Appeal to NICE concerning the Guideline Committee for ME/CFS

please signJohn Peters informs me: “Anyone can sign. The letter is going off with a couple of dozen signatures, but the petition is open to all.”

The petition is here. Please sign.

For many years, patients, charities and scientists have listed the deep flaws in studies promoting CBT and GET for ME/CFS, but NICE has accepted the research uncritically and a major part of its advice on the illness follows this approach. In the past a majority of the members of the Guideline Committee have had a conflict of interest.

In the USA, this research has been rejected by the Centers for Disease Control, the Food and Drug Administration, and the Agency for Healthcare Research and Quality. They and the National Institute of Health and the Institute of Medicine/National Academy do not consider CBT and GET to be effective.

There may be 250,000 patients with ME/CFS in the UK: NICE guidelines not only affect the way they are treated by the medical profession, but may be used by insurance companies and benefit agencies. These agencies may place inappropriate expectations on patients to undergo such therapies, despite a lack of evidence that they are safe, and in the case of GET, a strong response from patients that they can cause severe harm.

We call on NICE to ensure:

1. The process of deciding who determines the membership of the Guideline Committee is open and involves stakeholders.

2. Whoever appoints the members of the Guideline Committee does not have any involvement in research into CBT-GET or is currently using these interventions to try to treat ME/CFS or is a colleague of anyone associated with the CBT-GET model.

3. The selection of members of the Guideline Committee is also an open process and involves stakeholders.

4. No one who has previously been a member of an ME/CFS Guideline Committee is eligible to sit on this new committee.

5. No one with a conflict of interest is allowed to be a member of the Guideline Committee, and that conflict of interest includes any financial interest or researcher allegiance or close working association with someone linked to the CBT-GET model.

6. Stakeholders should have a right of appeal with cause against members selected.

Full letter sent to Sir Andrew Dillon: https://www.s4me.info/threads/grahams-finalised-letter-to-nice-january-2018.1885/

More information here: https://www.youtube.com/watch?v=7Y6XFipQigE&feature=youtu.be

On the previous NICE Guideline Committee: https://www.coyneoftherealm.com/blo…based-on-political-considerations-an-exchange

And: https://meagenda.wordpress.com/2008/12/19/a-nice-dilemma-by-margaret-williams-part-two/

Read the letter

Coyne of the Realm’s open letter to the National Health and Research Medical Centre (NHMRC) of Australia

I received the  message below from Australia. I attempted a timely response to the National Health and Research Medical Centre (NHMRC) concerning their convening of an Advisory Committee to provide advice on research, funding and treatment of Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS). [Please don’t let this establish an expectation that I can respond to such requests in the future, but this time I did.]

If you have any time to write to the NHMRC at me_cfs@nhmrc.gov.au before Thursday  I’d appreciate it enormously. As you know, professionals hold much more sway with government than us patients.

kangaroo_600_600My assessment of the situation in Australia:

To put it bluntly:  Detection and diagnosis, as well as research and public policy concerning Myalgic Encephalomyelitis (ME) in Australia are a disaster. There is a high likelihood of the situation becoming worse.

The letter to NHMRC

To whom it may concern:

I understand that an Advisory Committee is being established to provide advice on research, funding and treatment of Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS). I am told that it will convene on December 7 and that you are open to input from the international scientific community. I hope these comments reach you in time or that you otherwise will consider them.

By way of introduction, I am a Professor Emeritus of Psychology in Psychiatry at the Perelman School of Medicine of the University Of Pennsylvania. I have had a visiting professorship in the School of Psychology at Australian National University. I regularly come to Australia. In the past, I have given keynote addresses at the Australian Behavioural and Cognitive Therapy Association in Sydney, presentations at the World Congress of Behavioral and Cognitive Therapies meeting in Melbourne, a keynote at the Australian Skeptics National Convention in Brisbane and numerous talks and workshops on critical thinking and science writing throughout Australia. I particularly enjoy presenting to Australian audiences, because I feel so free to speak directly with a candor that does not always go over well elsewhere. I write here in that spirit and with that candor.

I have no financial conflicts of interest to declare with respect to myalgic encephalomyelitis a.k.a. chronic fatigue syndrome in terms of receiving any financial support from anyone for my opinions.

To put it bluntly:  detection and diagnosis, as well as research and public policy concerning ME in Australia are a disaster and there is a high likelihood of the situation becoming worse.

Epidemiologic data suggest that Australian GPs employ loose criteria for detection and diagnosis, seemingly considering a serious medical condition as simply being a highly prevalent “chronic fatigue”. The risk is that substantial numbers of patients may be denied treatment for treatable medical and physical conditions, whether already diagnosed or not yet diagnosed. Accurate diagnosis of these conditions may be delayed. Much of the treatment research similarly employs loose criteria. The combined failure of some Australian treatment studies to exclude minor common mental problems, the reliance on subjective self-report outcomes and the unblinded designs would lead to even homeopathy appearing effective. Generalizations are being made from patients who do not have the cardinal symptom of postexertional malaise (PEM) to patients who do not participate in the trials, but who have PEM and are at risk risk of harm from receiving these treatments.  In the United States, with stricter diagnostic criteria have now been adopted, Australian treatment studies are not admissible evidence. I’m not at all suggesting blindly following the Americans, but I think their extensive documentation empirical evidence for this position should be considered in the own right. RACP Chronic Fatigue Syndrome Clinical Practice Guidelines have rightly been criticized by patient groups as leading to misdiagnosis, unrealistic expectations for psychological approaches to ME, and and for ignoring accumulating evidence of biological parameters to properly and strictly diagnosed ME.

A planned RCT of online continuing education for health professionals funded by the Mason foundation would likely ensure the bad guidelines potentially leading to ineffective treatment and harm to some patients are going to be more consistently applied.

Australia is convening an advisory committee concerning research, funding, and treatment at a time when the Americans have already begun such a reevaluation, the Dutch are about to, and the British have announced a reconsideration of NICE guidelines. It is important to achieve a balance of viewpoints in the makeup of that advisory committee in terms of general practitioners, consumer/patients/advocates, and researchers. The risk is that glaring problems in the status quo will be perpetuated and emerging research in re-evaluations will be ignored.

To understand how some of these issues can be dealt with, I recommend a summary of a meeting held at the UK House of Lords in September 2017 between Professor Mark Baker, Director of Guidelines, NICE, and, Mr P Boorman, Communications, NICE and patient representatives for a summary of some of the issues involved in assembling committees reevaluating guidelines on myalgic encephalomyelitis.

I’ve examined a recently updated list of the membership of the advisory committee. It’s laudable that there are representatives of advocacy groups are members. However, there should be some concern about such groups that stand out from other advocacy groups in supporting treatments the other groups consider potentially ineffective or harmful. Similarly, it is laudable that Professor Andrew Lloyd is among the members. However, he has passionately and emphatically spoken out in favor of cognitive behaviour therapy and graded exercise therapy, which, for good reason, are no longer recommended by the American Agency for Healthcare Quality Research or Center for Disease Control. I’m particularly concerned by statements attributed to Professor Lloyd in a recent letter from Professor Rodney Phillips, Dean of NSW Medicine. They are almost verbatim from what I get when I submit statements from a member of the Dutch Health Council to Google translator. Perhaps they are drawing on the same talking points. I would hope that the presence of Professor Lloyd would be balanced with the presence of academics from MCRI, the ANU and Melbourne University who hold decidedly different points of view.

I am a member of the Cochrane Collaboration. I shared in one of their Bill Silverman Prize awards for my alerting the collaboration to conflict of interest as a risk of bias. In raising issues about balancing competing interests on the advisory committee, I’m not suggesting financial conflicts of interest, but that clear, strongly held beliefs that might be resistant to contrary evidence.

