Science, Kansas and the Wizard of Washington

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November 10, 2022 | 8 Comments


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    Despite progress in data transparency, the FDA still keeps its data secret
    Maryanne Demasi, PhD from Maryanne Demasi, reports
    7:25 AM (2 hours ago)
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    Despite progress in data transparency, the FDA still keeps its data secret
    NOV 10

    History shows that hiding clinical trial data can be deadly.
    Vioxx is a well-known example of how the US drug regulator withheld important information about the harms of the drug for over three years, before it was withdrawn from the market and tens of thousands of people died as a consequence.

    Numerous initiatives have been launched over the past two decades to improve access to trial data after it became evident that what was reported in peer-reviewed journals was often cherry-picked and misleading.

    Eminent scientists have succeeded in gaining access to trial data from the European and Canadian drug regulators, but a recent analysis published in the Journal of Law, Medicine, & Ethics, found that the US FDA still lags behind others when it comes to data transparency.

    Europe ahead of the pack
    Drug regulators have traditionally been the guardians of a treasure trove of trial data which they kept hidden from the public. But, over a decade ago, the efforts of Danish professor Peter Gøtzsche turned that on its head.

    Prof Peter Gøtzsche, Institute For Scientific Freedom, Denmark
    Gøtzsche and his PhD student were studying the effects of an anti-obesity drug and requested the trial data held by the European Medicines Agency (EMA).

    “We already had good evidence that the efficacy and harms of drugs were incompletely reported in the medical journals, so by asking for the regulatory data for the anti-obesity pills, we were convinced it would get us closer to the truth”, said Gøtzsche.

    At first, EMA denied their request, saying that it needed to protect commercially confidential information, but Gøtzsche was undeterred. He made a formal complaint to the European Ombudsman.

    After an arduous 3-year process, the Ombudsman accused EMA of “maladministration” for refusing to share its data – it was a serious and embarrassing charge, so EMA had no choice but to capitulate.

    In 2013, EMA announced that it would provide public access to regulatory data – which included study reports, protocols and the raw anonymised patient data in statistical programmes enabling anyone to independently scrutinise the data for all new drugs that it approved.

    It was a bitter-sweet moment for Gøtzsche.

    “I was satisfied with the outcome, but I also felt a bit betrayed. When EMA praised itself for being transparent, it conveniently omitted telling the public that it was basically forced to make the decision because of my efforts and that of the Ombudsman,” said Gøtzsche.

    “I’ve been around a while to know that this is exactly how the drug industry operates. They cover up their failures while praising themselves for what others force them to do,” he added.

    Millions of pages containing trial data have since been released. Interestingly though, this remarkable feat has gone largely unrecognised and the response from the research community has been rather tepid.

    Gøtzsche suspects it’s because analysing regulatory documents is complex and requires experience to decipher regulatory data – skills that few researchers have.

    “It is a huge job to do systematic reviews of clinical study reports held by drug regulators, but it is the difference between producing reliable reviews or merely “garbage-in, garbage-out” reviews,” said Gøtzsche.

    Since then, Gøtzsche’s group showed this was the case for reviews of antidepressant drug trials.

    When they compared data from medical journals to that from regulatory documents, they found major discrepancies such as underreporting of harms, including suicide attempts and aggressive behaviour.

    Canadian regulator in the cross hairs
    Following the landmark policy change in Europe, researchers believed it would help unlock regulatory documents elsewhere that were historically kept hidden from the public.

    In 2016, Peter Doshi, professor at the University of Maryland and senior editor of The BMJ requested the release of unpublished clinical trial data relating to antivirals for the treatment of influenza (Tamiflu, Relenza) and three human papillomavirus vaccines from the Canadian drug regulator, Health Canada.

    After some resistance, Health Canada agreed to allow Doshi access to the documents but imposed a confidentiality agreement that would prevent him from making his findings public.

    When Doshi refused to sign the confidentially agreement, his request for access to the trial data was denied, so he filed a lawsuit in a federal court seeking a judicial review of the regulator’s decision.

    Remarkably, in 2018, in the case of Peter Doshi v. Attorney General of Canada, a federal court judge ruled in favour of Doshi and in the public’s interest, ordering Health Canada to hand over the trial data for independent scrutiny.

    It was hailed a “major victory” for transparency and after the win, Doshi told The BMJ, “For me this case has always been about something larger than my specific request. It is about the principle of transparency. If my case sets a precedent and Health Canada begins making clinical trial data available to others—promptly, and without imposing confidentiality agreements—that will be the real victory.”

    Notably, the Canadian drug regulator has gone one step further than EMA by proactively releasing data for not only approved drug submissions, but also “unapproved, and withdrawn drug and biologic submissions…Class III and IV medical device applications.”

    What about the US FDA?
    The US FDA houses the largest known repository of clinical trial data in the world, but it doesn’t proactively share it.

