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Scary viruses and clinical trials

Some people think the Rio Olympics might cause the Zika virus to spread all over the world. Reddit is not a reliable place for sensible political commentary, but I am heartened at how up-voted comments like these are:

mixmastamikey: “Global Health Disaster” How about just “Global Disaster”… Why the fuck can’t we reuse olympic venues? Seriously why does a different country need to host the olympics every 4 years. Cant everyone just buy a fucking island and call it olympic island maybe update a few things here and there.

BlueBlazerIrregular: But then the IOC wouldn’t be able to steal millions and would lose out on all that graft and bribery. Think of the rich for once! They are people too!

kangamooster: Hmm, I guess you could consider lizardfolk people….

Kamuiberen: Wait, are we talking about IOC or FIFA here?

BlueBlazerIrregular: Same modus operandi

Anyway it seems unlikely that the Olympics will be stopped or moved and I am not sure if doing so would really make any difference. I am hopeful of solving problems with technology, though. I am quite keen on the plan to exterminate all mosquitoes. And then there is IBM’s rather interesting research into a chemical that blocks viruses in general.

“We began to think, how can we move forward and kind of attack the virus in a very different way,” says Hedrick. “Instead of going after its RNA or DNA, we looked at the glycoproteins that surround…the virus.” No matter what the virus and how it mutates, it’s going to have these substances on the surface; they have electric charges (some positive, some negative) that a chemical can stick onto. What the researchers developed is a polymer that adheres to the virus, blocking it from hooking onto a victim cell in the body.

The idea is to put the molecule in soap and hand-wipes, but it could also be put into a person.

Assuming it works as well as the researchers say, the macromolecule couldn’t come soon enough to handle frightening outbreaks like Zika, Ebola, and chikungunya. But it hasn’t quite come yet. “My gut feeling is, something like a wipe, something like a hand cleaner is going to be relatively straightforward to move to market,” says Hedrick. “It you market it as a true antiviral, I would imagine it would take 3, 4, 5 years maybe maximum.” Getting the macromolecule into humans, where it uses all three of its powers, would require clinical trials than could extend over several years.

Serious question: why the need for such long clinical trials? What is wrong with marketing something with the caveat that it is not fully tested yet and it might be a cure worse than the disease but if you have a terrible enough disease it might be worth a try?

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34 comments to Scary viruses and clinical trials

  • pete

    Serious question?

    Why do we need the state to be involved with professional sports competitons at all?

    Scrap Team GB funding.

    If they can’t go to Rio they won’t catch any diseases over there.

  • What is wrong with marketing something with the caveat that it is not fully tested yet and it might be a cure worse than the disease but if you have a terrible enough disease it might be worth a try?

    Oh for fuck sake, Fisher, did you not spare even a moments thought for the not so small army of regulators and supporting bureaucrats that would be put out of business, pushing them into the heartless capitalist wasteland where a degree in women’s studies counts for as much as well developed haemorrhoids? Most people who die from these things are brown and most of the regulators are white, so are you seriously suggesting the convenience and righteous self image of a secular priesthood of Caucasians is less important than the lives of a few Third Worlders? Sheesh.

  • Rob Fisher (Surrey)

    Dammit Havilland, why do you let me post these half-baked badly thought out articles? What kind of blog proprietor are you?

  • Why do we need the state to be involved with professional sports competitons at all?

    Indeed.

    Scrap Team GB funding.

    Quite.

    If they can’t go to Rio they won’t catch any diseases over there.

    But what makes you think state funding is the only option? Corporate sponsorship seems a very reasonable alternative that could bring athletes into virus infested hellholes in pursuit of gold medals.

  • What kind of blog proprietor are you?

    The evil kind 🙂

  • John B

    ‘Serious question: why the need for such long clinical trials…’

    Serious answer: because this would put thousands out of work in labs, regulatory consultancies/departments and… Oh the horror! lots of bureaucrats minus jobs too.

    Drug regulation is a multibillion $/£/€ industry and gives Government yet another control over the Masses. And the regulatory process has to be repeated in each destination market, because, for example, the US regulators will not accept approvals by the UK authorities.

    Doing away with all but basic regulatory requirement, and mutual acceptance of approvals would get drugs to market in about a quarter of the time, produce a wider selection of drugs and lower prices considerably.

