fresh air…

Posted on Saturday 28 July 2012

The record amounts of the recent GSK settlement [Biggest Deal Ever: Glaxo Pays $3B For Bad Behavior] and the one pending for Johnson and Johnson [J&J Penalty May Total $2.2 Billion ] for false advertising may not satisfy those who point to the billions made from these drugs and the damage done. And the failure to bring the human perpetrators in industry and medicine itself to justice may be equally frustrating. I’m among the ranks of the dissatisfied. But there are a couple of things to note about all of this. People want to feel better, and so they took these drugs. The doctors that gave them wanted to help people feel better too, so they prescribed them. The drugs weren’t that good, but they were handed out and taken like candy, yet the truth is that they are only really effective for a specific, selected subgroup of patients. Here’s the thing. If they had been as effective as advertised, there wouldn’t have been a need to advertise them in the first place. A few years back, Dr. Bernard Carroll made this analogy on the Healthcare Renewal blog:
… As for the charge that psychiatrists and primary care physicians just throw drugs at mental health problems, that is nothing new. It is a reflection of the professional pragmatism that permeates medical practice. Think back to the 1950s when the new wonder drugs called antibiotics were handed out like Pez, mostly for people who did not really need them and who would not benefit from them. The working principle was misguided simplicity and pragmatism, which minimized and discounted the risks. Even today the over-use of antibiotics remains a public health concern. Just as in the 1950s patients with nonspecific upper respiratory symptoms were “given the benefit of the doubt” and were prescribed an antibiotic on the reasoning that it might help them while probably not hurting them, so today patients with nondescript depressive or anxiety symptoms are prescribed an SSRI drug on the same reasoning. The cost of this approach in wasted money, in unnecessary side effects, and in unproductive clinical management is non-trivial.
And as for the state of the art…
Psychiatry, The Pharmaceutical Industry, and The Road to Better Therapeutics
by H. 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?
How refreshing to read such an honest assessment of the current era! particularly from someone who has been involved in industry himself:
Department of Psychiatry, University of British Columbia Vancouver, B.C., Canada. Subsequent to his academic career, Dr Fibiger was Vice President of Neuroscience at Eli Lilly and Company, Vice President of Neuroscience at Amgen, and Senior Vice President and Chief Scientific Officer at Biovail Laboratories International.
I would, however, quibble with his priorities in "So how did we get here and more importantly, what do we need to do to find a way forward?". I don’t think "a way forward" trumps "how did we get here?". "a way forward" sounds too much like NIMH Director Tom Insel’s recurrent schemes to keep the ball rolling [just plain crazy!…], more Myth of Sisyphus than scientific progress to my mind. In fact, Dr. Fibiger goes on to make the point himself:
The discovery of all three major classes of psychiatric drugs, antidepressants, antipsychotics, and anxiolytics, came about on the basis of serendipitous clinical observation. At the time of their discoveries, the mechanisms by which these molecules produce their effects were unknown, and it was only later that antipsychotics were shown to be D2 receptor antagonists, antidepressants monoamine reuptake inhibitors, and anxiolytics GABA receptor modulators. It is interesting and perhaps instructive to consider whether any of these classes of drugs could have been discovered by current drug discovery strategies. For example, what genetic or preclinical data exist that point to the D2 dopamine receptor as a likely target for antipsychotic activity? Presently there are no genetic data that suggest that this receptor is expressed or functions abnormally in psychotic disorders. And without the benefit of the prior clinical validation, it is difficult to see how preclinical data alone would point to the D2 receptor as an interesting potential target for the treatment of psychotic disorders. The same can be said for monoamine transporters with respect to depression where, like psychosis, there are no animal models based on disease pathophysiology and no compelling preclinical data pointing to these as potential targets for antidepressant drugs. This raises a troubling question: if in retrospect the three major classes of currently prescribed psychiatric drugs would likely never have been discovered using current drug discovery strategies, why should we believe that such strategies are likely to bear fruit now or in the future?
Like the old gestalt book title said, Don’t push the river. It flows by itself. We don’t need a driver for human curiosity – "serendipitous clinical observation" is the stuff of good science. What we have to offer is the scientific methods of proof, the Hippocratic Oath to do no harm, and the integrity to put these things before all others. I agree that "a massive experiment has failed," but again I’d quibble. The real "massive experiment" that failed was allowing therapeutic zeal and entrepreneurism to gain an unprecedented upper hand. And I don’t "wonder why it took so long for industry to abandon psychiatry therapeutics". I think it’s abundantly clear why. But none of these criticisms are aimed at Dr. Fibiger. I found these comments generally on the mark, and a welcome breath of fresh air.
    July 28, 2012 | 2:27 PM

    What we have to offer is the scientific methods of proof,

    Are today’s scientists even grounded in the scientific method? With BigPharma/big bucks ‘driving the bus’ . . . it seems (from the outside) that many scientists are given the desired answer, and then experiment to find the pathways that express the question.

