Clinical trials can be fake – and dangerous – too

Clinical trials can be fake – and dangerous – too

Worse than Fake News

From 2013 to 2016, more than two dozen people who thought they were participating in a clinical trial to obtain a vaccine for herpes. The participants, from the Caribbean island of St. Kitts and in the state of Illinois, had no idea that the Southern Illinois University (SIU) professor had never gotten approval for the so-called clinical trials from the U.S. Food and Drug Administration (FDA), a safety panel or the government of St. Kitts and Nevis. Participants had side effects such as dizziness, aches and ringing in the ears, although nobody had life-threatening issues.

This information was revealed after the fact, according to an article in Futurism (www.futurism.com).  However, as the article points out, “the fact that some of the shots were administered in hotel rooms might have been a good clue.”

Although the researcher, William Halford, died in 2017, the FDA has begun a criminal investigation into him and anyone else who might have been involved, according to the Washington Post. Halford developed the vaccine with a virus he created in his lab, and the FDA wants to know if other participants, people from SIU or employees of Halford’s company violated FDA regulations by helping him with the bogus clinical trial. Besides not getting safety approval, Halford failed to get written consent from his patients to receive injections of live viruses or a clinician to supervise the injections. While it is unusual for the FDA to do a criminal investigation instead of an administrative sanction, the agency is showing the seriousness of the case, especially because Halford was not even a medical researcher.

There have been other fake clinical trials. In 2017 the government’s legitimate clinical research site, ClinicalTrials.gov, hosted several trials for stem cell treatments not yet approved by the FDA. It even charged a fee for subjects to participate. At a Florida clinic, a trial intended to determine “whether stem cells could treat vision loss caused by macular degeneration, left three women permanently blind,” according to Futurism. In 2016 it was reported that 351 businesses, in 570 clinics in the U.S., provide stem cell therapies not yet FDA approved.

Futurism recommends ways to check out the validity of a clinical trial:

Forget about any trial that asks for up-front payment. Because the treatments are experimental, they are usually covered by the sponsoring agency or grant running the trial or insurance companies. The latter might even pay for costs such as transportation to the clinic or additional testing.

See who is funding the trial. The ClinicalTrial.gov site has this information. If it is an unfamiliar company or no sponsor is listed, additional digging is required.

Be sure to fill out informed consent paperwork, in understandable language. In addition, ask the researchers questions and obtain satisfactory answers. There is a list at the National Institutes of Health (NIH) website.

Make sure the trial has approval by an IRB, which guarantees that “risks are reduced and are outweighed by potential benefits,” according to the NIH. Ask the sponsor or researchers whether the has been approved.

Use common sense. If something looks fishy, like medical injections in a hotel room, it probably is.

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