Monday, January 28, 2013

Clinical Trials and Dignity of Life

The Peace Weekly column on the culture of life reports that clinical tests often do not respect the dignity of those tested.  One striking example, mentioned by a Catholic University professor, took place in the US between 1932 and 1972 . Nearly four hundred black, poor and illiterate persons were involved in a clinical test on syphilis. They were never told they had syphilis, or what the tests involved, or did they give permission for the tests.

Gaining more knowledge of the natural progression of syphilis was the object of the tests. And even though the researchers had enough knowledge for remedial treatments, they were not interested and prevented  their test subjects from getting help. It was clearly the exploitation of a poor and vulnerable group without the resources to do anything about it.

Also mentioned in the column was a group of pharmaceutical companies conducting clinical tests in India in 2005. The subjects--minors, the disabled, illiterate, poor, and tribal people--were encouraged by their doctors to join the clinical tests. The columnist said that the consent to the test was not clearly ascertained, and that the minors did not receive their parents' approval. During the clinical tests about 1,730 died.

Today,  young people with part-time jobs and college students volunteer for clinical tests because of the money being offered. The invitations to volunteer are often seen on Internet portals.  Many of these invitations are for bioequivalence testing, which ascertain whether the generic medicines are absorbed into the body as well as the brand-name products, whether the generic delivers the same therapeutic effect as the brand counterpart, and whether it can be safely substituted for the brand product.

The columnist reminds us that when a patent for a drug runs out, other drug companies can manufacture and sell that drug as a generic. This is the reason pharmaceutical companies have trials to prove that their generic product has the same therapeutic effect and is as safe as the brand counterpart. One week they use the brand name drug and the following week the generic drug, analyzing and comparing the effects of the two.

Many laws are now on the books, thanks to the 1932-72 case, to prevent the abuses. Our columnist concludes with the hope that the government, the pharmaceutical industry, and related organizations will be more concerned with their test subjects than they have been in the past. She hopes for the day when the clinical tests have an oversight committee established to periodically study the trials and make sure the rights of the subjects are respected.


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