Palisadian Watchdog Group Launches FDA Legal Battle

By MATTHEW MEYER | Reporter

The Palisadian Center for Responsible Science is taking the FDA to court over what it deems life-saving changes to the way clinical participants are warned about the dangers of volunteering for drug trials.

Former participants and the father of a boy who died while participating in a cancer therapy trial are joining CRS in the suit, which was announced on Oct. 24 after the FDA rejected a formal petition to make the changes.

The plaintiffs are demanding more explicit warnings in the FDA’s “informed consent” protocols—the procedures by which medical trial administrators must explain to subjects any harm that could befall them during testing.

Specifically, the group says trial participants need to be given a better understanding that “the drugs they are being given have been tested largely in animal models,” and that animal testing is not necessarily predictive of the risks to human subjects.

Tamara Drake, CRS’ director of research and regulatory policy, said that means current informed consent procedures may be luring trial participants into a false sense of security.

“You read all of these forms [and] you’re feeling pretty secure,” she said. But without a specific explanation about the effectiveness of pre-clinical trials, “there’s a huge omission.”

The group says many participants might not realize how often clinical trials have fatal consequences.

Through media reports and SEC filings, CRS cites a list of “at least 153 treatment-related deaths in clinical trials in the last four years.”

“I will never say that’s the number of people that have died,” Drake added. “I say that’s at least how many people have died … If it’s disputed by the FDA, then they can tell us how many.”

CRS first asked the FDA for the expanded, specific warnings through a citizen petition.

In their rejection letter, which is available in its entirety on CRS’ website, the FDA stood by its current informed consent guidelines, stating that CRS failed to provide evidence of “how the proposed warnings would be understood by prospective research subjects.”

The letter also cited concerns that requiring such warnings would hinder the guidelines’ flexibility to be applied broadly across trials.

Now that the debate has developed into a lawsuit, FDA officials declined a request for further comment.

Alan C. Milstein, a noted clinical trials litigator, will represent CRS and its fellow plaintiffs in front of a Federal District Judge in Washington, D.C.

CRS was founded in 2012 by a Palisadian woman who, Drake said, is still actively involved in the day-to-day operations of the young organization but prefers to remain anonymous.

CRS has attracted financial support from other prominent Palisadians, including “Simpsons” co-developer Sam Simon, who was deeply involved in varied charitable works until his death from cancer in 2015.

The group’s board of directors includes doctors, scientists and pharmaceutical industry leaders.