Questionable herpes vaccine research backed by tech heavyweight Peter Thiel may have jeopardized $15 million in federal research funding to Southern Illinois University School of Medicine. That's according to documents obtained by a Freedom of Information Act request by The State Journal Register.
In August, Kaiser Health News reported that Thiel and other conservative investors had contributed $7 million for the live-but-weakened herpes virus vaccine, developed by the late SIU researcher William Halford. The investments came after Halford and his private company, Rational Vaccines, had begun conducting small clinical trials in the Caribbean nation of St. Kitts and Nevis. With the off-shore location, Rational Vaccines' trial skirted federal regulations and standard safety protocols for human trials, including having approval and oversight from an institutional review board (IRB).
Experts were quick to call the unapproved trial "patently unethical," and researchers rejected the data from publication, calling the handling of safety issues "reckless." The government of St. Kitts opened an investigation into the trial and reported that health authorities there had been kept in the dark.
Related Stories
Unregulated herpes experiments expose 'black hole' of accountability
Recent revelations that a U.S. researcher injected Americans with his experimental herpes vaccine without routine safety oversight raised an uproar among scientists and ethicists. Not only did Southern Illinois University researcher William Halford vaccinate Americans offshore, he injected other participants in U.S. hotel rooms without Food and Drug Administration oversight or even a medical license. Since then, several participants have complained of side effects.
But don't expect the disclosures after Halford's death in June to trigger significant institutional changes or government response, research experts say. "A company, university or agency generally does not take responsibility or take action on their own to help participants, even if they're hurt in the trial," said Carl Elliott, a professor in the Center for Bioethics at the University of Minnesota. "These types of cases are really a black hole in terms of accountability." The federal government once scrutinized or even froze research at universities after learning of such controversies. Now, experts said, the oversight agencies tend to avoid action even in the face of the most outrageous abuses.
Experts said the U.S. regulatory agencies are especially unprepared to deal with off-the-grid experiments like Halford's. He recruited subjects through Facebook and in some cases didn't require signed consent forms, or informed participants outright that the experiments flouted FDA oversight. These patients, many who struggle with chronic, painful herpes, proceeded anyway in their quest for a cure. After Halford's offshore trial, Peter Thiel, a libertarian and adviser to President Donald Trump, pitched in millions of dollars for future research.
Previously: Hopes of Extended Lifespans Using Transfusions of Young People's Blood
University Could Lose Millions From "Unethical" Research Backed by Peter Thiel
Groups funded by Charles and David Koch have launched ad campaigns aimed at urging Congress to pass legislation that would make it easier for terminally ill patients to try experimental treatments. The bill passed the Senate unanimously, but FDA Commissioner Scott Gottlieb told the House in October (archive) that the FDA already approves 99% of requests for expanded access/compassionate use, and that the primary roadblock is not the FDA, but drug supply constraints. He said that pharmaceutical companies do not continuously manufacture a drug undergoing clinical trials, but instead produce "discontinuous batches":
Several deep-pocketed political advocacy groups founded by Charles and David Koch are ramping up their advocacy before Congress on a niche issue: access to experimental drugs.
On Monday, several Koch-backed groups, including Freedom Partners and Americans for Prosperity, launched an ad campaign urging Congress to pass so-called "right-to-try" legislation, which aims to help terminally ill patients access experimental treatments that haven't yet been approved by the Food and Drug Administration. The Senate unanimously passed a right-to-try bill from Sen. Ron Johnson (R-Wis.) last August, but it has since stalled in the House. Supporters, including lawmakers on Capitol Hill and other off-the-Hill advocates, are focusing their efforts this month on the Energy and Commerce Committee, which would likely have to clear the legislation before the full House could vote on it.
The new ad campaign — also sponsored by Generation Opportunity and The LIBRE Initiative — directly addresses Congress, saying at the end of one commercial, "Congress, give patients a chance. Pass right to try." In addition to a series of digital ads focused on D.C. and key congressional districts, the campaign will include lobbying efforts by the groups, according to a press release. In a letter sent Monday to Committee Chairman Greg Walden (R-Ore.), executives wrote, "We strongly urge your committee to act expeditiously to approve Right to Try legislation and send the bill to the House Floor for a full vote."
Johnson told STAT he's doing everything he can this month to get the legislation passed, and suggested the vice president might become even more engaged. Vice President Mike Pence has supported right-to-try efforts since he signed a similar law as governor of Indiana.
Related: What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
FDA Nominee is a Proponent of "Adaptive Trials"
Texas Sanctions FDA-Unapproved Stem Cell Therapies
University Could Lose Millions From "Unethical" Research Backed by Peter Thiel
"Black Hole" of Accountability for Drug Trials Flouting FDA Oversight?
Drug Approvals Sped Up in 2017
Netflix's CEO offered to resign from Facebook's board in 2016, citing his fellow board member Peter Thiel's support of Donald Trump:
Netflix CEO Reed Hastings — who called his fellow board member Thiel's support of Trump "catastrophically bad judgment" in an email leaked to the Times — also offered to resign over his disagreement with Thiel, according to a Wall Street Journal report published Thursday. Sources told WSJ that Facebook CEO Zuckerberg declined Hastings' offer to resign. Facebook declined to comment on the matter to Business Insider.
