest of the world. Remember the Declaration of Helsinki is an INTERNATIONAL declaration and the ethical standard of the World Medical Association. Are we really comfortable arguing that American medical ethics is unique and thereby subject to different ethics and morality than the rest of the world? Helsinki provides protections to some of the most vulnerable populations of developing nations who are most at risk for exploitation. To suggest that “American individualism” and “informed consent” lacks recognition by the Declaration of Helsinki hardly proves the invalidity of the standards the rest of the world adheres to.
Q: What is your opinion on the ethics of placebo trials, specifically for adult stem cell therapy?
Answer: I am of the view that placebo trials are unethical because they deny available treatments for disease to sick and suffering patients. While the objection to this view is of course utilitarian (the good gained through medical advance for the many outweighs the suffering of the few), the violation of the liberty and personhood of the few is not and should not be tolerated for the supposed advances in medicine, especially when those advances are denied to the most disadvantaged and vulnerable segments of American society. Conducting placebo trials on people with chronic diseases like MS who are hoping they are the chosen few to receive the stem cell treatment for their disease is cruel and morally deplorable. It suggests that their lives and suffering are of no consequence when compared to the advance and profit of corporate sponsored research. Such a system is dehumanizing, since it necessitates the exploitation of sick and dying people for medical advance.
As such I would stand with my previous articulations, if aMSC offer a tangible and/or perceived to be tangible benefits to the patient, then the patient in consultation with their doctor should be able to obtain treatment.
Q: Are autologous (your own) adult stem cells more ethical to use in experimental human trials? This source is the lowest risk type of stem cells for therapeutic use, while risk increases with the other sources, allogenic (donor cells), embryonic, Induced Pluripotent (IPS). Shouldn't the lowest risk source get the greatest focus while we are still early in the research process and not let this research be outweighed or suppressed, by the profit potential of making drugs from donor sources?
Answer: I do not know if the first question dealing with the type of cells used is as much of a question of ethics as of scientific and medical expediency which might have ethical or moral consequences. Let me explain. It might be the case that autologous cells, if they have the least potential for mutation and pose the least risk to patients, would be the best choice for researchers trying to produce a safe and effect treatment for ailments, but scientists may have other goals in investigating other stem cell sources.
If this research on autologous cell research is stalled or avoided based for less effective cell cultivation, then the choice pursued by researchers on the whole has not effectively done anything to lessen the suffering of patients. The scientific community made the wrong choice or perhaps had misguided expectations in other cells which failed to produce worthwhile treatments. The consequence is that medicine has not produced anything worthwhile for patients who might have been helped had they chose differently. This is not optimal but not unethical. If the work on adult stem cells is purely based on research, then there is not an ethical mandate (at least by Belmont) to address the suffering of patients, but if this is a human trial on ailing patients I would say that there is a duty by the doctor to pursue the most promising treatment.
Now if the research on autologous stem cells is being suppressed or stalled for profit or the capitalist gains of pharmaceutical companies then this is unethical since it prevents medical innovation to treat patients, and ultimately perpetuates the suffering of those afflicted by disease.
Q: Could you articulate why you take a patient's right to stem cell therapy to be a civil rights issue? Specifically why and/or how your view differs from contemporary bioethics commenting on this issue, and what you take to be the responsibility of bioethicists dealing with this issue as academics and social activists commenting on these newly emergent therapies.
Answer: While the idea of informed consent is largely taken to be intuitive, in reality it arises as a response to the horrors of human experimentation conducted during the Tuskegee Syphilis study undertaken by the U.S. Public Health Services from 1932-1972. For 40 years, this study, funded by the government in Macon County Alabama, sought to determine the effects of untreated syphilis on Black men. These men were denied treatment, even when penicillin became readily available as treatment for the infection in the 1940’s. They were forced to endure lives of pain, impairment, and suffering through no fault of their own. The Belmont Report, the document created in 1979 as a means to guide and define the ethical parameters of medical research and treatment of human subjects, offers concepts that I believe push us to a novel understanding of treatment and the necessity for utilizing innovative treatments as a means to address social injustice, and human suffering which leads us to conclude that Belmont can be understood within the spirit of a Civil Rights doctrine. In other words, it is my belief that the Belmont Report implies a duty to address suffering and provide treatment to relieve that suffering through innovative technologies In short, it is my view that Belmont, rather than simply creating criteria to prevent the abuse of individuals by doctors, seeks to respond to the dehumanization of the victims of the Tuskegee experiment.
