Surprise! DES Suits Filed
It didn't take long—the nation's plaintiffs' attorneys have begun recruiting clients who allegedly were harmed by a drug-eluting stent. One suit, filed in Palm Beach, Fla., County Circuit Court, claims that Johnson & Johnson's Cordis unit failed to warn that its Cypher stent might be associated with a higher risk of clotting, heart attack, and death. The plaintiff, 46-year-old Sean O'Shea, said that he began having chest pains after he stopped taking clopidogrel (Plavix), which he'd taken after two procedures in 2005 in which he received five stents. Mr. O'Shea's attorneys, Babbitt, Johnson, Osborne, and LeClainche of West Palm Beach, allege that he suffers permanent disability, mostly from bleeding related to his now-resumed Plavix regimen. Plaintiffs' attorney firms have set up Web sites to recruit patients, including Pulaski & Middleman's
www.drugcoatedstentattorney.com
Generic Plavix Blocked Again
The reintroduction of a generic version of Plavix just got pushed further off into the future. The U.S. Court of Appeals for the Federal Circuit in Washington ruled last month that generic sales should be halted until the Plavix patent can be validated. The ruling was the latest in an ongoing battle among generic maker Apotex Inc. and the two companies that make and sell Plavix, Sanofi-Aventis and Bristol-Myers Squibb, which allege patent infringement by Apotex. In late August, the U.S. District Court for the Southern District of New York ruled in favor of the brand name companies and granted a preliminary injunction against sales of the generic, which had been on the market a few weeks. Apotex did not have to recall product already in distribution. The generic had made a significant dent in Plavix sales, pegged at $6.3 billion worldwide in 2005.
New Code for Plaque Test
The American Medical Association has issued a unique category I CPT code for a diagnostic that measures lipoprotein-associated phospholipase A2. That inflammatory enzyme is found in unstable, rupture-prone plaque. The only Food and Drug Administration-approved test is made and sold by diaDexus of South San Francisco. The company said the code—83698—was issued under the pathology and laboratory section of the CPT I schedule. The Centers for Medicare and Medicaid Services is recommending a payment of $47.43 for the blood test, effective January 1, 2007.
ACC-MedAxiom Alliance
The American College of Cardiology is joining forces with the quality improvement consulting company MedAxiom. ACC will promote MedAxiom's programs to its members, and MedAxiom will do likewise to its client base. Through March 2007, MedAxiom is offering ACC members a 10% discount on subscriptions to its services, which include statistical analyses and benchmark reporting systems, workflow and process redesign, and strategic planning. The two organizations also are developing a leadership institute, which they expect to launch in 2007, according to the ACC.
Von Eschenbach Confirmed for FDA
Almost 9 months after he was first nominated to be commissioner of the FDA, Dr. Andrew von Eschenbach was finally confirmed by the Senate by an 80–11 vote in the wee hours of the 109th Congress. Confirmation came after an 89–6 vote to limit debate on his nomination. The naysayers included Sen. Chuck Grassley (R-Iowa), who voted against invoking cloture and against confirmation. Sen. Grassley has been one of Dr. von Eschenbach's most vocal critics. As chairman of the Finance Committee, he and his staff have been investigating what they call an inappropriate approval of the antibiotic Ketek (telithromycin). Sen. Grassley maintains that Dr. von Eschenbach has stonewalled committee investigators, and in an agitated floor statement during the nomination vote, he accused the nominee of hiding documents and intimidating FDA employees who dissented. With Democrats taking control of Congress, Sen. Grassley will lose his Finance Committee chairmanship. But he warned his colleagues across the aisle that Dr. von Eschenbach was a prime illustration of concerns about the lack of Senate oversight of the Bush administration. “I believe we need to send a message to the executive branch that it's not okay to impede congressional investigations. It's not okay to limit the Senate's access to documents, information, and employees of the executive branch,” the senator said.
Poll: No Off-Label Use
About half of Americans said physicians should not be allowed to prescribe pharmaceuticals for unapproved uses, according to a recent WSJ.com/Harris Interactive poll. About half of those polled—approximately 3,000 adults in November—were not even aware that the FDA allowed off-label prescribing. But, 48% said it should not be allowed; 27% said it was fine, and 24% were not sure. A majority (69%) said drug companies should not be allowed to promote off-label uses, while only 12% said this was permissible. Sixty-two percent said they strongly agreed with the statement that prescription drug use for unapproved indications should be prohibited except in a clinical study.