In our continuous series about undeclared conflicts of interest comes a great blog post from the Wall Street Journal. In it JAMA’s editor in chief, Catherine DeAngelis, M.D, interviewed about a certain Jonathan Leo, had these choice words to describe him:
“this guy is a nobody and a nothing. He is trying to make a name for himself. He should be spending time with his students instead of doing this.”
Jonathan Leo is Associate Professor, Neuroanatomy & Assistant Dean of Students, DeBusk College of Osteopathic Medicine. Compared to me, that is hardly nothing! When you’ll have read the cause of Dr. DeAngelis clear anger, a remarkable letter to the BMJ from March 5, entitled “Clinical Trials of Therapy versus Medication: Even in a Tie, Medication wins” you’ll agree that we should all be proud to be declared “a Nobody and a Nothing”.
It is a fine example of why we must remain constantly vigilant about published articles in even the best peer-reviewed publications. In his letter to BMJ, Leo wrote:
Central to the idea of evidence-based medicine is that the choices made by patients and doctors to use a certain treatment should at least in part be based on scientific studies published in peer reviewed academic journals. For a patient diagnosed with a mental disorder, the choice often comes down to whether to use behavioral therapy, psychotropic medications, or a combination of the two. We think the following story will shed some light on how conflicts of interest can complicate the decision making process.
He then went on to demonstrate that:
- the study results were unclear and another fine example of the abuse ofstatistical illiteracy to convey inaccurate theories.
- the authors where either responsible of an outright deceipt or of an involuntary omission (yeah, right!). One of them had been on the Speakers Bureau list of the pharma company producing the drug mentioned in the study.
- he had contacted JAMA to inform them of the omission of this conflict of interest in the published paper, in clear violation of the journal’s own conflict of interest policy.
It took five months for JAMA to publish that letter along with an acknowledgement from the original authors that indeed the difference between therapy and medication was not statistically significant. But if you go and read the abstract you’ll still read the following:
Objective To determine whether treatment with escitalopram (Lexapro) or problem-solving therapy over the first year following acute stroke will decrease the number of depression cases that develop compared with placebo medication.
Conclusions In this study of nondepressed patients with recent stroke, the use of escitalopram or problem-solving therapy resulted in a significantly lower incidence of depression over 12 months of treatment compared with placebo, but problem-solving therapy did not achieve significant results over placebo using the intention-to-treat conservative method of analysis.
[Emphasis added]
Reading the full text article, you’ll find out that the study was financed by a grant from the NIH.
Your doctors, almost certainly don’t have the time, and most do not have the inclination to challenge what is published in JAMA, NEJM or any other major medical publication. Too often, I am afraid, they have lost the ability to be critical of their peers. As informed and engaged patients, this role has now fallen squarely on you.
The moral of this story is summarized in the fact that after making the demeaning comments about Jonathan Leo and after putting unacceptable pressure on him, his superiors and his academic institution, JAMA published, on March 11, the following letter from the original article authors:
Incomplete Financial Disclosure in a Study of Escitalopram and Problem-Solving Therapy for Prevention of Poststroke Depression
To the Editor: We would like to report an incomplete financial disclosure in our study of escitalopram and problem-solving therapy for prevention of poststroke depression, resulting from erroneous recollection of the appropriate dates for speaking presentations sponsored by pharmaceutical companies and ownership of pharmaceutical stock [….]
In September 2003, Dr Robinson received financial support for expenses from Lubeck to present his research data at a meeting of the Consultation Psychiatrists of the European Union in Spain; no honorarium was paid. In October 2004, he received honoraria and expenses for 2 presentations in Tucson, Arizona, which were sponsored by Forest Laboratories and paid through the intermediary, Sudler and Hennessey, New York, New York. He was a member of the speakers’ bureau for Forest Laboratories in 2004 and perhaps 2005, but this was the only presentation during the 5-year reporting window from 2003 to 2008. In November 2004, he was paid an honorarium and expenses for participation in and speaking at a meeting in Houston, Texas, as part of the Pfizer speakers’ bureau training program. In January 2005, he presented a lecture in Davenport, Iowa, for which he received an honorarium and expenses paid by Pfizer. Dr Robinson tried to obtain from both Forest Laboratories and Pfizer Pharmaceuticals the period of time they considered him to be a member of their speakers’ bureaus, but the companies did not respond.
