ScandalGive me 90 minutes. Whoever you are, whatever your connection to or interest in ME/CFS, take 90 minutes to listen to this discussion with academic/journalist David Tuller, DrPH (Lecturer at the School of Public Health and Graduate School of Journalism at University of California, Berkeley) about the PACE trial of Cognitive Behavioral and Graded Exercise Therapies for the treatment of CFS.

The fact that this incredibly flawed study has not been retracted (let alone was published in the first place) is a scientific scandal of epic proportions, and it is harming patients right now.

Take 90 minutes and listen to David Tuller explain it all. It is worth your time. I can only explain it by analogy.

Imagine that there is a clinical trial of a chemotherapy drug for breast cancer. Imagine the following facts about that chemotherapy clinical trial:

  • Patients did not give valid informed consent because they were not told about that several of the investigators were consultants for the manufacturer of the drug.
  • The trial is not blinded, so the subjects and the scientists know who is getting the trial drug and who is not. There is also no placebo in the trial.
  • Not everyone in the trial has breast cancer; some have other kinds of cancer.
  • To get in the trial, a subject had to have a tumor smaller than 1.5 cm. Post hoc changes in design declared that tumors smaller than 2 cm would be counted as success. In other words, you could enter the trial with a 1.5 cm tumor, the tumor could get bigger, and as long as it was smaller than 2 cm you were counted as successfully treated.
  • At the beginning of the trial, 13% of the trial subjects already met the primary outcome measurement of a tumor being less than 2cm in size.
  • Subjects treated with the trial drug are more likely to have their cancers progress – either spreading to new sites or getting larger. The scientists insist this is not true.
  • Despite all the flaws and other decisions which interpret the data very favorably for the trial drug, only 25% of people getting the trial drug show any improvement at all.

No one in their right mind would believe that this chemotherapy drug should be approved. No Institutional Review Board would even approve such a trial in the first place, and no journal would publish such a paper. The scientists would be investigated for fraud and misconduct. No medical association or government agency would cite this study, nor rely upon it in formulating treatment guidelines.

Yet this is EXACTLY the level of scientific scandal in the PACE trial.

I am not exaggerating. Every bullet point in that list simply takes problems in the PACE trial and projects them onto a chemotherapy clinical trial. And that is not even the full exhaustive list of PACE flaws.

As I reported in May, twelve ME/CFS organizations asked the Centers for Disease Control remove all recommendations based on the PACE trial from its medical education material, and asked the Agency for Healthcare Research and Quality to examine the issues raised in Dr. Tuller’s investigation and revise its systematic evidence review. To my knowledge, neither agency has taken action on these requests.

Patients are being harmed – right now, today – by recommendations based on the fatally flawed PACE trial and the follow up papers. This study should never have been conducted. Once conducted, it should never have been published. Now published, it should be retracted.

The study was published five years ago.

Listen to David Tuller’s explanation of what he found in his investigation of the PACE trial. If you agree that science can and must do better, if you agree that the PACE trial should be independently investigated, then speak out! Write to The Lancet, as these scientists have done and as more than 12,000 advocates have done, and demand that CFS science be held to the same standard as any other kind of science.

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19 Responses to Scandal

  1. CFS science should be held to a much higher standard than everything else BECAUSE it has been so badly treated by ‘science’ and ‘medicine’ in so many cases.

    I know of no other disease (okay, maybe Freud and ‘hysteria’) where the victims have been systematically disparaged, ignored, and called liars, as with CFS/ME.

    Scandal is the PACE ‘trial.’ Scandal is how the CDC has diverted money from research, and is doing it still. Scandal is how so many PCPs tell their ‘patients’ there is nothing they can do about it, don’t recognize it, and are not even interested in learning.

    • Deborah Leigh Irizarry says:

      The number one activity identified as the mark of CFS or SEID is exercise intolerance. The PACE study is a product of disability insurance’s aim to discredit the disease of SEID by advocating a treatment that makes CFS worse.

  2. Freda says:

    t agree that this trial should never have been done. However given that it was going to be done it should have been done in accordance with the published trial protocol, which it wasn’t. Despite the authors altering the trial protocol, to make the trial look “successful”, the results were still woeful.
    Severely ill people on entry were only slightly less severely ill on exit.
    Many people were harmed, the hallmark of ME is post exertional exacerbation of their symptoms after exertion – the onset of this relapse is delayed and typically occurs 24 hours or more AFTER exertion, not captured by the authors.
    Sadly there are safe ways to manage activity/rest/exercise as described by exercise physiologists eg Workwell Foundation.
    One of the saddest things about PACE is the amount of harm it has caused to people with ME.
    Those harmed directly by trying a PACE style GET program.
    Many more harmed directly by rejecting all exercise. Safe, sustainable activity management is possible using heart rate monitors and listening to your body.
    Typically the first step is to REDUCE activity not increase, as per PACE.
    So sad that the UK is spending millions of pounds on defending the indefensible.

  3. Hutan says:

    Great analogy. But it should go even further.

    Instead of
    ‘Despite all the flaws and other decisions which interpret the data very favorably for the trial drug, only 25% of people getting the trial drug show any improvement at all.’