    In 2018, the FDA launched a new pilot program to proactively publish clinical study reports from the pivotal studies of nine recently approved drugs – but the agency put an end to that program in March 2020.

    “It is just so typical of the FDA, which is very beholden to industry, and which some have dubbed the Foot Dragging Agency when it comes to the public interest,” said Gøtzsche.

    Now, the only mechanism to ascertain regulatory data for FDA-approved drugs is to submit Freedom of Information Act (FOIA) requests, a lengthy process which often results in heavily redacted documents of limited value.

    A study by US researchers, analysed the FDA’s willingness to release data, compared to other regulators, EMA and Health Canada.

    They found that between 2016 and April 2021, EMA released data for 123 unique medical products, while Health Canada released data for 73 unique medical products between 2019 and April 2021.

    In stark contrast, the FDA only proactively disclosed data supporting one single drug that was approved in 2018, clearly demonstrating that the agency has failed to keep pace with the European and Canadian regulatory bodies.

    The problem of data secrecy within the FDA has been especially evident during the pandemic. Recently, I reported in The BMJ that the agency had failed to disclose covid-19 vaccine ‘safety signals’ derived from post-marketing data.

    Also, the non-profit group, Public Health and Medical Professionals for Transparency had to sue the FDA for access to trial documents used as the basis for licensing Pfizer’s covid-19 mRNA vaccine. Initially, the agency wanted 75 years to release all the data but a Federal Court Judge rejected its request, ordering the release of the documents at a rate of 55,000 pages per month, taking approximately 8 months.

    Given the widespread use of this important public health intervention, and the billions of dollars in public funds used to conduct vaccine research and development, these data should have been made publicly available immediately.

    Data secrecy has undermined the health care system by subverting the allocation of scare resources and eroding public trust. The damage done to people’s confidence in vaccines, and medicines more broadly, will be felt for generations and likely to harm public health.

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  2. ‘a morality play in SSRI-landia’

    ‘It’s the process that turned a limited and fickle drug like Prozac into a blockbuster by denying and hiding its foibles.’…

    it’s not our drugs…

    Emergence of Intense Suicidal Preoccupation During Fluoxetine Treatment
    by Martin H. Teicher, M.D., Ph.D., Carol Glod, R.N., M.S.C.S., and Jonathan O. Cole, M.D.

    American Journal of Psychiatry. 1990 147:207-210.

    Six depressed patients free of recent serious suicidal ideation developed intense, violent suicidal preoccupation after 2-7 weeks of fluoxetine treatment. This state persisted for as little as 3 days to as long as 3 months after discontinuation of fluoxetine. None of these patients had ever experienced a similar state during treatment with any other psychotropic drug.

    “Antidepressants occasionally promote suicidal actions in severely depressed-patients by enhancing drive and counteracting psychomotor retardation. However, standard antidepressants are not known to induce severe and persistent suicidal ideation in depressed patients free of such thoughts before treatment. We have recently observed several complex patients who appear to have had serious paradoxical responses to fluoxetine that were characterized by intense, violent suicidal thoughts…”

    Posted on Wednesday 16 January 2013

    ‘it created a firestorm’ – see full text

    It’s not that different from multiple other situations in medicine with all kinds of medications. So what’s the big deal? Why did Lilly, knowing about Akathisia even before the drug was approved, try to keep it such a secret? Why code suicidality in studies as something else? Why attack doctors who brought it to attention in articles? Why trivialize “anecdotal reports”? By any rational logic, the drug reps should be handing out Teicher’s article on their sales calls. “Watch out for  Akathisia!” “It’s a rare but important side effect!” But none of the manufacturers or the KOLs seem to ever do that. They mumble the warnings at the end of the tele-commercials, or in the scrolling small print on the printed ads. They finance increasingly bizarre articles and meta-analyses claiming a safety and an efficacy beyond the medications’ possibility to deliver. And they do it every time, at least in this modern era. But if these modern psychiatric drugs were presented with their actual efficacy and their side effects had been accurately characterized, they would never have been blockbusters. They would still be on the market and would still be of value, but they would be used much more carefully, primarily by people experienced in their use. There would have been many fewer doses of Prozac sold to fewer patients. Profits would have been only modest, court settlements rare. It’s not Prozac that’s a problem. It’s just a chemical.  It was the entrepreneurial orgy that accompanied it.

