1 Boring Old Man

Surprise!

Another nail in the APA’s coffin…..

“It is done …”
and “the planes don’t land.”
But everyone is going to buy a ticket anyway.

From Feynman: “In the South Seas there is a cargo cult of people. During the war they saw airplanes land with lots of good materials, and they want the same thing to happen now. So they’ve arranged to imitate things like runways, to put fires along the sides of the runways, to make a wooden hut for a man to sit in, with two wooden pieces on his head like headphones and bars of bamboo sticking out like antennas–he’s the controller–and they wait for the airplanes to land. They’re doing everything right. The form is perfect. It looks exactly the way it looked before. But it doesn’t work. No airplanes land. So I call these things cargo cult science, because they follow all the apparent precepts and forms of scientific investigation, but they’re missing something essential, because the planes don’t land.”

The DSM-5 truly represents cargo cult science.

It will take some time to process that this is the psychiatric diagnostic bible that is meant to potentially take the field of North American mental health care through to 2030. Including what, at that point, will have been about 50 years of the MDD category.

As you say, for DSM-5, “it is done….”

However, the end of the DSM-5 process is the beginning of the DSM-6 process.

1980 DSM III
1994 DSM IV
2012 DSM 5
2026-2030 DSM 6?

The beginning of a process that will decide the shape of that manual. That will also decide whether or not there will be the hegemony for that manual that there has been (and probably sadly still will have been) for its predecessors.

It strongly appears that the past few years, including the vast majority of public “input” and the field trials, has been perfunctory.

The individuals with sufficient power within the APA pushed forward their agenda. The individuals with sufficient power within the APA also calculated that there will not be enough of a risk/cost to going ahead with this that they have pushed forward their agenda essentially unchanged. And, there are were no major players outside APA with the power to have impacted all this who felt that, on balance, it is was in their best interest to actively oppose all this.

If none of those 3 factors change then the situation in 2026-2030 will be DSM-6 redux. Those factors of who is in power in the organization, what they feel is their – and the organization’s – exposure, and what external powers can be engaged to impact/mitigate their agenda.

Of course, these are also the same factors impacting the obstructionist stances of the professional societies when it comes to ameliorating the corruption of the psychiatric literature.

What is going on (or maybe more aptly, what is not going on) is clear when we see the kind of verbiage put forward about both the DSMs and the experimercials. We can just go back to Feynman:
“Now it behooves me, of course, to tell you what they’re missing. But it would be just about as difficult to explain to the South Sea Islanders how they have to arrange things so that they get some wealth in their system. It is not something simple like telling them how to improve the shapes of the earphones.”
Feynman speaks of “a kind of scientific integrity” and says:
“The easiest way to explain this idea is to contrast it, for example, with advertising. Last night I heard that Wesson oil doesn’t soak through food. Well, that’s true. It’s not dishonest; but the thing I’m talking about is not just a matter of not being dishonest, it’s a matter of scientific integrity, which is another level. The fact that should be added to that advertising statement is that no oils soak through food, if operated at a certain temperature. If operated at another temperature, they all will– including Wesson oil. So it’s the implication which has been conveyed, not the fact, which is true, and the difference is what we have to deal with.”

What’s going on is clear.
How an individual can effectively and sizably impact any of those 3 factors remains much less clear.
Watching Dr. Frances’ PR campaign and its impact, or lack thereof, I am left with the impression that this is not a war of ideas but a war of power and culture. While I sincerely hope that the thatwhichcannotbenamed-6watch website has already launched (or will shortly), it is even clearer now that that will not be enough.

Sad.

Off Topic:

Does anyone who reads this blog know if AACAP publishes the names of the chairs and individual members of its various committees? In particular the Committee on Quality Issues, the CME committee, the Nominating committee, and the Ethics committee?

annon,

look here around page 27

Hey! I was just cured of my Asperger’s!!! And by committee vote! Wow that was easy!

Do no harm, the Hippocratic oath, means that treatment that results in worse outcomes in the aggregate than no-treatment/ natural healing, is doing harm.

