FDA May Begin To Crack Down On Stem-Cell Therapies
Also in public health news, the penicillin shortage endangers people with syphilis. Meanwhile, in tobacco news, black health experts target menthol cigarettes and questions are raised about Newport's aggressive campaign aimed at younger smokers. And Stat reports on transplant ethics when the donor overdosed.
The Washington Post:
Stem-Cell Clinics Face New Scrutiny From Federal Regulators
The FDA, which has taken a mostly hands-off approach toward the rapidly proliferating stem-cell clinics, is signaling that some of the treatments should be regulated as drugs are, which would require advance approval. That would entail a lengthy process, with extensive safety and effectiveness data, at a potential cost of millions of dollars. The issue has ignited a fierce debate among physicians, patients, scientists and politicians about whether the agency should crack down on therapies that critics deride as snake oil but that some patients swear by. And it is fueling a broader, longer-term debate over how cellular therapies should be regulated. (McGinley, 9/12)
Penicillin Shortage Threatens Syphilis Patients
Pharmacists are concerned that several forms of penicillin are in shortage, including one used as the primary treatment for syphilis. Penicillin G Benzathine, which comes in a pre-filled syringe known by the brand name Bicillin L-A, has been in shortage since spring. The medicine is the first-line treatment for syphilis, meaning that, although there are alternatives, it is highly preferred over other treatments. (Rubenfire, 9/13)
The New York Times:
Black Health Experts Renew Fight Against Menthol Cigarettes
Menthol cigarettes account for about a third of all cigarettes sold in the United States, and they are particularly popular among black smokers — about four out of five report smoking them, according to federal surveys. The effects are devastating: About 45,000 African-Americans die each year from smoking-related illnesses — the largest cause of preventable death, more than homicides, AIDS and car accidents. Black men have the highest lung cancer mortality rate of any demographic group. (Tavernise, 9/13)
The Wall Street Journal:
Newport’s ‘Pleasure Lounge’ Aims To Ignite Cigarettes Sales
Workers for Newport, the nation’s No. 2 cigarette brand, spent the summer handing out coupons for cigarettes at a price of $1-a-pack. That is five cents a smoke. Usually they cost about seven times that much. The vouchers—distributed at concerts, bars and convenience stores—have been part of an aggressive push by Newport-owner Reynolds American Inc., to target young adult smokers and boost Newport sales. (Mickle and Valentino-Devries, 9/13)
Should Transplant Surgeons Tell Patients Their Donor Was An Addict?
Under normal circumstances, a doctor would not consult the patient before accepting an offered organ. Once an algorithm has determined that an organ could be a good match for a recipient, that person’s surgeon has an hour to make sure it is indeed a good fit. If it’s not, the organ goes to the next patient on the list. But in special cases, the surgeon needs the patient’s informed consent before accepting the organ. It could be that the kidney or lung comes from an older donor, and so may not last very long. Or the donor could be defined by the Public Health Service as being at an “increased risk” of carrying an infectious disease such as hepatitis C or HIV. (Boodman, 9/14)