    In the comments section to a recent post, I’m asked the question, “SO on balance: HAVE ANTIDEPRESSANTS DONE MORE HARM THAN GOOD?” followed by a confrontation, “What is this rally against the biological psychiatry? You can dig up as much crap as you want. [actually you can do it in any field.] But unless you can address the above, all you’ve got going here is a morality play in SSRI-landia.” It deserves an answer. It implies that the point of this blog is an attack on Biological Psychiatry or the antidepressants. I think that question is a false dichotomy, or maybe addressed at the intent of some other blog. I’d rather answer this question, “Have the antidepressants done more harm than they would have if they’d been used carefully, based on the honest scientific evidence?” I’d say “You’re damned straight they have! By a mile!” And as for “all you’ve got going here is a morality play in SSRI-landia.” That’s pretty much exactly what I intend – morality. And if being put off by those Lilly emails from the dawn of time where people are lobbying for accurate reporting of Clinical Trial data, but then caving in, saying “Of course, at the end of the day, we will do what we are told to do” is my being a goodie two-shoes, I accept the designation gladly and wish I’d known to put them on sooner. I still practice general psychiatry in an out-patient clinic and use these medications in that practice every time I work – at least some of them. With the depressed, I mention and describe Akathisia to every SSRI/TCA naive patient I prescribe for, and give them a number to call if they have any problem [and they do sometimes – have any problem and call]. I try to paint a realistic picture of what is to be expected from the medication and stop the drug if there’s no response. When people discontinue SSRIs, I taper them slowly and warn about withdrawal symptoms [my track record treating withdrawal symptoms by adding another drug is somewhere around zero]. I never use the short-acting SSRIs because the withdrawal is often so difficult. I learned to do all those things by reading studies and writing this blog [because I didn’t know all the dangers before]. I expect by national standards, I’m a light-weight prescription writer. No apologies for that. And in the time available in a charity clinic, I have a go at finding out what’s going on in the patients’ lives that might be making them or keeping them sick, and help if I can.

    And as for “You can dig up as much crap as you want”, psychiatry would be a hell of a lot better off right now if there weren’t so much crap to dig up. Looks like the Augean Stables to me. This isn’t a “rally against the biological psychiatry” – it’s a rally against the Eli Lilly and friends that joined in the fun and the lying and way over-promised, minimizing needed truths. And as for our current drugs, I see them kind of like I saw steroids, anti-metabolites, anti-hypertensives, etc. when I was an Internist. If you learn how to use them well and stay on the light side, you can help a lot of people, even cure a few, but the potential to do some major damage is always in the room, so you’ve got to be careful. It’s not our drugs that are the problem. It’s not even Akathisia itself. It’s the process that turned a limited and fickle drug like Prozac into a blockbuster by denying and hiding its foibles…

    ‘It’s just a chemical.  It was the entrepreneurial orgy that accompanied it.’ …

    • Lilly has lost loads of dollars in this exquisite scam – so did shareholders, some of them must have known about Lilly’s disgusting history before investing

      Twitter Blue scam account may have cost Eli Lilly billions of dollars
      Jon Silman Nov 11, 2022 6:39 pm
      tumblr twitter verification
      Credit: Tumblr
      Pharmaceutical company Eli Lilly is the latest corporation to take a hit from Elon Musk‘s chaotic Twitter takeover. A fake account impersonating the company, with a blue checkmark purchased for $8, tweeted that the company was now giving away insulin for free.

      The fake account posted the tweet around 1:30 p.m. on Nov. 10 and it stayed online for several hours. While it was up it garnered thousands of likes and retweets. By Friday morning, the account’s verification status was gone and it was set to private.

      However, the damage had been done, with LLY shares plummeting 4.5%, according to Investor’s Business Daily. Other health stocks took a beating as well. Here’s a screenshot of the offending tweet:

      The company was forced to respond to the situation from its actual account. “We apologize to those who have been served a misleading message from a fake Lilly account.”

      Insulin is a drug that was publicly funded and given away by its creator Frederick Banting in 1923. He refused to put his name on the patent, claiming it was unethical to profit from a medicine that saved lives. The cost of the drug has tripled over the last ten years, reaching $450 by 2016.

      It’s gotten so bad that people ration their doses to afford the costly drug. In a lengthy thread about the topic, The Jewish Vote co-founder Rafael Shimunov called out Eli Lilly for its greed.

      “Eli Lilly stock isn’t just tanking because of a satirical Tweet on Musk’s hellscape, it’s tanking because millions of people are asking why we have to pay for insulin, when it was made to be free. That’s why other insulin stocks are falling too.”

      Former presidential candidate and Vermont Senator Bernie Sanders also singled out Eli Lilly.

      Someone else tweeted that “it cost some hero $8 to evaporate billions in Eli Lilly stock value. Elon accidentally created one of the most cost effective anti capitalist tools in history.”
      Sure the company lost billions but it’s hard to feel bad when there are people who literally only take half their insulin doses just to afford the costly drug. As for Twitter, there are lawsuits coming. So many lawsuits.

