Medical scandals always involve life and death situations. Here are four notable scandals that had plagued the supposed respectable field of medicine.
Chinese Heparin Contamination
In March 2008, the Food and Drug Administration (FDA) announced major recalls of the blood thinning drug heparin produced by Baxter International, following discovery of contaminated raw heparin stock imported from China used in its production. The raw heparin supplies, which originated from the China-based branch of American pharmaceutical firm Scientific Protein Laboratories (SPL), were neither subjected to inspection by the US FDA officials in violation of FDA regulations nor were they certified as safe for pharmaceutical use by the Chinese FDA since the company was not registered as a drugs company but as a chemical manufacturer. In turn, SPL obtained its porcine intestines-derived heparin from its joint venture partner, Changzhou Techpool, as well as Ruihua Biomedical Products and a number of small unregulated family workshops, most of which refused to have their facilities inspected. In fact, an anonymous source bluntly commented during the investigation that “China simply has no regulatory regime to speak of.”
The contaminant has been identified as a chemically altered form of chondroitin sulfate, which is a dietary supplement made from animal cartilage used to treat arthritis, and does not possess any anti-clotting properties. The Federal authorities stopped short of saying that the contaminant, “over-sulfated” chondroitin sulfate, was a deliberate act of Chinese drug counterfeiting rather than an accidental lapse in the manufacturing process, considering that it costs at least 90 percent cheaper and that it virtually mimics the real drug. The tainted blood thinner has found its way to at least 11 countries including Canada, Australia, Germany, Japan and France. In the US alone, at least 81 deaths and around 800 reports of serious allergic reactions were believed to be linked to these ingredients. There are growing concerns over the safety of China-made products over the last two years as thousands worldwide have been killed or injured by poisonous toothpaste, toys, pet foods and more recently infant milk.
In 1955, Cutter Laboratories of Berkeley California was one of five pharmaceutical companies that were licensed by the United States government to mass produce the Salk’s newly developed formaldehyde-inactivated polio vaccine. In what became known as the Cutter Incident, Cutter failed to completely inactivate or kill the harmful poliovirus in a few production pools, resulting in the production of vaccines that contained live ones instead. The entire lot was immediately recalled but almost 400,000 doses had already been administered to healthy grade school children. Of the estimated 120,000 children who were inadvertently injected with the defective vaccines, 40,000 developed mild symptoms, 200 developed paralytic poliomyelitis and at least 10 died of polio infection.