    Actually, despite all the flaws, only 25% of people getting the trial drug reported that they FELT better. And this was after receiving a newsletter and the administering nurses all telling them how wonderful the drug was.
    On any objective measure, such as a decrease in the size of the tumour or the ability to get back to work, the people getting the trial drug showed no significant improvement whatsoever.
    And yet still, the drug was hailed as a wonder treatment and approved for use throughout the world.

  4. Simone says:

    “To get in the trial, a subject had to have a tumor smaller than 1.5 cm. Post hoc changes in design declared that tumors smaller than 2 cm would be counted as success. In other words, you could enter the trial with a 1.5 cm tumor, the tumor could get bigger, and as long as it was smaller than 2 cm you were counted as successfully treated.”

    Great analogy!

    Not only could the tumour get bigger, but the researchers didn’t even measure the size size of the tumour, but just asked the participants themselves whether they thought their tumour had grown or shrunk.

    Ludicrous. Junk science.

    • J Alle says:

      Exactly! They asked if they felt better. That was after multiples sessions (12?) spent trying to convince the patients that they were not ill in the first place. originally, they were going to use pedometers to track patients’ activity, but that was tossed aside. This meant objective data that could have been obtained, was not.

  5. Mary Dimmock says:

    Brilliant, Jennie.

    As you say, this is just the start but this alone should be enough.

    The fact that it is not is indeed a scandal.

  6. Sasha says:

    Very well put, Jennie!

    It’s appalling that the misleading claims made in the PACE trial haven’t been retracted. It’s shameful for UK science (I’m a Brit) and shameful for The Lancet in particular.

  7. Pingback: Scandal – says Jennie Spotila – no retraction of PACE trial | WAMES (Working for ME in Wales)

  8. Amy says:

    Genius analogy, Jennie. Makes it all so clear. And horrifying. And outrageous.

  9. jimells says:

    I sure hope Dr Tuller is investigating exactly who is controlling the policy to bury the illness, and exactly which disability insurers are calling the shots. Until those individuals are revealed and held to account (preferably in a criminal proceeding) our nightmare will not end.

    Even if all the currently promising research were to show exactly what is wrong and result in a 100% guaranteed cure, effective treatment would *still* be inaccessible to the 99% of patients who have never been diagnosed or whose doctors (including my own useless primary care provider) insist the illness is “primarily psychological” and therefore should not be treated.

    It took a huge effort to bring the tobacco industry to heel. It will take a similar effort to smash the hold that the disability insurers and their psychopathic psychiatrists have on M.E. policy. I am not optimistic this will happen any time soon.

  10. Kathy says:

    Can the scientists who did the Pace trials and/or the publishing journal be sued? They knowingly did harm to us all.

  11. kathy d. says:

    I don’t think it’s only the disability insurers, but also the health insurance companies, which don’t want to pay for medical care and the government, too, which doesn’t want to add beneficiaries for Social Security disability, Medicare and Medicaid.

    Kudos to David Tuller for continually doing a good job for ME/CFS sufferers. We should give him an honorary award for his hard, intelligent work on our behalf.

  12. cinderkeys says:

    If you’ve read Trial by Error, the only new information in the podcast involves the researchers and the Lancet STILL being unresponsive. But that’s all right. I could listen to David Tuller talk about this all day. There aren’t enough honorary awards in the world for the work he’s done.

  13. A.K. says:

    MIA w/ME since 2008.

    First of all, great article- very informative!

    What makes me sick to my stomach are these people in positions of authority who continue to deliberately embrace ignorance concerning this disease.

    Despite there being more than enough proof to show ME is in fact physiological,
    they’re still taking on the tone that it’s mostly psychological (“all in our head”)- and sadly, the basis on which these studies & trials were designed and carried out.

    I too believe the insurance & pharmaceutical companies have played a big role in this- as long as the false notion remains that it’s mostly psychological, they can continue manufacturing more & more new drugs (namely antidepressants). Bottom line: It’s all about the money, and I doubt there would be a lot of profit gained due to the large amount of research still needed in order to develop an effective treatment or cure for ME.

    I was sick for 2 years, dealing w/doctors treating me with disdain & indifference before finally finding a primary care physician who took me seriously and continues to do so. In fact, he takes a genuine interest in my case and encourages me to keep him up-to-date. There’s not a lot he can do of course, but he does what he can to at least keep me more comfortable. A rare jewel now days.

  14. Lidia Thompson says:

    It’s get even worse I’m afraid. First, the GMC imposes limits on Dr Nigel Speight’s license, a (much-loved) paediatrician in the UK who has been involved in many cases throughout Europe where children with ME/CFS are being threatened with removal from their families by the social services. Soon after that, we hear that the Bristol group publish a protocol for the study of Graded Exercise Therapy in children and young people with ME/CFS.
    This will be a non-blinded study with self-reported outcomes … IN CHILDREN … who are so easily ‘persuaded’.
    Dr. Esther Crawley is part of this study. She is involved with AYME which is the only ME/CFS charity in the UK which did not ask for the release the anonymised PACE trial data.

  15. Richard Dietzel says:

    I don’t have any issue with researching approaches to treating ME, that’s a good think, if they had reported that their approach had failed THAT would be good science. A study failing is not a failure of science it is all information, useful information. Manipulation and fraud are bad science, bad policy, bad period.

    In the mid Aughts I read a little article about dome study being done by Physical therapy researchers at the University of the Pacific in Stockton, one reason I looked at Stockton as a possible relocation site for me, but they were dumped by UOP which may be a plus.

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