For decades, antipsychotic drugs were a niche product. Today, they’re the top-selling class of pharmaceuticals in America, generating annual revenue of about $14.6 billion and surpassing sales of even blockbusters like heart-protective statins. While the effectiveness of antipsychotic drugs in some patients remains a matter of great debate, how these drugs became so ubiquitous and profitable is not. Big Pharma got behind them in the 1990s, when they were still seen as treatments for the most serious mental illnesses, like hallucinatory schizophrenia, and recast them for much broader uses, according to previously confidential industry documents that have been produced in a variety of court cases…
The companies all say their antipsychotics are safe and effective in treating the conditions for which the Food and Drug Administration has approved them — mostly, schizophrenia and bipolar mania — and say they adhere to tight ethical guidelines in sales practices. The drug makers also say that there is a large population of patients who still haven’t taken the drugs but could benefit from them.The industry continues to market antipsychotics aggressively, leading analysts to question how drugs approved by the Food and Drug Administration for about 1 percent of the population have become the pharmaceutical industry’s biggest sellers — despite recent crackdowns. Some say the answer to that question isn’t complicated. “It’s the money,” says Dr. Jerome L. Avorn, a Harvard medical professor and researcher. “When you’re selling $1 billion a year or more of a drug, it’s very tempting for a company to just ignore the traffic ticket and keep speeding”…
Neuroleptic drugs — now known as antipsychotics — were first developed in the 1950s for use in anesthesia and then as powerful sedatives for patients with schizophrenia and other severe psychotic disorders, who previously might have received surgical lobotomies. But patients often stopped taking those drugs, like Thorazine and Haldol, because they could cause a range of involuntary body movements, tics and restlessness. A second generation of drugs, called atypical antipsychotics, was introduced in the ’90s and sold to doctors more broadly, on the basis that they were safer than the old ones — an assertion that regulators and researchers are continuing to review because the newer drugs appear to cause a range of other side effects, even if they cause fewer tics…
Over the years, as psychiatrists learned more about the drugs’ risks, companies promoted them more to family doctors, pediatricians and geriatricians. Pfizer paid more than 250 child psychiatrists to promote its antipsychotic, Geodon, at a time when it was approved only for adults, according to a government filing with the Pfizer settlement last year. High-prescribing doctors pocketed extra money in the form of research payments, speaking fees, gifts, meals and junkets — some of which the government has specifically termed illegal “kickbacks”…
Lew Morris, chief counsel for the inspector general of the Department of Health and Human Services, says he is serious about bolstering government efforts to reform or punish drug makers for illegal sales of antipsychotics. “The message we want to send to the industry is it’s not just the same-old, same-old,” he said in an interview. He agrees that few industry employees have gone to jail for white-collar crimes, but says this may change soon. “We’re targeting managers and executives who should have known,” he said.
Mr. Morris says some companies are “too big to debar” from government contracts, since doing so would just hurt patients needing medicine. But he says discussions are under way about forcing one health care company to sell off a subsidiary accused of fraud. And directors who ignore information may face more risk of shareholder suits, he says. Over the next year, the government is adding at least 15 prosecutors and 100 investigators to pursue health care fraud…
I’ll admit that some of my obsession with Dr. Nemeroff’s antics is not motivated by his selling out to drug manufacturers and his making personal money as a drug shill. It’s motivated by what he and his pals did to Psychiatry itself. In the guise of being scientific and medical, they marginalized the study of "the mind" and turned Psychiatry into something of a hack brain pseudo-science. Some of their criticism of my other interest – Psychoanalysis – was perfectly valid, but evaporating it wasn’t. And their trivializing Psychotherapy in general was simply a shame – that’s all – just a shame. It actually didn’t have much effect on my life. People like me were in even greater demand as the supply decreased, so I just went about my life somewhat oblivious to what was happening specialty-wide. I read my favorite journals, went to meetings I liked, and threw the stacks of throwaway journals that accumulated in my mailbox away. I continued to teach at Emory, and whenever Charlie came up, invisible shades came down and I barely registered what was said. It was always political rather than about anything I was interested in, and that kind of politics holds no interest for me. I think I was in the mode of life is too short to worry about things you have no control over. I now regret that.
The thing that got my attention wasn’t Nemeroff’s increasingly bad Press and ultimate defrocking. It was something else. After a few years of time away from the world of mental health, I agreed to do some volunteer work at a local free clinic and at an agency that treats kids and adolescents. It was not the kind of work I did in private practice. It was more like my days in the clinics at Grady [Atlanta’s Charity Hospital] a long time ago. I think it’s grand fun and look forward to doing it [so long as it’s not all the time]. It was there that I woke up to what had been happening in Psychiatry. Most of the patients were on absurd drug regimens. Atypical anti-psychotics, anti-convulsants, stimulants, multiple antidepressants, all mixed together like alphabet soup. At first, I felt old and obsolete. So I actually bought some psychopharmacology books to bone up on the drugs. But I recovered quickly. People had been put on these things by general practitioners chasing symptoms. I started slashing at the polypharmacy with good results.
But then I had to send some people to the hospital, and they came back on these odd concoctions treated by Psychiatrists. About that time, Charlie Nemeroff was all over the news, and I began to read about the stuff that the above article is documenting. I guess I thought that Psychiatry had been invaded by neurochemists, and hadn’t really realized that it was the Pharmaceutical Companies that fueled the takeover. All of that rambling was to say that the misuse of medications is so ubiquitous that it hit me in the face working only part time in rural clinics in a the mountains of Georgia – way off the beaten path [as far off as my wife could tolerate]. And here’s the most important part. Those extra moderately dangerous drugs being used for off-label reasons just aren’t helpful to patients. I’m still looking for some depressed patient who was "treatment resistant" with conventional antidepressants who really responded to adding an atypical anti-psychotic. That might be effective downtown, but it just doesn’t help up here in the country.
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