Has Stephen Stahl Gone Off the Deep End? You Decide.

A reader of my blog alerted me to this rambling blog post by Stephen Stahl on his NEI blog. I've pasted his article and my response below--or you can read the whole thing on his site. I’ll be curious to hear your thoughts. 

Here is Dr. Stahl’s post, dated August 23 2011:

"Are future psychiatric treatments doomed? Be careful what you ask for...you just might get it."

Nobody likes drug companies these days. Worse than tobacco companies and big oil companies! Supposedly they have ruined CME and have corrupted psychiatric experts as consultants, lecturers and research grant recipients! Drug companies only engage in expensive patent extension gimmickry and offer no true innovations! Let’s criminalize the marketing of psychiatric drugs, levy billions in fines to Pharma, force out their CEOs and even make them and their Pharma collaborators take the “perp walk” on their way to court in chains and orange jumpsuits and in front of the cameras! Get out of our professional societies! Get out of our journals! Get out of our medical centers! Good riddance!!!

Well, if that is what we have been asking for, we are now getting it. Drug companies have already largely pulled out of our meetings, our live CME and our medical centers. Next, the Pharma-scolds want Pharma to stop doing even legally sanctioned FDA activities such as peer-to-peer dinner meetings (many academic faculties now banned by their medical schools from participating), sampling by sales reps (many clinical centers ban reps), and legal freebies (no coffee or bottled water even allowed in Massachusetts let alone a book). If these Pharma nay-sayers and payors had their say, the new “American Textbook of Psychiatry” would be the Physicians Desk Reference with religious adherence to following the label. This in a field where over half of legitimate practice is off label! And this is progress? 

Pharma have heard these protests loud and clear and are now pulling out of psychiatric research. Two of the biggest defectors are the two British companies Astra Zeneca and GSK, who have shuttered all their laboratories for mental health research for good, closing facilities all over the world including those the US, UK and Italy and elsewhere. Also, Pfizer bought Pharmacia/Upjohn and closed their CNS research center in Kalamazoo, Michigan; bought Parke Davis and closed their CNS research center in Ann Arbor, Michigan; bought Wyeth and closed their CNS research center in Princeton, NJ; and then for good measure closed their own CNS research center in the UK. Merck closed their CNS research center in the UK where I worked in the 1980s, then bought Organon/Schering Plough and closed their CNS research center in the UK/Scotland for good measure. I could go on and on. This has had a devastating impact especially on the US and the UK. In fact, the UK has gone from a leader in CNS Pharma Research Centers, to having no big Pharma CNS research at all, with thousands of unemployed R and D scientists there and no prospect of CNS therapeutic innovation coming from their shores in the foreseeable future. 

Undoubtedly this is to the great delight of the anti-psychiatry community, lights up the antipsychiatry blogs (e.g., Carlat, http://carlatpsychiatry.blogspot.com/ ), who attract the Pharmascolds, scientologists and antimedication crowd who believe either there is no such thing as mental illness, that medication should not be used, or both. Did you know that psychiatric illnesses are pure inventions of Pharma and their experts to treat patients that do not exist with drugs that are dangerous and do not work with the purpose only of profiting themselves? Stop the profits! Make mental illness go away by legislation and committee! Treat human mental suffering with love and peace and all will be well! Who needs mental health professionals and their diabolical drugs anyway? 

If you were in the Pharma business, would you work with psychiatry anymore? So, we have gotten what many of us have asked for. No Pharma. But that also means no new drugs. This has sparked a crisis in mental health therapeutic research worldwide but especially in the UK and US. The UK in fact is having a crisis meeting at the Royal Society of Medicine in August, where I am attending with about a dozen others, including the head of the NIMH from the US, the head of the MRC from the UK, and various UK and US academic and industry leaders to discuss what we should do about this. The last time I went to such a meeting was in 1987, where I co-chaired a meeting on this same topic with the famous Paul Janssen (now deceased), the prize winning inventor of Haldol, Risperdal, Fentanyl, Lomotil, and more. At that time I stated that the future could not be more promising (Stahl 1987). What a difference 25 years makes! Returning now to the same Royal Society of Medicine with others, but now with our collective tail between our legs, we are stating that “things could not be worse.” Were the last 25 years of mental health treatments discoveries so worthless as to discard these efforts for the future? Once you stop things, it takes a long time to start it up again. David Nutt, UK psychiatrist extraordinaire and a good friend who will be at the meeting at the RSM, is recently quoted in the UK press as saying, "What we have forgotten, and must not forget, is if we stop this research we will have a dead space of 20 to 30 years before we can re-tool again.”

