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.

USA TODAY Scientist says FDA called journal to block Vioxx article 28 Nov 2004

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.

Sources:
  1. WALL STREET JOURNAL, FDA Removes Panel Member From Drug Review, Nov 12 2004
  2. http://www.ahrp.org/infomail/04/11/15.php
  3. http://www.gooznews.com/archives/000091.html
  4. http://www.ahrp.org/infomail/04/11/12a.php

sharpening teeth MHRA

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.

Read further:
  1. The Scott Gottlieb example - The Carpetbagger Report (2005-09-26).
  2. Corporate Crime Reporter: Zheng Xiaoyu Meet Lester Crawford.
  3. Henderson, Diedtra. "FDA official recused in flu fight - His ties to drug firms spark questions over agency hiring policies", Boston Globe, 2005-11-12.
  4. Mundy, Alicia. "Wall Street biotech insider gets No. 2 job at the FDA", The Seattle Times, 2004-08-24.
  5. Blumsohn, Aubrey (2007-09-01). Gottlieb pronounces on pharmaceutical research integrity. Scientific Misconduct Blog.
  6. Poses, Roy (2007-08-31). Conflicted View on the Pitfalls of Government-Sponsored Comparative Effectiveness Research. Health Care Renewal.

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Comments on: Memory Hole (12 November): Corruption of medicines "regulation"

 

Anonymous alotafloss said ... (December 18, 2007) : 

"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..."

Given the riveting action shown by the MHRA in the three years between 2004 and 2007 on a large number of issues, I suspect the dental diagnosis is either a) that the "sharper teeth" are still in the stage of growing through the gums, b) its a genetic case of early onset dental caries, or c) the teeth were implanted into rotten gums and have since fallen out.

 

Anonymous spotthelapdog-inc said ... (December 18, 2007) : 

I believe its a case of breed choice.

If you want a hunting dog its best to opt for a soft-mouthed breed such as a Retriever.

If you require a dog for rescue services, then pick one with the stamina to undertake water or mountain rescues like the Pyrenean or St Bernard.

If you need a farm hand, then a herding dog such as a Border Collier is a definite plus.

If you want a 'non working' dog which is perfectly happy to pander to your whims and doesn't mind relatively little exercise, then there are a variety of species that are known as "Companion Dogs" or "Lap Dogs" to choose from, the smaller of those being the "Toy Dog" breeds.

If have good reason to feel particularly vulnerable and need a dog thats intelligent, loyal, steadfast and large enough to protect you and your family effectively ....its usually a mistake to choose a Lap Dog.

 

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