Institute of Medicine report concludes that the FDA is not doing adequate job of assessing drug benefits and risks

Two weeks ago, I headlined my blog with this question: Is the FDA violating its own mandate to approve safe drugs? Four days later, the national Institute of Medicine (IOM) released a 233-page report concluding that FDA’s current approach to drug oversight “is not sufficiently systematic and does not ensure consistent assessment of benefits and risks associated with a drug over its lifecycle.” In other words, the FDA may indeed be violating its own mandate.

The IOM report was mentioned almost in passing near the end of a Nature article today on the debate over an earlier journal study that found significant noncompliance with a 2007 federal law that requires researchers to post clinical trial results on a publicly available website. The Nature article focused on the fact that the FDA and the NIH disagreed with the findings of several researchers who reported in the British Medical Journal that only 22% of trial sponsors posted their results within one year of completion, as the law requires.

The FDA, in response to letters from Congress investigating this lapse, argued, among other things, that the BMJ researchers included some trials that were completed before the 2007 law came into effect, and did not exclude some — such as uncontrolled trials — that are exempt from the reporting requirements. According to Nature magazine, the researchers stand by their results and note that the FDA itself is having trouble determining which trials should be included under the 2007 mandate.

Regardless of who is right in this particular dogfight, the fact remains that the Institute of Medicine, possibly the most respected advisory body in medicine, has determined that the FDA is not doing an adequate job when it comes to drug safety oversight. The IOM report makes a number of recommendations, including:

  • that the FDA should “adopt a consistent decision-making framework for regulatory actions across the lifecycle of all drugs…”
  • that the agency should require, for each new drug and for already
    approved drugs for which there are questions of safety, “a
    publicly available and understandable document that would capture information about a drug before it is approved and throughout its time on the market.”
  • that the FDA should develop more tougher and more consistent guidelines about what kind of controlled trials they consider scientifically valid in determining both efficacy and safety.
  • that the FDA should work with other federal agencies in evaluating and resolving concerns about the ethics and quality of the increasing number of clinical trials performed outside of the United States.

Last week, the British Parliament came out with a report concluding that Rupert Murdoch is unfit to run News Corp., and its findings made headlines on this side of the Atlantic. How come when the Institute of Medicine comes out with a 233-page report concluding that the FDA is not doing its job, the only mention I can find of it is near the bottom of a short news article in one scientific journal? Why doesn’t this report merit front-page news too?

Hat tip to Paul Thacker for alerting me to the Nature article.




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One Response to Institute of Medicine report concludes that the FDA is not doing adequate job of assessing drug benefits and risks

  1. Stop.Psychiatry says:

    My general objection is to psychiatry as a scientific endeavor. Psychiatry is the area of medicine where the abuse is more pervasive because psychiatry has been reduced to prescription of drugs that treat disorders for which there is not a single biological marker that can be identified as their cause. The FDA allows this to go on for justifiable reason.

    First, I want to apologize for telling my story anonymously. As you will see, the whole episode was very humiliating. One of the many unfortunate effects of psychiatric misconduct is the continued stigma that exists in all things related to mental disorders so I am not ready yet to go public with this; maybe someday I’ll find the courage to discuss this openly but I am not there at this time. I am an American male, of European origin, in my late thirties. I only hold American citizenship and I only held American citizenship when this thing happened. I am highly educated with a doctoral degree from one of America’s best engineering schools. During most of my adult life I have struggled with a condition that was diagnosed as Obsessive Compulsive Disorder, OCD. The funny thing is that psychiatry dumps into this disorder all kinds of different types of mental distress. In my case it’s an exaggerated fear of contracting HIV through usual contact. Now, I don’t
    mean to say that this condition is not serious or that it doesn’t cause distress. However, it doesn’t warrant the type of abuse I am about to describe. When this episode happened I was married; my ex-wife was of great help, which probably avoided the ruin of my professional life. As the vast majority of people, I had a neutral position on the whole field of psychiatry. I assumed that it was just like any other branch of medicine, tested and confirmed by the scientific method to be 100% accurate both in diagnosis and prediction. All that changed a few years ago when I was involuntarily committed to a psychiatric institution and forcibly drugged in the European country where I was born for treatment of OCD while I was visiting my parents.

    Unlike the laws of the United States, the laws of that country afford psychiatrists all-encompassing power to commit whomever they wish and to drug people against their will. So any psychiatrist can order to involuntarily commit and drug forcibly any patient in cases in which a psychiatrist determines it to be necessary, regardless of whether a finding that the patient’s life or a third party’s life is in danger exists. I was forcibly detained; tied up for almost one day and then forced to stay in 2 different mental institutions for a total of 12 weeks. The psychiatrists I worked with during that time are amongst the most arrogant people I have met in my entire life, which shows that, if you give anybody such power, they will become inevitably corrupt. The humiliation that I endured will stay with me for the rest of my life. My parents asked the psychiatrist to commit me. Out of respect to them, I did not invoke the protections afforded by international
    treaties, of which both the European country that detained me and the US are signatories, to citizens detained against their will in a host country. So I was pretty much on my own, with the help of my ex-wife to fight this. I was lucky that the company I was working for at the time here in the US was very patient with me; my ex-wife was able to manage the situation with them, but those psychiatrists who committed me couldn’t care less about my professional situation here in the US or whether I could be laid off for not showing up to work. Needless to say, the relationship with my parents has become strained as a result of the episode.

