Bioethics Debate: Ethics of U Penn Surgical “Drug Implant” Experiment

This debate between AHRP President, Vera Sharav and Bioethicist, Paul Root Volpe, Ph.D., University of Pennsylvania, was prompted by an October 7 infomail.

The reasons for AHRP’s opposition to drug implants for psychiatric patients are explained here: https://ahrp.org/ahrpspeaks/drugimplant1103.php

—–Original Message—–
From: Paul Root Wolpe
Sent: Tuesday, October 07, 2003 6:17 PM
To: VERACARE
Subject: Re: Ethics of U Penn surgical “drug implant” experiment

Dear Vera,

I would like you to carefully read over what you wrote below. [See: Oct 7 Infomail: Ethics of U Penn surgical “drug implant” experiment ]

With no evidence, and without asking me, you assume that because I am a “bioethicist” I have “hidden” financial obligations; simply by membership is some nebulous class you imply that I must sit on coporate boards and be owned by the drug industry.

For someone who prides herself on defending the weak, such innuendo, guilt-by-association, and “wink-wink” irony is lamentable. i am a long, long time subscriber to your list and its predecessor, and I resent being the target of your uninformed implications.

I sit on no corporate boards. The only money i have ever taken from a drug company is some talks I have given at conferences, which is a trivial amount of my income, and otherwise I have refused all drug income. Our Center — probably to your surprise — has very little drug money (GMOs, on the other hand…).

On the panel that I set up we had the strongest anti-psychiatric drug patient advocates I could find, and there were moments of great tension and conflict. To imply, without being there and without talking to anyone, that you have any idea what happened there is exactly what tabloid journalists do.

The step we took was unusual. Instead of just launching a technology, everyone be damned, I invited opponents to come and tell the inventors why they thought the technology was dangerous. Did it influence them? Perhaps not. But to belittle the effort without information is exactly what will erode people’s confidence in the emails you send, as it has shaken mine.

I wish you had bothered to find out what happened there before you assumed the worst.

Paul Root Wolpe

Paul Root Wolpe, Ph.D.
Departments of Psychiatry and Sociology
and Center for Bioethics
University of Pennsylvania

Chief of Bioethics
(Care and Protection of Research Subjects and Patients)
National Aeronautics and Space Administration (NASA)

Center for Bioethics:
3401 Market St., Suite 320
Philadelphia PA 19104
(215) 573-9378 or 898-7136
(215) 573-3036 (fax)

Penn’s Center for Bioethics: http://bioethics.upenn.edu
American Journal of Bioethics: http://www.bioethics.net

—–Original Message—–
From: VERACARE
Sent: Friday, October 10, 2003 10:16 AM
To: Paul Root Wolpe
Subject: RE: Ethics of U Penn surgical “drug implant” experiment

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
https://ahrp.org
Contact: Vera Hassner Sharav
Tel: 212-595-8974
e-mail:

Paul,

Perhaps you haven’t recently visited U Penn’s Center for Bioethics website and noted its copious sources of industry funding. http://www.med.upenn.edu/bioethic/funds/

I have nothing against you personally, but suggest that it is quite impossible for a bioethicist who is at a bioethics center that is heavily reliant on biotech / pharmaceutical industry financing can pretend to be protecting the interests of (in this case) a mostly disenfranchised class of human beings who are abused by the mental health system. If you haven’t I suggest you read the President’s Commission on Mental Health Report.

I have received numerous reactions to the U Penn implant experiment, and let me tell that you those who are unaffiliated with or (more accurately) in partnership with research stakeholders, were even more outraged by this horrific experiment. I have not yet confirmed, but one source informed me that one of the monkeys on whom the device was tested, ripped it out!! The implant and the chemical restraint that it delivers are likely unbearable.