    But then what would all the little elves and helpers in the regulatory sector and bureaucracies do?

  • Rob Fisher (Surrey)

    The evil kind

    That moment when https://www.youtube.com/watch?v=hn1VxaMEjRU

  • QET

    Don’t be surprised when, just as with the suppression of bacteria which has led to the necessity for fecal transplants (imagine going back in time and telling Bacon or Diderot that the Enlightenment would improve the human condition so thoroughly that it would become necessary to transplant someone’s sh*t into someone else), the general suppression of viruses leads to the discovery, following the prolonged suffering of many persons, that human biological function depends in some ways on some viruses. That is not an argument in favor of lengthy clinical trials (as these could not ever disclose that result), just a caution of the sort Jeff Goldblum’s character gave in Jurassic Park when assured that steps had been taken so that the dinosaurs could not reproduce.

  • Rob Fisher (Surrey)

    Wow, QET, once googled, a thing cannot be un-googled. I note from the Wikipedia article: “There is evidence that looks hopeful that fecal transplant can be delivered in the form of a pill.[56] They are available in the United States but are not FDA-approved as of 2015.”

  • llamas

    There was an epidemiologist on NPR last night making this point, with some very cogent arguments.

    But, of course, as other commenters noted, so many people are making so much money (both legitimate and non-legitimate) off the Olympic ‘Games’ that the potential health impacts will not be allowed to interfere. Same goes for the horrible diseases that many of the athletes going to Rio are at risk of.

    Since most people experience the Olympics via television, for most sports, why do the athletes even have to travel to one place? Most sports don’t require them all to be physically present at the same place and time. So do it remotely, online.

    llater,

    llamas

  • staghounds

    Some little country is missing a bet by not fast tracking its new drug approval process. Or, for that matter, deregulating the practice of experimental medicine altogether.

  • Fred Z

    staghounds: google ‘cancer treatment in Mexico’.

    One of my wife’s cousins has a form of cancer for which current normal medicine (standard medicine? regulated medicine?)can do nothing.

    So she goes to Mexico for what I expect is utter bogus treatment, but it’s her money, her life and good for her.

  • Stonyground

    “So she goes to Mexico for what I expect is utter bogus treatment,…”

    Is it anything to do with this?

    http://skepdic.com/psurgery.html

  • Laird

    “Why the need for such long clinical trials?” isn’t really a serious question. We all know the answer. Leaving aside all the jobsworths whose livelihoods depend upon maintaining the current system, and the benefits of regulatory capture to the drug industry giants, the fundamental conceit is that it is government’s job to “protect” its citizens, and in order to do so it must closely and minutely regulate every aspect of what is called (without intended irony) the “health care system.” In the US, the FDA is statutorily charged with ensuring not only the safety but also the efficacy of any drug which is permitted to come to market. That cannot be achieved without these long clinical trials, which provide a veneer of science to what is actually a regulatory morass in which science takes a back seat. (As an example of that, see this recent Wall Street Journal about a drug for a rare and fatal form of muscular dystrophy which an FDA “panel of experts” has recommended denying approval, notwithstanding clear evidence of its value. Apologies if it’s behind a paywall.) Aspirin would not be allowed on the market if it came before the FDA today; it is only available because it’s grandfathered in. And we certainly can’t rely on the work of other countries’ regulatory agencies; clearly they are not up to our elevated standards. (Sniff.)

    The entire drug regulatory approval process is both dysfunctional and indefensible. Placebo trials in cases of life-threatening disease are inherently and irredeemably immoral, and should be outlawed. People should be able to use whatever medications they (and their doctor) deem best. The FDA should be abolished. At most, its only role should be to conduct (and/or monitor) clinical trials and issue recommendations. But that’s a lot of “shoulds”, and unfortunately it’s not the world in which we live. Meaningful change isn’t likely to happen any time soon.

  • Fred Z

    Stoneyground: No, it’s some treatment with a chemical to do with peach pits. Laetrile? Plus other bits of unlikely muck.