Finally, my own non-financial declaration of interests: I requested data that the PACE trial investigators had promised would be available as a condition for publishing in PLOS One, the megajournal where I am an Academic Editor. I had thought there would be a timely response to a straightforward request. Two years later, the investigators continue to refuse produce the data, and the Journal has taken the extraordinary step of placing an Expression of Concern on their article, which many interpret as the first step before a retraction.

Similarly, I have raised issues and dueling blogs with David Tovey, a senior administrator at the Cochrane concerning financial conflict of interest and switched outcomes in Cochrane reviews of graded exercise therapy. I was very surprised and disappointed when Dr. Tovey refused my request for individual participant level (IPL) for independent-re-review of a systematic review and meta-analysis in which the PACE investigators were directly involved. These experiences leave me with seriously concerns about the validity of the PACE trial and the Cochrane reviews that depended on studies with similarly coordinated switching of outcomes. So, do take these intellectual and scientific commitments of mine into account, but also consider the need for balance in the membership in the advisory committee for similar intellectual and scientific commitments.

Thank you for your consideration and do not hesitate to contact me if I can be of further assistance.

Sincerely,

James C Coyne, PhD

 

Unethical: Why Bristol University SMILE trial should not have been conducted with chronically ill children

If it should have been conducted at all, the first clinical trial of Lightning Process should not have been conducted with chronically ill children. Safety and efficacy had neither been established with adults, nor healthy children.

Phil Parker, developer of the trademarked, commercial Lightning Process package claims that is not a psychological treatment, but a physical one. He further claims its scientific basis is an amalgamation of neurolinguistic programming, osteopathy, and life coaching.

not psychologicalThere is no plausible scientific mechanism by which Lightning Process would work. A small minority of vulnerable adult and child patients with chronic fatigue syndrome are drawn to the false claims of the health benefits lightning process, which the UK Advertising Standards Authority now forbids posting on the web. This is a truth-in-advertising-problem, not justification for launching a clinical trial. 

Researching the Lightning Process is no more ethically and scientifically justified than researching Prince Charles’s claims that (organic) coffee enemas can slow progression of cancer. Yet, the logic is the same that has been used to justify the SMILE trial.

Protecting-children-520x350Pediatrician Esther Crawley should undergo remedial ethics training and I recommend an excellent source below.

No parents should consent to their children participating in clinical trials of Bristol University, until a transparent independent inquiry reports how and why the SMILE trial was approved.

A belated praise to the parents who stood up against Professor Esther Crawley and all her nastiness. She should apologize to you.

Required reading for Professor Crawley and relevant administrative staff of Bristol University

Ethical Conduct of Clinical Research Involving Children. Edited by Marilyn J. Field and Richard E. Behrman. 448 pp., illustrated. Washington, D.C., National Academies Press, 2004. $57. ISBN 0-309-09207-8

Although the price is listed as US$57. A free downloadable PDF is available here 

No excuse, Professor Crawley, overcoming your being ethically challenged can start with some free reading.

An excellent summary is here Institute of Medicine (US) Committee on Clinical Research Involving Children; Field MJ, Behrman RE, editors. Ethical Conduct of Clinical Research Involving Children. Washington (DC): National Academies Press (US); 2004. Summary.

Ethical Conduct of Clinical Research Involving Children.

REGULATORY CONTEXT  

INTERPRETING RESEARCH RISK AND OTHER REGULATORY CONCEPTS 

UNDERSTANDING AND AGREEING TO CHILDREN’S PARTICIPATION IN RESEARCH  

REGULATORY COMPLIANCE, QUALITY IMPROVEMENT, AND ACCCREDITATION  

ROLES AND RESPONSIBILITIES IN PROTECTING CHILDREN INVOLVED IN RESEARCH  

Some key excerpts

The special ethical and regulatory protections for children may preclude potentially important clinical studies that would be approved for adult participation. This prospect can put pressure on those involved in developing or reviewing studies that include infants, children, or adolescents. A strong system of protections for adult and child participants in research will provide support and guidance for all involved to help them fulfill their legal and ethical responsibilities in such situations.

And

Notwithstanding the expected benefits of policies to increase the amount of research involving infants, children, and adolescents, some caution is appropriate. Unlike most adults, children usually lack the legal right and the intellectual and emotional maturity to consent to research participation on their own behalf. Their vulnerability demands special consideration from researchers and policymakers and additional protections beyond those provided to mentally competent adult participants in research.

And

As discussed later in this chapter, instances of unethical research practices involving children have prompted public criticism and concern that has contributed to the development of current federal regulations to protect both child and adult participants in research. Since the 1960s, policymakers, researchers, research institutions, and research sponsors have taken a number of steps to strengthen ethical standards and policies for human research and to create formal programs, including institutional review boards (IRBs), to approve and monitor research. Clinical studies funded, conducted, or regulated by the government are now subject to a (mostly) common set of provisions for the protection of human participants in research, including special protections for children. One result is that some potentially important clinical studies that would be approved for adult participation cannot be approved for participation by children.

a9062388703d9f42237ea708b2e088f1--protective-boyfriend-quotes-protective-quotesParents’  “intimate and profound duty to protect and promote their child safety and well-being in research”

…The committee recognizes the important role of parents. They have a most intimate and profound duty and desire to protect and promote their child’s safety and well-being in research, as in all realms of life. Chapter 5, in particular, has discussed how investigators, IRBs, and others can effectively and compassionately support parents in fulfilling their responsibilities and, thereby, help them to feel that they have done the right thing for their child, whatever their choices about the child’s participation in research. Once parents have agreed to their child’s participation in research, they—and older children and adolescents—may sometimes have crucial responsibilities for following the research protocol (e.g., administering medicines or bringing the child in for research appointments). Investigators need to make sure that parents and older children and adolescents understand any such responsibilities before they agree to research participation and that they have appropriate support in adhering to the protocol during the course of the research

Selected Recommendations

Recommendation 4.1: In evaluating the potential harms or discomfort posed by a research protocol that includes children, investigators, and reviewers of research protocols should

Interpret minimal risk in relation to the normal experiences of average, healthy, normal children;

Focus on the equivalence of potential harms or discomfort anticipated in research with the harms or discomfort that average, healthy, normal children may encounter in their daily lives or experience in routine physical or psychological examinations or tests;

Consider the risk of harms or discomfort in relation to the ages of the children to be studied; and

Assess the duration as well as the probability and magnitude of potential harms or discomfort in determining the level of risk.

In Section 406 of 45 CFR 46, federal regulations permit research that involves a minor increase over minimal risk without the prospect of direct benefit if the research involves children with a disorder or condition, is likely to yield vital knowledge about that disorder or condition, and entails research experiences that are reasonably similar to those that such children encounter in certain other situations. Consistent with the interpretation of minimal risk, the interpretation of this level of research risk should not allow a higher threshold of risk for children who are exposed to more risk in other aspects of their lives (Recommendation 4.2). Also, consistent with the language of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which defined this standard in 1977, the risk allowed under this category can be only slightly above minimal risk.

Recommendation 4.3: In determining whether proposed research involving a minor increase over minimal risk and no direct benefit can be approved, the term condition should be interpreted as referring to a specific (or a set of specific) physical, psychological, neurodevelopmental, or social characteristic(s) that an established body of scientific evidence or clinical knowledge has shown to negatively affect children’s health and well-being or to increase their risk of developing a health problem in the future.

