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
Related Stories
Apparently, Peter Thiel Is Very, Very Interested in Young People's Blood
According to the article, ...
More than anything, Peter Thiel, the billionaire technology investor and Donald Trump supporter, wants to find a way to escape death. ... if there's one thing that really excites Thiel, it's the prospect of having younger people's blood transfused into his own veins. ... according to Thiel, it's a potential biological Fountain of Youth - the closest thing science has discovered to an anti-ageing panacea.
[...] After decades languishing on the fringes, it's recently started getting attention from mainstream researchers, with multiple clinical trials underway in humans in the U.S. and even more advanced studies in China and Korea.
[...] In Monterey, California, about 120 miles from San Francisco, a company called Ambrosia recently commenced one of the trials. Titled "Young Donor Plasma Transfusion and Age-Related Biomarkers," it has a simple protocol: Healthy participants aged 35 and older get a transfusion of blood plasma from donors under 25, and researchers monitor their blood over the next two years for molecular indicators of health and ageing. The study is patient-funded; participants, who range in age from late 30s through 80s, must pay $8,000 to take part, and live in or travel to Monterey for treatments and follow-up assessments.
I thought I would bring this development to the attention of the Soylent News community. I also have a question. The article claims that the practice is known as parabiosis. But Wikipedia says "parabiosis is a class of techniques in which two living organisms are joined together surgically and develop single, shared physiological systems, such as a shared circulatory system." This definition seems to include the relevant 1950s rat experiments. But I believe it does not cover the Monterey experiment, nor the kinds of human treatment that Thiel and others are seeking. Am I right about this? And if so, is there better word to use?
Also, feel free to comment any fictional examples you know of. Did Montgomery Burns ever partake, for example?
[Continues...]
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.
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
(Score: 4, Interesting) by BsAtHome on Sunday December 24 2017, @07:30PM (9 children)
Once you establish a no-consequence environment, it will just get worse. If someone can get away with something, then there will be someone who will try that, no matter how wrong (and I am not talking about lack of punishment). In the end, you make something despicable today into something accepted tomorrow.
The Big question is why we are so complacent about this. This is a question I am pondering for some time now. Why are we not more proactive (and reactive) to prevent obvious wrongs from becoming the new norm? This happens not only in medicine, but there are numerous areas in society where we too can observe the same attitude.
(Score: 3, Insightful) by MostCynical on Sunday December 24 2017, @07:40PM (1 child)
Where "free market capitalism" meets "anarchic free-for-all"
"I guess once you start doubting, there's no end to it." -Batou, Ghost in the Shell: Stand Alone Complex
(Score: 4, Insightful) by frojack on Sunday December 24 2017, @09:17PM
Its called regulatory capture [wikipedia.org] and its caused not only by corporate over-reach but also by common citizens demanding government "get out of the way" [reason.com].
In fact, I suspect public demand has a lot more influence on this sort of thing than "free market capitalism". The capitalists can't simply point to an FDA approval to absolve them of all liability. They still have to face huge law suits. [governing.com]
People tend to forget that one hard nosed lady at the FDA prevented the Thalidomide tragedy [toxipedia.org] from affecting the US. But then she didn't have to face a large body of citizens clamoring for the FDA and the DEA to remove prescription restrictions on their recreational drugs of choice.
Every demand to legalize all drugs or voodoo cancer treatments just begs for more of this to occur in the future.
No, you are mistaken. I've always had this sig.
(Score: 3, Funny) by JoeMerchant on Sunday December 24 2017, @10:32PM
When I was considering moving to Hilo, some of what I read about Hawaiian politics might explain: "Yes, it's wrong, it's totally unfair, bad people are getting away with things and good people are suffering as a consequence..." and it's still a paradise on earth even with all that going on, so why get all worked up about making things right, when things are still pretty good anyway?
Modern life is pretty damn easy, people have enough to eat, they can mostly avoid wars, and there's lots of new shiny to put in your shed... is it really worth diminishing your personal quality of life to start some crusade for justice?
🌻🌻 [google.com]
(Score: 0) by Anonymous Coward on Monday December 25 2017, @05:50AM (2 children)
How do you expect this to stop? Should it even stop?