Since the 1960’s, oppressed racial groups in America have asserted their right to optimal health as a minimal standard of America’s democratic creed. African American civil rights leaders ranging from Dorothy Height (one of the drafters of the Belmont Report) to the Black Panthers have asserted that “health is politics by other means.” Pain and the suffering that one endures from disease is an obstacle to democratic participation and obstruct the individual’s ability to pursue life, enjoy liberty and find happiness. Alondra Nelson’s Body and Soul: The Black Panther Party and the Fight Against Medical Discrimination (2011) is a great historical illustration of how the Belmont Report was generated as a document responding to the abuses African Americans believed they suffered at the hands of government intervention into their lives for profit and unbridled experimentation. This is similar to the story of Henrietta Lacks, an African American woman whose cells were taken from her purely for research and used to establish the HeLa immortal cell line. When we do not own our bodies or control the cells within, history has shown that these denials are connected to the evils of racism and the inevitable devaluing of human life.
Contemporary bioethical scholarship altogether ignores the historical context of the Belmont Report. It is easier to speak about the abstract ideas like informed consent and how medical innovation threatens that alleged paramount value. This interpretation, however, is a gutting and watering-down of the Belmont Report’s thrust. The Belmont Report is extremely clear, “when a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research.” In other words, new treatments, insofar as they are designed with the therapeutic agenda of enhancing well-being, do not necessarily demand the authoritarian regulation of research. If we are serious about preserving the respect for persons, then it may be the case that alleviating the suffering, pain, and denial of treatment is the better way to fulfill our mission.
Q: Many bioethicists claim the FDA has the right to protect citizens from stem cell therapies under the view that the government should make sure doctors do no harm, how would you respond to this alleged duty?
Answer: I would argue that such claims are selective, and are based on the erroneous premise that “the cells in our bodies are drugs.”
If the FDA has a duty to “do no harm,” then how can we understand the multiple failures of FDA regulation to protect citizens and patients from drug manufacturers (http://www.fda.gov/drugs/drugsafety/DrugRecalls/default.htm) and faulty medical devices (http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/default.htm)? Given the impressive list of recalls on both devices and drugs just this year, why would I trust an agency that former commissioner Andrew Von Eschenbach argues, in the Wall Street Journal (April 2012) is an “agency in which science based regulations often lag behind scientific discovery…[which] forces the FDA to slow approval of new treatments and at times create acrimonious litigation between the FDA and innovators, not to mention disillusionment amongst patients.” Similarly an article by Michael Freeman and Mitchell Fuerst in the Journal of Translational Medicine has argued that FDA over-regulation of regenerative medicine is not only caused of the nascent financial crisis of regenerative medical technologies, but “threatens to smother innovation in a nascent clinical movement
that is already successfully translating promising therapies involving adult stem cells from the lab to the clinic” (1).
Suppose we grant the view proposed by bioethicists that “the FDA has the duty to do no harm” to patients. How then do we both hold this position, and allow for the harm and in some cases deaths of patients caused by FDA approved drugs and devices? Remember the bioethicists who are supporting FDA regulation are arguing that “no harm,” not “lesser harm” justifies FDA regulation of stem cells. If the FDA is supposed to prevent harm to patients but fails to do so in its approvals, then the organization’s function is ethically illegitimate since its regulation fails to protect the health and safety of the patients it has a duty towards. If the supporter of FDA regulation responds, as they are almost forced to, that “no system or agency is perfect,” then given this admission, what ethical or moral evidence exists to support their view that FDA regulation is more effective and hence ethically superior to that of states or IRB’s.
The selectivity of this argument by some bioethicists concerns me. It concedes the reality that governments, corporations, and institutions—all driven by profit and legitimacy to some extent—are responsible for the healthcare crisis in America. This crisis signals the immaturity of American medical ethics and moral thought. When compared to other western industrial democracies, the ethical consciousness of America continues to fall short. Most other western democracies have recognized one’s access to healthcare as a human right, so for American bioethicists to maintain that we have the burden of tolerating the immorality of allowing sick citizens to suffer, while excusing the physical harm and death caused by governments, hospitals, corporations, and medical practitioners, reeks of intellectual dishonest and political ideology. All the factors that culminate into patient suffering are excluded from ethical discussions, because all we are supposed to care about when we discuss the ethics of stem cell technology is FDA regulation and how our surrender of personal liberty over our health, our bodies, and our blood offers us safety in return.
