1 Boring Old Man

Protecting generalism: moving on from evidence-based medicine?

by Joanne Reeve

British Journal of General Practice. 2010 60[576: 521–523.

[full text on-line]

Quality of decision making in modern health care is defined with reference to evidence-based medicine. There are concerns that this approach is insufficient for, and may thus threaten the future of, generalist primary care. We urgently need to extend our account of quality of knowledge use and decision making in order to protect and develop the discipline. Interpretive medicine describes an alternative framework for use in generalist care. Priorities for clinical practice and research are identified.

hat tip to jamzo…   

The other thing I’ve noticed is that whatever clinical medicine means, it is site and specialty independent. I’ve been in lots of settings wearing many hats, but they all seem like they’re part of the same thing – more similar than different. And that includes the appalachian charity clinic where I now volunteer some – a different clientelle from the medically ill, the inner-city poor, the chronic mental patients, the urban heavily-educated, etc of former days. No, I’m not going to wander off on some 60s speech about people all being, after all, people. In fact, the people are all different. It’s clinical medicine that’s the same.

Evidence-based medicine [EBM] was first described as an approach to teaching the practice of medicine. Twenty-five years on, it has become an assumed standard of ‘best’ or even ‘reasonable’ practice. EBM recognised a need to support healthcare professionals in maintaining an up-to-date working account of the ever-expanding scientific knowledge about illness and health care. Defined as the ‘judicious application of best evidence in making clinical decisions about this individual’, EBM acknowledges both the value and necessity of external research evidence integrated with clinical expertise in clinical decision making. Good doctors use both; neither alone is enough. EBM describes an ‘ideal of practice’ and few GPs would reject a principle of evidence-informed decision making.

The legitimate use of knowledge is a defining aspect of modern clinical practice, and shapes ideas about quality in practice. The ability to integrate knowledge to provide individualised care should be seen as a marker of quality in generalist practice. The profession should be judged not purely by what knowledge it uses, but by the way it uses it. We therefore need to shift the gaze from easier to measure but limited accounts of practice based on the application of certain knowledge to a more appropriate assessment of knowledge use, in order to strengthen and preserve core elements of the discipline and promote and support the health needs of the public.

Pharma companies launch portal for access to trial data

AllTrials News

3rd January 2014

An online portal where researchers can request access to anonymized patient-level clinical trial data from five pharmaceutical companies has been launched at www.ClinicalStudyDataRequest.com. Last year GSK was the first company to launch an online system for researchers to request access to trial data. GSK has now been joined by Roche, Boehringer Ingelheim, Sanofi and ViiV Healthcare. The five companies are inviting all other industry, academic and non-profit trial sponsors to join them and include their studies on the portal too. 

GSK committed to making information from clinical trials since 2000 available. Sanofi announced yesterday that it will offer access to information only from trials of drugs approved after 1st January 2014. We are pleased to see the launch of the portal and that mounting pressure is bursting the banks of secrecy. But we think Sanofi can do better. Most of the medicines we use today came on the market, and were therefore tested in clinical trials, decades ago. We’re looking forward to congratulating more companies for committing to make information from past trials available this year.

About: Access to the underlying [patient level] data that are collected in clinical trials provides opportunities to conduct further research that can help advance medical science or improve patient care. This helps ensure the data provided by research participants are used to maximum effect in the creation of knowledge and understanding. Researchers can use this site to request access to anonymised patient level data and supporting documents from clinical studies to conduct further research. Study sponsors who have committed to use this site are Boehringer Ingelheim, GSK, Roche, Sanofi and ViiV Healthcare. Other clinical trial sponsors and funders are invited to join with the aim of transitioning to a fully independent system which allows access to data from clinical trials conducted by multiple companies and organisations. It is hoped that such a system will be put in place as soon as possible. If you are a study sponsor interested in listing studies on this site, contact information is provided here.

