April 26, 2024

Clinical trials create ‘underclass’ of professional participants, bioethicist claims

Michael Cook

Safety testing could violate Helsinki Declaration
American pharmaceutical companies are creating an
“underclass” of people who are making a modest living out of participating in
Phase 1 clinical trials, alleges bioethicist Carl Elliott and Roberto Abadie in
the New England Journal of Medicine.
Under current arrangements, universities are outsourcing clinical trial to
companies whose ethical standards are overseen by for-profit ethics committees.
Are poor people exploited when they take money for this work? The authors say
Yes.

They argue that placing the burden of safety testing
on the poor appears to contravene the Declaration of Helsinki. This states that
medical research is ethically justified only if there is a reasonable chance
that subjects will benefit from the results. Also, American regulators are not
well equipped to oversee “a highly competitive, market-based, multinational
research industry”. Furthermore, they claim, “most sponsors apparently do not
provide free care or treatment for subjects who are injured in these trials”.

Ultimately the problem is that many participants see
their involvement as a job in which the notions of “volunteering” and
compensation for expenses have an altogether different meaning. It is not an
act of altruism and many subjects depend on income from trials to support
themselves – without “the rights or benefits that come with a good job, such as
workers’ compensation, the right to unionize, disability benefits, or health
insurance”. As one Philadelphia subject explained, it is “a mild torture
economy". ~ NEJM, May 29

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2 thoughts on “Clinical trials create ‘underclass’ of professional participants, bioethicist claims”

  1. It is unbelievable. The explanation of the clinical trial worker explains it all “mild torture economy”.
    All workers shoould have the rights for compensation and health insurance.

  2. Good stuff.. I personally believe that the entire process of human experimentation is a double edged sword. While on one end it does indeed promote research and does help out a lot of people financially, one certainly has to look up and sense if it really promotes anything good

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