Go Figure: A Geek Tragedy

September, 19, 2016 | 21 Comments

Comments

  1. At the risk of being accused of hyperbole, I assert that most living things on our planet are caught up in the human hubris of releasing thousands of chemicals into the environment without knowing the longterm bio-accumulative and synergistic effects. These chemicals include not just pharmaceuticals and pesticides, but also food additives, cosmetics, cleaning products, industrial waste, etc., many of which have been found to be endocrine disrupters or carcinogens. Many of these substances have never been tested for safety (they were grandfathered or generally recognized as safe), but if they were, as you point out, since their short-term acute effects seemed trivial, regulators allowed them into the supply chain, and once they’re in, they’re difficult to remove and in any case will persist in the air, soil, and/or drinking water for many years. Even though DDT was banned in the US in 1972, it’s still found in breast milk and fatty tissue*, and it’s still used in some developing countries.

    *Jaga K, Dharmani C. Global surveillance of DDT and DDE levels in human
    tissues. Int J Occup Med Environ Health. 2003;16(1):7-20. Review. Corrected and
    republished in: Int J Occup Med Environ Health. 2006;19(1):83. PubMed PMID:
    12705713.

  2. David, you have the knack of putting into words – actually a whole history lesson – the very ideas that many of us have been putting into (in comparison) very poorly constructed sentences – the knowledge that humans are very poor learners and repeat the same type of mistakes generation after generation!
    Surely, we should have been able to deduce by now the truth of the saying ‘if anything sounds too good to be true, it probably is’. Instead, we put all our faith in any new, fashionable idea that comes along – having read only the bits that we want to see before we try them. The saddest fact, to me, is that, these days, despite all that ‘modern science’ can offer, we are only given the ‘truth’ of such a minimal number of trial cases although, in most instances, many different tales are left untold. Maybe that was also true back in the day of DDT trials – but now we KNOW the consequences, shouldn’t it be considered a crime to KNOWINGLY continue in the same vein?

  3. I was amazed by the story of Domenjoz’ “testing” of DDT … on the lice. It killed them reliably, of course. Was there really no testing of the effects on people – or other living things in the areas being sprayed? Yikes.

    In medical research, they call this sort of thing a “Surrogate Outcome.” The real outcome, of course, is the long-term health of the people being treated, which might not be captured at all in most RCTs of medicines OR pesticides. In order to do so you’d have to be able to track both the decrease in the number of cases of typhus or malaria, and any increase in illnesses caused by the pesticide. (Not to mention the harms caused to plants and animals, which might take a generation or more to harm the future of humanity.)

    A “Surrogate Outcome” is a result that’s faster and easier to track, and that you *assume* will lead to the long-term outcome. Like “number of lice killed.” Or “cholesterol level in blood,” when it comes to statins. Trouble is, the real outcome doesn’t always match the “surrogate outcome”, to put it mildly.

    The U.S. Senate is now poised to pass a “21st Century Cures Act” that will, among other things, make it easier to get drugs approved by relying only on surrogate outcomes – or in some cases, without any Randomized Controlled Trials at all, if there are “case studies” showing impressive improvement in a few patients …

    • What you are saying is so, so frightening Johanna, and yet when I think – and re-think – about it, how different will the situation be really? ‘It’s worked for a few’ without RCTs, as opposed to ‘ we tried it out on many but we’re only telling you about the few positive results’ with RCTs – takes us to almost the same place really, don’t you think? Either way, it takes us nowhere near to the true picture – that’s for sure!

    • Here is another case of ‘money talks’ or ‘never mind the plebs’. This is totally non-medical but relevant inasmuch as there were many protests but no ‘high- ranking listeners’.
      A good few years ago, a tranquil, close-knit rural community disappeared under water. Not a natural disaster, oh no, water was needed for an expanding urban area of England – so it was thought a wonderful idea to drown a Welsh community for the benefit of another nation. There were promises galore but the reality is that no amount of money could ever replace that which was lost – and, once lost, if was impossible to reproduce the same atmosphere elsewhere.