[Emphasis added]
We would like to apologize to the editors and readers of JAMA for our failure to report these financial disclosures in our article. Although Forest Laboratories provided honoraria and expenses through their speakers’ bureau for Dr Robinson, neither the design, analysis, or any of the expenses (including the cost of medications) of our study were supported by monies, materials, or any intellectual input from Forest Laboratories. We sincerely regret this lack of transparency in our initial disclosures that resulted from these errors of memory.
Gimme a break! You really believe that providing this forced letter will change anything? Is the main author suffering from Alzheimer disease? Should errors of memory be an acceptable and scientific explanation for forgetting about conflict of interest rules but remembering all the good stuff about the drug you are touting with conflicted science? Did the author suffer from errors of memory when he told AP: “I hope I don’t have a stroke, but if I do, I would certainly want to be placed on an antidepressant.” That AP story starts with:
Doctors may want to give stroke victims antidepressants right away instead of waiting until they develop depression, a common complication, new research suggests.
As mentioned by another blogger Dr. DeAngelis is the 2009 recipient of the American Academy of Child and Adolescent Psychiatry (AACAP) Catcher in the Rye Humanitarian of the Year Award because of her leadership on discussions of conflicts of interest in medicine.
The drug company, Forrest laboratories, is currently being sued by the U.S. Department of Justice for, among other things, the “placement” of positive news stories in the media about Lexapro.
Surrounded by such experts, I’ll repeat:
I am a nobody and a nothing, and I am proud of it!
In the old days (like last year?) someone like Catherine DeAngelis could have gotten away with such a “nothing” statement because it would have stayed on the inside — among only DeAngelis, Dr. Leo and others with interest in that particular story.
But now? With social networking, blogs and the ease of information sharing, such statements are easily shared, easily outed — transparent.
The rules have changed. Exposure will force the old, conflict-of-interest guard to clean up their acts — or — they may (frighteningly) look for stronger, tougher, bunkers to hide behind.
It’s going to be a bumpy ride for the old guard. Being “nothing” will be a real advantage.
Three cheers for Dr. Leo.
Trisha Torrey
EveryPatientsAdvocate.com
Well, let’s call her out: Dr. DeAngelis, on what basis do you assert that Jonathan Leo is a nothing and a nobody? What right do you have to tell anyone, MD or not, to stay out of a discussion?
Really?
And, more to the point, how do you think telling people to butt out will improve the quality of patient care and outcomes?
The recent JAMA controversy is no surprise. JAMA was a major sponsor of recent Peer Review Congresses, subsidized to a large degree by several major drug companies. For one such congress, they wrote that discussions of ethics of peer review would get low priority, and, in fact, rejected a submission for the congress that was about ethics of peer review.
A major ethical issue of peer review and biomedical research is that of scholars/doctors being on the take from the drug companies. Obviously, DeAngelis did not want to hear about specific conflicts of interest at JAMA. The vicious personal attack against Leo would seem to indicate that he hit a raw nerve (in his role as prof. of neuroanatomy).
I think DeAngelis should resign, and JAMA should change their editorial strategy regarding scholarly debate and discussion.
Gordon, speaking as someone who’s trying to educate patients about being responsible partners in their care, the subject of possible corruption (yes that’s a strong word) in the peer review process is important to me.
But I don’t just want to rant; I want to be able to point thoughtful people to clear evidence (you should pardon the expression) of things like this.
So: do you have a link to where JAMA wrote that ethics would get a low priority?
Thanks – this is important. To me, anyway.
It strikes me that continued pharma support of JAMA or any other journal (no matter how directly or indirectly that takes place), will eventually serve to render the publication worthless. JAMA has been an ivory tower for a long time. But as we are learning in the news every day now, ivory towers don’t last forever. There will be no bail out of a long-standing, but corrupted, reputation.
I have already stopped referring patients to the articles in JAMA. Its reputation is already stained, not just for accepting, then refusing to disclose in a timely manner material that suffers from “errors of memory” – but for insisting they had nothing to come clean about. That’s the true definition of arrogance, and arrogance will only serve to bring them down faster.
And if I were a medical professional looking for a place to publish? If I didn’t want to disclose, I’d head straight to JAMA. But if I wanted to keep my objective, well-respected reputation intact? I’d be looking for publication elsewhere.
