1 Boring Old Man

Karen Wagner on Treating Kids With Antidepressants

Fiddamans blog

by Bob Fiddaman

January 31, 2014

[full text on-line]

You’d have to be from the planet Zog if you didn’t know who Karen Wagner was.

Her name is synonymous with antidepressant pediatric studies. She added her name to the Paxil 329 ghostwritten paper without actually looking at the raw data [which showed an increased rate of suicidal thoughts in kids taking Paxil] – The result of that piece of Pharmafia fraud told millions of prescribing physicians that Paxil was safe to use in children and adolescents…when in actual fact it wasn’t. Wagner has been relentless to disprove those who believe antidepressant use in kids is wrong. She sees no problem with it…despite overwhelming evidence that shows just how dangerous antidepressant use in kids can be.

An article published in Clinical Psychiatry News [Treating youngsters’ depression means going off the FDA grid] a couple of days ago shows Wagner, once again, promoting the use of SSRi medication in children and adolescents. Wagner was present at a psychopharmacology update held by the American Academy of Child and Adolescent Psychiatry where she claimed that "…60% of youngsters will respond favorably to their first antidepressant medication – generally a selective serotonin reuptake inhibitor (SSRI)" Wagner also went on to claim that Switching to a different antidepressant will help about 50% of those who don’t respond. But adding psychotherapy will grab about 10% more – bringing the total response rate up to around 70%". She was referring to a 2008 study, TORDIA [Treatment of Resistant Depression in Adolescents].

So, Wagner hits the stage at these types of events, she’s a key opinion leader, in other words, those employed in the same field as her look up to her, respect her, hang on to her every word. She is the Geldof of the pop world, pushing her message at every given opportunity. Quite why she sticks her middle finger up at evidence that shows kids kill themselves whilst on these drugs kind of alarms me.

So, is Wagner on a mission to help depressed children and teens, does she genuinely care about this population or are there more sinister undertones? It would help if she and the article published in Clinical Psychiatry News was actually more transparent about her relationship and financial ties to the pharmaceutical industry [Pharmafia]. Upon reading the article I had to do a double take at the end… "Dr. Wagner has no financial relationships with pharmaceutical companies"…

Venlafaxine is one of many antidepressants that are not approved for use in children and teens. Treating depression in youngsters almost always means off-label prescribing. Only two antidepressants – fluoxetine and escitalopram – are Food and Drug Administration–approved for children and teens, and only fluoxetine is approved for children younger than 12 years. And data are actually mixed about fluoxetine; a recent published study showed it was no different from placebo over 6 months. Of the older, more well-known antidepressants, only two have positive data for youngsters. One randomized study of citalopram posted positive findings for its primary endpoint [American Journal of Psychiatry 2004;161:1079-83]. The other is sertraline, which had positive overall findings in a pooled analysis, although the individual studies were negative [JAMA 2003;290:1033-41].

Studies on all of the other drugs were negative, including mirtazapine [two studies], nefazodone [two], paroxetine [three], and venlafaxine [two].

The newest evidence for duloxetine in youngsters with depression looks lousy. In two highly anticipated, yet-unpublished, phase III trials, duloxetine and fluoxetine – which is already approved for kids – completely fell apart relative to placebo, Dr. Wagner said…

That leaves the Treatment of Resistant Depression in Adolescents [TORDIA] study, one of those NIMH funded clinical trials contemporary with many of the other industry funded trials she mentions. She was an author on that one too. I’ve never commented on that study – for a reason. It’s super-convoluted and reported in pieces in a bunch of different journals. But since it’s the center of her talk, I expect I’ll dig up those papers and go through it soon [but don’t hold your breath for great clarity].

Prenatal Depression in Women Hospitalized for Obstetric Risk

by Anna R. Brandon, Madhukar H. Trivedi, Linda S. Hynan, Paula D. Miltenberger, Dana Broussard Labat, Jamie B. Rifkin, and C. Allen Stringer

Journal of Clinical Psychiatry. 2008 69[4]: 635–643.

[full text on-line]

Objective: Little is known about depression during pregnancy in women with high maternal or fetal risk, as this population is often excluded from research samples. The aim of this study was to evaluate depressive symptoms and known risk factors for depression in a group of women hospitalized with severe obstetric risk.