So, if you did not intend to serve as a bioethicist / facilitator for the purpose of assuring that this untenable, inhumane experiment would gain approval by the IRB, consider well why bioethicists are in demand on industry / government “ethics advisory panels?” It isn’t to protect the rights, welfare, and dignity of the patients / subjects. It is to lend legitimacy to healthcare policies that push the envelope beyond ethical practice. Such policies would likely not be approved if community representatives participated in the deliberations.

As I recall, Glenn McGee wrote about it when he quit a corporate advisory panel.

Best,

Vera

—–Original Message—–
From: Paul Root Wolpe
Sent: Friday, October 10, 2003 12:18 PM
To: VERACARE
Subject: RE: Ethics of U Penn surgical “drug implant” experiment

Vera,

I think you are missing the point.

If, after seeing you in some event, I wrote an article that made the claim:

“Vera Sharav is a well known advocate for patients. Many studies have shown that patient advocates are often subsidized by corporate interests — Pfizer has given money to NAMI, for example. Therefore you cannot trust patient advocates like Sharav because they are beholding to corporate interests. In fact, some patient advocates sit on corporate boards, so don’t trust anything Sharav says.”

You would be rightly upset. Including someone in a group, making a generalized statement about that group, and then imputing that characteristic to the individual is the definition of bigotry; I know, I am a sociologist and have taught that very definition in classes on race relations. It is precisely what you did in that email.

And your example about Glenn is exactly the point; there he was, on a corporate board, and when they tried to something he thought was wrong HE RESIGNED, very publicly. By the claims of your email, that should never happen; after all, if we are shills of corporate interests, why would we resign and cut off our sources? Do you think any other Board will hire him now that he showed he has integrity? If bioethicists are patsies of corporate interests, this could never have happened.

Penn takes corporate money — openly (what other Center lists all their sources like ours?) setting limits on amounts, etc. so we are not disproportionately influenced. And, this may surprise you, in my experience corporate money has come into our Center with far fewer strings attached than Foundation money, which no one thinks of as tainted.

Yes, a monkey scratched out his implant. Monkeys will also stop you from giving them injections, won’t take pills willingly, won’t open their mouths and say “ah”. The fact that a monkey scratched at the site of a minor operation tells us nothing. These implants may be the worse idea since lobotomies or the best option for certain restricted psychiatric patients since they took the chains off of them. I don’t know. Unlike you, I am not willing to make a judgment ahead of time with absolutely no data just because it seems politically correct to do so. There were patients with mental illness there, including one on the panel, who think it is a terrific idea; his comment, very telling, was: “No, I would not take this now. I am well able to control my meds. But right after I got out of the hospital, when I was unable to care for myself and my mother had to stay home and watch me 24 hours a day, I think it would have been great to have this technology.”

Tell me clearly (without hyperbole or innuendo) why this experiment is “horrific” “untenable” and “inhumane”. tell me why it pushes the “envelope beyond ethical practice.” If the implants turn out to be benign in terms of their base product (a polymer that has been used for decades in dissolving stitches, etc, with virtually no report of problems), then they are no more horrific than taking pills, unless they are used coercively; I spent an enormous amount of time at the session decrying any coercive use of them. Of course, if you are a scientologist-type who believes all of psychiatry is witchcraft, then it is not implants, but psychotropic drugs in general, you have to oppose.

I admire your strong stance for subject rights and freedom. But i believe it is precisely your predictable, knee-jerk reaction, and lack of appreciation of any subtlety or nuance in these complicated and controversial cases, that diminishes your influence.

Paul

—–Original Message—–
From: VERACARE
Sent: Thursday, October 16, 2003 4:57 PM
To: Paul Root Wolpe
Subject: RE: Ethics of U Penn surgical “drug implant” experiment

Paul,

Let me answer your last question first. 1. You ask “why this experiment “horrific” “untenable” and “inhumane”?

The experiment is inhumane because the drug used haloperidol (Haldol), is not tolerated by most human beings who have been exposed to it.

