Sheller’s Appeal Demonstrates FDA’s Indifference to Drug Harm

Jim Gottstein, JD
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As I wrote in Let’s All Support Stephen Sheller’s FDA Petition to Revoke the Pediatric Approval of Risperdal, Stephen Sheller’s law firm (Sheller, PC), which represents hundreds of boys who were prescribed Risperdal and then grew breasts (gynecomastia) as a result, filed a petition with the Food and Drug Administration (FDA) to change the label and revoke its approval for use on children.  During the course of discovery for litigation in its Risperdal cases, Sheller became privy to documents not provided to the FDA that showed Johnson & Johnson hid the problem.  However, Sheller is prohibited in those court cases from disclosing these documents.  Therefore, Sheller also asked  the FDA to order Johnson & Johnson to release him from the confidentiality requirements so he could provide them to the FDA.

The FDA’s response, denying Sheller’s petition last November, demonstrates both how unconcerned the FDA is about the massive harm to children caused by Risperdal — most of which is paid for by the federal government — and its “don’t confuse me with the facts” attitude.

Then, when Sheller appealed to the United States District Court for the District of Pennsylvania, in Sheller PC v. Food and Drug Administration et al., the United States Department of Justice moved to dismiss (throw the case out of court) on the grounds that Sheller did not have any right to appeal because he was not personally harmed:

“Sheller appears to assume that the purported injuries suffered by the children it represents in the personal injury litigation against J&J suffice as injuries to Sheller for purposes of this case.”

Just last Friday, May 1, 2015,  Sheller, PC filed its First Amended Complaint in which Sheller says it is harmed because Johnson and Johnson is using the FDA’s denial of its petition in Sheller’s court cases to argue they should be dismissed on the grounds the FDA has found that young boys growing breasts is not a serious adverse effect.

The only real disagreement I have with Sheller, PC’s approach is that it argues adolescents should be switched to other neuroleptics in order to reduce the risk of gynecomastia.  While Risperdal probably is the worst for gynecomastia, all of the neuroleptics are so harmful they should not be given to children or adolescents and for that matter should rarely, if ever, be given to adults.  Certainly, they should never be forced upon people.

In any event, this proceeding starkly illustrates that the FDA is indifferent to harm caused by drugs it approves, and is not even pretending to be interested in learning the facts.

Sadly, this is not news.

Another thing this proceeding illustrates is just how hard it is to use the legal system to get the FDA to do its job.  Sheller is to be commended for taking this on.

This is a very important case.  If it is successful, it will give hope of forcing the FDA to follow its mandate to protect the public from harmful drugs.

The FDA Docket is mostly available here and I will try to keep the PsychRights Page on the Sheller Appeal  up to date.

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21 COMMENTS

  1. “It sounds like some FDA bureaucrats are reluctant to alienate potential future employers. The system is truly rigged.”

    Yes, this, too, is the profit motive at work. They either sit around in bureaucratic stupor, unwilling to make waves until they retire with taxpayer funded pensions, or they are angling to make serious money working for pharma. There is no benevolent, ethical or competent government authority to protect us, including the most innocent, defenseless and vulnerable members of our society. We are truly on our own.

    This is America’s shame. I did not think it was possible to top the abuse of psychiatry by the late, unlamented Soviet Union, who drugged inconvenient dissidents who dared to speak truth to power, but I was wrong. Drugging children who have zero choice (the dissidents had the choice not to speak out — not much of a choice, but a measure of choice nonetheless) is the lowest of the low. For shame.

    • It’s a win-win for the two specialities that profit from “treating” differentness: plastic surgeons, many of whom live off cosmetic procedures, and psychiatry, to treat the boys for whatever the emotional sequelae of growing breasts might be. It is probably the chance to jack up mom on Abilify and Dad on Ambien, too. Talk about putting a spark back in your marriage. Think powder keg.

  2. Is the combined power of the drug companies , considering having the power to make things happen as they choose and economic generation , equivalent to the power of a country like say the old Soviet Union which they say was expansive enough to have included 9 time zones ? Is there anything they want to do that the government can say no to at present ? Are they not in effect a part of the government ? If this is a Theraputic State even controlling the water and food supply, is fighting against coercive psychiatry going to be enough ? As we watch the powerful stride along more arrogantly with each step. Am I overreacting or understating the problem ?

    • Perhaps understating.

      Google is a private company, and in its truthiness initiative has hinted at de-listing pages with content it deems bogus. I saw it in action when I searched for lubitz medication side effects.” The first result was from CCHR, and it came with a feedback box that asked me what I thought of the content. If CCHR is under scrutiny, how far behind are MIA and liked-minded sites? Yes, I know CCHR has the taint of L Ron Hubbard and his spawn, but I just took a look at their content. It’s boilerplate information you can find anywhere in the realm of critical psychiatry, and no mention of Scientology that I could see. Google is doing the FDAs dirty work, and probably without being asked.

