Like it? Share it!

Sign up for news and updates!






Enter word seen below
Visually impaired? Click here to have an audio challenge played.  You will then need to enter the code that is spelled out.
Change image

CAPTCHA image
Please leave this field empty

Login Form



No, JAMA, You're Doing It Wrong PDF Print E-mail
Swift
Written by Joe Albietz   

Conflicts of interest are a major point of concern within modern medicine. Ideally, physicians and patients want to make decisions based solely upon what is right for the patient; it is what we strive for. In the past it was commonplace for physicians to accept gifts from drug companies, some were small, a pen or a lunch, others were far more substantial. Many physicians thought they could benefit from the drug companies’ attention while remaining unaffected in their medical decision making. They were wrong.

A growing avalanche of studies proved that in spite of physicians’ best intentions, their prescribing practices were clearly influenced by the drug companies. Furthermore, it is very clear that studies sponsored by pharmaceutical companies are statistically more likely to show a favorable outcome for the drug or therapy in question. This was compounded by the fact that money spent advertising directly to physicians had to come from somewhere, and in fact came from the pockets of patients. Such a relationship between physicians and drug companies is a clear conflict of interest and damaged the relationship and trust between physicians and patients.

As a result, most academic institutions, including my own, and many private physicians have stopped accepting any and all gifts from pharmaceutical companies. It is no coincidence that at the time drug company sponsorship was being shunned by physicians that direct-to-patient advertising became more common.

Sometimes it is necessary to work with private companies, though. Even if a drug, vaccine, or tool is developed independently, someone must manufacture and distribute it. Within our current economic system, that is usually a private company. In order to minimize the impact of these relationships, the medical community is attempting to operate with the greatest amount of transparency possible. Most talks, presentations, and papers are now preceded with a disclosure statement where all conflicts of interest, if any, are made clear. (Mine, for the record, is included in my bio).

A failure to disclose a conflict of interest in a publication, when discovered, casts a shadow across the study, its authors, and the paper in which it appeared, even though the omission may have been an honest mistake rather than intentional obfuscation.

It is for this reason that the recent actions of the Journal of the American Medical Association (JAMA) are so unfortunate. In May 2008 JAMA published an article investigating the effect of Lexapro or problem solving therapy on the development of depression in stroke patients which claimed that Lexapro appeared to prevent the onset of depression in stroke patients (1).

After its publication, serious criticisms were raised against the study. One criticism pointed out that though Lexapro was more effective than placebo, it was no better than the problem solving therapy. Thus the recommendation made publicly by its lead author to begin all stroke patients on Lexapro to prevent depression was unwarranted.

The second criticism dealt with undisclosed conflicts of interest. The lead author had served on the speaker’s bureau for Forest pharmaceuticals, the maker of Lexapro. While this does not invalidate the study, it raises the specter that Forest’s influence may have colored the study’s results or presentation, and is therefore important information to be publicly available.

The first of these criticisms was raised in a letter to JAMA and was subsequently published within JAMA. The second concern, the one about conflicts of interest, was likewise brought to JAMA’s attention, but after 5 months was instead published within the British Medical Journal (BMJ), serving as a call to action to hold physicians and researchers to an even higher standard regarding conflicts of interest within medicine (2). The author of the BMJ letter, Dr Jonathan Leo, while he may have sought to publish this criticism within JAMA, was well within his rights to publish it in another journal.

JAMA appears to disagree. Dr Leo received a call from the JAMA executive deputy editor Phil Fontanarosa which was summarized by a JAMA spokesperson as “[JAMA] didn’t think Leo was taking a very good approach by taking this confidential process within JAMA out to media and another medical journal. It’s just not the way things are handled here.” (3) In other words, JAMA is embarrassed that they failed to discover this conflict of interest on their own prior to publication, and would have liked the opportunity to save face. That is understandable. But are they entitled to an internal “confidential process” once a paper is published? In my opinion, no.

JAMA apparently went even further. According to Dr Leo the phone call with Fontanarosa was much more charged, with threats including, “You are banned from JAMA for life. You will be sorry. Your school will be sorry. Your students will be sorry.” The Wall Street Journal’s Health Blogs interviewed JAMA’s editor-in-chief, Catherine DeAngelis about the incident, wherein she referred to Leo as “a nobody and a nothing.”(3) Is it appropriate to “apply pressure” on a critic through their superiors to force a retraction, to ban them from your journal, or to threaten anyone? Absolutely not.

