Pradaxa documents speak to widespread scandal

The U.S. Food and Drug Administration (FDA) works hard to ensure that prescription medications are both reasonably safe and effective before they are made accessible to patients. In addition, the FDA makes significant efforts to revise warnings and/or recall any prescription medication that proves to be a truly dangerous drug after it hits the market. However, these efforts are only beneficial when drug manufacturers and researchers are forthcoming about information they learn about these drugs over time.

According to recently unsealed legal documentation, employees of the manufacturer of a popular prescription blood thinner not only pressured the author of an internal research paper on the drug to revise the study, some employees believed that the entire study should be quashed.

This scandal points to a fundamental challenge that exists within the drug manufacturing industry. If research indicates that one’s product is dangerous, defective or otherwise harms patients, the money and effort which have been poured into the drug’s research, manufacture and marketing must either be supplemented with additional funds aimed at fixing the problem or the drug must simply be pulled.

Yes, drug manufacturers are businesses and it is not wrong for businesses to want to turn a profit in exchange for effort exerted. However, if profits are pursued at the expense of patient safety, then the entire aim of creating prescription drugs for consumer benefit becomes completely compromised. The unsealed Pradaxa documents speak to a problem that directly affects those harmed by the drug but also more widely to patient safety concerns within the drug industry as a whole.

Source: New York Times, “Study of Drug for Blood Clots Caused a Stir, Records Show,” Katie Thomas, Feb. 5, 2014