So where is Dr. DeAngelis? Does she think we’re not noticing?
Hey, Dave! Who are you? Probably just another nobody. Why do you think Dr. DeAngelis would ever pay attention to you or me? We are not those who pay for the journal. JAMA is not geared toward us.
Hi Dave;
I have been a lurker on your blog since the e-patient publication, so thanks for your efforts. I appreciate your efforts and the words of true wisdom from your followers, including Gilles. This issue of ‘I am a nothing’ is entering into discussions more and more often. A couple of years ago while attending a Patient Safety conference, I asked the question to an audience of healthcare professionals and industry reps the same thing. Are we treating patients as a Nothing. Stunned silence ensued only of which the statement was affirmed by the patients/consumers themselves and James Conway(IHI). Interstingly, some of the patients/consumers felt I was speaking about myself as opposed to the wider community. Afterwards, I brought this question to our ACOR members (thanks to Gilles). The question put to the survivours was:
“I am a Nothing”
Your Comments – how do you feel about this phrase?
Responses ranged from: “this person needs medical attention” to a direct quote: “I feel I am a nothing only in terms of fighting this
disease of ovarian cancer. I have never felt more
powerless in my entire life.” (quotes with permission but anonymous – my choice).
I left the patient safety communities for two reasons. One was due to the usual power infighting and the other and most importantly was a personal disagreement with the apology philosophy.
Patients are treated as ‘somethings’ very often by generous and caring healthcare professionals and then there are the others where ‘I am a Nothing’ means nothing and the statement is not understood.
Whether Patient or Professional, until we value the abilities, intellect and knowledge of all peoples, we will not progress.
So, like many/some of you, that black hole remains for only the few like Jonathan Leo who rise to the occassion but cannot escape the results. In Toronto, Dr Nancy Oliveri spoke out about a particular children’s clinical trial and was ostracized both by her peers and the medical community.
How to overcome these issues is elusive, which is not a helpful thought, but acknowledging each day that we hope for eventual truths. When is the question.
Dear Nothing,
Your story about Oliveri being ostracized reminds me of what my smartest friend said: “Science is a fashion business. Those who offend the current shared fashionable belief are shunned as if they were wearing last year’s shoes.”
I’m no student of that subject. He alluded to the book The Structure of Scientific Revolutions, and cited how people like Lister and Judah Folkman were trashed for decades (decades!) because they didn’t toe the line.
So what’s the e-patient takeaway? I think what patients need to realize is that if your butt is on the line and you need answers you can stake your life on, don’t listen to anyone who’s trashing anyone else. And do NOT presume that the peer reviewed clinical trial process is trustworthy.
It keeps coming back to “Who will vet the vetters?”
I have been known to say that authoritative publications will soon be dead.
They will become completely irrelevant if the Editors-in-chief keep having the elitist attitude that was acceptable before the advent of the participatory society.
Considering that JAMA is the journal of the AMA I would be more than surprised if they are ever able to embrace the democratization of knowledge. Just look at the incredible level of medical paternalism expressed in their patient pages.
After all, having expert knowledge that was historically not shared, has been the basis for the doctors compensation.
In any case, this latest JAMA snafu demonstrates once again that HC reform must come from the base (us, the citizens) and not from HC professionals.
“I am nothing”… your patient safety congress reminds me of a conference I spoke at last year. The audience was all payers, private, govt and non-profit. The topics were all “what works, what doesn’t” focused. Of course “works” was defined as not spending money.
I was the 8th speaker to stand at the podium. My first remark was a thank you to those who invited me to speak. My second remark was that I had observed that not one of the 7 speakers before me, nor those who asked questions of them after each talk, had one time used the term “patient.” Not one. The room was silent but for one woman who gasped. Most attendees looked down at their feet. I had made my point.
Which is truly your point, too… that American healthcare is more about everyone else, but rarely about the patient. Even those who think, or want us to think, they are focusing on what’s best for patients, aren’t.
Thanks for the link, as above. John M. Grohol was right on the ‘money’ – pun intended. At the time the e-patient paper was published, I circulated it widely as I am sure many others did and both to the e-patient and professional communities. With isolated examples, it elicited few responses – that black hole once again.