The pharmacological dominance is undermining psychiatry because of damage to individuals and families, to society, – and loss of public trust.
Psychopharmacological psychiatry is unsustainable. The truth is out, and in the news. Iatrogenic illenesses, early death, rampant corruption all across the snake-oil-peddling quack-speciality.

Roger Whitaker spoke in Denmark recently. His books are being ranslated into Scandinavian languages. BMJ touted its ending. More people are questioning the corruption of medicine and seeking other ways to alliviate suffering than Big Pharma poison in ever more expensive versions.

Waves are building up. The word bore, from old Norse, has several meanings, including an increasing – often dangerous, incoming wave. You chose an apt name for your blog, old man! We are watching. Bora is on it’s way …

http://claudiamgoldmd.blogspot.com/

http://claudiamgoldmd.com

Sunday, December 2, 2012

A relational view of DSM V: a care-rationing document?

….

“DSM V might have some role if it is used simply as a way to guide thinking. One of its original aims was to offer a structure for clinicians to recognize similarities and differences among their patients and to talk to one another about them. (The DC 0-3, a similar document, includes a relationship classification and offers a much more comprehensive model for understanding emotional problems.)

But that is not how it is used. It is essentially a document that rations care. The issue of the elimination of the diagnosis of Asperger’s is a complex one and beyond the scope of this post. However, the frequently made objection that people who have this diagnosis will no longer be eligible for help, supports this way of understanding the DSM.

If DSM, then, is a care-rationing document, the solution is not to spend years refining the categories. The solution is to improve access to care. “

I’m surprised they didn’t have the announcement on TV like The Grammy or Oscar nomination shows. Maybe they could have had a singer with one of the new diagnostic categories do a song. With all the egos in that room, was there damage to the facility?

I agree with annonymous, the DSM-5 “process” was a ritual. Everyone played an assigned role, compensated by the stipends or honoraria or expense accounts that eventually cost the APA $25 million.

The ritual produced a holy artifact. Here, I agree with Claudia Gold. The purpose of DSM diagnoses is to get reimbursement from insurance companies, not to describe psychiatric conditions.

Accurate diagnosis in psychiatry is not essential to treatment, either. Clinical treatment consists of arbitrary prescriptions of psychiatric drugs serially or in combination, until the patient stops complaining.

Reliability in diagnosis is so last century. Psychiatry has gone post-modern.

1BOM,

Thank you.

Thinking about the power structure in these organizations got me thinking more about Committee chairs and how they help apportion and maintain those power structures. And how that might influence how the organization behaves.

Here are 3 observations off the bat:

Chair AACAP Ethics Committee
(since ?- present):
Arden Dingle
http://1boringoldman.com/index.php/2011/09/30/psychiatry-inc/

Chair AACAP CME committee
(since ?-present)
http://www.pharmalot.com/2011/07/at-the-feet-of-a-master-biederman-his-proteges/

Oscar G. Bukstein
Co-Chair of Workgroup on Quality Issues Committee
(since 2004-present)
(involved in all AACAP Practice Parameters)
Advisor/Consultant: Haymarket Media
Speakers Bureau: Advanced Health Media, LLC, CMP Media LLC, Haymarket Media, I3 CME, Informatin Television Network, Optima, McCallum Group, McNeil Pediatrics Division of McNeil-PPC, Novartis Pharmaceuticals Corporation, Optima, Sci-medica Group, LLC, Shire US Inc.
(and possibly more?)

Sorry, forgot to put Dr. Jeffrey Bostic’s name up there.

Oh,

Dingle is director of the Child Psychiatry Fellowship at Emory.

Small world.

So, ya goin’ to blog about CPT next?

AACAP GUIDELINES ON CONFLICT OF INTEREST FOR CHILD AND ADOLESCENT PSYCHIATRY RESEARCHERS
Prepared by the AACAP Consensus Building Panel on Conflict of Interest for Researchers
Arlington, VA – August 19, 2008
Last Reviewed and Approved by Council on January 30, 2009.

