No, irritable bowel syndrome is not all in your head.

Updated May 22, 2016. I have added an opening summary, as well as a few links for readers who may want to learn more about IBS as a physical health problem about which we are learning a lot, not a mental health issue.

Irritable bowel syndrome (IBS) has symptoms in common with other physical conditions. IBS ranges in severity from mild and infrequent episodes to more frequent,severe, longer, and more debilitating episodes. It is thus a chronic recurrent condition that for many patients in many healthcare contexts remains an undiagnosed pattern of recurrent, but different symptoms that are presented without much relief.

Often IBS is effectively managed in primary care with lifestyle management and monitoring and identifying of triggers. However, when IBS is not effectively dealt with in primary care, a patient may need a referral to a specialist. This article argues that first specialist who  is considered should be a gastroenterologist, not a mental health professional.

Evidence is accumulating that IBS is often a disturbance in the gut-brain relationship. In that sense, it has a psychological component. But it is important to recognize that it is a matter of the gut influencing the brain by way of well-documented pathways.

IBS is increasingly seen as a  disturbance in the microbiota or microbiome (I explain what that means below) of the gut. President Obama has directed the NIH to study the human microbiota or microbiome as part of a larger initiative studying these phenomena in other ecological systems, including soil. There is a lot of enthusiasm for this broad initiative, but also some caution that the enthusiasm should not get too far ahead of the data. I have added some links about this.

Anxiety and depression often accompany IBS. The symptoms may reflect the uncertainty and discomfort of trying to managing an ill-defined condition. But this distress also may be a direct effect of the gut on the brain, again through increasingly known pathways.

Patients with undiagnosed IBS challenge and ultimately frustrate physicians. When physicians cannot resolve their complaints, patients sometimes get mistreated and blamed for their condition.

Previous explanations for IBS focused on it being an expression of unconscious conflicts. Psychoanalytically oriented explanations suggest anal conflicts in which the patient struggles with hostility that she cannot express directly. IBS can been seen as a conflict between retaining in expelling fecal contents. Diarrhea or loose bowel movements can be seen as symbolically crapping on somebody in a situation where anger cannot be directly expressed. Such explanations are creative and  even literary, but they are  testable hypotheses about an individual patient. Such ideas just do not hold up in research studies, often because the hypotheses cannot be coherently expressed with key variables  assessed with validated measures.

I’m not a physician and I’m not a position to offer advice to individual sufferers from IBS. But if I or a family member developed what looked like IBS, and it could not be brought under control in primary care. I would not recommend referral not to a mental health professional as the next step.

In the UK, IBS is considered a medically unexplained symptom (MUS). IBS patients are likely to be referred to psychological interventions for which there is only weak evidence. Patients with IBS may have to get educated on their own about the condition and fend for themselves in a medical system that is unresponsive to them.

Finally, some readers have attempted to leave comments on this blog post discussing benefits they sincerely believe they have received from treatments, including dietary supplements for which there is not scientific evidence. I have not accepted those comments for posting. I’m very skeptical of alternative and complementary medicine which is basically  unproven medicine. I also see suffers from IBS vulnerable to exploitation by all sorts of deliberate or innocent quackery.

A segment of CBS This Morning Saturday News showed the view of Irritable Bowel Syndrome (IBS) as  “all in your head” is outmoded. Placing the source of IBS as “all in the head” is unlikely to lead to improvement in a chronic, intermittent condition affecting millions of people, and disproportionately women.

Jonathan LaPookThe Host Was CBS News Chief Medical Correspondent, Jonathan LaPook.

 

 

 

 

 

 

Mark Pimental

Mark Pimentel MD (@MarkPimentelMD) on Twitter

He was interviewing Mark Pimental, MD, Associate Professor of Medicine, and Director of the G.I. Motility Program of Cedars-Sinai in Los Angeles.

 

 

 

 

 

 

 

At one point, Dr. LaPook poked fun at the obsolete approach to IBS in which physicians patted women on the head and told them that their condition was result of anxiety and depression.

pat on the head.PNGDr. Pimentel offered a view of IBS coming out of his research and specialty practice:

Irritable Bowel Syndrome (IBS) is one of the most common chronic medical conditions, affecting 10%-15% of the population in the United States and worldwide. Work on two distinct fronts has suggested that the pathophysiology of IBS may have microbial origins. First, a series of studies and meta-analyses over the last decade suggests that IBS can develop after a single episode of acute bacterial gastroenteritis (referred to as post-infectious IBS (PI-IBS). While these subjects exhibit characteristic gut immunologic changes (in the mucosa and myenteric ganglia), the mechanisms underlying the transition to an IBS phenotype remain unknown. Second, subjects with IBS have been shown to have specific changes in luminal bacterial contents, the most common of which is small intestinal bacterial overgrowth (SIBO), a condition whereby coliform bacterial counts in the small bowel become excessive. The presence of SIBO in IBS subjects has recently been confirmed by both small bowel culture and by quantitative PCR (qPCR) of duodenal contents.

Dr. LaPook advised sufferers of IBS to work with their primary care physicians to determine whether lifestyle changes could avoid episodes of IBS or at least make them less frequent and severe. If these efforts were not successful, Dr. LaPook recommended that they consult a specialist – a gastroenterologist, not a mental health professional!

More resources about contemporary views of IBS

Here’s a link to a US National Institute of Health webpage about Symptoms and Causes of Irritable Bowel Syndrome:

What causes IBS?

Doctors aren’t sure what causes IBS. Experts think that a combination of problems can lead to IBS.

Physical Problems

Brain-Gut Signal Problems

Signals between your brain and the nerves of your gut, or small and large intestines, control how your gut works. Problems with brain-gut signals may cause IBS symptoms.

GI Motility Problems

If you have IBS, you may not have normal motility in your colon. Slow motility can lead to constipation and fast motility can lead to diarrhea. Spasms can cause abdominal pain. If you have IBS, you may also experience hyperreactivity—a dramatic increase in bowel contractions when you feel stress or after you eat.

Pain Sensitivity

If you have IBS, the nerves in your gut may be extra sensitive, causing you to feel more pain or discomfort than normal when gas or stool is in your gut. Your brain may process pain signals from your bowel differently if you have IBS.

Infections

A bacterial infection in the GI tract may cause some people to develop IBS. Researchers don’t know why infections in the GI tract lead to IBS in some people and not others, although abnormalities of the GI tract lining and mental health problems may play a role.