Recommendation 4.1 In evaluating the potential harms or discomfort posed by a research protocol that includes children, investigators, and reviewers of research protocols should

Interpret minimal risk in relation to the normal experiences of average, healthy, normal children;

Focus on the equivalence of potential harms or discomfort anticipated in research with the harms or discomfort that average, healthy, normal children may encounter in their daily lives or experience in routine physical or psychological examinations or tests;

Consider the risk of harms or discomfort in relation to the ages of the children to be studied; and

Assess the duration as well as the probability and magnitude of potential harms or discomfort in determining the level of risk.

CDC – Don’t just discreetly change recommendations for treating chronic fatigue syndrome, publicize the changes!

 

Original Title: BLDG21_0023.jpgNo one is going to notice important changes to Center for Disease Control recommendations for treating chronic fatigue syndrome unless explanations are often and disseminated.

Unless you stumbled on it by accident, you had to be a routine watcher of the CDC website to have noticed a discrete last summer in the agency’s recommendations for treating chronic fatigue syndrome/myalgic encephalomyelitis.

CDC Removes Reference to Disputed ME/CFS Therapies From Website

Last summer: David Tuller University of California, Berkeley lecturer in public health and journalism and activists noted

The CDC website now advises patients to develop an individual management strategy with a health care provider and warns them not to overexert themselves. (However, a separate page about ME/CFS in the CDC’s features section still includes advice about “graded exercise.”)

And

In an email sent in response to questions about the changes, the CDC did not specifically mention graded exercise therapy and cognitive behavior therapy, or concerns about the PACE trial, but said that it rewrote the website section to avoid “confusion” associated with its previous recommendations and to eliminate medical jargon.

“We continue to believe that exercise can be useful for some ME/CFS patients, and also are trying to emphasize that people need to be careful not to overdo it and push themselves so far that it harms their health,” the emailed statement reads. “We also state that talking to a therapist to help find strategies to cope with their illness may be helpful. We know from our past discussions with patients and their loved ones that there has been confusion about what we recommend related to exercise and therapy. We hope that the updated website provides more clarity.”

At the time, the CDC made in promised to Tuller and the patient community that has not been kept:

The CDC also promised to disseminate information about the website changes once the agency has updated the companion pages for health professionals.

Now, a new article by Tuller and science and health journalist Julie Rehmeyer asks

Why did it take the CDC so long to reverse course on debunked treatments for chronic fatigue syndrome?

I highly recommend this article and agree:

While the CDC deserves credit for having removed information based on bad science, that alone is not enough. The agency must also undo the damage it has caused.

I agree well as with Tuller and Rehmeyer’s three recommendations to the CDC:

Acknowledge more publicly that the CDC got things wrong.

And

CDC must actively disseminate the news that it no longer recommends these two ineffective and possibly harmful therapies and that no legitimate evidence supports their use.

And

Reach out directly to health care and medical organizations, such as Kaiser Permanente and the Mayo Clinic, to urge them to stop recommending the treatments and ensure that the information they provide is truly up to date. That outreach should include the UK’s National Institute for Health and Care Excellence.

 

 

 

 

What?! Homeopathy and acupuncture for symptoms of autism

giphy

 

Let’s get the American Association for the Advancement of Science (AAAS) to stop publicizing junk studies of acupuncture for symptoms of autism intended to exploit parents NOW.

 

 

Changes are ordered by Advertising Standards Authority for Ireland (ASAI) in the Facebook Page advertising acupuncture for autism.

  • Yet, an enterprising journal editor got the AAAS’s Eurkalert to distribute worldwide a press release for a junk study of acupuncture for autism that his journal published.

  • Some lessons and practice in skills in detecting junk studies.

  • Let’s recognize The Journal of Alternative and Complementary Medicine (JACM) as a Quack! purveyor of junk promotions of discredited and unproved treatments disguised as science.

  • Let’s watch for the next move of the Editor of JACM’s next move in his avowed effort to gain legitimacy and reimbursement for acupuncture.

  • Let’s tell AAAS to stop making excuses.

  • Tell AAAS to get EurekAlert to screen press releases before distributing them. As it stands, EurekAlert is damn confusing to lay persons who consider the AAAS bran attached to anything as indicated a trusted source. [At the end of this blog, I make it easy for you to lodge a protest.]

Ireland’s Advertising Standards Authority investigated a complaint. As a result, the ASA has informed a homeopath not run a Facebook advertisement in its current form.

The homeopath was told by ASAI not to run a Facebook advertisement in its current form again because the page suggests she could treat the symptoms of autism. The ad by Almond Homeopathy stated the homeopath had:

“the great pleasure of meeting and working with many children diagnosed with ASD and the greater pleasure and joy of helping them overcome many of their symptoms that were holding them and their families back from getting the most out of life.”

The Facebook Page also referenced a blog which contained a reference to a child whose “learning, relationships and speech” had improved

The advertiser defended her FB page by declaring  that  she was a qualified homeopath, registered with the Irish Society of Homeopaths.

She said she treated the person, not their condition or disease, and did not claim to be able to cure anything or anyone.  However,

The ASAI’s complaints committee said that, while noting the advertisers’ comments that she was a qualified and licensed homeopath and registered with the Irish Society of Homeopaths, it was aware from a previous case that the Department of Health had confirmed that there was no statutory regulation of complementary therapists.

The committee also said the wording of the post and the heading of the blog post would give readers the impression she could treat the symptoms of autism.

About the same time, EurekAlert’s posted on Twitter a link

New study from KKI shows feasibility of acupuncture in young children with ASD

To the naïve reader, the item appeared to be a story, not  the pasted in press release that it was, but that was not the case. Where one would have expected the name of a journalist, the publisher’s name was listed.

MARY ANN LIEBERT, INC./GENETIC ENGINEERING NEWS

New Rochelle, NY, June 19, 2017-A pilot feasibility study to determine if young children with autism spectrum disorder (ASD) and their parents would tolerate and adhere to an office- and home-based acupuncture/acupressure intervention showed completion of all 16 biweekly sessions and measurements of their effects before, during, and after the protocol. The study design and results, which suggest further controlled studies of this intervention approach in ASD, are published in the Journal of Alternative and Complementary Medicine (JACM), a peer-reviewed publication from Mary Ann Liebert, Inc., publishers. The article is available free on the JACM website until July 19, 2017.

Coauthors Lana Warren, EdD, OT/L and Patricia Rao, PhD, Kennedy Krieger Institute, Baltimore, MD, and David Paton, DAc, LAc, Starting Point Acupuncture and Health Services, Catonsville, MD, identified the most positive outcome of the study as the high compliance rate, with all parents of the children ages 3-10 completing the intervention. The researchers measured the effects of the intervention on factors such as the children’s behavior, ability to pay attention, sleep, and aspects of parenting stress. In the article entitled “A Pilot Observational Study of an Acupressure/Acupuncture Intervention in Children with Autism Spectrum Disorder,” most parents reported that the intervention had a positive impact on their relationship with their child.

The editor of JACM chimed in:

“While a small study, the tolerance and adherence with acupressure this pilot are both hopeful signs for families of those in their care with autism spectrum disorder,” states JACM Editor-in-Chief John Weeks, johnweeks-integrator.com, Seattle, WA.

Before getting to the horrible little study itself, note how the AAAS  denies responsibility for what it posts:

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

Note also that AAAS has said it employs 20 staff to monitor its presence in social media and tweak publicity.

The “pilot study” was:

Warren Lana R., Rao Patricia A., and Paton David C. A Pilot Observational Study of an Acupressure/Acupuncture Intervention in Children with Autism Spectrum Disorder. The Journal of Alternative and Complementary Medicine. May 2017, ahead of print. https://doi.org/10.1089/acm.2016.0257\

The Abstract

Objectives: To determine whether children with autism spectrum disorder (ASD) would tolerate an acupressure/acupuncture intervention and whether parents would adhere to a twice-weekly, 8-week intervention protocol. Second, to further understand best measures to use to capture impact of intervention on behavioral and regulatory functions.

