Healthy Skepticism Library item: 2657

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Healy D.
Contra Pfizer
Springer Publishing Company ( originally from Ethical Human Psychology & Psychiatry Volume 7, Number 3, Fall/Winter 2005 ) 2005 Oct 15
http://www.springerpub.com/default.aspx?pid=68

Keywords:
Pfizer Healy Zoloft SSRIs FDA

Notes:

Ralph Faggotter’s Comments:
Not infrequently a medication will exacerbate the very problem which it is trying to help.
For example, sometimes beta-blockers will make heart failure worse.
SSRIs when used for depression (or any other purpose) can sometimes make a person feel so rotten that they feel suicidal. Now this potentially puts doctors in a dilema and could make them think twice before prescribing SSRIs, which explains why drug companies are so touchy about the link between SSRIs and suicidal thinking. Furthermore, if some-one starts taking an SSRI and then suddenly and unexpectedly commits suicide it makes people ( especially lawyers) wonder if the SSRI was responsible for the suicide. This therefore explains why any influential authority (like David Healy ) who is bold enough to point out the link is likely to be the recipient of the unalloyed displeasure of the pharmaceutical industry.

Full text:

Contra Pfizer
A featured article in Ethical Human Psychology & Psychiatry Volume 7, Number 3, Fall/Winter 2005

Contra Pfizer

David Healy, MD
North Wales Department of Psychological Medicine Wales, UK

Against a background of longstanding concerns that antidepressants may trigger suicidality, the Food and Drug Administration (FDA) in 2004 convened two committees to review the issues. Prior to the second meeting Pfizer posted an extensive ad hominem attack on me on FDA’s website. There was no opportunity to post a response. This article covers the points made in response and sheds some light on pharmaceutical company handling of debates about adverse events.

In July 2004, Pfizer posted an ad hominem attack on me on the Food and Drug Administration’s (FDA) Web site under the heading of documents relevant to a then forthcoming Psychopharmacologic Drugs Advisory Committee (PDAC) hearing on the use of antidepressants in children (Ryder, 2004). FDA refused to post my response to the issues raised in the Pfizer document. This response has been adapted for a freestanding publication, and may be timely in light of the fact that the FDA has scheduled a further hearing on treatment-induced suicidality in adults for the fall of 2005. In completing this piece, I remain heavily constrained by confidentiality orders, and it can be noted that Pfizer has attempted to enforce such orders vigorously by means of court action.

Pfizer’s letter starts with a commitment to open debate. The letter then seeks to attack my credibility in an ad hominem way rather than to address the scientific issues. This attack comes despite the fact that I have been previously invited by Pfizer to chair symposia for them, to author articles for journal supplements for them, to give international guest lectures for them, and to adjudicate on studies submitted for Pfizer research awards for them. Clearly, at one point Pfizer thought me a credible scientist in the area of psychopharmacology.

More recently, however, when scientists from Pfizer have sought to have me come and speak at forums, they have been told by their superiors that this is not appropriate. Of even greater interest is that the senior Pfizer physician representing sertraline at the September hearings, Dr. C. Kremer, when working for another company had been a key person supportive of my involvement as an expert witness in court actions involving fluoxetine.

It has in fact been very difficult to get issues of suicidality and psychotropic drugs debated in academic forums. In one of the few such forums, at an Irish College of Psychiatrists meeting in 2003, my understanding is that many clinicians and academics in the audience were briefed by individuals linked to Pfizer and GlaxoSmithKline on issues to raise with Healy. Many of these issues are reproduced in this letter from Pfizer.

At other scientific meetings to which I have been invited to contribute on these issues, such as the International Society of Pharmacoepidemiology annual meeting, distinguished academics with links to some of the major companies producing selective serotonin reuptake inhibitors (SSRIs), who have never heard me present the data, it would appear, apparently sought to have me removed from the scientific program. Yet, when later given the chance to challenge the points I make, they have failed to ask me any questions in public.

I believe this effort to close down debate has little to do with the scientific issues, in that my work on these points has been extensively peer-reviewed and published in six different journals. I have taken the unusual step of presenting many of these reviews, especially the negative ones, on the Internet to make it clear where others differ in their interpretations of the data (Healy, 2004). I believe the issue has much more to do with my temerity in being prepared to testify as an expert for plaintiffs. Since my involvement as an expert witness, I have received documents from at least one public relations company working for one of the relevant SSRI companies that have listed me as a problem to be managed, and I think what we are witnessing here is part of the management strategy.

Before proceeding, it is worth putting the issue of expert witnessing in context. In over 90% of the SSRI cases on which I have been approached, I have given the view that the injuries in question have not been caused by the SSRI. I have charged nothing for the great majority of these reports, or nothing for any reports I have offered to coroners’ courts for the purposes of inquests.

Moreover, regarding actions by plaintiffs in general, far from being plaintiff friendly, I have been used as an expert by the National Health Service in the United Kingdom, and in that capacity have offered reports favoring the defense rather than plaintiffs in, again, over 90% of cases.

It should also be noted that I have no interests in any competing treatments. I use antidepressants, including SSRIs, to treat both adults and children, and, as a former secretary of the British Association for Psychopharmacology, convened a consensus conference and authored the ensuing guidelines on the issue of treating children with psychotropic drugs (BAP, 1997). These guidelines endorsed the cautious use of such drugs, a position I maintain to this day.

SPECIFIC RESPONSES TO PFIZER

In its July 2004 letter to the FDA, Pfizer made 12 points to which I will respond.

First

First, the company claims its depression program has shown no evidence of suicidality. In fact, Pfizer’s depression program has a roughly 50% failure to demonstrate efficacy in clinical trials, and many of the trials undertaken with Zoloft remain unpublished. So poor were the results from the early trials that they raised concerns that this drug might not get approved, as publicly available memoranda from Dr. P. Leber to Dr. R. Temple indicate (Leber, 1991a, 1991b).

To view the complete article please click on the link below.
Contra Pfizer by David Healy

This was a featured article in Ethical Human Psychology & Psychiatry Volume 7, Number 3, Fall/Winter 2005

Visit the Ethical Human Psychology & Psychiatry website