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Food and Drug Administration concerned over study bias

On Behalf of | Sep 19, 2016 | Pharmaceutical Litigation

People in Ohio and across the country have been indoctrinated to read labels. They are told that labels on everything from cereal to cigarettes contain important information to help them make educated choices. However, the Food and Drug Administration is following the money trail after a leading pharmaceutical company petitioned to have serious warnings removed from the labels of one of its products. Consumers may now suspect that once trustworthy labels may not be entirely truthful.

Drug companies routinely hire doctors to study the side effects of their products. The tests are apparently blind, so doctors are not told who receives the drug or a placebo. Nevertheless, the FDA noticed suspicious data resulting from studies conducted by doctors who were also well compensated by the Pfizer pharmaceutical company for advocating the drug. Doctors who were paid over $25,000 for speaking and consulting engagements sponsored by Pfizer seemed to report lower instances of negative side effects than those who were not.

The drug in question is Chantix, a smoking-cessation drug that earned Pfizer over $670 million last year. The drug’s label contains warnings about serious side effects including suicidal thoughts or behavior. In studies where patients with psychiatric disorders used Chantix, doctors compensated by Pfizer reported that 1.8 percent of patients exhibited neuropsychiatric side effects. Those doctors who were not paid by the company reported that 6.4 percent of the patients exhibited those side effects.

The Food and Drug Administration is concerned about the discrepancy. When dangerous or deadly side effects are downplayed, people in Ohio may not be able to make wise decisions when choosing pharmaceutical products. A drug that is supposed to help one make a healthy choice like quitting smoking make actually bring about life-threatening consequences. In those cases, people may seek advice from a lawyer with experience in pharmaceutical liability.

Source: bloomberg.com, “Doctors Downplaying Drug’s Suicide Risks Attract FDA’s Scrutiny“, Anna Edney, Sept. 13, 2016


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