Moving right along:
the next steps as a progression to the white paper is?
and:
the elephant-in-the-room of the day question is this: how to move forward without selling our soul(s)?
Warning: this is in the category “comments long enough to be a post.”
Trisha, I had a very similar reaction in my gut when I attended the “Transforming Healthcare” evening in Boston on 2/26. I was psyched at having been invited to attend as media; I promoted it sincerely and enthusiastically on my blog.
But what a disappointment it was.
At the time I commented here, “Everyone was talking about doctors and systems and money. Patients were *almost* not mentioned, except as a problem.”
The only thing, the only thing, anyone talked about was the money and how it passes from hand to hand. And how businesses could “participate” in the federal stimulus package.
The worst twist had to do with a great thing the conference organizers had added: a “UserVoice” feature on the event site, so people could submit questions for the panel, and people could vote questions up or down. By far the most-voted question was about funding for patient communities like ACOR:
That question got (still has) 109 votes; the second closest had 37. But the moderator spent only 90 seconds on it.
Not only that; he’d been briefed on the fact that a patient had authored the question, but he announced it as anonymous. (I’d signed it that way by mistake, but he’d been briefed.)
The event organizers have reached out to me to agree that the questions were mishandled and explore what more we can do. I’m not talking about them, I’m talking about how the entire stinking culture (there, I said it) has become thoroughly disconnected from “How are the patients doing?”
I feel like it’s just two big steps removed from the morality of AIG executives – except the people working in healthcare don’t even realize it. They’re just all wrapped up in their own knots. (See A Thousand Points of Pain and Comprehending the US Healthcare Budget, including commments.)
There’s more to the story of that evening but that’s enough for now. Most importantly, it left me with the impression that our best path to getting what we need is to take responsibility for it ourselves.
What a total waste of money it would be if we spend billions putting EMR systems in doctors’ offices when most of them don’t want one and 90% of doctors ignore the drug interaction warnings such systems can emit. (That’s a brand new article in the Annals of Internal Medicine, co-authored by our own Danny Sands.)
Seriously. What are we doing, feeding a dysfunctional mess while those of us who’d be VERY motivated to get it right are largely disenfranchised?
As always (well, mostly), I’m not looking to rant here – I’m seriously wondering, what do we do to create a world of healthcare that works well?
I’m starting to think, open source, interoperable data formats, simple, straightforward, focused on what we need it to do.
Rather like what the “hard hats” did at the VA, long ago … coding for self preservation.
btw, “Nothing”:
I just laughed out loud when I read your kind words about “my efforts” and those of “my followers including Gilles.” :–) Gilles is one of the earliest specimens of e-patient behavior spotted by Doc Tom Ferguson; Gilles created ACOR, the cancer patient community that served me so well in my disease.
When I recovered and wondered what I’d do with my new life, I discovered the e-patient world, and *I* took *their* name, not the other way around.
Anyway, glad you’re aligned. Welcome, and thanks for the acknowledgement. Spread the word.
I would like to see an open text publication possibly entitled ‘Patients’ Voices’ and I do mean patients’ voices, as opposed to, an analysis of what patients are thinking or their ‘perceptions’. Irrespective of current economic conditions, a publication funded and paid for by a well recognized publisher such as BioMed and yes, maybe even JAMA.
I am reminded by this conversation that on the screenshot of DailyStrength’s treatment community for depression that I use in my Health 2.0 talks, Lexapro is regarded as less effective than prayer, and crying among other “therapies” :)
But now I’ve discovered that you’re all a bunch of “nothings and nobodies”, I suppose I should seek out higher rent company! :)
Matthew! Got a screen shot of that slide, or URL, that we could post here? Might be a powerful communicator! (I looked briefly at http://DailyStrength.org and didn’t spot one.)
You SHOULD seek out higher rent company. Have ’em bring dinner. :)
===
Sandi, what would be the difference between the open publication you propose, and a blog or a user forum?
The new Society for Participatory Medicine will have a journal, and (I hope) other online resources. What would you like it to have?
Dave, there are many d-patients. One of the communities I am involved with had a discussion on patients stories. Out of interest I Googled ‘nurse’ and ‘doctor’ stories and they are alive and well through Tweeter, blogs, news items, books etc. There was much overlap, but millions of ‘hits’ – professionals as patients.
