WHI Results Still Confusing
Just 18% of physicians said they have “no confusion at all” about the results of the Women's Health Initiative study, according to an online survey of more than 400 physicians conducted on behalf of The Hormone Foundation. In addition, only 15% said they believe patients accurately understand the risks of hormone therapy. The results “underscore the importance of physicians' role in educating patients and [the public] on menopause management,” said foundation director Paula Correa. The survey, sponsored by Novogyne Pharmaceuticals, also found that 74% of physicians still consider hormone therapy as a first-line treatment for menopause symptoms. Novogyne manufactures the hormone therapy patches, Vivelle-Dot, Vivelle, and CombiPatch.
Aventis Settles Pricing Fraud Case
Drugmaker Sanofi-Aventis has agreed to pay more than $190 million to settle allegations of fraudulent drug pricing and marketing against Aventis Pharmaceuticals, one of its predecessor companies. According to the U.S. Department of Justice, Aventis used the difference between the inflated prices that were used to set reimbursement rates and the actual prices charged to customers to market the antiemetic, Anzemet. In doing so, it caused fraudulent claims to be submitted to Medicare and other federal health care programs. The case arose after Ven-A-Care of the Florida Keys Inc. filed a False Claims Act suit, which allows a private person to file a whistle-blower suit on behalf of government. To continue working with federal programs, Sanofi-Aventis agreed to report accurate prices. Almost $180 million of the settlement will go to the federal government and the balance, to states and the District of Columbia. The whistle blowers will receive about $32 million.
Insurance Premium Increase Slows
Employer-sponsored health insurance premiums rose on average 6.1% in 2007, reflecting a continuing slowdown in premium increases. The 2007 premium increase is the smallest hike since 1999, according to an employer survey by the Kaiser Family Foundation and the Health Research and Educational Trust. But experts say the slowdown is likely temporary and isn't providing relief to individuals or employers. In fact, the 6.1% increase is higher than the average increase in wages (3.7%) and in the overall inflation rate (2.6%). In 2007, the average premium for family coverage in the United States is $12,106 with workers paying about $3,281 for their share of the policy. The market continues to be dominated by preferred provider organizations, which insure about 57% of covered workers; consumer-driven plans account for only about 5%. For details, visit
Rise in Adverse Drug Event Reports
The number of serious and fatal adverse drug events (ADEs) reported to the Food and Drug Administration more than doubled between 1998 and 2005, according to a report in the Sept. 10 issue of Archives of Internal Medicine. The agency defines a serious adverse event as an event resulting in death, a birth defect, disability, hospitalization, or that requires intervention. During the 8-year period, 467,809 serious events met the inclusion criteria. The number of reported serious ADEs increased from 34,966 in 1998 to 89,842 in 2005, a 2.6-fold increase; the number of reported deaths during that time increased 2.7-fold, from 5,519 to 15,107. The increase was largely a result of expedited reports from manufacturers of serious events not included on the label. Contrary to expectation, drugs related to safety withdrawals accounted for a “modest share” of reported events and declined over time. Of the 15 drugs most frequently cited in fatal events, there was a “disproportionate contribution of pain medications [7] and drugs that modify the immune system [4].” Drugs named in serious ADEs spanned a variety of classes, but within that group, events tied to 13 new biotechnology products increased almost 16-fold, from 580 in 1998 to 9,181 in 2005.
Bill Seeks MD Gift Disclosure
Legislation in the Senate would require quarterly disclosure of gifts, honoraria, travel, and other payments to physicians by pharmaceutical, medical device, and biotechnology manufacturers. S. 2029 was introduced by Sen. Chuck Grassley (R-Iowa) and Sen. Herb Kohl (D-Wisc.) and would apply to manufacturers with more than $100 million in gross revenues. The U.S. Health and Human Services Department would be required to make the disclosure data available on the Internet. Penalties would range from $10,000 to $100,000 per violation. Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said in a statement that his group had not yet reviewed the bill but that contact with physicians is essential for education purposes. The group's guidelines suggest gifts to physicians should not exceed $100. The American Medical Association had also not yet read the proposal, but in testimony earlier this year, noted that it has extensive guidelines on accepting anything from industry.