If we shut down, then we and our patients with depression, schizophrenia and other mental illnesses lose hope for any improvement in their situation in our lifetimes. I still think we can innovate (Stahl 2006), but we need a new model and I will get back to you with suggestions from the Royal Society of Medicine meeting when I return. Some good ideas are coming mostly from Europe as the US is still intent on shutting down Pharma. As a former Lilly president told me recently, “We will someday be a great Chinese drug company.” To reverse this trend and keep this industry in the US, we can try to support innovation through the NIH, and I have volunteered to serve on advisory committees on new drug development if that ever gets off the ground; but this NIH drug development effort is now threatened by the current US budget austerity. We can try to do it though academia, or small companies. The ECNP (European College of Neuropsychopharmacology) of which I am a member has some creative ideas which I strongly support such as trying to persuade drug companies to share the information they already have, putting details of their research and unused potential drug discoveries into a "medicines chest" that outside organizations can exploit, with the ECNP providing insurance against any potential litigation. Medicines for brain disorders take longer to develop than for other conditions - on average, 13 years - and there is a high failure rate. It looks like the UK and the Europeans are much more active in trying to resuscitate mental health therapeutics, while we in the US remain hell bent on destroying what is left of it. We can join the British and the Europeans and move forward, or we can completely kill this industry and wait a decade or two, while experiencing no progress and thus leave a legacy of no innovation and no apparatus to innovate. We will have to see if our children or grandchildren who become mental health professionals want to rebuild a Pharma industry that is interested in mental health or if yet another industry leaves the US for good.

Be careful what you ask for. You might just get it.

Here is my response, dated August 27, 2011:

Dr. Stahl: Your rant is long on rhetoric but short on fact.

Your key argument appears to be that increasing regulations on pharmaceutical marketing techniques have led to the drying up of the CNS pipeline. While you provide no evidence to back up your argument, there are many reasons to question this.

1. Other fields of medicine have seen a boom in new agents--diabetes, oncology, and cardiology are examples. New rules in academic medical centers limiting participation in speaker’s bureaus, access to drug reps, and gifts from drug companies have applied in these fields as well as psychiatry--but appear not to be limiting innovation.

2. In psychiatry, many potentially novel agents have been developed and tested during the "pharma-scold" era but have failed in clinical trials because they have simply not worked, not because medical schools have told their faculty not to accept money to tout them. Examples are numerous, and include Substance P antagonist and mifeprestone for depression, J & J's anti-amyloid bapineuzumab for dementia (along with many other anti-amyloid agents from other companies), and Lilly's anti-glutamate agent mGlu2/3 for schizophrenia.

3. Drug companies have introduced many psychiatric medications over the last two decades, but they have made the business decision to invest heavily in me-too agents, some of which, such as Pristiq and Invega, are embarrassingly blatant patent-extenders with no clear advantages over existing agents. Perhaps if companies had invested more resources into developing truly novel compounds, they wouldn’t be in the pickle they are in.

The reason that some companies are pulling out of CNS drugs is not because of the Carlat Blog (though I’m flattered that you believe I have so much clout) but because the brain is an incredibly complex mechanism and we have yet to work out the basic neurobiology underlying mental illness. As a psychiatrist, I prescribe drugs all the time and I know both their promise and limitations. Far from being “anti-psychiatry,” I would welcome novel drugs to ease my patients’ suffering.

Please show us some evidence for your position. That would be better than more low blow ad hominem attacks on those of us who are trying to improve the pharmaceutical industry by making it more ethical.