Beware the leaven.

[The Leaven – exploring the relationship between science and religion (cont)]

Whereas religion uses faith to dispel anxiety caused through uncertainty, science calls upon facts to achieve the same purpose. In the Old Testament, leaven was omitted from sacrifices in order to increase the purity of offerings thereby eliminating the chance of offending a deity. The fact a sacrificial offering was taking place at all accentuates the extent that fear manifested through uncertainty. Individuals would go to enormous lengths and effort in order to eliminate risk. Through scientific evaluation, most of us now rely on facts rather than sacrificial offerings to protect us from disease and other catastrophes. For instance, we are aware that Food and Drug administrative laws exist to protect consumer’s interests. Although, this still doesn’t entirely eliminate uncertainty, as trust in the regulators also relies heavily on faith. The public must rely on scientists and other professionals to have obtained experimental evidence according to the ethics of the law.

In pharmaceutical development, research occurs initially within a controlled laboratory environment until a new drug is released on to the market, at this point there is no barrier between science and the public. Whenever we take a prescribed drug we assume that it is going to be beneficial or, if this were not the case, the consequences to the prescriber would be so detrimental that the risk of malicious activity would be fairly small. Occassionally, drugs are released without all the necessary research being completed, sometimes with catastrophic consequences. A classic example of this was the thalidomide scandal in the 1960’s. Thalidomide still evokes images of human suffering. It earned this reputation because of the deformities it inflicted onto unborn children. Thalidomide was given to pregnant women to assist sleep and prevent morning sickness. The drug interfered with foetal development to produce deformities that included missing or abnormal limbs, spinal defects, cleft palates and the abnormal formation of many vital organs. Forty percent of cases lead to mortality during or shortly after birth.

Consequences of thalidomide. Tony Melendez aged 4. He is now an award winning singer and guitarist who plays with his feet. Image: Reuters

A German pharmaceutical company, Chemie Grünenthal, first marketed thalidomide in 1957 as a hypnotic to induce deep sleep without producing the side effects associated with other barbiturates available at the time. In 1956 the research of Wilhelm Kunz found it depressed the nervous systems of animals without fatalities. It was considered to be a safe alternative to contemporary medicines because its low toxicity could prevent an accidental or intentional overdose. A marked increase in deformities in newborns of patients taking the drug caused physicians to demand it be withdrawn from the world market in 1961. Astonishingly within a relatively short span of time between the first appearance of the drug and its subsequent withdrawal it had adversely affected the lives of more than 10,000 individuals.

Controversy surrounded the way in which the drug companies had marketed and produced thalidomide. It was argued that the disaster could have been averted if correct scientific procedures and protection were followed. Not until after the drug was removed from the market were extensive reproductive tests in animals carried out. Normally the pharmaceutical company would carry out and publish extensive reproductive studies in animals. Yet in the case of thalidomide, a drug that was being prescribed to pregnant women, similar studies had not been undertaken. Controversies such as this reflect the ambivalent relationship between science and other social institutions such as the media, regulatory systems and commerce. The media played an important role in the in the thalidomide case, contributing to legal history when the Sunday Times won an important case against Her Majesty’s Attorney-General in the European Court of Human Rights. The article that evoked this response exposed the shortcomings of the Distillers Company (Biochemicals) Limited, that marketed the drug as Distaval. Lack of experimental studies prevented the drug from reaching the American market as the chronic toxicity data was incomplete. The Food and Drug Administration (FDA) criticized the lack of long-term scientific studies and was concerned about the evidence that the pharmaceutical company were withholding, they were particularly apprehensive about the drugs reported side effect of peripheral neuritis.

The thalidomide controversy immediately led to tighter controls on the introduction of new drugs in the form of an independent Committee on Safety of Drugs. Eventually a Medicines Act was established in 1968 and the Committee on Safety of Medicines was formed in 1971. The USA had the Pure Food and Drugs Act in place as early as 1906. Evaluation to ensure drug safety was established by The Federal Food, Drug and Cosmetic Act in 1938 governed by the FDA founded in 1931. The FDA demanded scientific evidence to evaluate thalidomide, it was not available and therefore the drug was not granted a license to be marketed. If the same procedures had been followed in other countries the number of affected individuals may have been substantially reduced.

The thalidomide controversy drew the attention of the public towards the morality of the pharmaceutical companies and many aspects of scientific research. Tensions existed between public health issues and economic priorities. Pharmaceutical companies exploited scientific discovery for financial gain that appeared to obliterate human compassion, with individuals passing responsibility so that no body was eventually held to account. Not only were the victims facing the physical and mental hardship of overcoming severe disabilities but they also faced a long fight to receive compensation. The science of actually manufacturing the drug was not fully responsible for the thalidomide controversy. If thalidomide occurred naturally, say as a plant extract, and was not synthesized in a lab these problems would still have existed. It was the marketing of the substance as a drug that caused the problems. The lack of scientific evidence that ensured the drug was safe. The public learnt that scientific evidence could be manipulated by financial gain. Controversies such as this cause people to lose faith in science. In this case essential research was not presented in order to release the drug on to the market and the British authorities failed to regulate the pharmaceutical company concerned or compensate the victims.

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