Policy & Practice


Wyeth Loses Prempro Suit

A Pennsylvania jury has found that the hormone therapy Prempro was a cause of a woman's breast cancer in the case of Jennie Nelson v. Wyeth. At press time, the liability phase of the trial was set to begin; the jury will determine whether Wyeth is liable and is required to pay $1.5 million in compensatory damages. The jury will also decide whether punitive damages should be awarded to the plaintiff. Wyeth officials plan to argue that they “acted responsibly” by performing and supporting studies that evaluated the benefits and risks of hormone therapy, according to a company statement. Wyeth officials also disagreed with the jury's conclusion that Prempro caused the plaintiff's breast cancer, saying there was no scientific basis for that finding. The decision comes on the heels of a September Wyeth victory in a federal case alleging that the Premarin and Prempro products had caused the plaintiff's breast cancer. In the case of Linda Reeves v. Wyeth, the jury said that the plaintiff had not proved that the company had inadequately warned patients of the known risks of hormone therapy treatment.

Teen Abortion Restriction Stalled

Abortion rights advocates are claiming victory after attempts to bring up the Child Interstate Abortion Notification Act were stopped in the Senate. The lack of votes in the Senate means that the legislation, which passed the House in September, is unlikely to reach the president's desk this year. S. 403 would impose fines or prison time on anyone who assisted a minor in crossing state lines to access abortion services in an effort to skirt parental notification and consent laws in the minor's home state. Physicians would also be liable under the law if they performed an abortion on a minor from another state unless they notified the parent at least 24 hours before the procedure.

AIDS Treatment Wait Lists Persist

State AIDS Drug Assistance Programs continue to struggle to keep up with demand, according to the October report of the National Alliance of State and Territorial AIDS Directors. As of September 2006, 302 individuals were on waiting lists for HIV treatment in six states. AIDS Drug Assistance Programs (ADAPs) around the country serve individuals with HIV/AIDS who are low-income, uninsured, or underinsured. Three states also have implemented cost-containment measures such as offering a reduced formulary or imposing an annual per capita expenditure limit. Increased funding is needed to meet demand, according to Julie Scofield, executive director of the National Alliance of State and Territorial AIDS Directors, estimated at $197 million more than the fiscal year 2006 funding levels. “Without a permanent commitment to stable, predictable funding at levels that keep pace with demand, waiting lists will soon become a permanent feature of ADAPs,” she said in a statement.

Supplement Use Undisclosed

More than one-fifth of individuals taking prescription drugs also took a nonvitamin dietary supplement in the last year, according to a study published recently in the Archives of Internal Medicine. Further, 69% of those who used both prescription drugs and supplements failed to tell a physician about their supplement use, the researchers found. The researchers analyzed data from the 2002 National Health Interview Survey, which included 31,044 respondents. Of prescription medication users, the highest rates of supplement use were among menopausal women (33%), individuals with chronic gastrointestinal disorders (28%), and individuals with severe headache or migraine (28%). Patients with heart failure, coronary heart disease, or a history of myocardial infarction were among those reporting the lowest rate of supplement use.

Coalition Seeks More FDA Funds

A coalition of strange bedfellows has joined together to call on the White House and Congress to increase funding for the Food and Drug Administration, saying that the agency's mission and responsibilities have expanded hugely while its appropriations have failed to keep up with inflation or with the growing largess going to other agencies like the National Institutes of Health. That NIH investment will likely result in a large number of new products, all of which the FDA will have to regulate, according to the Coalition for a Stronger FDA. The agency also needs help coping with growing pharmaceutical, medical device, and food safety issues, the group said. The coalition includes the Consumer Federation of America, the Center for Science in the Public Interest, the Grocery Manufacturers Association, the Biotechnology Industry Organization, and the Advanced Medical Technology Association, among others. Cochairing the coalition are the last three secretaries of Health and Human Services: Tommy G. Thompson, Donna E. Shalala, and Louis Sullivan.


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