Now, Thiel may resign from Facebook's board instead in the midst of packing up and leaving the Bay area:
The founder of PayPal and a prominent investor in Silicon Valley, Thiel is reportedly moving his investment firms Thiel Capital and Thiel Foundation out of the Bay Area and into Los Angeles this year, according to WSJ.
In L.A., Thiel is also reportedly planning to build "a right-leaning media outlet to foster discussion and community around conservative topics." Thiel bankrolled the lawsuits that eventually forced Gawker Media into bankruptcy, and has been trying to buy Gawker's now-defunct flagship site.
Although Thiel has called Silicon Valley a "one-party state", in the 2016 Presidential election, Hillary Clinton beat President Trump 72 percent to 22 percent in Los Angeles County.
The Guardian also has an article about Thiel's involvement in New Zealand.
Also at Ars Technica, The Mercury News, LA Times, and Vanity Fair.
Related: Peter Thiel Acquires NZ Citizenship and Large Property
Everything Wrong with Peter Thiel's Doomsday Survival Plan
University Could Lose Millions From "Unethical" Research Backed by Peter Thiel
"Black Hole" of Accountability for Drug Trials Flouting FDA Oversight?
Peter Thiel Makes a Bid for Gawker.com
FDA Launches Criminal Investigation Into Unauthorized Herpes Vaccine Research
The Food and Drug Administration has launched a criminal investigation into research by a Southern Illinois University professor who injected people with his unauthorized herpes vaccine, Kaiser Health News has learned. SIU professor William Halford, who died in June, injected participants with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without safety oversight that is routinely performed by the FDA or an institutional review board.
According to four people with knowledge about the inquiry, the FDA's Office of Criminal Investigations is looking into whether anyone from SIU or Halford's former company, Rational Vaccines, violated FDA regulations by helping Halford conduct unauthorized research. The probe is also looking at anyone else outside the company or university who might have been complicit, according to the sources who asked not to be identified because of the sensitivity of the matter.
The FDA rarely prosecutes research violations, usually choosing to administratively sanction or ban researchers or companies from future clinical trials, legal experts said. Even so, the agency is empowered to pursue as a crime the unauthorized development of vaccines and drugs—and sometimes goes after such cases to send a message.
[...] Rational Vaccines was co-founded with Hollywood filmmaker Agustín Fernández III, and the company received millions of dollars in private investment from investors after the Caribbean trial, including from billionaire Peter Thiel. Thiel, who for months has refused to respond to questions from KHN, contributed to President Donald Trump's campaign and is a high-profile critic of the FDA. Thiel is part of a larger libertarian movement to roll back FDA regulations to speed up medical innovation.
Three people have sued Rational Vaccines over the experimental injections.
Also at STLtoday.com.
See also: Can We Gene-Edit Herpes Away?
Previously: University Could Lose Millions From "Unethical" Research Backed by Peter Thiel
(Score: 1, Insightful) by Ethanol-fueled on Thursday November 16 2017, @06:10PM (24 children)
Those who are crying need to shut the fuck up. If anybody needs a herpes vaccine, it's the Caribbean.
(Score: 5, Insightful) by Runaway1956 on Thursday November 16 2017, @06:23PM (10 children)
That's all well and good. But, ethics remain an important issue. If you don't have the time, or the compassion, to ensure that your test subjects don't drop dead from your tests, then you don't need to be testing medical stuff at all. Can't bear the thought of any kind of ethical oversight? You need to keep local health officials in the dark? There's something bad wrong with your methodology. If your methodology sucks, there is every reason to suspect that your results are bad too.
How many drugs have we seen come to market in the past decade or two, only to learn much later that the side effects are worse than the problems for which they were prescribed?
Ahhh, to hell with recent decades - how 'bout some nice, relaxing thalidomide? Have a truckload, so you can share it with all of your child bearing age female friends and relatives.
https://www.youtube.com/watch?v=eFTLKWw542g [youtube.com]
(Score: 3, Insightful) by Anonymous Coward on Thursday November 16 2017, @07:05PM (3 children)
see, this is why i don't mind runaway.
he's principled even if he does lean quite rightward.
conservatives do not have to be 100% profit and revenue maximizng at the expense of the actual customers they depend on.
the very fact that the topic had '"unethical" in quotes led me to believe we'd be biased right from the start--which we were with the academic witchhunt comment--but runaway helped set the proper tone.
ethics matter to everyone. you dont have to be red or blue to do unto others as you'd want done to you.
(Score: 3, Insightful) by aristarchus on Thursday November 16 2017, @08:06PM (2 children)
I totally agree. I even had to mod Runaway up. It hurt, but I did it anyway, because he's right. For once.
(Score: 1, Funny) by Anonymous Coward on Thursday November 16 2017, @09:24PM (1 child)
got your mod points back, eh?
(Score: 2) by aristarchus on Friday November 17 2017, @12:33AM
Twice as many, it seems.
(Score: 3, Insightful) by wisnoskij on Thursday November 16 2017, @10:47PM (2 children)
The story seems to be saying that a company is developing a drug in the Caribbean , that would greatly help the Caribbean, while following all Caribbean guidelines and requirements.
I don't see what concern it is to us what laws and regulations the Caribbean decides are necessary to restrict life saving medical research.
(Score: 0) by Anonymous Coward on Thursday November 16 2017, @11:07PM
It involves Peter Thiel! Hate!
