Cardiovascular Business - January/February 2008 - (Page 37)

get a daily dose of Cardiovascular business News, visit Cardiovascularbusiness.com, or sign-up for the weekly newsletter @ subs.CardiovascularBusiness.com á oversight committee questions FDa on dealings with pharma reps “this is no basis for withholding from the Committee communications about the use of journal articles that FDA received from private drug companies.” — rep. Henry Waxman á Cabg proves more efficacious than drug-eluting stents raft guidance by the FDA allows drug companies to use journal articles to market potentially dangerous off-label uses of drugs and medical devices without prior FDA review and approval. If Congress gets its way, that practice may stop. Rep. Henry Waxman, D-Calif., chair of the Oversight and Government Reform Committee, sent a letter on Jan. 22 to FDA commissioner Andrew von Eschenbach, MD, requesting documents related to the draft guidance. An FDA memo previously turned over to Waxman showed that FDA officials, including former chief counsel Dan Troy, and pharmaceutical industry representatives urged von Eschenbach to issue the draft guidance. Waxman wants more information but the FDA has refused D saying the documents are pre-decisional and, therefore, privileged information. “This is no basis for withholding from the Committee communications about the use of journal articles that FDA received from private drug companies,” Waxman said in the letter. “This is also no basis for withholding internal FDA communications where — as in this case — there is evidence that FDA’s actions may be unduly influenced by regulated companies.” Waxman has demanded to receive by Feb. 5 all documents since Jan. 26, 2001, relating to the new draft guidance and all documents between January 26, 2001, and April 13, 2007, including internal FDA communications, relating to the dissemination of reprints and textbooks. By Justine Cadet or patients with multivessel disease, coronaryartery bypass grafting continues to be associated with lower mortality rates than does treatment with drug-eluting stents and is also associated with lower rates of death or myocardial infarction and repeat revascularization. Numerous studies have compared the outcomes of CABG and coronary stenting. However, little information has become available since the introduction of drug-eluting stents, according to Edward L. Hannan, Ph.D., in the department of health policy, management, and behavior at the University at Albany. Hannan and colleagues compared adverse outcomes (death, death or myocardial infarction, or repeat revascularization) through Dec. 2005 in patients who received drug-eluting stents or underwent CABG in New York State between Oct. 2003 and Dec 2004 (NEJM 2008;358[4]:331-341). CABG was associated with lower 18-month rates of death and of death or myocardial infarction both for patients with three-vessel disease and for patients with two-vessel disease compared with treatment with drug-eluting stents. Among patients with three-vessel disease who underwent CABG, as compared with those who received a stent, the adjusted hazard ratio for death was 0.80 and the adjusted survival rate was 94% versus 92.7% (P=0.03); the adjusted hazard ratio for death or myocardial infarction was 0.75 and the adjusted rate of survival free from myocardial infarction was 92.1% versus 89.7% (P<0.001). Among patients with two-vessel disease who underwent CABG, as compared with those who received a stent: → the adjusted hazard ratio for death was 0.71 and the adjusted survival rate was 96.0% versus 94.6% (P=0.003) → the adjusted hazard ratio for death or myocardial infarction was 0.71 and the adjusted rate of survival free from myocardial infarction was 94.5% versus 92.5% (P<0.001). By C.P. Kaiser F CardiovascularBusiness.com Cardiovascular Business http://CardiovascularBusiness.com http://subs.CardiovascularBusiness.com http://CardiovascularBusiness.com

Table of Contents Feed for the Digital Edition of Cardiovascular Business - January/February 2008

Cardiovascular Business - January/February 2008 Contents The Ticker: Quality Pays in Several Ways Cover Story: The Proof: Why Evidence-based Medicine Improves Cardiac Care Clinical Study Digest: Co-payments and Cath Labs Cardiac PET/CT Fills in Gaps Left by SPECT Tapping into IT to Improve the Office-Based Practice SPECT–Proving Its Value Cardiac Images in the EMR: Just a Click Away The Top 20 Ways to Market Your Cardiac CTA Practice The Big Picture: Medical Displays for Cardiac Images Statins Work But Pharmacoeconomic Caveats Abound Driving Data Protection: Opting for Storage On- or Offsite News & Views Calendar Reader’s Resource

Cardiovascular Business - January/February 2008

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