{"id":24941,"date":"2012-07-04T10:35:30","date_gmt":"2012-07-04T14:35:30","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=24941"},"modified":"2012-07-04T10:35:30","modified_gmt":"2012-07-04T14:35:30","slug":"just-plain-crazy","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2012\/07\/04\/just-plain-crazy\/","title":{"rendered":"just plain crazy!…"},"content":{"rendered":"\n

What do you call it when two mutually exclusive things are both happening? It’s not a double bind<\/em>, or a dilemma<\/em> – maybe something more like a a paradox<\/em>? a conundrum<\/em>? an enigma<\/em>? <\/p>\n

On one side of the equation, the press is filled with huge financial penalties levied on the manufacturers of psychiatric drugs for a laundry list of grossly fraudulent behaviors, like in Ed Silverman’s recent post<\/font><\/strong><\/u><\/a> about the $3 B GSK settlement:<\/div>\n
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The $3 billion settlement dwarfs previous agreements reached by Pfizer and Eli Lilly for assorted marketing infractions, although the $1.6 billion deal reached by Abbott Laboratories for its Depakote anti-seizure med continues to hold the record for the largest payout by a drugmaker over violations involving just one particular medication [back story here<\/a><\/strong>]. We should note that the deal was acknowledged last November, but final details had not yet been resolved [see this<\/a><\/strong>]. The Glaxo deal is also the latest in a long series of such settlements involving similar allegations that have been brought against nearly every large global drugmaker over the past several years.<\/font><\/strong> Another such deal involving Johnson & Johnson and its Risperdal antipsychotic is expected to be announced shortly [read here<\/a><\/strong>].<\/sup><\/div>\n<\/blockquote>\n
And in each instance, their misbehavior involves highly placed academic psychiatrists. In the case of GSK, a centerfolds were Study 329, a ghost-written distorted report on their Study 329 by Martin Keller, then Chairman of Psychiatry at Brown University; a ghost-written textbook by Charles Nemeroff and Alan Schatzberg, chairmen of Emory and Stanford respectively; an editorial and clinical trial [both ghost-written] by Dennis Charney, now Dean at Albert Einstein; the list goes on and on. With J&J’s Risperdal, medical articles were being ghost-written by Exerpta Medica faster than they could even find guest-authors to sign on. With AstraZeneca’s Seroquel, the author of their premier article and clinical trial, Richard Borison, Chairman of Psychiatry at the Medical College of Georgia, went to prison for ten years for massive levels of fraud. And so it has gone in case after case. None of it could’ve occurred without complicity and participation from psychiatric academicians. <\/div>\n

