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FDA Scraps Helsinki Declaration on Protecting Human Subjects


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The FDA formally declared that it will no longer require that clinical trials submitted to the agency to get regulatory approval for a new drug adhere to the Helsinki Declaration.

The new rule, which goes into effect next October, was supported by the drug industry but opposed by numerous public interest, patient advocacy, and consumer groups.

The new rule requires only that trials conducted abroad by drug manufacturers follow good clinical practices (GCP) and include a review and approval by an independent ethics committee.

There's nothing in GCP guidelines that requires patients in the control arm of a trial get access to already proven therapies.


This article explains the significance of the FDA decision.

http://www.nature.com/embor/journal/v7/ ... 00743.html

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Some critics have said that clinicians, consumers and payers need to know whether or not a new treatment is better than other existing comparable treatments, not a (is this better than nothing) placebo.

The trials with people in this instance are ones who ought to be on some sort of medication. So providing them with nothing, rather than an existing drug, is a serious situation.

It's been an ethical question for a long time here in the United States. Some cannot see that anyone would do something so unethical as set up a trial that did not offer the chance at the current standard of therapy versus a new drug.

Being on a placebo for a few months means that a cancer seriously can progress to the point that treatment would no long benefit them. No thanks! I'd skip clinical trials.

There are some medical oncologists utilizing cell-based bio-markers for years in their managment of their cancer patients that feel it is unethical not to use them, as opposed to "trial-and-error" treatment. Science is in the eye of the beholder. If you know something works better than nothing......

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  • 4 weeks later...


I'm confused. On one hand, the FDA refuses to allow Stage IV cancer patients (technically "no-hopers") to take experimental drugs even though they're dying anyway (at which point I'd take ANYTHING rather than do nothing), but at the same time, they'll allow drug companies to conduct clinical trials that don't provide participants with the minimum to survive and/or prolong survival?

Isn't this inconsistent?


Life is a Terminal Condition

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  • 8 months later...

GoozNews has reported that the Dutch non-profit Wemos International, which works to protect human subjects in clinical trials, accused GlaxoSmithKline of having run a breast cancer trial in India that violated international norms on protecting human subjects.

The trial involved Tykerb (lapatinib), which had been approved in the United States for woman stricken with breast tumors that overexpress the Her2 gene. The NGO's press release suggested Indian women could not offer meaningful informed consent to participate in the trial since it was the only way for most Indian women to gain access to the drug.

The Wemos report also accused AstraZeneca of running a trial for a schizophrenia drug that used placebos in the comparison arm when other approved treatments were available.

The U.S. withdrew from the Helsinki Declaration, which prohibits placebo-controlled clinical trials to test new drugs for serious or life-threatening diseases when other effective therapies are already available.

http://www.wemos.nl/en-GB/Content.aspx? ... ws&id=3095

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