Bill Seeks Consent for Off-Label Rx
A new bill in the California assembly would require physicians and surgeons to get informed consent from their patients before “prescribing, administering, or furnishing” a prescription for off-label use. A failure to adhere to the requirement would be considered a violation of the Medical Practice Act, which means physicians could be charged with a crime. The California Medical Association opposes the legislation. In a statement, the CMA said existing law is enough because physicians can be held liable for not disclosing risks. Off-label use often saves lives, the statement said. A.B. 2856 was introduced by Assemblywoman Loni Hancock (D-Berkeley). It would require physicians to specify that a medication is not approved by the Food and Drug Administration for the use that the doctor is recommending, that the risks are unknown, and that there is not a consensus on the drug's efficacy. A patient could withdraw consent at any time.
Women's Heart Health
A group of female lawmakers has introduced a bill to require gender-specific data in new drug and device applications and to expand free screening for low-income women. The HEART (Heart Disease Education, Analysis and Research, and Treatment) for Women Act (S. 2278) was introduced by Sens. Debbie Stabenow (D-Mich.) and Lisa Murkowski (R-Alaska). Reps. Lois Capps (D-Calif.) and Barbara Cubin (R-Wyo.) introduced the House companion bill (H.R. 4747). Few people realize that heart disease is the No. 1 killer of women, said Rep. Capps in a statement. The bill seeks to fund an education awareness campaign for physicians and patients, and to bar Food and Drug Administration approval of a drug or device if it does not include gender, race, and ethnicity data. It also calls for an annual report on women and heart disease to be compiled by the Agency for Healthcare Research and Quality and for hospital-quality data to be reported by gender. Finally, the bill would expand the WISEWOMAN (Well-Integrated Screening and Evaluation for Women Across the Nation) heart disease and stroke screening program from 14 states to all 50. The bill is supported by the American Heart Association, the American Stroke Association, and the National Coalition for Women with Heart Disease.
Smoking Rates Drop
The number of cigarettes sold in the United States in 2005 dropped 4.2% from 2004, the largest 1-year percentage decrease in sales since 1999, according to figures compiled by the Treasury Department. “We are pleased to see that the long decline of cigarette consumption is continuing,” Cheryl Healton, Dr.P.H., president of the American Legacy Foundation, said in statement. “We also know that for the first time in the United States, there are more former smokers than current smokers.” The National Association of Attorneys General also applauded the numbers, noting that the drop continues “the unprecedented long-term decline in cigarette smoking that began with the settlement of lawsuits” brought by state attorneys general against the major tobacco companies.
Survey: Part D Enrollees Happy
A new survey of Medicare beneficiaries who are receiving Part D drug benefits finds them to be largely satisfied. The survey—conducted 10 weeks into the new coverage—was paid for by America's Health Insurance Plans, and conducted by Ayres, McHenry & Associates Inc., a Republican polling firm. The poll surveyed 408 of the 5.2 million people over age 65 years who have self-enrolled in Part D, and 401 of the 6.5 million “dual eligibles,” who were automatically enrolled because they had Medicaid drug coverage. Of those who self-enrolled, 66% said that it had been worth the time and effort to enroll, and four-fifths (84%) said that they had no problem signing up. The majority—85%–90% of both groups—said they had no problem using the new benefit. Ron Pollack, executive director of the advocacy group Families USA, said it was not surprising that beneficiaries who went to the trouble to sign up were happy. Shockingly few have signed up, however, said Mr. Pollack. According to the poll, among those who regularly take a prescription drug—90% of the self-enrolled and 83% of dual eligibles—79% said the plan covered the drugs they needed. Mr. Pollack said that was a step backward for the low-income group, who had 100% coverage under Medicaid. A little more than half (59%) of self-enrolled seniors said they are saving money. Forty-six percent of the self-enrolled and 35% of automatically enrolled seniors said Part D critics were bashing the plan to score political points; 14% in both groups said politicians were sincerely trying to fix the plan; about half were undecided.