Submission: Researchers can submit research proposals and request anonymised data from clinical studies listed on this site. Study sponsors will add more studies when the site is updated. Information on sponsor’s criteria for listing studies and other relevant sponsor specific information is provided in the Study sponsors section of this site. Researchers can also submit enquiries to some study sponsors to ask about the availability of data from studies they have not listed on this site.
Find out more »

Review: Research proposals are reviewed by an Independent Review Panel. The study sponsors are not involved in the decisions made by the panel.
Find out more »

Access: Following approval and after the relevant study sponsor or sponsors receive a signed Data Sharing Agreement, access to the data needed for the research is provided on a password protected website.
Find out more »

The AllTrials Petition holds that the obvious solution is to make the raw, subject level data available – data as it appears when the blind is broken so that it can be analyzed independently. Some version of Data Transparency is going to happen it seems. The recent House of Commons Report is just one indicator among many. But which version? The version above is GSK’s offering that has begun to spread. First, they continue to simply not mention the why of Data Transparency, to check their work because it damned sure needs checking given the behavior industry-wide. They call it Data Sharing – so others can do further research on their data·sets [that’s called Making a Silk Purse out of a Sow’s Ear in some circles]. This is no time for this kind of make·nice talk. But their face-saving reframing doesn’t matter so much as the access to the data.

Secure use of individual patient data from clinical trials

by Patrick Vallance and Iain Chalmers

The Lancet 2013 382[9898]:1073–1074.

[full text on-line]

Publishing the results of all clinical trials, whoever funds them, is required for ethical, scientific, economic, and societal reasons. Individuals who take part in trials need to be sure that data they contribute are used to further knowledge, prevent unnecessary duplication of research, and improve the prospects for patients.

Endorsement of these principles is clear in the support received for the UK-based charitable trust Sense about Science’s campaign demanding that all clinical trials should be registered and reported. However, although the campaign recognises the advantages of analyses based on individual participant data (IPD), it is not calling for open access to IPD. The campaign recognises that risks to personal privacy must be taken seriously. These risks are not just theoretical: a recent study was able to identify 50 individuals from public websites that contained genetic information. The research community must work with others to define what constitutes appropriate protection of identifiable information if it is to retain public trust in the use of IPD.

…The advantages of IPD analyses have prompted calls for wider access to such data, and we support these calls. However, robust arrangements are needed to minimise the risks of breaches of patient confidentiality. The experience gained within trialists’ collaborations is important, since, as far as we are aware, they have an unbroken record of maintaining patient confidentiality in their IPD analyses…

They’ve successfully co-opted every previous attempt at reform – from Kefauver in 1962 through clinicaltrials.gov, to now. We can’t let them do it again. Right now, the GSK version is being tested in action and they are on their best behavior. I’m sure that the results not just of the study, but of this process will be published. I’m thinking that at the least, there should be some binding mechanism to over-ride the decisions of the independent board if it’s being used to obstruct legitimate discovery. And I think that it should be made explicit that checking the data·analysis is a valid research project. And what about reporting on clinicaltrials.gov?

Big Data + Big Pharma = Big Money

ProPublica

by Charles Ornstein

January 10, 2014

Need another reminder of how much drugmakers spend to discover what doctors are prescribing? Look no further than new documents from the leading keeper of such data. IMS Health Holdings Inc. says it pulled in nearly $2 billion in the first nine months of 2013, much of it from sweeping up data from pharmacies and selling it to pharmaceutical and biotech companies. The firm’s revenues in 2012 reached $2.4 billion, about 60 percent of it from selling such information. The numbers became public because IMS, currently in private hands, recently filed to make a public stock offering. The company’s prospectus gives fresh insight into the huge dollars – and huge volumes of data – flowing through a little-watched industry.

IMS and its competitors are known as prescription drug information intermediaries. Drug company sales representatives, using data these companies supply, can know before entering a doctor’s office if he or she favors their products or those of a competitor. The industry is controversial, with some doctors and patient groups saying it threatens the privacy of private medical information. The data maintained by the industry is huge. IMS, based in Danbury, Conn., says its collection includes "over 85 percent of the world’s prescriptions by sales revenue," as well as comprehensive, anonymous medical records for 400 million patients. All of this adds up to 10 petabytes worth of material — or about 10 million gigabytes, a figure roughly equal to all of the websites and online books, movies, music and TV shows that have been stored by the nonprofit Internet Archive.

IMS Health says it processes and brings order to more than 45 billion health care transactions each year from more than 780,000 different feeds around the world. "All of the top 100 global pharmaceutical and biotechnology companies are clients" of its products, the firm’s prospectus says. Dr. Randall Stafford, a Stanford University professor who has used IMS data for his research, said the company has grown markedly in recent years through acquisitions of competitors and other companies that host and analyze data. As the pharmaceutical industry has consolidated, he says, IMS has evolved by offering more services and expanding in China and India. "They’ve been trying to beef up their competitiveness in some areas by making all of these acquisitions," he said.

