Judge: FDA can't police drugs alone

As Eli Lilly went up to bat in the big Zyprexa trial in Alaska [1], the judge said lawsuits play a vital role in drug safety. Without them, claims of safety problems "might well go unaddressed," Judge Mark Rindner told the court. Evidence the State of Alaska presented over the past two weeks, he said, shows that the FDA "isn't capable of policing this matter."

Why the commentary? After the state rested its case, Lilly asked the judge for an immediate verdict in its favor (a routine step at this stage of a trial). The FDA should be dealing with these matters, not states, the lawyer said. Rindner, of course, begged to differ.

So the case proceeded. Lilly trotted out a couple of experts: One not only questioned the link between Zyprexa and diabetes, but the link between weight gain and diabetes. Another said doctors should have known about the weight gain problems anyway, and that Zyprexa's side effects are far outweighed by its benefits. The drugmaker will continue to tell its side of the Zyprexa story this week. Stay tuned.

- read the story [2] at the Anchorage Daily News
- check out the item [3] at Pharmalot

Related Articles:
Did Lilly chief support off-label promos? Report [4]
Former FDAer: Lilly hid risks for profit. Report [5]
Lilly gears up for Alaska's Zyprexa trial. Report [1]
Lilly strengthens Zyprexa warnings. Report [6]