    And then there is the forced drugging and the side effects. The American Psychiatric Association, APA, recommended pharmacological regime for OCD treatment involves the prescription of serotonin reuptake inhibitors, either modern SSRIs or older ones such as tricyclic antidepressants -like clomipramine-, at doses that are 2-3 times higher than what is prescribed for normal depression. It is normal practice to supplement the prescription of these antidepressants with antipsychotic medication to “strengthen the effect of the antidepressant drug”, whatever that means. I continued with the medication regime upon coming back to the US. Over the course of 12 months I was prescribed (though at different times) escitalopram, clomipramine, sertraline, risperidone, olanzapine and lorazepam. Even though the APA also says that Cognitive Behavioral Therapy, CBT, alone is more efficient than meds for the treatment of OCD, I was made very clear that unless I agreed to
    be put on a medication regime, I would not be released from my involuntary commitment. So I had no choice but to agree to be put on meds if I wanted to get out of there. Upon my return to the US, I started to be treated by a psychiatrist (meds) and a clinical psychologist (CBT). At the time of my admission to the European hospital, I was given comprehensive blood tests that showed all my biological markers within normal range, those of kidneys and liver in particular. Upon learning of my medication regime, my American psychiatrist ordered new blood tests that showed clear kidney impairment. The creatinine serum level had gone from 1.2 mg/dL to 1.6 mg/dL in 3 months (normal range is <= 1.2 mg/dL). Other markers looked normal. I was sent to a kidney specialist who, after all kinds of tests, couldn't find the cause of kidney malfunction other than the meds I was taking which were "supposed" to be harmless. A few months later, I had new blood tests and this time not only the kidneys didn't show any improvement, but it was the liver markers AST/ALT that were out of range. An ultrasound test showed also that I had began to develop fatty liver. After months that showed no improvement of these two conditions -in addition to the fact that I had been experiencing other side effects associated with antidepressant/antipsychotic sue such as increased cholesterol levels and weight gain-, and against the advice of my American psychiatrist, I made the decision of stopping all medications. One month and a half later, I had a new blood test performed on me and bingo!; the AST/ALT markers were back within range while the creatinine serum level went down to 1.2 mg/dL (in all blood tests I had while I was on meds it had been oscillating from 1.4 to 1.6; my most recent reading before I decided to stop the meds was 1.6). I am not a medical doctor, but I have an excellent doctoral education in the field of signal/statistical processing. The data collected from my case shows very convincingly that in my case these medications were causing significant side effects that risked to cause long term damage to my kidneys and to my liver. To distance myself from this episode, I decided to stop CBT as well and I learned several things from this ordeal,

    1- Psychiatrists in general love to prescribe drugs. They will use any excuse they can find to do it, even if, as it is widely admitted, the field of psychiatry has yet to find a single biological marker that can be reliably described as the cause of any mental disorder. As to why this is the case, originally I thought it had to do with psychiatrists desire to be considered as equals by doctors who practice other specialties of medicine, a reason that doesn't speak very highly of psychiatrists' inferiority complex but which is understandable. However, after the episode of my involuntary commitment was distant in time, I began to research on the topic and I am appalled at what I found. I was made aware of the work by US senator Chuck Grassley which exposed the undisclosed financial ties to big pharma of "prestigious" psychiatrists such as Joseph Biederman, Charles Nemeroff, Martin Keller or Alan Schatzberg -the latter served as president of the APA even
    after the extent of his misconduct was publicly known-, the APA, and its front groups such as NAMI; right now I am more of the opinion that it has to do with a more mundane reason: greed. All these people engaged at some point or another in ghost writing, a practice that consists in that somebody hired by a pharmaceutical company writes a book or an article promoting a drug or a given clinical practice. The article/book is then presented as authored by the psychiatrist in question. The end result is that few people question the findings of the work, regardless of its scientific quality, because it is promoted as authored by some "prestigious" doctor. Of course, the "prestigious" doctor is duly paid by the pharmaceutical company for the cooperation.

    2- The guides of the APA, such as the DSM, have far reaching effects beyond the American market. The DSM was used to give me the OCD diagnosis in the European country where I was involuntarily committed. If the DSM, as it seems to be the case for DSM5, begins to promote the over use of psychiatric drugs, its effects will be felt not only here in the US but worldwide, which takes me to the third point.

    3- The US is, as it has been in many other instances, a pioneer in the protection of individuals' rights, in this particular case psychiatric patients' rights. A series of opinions by the US supreme court in the seventies, O'Connor v Donaldson and Addington v Texas in particular, limited the ability of American psychiatrists to involuntarily commit patients to psychiatric institutions except in those cases where the life of the patient (or the life of a third party) is in imminent danger. Subsequent decisions also limited psychiatrists' ability to drug patients against their will. All this is relevant because I was able to make the decision of stopping all medications without the fear of retaliation only because I am an American living in America. This decision might have meant a trip back to the psychiatric ward in that European country, despite the severe effects I was experiencing. That is not to say that psychiatrists do not abuse their power in the US, there is plenty of evidence to the contrary, however, their ability to abuse patients is severely limited. Ideally, we should have the current practice of psychiatry disbanded and the DSM abolished. That is unlikely to happen, at least in the short term, because there are so many special interests (the APA, big pharma, the FDA) interested in maintaining the status quo. However, we can all fight so that their negative effects are attenuated, not only for our fellow Americans but also for the sake of millions of innocent people who live in countries which are less protective of patients' rights and who are likely to be abused by the psychiatric establishment of their countries with an expansive revision of the DSM.

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