IMS has especially expanded its database of anonymous patient records, which can match patients’ diagnoses with their prescriptions and track changes over time, Stafford said. IMS sells two types of products: information offerings and technology services. The information products allow pharmaceutical companies to get national snapshots of prescribing trends in more than 70 countries and data about individual prescribers in 50 countries. IMS’s prospectus offers examples of the questions companies are able to answer with its data, including which providers generate the highest return on a sales rep’s visit, whether a rep drives appropriate prescribing and how much reps should be paid…

• How the Official Psychiatric Guidebook Deals With the Internet
• Doctors don’t fully understand biology of depression
• Mind Mysteries: Docs seek to understand depression

When I Google David Kupfer under News, I find these three articles near the top, all from December. But I don’t find anything about this:

Failure to Report Financial Disclosure Information

by Robert D. Gibbons, PhD, David J.Weiss, PhD, Paul A. Pilkonis, PhD, Ellen Frank, PhD, and David J. Kupfer,MD.

JAMA Psychiatry. Published Online: November 20, 2013. doi:10.1001/jamapsychiatry.2013.3888

[full text on-line]

To the Editor: We apologize to the editors and readers of JAMA Psychiatry for our failure to fully disclose our financial interests in an article1 that reported a diagnostic tool, the Computerized Adaptive Test for Depression [CAT-DI]. Following acceptance of the paper, we disclosed that “The CAT-DI will ultimately be made available for routine administration, and its development as a commercial product is under consideration.” The company that owns the rights to CAT-DI and several related tests is Psychiatric Assessments, Inc [PAI], which uses the trade name of Adaptive Testing Technologies [ATT] on a website describing these tests. Lead author Robert D. Gibbons, PhD, is the president and founder of PAI,which was incorporated in Delaware in late 2011, then registered to do business in Illinois in January 2012. Dr Gibbons awarded “founder’s shares in PAI” to us, yet all 5 of us failed to report our financial interests in connection with our article and again in a Reply to Letters to the Editor regarding the article. Neither PAI nor ATT has released the CAT-DI test [or any other test] for commercial or professional use, but our ownership interests were relevant to the research article and Reply we submitted and should have been disclosed to the editors. Our submitted disclosure lacked transparency, and we regret our omission.

WHEN IS DISCLOSURE NOT DISCLOSURE?

Hint: When it is made by the Chairman of the DSM-5 Task Force.

Healthcare Renewal

by Bernard Carroll

November 21, 2013

[full text online]

As I am not a person who suffers fools or insults gladly, their evasive response caused me to do some checking. I quickly learned that the gang of five are shareholders in a private corporation. Before their paper was accepted by JAMA Psychiatry, the corporation was incorporated in Delaware and soon after registered to do business in Illinois. Those facts were not disclosed in the original report or in the published letter of Reply to me. These omissions were acknowledged in the notice of Failure to Report that appeared on-line today.

It gets worse. Other things that I learned – and that I communicated to the journal – make it clear that the corporate train had left the station in advance of the letter of Reply. For instance, a professional operations and management executive [Mr. Yehuda Cohen] had joined the corporation. He had established the corporate website, where he was featured as a principal, along with the gang of five. The website also displayed a professionally crafted Privacy Policy, dated ahead of the letter of Reply. This document identified what appears to be a commercial business address for the corporation. The notice of Failure to Disclose is silent on these facts.

• careful watching…
• insider trading…
• DSM-5 retrospective I…
• DSM-5 retrospective II…
• DSM-5 retrospective III…
• royalty?…

In a statement, APA Medical Director and CEO James Scully says the DSM-5 development process “is the most open and transparent of any previous edition of the DSM. “We wanted to include a wide variety of scientists and researchers with a range of expertise and viewpoints in the DSM-5 process. Excluding everyone with direct or indirect funding from the industry would unreasonably limit the participation of leading mental health experts in the DSM-5 development process.”