A drug company creates a shell company for a new drug, limiting liability. That drug-specific company seeks a separate company to do the testing. One is created, owned by a testing company. That new company then contracts out... and before long it is 8 step removed. Some company located in the Cayman Islands is doing drug tests in Eritrea or Djibouti, where life is cheap and the alternative to being tested on is to go fight for a warlord or go be a sex slave. It's the kind of place where kids fight over a maggot-infested hide because they are hungry, and their mom tries to ration it. Given the alternatives in a place like that, drug testing is a pretty sweet job.
(Score: 3, Insightful) by sjames on Monday December 25 2017, @06:55AM (1 child)
Until a test leaves you with a permanent disability and the company throws you to the wolves without even a fighting chance. And keep in mind, they will make sure their offer is only SLIGHTLY better than the other terrible offers even though for the cost of a single executive luncheon, they could set up the trial participants for life. Disclosing the actual risks and then paying enough to make it worthwhile is the LAST thing they'll do.
Not so good for the eventual market either when the testing company sweeps the occasional devastating permanent side effects under the rug.
(Score: 0) by Anonymous Coward on Monday December 25 2017, @11:57AM
Sounds a lot like the ratings agencies which needed to keep giving out A+++ ratings otherwise the banks would go somewhere that would.
(Score: 1) by khallow on Monday December 25 2017, @06:23AM (2 children)
The ugly part is that testing a new treatment in a low regulation part of the developing world is a lot cheaper than doing it in the US. For example, a pharm company could secretly test a group of new drugs in the developing world and then once they have a good idea what works, use parallel construction to test only the drugs that show strong positive results officially. That alone would greatly reduce R&D costs even when the latter research continues to be done in the developed world.
Currently, whoever doesn't fully play by the rules has a significant advantage over those who do. While some of that may be unavoidable, we can veer away from regulations that make that worse.
(Score: 0) by Anonymous Coward on Monday December 25 2017, @12:01PM (1 child)
I see, so the solution is to remove regulations in order to... what now?
(Score: 1) by khallow on Monday December 25 2017, @12:40PM
Cheaper, faster, and better medical advances in our lifetimes and those of our descendants. The opportunity cost of making every medical advance subject to a lot of costly regulation is that billions of people will die prematurely. It also protects high value cartels via the creation of considerable barriers to entry.
It also encourages widespread disregard for law (via the advantages from breaking rules rather than obeying them). In this story, a dying researcher took big short cuts because there was otherwise a good chance that the research would never happen. He won't pay for the consequences of his actions because he is already dead. Other ways will be figured out.
(Score: 2) by arcz on Sunday December 24 2017, @10:14PM (2 children)
Letting people make their own decisions about their body and not having the FDA regulate this?
(Score: 4, Insightful) by JoeMerchant on Sunday December 24 2017, @10:19PM
Fine, make your decisions based on what information? Trade secrets and marketing flak?
I am in favor of letting more therapies reach market, but only with more transparency in the testing trials methods and results.
🌻🌻 [google.com]
(Score: 2) by frojack on Monday December 25 2017, @02:11AM
Don't be lining up at the trough I'm forced to fund to save your ass after you do that.
You sound like the kind of guy that wants totally free health care.
As far as I'm concerned, You can have any drug you want, as long as you have one of these. [washingtonpost.com]
No, you are mistaken. I've always had this sig.
(Score: 2) by JoeMerchant on Sunday December 24 2017, @10:25PM (20 children)
FDA regulation of major Pharma vendors is like an African wild dog wandering into a Gorillas' den to check and make sure everything is on the up and up. The Gorillas won't kill the dog outright, because he has lots of friends who could be a real PITA if they swarmed in, but they're also not exactly going to let the dog sniff everything before he leaves.
Trade secrets need to end for these kinds of regulated industries - if a company is going to engage in drug testing, then ALL the drug tests they are performing, or paying for others to perform on their behalf, need to be fully disclosed before they even start. As it is, a drug with a promising market can have dozens of trials started, and shut down at the first sign of an adverse result, and just keep trying until they distort the statistics enough to get an acceptable result to go to market with.
🌻🌻 [google.com]
(Score: 1, Disagree) by khallow on Monday December 25 2017, @06:27AM (19 children)
That's completely unrealistic. We already live in a world where companies throughout the world can rip that off. Making the whole process public, means that these regulated industries would be doing the research for free for someone else who isn't similarly regulated.
(Score: 2) by JoeMerchant on Monday December 25 2017, @09:17PM (16 children)
Better to trust the drug makers to tell the truth than to risk that their profits might be diminished?
