1 Boring Old Man

Psychiatry, The Pharmaceutical Industry, and The Road to Better Therapeutics
by Christian Fibiger
Schizophrenia Bulletin. 2012 38[4]:649-650.

Psychopharmacology is in crisis. The data are in, and it is clear that a massive experiment has failed: despite decades of research and billions of dollars invested, not a single mechanistically novel drug has reached the psychiatric market in more than 30 years. Indeed, despite enormous effort, the field has not been able to escape the “me too/me [questionably] better” straightjacket. In recent years, the appreciation of this reality has had profound consequences for innovation in psychopharmacology because nearly every major pharmaceutical company has either reduced greatly or abandoned research and development of mechanistically novel psychiatric drugs. This decision is understandable because pharmaceutical and biotechnology executives see less risky opportunities in other therapeutic areas, cancer and immunology being the current pipeline favorites. Indeed, in retrospect, one can wonder why it took so long for industry to abandon psychiatry therapeutics. So how did we get here and more importantly, what do we need to do to find a way forward?…

In order to recapture industry’s investment in psychiatric drug development, major changes in psychiatry will need to take place. These changes are necessary along the entire value chain, including both preclinical and clinical domains. What the field lacks is sufficient basic knowledge about normal brain function and how its disturbance underlies the pathophysiology of psychiatric disease. Because of this, as the record now clearly shows, it remains too early to attempt rational drug design for psychiatric diseases as currently conceived. The most obvious solution here is expanded investment in neuroscience. By necessity, this will be driven primarily by the efforts of clinical and basic scientists in academic settings because industry no longer has the appetite or the resources to engage in such activities. It is worth emphasizing that industry is in the business of making drugs, knowledge sometimes being a fortuitous byproduct. Academia is in the business of generating knowledge, and knowledge is what is needed at present. If we are successful in making the necessary changes, given the enormous level of unmet need left by existing psychiatric drugs, there is no doubt that industry will return and reinvest…

The Illusions of Psychiatry
The New York Review of Books
by Marcia Angell
July 14, 2011

In the late 1970s, the psychiatric profession struck back—hard. As Robert Whitaker tells it in Anatomy of an Epidemic, the medical director of the American Psychiatric Association [APA], Melvin Sabshin, declared in 1977 that “a vigorous effort to remedicalize psychiatry should be strongly supported,” and he launched an all-out media and public relations campaign to do exactly that. Psychiatry had a powerful weapon that its competitors lacked. Since psychiatrists must qualify as MDs, they have the legal authority to write prescriptions. By fully embracing the biological model of mental illness and the use of psychoactive drugs to treat it, psychiatry was able to relegate other mental health care providers to ancillary positions and also to identify itself as a scientific discipline along with the rest of the medical profession. Most important, by emphasizing drug treatment, psychiatry became the darling of the pharmaceutical industry, which soon made its gratitude tangible…

As psychiatry became a drug-intensive specialty, the pharmaceutical industry was quick to see the advantages of forming an alliance with the psychiatric profession. Drug companies began to lavish attention and largesse on psychiatrists, both individually and collectively, directly and indirectly. They showered gifts and free samples on practicing psychiatrists, hired them as consultants and speakers, bought them meals, helped pay for them to attend conferences, and supplied them with “educational” materials. When Minnesota and Vermont implemented “sunshine laws” that require drug companies to report all payments to doctors, psychiatrists were found to receive more money than physicians in any other specialty. The pharmaceutical industry also subsidizes meetings of the APA and other psychiatric conferences. About a fifth of APA funding now comes from drug companies.

Drug companies are particularly eager to win over faculty psychiatrists at prestigious academic medical centers. Called “key opinion leaders” [KOLs] by the industry, these are the people who through their writing and teaching influence how mental illness will be diagnosed and treated. They also publish much of the clinical research on drugs and, most importantly, largely determine the content of the DSM. In a sense, they are the best sales force the industry could have, and are worth every cent spent on them. Of the 170 contributors to the current version of the DSM [the DSM-IV-TR], almost all of whom would be described as KOLs, ninety-five had financial ties to drug companies, including all of the contributors to the sections on mood disorders and schizophrenia…

Now, it’s very easy to cast blame. Fibiger sees the last three decades as a massively failed experiment in which no new psychiatric drugs of note arrived because the academic scientists didn’t give industry enough to work with. It’s hard to even read that without laughing aloud. Organized and academic psychiatry has talked of little other than new drugs and advances in neuroscience for this whole period. The most lucrative pharmaceuticals for all time have been new psychiatric drugs. He makes no mention of the staggering profits, the ubiquitous corruption, or the fact that industry has owned a lot of the very people he’s blaming – academic psychiatrists. And all of those ads in our journals or on television didn’t mention that it was all just one great big experiment. His point is, however, correct in that "a massive experiment has failed: despite decades of research and billions of dollars invested, not a single mechanistically novel drug has reached the psychiatric market in more than 30 years."

Likewise, the word is out. While the general populace may not read the New York Review of Books or Robert Whitaker’s Anatomy of an Epidemic, some version of their contents has filtered into the general fund of knowledge. The experiment that we didn’t know was an experiment has largely failed. The experimenters that we didn’t know were experimenting have fled the scene. And psychiatry proper is left in dubious straits, a position we earned by collusion. The gambles made by Dr. Sabshin’s medicalization, Drs. Robins’ and Guze’s neoKraepelinian Tenets, and Dr. Robert Spitzer’s DSM-III revision combined to solve a problem in 1980, but contributed to the one we have now in the process.