Oscar Bukstein, M.D. – Dr. Bukstein is a professor of child and adolescent psychiatry at the University of Pittsburgh. He receives extramural funding support from the NIH. He is vice- chair of the Institutional Review Board at his institution. He is co-chair of the AACAP Work Group on Quality Issues which is responsible for the development of the practice parameters and a member of the Substance Abuse and Addiction Committee. He is the member of a CME speaker’s bureau which allows him to control the content of his presentations. He also has edited a book that was published last year.

Melissa DelBello, M.D. – Dr. DelBello is an academic child and adolescent psychiatrist whose research and academic careers have focused on neuroimaging techniques to study adolescents with bipolar disorder. She is a member of AACAP, and serves on the AACAP Program Committee as the Chair of the Annual Meeting Institutes and the AACAP Work Group on Research. A portion of her funded research is supported by pharmaceutical industry. She has also received more than $10,000 for advisory and consultation with private industries, mostly for participation in research, consulting and speaker’s bureaus. She is the Vice Chair of Clinical Research for the Department of Psychiatry at the University of Cincinnati. She is also the Director of Research, Training and Education for the Division of Child Psychiatry at the Cincinnati Children’s Hospital Medical Center. She spends 15% of her time seeing patients in clinical practice at the Cincinnati Children’s Hospital Medical Center.

A.J. Allen, M.D. – Dr. Allen is a child and adolescent psychiatrist, a member of AACAP, and a member of the AACAP Pediatric Psychopharmacology Initiative Subcommittee of the Work Group on Research. Dr. Allen is currently a full-time employee of Eli Lilly & Company serving as the Medical Director for Strattera. He is also a share holder in Eli Lilly & Company. He participated in the February, 2008 AACAP consensus-building conference to develop conflict of interest guidelines for practitioners.

Allen Frances MD blasts the approval of the DSM-5:

Our patients deserve better, society deserves better, and the mental health professions deserve better. Caring for the mentally ill is a noble and effective profession. But we have to know our limits and stay within them.

“DSM 5 violates the most sacred (and most frequently ignored) tenet in medicine- First Do No Harm! That’s why this is such a sad moment.”

http://www.psychologytoday.com/blog/dsm5-in-distress/201212/dsm-5-is-guide-not-bible-ignore-its-ten-worst-changes

Guidelines on Conflict of Interest for Child and Adolescent Psychiatrists

Prepared by the AACAP Consensus Building Panel on Conflict of Interest
Washington, DC, February 14, 2008

Last Reviewed and Approved by Council on January 30, 2009.

A.J. Allen, M.D. – Dr. Allen is a child and adolescent psychiatrist, a member of AACAP, and a member of the AACAP Pediatric Psychopharmacology Initiative Subcommittee of the Work Group on Research. He currently does not see any patients. Dr. Allen is currently a full-time employee of Eli Lilly & Company serving as the Medical Director for Strattera. He is also a share holder in Eli Lilly & Company.

Melissa DelBello, M.D. – Dr. DelBello is an academic research child and adolescent psychiatrist whose career has focused on developing and using imaging techniques to study children and adolescents with bipolar disorder. She is a member of AACAP, and serves on the AACAP Program Committee as the Chair of the Annual Meeting Institutes. A portion of her funded research is supported by pharmaceutical industry. She has also received more than $10,000 for advisory and consultation with private industries, mostly for participation in research, speaker’s bureaus and industry-sponsored symposia. She is the Vice Chair of Clinical Research at the University of Cincinnati. She spends 20% of her time seeing patients in clinical practice at the Cincinnati Children’s Hospital Medical Center.

Neal Ryan, M.D. – Dr. Ryan is the AACAP Program Committee Chair and participates in the AACAP Work Group on Research. He sees patients through private practice and does some research. He is a full professor of child psychiatry at the University of Pittsburgh Medical Center, has an endowed chair, and serves as an unpaid corporate board member for an informatics company which is a subsidiary of the University of Pittsburgh Medical Center. Dr. Ryan has participated in speaker’s bureaus many years ago but has declined to do so since. He currently is not serving on any advisory boards and currently does not receive any research support from private companies.

