Saturday, October 20, 2007

Memory Hole (20 October): The Protectors

Scientific Misconduct Blog Memory Hole: Events of October the 20th

Quotes of the day

This and no other is the root from which a tyrant springs; when he first appears he is a protector.
Plato circa 400 B.C.

A good deal of tyranny goes by the name of protection.
Louise Erdrich

60 years ago today: Academic Freedom is un-American

On 20 October 1947 the House Un-American Activities Committee opened hearings into supposed communist influence in the motion picture industry.

22 years ago today: Secret C.I.A funding at Harvard

On 20 October 1985 it was reported that Nadav Safran, a Harvard Professor of Near Eastern Studies had been receiving confidential research funding from the Central Intelligence Agency ("Harvard Widens Inquiry in C.I.A. Aid to Professor," New York Times 20 Oct 1985). Part of the agreement was that he should submit his manuscripts to the CIA for prior approval. Several scholars had earlier withdrawn from a conference on Islamic fundamentalism at Harvard after learning that the CIA was one of its sponsors. Safran was later forced by his colleagues to resign his Harvard position. See some discussion in the Harvard Crimson of 1986.

6 years ago today: UK Government accused of coverup over sheep research

On 20 October 2001 the UK Labour Government was accused of trying to hide details of the disastrous scientific investigation into BSE in sheep.

2 years ago today: Pargluva and regulatory failure

On 20 October 2005 an important article was published JAMA (Brophy JM. Selling safety - lessons from muraglitazar. JAMA 2005; 294) indicating various techniques used to provide a deceptive impression of the drug Pargluva (muraglitazar) to a puppet FDA panel. For the methods used to mislead see the summary at Health Care Renewal.

The FDA panel reviewing Muraglitazar had known of concerns, but had conflicts of interest. They backed the drug regardless of the absence of any evidence of meaningful efficacy (NYT). The summary of the FDA meeting (available on the internet archive here) indicates concerns about increased heart failure and cardiac death with Pargluva (short term cardiac death rate 0.3% with Pagluva 0% with Actos, CCF 0.75% for Pargluva vs 0% for Actos). Five clinical trials had been notified to the FDA (the "clinical trial register") but were not available in published form.

The parallel scientific report in JAMA concluded "muraglitazar should not be used or approved to treat patients with diabetes until an appropriate dedicated trial to assess cardiovascular outcomes is performed." - which is exactly the conclusion an honest FDA panel should have reached.

On 18 March 2006 Bristol-Myers Squibb discontinued the development of muraglitazar.

2 years ago today: Nature study on distortion of clinical guidelines

On 20 October 2005 the journal Nature reported on their investigation of "independent" clinical guidelines ("Cash interests taint drug advice" Vol 437/ 20 October 2005). The results of the survey showed that "drug companies are distorting decisions about how their products are being prescribed". Surprise.

"Nature found that more than one-third of authors declared financial links to relevant drug companies, with around 70% of panels being affected. In one case, every member of the panel had been paid by the company responsible for the drug that was ultimately recommended." Nature studied over 200 guidelines deposited with the US National Guideline Clearinghouse. Only 90 contained details about conflicts of interest. Of those, just 31 were free of industry influence.

In one example uncovered by Nature, guidelines for the treatment of anaemia in HIV positive patients were written by a working group selected by Paul Volberding at UCSF. Volberding convened the group at the request of Ortho Biotech. Ortho Biotech funded the meetings and all six members were paid by the company for lecturing or consultancy. The group's guidelines (P.Volberding et al. Clin. Infect. Dis. 38, 1454-1463; 2004) recommend use of epoetin alpha, a drug marketed by Ortho Biotech.

Patients die as a result of schlock science - does anyone care?

2 years ago today: David Healy, the BMJ and Academic Stalking

On 20 October 2005 Professor David Healy gave a landmark talk at Columbia University. Amongst other things he detailed the role of lawyers at the British Medical Journal in the peer review process: "our best journals refuse to take articles on the basis of sheer terror about what pharmaceutical companies might do to them rather than on the basis of any concerns about the scientific merits". The lecture was scheduled as a debate between Healy and James Coyne (University of Pennsylvania), but Coyne pulled out. Coyne had an interesting role in the stifling of academic debate (see Academic Stalking) as did academics at Oxford University. Sickening reading.
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