Earlier this year Vytorin’s effectiveness was called into question, producing a marketing problem for its manufacturer, Merck and Schering-Plough. This time the allegations are more serious. The FDA warned the public about muscle injuries linked to simvastatin, which is used in the controversial cholesterol drug Vytorin, and the heart-rhythm medication amiodarone. The FDA issued a warning to those taking simvastatin to watch out for symptoms of cramps, pain, tenderness, stiffness or spasm in their muscles. Simvastatin is marketed as Zocor and is known as a statin.
In a move to bolster the public’s confidence in the FDA as well as lessen the conflicts between drug and medical device advisory boards and the doctors who serve them, the FDA has placed a $50,000 cap on payments a doctor can receive from a pharmaceutical company and/or a medical device maker and still serve as an expert consultant on the FDA advisory panel. The problem has led to many raised eyebrows and serious questions concerning conflicts of interests when doctors who are at times receiving six figure salaries from these companies also serve on the FDA advisory panels. Their judgment is suspect at best and the public’s confidence in their ability to be impartial is hampered.
The new rules bar the participation of an expert, if that person, their spouse or minor child has conflicting financial interests of more than $50,000. Under the new rules, there generally won’t be waivers for conflicts above $50,000, and waivers for smaller conflicts will be allowed only if the FDA determines “there is an essential need for the adviser’s particular expertise.”