Dr. Wolpe’s Accusations and Dr. Healy’s Response


Dr. Wolpe’s Accusations and Dr. Healy’s Response

—–Original Message—–
From: Paul Root Wolpe
Sent: Tuesday, October 28, 2003 4:30 PM
To: VERACARE
Subject: Re: Ethics of U Penn surgical “drug implant” experiment

Vera,

We will have to agree to disagree, so this will be my last email on this. A few reactions:

I have tried to “personalize” our disagreement? Allow me to quote the email that started all this:

At 5:00 PM -0400 10/7/03, VERACARE wrote: one of Penn’s senior fellows at the Center for Bioethics, Paul Root Wolpe, PhD, who is Director of Psychiatry and Ethics at the School of Medicine. 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.

So please, when you use innuendo that impunes my motives and career, using common rhetorical devices like “no doubt” which are substitutes for any actual substantiation of claims, please don’t accuse ME of insisting on personalizing this.

I know all about psychiatric drugs. I have also seen people in major depression and floridly psychotic. I, like so many of them, would choose the meds over killing myself or living the tortured life of the schizophrenic. You can quote all you want people who object to psychiatric meds, and I would be happy to quote back as many experts who think they are godsends. The point is that I believe people should have a choice. This technology is simply one more choice.

I know Carl Elliot well, am a friend of his, and reviewed his latest book in the current edition of AJOB. I have read everything he wrote about Healy. He is wrong, and if you knew more about the Healy case than just what is in Carl’s article, you would know that Healy utterly misrepresented himself and has since retracted almost everything he claimed. He has recently admitted, for example, that he received substantial fees from Pharmacia, the manufacturer of reboxetine, as well as other Big Pharma that he never disclosed to the Hastings Center Report (as he promised to do) or any other venue during his “victimization.” He also now says that Lilly DID NOT influence the rescinding of his offer (this is Healy talking, not Lilly). You would hardly believe his latest “personal disclosure” statement in an article he recently published:

In recent years Dr. Healy has had consultancies with, been a principal investigator or clinical trialist for, been a chairman or speaker at international symposia for, or been in receipt of support to attend meetings from: Astra, Astra-Zeneca, Boots/Knoll Pharmaceuticals, Eli Lilly, Janssen-Cilag, Lorex-Synthelabo, Lundbeck, Organon, Pharmacia & Upjohn, Pierre-Fabre, Pfizer, Rhone-Poulenc Rorer, Roche, SmithKline Beecham, Solvay, and Zeneca. Dr. Healy has been an expert witness for the plaintiff in five legal actions involving SSRIs and has been consulted on a number of other attempted suicide, suicide and suicide-homicide cases following antidepressant medication, in the majority of which he has offered the view that the treatment was not involved. Dr. Healy has also been an expert witness for the defense on a series of LSD (46) and ECT (1) cases.

Again, that is Healy himself disclosing, admitting that in the majority of cases he testifies that SSRIs are not involved. In other words, the story Carl told about Healy, and the story Healy USED to tell about himself, are patently false.

You say i do not appreciate the significance of Healy and Olivieri; of course I do, especially Olivieri, who I lecture about to medical students. But they are clinical researchers; that is the point you have consistently refused to address. Pharma has a hold over them that is simply does not have over bioethicists. Which does not say that some biothicists are not influenced by Pharma. Of course they are. What it does say is the other point I have made over and over and that you have never responded to: the fact that “bioethicists” can be influenced by drug money does not mean that I am, any more than the fact that “patient advocates” can be influenced by drug money means that you are. And it is just ridiculous to say that, because a clinical researcher asked Art for a recommendation that he took, that Art therefore “does clinical trials.” I mean, really. If the researchers decide not to use these implants on people because they read your CIRCARE column, are you then a clinical researcher?

The problem, Vera, is that you will just lump together any political issue that you think makes your ideological point; you simply obscure the differences between “bioethicists” and a particular bioethicist, or someone who gives advice to a clinical researcher and someone who does clinical research.

And if my insistence in using “scratched” to describe what hte monkey did (the word the researchers who were there used, by the way) is ideological, than your insistence on using the words “rip through his chest to yank the implant out” is equally ideological. I, at least, heard what happened from the people who were there, and use their description. You just make up the most emotionally volatile words you can think of as scare tactics.

And, finally, you misrepresent who is targeted by the researchers. There are many psychiatric patients who miss taking their meds for many reasons, not just because they “choose” not to take them. Patients come to doctors asking for ways to make sure they take their meds; that is why the two week injections that are offered now are very popular among patients.

