Suicide Science

Dr. David Dunner of the University of Washington's Department of Psychiatry admitted he"ghostwrote" an article that appeared in the March 1995 issue of the journal EuropeanNeuropsychopharmacology (EN) on behalf of pharmaceutical manufacturer SmithKline-Beecham (which has sincemerged with GlaxoWellome to become Glaxo-Smith-Kline, or GSK).

Dunner had purportedly analyzed the data of clinical studies involving GSK's antidepressant andanti-anxiety drug Paxil and concluded that it is less likely to lead to suicidal thoughts than the olderantidepressant imipramine and placebo (sugar pill). Dunner never looked at any of the data but he was stilllisted as an "author" of the article.

Meanwhile, Dr. David Healy of the University of Wales Department of Psychological Medicine presented adifferent analysis of this same data during the Paxil trial last year. The family of Wyoming resident DonaldSchell, 60, sued GSK in federal court after he shot his wife, daughter, granddaughter and then himself todeath in 1998 after two days on Paxil. Healy testified on behalf of the plaintiffs. He argued GSK's internalrecords demonstrated that there is a substantially increased suicide risk for patients put on Paxil. The juryagreed with the plaintiff's position that Paxil was primarily responsible for Schell's actions and awardedthem $6.4 million in June of last year. The judge in the case rejected GSK's challenge of Healy's testimonyand sent them packing to a federal appeals court in Denver in August. A suicide warning has since been put onthe label for the drug, not here in the United States, but in Britain, where it is known as Seroxat.

Where did Dunner's stunning admission of having ghostwritten such an important article appear? In either ofthe local dailies the Seattle Times or Post-Intelligencer? No, not even close. A Seattle resident would haveto purchase a ticket on the next British Airways flight from SeaTac to London to meet the author of thearticle Dunner was quoted in: Sarah Boseley, health editor of the Guardian. Boseley's February 7 articleconfirmed what I have suspected all along about Dunner: He has little or nothing to do with the actualresearch and writing behind many of the articles where his name, D.L. Dunner, appears.

The current situation in peer-reviewed publication in academic and clinical medical research is starting toresemble the Church's control over publication of anything in, say, 1300. The pharmaceutical industry fundsmost of the research into the crucial Phase III clinical trials that lead to FDA approval for marketing drugs(the truth is most of the cost of bringing a drug onto the market is put up by tax payers). This gives thedrug companies an enormous amount of influence over study design and, most crucially, they typically retaincontrol over study data as proprietary information.

The end result is that it's difficult to find a published article in peer reviewed medical journals dealingwith clinical drug studies that weren't supported by funding from the drug's manufacturer. Most medicaljournals are now dependent on pharmaceutical industry advertising to stay in business. This didn't stop 13prestigious journals, including the Journal of the American Medical Association, New England Journal ofMedicine and Britain's Lancet, from publishing an editorial in September of last year condemning theconditions put on researchers by the drug companies as, "draconian for self-respecting scientists, butmany have accepted them because they know if they do not, the sponsor will find someone who will." Theaim of the journals was to implement editorial policies to authenticate authorship of articles.

"The pharmaceutical companies usually retain the right to withhold the information their researchersfind that they don't want the public to see," said Keith Hoeller, community college instructor inpsychology in Seattle and editor of Review of Existential Psychiatry and Psychology (who also brought theBoseley article to the author's attention). "These kinds of contractual stipulations also provideresearchers with incentives to find the kind of results the drug companies are looking for in the studies theyfund."

"It would be a simple matter to say that the data is inherently unscientific while it remainsproprietary," said David Healy. "There is no other branch of science in which the raw data remainsinaccessible to investigators generally and indeed essentially to the public." We can all see whathappened when the clinical data in the Paxil trials became a scientific matter in a court case last year. Thistells us that there may be something to what many critics of the marketing of psychiatric drugs during the'90s suspected all along: The public has been fed a self-serving party line about the efficacy and safety ofPaxil, Prozac, Zoloft, and all of the other newer antidepressant drugs.

Actually Dunner is anything but friendly and approachable on the topics being reviewed in this article.Dunner won't talk to me about what he knows about the side effects of the newer antidepressant drugs and hisconflicts of interest with the pharmaceutical industry. I don't mind Healy's willingness to discuss thesematters with me. It's just that I help pay Dunner's salary and help fund his department every time I payWashington state's regressive sales tax, not Healy's. None of this is a problem in the area of financialconflict of interest though, as I have recently received copies of Dunner's honoraria and conflict of interestrecords from the UW.