(Score: 3, Informative) by Runaway1956 on Friday November 17 2017, @02:25AM
You might want to follow the links within the summary? Seems to be saying:
"An “active investigation” has begun in St Kitts and Nevis over allegations that a US-backed vaccine test took place in the federation to evade American safety oversight.
In a statement this evening, the country’s chief medical officer said in a statement via the Ministry of Health and Social Services, that a number of organisations have been kept in the dark over clinical trials.
“The Ministry of Health states categorically that neither the cabinet, the Ministry of Health, the office of chief medical officer nor the St Kitts and Nevis Medical Board has ever been approached on this project,” the statement read.
http://wicnews.com/caribbean/investigation-underway-clinical-trials-st-kitts-nevis-51245133/ [wicnews.com]
So, obviously, guidelines and requirements of St. Kitts and Nevis were evaded, right along with all pertinent US guidelines and requirements.
(Score: 2) by TheRaven on Friday November 17 2017, @10:17AM (2 children)
Thalidomide is an interesting example, because it's also a case of unintended consequences for reactionary regulation. In the wake of the Thalidomide trials, the restrictions on women participating in clinical trials were tightened up a lot to the point that some drugs made it to market without any testing on women at all. This came to light recently in the context of sleeping pills, some of which are significantly more effective on women to the point where the recommended dose can leave women dangerously sleepy in the mornings when they try to drive to work.
Oh, and Thalidomide is still used and is quite effective, doctors just have to be very careful about who they prescribe it to.
sudo mod me up
(Score: 2) by Runaway1956 on Friday November 17 2017, @02:45PM (1 child)
Those unintended consequences you mention are more a result of over reaction, than a proper reaction. IMHO, women should be included in any and all research and tests. But, women should be properly INFORMED. To lazy to go in search of thes story again, but some dude in Toronto was earning money in collge through some of these clinical tests. They gave him some stuff that caused some pretty serious side effects. The thing is, he wasn't properly informed. He didn't know to watch for the symptoms he developed. At his next scheduled appointment, he told the researchers about his symptoms, and basically, he was kicked out of the clinical test program. Blackballed. He couldn't get any more work for that group, or any similar group.
People, male or female, should have the opportunity to participate in research. But, both male and female should be fully informed. If Jenny Freshman understands that a clinical trial has a chance in thousand/million/billion of causing birth defects, then she can decide whether she wants to take that risk. A bunch of politicians shouldn't be making that decision for her. So long as Jenny is fully informed, it's her decision.
(Score: 2) by FatPhil on Saturday November 18 2017, @01:05AM
Great minds discuss ideas; average minds discuss events; small minds discuss people; the smallest discuss themselves
(Score: 2, Informative) by Anonymous Coward on Thursday November 16 2017, @06:28PM (1 child)
And nobody needs Peter Thiel either.
(Score: 3, Touché) by HiThere on Thursday November 16 2017, @07:05PM
Sorry, but a good herpes vaccine would be very important. You'll probably need to take it as a young child to get full benefit. And that means careful research ahead of time is mandatory.
I agree with you about Mr. Thiel, though.
Javascript is what you use to allow unknown third parties to run software you have no idea about on your computer.
(Score: 0) by Anonymous Coward on Thursday November 16 2017, @06:30PM
Found the next volunteer :D I think this manly man would also like to test every other experimental treatment available as well, perhaps his body will develop anitbodies for super-aids. Just put it waaaay up in his butt.
(Score: 2) by NewNic on Thursday November 16 2017, @07:35PM
In the same way there was a need for a drug to prevent morning sickness in pregnant women?
There are good reasons for the rules on drug and vaccine trials.
lib·er·tar·i·an·ism ˌlibərˈterēənizəm/ noun: Magical thinking that useful idiots mistake for serious political theory
(Score: 3, Insightful) by edIII on Thursday November 16 2017, @07:46PM (8 children)
Than how about you take it fucker? Why does that massive piece of shit Thiel get to live like an emperor with the best medical? Oh, yeah, that's right... it's because he has no respect for ethics, no respect for the law, no respect for the lives of other people, and just sees people like human lab rats to do as he pleases.
You want us to shut up? Then how bout both you and Thiel shut the fuck up about our protestations, take the damn medicine yourselves? Why should Thiel be excluded from the test groups?
If you want to benefit from Nazi fucking medicine, then you better be prepared to fully contribute to their medical "programs".
Technically, lunchtime is at any moment. It's just a wave function.
(Score: 5, Touché) by takyon on Thursday November 16 2017, @07:59PM (6 children)
Did the Nazis pay the people they experimented on? Did they give any of them treatments with the expectation that they would be cured?
What's your price? Much higher than the Kitts islanders'? But you're more than willing to make their decisions for them.
Geez, you're more manipulative than Thiel!
[SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
(Score: 2) by JNCF on Thursday November 16 2017, @09:01PM (4 children)
Thiel has also been interested in sea-steading. Last I read, he had given up the idea due to economic infeasibility. I've always felt like a no-holds-barred medical testing ground might be one of the easiest ways to recoup costs on such a project. Bonus anarchy-points if you're willing to do organ (head?) transplants that other nations ban.
(Score: 2) by takyon on Thursday November 16 2017, @09:13PM (1 child)
The head transplant is still up in the air: https://themerkle.com/russian-billionaire-will-not-partake-in-human-head-transplant-after-all/ [themerkle.com]
[SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
(Score: 2) by lx on Thursday November 16 2017, @10:46PM
Thanks for that mental image.