Method: In the antenatal unit, 129 inpatients completed the Edinburgh Postnatal Depression Scale [EPDS], the Dyadic Adjustment Scale [DAS], and the Maternal Antenatal Attachment Scale [MAAS] from October 2005 through December 2006. A subset of women were administered the Mood Disorder module of the Structured Clinical Interview for DSM-IV Axis I Disorders [SCID] based upon a score of ≥11 on the EPDS. Obstetric complications were classified according to the Hobel Risk Assessment for Prematurity.

Results: Fifty-seven of the 129 women [44.2%] scored 11 or greater on the EPDS, and at least 25/129 [19%] met the DSM-IV criteria for Major Depressive Disorder [MDD]. Mothers reporting high attachment to the fetus on the MAAS reported lower severity of depressive symptoms [rho=−0.33, p< 0.001]; those reporting interpersonal relationship dissatisfaction on the DAS endorsed higher depressive severity [rho=−0.21, p=0.02]. Severity of obstetric risk was unrelated to depression but, one complication, incompetent cervix, was positively associated with level of depressive symptomatology.

Conclusion: Findings indicate a higher prevalence rate of MDD in women with severe obstetric risk than that reported in low-risk pregnancy samples, suggesting the need for routine depression screening to identify those who need treatment. Fewer depressive symptoms were reported by mothers reporting strong maternal fetal attachment and greater relationship satisfaction.

• "Fifty-seven of the 129 women [44.2%] scored 11 or greater on the EPDS, and at least 25/129 [19%] met the DSM-IV criteria for Major Depressive Disorder [MDD]"
• "… the data indicated the proportion of those with MDD was at least 19%, higher than reported in other studies of perinatal women."

"Conducting pure research in a hospital unit such as the setting for this study and with a population such as this one is a challenging task. The process of pregnancy and childbirth has always been unpredictable, which is illustrated by the rate of exclusions that occurred because mothers either delivered or were discharged within 72 hours of admission, even when this was not expected."

"Corroborating previous work, prenatal depression is significantly associated with psychiatric history, lower maternal fetal attachment, and higher relationship dissatisfaction."

"… a pregnancy may be defined “high risk” on the basis of an increased probability of fetal anomaly, compromises to maternal or fetal health, or significant risk for maternal or fetal demise."

"The protocol required two face-to-face interviews and the completion of a packet of self-report measures, a process that may have seemed overwhelming to patients already overwhelmed with the implications of their obstetric complications and the effect of hospitalization upon their spouses and families."

Prescribing of Psychiatric Medication to Bereaved Parents Following Perinatal/Neonatal Death: An Observational Study

by Jeffrey R. Lacasse and Joanne Cacciatore

Death Studies doi:10.1080/07481187.2013.820229

To examine psychiatric prescribing in response to perinatal/neonatal death, we analyzed data from a cross-sectional survey of 235 bereaved parents participating in an on-line support community. Of the 88 respondents prescribed medication, antidepressants were most common [n = 70, 79.5%] followed by benzodiazepines/sleep aids [n = 18, 20.5%]. Many prescriptions were written shortly after the death [32.2% within 48 hours, 43.7% within a week, and 74.7% within a month]. Obstetrician/gynecologists wrote most prescriptions given shortly after loss. Most respondents prescribed antidepressants took them long-term. This sample is select, but these data raise disturbing questions about prescribing practices for grieving parents.

If the intent of the authors of the first paper is to highlight the fact that the threat of fetal loss is a big deal in the life of a mother, even a reluctant mother, more power to them. I’d only suggest they find another term for it. As to the second paper, it highlights the epidemic of inappropriate uses of psychiatric medications everywhere, and the even worse fact that routinely, their use becomes long term. I’ll probably get myself in trouble with the authors saying this, but in acute bereavement, sometimes the most helpful thing in the world is a few good nights of sleep – even that is with the accent on "a few." But a third of them on antidepressants? Absurd.

J&J chooses Yale to review requests for clinical drug data

Reuters

Jan 30, 2014

Under the agreement, the "Yale Open Data Access Project," will independently review and make final decisions regarding all requests for information on the company’s drug clinical trials, including anonymous patient data. Johnson & Johnson has selected the Yale School of Medicine to review requests from investigators and physicians looking for access to clinical trial data involving the diversified healthcare company’s pharmaceuticals.

