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]

Determining causality of problems

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.

Refusal to do a study for reported side effects

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.