Let’s not pop the champagne corks just yet to celebrate the recent announcement of new guidelines for Big Pharma from the trade group Pharmaceutical Research & Manufacturers of America (PhRMA).  The wordy guidelines are called Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results. They went into effect last week, and are a response to mounting scandals and scrutiny about how clinical research trials are conducted and reported. These new principles also cover issues like authorship contributions and medical ghostwriting; disclosure of financial conflicts of interest; public registration of clinical trials; and publicly accessible summaries of all clinical trial results.

These last two are apparently a stab at addressing the current reality that negative clinical trial results either never see the light of day or are only selectively reported to favour the drugs being tested. The principles have been hailed by some as a step in the right direction, although many point out that they may have more bark than bite in addressing, for example, the chronic problem of medical ghostwriting. Continue reading →