Indeed, Haldol was the drug of choice used by Soviet psychiatrists to punish political dissidents. Here is what Leonid Plyushch, a mathematician who had spent several years in the psychoprisons where haloperidol was administered as a form of torture (his word). In a speech before the NY Academy of Sciences in 1976, he said: “Along with me there were common criminals who simulated [mental] illness to get away from labor camps, but when they saw the side effects–twisted muscles, a disfigured face, a thrust-out tongue–they admitted what they had done and were returned to camp.” [see Mad in America by Robert Whitaker, p. 217]

The New York Times likened the administration of neuroleptics to people who weren’t ill, to “spiritual murder,” calling it “a variation of the gas chamber.”

By suggesting, as you do, that a knowledgeable critic of patient abuse and institutional psychiatry’s coercive misuse of psychotropic drugs, might be “a scientologist-type,” is a sign of grasping for the wind. It suggests either ignorance of these drugs’ adverse effects, or deliberate denial of the facts.

1. If you were to state in a published article, –“you cannot trust patient advocates like Sharav because they are beholding to corporate interests”– you would be more than foolish. I publicly challenged NAMI not to take money from pharmaceutical companies, and when I could not persuade the majority to stay clean of industry influence, I resigned. Such a statement would, therefore, be libelous.

2. You seem to think that just by disclosing corporate funding sources (ie., likely conflict of interests) bioethicists (and other research stakeholders) are free and clear. In point of fact, disclosure does NOT eliminate the bias or the negative impact on either clinical practice or clinical trials. Disclosure of conflicts of interest does not improve the safety of human subjects nor does it cleanse the scientific literature of biased, pro-industry reports. Indeed, the safety of newly approved products is uncertain because negative research findings are concealed.

3. You said “in my experience corporate money has come into our Center with far fewer strings attached than Foundation money…” I don’t know where you’ve been these last 10 years! Ever hear of Nancy Olivieri or David Healy both of whom had been penalized for exercising academic freedom?

Olivieri was threatened with lawsuits by Apotex, the sponsor of a trial she conducted whose results were negative. She was threatened with a lawsuit if she disclosed those findings to the patients in the trial, and when she published those negative results the University of Toronto fired her.

David Healy was hired as director of the Mood Disorder Program at the University of Toronto’s Center for Addiction and Mental Health. He delivered a talk in which he discussed (among other things) evidence of a link between SSRI antidepressants (Prozac, Paxil, Zoloft et al) and emergent suicidal thoughts and actions in a minority of patients. He criticized these drugs’ manufacturers for failing to disclose the risks or to study the problem.

Executives of Eli Lilly (Prozac manufacturer), who had pledged $25 million to U of T were displeased. The company didn’t have to put any “strings” into the contract–besides Lilly had earlier withdrawn a $25,000 contribution from the Hastings Center for publishing critical articles about Prozac. The University of Toronto rescinded Healy’s contract. (See AHRP website for several conflicts of interest articles about these and many other cases.)

1. You quote Jonathan Stanley, J.D., the son of multi-millionaires who acknowledges he would not volunteer for an implant. The rich have options others do not. What you neglect to say, is that his family foundation, the Stanley Foundation, that is funding this research, also promote and subsidize the Treatment Advocacy Center, an organization that lobbies nationwide for legislation to legitimize forced drug treatment for psychiatric patients.

Finally, you acknowledge that a monkey testing the implant did indeed rip it out of his chest. What more evidence do you need (at least) to suspect that the implant and / or the drug being released are intolerable? By trivializing the distress of a monkey you hardly demonstrate the capacity to empathize with disadvantaged human beings.

For psychiatric patients who cannot tolerate the drugs’ debilitating side effects, the proposed surgical implant experiment is inhumane as it would cause them considerable suffering.

Vera Sharav

—–Original Message—–
From: Paul Wolpe
Sent: Thursday, October 16, 2003 5:35 PM
To: VERACARE
Subject: RE: Ethics of U Penn surgical “drug implant” experiment

Vera,

1. I agree with you about Halderol, and made that very case at the session. But you do not say that in your original piece in VERACARE, you simply say that implants are inhumane. Had you been more specific, I would have agreed with you. I think it is wrong to use them for Halderol in general, but i see nothing wrong with implant technology per se.