Small Intestinal Bacterial Overgrowth

Normally, few bacteria live in your small intestine. Small intestinal bacterial overgrowth is an increase in the number or a change in the type of bacteria in your small intestine. These bacteria can produce extra gas and may also cause diarrhea and weight loss. Some experts think small intestinal bacterial overgrowth may lead to IBS. Research continues to explore a possible link between the two conditions.

Neurotransmitters (Body Chemicals)

People with IBS have altered levels of neurotransmitters—chemicals in the body that transmit nerve signals—and GI hormones. The role these chemicals play in IBS is unclear.

Younger women with IBS often have more symptoms during their menstrual periods. Post-menopausal women have fewer symptoms compared with women who are still menstruating. These findings suggest that reproductive hormones can worsen IBS problems.

Only at the bottom of the page is any reference to the traditional view that IBS somehow expresses psychological conflicts.

The dominant theme of the fact sheet is that IBS is often a disorder of the brain-gut signaling. However, the signaling problem originates in the gut which influences the brain.

Here is a link to a freely available  article in JAMA, the Journal of the American Medical Association, Small Intestinal Bacterial Overgrowth: A Framework for Understanding Irritable Bowel Syndrome.

IBS as a disorder of the microbiota or microbiome.

A microbiota is “the ecological community of commensal, symbiotic and pathogenic microorganisms that literally share our body space”.[1][2] Joshua Lederberg coined the term, emphasising the importance of microorganisms inhabiting the human body in health and disease. Many scientific articles distinguish microbiome and microbiota to describe either the collective genomes of the microorganisms that reside in an environmental niche or the microorganisms themselves, respectively.[3][4][5] However, by the original definitions these terms are largely synonymous There are trillions of microbes in the human microbiome, although the entire microbiome only accounts for about for 1-3% total body mass,[6] with some weight-estimates ranging as high as 3 pounds (approximately 48 ounces or 1,400 grams).[n 1] Research into the role that microbiota in the gut might play in the human immune system started in the late 1990s.[9] The microbiome of the gut has been characterised as a “forgotten organ”,[10] and the possibility has been raised that “the mammalian immune system, which seems to be designed to control microorganisms, is in fact controlled by microorganisms”.[11] The human microbiome may have a role in auto-immune diseases like diabetes, rheumatoid arthritis, muscular dystrophy, multiple sclerosis, fibromyalgia, and perhaps some cancers.[12] A poor mix of microbes in the gut may also aggravate common obesity.[13][14][15] Since some of the microbes in the human body can modify the regulation of some neurotransmitters, it may be possible to use certain microorganisms to supplement treatments for depression, bipolar disorder and other stress-related psychiatric disorders.[16]

BMC Medicine is assembling a new article collection “The Microbiome and Man,” guest edited by Dr Omry Koren.

But I warn you it is heavy going and highly technical.

Here’s a more accessible link describing President Barack Obama’s National Microbiome Initiative:

Microbiomes are the communities of microorganisms that live on or in people, plants, soil, oceans, and the atmosphere. Microbiomes maintain healthy function of these diverse ecosystems, influencing human health, climate change, food security, and other factors. Dysfunctional microbiomes are associated with issues including human chronic diseases such as obesity, diabetes, and asthma; local ecological disruptions such as the hypoxic zone in the Gulf of Mexico; and reductions in agricultural productivity.

Here is an interesting link to an account of a participant in a citizen scientist effort to map the human microbiota, Some of My Best Friends Are Germs:

 Microbiomes are the communities of microorganisms that live on or in people, plants, soil, oceans, and the atmosphere. Microbiomes maintain healthy function of these diverse ecosystems, influencing human health, climate change, food security, and other factors. Dysfunctional microbiomes are associated with issues including human chronic diseases such as obesity, diabetes, and asthma; local ecological disruptions such as the hypoxic zone in the Gulf of Mexico; and reductions in agricultural productivity.

This article from USA Today is reasonably well-informed:There’s 10 trillion microbes on you; the White House wants to figure them out.

This freely available article from Nature expresses enthusiasm about the US initiative, but indicates that there are some challenges ahead that require an international effort. It’s balanced: Microbiology: Create a global microbiome effort.

The outmoded view of IBS is dominant in the UK

Suzanne O’Sullivan’s  “It’s All in Your Head “is a collection of obsolete and simply wrong ideas about “psychosomatic conditions” in itself an outmoded term, but still in circulation in the UK. She specifically mentions IBS in an editorial based on the book in The Lancet:

 Some 20% of people in the UK have irritable bowel syndrome. This is one of the most common reasons for people to present to a gastroenterology clinic. It is also a condition that is affected by psychological distress and where no organic bowel disease is evident. And yet, to convince patients that psychosomatic disorders are an everyday problem that could affect any sort of person is very difficult. To tell somebody that their medical complaint might have an emotional cause is often met with anger. It is hard to believe that we can lose control of our bodies so completely and without our knowledge. And if our subconscious has chosen to mask our psychological distress and express it in a way more palatable to us then it follows that to remove the mask will be painful.

Suzanne O’Sullivan suggests the role of the physician in the UK is to convince the patient that IBS is all in her head. The notion that “our subconscious is choosing to mask psychological distress” is at the root of the problem would be considered rubbish by informed American professionals. It’s one of many neo-crypto-psychoanalytic ideas that of have crept into CBT in the UK, despite lacking empirical evidence and being untestable with the individual patient.

O’Sullivan doesn’t tell us, but she’s referring to the old psychoanalytic literature that considers IBS as expressing unresolved anal issues acquired in potty training. Then she expresses confusion why some patients are offended by this.

Stay tuned for a blog post in Mind the Brain that traces this idea to the fraudulent data of Hans Eysenck.

Simon Wessely has praised Suzanne O’Sullivan’s book.  It was picked for Wellcome book award as a ‘thoughtful, humane and heartfelt’ study” by Baroness Joan Bakewall. The  Baroness  closed her Twitter account and fled social media after making uninformed comments blaming sufferers of anorexia for their condition:

Bakewell, 82, said: “I am alarmed by anorexia among young people, which arises presumably because they are preoccupied with being beautiful and healthy and thin.

“No one has anorexia in societies where there is not enough food. They do not have anorexia in the camps in Syria. I think it’s possible anorexia could be about narcissism.”

She added: “To be unhappy because you are the wrong weight is a sign of the overindulgence of our society, over-introspection, narcissism, really.”

