Pharmaceutical Company Tries To Evade FDA Standards By Holding Clinical Trial On Caribbean Island


The company Rational Vaccines think they have a vaccine against herpes, but their plans for trials didn’t meet the US Food and Drugs Administration (FDA) rules. Rather than accept the FDA’s concerns, Rational Vaccines opted to run the trial in the Caribbean island of St. Kitts. However, their findings have been rejected by peer reviewed journals and the St. Kitts’ government is investigating.

Anti-vaccine campaigners like to claim vaccine safety testing is loose or non-existent. While historically standards were not always ideal, modern vaccine trials need to pass very rigorous standards to be allowed onto the market, at least in developed countries. However, rigorous also means slow and expensive. Many worthy ideas haven’t even been tried because they are too expensive, while others take a frustratingly long time to reach the public.

Naturally, people disagree on how to balance the need for safety and the desire to keep costs down. Film director Agustín Fernández III and Dr William Halford, the founders of Rational Vaccines, think the FDA has tilted too far in the direction of caution, and have found some big financial backers to help them, including Peter Thiel, who co-founded PayPal and has used his fortune to invest in many projects designed to escape government restrictions.

The problem for Rational Vaccines is that their idea for preventing and treating herpes involves a weakened but live virus. While this is an approach that has been used with great success in the past, for example against measles and polio, it also carries much higher risks, inducing FDA caution.

Drug companies do a lot of testing in poorer nations, where costs are lower. Historically, some companies have also regarded these participants as more expendable, leading to lower safety standards. Bad publicity in both fact and fiction has caused more reputable companies to raise standards, however, so that safety procedures elsewhere often match those the FDA uses at home. Rational Vaccines went offshore, but with a twist. The trial was done in St. Kitts, but used 17 Americans flown over for a holiday and an injection.

Southern Illinois University, where Halford works, initially trumpeted the positive findings from the trial, but when the work was submitted to peer reviewed journals things came unstuck. Reviewers were scathing about both the ethics of the way the trial was conducted, and the unreliable methods used to report whether the vaccine worked as claimed.

The government of St. Kitts and Nevis claims they never approved the trial, and the University is checking to see if their own standards were met.

The future of the vaccine looks doubtful, and anti-vaxxers have been discredited again, but Kaiser Health News reports advocates of looser regulations are pushing Trump to force the FDA to relax its restrictions.

 

[H/T: Ars Technica]

 

Read more: http://www.iflscience.com/health-and-medicine/vaccine-company-tries-to-evade-fda-standards-by-holding-clinical-trial-on-caribbean-island/


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Pharmaceutical Company Tries To Evade FDA Standards By Holding Clinical Trial On Caribbean Island

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