Doctors aren't getting the skinny on drug side effects from pharma reps, a new study finds. Even the most
serious risks are often overlooked, the survey found. And while probes of off-label marketing abound, enforcement of risk disclosures during sales visits is mostly absent.
"Laws in all three countries require sales representatives to provide information on harm as well as benefits," lead author Barbara Mintzes of the University of British Columbia said in a release. "But no one is monitoring these visits and there are next to no sanctions for misleading or inaccurate promotion."
Researchers surveyed 255 family physicians in Canada, France and the U.S. The doctors were asked to fill out forms after each sales call. In all, some 1,700 visits were recorded between May 2009 and June 2010. Most of the doctors reported receiving little to no information about harmful side effects; in fact, sales reps failed to offer any
information about side effects and contraindications in 59% of the visits recorded.
In fact, serious risks were mentioned only 6% of the time--despite the fact that almost 6 out of 10 of the promoted drugs carry "black box" safety warnings.
French reps were the most conscientious. They offered info on serious risks during 40% of their visits. Canadian reps were least likely to share risk information; Vancouver salespeople disclosed no potential harms for 66% of the drugs they promoted, the study found. Significant contraindications came up only 14% of the time in both Vancouver and Montreal. The U.S. reps were slightly better, sharing those contraindications 17% of the time.
By Dr. Shruti Bhat
INTERPOL and 29 of the world’s largest pharmaceutical companies have joined forces in an initiative to battle counterfeit drugs. INTERPOL announced the creation of the Pharmaceutical Crime Programme to further build on the work of its Medical Product Counterfeiting and Pharmaceutical Crime (MPCPC) unit. The program is funded by $5.9 million (EUR $4.5 million) from pharmaceutical industry partners.
According to a press release the program will focus on the prevention of all types of pharmaceutical crime, including branded and generic drug counterfeiting as well as the identification and dismantling of organized crime networks linked to drug counterfeiting.
“Both brand-name and generic pharmaceuticals are susceptible to counterfeiting, putting patient lives at risk,” said Haruo Naito, president and CEO of Eisai, in the release. “This is why we have joined our colleagues across
the biopharmaceutical industry to partner with INTERPOL and expand the work of its Medical Product Counterfeiting and Pharmaceutical Crime Unit. We fully support INTERPOL's decision to establish a comprehensive initiative that will enhance its efforts to prevent medical product counterfeiting and pharmaceutical crime. Ultimately, this is about protecting patients around the world.”
Scientists may be one step closer to using stem cells to treat patients with Parkinson's disease. Carlsbad, CA-based International Stem Cell Corp. ($ISCO) has developed a method to treat the common neurodegenerative disease by replacing lost neurons with new neuronal cells derived from human parthenogenetic stem cells (hpSC).
Researchers manufactured highly pure populations of neural brain cells differentiated from hpSCs and transplanted them into the brains of African Green monkeys and rats with animal versions of Parkinson's disease. These neuronal cells functioned similarly to adult cells, and the researchers said they expressed greater levels of dopamine- the neurotransmitter that is essential to Parkinson's disease--than previously reported approaches.
There is human data to suggest implanting neuronal cell into Parkinson's disease patients can have benefits on the symptoms," said Simon Craw, executive vice president of International Stem Cell Corp., to FierceBiotechResearch,
citing two past U.S. and Swedish studies. Previously, researchers had studied fetal neuronal cells in relation to treating neurogenerative disorders like Parkinson's. But Craw said there are two major problems associated with that
research. First, the source of these cells presents an ethical issue since they must be taken from human fetuses, and second, fetal neuronal cell transplantation for Parkinson's has caused the movement disorder dyskinesia in some studies.
Researchers observed the rodents for 6 months and the primates for four months and saw behavioral improvements in both studies. There were no noticeable negative side effects, and the therapy did not produce any tumors in the animals. The company details its protocol in a paper in the Nature journal Scientific Reportsand will present the research at the American Academy of Neurology's annual meeting in San Diego on March 20.
Every year, about 60,000 people are diagnosed with Parkinson's disease. While deep brain stimulation and levodopa can alleviate some of the symptoms of the disease, they tend to become less effective over time.