Policy & Practice


New Osteoporosis Health Claims

Officials at the Food and Drug Administration are proposing to allow a new health claim stating that foods and dietary supplements containing both calcium and vitamin D have the potential to reduce the risk of osteoporosis. The FDA currently allows manufacturers to make only health claims linking calcium intake to a reduced risk of osteoporosis. The new proposal would also broaden the health claim that can be made for products containing calcium by dropping references to sex, race, and age. The change is being proposed based on an FDA review of the scientific evidence, including the 2004 Surgeon General's report on bone health and osteoporosis.

Part D Battle Begins in Congress

As promised during the midterm elections, House Democrats began work immediately on tweaking Medicare's Part D drug coverage. Rep. John Dingell (D-Mich.), along with 189 colleagues, introduced H.R. 4, the Medicare Prescription Drug Price Negotiation Act of 2007, which would require the Health and Human Services department to negotiate prices with drugmakers. The legislation was passed by the House in January by a vote of 255–170. While two senators have taken up the cause—Harry Reid (D-Nev.) and Benjamin Cardin (D-Md.)—it appears the Senate will take a more measured approach. The Senate Finance Committee held hearings Jan. 11 to investigate the impact of price negotiations. If the legislation is enacted as written, new prices would go into effect for the plan year beginning Jan. 1, 2008.

Stem Cell Research Debate Continues

Members of the House of Representatives approved legislation last month that would expand federal funding for human embryonic stem cell research. The bill, H.R. 3, must still be passed in the Senate and faces a potential veto by President Bush, who previously has vetoed the same legislation. In the meantime, states are moving forward with their own stem cell projects. New Jersey Gov. Jon S. Corzine (D) recently signed a law that authorizes the use of $270 million to build stem cell research centers and other facilities for cancer and biomedical research. The bulk of the funding ($150 million) is designated for construction of the Stem Cell Institute in New Brunswick; another $50 million will go to building other stem cell research facilities. The legislation also includes $10 million for cord blood collection to be used in support of stem cell research.

Cancer Care Time Costs Add Up

The cost of the time spent by cancer patients in fighting their illness amounted to approximately $2.3 billion in 2005, according to a study published in the January issue of the Journal of the National Cancer Institute. The researchers analyzed the time that cancer patients spent getting to and from appointments, waiting for care, consulting with physicians, and undergoing treatments. They valued that time at $15.23 per hour, the median U.S. wage rate in 2002. The researchers used data from the Surveillance, Epidemiology, and End Results-Medicare database to find the net patient time costs associated with cancer care for 11 common tumor sites. They analyzed records for 767,010 patients who were initially diagnosed between 1973 and 1999 and were 65 years or older during the study observation period of 1995–2001, and included 1,145,159 matched controls. The net patient time costs associated with medical care during the first 12 months after diagnosis were lowest for melanoma ($271) and prostate cancers ($842) and highest for gastric ($5,348) and ovarian ($5,605) cancers. In most cases, hospital stays accounted for the greatest net time costs.

Weight Loss Supplement Settlement

The Federal Trade Commission recently reached a settlement with manufacturers of four dietary supplement products to limit future advertising claims of weight loss and weight control. Manufacturers of the four products—Xenadrine EFX, CortiSlim, TrimSpa, and One-A-Day WeightSmart—also agreed to pay a total of at least $25 million in cash and other assets. The manufacturers did not admit any violation of the law as part of the settlement. The FTC had alleged that the manufactures of Xenadrine EFX had made false or misleading claims that the product could cause rapid and substantial weight loss. The marketers of CortiSlim faced charges from the FTC that they had falsely claimed that the product would cause weight loss and reduce the risk of serious health conditions. The TrimSpa marketers were alleged to have had inadequate scientific evidence to show that the product causes rapid and substantial weight loss and that one of its ingredients, Hoodia gordonii, works as an appetite suppressant. The marketer of the One-A-Day WeightSmart multivitamin settled FTC allegations that it made unsubstantiated claims of increasing and enhancing metabolism, preventing some weight gain, and controlling weight.

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