  <\/p>\n

On the other side of the coin, for the last year we’ve been assailed with dire warnings about something called the Empty Pipeline<\/font><\/strong><\/em> – no new psychoactive drugs in development and pharmaceutical companies shutting down research facilities as they flee CNS drug discovery altogether. From my vantage, this lament started with what I call Stahl’s Rant<\/font><\/strong><\/em> in August 2011:<\/div>\n
\n
Are future psychiatric treatments doomed?<\/font><\/strong><\/u><\/a>
Be careful what you ask for…you just might get it.<\/strong><\/u><\/a><\/sup>
NEI Blog<\/font><\/strong>
Neuroscience Education Institute<\/font><\/strong>
by Stephen Stahl
August 23, 2011<\/div>\n
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?…<\/sup><\/div>\n<\/blockquote>\n
And so it went. The pharmascolds<\/font><\/strong><\/em> [also a new term to me] had chased off the pharmaceutical companies who were pulling out of CNS drug development altogether. It was a self-pitying, blaming rant for all times. He spoke of a meeting in London to discuss the coming cataclysm – the Empty Pipeline<\/font><\/strong><\/em>:<\/div>\n
\n
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. 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?<\/sup><\/div>\n<\/blockquote>\n
One might, at this point, mention Dr. Stahl’s industry connections [from his disclosures in last month’s APA Meeting Program<\/font><\/strong><\/u><\/a>]:<\/div>\n
\n
Consultant:<\/font><\/strong><\/u> Janssen, Jazz Pharmacuetical, Biovail, Meda Corp, Alkermes, SK Corporation, Soffinova, Vivus, Allergan, Sepracor Inc., Servier, Covance, BioMarin, Meiji, Pierre Fabre, Prexa Pharmaceuticals, Propagate Pharma, Rexahn, Royalty Pharma, Cenerx, Eisai Inc., Merck & Co., Inc., Otsuka Pharmaceuticals, Pfizer Canada, PGxHealth, Schering Corporation, AstraZeneca Pharmaceuticals, Arena Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Cypress Bioscience, Dainippon Sumitomo Pharma Co., Ltd, Eli Lilly and Company, Forest Laboratories, Inc., GlaxoSmithKline, Labopharm Inc, Lundbeck, Neuronetics Inc., Marinus Pharmaceuticals, Novartis Pharmaceuticals Corporation, Pam Lab LLC, Pfizer Inc., Sanofi Pharmaceuticals, Inc. , Shire Pharmaceutical Development, Inc., Wyeth-Ayerst Pharmaceutical Company, Wyeth-Ayerst Laboratories, Vanda Pharmaceuticals, Solvay Pharmaceuticals, Inc. Grant Support:<\/font><\/strong><\/u> Pharmasquire, BMS, Eli Lilly, Lundbeck, Sanofi Aventis, AZ, Boehringer Ingelheim, Cephalon Inc., Dainippon Forest, Novartis, Pam Lab LLC, Pfizer, Schering Corporation, Sepracor Inc., Shire US Inc., Wyeth-Ayerst Pharmaceutical Company. Speaker’s Bureau:<\/font><\/strong><\/u> Merck, Schering Corporation, Pfizer Inc., Wyeth<\/sup><\/div>\n<\/blockquote>\n
And there were indeed such meetings in London, and a series of speeches and blogs by NIMH Director Tom Insel, and a recent symposium sponsored by the American Foundation for Psychiatry attended by a rogues gallery of tainted , compromised academics:<\/div>\n
\n
APF Convenes Unique Pipeline Summit<\/font><\/strong><\/u><\/a>
Psychiatric News<\/font><\/strong>
by Jun Yan
April 06, 2012<\/div>\n

<\/p>\n

With the pharmaceutical industry weary of investing in psychiatric drug development, collaboration across public and private sectors seems to be the only way to remedy a dearth of new treatments. Leaders from academia, government, the pharmaceutical industry, venture-capital firms, and clinicians met at APA headquarters March 8 to discuss the shrinking investment in new drug development for psychiatric disorders. The “Pipeline Summit” was organized and supported entirely by the American Psychiatric Foundation [APF] after APF was asked to convene the event by the leadership of the National Institute of Mental Health [NIMH] and National Institute on Drug Abuse [NIDA]. They are concerned that psychiatry is facing a prolonged drought of no new drugs for years to come. One by one, major pharmaceutical companies have slashed or abandoned neuropsychiatric research programs.<\/p>\n

There are huge unmet clinical needs in mental disorders and addiction,” said Jeffrey Lieberman, M.D., incoming president-elect of APA and chair of psychiatry at Columbia University, who moderated the morning session. “There should be tremendous interest in this area, but there is not.” Psychiatric research and development programs have gained a high-cost, high-risk, and no-return reputation in industry after dozens of failed programs, agreed senior managers from several major companies at the summit….<\/p>\n

One of APF and APA’s roles, Schatzberg said, is to continue to fight the stigma against psychiatry and psychiatric drugs. In addition to facilitating more collaboration between the government and the private sector, he proposed that APF and APA work with other stakeholders to create incentives for industry to reinvest in psychiatry… “APA has a role in shaping what future psychiatric practice looks like,” Schatzberg stated. “More needs to be done now if we are to have new treatments in the next decade for patients with psychiatric disorders”…<\/sup><\/div>\n<\/blockquote>\n

Their theme is consistent. Development of pharmaceuticals is a slow and difficult process and we need to make radical concessions to help the pharmaceutical companies along and keep them involved in CNS Drug development. The Pipeline<\/font><\/strong><\/em> of new drugs is empty and we have to fill it or, as Dr. Stahl claims, psychiatric treatments are "doomed<\/font><\/strong>."<\/font><\/strong> <\/strong><\/font>The most virulent version of this line of thinking, in my opinion, comes from Dr. Tom Insel himself, Director of the NIMH:<\/div>\n
\n
Experimental Medicine<\/font><\/strong><\/u><\/a>
NIMH – Director’s Blog<\/font><\/strong>
By Thomas Insel
June 12, 2012<\/div>\n

