Burn in Hell

In my last post, Psychotic doubt, we saw the most successful maneuver that has ever been devised for hiding dead bodies and silencing us when we are injured.

We saw a mechanism that acts like the authority of a psychoanalyst (when Freud was still in vogue), or an ecclesiastical authority (until recently), to silence dissent and cause someone who has been abused to doubt their sanity and blame themselves for something done to them.

This mechanism that allows companies, regulators, and academics to hide dead bodies by an appeal to evidence that in actual fact shows an increased risk of death on treatment is not just psychosis-inducing; it also has a Burn in Hell component to it.

This is how it happens.

Here is Ronald Krall being deposed in 2007. He is the head of Global Safety at GlaxoSmithkline.

Q:             Are you willing to tell the jury under oath that you are not aware of a single side effect that is caused by Paxil?

A:              I am prepared to say to the jury that I am not sufficiently familiar with all of the data for all of the adverse events to tell you that there is an adverse event that is caused by Paxil.[1]

Here is Ian Hudson being deposed in 2001, then head of Global Safety at GSK, later a member of the British regulatory apparatus, the MHRA:

Q.             Okay. So, your view is: It’s simply impossible for SmithKline Beecham to decide whether Paxil did or did not contribute to the homicidal or suicidal behavior of any one given individual; is that your testimony?

A.              We would certainly gather all the information, but on an individual case basis it would be impossible to decide whether paroxetine caused an event or not… It is impossible, on an individual case basis, from individual reports, to assign causality especially in a very complicated area such as this. That’s why, when we have issues, we review all the available data and make a determination, on the basis of all the available data, whether there is an issue or not.

Q.             Okay. Do you believe that it is possible that Paxil has caused any person, worldwide, to commit an act of homicide or suicide?

A:              I have seen no evidence to suggest that at all.[2]

If there is even a small possibility the problem could have been caused by chance, then it has been caused by chance.

Hudson and Krall are demonstrating the standard company approach to determining causality. In this case GSK had lots of reports of suicide, aggression, birth defects, or dependence. In many cases the doctor, or patient, or a company employee notes that the problem happened soon after the drug was started, cleared up when the drug was stopped, and reappeared when the drug was restarted. As a result in many cases a GSK employee has said the drug has caused the problem. Both men know this, but for Hudson and Krall there is still no evidence that their drug causes a problem — even when the dependence on Paxil (Seroxat) is universally recognized.

Why not?

For Hudson and Krall and regulators like Bob Temple or Ian Hudson (who is now a member of the British regulatory apparatus), if a clinical trial hasn’t confirmed a statistically significant link between treatment and an adverse event, then the adverse event hasn’t been shown to be caused by the treatment. If there is even a small possibility the problem could have been caused by chance, then it has been caused by chance.

The refusal to do a study while events pour in that meet all the standard criteria for causality is the real Burn in Hell moment.

While the company avoids doing a sufficiently large clinical trial to test out the link, there will never be any evidence that the drug causes a problem. The refusal to do a study while events pour into the company that meet all the standard criteria for causality is the real Burn in Hell moment. Thousands of reports can pour in, each making a compelling case that the drug has caused the problem, but a Hudson or Krall or Temple will feel comfortable saying under oath they have seen no scientific evidence that the drug causes a problem.

Unbelievable though it will seem, lawyers for pharmaceutical companies have recently advised that company coding staff, when faced with convincing evidence a drug has caused a problem (that is, when a problem appears after the drug is started and clears when it is stopped and reappears when it is restarted), should not code this as caused by the drug as they have been doing.

Catch-22

When patients report problems to the company and ask if there is any evidence the drug might be contributing, they are commonly referred back to the doctor who has prescribed the drug — who will be faced with the scientific literature, which will say there is no evidence that the drug has caused the problem.

When patients ask for evidence on a drug, they are referred back to their doctor — who will be faced with the literature, which will say there is no evidence that the drug has caused the problem.

Here is an unknown woman in 2001 contacting GSK. She terminated her first pregnancy, after radiology showed the baby had a serious heart defect (truncus arteriosus) and would likely not survive.

The response from GSK is as follows:

‘We are attaching a copy of our current product information for Paxil… Please review the section on USE DURING PREGNANCY.Further questions about your treatment should be directed to the physician, pharmacist or healthcare provider who has the most complete information about your medical condition. Because patient care is individualized, we encourage patients to direct questions about their medical condition and treatment to their physician. We believe because you physician knows your medical history, he or she is best suited to answer your questions. Our Drug Information department is available to answer any questions your physician or pharmacist may have about our products.

She responds:

‘This response is in regards to an email I sent you preciously [sic].  I was asking to see if you have any, or were in the process of any clinical trials for women who are currently on Paxil and pregnant.  I wanted to find out any information on women who were on Paxil during pregnancy and if they were able to have healthy babies.  I am in no way insinuating your product did this to my child.  I love the product and don’t think that I could have gotten through my panic attacks without the wonderful help of this miracle drug.  I just want to get pregnant again soon.  I do not want to put my unborn child through anything that would hurt him/her.  Please, if you do not have information, where is this information held?  Does anyone do studies like this?  Please any information that you may give me would be great’.

 

The birth defects this woman’s child had suffered were coded as almost certainly linked to Paxil but neither she nor her doctor were told this.

In internal company documents, the birth defects this woman’s child had suffered were coded as almost certainly linked to Paxil but neither she nor her doctor were told this.

This seems eerily reminiscent of appeals by Catholic cardinals to Canon Law (an idiosyncratic take on legal significance) when asked to account for their handling of abuse cases in the Church.

[1] Deposition of R Krall, Head of Global Safety GlaxoSmithKline, 2007.

[2] Deposition of Ian Hudson in Tobin vs SmithKline Beecham, December 15th 2000, 30–33.


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Comments

  1. Great post.

    What I find even more strange is that, in the case of Paxil, GlaxoSmithKline admit there is a withdrawal problem, a suicide link and a birth defect issue. They do this on the labelling…yet it has been done ‘after the event’ – in other words, they chose to add these warnings are items of disclosure were revealed in US courts.

    Whilst admitting their product causes the problems they then defend every single action brought against them for the very same problems they admit can occur when taking Paxil?

    It’s almost as if they feel they have vindicated themselves by confessing on a label.

    It’s similar to the murderer entering a confessional box, confessing his sins and saying 10 hail Mary’s to feel better about himself.

    We also have the money issue. Glaxo have it in abundance and they know that any suit brought against them all boils down to money.

    They hold life in the palm of their hands when distributing the drug and also when defending the drug.

    I think criminal charges are needed because their actions are criminal. Custodial sentences are also needed, a punishment that fits the crime, if you will.

  2. I don’t like drawing attention to myself, but, if I am in my doctor’s surgery 38 times howling with Seroxat withdrawal and then end up trying to hang myself eight weeks off Seroxat and the gp is telling me that ‘it is all my fault’ this puts me in the most diabolical mind set that it is possible to have. There is nowhere to go with it. I have nearly murdered myself because of a prescription drug and the sheer mental frustration of trying to prove my innocence when nobody wll listen is heinous and cripplingly frustrating.
    Criminal charges are needed, potentially a manslaughter charge and the only way I am going to get over this nightmare is to keep challenging the guilty verdict directed at me.

    • I could not agree more, having seen the effects of these drugs on both my two daughters and my elderly father. The drugs companies need to take responsibiliity and help people withdraw from these terrible drugs and there is nowhere to safely come off them.

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