  • QET

    In addition to reforming the FDA regime, there would need to be significant changes to the tort law regime. Those of us who went to law school remember the appalling case of the suicide who jumped to his death from a bridge, hitting an unshielded high-voltage wire on his way down, electrocuting himself instead of dying on impact with the ground. The power company was sued for negligence by the suicide’s widow and, yes, was found liable for wrongful death. Just because the common law system was once the pride of the Anglosphere does not mean it hasn’t evolved into a monstrosity that needs reigning-in like a fine stallion with rabies.

  • Laird

    Good point, QET. But it’s not directly germane to the “serious question” Rob posed.

  • Ken Mitchell

    “What is wrong with marketing something with the caveat that it is not fully tested yet and it might be a cure worse than the disease but if you have a terrible enough disease it might be worth a try?”

    Because doing nothing won’t get you in trouble, while doing something – ANYTHING – that might go wrong can get you sent to prison, or worse yet (to the standpoint of the average bureaucrat) have nasty things said about you.

  • Rich Rostrom

    “What is wrong with marketing something with the caveat that it is not fully tested yet and it might be a cure worse than the disease but if you have a terrible enough disease it might be worth a try?”

    Because that enables charlatans to extract large amounts of money from desperate people.

    Because the treatment may turn out to have nasty un-obvious side effects.

    Because the treatment may cost lots of money and do nothing. Bear in mind that nearly all medical care is paid for by third parties.

    I have a high IQ and a good background in science, but I know that I am not capable of accurately assessing the merits of a medical treatment. And if I’m not, what of a child? What of my 91-year-old mother, whose memory is failing? What of the 1/6 of everybody that have IQs of less than 85?

  • PeterT

    Rich makes valid points, but it isn’t the government’s role to protect people (or it should not be), especially people who are very ill and don’t mind taking a chance on a new treatment.

    QET, indeed. The common law is a great concept, but it requires common sense to work, and that is not so common nowadays. I wonder to what extent the common law is undermined by state backing – if you know that you can enforce judgements generally found to be idiotic, through the force of the state then presumably you will care less about making idiotic judgements.

  • Deep Lurker

    Serious question: why the need for such long clinical trials?

    Because the evils prevented by requiring long clinical trials are “that which is seen” and the evils caused by requiring long clinical trials are “that which is not seen.”

  • Paul Marks

    Yes get rid of the Department of Culture, Media and Sport (and lots of other departments as well).

    Only by getting rid of Departments (functions) will any real dent be made on government spending and the deficit.

    Olympics?

    Hold them at Olympia every four years – although it would be better if it was an independent city state (this united Greek state thing has not worked).

    The Z virus.

    Well yes – not good. In fact very bad indeed.

    Although Brazil is collapsing already.

    Having the games in Brazil is potty.

  • Sean

    The FDA didn’t approve Thalidomide. That was a good call on their part – no?

  • Julie near Chicago

    The FDA also horsed around so long before releasing the cancer drug Erbitux that Patient Abigail, aged 21, died of her cancer on the very day that the FDA decided that it would give a Dispensation in just this one case and allow her doctor to use the drug as a last-ditch measure.

    Here is a video of a debate on Off-Label Drug Usage, between Prof. Richard Epstein of the U. of Chicago and New York University Law Schools, and Dr. Ryan Abbott. Prof. Epstein is an eminent libertarianish Classical Liberal who knows a good deal about many areas of law, including patent law and laws affecting the pharmaceutical industry. His creds are more than solid.

    There’s plenty in it that speaks to our topic here, and both sides of the argument are well represented. 56 minutes.

    UToob-dot-com/watch?v=o8x3dGtBtVk

    A little different angle but just as good, Prof. Epstein’s discussion with Russ Roberts of EconTalk, in a podcast entitled “Property Rights and Drug Patents. Audio, a little over an hour:

    http://www.econtalk.org/archives/2007/02/richard_epstein.html

    And three suggested articles:

    At EconLib, “Pharmaceuticals: Economics and Regulation”

    by Charles L. Hooper:

    http://www.econlib.org/library/Enc/PharmaceuticalsEconomicsandRegulation.html

    And from The Hoover Institution’s “Defining Ideas,” Richard Epstein’s article “The Other Drug War”:

    http://www.econlib.org/library/Enc/PharmaceuticalsEconomicsandRegulation.html

    Prof. Epstein has lots of books behind him, of which the best-known is probably his Takings, which discusses that fraught topic. He also has a fairly recently-published book entitled Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation. The buzz from reviewers on this side of the Liberty/Progressivism Great Divide seems to be that the book is good but not great. I wouldn’t know: haven’t read it, and in any case I’d only be equipped to judge how persuasive it is to me personally.

