We’ve recently witnessed something rather remarkable – the Romney
video.
I’ve sworn off blogging about politics and this is no exception, I have another point in mind. I used up my political blogging libido during the second Bush term. The point I want to make has to do with transparency.
I expect that most of us sort of knew that Romney felt the way he spoke behind the closed doors of a private fund raiser. In some ways, he’s the most honest of the modern conservatives, so his views are relatively public even when sanitized by his speech-writers. But what’s remarkable is what happened when he said it in person on a public video. It made what was suspected into something very real. But how did it happen?
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1994: Tim Berners-Lee creates html [the "World Wide Web"]
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1996: 1boringoldman’s first Internet connection and email
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1996: PubMed introduced
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1998: Google incorporated
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2000: ClinicalTrials.gov
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2005: YouTube incoporated
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2007: iPhone introduced
When Martin Keller and Neal Ryan proposed what became Study 329, there was no World Wide Web. When they actually did the clinical trial, there was no ClinicalTrials.gov. And yet in the 1990’s, we thought of ourselves as living in the Information Age. Now apply those dates to these two charts:
When Alex Gorsky was deposed in May, he was questioned using subpoenaed emails – it probably never occurred to him that they would’ve seen the light of day. Mitt Romney had no clue that his private fundraiser would have an iPhone in the audience that would record his speech for YouTube. And some of our most popular television shows [the ones I call bad-person tv] count on on the ubiquitous CCTV cameras, access to vast databases, and DNA evidence to catch the bad guys, instead of our classic reliance on brilliant eccentric detectives. We live in an time beyond the age of information, it’s becoming an age of accountability that could barely be imagined even ten years ago.
There are some interesting posts on
Pharmalot today, among them
The Op-Ed: A Suggestion to Restore Faith in Pharma Studies is a call for clinical trial data transparency that comes from a different perspective than my own. Dr Harlan Krumholz of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation points to a recent NEJM article saying:
A study in this week’s New England Journal of Medicine reveals that industry sponsorship of clinical trials negatively influences physicians’ perceptions of the study quality and their willingness to change practice based on the results.
Now there’s a study I’d believe without even bothering to read it. He goes on to say:
Unfortunately, the result serves as an impediment to progress. The pharmaceutical industry is replete with respected and dedicated scientists who devote their professional lives to advance our ability to prevent and treat disease. Many landmark trials owe their support to the pharmaceutical industry. Many of these professionals are undoubtedly frustrated that their efforts may be less valued due to general impressions about industry.
Society depends on sponsorship by the pharmaceutical industry. It is the largest funder of biomedical research, accounting for about $40 billion and is responsible for supporting about a third of the studies in the government registry of clinical trials. The current environment of mistrust does a disservice to both society and industry. If physicians negatively perceive a study based on sponsorship, then it is likely that many good studies will be ignored and the translation of science into practice will be slowed.
Restricted access to industry data is, I suspect, an important factor that contributes to the lack of confidence in industry-sponsored efforts. Studies are kept behind closed doors and problems become public primarily when data are revealed through litigation. Calls for voluntary data release usually go unheeded…
Dr Harlan Krumholz is an Internist, and what he says might be applicable to Internal Medicine. I don’t even question that the "pharmaceutical industry is replete with respected and dedicated scientists who devote their professional lives to advance our ability to prevent and treat disease." But as for psychiatry, when I look at the charts posted above, there’s no single drug on the list that didn’t employ major scientific deceit in its marketing, and I can document most of those accusations with previous blog posts on this little out of the way blog. My problem isn’t with the "respected and dedicated scientists," it’s with the marketing departments and the executives that created a layer of deceit that has taken decades to expose.
Most of my professional friends and colleagues are "respected and dedicated scientists," psychiatrists and other mental health practitioners whom I’ve known for years and who have made their life’s work helping people with significant mental problems have better lives – as hard as that is to do in the modern world. But I would never mount a defense of psychiatry based on those people, because those who’ve shamed psychiatry in the last several decades actually do exist, and so long as their influence is felt so strongly, the specialty will live under a recurring dark cloud.
