Friday, October 12, 2007

Memory Hole (12 October): Efficacy

Scientific Misconduct Blog Memory Hole: Events of October the 12th

Quote of the day

Efficacy, n. Tendency of pharmaceuticals to produce salutary results. Attributable to extensive research, exacting experimentation, elaborate lawyering, pervasive marketing, gullible physicians, and a sales representative in a short skirt and high heeled shoes.
(From the Prattler)

Wyeth and HRT

Today (12 October 2007) Wyeth was hit with $134.5 million verdict. A Nevada jury awarded $134.5 million to three women who claimed Wyeth's hormone-therapy drugs caused their breast cancer. Jurors agreed that the company "concealed a material fact about the products' safety".

12 years ago on 12 October 1995 the information leaflet for Prempac-C read:
"Some studies with HRT have shown a small increased risk of breast cancer when HRT has been used over a long period of time."

I suppose the question is "what constitutes a warning?" and "what constitutes efficacy?" and whether these were adequately and honestly conveyed. Warnings without numbers attached are meaningless.

A BMJ Editorial from 2003 is worth reiterating:

"HRT promotion has depended heavily, although covertly, on industry involvement with scientists. In the 1960s American physician Robert Wilson wrote the influential Forever Feminine, extolling the virtues of HRT as a virtual fountain of youth for the "dull and unattractive" ageing woman. In an article in the New York Times last year (10 July 2002), Wilson's son conceded that Wyeth paid for his father's book and promotion of HRT.

In 2002 the powerful New York based Society for Women's Health Research, whose "sole mission is to improve the health of women through research," held a celebrity gala ostensibly celebrating women's "coming of age." It was entirely underwritten by Wyeth. In a Washington Monthly article entitled "Hot Flash, Cold Cash," journalist Alicia Mundy reported that only a few days after the Wyeth themed gala the company donated a quarter of a million dollars to the society.

Several weeks later, the WHI study results were made public. Wyeth was in a tailspin. They found support from the society, whose high profile chief executive, Phyllis Greenberger, and her staff went on national radio and television talk shows attacking the findings of the WHI study and its authors. "Instead of taking the side of its constituents," The society's staff failed to disclose their substantial links to Wyeth and other drug companies."

398 years ago today: Three Blind Mice

398 years ago on 12 October 1609 London songwriter Thomas Ravenscroft published ""Three Blind Mice".

8 years ago today: Lancet in a furious row

On 12 October 19999 the Lancet was "embroiled in a furious row with its own advisers over a decision to publish the controversial research on genetically-modified (GM) potatoes by Dr Arpad Pusztai."
Source: BBC

2 years ago today: Zimbabwe praised for rejecting food

On 12 October 2005 Zimbabwe was praised for rejecting food.

"INTERNATIONAL scientists, including those from the United States, have praised Zimbabwe and Zambia for rejecting genetically-modified food donations from the West to feed scores of their rural folk facing drought-induced food shortages. By standing firm against GMOs, said the scientists, the two governments avoided manipulation and deception, which could have resulted in their vulnerable poor being used as guinea pigs."
Source: Zim, Zambia stance on GMO food hailed, The Herald, Zimbabwe, by Wisdom Mdzungairi

A reminder that Zimbabwe is not London. The world loves to simplify. Problems are framed as left versus right, excessive regulation versus free enterprise. I wonder who made this decision.

2 years ago today: Angry response to Advisory Committee on Human Radiation Experiments

On 12 October 2005 it was reported that "Groups representing individuals who were the subject of human radiation experiments in the United States after the Second World War have reacted angrily to the main findings of the President's Advisory Committee on Human Radiation Experiments, which reported to President Bill Clinton last week."

They are "planning to formally reject an apology that was issued by Clinton when the report was released". "Clinton had offered "sincerest apologies to those citizens, their families and their communities" on behalf of the U.S. government." "Responding to the committee's findings that existing protections for human research subjects are "seriously deficient," Clinton asked all the federal agencies involved to review procedures for protecting the subjects of experiments, and to report back within three months to the planned National Bioethics Advisory Commission (NBAC)"
Source: Nature 377 (12 October 1995), p. 470.

2 years ago today: Science "at your peril"

On 12 October 2005 nearly 30 builders and decorators were reported to have received threatening letters from animal rights activists warning them not to work for Oxford University. Signed by the Animal Liberation Front (ALF), the letters tell the firms that work will be done "at your peril".

Is this appropriate?

Source: " Animal rights group threatens builders over new Oxford labs", Telegraph, 12/10/2005

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