Drug industry roundup: Fosamax trial focuses scrutiny on osteoporosis drugs; What about $4 generics; Recalls undermining confidence

The New York Times: A civil trial against the drugmaker Merck is now underway in Manhattan. A retired investigator for the U.S. army is one of 1,400 people suing the company on the premise that Fosamax, a Merck drug used by millions of women with thinning bones, caused them to develop jawbone ailments. Merck had previously won one of these "bellwether cases," but the Manhattan trial "is providing a palpable backdrop for a broadening debate among many doctors and researchers who are rethinking Fosamax and similar bone medications known as oral bisphosphonates, particularly as a treatment for women who have not yet developed osteoporosis" (Singer, 11/10).

The Wall Street Journal's Health Blog: Four-dollar generic drug prescriptions for medications such as the diabetes drug metformin, popularized at large retail pharmacy chains like Walmart, may reduce "economic barriers" to accessing medication—but may also have a negative "unintended consequence," according to Harvard researchers writing in the New England Journal of Medicine. "When consumers pay $4 cash for a prescription, there's no incentive for pharmacies to go through the hassle of submitting the claim," and that can adversely affect the claims data collected by insurers and pharmacy-benefit managers. The claims data is used by health care industry analysts to "evaluate and monitor the functioning of the health-care system," according to a co-author of the piece, and "quality improvement efforts" could be hindered in the absence of unreported claims. However, it's difficult to gauge how many "lost claims' aren't being captured," the researcher said (Hobson, 11/10).

Reuters/MSNBC: A "steady stream of high profile product recalls is undermining confidence in top drugmakers," a trend industry officials and experts attribute to "enhanced regulatory scrutiny." The lack of quality control may be a consequence of "drugmakers, biotechs and medical device companies prop(ping) up their profits through aggressive cost-cutting," an FDA official speculates. "Problems can stem from simply putting off routine plant maintenance to seeking cheaper overseas suppliers for seemingly innocuous materials used for storing and shipping products," and "good manufacturing practices may be the first thing to suffer" when mass layoffs occur in the healthcare industry" (Berkrot and Richwine, 11/10).


http://www.kaiserhealthnews.orgThis article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

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