Calls For Medical Paper Retractions Prompt NIH To Pause Experimental Stem Cell Treatment Trial
Fallout from questions raised about the research and journal publications from the lab of Dr. Piero Anversa, a controversial stem cell researcher, leads a federal agency to temporarily halt a clinical trial studying a stem cell therapy for heart failure patients. Also in the news are several reports about drug trials.
Heart Failure Study Paused Over Concerns About Disputed Cell Therapy Papers
A government agency has paused a clinical trial testing an experimental stem cell therapy in heart failure patients, a move made public on Monday and sparked by recommendations to retract 31 journal articles from the lab of a controversial cardiac stem cell researcher. “Recent calls for the retraction of journal articles in related fields of cell therapy research have raised concerns about the scientific foundations of this trial,” the National Heart, Lung, and Blood Institute said in a statement posted Monday. (Cooney, 10/29)
The New York Times:
He Promised To Restore Damaged Hearts. Harvard Says His Lab Fabricated Research.
For Dr. Piero Anversa, the fall from scientific grace has been long, and the landing hard. Researchers worldwide once hailed his research as revolutionary, promising the seemingly impossible: a way to grow new heart cells to replace those lost in heart attacks and heart failure, leading killers in the United States. But Harvard Medical School and Brigham and Women’s Hospital in Boston, his former employers, this month accused Dr. Anversa and his laboratory of extensive scientific malpractice. (Kolata, 10/29)
Conflicts Of Interest In Clinical Practice Guidelines An 'Intractable Problem'
Despite a parade of studies warning that treatment guidelines issued by professional medical societies fail to fully disclose potential financial conflicts, two new analyses report that the problem persists. In one analysis, researchers found that 57 percent of 91 authors who developed 18 different guidelines for several big-selling medicines had financial conflicts, and 25 percent of the authors did not disclose a conflict in the guidelines or supplemental materials. The median undisclosed payment was $522, while the average was $17,000. Moreover, none of the guidelines were fully compliant with disclosure requirements issued by the National Academy of Medicine. (Silverman, 10/29)
Lucrative Drug Trials Prompt Regional Hospitals To Join Forces
Small hospitals need money. Drug companies need patients for tests. Both sides say they’ve found a solution. Regional hospitals across the U.S. are banding together to make it easier for pharmaceutical companies to use their facilities for clinical trials, a strategy that could boost revenue and give drugmakers increased access to patients. (Hopkins, 10/29)
Novartis Cuts 20% Of Drug-Research Projects After Review
Novartis AG has dropped about a fifth of its research projects as the drugmaker narrows its focus on the most cutting-edge medicines. The pharmaceutical giant has reduced its drug programs to 340 from 430 after completing a review of its portfolio, Jay Bradner, president of the Novartis Institutes for Biomedical Research, said in an interview Monday. Among the research projects it’s no longer pursuing are medicines for infectious diseases. (Paton, 10/30)
J&J Loses Patent Fight Over Key Cancer Drug, Teeing Up Generic Competition
In a challenge to Johnson & Johnson (JNJ), a federal court ruled that a patent on a key drug — the big-selling Zytiga prostate cancer treatment — is invalid, triggering the likely arrival of lower-cost generic competition, possibly in a matter of days. The Friday decision had largely been expected by Wall Street analysts, who noted that a U.S. Patent and Trademark Office review board earlier this year had invalidated the same patent after determining it was not sufficiently inventive. The patent, which is due to expire in 2027, covered a method for administering the drug. (Silverman, 10/29)