Prescription drugs are an extremely important part of many Americans’ daily lives and can mean the difference between life and death. Obviously, you want to trust that your medications are effective and safe. The pharmaceutical industry claims that there is no need to worry, since they maintain that they follow the highest standards of quality. However, it appears that some drug companies aren’t as trustworthy as they would like to have you believe. In fact, in November GlaxoSmithKline pled guilty to knowingly distributing adulterated medication after a whistleblower, Cheryl Eckard, a company insider, tipped off federal investigators.
The extent of GlaxoSmithKline’s bad medicine is astonishing: after Eckard became the lead of a quality assurance team she made some horrific discoveries at a Puerto Rico plant manufacturing drugs for the U.S. For example, all the systems were broken, the equipment was broken, and the manufacturing processes were broken in the Cidra, Puerto Rico plant. Specifically, water tainted with bacteria was used to make tablets, failures on production lines made some drugs too strong and others not strong enough, and employees were contaminating the product by sticking their arms inside of tanks containing Bactroban, an anti-bacterial ointment. But the worst discovery was that employees were packaging the wrong drugs inside of the wrong bottles, and even mixing various drugs together in the same packages.
Eckard contacted the vice president of quality for North America for GlaxoSmithKline and informed him that he needed to contact the FDA immediately. She waited to hear announcements of recalls on the news, but they never came. Ian McCubbin, a senior vice president from Glaxo headquarters in London admits that the company made mistakes, but maintains that the same thing is not happening in the company’s approximately 80 plants around the world. In addition, he also argues that GSK was already working with the FDA before Eckard got involved. Indeed, the FDA already conducted an investigation at the Cidra plant before GSK sent Eckard in to help with quality control. However, Eckard found much more than the FDA had in terms of manufacturing problems.
This case highlights the need for adequate numbers of FDA inspectors. Dr. Avorn of Harvard Medical School, an expert in pharmaceuticals, states that FDA inspections of pharmaceutical plants are only occasional, so it’s up to the companies themselves to police their own behavior. Unfortunately, that doesn’t always happen, as in the case of Cidra, when quality and safety are sacrificed for the sake of profits.