The lede:

When revelers rang in the New Year, Robert Jarvik, MD, was the star of a massive Pfizer Inc. advertising campaign for Lipitor (atorvastatin). By the end of February, Pfizer had ended the campaign, under the pressure of a U.S. House Energy and Commerce Committee probe.

The committee’s chair, Rep. John Dingell (D, Mich.), charged that the ads misled the public because they created the impression that Dr. Jarvik is a practicing physician, when he is a biomedical engineer not licensed to practice medicine. The committee disclosed that Dr. Jarvik received $1.35 million under a two-year contract set to expire this month, according to media reports.

Dr. Jarvik, who had helped develop the Jarvik-7 artificial heart, defended his role as a physician spokesman, adding in a statement that his “credibility as a heart expert is fully justified and is fairly represented” in the ads.

But the controversy has sparked a broader conversation about the ethical ramifications of physicians serving as commercial endorsers. While the Lipitor campaign is the most prominent use of a paid physician spokesperson, it is not the only one.

The whole shebang.

The lede:

A patient safety project that helped more than 100 Michigan hospital intensive care units cut their average catheter-related bloodstream infection rate by 66% can start collecting outcomes data again. That was the ruling last month from the Dept. of Health and Human Services’ Office for Human Research Protections.

The move was viewed widely as a reversal of OHRP’s controversial decision last fall to order the hospitals to suspend data collection. OHRP acted then because researchers had misclassified the project as being exempt from federal human research subject regulations and did not obtain informed consent from ICU patients.

More broadly, the decision seemed to signal a new willingness by the agency to re-evaluate whether rules designed to protect patients involved in high-risk biomedical experiments should also be applied to minimal-risk, evidence-based quality improvement research activities.

The whole shebang.

The lede:

Hospitals that do fewer than 14 heart transplants a year see significantly more patients die within 30 days than do higher-volume transplant centers, according to a study of United Network for Organ Sharing data.

Researchers argued that physicians and policymakers should steer patients toward high-volume transplant centers to get better outcomes.

But other experts said transplant volume is not the only factor that should be considered when aiming for quality.

“This is not a new concept,” said study co-investigator John V. Conte, MD, director of heart and lung transplantation at Johns Hopkins Hospital in Baltimore, which handles 20 to 30 heart transplants annually. “The evidence shows that the more you do of any complex procedure, the better that people are going to be at it.”

The whole shebang.