Pharmacosis

There is a new Contagion out there. Kate Winslet beware.

This new epidemic has rapidly become at least the fourth leading cause of death and disability – it may even be the greatest cause of death because all we have counted so far are deaths in hospital where such deaths can be spotted. Where every other disease comes with a guideline for its management, this has none. Where in the case of every other disease we can appeal to an Evidence Base in order to make recommendations about treatment, in this case the Evidence Base is central to the transmission of the ‘virus’. Where every other disease has a name, this has none.

It used to be called iatrogenic disorder but this is a name that suits pharmaceutical companies. It blames doctors, when the greater part of the problem now stems from the information or lack of information doctors and the rest of us are being fed. Doctors are as much in the dark as the rest of us about what it is that we don’t know. This is why Pharmacosis, which suggests a loss of insight and a lack of access to reality, seems the right name.

The first manifestations of Pharmacosis were the limbless babies born in 1961 to mothers taking the hypnotic thalidomide. The latest manifestations are heart attacks caused by Merck’s Vioxx or GlaxoSmithKline’s Avandia, suicide on Wyeth’s Pristiq or Bristol-Myers’ Abilify, or diabetes from Lipitor or Zyprexa. The vectors that lead to the deaths these drugs cause lie in the 1962 amendments to the Food and Drugs Act put in place after thalidomide. These amendments forced companies to make drugs for diseases and to show drugs worked using randomized controlled trials (RCTs). Ironically the only drug that had been RCT tested and proven safe and effective before marketing in 1962 was thalidomide.

Just as with water-borne infections, where the contagion lies in something vital to life, Pharmacosis comes from the life-saving drugs we need. Or rather it comes from data-suppression and the scientific publications polished by company ghostwriters to made medicines look safe for consumption, but in fact which transform medicines into something more dangerous than chemicals. Medicines are chemicals that come with information about their safe use. Chemicals everyone knows are potentially poisonous and if used at all need to be used with care. The problem now is we are using an increasing amount of medicines stripped of their appropriate information with an abandon we would never adopt if asked to risk taking chemicals. When using drugs like this, we take the risk of poisoning by chemicals and add to that the risk of poisoning by misinformation. It is this spread by poisonous information that makes pharmacosis literally contagious and a new kind of illness.

Even the best doctors who try to avoid commercial contamination end up posing a risk to the rest of us. Companies understand them better than they understand themselves and provide suitably doctored articles, embodied in guidelines, to leave no rational option but to prescribe more of the latest drugs. Marketing diseases puts a moral obligation on doctors to treat. Marketing measuring tools produces figures for which a drug appears the only answer. Those few doctors who try to track down the source of the infection, like Kate Winslett in the movie Contagion, are ostracized and die early. Who can stand up against company sponsored evidence and survive?

There has been some push back. Companies have been forced to post their clinical trials in registers but we cannot get trial datasets supposedly because of patient confidentiality. While access to all the data would leave us better placed to assess whether the latest panaceas have the benefits claimed for them, we would still have a problem because of the 1962 amendments to the Food & Drugs Act which encouraged companies to develop drugs for diseases. Trials done in an illness are the most effective way to hide a drug’s problems. If Zoloft causes anxiety and suicidality, so does depression. If Zocor causes memory loss and muscle pain, so do cardiovascular conditions. The illness hides the problems in clinical trials and in clinical practice it is all too easy to say “it’s the disease not the drug” (see The spin that no data can overcome).

The widespread references to drug trials are in fact to condition trials, where drugs are tried on diseases. Companies also do drug trials – phase one studies done in healthy volunteers. These trials that uniquely reveal the risks of drugs are never registered. No data is made available even though there are no confidentiality issues.

In a never-published study of 12 volunteers in Leeds in 1983, 9 years before the antidepressant Zoloft was marketed, and 21 years before FDA required it to carry suicide warnings, after terminating a study early because all women on Zoloft had become anxious or apprehensive, noting thoughts of aggression and related difficulties, Pfizer concluded that Zoloft had caused these changes – as had other SSRIs in phase one studies (see Mystery in Leeds). The costs of non-publication of this trial are incalculable. We pay doubly, both in the high costs of the latest drugs and an even greater amount to treat the injuries these have caused.

