Nothing like a FDA advisory committee member putting in his “two cents” .. whose background has little/nothing to do with opiates/chronic pain
“It’s not any worse than other extended-release opioids on the market, but if we don’t start to re-think how we approve and regulate opiates, then we will never really change the problems we have with the opioid epidemic.” — Tobias Gerhard, PhD, of Rutgers University, at an FDA advisory committee meeting that evaluated Teva’s abuse-deterrent hydrocodone (Vantrela).
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Tobias Gerhard, BSPharm, PhD, FISPEAssociate Professor Department of Pharmacy Practice and Administration and Institute for Health, Health Care Policy and Aging Research Phone: (848) 932 8634 Email: tgerhard@ifh.rutgers.edu PhD, Pharmacoepidemiology, University of Florida BS, Pharmacy, Albert-Ludwigs University Freiburg, Germany |
Research
Dr. Gerhard’s research focuses on comparative safety and effectiveness of antipsychotic medications, pharmacological treatments of dementia, pharmacoepidemiological methods, and more generally research on use and management of therapeutics in Medicaid, Medicare, and privately insured populations.
Filed under: General Problems
Why am I not surprised with this? This idiot, along with the other idiots, are having problems approving prescription opioids that have been on the market for more than 50 years when they’re reformulated into an ER formula, yet they have no problem approving an antipsychotic(pimavanserin) to treat psychotic symptoms in patients with Parkinson’s disease even though they found that the benefits did NOT outweigh the risks:
“While Acadia’s drug had only modest benefits in most patients and was linked to serious safety issues, most panelists ultimately said it would fill an important need.
On a questionnaire measuring hallucinations and other symptoms, patients taking the drug showed a 23 percent improvement over patients taking a fake pill. According to FDA reviewers, that change represented a “minimal improvement” based on commonly-used clinical measures.
At the same time, negative health events, including death, were more than twice as likely in the drug group, affecting nearly 8 percent of patients. There was no clear explanation for the increased health problems seen with the drug compared to patients taking the sham treatment.
Ultimately, the FDA concluded that for every two patients who experienced a major reduction in their psychotic symptoms, one patient would suffer a serious adverse event.
Still, with virtually no alternatives, most panelists backed the drug.”
http://www.usnews.com/news/business/articles/2016-03-29/govt-panel-backs-drug-for-delusions-in-parkinsons-patients
(Oh, and they ended up approving it for this specific use.)
Unbelievable!
thank u for his email ,,Mr.Steve,,,,maryw