It’s all in your head”is also the view of IBS promoted by Trudie Chalder and her co-investigator Simon Wessely in a King’s College, London slide presentation aimed at getting primary-care physicians to refer patients to their PRINCE Project. PRINCE is an clumsy acronym for Persistent physical symptoms Reduction INtervention:  a system Change & Evaluation in Primary and Secondary Care.

first slide MUS presentation 2015-2-page-0

second slide MUS presentation 2015-2-page-0

third slide MUS presentation 2015-2-page-0

As can be seen, the brain-gut connection is portrayed as running from the controlling brain  down to the gut.

An article about CBT for medically unexplained symptoms is recommended for the GP’s self-study.

fourth slide MUS presentation 2015-2-page-0.jpg

The preferred treatment for IBS is CBT.

fifth slide-page-0.jpg

As an American, I can’t make a positive identification of this, but I strongly suspect a British attempt at humor. However, I find it quite revealing of how psychoanalysis intrudes into what passes for CBT in the UK. This is associated with lots of patient-blaming notions about somatic conditions expressing hidden conflicts about sex and aggression and dependency.

Participation in clinical trials should be based on patients being fully informed about alternatives. I don’t know if modern treatment of IBS is available in the UK. But if I had a friend who was approached by their GP in the UK about participating in PRINCE, I would recommend that the friend become acquainted with the contemporary view of IBS in the rest of the world, and if necessary, educate their GP.

The undoing of Pharma’s promotion of antidepressants as safe and effective for young people

The treasure trove: Annotated links to some relevant materials.

treasure troveMy recent post at Mind the Brain, Study protocol violations, outcomes switching, adverse events misreporting: A peek under the hood  concerns a must-read IJRSM article:

Jureidini, JN, Amsterdam, JD, McHenry, LB. The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance. International Journal of Risk & Safety in Medicine, vol. 28, no. 1, pp. 33-43, 2016

Which offers a detailed critique and re-analysis of:

Wagner KD, Robb AS, Findling RL, Jin J, Gutierrez MM, Heydorn WE. A randomized, placebo-controlled trial of citalopram for the treatment of major depression in children and adolescents. American Journal of Psychiatry. 2004 Jun 1;161(6):1079-83.

Letters to the Editor concerning the AJP article

 Shortly after the original article appeared in AJP, there was a series of letters to the editor commenting on the article and the authors responded:

RÉMY P. BARBE, M.D.,  Child Psychopharmacology, Effect Sizes, and the Big Bang

ANDRÉS MARTIN, M.D., M.P.H., WALTER S. GILLIAM, Ph.D., New Haven, Conn., JEFFREY Q. BOSTIC, M.D., Ed.D., Boston, Mass., and JOSEPH M. REY, M.D., Sydney, Australia. Child Psychopharmacology, Effect Sizes, and the Big Bang

MAJU MATHEWS, M.D., M.R.C.Psych., BABATUNDE ADETUNJI, M.D., F.A.S.A.M., JOANNE MATHEWS, M.D., BIJU BASIL, M.D., VINU GEORGE, M.D., MANU MATHEWS, M.D., KUMAR BUDUR, M.D., and SHINY ABRAHAM, M.D., Kottayam, Child Psychopharmacology, Effect Sizes, and the Big Bang

KAREN DINEEN WAGNER, M.D., Ph.D., ADELAIDE S. ROBB, M.D., ROBERT L. FINDLING, M.D., and JIANQING JIN, Ph.D., Dr. Wagner and Colleagues Reply

Additional Background Notes for the IJRSM article posted by JM Nardo

Here are links to more rich material, including documents that were received from Forest Laboratories and a history of attempts to get this article published. For these and other materials, I am grateful to John M Nardo, MD. I’ve included some other links to his relevant blog post as well

In addition to detailing the history of the IJ RSM article, Dr. Nardo provides:

Other relevant blog posts from JM Nardo

In this series of blog posts, Nardo comments on both the deconstruction of citalopram CIT-MD-18, but also a reanalysis in which he was involved that was published in The BMJ, Restoring Study 329.  Links to that important paper and relevant materials will be presented in the section below this one on his blog posts.

the jewel in the crown… Posted on Thursday 5 May 20

Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence
In our paper, we were able to obtain the raw data as the result of over a decade of work coming from multiple foci. Analyzing the data using the manufacturer’s own a priori protocol we found that the reported efficacy of the drug disappeared and that the safety of the drug had been exaggerated.

Having been intimately involved in one of these articles and knowing the authors of the other, I can attest to the herculean effort required to produce them. Both are the result of unfunded research. There were no Conflicts of Interest and they were largely done by senior people with no need for further credentialing. Unfortunately, the primary articles they analyzed are not exceptions. And at least in the domain of industry funded RCTs of CNS drugs, they’re the rule. Even worse, both studies involved medications for vulnerable youth. The mandate for change is clear as a bell…

the obvious irony… Posted on Thursday 12 May 2016

Having been intimately involved in one of these articles and knowing the authors of the other, I can attest to the herculean effort required to produce them. Both are the result of unfunded research. There were no Conflicts of Interest and they were largely done by senior people with no need for further credentialing. Unfortunately, the primary articles they analyzed are not exceptions. And at least in the domain of industry funded RCTs of CNS drugs, they’re the rule. Even worse, both studies involved medications for vulnerable youth. The mandate for change is clear as a bell…

this tawdry era… Posted on Saturday 14 May 2016

While this is only one example of many similarly misreported Clinical Trials, the access to the internal industry documents allowed these authors to leave nothing to our imagination. They prove that it’s ghost written; that it was framed by the industry executives for commercial gain before any academic author got near the data; that it was deceitfully written to hide its failings, on purpose; and that it was a negative Clinical Trial presented as positive and subsequently used to gain FDA Approval. Those points and more are abundantly clear in this easy-reading article…

I think it’s now our job to insure that all this dedicated work is rewarded with a wide readership, one that helps us move closer to putting this tawdry era behind us…

Dr. Nardo’s article in The BMJ:

Le Noury J, Nardo JM, Healy D, Jureidini J, Raven M, Tufanaru C, Abi-Jaoude E. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ 2015; 351: h4320

 

The article from which data were re-analyzed:

Keller MB, Ryan ND, Strober M, Klein RG, Kutcher SP, Birmaher B, Hagino OR, Koplewicz H, Carlson GA, Clarke GN, Emslie GJ. Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. Journal of the American Academy of Child & Adolescent Psychiatry. 2001 Jul 31;40(7):762-72.

