The Third Circuit just issued its opinion in Gunvalson v. PTC Therapeutics (link here), the case in which a trial court issued an injunction requiring a drug company, PTC Therapeutics, to provide an experimental drug to a patient outside of the context of a clinical trial. (One of our many earlier posts on
There’s been a controversy in both the scientific literature and the popular press recently about whether Merck’s “ADVANTAGE” trial of Vioxx was a “seeding” trial conducted for marketing purposes.
That subject has been too hot for us to touch, in part because Bexis’ firm is involved in the Vioxx litigation, so he couldn’t speak on
Everybody’s a critic.
We published a post last month analyzing Gunvalson v. PTC Therapeutics (here’s a link), in which a federal judge ordered a company to provide an experimental drug to a dying patient who did not qualify for a clinical trial. We wrote:
“Basically, a drug company would be crazy to open
A little over a year ago we caught considerable flak for our posts about Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007) (en banc), the case that ruled against any constitutional right of patient access to unapproved, experimental, but potentially lifesaving drugs. We said then
We’ve watched from a distance as the FDA has considered whether certain drugs indicated for epilepsy are associated with increased suicidality.
Please don’t confuse us with biostatisticians; we don’t even play ’em on TV.
But we looked at the evidence that epilepsy drugs are associated with suicidality, and we’re scratching our heads.
First, the FDA
We’re getting déjà vu all over again this morning, reading the story about spine surgery in this morning’s New York Times. It’s not just that it reminds us of Zyprexa – although it does – with a Times reporter talking to the plaintiff’s side and somehow gaining access to “confidential documents from a plaintiff’s
We’re taking it on the chin in the “comments” over at the Volokh Conspiracy. Jonathan Adler linked to our post yesterday about the Abigail Alliance case, and the scholars are lining up to say that pharmaceutical companies are not “state actors” and so would never be compelled to provide experimental drugs to terminally ill patients.
Nobody who reads our blog can have any doubt that we’re four-square in favor of allowing drug and device manufacturers (our clients) to engage in the truthful promotion of off label uses. It’s not just that we think the restrictions are unconstitutional (although we do); it’s that we think that off-label use saves lives and