Friday, 30 November 2012

MALARIA: drug company money and science

From:William Brieger

Date:Fri, Nov 30, 2012 8:49 am
When Robert Lindsay chose to become a medical researcher in the early 1970s, he did not do it for the money. His field—the effect of hormones on bone—was a backwater. It was also a perfect opportunity for a young researcher to make his mark and, he hoped, help millions of people who suffered from the bone disease osteoporosis. As the body ages, sometimes bones lose the ability to rebuild themselves fast enough to keep pace with the normal process of deterioration, and the skeleton weakens. Neither Lindsay nor anyone else understood much about why this happened, but there was reason to think that hormones might play a role. Some women develop osteoporosis shortly after menopause, when their hormone levels drop sharply, perhaps upsetting that balance between bone creation and destruction. If so, Lindsay reasoned, replacing the hormones with a pill might halt or even reverse the progress of the disease. From a tiny, underfunded clinic in Glasgow, Scotland, he set up one of the first clinical trials of estrogen replacement therapy for bone loss in postmenopausal women. Lindsay's star was rising.
His next project had big commercial implications and got the attention of the drug industry. Having moved to Helen Hayes Hospital, a rehabilitation center north of New York City, in 1984 he published work that established the minimum effective dosage of an antiosteoporosis estrogen drug called Premarin. Because the findings suggested that fighting osteoporosis was tantamount to encouraging millions of women to use the drug, it made Lindsay an important person in the eyes of the drug's manufacturer, Wyeth-Ayerst Laboratories. Indeed, the company gave him a role as an author of its informational video Osteoporosis: A Preventable Tragedy.
By the mid-1990s, when Wyeth got caught in a patent battle over Premarin, Lindsay was a staunch Wyeth ally. He came out against approval of a generic version of the drug that would have cut into sales even though the generic form would have made it easier for osteoporosis patients to receive therapy. His reasoning was that such versions might not be precisely equivalent to the brand-name drug, a fact that can be true with certain drugs but was also a position that happened to echo the company line. “All we're asking is that we don't approve something now and regret it” later, he told the Associated Press in 1995. Lindsay's close relationship with Wyeth and other drug companies carried on for decades, in ways that were sometimes hidden. He started allowing Wyeth to draft research articles and began taking tens of thousands of dollars from pharmaceutical interests that stood to gain from his research.
The scandal is not what Lindsay did so much as that his case is typical. In the past few years the pharmaceutical industry has come up with many ways to funnel large sums of money—enough sometimes to put a child through college—into the pockets of independent medical researchers who are doing work that bears, directly or indirectly, on the drugs these firms are making and marketing. The problem is not just with the drug companies and the researchers but with the whole system—the granting institutions, the research labs, the journals, the professional societies, and so forth. No one is providing the checks and balances necessary to avoid conflicts. Instead organizations seem to shift responsibility from one to the other, leaving gaps in enforcement that researchers and drug companies navigate with ease, and then shroud their deliberations in secrecy.......

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