The action comes amid growing pressure from outside scientists for access to raw data from clinical trials, reflecting general concerns that too many studies cannot be independently confirmed and may well be wrong. J&J, which sells drugs including blood thinner Xarelto and prostate cancer treatment Zytiga, said it is in the process of determining how best to share trial data from its other two areas of operation: medical devices and consumer products. "This is a multi-year effort on our part to try to contribute to advancing medical knowledge and science," Joanne Waldstreicher, J&J’s chief medical officer, said in a telephone interview.

Others drugmakers have made similar moves. Britain’s GlaxoSmithkline Plc has set up an online system to provide researchers with access to anonymous patient-level data about its medicines. Pfizer Inc Plc has set up an online system to provide researchers with access to anonymous patient-level data about its medicines.  said in December it would broaden access to information from its clinical trials to independent researchers and to patients who take part in the studies. Pfizer also set up an independent review panel of academic scientists to decide which researcher requests it would answer.

YODA Project

Yale University Open Data Access [YODA] Project

Each day, patients and their physicians make treatment decisions with access to only a fraction of the relevant clinical research data. Many clinical studies, including randomized clinical trials, are never published in the biomedical literature. The Yale University Open Data Access project has developed a model to facilitate access to patient-level clinical research data to promote wider availability of clinical trial data and independent analysis by external investigators.

The YODA Project model provides a means for rigorous and objective evaluation of clinical trial data to ensure that patients and physicians possess all necessary information about a drug or device when making treatment decisions. This process includes both coordinating independent examinations of all relevant product data by two separate qualified research groups and making all patient-level clinical research data available for analysis by other external investigators. The model is designed to provide industry with confidence that the analyses will be scientifically rigorous, objective and fair.

Of note, several features of the model are specifically focused on promoting transparency and protecting against industry influence:

• Any company engaging in the model must provide all relevant product data
• Two independent research groups, selected after a competitive application process, systematically review and analyze all relevant product data
• An independent Steering Committee, including leaders in the field of clinical research and biomedical ethics, advise the YODA project team
• A Clinical Advisory Committee, including leaders in the clinical practice that uses the product under evaluation, advise the project
• Project leadership are committed to transparency, publication, and making the data publicly available…

Conflicts of Interest

Psycritic

January 26, 2014

The following story was recounted to me by someone who was there:

He was indignant. Outraged, even. He was a department chair. A prominent psychiatrist and author of textbooks. A Key Opinion Leader in the field. How dare the New York Times question him? The psychiatry residents sat in silence as he went on his rant. Every other medical specialty does the same thing! How come they didn’t go after the orthopedic surgeons or the cardiologists, who made much more money from industry relationships than psychiatrists? They went after psychiatry and psychiatrists because of the stigma surrounding mental health. And what is this whole conflict of interest business, anyway? The New York Times even had an article on Michelle Obama’s clothing retailer having a conflict of interest. It’s ridiculous! And the senator who started all this, Senator Grassley? What about all of his campaign contributions? Does he have conflicts of interest?

He had more choice words for the Times and for Senator Grassley, but you get the idea. His mindset seemed to be that because what he was doing would ultimately help patients, he was beyond reproach as long as he was not committing any crimes. Since funding was limited, what was wrong with working with industry? When all the other specialties make more than psychiatrists, why shouldn’t psychiatrists take part in entrepreneurial activities?

Not surprisingly, he is no longer the department chair. However, five years later, this mindset about conflicts of interest still remains with some [many?] of psychiatry’s leaders. How else to explain the recent revelations about David Kupfer, chair of the DSM-5 task force? He failed to disclose that he was part of a company making a dimensional assessment for depression, both during the DSM-5 process and on an article that he co-authored with his business partner, statistician Dr. Robert Gibbons, who seems to be creating a commercial product with public money…

The ends do not justify the means. Just because someone else is doing it doesn’t make it right. These may be rote lessons from childhood, but it seems that some people have conveniently forgotten them. In my opinion, this most likely happens not because of greed, but when people truly believe that they are doing good; therefore they must be good, and their critics must be bad. Narcissism is a powerful and dangerous thing. 