Lynn Starr, M.D. – Dr. Starr is a behavioral pediatrician who has been invited to speak on issues of ethics involved in private pharmaceutical supported research at AACAP Annual Meeting Town Hall forums. She is a member of AACAP and currently serves on the AACAP Pediatric Psychopharmacology Initiative Subcommittee of the Work Group on Research. She currently does not see any patients. Dr. Starr is currently a full-time employee of Ortho-McNeil Janssen Scientific Affairs, LLC. She is also a stock owner in Johnson & Johnson.

Annon–Melissa DelBello investigated by Grassley–talk about a paid KOL–BIG time:

http://bipolarsoupkitchen-stephany.blogspot.com/2011/07/in-biedermans-public-shadow-melissa-del.html

I’m well aware. As was whoever at AACAP who chose to place Dr. DelBello as one of the few individuals on each of those panels. As you can see she was selected for both panels.

Contrast:

http://www.aacap.org/galleries/transparency-portal/February%202008%20-%20Martin%20Editorial%20COI.pdf

to

http://www.spine.org/Documents/TSJJune2011_Carragee_etal_Editorial.pdf

Dr. Neal Ryan’s disclosure above, while adhering with AACAP’s disclosure requirements, may be considered to belie the following:

Re Keller and Ryan approaching GSK Marketing for Funding (1995)
“Although the rationale for investigating long term outcome has merit, we in Clinical Research have been steadfast in not committing any resources or support to the post treatment follow-up project. We have repeatedly told Drs. Keller and Ryan that our commitment was to the main study only. ) But Keller and Ryan continue to press their case. Keller approached U.S Marketing directly, and according to Keller, U.S. Marketing has agreed to grant funding of $25,000 for 1995, increasing to $75,000 in 1996. The total costs for the full naturalistic follow-up period (which could be operational for the next 5 years) would be between $500,000 and $600,000?
http://dida.library.ucsf.edu/tid/upu38h10

Ryan and colleagues approaching GSK for further funding, and their characterization of Study 329 (2002)
“As you had suggested in our recent phone conversation, Dr. Birmaher, Dr. Ryan and I are proposing some post hoc analyses of the recently published study of paroxetine in adolescents with major depressive disorders (MDD) (Keller et al., 2001). Dr. Birmaher had presented some interesting findings at last year’s American Psychiatric Association meeting about the effect of comorbid disruptive behavior disorders on treatment response in the trial (Birmaher et al., 2000). We would like to reconsider these findings with a few additional statistical analyses, hoping to disseminate them to a larger clinical and research audience.”
“The recent paper (Keller et al., 2001) reported that paroxetine demonstrated efficacy over placebo in the overall sample, while imipramine did not. Additional analysis about the treatment responses of these comorbid subgroups would be of great interest to clinicians and researchers alike, and give Glaxo Smith-Kline the chance to remind practitioners that this study demonstrated paroxetine’s efficacy in an arguably more representative, comorbid sample of adolescents with MDD”
“Glaxo Smith Kline will certainly have the chance to review any abstracts or papers from these analyses before they are submitted for peer review and publication”
“We are excited about the possibility to shed further light on what has already been a landmark study in our field, and look forward to further discussion with you and others at Glaxo Smith Kline about these proposed analyses.”
http://dida.library.ucsf.edu/tid/vru38h10

 
Annonymous August 27, 2012 | 2:58 pm
 
Correspondence involving Ryan, Keller, Wagner (Emslie?) responding to GSK’s possible interest in distancing themselves from Study’s 329?s Initial Presentation of Information.(2004)
http://www.healthyskepticism.org/files/docs/gsk/paroxetine/study329/20040204RyantoKellerStrober.pdf
http://www.healthyskepticism.org/files/docs/gsk/paroxetine/study329/040514KellertoCarp.pdf
http://www.healthyskepticism.org/files/docs/gsk/paroxetine/study329/20040413KellertoRyanetal.pdf

