The lead is being buried. Halford has finally, after decades and billions of dollars wasted, created a therapeutic and preventative vaccine for herpes even while the FDA has only wanted to obstruct him. In a few years, we should be able to get a shot, and be immune from getting herpes.
People are asking why would the FDA intentionally only allow decades of failed subunit vaccines that most immunologists knew would never work? Well they already have anti viral HSV drugs, that are incredibly profitable and safe. You can't sue for something you don't try. Failed studies, or unpromising ones proceed for funding, is the main reason. When you take something to clinical trials, a lot of funding is generated and its incredibly expensive. Lots of people get rich. And subunit vaccines, are weak as hell, but also safe, so they like doing them. But they've been making failed HSV subunit vaccines for decades, and would continue doing so if it weren't for Halford.
There are other potential reasons too. It's a fact the FDA delays or outright denies better therapies or drugs to protect profit lines. They've also allowed less safe and less effective drugs to market. Done this for HIV and heart medication. But there are a shit load of failed subunit vaccine for HSV that few people had faith in. They've know how to make an effective herpes vaccine for years. It's close. Hate Thiel all you want, but don't let it be blind hate.
Yes, I think the lead is being buried by you.
Correct me if I'm wrong but Rational Vaccines, and its libertarian and anti-government investors, were already turned away once before this specific trail because they failed to adhere to FDA guidelines. Rational Vaccines, a company founded by William Halford, who is now dead (leaving co-founder and MOVIE PRODUCER Agustín Fernández III in charge) decided to completely side step them so they could go straight to human trials without any oversight or regulations that any first world government would require. They then hoped the their offshore human trials would show the same efficacy results or that they could massage their manuscript in a way to gain approval from more independent reviewers.
It didn't. Some excerpts:
1. There are numerous exaggerations throughout the manuscript; e.g., the manuscript states ”... vaccines are safe and elicit complete protection against genital herpes..". However, neither safety nor efficacy has been demonstrated by the data presented.
4. The author presents results of 2 experiments on humans, the first one a safety study that he conducted on himself. While self‐experiments are generally permitted, these still require IRB review. Please provide assurance that this protocol was IRB reviewed and that the participant signed an informed consent. Unfortunately, data on 1 person does not prove safety of a product.
5. The subsequent Phase 1 study was conducted on a Caribbean island nation. Again, no information about IRB for this study is provided, and the trial does not seem to be listed on clinicaltrials.gov. The data for efficacy are based on self-report on participants who were questioned by the author and other staff before and after. As the author states ”self‐reported cessation of genital herpes... should be viewed with skepticism." Agreed.
6. On Figure 8, there is an impressively small p value. However, how it was derived is not shown. Given that there were only 17 persons in this study, it is unlikely that an appropriate statistical test for performed to obtain this result.
2. Criticism of the herpes vaccine field. This author has written similar critiques of the herpes vaccine before, including the claim that previous work has focused on glycoprotein subunit vaccines. The author is not the only one to propose virus‐based vaccines, contrary to the way the manuscript reads. There have been tests of live‐attenuated viruses and there are current tests of replication‐defective vaccines. The author dismisses the safety issues of live attenuated HSV as vaccines. To say that the previous trials violate the Hippocratic Oath (p. 11, line 37) because there has not been more rapid testing is unwarranted criticism. To say that ”the world has little to lose" (p. 19, line 35) by more rapid testing of live HSV viruses is reckless.
6. Flying U.S. trial subjects to St. Kitt for the immunizations and then flying them back to the US is ethically questionable. Who is giving the immunizations in St. Kitt and who is following them medically when they return to the US? Where is the clinical protocol based? Is this an end run around the FDA?
2. The author claims that he was the first to suggest the use of live mutant vaccines in 2007. Unfortunately, this is not true. Live attenuated vaccines were already described in the late 90s (reviewed in Aurelian, 2004)
So the one publication that was willing to give them a look ended up seeing this whole operation as the joke others already knew it was. Making claims with no data or insufficient data, committing surefire ethics violations had this been conducted in the US, failing to provide answers to basic questions necessary to even consider approval, pretending other live-attenuated vaccine work doesn't exist outside of his work, and arguably worst of all, using the "what do we have to lose" argument.
The issue here is libertarians are doing what they always do. Trying to minimize government institutions as nothing but road blocks that offer no benefit to society. The regulations and oversight are in place because experimental trials using humans and live viruses are risky ventures that could lead to serious consequences for those being tested and the population at large. IRB boards are also needed to keep watch just in case anything unforeseen goes wrong or to prevent straight up abuse of human subjects. We can keep mutated lab mice caged up, or even destroy them, but we cannot do the same thing with humans.
You'd hope that corporations are more than capable of following their own strict guidelines that wouldn't present ethical ror more tangible risks for the public without needing government regulation. But it has already been proven that any industry controlled by investors, whose top motivation is profit above all, sometimes (often) throw those concerns to the wayside. Volkswagen and their emission scandal, Massey Energy and Upper Big Branch, BP/Transocean/Halliburton and Deepwater Horizon are just a few recent examples.
The FDA isn't perfect, but they're on the ball when it comes to this study and its highly suspect results. Rational Vaccines is free to conduct clinical trials offshore and come back to the FDA, they just have to present the proper evidence when they're done. Except Rational Vaccines and its investors failed to even setup an IRB outside the US on top of failing across the board to fool their colleagues.
So now they're resorting to politicizing the issue to get know nothing voters to neuter the FDA:
The push behind the vaccine is as much political as medical. President Trump has vowed to speed up the FDA's approval of some medicines. FDA Commissioner Scott Gottlieb, who had deep financial ties to the pharmaceutical industry, slammed the FDA before his confirmation for over-prioritizing consumer protection to the detriment of medical innovations.
”This is a test case," said Bartley Madden, a retired Credit Suisse banker and policy adviser to the conservative Heartland Institute, who is another investor in the vaccine. ”The FDA is standing in the way, and Americans are going to hear about this and demand action."
Fernández said he hoped the trials would put political pressure on the FDA to give the vaccine a closer look. He said his vaccine would be initially aimed at helping patients who experience the ”worst of the worst" symptoms. He believed the vaccine eventually would be shown to be effective in preventing the spread of the disease. According to the CDC, about 1 in 6 people ages 14 to 49 have genital herpes.
”I will not stop," said Fernández, who described the trials as his personal mission. ”Too many people are suffering." Before the trial, Halford tested the vaccine on himself and Fernández. After he failed to secure federal funding and an IRB, Halford moved ahead with the trial offshore.
They couldn't/refused to prove they had an effective vaccine so now the investors and special interests are using a dead man's
INCOMPLETE research to whine about money. I encourage others to read the
Kaiser Health News article about this situation. They do a more thorough job of explaining the true motivation behind Rational Vaccines and its financial backers, their specific issue with the FDA, and why the FDA and others aren't falling for this nonsense and aren't dropping protections designed to prevent abuse.