Top Psychiatrist Didn’t Report Drug Makers’ Pay

New York Times

By GARDINER HARRIS

October 3, 2008

… In 2004, Emory investigated Dr. Nemeroff’s outside consulting arrangements. In a 14-page report, Emory’s conflict of interest committee detailed multiple “serious” and “significant” violations of university procedures intended to protect patients. But the university apparently took little action against Dr. Nemeroff and made no effort to independently audit his consulting income, documents show. Universities, too, can benefit from the fame and money the deals can bring — a point Dr. Nemeroff made in a May 2000 letter stamped “confidential” that he sent to the dean of Emory’s medical school. The letter, which was part of a record from a Congressional hearing, addressed Dr. Nemeroff’s membership on a dozen corporate advisory boards…

“Surely you remember that Smith-Kline Beecham Pharmaceuticals donated an endowed chair to the department and that there is some reasonable likelihood that Janssen Pharmaceuticals will do so as well,” he wrote. “In addition, Wyeth-Ayerst Pharmaceuticals has funded a Research Career Development Award program in the department, and I have asked both AstraZeneca Pharmaceuticals and Bristol-Meyers [sic] Squibb to do the same. Part of the rationale for their funding our faculty in such a manner would be my service on these boards”…

But back to the thread, that’s how we ended up with such a collection of people in high places – people who could raise money for the University Departments like the part in red above. And "the rationale for their funding our faculty in such a manner would be my service on these boards" wasn’t the full story. It was the alliance with the universities, their academic reputations, and their credentials that accounted for pharma’s generosity – a commerce that was mutually advantageous for quite a while. While I wouldn’t argue for a minute with either Psycritic’s assessment of the mindset in question or his diagnosis, the former chairman mentioned above and Emory’s Dr. Nemeroff below were pointing out that they were just doing what they were hired to do. And, by the way, they were lining their own pockets along the way. I’m not sure they were just thinking they were doing good as a rationalization, from their vantage, they were doing their jobs. While the back story of all of this is obvious now, it wasn’t so obvious before – wrapped in a cloak of science, research, discovery, evidence-based medicine, a lack of transparency, and whatever one calls the sweet smell of success.

So rather than parse or defend my own words, I’ll just say for history that as the words of this blog attest, I’m Ben’s biggest fan, a contributer to AllTrials, and a promoter. I had read Wellcome research fellow in epidemiology on many of his articles. So, on a snowbound evening, I looked that up. Reading about Sir Henry Wellcome was interesting and I was awed that he had left his huge estate in a trust that has been such a boon to medical research. I also didn’t know that he was such an innovator in the creation of the pharmaceutical industry – tablets instead of powders, advertising, detailing doctors directly, research by pharmaceutical companies.

And so I thought it was wonderfully ironic that, probably without knowing it, Sir Henry had built in a fail-safe mechanism to monitor the industry he had a big part in founding. He created a mechanism to support scientists who were studying medicines, and one of them turned out to be Ben Goldacre – a tireless campaigner for honesty and transparency in Clinical Trials. That was to me an irony – and a good one. Those are the thoughts that were in my mind when I wrote that.

Improving, and auditing, access to clinical trial results

Editorial

by Ben Goldacre, Wellcome research fellow in epidemiology

British Medical Journal 2014 348:g213

The House of Commons Public Accounts Committee delivered a remarkable report on 3 January. Its initial remit was the United Kingdom’s £424m [€510m; $697m] stockpile of oseltamivir [Tamiflu], but the committee soon broadened out—with evident surprise—into the ongoing problem of clinical trial results being routinely and legally withheld from doctors, researchers, and patients.

This situation has persisted for too long. The first quantitative evidence on publication bias was published in 1986.1 Iain Chalmers described in 2006 how progress in the 1990s soon deteriorated into broken promises.2 Recent years have seen extensive denial. The Association of the British Pharmaceutical Industry [ABPI] has claimed that these problems are historic, and that results are now posted on clinicaltrials.gov. The recently defunct Ethical Standards in Health and Life Sciences Group,3 which most UK medical and academic professional bodies signed up to, falsely claimed that a “robust regulatory framework” ensures access to trial results.4 US legislation requiring all results to be posted on clinicaltrials.gov within 12 months of completion has been widely ignored,5 with no enforcement. There has also been covert activity from industry—a leaked memo on its “advocacy” strategy included “mobilising patient groups” to campaign against transparency.

