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The Food and Drug Administration (FDA) exists to make sure that drugs are thoroughly tested for safety and effectiveness before they’re made available to the public. Reducing the number of ineffective drugs and drug injuries is the goal of the FDA.
However, many people—especially drug manufacturers and others within the pharmaceutical industry—have long argued that FDA requirements are burdensome and that the industry is over-regulated. But several researchers recently looked at the information provided to the FDA by drug companies and found the opposite. In a review of an important report required by the FDA, investigators found that drug manufacturers failed to provide complete information more than half of the time.
The study looked at serious adverse drug events, one of the most important records of drug safety tracked by the FDA. As the name implies, serious adverse events are not to be taken lightly: They can include hospitalization, disability, a life-threatening development, and even death.
In 2014, more than half a million serious adverse event reports were filed. The study analyzed them based on a number of factors and found that reports filed directly by consumers and healthcare professionals were complete more than 86 percent of the time. This type of report, however, made up fewer than 5 percent of all reports that year. The large majority of reports—more than 500,000—were filed by drug manufacturers. Among these, complete information was much less common: On average, just over 40 percent of the time.
The missing data from the reports were vital items, including patient age, patient gender, date of the event, and a useful medical description of the event. Without complete information, the clinical value of these reports is greatly diminished.
None of the twenty-five largest reporters (not named, but presumably the largest drug companies doing business in the United States) had a completion rate better than 67 percent (and one was under 25 percent). A particularly worrisome finding of the analysis was that reporting was at its worst when a report included the death of a patient.
This report follows on the heels of other disturbing news about pharmaceutical companies and their marketing practices. Bayer Pharmaceuticals, the makers of Xarelto (rivaroxaban), was sued in March by patients claiming that Bayer and its parent company Johnson & Johnson withheld important clinical information about the safety of the drug. These same concerns had already been raised by medical researchers in England.
The issue of withholding drug trial data has been raised before, repeatedly. In 2015, the World Health Organization attacked organizations and individuals who hold back clinical trial data, calling the practice a waste of time and money, a danger to patients, and unethical. A 2014 parliamentary report in the United Kingdom also condemned the practice and named names, calling out the makers of Tamiflu for cherry-picking and withholding data. By some evaluations, the withheld Tamiflu data would have been enough to deny the drug’s approval.
These cases are not simple issues of dotting i’s and crossing t’s on paperwork. A 2014 Newsweek report discussed the case of a volunteer in a 2001 study who died from an unusual drug side effect that had been known about since 1978. The study’s supervisors hadn’t known about the risk because it had been kept out of the original reports. The most scandalous case might be that of a class of drugs used to treat irregular heartbeats. An unusually high risk of death was uncovered in 1980, but that result was never published. As a result, up to 70,000 patients in the United States may have died prematurely during the decade that these drugs were commonly prescribed.
Many drugs have been approved for use, and most are safe when prescribed and used correctly, but every day the list of dangerous drugs grows longer. Some drugs slip through gaps in the safety net, and when it is the result of deliberate misrepresentation of research on a drug’s potential to do harm, someone needs to be held accountable.
If you or a loved one have been harmed as a result of a defective drug, you are urged to contact the Indianapolis Drug Injury Attorneys of Wilson Kehoe Winingham. The lawyers at WKW can help you get the compensation you deserve. Call 317.920.6400 or fill out an online contact form for a free, no-obligation case evaluation.