My call for transparency is for two reasons. First, it’s because it’s finally possible eg the first section above. The mechanisms for accountability are in place now. We didn’t have that when these drugs flowed from the pipeline and people with questionable motives had their field days. So we actually can avoid the all-to-well documented misadventures of the past. Second, the amount of lousy and deceptive scientific publication in the last thirty years is a matter of public record. It’s the Augean Stables I spoke of in an earlier post. It needs to be cleaned out or at least clarified. In the realm of psychopharmacology, we need an accurate compendium of what the drugs really do for and to the people who take them. We don’t have that right now. Transparency about the data from the past would go a long way towards setting the record straight. I am not swayed by this argument, "The current environment of mistrust does a disservice to both society and industry. If physicians negatively perceive a study based on sponsorship, then it is likely that many good studies will be ignored and the translation of science into practice will be slowed." In psychiatry, that’s not true. "translation" is out, accountability is in. For us, the "current environment of mistrust" is a hard-won position still not widely enough accepted to have the necessary impact.
From my perspective, I would levy the same complaint towards the Third Party carriers. They’ve so misshaped psychiatry that it can’t really be practiced effectively right now, even by the best of our ranks of any theoretical persuasion. A little transparency in that direction would be a breath of fresh air. Managed Care has not been held accountable. People complain that their doctors don’t talk to them anymore, don’t spend enough time evaluating them. That is absolutely true for very demonstrable and concrete reasons. But there’s no way to mount an argument from within the wounded psychiatry of the present to oppose that force. If it is to be countered at all, it will have to come from the outside, and I just don’t hear any voices right now. So the only right thing to do is fight the enemy we know how to fight…
Here is a comment that I just posted on Pharmalot challenging Harlan Krumholz and endorsing Mickey’s point of view.
As the saying goes, a really effective new drug will sell itself, driven by the experience of patients and prescribers. For such products, marketing is an afterthought. Our problem in psychiatry is that marketing is deployed to create the deceitful impression of efficacy and safety for compounds that offer little true therapeutic advance. The campaign for use of atypical antipsychotic drugs in nonpsychotic depression is a classic example. I have written extensively about this example on the Health Care Renewal blog.
And at the same time, marketing is deployed to trash really effective old drugs that are off-patent. There is no better example of this than the desuetude of lithium in mood disorders, even in classic bipolar disorder.
So, I disagree with Harlan Krumholz that “…many good studies will be ignored and the translation of science into practice will be slowed” because of the funding source. We don’t need to lament the hurt feelings of good scientists who work in the corporations. Rather, we need to lament the rise of experimercials at the expense of real clinical science.
Thanks. I wish I’d said it that clearly…
My impression is that in areas outside of what Dr. Healy calls lifestyle drugs [eg statins], the medications in general medicine are handled more scientifically. In psychiatry, the silly business has been with the mainline drugs. So I’m giving Krumholz the benefit of the doubt because he’s not in psychiatry. I may be being too generous in that assessment…
1BOM,
It filled me with hope to read your post on accountability.
Then I thought of this question: Can you name one child psychiatrist linked to Study 329,the legal action against GSK, the legal action against Forest, or targeted by Thacker, who has suffered any significant career consequences as a result? Encountered any mistrust that they would really care about in the long run? Grassley tried to go after their eligibility for NIH funding, something that would have made a difference, and failed.
Dr. Neal Ryan
Dr. Karen Wagner
Dr. Melissa DelBello
Dr. Jeffrey Bostic
Dr. Mina Dulcan
This for Dr. Joan Luby:
http://www.cbsnews.com/8301-505123_162-42842712/updated-doc-who-urged-antipsychotics-for-3-year-olds-funded-by-j038j-az-and-shire/
http://www.furiousseasons.com/archives/2009/09/more_possible_nondisclosures_for_depression_in_3yearolds_researcher.html
Same one who shows up with Dr. DelBello here:
https://aacap.confex.com/aacap/2012/webprogram/Session9023.html
and here:
http://www.thebalancedmind.org/about/staff/cabf-scientific-advisory-council
“current environment of mistrust”
Can you name a single “respected and dedicated scientist” you know in American child psychiatry (know personally, know of, anything) who experiences mistrust when seeing those names? Maybe Biederman has developed a bit of name recognition, but he’s still going strong.
All of them are flourishing and outlasting their critics:
There’s your information regarding Thacker: “But I’m not working on pharma issues. I’m doing a book project about the hill.”