If these bioethicists believe it is the duty of doctors and the government (FDA) is to “do no harm” or “do lesser harm” then they should have to publically articulate 1) the actual/empirical harms that have been caused by the therapeutic use of adult mesenchymal stem cells, and 2) how specifically the FDA regulation of stem cells reduce these harms. Otherwise we are having a discussion about political beliefs and not ethics.
Q: When two ethicists disagree about what is "right" who prevails and on what basis?
Answer: Disagreement is part and parcel of the discipline of philosophy itself, and certainly evident in the bioethical literature. Remember bioethicists are arguing about everything from a patient euthanasia to homosexuality. Their disagreements reflect just as much if not more of their ideological and personal bias as any non-academic individual or professional. In 1997, Daniel Callahan published a piece entitled “Bioethics and Culture Wars,” in The Nation arguing that the idea of “who is right” is more a function of popular social consensus and ideology rather than an objective calculus that renders absolute truth. The problem arises when the academic field of bioethics, which applied ethicists know is not only fraught with disagreements and debates, but forms a very small part of the entire field of philosophy, becomes a specialized and authoritative project in the public mind that offers proclamations on ethics and morality as if those proclamations are universally accepted as true by the bioethical community.
Unfortunately, most academic bioethical research is conservative in nature. It does not aim to transform the social consciousness of society or radically alter how individuals, doctors, or medical institutions see the practice of medicine or the ethics of patient care. H.T.Engelhardt Jr. writes a brilliant chapter in Bioethics Critically Reconsidered: Having Second Thoughts entitled “Why Clinical Bioethics so Rarely Gives Morally Normative Guidance,” which argues that the advice secular bioethicists (the bioethicists who advise and consult clinically or outside the academy) offer “concerns the ethos established at law and in public policy within a particular jurisdiction…Secular clinical ethicists give guidance about an ethos established at law, including those who hire them successfully to navigate within the grey zones of that ethos, while also aiding in risk management, improved communications among patients, families, and physicians, the mediation of disputes, and risk managements, while also providing clarification about the implications of particular moral commitments” (164).
Given the function of the bioethicist you can see that what is “right” and who prevails is largely a matter of politics and institutional support rather than reason and sound moral judgment. Bioethicists largely affirm the basis of present laws as correct. In most cases, the bioethics chooses to support the status quo rather than reject outright the institutions that fund and support the prestige of professional bioethics. Being reformist in nature means that bioethicists can claim they in fact want and desire “radical” social change, but continue to support the institutions, ideologies, and popular consensus that make meaningful change slow to a snail’s pace. In the academy, who is “right” is largely a matter of who is funded more, who is cited more and who causes the most controversy in their writings and blogs. The more an academic bioethicist is recognized, even when they are disagreed with, the more they can lay claim to the correctness and impact of their work. In the academy, recognition, be it good or bad, is currency. If there are scholars you support on these issues, then you should cite and publicize their work, invite them to speak at your organizations, and support their efforts collectively. The academy is nepotistic and political so the people you see speaking on stem cells are not necessarily the most qualified or most correct.
Q: Generally do you think most ethicists would agree with the fact that patients have a "right" to their own stem cells--how much of a debate is this inside the bioethics circles?
Answer: I think most people, including bioethicists, would almost intuitively assume that a person’s blood and the cells in that blood belong to them. Unfortunately, I think that when we are talking about “stem cells” specifically, many bioethicists and academic philosophers will lean towards the already established legal interpretations of this issue to frame the philosophical interpretations about whether or not we should define stem cells as drugs.