30 Rapid responses to the BMJ article

The BMJ article by Le Noury, Nardo and colleagues has so far received 30 Rapid Responses Including a 18 January 2016  response from Martin Keller and the authors of the original Study 329, as well as the 03 February 2016 reply from Jon N Jureidini and the authors. Click here for the links.

Guilty pleas from Forest Laboratories and GlaxoSmithKline

The two pharmaceutical companies that produced ghost authored papers were subject to criminal and civil proceedings. They both pleaded guilty. Some excerpts from these proceedings are summarized in another blog post, When the US government cracked down on drug companies promoting antidepressants for children and teens. Other links to the proceedings are below:

Justice Department Files Suit Against Forest Laboratories for Illegally Marketing Celexa, Lexapro for Children

The actual filing

Drug Maker Forest Pleads Guilty; To Pay More Than $313 Million to Resolve Criminal Charges and False Claims Act Allegations

Complaint: United States ex rel. Greg Thorpe et at [Consolidated] Plaintiffs vs GlaxoSmithKline PLC, and GlaxoSmithKline LLC Defendents

GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data: Largest Health Care Fraud Settlement in U.S. History

When the US government cracked down on drug companies promoting antidepressants for children and teens

One in a series of three blog posts about Pharma’s promotion of medication for treatment of depression in young children and teens.

antidepressantsThis post concerns legal action by the US federal government in which two pharmaceutical companies pleaded guilty and had to pay large sums of money because of their promotion of misleading claims about about the efficacy and safety of antidepressants for children and adolescents.

This post is part of a three-part series exploring The discrepancy between Pharma’s promotion of antidepressants to children and adolescents and the evidence generated by clinical trials. The series is intended to be useful to anyone who wants to acquire a more in-depth understanding of how the pharmaceutical industry has misled professionals and mental health consumers about the efficacy and risk of antidepressant treatment for children and adolescents. I pay particular attention to re-analyses of data  from previously published in major psychiatric journals that showed claims in these journals about the effectiveness and safety of these medications for young people were exaggerated.

 Examination of other things I’ve written about antidepressants should establish that I don’t have an ax to grind and I certainly don’t consider myself anti-medication or antipsychiatry.

 One of my previous blog posts  discussed a study I had done with colleagues examining how psychotherapy compared with pill placebo, the standard comparator for antidepressants. We found that psychotherapy and antidepressants had modest, but comparable advantages over pill placebo.

Another of my blog posts discussed a study I had done with colleagues examining in 29 countries whether trends over time in the prescription of antidepressants were associated with trends in rates of suicide. We found it rather consistently that increases in prescription of antidepressants were associated with decreases in rates of suicide.

The present series was prompted by the publication of an article that described how previously confidential documents revealed that professionals employed by Forest Laboratories had ghostwritten an article in American Journal of Psychiatry. Authorship was then attributed to prominent mental health professionals, some of whom were paid for additional consultation and promotional activities. This particular AJP article was pivotal in convincing professionals and the public to accept the antidepressant citalopram (Celexa) for children and adolescents.

antidepressants-2Part one, the first blog in the series will soon be posted at Mind the Brain. It  provides a detailed “deconstruction” of the ghostwritten article claiming to demonstrate the citalopram was effective and safe for children and adolescents. The authors of this article relied on access to company documents released in a lawsuit and reanalysis of the data from the study. The re-analyses suggested that the drug was ineffective for both children and adolescents and its use was associated with significant adverse effects, including suicidal thoughts and behavior in some patients. The documents clearly demonstrated that Forest Laboratories were aware of the lack of benefits and the existence of risks with these medications, but suppressed and distorted findings in a ghostwritten article.

The second blog post will also be soon posted here at Quick Thoughts. It provides a rich set of links to other materials related to the American Journal of Psychiatry article that was systematically “deconstructed” in the new article, as well as the actual legal documents obtained in a civil action.

Additionally, the second blog post has links to materials related to another reanalysis reported in The BMJ of data from an article in Journal of the American Academy of Child & Adolescent Psychiatry and the controversies around both the original article and the re-analyses.

As with the deconstruction of the article concerning citalopram in American Journal of Psychiatry, the reanalysis reported in The BMJ failed to show that paroxetine (marketed as Paxil in the US and Seroxat in the UK) was safe and effective as claimed for children and adolescents.

This blog post summarizes two key legal actions resulting in the pharmaceutical companies Forest Laboratories and GlaxoSmithKline paying large fines for exaggerating benefits and hiding risks of antidepressants for young people. These misrepresentations involved publishing misleading articles in major medical journals and promoting off-label (unapproved) use in children and adolescents, when efficacy and safety had only been established for adults.

For what follows, it’s important to know that the antidepressant citalopram is a selective serotonin reuptake inhibitor (SSRI) that is actually a mixture of two enantiomers, molecules that are almost identical but are actual mirror images of each other, R-citalopram and S-citalopram. Forest laboratories claimed that that the S enantiomer, or S-citalopram was the more active antidepressant and began marketing it as Lexapro. Critics noted that Forest Laboratories’ tradename patent was expiring for citalopram 2003 and so other companies could have soon been in a position to market a generic citalopram. Isolation and approval of S-citalopram (Lexapro) would mean another patent would be effective until 2012. Evidence that Lexapro is actually more effective or has a mild or side effect profile is mixed.

Forest Laboratories and citalopram

In 2010, Forest Laboratories agreed to pay $313 million and plead guilty to “one criminal felony count of obstructing justice, one criminal misdemeanor count of distributing an unapproved drug in interstate commerce, and one criminal misdemeanor count of distributing a misbranded drug in interstate commerce.” The settlement was for three drugs, including the two antidepressants, Celexa and Lexapro.

Regarding Celexa, the criminal information and the False Claims Act complaint filed by the United States allege that Forest Pharmaceuticals promoted the drug for unapproved pediatric use. Despite a limited approval only for adult depression, Forest Pharmaceuticals promoted Celexa for use in treating children and adolescents suffering from depression. The government alleges that Forest Pharmaceuticals publicized and circulated the positive results of a double-blind, placebo-controlled Forest study on the use of Celexa in adolescents while, at the same time, Forest Pharmaceuticals failed to discuss the negative results of a contemporaneous double-blind, placebo-controlled European study on the use of Celexa in adolescents.

The government further alleges that Forest Pharmaceuticals’ off-label promotion consisted of various sales techniques, including directing its sales representatives to promote pediatric use of Celexa in sales calls to physicians who treated children and adolescents, and hiring outside speakers to talk to pediatric specialists about the benefits of prescribing Celexa to children and teens.

