The Plaintiff Was Unhappy [review of Side Effects By Alison Bass] — (The Wall Street Journal)

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The Wall Street Journal

Prozac improved the nation’s mood when it came on the market in 1987. Earlier antidepressants had caused many side effects and were potentially lethal in overdose. Prozac appeared to be both a godsend and a blockbuster. It was effective, easy to administer and less likely to be used by depressed patients as a means to commit suicide. It was a boon to the bottom line of its manufacturer, Eli Lilly, but it also became a cautionary tale for the drug industry—of pharmaceutical success inspiring suspicion, controversy and backlash.

Soon enough a Harvard professor, Martin Teicher, published reports of six patients who developed suicidal thinking while taking Prozac, and the Church of Scientology campaigned against it. By 1990 stories about the purported dangers of Prozac screamed from the headlines and fell from the lips of Hugh Downs on “20/20.” Was Prozac causing patients to commit suicide?

In 1991, the Food and Drug Administration convened a committee of experts to study the matter. As it turned out, Mr. Teicher’s six patients had been deeply depressed for years, medicated with multiple drugs and in several cases had attempted suicide before they first ingested Prozac. The Scientologists rested their arguments on anecdotes, not data. The committee concluded that Prozac did not trigger suicides in adults.

But the matter was not put to rest. For nearly two decades a worry over the “hidden” effects of antidepressants—and not just Prozac—have become a kind of cultural reflex. Thus the FDA has convened more committees and analyzed more data. The facts are not easily resolved, because the underlying illness (depression) is itself a risk factor for the adverse event (suicide), and the adverse event is mercifully rare. The latest evidence suggests that, for adults age 25 and older, antidepressant use is not associated with increased suicidality. A pooled analysis of nearly 100,000 patients, conducted by the FDA in 2006, showed no increased suicidality for adults ages 25 to 64.

In “Side Effects,” Alison Bass recasts this history of debate and analysis as one of corporate greed. She extends the “lessons” of Prozac to the antidepressant Paxil, lambasting GlaxoSmithKline, its manufacturer, for supposedly concealing inconvenient information. Her narrative is filled with you-are-there moments, in which heroic researchers challenge Paxil’s efficacy and safety and heroic prosecutors from the office of Eliot Spitzer, New York’s attorney general, prepare a 2004 lawsuit against the company.

It is a question of point of view. For Ms. Bass the judgment of researchers, together with their data and claims, are untrustworthy if they have received money from drug companies to finance clinical trials. She is particularly hard on a professor of psychiatry from Brown University who has defended Paxil. But if the drug companies didn’t pay for such trials, who would? And why shouldn’t companies seek advice from the best scientific minds and pay them for their efforts?

Most odd of all, Ms. Bass treats the FDA as a shill for industry, despite its having thoroughly reviewed the suicide matter and required warnings on product labels where it saw fit. She makes the usual complaint that the FDA has reduced its time frame for approving new drugs: “That sprint came with a price tag. A flood of questionable drugs was unleashed on the market, many of which,” like Vioxx, “would later have to be recalled.”

But she says not a word about how society suffers when the FDA approves new drugs too slowly, depriving patients of life-improving and life-saving medicines. Nor does she mention the studies showing that more rapid drug approval timelines in the European Union have not led to more drug-safety withdrawals. There are two sides to this story; Ms. Bass tells only one.

That tendency is on display elsewhere in “Side Effects.” In a matter as hard to determine as the effect of an antidepressant on the suicidal tendencies of depressed patients, Ms. Bass nowhere mentions the exculpatory adult data. As for pediatric patients: In April 2007 the Journal of the American Medical Association published an analysis of more than two dozen studies. It found that for children and adolescents on antidepressants, as The Wall Street Journal reported, “the risk of suicidal thinking or behavior is smaller than previously thought” and that “antidepressants were more effective than placebos in treating children and teens for major depression” and other disorders.

“Side Effects” belongs to a genre of investigative journalism that involves talking to plaintiffs, their lawyers and their expert witnesses, taking their stories as gospel and denigrating the opposing view because corporate money (apparently less pure than money from the plaintiffs’ side) supposedly has a corrupting effect. Ms. Bass admires David Healy, for example, a British psychiatrist and expert witness whom the drug companies have been “unable to discredit.” Surely a more even-handed account “since corporate fees are routinely cited” would mention the fees that Dr. Healy has collected for testifying for a dozen or more plaintiffs. She does not mention either that a court in 2002 rejected his testimony because of “glaring, overwhelming and unexplained” errors in his analysis.

“Side Effects” is lively and well-written, but readers should be warned that they may have an adverse reaction: a deep disquiet that only half the story has been told.

Mr. Herrmann is a lawyer in Chicago whose firm has defended drug manufacturers in product liability cases.

Original link to this reponse no longer available

Dr David Healy Response to the Herrmann review:

July 16th 2008

Dear Sir,

Being mentioned in any capacity is flattering and as such I don’t wish to take issue with Mark Herrmann’s implication in his review of Alison Bass’s Side Effects that my interests are conflicted, particularly as I’m serially on record as saying that my contacts with drug companies and others have unquestionably biased me. I don’t mind Mr Herrmann noting that my testimony was thrown out in one case, or failing to note the judge in the same case noted that Pfizer’s science was “extreme and incredible. Pfizer’s view of the applicable ‘science’ is heavily slanted towards its self-interest”, or failing to mention that in all other cases the courts have taken a completely different view of my testimony.

But Mr Herrmann’s review is misleading on the facts. Two years before the “anecdotes” about suicidality on Prozac surfaced in 1990, all adult clinical trials combined pointed to a doubling of suicidal acts on novel antidepressants compared to placebo. This has remained the case for every year since then. Furthermore in their submissions of adult data to FDA in the late 1980s and early 1990s, the major companies miscoded the clinical trial data for suicides and suicidal acts in a manner that minimised the problem. It took the regulator over a decade to catch up, after which the companies resorted to other ruses to hide the problems. And to this day, although they have asked companies for all their trials, FDA still have neither all the adult trials, nor all the data, and possibly not much of a clue as to how they’ve been outmaneuvered. He also fails to mention that such data as FDA does have shows an increased risk of completed suicides and suicidal acts in adults.

It is possible that Mr Herrmann as a trial lawyer who has acted on behalf of pharmaceutical companies could have written a compelling piece on the many ways companies fool both regulators and academics like me, that Alison Bass’ book doesn’t touch upon. He might have acknowledged the key point in the book, namely that while the key data is hidden, in clear breach of the norms of science, conflicting interests become an issue. But I don’t understand why he only mentions men in his review, when the book is all about women who took on the system.

David Healy MD