Tuesday, October 12, 2010

Drug makers take big hits over their schizophrenia drugs

Story of a NAMI whistleblower
An article by Duff Wilson of the NY Times  October 2 describes the heavy penalties facing the pharmaceutical industry in a series of lawsuits going on now, stemming from a history of the companies' aggressive marketing of newer-generation psychiatric drugs and the shadiness of their studies. It also brought to mind this story began a few years ago with some courageous whistle blowing by a former NAMI NYS board member who drew a lot of attention.

The article is a revelation of the boldness and greed that has marked the actions of drug companies, among the most profitable businesses in the US economy. For at least 20 years we've all been paying the bill. Sales of the new class anti-psychotic drugs like Risperdal, Zyprexa and Seraquel have been pushed to the limits through highly successful marketing campaigns to reap ever higher profits. It's not only that more people need to take the drugs now but that doctors are so willing to prescribe them. The charge is that the industry has bought off the professors and researchers who set the tone and local practitioners who prescribe these drugs to patients with serious mental illnesses.

According to court documents, the drug companies' schemes included “payments, gifts, meals and trips for doctors, biased studies, ghostwritten medical journal articles, promotional conference appearances and payment for postgraduate medical education that encourages a pro-drug outlook among doctors.”

The article claims that profits grew so big the companies knew their claims supporting one drug over another were probably false but they simply threw ethics to the winds. As the extent of the drug makers' payoffs to psychiatrists and university labs were exposed and the companies owned up to their fictitious claims, some of the biggest companies have settled lawsuits for millions of dollars. Government prosecutors have gone on the attack and have won large jury verdicts against them.

“The new generation of antipsychotics has also become the single biggest target of the False Claims Act, a federal law once largely aimed at fraud among military contractors. Every major company selling the drugs--Bristol-Myers Squibb, Eli Lilly, Pfizer, AstraZeneca and Johnson & Johnson--has either settled recent government cases for hundreds of millions of dollars or is currently under investigation for possible health care fraud,” the article points out.

“Two of the settlements, involving charges of illegal marketing, set records last year for the largest criminal fines ever imposed on corporations. One involved Eli Lilly’s antipsychotic, Zyprexa; the other involved a guilty plea for Pfizer’s marketing of a pain pill, Bextra. In the Bextra case, the government also charged Pfizer with illegally marketing another antipsychotic, Geodon; Pfizer settled that part of the claim for $301 million,” the Times continues.

“Lawyers suing AstraZeneca say documents they have unearthed show that the company tried to hide the risks of diabetes and weight gain associated with the new drugs. Positive studies were hyped; negative ones were filed away.”

Blowing the whistle on the drug makers
The interesting thing is that a former NAMI-NYS board of directors' member, Vera Hassner-Sharav, was among the first to blow the whistle on the cozy relationships that had developed between researchers and academics in psychiatry and the drug companies pushing the new drugs for schizophrenia. This was about 2002-03 when Vera, who was a career research librarian in NYC and no longer on our board, published findings on her website that were so incriminating against the companies they couldn't be ignored. She testified before Congress as I remember and her data and analyses were soon picked up by the national news media and became the focus of a Congressional investigation. Some of the culprits have paid fines and lost academic standing as a result of the inquiry, while the purge continues.

There's a second point to be made here—the complicity of many of those professors and psychiatrists who advised us about the relative merits of the different anti-psychotic drugs at the annual Columbia- Psychiatric Institute Schizophrenia Conference and our annual NAMI conferences. These teachers and advisers, sometimes in their long white coats, showed graphs and charts to convince us of the superiority of one drug over another. We were told year after year by the same speakers that Clozaril was in a league of its own as the best of the newer anti-psychotics; and the entire class of the new drugs caused less side effects than the older drugs. We never doubted them or the reasons for the popularity of some of these drugs among the local psychiatrists prescribing for our children. Since then we've lost respect for some of the doctors and their sources.

Older drugs don't match the newer ones
Despite the high profits and abusive marketing of the newer anti-psychotic drugs, the article passes along claims that the newer drugs aren't significantly better than the older ones and are far more expensive. It soft pedals the fact that the older class of these drugs, beginning in the 1950s, like Prolixin and Haldol, “could cause a range of involuntary body movements, tics and restlessness, and people stopped taking them.”

The second generation of anti-psychotic drugs came in in the 1990s. These were sold to doctors more broadly on the basis that they were safer than the old ones, the Times piece states. However, it quotes Dr. Jeffrey Lieberman, chairman of Psychiatry at Columbia as saying: “Contentions that the new drugs are superior have been greatly exaggerated. Such assertions may have been encouraged by an overly expectant community of clinicians and patients eager to believe in the power of new medications.” And Robert Whitaker, a writer and critic of the new meds, adds: “They sold the story they're more safe when they aren't. They had to cover up the problems.”

Wait a minute. Neither of these criticisms are on the mark. The earlier schizophrenia drugs that began in use in the 1950s had terrible side effects that have never been matched in severity by the second generation drugs. Many patients suffered horribly from tardive dyskinesia, marked by a noticeable twisting of the tongue, or clenched hands, contorted face or repeated jerks of the head. Imagine a young man with these extraordinary features, caused by the drugs themselves, trying to appear normal to his girlfriend. Or imagine a young man wanting to hang out with his former high school buddies only to find he's being shunned because of his grimaces. Besides, the older drugs didn't always work; they just faded away sometimes leaving the patient dazed and out of control, and this happened more often than with more modern meds. Those are the real circumstances that young men and women on the older schizophrenia drugs faced. In fact, the new class of drugs mostly eliminates the twists and contortions that showed up previously. I believe even the doctors fail to recognize how crippling the earlier drugs were. (Roy Neville)

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