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Non-Profit Questions Disclosure Practices of Drugs Tested on Patients

Filed July 9th, 2014 Eric

A non-profit company is raising concerns over clinical trial participants being unfairly placed at risk because they are not informed the drugs being tested on them were previously tested only on animals.

The Center for Responsible Science (CRS) believes the risk is substantial. The non-profit said the problem lies in the consent paperwork, where the wording generally fails to mention animal testing and the extent to which this can identify whether a drug is safe to give to humans, the Wall Street Journal reported. Given these concerns, the CRS is pushing for the FDA to upgrade its regulations to better reflect animal testing in clinical trial documentation that patients are given.

In a petition, CRC claims that many drugs that “appeared safe in animal studies have resulted in severe adverse reactions and deaths when given to humans.” As far as the non-profit is concerned, the FDA’s failure to mention such a risk has given the pharmaceutical industry a pass, according to the Wall Street Journal.

FDA regulations concerning clinical trials currently describe “any reasonably foreseeable risks and discomforts” be disclosed to clinical trial participants. Because of this, clinical research organizations or drug makers can avoid informing participants that pre-clinical animal testing may not predict the degree of risk the trial participants will be subjected, according to the petition.

The CRC cited a 2004 report from the FDA that pointed out a vast majority of drugs that pass though pre-clinical animal testing subsequently fail during clinical trials when the same drug is tested in humans, the Wall Street Journal reported. The FDA report also noted that traditional tools used to measure product safety, including animal toxicology, had barely changed over the decades.

The non-profit also references the ethical issues in not properly informing research participants of the risks involved with the drugs they are testing.  The CRS said failure to more thoroughly explain such risks is an ethical lapse. The non-profit believes regulations governing clinical trials should require that clinical trial investigators make full disclosures to participants that are in line with the disclosures patients would receive from their physician if the drug being tested was being prescribed, the petition said.

The FDA filed a letter on a government web site to acknowledge that it received the petition last month, but complete no response to the petition has been made.

The Wall Street Journal noted that the issue is just one of several concerns that have been voiced about informed consent. Critics in the US have argued for years that paperwork given to trial participants can be confusing and may not clearly explain issues such as liability or compensation for injuries, the Wall Street Journal reported.

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