2. It is funny you should say that about libel, as at least three people emailed me and told me to sue you as they saw your email about me as potentially libelous. Let me see if I have this straight: you would accuse me of being foolish and potentially libelous for publishing something about you without knowing anything about your stand on it, simply by lumping you in with other patient advocates, when THAT IS EXACTLY WHAT YOU DID TO ME. I am very glad that you admit that such an action is foolish.

3. I do not think at all that disclosure is enough, and have made that very point in print and in lectures around the country many times. My point was not that it is enough, simply that we do it and others do not.

4. Your long diatribes about the Olivieri and Healy case, both of which I know well and one of which (Healy) I have been on a national panel about, are totally besides the point. We have never signed an Olivieri-type contract that gives a company veto power over anything we produce, to the contrary; we sign careful contracts that they have absolutely no right, after they give us a grant, to have any say whatsoever in any product we create, and we retain absolute right to publish anything we want. We do not do clinical trials. Your tendency to lump everything together is one reason that people who are careful about things — facts and accusations — do not listen to you. Not all bioethicists are alike, not all money originating with a drug company are alike. To take an unrestricted drug company grant to study the ethics of discrimination in drug access with full right to publish anything we find is completely different than the cases you cite. We have had much less interference from drug companies than foundations, and your picking two famous cases where that did not happen is a specious argument.

5. Stanley was jut one example. Others in the audience who suffer from mental illness expressed a desire for this technology as well, and they were not all “wealthy”.

6. You have absolutely no idea why that monkey scratched the implant out, and neither do I. Unlike you, I do not make interpretations about things I know nothing about in order to fulfill my agendas. I do not trivialize the monkey’s distress, i simply state that I have no idea why he scratched it out (while the others did not) and neither do you. It is simply another case where you make accusations and draw conclusions without evidence. the implant he scratched out had no drug in it. Yet the material has been used for forty years in a variety of implants.

Finally, you write that “for patients who cannot tolerate the drug implants debilitating side effects” the implant experiments would be inhumane. This is the most shocking statement of all, because it implies that you know absolutely nothing about Phase I trials, surprising in someone who runs a newsletter about research. No “patient” (actually, subject) would get this without their full consent, no impaired subject will be approached, and if they suffered the implant would be removed. But, of course, since you start with the a priori assumption that all researchers are inhumane, unethical shills looking to make money on the suffering of others, that is clearly what you would believe no matter what the evidence is to the contrary. It is too bad, because voices like yours would be a powerful potential ally to subjects if you weren’t so willing to throw objectivity and clear thinking out the window in service of your biases.

Paul

—–Original Message—–
From: VERACARE
Sent: Monday, October 27, 2003 12:12 PM
To: P. Wolpe
Subject: Ethics of U Penn surgical “drug implant” experiment

Paul,

To reiterate, the drugs used for the treatment of schizophrenia– including the old neuroleptic, Haldol, as well as the ‘atypical’ neuroleptics, such as Zyprexa, Risperdal, Seroquel, Clozaril–in and of themselves all trigger debilitating adverse side-effects in a significant proportion of patients.

They do so by interfering with normal hormonal and central nervous system functions. Many people who are knowledgeable about these drugs’ long-term effects believe them to be worse than the symptoms they treat. See: Robert Whitaker, Mad in America, 2002 See also, Sharav VH 2000 Bibliography, Evidence of Neuroleptic Drug-Induced Brain Damage in Patients, at: https://ahrp.org/risks/biblio0100.php

Indeed, the FDA’s approval of Zyprexa for bi-polar disorder was for short-term use only! And recently the FDA acknowledged that the so-called ‘atypical’ neuroleptics induce early onset diabetes. See: http://my.webmd.com/content/article/74/89073.htm

Even if these drugs were not also linked to brain damage, liver damage, and heart damage, who will take responsibility for inducing diabetes in adolescents and young adults? A bioethicist?