      Regarding the food supply, a big chunk of the doctors who wrote that stink mail to Columbia suggesting Dr Oz should be fired were GMO shills. Though many in the public are aware that Dr Oz was under fire for his statements about GMO labeling (in favor) and coverage of herbal supplements that don’t act as advertised, he also endorses natural remedies over antidepressants for the treatment of depression. Only diet treatments were emphasized in coverage of the story.

      The author of SHRINKS wrote a nasty little note to the NYTimes, to take a nip at the ankles of Dr Oz (who is said to be an excellent surgeon, by the way).

      To the Editor:

      Re “Dr. Oz Is No Wizard, but No Quack, Either,” by Bill Gifford (Sunday Review, April 26):

      I want to illuminate the real and valid concerns of the academic medical community over the behavior and actions of Dr. Mehmet Oz, a faculty member and cardiothoracic surgeon at Columbia University Medical Center.

      The concern by fellow physicians over Dr. Oz’s approach to health care as demonstrated on his television show stems from the fact that physicians and medical researchers are held to standards that require not just honest communication but also credibility based on fact.

      Boundaries do indeed need to be pushed, and consumers do need to do homework, but recommendations need to be rooted in scientific evidence and medical facts.

      Since his foray into daytime television, by way of Oprah Winfrey, Dr. Oz has strayed from the strict standards characteristic of the medical field and particularly academic institutions.

      You can’t have it both ways: You can’t have the credibility of an elite academic institution and not be held to its standards.

      JEFFREY LIEBERMAN
      New York

      So yes, the crunch you hear as the boot strikes the ground is the bones of Truth and Justice, who apparently proved ineffective and laden with adverse events in a clinical trial run by Keller and Thase and funded GSX.

  3. Jim – I couldn’t have seen how to get more informed as effortlessly as you made it possible for us here, about this raging duplicity underpinning FDA official policy and procedures. Are academia and the press dead? I always wonder. In your opinion, are there any trade journals for following litigation and precedent that get the big picture on all this right, and does any one commentator or pundit, that is, some responsible intellectual, stand out and keep this vital newsworthy material in the news and discussed to the attention. Is it so convolutedly cordoned off by redtape and doublespeak that only lawyers can act to change it? Constant mention of the character of FDA commitments to the public health needs here seems not to matter enough yet, and somtimes just appears like the critic’s way of establishing their own reputation as a crusader for social justice. Your work for us is so clear and to the point. I wonder where else to turn for further explanation and ideas of how to respond. Thanks very much.

  4. If psychiatry is looked at as a drug delivery and compliance monitor and inforcer for the drug companies , who seem to be totally oblivious of any moral codes whatsoever. Why shouldn’t we expect them to deliver drugs in our water or food or air to protect themselves or to increase business? Aren’t they already filled with chemicals and genetic engineering as we speak ? They also have AMA doctors to deliver them through pharmacies And dentists to implant toxic heavy metals and also inject stuff near our brain . Drug delivery , let me count the ways . I do distill my water.

  5. We need need more psychiatrists like Sami Timimi and Peter Breggin who listen to young people and try to solve their problems without medication.
    After reading Cracked by James Davies , I think Senator Grassley understands how the FDA works and he could possibly help.
    All clinical trials should be published for all the drugs currently on the market.

  6. Jim, can you think of any way people reading MIA can be helpful in this?

    While I am not sure of your general politics, I think one thing that could be helpful is that this particular case shows the influence of the uncontrolled influence of drug corporations on the government, something that Bernie Sanders might be convinced to start talking about in relation to psychiatry.

    After May 16, I hope to try to get some of our more political movement people to focus on influencing him to talk about our issues, Keep in mind that in 1985, he addressed our last Conference on Human Rights and Psychiatric Oppression when he was mayor of Burlington, Vermont. No other politician has ever done something like this, as far as I know.

    • Ted, I am not in favor of politicizing the issue, and I am not inclined to look to the government for help. Think Justina Pelletier. Psychiatric drugging is a of form of social control, and I have a sneaking suspicion that government authorities like having the option to subdue outspoken, inconvenient people. Change will come only when there is a critical mass of the public ready to hold Big Pharma and government “watchdogs” accountable. It can — and I believe it will — happen, just as it did with the tobacco companies (no right to advertise their offerings, big liability settlements), but, unfortunately, we we are not anywhere near that point.

  7. Thanks for all you’re doing, Jim. What a horrible situation a country is in, from a legal perspective, when that country’s government actually believes in scientifically invalid disorders, which are cured with the antipsychotics. We need to bring back an ethical justice system, that doesn’t believe in fictional disorders. Shame on the US.