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Non-Profit Group Pushes FDA to Reveal Prior Pre-Clinical Animal Testing to Clinical Trial Participants

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A non-profit organization is fighting to make sure that those who participate in clinical drug trials are informed when the drugs have been tested previously on animals.

The Center for Responsible Science is pushing for the U.S. Food and Drug Administration (FDA) to upgrade its regulations to reveal animal testing in the clinical trial documentation given to participants. The group says the documentation rarely mentions animal testing and whether or not that information can help predict whether a drug is safe for use in humans, according to The Wall Street Journal’s Pharmalot blog.

The Center argued in a recent citizen’s petition that even though animals are considered “the gold standard during pre-clinical testing,” many drugs that appeared to be safe for animals have caused severe adverse events in humans, including death. What’s worse, according to the non-profit group, is that the pharmaceutical industry is getting away with it because the FDA fails to mention the risk, Pharmalot reported.

At the moment, the FDA is only required to describe the potential risks and discomforts that a drug could cause trial participants. This allows pharmaceutical companies, research organizations and institutional review boards to avoid disclosing that pre-clinical animal testing may not be an accurate litmus test for the risks that participants may be exposed to, according to Pharmalot.

A 2004 FDA report notes that the vast majority of drugs that pass pre-clinical animal testing go on to fail human clinical trials, and that the methods traditionally used to measure product safety, including animal toxicology, have greatly evolved over the decades. The Center for Responsible Science is using the report as ammunition to insist that the FDA become more transparent about its pre-clinical animal test findings, Pharmalot reported.

The group calls the FDA’s unwillingness to share these risks an ethical lapse in judgment and says that clinical trial regulations should “mandate that [clinical trial] investigators make disclosures” to participants that are “analogous to the disclosures patients would receive from their physician if the drug being tested was being prescribed,” according to Pharmalot.

Last month, the FDA filed a letter on a government website acknowledging the petition was received last month, but it remains to be seen whether the agency will comply with the Center’s requests. The Center for Responsible Science is not alone in its criticism of drug trial regulations, however. Pharmalot reports that many experts in the U.S. say the paperwork given to trial participants is confusing and does not always clearly explain liability issues or compensation for injuries.

breakinglawsuitnews.com disclaimer: This article: Non-Profit Group Pushes FDA to Reveal Prior Pre-Clinical Animal Testing to Clinical Trial Participants was posted on Thursday, July 10th, 2014 at 1:39 pm at breakinglawsuitnews.com and is filed under Other Lawsuits, Personal Injury Lawsuits.

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