A recent book on Big Pharma’s way, now superseded in this connection, of defending its business surrounding psych meds; and some tidbits from my files, offering some background insights and reflecting how times have changed
[This is a collection of notes derived from different sources, on a very important topic that, in a sense, I have wanted to write on for many years—since the early 1990s or so. As it happens, any “public need” for the kind of story I first wanted to write seems to have been superseded by the fact that, today, black-box warnings about various psychoactive medications, such as antidepressants, have been required by the FDA, not least about the potential for suicidal thought that seems triggered by the medications as a side effect, at least early in a patient’s use of them. Also, my sources here, and the way I write from them, are from different scattered “locations” or entities with varying levels of credibility and/or expertise, and I also am not trying to be definitive here. Finally, a folder I had on material relevant to this, including a copy of a short article on antidepressants causing suicidal thought, I cannot find lately. But no great loss: what other resources in my records I found will be enough for now.]
I. The book
Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial, by Alison Bass (Chapel Hill , N.C. : Algonquin Books of Chapel Hill , 2008).
This is a look at what would turn out to be—even if focus on this was not the author’s express purpose—the rather tortured historical background of (if not a simple, efficient impetus for) changes in FDA-required labeling about the risk of suicidal ideation triggered by medications meant to treat depression (other medications, such as for smoking cessation, also come with this warning). More to the point of the book, it includes the very interesting ways Big Pharma companies have responded to issues of highly serious or allegedly fatal side effects of their medications, from the late 1980s through about 2008, when Ms. Bass’s book was published.
Things, of course, have been changing since the years of the start of this book’s story, in part because the idea of hiding gravely negative side effects from medications that are being planned for market has been going by the wayside as a matter of company policy. The difference between 1991 and today is like a complete swing of the pendulum from one side to the other.
Not unrelatedly, a very recent example of the even more veil-lifting policy—that of making study results available to others, as notoriously hadn’t been done before—is seen at least with one Big Pharma company, GlaxoSmithKline—which, independent of the matters this book discusses, also happens to be a player in this book’s story. See this recent New York Times story on a new policy of Glaxo’s.
The story includes a lawsuit against Eli Lilly, Greer v. Eli Lilly, filed in 1991, by Joan Greer alleging wrongful death in the suicide of her husband, Michael Rosenbloom, a prominent attorney in the Washington , D.C.
Another case the book looks at, drawing about as much of the book’s episodic focus as the Greer case, is a civil lawsuit filed in 2004 by the New York State Attorney General’s office against GlaxoSmithKline (e.g., pp. 47 ff.).
This book presents its overall tale as a sort of mystery, via several cases (alternating between cases), though its order (one chapter per segment of a given case) involves an occasionally backtracking time structure. Actions are described in a sort of dramatic fashion, with something of fictional technique in how conversations and other incidents in individuals’ lives are recounted, but this all is based on interviews with the people involved. The writer, Alison Bass, was a reporter for the Boston Globe and the Miami Herald, and has written for other publications, such as Psychology Today. She had no reason to fictionalize her look at Big Pharma after having written on it investigatively for some years.
The Greer case and Dr. Teicher’s later humiliation
There are a few glimpses, within the episodes involving Lilly, of a situation involving Martin H. Teicher, Ph.D., M.D., one of the psychiatrists who worked within the functionally united trio of Harvard Medical School, McLean Hospital, and the Mailman Research Center. (Dr. Teicher also apparently has a blog—see here. Other psychiatrists associated for many years with this set of facilities have been Ross J. Baldessarini, M.D., and Jonathan O. Cole, M.D.; Cole is referred to in Bass’s book for the first time on p. 11.)
Bass notes that at McLean Hospital, it was expected that an ambitious psychiatrist do three things at once: see hospital patients; do psychiatric research; and maintain a private practice (p. 9). Teicher did all of these, and his work was impressive enough that, in 1988, he became director of the hospital’s newly endowed research program in developmental biopsychopharmacology (p. 9).
Teicher was also an author, along with colleagues C. Glod and Jonathan O. Cole, of a report that made a lot of news and aroused controversy, in ways we’ll see. It was the case report (of six cases), “Emergence of Intense Suicidal Preoccupation during Fluoxetine [Prozac] Treatment,” in the American Journal of Psychiatry 147 (2) (February 1990), pp. 207-10. (Bass’s book fumbles the page numbering when her end notes section cites this article.)
After hesitation at doing this sort of thing, Teicher became an expert witness in the Greer lawsuit against Eli Lilly. Ms. Greer’s attorney had contacted Teicher and in 1990 he accepted the role of expert witness (pp. 30-33, 79-80). In a different context, he had seen documents among the “data on file” of Lilly related to Prozac, which had been submitted to the German version of the FDA in 1984 (in order to get German approval for marketing Prozac there) (pp. 39, 81), and within these documents he saw there was data linking the medication to increased suicidal ideation and tendencies. But this same data were not reported to the U.S. FDA at a special hearing conducted, in September 1991, specifically on the risk of suicidality posed by Prozac (pp. 29 ff., 39, 81).