Keller states in the June 2004 to Ryan, Strober, Emslie, and Wagner:
“we are not without leverage if we are dissatisfied and want to play a little hardball of our own.”
“if we want to fight that battle we will have to go to senior management. I am willing to do that if we agree that after the changes are made to this draft we are still hung out to dry.”
“so that it is 100% clear in this paper that there is no way to read it and think that 329 is being criticized and that it was not written with complete integrity and accuracy given the data we had and should have had as investigators, on the part of investigators and our collegues from SK who worked on it.”
“otherwise we would look foolish, naive, incompetent, or “biased” (the most likely accusation that will be made) to present things in a way that was favorable to SK, disregarding our responsibility to the proper scientific method, to the public, children and their families.”
After Keller discussed going to more senior management in October 1999 about SKB McCafferty’s holding up the 329 JAACAP manuscript, in November 1999 the manuscript was submitted.
In April 2004 GSK’s Carpenter is stating “there is a corporate need/obligation to communicate the key safety and efficacy data from all of these studies to the medical community in a manner which is consistent with the newly revised labeling ASAP. Consequently we have drafted a “review” manuscript which we hope to submit for publication very soon (attached below for your review). This paper presents the key efficacy and safety data for each of the studies individuallyl and it also presents the results of analyses of the pooled dataset (all three studies combined).”
In June 2004 Keller then discusses possibly going to senior management if “dissatisfied.” This apparently out of concern that they could be viewed as “disregarding our responsibility to the proper scientific method, to the public, children and their families.”

 
Mickey August 29, 2012 | 9:58 pm
 
Evaluation of Suicidal Thoughts and Behaviors in Children and Adolescents Taking Paroxetine
by Alan Apter, M.D., Alan Lipschitz, M.D., Regan Fong, Ph.D., David J. Carpenter, M.Sc., Pharm.D., Stan Krulewicz, M.A., John T. Davies, M.Sc., Christel Wilkinson, M.Sc., Philip Perera, M.D., and Alan Metz, M.D.
JOURNAL OF CHILD AND ADOLESCENT PSYCHOPHARMACOLOGY 2006 16[1/2]:77–90.
Do you have a sense of what, of anything, was missing from that presentation of the data now that you have fuller access to the data.
Not yet, but I’m thinking about it. I’m not sure this paper is the same as the one they were emailing about. It might be a version modified by their complaints. It ends with:
“We are grateful to Karen Wagner, M.D., and Neal Ryan, M.D., for their assistance in reviewing and classifying the blinded case narratives…”

And, then there is this irony:
American Academy of Child & Adolescent Psychiatry, Oct. 28-Nov. 2, 2008
“Another theme of the meeting was the relationship between the academy and the pharmaceutical industry, Ryan said. During a plenary address, Catherine D. DeAngelis, M.D., editor of the Journal of the American Medical Association and recipient of the academy’s annual “Catcher in the Rye Humanitarian of the Year Award,” delivered a speech entitled “Conflict of Interest in Medical Research: Facts or Fiction.” “She addressed the importance of ensuring that studies are well-reported with correct statistical analysis and talked about some of the things that have gone astray in some publications,” Ryan said.
“Dr. DeAngelis has demanded that the medical community re-examine and reflect on conflicts of interest to assure transparency and she continues to raise the bar on behalf of quality research being delivered to families,” AACAP president Robert Hendren, D.O., said in a statement.”
http://www.ecommunity.com/news/physicianstory.aspx?id=620928

Contrast:
http://www.spine.org/Documents/TSJJune2011_Carragee_etal_Editorial.pdf

to this:
” In response to their request to see the author’s reaction, the editor of JAACAP who had accepted this article, Dr. Mina Dulcan, responded with a nasty-gram for all times… Dr. Dulcan’s letter says, “Many highly expert child and adolescent psychiatrists were participants in that study, and others that were similar, and others equally expert contributed to the review process.” And when interviewed by Panorama, she said, “We rank, and this is a worldwide ranking, we rank number one in child mental health and number two in paediatrics” and “Oh I don’t have any regrets about publishing at all. It generated all sorts of useful discussion which is the purpose of a scholarly journal.”
http://1boringoldman.com/index.php/2012/09/04/the-lesson-of-study-329-naked-emperors-fractious-queens/
Full letter also here:
http://www.healthyskepticism.org/files/docs/gsk/paroxetine/study329/Dulcan.pdf

Keep in mind that Dr. Dulcan would not have been able to greenlight the 2001 abstract unless some person(s) at AACAP believed her to be the best person to act as the journal’s guardian. Nor would she then have remained the journal’s guardian from 2002-2007 unless some person(s) at AACAP continued to believe this.

