GSK and the MHRA: Conflict of Interest?


http://fiddaman.blogspot.ie/2013/09/former-glaxo-safety-officer-becomes.html?utm_source=Paxil+News&utm_medium=twitter

Thursday, September 26, 2013

Former Glaxo Safety Officer Becomes Head of MHRA

Ex Glaxo Employee Ian Hudson. Now in charge of  the safety and well-being of the British public.

Former Glaxo [then SmithKline Beecham] World Safety Officer Director Dr Ian Hudson has took over the role of Chief Executive at the MHRA.

Hudson, who after leaving Glaxo in 2001, became the MHRA’s Licensing Director, responsible for overseeing the benefits and risks of drugs before they hit the market.

It is unknown why Former MHRA chief, Kent Woods, whom I’ve had much correspondence with over the years, retired.

Hudson, whilst working for GSK, was a witness for the defence [GSK] during the Tobin v SmithKline Beecham Pharmaceuticals. Donald Schell was put on Paxil [Seroxat]. Forty-eight hours later he put three bullets from two different guns through his wife’s head, as well as through his daughter’s head then through his granddaughter’s head before shooting himself through the head.

Hudson was appointed GSK’s World Safety Officer in 1999. His department was responsible for adverse events that were sent in by health professionals and members of the public.

Whilst under oath Hudson told Andy Vickery, attorney for Tobin, about his role in reviewing the link between Paxil and aggression.

“We reviewed the topic of aggression last year. At that time we said that we would keep aggression under review.  In addition, there was considerable noise in the media earlier this year about Fluoxetine.  So having said that we would keep this topic under review, we rereviewed this topic this year and it was also prompted by considerable concern being expressed, considerable noise being expressed in the media.  There were a series of articles in the “Guardian”. [British Newspaper]

Hudson was then asked by Vickery what he intended to do with the report once it was finalised, adding; Do you intend to submit it to any governmental agency?

Hudson replied:

“If a Government agency requests information on aggression and Paroxetine, we would, but we do not intend to proactively send it to them at this stage.  This was an internal review. We do many internal reviews on many topics.”

This doesn’t really install confidence in informed consent. If Hudson was back then stating that his findings would not be reported to the drug regulator then one can only assume that he still holds the belief that pharmaceutical companies are entitled to hold on to information that could endanger the public.

Later in the deposition Andy Vickery put the following to Ian Hudson:

“Dr. Hudson, are you aware of the body of literature concerning the relationship between serotonin and suicide?”

Hudson replied with…

“In general.  I’ve seen some summary information on that.  I’ve not reviewed that information in detail.  I would, again, delegate that to people within my department and also other psychiatrists within the company who are more closely involved in Paroxetine then I am, people such as Dr. Wheadon.”

Pushing Hudson for an answer Vickery then asked…

“Let me just ask you this:  Do you know whether or not there is any association between levels of serotonin or the serotonin metabolite 5-HIAA and suicidal behavior?”

Hudson answered…

Yes, I believe there is a correlation. I have seen in the literature summary
information that implies that there is a correlation between low levels of serotonin or 5-HIAA in patients’ suicidal activity.

Vickery later asked Hudson:

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

Hudson answered:

“I have seen no evidence to suggest that at all.”

Hudson’s deposition can be viewed in full here.

Now Ian Hudson is the head honcho at the MHRA. If you take the time to read the complete deposition of Hudson you will see how he [whether under instruction or not] clearly deflects the blame of suicide and aggression onto other ‘factors’ rather than implicating Paxil.

And now this guy is in charge of regulating medicines in the UK. Do you think his presence will alter the MHRA’s stance on the safety and efficacy of SSRi type medications?

Well, I have seen no evidence to suggest that at all.

Bob Fiddaman

 

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One comment

  1. HarryK

    I also have my concerns about someone with such close links to Glaxo being in charge at MHRA. It is the MHRA for example that have set the ball rolling with regards a potential ban on electronic cigarettes. Obviously Glaxo profit from products that will lose sales due to ecigs, namely nicorette, patches gums etc. It was reported in The Times, that the MHRA used Glaxo scientists to draw up the impact statement on the licensing of ecigs for the government. The impact statement was grossly inaccurate favoruing the ban of ecigs to make way for the continued profit making of Glaxo from thei ineffective nicotine patches and gums.

    Ian Hudsons response in a letter to the Times, to the use of those with vested interests in this matter, was that it was difficult to find people to do the impact statement who didnt have vested interests. Nonsense of course, there are many in industry and academia who could have been used. But no Ian Hudson said it was too difficult a job to go outside his inner Glaxo circle to get some rational input.

    It is indeed not right that he should be in such a position and it looks to me like Glaxo are now actually pulling the strings of MHRA and subsequently our government

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