According to the Department of Justice website, GlaxoSmithKline (the makers of the drug in question) recently admitted to fraud allegations and their failure to report safety data. This stems from an accusation that the company was actively promoting the drug to be used for purposes other than what was intended. While the medication itself has proven effective when used as intended, which is to be for cancer patients receiving chemotherapy, birth defects have been noted in children whose parents took Zofran during their first trimester as a way to alleviate morning sickness.
A Case of Misleading Advertising
One might rightfully wonder why pregnant women are taking a drug aimed at helping individuals receiving cancer treatment, and the answer would be rather troubling. As the drug itself was known to help with the stomach problems and feeling of nausea that people receiving chemotherapy have been complaining of for years, the drug manufacturer carried this over to tout it as a remedy for common morning sickness. Not only had the FDA not approved the use of the drug for this purpose, it had apparently not even been tested. The result was misleading advertising of a disastrous proportion, as children are now suffering from birth defects as a result.
Lessons to Be Learned from Zofran
While the fine levied against this particular drug manufacturer is high at $3 billion, the cost is much higher regarding the loss of trust that members of society now feel towards many new prescription drugs. The television is ripe with commercials touting the new and greatest remedy for many diseases that have long since left individuals feeling sick and uncomfortable. Naturally, any drug that can safely help restore a sense of normalcy is what we all people living with such maladies crave. The reality is, however, that there seems to be a new report of defective drugs and medical devices hitting the airwaves on a regular basis.
As consumers, we want to know that we are protected and safe. This is particularly important from the perspective of the drugs we take and the medical devices we trust to fix and correct injuries and disease. In doing so, we are at the mercy of the FDA, or doctors, and the drug manufacturers themselves.
In the case of Zofran, the issue is even far more troubling as innocent children are now affected because of a decision made by adults to promote a drug to be used for an unintended purpose. This is a cost that is way too high to put a price tag on. The hope is that such cases, and the corresponding financial judgments, will begin to shine a spotlight on an issue that needs to be remedied. While mistakes inevitably happen, as humans do err from time to time, it should become the exception rather than the norm once again.