During the ‘Where’s the Patient’s Voice in Health Professional Education’ conference (Vancouver 2005) a small group of patients spontaneously presented their ‘wish’ list to the audience. It’s a sensitive issue and the exercise was met with some opposition. Some professionals felt ‘left out’. There are, however, some who can bridge that issue, such as Tom Ferguson, but the question remains often: who’s on first base?
The patients stories seem currently on their way to be supplanted with hcp-patients stories, a small but important distinction. Why? Because I believe that special place for patients is being slowly eroded. This is a whole huge discussion, but I believe it is time for patients to take the next step to include their stories but take those stories to the next step.
Therefore, the rationale for a patients journal.
The difference between blogs etc and a journal, or as part of a distinct section of a journal is to level the playing field. As an example, the JCO has a section which I faithfully follow. It’s a very good part of the journal entitled “The Art of Oncology – When the Tumor is Not the Target” but it is primarily authored by health care professionals. Sometimes it leaves me with a feeling of a sales pitch but other times it gives true value, not to mention that this particular section is open access.
The chances of getting an article published in this section is very low due to the high volume of contributions – so it is the target and the exposure that is of value. One example where patients could make a difference is a key one and that is QOL indices. A recent published article (can’t remember where right now) stated that the currently used indices are not valid and do not reflect, accurately, real life QOL concerns. Patients know this. So, another example of why an open text/patients journal would be helpful.
Sorry for the rambling!
I am thrilled to see this discussion yet sad since the topic deserves substantial public attention, careful consideration, and ACTION.
Having worked in healthcare for almost 30 years in hospitals and with an IT vendor, I frequently serve as a resource and patient advocate for family and friends.
Despite the patient safety initiatives spawned by the 1999 IOM report, most individuals are clueless when it comes to the dangers and limitations of the current healthcare “system”.
Ownership of one’s lifestyle and healthcare choices and securing access to one’s medical records is essential to navigate the HC maze.
Having a chronic health condition myself, I’ve done sustantial research over the years since physicians provided minimal help or hope.
Patient communities may be wonderful but it seems many are sponsered by HC industry players with a vested interest.
Integrative, participatory medicine where patients and their various providers (not just docs)can freely exchange information will subtantially improve our health and lives.
This discussion has already made me feel better!
Timely, since I received the email alert just now from the Journal of Cancer Survivorship. I actually had forgotten about this publication! The articles are open text.
March 2009 article index:
http://tinyurl.com/d56guk
The volume of articles is quite low. Maybe the timing and opportunity is right to seek an expanded viewpoint. Why re-invent the wheel?
If you think that we, the proud Nobodies of JAMAland, are the only ones taking umbrage with any hint of a conflict of interest you should read these recommendations.
They are the newly published recommendations of MedPac to the US Congress. MedPac (the Medicare Payment Advisory Commission) is an independent Congressional agency established by the Balanced Budget Act of 1997 to advise the U.S. Congress on issues affecting the Medicare program.
Clearly the MedPac commissioners are not joking about changing the rules of engagement about the public reporting of physicians’ financial relationships with any manufacturer or distributors of drugs, biologicals, medical devices, and medical supplies (and their subsidiaries)
except this, Gilles, regarding the Helsinki Declaration:
“FDA abandons Declaration of Helsinki for international clinical trials”
http://tinyurl.com/dnllmm
[2022 update: the links in this 2009 comment are defunct now]
Here is another good one:
http://eplayer.clipsyndicate.com/cs_api/get_swf/2/&csEnv=p&va_id=866724&wpid=0
For more info about that fraud: http://www.plastic.com/comments.html;sid=09/03/13/04170842;cid=3
Gilles,
The scary part about this Reuben video focusing on his fraudulent research results is that his own colleagues just happened to catch him by doing an audit. I wonder how many research projects haven’t been audited? and I wonder what compelled them to do the audit to begin with? and I wonder which projects were found to have problems that weren’t made public?
Too often something like this is simply the tip of the iceberg…
Trisha,
to answer your question I will just give you another incredible and thoroughly disgusting example of the greed that is unfortunately present in the system: UPMC, Once Transplant King, Takes Risks to Regain Crown. It’s about the University of Pittsburgh Medical Center, a pioneer in liver transplantation and a not-for-profit organization.
