Can researchers accurately review the safety and efficacy of a new drug without actually analyzing the raw data harvested in clinical trials?
The Milwaukee Journal-Sentinel took an in-depth look at that question, as well as the financial ties that existed between the six co-authors of a major international study on Multaq and Sanofi-Aventis, which expects to reap hundreds of mullions of dollars a year from sales of the drug.
Richard Page, chairman of the department of medicine at the University of Wisconsin School of Medicine and Public Health, put his name along with others on the Multaq paper, even though Sanofi-Aventis managed the project and Page never saw the raw data on which the paper was based. All six investigators who co-authored the study had done work for the company.
"These companies, if they were falsifying data, wouldn't be kept in business if that were found out," Page said. "I was satisfied and remain satisfied that the study was conducted in an appropriate way."
No one has suggested the investigators acted unethically, but some find it troubling that drug companies can manage all the data and then distribute their conclusions directly to researchers responsible for papers that can influence sales of a drug.
"If data are cut and shaved and trimmed and manipulated to make a point and that doesn't represent truth or the way a drug behaves, science is harmed and, more importantly, patients are harmed," says Eric Campbell, an associate professor at Harvard Medical School.
- here's the story from the Milwaukee Journal-Sentinel