FDA Avandia safety review – a done deal…?

Six doctors with financial ties to the pharmaceutical industry, including stock holdings or speaking fees, will be among members of a U.S. advisory panel on the use of a GlaxoSmithKline Plc diabetes medicine linked to heart risks.

The doctors will discuss the safety of the drug, Avandia, and similar treatments at a July 30 meeting convened by the Food and Drug Administration. As many as four of the six doctors with conflicts may vote on recommendations to the FDA, according to financial disclosure documents released by the agency. The agency wouldn’t say how many members the committee will have.

The FDA was criticized by lawmakers for allowing conflicts of interest among members of an advisory panel in 2005 that concluded benefits outweighed risks for pain drugs, including Merck’s Vioxx, which already had been withdrawn, and Pfizer Inc.’s Celebrex and Bextra. Ten members of that 32-person panel had financial ties to companies whose products were examined. Without their votes, the panel recommendations would have been reversed for Vioxx and Bextra.

Some members of the panel on Avandia own stocks through mutual funds, collect speaking fees or advise drugmakers that compete against companies whose products are to be discussed at the meeting. In addition to Avandia, the panel is expected to discuss similar medications, including Takeda Pharmaceutical Co.’s Actos.

The FDA’s documents for Thomas Pickering, a professor at Columbia University Medical Center in New York, said he was paid less than $10,001 a year for serving on a drugmaker’s advisory board and had stocks in drug companies.

Pickering, 67, who is a voting member of the panel, said in an interview that he served earlier this year on an advisory board to Bristol-Myers Squibb Co., a New York-based drugmaker, and holds mutual funds that invest in pharmaceutical companies. The financial ties won’t affect his recommendations, Pickering said.

Another voting member, David S. Schade, a professor at the University of New Mexico School of Medicine in Albuquerque, received less than $10,001 a year as a member of a speaker’s bureau for a drugmaker whose products compete with those to be discussed at the panel meeting, according to the FDA. He also received less than $10,001 a year as a consultant to a pharmaceutical company on an unrelated product. The names of the companies were expunged on the documents made public. Schade didn’t return a phone call.

Morris Schambelan, a professor of medicine at the University of California, San Francisco, received less than $10,001 a year as a member of a drugmaker’s “complications committee” that focuses on side effects of antiviral medications, according to the FDA. Schambelan, a voting member, was out of the country and didn’t return phone calls.

John R. Teerlink, another Avandia panel member, holds stock in a health-sector mutual fund, according to the FDA. Teerlink, director of the heart-failure clinic at the San Francisco Veterans Affairs Medical Center, also received $10,001 to $50,000 a year as a study reviewer for a drugmaker, which he identified as Bristol-Myers. The FDA paperwork doesn’t make clear whether Teerlink will vote.

Read the whole Bloomberg article here.

2 Responses to “FDA Avandia safety review – a done deal…?”

  1. truthman30 Says:

    Without independent regulatory bodies ( seperate from industry conflicts of interest) , drug regulation will remain corrupt , unethical and untrustworthy…

    The MHRA is no different than the FDA …

    http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=83

    These are the known members of the MHRA’s executive board who have previously worked for Glaxosmithkilne…

    Alison Davis took up the post of Director of the Information Management Division of the MHRA in January 2006. She graduated in chemistry and initially worked as a pharmaceutical research chemist before moving into the IT field in 1986. Since then, Alison has held a variety of IT posts with Glaxo, DuPont and DuPont Pharmaceuticals. For the past four years she has been based in Paris, as Director of IM for the Europe, Middle East and Africa region of Bristol-Myers Squibb’s Worldwide Medicines Division.

    Gerald Heddell took up the post as Director of the Inspection & Standards (I&S) Division on 4 January 2005.
    Gerald is a microbiologist who is a Chartered Biologist and a member of the Institute of Biology and the Royal Society of Chemistry. Since leaving the NHS in 1978, he has worked in a succession of progressively senior roles in manufacturing and quality assurance for The Wellcome Foundation, Glaxo Wellcome and GlaxoSmithKline. Gerald has experience in most aspects of pharmaceutical manufacture and control, with a particular interest in sterile products.

    Dr Ian Hudson is a physician who has practiced as a paediatrician for a number of years. He was formerly a research fellow at the University of Glasgow. He joined SmithKline Beecham in 1989 where he held various appointments in clinical research and development. He joined the MCA (Medicines Control Agency) in January 2001 as Director of the Licensing Division. He is the CHMP (Committee for Human Medicinal Products) delegate for the UK.

