[lou_lou]

Amgen Says:

Doctors Reevaluating Initiation of ESA Therapy
Physicians are reevaluating when to initiate therapy with erythropoiesis-stimulating agents (ESAs), Amgen announced during its first-quarter earnings call.
“We estimate about 25 percent of doctors are reassessing when to initiate therapy,” George Morrow, Amgen’s vice president of commercial operations, said. “This remains one of the most uncertain areas going forward.”

Amgen markets two ESAs, Aranesp (darbepoetin alfa) and Epogen (epoetin alfa). Sales of Epogen increased 3 percent to $625 million during the first quarter of 2007, compared with the same period last year.

Sales of Aranesp increased 14 percent to $1.02 billion during the first quarter of 2007 versus the first quarter of 2006. However, sales were down nearly 7 percent from the fourth quarter of 2006. Amgen said the results reflected both “soft January sales results from modest … buyings in December” and safety concerns with ESAs that the FDA highlighted in March.

The FDA’s concerns with ESAs included a warning to physicians that target hemoglobin levels should not exceed 12 grams/dL for patients with chemotherapy-induced anemia, and those with kidney disease.

The agency also said it would discuss the apparent effects these products have on patients with cancer at a May 10 Oncologic Drugs Advisory Committee meeting. It plans to specifically address reductions in time-to-progression and potential contributors to tumor growth.

Research Subjects Don't Understand Informed Consent, Experts Say
Fewer than half of study coordinators and principal investigators surveyed at a recent institutional review board (IRB) conference said they check whether clinical trial subjects actually understand the informed consent forms (ICFs) they sign, according to an official at BBK Worldwide.

Moreover, a recent study by the Institute of Medicine published in the Archives of Internal Medicine found that only three out of 10 subjects “said they fully understand what they have heard,” Tammi Jaynes, global training specialist with INC Research, said.

The same survey found that 57 percent of participants in one study “did not recall that the treatment they were receiving was part of a clinical trial,” she added. Linda Wolf, who does site support services for BBK Worldwide, and Jaynes spoke following a workshop on informed consent at the Association of Clinical Research Professionals’ annual conference.

It is not unusual for an ICF to be 13 to 15 pages long, which raises serious questions of just how much subjects really understand before they sign it, Jaynes said. “Assessing comprehension is so important. And with the decisionally impaired, did they sign during their period of lucidity? People gloss over it, and some people may be embarrassed to ask questions.”

“You must make sure that subjects understand what they are volunteering for,” Deborah Toich, human research protection communications manager for the independent IRB Chesapeake Research Review, said in a separate presentation at the conference.

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FDA Proposes Warnings to Young Adults Using Antidepressants
Young adults beginning treatment with antidepressants should be warned about an increased risk of suicidal thoughts and behavior, U.S. health officials said Wednesday.
International Herald Tribune

Drugmakers Face $140 Bln Patent Loss: Report
The world's top drugmakers face the loss of $140 billion in annual sales by 2016 as key product patents expire and cheap generic versions of their blockbuster medicines hit the market, according to a report on Wednesday.
Yahoo Finance

Cardiome Licenses Eli Lilly Compound
Cardiome Pharma Corp. said Monday it received exclusive worldwide rights to Eli Lilly & Co.'s protein GED-aPC, which will initially be developed as cardiogenic shock treatment.
ABCmoney