“Mina K. Dulcan, M.D., editor extraordinaire, 1997-2007.”
“Her decisions and leadership were always thoughtful and measured. She chose her battles well, stood her ground, and let the science shine through.”
– Virginia Anthony and Dr. Robert Hendren
http://psycnet.apa.org/psycinfo/2007-18374-001

And then there is the current editor of the journal:
http://1boringoldman.com/index.php/letter-to-dr-andres-martin/
And the editorial listed above:
http://www.aacap.org/galleries/transparency-portal/February%202008%20-%20Martin%20Editorial%20COI.pdf
Will he be felt by AACAP to be the best person to act as the journal’s guardian for a full decade as they did with Dulcan?

Plus that Dr. Bennett Leventhal refers to AACAP’s requirements for disclosure in glowing terms:
http://www.aacap.org/cs/AnnualMeeting/2012/operating_principles

While Paul Thacker characterizes disclosure requirements that match AACAP’s I the following terms:
“And Thacker cautions that industry lobbying will attempt to influence the final outcome. “My fear is that they’ll go for the most watered-down version and only require disclosing conflicts in the last two years, or not require actual relevant dollar amounts,” he says.”
http://www.pharmalot.com/2012/11/one-stop-shopping-proposed-for-conflict-disclosure/

The behavior of these professional societies is very unlikely to change in any substantive manner unless issues of their governance are addressed. Without a sustained and concerted effort to change that governance we are facing another 15 years of more of the same. It remains to be seen if there are any groups within, as well as outside, these societies that have both the will and the means to mount such sustained efforts effectively.

Voices of dissent are not being heard from within the AACAP, within the APA, or a number of other organizations. The extent to which that is because they largely don’t exist vs are not allowed by the current heirarchy (which appears to resemble more an oligarchy covered in the trappings of democracy) remains unclear.

It is clear that if those voices exist within these organizations they have not done an effective job in shaping the bylaws of their organizations so that they can be heard.

In 2012, in the context of the 2008 Grassley investigations and the 2009 Forest lawsuit and the 2012 GSK settlement …etc, Dr. Leventhal speaking for AACAP says:
“AACAP has long been a leader in managing disclosures and potential conflicts of interest that can and do interfere with objective conduct of science and clinical practice.”
and
“In this time of our own careful attention to transparency, disclosure, and integrity, you should be proud to have been at the vanguard of setting and maintaining principles and guidelines for behavior. We hope that you will continue to support our collective effort. Thank you for taking this matter seriously. It is your attention to these details that make us stronger and leaders in the ethical practice of medicine.”

“AACAP has long been a leader in managing disclosures and potential conflicts of interest that can and do interfere with objective conduct of science and clinical practice.”

This is the voice of the current governance.

Institutions like the Edmund J. Safra Center for Ethics, and individuals such as Paul Thacker, can investigate and publish as much as they want, but reaching out and empowering organizational change within these institutions that alters the hegemony might go further towards achieving real change in these organizations.

Might give scientists and clinicians who do not agree with the assessment above, and the parallel ones mouthed across like-minded organizations, some hope that real change can be achieved and might give them some ability to enact it.

Those who would like to feel a true pride. A true sense of being at the vanguard. A sense of integrity that scientists and clinicians continue to yearn for despite all that has passed. A path for being both collegial and feeling true to that sense of integrity. An ability to read the literature without having to exercise the cynicism it currently demands.

http://www.spine.org/Documents/TSJJune2011_Carragee_etal_Editorial.pdf

Phenomenal. Do no harm.