WASHINGTON — Defying U.S. safety protections for human trials, an American university and a group of wealthy libertarians, including a prominent Donald Trump supporter, are backing the offshore testing of an experimental herpes vaccine.
The American businessmen, including Trump adviser Peter Thiel, invested $7 million in the ongoing vaccine research, according to the U.S. company behind it. Southern Illinois University also trumpeted the research and the study’s lead researcher, even though he did not rely on traditional U.S. safety oversight in the first trial, held on the Caribbean island of St. Kitts.
Check out: https://slatestarcodex.com/2017/08/29/my-irb-nightmare/
I sat on the Stanford IRB for 3 years and this little vignette is so on the mark!
I remember the hub-bub over Buyers’ Clubs in the 80’s for AIDS therapies, which were deemed illegal and unethical. Eventually, the bureaucrats got out of the way, as I recall. And FDA has spent way too much time and taxpayer money making commercials about the evils of smoking. FDA’s mission statement used to (and may still) include the phrase “to promote the public health.” Being a roadblock to innovation in drug, vaccine and medical device development does nothing to promote the public health. As another commenter wrote so eloquently and concisely, “Before the rules were this strict, we got smallpox, polio, tetanus, and other vaccines. Maybe look at the rules?”
Why don’t you learn what is required for approval before you print such hack policy pieces. If this vaccination is intended to be approved/marketed in the U.S., the FDA will evaluate and scrutinize the data generated as part of the development process as closely as it does for those that conduct studies in the U.S. They will not approve a therapy that is not up to the standard that is required. Next time you decide to write an article on therapeutics development, hire someone who knows a thing or two about regulatory standard and the requirements for approval.
What a homophobic and bigoted article! He’s doing internationally what the cishet community in America has blocked.
What a scandal, curing LGBTQ+ sufferers without your precious paperwork!
Since when were LGBTQ people the only ones getting herpes? I’d wager straight people are more numerically affected by herpes than LGBTQ people.
The real racketeering seems to be by the FDA, the peer-review community, & others in the supply chain that stand to lose billions of dollars, if expedited or streamlined testing like this is allowed.
How do you know the sexual orientation of those who participated in the study?
A bit of a bigoted and parochial comment here. Why is the scope of your outrage limited? Any reason why we can’t say that herpes is a problem for all communities? No idea why you think this is this a hetero versus lbgt thing. It’s clearly a regulations versus common sense thing. But way to be divisive, hater.
Before the rules were this strict, we got smallpox, polio, tetanus, and other vaccines. Maybe look at the rules?
Well said!
Because the individuals are going back and forth from the U.S., they could be prosecuted for a conspiracy to violate FDCA rules and regulations. They (the individuals running or funding the activities) are also open to prosecution, both criminally and civilly, under RICO. The University may have liability for similar types of violations, especially given that they were doing acts that appear to promote illegal conduct. It is not unusual to see rich individuals let their arrogance go to their ego, and prevent them from properly assessing the risk (and stupidity) of what they are doing. Given that these are potential criminal acts, any liability waivers by the test subjects would probably be invalid/void, so if problems arise from the so-called vaccine, these promoters and facilitators (plus those carrying out the actual program) face civil liability, and punitive damages would likely be available for the harm they have caused.
It’s stupid that you are so eager to massively expand government powers to shut down medical trials PEOPLE WANT because some petty bureaucrat doesn’t like it. You’re need to politicize every aspect of our lives, including the most intimate parts, such as medicine, is disgusting.
The FDCA would only apply if the drugs were manufactured, distributed or administered in the US. It doesn’t apply to US citizens traveling to sovereign countries for medical treatments.
This is awesome! Conducting clinical trials in the US is massively expensive. It’s time to disrupt the regulatory framework that big pharma uses to prevent competition and extort the market.