Medical Device Daily Washington Editor
The Agency for Healthcare Research and Quality (AHRQ) recently published the results of a study comparing the various approaches to dealing with hip fractures, and the news for device makers is both good and bad: nobody's device looked any worse than the others, but none of them looked particularly better.
According to the report, posted to AHRQ's web site on Aug. 5, the analysis looked at fractures immediately under the femoral head as well as those occurring in and under the trochanter, the broad superstructure connecting the femoral shaft and the head. AHRQ's review of data drew from Medline and two other web-based sources, the Cochrane Library and Scirus. AHRQ states that it also peered into data posted at ClinicalTrials.gov, and the agency said it had engaged "expert consultants."
The results of the study were that "mortality does not appear to differ by device class or by devices within a class," according to the AHRQ report, noting also no difference in pain, functioning or quality of life. The study indicated that some internal fixation devices offer a more rapid return to functionality for the patient, but "such gains are very short lived."
As for the efficacy of total hip replacements, AHRQ states that it noted "improved patient outcomes over internal fixation," but the data are not sufficiently exhaustive to ensure that those outcomes "would continue to hold if the analyses included the full complement of relevant covariates," such as age, gender and the patient's ambulatory state prior to the fracture. Even the type of fracture does not seem correlated to outcomes, although the statement notes that outcome measures vary, making such comparisons difficult to make.
Medical Device Daily was unsuccessful in attempts to obtain comment from the American Academy of Orthopedic Surgeons (Rosemont, Illinois) and Stryker (Hopkinton, Massachusetts).
Schultz out: CDER's Woodcock next?
Dan Schultz, MD, recently posted his resignation as the director of the Center for Devices and Radiological Health, a move that some anticipated given the furor over recent 510(k) authorizations, but Schultz may find he is not the only center director at FDA whose neck ends up on the chopping block. In this instance, however, a member of the regulated industry is leading the charge after a seven-year effort to win the agency's approval of a generic drug. Janet Woodcock, MD, director of the Center for Drug Evaluation and Review, is now under the gun for her affiliation with a drugmaker in a spat between firms over a generic form of the blood thinner Lovenox (enoxaparin), made by Sanofi Aventis (Paris).
The spat between Amphastar (Rancho Cucamonga, California) and Woodcock follows a patent fight between Sanofi and Amphastar, which went to court in California, where Amphastar won a ruling of inequitable conduct in 2007 against Sanofi in the latter's alleged attempts to illicitly protect its patent. However, FDA has yet to approve Amphastar's generic, and the company is arguing that Woodcock's cooperation in writing a scientific paper with another firm attempting to obtain approval for a generic for Lovenox, Momenta Pharmaceuticals (Cambridge, Massachusetts), is the reason Amphastar has not won approval.
Woodcock had served as deputy director and chief medical officer of the agency until March 2008, when she was tapped to take the formal title of director of CDER, a position she had served on an interim basis. FDA has to date offered no comment on the controversy.
Vandy scores big in ARRA nursing funds
The Department of Health and Human Services announced that a total of $13.4 million in funds had been awarded for beefing up the nation's supply of nurses in high-need clinics and hospitals, and a quick look at the numbers makes one thing clear: Vanderbilt University Medical Center (Nashville, Tennessee) did quite well for itself.
HHS's Aug. 12 statement notes that most of the funds ($8.1 million) will repay student loans for 100 nurses who work for two years in facilities with nursing shortages while the balance of $5.3 million will offset student loans for graduate nursing students who will remain on as faculty members for at least four years in nursing schools. The funds are part of the $787 billion stimulus package passed earlier this year under the American Recovery and Reinvestment Act.
A quick examination of the awards demonstrates that someone at Vanderbilt University Medical Center (Nashville, Tennessee) knew how to apply for the loans. Of the $5.3 million going out for graduate nursing students, Vandy snapped up more than $450,000, which comes out to almost 8.5% of the total, a hefty share considering that the total is split up between 65 nursing colleges. The next highest award of roughly $367,000 went to Case Western Reserve University (Cleveland).
Vandy also employs seven of the 100 nursing school graduates students whose loans will be at least partly forgiven for working at the institution. Coming in a distant second is MetroHealth Medical Center (Cleveland), which, as it turns out, is affiliated with Case Western.
Mark McCarty, 703-268-5690; email@example.com