Dr. Richard Friedman, a psychiatry professor at Weill Cornell Medical College, recently had an article in The New York Times titled,“A Call for Caution on the Antipsychotic Drugs.” His article starts off with a brief synopsis of the rise and marketing success of the antipsychotics. He cites their incredible marketing success, the initial use of the drugs to treat schizophrenia, and their skyrocketing use for conditions other that schizophrenia. Dr. Friedman then goes on to criticize the overuse of the antipsychotics. It is heartening that academic psychiatrists are starting to acknowledge the problems with these medications. However, all of his criticisms, in much stronger terms, were made ten-years ago by numerous authors. It is much harder to predict a societal trend, which these earlier critics did, than it is to criticize the medications after almost every manufacturer has been fined billions of dollars for illegal marketing.
In 2002, in the last chapter of Mad in America, Whitaker addressed the coming overuse of the atypicals. In his words, “By the late 1980’s, the pharmaceutical industry’s storytelling apparatus had evolved into a well-oiled machine. The creation of a tale of a breakthrough medication could be carefully plotted. Such was the case with atypicals, and behind the public façade of medical achievement is a story of science marred by greed, deaths and the deliberate deception of the American people.”
In 2005, the CATIE Trial was published and the results suggested that the atypicals were no better than the older medications. Peter Jones, one of the study’s authors, in reference to how the medical field mistakenly came to believe that the newer drugs were better, stated, “Duped is not right. We were beguiled.” But even before CATIE was published there were numerous critics who pointed out the problems with the atypicals. In 2002, David Cohen concluded that the biased study designs were likely responsible for the purported benefits of the medications. David Healy pointed this out in his 2002 book, The Creation of Psychopharmacology.
Trying to figure out how this happened or how to prevent it from happening again is much more complicated. Is it the fault of the companies, the academics, or the physicians in the trenches actually seeing patients? According to Friedman, who is at an academic medical center, “I and many of my colleagues have seen dozens of patients with nothing more than everyday anxiety or insomnia who were given prescriptions for antipsychotic medication.” The scenario he seems to be painting is that he and his colleagues at academic medical centers are not the ones writing all the unnecessary prescriptions, and are instead shaking their heads in frustration at the unnecessary prescriptions being written by physicians in the trenches. But to absolve academicians from any blame for the overuse of these drugs, and to instead find fault with practicing clinicians, is at odds with what we know about how the medications have been presented in the medical literature.
The problem with the overuse of the antipsychotics, as almost everybody acknowledges, is that the medical literature on these medications is little more than an infomercial. For anyone who wants to have their eyes opened just read the Rothman Report, which lays out how the medical literature was co-opted by the companies. The atypicals have been promoted for everything from borderline personality disorder to ADHD. In one study of children in Florida on Medicaid almost 40% of the children (age 0-18) taking an atypical were diagnosed with ADHD. Can the doctors in the trenches really be faulted for following the literature? Aren’t they supposed to do this?
Dr. Friedman is certainly correct that one solution to the problem with the atypicals is for clinicians to be more careful with their prescribing, but isn’t this really just another way of saying that clinicians should be more skeptical of the peer reviewed literature? Just because a trial is published in a peer-review journal does not mean that it has a certified stamp-of-approval. A much more substantive solution to the problem would be for universities and journals to enact polices that would strengthen the literature, such asbanning ghostwriting . Unfortunately, many universities still allow manuscripts to be published with invisible corporate authors. Unless this practice is banned, the story with the atypicals will simply repeat itself with the next generation of antipsychotics.
Even the FDA never bought into the atypical story line. In the FDA review of Risperdal in 1992, they stated, “We would consider any advertisement or promotion for Risperdal false, or misleading or lacking fair balance under Section 502 of the Act if there is a presentation of data that conveys the impression that Risperdone is superior to haloperidol or any other marketed antipsychotic drug product with regard to safety or effectiveness.” Almost twenty years ago the FDA forbade the companies from saying that their medication was any safer or better than the older medications. For the companies this presented a quandary. How do you convince consumers to pay significantly more money for a product that is not better than the older, cheaper version? As we now know, the companies overcame this hurdle and the medications went onto phenomenal commercial success, in large part because academicians did not have to abide by the FDA rules, and were able to say things which the companies were forbidden to say.
Dr. Friedman’s own piece in The Times had this statement, “Let’s be clear: The new atypical antipsychotic drugs are effective and safe.” On one level there is little argument with this statement, because if the FDA doesn’t consider a medication to be safe and effective they will pull it from the market. But on another level, just being “safe and effective” is not a strong endorsement, and it lacks any justification for the exorbitant amounts of money that have been paid for these medications. Their commercial success was due to the fact that they were advertised as “better” not just safe. As Texas and 36 other states have pointed out, they now realize that they were misled about these drugs being better, and they are recouping their money. Texas recently announced a $181 million settlement with Johnson & Johnson over several antipsychotics.
If one looks deeper into the medical literature, let’s be clear, there is little argument that in the clinical trial literature the side effects of these drugs were minimized, in some cases problematic information was buried, while their effectiveness was exaggerated.