Design: This is an observational pilot study with pre-, mid-, and postintervention measures.

Settings/location: The intervention was carried out in a private practice office in a large metropolitan area.

Subjects: A total of 10 children of ages 3–10 years with ASD and one of their parents participated.

Interventions: A total of 16 biweekly treatment sessions of acupressure and/or acupuncture were carried out by a licensed acupuncturist, and a daily home-based acupressure intervention was carried out by a parent.

Outcome measures: Attendance, tolerance of intervention, parent compliance with home program, and parent compliance in completing daily diary and five standardized measures of behavioral and regulatory functions pre-, mid-, and postintervention were recorded.

Results: The 10 children in this observational study, collectively, tolerated the intervention and parents adhered to the 16 sessions, biweekly protocol, and home protocol, as well as completing daily diary and five standardized measures at three different time intervals. The five measurements appeared to be sensitive to behavioral and regulatory functions that may improve with this type of intervention.

Conclusions: The results of this observational pilot study suggest that acupressure/acupuncture is a feasible intervention for children with ASD that merits rigorous evaluation through a randomized controlled trial.

Probing the article

Keep in mind:

There is no evidence that acupuncture is anything but an elaborate placebo ritual. The ritual involves efforts to communicate hope and acupuncturists are trained to express a sense of progress when patients wince or express discomfort.

There is no specific scientific mechanism by which acupuncture could be expected to affect physical and mental health outcomes.

This is not a randomized trial. Any changes observed  could be chance variation or return to the usual behavior of the patient from the whatever increase in problems motivated seeking health.

Outcomes are not objective, but depend on the subjective ratings from parents who have invested time in repeated traveling to the clinic where treatment is provided. The parents are not blinded, they know their child is receiving a treatment that the clinic communicates is effective. There is no comparison-control group. It is a very different situation than getting the same ratings from teachers who know the children, but do not know if they have received treatment.

A sample of 10 is inadequate (underpowered) for any claims of efficacy or effectiveness. In a randomized trial, a sample of 30 patients per group is needed to detect half the time when the effectiveness of a  treatment that actually has moderate-sized effects. Half the time the effects of the treatment would be missedWhen statistically significant results are found, they are likely to be flukes. Any results that reached significance would have to be a large difference. The literature on psychotherapeutic interventions for mental health problems is littered with unpowered studies claiming significant effects that do not replicated in larger studies.

Why is that? There is a strong confirmation bias in what gets published. Expectable null findings do not get published. The positive effects from small studies that do get published are likely to chance, selective reporting, or the researchers exercising some selection and control of what is reported that they should have.

The ability to detect moderate sized effects drops off quickly as sample size decreases.

A sample of 10 patients would need huge effects. Most statistics do not perform well with such a small sample.  Sampling error or just plain noise affect results: Loss of one patient or adding of another could dramatically affect results. But statistical analyses depend on assumptions being met about the distribution of data. These assumptions are not likely to be met with 10 patients and could not even be tested.

The bottom line: Competent, well-meaning psychotherapy researchers do not even claim any evidence a treatment is effective from a sample  of 10. Authors who make such claims are fools or are trying to fool their readers , or both.

An added bonus guide with helpful tips from a source I trust

Small studies: Be vigilant when writing about them and skeptical when reading about them – HealthNewsReview.org

Nonetheless, the authors make some dubious claims

Unexpectedly, the most robust finding of the current pilot observational study was significant improvement in children’s expressive and receptive social communication after the intervention. These findings are consistent with previous studies reporting significantly improved social communication after acupuncture, including language comprehension and social interaction.14,18 However, they were unexpected because the acupoints selected for intervention in the current study were chosen to target areas of the body corresponding to behavioral and regulatory problems, not areas known to be involved with social communication.

Beware of unexpected robust findings from such little studies. The authors admit that they were not  stimulating the bogus acupuncture points that are supposed to produce such change. They cite crap studies that nonetheless suggest such results should be found.

Although not statistically significant, the current findings indicated some improvement in sleep delay after the intervention, which may be worth further investigation.

Sure, the authors would be better off consulting tea leaves or the children’s horoscopes. They are sorting through lots of measures searching for other significant ones to crow about. When they come up  empty handed, they declare success and call for more research.

Of note, sensory processing concerns associated with ASD, particularly tactile, which had been anticipated to be problematic in AIs, did not manifest in the child participants in this study, with the exception of their general dislike of maintained deep pressure in one location. It should be noted that the initial acupressure strokes administered during the intervention were those that promote calming and quieting per Chinese Medicine theory. response to treatment.

Let’s go back to what the editor of this journal said in the press release:

“While a small study, the tolerance and adherence with acupressure this pilot are both hopeful signs for families of those in their care with autism spectrum disorder,” states JACM Editor-in-Chief John Weeks, johnweeks-integrator.com, Seattle, WA

Quack, Quack,

 

Any journal that would publish such irresponsible stuff deserves a warning to ward off naïve and vulnerable readers. Nija Ezard Ernst says

I only see one solution: completely disregard certain journals that have been identified to regularly publish nonsense. Sadly, the wider medical community is far from having arrived at this point. As far as I can see, the problem has not even been identified yet as a serious issue that needs addressing. For the foreseeable future, we will probably have to live with this type of pollution of our medical literature.

The JACM Editor-in-Chief John Weeks is well known to the skeptical community who watch for quacks. Like the EverReady Bunny, he jumps at opportunities to promote the reimbursement of dubious, unproven treatments. For instance:

The Academic Consortium for Complementary and Alternative Health Care (ACCAHC) is a group of “complementary and alternative medicine” educational organizations representing chiropractors, naturopaths, acupuncturists, homeopaths, ayurvedic practitioners, direct entry midwives and massage therapists. The executive director is John Weeks, a relentless promoter of “integrative medicine,” both on the Integrator Blog website and in the Huffington Post. The ACCAHC is dedicated to ensuring that its members and the practitioners they represent are included in all aspects of health care, such insurance reimbursement, financial resources for education and delivery models. ACCAHC’s stock-in-trade is its practitioners’ supposed expertise is being patient-centered, holistic, taking into account the whole person and such, as well as an alleged emphasis on healthy lifestyles, nutrition, well-being, and the like.

AAAS puts this stuff out there because it makes money. You can tell them to stop. Contact them at their website, go to their Facebook page. Share and Tweet the link to this blog post, tweet to EurekAlert.

EurekAlert is promoting quack treatments to vulnerable parents of children with autism and it must stop. Readers may not notice that distributing through the EurekAlert doies not constitute endorsement by the widely respected Association for the Advancement of Science, despite the disclaimer at the bottom of the page.

Contact EurekAlert!

E-mail: webmaster@eurekalert.org

Phone: 1-202-326-6716

Fax: 1-202-898-0391

Address:

EurekAlert!/AAAS

1200 New York Avenue, NW

Washington, DC 20005

USA

Twitter: @EurekAlert

Facebook: facebook.com/EurekAlert

 

Breaking News: PLOS One issues Expression of Concern for PACE trial paper

experssion of concern

Expression of Concern: Adaptive Pacing, Cognitive Behaviour Therapy, Graded Exercise, and Specialist Medical Care for Chronic Fatigue Syndrome: A Cost-Effectiveness Analysis

Several readers have raised concerns about some of the analyses reported in the article and made requests for the data underlying this study.

The PLOS ONE policy governing the sharing of data that applies to articles submitted before March 3, 2014, requires that authors agree to make freely available any materials and data described in their publication that may be reasonably requested for the purpose of academic, non-commercial research (http://journals.plos.org/plosone/s/file?id=c4aa/PLOSONE_data_policy_before_2014March.pdf).

