It appears that drug manufacturers may have been submitting incomplete reports of side-affects to the FDA for a very long time. When researchers analyzed the serious adverse event reports made to the U.S. Food and Drug Administration (FDA) in 2014, they found that reports filed by drug makers were incomplete more than half of the time, while more than 86 percent of those filed directly by health professional and consumers were complete. That’s a huge difference and is quite alarming.
The FDA’s Adverse Event Reporting System (AERS) is a crucial tool in evaluating drug safety in an age where drugs are approved quickly with little clinical testing. Incomplete data compromises the usefulness of the usefulness of this tool in formulating future warnings that could prevent injuries and save lives.
The report, published in the journal Pharmacoepidemiology and Drug Safety, evaluated serious adverse event reports for completeness. For the purposes of the study they needed to include all of the following to be considered complete: age, gender, event date, and at least one medical term describing the event.
Of the 528,192 new case reports received by the FDA in 2014, 4.7 percent were received directly from health professionals or consumers. Of those, 86.2 percent were complete. Another 95.3 percent of the reports were from drug manufacturers. Drug makers submit two types of reports. Expedited reports are to be made within 15 days of learning of a serious side effect. Periodic reports are made at a later date. Only 40.4 percent of the expedited and 51.3 percent of the periodic reports were complete.
When you consider this in addition to the recent revelation that Bayer and Johnson & Johnson appear to have misled editors of the New England Journal of Medicine relating to Xarelto, it’s no wonder so many people distrust the pharmaceutical industry. The more the public learns about the corporate culture of the drug industry, the more the distrust grows. Unfortunately, the public has been largely uninformed about the manner in which the huge drug companies operate. Once they really are informed, the public will be outraged.
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