Pharmacosis

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

Disease with no name

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.

Fifty years incubating

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.

the contagion lies in something vital to life

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.

Who can stand up to the virus and survive?

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.

How do we escape when the infection and treatment are one?

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.

Wake the doctor.. 

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.


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You and your meds. Give the real story. Get the real story.

Pharmageddon

Pharmaceutical companies have hijacked healthcare in America, and the results are life-threatening.

 

Dr. David Healy documents a riveting and terrifying story that affects us all.

 

University of California Press (2012)

 

Available on Amazon.com

 

Comments

  1. dearieme says:

    You’ve weakened your argument by using “chemical ” to mean – well, I’m not sure exactly what you mean, but it’s clearly being used as a boo-word. It invites crooks and dolts to advocate using “natural remedies” – look, no chemicals.

    Must do better.

  2. If I ever end up in a courtroom suggesting that ssris’ can cause suicide/aggression/violence then I will bring up the following:

    Corporate Manslaughter

    The Corporate Manslaughter and Corporate Homicide Act 2007 is a landmark in law. For the first time, companies and organisation can be found guilty of corporate manslaughter as a result of serious management failures resulting in a gross breach of duty of care.

    The Act, clarifies the criminal liabilities of companies, including large organisations, where serious failures in the management of health and safety result in a fatality.

    I am quite aware that all ssris’ can leave ‘an individual stranded’ in a world of suicide and violence and aggression, but if we look at Seroxat for a moment.

    If GSK pay out billions in compensation in the US to Paxil, and then make a corporate decision to defy this hiccup and continue to market the product worldwide then this corporate decision is beyond doubt Corporate Manslaughter.

    The decision was made and corporate greed, notwithstanding, litigant success in the US, kept them on the quest to corner their particular market.

    Seroxat prescriptions have dropped so low now, that GSK have for two reasons dropped their interest.
    They know their product was faulty.
    They have dabbled in ssris and got their fingers burnt.

    The decision by GSK to continue to market their drug worldwide having lost the battle in the US, was a death sentence to some of us which trickled down through the countries, through the towns, to a small and remote village in Argyll. Scotland where I unfortunately happened to be.

    We have to leave the doctors out of the equasion because they deal with isolated incidents which they are not equipped to deal with. If, they had many patients who were aggressive, violent, suicidal they would get it. But sadly, they don’t. Each and every isolated incident is not enough for anyone to see the light.

    Let’s get back to the ‘severe adverse reaction to prescription drugs’ and get on with the immense task of accusing the manufacturers.

  3. Johanna says:

    Prescription drugs are indeed chemicals, and it is good to be reminded of that. With regard to psychotropic medications, I would like to see a return to the use of the term “chemotherapy” of mental disorders – which some physicians used to use earlier in the age of psychopharmacology.

    Would I take “chemotherapy” if I had a life-threatening or totally life-disrupting illness? You bet. But I would also give a lot more thought to balancing the benefits against the risks. I would be on the alert for serious side-effects, and would not allow my doctor to just shrug them off. And it would be a lot harder to persuade me that I ought to stay on “chemotherapy” for the rest of my life, “like a diabetic taking insulin.” Currently, given the marketing blitz that has occurred for antidepressants, too many people think they are serotonin supplements of some sort, and thus harmless. You even hear people propose, lightmindedly, that they be put in the water supply — along with Lipitor to give us all healthy hearts (not). No wonder Abilify and some of the other antipsychotics have been trying to rebrand themselves as “antidepressants.”

  4. dearieme says:

    “Prescription drugs are indeed chemicals”: all material entities above the nuclear level are chemicals. It’s a dangerous choice of word for the reason I gave above.

  5. Your objection to the use of the word chemicals is simply an attempt to avoid the argument, because you know deep down that Dr Healy’s position is solid and backed by evidence. I have been trying to pin down the fallacy you are using…any thoughts?

    It seems that the Health & Safety Executive and European Health & Safety law makers are guilty of a similar use of the word chemical…apparently inviting crooks and dolts to advocate ‘natural products’ also?

    I am fairly sure the HSE Chemicals Guidelines or European Health & Safety laws such as CHIP or REACH etc, aren’t applicable to everything that a professional chemist would label as a chemical. A little bit of good sense is needed when dealing with the English language.