We assessed the concerns raised and the requests for data and we sought advice from two editorial board members. The advice we received was that the individual-level patient data for Tables 1,2,3,4 and 5 are necessary to replicate the cost-effectiveness analyses reported in the article. In line with the advice received, we contacted the authors to request the individual-level patient data for these tables. The authors raised concerns related to patient confidentiality and specifications under the consent sought from participants at the time of recruitment for the trial.

In consideration of the requirements for ethical oversight of data access that may apply to datasets involving human subjects, we contacted the authors and Queen Mary University of London, where the dataset is held, to request that steps be taken to develop a mechanism that would allow requests for data to be independently reviewed and the data released in accordance with our policy while respecting patient privacy. The authors and Queen Mary University of London shared the data policy in place at the institution, however we consider that aspects of the existing framework impose limitations and conditions not aligned with our editorial policy.

The authors have offered to release aggregated data from the study but have reiterated reservations about the public release of individual-level patient data. The journal policy does not require public release of anonymised patient-level data, but does require a suitable framework for data access for the purpose of academic, non-commercial research. While the release of summarized data does not fully comply with the journal requirements, we welcome that the authors are now willing to share summarized data, and we will provide this once it is made available to us.

In spite of requests to the authors and Queen Mary University of London, we have not yet received confirmation that an institutional process compatible with the existing PLOS data policy at the time has been developed or implemented for the independent evaluation of requests for data from this study. We conclude that the lack of resolution towards release of the dataset is not in line with the journal’s editorial policy and we are thus issuing this Expression of Concern to alert readers about the concerns raised about this article.

Statement from the authors

We disagree with the Expression of Concern about our health economic paper that PLOS ONE has issued and do not accept that it is justified. We believe that data should be made available and have shared data from the PACE trial with other researchers previously, in line with our data sharing policy. This is consistent with the data sharing policies of Queen Mary University of London, and the Medical Research Council, which funded the trial. The policy allows for the sharing of data with other researchers, so long as safeguards are agreed regarding confidentiality of the data and consent as specified by the Research Ethics Committee (REC). We have also pointed out to PLOS ONE that our policy includes an independent appeal process, if a request is declined, so this policy is consistent with the journal’s policy when the paper was published.

During negotiations with the journal over these matters, we have sought further guidance from the PACE trial REC. They have advised that public release, even of anonymised data, is not appropriate. As a consequence, we are unable to publish the individual patient data requested by the journal. However, we have offered to provide key summarised data, sufficient to provide an independent re-analysis of our main findings, so long as it is consistent with the REC decision, on the PLOS ONE website. As such we are surprised by and question the decision by the journal to issue this Expression of Concern.

Wielding a pen like a sword: Blogging for disruptive innovation in scientific publishing

This interview with Jon Ehlai took place almost a year ago to the day. Watch in the next ten days when I will try to live up to this description. I will ask your support for some new ‘quixotic campaigns’ to fix a few things. People get ready….

“Coyne promotes open access, data sharing, transparency, and good research and publishing practices. He detests p-hacking and questionable research practices, along with the questionable publishing practices that encourage and protect bad science. His blog posts identify these threats to the trustworthiness of the literature and he provide readers critical tools and practice detecting such problems for themselves. He has been known to organize sometimes quixotic campaigns to get conflicts of interest exposed and bad science retracted. Someday he might just succeed in getting some junk science actually retracted, but he keeps coming close. He has fun in the meantime.”

I’m James Coyne, Professor of Psychology, and this is how I work

James Coyne, AKA as CoyneoftheRealm in social media, is the author of over 400 scientific papers and has been recognized as one of the 200 most influential psychologists of the second half of the 20th century, slipping in at number 200. While he keeps publishing peer-reviewed articles, he now devotes time to blogging at PLOS Mind the Brain, Quick Thoughts, and occasionally the premier blog for skeptics, Science-Based Medicine. He is a regular presence on Twitter and Facebook. He uses social media to keep up on the latest ideas, to try out and refine his own, and for organizing campaigns and writing groups to improve the trustworthiness of psychology and biomedicine. He also gives workshops around the world on improving scientific writing and critical thinking skills, which he hopes soon to have available as webinairs.

Coyne promotes open access, data sharing, transparency, and good research and publishing practices. He detests p-hacking and questionable research practices, along with the questionable publishing practices that encourage and protect bad science. His blog posts identify these threats to the trustworthiness of the literature and he provide readers critical tools and practice detecting such problems for themselves. He has been known to organize sometimes quixotic campaigns to get conflicts of interest exposed and bad science retracted. Someday he might just succeed in getting some junk science actually retracted, but he keeps coming close. He has fun in the meantime.

Now Professor Emeritus of Psychology in Psychiatry in the Perlman School of Medicine of the University of Pennsylvania, Jim is a Professor of Health Psychology at the University Medical Ctr., Groningen, the Netherlands, where he commutes from Philadelphia 6-8 times a year. He is also a Distinguished Visiting Professor at the Institute for Health Policy at Rutgers, the State University of New Jersey, and a Distinguished Visiting Professor in the School of Psychology, Australian National University.

Location: Philadelphia, but I can almost as often be found somewhere in Europe or Australia.
Current Gig: Professor Emeritus of Psychology in Psychiatry in the Perlman School of Medicine of the University of Pennsylvania; and Professor of Health Psychology at the University Medical Ctr., Groningen, the Netherlands.
One word/phrase that best describes your work: Focused.
Current computer: Aging Dell Inspiron.

What apps/tools/software can’t you live without?

Dragon NaturallySpeaking voice recognition software and a Logitech headset are absolutely essential to how I write. Being a writer is central to my professional identity.

What’s your best time-saving shortcut or life hack? 

Writing times of a few hours punctuated by breaks in which I’m away from the computer. Breaks allow me to rethink what I’m writing, even though I seemed to put the writing out of my mind and I am focused on other things.

Sometimes I take my current writing project to a coffee shop or park, but on a beatup old iPad. I deliberately don’t learn how to edit on the iPad. I want to be able to a look at what I am working on without being able to do anything about it.

I don’t believe in binge writing. I believe it stifles creativity and drains writing of the fun it can be.

What’s your workspace set up like?

A four-foot marble perch at a window overlooking the corner below.

marble perch

How do you keep track of things you need to do (any to-do-list apps)? 

Notepad on my iPhone. I also keep a mental procrastination list that tells me the next best thing to do when I don’t want to do what I need to do.

Besides your phone or computer, what gadget can’t you live without, and why?

 A classic iPod with a portable Sony speaker linked by Bluetooth.

What everyday thing can you do better than most people? What’s your secret?

I am self-conscious about being a writer in perpetual development. I read like a writer, constantly identifying what I like and don’t, and why. I am always looking to refine my skills and efficiency.

I use a quick, uninhibited writing strategy to produce free form first drafts. I follow this with multiple revisions until I get to a final crafted piece of writing of which I can be proud. This process could go on forever. Knowing when to keep at it and when to stop is critical.

I work on multiple projects at once and use quiet time when I’m not writing to reformulate what I’m working on.

What do you listen to while you work?

I’m eclectic to the point of promiscuous in my taste for music, drawing on an iPod loaded with two months of music ranging from classical to soothing jazz to 70s and 80s classic rock and beyond. Background music is important, but which music varies greatly with my mood and stage of writing.

What are you currently reading?

I like to read multiple books at a time, mostly on Kindle.

  • Rodrick Buchanan’s biography of Hans Eysenck, Playing with Fire.
  • John Williams’ Stoner.
  • Alice Drager’s Galileo’s Middle Finger.

How do you recharge?

Long walks, I try to log 4-5 miles a day, visiting favorite coffee shops, used CD stores, and foodie places like Philly’s famous Reading Terminal and open air and ethnic markets.

