The Declaration of Helsinki renders protection to human subjects in clinical trials. It gives a set of ethical guidelines to follow while conducting clinical trials involving human subjects.
The Declaration isn’t so much a law as it is a set of guidelines. But, in the global scenario countries do tend to stick to these guidelines and not violate them.
But not the FDA.
In April of 2009, the FDA issued a statement saying American trials conducted outside the United states would no longer be required to adhere to the Declaration of Helsinki. This also means that pharmaceutical companies can use placebo instead of the current standard of medical care as the control.
Why would the FDA do this? The United States conducts clinical trials in so many countries including developing countries such as Brazil, India, China, and so many African countries.
The people in these countries may not necessarily be educated, literate, and many may not be able to understand the details of the informed consent form. But, they would still agree to participate in the trial because of the compensation they receive, however menial it is.
These underprivileged people are easy targets for unethical practices of the pharmaceutical companies.
Also, using a placebo instead of a comparable treatment may lower costs of the trial, but the trial is not being conducted with scientific integrity. Results of these trials wouldn't give us clear idea of the effects of the drug being tested, because the drug is being tested against a placebo (=nothing)!
Shouldn’t the FDA ensure that these people are protected in the same way that Americans participating in trials are? Aren’t all people equal?
Look what happened with Pfizer in Nigeria. Does the FDA want the blood of innocent people on it’s hands?
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