Faced with plagues in the past we have taken evasive maneuvers but how do we escape when the source of infection and treatment is the same – prescription-only medications? Unlike pilots whose safety coincides with ours absolutely, our doctor’s does not. On average she reports around 1% of treatment related deaths. Unlike the near misses reported by pilots, which lead to changes in the system, a doctor’s reports are dismissed by regulators as anecdotes. How do we escape when the virus ensures medical journals and academic societies side with companies rather than doctors?

How do we escape when the Supreme Court makes companies producing generic versions of contagious drugs legally immune from actions for injury? Ten years ago in Let Them Eat Prozac I made a prediction that the makers of generic prescription drugs would be immune to lawsuits from people killed or gravely injured by medicines – this came to pass a little over two months ago.

There are solutions. A registry for phase 1 trials and mandatory access to their data would help. Another is to encourage patient reporting of adverse events, if doctors won’t. If none of these solutions work, there is a quirk built into the virus that may yet help us – it triggers medical groups to commit professional suicide. On several occasions recently the American Psychiatric and Medical Associations have ridden to the defence of drugs, claiming they work well and are safe. Do we need experts to handle wonderful risk free miracles when there are cheaper prescribers than doctors? If doctors wake up to the risk to themselves of risk-free drugs, who knows in helping themselves they might help the rest of us.

Readers can also view my blog posts (see Pharmacosis) and find further information at www.davidhealy.org or visit my Facebook page.

5 COMMENTS

  1. Dr. Healy, thank you! I’m presently making my way through “Pharmageddon,” and find myself grimly nodding agreement. In an earlier attempt to conduct my own investigation into the socially-transmitted psychopathology you call pharmacosis, I had called up the US Food and Drug Administration. This was to be my two-year follow-up on a Medwatch report I had submitted to their attention.

    Unsurprisingly, there had been no interim reply from their agency. Unsurprisingly, my report was not to be found in the few awkward attempts to recall keywords and phrases for a search of the records: “quetiapine,” “withdrawal emergent,” “first episode psychosis,” “resolved on re-introduction.” I had lost my tracking #, and so had to come to a point quickly.

    Surprisingly the pharmacologist on the other end of the line was herself surprised to learn that quetiapine (trade name Seroquel) and other AAPs are often prescribed for off-label uses such as insomnia, for which indication she seemed sufficiently alarmed. I made sure to repeat “no prior history.”

    “…and the potential clinical implications–” I pressed.
    “Yes, yes. I’m aware.”

    Her advice was startling in that it seemed both impartial and fairly reasonable. Though perhaps not totally satisfactory, it points a way to public action. Medwatch reporting, she said, was the way to wake the old regulatory watchdog, so-to-speak, though it’s admittedly hard-of-hearing. It is absolutely valid, she insisted, to initiate one as a patient, as I had, or as a doctor, regardless of hard evidence of a pharmacogenic fallout. Mere suspicion that a drug had caused a problem was sufficient to write and submit a Medwatch report.

    I am as skeptical as I think reasonably possible of the FDA’s ability and inclination to resolve such a massive systemic problem. Their public conflict of interest statement is nothing short of ridiculous. It effectively says “it happens here because it must… dearth in the market of qualified professionals, yknow.” (The conclusion and its justification both simply false.) However, it might be the case that they would have no choice but to respond to a massive influx of adverse event reports.

    Being a fair-minded sort, I wanted to post a general appeal in this public forum. If the FDA or its representatives complain as this one had, that they are powerless with insufficient reporting, then I suppose I’m game. If, for no other reason, to figure out if our watchdog is merely hard-of-hearing or also lacks teeth. One more time for US-based readers: “Medwatch.” (And erhmm. Don’t lose your tracking #s like I did…)

    Deep gratitude to Dr. Healy, Robert Whitaker, and all the folks working to sort out this tangle.

  2. Continue to do your good work and eventually, I hope, what you are saying will filter through to your colleagues and more and more will end up on your side. It all is pure common sense, as far as I am concerned. By the way, zyprexa doesn’t only give you diabetes. It can do what antidepressants do; it can drive you to suicide because of akathisia and the way it tampers with your sleep paterns. I have first hand experience of this.

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