I have responded to your criticism even though you have consistently attempted to personalize our disagreement about a drug implant for psychotropic drugs. Your objected to my criticism of bioethicists who, for the most part, play an industry-friendly role in efforts to legitimize utilitarian ethics in medicine. In the Oct 7 Infomail I stated: “Given that bioethicists are not free of financial conflicts of interest, having close ties to the biotech / drug industry, the unacknowledged purpose of such discussions is, no doubt, to pave the way for legitimizing “drug implant” technology “by consensus”–a favorite method for pushing through dubious public policies.”

My statement is borne out by the evidence. If you haven’t I suggest you read Carl Eliot, a bioethicist who doesn’t pussy foot around the facts: “Pharma Buys a Conscience,” in The American Prospect, 2001 at: http://www.prospect.org/authors/elliott-c.html .

Simlarly, Canadian ethicist, Arthur Schafer, notes, “It should be mentioned, in parentheses, that bioethicists – who are latecomers to the drug industry gravy train – seem equally confident that their judgment is not prejudicially affected by the acceptance of money and other benefits from industry.” See: “Biomedical Conflicts of Interest: a defense of the sequestration thesis– Learning from the cases of Nancy Olivieri and David Healy, in the Journal of Medical Ethics, 2003 at: http://jme.bmjjournals.com/cgi/data/28/2/DC1/12

You characterize my brief description of two “causes celebres”– Nancy Olivieri and David Healy–as a “long diatribe,” claiming “We have had much less interference from drug companies than foundations.”

This statement demonstrates that you clearly do not appreciate the significance of these case examples–as Schafer does: “If respected researchers, such as Olivieri and Healy, can experience persecution from their own hospitals and university for disclosing potential risks to patients then which other researchers will be brave enough to speak out in a manner likely to attract drug industry disapprobation?”

Notwithstanding your participation on a panel discussion about Healy, it does not appear that you appreciate the significance of the Olivieri and Healy cases. Your complaint that I made “a specious argument” by “picking two famous cases where that did not happen” is unintelligible. The cases are the personification and symbol of victimization by the corporate stranglehold on academia. Panel discussions devoid of resolutions to disengage from the corporate yoke are meaningless– as these discussions do nothing to lift the threat to the careers of doctors of integrity who put their careers on the line.

Inasmuch as it was disclosed in a lawsuit that it was Art Caplan’s recommendation that led to the selection criteria for the fatal gene transfer experiment at U Penn that killed Jesse Gelsinger, your claim “We do not do clinical trials” is not borne out by the facts.

You are right that we do not know exactly the circumstances that led a monkey to rip through his chest to yank the implant out, inasmuch as that experiment has not been published. However, your insistence on using the term “scratched” to describe what the monkey did is an attempt to trivialize the monkey’s distress.

Finally, you defend the experiment claiming: “No “patient” (actually, subject) would get this without their full consent, no impaired subject will be approached.” That claim is patently false and contradicts the acknowledged purpose of the implant. According to the U Penn researchers, the purpose of the drug implant is to overcome patient “non-adherence with medication.”

That means patients who refuse to take the existing drugs (mostly) because of adverse side effects, are being targeted for the surgical drug implant. These patients could be implanted only by coercion–since given a choice, they have refused to take the drugs. See: Steven J. Siegel, Karen I. Winey, Raquel E. Gur, Robert H. Lenox, Warren B. Bilker e, Debbie Ikeda, Neel Gandhi b and Wen-Xiao Zhang. Surgically Implantable Long-term Antipsychotic Delivery Systems for the Treatment of Schizophrenia. Neuropsychopharmacology, Vol. 26 (6) (2002) pp. 817-823 http://www.elsevier.com/gej-ng/10/33/33/53/43/38/article.html

Vera Sharav