Do anemia warnings signal new limits?

Is it a pre-emptive strike? Late Friday Amgen added new warnings to the embattled anemia drugs Aranesp (Amgen) and Procrit (Johnson & Johnson). The labeling for those drugs now warns that they sped up tumor growth and increased the risk of death in patients with breast cancer and cervical cancer. The additional "black box" warnings came less than a week before an FDA advisory committee meeting where experts will review safety data for the drugs.

The anemia meds have been under public scrutiny since last March; since then, the FDA, Canadian regulators, the Center for Medicare Services, and the Department of Veterans Affairs all have issued warnings or restrictions on the use of the drugs. Sales of the drugs have fallen off by a quarter, and Amgen's shares have dropped by some 27 percent.

Most analysts are expecting sales to drop further after Thursday's advisory panel meets. The group could recommend halting use of the drugs for certain cancers or in all cancer patients. Even if the FDA cuts off only some cancer indications, Amgen's anemia drug sales could lose between $150 million and $250 million, one analyst said. The effect would be worst if FDA changes led to tougher restrictions from Medicare, which last fall stopped reimbursing docs who administer the drugs unless they're given at low doses.

Amgen scientists are expected to fight against new limits by arguing that any safety problems have arisen in patients given higher-than-recommended doses. Also, the company contends that the drugs' risks don't outweigh the hazards of the alternative treatment: blood transfusions.

- read the report [1] from the Houston Chronicle
- check out the AP article [2]
- see the analysis [3] in Business Week

ALSO: Amgen CEO Kevin Sharer [4] said last year was the most difficult in Amgen's history. "This is the most challenging time," he told The Wall Street Journal in a Q&A published today. Sharer also talked about innovation and new drugs.

- find the Q&A [5] in the WSJ

Related Articles:
Study: Anemia meds hike death risk 10%. Report [6]
Medicare: Right to restrict anemia meds. Report [7]
New Medicare cap on anemia drugs could hammer Amgen. Report [8]
Amgen income hammered as anemia drug use drops. Report [9]
FDA: More risks from anemia drugs. Report [10]
Analyst: Anemia drug warnings 'not bad'. Report [11]