* * * *
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: www.bioethics.net


 

—–Original Message—–
From: David Healy
Sent: Sunday, November 02, 2003 6:35 PM
To: Vera Sharav; Vera Sharav
Subject: i know carl elliot

My attention was drawn to recent correspondence between Vera Sharav and Paul Wolpe on the issue of delivering antipsychotic drugs through surgical implants. Vera Sharav’s point that these experiments might be paving the way for a technology to deliver some of the newer antipsychotics is a striking observation. Johnson & Johnson have recently gone through an extraordinarily elaborate procedure aimed at producing a long acting injectable form of risperidone (Risperdal Consta) that would not cause too many extrapyramidal features. Such features might have jeopardised the marketing status of risperidone as an atypical drug; the means of avoiding this marketing own goal is a deceptive technology that looks like it might cost lives. These technologies in general from a company point of view are less about producing benefits for patients and more about gaining market share. Against this background, and a background in which some of the agents that might be delivered in this way have the highest recorded death rates in psychotropic trial history, Ms Sharav’s observations it seems to me need to be taken seriously.

Many of Paul Wolpe’s points in response also seem reasonable. But whatever the merits of his initial position, some recent comments seem incorrect. I will pick these up sequentially but will first address an earlier point made by Dr Wolpe.

Dr Wolpe: “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”.

I would love to know just what national panel is referred to here. I am aware of no national panels that have considered my case, and certainly no m embers of any national panel have consulted me regarding the details of my case. It would seem therefore that a group of individuals have seen fit to decide my case in absentia without doing me the courtesy of asking for details or affording me details of the sentence afterwards.

There appears to be a curious U Penn link here. In the midst of my difficulties with the University of Toronto, that university, for reasons that remain unknown to me despite questioning, saw fit to direct the media to a Dr James Coyne of U Penn. Dr Coyne, who made a number of the same points made by Dr Wolpe, has been a consultant to Chamberlain Communications Group, who were at least then a public relations company doing work for Lilly, who had me around this time listed as a problem to be dealt with.

I have been involved in a number of debates on issues related to antidepressants and suicide where it has seemed that those opposing me have been in receipt of both grossly inaccurate material, and confidential details, that it would appear can only have come either directly or indirectly from SSRI producing companies. If Dr Wolpe can shed any light on how this happens, he might be able to make a significant contribution to the academic freedom debate.

Against this background, I would appreciate details from anyone of just who the members of this panel were, at whose behest they met, just what briefing material they had and what conclusions if any they came to.

As regards the specific points raised by Dr Wolpe:

First, “I know Carl Elliot well, am a friend of his, and reviewed his latest book in the current edition of AJOB”.

This phrase, which has echoes of Dan Quayle’s vice-presidential debate, is a matter for Carl Elliot.

Second: “I have read everything he wrote about Healy. He is wrong, and if you knew more about the Healy case than just what is in Carl’s article, you would know that Healy utterly misrepresented himself and has since retracted almost everything he claimed”.

This appears libellous. I am not aware of misrepresenting myself or utterly misrepresenting myself or of having retracted everything or indeed anything I claimed, as will perhaps become somewhat more clear below. My views on certain issues stem in great part from close contacts with industry that I have never sought to downplay much less conceal.

Third: “He has recently admitted, for example, that he received substantial fees from Pharmacia, the manufacturer of reboxetine, as well as other Big Pharma that he never disclosed to the Hastings Center Report (as he promised to do) or any other venue during his “victimization.”

For the record, I am not aware of ever concealing my links to Pharmacia or any other pharmaceutical company. The initial overtures to me regarding a post in Toronto came at a meeting sponsored by Pharmacia, set up by individuals within the University of Toronto. Such links may well have looked attractive to the University of Toronto.

The details of my links to Pharmacia are outlined in Let Them Eat Prozac, recently published by Lorimer in Toronto, available through www.formac.ca. Much of the material is also on a website www.healyprozac.com , which makes available a number of chapters from this book and supporting documentation. All proceeds from the book go to an academic freedom fund within The Canadian Association of University Teachers.

This book it should be noted, and in particular the Pharmacia sections, had been almost completely written before I ran into difficulties with the University of Toronto. A minimal amount of material was added afterwards to incorporate the story of my sacking and the developments in the Tobin case.

Fourth: “He also now says that Lilly DID NOT influence the rescinding of his offer (this is Healy talking, not Lilly)”.

There is a general perception that pharmaceutical executives do not pick up telephones and order someone to be dismissed – that this is not the way the system works.

I have never claimed anything other than this and do not now do so, although some may find the published details in Perspectives in Biology and Medicine and Let Them Eat Prozac possibly supportive of a more specific interference than this, something beyond what might be termed a general ability of industry to get in between the cracks, even between colleagues who are all concerned about the undue effects of corporate influence.

Fifth: “You would hardly believe his latest “personal disclosure” statement in an article he recently published”:

In recent years Dr. Healy has had consultancies with, been a principal investigator or clinical trialist for, been a chairman or speaker at international symposia for, or been in receipt of support to attend meetings from: Astra, Astra-Zeneca, Boots/Knoll Pharmaceuticals, Eli Lilly, Janssen-Cilag, Lorex-Synthelabo, Lundbeck, Organon, Pharmacia & Upjohn, Pierre-Fabre, Pfizer, Rhone-Poulenc Rorer, Roche, SmithKline Beecham, Solvay, and Zeneca. Dr. Healy has been an expert witness for the plaintiff in five legal actions involving SSRIs and has been consulted on a number of other attempted suicide, suicide and suicide-homicide cases following antidepressant medication, in the majority of which he has offered the view that the treatment was not involved. Dr. Healy has also been an expert witness for the defense on a series of LSD (46) and ECT (1) cases.