The False Claims Act complaint also alleges that Forest engaged in such marketing conduct in connection with Lexapro, which, at that time, also lacked any approvals for pediatric use. The civil complaint further alleges that Forest used illegal kickbacks to induce physicians and others to prescribe Celexa and Lexapro. Kickbacks allegedly included cash payments disguised as grants or consulting fees, expensive meals and lavish entertainment. The civil complaint alleges that as a result of the foregoing conduct, Forest caused false claims to be submitted to federal health care programs.

Lexapro was approved for use for acute and maintenance treatment of Major Depressive Disorder in adolescents, 12 – 17 years of age, on March 19, 2009.

Anyone who had purchased Celexa for someone under 18 from 1998 to 2013 or Lexapro from 2002 to 2013 became eligible for partial to full refunds.

GlaxoSmithKline and paroxetine

In the largest health care fraud settlement to date, GlaxoSmithKline agreed in 2012 to plead guilty and pay $3 billion to resolve allegations of fraud and failure to report safety data for a number of drugs, including paroxetine for depression in teenagers and adolescents. The settlement specifically said about paroxetine:

In the criminal information, the government alleges that, from April 1998 to August 2003, GSK unlawfully promoted Paxil for treating depression in patients under age 18, even though the FDA has never approved it for pediatric use. The United States alleges that, among other things, GSK participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy. At the same time, the United States alleges, GSK did not make available data from two other studies in which Paxil also failed to demonstrate efficacy in treating depression in patients under 18. The United States further alleges that GSK sponsored dinner programs, lunch programs, spa programs and similar activities to promote the use of Paxil in children and adolescents. GSK paid a speaker to talk to an audience of doctors and paid for the meal or spa treatment for the doctors who attended. Since 2004, Paxil, like other antidepressants, included on its label a “black box warning” stating that antidepressants may increase the risk of suicidal thinking and behavior in short-term studies in patients under age 18. GSK agreed to plead guilty to misbranding Paxil in that its labeling was false and misleading regarding the use of Paxil for patients under 18.

 

How competition between APS and APA for prestige fueled the crisis of reproducibility in psychology

This blog post is truly a quick thought that needs refinement. I invite comments and criticisms, and particularly suggestions for more links and details to what I believe is an important message. Please correct me where you believe I am wrong or exaggerating.

 Counting papers is “a great way to measure whether a scientist puts ambition ahead of curiosity, scientific rigor and the quest for knowledge

stop_the_hype_by_thegoldenbox-d9ewr6xAssociation for Psychological Science (APS)   has strived for the distinction of being the more scientifically oriented of the two main organizations for American psychologists. APS was born out of an intense political struggle within its current rival, American Psychological Association (APS). Although historically the APA had eminent scientists as its presidents, a group of ambitious entrepreneurial psychologists were taking over. Their goal, and this “dirty dozen” succeeded, was to establish and accredit lucrative, freestanding professional training programs conferring PsyD degrees.

Once scorned, and confronted by seemingly insurmountable odds, the following fourteen professional psychologists, affectionately called The Dirty Dozen, changed for all time the face of the American Psychological Association (p. 270)

Unlike the existing PhD degrees, these degrees did not require dissertations, but could serve as the basis for licensure of clinical psychologists. These professional training schools de-emphasized research, as compared to traditional PhD programs, and the graduates were going to quickly make up the bulk of new members to APA. This made the previously dominant research-oriented psychologists uncomfortable. The shift in power was among the reasons many left. Some formed an alternative, first known as the American Psychological Society.

APS was politically and financially disadvantaged by its size, but also by the existing prestige of APA journals.  Offered at considerable discounts as part of the privileges of membership, they were an incentive for sticking with APA.

The stage was set for an intense competition between APS and APA for the claim to having the most prestigious journals.

Prestige is quantified by Journal Impact Factor (JIF). Despite the numerous deficiencies of JIFs has measures of scholarly accomplishment, they are widely accepted as measures of scientific accomplishment by hiring and promotion committees of universities and funding agencies.

Candidates competing for jobs, promotion, and grants can be quantitatively compared on the basis of the JIFs of the journals in which they publish, even if these numbers are distorted measures of actual accomplishment and easily gamed.

The exact algorithms by which JIFs are calculated are obscure. The JIFs reported by the authoritative  INCITES Journal Citation Reports cannot be precisely replicated. However, JIFs are somehow a quantification of the number of times on average a paper is likely to be cited within two years after it appears in print.

The validity of JIFs as predictors of how many times a particular paper will be cited is at its lower level since JIFs first came into use.

JIFs are easily gamed.

The notion of papers being published at a particular point in time is tied to an earlier period in which articles were primarily printed on paper, bundled in journals that were mailed an ultimately bound in volumes on library shelves.

The advent of Internet-based open access journals  with immediate availability on the web posed a challenge to traditional journals of the for-profit publishers and traditional professional organizations.

There was an open access advantage the traditional journals had to overcome. The response to this challenge was the creation of “early view” articles available on websites before articles were actually assembled into paper journals.

JIFs somehow calculated by the number of times a paper cited within two years after it “appears” in a journal. So, availability of “early view” articles could start the clock early in terms of accumulating citations before paper journals actually were physically available.

Researchers who will potentially cite a particular article X can quickly turn out another article Y with a citation of X that will contribute to the JIF of the Journal in which article X appeared.

The key is for these researchers to become aware as quickly as possible of the availability of “early view” articles that are candidates for citing.

Press releases and other notifications in the social media become particularly important for getting the articles cited that will raise JIFs.

In the competition between APS and APA, press releases become particularly important for raising JIFs.

But not just press releases, rather, press releases that report innovative and breakthrough studies that will get echoed and churnaled by lazy journalists across social and conventional media.

The innovative and the breakthrough study, or at least one that can be tortured into having the having these characteristics, gets favored over more transparently reported, trustworthy and durable studies.

Notoriously, an outgoing editor of APS’s Psychological Science   proudly declared that he had rejected over 6000 submissions in his five years as editor without the manuscript is going out to reviewers

Potential authors also wondered why papers are declined without full review (i.e., “triaged,” reflecting a policy to devote most editorial resources to papers that were considered stronger candidates for publication). That was an easier question to answer: Given the volume of papers that fell in this category (more than 6,000 submissions over 5 years), a few prototypes emerged. We even gave them names (which reflected the age of the editorial staff):

At the top of his three reasons was:

The Pink Floyd Rejection: Most triaged papers were of this type; they reported work that was well done and useful, but not sufficiently groundbreaking. So the findings represented just another brick in the wall of science.

