Drug Safety Hearings Put Companies, FDA, on Defensive
February 15, 2005 06:11

http://www.foxnews.com/story/0,2933,147862,00.html

Wednesday, February 16, 2005

By Todd Zwillich

Manufacturers traded claims on the safety of their arthritis drugs while FDA (search) officials defended their handling of safety information at the opening day of a federal inquiry into the risks and benefits of Vioxx and similar medications.

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FDA Holds Hearing on Arthritis Drug Safety
FDA to Establish New Drug Oversight Board

Tuesday, February 15, 2005
By Todd Zwillich

The fate of a highly controversial class of painkillers is likely to be decided at a federal inquiry scheduled to open later this week.

In three days of hearings set to begin Wednesday, the FDA and a panel of outside experts will investigate the safety of arthritis drugs called Cox-2 inhibitors (search). This group includes Vioxx, Celebrex, and Bextra ...

FDA documents show that the hearings will focus on evidence that the drugs increase the risk of heart attacks and stroke, a finding that pushed Vioxx?s manufacturer to pull it from the market in September 2004. This has also led many experts to call for a broad re-evaluation of the other Cox-2 inhibitors...

Subject: FDA MedWatch - Implantable cardioverter-defibrillator (ICD) and c ardiac resynchronization therapy defibrillator (CRT-D) models with potent ial battery shorting mechanism

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Medtronic, Inc. and FDA advised physicians about a potential battery shorting mechanism that may occur in a subset of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) models. In a letter to physicians, Medtronic reported that batteries have experienced rapid battery depletion due to this shorting action. If shorting occurs, battery depletion can take place within a few hours to a few days, after which there is loss of device function. There are no reported patient injuries or deaths. Devices with batteries manufactured between April 2001 and December 2003 may exhibit this shorting action. Potentially affected models are the Marquis(tm) VR/DR and Maximo(tm) VR/DR ICDs and the InSync I/II/III Marquis(tm) and InSync III Protect(tm) CRT-D devices.

The company running South Carolina's largest medical malpractice insurer stated that "our data is just notadequate" to guarantee that a cap on non-economic damages would lower doctors' malpractice premiums. The company joins the growing ranks of insurers that... (Read Article)

http://www.forbes.com/technology/sciences/2005/02/15/cx_vc_0215fdamini.html

FDA Seeks Shelter From Drug Storm

The announcement comes just before the FDA begins an unusual three-day meeting to review the safety of painkillers like Merck's (nyse: MRK - news - people ) Vioxx, and Pfizer's (nyse: PFE - news - people ) Celebrex and Bextra. In testimony to Congress last November, key FDA researcher David Graham warned that the agency was incapable of defending the public against another drug disaster (see: "Face Of The Year: David Graham").

A veteran scientist at the U.S. Food and Drug Administration said on Monday he had decided against presenting new data on the heart risk of pain relievers at a highly anticipated meeting later this week, saying he felt intimidated by FDA officials.

EMAIL From: Joan Claybrook & Frank Clemente Feb. 15, 2005 The Health Subcommittee in the U.S. House of Representatives held a medical malpractice hearing last week at which Public Citizen testified. To view the testimony of Sidney Wolfe, MD, director of Public... (Read Article)

But Wall Street analysts and battalions of lawyers will be intently watching testimony by and about Merck because the company faces hundreds of lawsuits over Vioxx, some of them scheduled to go to trial as early as May in Alabama and Texas. Consolidated groups... (Read Article)