    I doubt you need to write a method statement before handling every material entity above the nuclear level.

  6. Anti-depressant is a term conjured up by pharma, it has no merit, it has no real significance, until fatalities occur.
    Well, fatalities have occurred and as I have said before, it is not good enough that perhaps a one chance in ten thousand, that someone will have an ‘adverse reaction to these chemicals’ and perhaps be aggressive, suicidal and violent is not enough to stop them being prescribed.

    We all see the point, these pills give millions a calmish, zombieish sort of life, not the life perhaps that they should be having, but, hey, if it keeps them up and on, then all to the good.

    But, every so often, these chemicals make people enact bloodcurdling scenarios.
    That is the point.

  7. dearieme says:

    “Your objection to the use of the word chemicals is simply an attempt to avoid the argument,…”: you must have a reading comprehesion problem. My objection, as I said, was that he had weakened his argument.

  8. Any chance that you could show me the data that it is more often that not?
    If I had that important piece of data then I could, without embarrassment, do something about the surgery who left me hanging by a thread.

    Actually, is that the right answer, because ‘more often that not’ implies that most people have aggressive, suicidal, dangerous tendencies off, on, off, on ssris. Millions of people take ssris all over the world, some keep taking them for life, some for a few years, some for a short term and the majority seem publicly content aah, is that it? the majority are content, but unaware that by the grace of good doctoring, their life is in the balance?

    I would be extremely grateful for some edifying and illuminating facts and then, perhaps, I will understand where it is I am going?
    Thanks.

    • Read Cri de Coeur and Once is Never – the data for suicidal acts shows an doubling on drug compared to off – the data for aggressive acts is similarly double

  9. I wonder whether or not various medical associations would rise up as one if members really knew the true impact of the “Learned Intermediary” doctrine that takes informed consent a step further or if more patients would sue under this principle. Learned Intermediary is a defense doctrine used in the legal system of the United States and Canada. It states that a manufacturer of a product has fulfilled his duty of care when he provides all of the necessary information to a “learned intermediary”, usually a physician, who then interacts with the consumer of a product. It is primarily used by pharmaceutical and medical device manufacturers in defense of personal injury suits. In a majority of states, the courts have accepted this as a liability shield for pharmaceutical companies. The Learned Intermediary doctrine was adopted by the Supreme Court of Canada in Hollis v Dow Corning Corp., [1995] 4 S.C.R. 634 December 21, 1995. A majority court decision stated that the principles underlying the doctrine of “informed consent” apply to the relationship between manufacturers of medical products and consumers. In this case, although the number of adverse events was statistically small over the relevant period and the cause of these events was unknown, Dow had an obligation to take into account the seriousness of the risk posed to each user consumer. Indeed, it is precisely because the events were “unexplained” that Dow should have been concerned. Since the manufacturer is in the best position to know the risks attendant upon the use of its product and is also in the best position to ensure that the product is safe for normal use, the primary duty to give a clear, complete, and current warning must fall on its shoulders. A manufacturer, given the greater likelihood to overvalue a product and under-emphasize its risk, should from a policy perspective be held to a strict standard of warning consumers of dangerous side effects to these products The “learned intermediary” rule is applicable in the context of this case. Dow’s warning to the doctor here was inadequate. The court ordered a new trial because it was not satisfied that Dow had provided adequate information. If, however, the court had decided that Dow had provided all requisite information, the onus would have fallen on the doctor to advise the patient of all possible risks and pay the price of the damages caused. The use of the term “learned intermediary” was first used in the Eighth Circuit decision of Sterling Drug v. Cornish (370 F.2d 82, 85), in 1966, and has now become the prevailing doctrine in the majority of jurisdictions in the United States. Justice Murphy in Robinson stated; “Pharmaceutical companies then, who must warn ultimate purchasers of dangers inherent in patent drugs sold over the counter, in selling prescription drugs are required to warn only the prescribing physician, who hats as a learned intermediary between manufacturer and consumer.” Recently, this doctrine has been call into question because the courts feel it is complicated by direct to consumer advertising, which pushes prescription drugs on people but still the doctor carries the burden of supplying the patient with information on all devices and medications, negative or positive. This places a huge responsibility on the most punctilious of physicians if the manufacturer has not provided all required information.