I often take breaks in the afternoon to catch recitals at the Curtis Institute or matinee art films.

What’s your sleep routine like?

Because I travel so much, I often don’t escape the influence of jet lag and time zone changes. I’m up at 5:30 or 6 AM writing, may take a short nap after one or after the 6:30 PM news. I make good use of waking up in the middle of the night to think about what’s going on in my life and I have learned not to get up then.

What’s the best advice you’ve ever received?

My mentor Paul Watzlawick telling me ‘the situation is hopeless but not serious.’

Must original investigators get authorship in re-analyses of their shared data?

Last year in New England Journal of Medicine editors Dan Longo and Jeffrey Drazen made a brazen attack on the very idea of routine data sharing.

The editors introduced what they hoped would become a derogatory term of shame, “research parasites” who

 had nothing to do with the design and execution of the study but use another group’s data for their own ends, possibly stealing from the research productivity planned by the data gatherers, or even use the data to try to disprove what the original investigators had posited.

Instead, the editorial gave rise to researchers proudly wearing “research parasites” T-shirts to conferences (I want one!), and then an actual annual reward for best achievement of a research parasite.

An exceptionally well-written letter published in Nature: Genetics, Celebrating parasites -provides descriptions the accomplishments of past and current winners of the annual research parasite awards.

But I think the letter will be remembered for the clearly articulated description of the necessity of secondary data analyses, and the need for such analyses to be conducted and interpreted independent of the individual investigators who generate data.

Some quotable quotes

The act of rigorous secondary data analysis is critical for maintaining the accuracy and efficiency of scientific discovery. As scientists, we make predictions, perform experiments and generate data to test those predictions. When we ask rigorous questions, we obtain more accurate findings that can prevent harm. For example, Vioxx was evaluated for use in treating pain associated with rheumatoid arthritis5. Questions were raised shortly thereafter about its cardiovascular effects6. Independent researchers, using data from multiple studies, identified a drug-associated increase in cardiovascular event risk7. These research parasites identified important side-effects of this drug, correcting incomplete information on the drug’s safety profile.

Parasites also improve efficiency: many data sets were originally designed for specific questions, but these data may also answer distinct but related questions. Investigators can refocus data sets via meta-analysis to reveal general patterns that become apparent only with many studies. Data sets can also be individually useful. New researchers can often bring their own creative ideas to existing data, leading to novel breakthroughs and disruptive innovations.

Importantly, the Nature: Genetics letter explains why secondary analyses of data should not routinely involve original investigators as gatekeepers of co-authors.

Under some proposals for data reuse, data would be shared with researchers working in concert with the investigators who initially analyzed the data1. We expect that this would counteract the recent focus of the US National Institutes of Health (NIH) on rigor, transparency and reproducibility. Any procedure that includes data generators as gatekeepers has the potential to compromise rigor and robustness. As gatekeepers, researchers could withhold data from those with contrary views or a reputation of challenging the status quo. We must expect data sharing to lead to some conclusions being challenged and, ultimately, refuted. If this fails to occur, it indicates a problem with the process and not the correctness of conclusions.

The Struggle over release of the PACE trial data

As many readers know, I’m engaged in a struggle with the senior editors of PLOS One who are protecting the investigators of the PACE trial of cognitive behaviour therapy and graded exercise therapy for chronic fatigue syndrome in their continued refusal to release data they had promised would be available as a condition for publishing in PLOS One.

Release of the data is crucial because:

  1. The investigators had promised the data would be available as a condition for publishing in PLOS One.
  2. The trial was funded in large part with public funds.
  3. The investigators eventually declared financial conflicts of interest they did not disclose to the patients providing data for the trial.
  4. The investigators switched scoring of some primary subject of self-report measures after learning from colleagues conducting another trial that the primary outcomes specified in the PACE trial protocol would be unlikely to produce significant effects.
  5. The investigators suppressed objective behavioral performance and return-to-work data needed to calculate secondary recovery that would have similarly demonstrated a lack of effects of these therapies.
  6. The PLOS One article argues that cognitive behavior therapy and graded exercise therapy were cost-effective, but to be cost-effective, interventions need first to be demonstrated to be effective.
  7. The PLOS One article prominently misrepresents on the first page the investigators as having complied with data sharing policies.

The Nature: Genetics article never explicitly mentions the PACE trial. However, it marked a major breakthrough for critics of the PACE trial when Journal of Health Psychology published an open-access series of commentaries that Harriet Hall blogged about in Science-Based Medicine .

Treating Chronic Fatigue Syndrome with Cognitive Behavioral Therapy and Graded Exercise Therapy: How the PACE Trial Got It Wrong

The struggle to access the trial data

Critics pushed for an independent review of the trial data. They submitted dozens of freedom-of-information (FOI) requests for PACE-related documents and data. The National Institutes of Health (NIH) and the Institute of Medicine (IOM) chimed in, and experts said the deconditioning hypothesis was flawed and untenable. The authors claimed they were being persecuted by patients and advocacy groups. They had received death threats and a phone threat of castration, and one had been stalked by a woman who brought a knife to one of his lectures.

When the trial data were finally made available (only after long persistence, many FOI requests, and a court order), an independent group did a preliminary analysis of “recovery” from CFS using individual participant data. It found that the previously reported recovery rates had been inflated by an average of four-fold. Re-analyzing the data according to the published trial protocol revealed that the recovery rate was 3.1% for SMC alone, 6.8% for CBT, 4.4% for GET, and 1.9% for APT. These differences were not statistically significant.

Fiona Godlee wrote in an editorial in the British Medical Journal (BMJ) that when there is enough doubt to warrant independent re-analysis, “Such independent reanalysis and public access to anonymised data should anyway be the rule, not the exception, whoever funds the trial.”

The authors of the re-analysis said,

The PACE trial provides a good example of the problems that can occur when investigators are allowed to substantially deviate from the trial protocol without adequate justification or scrutiny. We therefore propose that a thorough, transparent, and independent re-analysis be conducted to provide greater clarity about the PACE trial results. Pending a comprehensive review or audit of trial data, it seems prudent that the published trial results should be treated as potentially unsound, as well as the medical texts, review articles, and public policies based on those results.

Amen. Except I have to add that Harriet Hall got two critical points wrong.

After a legal struggle in which the PACE investigators spent almost 250,000 British pounds lost an appeal and were compelled to release a very limited portion of their data. These are the data that were subject to re-analyses.

In in the Lower Tribunal hearing in which the PACE investigators lost their appeal and were compelled to release the data, one investigator had to concede that reports of death threats were exaggerated and simply false.

Neither the original primary report of outcomes for the PACE trial published in The Lancet nor the claims of cost-effectiveness published in PLOS One can be independently evaluated without release of the data promised as a condition for publishing in PLOS One.

I renew my request that the senior editor at PLOS One obtain release of the data so that I and others can analyze it.

Release is important for clinical and public policy influenced by the claimed results of the PACE trial, as well as the reputation of PLOS One as the premier open access make a journal with enforced data sharing.

And no, dammit, I am not going to let the PACE investigators tell me how to conduct my forensic exploratory analyses nor invite them to be authors. They would just mess up my efforts and produce results consistent with their financial conflicts of interest like investigators did in their own publications.

I blog at a number of different sites including Quick Thoughts, PLOS blog Mind the Brain, and occasionally Science-Based Medicine. To keep up on my writing and speaking engagements and to get advance notice of e-books and web-based courses, please sign up at CoyneoftheRealm.com

Donate unwanted statistics and methodology books to an international resource center

It is very cheap to donate books to a great project, especially if you live in the US or Canada, a bit more expense if you do not. Regardless, please read on.

