M.S. Drug Linked to Liver Damage

[flashl]

WASHINGTON (AP) — Shares of two drug makers, Biogen Idec and the Elan Corporation, fell Wednesday after the companies reported that some patients had liver injuries after taking the drug Tysabri, a treatment for multiple sclerosis and Crohn’s disease.

The companies issued a warning to doctors that signs of liver injury appeared in patients as early as six days after first taking Tysabri. Shares of Biogen Idec fell $1.40, to $60.13; Elan’s American depositary receipts fell $1.54, to $22.77, in trading on the New York Stock Exchange.

The Food and Drug Administration posted the warning online and said patients with any signs of liver damage should stop taking the drug. Regulators updated the product’s labeling to highlight liver risks last month, when it was approved to treat the intestinal disorder Crohn’s disease.

A spokeswoman for Biogen said the company had sent the letter to 2,500 doctors who prescribe the drug for multiple sclerosis and may not have seen the updated labeling. She said liver problems had been reported by fewer than one in 1,000 Tysabri patients. The drug posted sales of $343 million for Biogen last year.

NY Times

[independentpiney]

1. potential risks outweigh the benefits with most MS drugs

in my opinion. and their success rates are really not that high. I keep hoping they'll get a real breakthrough soonn.

[flashl]

2. We have gotten very cerebral about the notion of benefits.

Cancer Drug Ruling Will Have Wide Impact

A decision expected Friday on federal approval for Genentech's Avastin cancer drug could have ramifications for all companies developing cancer medicines.

Genentech made its case for Food and Drug Administration approval of Avastin using a widely debated measure of drug effectiveness that focuses on tumor growth, not patient survival.

...

In December, a panel of outside FDA advisers voted 5 to 4 against Genentech's application, arguing the drug's benefits did not outweigh dangerous and toxic side effects.

Chicago Tribune

[independentpiney]

3. Sounds like the FDA advisers made the right call on that

Genentech made its case for Food and Drug Administration approval of Avastin using a widely debated measure of drug effectiveness that focuses on tumor growth, not patient survival.
I don't want to think of the consequences if that measure of effectiveness gained acceptance.

[flashl]

6. FDA approved it. nt

[Celebration]

7. FDA now totally out of control

Completely ridiculous endpoint. Let's hope the breast cancer patients do their own research on this. Unfortunately, oncologists have a vested interest in the chemotherapy that they sell.

They pick on cherry growers, fail to inspect heparin manufacturing facilities, and now this. Oh, not to mention that they tried to shut up David Graham, their own employee, on Vioxx.

Who does everyone think they serve?

Ugh. Blah.

[Jim__]

9. Do you know what the rationale for their decision was? - n/t

[flashl]

10. Here is an article ...

the Food and Drug Administration's approval was conditional, allowing the drug to be sold based on limited studies. Genentech will be required to submit more studies to win full FDA approval, a process likely to take several years, said Dr. Richard Pazdur, director of the FDA's Office of Oncology Drug Products.

If those studies turn up new concerns about the drug's safety or evidence it isn't effective, the FDA could revoke Avastin's approved use for breast cancer, he said.

Trading Markets

[Jim__]

12. Thanks - n/t

[mzmolly]

11. Not at all surprised.

:(

[Jim__]

4. I can't get your link to work - I get to the Tribune - but page not found. - n/t

[flashl]

5. Tribune must have re-org pages. Try one of these

PHYSORG

Miami Herald

[Jim__]

8. Thanks - they both work. - n/t