There’s this about Healthy Skepticism:
http://brodyhooked.blogspot.com/2012/09/healthy-skepticism-in-peril.html
I guess Jureidini and Healy are still going strong. I wonder in 5-10 years what presence they will have in the landscape of American child psychiatry compared to the others above. They managed to obtain the black box warning for SSRIs. They won that battle. And the war?
Re pharmaceutical companies, even if the penalties were insufficient there are examples of some impact to point to. For any of these child psychiatrists? Anything?
It’s disheartening to see Thacker having moved on.
You earlier referred to thin ice and that once things go bad they go downhill in a hurry.
Thin ice?
Again, can you name a single “respected and dedicated scientist” you know in American child psychiatry (know personally, know of, anything) who experiences mistrust when seeing those names? A single one who speaks to how apt your Augean Stables analogy really is, to how terrible the child psychopharmacology literature has become?
We’re lucky to have your voice. Particularly since you are a zealot (and this is what is needed) and your posts are impassioned without being harangues (I do not say the same for my comments).
But, how can a mostly retired adult psychiatrist living out in the woods, and sometimes treating adolescents, learned though he may be, be the closest we get?
Seriously? It’s like falling through the looking glass.
The behavior of Drs. Ryan, Wagner, DelBello, Bostic, …etc. American child psychiatrists could not care less. 8000 of them. You can Google till your fingers bleed and you can’t find one prominent american child psychiatrist (I’m not even sure you can find one obscure one) who directly criticizes the actions of those individuals and/or AACAP. And, no one who matters to them cares that they don’t care.
Not
a
one.
It’s like the tree falling in the forest question. Who’s listening? Who cares?
I’m not sure why the site again blocked the last comment. Perhaps the site has an automatic Harangue detector.
Well said.
Steve Licas
I too was struck by the “pharmaceutical industry is replete with respected and dedicated scientists who devote their professional lives to advance our ability to prevent and treat disease” sentence. I’ve seen this general “good people stuck in a bad system” meme echoed repeatedly as of late in articles regarding the pharma scandals, from both apologists and antagonists. Not sure if it’s a coordinated construct to minimize the obvious corruption or simply lazy cliche usage. Either way it’s BS.
There’s a real problem with this line of thought. By blaming the system, it absolves individuals of the multitude of unethical personal decisions that in aggregate form “the system”. Can a truly good person continue to participate in a bad system? There are probably some that honestly believe theirs is a noble profession. Far more likely are those that ignore obvious signs of a corrupt corporate culture as they have mouths to feed, kid’s college tuition to pay, or just simply enjoy their Hawaiian vacations. While this is understandable behavior, it hardly qualifies as good. Indifferent might be a better description. “Indifferent people choosing to participate in a bad system for personal gain” doesn’t quite have the same ring to it.
Never give up. Never. There are excellent child and adolescent psychiatrists ‘out there,’ and we need many more. The ‘sicker’ our society becomes, the more help we and our children will need. The ability to tolerate ambiguity must be learned, modeled, and taught both at home and ‘on the couch.’ Parents are working together to create safe ‘places’ for each other, venues where challenges are elucidated and solutions proposed. Many of these ‘places’ are within the confines of land-based Virginia Satir-and-CBT-variant therapists’ offices, and there are many more online ‘virtual communities.’ For those of us who cannot afford therapy, adaptations of the Twelve Steps of Alcoholics Anonymous (along with the online- and land-based meetings/fellowships) are being used as a successful problem-solving model. Anyone who is not suffering from a degree of ‘cognitive dissonance’ as a result of trying to live–let alone, thrive (especially with limited financial resources) in our nation/world as it is today–is in my view emotionally ill. We must work together, as families, communities, and therapeutic alliances, of we will certainly ‘hang separately.’ End of Rant 🙂 P.S. I have bipolar disorder, hypomanic; three of my five children are similarly ‘spectrally gifted,’ and escaped from formal schooling at around age 15, and although still ‘works in progress,’ all five young-to-middle-aged-adults are doing well (stable relationships/moderately well-paying jobs/twelve-step programs/supportive therapeutic help/etc.). Thank you and God bless to all the mental health professionals who have guided us.