This is a follow up to my recent blog post about an opportunity to donate statistics and methodology books to the Serageldin Library of Alexandria. It is a chance to participate in making the library an incredible resource, perhaps the first and largest research methodology library in the world.

The post:

landfill

An appeal: Please don’t send your old statistics books to the landfill

The post presented an opportunity to get rid of some unwanted books to an excellent cause, but it was confusing. For a start, my blog post did not state where to send the books (!). There was a reason for that, which I will explain here.

Why didn’t I say where to send the books?

The unusual answer is that a warehouse in New York will only be available for a short time. Shortly, the address will be announced. The boxed books will be placed in a cargo container and shipped to Serageldin Library of Alexandria in Egypt. Stay tuned…

Ron LaPorte explained:

 I may have caused a little confusion.

  1. The main drop spot is a NYC warehouse (we do not have its address as yet)

  2. Janet McDougal is setting up a place to send books in Canada. The cost to send a book from Canada to the US is high. Therefore the costs in Canada are a lot less.  Also, if you plan to take this off your taxes, it seems like this would be a lot less complicated. (Please, please, do not take tax advice from me)

  3. Bring a Book to JSM [Joint Statistical Meeting, Baltimore, July 29- August 3, 2017. ,https://ww2.amstat.org/meetings/jsm/2017/ ]. I am liking this more and more.  On you way out the door to catch the plane to Baltimore, all 5000 people coming need grab a few books, and bring them with you.  We are discussing establishing a drop off table.  The cost to send  books to NYC is not much, $2.64/pound.  We can ask the donors like you to give us $5.12 for each book.  Or we can look for some generous donor. I kind of like us all contributing $2.64 each book to NYC, and then on its way to Egypt. Also, we can broaden this as to send a book from Tokyo to Egypt costs 450 yen, or about $4.00

Egypt?! Someone asked if the Library of Alexandria was a metaphor or may a digital metaphor for some sort of online site.

 That is actually a really cool idea. I’ll pass it on to Ron — That someone, maybe an army of volunteers scan in books and make them available open access, worldwide.

But for now, Serageldin Library of Alexandria is actually a physical place in Egypt you can visit.

Research Methods Library of Alexandria – http://ssc.bibalex.org/helpdesk/introduction.jsf

Bibliotheca Alexandrina (BA) African Networks – http://afn.bibalex.org/GeneralPortal.aspx

Visit Egypt? Isn’t that dangerous right now, especially for an American?

You don’t have to go there. But if you want to go, Ron LaPorte is arranging a kickoff meeting. If you go, he will arrange a personalized tour of the Library of Alexandria, and develop trips to the Pyramids.

As for the danger, Ron says:

In the past 10 years 1 American was killed. The risk of being killed in Cairo is probably 1/200 that of being killed in Detroit, or where you are living now.  Coming to Egypt will therefore reduce your risk of being shot.

Who is this LaPorte guy?

Ron is Emeritus Director WHO Collaborating Center and Professor Emeritus Epidemiology, University of Pittsburgh. Learn more about his fab Supercourse Project – www.pitt.edu/~super1 and Science Supercourse – ssc.bibalex.org. With those web links you can access all kinds of lectures and slide presentations and download them for your own use. Or you can donate your own lectures and slideshows.

Maybe you don’t know how cheap it is to send books and other media within the US, but if a box is clearly marked “media,” the cost through the US Postal Service is quite cheap [. I just sent 4 pounds of CDs to my mother-in-law in Arizona for about $6.

I was asked by a psychologist if psychometrics books were sought. I asked Ron and got an answer:

 We have received numbers books from Agriculture, economics, physics, etc.  I found it easier to say that we wanted research methods books rather than try to delineate research methods books by discipline.  I just do not know for example, the research methods that are used in Psychology.  I have been talking also for example with some leading historians as they have their own set of research methods, but still grounded in the traditional classical statistics.  I want to have as complete collection as possible at the Library of Alexandria, not only for helping those in developing countries, but also for their archival value so that we can examine the evolution of research methods.  I have been reading about this history of statistics, and was amazed as to how much our discipline of psychology was there in the beginning and help shape it.  It is most interesting.

And now for an update from Ron:

king tut.PNG

Dear Global Friends,

We wanted to ask your help to build the first and largest research methods library.  We would appreciate support with your books, and a contribution.

If first wanted to thank you all, things are moving very well for the second set of donations this year. In addition to people directly shipping to the warehouse, we are arranging at the Society for the Epidemiologic Research, and the Statistical Society of Canada for a research methods book drop off. We also have also approached the American Statistical Society, the Joint Statistical Meeting, and the International Epidemiology Society.

We ask faculty going to a meeting  to bring several research methods books, and drop them into the box, then they will shipped to a warehouse in NYC prior to sailing to Alexandria.

I have talked with the head of the Library of Alexandria, and he has put together a major piece to allow this to happen. In addition to paying the large expense to ship the books from NYC to Alexandria, he has agreed to rent a warehouse for the summer so that people could send their books virtually at any time.  Last year we only had a week making things really complicated for Hend, Lamia and I.  Thus right after the SER, SSC, and hopefully JSM, and ACSM, and others we can ship the books.  This indeed makes it feasible.

We now have probably 70% of the fund raising done mainly from the library. Also, a former  student of mine contributed. If we can gather the last 30% with your help we will have a wonderfully complete library. You will be honored on out donor page, and you contributed noted in the permanent collection at the Library.

We are aiming for a donation of 10,000 books as this appears to be the maximum a container can hold.

Please contribute your books, and support.

Ron

I blog at a number of different sites including Quick Thoughts, PLOS blog Mind the Brain, and occasionally Science-Based Medicine. To keep up on my writing and speaking engagements and to get advance notice of e-books and web-based courses, please sign up at CoyneoftheRealm.com

Couch potato shaming: New York Times’ click bait, fear mongering campaign against sedentary behavior

tweet-being-worse

Who would object to a suggestion we get more exercising as a way to promote well being and longevity?

But does a New York Times journalist, Gretchen Reynolds, have to keep hammering us with the importance of exercising with fear-inspiring clichés and badly reported science?

A call to action: Citizen scientists arise!

I’ll end this blog post with some concrete suggestions for actions that concerned citizen scientists can take to alert others to hide and improve the health information circulating in their social network communities.

Cliché alert

The tired cliché of a December 2016 article in the New York Times by this journalist is exposed when  you  Google “New York Times” and “couch potato”.

google-search

There are multiple reasons to maintain physical activity, particularly for aging persons, but it’s not clear that a fear mongering campaign will be motivating.

The fear may be demotivating and the repeated message may well simply contribute to dulling the public against legitimate warnings about modifiable health risks.

It’s not at all clear that the largely correlational research being reviewed points to a causal relationship or a modifiable health risk factor.

Sedentary behavior is correlated with other risk factors, and background variables like increased white-collar jobs.

It is increasingly controversial whether increased physical activity is by itself an effective weight loss strategy.

Why would the respectable New York Times resort to this “couch potato” campaign? Follow the click links to the money.

The December 2016 couch potato story

keep-it-moving

Zero in on the research that is the occasion of this story:

For their study, researchers from the University of Texas at Austin asked seven healthy young male volunteers to wear monitors and spend four active days in a row and four sedentary days in a row. When active, the subjects walked as often as they could, averaging more than 17,000 daily steps, and ended up sitting for a total of roughly eight hours a day on average; when sedentary, they sat for 14 hours or so.