🌻🌻 [google.com]
(Score: 1) by khallow on Wednesday December 27 2017, @02:06PM (15 children)
The same level of trust happens anyway. The immediate competition, some which might predate the drug maker's introduction of the medicine by years, is what is new.
(Score: 2) by JoeMerchant on Wednesday December 27 2017, @02:39PM (14 children)
I disagree - transparency in drug trials would refocus drug development toward things that stand up to scrutiny, instead of things that make a splash when direct marketed to the public. If these things that stand up to scrutiny are co-developed by competitors, isn't that a good thing? But, but... profits??? Boo, f-ing hoo - develop something that's worthwhile, like significant improvements in heart disease, cancer, obesity, or a rare but totally curable disease - put the IP out there as patents BEFORE starting the trials, do the trials in the open, and if it's so good that knockoffs are beating you to market, use the well established IP protection mechanisms to get your profits back. If it really takes more than 20 years to go from concept to ROI, maybe refocus your efforts on something with more immediate returns?
🌻🌻 [google.com]
(Score: 1) by khallow on Wednesday December 27 2017, @03:50PM (13 children)
I think I made my point clear long ago. Paying enormous sums to create new markets mostly for your competitors who don't have to follow the rules is not a business model that works. I notice you don't make the obvious revision to your ideas to undermine my complaint - releasing such data after approval by the respective approval agencies. That's plenty of time to inform physicians of the risk of new treatments and to establish any liability for negligent or criminal research practices.
(Score: 2) by JoeMerchant on Wednesday December 27 2017, @04:42PM (12 children)
And I see that you miss my central point: when all this is done "in the dark" the data can be not only doctored, but more easily manufactured per the following scenario:
New drug with blockbuster market sales potential identified: don't just start one trial, start 12 secret trials, or 20 if it's got really big potential. If any trials start to show bad results, shut them down, bury the results as "trade secrets" and continue the trials that are achieving more promising results. When the trials are nearing conclusion, make an internal secret decision: "Will release of this drug net us big profits?" which is often different than the decision that would be made by doctors and patients if they had all the information available about the drug, its efficacy and side effects in all trials to-date.
The respective approval agencies, first don't approve - they give permission to market, and second, are not privy to all information - they only get what the company shares with them. They demand sufficient information to prove safety and efficacy, but they cannot demand all available information because: trade secrets.
🌻🌻 [google.com]
(Score: 1) by khallow on Thursday December 28 2017, @12:30PM (5 children)
I guess you'll just have to decide whether having these treatments in the first place is more important than some level of fraud. I don't think fraud is that serious an issue, sorry.
(Score: 2) by JoeMerchant on Thursday December 28 2017, @01:37PM (4 children)
I think that fraud that results in death, permanent disability, and serious injuries is more important than monetary considerations.
When treatments amount to rolling the dice, the patient deserves to know the real odds.
🌻🌻 [google.com]
(Score: 1) by khallow on Thursday December 28 2017, @05:43PM (3 children)
Like the health of billions of people? Those monetary considerations? Monetary considerations means that money returns to the researchers who can then self-fund themselves to do more research for more health care treatments. It's not perfect, but it does work.
It's not ignorance of the odds that is the danger here, but the fairly well-known risks of doing something expensive, but valuable to society, without getting corresponding compensation for doing it. Those odds are really bad.
(Score: 2) by JoeMerchant on Thursday December 28 2017, @06:13PM (2 children)
And, trusting the profit makers to execute the development process "in the dark..." I don't like those odds.
Also, what lots of people are willing to pay high prices for, and what is long-term valuable to society are not usually the same things - drug makers are targeting the former, while wearing the mantle of the latter.
🌻🌻 [google.com]
(Score: 1) by khallow on Thursday December 28 2017, @06:28PM (1 child)
As I noted earlier, you could have nipped this whole thing in the bud by advocating for revealing all such research data after approval or final rejection (sigh, "permission to market") by the FDA and related regulators. It's still quite timely for the public and any lawsuits to come from bad faith medical research (which already can access such data via the discovery phase of a lawsuit). Meanwhile I don't see the reason you should be informed prior to that point. The unintended consequences of such a regulation (such as most medical development moving to countries without such regulations, leaving the US years behind in medical research) certainly aren't worth any slight knowledge you might gain by this.
(Score: 2) by JoeMerchant on Thursday December 28 2017, @07:58PM
for what it's worth, that one is called "denial," with the implication that the denied party is (usually) free to apply again once having addressed the listed reasons for denial of application.
