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TRIALS AND TRIBULATIONS

Doctor Who Faked Drug Research Permanently Debarred

The weekly round-up of failed trials, missed targets, and other business mishaps.

The Burrill Report

Scott Reuben, former chief of acute pain at a hospital in Massachusetts who pleaded guilty in 2010 to healthcare fraud, has been permanently debarred from providing services in any capacity to a person that has an approved or pending drug product application. In addition to the debarring order, the U.S. Food and Drug Administration also will not accept or review any abbreviated new drug application submitted by or with Reuben’s assistance. Reuben pleaded guilty in 2010 to healthcare fraud and served a six month jail sentence when it was revealed that he had faked research for a dozen years in published studies suggesting substantial benefits from drugs such as Vioxx and Celebrex. Reuben received thousands of dollars in grants from various drugmakers to run studies on their drugs, but fabricated patient data and submitted article based on fictitious results to medical journals.

Geron said it will layoff nearly 40 percent of its workforce and discontinue further development of its stem cell programs to focus on oncology. The move puts an end to Geron’s decade-long run as a forerunner in the embryonic stem cell field. Geron CEO John Scarlett in the “current environment of capital scarcity and uncertain economic conditions,” the company decided to focus it resources on advancing its lead cancer drugs, now in mid-stage development. As part of the decision, Geron is eliminating 66 full-time positions. The layoffs are expected to cost the company approximately $5 million in the fourth quarter of 2011 and approximately $3 million in the first quarter of 2012. Despite the move, Geron plans to follow all currently enrolled patients in its early-stage clinical trial for its stem cell therapy in spinal cord injury and update the U.S. Food and Drug Association on its progress. Geron’s shares fell 20.5 percent on the day of the announcement.

Employees at Novartis’ Nyon, Switzerland facility held a protest when their request to meet with CEO Joe Jimenez to discuss job-cutting plans went unanswered. In the one-day strike, workers opposed Novartis’ plan to close the Nyon plant and cut 320 jobs, or almost half of the facility’s workforce. The Nyon workers say they want direct dialogue with Jimenez and want Novartis’ leadership to consider alternate proposals before moving forward with the job cuts and plant closure. Jimenez said in a statement that he wishes to continue the dialogue with Nyon employees and plans on meeting with them in due time. He has asked Armin Zust, Novartis’ Swiss director, to handle talks with Nyon employees in the interim.

An experimental heart medicine being developed by Merck failed to meet a key late stage study goal, according to data presented by the American Heart Association. The drug, Vorapaxar, was designed to work through different biological pathways than other blood-thinning drugs on the market. Though Merck had halted further studies on one of its clinical trials of Vorapaxar in January, data from the trials were not made public until this week. Data published in the New England Journal of Medicine showed that 18.5 percent of patients in the Vorapaxar group had a cardiovascular related event compared to 19.9 percent of patients in the placebo group. The difference was not considered statistically significant. The study also showed patients on Vorapaxar had more serious bleeding events, including brain bleeding. Merck said it would wait for the results of a second Vorapaxar study, which involve patients with cardiovascular disease, before deciding whether to continue development of the product.

Sanofi’s Multaq drug, approved to treat patients with irregular heart beats, was found to double the risk of death in those with a permanent form of arrhythmia. Results of the new trial, which was conducted on a population of patients for which the drug isn’t approved, stood in stark comparison to an earlier trial, which mainly studied patients with intermittent arrhythmia. The newer study found that there were 21 deaths from cardiovascular causes among patients in the Multaq group compared with 10 in the placebo group. There were also 23 strokes in the Multaq group compared to 10 in the placebo group. The critical issue facing Sanofi now is whether or not the results in patients with permanent heart arrhythmia apply to patients who are using Multaq for the approved indication. France’s regulatory body, Haute Autorite de Sante, has already deemed the drug too risky and the French government will no longer pay for Multaq.

Bayer says it intends to sell part of its Mishawaka manufacturing site to Siemens, potentially putting 270 people out of work. Currently 130 employees at the plant work for Bayer to produce Siemens Healthcare Diagnostic products and Siemens has indicated that it will keep those jobs in Mishawaka and continue to operate there. Approximately 270 other workers manufacture products for Bayer Diabetes Care, work in research and development, or work in quality affairs. Bayer’s Diabetes Care division will be moved away from Mishawaka and workers may be considered for opportunities at the yet to be determined new location. The rest of the workers may be considered for a position at Bayer’s new headquarters in New Jersey. Bayer has recently been working to bring multiple facilities together in its New Jersey headquarters and this move is part of that operational restructuring.



November 17, 2011
http://www.burrillreport.com/article-doctor_who_faked_drug_research_permanently_debarred.html

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