Personally, I think this story has a more ominous portend than that. First, the lead author on the papers is bio·statistician Robert Gibbons who has spent a lot of time writing papers that recommend ignoring the black box warnings about possible suicidality on Neurontin, antidepressants in children, and most recently Chantix. The articles are based on special access to data provided by the drug companies but unavailable to anyone else. And in each case, Pfizer drugs have been involved. And each publication has been accompanied by a lot of publicity. A shaky track record. Second, Dr. Kupfer’s involvement in this commercial enterprise is a huge unacknowledged conflict of interest. Had it been acknowledged, I doubt very much that the articles would’ve been published at all. And had it been acknowledged on the DSM-5 site, it would’ve turned heads. Third, and perhaps most ominous is the product itself. These tests are designed to be "quickies." The tests are designed to get to some index for anxiety and depression with as few questions as possible. This looks like something designed for primary care physicians’ waiting rooms and could only lead to even more over·medication than we have already. And finally, Dr. Carroll’s original criticisms about their validity of the test were not addressed [Not Ready for Prime Time].

Monday, I wrote about the strange story of Richard Noll’s article, When Psychiatry Battled the Devil, in the Psychiatric Times [the unforgotten unremembered…]. In that article, Richard, a psychologist and historian at DeSales University, reminded us of a largely forgotten story. In the period from the mid 1980s to the mid 1990s, there was an epidemic of children in day-care and adult patients alleging that they had been sexually abused in rituals performed by Satanic Cults, rituals that involved sacrificing of babies, drinking blood, and a panoply of other heinous acts. This was no isolated incident but a nationwide phenomenon. There were supposedly Satanic Cults all over the place. Day-care workers went to prison over these allegations. Treatment units were opened. Some therapists became specialists. And then it was gone, and largely forgotten.

Richard’s article is fascinating, documenting the story and talking about the professionals who bought this whole thing, and how it even influenced the DSM-IIIR revision of Dissociative Disorders, and how it ended. His point was that several decades had passed, and it would be a good time to look into the whole crazy story in hopes of preventing a recurrence of the modern-day Salem Witch Trial atmosphere that surrounded the whole scene – and trying to understand what happened. His article was published in the Psychiatric Times on-line on December 6th. I read it around then, sent Richard a note, and bookmarked it for a later blog. When I went back to look for it, it was gone. The link took me to another article. Come to find out it was pulled on December 14th, with no explanation. When Richard inquired, he was told "Sorry" there were "liability" issues, maybe the story wasn’t appropriate," etc.

On further reflection and internal discussion, we have decided that we would like to repost your article. But before doing so, we’d also like to give some of those cited the opportunity to respond or provide comment – if they wish…

Richard responded to the Psychiatric Times saying that he would agree to a re·posting if they apologized to their readers, posted a response from Drs. Kluft or Braun or both, and let him respond to what they have to say. His article is on the Internet for posterity already. I think the Psychiatric Times needs to explain this little bit of foolishness. The PsychiatricNews is the official paper of the APA. The Psychiatric Times  is an independent publication. They published Allen Frances’ criticisms of the DSM-5, and haven’t shied away from controversy in other matters – so this isn’t their usual M.O.

The Real Victims of Satanic Ritual Abuse

The dangers were imaginary, but the consequences were not.

Slate

By Linda Rodriguez McRobbie

January 7, 2013

[full text on-line]

Among the atrocities that Frances and Dan Keller were supposed to have committed while running a day care center out of their Texas home: drowning and dismembering babies in front of the children; killing dogs and cats in front of the children; transporting the children to Mexico to be sexually abused by soldiers in the Mexican army; dressing as pumpkins and shooting children in the arms and legs; putting the children into a pool with sharks that ate babies; putting blood in the children’s Kool-Aid; cutting the arm or a finger off a gorilla at a local park; and exhuming bodies at a cemetery, forcing children to carry the bones. It was frankly unbelievable — except that people, most importantly, a Texas jury, did believe the Kellers had committed at least some of these acts. In 1992, the Kellers were convicted of aggravated sexual assault on a child and each sentenced to 48 years in prison. The investigation into their supposed crimes took slightly more than a year, the trial only six days…

This summer, we wandered in uncharted territory – Baltimore, Annapolis, the Civil War sites – Antietem, Gettysburg, and Harper’s Ferry. I grew up on the side of Missionary Ridge where many of my friends had cannons, markers, or monuments in their yards for us to climb on. The Chickamauga Battlefield Park and Lookout Mountain added to the Civil War aura. But I’d never been to the "northern" battlefields and so it was a great trip to see those places I’d only read about. One place, Fredrick Maryland stood out in persistent memory. It was  a town that got turned into a hospital during all the nearby battles and there was a museum I wroite about earlier [in the museum…] called The National Museum of Civil War Medicine – a high point for me. It’s not very big or particularly well funded or appointed, but it made the grade in content – the story of Clara Barton, the medicines of the times I wrote about earlier, the birth of triage, hospitals, ambulances, and the story of the field amputations.

