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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
(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?
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(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?
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(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.
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(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.
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(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.
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(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.
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(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.
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(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.
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(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.
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