Much to my dismay, I have not read of any contemporary debates of the “rights of individuals to their own stem cells” in American bioethical journals. Earlier this year, Bioethics published a nice and well stated piece by Tamra Lysaght and Alastair V. Campbell, “Broadening the Scope of Debates around Stem Cell Research,” which looks at the use of autologous stem cell treatment and FDA regulation of this dawning technology, but this is only one piece and does not specifically address the question of individual rights to their own cells and the boundary such a right would set on governmental, understood in this case as FDA, regulation of these blood products. Similarly, Donrich W. Jordan has raised this as a hypothetical issue in an article entitled, “Regulatory Crackdown on Stem Cell Therapy: What would the position to be in South Africa,” in the South African Medical Journal (2012), but again this article does not specifically address the ownership of one’s stem cells.
Q: Generally are bioethicists concerned with the problem of the FDA being a gatekeeper--do bioethics feel that society has a compelling need to control our healthcare decisions or do they lean more toward freedom for the patient? When does "society" have an ethical place "protecting" people if the treatment choice affects none other than the patient?
Answer: I have found that criticisms directed against the FDA from bioethicists come from news articles and popular media like blogs or online magazines. Since bioethicists range across multiple disciplines like law, sociology, public health, philosophy, and medicine, the opinions over whether “society’s duty to protect people” outweighs the “freedom of the patient” differs.
Society, which is more adequately understood as government, has a duty to protect people from medical treatments when said treatments constitute a public health concern. When a treatment solely affects the patient, I do not see a compelling case for “societal/governmental” intervention. The assumption behind such interventions, an assumption that has been explicitly stated in other ethical debates like that of euthanasia, is that the government and it citizens shoulder the burden of protecting patients suffering from disease from themselves. This concern is more political in nature (what legal and governmental powers determine an individual’s right to life) than moral, since what is best for the patient is ignored or outweighed by some larger social interests.
Q: How much of a role do you believe is played by FDA, Big Pharma and the research community in stalling the access of patients to experimental stem cell treatment? It seems rather strange that the FDA went after Celltex in what I consider record time compared to their usual glacial pace and yet many small clinics continue to operate quite openly. Were they more threatened by Celltex because of the size of the company or the people involved with it as well as Governor Perry's influence? Was pressure put on them from those that want Celltex to fail?
What is really going on in this country? I don't buy for a moment that the risk of having a doctor treat me with my own stem cells is greater than the risk of the terminal disease I have. There is no evidence of mass deaths or even life-threatening side effects except for a very few incidents and some of those are not proven to be the result of the stem cell treatment itself. Tens of thousands are being treated at offshore clinics. Quite frankly, I am disgusted reading all the articles and press releases about this scientist or this company treating rodents with tremendous success. We are told that in 5-10-15 years that
such treatment might be available for humans. Are these people insane? Most of us who are very ill will be dead by then or living like vegetables incapacitated by our disease. I actually find all this "dangling carrot" research offensive in light of the fact we are being denied our most basic civil rights in accessing our own stem cells.
Answer: Unfortunately, the opinion I have on this matter is primarily hypothesis and speculation. However, my readings of FDA approvals and the BiDil controversy certainly lead me to conclude that economic and racial categories, profit, and corporatism are involved in the decisions of this agency. As such, I can only hypothesize what specific interests or motives the FDA had in its review and criticism of Celltex.
It is common practice for any detractor and critic of governmental authority to be labeled “a conspiracy theorist,” and while I cannot offer any “facts of the matter” that can establish the connection between the FDA, Pharma and the attack on Celltex, I believe Americans and patients would be naïve to not seriously look at the relationship between the corporatization of medicine and the role of government. These questions are usually dismissed by “popular bioethicists” on blogs and online publications, but in reality the criticisms you are waging against the FDA and the government are quite legitimate and have a long history in the bioethical literature. For example, Howard Waitzkin’s “A Critical Theory of Medical Discourse: Ideology, Social Control, and the Processing of Social Context in Medical Encounters,” appeared in the Journal of Health and Social Behavior in 1989 and argues that despite the doctors intentions they inevitable answer to and reproduce institutional regulations over health that devalue the patient. More recently, Alan Peterson published an essay entitled “Governmentality, Critical Theory and the Medical Humanities,” in the Journal of Medical Humanities (2003) demanding that the relationship between citizens and the power of the state in deciding medical treatments be made primary in research about healthcare and institutions.
Your intuitions about these institutions certainly have academic support, the problem, as is always the case when criticizing governmental practices, is the type and amount of evidence needed to convince conservative minds dedicated to the status quo.