(Score: 2) by takyon on Thursday November 16 2017, @09:14PM (1 child)
Older articles:
http://www.newsweek.com/head-transplant-sergio-canavero-valery-spiridonov-china-2017-591772 [newsweek.com]
http://www.newsweek.com/rat-head-transplant-sergio-canavero-xiaoping-ren-590925 [newsweek.com]
[SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
(Score: 2) by JNCF on Thursday November 16 2017, @09:27PM
Hence the question mark. It might become reality sooner with some sketchy testing on impoverished people, though!
(Score: 5, Informative) by edIII on Thursday November 16 2017, @10:15PM
Paying doesn't mean much. There are desperate people in the world willing to subject themselves to horrible things. Just because you find somebody willing, doesn't mean that it was intrinsically ethical. No there probably was no expectation of a cure, but most medical subjects have to put up with scary side effects and the unknown nonetheless.
I'm not making their decision for them, but saying that Peter Thiel shouldn't be able to exploit their desperation for money. I'm saying that if somebody wanted to participate, even to be paid for it, that there needs to be oversight by impartial people. Like say, a medical review board. I'm not making their medical decisions for them, but it certainly seems like Peter Thiel and his investors are. They are the players in the game with the most power and information, and they're using that to manipulate people with less power, less information, and less sophistication. The medical review boards and U.S bureaucracy are at the very least designed to support the patient. So that patients are not left with the situation of trusting their doctor on their word.
There is a reason why doctors post their degrees in their offices.
Not sure how that is manipulation when I express facts. Fact: Peter Thiel is benefiting from unethical medicine trials in a fairly unregulated country while lying to both the participants, the governments of both countries, and the entire medical community. So just like the Nazis, it was always about gaining power and information at the expense of people they don't consider equals, or human. Yes, I claim that it is Nazi medicine, in that it has no intentions of working with the medical communities worldwide, or being subject to their review, judgement, etc. Sorry, but that certainly fits the Nazi description to me.
If it is medicine that he needs, then he can be part of the trials. You seem to be held up because the islanders agreed, but I think that ignores the ignorance and duress that they suffer from. Informed consent is something easy to achieve when the person consenting doesn't really understand, and very dangerous when the person consenting is trusting somebody (like a researcher or doctor) to be concerned about their well being, when patient well being is clearly not a major factor.
People convert to Christianity on a regular basis when the priest arrives with bibles *and* food or medicine. Saying that it was their choice just seems simplistic and deliberate ignorance.
Technically, lunchtime is at any moment. It's just a wave function.
(Score: 1, Troll) by crafoo on Friday November 17 2017, @01:30AM
We all benefited greatly from Nazi medicine. You directly benefited from Nazi medical science. It was a treasure trove of information and advanced medical science by decades, maybe more. Thiel's team seemed to adhere to the local laws. I don't see anything necessarily wrong with this. Not everyone must comply to your moral code. You can express your dismay and anger. It doesn't make you right or "more correctly moral".
(Score: 5, Interesting) by acid andy on Thursday November 16 2017, @06:10PM (15 children)
In science, data is data, surely? How many modern technnologies, especially in medicine, were built on knowledge gained in the past through deeply unethical practises? If this is the way you feel, surely all those data should be ignored too and all studies redone with an ethical-only grounding?
If a scientific study causes participants (voluntary or otherwise) a certain amount of harm, surely striking out the results renders that harm pointless? Worse, there's a good chance similar harms may end up being repeated, once they happen in a context that people are happy to label as sufficiently "ethical".
That said, I don't agree with what was done.
If a cat has kittens, does a rat have rittens, a bat bittens and a mat mittens?
(Score: 0) by Anonymous Coward on Thursday November 16 2017, @06:31PM (4 children)
I think the deciding factor is that herpes is no big deal. Sure, we all (er, 2/3rds of us) would like to not have to worry about it, but it's a manageable cosmetic issue.
(Score: 0) by Anonymous Coward on Thursday November 16 2017, @07:12PM
Fuck that. Get rid of it, now. It's disgusting and rancid.
(Score: 3, Informative) by HiThere on Thursday November 16 2017, @07:13PM (2 children)
Herpes is, or appears to frequently be, a factor tending to lead to cancer. I wouldn't say it's "no big thing". That said, IIUC it hides inside neurons sometimes for decades before emerging. And, of course, it comes in multiple varieties. *Some* of them probably actually are "no big thing". Others are delayed action explosives. And one vaccine probably won't handle all the varieties.
Google got me to:
http://justherpes.com/facts/how-long-does-herpes-lie-dormant/ [justherpes.com]
https://www.ncbi.nlm.nih.gov/pubmed/4353788 [nih.gov] --Javascript required
Javascript is what you use to allow unknown third parties to run software you have no idea about on your computer.
(Score: 3, Interesting) by Immerman on Thursday November 16 2017, @08:43PM (1 child)
I think the herpes link may have been discredited - your pubmed paper is from 1973, and everything more recent I found with a quick search says there is no such link.
HPV on the other hand has a solidly confirmed link to cancer.
(Score: 0) by Anonymous Coward on Thursday November 16 2017, @09:21PM
i would hazard to suggest that it was HPV back then that caused the cancer, but herpes is what was blamed.
HPV had only recently been discovered as both an STD and known causation of cancer in people. More populary, such cancers were attributed to different lifestyle choices--but choices that sadly very much coincided with the spread of the hpv virus.
