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Thursday, August 03, 2006

The Doctor is Out

There is a doctor in England who received a 250 thousand dollar grant from Procter and Gamble. He claims that the company had denied him access to key data and then tried to ghostwrite his analysis of it. The doctor and one of his superiors were to evaluate the effectiveness of P&G's osteoporosis drug, Actonel. Their analysis was suppose to further demonstrate how Actonel affects women's bones and their susceptibility to fractures. The doctors superior (and cohort in this research) had already reviewed blood and urine samples from two previous P&G clinical trials of Actonel. The doctor was supposed to evaluate a third trial, with the aim of providing a final analysis of all three.

The doctor and his staff reviewed data from thousands of blood and urine samples from women with osteoporosis. They were blinded as to who had taken Actonel and who had been given the placebo. This is of course the fun part of science. Get you facts straight then open the envelope to see which group is which. Did the drug work. Procter and Gamble however didn't want the doctor to go that far. They had a ghostwriter who would take his information and use what was needed to publish a paper with a positive spin. They would be using his name on the publication but not necessarily his conclusions. The doctor repeatedly asked for the codes so he could properly interpret the results. They refused.

Ironically, P&G continued to pursue their plan to write up a manuscript using the doctors analysis which they expected him to present at the American Society of Bone and Mineral Research. The ghost writer would "help write up the Actonel manuscripts for publication" and the doctors name would be listed as an author. Noting that he and his superior could be guilty of scientific misconduct if they let their names be listed as authors without having seen the underlying data P&G came up with a compromise. They would let him perform his own analysis of his data but they would let him review what the company had worked out.

He went to their headquarters and saw what they were working on. On one critical graph on fracture rates, he noticed that 40% of the data was missing. He believed that inclusion of that 40% of data would have disproved P&Gs key message about their drugs effectiveness against bone fractures. As a scientist, the doctor could not allow this. After many months of trying to get P&G and the university to do the right thing, he decided to go public with his story. He was suspended from the University.

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