“Instead of a regulator and a regulated industry, we now have a partnership. That relationship has tilted the agency away from a public health perspective to an industry friendly perspective.” This is the assessment of Dr. Michael Carome, director of health research for Public Citizen, on the current state of affairs at the Food and Drug Administration.
Earlier this summer, ProPublica published a damning look at the ...
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With over 100,000 pelvic and other gynecological mesh cases pending in courts around the country, one question that has been on everyone’s mind is much closer to an answer thanks to some investigative reporting that aired earlier this month on CBS’ 60 Minutes.
The question is a simple, yet far-reaching one: what could possibly have gone so wrong with these devices as to cause this ...
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As horrible as it can be to endure a life with rheumatoid arthritis, the side effects of the drugs most commonly associated with the treatment of the condition are equally, if not more terrible. In an analysis of more than half a million side effect reports from these medications, clear patterns emerged that indicate strong links to heart attacks, strokes, and heart failure.
Actemra was marketed ...
continue reading...Bloomberg reports that the FDA has issued a safety announcement for Intercept’s Ocaliva, a drug designed for a rare liver disease known as primary biliary cholangitis. The announcement comes after at least 19 deaths were attributed to the medication, which was only introduced in May of 2016.
Intercept claims to have explicitly warned doctors of the specificity with which they must prescribe Ocaliva and how it must be taken ...
continue reading...Endo Pharmaceuticals has officially withdrawn Opana ER from the market at the FDA’s request. The extended release opioid medication recently became the subject of an inquiry by the agency because of the specific way it was being abused.
Opana ER was designed to slowly and steadily medicate a patient as an extended release medication. However, when crushed, snorted, or injected, an abuser can get the full dose ...
continue reading...A recent study published in the Journal of the American Medical Association has identified that one-third of FDA-approved drugs carry a safety risk that is found after the medications have already gone to market. It’s a rate that’s both alarming and unexpected from an agency that is supposedly charged with protecting the public’s health.
Joseph Ross, an associate professor of medicine and public health at Yale ...
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