This is what I got from the main WSJ article:
The real reform of the healthcare system will not happen until the American public realize we all must pay attention to the real costs of care and where the excesses are. AIG is not the only company in the country where the culture if greed has invaded the corporate philosophy. We are no longer in a position where we can behave like ostriches, just because we think we are not paying for health care. WE ARE! In many direct & indirect ways.
Followers of this threat, if you haven’t done so yet, you MUST read the other coverage of this story. Start with this great post What was JAMA and Catherine DeAngelis thinking? by John Grohol on PsychCentral. He links to must-read posts on Furious Seasons (who scooped the WSJ) and Mind Hack. And be sure not to overlook the WSJ post, also linked from there.
Really, this is must-read stuff.
Given how odd this all is (read the posts to understand), could there really have been a death threat somewhere along the line, as one commenter suggests? Probably not, I imagine, but it sure is weird.
Curiouser and curiouser:
Battle brewing among physicians, JAMA over conflict-of-interest investigations (FierceHealthIT)
JAMA’s responded to this story with a new policy: they want everyone in whistleblower cases like this to be gagged until JAMA has decided whether they think action is needed.
Considering how DeAngelis behaved in this case (and yes I think behaved is an appropriate word), I frankly don’t think I’d trust their judgment.
After all, Dr. Leo (the original “nobody and a nothing”) submitted his concern to JAMA five months earlier and they did nothing – then DeAngelis trashed him for taking it outside the JAMA walls: “This is not how we do things.”
Really? And just how DO you do things? And what’s your priority – patient safety, integrity, or covering members’ reputations regardless of the other factors?
WSJ update today: JAMA Sets New Policy in Wake of Disclosure Flap. JAMA now says the phrase “nobody and a nothing” was misreported – but hasn’t said anything to the WSJ itself about it.
Perhaps they themselves don’t practice their own recommendation of first speaking to the publisher in question?
Gilles, you will be happy to know that we now have scientific proof you are perfect. (It must be true because it arrived in my email.)
A lot has happened in this story since our last notes on 3/23.
Ted Eytan’s post today Health Care Renewal: JAMA Editors Try Attacking the Messenger led me to read that post on the Health Care Renewal blog. It’s a detailed deconstruction of the story and JAMA’s response to it.
Somehow, we here missed that on 3/20, JAMA actually published what HCRenewal calls “a rather extraordinary editorial” in which they reveal:
– They first heard from Leo last October. Five months earlier.
– They began using “due diligence” to “investigate” the “assertion.” I put all that in quotes because this wasn’t insider allegation of misdeeds, it was simply pointing out public information, which the HCRenewal writer dug up in 5 minutes using the “due diligence” of merely googling. It’s WEIRD that JAMA would claim theyh need to be lawyerly; it was no more complex than looking up an “alleged” phone number.
– JAMA never responded to Leo, yet they then said that he’d done a “serious breach of ethical confidentiality” by telling someone else about this publicly available “phone number.”
– The editorial then disclosed that when they called Leo and he wouldn’t “acknowledge any problems with his actions,” they (JAMA) became “argumentative”! (This must be a really weird editorial for JAMA believers to read!)
– The editorial goes on to report that they threatened him with no more publications.(!!) What is this, are they trying to make a public example of him??
– And, they go on to say that they then called his dean and complained about him.
– Finally, they complain about the BMJ having the audacity to publish something about JAMA without asking first.
The HCRenewal post goes on to link to other reports on this odd case in the “Hooked: Ethics, Medicine and Pharma” and KevinMD blogs, plus Professor Leo’s response.
This is really weird. Has somebody infiltrated the AMA and is trying to sink it once and for all?
If not, I’m wondering if someone had a stroke, inducing an odd personality change.
Another update about this fiasco: The author wrote a letter to the BMJ where he complains of the undeclared conflict of interest of Dr. leo who basically should not have complained about the original undeclared conflict of interest and invalidity of the research results because he is/was a board member of an organization who doesn’t advocate constantly for drug usage!
HELOOOOOO! Does anyone really believes that someone on agreement with the original author would have complained about his results???
In any case, it makes for a very interesting reading and the follow-up combine to keep this story as a shining example of why we should relegate the paternalistic model of medicine to a dark and humid room of the Smithsonian.
See http://www.bmj.com/cgi/eletters/338/feb05_1/b463#211102