  3. Is Dr Emslie by any chance related to ‘GE’ in this article from BMJ Best Practice?

    “GE has received research funds from BioMarin, Eli Lilly, Forest Laboratories, GlaxoSmithKline, and Somerset; has served as a consultant for Biobehavioral Diagnostic Company, Bristol-Myers Squibb, Eli Lilly, Forest Laboratories, GlaxoSmithKline, INC Research Inc., Lundbeck, Pfizer Inc., Seaside Therapeutics, Shire Pharmaceuticals, Valeant, Validus Pharmaceuticals, and Wyeth Ayerst; and has been on the speaker’s bureau for Forest Laboratories.”

    His association with Forest Laboratories is interesting as in September 2010, the company agreed to pay $313 million to resolve allegations of civil and criminal liability. One of the pharmaceutical-related charges was a misdemeanor charge of illegally promoting the Celexa and Lexapro for unapproved uses in treating pediatric depression.

  4. In Jungian psychology, there is to my mind a parallel with this 1910 coming of age novel of Dorothy and our current time. Back then it was opium that many people used to ease their emotional pains and torments. This is alluded to in the novel when Dorothy and her companions are trying to find their way back to the yellow brick road to enlightenment. The wicked witch of the west conjures up a poppy field which causes Dorothy to abandon her quest (symbolized by falling asleep). Today, opium has been replaced by SSRI’s for those suffering disunity with the world ( or the State of Kansas) in which they find themselves.

    I find it coincidently interesting too, from another angle, that the Wizard of Oz has been mentioned in this article.
    Something that has been going through my mind since I first heard Jordan Peterson explain that the hierarchy of lobsters is dependant on serotonin. [1]
    A lobster that loses a fight is a depressed crustacean. (I’m paraphrasing heavily for brevity). Yet, if you give him serotonin, he soon gets back into the fight for dominance over other lobsters.

    So say Dorothy had been a boy (say Derrick) and his aunt had been a widow, leaving Derrick without a male role model who set behavioural boundaries. Would Derrick’s archaeopsyche ego (represented by the Cowardly Lion who also posses the ‘Activator Temperament’) sudden, not only find courage (and its companion ‘anger’) if he found himself in a field of St. John Wort (taking literary licence here, as this herb is a SSRI) instead of poppies? And what if the Tin Woodsman without a heart (representing Derrick’s neopsyche ego) had been staved of loving care. After all, he was rusty, stiff and so unable to use his axe to chop problems down into manageable size let alone do it with loving care. And what if the Scarecrow (representing Derricks exteropsyche ego) was not competently clueless but had memorised mainly violent solutions to life’s many complex problems without any compensatory influences from a father figure.
    And what if Derrick did not have the benefit of guidance from Glinda (therapist) the good witch of the North?

    Would the field of St. John Wort have caused Derrick to turn away from his path and try to relieve his angst by taking out as many of the Munchkins (representing the common people) as he could in the style of a modern day mass shooter?

    [1] Lessons from Lobsters | Jordan Peterson

  5. Ah, Dr. Graham Emslie, the same guy who was reprimanded by the Texas Medical Board after it learned one of Emslie’s patients, an unnamed male, died by suicide whilst under his “care”.

    Emslie prescribed stimulant and sedative medications to the patient for several years without appropriate evaluation, monitoring, and medical record-keeping. The patient went on to kill himself. Emslie claimed he knew the patient who was the brother of an acquaintance of Emslie’s daughter.

    When asked for the 17-year medical records of the now-dead patient, Emslie told the Texas Medical Board the records could not be produced. Emslie claims he only kept “scant” records scribbled on a notepad. The board was also told that Emslie regularly prescribed benzodiazepines and amphetamines over the telephone without physically examining his patient. (remote prescribing)

    More here –

  6. Let them eat Prozac…

    Dr. John Virapen, Eli Lilly and Prozac

    Irish blogger Leonie Fennell has a fascinating post up regarding the SSRi Prozac [fluoxetine]

    Her post focuses on a recently released video where Dr. John Virapen, who worked in the pharmaceutical industry for over 35 years, opens the seedy door to the psychiatric and pharmaceutical industry.

    Leonie’s Blog

    Prozac, Eli-Lilly and bribing the Swedish government.

    Let them eat Prozac

    On the face of it, the investigation of possible hazards posed by SSRIs does not seem to have followed the conventional dynamics of science, where anomalies in the data are supposed to spur further investigation. In this case, debate has been closed down rather than opened up. Journals that might have been thought to be independent of pharmaceutical company influence have “managed” not to publish articles and the appropriate scientific forums have “managed” not to debate the issues.

    Is this evidence of undue pharmaceutical company influence?

    Is it evidence of the power of the current epidemiological paradigm in medicine that effectively only values one form of evidence – that stemming from Randomised Controlled Trials?

    Archive for Prozac (fluoxetine)

    SSRI Stories…

  7. Those drugs turned my family member into a zombie. Had a college degree, good job and family. Now can’t work or function in any way. No one takes responsibility. Profit is all they care about.

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