Psychological science has no monopoly on “Pink Floyd rejections.” APA’s Journal of Personality and Social Psychology relies on the strategy for its competition with APS, but its editors just do not brag about it.

pink floyd study -page-0Bricks-in-the wall studies are denigrated. These include most research that is well conducted and transparently reported. Also included are null results and replications of previously published studies, particularly those that do not yield positive results, are not welcomed.

reject as Pink Floyd study

But such “bricks in the wall” are likely more trustworthy than the over 50% of Journal of Personality and Social Psychology and Psychological Science articles evaluated in the Open Science Collaboration’s (OSC) Replication Project: Psychology that did not reproduce with the same strength of effects.

APS and APA are in a vicious competition to accumulate citations by promoting hype. This contributes to the reproducibility crisis in psychology for which replication of initiatives are showy, but ineffectual solutions.

I have no interest in restoring the prestige of APA after lots of blows to it, including its protection of psychologists who facilitated and participated in “enhanced interrogation.”

But I’m pained by how its competitor for the loyalty of psychologists is so damaging itself by deliberate questionable publication practices. It is soiling its brand  with questionable and even junk science. How about we get a hashtag campaign going for APS – #stopthehype.

 

Half year passes without release of PLOS One PACE trial data

A half a year has passed since I made the request for the PACE trial data used in a PLOS One article.

timepassing

  • Greater transparency is a must in the ongoing negotiations about release of the data between PLOS One and PACE investigators and their lawyers.
  • The needs of stakeholders other than the PACE investigators must be recognized and the stakeholders need to be engaged in a more transparent process.
  • Retraction of the PACE PLOS One article is an attractive option that would highlight that the PACE investigators are hiding something in their data.

It has been over 180 days since I formally requested on November 13, 2015 the data from PACE cognitive therapy for chronic fatigue syndrome trial used for an article in PLOS One. The latest communication suggests that the management of PLOS  is still negotiating with lawyers from Queen Mary University, London. Agreement seems to be reached that any release of data will require a preregistered plan of analysis.

The PACE investigators notoriously did not stick to the analyses originally proposed in their protocol. Not doing so and a lack of transparency as to what analyses specified original proposal would yield raises serious questions about what they are hiding.

data-sharing-graphic-370x229

Please pass the data.

Having published an article in PLOS One, the PACE investigators should be held to their promise of sharing their data or have their paper retracted. I would be comfortable with the latter decision because it would affirm that the investigators have something to hide.

I’m concerned what half a year of nontransparent negotiations with no results mean for the data sharing policies of PLOS One.

Meanwhile, another PLOS One article  has appeared that not only has undeclared conflicts of interest, but an apparent conflict of interest in the PLOS Academic Editor has appeared. An investigation by the journal confirms that the authors do indeed have a conflict of interest that must be declared in an erratum. But time is passing with no such erratum being posted. No decision has been reached about my complaint about the apparent conflict of interest an academic editor from the same department as the authors making the decision to the article to publish it. The article is essentially a poorly designed, crass experimercial with limited contribution to the literature, but instead designed to promote services of a complementary medicine center.

But important to the struggle over release of the PACE trial data, the authors of this second dubious article refused to share the data for reanalysis. Continued delay in resolving the earlier request for the PACE trial data can only mean delay in resolving the clear-cut issue with this other article. Moreover, a decision regarding the PACE data reflecting anything but a reaffirmation of the PLOS One requirement for data sharing would be a barrier to resolving this other failure to share data and a signal to other authors that they do not have to share their data if they publish in PLOS regardless of what they have read.

I think it’s high time for PLOS One to announce a deadline for release of the PACE trial data, which if it is not met will result in a retraction.

But more immediately, the management of PLOS One should adopt a policy of greater transparency in the negotiations with the PACE investigators and their lawyers. There are numerous other stakeholders :

– Readers for whom the credibility of PLOS articles is based on the availability of data allowing independent confirmation of the interpretation and conclusions expressed by particular authors.

– Authors who select PLOS One because of its commitment to data sharing.

– Patients and policymakers who depend on the trustworthiness of the results reported in the PLOS One article.

– Thousands of PLOS One academic editors and reviewers who donate their time for free because of the commitment of the journal to data sharing.

where-does-the-time-goIt would be a pity if PLOS One made any concession to the lawyers of Queen Mary University and the PACE investigators by restricting access to the data used in the PLOS One article.

It would be a blow to the fine reputation of PLOS One and a blow to an already faltering movement for routine sharing of data for all peer-reviewed scientific publications

 

Ellen Langer: genius or quack?

Ellen Langer: genius or quack –or master self-marketer?

  • Another lesson we need to be wary of trustworthiness and authority established by awards or celebrity status.
  • We need to be skeptical of the publicity machines that confer celebrity status on “scientists.’
  • We need to be skeptical about scientists who gather such recognition. It could be just a clever strategy to promote some product they are selling.  Check to see if they are selling something.
  • We should not be distracted by awards from the question ‘Is what they are claiming based on the best quality science?’

Never confuse eminence-based with evidence-based, even if something’s coming with awards from big-name universities. – Robin N. Kok

quckEllen Langer has been dubbed “mother of mindfulness” and “mother of positive psychology.” She can now also claim to be a genius and has a Liberty Science Center Genius Award to prove it.

The website announcement of her award apparently draws on a description of her that has been widely used elsewhere:

Ellen Langer, PhD, is a social psychologist and the first female professor to gain tenure in the Psychology Department at Harvard University. She is the author of eleven books and more than 200 research articles on mindfulness written for general and academic readers. Her best-selling books include Mindfulness; The Power of Mindful Learning; On Becoming an Artist: Reinventing Yourself Through Mindful Creativity; and Counterclockwise: Mindful Health and the Power of Possibility. The Wiley Mindfulness Handbook is an anthology on mindfulness in which leading researchers integrate work derived from her western scientific theoretical base of mindfulness with research on eastern-derived forms of meditation.

An announcement on the Association for Psychological Science (APS) website elaborates:

LSC is honoring Langer — a Harvard social psychologist — in recognition of her achievements as the “mother of mindfulness.” Langer has written extensively on the illusion of control, aging, stress, decision-making, health, and of course, mindfulness. She is particularly well-known for her findings on the power of social cues to make us feel and act younger and healthier than our chronological age. In a classic 1981 study, Langer had elderly men live in a retreat that was retrofitted to look like 1959 and speak of the past in the present tense as if they were living in that year. The men experienced improvements in vision, hearing, strength, and other abilities, and actually appeared younger as well.

