While there’s reason to be encouraged that awareness of the invasion of Medicine by the Pharmaceutical Industry is increasing and, at least in Psychiatry, PHARMA is moving away from flooding the market with CNS Drugs, there remain huge forces supporting the inappropriate medication waves that have played havoc with the rational practice of Medicine. One such force is the lucrative Clinical Research Industry – represented by the Association of Clinical Research Organizations [ACRO]. They seem to have a finger in almost every pie you can think of, and the plates are spinning at light speed. One of their central issues is Globalization of Clinical Trials for the obvious reason that it’s easier to outsource Clinical Trials abroad because of recruitment, cost, and speed. Take a look at this scientific article showing that these trials are equivalent to US trials. Don’t miss the Conflict of Interest statement at the end:
Declaration of Conflicting Interests:
The author(s) declared a potential conflict of interest with respect to the research, authorship, and/or publication of this article: Dr Desai is a member of Shivani Enterprises Inc, which serves as a consulting organization to the Association of Clinical Research Organizations (ACRO) on a contractual basis.
But they’ve got their tendrils in every issue. One interesting place to look is their Partnerships – there’s an organization lobbying for the other side of every issue you can imagine. For example, the front burner issue these days is Data Transparency. Well, check out the International Pharmaceutical Privacy Consortium [IPPC] – spinmeisters using patient privacy as an excuse for data secrecy. Take a look at their Membership. Or have a gander at a few of ACRO’s updates spread thoughout 2012:
| ACRO UPDATES | |
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| December 12, 2012 | Peddicord Elected to CDISC Board |
| November 28, 2012 | ACRO Statement Regarding Access to Medicine Index |
| September 27, 2012 | Television’s Assault on Medical Research |
| September 14, 2012 | ACRO Comments on PCORI Methodology |
| September 13, 2012 | Physician Payment Sunshine Statement |
| August 14, 2012 | New ACRO Video Series Debuts |
| July 18, 2012 | Statement on European Clinical Trial Rules |
| July 12, 2012 | No Regional Differences in Quality of Clinical Trial Data |
| June 6, 2012 | ACRO Pushes Global Trials Language in PDUFA |
| May 16, 2012 | ACRO Takes To Video To Advise FDA on Innovation |
| April 20, 2012 | ACRO Testifies to FDA on Clinical Trial Modernization |
| March 19, 2012 | ACRO Launches YouTube Channel |
| March 2, 2012 | ACRO Comment on Dateline NBC |
| February 17, 2012 | ACRO Comments on PCORI Research Agenda |
| February 17, 2012 | ACRO Comments on Physician Payment Sunshine |
| January 3, 2012 | ACRO Comments on Washington Post Article |
If you’re writing a dissertation on the use of spin in business communications, you’ll never find a more concentrated place for examples than this web site [backed by a 30 Billion Dollar industry].
You are concerned about the “forces supporting the inappropriate medication waves that have played havoc with the rational practice of Medicine,” you speak in the last post of the psychotropic medication practices re chidren and at the end you stated “Sunlight is the best disinfectant”…
You speak of opponents. With friends like these …
I urge you and Dr. Carroll to shine a light on this, before it becomes a done deal:
Looking further at Neal Ryan, Melissa DelBello, …etc and AACAP brings up this:
A project called Back to Project Future that is meant to chart AACAP’s course for the NEXT 10 years. The BPF is “developing a consensus around priorities and action steps for AACAP in three key areas: Service/Clinical Practice; Training and Workforce; and Research. The project will be completed when its report is submitted to the AACAP Council for consideration at the 60th AACAP Annual Meeting in 2013.”
http://www.aacap.org/cs/media/view_news_release?pressrelease.id=1484
This is the Research Subgroup:
Neal Ryan, Leader
Kiki Chang
Melissa Del Bello
Mary Margaret Gleason
Young Shin-Kim
Daniel Pine
John Walkup
Bonnie Zima
http://www.aacap.org/galleries/default-file/BPF_FAQs.pdf
This looks a lot like a team you’d put together to discuss prophylactic psychopharmacology of very young children, as delivered by primary care providers, to target possible emerging mood and autistic disorders.
Recall that it is Dr. Neal Ryan who said:
“Q: Do you think the prescription of antidepressants by family MDs and pediatricians are part of the problem?
A:No. I think it is critical that we find treatments that primary doctors can use. They are the 1st line of therapy for uncomplicated depression.”
http://apps.psychiatry.ufl.edu/Newsletters/Archive/Ryan/ryan.html
Then there is always the fact that he was one of the 2 main psychiatrists behind this:
“19. Study 329 did not show that Paxil was more effective than a placebo on either of its primary endpoints or any of its predefined secondary endpoints.” Yet he allowed this study to be used after its publication in 2001 to heavily promote the use of paroxetine (at the expense of fluoxetine which is what was being pushed by GSK’s competitor at the time) in depressed youth. Referencing it in 2002 as follows (when attempting to elicit further funding from GSK):
“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://www.justice.gov/opa/documents/gsk/us-complaint.pdf
page 5
http://dida.library.ucsf.edu/tid/vru38h10
In addition to everything else you’ve detailed about Study 329 here.