    When the correct answer is 19, arithmetic ‘scientists’ can device all sorts of equations that will yield the correct answer. [(3×6) + 1 = 19; 38/2 = 19; 15+4=19]; but this all presupposes the dictate that “19 is the correct answer.” Until the ‘science’ is put back into scientific method, those outside-the-box thinkers, who still understand and embrace scientific methodology, rarely prosper.

    July 28, 2012 | 5:01 PM

    Amen. As long as the drive behind their search is to demonstrate that their unproven theories and classifications are correct, then they are not only not being scientific, they’re not working on the problem.

    July 29, 2012 | 12:45 AM

    I have a very different take on what has happened, & what will happen going forward…

    “People want to feel better, and so they took these drugs. The doctors that gave them wanted to help people feel better too, so they prescribed them.”

    Not Quite! People took these drugs because they were lied too…told they were sicker than they were…biologically diseased in fact…they made the unforgivable sin of actually trusting a doctor…

    Doctors handed drugs out like candy because it was profitable; not only did they gain a false sense prestige while falsely validating & propagating an unimaginable professional myth…they did so by their own free will…all the while wearing blinders to their actual patients health..that is not medicine….that measures out to be nothing more than professional egocentric greed gone completely out of control..

    When will the excuses & apologist propaganda stop…two of the top five selling drugs still to this day in America are anti-psychotics…there are no more “we didn’t know” excuses…I’m sorry to have to lay it out on the line here like this…but Psychiatry today is not about “doing no harm” or has it been for many decades as a greater whole; it’s been about making money and maintaining an ill gotten & false medical validity..

    These drugs didn’t become top sellers & mega blockbusters by pharmaceutical marketing alone…it took not just a few bad doctors to sell out; but a vast majority of them to deny what was right in front of their eyes….PATIENTS

    Oh! Let’s add up all the fines the pharmaceutical Industry have paid out to date…it is less than the accumulated interest on the profits they have made in this diabolical scam…they have not been curtailed or punished in the least…

    That is why nothing has, or will really change…because “people” talk about some futile distant future & make statements like “we know better now”; while forgetting the harsh & sad living reality that absolutely no one has been truly held accountable…not Big Pharma, not doctors, not psychiatry..

    I guess people just don’t get it….these small cry’s from the fringe are so marginalized & drowned out everyday by the behemoth corporate marketing machine & their aligned medical cronies…”change” is just another illusion being sold wholesale…

    and the beat goes on……

    July 29, 2012 | 3:47 PM


    When the basic facts are reviewed with simple common sense, and expressed in plain language, as you have accomplished here, there is— I believe, another aspect of accountability on the table. What is the role of any literate, mature individual regarding full possession via comprehension of the scope and potential for *more* harm to ourselves, loved ones and fellow human beings from this very real example of : ” professional egocentric greed gone completely out of control” ? Everyone who reads your post and has done enough research and /or had enough personal or professional experience with or within psychiatry to know you have stated the reality of the situation, has , in my opinion, a pressing urgency to reflect on and review their own definition of the term, *accountability*. What we do, say– or don’t do and don’t say once we have gained this knowledge is a statement of the degree to which our society does or does not value our children.

    Children are not seeking a psychiatric diagnosis or a *broken brain* label for their emotional pain and mental anguish, nor are they naturally compliant with being drugged and forced into playing the role of a *psychiatric patient*. For kids, the damage from the *lies* told by Timothy Wilens MD, associate professor of psychiatry Harvard Medical School and prominent child/adolescent psychiatrist , Mass. General Hosp. Boston in his 2009 book :”Straight Talk about Psychiatric Medications for Kids”; for kids, there is ONLY the certainty of harm. Would a new word or term to describe this particular type of child abuse help us to get a grip on our role in stopping it?

    What would you call damaging the minds and spirits of children for financial rewards? What could we call a medical doctor who made good his promise to J&J, by opening the preschooler and up market for Risperdal? What should we say about the apathy of the FDA, NIMH (tax dollar- for the people- enterprises) just regarding this never seen before– new kind of child abuse?

    Who might be held accountable, IF this difficult to label form of child abuse is not stopped? Everyone who knows about it and says or does NOTHING.

    BE THE CHANGE… super heroes are also myths….

    July 29, 2012 | 4:07 PM

    Fibiger’s concern is drug development, not safety or patient well-being. Why should we expect new drugs to be safer and more effective than old drugs, while marketability tops safety and effectiveness as priorities in research?

    And, let us not forget, the financial penalties drug companies pay are only part of the story of their malfeasance. The other part of the story is patients INJURED — not merely suffering transient side effects but INJURED — by these drugs so cavalierly prescribed and effects ignored by doctors all over the world.

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