  10. I understand this, sadly we do not have ‘learned intermediary’ defence in the UK. Learned intermediary is a faux pas in this country because clinicians are not learned in any way, shape or form about severe abrupt discontinuation symptoms from anti-depressants.

    But, we do have the patient information leaflets, in the case of Paroxetine, from 1996 until the present.

    These leaflets changed considerably. My leaflet circa 1996 in my packet of pills gave little information as to side-effects which could seriously have affected my clinician’s judgement.

    Many suicides peaked around 2002 from Paroxetine.

    Latterly, the patient information leaflet spells out all the side-effects which might occur and subsequently suicides have gone down. Not only that, Paroxetine prescriptions have dropped considerably.

    Paroxetine won’t be around much longer; Glaxo have more or less pulled the plug on this drug in the UK.

    My point is that circa 1999, when all hell broke loose and Paroxetine caused lives to be lost, the doctors had the ‘get out of jail free’ card because no-where in leaflets did it give cause for concern that a patient might be triggered into suicide by being prescribed this drug.
    The leaflet today describes mania, psychosis, emotional lability, etc. and says ‘if you experience any of these side-effects’, see your doctor.

    Would a doctor today recognise the same symptoms that occurred in 1999, or would that same doctor, in 2012, still refuse to accept that these drugs, despite the pil leaflet spelling it out loudly and clearly, in a way that is reasonably precise and unambiguous, still refuse to accept that Paroxetine can cause suicide?

    If Seroxat Two had come along, following on from Seroxat One, then Glaxo would have been naive and stupid. But naive and stupid they are not and I would like to pass ‘go’ and collect my £200.

    • David_Healy says:

      The learned intermediary doctrine applies in the same way in the UK. If doctors aren’t informed of the risks, they seem to be putting their heads in a noose

  11. My lawyer acquaintances tell me that the noose is tightening as more and more personal injury cases appear in Canada and the US, directed against physicians not, as was previously common, against the manufacturers. These cases seem to hinge not only on lack of informed consent but, as a result, medical battery.

  12. Medical battery is something I am completely aware of and personal injury.

    I would just like to run something past you.

    My gp was advised by the psychiatrist that when I was to come off Paroxetine, I should be given Fluoxetine to counter any abrupt discontinuation symptoms.

    She did not do this and eight weeks down the line the inevitable tragedy occurred.

    She then made up a fabrication in a referral saying she did give me Fluoxetine obviously not wanting my near death on her conscience and knowing she had made a huge error.

    I recently went to a large law firm in Glasgow to get some justice as to her obvious and proven fabrication; this was clearly said in her referral, and despite a legal gp going through my medical records, the end result was to say there was no evidence to support my case that Paroxetine can cause loss of life and despite, her fabrication, they could not support my case.

    That was pretty devastating.
    I sent my formal complaint to the surgery about her fabrication and the chief doc said he was a very busy man and didn’t have time to read it.
    The chief psychiatrist said ‘it was not normal procedure to check on medication prescribed by a gp’.
    This would be laughable, if it wasn’t so serious.

    So, a gp commits undeniable criminal intentions to deceive and I am left with not a leg to stand on.
    In the normal course of events of a gp mis-managing medication, I would have a case but because it is an ssri, I have no recourse.

    Tempted as I am to send this whole catastrophic case of medical errors to the Medical Health Council, I know that they will come back to me and say there is not enough evidence to support my case.

    This case of mine could be massive; corruption, lies, deceit, almost culpable homicide, but it seems that I do not have a prayer to expose it…………………………

    • David_Healy says:

      Annie
      Without all the details of your case, little can be said, except this – there is clear evidence that withdrawal from paroxetine can cause loss of life.
      One of the most famous medical negligence cases ever made worse by legal mishandling happened in Glasgow – you can read about it in The Authobiography of Elizabeth Storie (1859).

  13. Thank you for your comment David. This is a terrible thing to live with and made worse because of the disturbing way in which doctors and psychiatrist can get away with murder.

    I won’t bang on anymore; I have been through such dismal and disappointing behaviour from people who are supposed to save lives not push them into a suicidal situation from prescription drugs because, actually, they are not very intelligent.

    I have had to raise my head above this condemnation of my character, in fact, assassination of my character, and I can only thank god that I have a high sense of right and wrong which enables me to do this. They could have beaten me into the ground, but they didn’t.