On the battlefields, the guides made much of the field amputations and the piles of limbs outside the field hospitals – adding to the narrative’s theme of the carnage of our Civil War bolstered by overwhelming numbers of dead and wounded. But in the museum, the amputations were not seen as medical barbarism but rather as a medical advance. There, the story was of inevitable infection, sepsis, and death without quick amputation. The large Civil War miniballs carried clothing into the wound and apparently infection was guaranteed. The guide lead his patter with "This is a trip back to a time when it was the Art and Practice of Medicine that mattered. It was a time before Science came to Medicine. Forget about diseases – and treating diseases. This was a time for treating symptoms." And the medication exhibits drove that home. Also apparent, they were helpless in the face of the dysentery that killed many more soldiers than the bullets in battle. What they had was morphine for pain, ether/chloroform for anesthesia, saws and scalpels for amputations, soap & water for antisepsis, and whiskey – otherwise, many toxic chemicals with no medicinal value of note – used liberally.

Since that trip, I’ve thought a lot about the sources of medical knowledge about medications. There’s the wisdom of the ages [in psychiatry that would be the antiquity, plus drugs from  the 1950s]. Then there’s the literature, and expert opinion [CME, meetings], and personal experience. Both the literature/expert opinion avenues have long been shaky in psychiatry, so that most of what I’ve learned has been from personal experience. It wasn’t that way in internal medicine, or at least much less so, and I’ve missed the comfort of trustable sources of information. So I’ve personally been conservative and ridden on the trailing edge of things. I was struck in visiting that old museum, that many of the medications in those pretty old colored glass bottles were toxic, often heavy metal derivatives. They might make one sick, but it’s doubtful they did anything actually useful. The analogy to the present is obvious. People are prescribed and take medications without apparent benefit often, and one wonders why in both cases.

I haven’t talked ADD/ADHD and you are astute to notice. I’ve avoided it for the same reason I avoid Thomas Szasz. But I’ll have a go at it soon.

I’m talking about a small number of patients. Making the diagnosis helped them all, in that the diagnosis and response to medications was explanatory, it gave reason for their failed attempts at change. A few chose to not use medications – explanation was enough. Some used medications for impossible tasks like sitting in a long meeting. Most chose to use medications more or less regularly. So another reason I don’t talk about it is that I’m no expert and my experience is with a particular cohort of patients.

Most people who want to discuss ADD/ADHD want to talk about the overmedication of children, or about whether ADD even exists, or whether it’s a brain disease, or if psychiatrists believe medication is the answer to all mental illness, or if mental illness fits the medical model, or if mental illness even exists, or some other surrogate topic. For one thing, I don’t know the answer to many of those things. For another, I have no interest in being a straw man in those discussions. As they say, been there, done that, got a tee shirt.

I have no question that children have been massively overdiagnosed and overtreated. They have. I also have no question that both ADHD and ADD exist as syndromes. I’ve seen them both. I have no question that stimulants have an effect that is paradoxical in those cases. In the 60s, taking stimulants to stay up all night and study wasn’t drug abuse, it was the sign of being a good student. The diet pills were ubiquitous in the dorms and frat houses of my youth and they didn’t calm anyone down, including me. I have no question that either version is psychological based on my own experience and seeing patients who had chased their symptoms through many kinds of psychotherapy including analysis.

Some incorporate the symptoms as a temperment – multitasking can be a skill in many walks of life. For others, it can be a real disability. People with the ADHD version get a lot of negative feedback about behavior they really can’t change and have painful self esteem issues. People with ADD [no H] take a private hit because of things they see others do that they can’t do. Example: a born techie had dropped out of engineering school because he couldn’t do triple integrals and become a Social Worker, spending his spare moments with HAM radios and building computers. He felt like a total failure. On medication, he bought a Calculus Book and worked those long triple integrals with ease. He didn’t go back to engineering school, but just the explanation and the mastery was worth its weight in gold to him. That’s one of many such examples.