Despite this, we have achieved considerable progress. The AllTrials.net campaign, started 12 months ago, calls for all trials on all uses of all currently prescribed treatments to be registered, with their full methods and results reported.7 It now has the support of most medical and academic professional bodies as well as the National Institute for Health and Care Excellence [NICE], Medical Research Council, Wellcome, more than 130 patient groups, 60 000 members of the public, and many in industry including GlaxoSmithKline. The Health Research Authority has announced that registration will be a condition of ethics committee approval.8 The BMA has passed a motion stating that withholding trial results is research misconduct,9 and the General Medical Council is re-examining its guidance on the matter.

There have also been extensive new proposals for greater transparency from European Union legislators, the European Medicines Agency [EMA],10 and industry bodies.11 All, however, share the same loophole—they all propose improved access to information on trials conducted from 2014 onwards. This means that almost all trials relevant to current medical practice would be exempt [including, for example, those on oseltamivir].

We now have an unprecedented opportunity for change, with considerable support from medical and academic professional bodies, policy makers, patient groups, and—importantly—the public. It’s time to consider what practical improvements can be made.

Firstly, by whatever means necessary, the methods and results of all previous trials must be accessible to the medical and academic community, which produces the guidelines and systematic reviews that inform patient care. It is commonly assumed that it would be difficult to enforce demands for trial results from diffuse global organisations, but we have never tried simply asking in an organised fashion. For example, the EMA could ask all research organisations and companies with a marketing authorisation for full methods and results of all trials they have conducted, so that these can be posted online, on the first ever register of trials that aspires to be a complete record of all research. If this invitation is declined, we could be told.

Secondly, while the current state of secrecy continues, there is much to be done with the most basic research tool in medicine—audit. Industry is quibbling over the precise proportion of trials that go undisclosed. This should not be a matter of debate. We need a trials observatory, covering all trials on all currently used treatments, that matches registry entries and other sources of information on completed trials against sources of results, whether those are in academic papers, clinical study reports, regulatory documents, or online postings. From these data we could derive live dashboards on transparency to drive up best practice, identify the best and worst companies for missing results, the treatments where most information is missing, the best and worst investigators, and more.

This is actionable information. If routine audit shows a particular principal investigator is performing badly, with many unreported results, should ethics committees grant them access to more trial participants? Will patients participate in trials for companies that withhold results? If two treatments have equivalent benefits, but one comes from a company with a track record of transparency and the other from a company that actively undermines the transparency campaign, are those two treatments still equivalent, and which should a cautious clinician prescribe?…

Henry Wellcome’s last years

Increasingly lonely, Wellcome spent his last years preparing for his life’s work to be carried on after his death, for the benefit of mankind. Wellcome grew increasingly lonely in the 1910s and 1920s. He had separated from his wife Syrie in 1910 and one by one his close friends – never many in number – grew old and died. In his early 60s he had no one with whom he could share his deepest interests. Even so, his passion for history and collecting remained undimmed. At a time of life when many would slow down, he orchestrated an archaeological dig between 1911 and 1914 in the Sudan, continued rearranging and collecting for his Historical Medical Museum, and opened a museum on the history of medicine. Meanwhile, he remained very much in control of his company, suggesting avenues of research for his scientific laboratories and adapting his enterprises to the strains of World War I. Such was his industry that a member of staff later commented that “one of the things about Sir Henry was that he never thought he would die.”

Knighthood

He finally found recognition for his impact on the worlds of business and scientific research in 1932, when he was knighted. Many people were surprised that a man who had done so much for British scientists [and so much for Britain in such a time of need] had had to wait so long before receiving a knighthood. The scandal of his divorce is likely to have played a part. In 1932 he was also made an honorary Fellow of the Royal College of Surgeons – a very rare distinction for anyone not holding a medical degree, which indicated the high respect in which he was held by the medical profession.