<\/p>\n

In previous<\/a><\/strong><\/u> posts<\/a><\/strong><\/u> I have described the crisis of medication development for mental disorders. Medications developed over the past five decades have been prescribed widely but have not been sufficient for reducing the morbidity and mortality of mental disorders. Yet there is diminishing activity in research and development for new medications within either the biotech or pharmaceutical industries.<\/font><\/strong> While the development of psychosocial interventions and devices, including the use of mobile technologies, is promising, the absence of a robust development pipeline for more effective medications would be worrisome in any area of medicine and should be a grave concern to the mental health community…<\/p>\n

The answer to both questions is complicated. To ignore the need would essentially write off “hope” for those not responding to current medications, not only in the short term but over a 15 year time frame. One approach is to improve the pipeline, making it more efficient. The new NIH National Center for Accelerating Translational Sciences<\/a><\/strong><\/u> [NCATS<\/font><\/strong>] will be developing resources, such as rescuing and repurposing existing medications, to reduce the time and cost of medication development…<\/p>\n

As a result, NIMH is shifting from large clinical trials that promise an incremental improvement to a model called “experimental medicine.” In experimental medicine, drugs are used as clinical probes and the immediate goal is not to develop a treatment but to identify or verify a target. Using proof of concept studies we can determine the ability of the drug to act on a target and affect a biological process or endpoint related to a clinical disorder, such as demonstrating that the new compound occupies relevant neural receptors or produces relevant changes in brain activity. This approach acknowledges that animal studies, while critical for neuroscience, are not consistently predictive of how medications will work in humans, homo veritas<\/em>. Experimental medicine focuses on human studies rather than rodent research. Clinical studies can be small but they include biomarkers and neurocognitive outcomes to determine mechanisms of action. Even negative results can be informative because if a proposed target is engaged, but there is no effect on a relevant biological process or endpoint, we can rule out that target. For example, antidepressant effects have variously been proposed to involve changes in serotonin neurotransmission, hippocampal cell birth, and changes in stress hormones, among many other effects. By ruling out some targets and focusing on those involved in the biology of the disorder, we can direct treatment development much more efficiently…<\/sup><\/div>\n<\/blockquote>\n

Dr. Insel came back to the NIMH after a sojourn in Atlanta where he directed Yerkes Primate Center, then a Translational Program both under the Department run by Charlie "bling-bling" "so toxic he glows" "boss of bosses" Nemeroff [who Insel rescued by recommending him for the Miami Chairmanship and recently rewarded with a NIMH Grant]. Translational Science means hurrying<\/em> research findings to the consumer [market]. Now he’s proposing accelerated<\/em> hurrying<\/em> [skipping steps]. He’s further suggesting that the NIMH take on the task of finding target compounds for industry to develop – through industry\/academic partnering – the Mantra<\/font><\/strong> for Insel’s decade at the NIMH.<\/div>\n

So back to my question, "What do you call it when two mutually exclusive things are both happening?<\/font><\/strong><\/em>" One thing being the very loud evidence that the union of government, academic and organized psychiatry, and the pharmaceutical industry present for a quarter century has brought us widespread levels of corruption, unheralded in the annals of medicine, and very questionable results. The other thing is being exhorted by these same groups to form even more permissive versions of these same alliances as the solution to the problems many of us think they caused. <\/p>\n

Is it a double bind<\/em>? a dilemma?<\/em> a paradox<\/em>? a conundrum<\/em>? an enigma<\/em>? No. It’s just plain crazy!<\/font><\/strong> <\/div>\n","protected":false},"excerpt":{"rendered":"

What do you call it when two mutually exclusive things are both happening? It’s not a double bind, or a dilemma – maybe something more like a a paradox? a conundrum? an enigma? On one side of the equation, the press is filled with huge financial penalties levied on the manufacturers of psychiatric drugs for […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-24941","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/24941","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=24941"}],"version-history":[{"count":36,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/24941\/revisions"}],"predecessor-version":[{"id":24977,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/24941\/revisions\/24977"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=24941"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=24941"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=24941"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}