    And from the MHRA’s agency board :

    (Alasdair Breckenridge resigned from GSK before working for the MHRA.. Although it fails to mention this on the MHRA website)

    Professor Sir Alasdair Breckenridge, CBE, was most recently Professor of Clinical Pharmacology at the University of Liverpool. He has been Chair of the Committee on Safety of Medicines (CSM) since 1999, a role which he relinquished when he became chair of the MHRA on its creation in April 2003. Previously, he was a member of the Adverse Reactions Group, and the Subcommittee on Adverse Reactions to Vaccines and Immunisation of the CSM. Between 1992 and 1996 he was a member of the Medical Research Council. He has worked closely as assessor to various programmes of the European Union, on committees of the World Health Organisation, and within the International Union of Pharmacology. Between 1987 and 1999, he was a member or the chairman of local and regional health authorities in the Northwest of England. He has held visiting professorships in Malaysia, New Zealand, Australia, South Africa and India. Sir Alasdair is married with two children. He is not affiliated to any political parties.

    It would be interesting to know which members of the MHRA still hold shares or stock/interests in GSK…( particularly at the time Seroxat was being licenced and relicenced)

    Is it no wonder that Seroxat got a licence ?
    Is it no wonder that side effects were played down?

    I wonder what’s happening to that 4 year criminal investigation into the condcut of GSK regarding suppression of clinical trial data of Seroxats adverse events ? ( seems to be taking a long time… Maybe theres been a lot of shredding and burying going on…? Who knows? )

    Quite amazing , how mass murder of patients with Seroxat was allowed to happen, under dubious and sinister circumstances, but for the MHRA and GSK it continues to be just “business as usual” …

    http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/5012003.htm

    Of note from this parliamentary minutes meeting :

    Examination of Witnesses (Questions 780 – 799)

    THURSDAY 20 JANUARY 2005

    PROFESSOR SIR ALASDAIR BRECKENRIDGE CBE, PROFESSOR KENT WOODS AND DR JUNE RAINE

    Q780 John Austin: Can I raise the issue of Seroxat and your knowledge and involvement. In 1998, I believe you were on the advisory board of GlaxoSmithKline or SmithKline Beecham, as it was at the time.

    Professor Sir Alasdair Breckenridge: No, let me just clarify that. From 1992 to 1997 I was a member of a scientific advisory committee of SmithKline. I resigned from that in 1997. This had been an extremely valuable exercise for my development in medicines regulation. We did not discuss specific products on that board; it was a matter of the larger picture of industry. I resigned from that in 1997 and this post had been taken up with the full cognisance of the then MCA. I discussed this with the MCA and I acted in a totally appropriate manner with respect to the decisions that I was party to there and in drugs and medicines regulation.

    Q781 John Austin: I was not suggesting otherwise. My question was whether you were aware or whether the company made you aware at the time of any testing that they were doing in relation to Seroxat and the use of Seroxat for children.

    Professor Sir Alasdair Breckenridge: We never discussed any medicines at all. That was never part of the remit of the scientific advisory board.

    Q782 John Austin: It is clear now that the company were aware of some negative results, particularly in terms of withdrawal. Were those ever communicated to you either in your role with SmithKline Beecham or subsequently in your role with the Committee on Safety of Medicines or the MHRA?

    Professor Sir Alasdair Breckenridge: With respect to me, as I have said already, certainly not and perhaps Dr Raine might like to answer the question about the communications to the Agency, if that is your wish.

    I suppose we are all entitled to believe what we like…
    And it is is my belief that there is something rotten within the MHRA ….
    And the stink of this rot comes from conflicts of interest…

    Alasdair Breckenridge worked for Glaxo’s scientific advisory board between 1992 and 1997 … Hmmmm

    Why do those dates ring a bell…?
    Well, It is between 1992 and 1997 that Seroxat was first licenced… It was relicenced in 1998 … Around the time that Mr Breckenridge was settling into up his role of “chair of the MHRA” … ( probably just coincidence of course)

    Mr Breckenridge has also made a comment back in 2005, I think this comment speeaks for itself…

    “We must not get hung up on safety but instead must focus on risk-benefit”

    http://64.233.183.104/search?q=cache:URk6cw9FglYJ:www.dh.gov.uk/prod_consum_dh/idcplg%3FIdcService%3DGET_FILE%26dID%3D4685%26Rendition%3DWeb+breckenridge+risk+benefit&hl=en&ct=clnk&cd=10&client=safari

    We must not get “hung up” on saftey? …

    Well if the attitude of the head of the MHRA is that we must not get too concerned about the safety of the medicines we take then is it no wonder that a defective, toxic, dangerous and lethal medication such as Seroxat was licenced when quite clearly the “benefits” of this medication outweighed the “risks” …

    The murky waters of the Seroxat Scandal just get deeper and deeper…

  2. Ogan Gurel Says:

    With respect to the Avandia controversy, you may find several articles in the Life Sciences Daily blog (http://blog.aesisgroup.com/) to be of interest. See, for example, the latest posting:

    http://blog.aesisgroup.com/2007/07/26/fda-report-on-avandia-just-issue–read-more-for-a-critique-of-the-critique.aspx

    as well as other postings in the blog on FDA reform and drug/device safety.


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