Market Swing to Noninjectables?
The number of botulinum toxin injections in 2007 far exceeded any other cosmetic proceduresurgical or nonsurgicalaccording to the American Society for Aesthetic Plastic Surgery's annual accounting of Americans' cosmetic predilections. However, the 2.7 million Botox injections were slightly down from 2006, when 3.1 million procedures were performed. The number of hyaluronic acid injections also dropped slightly to 1.4 million, as did injections of collagen and polyactate (Sculptra). Injections of calcium hydroxylapatite (Radiesse) increased by 55% to 119,000. And there was rapid uptake of noninjectables: Fraxel (167,000 procedures), IPL (647,000), and noninvasive tightening (258,000). Laser hair removal was still popular, at 1.4 million procedures, as was microdermabrasion (829,000 procedures). By comparison, the top surgical procedureliposuctionwas performed about 450,000 times. There's been a continued trend away from surgery. In 2007, nonsurgical procedures were 82% of the total cosmetic procedures. The sweet spot is the 35- to 50-year-old demographic, which accounted for 46% of all cosmetic procedures (surgical and nonsurgical). Women accounted for 91% of the total.
NSF-Gadolinium Cases Centralized
Discovery for 66 suits alleging that gadolinium-based contrast led to nephrogenic systemic fibrosis (NSF) has been consolidated in a federal court in Ohio. The plaintiffs allege that the gadolinium-based contrast agent used during magnetic resonance imaging led to NSF. NSF has occurred only in patients with preexisting renal compromise. The Food and Drug Administration has issued several warnings about gadolinium and NSF; in May 2007, the agency requested new black box warnings about the risk of NSF for the five products on the market. The discovery process for the product liability suits is now consolidated as multidistrict litigation 1909 in the U.S. District Court, Northern District of Ohio.
QLT to Divest Aczone
Vancouver, B.C.-based QLT Inc. said in mid-March that it would divest its acne therapy Aczone. The company made the announcement in the wake of the Food and Drug Administration's decision to remove a requirement for glucose-6-phosphate dehydrogenase screening and blood monitoring for users. The FDA decision was based on results of a postmarketing study submitted by the manufacturer. Aczone (dapsone 5% aqueous gel) was approved in July 2005. QLT owns worldwide marketing rights, but says it will now divest the product, as planned. "Management believed in the product and took the necessary steps to address the FDA's needs, ultimately dramatically enhancing the value of Aczone," said QLT CEO Bob Butchofsky in a statement.
Judge Rules for Journals
A federal judge in Chicago last month ruled that JAMA and the Archives of Internal Medicine do not need to release documents related to the confidential peer review process for studies on cyclooxygenase-2 inhibitors. Attorneys for drugmaker Pfizer Inc. had issued subpoenas last year to obtain all documents relating to the decision to accept or reject manuscripts, copies of rejected manuscripts, the identities of peer reviewers and their comments, and editors' comments regarding manuscripts, peer review, and publication decisions. But U.S. District Court Judge Arlander Keys of the Northern District of Illinois ruled that the journals can keep the documents confidential. "It is not unreasonable to believe that compelling production of peer review documents would compromise the process," Judge Keys wrote. Dr. Catherine DeAngelis, JAMA's editor-in-chief, and JAMA's editorial counsel, Joseph Thornton, wrote in an online editorial released March 24 that the ruling supports the confidential peer review process. "For months, JAMA and [Archives of Internal Medicine] consistently argued that the sanctity of the confidential peer review process should not be violated," they wrote. "JAMA and our Archives journals have historically and deliberately kept unpublished manuscripts and peer review comments confidential. This promise to reviewers and authors allows the peer review process to work in an unrestrained environment." A federal judge in Boston has not yet ruled on a similar request by Pfizer to force the release of documents from the New England Journal of Medicine.
Trouble Paying for Rx
Four in 10 Americansand half those regularly taking at least one medicationreported that they have trouble paying for drugs, skip prescriptions, or cut pills because of the cost of their prescriptions, a poll jointly conducted by USA Today, the Kaiser Family Foundation, and the Harvard School of Public Health showed. People were most likely to report one of those three issues if they lack drug coverage, if they have low incomes, or if they take four or more drugs regularly. The survey found that while the public values the products drug companies produce, they do not like what they charge and are suspicious of their motivation. Nearly 80% of Americans said that the cost of prescription drugs is unreasonable, and about 70% said pharmaceutical companies are too concerned about making profits and not concerned enough about helping people. But at the same time, the public overwhelmingly believes that recent advances in prescription drugs provide benefits, the survey found.