The morality view quick to blame the drinking and partying and smoking as the causes as opposed to what happened during those drunken smoke filled parties.
(Score: 3, Touché) by tibman on Thursday November 16 2017, @06:46PM (2 children)
It would be bad to create an incentive to do unethical science. If "data is data" then strip all names (and credit) from the data.
SN won't survive on lurkers alone. Write comments.
(Score: 4, Insightful) by DannyB on Thursday November 16 2017, @07:22PM (1 child)
If actual harm IS done, then be sure that names and credit for the harm IS or BECOMES associated with the data set.
To transfer files: right-click on file, pick Copy. Unplug mouse, plug mouse into other computer. Right-click, paste.
(Score: 4, Insightful) by deimtee on Friday November 17 2017, @01:33AM
No, data is data. If harm is done, then penalize the people who did the harm.
You can even make the penalty so big that others are dissuaded from unethical research, but throwing out the data once you have it is making that harm worse by rendering it pointless.
If you cough while drinking cheap red wine it really cleans out your sinuses.
(Score: 5, Informative) by sbgen on Thursday November 16 2017, @06:53PM (2 children)
Here is the link to the reviewer's report, (PDF) <https://liveherpesvaccine.files.wordpress.com/2016/12/peer-review-of-halford-manuscript-dec-2016.pdf>
Warning: Not a computer expert, but got to use it. Yes, my kind does exist.
(Score: 2) by acid andy on Thursday November 16 2017, @07:12PM (1 child)
Sounds like a classic RTFA moment then.
If a cat has kittens, does a rat have rittens, a bat bittens and a mat mittens?
(Score: 2) by sbgen on Thursday November 16 2017, @07:21PM
To be fair to you, the link was within another link. Fortunately I do this all day :-)) Also, it is unlikely that a scientific paper will be flatly rejected *just* for ethics reason or for being of a particular political belief.
Warning: Not a computer expert, but got to use it. Yes, my kind does exist.
(Score: 2) by DeathMonkey on Thursday November 16 2017, @07:06PM (1 child)
Do you trust data from "reckless" scientists?
(Score: 2) by acid andy on Thursday November 16 2017, @07:15PM
Not really.
If a cat has kittens, does a rat have rittens, a bat bittens and a mat mittens?
(Score: 4, Insightful) by Grishnakh on Thursday November 16 2017, @07:17PM
In science, data is data, surely?
No. There's a such thing as "bad data": data that's been tampered with or just plain made-up.
If you could somehow guarantee that data obtained unethically was actually accurate, then your point would be sound. But if the accuracy of the data is highly questionable (which is what happens when the methodology is questionable), then the data is basically worthless.
(Score: 2) by TheRaven on Friday November 17 2017, @10:27AM
An earlier poster has already Godwin'd this thread, so I'll point out that research from concentration camps is probably the canonical (though far more exteme) example of when this has happened before. Most of the medical community refused to use any of the results (it turns out you can get quite a lot of information about biology if you don't care if your subjects die / suffer excruciating pain). The reasoning was twofold: first, they didn't want to provide a justification for war criminals to claim that their work had saved more lives than it had harmed. Second, they didn't want to encourage people to repeat these atrocities in the future.
Ethics aside, there's another, more pragmatic, argument for ignoring this data. In recent years, pharmaceutical companies have been caught cherry picking trials. It's a variation of an old stock-market scam that goes as follows: You set up 20 trials comparing an ineffective drug against a placebo. As a result of random statistical variation, the drug will perform better than the placebo in some and worse in others. You quietly forget about the ones where it performed worse and publish the ones where it performed better. As a result of this, the FDA now requires that all drug trials be registered before they take place, including a lot of information about the participants and so on. It sounds as if this trial didn't do any of this, so the results are highly suspect.
sudo mod me up
(Score: 3, Insightful) by Freeman on Thursday November 16 2017, @06:28PM (10 children)
I believe in using good ethics to practice safe experimentation. On the other hand, I don't see a problem with someone knowingly signing up for a treatment that may / may not be safe. The issue is the skirting around the Official process put in place to ensure the entire process is being done in what is generally deemed ethical and safe.
Joshua 1:9 "Be strong and of a good courage; be not afraid, neither be thou dismayed: for the Lord thy God is with thee"
(Score: 2, Insightful) by Anonymous Coward on Thursday November 16 2017, @06:34PM (1 child)
That issue you mention is exactly why it can't generally be allowed. Unsafe experimental treatments should be extreme outliers with lots of scrutiny, otherwise we'll see people doing their research in backwater villages where scientific education is zilch and it is easy to convince sick people that the treatment is their only chance of living. Any such unsafe treatments should have the explanations and agreement recorded so that it is clear the patient understands the risks.
(Score: 2) by takyon on Thursday November 16 2017, @07:16PM
Treatments don't become widely used after a single human trial on some Caribbean island.
Well, maybe that is set to change.
[SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
(Score: 2) by DannyB on Thursday November 16 2017, @07:33PM (6 children)
We'll have the best clinical studies. I mean better than any other country. I promise. America will be number one. I mean about drugs. And drug tests. But I don't mean drug tests as applied to rich people testing for illegal substances, because that does not happen, but I mean we'll be number one in drug testing, done by our amazing wonderful Big Pharma, and I mean we have the bestest, biggest and priciest pharmacies in the world, and I have people calling me all the time to tell me that, because America is number one. We will create jobs. Many, many jobs. By employing the largest number of American workers in history in clinical studies. And friends, and I have lots of friends. Lots and lots of friends. Lots. And they ALL tell me that our Big Pharma drug studies will test something called efficacy, and will test the safety of these human subjects. And they'll like it, because they're getting paid for the safety. The people who are able to afford the drugs can be sure that they are safe knowing that many bothans died to bring us these drugs.