Sidebar: The Teicher report made a splash, and got colleagues trying to undermine it, in the early 1990s
I remember there being a big brouhaha about the Teicher report—the time I became aware of it was probably in early 1991; there was New York Times coverage of it. (I believe I cut out news clippings on it, but don’t know where they are.) At the time, with my own personal research into the issue of psychiatric-medication side effects, I was very aware of the tendency of professionals within the field to deny or downplay the significance of these, and the professional-peer reactions to the 1991 Teicher study tended to fit right in with this. (This all was the opposite of how this sort of thing is handled today, at least in terms of today’s “black box” warnings and even in anecdotal situations you hear about.)
In fact, there was a follow-up study by, I believe, a doctor named Maurizio Fava, M.D., who seemed to review data with the objective/hope almost to expressly counteract the Teicher report. The Fava study seemed to be taken as the last word on the issue. (I don’t have my documents related to this presently at hand.)
Bass recounts some of what went on at the September 1991 FDA hearing. One professional who seemed to go to some length, by reviewing data and being consistent in what could be said in line with this—without fully admitting Teicher’s findings and what they implied—was Charles B. Nemeroff, M.D., Ph.D. As I knew from my own past research, Nemeroff was one of the researchers of an important report that debunked, seemingly for all time, megavitamin therapy, a form of treatment for psychiatric (and other) problems that was popular in the 1970s: Morris A. Lipton, Richard B. Mailman, and Charles B. Nemeroff, “Vitamins, Megavitamin Therapy, and the Nervous System,” in Nutrition and the Brain, volume 3, edited by R.J. Wurtman and J.J. Wurtman (New York: Raven Press, 1979), pp. 183-264. I got a copy of this report in the late 1980s, and it was formative in my amateur thinking on megavitamins.
I say this, plus the following, as a prelude to remarking about Nemeroff: while Morris Lipton has been dead for some time, I was in touch with Mailman in the early 1990s, and he commented forthcomingly about how he considered megavitamin therapy to remain debunked. I also was in touch very briefly with Judith Wurtman, one of the editors of the volume, in January 1987; she is who informed me on the existence of this study. These professionals are willing (or were, in the old days) to correspond if you showed interest in and understanding of their work. All this I say to imply I never felt an animus toward Nemeroff, whom I also never tried to contact (I believe). In about 2002, I heard he was expounding for more or less public-education purposes on ideas about bipolar disorder and pharmaceuticals, conveyed to me by people within the Depression and Bipolar Support Alliance support-group network; what I heard, to me, smacked of his being pretty partisan in line with the Big Pharma industry.
Well, it turned out Nemeroff received a slew of bad publicity in 2008, which also was covered by The New York Times, when Senator Charles Grassley started investigating him and/or publicizing some findings or allegations on Nemeroff’s “taking and not disclosing more than one million dollars in pharmaceutical fees,” according to an e-mail I received by December 1, 2008, related to the NPR radio program “The Infinite Mind,” produced by Bill Lichtenstein. (I have a copy of this e-mail on file.) The 2008 reports made Dr. Nemeroff to be something of a glaring case of a research psychiatrist made biased by the fees he got from Big Pharma. (His rather small Wikipedia bio also conveys some of this 2008 news.) This news saddened me, given my previous knowledge of him as a responsible steward of public information about psychiatric care, as implied by the 1979 megavitamin study.
Another researcher who engaged in tactics to fight Teicher’s presenting his own findings about the issue of Prozac and suicide at the September 1991 FDA hearing was Daniel Casey (Bass’s book, pp. 40-41), whom I’m familiar with in a small way from taped conference proceedings from the early 1990s, when I worked for Clinicians Publishing Group, a medical publisher in New Jersey. I hadn’t thought from what little I was exposed to of Dr. Casey that he would be a tendentious or dishonest researcher, and I’m not sure how much he was this way regarding Teicher at the September 1991 hearing.
This goes to show how Teicher’s research findings were greeted by colleagues. Now let’s see how Eli Lilly, maker of Prozac, dealt with legal challenges regarding the possibility of its drug causing suicidality or violence.
The outcome of a previous suit against Lilly—where court rules were remarkably bent
Bass notes that in 1994 Lilly won a lawsuit similar to Greer’s that it faced in Kentucky (pp. 79-80). Then in 1995 the judge on the case discovered that the reason Lilly had won was that it had paid the plaintiff’s lawyers and clients to “throw” the trial—i.e., to do something that would allow them, via the workings of the trial as it went before a jury, to lose. In 1997, the Kentucky Attorney General’s office released a report finding this to be the case; but it recorded the status of the case to be changed from having reached a jury verdict to being “dismissed as settled” (p. 80).
