Dr. Tadeusz Malinski, Marvin White Chair and Distinguished Professor of Chemistry and Biochemistry, was quoted in a column on “FDA suppresses concerns about Indian generics” by Roger Bate at the American Enterprise Institute.
“Are American patients taking unsafe medicines from Asia? Even posing that question is leading to unusually public confrontations between scientists and physicians on one side and the Food and Drug Administration on the other,” writes Bate.
“Six weeks ago I chaired a congressional briefing about the possibility that low-quality drugs are being sold here. There were several topics under discussion that day: corruption at India’s drug regulator and the quality problems it ignores; the felonies admitted to by Ranbaxy, one of India’s largest exporters to America; and increasing anecdotal evidence that American patients are taking inferior heart medications. But perhaps the most interesting points were covered by Preston Mason, a specialist in cardiological science at Harvard Medical School’s Brigham and Women’s Hospital. When Mason sampled atorvastatin (generic Lipitor) — the world’s most valuable drug — from Europe, the U.S., and Asia, he found 36 different versions with impurities that would undermine their clinical efficacy.
“Last week, Janet Woodcock—the FDA’s lead drug reviewer—inexplicably told Bloomberg that Mason’s team “didn’t use the proper method to extract the active ingredient” from samples “and therefore contaminated it themselves.” This is a major charge to level at a senior scientist with decades of research experience at a stellar institution—and she is wrong. Mason’s methods were perfectly sound according to credible independent scientists with whom I’ve spoken, such as Tadeusz Malinski, a professor of biochemistry at Ohio University in Athens who has been published extensively in the academic literature. Moreover, Mason followed the US Pharmacopeia method, the method any scientist, including those at the FDA, would normally follow.”
Read the rest of Bate’s column.
Six weeks ago I chaired a congressional briefing about the possibility that low-quality drugs are being sold here. There were several topics under discussion that day: corruption at India’s drug regulator and the quality problems it ignores; the felonies admitted to by Ranbaxy, one of India’s largest exporters to America; and increasing anecdotal evidence that American patients are taking inferior heart medications. But perhaps the most interesting points were covered by Preston Mason, a specialist in cardiological science at Harvard Medical School’s Brigham and Women’s Hospital. When Mason sampled atorvastatin (generic Lipitor) — the world’s most valuable drug — from Europe, the U.S., and Asia, he found 36 different versions with impurities that would undermine their clinical efficacy.
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