To transfer files: right-click on file, pick Copy. Unplug mouse, plug mouse into other computer. Right-click, paste.
(Score: 3, Insightful) by Zinho on Thursday November 16 2017, @09:58PM (5 children)
@RealDonaldTrump, did you forget to log out of your sockpuppet account before posting?
"Space Exploration is not endless circles in low earth orbit." -Buzz Aldrin
(Score: 0) by Anonymous Coward on Thursday November 16 2017, @10:19PM (3 children)
Expect further denials from DannyB.
(Score: 2) by DannyB on Thursday November 16 2017, @10:42PM (1 child)
Yep. I can only dream of having thought up the @realDonalTrump login first. But I didn't.
To transfer files: right-click on file, pick Copy. Unplug mouse, plug mouse into other computer. Right-click, paste.
(Score: 0) by Anonymous Coward on Friday November 17 2017, @11:42AM
@realDonalTrump is still available.
(Score: 2) by JNCF on Thursday November 16 2017, @10:45PM
As if one person on the internet has a monopoly on impersonating an inarticulate President. Again, I don't even think DannyB's writing is that similar to realDonaldTrump's given that they're mocking the same character.
(Score: 0) by Anonymous Coward on Friday November 17 2017, @01:38AM
You seem to be implying that @realdonaldtrump is the real account and DannyB is the sockpuppet.
Do you think @realdonaldtrump is actually the POTUS and he sometimes pretends to be DannyB?
(Score: 3, Informative) by SunTzuWarmaster on Sunday November 19 2017, @03:56PM
...And the primary thing that an Institutional Review Board (IRB) and Government Officials (GOs) do is to make sure that participants are informed of the risks and benefits of being in the trial - and that claims of the risk/benefit are true. Both of these governing bodies were neatly sidestepped by conducting the research overseas (IRB rules do not apply) and secretly (GOs left in the dark). Note that "traveling to a foreign country, getting people to sign a waiver indicating they won't sue and then injecting them with a live herpes sample" is, technically, legal (until a court says otherwise). Its hard to come up with something more unethical, however.
Note that following the IRB process would have added the ethical oversight (legally mandated for research in the States) and ~6 months to the project. Working with the Government could add more or less time depending on the structure/blessing/authority of the people involved.
(Score: 4, Interesting) by khallow on Thursday November 16 2017, @06:41PM (8 children)
The thing we need to remember here is that such bureaucracy delays and increases the expense of human research. It kills people too. And really what is the point of these boards? Is it for ethical concerns or to create a competitive advantage for large businesses who can buy compliant boards [slate.com]?
(Score: 2, Informative) by Anonymous Coward on Thursday November 16 2017, @06:56PM
Oh ho, finally you see why some things should not be for profit enterprises!
As for why we need ethics boards: Medical War Crimes [wikipedia.org]
(Score: 4, Insightful) by Grishnakh on Thursday November 16 2017, @07:20PM
The problem I see here is that the US FDA is not the global authority on what drugs are safe and can be allowed. There's many other nations out there, many of them quite advanced, that drug testing could be performed in.
If the FDA was getting in their way, why didn't they just go to some other country like Germany or Japan and do testing there, rather than some backwater country with no real regulation of drug-testing?
(Score: 2) by DannyB on Thursday November 16 2017, @07:46PM (1 child)
Try . . .
It's pretty bogus to portray the dumping of radioactive waste in the drinking water as an ethical concern. This was a deliberate challenge to the current bureaucracy surrounding radioactive waste disposal. (and challenge to the cost as well)
Some things are bureaucratic for a reason. And rightly so.
That cost of human research is because of ethics and humanity to treat other human beings as actual people. Not lab animals. People who have lives. Loved ones. Hopes, dreams, and wishes and fears. That is why early testing uses lab animals, which are cheaper. Even then, ethics and the minimizing of suffering is a concern.
Yes, people die from diseases we don't have approved cures for. It has always happened. For all of human history. And it's sad. The work to develop a safe cure or treatment is for the end result of ending that suffering. People who have the condition for the drug being tested are the very potential candidates to participate in a scientific study. That does not relieve the obligation to make the test as safe as possible.
But there are other ways. The Dilgar War Master Jha'dur infected the entire population of Latig IV with Stafford's Plague [wikia.com] just to see how long it would take for them all to perish.
To transfer files: right-click on file, pick Copy. Unplug mouse, plug mouse into other computer. Right-click, paste.
(Score: 1) by khallow on Friday November 17 2017, @07:44AM
If only sarcasm were a reliable test for fake problems. We have at least two examples of the above. People spazzing over trace leaks of tritium and of course, the drama over leaking of the Fukushima site into the ocean.
Or at least, theater resembling such concern.
The difference is that we can do something about it now.
(Score: 4, Informative) by edIII on Thursday November 16 2017, @08:14PM (1 child)
Yeah, it's not bogus at all. It's absolutely a concern over ethics, and you just proved our point by showing a rather stark lack of ethics and a for-profit infection in the bureaucracy we have. Already know that, tell us something new. But we do appreciate you posting it.
