Source: Boston Globe
Date: 1 February 2004

Talking back to Prozac

David Healy was among the first psychiatrists to prescribe Prozac. Now he's one of the fiercest critics of Big Pharma's "marketing" of depression. Did his outspoken views cost him his job?

By Joshua Kendall

FOR THE PAST several years, David has been taking on Goliath.

In a flood of academic publications and talks, the British psychiatrist David Healy has issued harsh criticisms of both the pharmaceutical industry in general and the nearly $20 billion-dollar-a-year antidepressant industry in particular. Healy's central charge: The manufacturers of Prozac, Paxil, Zoloft and the other drugs belonging to the family of antidepressants known as SSRIs (selective serotonin-reuptake inhibitors) have deliberately misled the public about both the safety and effectiveness of their popular products.

As he writes in his controversial new book, "Let Them Eat Prozac," forthcoming this spring from New York University Press, "Far from being the most researched drugs in history, these drugs have only been tested to the minimum extent needed to get on the market and to develop that market." And to develop that market, Healy charges, drug companies have helped exaggerate the extent of serious depression. What's more, he says, for a small but significant minority of patients, Eli Lilly's Prozac and its siblings may actually increase rather than reduce the risk of suicide.

The Times Literary Supplement has called Healy "the leading international authority on the history of psychopharmacology." In this age of specialization, Healy, 49, is as comfortable discussing Aristotelian physics as the physiology of brain chemistry. Though he has been involved in clinical trials and conducted a wealth of studies on the effects of psychiatric drugs, his scholarship -- consisting of about a dozen of books and over 100 journal articles -- goes beyond the number-crunching of empirical research to explore the intersections of psychiatry, the philosophy of science, and cultural criticism.

Until recently, Healy's outspokenness had little effect except to wreak havoc on his own career. The SSRI manufacturers that used to shower him with consulting fees have dropped him like a hot potato. "Several drug reps have informed me they are no longer permitted to include me in their in-house educational programs geared to primary-care physicians," said Healy in a recent telephone interview. In addition, three years ago, following a controversial speech, the University of Toronto gave Healy his walking papers just as he was about to assume a prestigious professorship, citing his "incompatible" approach.

But these days Healy's ideas are getting a second look. In December, Britain's Medicines and Healthcare Products Regulatory Agency sent a letter to doctors and health care professionals advising against the use of all but one SSRI in the treatment of depression in children under 18, citing an increased risk of suicide. And tomorrow the FDA will hold public hearings on the purported link between SSRIs and suicidal behavior in children.

As Healy explains, "Drug companies are taking these hearings very seriously because of the vast implications for the much more lucrative adult market."

A decade ago, Healy hardly seemed like a likely candidate to emerge as psychopharmacology's Public Enemy No. 1. In many respects he was the very incarnation of contemporary biological psychiatry: secretary of the British Association for Psychopharmacology, a leading researcher on the effects of the iconic neurotransmitter, serotonin, and a skeptic who dismissed talk therapy as a romantic fantasy. Healy has no use for the antipsychiatry camp, which charges that mental illness is a social construct, not a real disease. "I am as biological as you can get. The idea that we should all be able to stand on our own without pills is nice, but not very realistic," he says.

Today, as a Reader in Psychological Medicine at the University of Wales College of Medicine, Healy still heads a psychiatric inpatient unit where his armamentarium consists largely of electroconvulsive therapy (ECT), or shock therapy, and heavy doses of the standard psychiatric medications: antidepressants, antipsychotics, mood stabilizers, and tranquilizers. Like many psychopharmacologists, he often concocts his own drug cocktails -- medication regimens that combine a number of different psychoactive agents. In short, Healy is no enemy of pills.

At the heart of Healy's oeuvre are two widely acclaimed books, "The Antidepressant Era" (1998) and "The Creation of Psychopharmacology" (2002), both published by Harvard University Press. The books stemmed from Healy's extensive interviews with many of the psychopharmacologists who have made key discoveries over the last half-century. But rather than merely recounting the inspired moments of scientists, Healy also addresses the broad social, political, and economic currents that enabled biological psychiatry to emerge virtually out of nowhere in the 1950s and triumph over psychoanalysis within a generation.

One of Healy's main arguments is that the drug industry has played a much greater role in shaping our understanding of psychiatric illness than has previously been acknowledged. Ever since 1962, when FDA regulations underwent changes designed to improve drug safety, companies have been forced to develop products targeted to specific diseases rather than general conditions such as "neurosis" or "stress." As a result, the companies have gone into the business of marketing not just pills, but the diseases that they are supposed to cure. In other words, Healy argues, first come the pills and then the disease.

Back in the 1950s and '60s, anxiety was the illness du jour, and tranquilizers like Valium the prescribed treatment. Depression was just a blip on the radar screen, presumed to affect perhaps one in 10,000 in the general population, and typically treated with hospitalization and perhaps electroshock therapy."

Indeed the idea that there might be a depression that drugs could treat had in one sense to be invented as had the idea of an antidepressant," writes Healy in "The Antidepressant Era." The first generation of antidepressants hit pharmacy shelves around 1960. Without much of a market, they were by and large a commercial flop. They also had many troubling side effects.

