Capital Capsules for Sept. 17, 2001
The consumer activist group Public Citizen has petitioned the FDA to halt the production and sale of dietary supplements containing ephedrine alkaloids, such as ephedra and ma-huang, charging that they increase the risk for heart attacks, strokes, seizures, and hypertension. "These supplements are marketed as all-natural and safe, but in reality they are not safe," said Sidney M. Wolfe, M.D., director of Public Citizen's Health Research Group. "They can harm and kill."
Public Citizen said it obtained FDA records of 3,308 adverse events related to nutritional supplements and found 1,398, or 42%, were associated with ephedra, including 81 deaths between 1993 and 2000. There also were reports of 32 heart attacks, 62 cases of cardiac arrhythmia, 91 reports of hypertension, 69 strokes, and 70 seizures.
"We don't feel the data ... justify this call for a ban," responded Corinne Russell, the Consumer Healthcare Products Association's v.p. for public affairs. "Numerous experts have severely refuted much of the data [Wolfe is] referring to here."
Some 200 products containing ephedra are aimed in the United States at dieters, body-builders, and athletes. Often the products are combined with caffeine or other stimulants. In June, Canadian health officials warned consumers not to take any of them. In 1997, the FDA wanted ephedra labeling to recommend that daily consumption be held to 24 mg and that use should not continue for more than seven days. The agency later backed down in the face of industry opposition. It also held two days of public hearings on ephedra's safety last year but reached no conclusions.
CVS Corp. has agreed to pay the federal government and 20 states $4 million to settle allegations that it dispensed partially filled Rxs because of short stocks but billed the government for the full amounts. In some cases, the patients returned to pick up the remaining medication, other times they did not. The chain also signed a corporate integrity agreement with the HHS Office of Inspector General that sets out strict procedures for handling partial-fill claims. NACDS recently complained to the OIG that it had cracked down on pharmacies over partial-fill billing without giving them guidance on how they should proceed. In 1999, Walgreen Co. settled a similar case, and in July, Eckerd agreed to pay $1.7 million in federal criminal fines.
An NIH report found that federal research funds contributed to the development of four recent "blockbuster" drugs, but the agency admitted the government's direct contribution to the final product is "limited and difficult to determine." The drugs are Epogen (erythropoietin, Amgen), Neupogen (filgrastim, Amgen), Procrit (erythropoietin, Ortho), and Taxol (paclitaxel, Bristol-Myers Squibb). NIH looked at 47 drugs with sales of at least $500 million in 1999. Critics have long complained that drugmakers get substantial federal help, but taxpayers get stuck with high prices for their investment.
Mike Conlan. Capital Capsules.