    So for a bashing of the good Professor and his foul book from The Other Side, persons might try a review of the book by a David B. Ross, presented on … wait for it … a website of the National Institutes of Health.

    URL: www , ncbi , nlm , nih , gov/pmc/articles/PMC2096443/

    (I’m evading the Smitebot since we no longer have SmiteCats to keep us amused while it considers whether our remarks are in noncompliance with The Law; I hope the correct URL is clear from the ersatz link.)

  • Mr Ed

    Why do we need the state to be involved with professional sports competitons at all?

    Because Mussolini had a Minister of Sport and all that exercise stops fatties from costing the NHS money better spent on whatever.

    And you wouldn’t want the Fascists to keep all the good ideas, would you?

    Strength through Joy to you all.

  • Rich Rostrom

    Everybody wants to hear good news about drugs, and will believe any sort of good report: not just patients, but investors. Derek Lowe at In The Pipeline has noted biotech and pharma startups that burn through hundreds of millions of $ for nothing. In many cases there is a cadre of loyal investors who follow the company over the bankruptcy cliff.

    That’s how much pressure there is to say yes, and pour money into these drugs – to develop them, or to provide them. The leaders of these companies are usually true believers too: if we could just fund one more clinical trial; we just need to tweak the furyl group and adjust the dosage; several of the patients showed substantial positive markers (even though they all died).

    Somebody has to say no; that’s the FDA’s job.

  • Alisa

    Somebody has to say no; that’s the FDA’s job.

    Only because the FDA took upon itself – it should properly be the investors’ job.

  • Laird

    Actually, it should properly be the patients’ (and their doctors’) job. The FDA can monitor tests and disseminate data and recommendations, but that’s all.

  • Julie near Chicago

    Laird, may I shake your hand, sir. :>)

    Alisa, Prof. Epstein makes that same point as to the FDA’s original remit.

    Also, as above, he mentions the fact that there are private networking organizations that collect info that doctors submit on what they’ve tried and how it worked. He points out that there are some reasons why the docs would just as soon pass up the opportunity to contribute to FDA or NIH databases, because of the mountain of paperwork involved and because of the exposure to malpractice claims it causes. (Not, I’m sure, that any of the govt. medical agencies would abuse their powers nor mistake their remit for a fog blanketing the globe.)

    Every so often he points out the success of Underwriters Laboratories (no possessive apostrophe in the name, which has bugged me since I was old enough to spell it) as a private testing agency.

    Ryan Abbott, of course, thinks the parallel is incompetent, irrelevant, and immaterial.

  • Laird

    Underwriters Laboratories

    Julie, are we going to have another argument about plurals and possessives? 🙂

  • Julie near Chicago

    No, Laird, as I already shot my bolt parenthetically just above. Besides, it is far too late to run the grammatical gauntlet — I still have to watch a movie before I can go to bed. So you will just have to forgo teasing me, and mumble argumentatively to yourself.

    And a happy 🙂 to you too!

  • gongcult

    Some of the sailors on sailing anarchy.com blogged that they will no way in he’ll will sail in that filth.some of the arrogant”Olympics contenders” are willing to risk it.What about the thousands of Olympic spectators who will be at risk and might possibly transmit the virus if they get infected? A global catastrophe perhaps?

  • Mr Ed

    The scientific problem with the polymer is likely to be that wiping yourself with it is all well and good, but the zika virus has an insect vector and so spreads via blood and bodily fluids, so the polymer will do nothing when an insect probe pierces the skin and the critter sucks your blood. Getting the polymer to stick to the virus and only the virus in vivo is the major challenge.

    And glycoproteins can mutate as well. Great idea, long, winding road ahead.

  • Mr Ed

    And on a lighter note, or perhaps a heavier note, I have just seen this article about various biological hazards.

    Ungainly as it is, the hippopotamus is the world’s deadliest large land mammal, killing an estimated 500 people per year in Africa. Hippos are aggressive creatures, and they have very sharp teeth.
    And you would not want to get stuck under one; at up to 2,750kg they can crush a human to death.