Investors always challenge everything, because they only have ONE concern: profitability. Ethics, humanity, accountability, all go out the window, and are subjugated by Capitalism. As ethics and accountability nearly always hurts profit, at least in the eyes of the sociopathic avaricious parasites infecting humanity (aka investors). It's like mob mentality where a person might normally be fine, but when presented with decisions over an investment, promptly lose their humanity in the face of lost profits.
You love competition and the myth of the free market so much, so why did they choose the Caribbean again? That's right, to make their principled stand against the problematic ethics and their application in the U.S? Bullshit. Like somebody else pointed out, they could just choose a more progressive country. Instead of going to any other major 1st world country, they decide to go to a backwater island with the tiniest fraction of medical bureaucracy to be found. Then they lied to that tiny bureaucracy to be freed from it.
If they had a legitimate case, especially as investors, they would've chosen a country where they could actually bring a product to market after enough proper science that convinced a 1st world country. This was just a waste of fucking money while they "tilt at windmills" fighting the FDA.
Yeah, only if they can show a real product, done with real science, within a medical community that could be trusted. Otherwise, the American people are just going to see a pharma drug produced under almost no oversight beyond the oversight of the investors themselves. Uh huh, the American people are just so trusting of pharma companies and their investors right? If they had anything to begin with, they could have a European pharma company bring it to market in the EU. When Americans consistently hear of friends and relatives "across the pond" living better lives with a good treatment for herpes, THAT will motivate them to demand action. Although as I say that, I giggle a little bit in a morbidly depressed way, at the very idea that anybody in power gives a shit what the people think anymore.
No, this was an issue of ethics from the very beginning, and specifically, the ethics that should be able to constrain investors, and that investors don't want constraints when going after profits. After all, anything that reduces profits is wrong when the predominant ethics on the planet are driven by Capitalism. It's not might makes right, but profits make right.
Technically, lunchtime is at any moment. It's just a wave function.
(Score: 1) by khallow on Friday November 17 2017, @12:53AM
It's cheap, near the US by vicinity, and not subject to US regulation.
(Score: 2) by meustrus on Thursday November 16 2017, @09:10PM (1 child)
Premise: The processes in place fail at their purpose (ensuring research is ethical and methodologically sound) because of institutional corruption.
Peter Thiel's response: Burn it all down, those processes don't need to exist anyway.
If the premise is correct, the response makes things better. But it doesn't make things right.
If there isn't at least one reference or primary source, it's not +1 Informative. Maybe the underused +1 Interesting?
(Score: 1) by khallow on Friday November 17 2017, @01:07AM
It does however underline an important point. Medical research doesn't have to happen in the US. It doesn't have to honor US regulations. And it doesn't have to benefit US citizens. When you create rules that only the "ethical" have to follow and which cost many lives and generate huge costs, then you create enormous incentives for behavior that doesn't follow those rules.
(Score: 1, Interesting) by Anonymous Coward on Thursday November 16 2017, @06:41PM (7 children)
A thoroughly shitty article, made to assault and sully Peter Thiel.
The article does not even list the strain this vaccine is made from, or is meant to work against. It leaves this out so everyone automatically assumes it's for genital herpes. Is it? I don't fucking know, it was not in the fucking article. But I do know there are many strains, and most are benign to large sector of population, but manifest symptoms in a small subset. I know this because I have a persistent infection that causes occasional cold sores, and is of such a strain that does not affect almost anyone but me. I guess I lost genetic lottery on that one, and my immune system does not sufficiently suppress the virus that 80% of the population has, and exposure to it has given people limited immunity to genital herpes (though you should not test this immunity :). Would I welcome a vaccine for this shit? Sure if it works for me, I'd love it. It's not life threatening, and I mostly learned what triggers outbreaks and try to avoid it, but shit it's still inconvenient when it happens, and rather unsightly.
Was this research for profit? I don't know. It's not in the fucking article. For all I know Peter Thiel suffers from benign herpes also, and would love to have that disease eradicated, so he figured he can toss some money onto something that looks promising and helps people, I'm sure he can afford it. But once again this is as much a conjecture on my part as everything else is on part of the "reporter."
Fuck this article, and fuck that shitty website.
(Score: 0) by Anonymous Coward on Thursday November 16 2017, @06:52PM
Careful, there, sonny! You might catch herpes! Best to stick to congress with known clean people, like Peter.
(Score: 2, Informative) by Anonymous Coward on Thursday November 16 2017, @07:12PM (2 children)
Right, the entire point is to criticize one of your homeboys. You realize that moronic reactions like yours are why conservatives and their offshoots have developed reputations for being ignorant and harmful to modern society right? When the actual government of St. Kitts does an investigation (in case you missed the link to a separate site Investigation underway [wicnews.com]) it should tell you that this is more than just some #fakenews hit story. If I was investing millions of dollars I would at least ask WHY the research is being done on some tiny island instead of at the actual University, so in this case it is very likely the investors knew that some ethical lines were being crossed.
(Score: 2) by HiThere on Thursday November 16 2017, @07:17PM (1 child)
Also, if this is like some similar cases, the data itself is suspect. Just because someone hands you some data doesn't mean you should believe it if the provenance is dubious.
Javascript is what you use to allow unknown third parties to run software you have no idea about on your computer.