  4. It goes on and on. The lessons of history never seem to over-ride so-called Prgress, things apparently done for the greatest good of the greatest number.
    We spent ages campaigning against the genetic modification of foods, and against the cavalier approach of Monsanto. I actually thought we had halted that, but no, it’s creeping back again under the radar.
    We’re told we need it to feed the starving peoples of the world. Surely it would be better to find ways of naturally improving (feeding and irrigating poor depleted soil) so they could produce reliable crops of naturally healthy food. Not genetically modify everything so they have to pay Monsanto for the privilege of using their own seed.

    A little stream runs through our village. New affordable houses were built, (too many for the little site, we felt, like dark rabbit hutches) with a sewage treatment plant, designed to discharge into it. The village protested ahead of time, when we were cynically told things were open to ‘consultation’. The Water Board said they use ‘models’ to assess likely problems. They wouldn’t listen to us. It went ahead. Our MP played ducks and drakes, pretended to help, but had no intention of so doing. He wasted our time and hope. There have, needless to say, been problems with the smelly treatment plant, which we have alerted the powers-that-be to. The Environment Agency seem powerless to do anything. It is the age old problem of constant frustration – we told them so ahead of time and it was common sense, but money talks. Easy to see how Silent Spring happened.

    You can’t take the money when you go, though. I wonder if you can look back (when you get there) with great regret at the destruction you caused in a beautiful world. I do hope so. I especially hope that all the well paid ghost writers and BSers in Big Pharma find themselves experiencing the destruction of their minds and bodies that they’ve inflicted on others, and that the doctors, who didn’t bother to use their intelligence to think carefully about what they were prescribing, experience the hell they’ve facilitated.

  5. What were we saying about ‘surrogate endpoints’..

    https://www.statnews.com/pharmalot/2016/09/19/sarepta-fda-duchenne-behind-the-decision/

    Until now, the FDA had not approved a drug to treat Duchenne, prompting parents and some lawmakers to argue for accelerated approval4, a process that relies on surrogate endpoints instead of actual medical benefits to endorse a drug.

    https://www.statnews.com/pharmalot/2015/11/19/pharmalot-duchenne-advocacy-fda/

    But their victories have also raised uncomfortable questions.

    But in late 2013, a bomb dropped: A 186-person trial that was testing drisapersen, the competing drug then being developed by Prosensa Therapeutics and its partner GlaxoSmithKline, failed. The drug did not produce a meaningful difference7 in a six-minute walking test compared with boys who were on a placebo for close to a year.

    http://www.gsk.com/en-gb/media/press-releases/2013/gsk-and-prosensa-announce-primary-endpoint-not-met-in-phase-iii-study-of-drisapersen-in-patients-with-duchenne-muscular-dystrophy/

    Did the FDA set ‘a dangerous precedent’ with its latest drug approval?

    https://www.statnews.com/pharmalot/2016/09/19/fda-sarepta-precedent/

    But the approval may have set a precedent that could rocket through the health care system, opening the door for drug makers to get more medicines to market — even with scant evidence that they work.

    • Annie has touched on an important controversy here – the FDA approval on Monday of a new drug for Duchenne’s muscular dystrophy (DMD). And it don’t look good.

      The trial of “eteplirsen” from Sarepta Therapeutics involved only 12 patients. There was no control group – their results were compared to “historical data” on other patients with DMD. And while Sarepta’s drug apparently helped some patients boost their levels of a muscle protein called dystrophin, there was no evidence that this improved their ability to walk. At the very best, the drug produced some improvement on a surrogate endpoint that made no difference in real life. Even FDA head Robert Califf conceded there were “major flaws” in the evidence – but he approved the drug anyway.

      Sarepta won, in part, by exploiting desperate parents of young boys with DMD, most of whom progressively lose the ability to walk and die in young adulthood. The boys and their families were trucked to Washington, D.C. to make emotive pleas: “FDA, please don’t let me die early.” Meanwhile, the FDA actually cited the financial state of Sarepta, arguing that the company “needed to be capitalized” in order to guarantee it the money to conduct future research. Sarepta will have until at least 2021 to show the FDA the drug actually works.