And describes the celebrity-studded gala at which her award will be given:

LSC has held the Genius Gala for the past 5 years to honor great thinkers in science and technology. Past honorees include Jane Goodall, Oliver Sacks, Temple Grandin, Richard Branson, Jeff Bezos, J. Craig Venter, and Vint Cerf. About 700 people are expected to attend this year’s gala, hosted by LSC President and CEO Paul Hoffman with celebrity presenters Susan Sarandon, Buzz Aldrin, and singer–songwriter will.i.am.

I have previously blogged about Langer  classic study  with  Judy Rodin that claimed that giving nursing home residents a rubber tree plant for which they had responsibility led to greater survival of the nursing home residents, not the plant. The comparison group was a group of nursing home residents simply being given a rubber tree plant without any responsibility for caring for it. Not surprisingly, these “too good to be true results” were shown to be a product of a statistical error. A later erratum statement has languished in obscurity, with little sign of affecting the echoing of the originally claimed results in textbooks and in media coverage of Langer.

Students in intro psych classes  continue to learn that Ellen Langer gave plants to nursing home relatives and that simple intervention led to these elderly people living longer. The lesson is supposed to be that a sense of control can have extraordinary health benefits. Maybe, but it is a myth that the classic study showed that.

I later blogged about Langer’s claims  about a study she was launching in Mexico:

The shrinking-tumor study will involve three groups of 24 women undergoing therapy for Stage IV breast cancer. One group is a no-treatment control. Two of the groups will be sent to a resort in Mexico supervised by Langer and her staff. One group going there will simply receive social support from the other women patients. The other intervention group will live for a week in environment saturated with cues invoking 2003, a time prior to their diagnosis with breast cancer.

They will be told to try to inhabit their former selves. Few clues of the present day will be visible inside the resorts or, for that matter, outside them. In the living areas, turn-of-the-millennium magazines will be lying around, as will DVDs of films like “Titanic” and “The Big Lebowski.”

langer businessSurely, such a study would have trouble getting through a human subjects committee. There is no scientific basis for assuming such an intervention would work, so why take up the time of people who believe that they are facing death? As I also noted in my blog, there are also conflict of interest issues involved in the lucrative arrangements that Langer has made with a resort in San Miguel, Mexico for housing not only the study, but for the patients’ caregivers who might want to accompany them to Mexico.

Langer’s claims of launching such a study continue to echo in the media, but there’s no signs of the study actually been launched. There also claims of her having a parallel study being launched in India of men with metastatic prostate cancer.

The APS announcement of her genius award makes reference to her “classic” 1981 study of aging men being taken to a retrofitted retreat lodge. Being transported back to an earlier tine in their life resulted in -at least according to the APS- “improvements in vision, hearing, strength, and other abilities, and [they] actually appeared younger as well.”

Really? Let’s look at the evidence for this wild claim. Like a lot of Langer’s claims made in the media, this one has never made it into a peer-reviewed journal. My blog describes results of an exhaustive search for evidence that only brought me back to a chapter a book edited by Langer herself.

I just checked Google Scholar again to see if further results associated with claims about these men or Langer’s other health projects had showed up in the literature yet. Nope.

I’ll stick with my labeling of Ellen Langer as a quack exploiting the hopes of desperate people facing death. But what do we make of the Liberty Science Center Genius Award and it’s being announced by the supposedly sciencey Association for Psychological Science?

The simplest answer is that everybody wants to be associated with celebrities, even the APS, which is apparently desperately seeking celebrity psychologists to promote.

If Liberty Science Center declares Ellen Langer a genius with an award conferred by celebrities, she is for the purposes of APS, a celebrity psychological scientist.

No matter that most of Ellen Langer’ important claims cannot be independently substantiated and involve invoking ridiculously on scientific explanations to account for them. No matter that she evades peer review.

APS likes to be associated with celebrity scientists, even if they are quacks. APS will help create the appearance that psychologists are credible scientists and celebrities.

Lessons learned

A simple, recurring lesson: just because a supposed “scientist” receives awards, it does not make the health-related advice that they offer evidence-based. We should remain skeptical of the products that they are selling, whether they are self-help books or trips to expensive spas. Maybe we should be extra skeptical.

I don’t know about you, but I get damned angry at the APS sacrificing its integrity and damaging itself as a trusted source by promoting this crap. This is not the first time that APS has let the public down with promotion of bad science that exploits people in need of credible psychological advice

You just can’t interpret claims as being credible because they are endorsed by the APS. You have to look at the evidence.

But there are further lessons.

Many psychologists are marketing all kinds of rubbish advice based on weak research that is p-hacked – results are tortured and made to speak all sorts of untruths. Take a close look and their research and you will frequently see it is  tainted by all kinds of questionable research practices.

Some psychologists fancy themselves to be like rock stars and self-consciously building careers this way and expecting to reap the rewards. They can get help. Psychological organizations like APS promote them,  whether they are  selling self-help books or launching lucrative initiatives like corporate speaking tours or workshop series.

Check out the Harvard psychology faculty, past and present. Ellen Langer is not the only one doing this, but she does it particularly masterfully well.

Maybe we  should be particularly skeptical about sciencey psychology merchandise coming out of Harvard.

There is a reason that some of the Harvard faculty are so upset about organized, independent efforts to replicate their findings. They could lose money.

 

 

When Simon Wessely shoved a Hans Eysenck scandal under the rug

Updated May 7, 2016

I have also now responded to Sir Simon Wessely ‘s comment on Twitter about this post. I invite a further reply from him.

  • Soon there may be a renewed call for an investigation of misconduct by famous UK psychologist Hans Eysenck.
  •  What happened the last time reflects on the ability of UK academia to self-correct atrociously bad science and bad publication practices.
  •  As we are currently seeing in other scandals, UK academia looks after its own, no matter what.

swept-rug-BruceKrasting-flickr-370x242The centenary of the birth of UK psychologist Hans Eysenck in March has already been marked by release of a special collection of articles from  about Eysenck from the archives of the British Psychological Association’s The Psychologist.

The centenary  will be also be celebrated with a special commemorative issue of Personality and Individual Differences, one of the journals that he started and edited. I assume many of the articles will praise Eysenck’s accomplishments as the founder of British clinical psychology, his key contribution to establishing cognitive behavior therapy in the UK, and his overall status as one of the most cited psychologists of all time.