It was this sort of thing, Bass suggests—the possibility that Lilly could go to any extreme not to lose a wrongful-death lawsuit against it—that Teicher (wittingly?) faced when he was serving as an expert witness in the Greer case (p. 80).
A tough deposition, and manipulation of his family situation, as well as raising issues about a difficult patient
In the lawsuit, in 1996, Teicher was eventually deposed by an attorney for Eli Lilly, Nina Gussack of the firm Pepper Hamilton in Philadelphia; she was a capable and aggressive woman who would eventually show how tough she could be working for her employer (pp. 80 ff.). After Teicher had revealed what he knew about the hidden information on the medication’s causing suicidal ideation (p. 82), as he found in his free time after being deposed, his wife—who was a cancer researcher—was suddenly offered a choiceworthy career opportunity to work for Lilly at its headquarters in Indianapolis, several states away from where Teicher and she had been living, in the Boston area (pp. 82-83). She (taking with her their children) would end up taking this opportunity, which of course posed rather difficult stresses for Teicher (see, e.g., p. 104).
Another step in the lawsuit that started to prove quite daunting for him was when, after the first day of the deposing process, Gussack brought up a subject in his 1990 case study that I mentioned above, Patient #6 (p. 83). This patient was a female with borderline personality disorder and a serious substance-abuse problem, who (sometime after the study was conducted, I believe) had also filed a lawsuit against Teicher alleging he had had sex with her, which was untrue (pp. 83-86).
Bass states she does not believe Teicher had sex with the patient, noting that Teicher crossed a line in terms of giving Patient #6 a gift, as he conveyed to her because he had been impressed (caught in an emotional undertow, I would say) by how suicidal the patient was. Bass likens this move to the earlier boundary-crossing (and yet not having sex) that happened in another case whose legal paperwork Bass studied as a journalist, the lawsuit against psychotherapist Margaret Bean-Bayog (a Ph.D., I believe), who treated a medical student, Paul Lozano, who committed suicide when in her care (Bass, p. 87); Lozano’s family had filed a wrongful death suit.
Coincidentally, a letter to the editor I wrote on the Lozano case was published in The American Scholar in its summer 1994 issue; the Scholar had had a long article, by Johns Hopkins psychiatrist Paul R. McHugh, M.D., on the Lozano/Bean-Bayog case, which attracted considerable response in letters from others. I in my letter did not speak from expertise other than from a sort of existential background; my letter was pretty amateurish. But the Lozano case raised a complex set of issues of psychiatric ethics, responded to by people from a wealth of backgrounds.
II. From among my old papers: Signs of early-1990s vigilance about Prozac
As I said, I couldn’t find a folder that concentrated several of my records on the issue of antidepressants triggering suicidal ideation, but I did find the following, which is pretty choice. I have photocopies, which I believe I received in the early or mid 1990s, from some activist whom I think I was put in touch with by what became MindFreedom International, which used to be Support Coalition International, and before that was the publication Dendron, presided over by longtime activist David Oaks, located in Eugene, Oregon.
Among these photocopies are a copy of the cover of the February 7, 1991, New England Journal of Medicine, and the page of the relevant little article in it, a sort of end-noted letter that describes cases, headed “Suicidal Ideation Related to Fluoxetine Treatment,” by Prakash Masand, M.D., Sanjay Gupta, M.D., and Mantosh Dewan, M.D., of the Health Science Center of the State University of New York at Syracuse. Among their end notes, with which they orient their own findings, is Teicher’s 1990 study.
Along with this are two photocopies of communications apparently from the Center for Drug Evaluation and Research (CDER) of the FDA, one being a handwritten note by Dan Gelling, signing for (?) Alan Greenberg, Acting Chief of Surveillance and Data Processing at CDER. The original fax is time-stamped May 30, 1991, and the note says, “Since marketed in 1988, by Eli Lilly, PROZAC (fluoxetine) has had the highest number of adverse event reports submitted to the FDA National Adverse Drug Reaction Reporting System database. The database dates back to 1969. In 1990, PROZAC had the largest number of reports.”
Another page, a photocopy of a fax time-stamped July 2, 1991, has a table of figures headed “120 deaths attributed to Prozac,” including 33 murders, with subsets broken down by seven states and another figure of 15 “confidental reports” of murders. There are also 87 total suicides, broken down by 27 states, with an additional 20 suicides in “confidential reports.” A footnote explains, “Some locations have not been revealed as they were reported to CCHR in confidence.” The organization or office in charge of this information, “CCHR,” is apparently the Citizens Commission on Human Rights.
III. Peter Kramer’s book on Prozac