I wrote this long response because I was asked, but I would make several points. In seeing the kind of cases I saw, the biggest errors were applying one’s training and interests to a case without making sure it fit. It’s an error I’ve made myself, probably more times than I know. I came to call those categorical errors. In practice, I saw a lot of those – things like undiagnosed ADD or learning disabilities; kids who grew up with severe visual deficits corrected later but hadn’t considered how much it effected their development and self concept; people whose symptoms were underpinned by life events, actual trauma, or peculiar environments of development; people who had crazy or addicted parents – the invisible "elephant in the room" problem. It was ironic to me that I’d left the world of mainstream medicine to chase the workings of the psyche, but how much the psyche lead back to the more concrete life narrative – the physical, circumstantial, and interpersonal experiences of life.

So I guess I put ADD/ADHD in the category of a syndrome with fairly typical signs and symptoms. I don’t know the why of it, only the what. For many, treatment with stimulants is helpful, for others unnecessary. When I see a case, I see my task as to be sure the diagnosis fits and to help the patient understand it in so far as I understand it, focusing on its ramifications. What I learned from my daughter was that the use of medication is a journey for the patient to negotiate, not for me to direct. All of the patients read the books and haunt the Internet and that’s fine with me. They’ve been good teachers. I have no clue how to translate the fact that it’s overdiagnosed and overtreated in general into the management of a single case, so I have little to say about that. The cases I saw were underdiagnosed.

Why the Public Accounts Committee Report on Tamiflu Is Important for Us All

Huffington Post UK

by David Tovey

03/01/2014

Most people assume that when they visit their doctor they will receive impartial and expert advice based on the best current research. This expectation forms the basis for much of the trust invested in doctors and other health professionals. In practice, the medical literature expands at a speed such that even the most committed clinician could not expect to keep abreast of it all. Many doctors read a sample of the highest profile journals in their speciality, but even this is insufficient. Research published in such journals usually represents a small sample of that conducted, and is skewed towards those studies that showed the treatment in question in a favourable light.

To overcome these problems, the past 30 years has seen the growth of a different form of research article: one that looks to summarise all the high quality research, not just the small proportion that has made it into The Lancet or BMJ. These articles are known as "systematic reviews" and the largest international producer of these is a network of researchers started 20 years ago in Oxford but now spread across 120 countries and including over 30,000 individuals. The organisation is called Cochrane, after a British researcher of the same name, and Cochrane Reviews are widely seen as representing the highest quality evidence on which health care decisions can be based.

The problem is that only about half the studies completed are published in journals at all. Despite the fact that this problem has been recognised for decades it has not been effectively tackled despite many attempts to do so. This failure has meant that health professionals and the public frequently have overly optimistic impressions of how effective treatments are. This is not simply an academic issue – it means that people have died or become ill as a consequence of misplaced advice from their health professionals. The problem was highlighted recently by the publication of Ben Goldacre’s book, "Bad Pharma". This was followed up by the setting up of the AllTrials campaign by Goldacre, Sense about Science, the BMJ, Cochrane and many others. The campaign calls for public and full disclosure of the methods and results of all research involving patients, on all treatments in current usage – a fairly modest and reasonable request you might think.

Everyone has heard of Tamiflu, a treatment developed by an iconic drug company, Hoffman-La Roche, to prevent and treat "flu". The reason for the drug’s fame is that in the 2000s, many governments responded to a recommendation from the World Health Organisation [WHO] to stockpile the treatment, for use in a potential influenza pandemic. The Public Accounts Committee has assessed the cost of stockpiling the treatment in the UK alone as being £424million. The WHO recommendation was based on the publication of a paper that summarised 10 trials and appeared to show that Tamiflu prevented severe complications of influenza. To be fair, the Cochrane Review team looking at this question was among those persuaded [albeit briefly] by this evidence, until a Japanese researcher pointed out that only a fraction of the research had been published. It proved to be a milestone.

The Cochrane team, led by Dr Tom Jefferson, realised that the feedback was crucial and set out to piece together a full picture of the studies conducted irrespective of whether the studies had been published in medical journals or not. They also approached the investigators of the studies that had been published and established that none of these had access to the trial data -which was held by Hoffman-La Roche. The Cochrane team therefore asked repeatedly for the full information and were refused despite a number of private and public assurances to the contrary. The researchers decided to pull together a comprehensive analysis of all the studies and data submitted to regulatory organisations such as the US Food and Drug Administration [FDA], European Medicines Agency [EMA] and in the UK the Medicine and Healthcare products Regulatory Agency [MHRA] and National Institute for Health and Care Excellence [NICE]. The team realised that the extent of the missing data was far greater than could have been imagined – indeed the unpublished studies represented a large majority of the research completed, including the largest single trial of Tamiflu. Also, there were inconsistencies between the "Clinical Study Reports" [CSRs] submitted to the regulators and the published study reports.

