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.