Harvard Prof On Stats Shifts
February 07, 2008
Not long ago, on a bleak winter morning when the U.S. Congress and the New York governor and the Connecticut attorney general and the second most important medical journal were trashing the industry, we banged out an email to Scott Evans.
He’s a senior research scientist in Harvard University’s School of Public Health. He teaches biostatistics there,…more...
November 26, 2007
Earlier this month, after months of negotiations, Merck announced a large but manageable $4.85 billion settlement of an unknown number of Vioxx plaintiffs who can prove they took the drug and suffered strokes or heart attacks.
Those plaintiffs still have to approve the deal. But it appears to be a watershed win for Merck, which had tenaciously…more...
Three Ticking Clocks
November 07, 2007
In another significant win for medical journal editors in their new role as regulators, Bayer suspended sales of anti-clotting drug Trasylol (aprotinin), which had been implicated in kidney failure, cardiovascular problems and mortality risk. The drug had approximately $135 million in 2007 sales.
We have no special knowledge of Trasylol. All we can say is that for…more...
‘Enough--This Is The Label’
October 01, 2007
At the annual conference of the Regulatory Affairs Professionals Society (RAPS), held in Boston last week, the FDA’s Sandra Kweder (deputy director of the Office of New Drugs in CDER) gave a well-attended talk packed with sugary rhetoric.
Such statements could be taken as indicating that nothing will change in the agency’s stance toward the industry. But…more...
New FDA Review Process
RAPS: Kweder of CDER, Part I
The FDA’s Sandra Kweder talks about Vioxx, a consultant’s study of its process, and how that process is about to be standardized across all sections of CDER. A report from the 2007 RAPS conference for regulatory affairs pros.
Quintiles Safety Spinoff
iGuard Post-Marketing Database
A Quintiles offshoot has created an online drug-safety hub which simultaneously offers nifty color-coded warnings to consumers about their prescriptions and a potentially valuable post-marketing research tool for the industry.
Avandia, etrials, FDA on e-CRFs
News for Tuesday, May 22.
Thinking Beyond The Label
FDA On Drug Safety
A senior FDA official tells the Post-Approval Summit what the agency is going to do and would like to do in the post-Vioxx era.
Legal Prowess, PR Fumble
Merck’s Deeper Peril
An article in the Harvard Business Review in February 2007 outlines the mistakes of companies that do not engage the media, and offers a prescription for regaining a good public image.
Zyprexa Documents Case
Lilly Judge Spanks NYT
A federal judge is irritated with the media and orders a lawyer and physician to return secret documents that have already been widely posted on the web.
Pharma's Reputational Rehab
On Winning Hearts And Minds
Our sense is that ordinary Americans could still be persuaded that the drug industry serves an important role in taking basic scientific research and delivering it to a local pharmacy or loved one. But the industry needs to produce its scientists and specify how its products improve life, save money and prevent surgery.