They therefore decided to produce a systematic review of data held in the CSRs, and to ignore published study reports – the first [and still only] time this had been undertaken within Cochrane. This is also a major undertaking given that they estimate that there are over 150,000 pages of data involved. The first version of this review was published in February 2012. This review noted that despite the assurances, Roche had still not provided access to all relevant data, and concluded that there remained uncertainty as to whether Tamiflu was effective in reducing the complications of influenza.

It is therefore not surprising that the Public Accounts Committee [PAC] has registered its concerns and its strong recommendation that all data from clinical trials should be made public. The conclusion that millions of people have been exposed to a treatment, at enormous cost to the public purse, despite the fact that independent researchers have been unable to verify it as being effective or safe, should trouble us all. That despite all the billions of public money spent worldwide on health research we are in this position of ignorance of the effects of most of the treatments taken every day is a true scandal of our times. The Public Accounts Committee report is a major endorsement of the Alltrials campaign. The Committee’s recommendations, if followed through, will lead to better understanding, by health professionals and the public, of the effects of medical treatments – and to more rational and safe healthcare decisions.

And what of the Cochrane Review on Tamiflu? In recent months both Roche and another drug company, Glaxo Smith Kline [GSK] have provided access to the full clinical trial data on two anti-influenza drugs, including Tamiflu, although with some information partially redacted. The research team, which receives financial support from the UK National Institute for Health Research, is expecting to complete its analysis in early 2014 and then, perhaps, we will know whether the billions invested globally in Tamiflu was worth the cost.

I’m sitting here looking at my used copy of the 650 page Cochrane Handbook of Systematic Reviews and Interventions, and it reminds me of a few other things to say. The Cochrane reviews aren’t always easy to read. They are really into both detailed and systematic so they can be an undertaking at times. I’m not complaining, just warning the uninitiated. They’ve come up with some marvelous techniques for analyzing and comparing results like funnel plots and forest plots [see examples in a breath of fresh air…]. But depending on the author, they can be encyclopedic. Another thing I like about them is that they sometimes reach tentative conclusions. They don’t claim to be the word, a self-skepticism I respect, but it can be off-putting to the more concrete among us.

Back before Christmas, I read an article by Richard Noll, psychologist and scholar [one of those…], in the Psychiatric Times and flagged it for a later blog. But when I went back, it wasn’t there. How come? How come indeed! The Psychiatric Times unpublished it for reasons that sound pretty flimsy – liability issues they claimed. Gary Greenberg [Book of Woe] has the whole story [Mistakes were made, Part 2]. So what was that all about?

You may remember that at the end of the 1980s, about the time that my wife was crushing on him, the country was riveted by accounts of Satanic Ritual Abuse. In a word, there was a sudden outbreak of people, mostly children, claiming to have been forced by Satanic cults to witness and/or participate in heinous acts, like cutting out babies’ hearts and eating them, often in day care centers. The stories were disturbing and implausible, but they could not be refuted, because it is impossible to prove a negative. They were perfect fodder for a moral panic, and that is indeed what happened. The results included the jailing of over 100 day care providers [some of whom remain imprisoned], the sundering of some communities, and  children unalterably confused about what had happened [or not happened] to them…

… Just 25 years ago, American psychiatry was infected by a psychic pandemic that originated outside the profession. In 1983 it broke out of a reservoir of religious, legal, psychotherapeutic, and mass media mixing bowls. Children in US day care centers and adults in psychotherapy told 2 distinct versions of their malady. By 1988 some elite members of the American Psychiatric Association [APA] were making it worse. They had become its vectors. Then other elite psychiatrists stepped in to quarantine the profession. Eventually, just like the last wave of the influenza pandemic, after 1994 it ended as suddenly and incomprehensibly as it had started.

As our medical schools and graduate programs fill with students who were born after 1989, we meet young mental health professionals-in-training who have no knowledge or living memory of the Satanic ritual abuse [SRA] moral panic of the 1980s and early 1990s. But perhaps they should. Cautionary tales may prevent the recurrence of pyrogenic cultural fantasies and the devastating clinical mistakes they inspire. But who should tell this tale? To those of us who are old enough to have been there, that era already seems like a curious relic of the past, bracketed in our memory palaces behind a door we are loathe to open again.

