Inhibiting the production of vaccines

vaccines.jpgThe ever-observant Walter Olson points us to this interesting Theodore Dalrymple review of the new book The Cutter Incident: How Americaís First Polio Vaccine Led to the Growing Vaccine Crisis (Yale University Press 2005) by Paul Offit, a professor of pediatrics at the University of Pennsylvania.
Dr. Offit’s book tells the story of how a heartbreaking disaster caused by mass immunization during research ó a disaster that helped lead to the major medical and scientific breakthrough of virtually eliminating polio from much of the world — led to a legal ruling that has subsequently inhibited pharmaceutical companies from developing and manufacturing vaccines. During the early stages of polio immunization, the Cutter Company followed the then-imperfect instructions regarding production of the vaccine to the letter, but those instructions — together with the then-imperfect scientific knowledge regarding the vaccine — proved inadequate to guarantee the vaccineís safety. As a result, the live polio virus survived in some of the company’s vaccine, which was distributed to a large number of people. Seventy thousand of those immunized by the faulty vaccine experienced the transient flu-like symptoms of mild polio, 200 wound up being paralyzed by polio, and 10 died from the disease.

Some of the victims then hired the most flamboyant plaintiffsí lawyer of the time, Melvin Belli, who proceeded to sue the Cutter Company for all that it was worth. Although the trial was essentially a draw, the outcome nevertheless established a principle that would be nearly fatal to the production of vaccines in America:

The trial established beyond reasonable doubt that Cutter had not been negligent. But the judge statedóas a matter of law, so that the jury was powerless to disagreeóthat the company was liable for damages, even if it had done nothing wrong, simply because its product had harmed its recipients. This principle of absolute liability soon found itself defended in legal journals on the grounds that a large company was best able, via its insurance, to distribute the costs of risks among all the relevant parties, and society as a whole would benefit from the arrangement.
Quite apart from its repugnance to natural justice, this principle has been disastrous to the manufacture of vaccines. It opened the way for huge claims against the manufacturers. Since the courts are often cavalier in their complete disregard of scientific evidence, awarding huge damages against companies not only innocent of any negligence but whose products have done no objectively demonstrable harm, it is not surprising that pharmaceutical companies have largely withdrawn from the vaccine market. For them, the potential profits are small, and the risks great. SmithKlineGlaxo, for example, one of the worldís largest vaccine producers, withdrew its safe and effective vaccine against Lyme disease because of the expense of defending it against speculative tort actions of no merit. One almost wishes that an epidemic of Lyme disease would strike the whole tribe of tort lawyers.

2 thoughts on “Inhibiting the production of vaccines

  1. One of the presumptions in such legal mayhem is the harm done. The threshold for demonstration has been unrealistically low and often based on junk science. The use of silicone breast implants, for reconstruction in cancer patients, was a blatant example of science that more speculation than reality. In the vaccine field, the addition of a simple preservative, thimerosol, became the object of great concern and caused manufacturers to alter their processes, at enormous cost, on the presumption of toxicity. Once again, junk science prevailed. One problem with vaccines is that they work indirectly by altering our immune system. Individual responses vary so widely that someone will always be harmed. The smallpox vaccine causes a severe disease in a small percentage of people. The MS drug Tysabri, though not a vaccine, per se, also works by altering our immune system. For those who suffer from this incapacating disorder, a 1/1000 chance of brain inflammation is a risk worth taking. Lastly, there is an experimental vaccine for Alzheimer disease, being developed by Elan, that was pulled because a small percentage of patients developed a brain inflammation. The sad truth was that it appeared to work. However, the realization that anything less than absolute safety can be construed as negligence will ultimately hurt those patients.

  2. One vaccine lawsuit — and the damage it did

    At City Journal (published by the Manhattan Institute), Theodore Dalrymple reviews Paul Offit’s “enthralling” new book The Cutter Incident, and the story it tells of a medical catastrophe and resulting lawsuit with far-reaching consequences: “The plain…

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