Frustrated Justices
November 20, 2008
As many readers know, the Supreme Court is considering the case of a Vermont musician, Diana Levine, who lost an arm when a physician assistant didn’t fully consider the label on a Wyeth anti-nausea drug. The legal debate is stark: can the FDA’s approval take precedence, or “preempt,” state courts hearing liability cases?
Earlier this year, we…more...
Public Citizen Gadfly
November 04, 2008
Sydney “Syd” Wolfe, director of Public Citizen’s health research group, is scratching his head. Tequin (gatifloxacin)—an antibiotic that Public Citizen had campaigned against—was pulled from the market by its manufacturer, Bristol-Meyers Squibb (BMS). But BMS said that was because of lagging sales. That was two years ago.
In September of this year, the FDA formally announced that…more...
Proactive Safety
October 30, 2008
Does the pharmaceutical industry need to rethink the management of drug safety data and pharmacovigilance? A few companies already are. That was clear at this year’s annual Society For Clinical Data Management (SCDM) meeting. Appropriately, the session tried to explore the tenuous technological links between two areas of human expertise: the medical interpretation of drug safety issues…more...
Crowdsourcing Drug Safety
October 15, 2008
Hugo Stephenson is floored by the growth of iGuard, the consumer-oriented online medical monitoring service he started last year with financial support from Quintiles.
iGuard turns one this month. When it was launched, Stephenson expected to have perhaps 60,000 people signed at this stage. Instead, iGuard now has 750,000 members, and that is expected to surge to…more...
Pondering EHR Access
September 15, 2008
Today’s news about Merrill Lynch and Lehman Brothers is interesting. Trillions of dollars in mortgage securities that seemed safe a year ago are radioactive. Wall Street thought the risk could be papered over with accounting gimmicks and legal jabbering. That worked for a while.
But the tricky thing about risk is that it has a certain scent—an…more...
Ready for REMS
August 25, 2008
One curiosity of the drug safety controversies of the past few years is the low profile of most of the software companies in the niche. One could read the newspaper or your favorite business magazines and imagine that the industry didn’t have people or systems to manage and predict adverse events, that Medwatch paperwork and other forms…more...
New Woodcock Role?
July 03, 2008
Just as the FDA has received the resources to make a major push into post-marketing drug-safety surveillance under the Food and Drug Administration Amendment Act (FDAAA), the Pharmaceutical Research and Manufacturers of America (PhRMA) says it’s doing the same thing.
PhRMA says its effort began long before the FDAAA legislation was enacted by Congress last fall.
PhRMA…more...
Business As Usual
May 20, 2008
Because of the random sighting of Ira Spector at one conference or another, we’ve always had a soft spot for Wyeth. We don’t know Spector—no need to fret he has been consorting with the news media. But from remarks by Spector and his lieutenants over the years, we’ve gathered Wyeth seems to have anticipated most of the…more...
January 8, 2009
Business As Usual
Joseph Camardo spoke at the Post-Approval Summit at Harvard, and was wicked smart. Even so, what he didn’t say perturbed us.
Database Finds 150K Patients
The health outcomes division of the i3 brand discusses trials that are professionally designed and run on the computer.
IND Ethics Loophole
University of Maryland physicist Adil Shamoo, founder of CIRCARE, says there are gaps in existing law that leave patients exposed.
Shark Repellent
A new name for the safety products from Phase Forward, plus insights into faster responses to safety crises.
A-List Of Speakers At Harvard
With Mark McClellan and Janet Woodcock on the agenda, the Outcome meeting will be another illuminating event this year.
Strategies from Wyeth, Actelion & Pfizer
A report from the Clinical Trials Congress about risk. One message: start a regulatory conversation early. And consult your preclinical team.