JAMA is apparently determined to undermine public trust in the scientific literature, the foundation of evidence-based medicine. According to the Wall Street Journal on March 23rd, JAMA has now adopted a new policy in which “anyone asserting that study authors have failed to disclose conflicts of interest should keep the matter confidential until JAMA investigates.” (4) The authors of an article and the journal in which it appears do not retain the right to control professional or public discussion over the article once it is published. JAMA may request the option to be the first revise errors in its publication, but cannot censor the writing of others or criticism of its journal.

This incident has been mishandled by JAMA from the beginning. Mistakes happen, even within the best of journals and the most conscientious investigators. The appropriate response from JAMA would have been a prompt and humble correction of whatever error has occurred within its pages (which was done on March 11th, 2009 (5)), and an improvement in quality control within the journal. Not an attempt to silence or intimidate critics, nor the adoption of a policy that amounts to an ineffectual gag order on the medical community.

While we as skeptics rightfully tend to focus on alternative medicine, we cannot neglect to criticize modern medicine when it falls short of the standard. We are trying to broaden the acceptance of evidence and science based medicine, trying to hold all therapies, drugs, researchers and practitioners to the same standards of evidence. In order for this to succeed, the scientific literature must be reliable and transparent. Anything less not only impedes progress but also undermines the public and professional trust in the foundation of the entire project. Everyone will suffer from such a failure, but no one more than the public, the patients. And that is unacceptable.

 

References:

  1. Robinson RG, et al. Escitalopram and Problem-Solving Therapy for Prevention of Poststroke Depression. JAMA. 2008;299(20):2391-2400 http://jama.ama-assn.org/cgi/content/abstract/299/20/2391
  2. Leo, Jonathan. Clinical Trials of Therapy versus Medication: Even in a Tie, Medication wins. BMJ 5 March 2009; 338:b463 http://www.bmj.com/cgi/eletters/338/feb05_1/b463#208503
  3. Armstrong, David. JAMA Editor Calls Critic a ‘Nobody and a Nothing.’ WSJ Health Blog. March 13th, 2009. http://blogs.wsj.com/health/2009/03/13/jama-editor-calls-critic-a-nobody-and-a-nothing/
  4. Armstrong, David. JAMA Sets New Policy in Wake of Disclosure Flap. WSJ Health Blog. March 23rd, 2009. http://blogs.wsj.com/health/2009/03/23/jama-sets-new-policy-in-wake-of-disclosure-flap/
  5. Robinson RG, Arndt S. Incomplete financial disclosure in a Study of Escitalopram and Problem-Solving Therapy for Prevention of Poststroke Depression. JAMA. 2009;301(10):1023-1024. http://jama.ama-assn.org/cgi/content/extract/301/10/1023-a

Disclaimer: Dr Albietz has no ties to industry and no conflicts of interest to disclose. The views expressed by Dr Albietz are his alone, and do not necessarily represent the views of his department or institution. The information provided is for educational purposes only and should not replace a therapeutic relationship with a licensed and accredited medical professional.

 

Trackback(0)
Comments (27)Add Comment
...
written by bosshog, April 01, 2009
"Even if a drug, vaccine, or tool is developed independently, someone must manufacture and distribute it. Within our current economic system, that is usually a private company."

Our "current" economic system? Did I miss a memo or something?
report abuse
vote down
vote up
Votes: -4
What a wonderfully conceived, well-written piece!, Lowly rated comment [Show]
An update and a clarification
written by Jalbietz, April 01, 2009
Between the time this was written and posted Orac at Respectful Insolence has written a follow up. The AMA apparently has an oversight committee investigating the behavior of the JAMA editors in question:

http://scienceblogs.com/insolence/2009/03/the_ama_investigates_catherine_deangelis.php

@Bosshog and @Human Person Jr, I was not making a political statement with that choice of words. The word "current" could have been deleted and the sentence would retain my intended meaning.

-Joe Albietz
report abuse
vote down
vote up
Votes: +9
It's still happening!
written by BillyJoe, April 01, 2009
Joe speaks in the past tense regarding pharmaceutical company influence on medical practitioner prescribing behaviour. Let me assure readers that the situation, at least in Australia, is far from in past tense. It is still happening and medical practitioners continue to deny the influence despite all the evidence to the contrary (including the fact that these companies spend $300 million dollars last year on so called "educational activities" for doctors which they are presumably doing out of the kindness of their hearts.)

BJ
report abuse
vote down
vote up
Votes: +4
...
written by BillyJoe, April 01, 2009
While we as skeptics rightfully tend to focus on alternative medicine, we cannot neglect to criticize modern medicine when it falls short of the standard

Let me also assure Joe, that pharmaceutical companies have not missed out on their fair share of criticism in sceptical cirlces (ie Ben Goldacre), including here on the forums.