As for "revealing all such research data after" - that's the enforcement paradox: beyond the veil of secrecy, one can never know how much data was collected, how many trials were terminated in the dark. Discovery won't happen when the lawyers have no knowledge of the other (drug) trials. In a perfect world where everybody does what they are supposed to, sure, this could work. In a world of secrets and liars? Not as well.
🌻🌻 [google.com]
(Score: 1) by khallow on Thursday December 28 2017, @12:48PM (5 children)
The FDA sure does. And permission to market is approval, even if that were all the FDA does.
(Score: 2) by JoeMerchant on Thursday December 28 2017, @01:41PM (4 children)
Inside the industry, FDA makes it abundantly clear: they do not approve anything, they just give permission to market - the broader public continues with the perception of FDA approval (and the press perpetuates this misunderstanding), but that is not what they do. vis. when something goes wrong, who is on the hook for damages from lawsuits? Not FDA.
🌻🌻 [google.com]
(Score: 1) by khallow on Thursday December 28 2017, @05:46PM (3 children)
Completely irrelevant to FDA approval.
And I already noted that is approval.
(Score: 2) by JoeMerchant on Thursday December 28 2017, @06:24PM (2 children)
Note all you like, it's just semantics, and you are indeed in the majority of the population with equating FDA permission to market as "FDA approval."
What I am telling you is that for the last 25+ years, in face-to-face meetings with FDA officials in Rockville, Maryland, face to face with FDA field agents on inspections, and countless ex-FDA employees turned consultant, they all explicitly state "the FDA does not approve anything, the agency is adamant about that point."
If you want to go on equating "permission to market is just the same as approval" then, you're one of the millions that the FDA has been trying, ineffectively, for decades to reframe their semantics. I work in a larger medical device company today, and the majority of employees in R&D still believe "FDA approval" is a thing, it's only the ones who deal directly with FDA who have gotten the message.
FDA is _almost_ as good at getting this message out as they are enforcing the spirit of the regulations they are charged with. Which is a large part of my basis for believing that FDA regulation of the drug industry is, in its current manifestation, insufficient and dangerous to the general population. Not calling the industry as a whole detrimental, but operating with a level of risk of death and injury that is too high for the benefits they proffer. Too willing to take those risks in the pursuit of monetary profits, because monetary profits are the driver - benefits to society are incidental.
🌻🌻 [google.com]
(Score: 1) by khallow on Thursday December 28 2017, @06:46PM (1 child)
You should be as well.
Words have meaning. I get the game that is being played here. No doubt there is some conflicting rules where the FDA are supposed to approve, but not approve stuff at the same time. This is their legal out whereby approval goes by another name. It is nothing more. Social Security does the same legal fig leaf with its pay-as-you-go system which is supposed to have a treasury bond fund backing its payments, but it doesn't. That doesn't stop them from yacking about the fund as if it were a real thing. So does US intelligence which isn't supposed to spy on residents of the US.
The FDA can "reframe" all they want. Meaning doesn't change.
I get you have a problem with this, but so what? There has to be a large monetary benefit to the medical industry in order for it to do its job at this scale. They can't run off of good feelings.
(Score: 2) by JoeMerchant on Thursday December 28 2017, @08:02PM
What I also hope you get is that I don't mind them making large profits, but I want those profits to derive from truth, transparent actions, and tangible benefits to society - not fast and loose "science" with a fig leaf of regulatory permission to market.
🌻🌻 [google.com]
(Score: 2) by urza9814 on Tuesday December 26 2017, @03:45PM (1 child)
Isn't that what patents and copyrights are for? If you're testing publicly and you get ripped off, you can point to the existing trials and demonstrate that you invented the thing first, and your would-be competitor better be operating solely in third world countries if they hope to continue. If you do it all in secret, you can still get ripped off, and while it's a bit harder to do in the end you have no public evidence and can't do a damn thing about it.
(Score: 1) by khallow on Tuesday December 26 2017, @04:06PM
In part, but security through obscurity doesn't have to be perfect in order to work.
Plenty of them already do.
They won't be able to do a damn thing [raps.org] about it in most cases anyway.
So notice that there are already vigorous generic producers competing in US markets and often producing generic versions of medications before the US creator can legally enter a market. That won't get better, if the creator of a medication has to telegraph their discovery years before they can get approval in any market.