(Score: 2) by takyon on Thursday November 16 2017, @07:27PM
Sanity check - it's a starter data set.
If it gives you an idea that it works or not, it can inform another trial.
Does a rigorous trial actually require an institutional review board? Do these boards check to make sure the data wasn't "massaged" in "ethical" trials?
[SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
(Score: 0) by Anonymous Coward on Thursday November 16 2017, @07:44PM (2 children)
> For all I know Peter Thiel suffers from benign herpes also, ...
In that case, he should volunteer for the experimental treatment himself. There is a long history of self-experimentation in medicine.
(Score: 5, Touché) by DannyB on Thursday November 16 2017, @07:50PM
He could volunteer for experimental lobotomy to see if it reduces sociopathic tendencies. It would be a scientific study. With all the rigor and ethics that he practices on other human subjects.
To transfer files: right-click on file, pick Copy. Unplug mouse, plug mouse into other computer. Right-click, paste.
(Score: 0) by Anonymous Coward on Thursday November 16 2017, @08:15PM
More than likely the motivation he has in this is a totally different kind of self-experimentation, medically speaking. Pete's a well-know vampire. He believes in "young blood" transfusions staving off aging. So who else besides vampires would have a sincere, if self, interest in cleaning up the blood supply from unwanted viral infections? Hmmm?
(Score: 1, Interesting) by Anonymous Coward on Thursday November 16 2017, @08:46PM (1 child)
Weren't we all cheering those sidestepping bureaucratic FDA regulations a couple of years ago? Is it only cool when characters played by Matthew McConaughey do it, not right-wing billionaires?
(Score: 0) by Anonymous Coward on Thursday November 16 2017, @10:29PM
Not I. Bureaucracy can be annoying but it is a necessary burden. When it turns evil we simply need to update our laws / policies / regulations.
(Score: 0, Offtopic) by Anonymous Coward on Thursday November 16 2017, @10:02PM (1 child)
When conducting a clinical trial, whose laws should apply? The US has the most strict laws around this, with Europe and Japan being much lighter, and Africa and South America being far less stringent. The US is also the most expensive place to perform a trial since it has a high cost of living. So if a US company wants to release a vaccine in Europe, but perform the clinical trial in Africa, whose laws should govern the way the trial is run? The FDA and related regulatory bodies will based the decision to permit the vaccine solely based on the data from the trials. But they have no jurisdiction over the treatment of those people. In practice, a company probably will apply the greater of: its own moral standards, and the standards set by the laws of the nation the trial is conducted in.
(Score: 2) by All Your Lawn Are Belong To Us on Friday November 17 2017, @04:38PM
You raise a really good question that gets to the heart of the ethical dilemma, AC. To me, there are three approaches which should control (and in this case were apparently ignored). The first is that an Illinois institution was involved as the patent holder and academic home of the principal investigator. Whether it was actually connected or not is an open question that has much bearing - the article seems to paint it both ways a little. We can also take a remove and ask under what jurisdiction is Rational Vaccines chartered? Either, or both, should immediately dictate the minimum level of concern applied. If Rational Vaccines was chartered out of St. Kitts and Nevis, then it is the Kittian standards that should be used at minimum. If a university in the United States has any kind of sponsorship (or is the patent holder in this case,) then their standards should apply if stricter.
I say "minimum" because a second approach could be the California approach.... simply make sure that all regulations of all jurisdictions are satisfied during the process. That may the most restrictive requirements of all stakeholding jurisdictions are satisfied.
But lastly, the notion that patients were actually FLOWN IN to the region where testing was done seems to say that the jurisdiction was shopped for regulatory dodging. It's not like this is some rare condition where the number of available patients would be so scarce that patients needed to be imported to obtain a sample size. (At least, I assume not). Further, as I've been trained, it is perfectly normal to expect to have to get an IRB signoff before one conducts research on human subjects and the story portrays that they tried and failed to get a signoff. So they proceeded to find a way to ignore the way research is normally conducted in the US and circumvent what are intended to be safety controls. And this was done willingly and apparently in full knowledge of what correct procedure should be, anywhere in the United States.
To me, the whole thing reeks of trying to forum shop. It's not only ethically wrong, but morally bankrupt. The company should be investigated to the full extent the law allows, and if it really was that they tried to pull a fast one, be punished accordingly.
This sig for rent.
(Score: 1, Interesting) by Anonymous Coward on Thursday November 16 2017, @11:38PM
No private corporation should every be able to lock away research funded by U.S. taxpayers. If the company wants to lock it away, they can fund all the research on their own. When will stop this "corporations first" attitude?
(Score: 2) by Entropy on Thursday November 16 2017, @11:54PM (2 children)
Stem cells, vaccines, whatever. Lets destroy our edge in medical research so that only countries that are not whiney special snowflakes can actually do research that matters. This reminds me of their idiotic no encryption export thing that resulted in all encryption research being done outside the US.
(Score: 0) by Anonymous Coward on Friday November 17 2017, @01:25AM (1 child)
Do you have to be stupendously evil ALL the time? By your logic we should support slavery. Imagine what an economic powerhouse the US would be!! Asia would have never gotten our outsourced industries and even when when they built their own we'd still win with rock bottom labor costs. Do you feel stupid yet?
(Score: 2) by Entropy on Friday November 17 2017, @02:26PM
Wow, you make slavery sound pretty awesome.