Are Drug Companies Failing to Report Adverse Effects of Certain Drugs?

Are Drug Companies Failing to Report Adverse Effects of Certain Drugs?

By McCarton Ackerman 08/04/15

Drug companies are being accused of hiding painkiller risks while overstating their benefits.

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New findings out of the University of Minnesota show that numerous drug manufacturers could be contributing to addiction issues across the country by failing to report adverse effects of their medications in a timely manner.

The Food and Drug Administration mandates that drug manufacturers forward reports about negative or life-altering side effects from their products within 15 days of learning about the problem. However, the research team at the University of Minnesota found that 10% of all reports aren’t being submitted within that deadline, leading to 100,000 reports over a 10-year period that were submitted late.

In addition, 40,000 deaths were also reported late. Manufacturers reported nearly 30% of these deaths to the FDA a full year or more after first learning of them.

"In the current regulation by the FDA, there is no discretion allowed with respect to the 15-day reporting window," said Paul Ma, a researcher and one of the paper's authors. "It does not say you are allowed more time if x, y, or z; it's just a flat-out 15-day reporting window because ... the FDA wants this information collected and reviewed as soon as possible."

Such neglectful behavior is why several major cities and counties across the country are now suing major pharmaceutical companies for contributing to addiction in their community. Chicago filed a lawsuit in June 2014 against five drug companies, including Johnson & Johnson, accusing them of creating addicts by pushing for excessive use of opioid painkillers.

Lawyers for the city have accused these drug companies of hiding the risks associated with painkiller use while overstating the benefit. A state court complaint filed on Monday noted that “the city has paid for nearly 400,000 claims for opioid prescription fills, costing nearly $9,500,000, and suffered additional damages for the costs of providing and using opiates long-term to treat chronic non-cancer pain.” The city is seeking unspecified monetary damages from the drug companies.

"For years, Big Pharma has deceived the public about the true risks and benefits of highly potent and highly addictive painkillers in order to expand their customer base and increase their bottom line,” said Chicago Mayor Rahm Emanuel in a statement. “It’s time for these companies to end these irresponsible practices and be held accountable.”

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McCarton Ackerman is a freelance writer and editor living in Portland, Oregon. He has been a contributor for The Fix since October 2011, writing on a wide range of topics ranging from medical marijuana in Colorado to the world's sexiest drug smugglers. Follow him on Linkedin and Twitter.

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