      On Monday, Sarepta Therapeutics blandly announced that their dubious miracle would cost about $300,000 per year. “We tried to be reasonable,” the CEO said. We don’t even know for sure that this drug is safe to take for a year – much less if it will add either time or quality to anyone’s life. This is not a case of “compassionate access” to an unproven experimental drug for dying patients. This is an uncontrolled but wildly profitable experiment on sick kids, and a highway robbery of their families and communities.

      Big thanks to Ed Silverman of Pharmalot for bringing us the whole story …

  6. The CEP Campaign…addressing the .eek tragedy

    “Side effects and withdrawal effects can be very severe and last for months and sometimes years, often leading to disability and sometimes suicide”

    http://cepuk.org/2016/09/21/support-campaign-recruit-mps-demand-national-helpline-prescribed-drug-dependence/

    The All Party Parliamentary Group for Prescribed Drug Dependence (APPG for PDD)

    The APPG is addressing the growing problem of prescribed drug dependence (PDD). Increasing numbers of prescriptions for addictive, psychoactive drugs are being given to both adults and children, including benzodiazepines, antidepressants, antipsychotics, stimulants and painkillers. While these drugs may help some people in the short term, there is growing evidence that long-term use leads to worse outcomes, and many patients report devastating persistent withdrawal and other negative effects. The APPG for PDD will engage with this issue by demanding appropriate services for those affected, proper training for medical professionals, reduced prescribing through adherence to new and existing guidelines, better data regarding the prevalence of PDD and more research into long-term harms associated with PDD.

    The Chairman of the APPG is Paul Flynn MP.  The co-chairs are Lord Patel of Bradford, David Tredinnick MP, Baroness Masham of Ilton and the Earl of Sandwich.  The APPG website can be found at prescribeddrug.org.

  7. Journalists behave like psychiatrists.

    She mentions China; journalists talk about China fine.

    She desists from talking about US.

    Journalists desist from talking about $$$3 Billion Fine.

    Patient mentions a worry.

    Psychiatrist leaps on worry; prescribe an SSRI.

    The level of reporting was spontaneous, overnight, knee jerk, and really not revealing; apart from her gender, which seems to have caught their imagination..

    Emma is going to develop the Consumer side of things, as with L’Oreal; GSK have lost their wherewithall

    http://www.bbc.co.uk/news/business-37416282

    http://www.ibtimes.co.uk/glaxosmithklines-new-boss-who-emma-walmsley-1582379

    http://www.wsj.com/articles/glaxosmithkline-names-emma-walmsley-as-new-chief-executive-1474353563

    A flying start…press on board…the ship keeps sailing…

  8. http://www.madinamerica.com/2016/09/go-figure-a-geek-tragedy/

    Serious drug side effects are massively underreported in medical papers

    http://www.wired.co.uk/article/drug-side-effects

    GlaxoSmithKline has promised..
    http://www.gsk.com/media/280827/disclosure-of-clinical-trial-information-policy.pdf

    J on September 21, 2016 at 6:32 pm said:

    Scary, but informative! People should send this article to their psychiatrists – and anyone else who believes that psychiatrists want to or *can* set limits on their power to “treat” their patients to a date with the grim reaper.

  9. The BMJ ‏@bmj_latest 15h15 hours ago

    “Clear eg of the absurdity of industry’s ghostwriting definition is #Study329 ”

    #BMJresponse http://www.bmj.com/content/354/bmj.i4578/rr-3 … http://www.bmj.com/content/354/bmj.i4578 …

    Re: Ghostwriting: the importance of definition and its place in contemporary drug marketing

    21 September 2016

    Alastair Matheson
    Independent consultant
    Toronto, Canada

    http://www.bmj.com/content/354/bmj.i4578/rr-3

    A hugely fascinating discourse from Aspen Institute on Business in Pharmaceuticals…streamed live at 5.00 pm.yesterday

    https://www.youtube.com/watch?v=hHUXGqYjSDU

    Competing interests: I am a supporter of innovative pharmaceutical research and have affection for, and friendships within, pharmaceutical corporations and also the marketing and publications trade, whose employees I consider to be ethical and professional. As stated in my article, between 1994 and 2012 most of my income came from consultancy and writing services provided to pharmaceutical corporations, either directly or via marketing agencies. In 2015 I acted as a paid expert witness on behalf of the plaintiffs in a US federal legal action against a drug company.