On the evening of the fourth day, the men ran for an hour, and the next morning they ate a high-fat, sugary breakfast — basically “ice cream and half and half,” says Edward F. Coyle, a professor of kinesiology and health education at the University of Texas and senior author of the study. In one of their earlier studies, the researchers found that this workout leads to a healthful reduction of triglycerides — fats associated with heart disease that enter the bloodstream after meals — following the next morning’s breakfast. And indeed, when the men were regularly active and ran, their bodies reproduced this same healthful effect. But when the men instead sat for 14 hours a day, running did not bring down the high levels of triglycerides in their blood.

So we are talking about an intensive, but otherwise unimpressive study of seven healthy guys without measures of long term health outcomes. But there is speculative hope for the future of this research:

They hope future experiments will reveal the cellular mechanisms at work and also test if the same dynamics are found in people who are not young, healthy and male (as Coyle suspects will be the case). For now, even though the study’s findings are preliminary, they reinforce the message that we should walk and move as much and as often as we can.

A Google search takes us back to another couch potato article by this journalist in the New York Times:

marathon  couch.PNG

In effect, the data showed that “time spent exercising does not supplant time spent sitting,” said Harold Kohl, a professor of epidemiology and kinesiology at the University of Texas and senior author of the study. “It seems that people can be simultaneously very active and very sedentary.”

The study does not necessarily intimate, however, that being a marathon runner and couch potato is in any particular way harmful, Dr. Kohl pointed out. He and his colleagues did not measure the runners’ health, he said, only their lifestyle. “It is impossible to say” based on their data, whether heavy training would ameliorate any undesirable effects of sitting or whether such effects even would occur in the supremely fit.

Yeh, right, but why is this journalist making such a fuss?

Still, the findings are a cautionary reminder that many of us, including the most physically active, may be more sedentary than we imagine. “The fact is that exercise, even at very high doses, does not occupy much time in most people’s days,” said Dr. Whitfield, who himself used to train for triathlons. And while the science about the health impacts of prolonged sitting may still be incomplete, he said, “it’s pretty safe to say that it would a good idea for most of us to spend more of our time up and moving.”

Sure, but probably best not achieved with motivation from fear-mongering BS in the New York Times.

When the couch potato went global

couch-potato-goes

The consequences for global and personal health are punishing and likely to grow more so, reports another first-of-its-kind study in the Lancet series. In it, the authors conclude that sitting around most of the day has become as deadly as smoking or obesity.

Beware of first-of-its-kind large epidemiological studies with deceptively neatly apportioned attributable risk 

Specifically, using data from W.H.O. and other large population studies worldwide, the researchers determined that inactivity is linked to about 6 percent of all instances of heart disease on Earth; 7 percent of Type 2 diabetes cases; and 10 percent of all breast and colon cancers, including among people who don’t smoke and are of normal weight.

About 5.3 million people a year die from diseases tied to physical inactivity, the authors calculated.

By comparison, about 5.1 million die annually because of smoking, as an accompanying comment article points out.

“It seems clear from our data that physical inactivity, on a global scale, is at least equivalent to smoking and obesity,” in terms of its deleterious impact on people’s health, says Dr. I-Min Lee, a professor of epidemiology at the Harvard School of Public Health, who led the study.

But what does this “equivalency” mean? Smoking is a discrete behavior and targeting it has been shown to have observable effects on health of individuals and populations. As measured in these kind of studies, “physical activity” remains a less precise “behavior” entangled with a full range of the variables (confounds) that might explain some of the effects that are observed, but also that may get in the way of modifying physical activity and observing the expected changes in health. This is all another way of saying this kind of large-scale correlational data is quite messy if one wants to tease out specific modifiable risk factors. So the equivalency is not so equivalent.

Corrections: An earlier version of this article misstated that a third of global biomass exists in North America; it is a third of global biomass due to obesity, not biomass over all.

Haha, we all make mistakes, but in a campaign characterized by lots of exaggeration, this becomes a funny commentary.

But wow, as a reader noted, expressing these associations in biomass sure gets attention, even if it invites a rejoinder from readers.

Tim B Seattle

“reported that, worldwide, people’s waistlines are expanding, with the total combined weight of human beings on Earth now exceeding 287 million tons. About 3.5 million tons of that global human biomass is due to obesity, a third of which exists in North America, although we account for only 6 percent of the world’s population.”

This is the first time I have read the word ‘tonnage’ when speaking about human beings. This is grotesque and the future medical bills will overwhelm many systems and countries. Another idea for reducing tonnage, how about sensible long term goals toward human population reductions, with our numbers now past 7 billion and adding another billion in 12-13 years.

And then there is another reader’s observation that sedentary behavior may not be a “lifestyle” choice:

DCserver Washington, DC

I don’t think its a really a ‘lifestyle’ choice. Its office jobs. As more of the world follows our path to office 9-5s, this trend will continue. Never in my life have I had such little energy and had to watch what I ate as when I started working in offices. Standing desks and pedaling aside, it is going to take a cultural shift to include some kind of physical activity in work culture, be it mandated outdoor meetings, attire changes, or flexible work hours to accommodate more activity. Unfortunately, lately it seems the opposite: all my colleagues eat lunch at their desks, work late hours, and take cabs to meeting locations easily within walking distance (because otherwise they’d arrive hot and sweaty in their wool suits).

And before this article was the Active Couch Potato article

 active couch.PNG

Can someone exercise and still be a couch potato? That peculiarly modern question motivated a new study from Finland in which a group of healthy, physically active volunteers donned special shorts that measure muscular activity in the legs. The volunteers then went about their daily lives.

All were diligent exercisers. Some ran. Others lifted weights or played soccer. A few Nordic-walked. On one day during the study, they worked out as usual. On another, they did not exercise.

Throughout, the shorts measured how much they actually moved.

The study involved healthy volunteers observed for one to six days. Only 27 of 80 provided usable data.

Why is the New York Times in this campaign?

Like a lot of print media, the NYT is in transition to being much more dependent on the Internet for attracting readers. Like a lot of print media, it faces a financial crisis because it’s harder to make money from people reading articles on the Internet, rather than buying papers. Sure, there are still the benefits of advertisement, but this does not generate enough to compensate for the loss of paid subscriptions

People have come to expect that articles will be for free that they find on the Internet. The New York Times has to keep meeting that expectation but increase paid subscriptions. For a while, when you clicked on a link on your computer or mobile device, you were taken to an article, but also a pop-up that cautions you to register and receive 10 free views a month or, better, buy a subscription.

But now, at least on mobile devices something different is happening. If you click on a link, you briefly see the article but the view is quickly replaced by a pitch for a subscription. Apparently someone using a mobile device still has the 10 free views a month, but can’t access them on the mobile device.

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As we saw in its coverage of the recent US election, the New York Times provided some superb, in-depth investigative reporting, but that costs money. Media like the New York Times cannot afford to continue to give away free product. But consumers are used to getting their news for free and, at least for now, will go to competitors.

Expect to see a lot more of what is now free on the internet becoming a mixture of free and paid, premium. Fair enough, the free lunches may be coming to an end.

Suggestions for citizen scientists working together to improve health information in social media

Expect to see a lot of clickbait headlines from otherwise respectable media.

Before liking or retweeting a link on Twitter, you might consider examining what is the evidence base for the claims are being made.

In the case of the December 2016 New York Times article, you could have quickly discovered that the claims were based on a very modest and overhyped study.

Wouldn’t it have been great if some citizen scientists took it upon themselves to put in “based on a study of 7 healthy guys” before retweeting?

Wouldn’t it have been great if some citizen scientist with more time on their hands had done some googling and discovered that this journalist, writing in this source, engages in fear mongering to the point of cliché?

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I will soon be offering scientific writing courses on the web as I have been doing face-to-face for almost a decade. Sign up at my new website to get notified about these courses, as well as upcoming blog posts at this and other blog sites.  Get advance notice of forthcoming e-books and web courses. Lots to see at CoyneoftheRealm.com

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