Tuesday, January 19, 2010

Health Headlines - January 19

FDA Wants to Tighten Tanning Bed Regulations

Stricter regulation of tanning beds will be discussed at public meetings beginning in March, says the U.S. Food and Drug Administration.

"We don't recommend using them at all, but we know people do use them so we want to make them as low-risk as possible," Sharon Miller, the FDA's UV radiation specialist, told the Associated Press.

Currently, the FDA regulates tanning beds as "Class I devices," a low-risk classification that includes bandages. While tanning beds do carry some warnings about skin cancer risk, the FDA has decided the warning labels should be more visible to consumers and include stronger wording about the risks.

No new science justifies increased FDA regulation, according to the Indoor Tanning Association, the AP reported.

Last summer, the World Health Organization's cancer division declared that tanning beds definitely cause skin cancer. This came after an analysis of numerous studies showed that people who use tanning beds in their teens and 20s have a 75 percent increased risk of melanoma, the deadliest type of skin cancer.

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New Bone Marrow Transplant Technique Promising: Study

U.S. scientists say they've conducted the first human tests of a new technique that may eventually eliminate the need to find matching donors for patients who need bone marrow transplants.

The team at the Fred Hutchinson Cancer Research Center in Seattle found a way to manipulate a signaling pathway in order to greatly multiply the number of umbilical cord stem cells available for transplant, BBC News reported.

The technique proved successful in initial animal studies and subsequent tests in human patients. The study appears in the journal Nature Medicine.

"The holy grail is to have an 'off the peg' source of unlimited numbers of 'neutral' stem cells which can be given to any patient safe in the knowledge that they will not cause the very difficult 'graft versus host' problems that lead to rejection and often the death of the patient," Dr David Grant, scientific director of the charity Leukemia Research in Great Britain, told BBC News.

"This is a promising development towards this because the concern has been that once stem cells start 'growing,' they lose their stem cell properties and progress to ordinary blood cells with a very limited lifespan.," Grant added.

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FDA Warns of Counterfeit Alli Weight-Loss Drug

A warning about a counterfeit and potentially harmful version of the popular over-the-counter weight loss pill Alli was issued Monday by the U.S. Food and Drug Administration.

The agency said preliminary laboratory tests conduced by Alli manufacturer GlaxoSmithKline revealed that the counterfeit version of Alli 60 mg capsules (120 count refill kit) don't contain orlistate, the active ingredient in the genuine product.

Instead, the counterfeit pills contain sibutramine, a drug that shouldn't be used by certain patients or without physician oversight, the FDA said. In addition, sibutramine may cause harmful interactions with other medications a patient takes.

The counterfeit version of Alli was sold over the Internet. GlaxoSmithKline began receiving consumer reports of suspected counterfeit Alli early last December.

While the counterfeit Alli looks like the authentic product, a few notable differences exist, the FDA said. The counterfeit Alli has:

  • Outer cardboard packaging missing a "Lot" code.
  • Expiration date that includes the month, day and year (e.g., 06162010). The expiration date on authentic includes only the month and year (for example, 05/12).
  • Packaging in a plastic bottle that has a slightly taller and wider cap with coarser ribbing than the genuine product.
  • Plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with "SEALED for YOUR PROTECTION."
  • Contains larger capsules with a white powder, instead of small white pellets.

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Doctor Accused of Faking Painkiller Studies

A U.S. doctor has agreed to plead guilty to health care fraud in connection with faked research on painkillers that was published in medical journals.

Anesthesiologist Dr. Scott Reuben, the former chief of acute pain at Baystate Medical Center in Springfield, Mass., agreed to plead guilty in exchange for a more lenient sentence that includes up to 10 years in prison, a $250,000 fine and forfeiture of assets worth at least $50,000 that he received for the research, according to court documents, the Associated Press reported.

It's alleged that Reuben applied for and received research grants from drug makers but never performed the studies. Instead, he made up some or all patient data contained in 21 studies published in anesthesiology journals between 1996 and 2008.

The ruse was discovered after the hospital launched a routine review last year. Baystate Medical Center has asked the journals to retract the studies, the AP reported.

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