    #study329
    https://twitter.com/hashtag/Study329?src=hash

  10. Back to Rachel Carson’s Silent Spring for just a moment. BBC Radio 4 ‘Any Questions’ Friday 22nd Sept at 8pm. The question of Fracking came up. Most of the team and audience are very much against. Unproven safety, why do we need to take such risks etc? My question in my head, want to scream at them, why do we rush headlong into these projects, with the carrot of saving money waving ahead of us. The Tory member of the team defends it. Words to the effect of, yes, I know it’s unpopular to say this but we’ll be running out of power, and anyway, If it doesn’t work, we can stop. He’s got to be kidding, right?
    When our water courses are full of muck, and our world even more contaminated, we’ll decide to stop. But cheer up folks, the energy bill will go down a bit, oh, grat.

    But of course, when the water courses are full of muck, and the samples show it, it won’t be due to Fracking. It’ll be due to some geological changes that were happening anyway. No muck will stick to that industry. Just like no muck sticks to Big Pharma although it’s been put inside so many thousands.

    Come on Jeremy Corbyn – let’s stand up for real Progress, unlimited by corporate bribery. I love the comment I heard made by a journalist yesterday, describing his defence of his leadership campaign against ex-Big Pharma corporate employee Owen Smith; ‘it’s been like a contest between Red Rum and a donkey’. Wonderful. Politics is changing. I bet Jeremy would have no truck with Big Pharma, and he doesn’t have to be PM to do that, he just needs to put a spotlight on them again and again, and get the people’s voice heard and taken seriously once and for all. And whatever we may think of him as a new kind of leader, I cannot imagine him being bought off against principle by anyone. Which, I feel, is why so many are scared of him and want rid of him.

  11. PS – Emily Thornberry, Labour MP and staunch supporter of Jeremy Corbyn is on the APPG team that Annie has alerted us to. Are we all going to submit depositions to them, en masse, putting them in our pictures? There only seems to be a place where we can sign up to be kept informed of how they are doing, shouldn’t we be blitzing them with our APPG experiences? Emily Thornberry would seem a good choice to write to.

  12. Scientic integrity through Data Based Medicine

    Inverstigation results

    BMJ Publishes Study Revealing How Flawed Drug Research Fails a Trusting Public

    Dr. Healy says he believes that the issues uncovered are bigger that what happened with Study 329. “This was not an anomaly, but rather what has become standard industry practice for branded medicines. It raises many questions about drug safety, the limitations of randomized controlled trials, the need for access to individual patient level data, and the question of how to reduce harms from misleading health information.”

    Fellow author Dr. Jon Jureidini says, “Our reanalysis of Study 329 reveals that drug regulators, pharmaceutical companies, senior ‘independent’ researchers, and journal editors are all failing patients. The core problem is that the process for safety and effectiveness testing is left to drug manufacturers, who have a vested interest in seeing positive results without the medical and scientific community being able to scrutinize what they are doing.”

    http://study329.org/bmj-publishes-study-revealing-how-flawed-drug-research-fails-a-trusting-public-2/

  13. $$$3 Billion seems a very popular figure..

    Dear Priscilla and Mark

    You are making a wonderful contribution in your pledge of $3 billion to medical research

    http://www.alltrials.net/news/open-letter-zuckerberg-pledge-medical-research/

    Zuckerberg and Chan aim to tackle all disease by 2100

    By Leo Kelion Technology desk editor
    21 September 2016

    From the section Technology

    Facebook’s founder Mark Zuckerberg and his wife Priscilla Chan have pledged $3bn (£2.3bn) to fund medical research over the next decade. …

    http://www.bbc.co.uk/news/technology-37435425

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