Yale University's Dr. Krumholz -- On The Lessons of Glaxo's Avandia -- For Merck

As the Forbes opinion by-line notes, Dr. Harlan Krumholz is a cardiologist and the Harold H. Hines professor of medicine and epidemiology and public health at Yale University. In the past, he did consulting for plaintiffs' lawyers suing Merck over Vioxx. This morning (yet again!), he hits the nail on the head. Do go read it all -- as the object-lesson applies to all of pharma -- here is the concluding snippet:

. . . .What is clear: Glaxo failed to disclose its own concerns even as it sought to discredit outside researchers who were raising questions about the drug.

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.

And on all sides there should be a commitment to protect against the intimidation of academics who are willing to raise questions about the safety and effectiveness of company products. The free flow of information about the effects of drugs and medical devices will best serve the public's interest. . . .

Indeed. In so many ways, big pharma -- in the last decade, at least -- has resembled nothing so much as a 350 pound man, tip-toeing around, in a dimly-lit, bare concrete-floored basement, and in six-inch stiletto-spike heels, to boot(!) -- with the that floor covered -- wall to wall -- in banana-peels, underfoot: "all in all, it was just a matter of when, not whether. . ." he would fall -- and break his back. Yeh -- it's been like that.

[Image, above right, is from my story detailing the new whistleblower protections that all Merck employees garnered -- when the bust-up transaction closed, as a result of Schering-Plough's (and legacy Merck's) various DoJ plea bargains. Either the companies will choose to disclose voluntarily, or their employees will begin to blow the whistles. Or there will be more legislation.]