About all manner of pharmaceutical scientific misconduct, bad science, and related curious incidents. If you're not outraged, you're not paying attention.
Thursday, November 22, 2007
Memory Hole (12 November): Corruption of medicines "regulation"
Scientific Misconduct Blog Memory Hole: Events of November 12th
Quote of the day
"We could make no greater mistake than to be lulled into a sense of false security by believing that some disembodied force called the government will act like a beneficent big brother and make certain that the special interests will not predominate. If the general welfare is to be protected, it will be protected by the actions of people, not the government." -Dr. A. DALE CONSOLE, former medical director for drug giant ER Squibb (as quoted in Peretz Glazer and Migdal Glazer, ISBN 0465-09173-3)
3 years ago today: FDA shows "respect for the scientific process" by intimidating scientist
On 12 November 2004 a Food and Drug Administration (FDA) official called the Lancet in an attempt to prevent publication of a study that raised concerns about the drug Vioxx. The article would have embarrassed the FDA
The author, David Graham pulled the paper at the last minute because he feared for his job. The study was due to be posted on the Lancet website on Nov 17th 2004. FDA Acting Commissioner (and convicted criminal) Lester Crawford said that Galson contacted Lancet editor Richard Horton "out of respect for the scientific review process."
Horton responded: "You will not be surprised if I say that I was a little taken aback to get your call on Friday (Nov. 12). It is very unusual indeed for a member of the employing institution of an author to contact us in the middle of the review and publication process of a manuscript."
On November 18th Graham told a Senate panel that the FDA is "virtually defenseless" against another "terrible tragedy and a profound regulatory failure". Excess deaths resulting from the use of Vioxx have been estimated at 100,000.
3 years ago today: FDA: Being honest is a conflict of interest
On 12 November 2004 the FDA removed Dr. Curt Furberg from an FDA advisory committee for alleged "intellectual conflict of interest" (but more likely to protect Pfizer). Furberg had previously analyzed the data relating to Bextra and had concluded that Bextra carried cardiovascular risk (similar to Vioxx).
Sandra Kweder, acting director of the FDA's office of new drugs, said "If he's already expressed a particular point of view, and especially written a paper on it, would be difficult to expect him to come to such a meeting and be objective about the subject".
What a corrupt muddle. Apparently (but not always) being a scientist and taking a scientific approach is a conflict of interest. FDA's action against Dr. Furberg contrasts sharply with the agency's infinite tolerance of overt and extensive financial conflicts of interest of its advisory panel members.
3 years ago today: Sharper teeth for the UK Medicines "Watchdog"
On 12 November 2004 it was reported that the UK government announced sweeping changes to the "independent" and "transparent" medicines watchdog body after years of criticism and pressure, banning those who sit on its central licensing committee from having any personal or financial interests in pharmaceutical companies [Sharper teeth for medicines watchdog, The Guardian, November 12 2004]. (Duh!)
In March 2003 a review committee of the UK Medicines regulator tasked with looking at the safety of GSK's drug Seroxat had to be disbanded when it was revealed that half the members had share holdings in GlaxoSmithKline. Here are some later and ongoing members of the MHRA and their personal interests in just this one company:
Professor A Breckenridge - GSK Fees Professor H Dargie - GlaxoSmithKline Consultancy Dr M Donaghy - GSK Shares Dr J C Forfar - GSK Shares Dr R Leonard - GSK Fees/ Publicity work Prof D J Nutt - GSK Consultancy Psychotropics and 300 shares (1) Professor J F Smyth - GSK Consultancy Professor Christopher Bucke - SKB Shares Prof Nicholas Mitchison - GSK Shares Dr Brian J Clark - GSK PHD student funding Professor Robert Booy - GSK Consultancy Professor S M Cobbe - GSK Research grant Professor J E Compston - GSK Consultancy Dr A Glasier - GSK Shares (£10,000) Dr Andrew A Grace - GSK Consultancy Dr P Hindmarsh - GSK Consultancy on growth, probably lapsed by now Professor P D Home - GSK Consultancy - Ex-employee of GSK Dr R F A Logan - GSK Shares Professor R MacSween - SmithKline Beecham Shares Professor J O’D McGee - SmithKline Beecham Shares Professor David R Matthews - GSK Honorarium for advice Dr A Smyth - GSK Conference expenses Professor A D Struthers - GSK Shares Professor J C E Underwood - GSK Shares Dr A Gerard Wilson - GSK Consultancy Dr Rosemary Leonard - GSK Fees/ Publicity work Mr David P S Dickinson - GSK Fee paid work Dr Charlotte C D Williamson - GSK Shares Professor Anthony H Barnett - GSK Advisory work and lectures diabetes related products Professor V Krishna K Chatterjee - GSK Consultancy on preclinical research Professor Albert - GSK Shares
Professor Alistair Breckenridge [Link][Link][Link][Link] and Dr Ian Hudson [Link][Link][Link] are both former employees/advisors of GlaxoSmithKline, having been involved with GSK's drug Seroxat. Both now work for the MHRA.
The very definition of independence. If any of the above named have ever made any statement about selective reporting in GSK clinical trials, or GSK's study 329, or disputes their GSK funding, I would be pleased to hear from them to correct the record.
"Following the path of least resistance is what makes rivers and men crooked."
2 years ago today: Scott Gottlieb - what is the half-life of a conflict of interest?
On 12 November 2004 further concerns were raised in the press over the circumstances that led to the appointment of Dr. Scott Gottlieb to the position of deputy commissioner at the Food and Drug Administration. Gottlieb's absurd anti-science and anti-transparency stance, his conflicts of interest, and attempts to interfere with FDA decisions were causing anxiety. He was heavily criticised for attempting to intimidate staff behind the scenes in relation to a Pfizer osteoporosis drug. Gottlieb had also been appointed by one Lester Crawford (who was convicted of criminal offenses relating to his role as FDA Commissioner).
Upon taking his post Gottlieb recused himself for up to a year from any deliberations involving nine companies that are regulated by the FDA, including Eli Lilly, Roche and Proctor & Gamble. (In analogy with radioactive decay, one year is the well recognized decay time for the effect of a conflict of interest after switching off a current income stream).
"He came to this job with no regulatory experience, directly from Wall Street, where he served as a biotech analyst and stock promoter. Between them, Drs. Von Eschenbach and Gottlieb have whined incessantly about the need to speed drug development."
"When asked about his industry connections, Gottlieb said that he complied with all legal requirements".
For some depressing reason the British Medical Journal (a scientific journal?) decided to employ Gottlieb as a staff writer from 1997-2005.
Source: Henderson, Diedtra. "FDA official recused in flu fight - His ties to drug firms spark questions over agency hiring policies", Boston Globe, 2005-11-12.