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?
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]. We should note that the deal was acknowledged last November, but final details had not yet been resolved [see this]. 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. Another such deal involving Johnson & Johnson and its Risperdal antipsychotic is expected to be announced shortly [read here].
Are future psychiatric treatments doomed?
Be careful what you ask for…you just might get it.
NEI Blog
Neuroscience Education Institute
by Stephen Stahl
August 23, 2011Nobody 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?…
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?
Consultant: 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: 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: Merck, Schering Corporation, Pfizer Inc., Wyeth
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.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….
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”…
In previous posts 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. 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…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 [NCATS] will be developing resources, such as rescuing and repurposing existing medications, to reduce the time and cost of medication development…
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. 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…
So back to my question, "What do you call it when two mutually exclusive things are both happening?" 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.
FYI
http://psychologyofmedicine.blogspot.com/2012/07/age-of-rage-psychiatrists-battle-over.html
“Tuesday, July 3, 2012
The age of rage: psychiatrists battle over teen anger diagnosis – Montreal Gazette
Intermittent explosive disorder — a controversial mental illness marked by outbursts of uncontrollable rage — is so common among adolescents it affects one in 12 teens, a large new study finds.
Harvard Medical School researchers, in a study based on in-person interviews with more than 10,000 adolescents ages 13 to 17, found that about eight per cent met the criteria for intermittent explosive disorder, or IED.
The findings suggest the disorder is affecting hundreds of thousands of youths — close to six million in the U.S. alone, according to a statement released with the study.
But observers worry it could trigger a “manufactured epidemic” of mental illness among teens and lead to extreme but predictable teenage behaviour being labelled as symptoms of a mental illness requiring treatment — including mood-altering drugs.
According to the Diagnostic and Statistical Manual of Mental Disorders — psychiatry’s official catalogue of mental illness, now undergoing its first major revision in nearly two decades — IED’s central feature is impulsive aggression grossly out of proportion to the situation. People lose control, break or smash things and attack or threaten to hurt someone.
The study, published this week in the journal of Archives of General Psychiatry, is being described as the first to estimate the prevalence of IED in American adolescents. The researchers believe their findings could be extrapolated to Canada.
“If we can detect IED early and intervene with effective treatment right away, we can prevent a substantial amount of future violence perpetration and associated psychopathology,” senior author Ronald Kessler, professor of health care policy at Harvard, said in a statement.
But Christopher Lane, author of Shyness: How Normal Behaviour Became a Sickness, said IED has been a source of controversy since it was formally approved as a mental disorder in 1980.
“Uncontrollable anger and domestic violence are, of course, serious concerns requiring attention,” said Lane.
But equally concerning, he said, is the risk of “medicalizing” adolescence itself.
Disorders in the DSM are defined by a list of diagnostic criteria. A person can qualify for a certain diagnosis based on how many criteria they meet for that illness.
But there isn’t agreement on just how many “episodes” or outbursts of aggression are necessary for a diagnosis of IED. As well, some have proposed broadening the criteria to include outbursts that don’t involve threatened or actual violence, but do involve verbal aggression — insults or arguments “out of proportion to provocation.”
The new study is based on a national mental health survey conducted in the U.S. between February 2001 and January 2004. “
An interesting article appears in the June 30 print edition of the WSJ titled The Medication Generation by Katherine Sharpe.
A couple of highlights are:
The large number of children on antidepressants.
The continuing search for a drug to counter every supposed personality quirk of problem.
The rising evidence that these drugs make them unable to form the adult emotional bonds necessary for a whole and complete life.
The dependence, real or imagined, that there is a need to continue these drugs throughout their lives.
All topics of this blog.
I was also struck by the July 3, WSJ print article OxyContin Trial Planned for Kids by Timothy W. Martin. The sample size for this study is 150. Yep, we are going to use 150 kids to set the prescribing standards for an addictive drug that could be used by all of the children in the US. Scrapes and bumps could be treated with this drug, because hey, you don’t want to see a child in pain!
But people say I am cynical.
Steve Lucas
OMG.
“Fraud” and “corruption” works for me. When two or more institutions work together to keep a corrupt operation in the green and do so by sending a team out to dispense fraudulent tales of scientific woe that all of society will suffer from, lest the fraud and corruption continue, it’s called “conspiracy”.
Dr. Mickey, what we’re seeing are two opposing forces in a wrestling match.
On one hand, we have a weak, reactive regulatory function that moves only when there’s enormous outrage.
On the other, we have the usual suspects promoting their various agendas of empire-building.
It is ever thus, but in a neocapitalist system, the spoils are counted in the tens of $$ billions, and the usual suspects see the opportunity to increase their take even more by having government underwrite their explorations.
Direct communication via email- from me- to: with the main author [ Ronald C.Kessler] of the “study” [trolling for a new market for SSRIs, et al], at Harvard on IED in adolescents.
Dear Dr. Kessler,
I am extremely concerned about the oversight of a major finding of the study you authored and published in the Archives of General Psychiatry this month. I am writing to appeal to your sense of ” responsibility , integrity and the accuracy of the data analysis”, as stated was your role in this publication.
You “agreed” :
>â€The only sociodemographic correlates of lifetime IED that we were able to document are related to family structure and size. Adolescents who do not live with both biological parents and who have more siblings have elevated odds of IED. Not living with both biological parents is the most consistent sociodemographic correlate of mental disorders in the NCS-A and is likely to be a nonspecific risk marker for psychopathology, whereas having more siblings is associated in the NCS-A specifically with behavior disorders, including not only IED but also CD.â€
NOW, Dr. Kessler if I could coax to apply some of that critical thinking and enlightened education that students of the Harvard School of Public Health are pilfering , then a truly astounding breakthrough could be on the horizon. Although it appears to be an example of run of the mill common sense to link problems during adolescence that challenge and undermine [create a crisis] the development of identity, the milestone that sets the foundation for successful, happy, fulfillment in adulthood; though it is obvious that fractured family relationships that go hand in hand with all varieties of single parent households thwart the sense of security and support adolescents require to build and refine their individual identities; yes, and given that emotional intelligence, collaborative brain function that supports executive decision making — the prerequisite for impulse control, IS the very brain development that SHOULD be occurring during adolescence AND requires some support and guidance from caring, invested, adult role models… THERE IS ZERO EVIDENCE FOR LABELING MALADAPTIVE BEHAVIOR IN THE CONTEXT OF OVERWHELMING THREAT TO NORMAL DEVELOPMENT — A *MENTAL DISORDER*….
Pathologizing adolescent behavioral and emotional dysregulation in the context of a crisis that interferes with normal development, is no longer in vogue. Prescribing SSRIs and *atypical antipsychotics* for the disorders you and your colleagues have fabricated in defiance of evidence of the serious and potentially life threatening adverse effects of these drugs -especially with regard to the adolescent population is unethical, immoral and blatantly criminal! I strongly suggest you carefully consider the likelihood of an educated, outraged public holding you accountable for propagating a myth, in lieu of scientific evidence for biomedical psychiatry; willful deceit that has caused harm; and financial gain [greed] as the only possible motive that explains your actions. I appeal to your strong attachment for the status that has created your own sense of identity. I can’t imagine you would risk such a monumental loss through continuing to exhibit irresponsible, careless and unethical professional conduct.
kessler@hcp.med.harvard.edu
This is just target practice 🙂
Great letter, Katie, especially the appeal to his self-regard at the end.