1BOM, the behavior exhibited 10 years ago by Dr. Neal Ryan et al in Study 329 defined some of the tone of what followed in those next 10 years. This is who the AACAP has selected as the leader of the group that will propose the research priorities that will help shape the AACAP and the field for the 10 years to come.
Forum discussion involving Dr. Kiki Chang and sponsored by Astra Zeneca:
“Therefore, one of the fundamental problems that needs to be addressed is how to treat patients earlier before the illness progresses. Early diagnosis and treatment is an increasing challenge as the age of onset of illness decreases to adolescence and even young children. The notion of recognizing the illness earlier and treating it with sustained long-term prophylaxis to avoid developing rapid cycling has considerable merit.”
http://www.cnsspectrums.com/aspx/articledetail.aspx?articleid=861
Dr. Melissa DelBello“Preventative strategies for early-onset bipolar disorder: towards a clinical staging model.” 2010 PMID:21090835
Early screeing and intervention are areas of expertise for Drs. Mary Margaret Gleason and Bonnie Zima
In light of the last 10 years we will not be able to say in 10 years that we didn’t know what was coming.
What is a thing you can do? Shine a light on all this.
anonymous
Thanks for sharing–it is truly frightening what the AACAP’s plans are for children. I can’t help but wonder how many parents will be caring for adult children disabled by early phophylactic treatment.
These are the same idiots that determined (after the third Senate investigation) that monitoring the ongoing off label drugging of kids and counting the bodies was the best course of action…
Correction: Dr. Neal Ryan in that 2002 correspondence with GSK was not asking for more funding. He was asking for access to the data from the study.
http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=292
Health Care Renewal has a recent piece on impunity and its corrosive effects. Reading that piece I was reminded of Dr. Neal Ryan anf of these:
His going around, along with Dr. Martin Keller, SKB’s hesitancy to fund more work related to study 329 by going directly to the marketing department.
The letter he authored to JAACAP
Dr. Karen Wagner’s related promotion of paroxetine over fluoxetine for adolescent depression.
The correspondence with Keller when GSK wanted to be more open about the adverse effect data.
His references to when Dr. Angell In 2008 “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,”
The AACAP depression practice parameters in 2007, including Wagner and other 329 authors, and not even referencing the 2001 AACAP paper.
AACAP picking him for their AACAP consensus panel on conflicts of interest ethics (along with DelBello) in 2008.
This was his disclosure at that time:
“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.”
No statement of regret after the 3 billion dollar settlement by GSK earlier this year where exhibit 1 was his 2001 JAACAP paper that is referenced heavily in by the DOJ, including in item 19 above.
He is now leader of the group mapping out the future of child psychiatry research for the next 10 years.
Back to Project Future will truly be back to the future.
Do you think AACAP is likely to show any concern given that the head of the AACAP ethics committee signed off in 2006 stating that she had the utmost respect for Dr. Charles Nemeroff’s ethics:
“Due to Dr. Nemeroff’s extremely productive and successful career as a leader in academic psychiatry, he and others like him are asked to be on the boards of many pharmaceutical firms specializing in central nervous system agents. Through such collaborations, the development and testing of novel treatments are greatly enhanced and the safety of research subjects strengthened. Yes, these companies must make profits, but they also share with researchers a desire to find scientific truth, which usually isn’t as clear-cut as many believe. The overwhelming majority of academic researchers are proud of their independence and are dedicated to advancing their fields through quality research. At a time of diminishing funding, does it not make sense for industry-sponsored support to provide a viable alternative, especially if available in a no-strings-attached way with sufficient academic research oversight?
We are academic psychiatrists and researchers who are colleagues of Charles Nemeroff, and we have the utmost respect for his science and ethics. Some of us receive research support from pharmaceutical companies, some from federal agencies, some from both and some from neither. All of us want the best for the fields of science, medicine and psychiatry in their endeavors to better humanity.”
Do you not believe that The same actions taken over the last 10 years will be played out with impunity over the next 10?
As that first reference states:
“When you have a trial with so many distinguished investigators from elite institutions appearing in a top-notch psychiatric journal, it sends the message to those reading it: prescribing neuroleptics for similar patients is alright.”
This is possibly one of the kinds of “reminding” Dr. Ryan was referencing above when discussing above in his correspondence with GSK about using the Study 329 data.
Can you shine some light? As you know, there are different forms of transparency to care about. Please shine some light while there is still a slim chance it will make a difference. So this does not play out with total impunity. That there is a consideration of whether the approach brought to bear for the last 10 years by these academicians is the approach clinicians wish to see brought to bear in undiluted form for the next 10.
Greetings people! I have lately published an article , I can even call it a research about quite related subject . There is not much relevant info on that, but I`ve managed to find some on mobile phone jamming here .
http://neuroskeptic.blogspot.com/2012/12/neither-drugs-nor-therapy-prevent.html
http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=292
There are no voices in child mental health warning against this.
Would encourage also reading the comments section of the Neuroskeptic link.
We’re heading towards debates like these for toddlers:
http://www.healthnewsreview.org/2012/04/dueling-viewpoints-should-a-healthy-middle-aged-man-with-elevated-cholesterol-take-a-statin-drug/
Might delete the “Greetings people!” comment above which is clearly from a spambot.