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January 25, 2004
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Truth: a Bitter Pill for Drug Makers
  Times Headlines
By Greg Critser, Greg Critser is the author of the forthcoming "One Nation Under Pills" and "Fat Land: How Americans Became the Fattest People in the World," recently out in paperback.

Next month, an advisory committee of the Food and Drug Administration will meet to discuss what might arguably be the most tendentious issue in modern psycho-pharmacology: the use of antidepressants to treat childhood and teen depression and the drugs' possible role in teen suicide. This comes on the heels of Britain having banned the prescribing of Paxil for children under 18 and advising against most other commonly prescribed antidepressants for that age group.

But the FDA should really be debating bigger issues, including the role these drugs have come to play in society, and the ways the drug companies have distorted the truth about their products.

The current crop of antidepressants, mostly selective serotonin reuptake inhibitors, or SSRIs, have become, in a sense, cultural products as well as medical products. We have embraced them as a society, yet we are intensely conflicted about them. They are not just pills but stories we tell ourselves about how we should feel and how life should be lived pills as movies if you will. This may well be the reason we have such mixed feelings about antidepressants: We simply don't know how to assess them objectively, independent from the tales we have told ourselves.

One reason for that is the speed with which these drugs were launched out of the corporate womb and into the patient population. In the old days, before medicines were marketed directly to consumers, prescription drugs took years to gain a foothold and hence become profitable. Doctors stuck to the tried and true and were slow to embrace new drugs. But after Congress passed a law in the 1980s making generic drugs easier to get, brand-name companies had to become entrepreneurial; they realized they could no longer afford long waits for profitability.

This change led directly to a whole new marketing strategy at the big pharmaceutical companies: Rather than marketing to the relatively small pool of potential prescribers with psychiatric training, they cast a wider net: focusing on building demand among general practitioners and later, more directly, among patients themselves. To help general practitioners unfamiliar with antidepressants explain the drugs to their patients, the manufacturers created easily understood stories, maintaining that SSRIs, such as Prozac (made by Lilly), Paxil (GlaxoSmithKline) and Zoloft (Pfizer), were not like the previous generations of psych meds. They were not uppers or downers or tranquilizers that turned patients into zombies but more sophisticated compounds that simply reestablished our "natural" neurotransmitter balance. It was a powerful message to a generation of patients inclined toward the natural.

The balance story is not exactly a lie, but it's not exactly the truth, either. When pushed, in a lawsuit against his company, Alan Metz, vice president for clinical development at Glaxo, admitted in court papers, "It's not possible really to measure total serotonin." He added that "we do not know with absolute certainty about how any of the antidepressants work." If the drug companies can't really measure what normal serotonin levels are, and they don't know really how the drugs work, then how can we say they restore balance?

A more accurate version of the message would be this: Varying levels of various neurotransmitters, including serotonin, are associated with varying levels of depression. But that doesn't make as good a story, and so the industry has aggressively and successfully promoted the notion of neuro-balance. SmithKline, before its merger with Glaxo, explained Paxil's effects with animations of a pool table, on which balls ricocheted madly until they were put back in order by Paxil. Pfizer, the largest pharmaceutical company in the world, sponsors "Brain: The World Inside Your Head," a traveling show for science museums in which the company tells children that depression may be caused by, you guessed it, "an imbalance in neurotransmitters."

So does this mean that the big pharmaceutical companies are evil, as the Church of Scientology and other conspiracy buffs have suggested? Of course not. It simply means that Pfizer, Glaxo, Lilly and the rest are doing what they are supposed to do: make money. If they have gained in recent years far too much cultural power, it is because we have given it to them.

Are the drugs evil? Again, not at all. They are, at least in the short run, quite valuable, if monitored closely. Even the foremost critic of SSRI overuse, the British specialist David Healy, still prescribes antidepressants other than Paxil to patients.

The chief myth is that SSRIs being restorers of "natural" balance are safer than previous generations of psychiatric meds and, therefore, OK for family doctors to prescribe. They are not necessarily safer, and they should be prescribed only by people trained in their use who will closely monitor patients.

Closely monitor means weekly follow-ups for the first three months something almost impossible in the modern managed-care environment where general practitioners average about eight minutes per patient to diagnose and prescribe. Follow-up appointments are tough to get. Yet nearly every study that has found SSRIs safe and effective looked at patients who received intense follow-up care. In the real world, most people who are prescribed SSRIs today are on their own.

This does not mean that only psychiatrists should prescribe them, but it does mean that any general practitioner who does so needs to have had substantial training in their use and a commitment to providing the necessary follow-up. That would not only make the process safer all around, it would free the general practitioner from simply endorsing a patient's self-diagnosis and request for treatment, which often happens. Better training would also provide doctors with the tools to resist the animated messages of the drug companies about these powerful psychiatric drugs. It also might make them consider providing a more accurate message to their patients, something like this: These drugs will stimulate some parts of your brain and tranquilize others. But you must report to me regularly, which is the only way I can make sure that the side effects don't turn into something harmful.

Those side effects can be major. Consider Paxil, approved in the early 1990s. Its biggest drawback is that going off the drug suddenly can cause serious withdrawal symptoms (or, as the company's legal staff insists on calling it, "discontinuation syndrome"), including suicidal despair. This was clear as early as 1996, when both the company and the FDA knew that the withdrawal syndrome flulike symptoms, depression, anxiety and other fun experiences like "brain zaps" (a feeling sort of like an electrical charge in the head) was, statistically speaking, Paxil's leading problem. Yet the company refused to put withdrawal syndrome on the drug's precautions label until 2001.

I once asked Jan Leschly, until 2000 the head of SmithKline, Paxil's maker, why that was so. We were sitting in a conference room of a large New York communications agency. Leschly, a charming onetime tennis pro from Denmark, was not surprised at the question. He said all the right things that the company would never purposely endanger patients, that it would be bad for business as well as morally wrong, and that "we may press [advertising regulations] but we would never, never go beyond it." But why, I asked, when withdrawal syndrome was clearly the leading adverse event reported to both the company and the FDA, did he not put that warning under the precautions section of the label, where general practitioners might comprehend its gravity? Why, in fact, did the company spend millions to justify not doing so? Leschly then made it clear he had had enough of me. "Some people will never have enough information," he said, sticking out his hand for a conclusive handshake. "That's it. I've got an attorney sitting down there waiting to see me. I've got to go."

The public is still waiting for an answer.

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