The first point is that this is my personal disclosure statement. The second is that this is fairly standard for disclosure statements I have made since before the Toronto affair. Many journals have chosen not to print it in full, with a recent British Journal of Psychiatry copy-editor for instance changing it to Dr Healy has links with all major pharmaceutical companies.

After first writing about Prozac induced problems in the early 1990s, Lilly offered me a consultancy with the company. I incorporated statements to this effect at the end of articles and have letters from 1995 from plaintiffs’ lawyers in Prozac cases who said they would never have consulted me if they had known of my prior links to Lilly.

At that time and subsequently I was involved in clinical trials for and was a speaker for SmithKline Beecham, the makers of the SSRI Paxil, and the largest amount of funding from pharmaceutical company sources that I have received to date has come from that source, and not from Pharmacia.

Some testimony under oath in Cassidy v Eli Lilly, taken in Chicago, on November 21, 2001, under questioning from A See, attorney for Lilly, might be of use here. I have left the text complete with redundancies

See: You have served as a consultant to Pharmacia and Upjohn regarding their antidepressant reboxetine? H: Yes, I have.
See: You have done clinical work for them?
H: No, I have done no clinical trials. I have served as a consultant for them. I have been a speaker for them, but done no clinical work.
See: You have gone to speak in front of peer groups?
H: Yes.
See: About Reboxetine?
H: I primarily talked about the role of the drug acting on the [norepinephrine] system in the case of people who were depressed.
See: And it happens that that’s the way reboxetine works?
H: Absolutely, yes.
See: And you have been compensated for that?
H: I have indeed.
See: Did you perform that work at the request of Pharmacia and Upjohn and your receipt of compensation from them for performing education functions and so on, did that make you a biased person?
H: I’m sure that the receipt of funds from Pharmacia and Upjohn as well as the receipt of funds from Lilly and SmithKline and others has biased me, yes. I think some sort of bias is inevitable. It is an issue of trying to manage that bias.

I have never lined myself up with those colleagues in psychopharmacology or bioethics or other disciplines who claim to be uninfluenced by the funding they receive.

Sixth: “Again, that is Healy himself disclosing, admitting that in the majority of cases he testifies that SSRIs are not involved. In other words, the story Carl told about Healy, and the story Healy USED to tell about himself, are patently false”.

I find it difficult to understand this point, and cannot see the link between the first and second sentences of this statement. Surely most people would want an expert who is not wedded to one and only one possibility. I remain potentially the most credible expert witness Lilly, Pfizer or SmithKline could have in many of their cases for exactly this reason, and one they might turn to if they did not feel that as one of the few experts prepared to testify on behalf of plaintiffs when the facts of the case call for it, that it was in their interests to attack my credibility. In contrast, experts who have testified for the companies have adopted a theoretical position that the alleged events could not in principle happen, and they seem therefore unable to give anything other than one stereotyped view.

Given the debate that has opened up at this point, it seems worthwhile to make a positive contribution to a very tricky area rather than just to carp about details, and at the same time to add a new element into any consideration of conflicts of interest. This contribution comes from knowing something about both the Olivieri case, which remains the key academic freedom case in medicine, and from conversations with others.

Quite aside from any links Nancy Olivieri had with Apotex, there is an aspect of her case rarely mentioned. Clinical facilities usually offer financial “rewards” for what would increasingly be called good corporate behavior. In the Hospital for Sick Kids, this was called a good citizenship bonus. Dr Olivieri as I understand it almost uniquely failed to register on the scale for determining payouts of this sort.

In my case in Britain, there is a merit award system, for which two of the key features for academics are advocacy on behalf of patients and academic output; successful individuals also require institutional support from organisations like the Royal Colleges and employing universities. My output in terms of books and articles is well above the norm, and many regard much of my other work including the legal work as patient advocacy. When told that I have had no recognition in terms of the national merit award system, most colleagues are astonished.

This echoes something I hear repeatedly, which is that overt harassment is often not the greatest problem when one speaks out about issues. It is rather the promotions, recognitions and other things that do not happen that end up being more important. For this reason, a willingness to debate on Dr Wolpe’s part, even if some of the claims appear libellous, seems to me infinitely preferable to hearing that there are national panels that have sat in silent judgement. However it would also be helpful if Dr Wolpe substantiated the points made or else withdrew them.

This other dynamic also sets up a final point, which is that as part of more than one legal action, my entire tax accounts have been made available to the other parties. Despite what may seem like a formidable conflict of interest list, as outlined above, in part because of the things that have not happened, it has I believe been clear to others who have had access to my accounts that overall I would have earned considerably more money had I never gotten involved in these issues than I have since earned. Standard conflict of interest statements make no allowance for possibilities such as this, and in the process anyone who falls foul of the establishment risks a double jeopardy as Dr Wolpe’s interpretation of my position appears to indicate.