Medical Scandals

Chinese Heparin Contamination

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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.

Cutter Incident

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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.

The disaster spawned lawsuits that resulted in the 1957 “liability without fault” jury ruling, that is, companies are financially liable for their products without being negligent in the design or production of those products. The decision set a dangerous precedent because only a few US companies today are willing to make lifesaving vaccines without liability protection; and without vaccines, there can be no protection against a full blown pandemic. In fact, the US relies on England, Belgium and France for its entire influenza vaccine requirements.

Elixir Sulfanilamide Disaster

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The Elixir Sulfanilamide disaster was a mass poisoning incident that took place in the United States in 1937. Sulfanilamide had been proven for some time to be a safe and effective treatment for streptococcal infections in tablet and powder form. However, in June 1937, Harold Watkins, the chief pharmacist and chemist for the drug manufacturing firm S. E. Massengill Co., created the syrup form of the drug using diethylene glycol (DEG) as solvent and added some raspberry flavoring. The new formulation was not tested for its toxicity as the food and drugs law at the time did not require safety studies on new drugs. Had pharmacological studies been conducted, it would be known that DEG, an anti-freeze chemical, is deadly poisonous to humans.

The company began marketing and distributing “Elixir Sulfanilamide” in early September 1937. A month later, the American Medical Association received a report of a number of deaths linked to the consumption of the medication. Upon notification, the FDA made an extensive effort to recover the distributed medicine. It is estimated that at least 100 people, mostly children, suffered horrendous deaths from the effects of DEG that included convulsions and kidney failures. When pressed to admit liability, the firm’s owner replied: “We have been supplying a legitimate professional demand, and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part.” Watkins obviously did not share the same sentiment, having committed suicide upon learning of the deadly results of his latest creation. The public outrage that ensued led to the passage of the 1938 Federal Food, Drug, and Cosmetic Act, requiring companies to perform safety tests on new drugs and submit their results to the FDA for approval before being allowed to market their product.

Gurgaon Kidney Scandal

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The Gurgaon Kidney scandal is one of the largest transplant rackets that has gripped India in recent years. In January 24, 2008, a massive illegal transplant racket was uncovered when the police raided the guesthouse and hospital of Dr. Amit Kumar in Gurgaon, a booming IT city just outside of New Delhi, India. The modus operandi of the gang was simple. Most of the victims were lured to the clinic with the promise of a good paying job, but were instead asked to sell their kidneys; and those who resisted were either forced to do so at gunpoint or drugged against their will, only to find out that their kidneys had been removed once they regained consciousness. They were paid 50,000 rupees ($1,250) to keep their surgeries under wraps, and their kidneys transplanted to wealthy patients, usually non-resident Indians and foreigners, for 10 to 40 times as much.

Several people were arrested including some doctors and nurses during the raid. At least 5 foreigners, who were found staying in the luxury guesthouse awaiting kidney transplants, were also arrested but would be released shortly thereafter. Kumar, the alleged ringleader of the racket, seemed to have been tipped off and managed to escape, triggering an international manhunt that led to his arrest in neighboring Nepal two weeks later. The probe into the transplant ring revealed that some members of the local police were paid about 2 million rupees ($50,000) to help the accused evade arrest. It is estimated that Kumar has performed between 500 to 600 kidney transplants in the past decade, amassing a fortune of billions of Indian rupees. Such stories are hardly new in India, but as long as kidney failures become more prevalent in rich countries usually due to obesity-related diseases, the resulting transplant organ shortage will certainly fuel a black market that exploits the underprivileged.

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