In the 1980s thousands of patients insisted that they were recovering childhood memories of physical and sexual abuse during Satanic cult rituals. In addition to the red or black robes of the abusers and other paraphernalia of devil worship familiar to any horror film devotee, these memories often included the ritual sacrificial murder of children, blood-drinking, cannibalism, bestiality, and incest. Famous believers in SRA ranged from Gloria Steinem to Pat Robertson. A prominent historian of religion has argued that “the emergence of SRA motifs” served as “a kind of feminist and evangelical Christian pornography.”

Clinicians who then believed in the factual basis of the claims [and there were many] have probably spent the last 30 years asking themselves, “How could I have been so …?” [fill in the blank]. Or perhaps they are still saying to themselves, as the authors of one book suggest in their title, Mistakes Were Made [But Not By Me]…

Had I written about it right off, I would’ve talked about some of those patients I saw back then in consultation, or how one of the candidates in our analytic institute became a national figure trying to debunk this wave of hysteria that swept through the mental health community, or maybe how it all fit in the craziness of that period. But right now, that’s no longer the story. The story is why did the Psychiatric Times unpublish it?

The recent revelations of Dr. Kupfer’s misadventures with conflict of interest [insider trading…, DSM-5 retrospective I… et al] remain limited to an odd blog post here and there. Google News only yields Kupfer’s preChristmas Huff Post article, How the Official Psychiatric Guidebook Deals With the Internet, about the DSM-5’s provisional Internet Gaming Disorder [the operative saying here is you couldn’t make this stuff up]. I’m borrowing a term here from commenter Annonymous to raise the question, Do we have Royalty in the APA hierarchy? people whose position renders them immune from criticism. Does Dr. Lieberman’s position as president of the APA immunize him from the questions being raised about the CAFE study? Was Dr. Schatzberg’s continuing as APA president relatively unscathed by Senator Grassley’s Investigation or the revelation that he had signed on to a ghost-written textbook an example of the same thing – Royalty?

Obviously, the way I’m saying this reveals my opinion – no Royalty allowed. If anything, I believe there is a responsibility of office to adhere to a higher standard rather than be afforded a bye when misbehaving. This instance highlights the limits and confusion of our current way of handling the whole question of Conflicts of Interest [COI]. The requirement to list conflicts of interest and the funding sources for academic articles is a relatively recent practice, and it has been a big help – though more recently, some journals make you work to find them in an online version. When I read an article, I read the title, the list and order of the authors, and then the COI and funding information before I read the article itself. I still look for editorial assistance, though it’s rarely there anymore. That introduction heavily informs my reading. And I’ve become a paranoid reader. I used to scan articles, now I read all the words, look at the graphs and tables, and am on the lookout for tricks. I don’t like that way of reading, but it has become a necessary habit. And I always wonder who actually wrote the article.

There are a number of people in psychiatry whose names are on an inordinate number of papers. I think of them as sign-ons – people with outrageous resumes, and I find myself saying uh-oh when there are several pn the author by-line. I actually had Dr. Kupfer on that list in my mind – a frequent flyer. And in his conduct of the DSM-5 Revision, I thought he was an ideologue with a hidden agenda as I’ve said [DSM-5 retrospective I…]. But I didn’t think of him being someone who would be involved in a company that was going to capitalize on the Manual he was in charge of revising. That came as a surprise. And the other thing about this incident – I can think of no way that this was a mistake or an oversight. The declaration here was actively withheld from view. I can’t see it as having anything to do with pharma. This was an independent enterprise for personal gain until proven otherwise. I wasn’t surprised by Dr. Gibbons. His track record is perfectly consistent with this kind of questionable behavior.

As a teen, I spent a couple of years in a school I now jokingly call the ____ school for military christian boys – no crimes or sins got me there, just being a 50s kid too focused on being a 50s kid. There was an honor code at the school, and if convicted of breaking it by the honor council, the offender was marched before the student body at morning assembly to make a public confession and apology, losing all rank and privilege. One morning, the highest ranking cadet officer, himself a member of the honor council, appeared with an apology for cheating on a chemistry test and spent the rest of his senior year carrying an M1 rifle on his shoulder at drill like the rest of us. He’s someone I knew much later in medical school. I once got up the courage to ask him about it, and he said it was the single most important event in his life. It was pretty important to me too. After two years, I returned to the land of the living [public school], but that honor code has never left. It was a good thing.