    My little girl is not going to spend the rest of her life wondering why her mother was taken to accident and emergency in an ambulance having nearly taken her life. Her ‘brilliant education’ was ceased, our relationship was put in severe jeopardy, and nothing makes a woman so strong than damage done to their children which is why I admire Maria, and Neil Carlin so much.
    You do it in the most powerful way you can when your beloved offspring have been harmed and are also, perhaps, not here any more.

    So, I have said it all on your blog and can say no more. I am sure we will meet one day when this medical fiasco reaches it peak. But, in the meantime, thanks for the recommendation of Elizabeth Stone which I will certainly read.

    I am quite looking forward to writing my own story, when I am old and grey and when this whole medical mishmap is brought to it’s conclusion.
    Thanks.

  14. Personal injury through malpractice is one of the most difficult things to battle. One of the problems is that the lawyers know next to nothing about the medical issues and resort to common law and tort law to discourage what they perceive as being a potential loss and not looking good on their CVs. Whenever I have testified as an expert witness, I insist on having at least two hours first with the lawyers to teach them the real issues, what the opposition will claim, how they should come back – in a word, run the whole case through. I do empathize with you because there are few things more devastating than to be told that you have no case other than to be told that you do have a case but the opposition will keep you going until you run out of money because the malpractice insurers have millions to spend. If you have the strength, I hope that you succeed in finding a way to obtain justice.

  15. Thanks.
    When I arrived at the lawyers offices and told them my story and evidence they were horrified and I spent four months with Scottish legal aid and a legal gp going through my medical records.

    Normal smart people understood but once the gp became involved it was all thrown out with the bathwater.

    I have the strength and I am methodically, carefully and clearly putting it all together. I am producing a biopic, a spellbounding case of lies and deceipt, ignorance and stupidity and I cannot wait for the day that ‘my day will come’.

    You are most laudable with your comments and please continue.

  16. This is probably a very naive question but what made a group of lawyers believe that a GP was an expert in either psychiatry or psychopharmacology? We have a number of firms, composed mainly of retired GPs , who set themselves up to provide consultation to lawyers as to whether or not they are likely to win a malpractice suit. At various times, I have been approached to join such firms and have always refused because their approach is to advise against taking the case – just in case it’s lost which wouldn’t look very good on their PR and- after all, they get the same huge fee anyway, don’t they? I wonder if you may have fallen victim to something similar.

  17. I’m afraid it’s back to the thorny old problem.
    The legal gp had gone through my medical records with a fine toothcomb. It was a painstaking report over many, many pages.

    Most of the report was cringeworthy dissecting my life prior to 1988, when Gaminil was the subject in question and which heralded then, the beginning of the perversion of what was happening to me.
    My arguement fell on deaf ears because she almost skipped over the fiasco with Paroxetine saying ‘the first withdrawal did not go so well’.
    That was so crass, I was stunned.
    The summing up by the lawyer, who was completely behind me, was to say there was not enough evidence to suppose Paroxetine caused loss of life.
    This is the dilemma and I know and you know and David has told me Paroxetine doubles the risk, but until the case of Paroxetine is proven in a court of law, I am fighting a losing battle.

    Chicken and egg for me. If it is legally proven that Paroxetine causes loss of life then and only then, will I have a case regarding the miscreance of the gp.
    I think now, that I was getting ahead of myself trying to take the surgery to account at this time as the brick wall of denial is prevalent.
    One is guilty until proven innocent and there is nothing more important to the innocent than proving their innocence.
    Thanks for the comment which is not naive at all; I guess they were just not brave enough to stand by their own principles and the final decision has to be down to the legal gp, quite why, is anybody’s’ guess.
    I will say this, when the gp lies about giving me Fluoxetine and her boss telephones me at home from his other practice in Canada and threatens me that he is too busy to read my allegation, it is not rocket science to see that I have been ‘stiched up’ and that is so appalling, given the circumstances, which is why I went to the lawyer in the first place.
    This was bad lawyering and for me to be beholden to this legal gp is the route at the moment.

    • David_Healy says:

      Paroxetine has been shown in a court of law to cause loss of life. It also comes with a black box warning in the US that it may trigger suicide

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  1. […] on these also. The evidence base comes back to bite us in the case of  treatment induced death – Pharmacosis – which has become at least the fourth leading cause of death. Some drug must be responsible for […]

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