Boston Scientific agrees to pay $22 million to resolve dispute over alleged kickbacks.

The AP (12/24, Seaman) reported that "heart device maker Boston Scientific will pay $22 million to resolve allegations its Guidant division paid kickbacks to doctors to get them to use its heart devices" according to US attorneys. The physicians received between $1,000 and $1,500 "each in 2003 and 2004 to participate in four studies, called RaCE, RaCE II, RaCE III, and MERITS," the Justice Department said.
Bloomberg News (12/24, O'Reilly) reported that the studies were "designed to assess the performance of pacemakers and defibrillators, the US Department of Justice said...in a statement." But, the company was really "paying doctors to select Guidant devices over competing products, the government said." In a statement, US Attorney Carmen Ortiz wrote, "Although medical-device and pharmaceutical companies can use post-market studies legitimately to obtain information about how their products work in the field, they cannot use those studies, and the honoraria associated with them, to induce physicians to use their products."
Dow Jones Newswire (12/24, Kell) reported that in addition to paying the $22 million, Boston Scientific has also said it would adhere to a corporate integrity agreement with the Department of Health and Human Services.

NO HEALTH INSURANCE = 40% HIGHER DEATH RATE

Featured in Journal Watch: Mortality and Lack of Health Insurance
In a 12-year study, adults without health insurance had a 40% higher relative risk for death than did insured adults.
Journal Watch General Medicine summary

Advocate seeks to eliminate "discretionary" clauses in Texas health insurance plans.

The Dallas Morning News (12/17, Stutz) reports that "the state's insurance consumer advocate is seeking to eliminate the blanket authority of health and disability insurers to decide what their policies cover, a shift that could have a major impact on health insurance in Texas." Mike Geeslin, Texas' insurance commissioner, has been asked by "Public Insurance Counsel Deeia Beck...to end long-standing provisions in most health plans, called 'discretionary' clauses, that give insurers the right to interpret their policies and decide what benefits must be paid." So far, "twenty-two states have banned the practice, either through state law or new regulations."

GAO report finds FDA lacking in development of drug surveillance office.

The AP (12/9, Perrone) reports the Food and Drug Administration "still hasn't restructured its staff to better monitor drug safety, more than three years after experts recommended key changes in the wake of the Vioxx scandal." According to a report by the Government Accountability Office that will be released on Wednesday, FDA officials "have made some changes to drug oversight," although the agency "continues to give the bulk of its decision-making power to scientists who approve new drugs, rather than those who monitor the side effects of drugs on the market." The GAO "calls on the FDA to set a timetable for transferring new responsibilities to the surveillance office." In response, the FDA "said major decisions about drug safety are delegated to the new drugs division because that is 'where staff with the broadest expertise and experience' on product safety issues reside."

FDA Investigating Excess Radiation During CT Brain Scans

Physician's First Watch for December 8, 2009
David G. Fairchild, MD, MPH, Editor-in-Chief
The FDA has identified nearly 260 patients who were exposed to up to eight times the expected level of radiation during CT perfusion scans of the brain, the agency announced on Monday.
The problem was first noted in October, when it was discovered that 206 patients had radiation overexposure at Cedars-Sinai Medical Center in Los Angeles during an 18-month period. Since then, the FDA has learned of "at least 50" additional cases involving more than one scanner manufacturer and is investigating cases in other states. Some patients have reported hair loss and skin redness after their scans.
To prevent additional problems, the FDA has issued interim recommendations for imaging facilities, such as reviewing whether patients have had excess radiation exposure and reexamining radiation dosing protocols.
FDA news release (Free)
Associated Press story (Free)