Preparations for the future

With no one to hand over his empire to, Wellcome used his last years to consolidate his various enterprises and make suitable arrangements for mankind to benefit from his life’s work. In 1924, he established The Wellcome Foundation Limited, a private limited company, which brought together his non-commercial and commercial interests under a single corporate umbrella. In 1931, the construction began of the Wellcome Research Institution on Euston Road, designed to house his research laboratories and collections. It was completed in 1932, renamed the Wellcome Building in 1955, and now houses Wellcome Collection. In his will, signed on 29 February 1932, Wellcome vested the entire share capital of his company, The Wellcome Foundation Limited, to the Wellcome Trust. The appointed Trustees would be charged with spending the income according to Sir Henry’s wishes. Four years later, on 25 July 1936, Henry Wellcome died, aged 82, at the London Clinic. He was cremated at Golders Green and in 1987 his ashes were buried in the churchyard of St Paul’s Cathedral…

He founded the pharmaceutical company Burroughs Wellcome & Company with his colleague Silas Burroughs, which is one of the four large companies that merged to form GlaxoSmithKline. In addition, he left a large amount of capital for charitable work in his will, which was used to form the Wellcome Trust, one of the world’s largest medical charities. He was a keen collector of medical artifacts.

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…

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”…

The research of 3 psychiatrists in particular caught the profession’s attention: Richard P. Kluft of the Institute of the Pennsylvania Hospital in Philadelphia; Frank W. Putnam of the National Institute of Mental Health; and Bennett G. Braun of Chicago’s Rush Medical College.

Its newsletters vilified clinicians such as Bennett Braun and others who had done so much to legitimize the paranoid mass delusion of Satanic cults.

It’s snowing here in Georgia. Cold, like the cold that requires a fire in the fireplace. Which, of course lead to a long winter’s nap. And on awakening, there’s a Huffington Post piece about Richard’s article in my in-box by Allen Frances [Sex and Satanic Abuse: A Fad Revisited]. He had an interesting vantage for that piece of history, as it came in his DSM-IV Chairmanship. Another good story.

So I’ll pick up where I was headed before the nap. We’re apparently not taken with the idea of learning from our past in psychiatry. Living in the world of subjectivity has us traveling some mighty peculiar byways, and sometimes our detours go too far unchecked. Our critics delight in pointing out the absence of firm objective anchors, absent lab tests, disease markers, pathognomonic signs and symptoms, clearly visible tracks in the primordial ooze. They say it makes psychiatry a non-science, witchcraft like this bizarre story we’re reading here – chasing Satanic Cults living in the shadows. I see it differently. I was drawn from the labs of hard science to the subjectivity of my patients. It was where they felt their pain, and untangling their stories was more like feeling one’s way through an unexplored labyrinth than following well defined road signs. It was filled with false starts and surprises, paradoxes to decipher, no two cases the same. It was a little like my research career – starting with hunches, but it required learning how to reject the many that weren’t on target, and following those that were  – learning how to navigate in the twist and turns of a life.

One of the essential tools was history – the patient’s history, my history, the history of the therapy, being able to see the mistakes along every path – often more in retrospect than at the time. So I’m particularly put off by the recent reticence to re-examine our history with the kind of microscope it deserves. We need to look at the last quarter century of psychiatry getting stuck in some kind of biological dream with the medicines. We need to carefully examine why we were so vulnerable to the invasion of the marketing arm of the pharmaceutical industry. We need to figure out how we let the needs of the insurance industry paint us into such a small and stifling corner – "med checks." And we need to understand why, except for people like a younger Richard Noll, George Ganaway, and some others, a subsegment of psychiatrists went much further down the Salem Witch Trials road than seems rational.

It doesn’t matter if Drs. Braun and Kluft are embarrassed, or we’d rather not revisit the lobotomy days or the outrageous era we seem to be finally escaping where a subset of our higher ups went along with the kind of hanky-panky that gave us Paxil Study 329 and TMAP. Gullibility is part and parcel of traveling subjective pathways, and it may well be embarrassing, but if we always re-evaluate our misfires, we iterate back to the path we need to travel. Only a small number engaged the battle with the devil, but the majority of us didn’t react fast enough to prevent that outbreak of mass hysteria from doing some damage. And it doesn’t matter if it’s awkward to look back on this Kupfer Affaire I’ve been writing about and learn what we need to learn about Conflicts of Interest in high places [why? again…]. It’s what we need to do. It’s the way we learn.

May 3, 1919 – January 27, 2014