When fluoxetine, or Prozac, was discovered in the mid-1970s, Lilly was thinking of marketing it as an anti-anxiety agent. But the crash of Valium-mania in the late '70s changed all that. Suddenly, Valium went from "magic bullet" to dangerous and addictive substance. So, when Eli Lilly rolled out Prozac, the first of the SSRIs, in 1988, the company decided to market it as a safer alternative to the older antidepressants that could also be prescribed by primary care doctors, not just specialists.

Today it is commonly said that as many as 20 percent of Americans suffer from depression at some point in their lives. But Healy rejects the conventional wisdom that this startling increase over the last 50 years is due largely to improved diagnosis and reduced social stigma. "The Prozac story," writes Healy in his latest book, is one of a "wholesale creation of depression on so extraordinary and unwarranted a scale as to raise grave questions about whether pharmaceutical and other health care companies are more wedded to making profits from health than contributing to it."

In Healy's eyes, most of the patients diagnosed with mild or moderate depression would be better characterized as suffering from "community nervousness." Though Healy sees this condition as a real biological disorder, he emphasizes that it "could be due to a host of different factors such as overwork, stress, and constitutional deficits. But clinicians everywhere are diagnosing depression because that's what they have a treatment for," he says.

Healy claims he has not suddenly turned against the drug companies. "People often assume that I have had a conversion of some sort, but I haven't," he says. "The views that I am now putting forward about the power of the drug industry to market illness date back to the late 1980s." In Healy's rendering, what turned the tide in his reputation was his decision to serve as an expert witness in several high-profile lawsuits in the late '90s filed by the families of patients who had committed suicide while taking SSRIs. "All of a sudden, my credibility was constantly under attack, " Healy says.

Healy has no interest in seeing SSRIs banned outright. In fact, he still prescribes some of them. But he does think the drugs need to carry adequate warnings about their true risks. According to Healy, for a small minority of patients (roughly one percent in adults and three percent in children), the SSRIs can actually be far more dangerous than their predecessors.

The link between Prozac and increased suicide risk was first suggested by Martin Teicher, Carol Glod and Jonathan Cole of McLean Hospital in Belmont in an influential 1990 article. The study immediately met with fierce opposition, and at hearings held by the FDA in September 1991 a panel of 10 outside experts decided there was not sufficient evidence to conclude that Prozac increased the risk of suicide.

Healy, citing contradictory research and internal drug company memos submitted as evidence in lawsuits, maintains the FDA let Lilly off the hook too easily. In perhaps the most inflammatory sentence of his new book, he suggests there might have been a "conspiracy" by Lilly working in cahoots with the FDA to cover up the danger. (Healy says the FDA did not respond to his request to testify at the hearings this week.)

Lilly continues to assert that the disease rather than the medication causes suicide. This is also the position taken by the American College of Neuropsychopharmacology's (ACNP) Task Force on SSRIs and Suicidal Behavior in Youth, which issued a preliminary report last week examining 15 clinical trials involving more than 2,000 teenagers and children.

Healy dismisses the report as a "PR exercise." He cites problems with the data and points out, as other critics have, than 9 out of the 10 panel members have extensive financial ties to the pharmaceutical industry. (Such ties are not uncommon; Healy himself still consults for a couple of drug companies, including AstraZeneca, maker of the antipsychotic Seroquel.) And when it comes to what he sees as the industry's excessive influence on the academy, he cites his own story as Exhibit A.

Four years ago, Healy was appointed a professor of psychiatry at the University of Toronto's Centre for Addiction and Mental Health (CAMH). In November 2000, shortly before Healy was scheduled to move to Toronto, he gave one of his standard lectures at a meeting hosted by the university's department of psychiatry. In addition to giving an overview of the last 50 years of psychopharmacology, Healy charged SSRIs with causing "one death for every day that Prozac has been on the market" -- and accused his colleagues of overtreating depression under pressure from Big Pharma.

According to a report in The Toronto Star, several members of the audience were visibly upset after the speech. A few days later, the head of CAMH, David Goldbloom, dashed off an e-mail in which he fired Healy, noting that his lecture had shown that his "approach [was not] compatible" with the rest of the department. When a letter of protest to the university's president -- signed by 29 senior figures in the world of psychopharmacology, including two Nobel Prize winners -- failed to achieve a sympathetic response, Healy sued the university for $9.2 million Canadian, charging breach of contract, libel, and violation of academic freedom.

The centerpiece of the libel charge was a comment from a key university official published in a university newsletter that compared allowing Healy to air his views on Prozac and suicide to "letting a fool cry 'Fire' in a crowded theater." The case has since been settled out of court, and Healy now serves as a Visiting Professor of Psychiatry at the University of Toronto. The "crowded theater" statement has since been removed from the online version of the university newsletter.

In a recent interview about Healy's dismissal, a CAMH spokesperson "denied any influence on our decisions, direct or indirect or otherwise, by an outsider donor, funder, or individual and certainly not by a pharmaceutical company."

But Healy says it all comes back to the major theme of his books: "Scientific progress in psychiatry has been stalemated because Big Pharma's marketing efforts have overwhelmed the field.

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