Dr. Harlan Krumholz, in a Forbes column:
“I want to believe in America’s pharmaceutical companies. I want to believe that people in these companies believe that the best strategy for success is to do what is best for patients. I want to believe that they are interested in scientific truth and eager to know of any safety issues and ready to share that information with the public.
This week I was disappointed again.
Over the years GlaxoSmithKline has repeatedly reassured the public about the safety of its blockbuster diabetes drug Avandia. But this weekend the Senate Finance Committee released a report revealing that inside the company Glaxo’s own experts and advisors were raising concerns about whether the drug could cause heart problems all along. …
The report, based on more than 250,000 internal documents, provides a rare and unsettling glimpse into the decision by company executives to deflect safety issues–even as their own experts agreed with conclusions of outside researchers who were warning the public about possible harms.
This type of behavior is eroding the public trust in the pharmaceutical industry. The fix is simple: Once a drug is approved, all data relevant to drug safety should be placed in the public domain and independent investigators across the country should be able to use it. There should be big financial penalties for withholding relevant information. Drug studies sponsored by industry must be truly independent–outside of company control. Companies should give outside investigators independence over every aspect of the study. There are too many examples of companies wresting control of clinical studies from their consultant investigators for reasons that seem more related to product promotion than clinical science.”