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.
Mad in America hosts blogs by a diverse group of writers. These posts are designed to serve as a public forum for a discussion—broadly speaking—of psychiatry and its treatments. The opinions expressed are the writers’ own.
I must say that you are one of only a few people whose blog posts here I appreciate. The bulk of blog posts on this site are just redundant blabbing. Yours are amongst the exception.
I second that praise. Your writing is really clear, forthright, and helpful. Thank you for posing this.
“Effective and safe?” Effective for what? The only thing they’ve been found effective for is psychosis. And they are NOT safe – they cause diabetes, obesity, and other metabolic problems, extrapyramidal symptoms, akathesia and Tardive Dyskinesia, and have a black-box warning for early death in the elderly. The atypicals and their earlier cousins are largely responsible for the 25-year-shorter average lifespan of a person diagnosed with a “serious mental illness.” What would they have to do to be “unsafe?”
I was saying the same thing to myself when I read that. If “atypical antipsychotics” are safe than we need to redefine the word safe as to include drinking gasoline and playing with loaded firearms. But what he was saying in this post is that they are officially considered safe because any drug that is FDA approved is technically, officially considered safe.
Great article. Thank you for pointing at the trends in the thinking of some mainstream academics.
About the FDA: “safe and effective” is actually the criteria for over-the-counter, so prescription drugs never fit that criteria. The criteria for FDA-approved prescription drugs would sound more like: “the drug provides benefits for a specific symptom for a majority of the target group, and the observed side-effects are deemed worth those benefits, even if that positive trade-off is not true for all individuals of the group”.
Part of the reason people end up on harmful polypharmacy is that even doctors are thinking “safe and effective” (and “my ass is covered by the FDA”), rather than thinking in terms of both taking a risk and evaluating a trade-off. If the decision is framed in terms of taking a risk and evaluating a trade-off, then it makes sense to involve the patient in the decision, and it makes sense to plan for the possibility that the drug might be counter-productive, and to consider other ways, or abandon the drug after trying it unsuccessfully.
You rightly point on how Friedman is saying things late and not in a very bright manner, but you are too mild:
– Friedman criticism about antipsychotics is based on his claim that a SSRI or a combination of two SSRIs are the right solution for “modern life” (I guess we have to wait ten or twenty more years of experience, before publishing on the danger of SSRIs).
– According to Friedman, antipsychotics are safe and effective without qualifiers for people diagnosed with bipolar or schizophrenia (even pharma papers don’t push the deception that far: the numbers-needed-to-treat, and effect-size they claim are very modest, pharma knows that contrary to academics, they are sometimes held liable for exaggerating too much).
Another awesome post Jonathan, thank you. The reality is there was professional literature which effectively demonstrated the fallacy of the APA and AACAP party line of the drugs being a safe and effective treatment for psychosis—it was literature which was ignored when the academic psychiatrists wrote their Practice Parameters and Treatment Algorithms which were became the Standard of Care in Mental Health treatment. The illegal marketing and the fraudulent billing which paid for the drugs prescribed off label could have never been done without those Practice Parameters and Treatment Algorithms, both of which substituted consensus when the research data did not support their use. Stanley is on the right track but IMO it is the Standard of Care which includes the parameters and algorithms used in clinical practice that is also used to absolve prescribers for the harm done to patients…Some professionals actually claim that not using these unethically developed standards would be unethical! The idea that patients can only be treated using these corrupt standards because they are “professionally accepted standards;” the fact that they are only “standards” because of a quasi-democratic process, not because they are based on or supported by the clinical research data. the parameters and the treatment algorithms are only standards of care because they were VOTED on—not because they are derived from ethical scientific research or based on the use of ethically sound medical judgement. Morally reprehensible really, all things considered. Ultimately, the Standards of Care in psychiatry are to persuade professionals to adhere to the bio-disease paradigm and serve the primary purpose achieving the marketing goals of pharma, while providing an affirmative defense for the professionals using them for medical malpractice.
Let’s look beneath the surface and attempt to examine the actual content and purpose of Dr. Friedman’s artice in the New York Times.
He appears to be only criticizing some of the extremes of the psychiatric profession. His article has an underlying defense of disease labels and the medication paradym of treatment. Now that the science that is suppose to validate their profession and practice is crumbling around them, and there is more publicity and evidence about the enormous amount of harm they are causing millions of people with all their medications, some psychiatrists (like Friedman) are scrambling to protect and defend their profession from a potential movement that aims to dismantle modern psychiatry.
Steve(above)was absolutely correct to raise the question about the use of the phrase “safe and effective.” This phrase was used in a totally uncritical way by Dr. Friedman and repeated by you in your blog contribution.
Most people writing on the MIA blog would clearly say that atypical antipsychotics are causing far more harm than good. Jonathan, is that your view based on your examination of the current science available? If you believe that to be true, then how can you uncritically repeat the phrase “safe and effective?” This makes no sense. And it makes no difference if the FDA chooses to use these words; since when do we suddenly grant them such respect and authority.
Correct use of language is very important for us to carefully examine in our movement. This problem with “safe and effective” made an otherwise good article tough to swallow at the end.
Thanks for the comments on this piece. I guess I wasn’t clear enough about the statement “safe and effective.” In no way do I agree with Dr. Friedman’s terminology here. When I saw his statement in the New York Times it sounded to me, and others, like someone was talking about a drug like aspirin – there are not many side effects and it’s pretty clear it works. The term safe and effective really doesn’t mean much when talking about a drug, but especially about such strong medications as the atypicals. Patients and doctors want to know “how safe? and “how effective?”
The phrase “safe and effective” might have been appropriate to use about the atypicals when they were just starting to come on the market and we didn’t know much about them, but there is way too much history behind us to use this term now. For at least ten years the side effects of these drugs were minimized. To simply state that they are “safe” is somewhat insulting to all the people harmed by the drugs. I contemplated adding a paragraph in the original post about all the problematic side effects including the increased suicides in the clinical trials, but figured that just the fact of so many dollars being paid out by the companies is evidence of how oversimplistic the statement is.
It is quite clear that the national discussion of the atypicals has gone way beyond statements about them being safe and effective. Sorry about being too vague in the original post about this.
Just to clarify, I know your work well enough by now to know that you were not saying they were safe and effective, just quoting Friedman’s statements. You’ve been one of the courageous pioneers in stating the truth about these drugs when it was politically unsafe to do so, and I’ve followed your quality scientific work for many years as the world has slowly caught up to what you already knew 10+ years ago. You’re one of my heroes, and I have tremendous respect for your work, as you have always done a great job of letting the research to the talking and keeping the rhetoric to a minimum. Thanks for this and all of your excellent work!
Thanks for your response and your clarification on the phrase “safe and effective.” I look forward to reading more of your posts in the future.
There is an important aspect of the adverse effects of all antipsychotics that I rarely see discussed. The extrapyramidal side effects cause impairment of swallowing leading to malnutrition, dehydration, choking/asphyxia most particularly in the elderly. “Safe and effective”? I would have to disagree. For many years we’ve known that the incidence of death by asphyxia in psychiatric hospitals is 100 times that of the general population, most likely due to the use of antipsychotics. Effective for control of hallucinations etc. they may very well be but safe? Not for many. I have spent over 25 years treating individuals taking antipsychotics prescribed by others and much of my time has been spent trying to avoid death from dehydration, malnutrition and asphyxia. The TD, akathesias and related adverse events are well known but the oropharyngeal dysphagia and its consequences remains a dirty secret.