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. For dermatologists, the requirements "would bring many a practice to a snail's pace," said John R. Valencia, a lobbyist for the California Society of Dermatology and Dermatologic Surgery. Karmi A. Ferguson, executive director of the organization, said the legislation "is on our hot list." If passed, the bill would not reach the governor's desk until September, but "we're hoping to kill it in committee," said Ms. Ferguson. AB 2856 was introduced by Assemblywoman Loni Hancock (D-Berkeley). It would require physicians to specify that the 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 efficacy. A patient could withdraw consent at any time.
Botox Popularity
In 2005, the most popular nonsurgical cosmetic treatment was Botox injection, with almost 3.3 million procedures, according to the American Society for Aesthetic Plastic Surgery. Laser hair removal was second, with 1.5 million treatments in 2005. Rounding out the top five: hyaluronic acid injection (almost 1.2 million); microdermabrasion (1 million); and chemical peel (more than 550,000). The total number of nonsurgical procedures dropped 4% to 9.3 million. Last year, Americans spent $12.4 billion on cosmetic procedures$8.2 billion for surgical and $4.2 billion for nonsurgical. To get the data, ASAPS sent 14,000 questionnaires to plastic surgeons certified by the American Board of Plastic Surgery and to other specialists.
MDs Preferred for Cosmetic Tx
A still-small but growing number of Americans are electing to have invasive (7% of those polled) and noninvasive (8%) cosmetic treatments even though these procedures are rarely covered by insurance, according to a Wall Street Journal Online/Harris Interactive Health-Care Poll. Noninvasive treatments included teeth whitening and cosmetic dental work, chemical and other facial skin resurfacing, filler injections, laser hair removal, or vein therapy. Most invasive procedures were not medically necessary, with the exception of bariatric surgery. Fifty-four percent of those who had bariatric surgery said the operation was medically necessary, but those who elected the surgery doubled from 23% in 2004 (when the last poll was conducted) to 46% in early 2006. Liposuction, on the other hand, was done more often as a medically necessary procedurefrom 4% in 2004 to 19% in the latest poll. About 81% of those who had liposuction said it was elective, down from 96% in 2004. Most procedures were performed by physicians, except for laser treatments, which were performed by a technician in 61% of the cases, a 25% increase from 2004. Those contemplating a cosmetic procedure said they were somewhat concerned (24%) or very concerned (32%) about receiving care from a technician instead of a physician. Not surprisingly, the number of complications has increased with the growing volume. Ten percent of patients said they'd had complications, compared with 7% in 2004.
Lester Crawford, Lobbyist
Former Food and Drug Administration Commissioner Lester Crawford, D.V.M., has taken a position at Policy Directions, Inc., a Washington, DC-based lobbying firm with drug, biotechnology and food company clients. Mr. Crawford will be senior counsel. By law, he will be barred from directly lobbying Congress for at least a year. Policy Directions declined to make him available for an interview. Mr. Crawford resigned abruptly from his FDA post in September, 2 months after he was confirmed by the Senate. In the 5 years of the Bush Administration, the FDA has had a permanent commissioner for only 18 months. (Mr. Crawford served in an acting capacity for 16 months without Senate confirmation.) In early February, Sen. Chuck Grassley (R-Iowa) wrote to White House Chief of Staff Andrew Card asking that a permanent commissioner be nominated, adding that the agency was adrift without such leadership.
Medicare Drug Prices Up?
Several new reports charge that prescription drug prices rose in the first month that Medicare beneficiaries were eligible for coverage under the Part D drug benefit. For example, Consumers Union said it found an average increase of 5%. The group compared prices in five zip codes for Lipitor, and for a bundled package of the top-selling therapy in each of five classes (including Lipitor), from December to January. In a letter to the organization, Dr. Mark B. McClellan, administrator at the Centers for Medicare and Medicaid Services, said the sample was not representative because Lipitor and Celebrex had wholesale increases that contributed to most of the rise. Instead, he said, the increases were partly because of the expected rise in average wholesale prices that occurs each January. In another example, a report by the Democratic staff of the House Committee on Government Reform found that between December and mid-February, the prices of the 10 most popular drugs used by Medicare recipients at the 10 biggest drug plans increased by more than 4% on averagefrom $1,144 to $1,194. The Pharmaceutical Care Management Association said the House report did not acknowledge that drug plans can't set prices.