If that’s the case, one contribution by UK psychiatrist Anthony Pelosi will stand out like a tuba joining a string ensemble, if it is anything like his past writings. Stay tuned.

Hans Eysenck oneIf he is consistent with his past writings, Tony may reignite earlier charges that Hans Eysenck was a fraudster, abused editorial privilege, and had huge, corrupting undisclosed conflicts of interest – payments not only from American tobacco companies but from their lawyers desperately trying to muster evidence that smoking did not cause cancer. Evidence that Hans Eysenck cooked up for them.

Then editor of The BMJ Richard Smith had backed Pelosi decades ago, as seen in Smith’s slides about editorial misconduct.

slide1 R Smith Eysenckslide 2 r smith should editors

Pelosi and fellow psychiatrist Louis Appleby had made their case earlier in two articles in The BMJ:

Pelosi AJ, Appleby L. Psychological influences on cancer and ischaemic heart disease. BMJ: British Medical Journal. 1992 May 16;304(6837):1295.

Pelosi AJ, Appleby L. Personality and fatal diseases. BMJ: British Medical Journal. 1993 Jun 19;306(6893):1666.

It was an extraordinary move for The BMJ to publish these articles. Lawyers had to clear them before they could be published. Note that Pelosi and Appleby’s scathing criticism of Eysenck’s work did not concern anything that The BMJ had published. Rather, they focused on articles that Eysenck had published in journals that he had founded and over which he still had editorial control. Try to find another example of The BMJ becoming a forum for this kind of thing, before or since.

Eysenck responded with a characteristically evasive and dismissive reply:

Eysenck HJ. Psychosocial factors, cancer, and ischaemic heart disease. BMJ: British Medical Journal. 1992 Aug 22;305(6851):457.

Pelosi made a formal complaint to the British Psychological Society.

According to Rodrick Buchanan’s biography of Eysenck, Playing with Fire:

The BPS investigatory committee deemed it “inappropriate” to set up an investigatory panel to look into the material Pelosi had sent them, and henceforth considered the matter closed. Pelosi disagreed, of course, but was left with little recourse.

Pelosi also made a complaint to the Committee on Publication Ethics (COPE):

Pelosi AJ. The responsibility of academic institutions and professional organisations after accusations of scientific misconduct. The COPE report 1998. London, BMJ Publishing 1998.

One might have thought that the fuss would grab attention in the British media. The only mention was an article by Simon Wessely in The Times. Wessely put out the fire.

Simon on Eysenck

 The normally calm pages of the British Medical Journal have carried a series of critical articles questioning the basis of what must be the most extraordinary claims ever made for the origin of cancer. At the heart of the dispute lies the ever controversial figure of Hans Eysenck, until recently professor of psychology at the Institute of Psychiatry, and his  Croat collaborator, Ronald Grossarth-Maticek.

Wessely identified Eysenck’s critics as members of the fold.

 … In a penetrating article, Tony Pelosi and Louis Appleby subjected Eysenck and Grossarth-Maticek’s series of papers to a critical analysis, which they have followed up with a second piece this week. According to the two psychiatrist, who both trained at the Institute of Psychiatry, the claims were too good to be true.

First, those with the cancer-prone personality died at an extraordinary rate – 121 times faster than the controls.

But there was praise for Hans Eysenck as well.

 Of course, Professor Eysenck, the most influential psychologists of our time, has faced many assaults before (including, unforgettably, physical ones). It would take more than a couple of psychiatrists to ruffle him.

And so it proved. His replies made no concessions to his critics. In essence, his reply was “either you believe these findings, or you don’t”. He was certainly correct on one point. If his results are true, the doctors have been scandalously negligent in ignoring what is the most dramatic breakthrough in the treatment of cancer for many years.

Wessely knew damn well these claims were not just too good to be true. Independent investigation by numerous scientists had revealed them to be fraudulent. Wessely missed his chance to join in calling for an investigation of Hans Eysenck. He passed on it and called for calm.

Of greater concern is that this affair has drawn attention away from the real progress has been made in the psychological management of cancer. In a series of careful studies spread over many years, British psychiatrists and psychologists have described the psychological impact of both the diagnosis of cancer and  the painful treatments that frequently follow. They’ve shown the effect of coping strategies on the prognosis of breast cancer – those who show either “fighting spirit”, or those who deny that there is any danger, seem to do better.

Simon was referring to a single, small, methodologically poor study making claims that having a fighting spirit prolonged life of cancer patients. As I have described elsewhere, a subsequent better designed study by the same authors could not replicate these findings. The authors expressed relief that their negative results provided some correction to the impression there earlier study had created. Namely, if having a fighting spirit does not matter for survival, patients who are dying from cancer cannot blame themselves or be blamed for not fighting harder.

As far as I can tell, there was no further comment in the British media.

Somehow, I don’t think Simon Wessely will be calling for an investigation of Hans Eysenck’s nefarious doings. As Yogi Berra would’ve said, it will be déjà vu all over again.theres-nothing-to-see-here

 Updated May 7, 2016.

Sir Simon Wessely has responded to my blog post on Twitter. I have invited him to respond further with a comment posted at this blog site. Meanwhile, I will reply to his tweet.

Simon tweet

My reply: Dr. Wessely, you conceded that for Pelosi’s articles to appear in The BMJ was truly extraordinary. There was pressure on the Institute of Psychiatry to investigate. There as also a formal complaint to the British Psychological Society. But instead of joining in a call for an investigation, you identified the “greater concern” that the “affair” has “drawn attention away from the real progress has been made in the psychological management of cancer.” What “real progress”?

Psychologist Maggie Watson would later express relief that a larger, better designed study did not replicate her very preliminary findings that adopting a “fighting spirit” allowed cancer patients to live longer. She was relieved because not replicating these findings meant cancer patients would not be blamed for succumbing to a dreadful disease. In retrospect, it was an improbable idea that could potentially hurt patients. And it was wrong.

In an 800 word editorial in The Times, you basically dismissed the serous issues that Pelosi and Appleby raised as a mere distraction. There was no further mention in the UK Press, no further investigation of Eysenck’s well documented fraud and scientific misconduct.

Do you think that was a good outcome? Does this “affair” have relevance to contemporary difficulties in UK academia correcting bad science and bad publication practices?

I welcome your reply. Thanks for having publicized my blog on Twitter.