Here is a brief summary. Since July of 1997 and up until the end of last year, Dunner made at least 80requests for outside professional work for compensation including 33 lectures sponsored by variouspharmaceutical companies, 14 for various universities and 11 on behalf of various professional societies andother organizations. No exact dollar amount is ever given on any of the records I have obtained. He alsospends at least a few days every year as a "reviewer" for various peer-reviewed academic journals.

Dunner's record also includes eight statements of significant financial interest. The most significant withregard to the Paxil clinical trial data is a disclosure he made in 1998. The disclosure was made regarding anapplication for a clinical trial dealing with Paxil in which Dunner would serve as an investigator at hisCenter for Anxiety and Depression. His Confidential Statement to the Vice Provost for Research states,"My involvement with SmithKlineBeecham (the pre-Glaxo merger owner of Paxil) involves being a member ofthe international advisory board related to paroxetine (Paxil)." In other words, Dunner's name appearedin the EN article not as an independent scientist but most likely as a part-time employee of the manufacturerof Paxil. This conflict of interest is not mentioned in the EN article.

Here is Dunner in his own word's in Boseley's Guardian article: "I don't know who saw it (the Paxilclinical trial data). I did not. My role in the paper was that the data were presented to us and we analyzedit and wrote it up and wrote references." Dunner's co-author Stuart Montgomery, then of St. Mary'shospital medical school in London, declined comment for the Guardian article. His other co-author is GeoffDunbar, a company employee (Dunbar's status as a SmithKline employee was mention in the EN article).

Healy figures about half of all articles appearing in medical journals today are ghostwritten jobs bypharmaceutical companies. What this tells us is that we should regard much of what we read in the publishedmedical literature with a level of suspicion similar to that of a citizen of the former Soviet Union readingPravda. In other words, take with a grain of salt any published article stating "studies show that drug Xis a safer and more effective treatment than drug Y and placebo."

The lack of candor most of the psychiatric profession and the pharmaceutical industry has about theseheavily marketed drugs has potentially deadly consequences for the patients taking them. According to Healy,"The evidence from across the board from all the companies producing SSRI's (i.e. Prozac, Zoloft, Paxil,et al.) is that their drugs can make 1 in 20 of us agitated to the extent that we drop out of trials."Healy figures that at least 250,000 people worldwide have attempted suicide because of Prozac alone and 25,000have succeeded. That sounds like a huge number but if you put 50,000,000 people on the drug, at least2,500,000 will become extremely agitated. If ten percent of that population attempts suicide because of theextreme agitation, that gives you 250,000. If ten percent of that population succeeds in carrying out theirsuicide attempt, you end up with 25,000 dead bodies. Put another 100 million people on Zoloft (comedian PhilHartman's wife Brynn), Paxil, Luvox (Eric Harris at Columbine) and the other more potent newer antidepressantsand you have might have another 50,000 dead bodies.

"The fact that (pharmaceutical) companies have chose to market them as antidepressants rather thanagents of agitation is a business decision rather than a scientific matter," said Healy. Yes, businesshas been great for the companies manufacturer these "antidepressant" drugs. The sales of these drugsis now a $10 billion-per-year industry. However, the outcomes for the patients put on these drugs have notnecessarily been all that great.

The four dead members of the Schell family are testimony to this fact. GSK's line in the Paxil trial thattheir drug didn't have enough time to "help" Donald Schell follows no coherent logic. What GSK issaying is that Schell needed to stay on the drug in his agitated state and his dose possibly needed to beincreased, a common occurrence in psychiatric practice. Increase the patient's dose and you get an even moreagitated individual. You still end up with the deaths of three generations of Schell's in Gillette, Wyoming onFebruary 13, 1998 with Paxil as the suspected culprit, no matter what kind of semantic games GSK wishes toengage in with this case.

How much longer is David Dunner going to remain silent about the record of harm these"antidepressant" drugs have caused? How many articles in Dunner's publication record wereghostwritten? How much longer are the Times and P-I going to quote Dunner as an unbiased expert on mentalhealth issues?

(Rick Giombetti lives in Seattle. He can be reached at: rickjgio@speakeasy.net)