BJ
report abuse
vote down
vote up
Votes: +2
...
written by tmac57, April 01, 2009
The nice thing about outside criticism is that it acts as a check to sloppy journalism of all kinds. It makes publications that take their reputation seriously, think twice about their content, so as to avoid embarrasment . JAMA should welcome all legitimate criticism as a tool to help them achieve higher standards.
report abuse
vote down
vote up
Votes: +5
...
written by Caller X, April 01, 2009
I had some snarky things to say based on having read the AP article a few days ago, but having reread the above, Dr. All-Beats makes several good points, although he hasn't learned to do a superscript here. Maybe it's not possible in articles.

But I wonder how long it will take for this to turn into a daisy-chain of backslapping; it's usually less than 24 hours.

written by bosshog, April 01, 2009
"Even if a drug, vaccine, or tool is developed independently, someone must manufacture and distribute it. Within our current economic system, that is usually a private company."

Our "current" economic system? Did I miss a memo or something?


As Radar used to say on M*A*S*H, "wait for it." You won't have to wait too long, and that is a political statement.

Shrug, my babies!!
report abuse
vote down
vote up
Votes: -4
...
written by Caller X, April 01, 2009
written by tmac57, April 01, 2009
The nice thing about outside criticism is that it acts as a check to sloppy journalism of all kinds. It makes publications that take their reputation seriously, think twice about their content, so as to avoid embarrasment . JAMA should welcome all legitimate criticism as a tool to help them achieve higher standards.


JAMA, in spite of having "Journal" in it's title, isn't journalism, it's "the scholarly literature". Journalism IS the outside criticism that the above article, a digest of information contained in journals and journalism, cited. The above article in and of itself will accomplish little or nothing except a paroxysm of mutual backslapping. (What do you call someone who is sceptical of sceptics?)

One source that was not cited was the March 30 Associate Press article, for which I graciously provide a link:

http://www.washingtonpost.com/...02131.html

Clap for the Wolfman, my babies!!
report abuse
vote down
vote up
Votes: -3
"its" NOT "it's"
written by Caller X, April 01, 2009
Res ipsa loquitur.
report abuse
vote down
vote up
Votes: +1
...
written by dr pepper, April 01, 2009
Those editors too should be called out.
report abuse
vote down
vote up
Votes: -1
...
written by dr pepper, April 01, 2009
BTW, what happened to the navigation buttons?
report abuse
vote down
vote up
Votes: +0
...
written by Caller X, April 01, 2009
Sometimes it is necessary to work with private companies, though. Even if a drug, vaccine, or tool is developed independently, someone must manufacture and distribute it. Within our current economic system, that is usually a private company.


If you mean companies like Pfizer and Eli Lilly, and Forest Laboratories, the parent of Forest Pharmaceuticals, the term you are looking for is probably "publicly held company."
report abuse
vote down
vote up
Votes: +0
Where is it.?
written by BillyJoe, April 02, 2009
...still looking for the daisy chain. smilies/cool.gif
report abuse
vote down
vote up
Votes: -1
...
written by Alan3354, April 02, 2009
Between the time this was written and posted Orac at Respectful Insolence has written a follow up. The AMA apparently has an oversight committee investigating the behavior of the JAMA editors in question:

http://scienceblogs.com/insolence/2009/03/the_ama_investigates_catherine_deangelis.php

@Bosshog and @Human Person Jr, I was not making a political statement with that choice of words. The word "current" could have been deleted and the sentence would retain my intended meaning.

-Joe Albietz

Throwing in the almost useless word "current" is popular. "What's your current location?", etc. It's as useful as "at this point IN TIME" - never a mention of our point in space.
report abuse
vote down
vote up
Votes: -1
x
written by BillyJoe, April 02, 2009
that is a political statement

Joe has stated that he did not intend it as a political statement, but it seems you know better what was on his mind.

Throwing in the almost useless word "current" is popular. "What's your current location?"

Thank you, that is how I read the line.

Hey, and still no daisy chain smilies/wink.gif

BJ
report abuse
vote down
vote up
Votes: +0
...
written by Caller X, April 02, 2009
x
written by BillyJoe, April 02, 2009

that is a political statement


Joe has stated that he did not intend it as a political statement, but it seems you know better what was on his mind.


"As Radar used to say on M*A*S*H, "wait for it." You won't have to wait too long, and that is a political statement."

Too much in a hurry to the ookie cookie competition to read it twice? I was saying that my saying "wait for it" was a political statement.

Learn to read, read to learn.

I still harbor a suspicion that his apparent distaste for the prospect of "work[ing] with private companies" tells me all I need to know about his political views, as does the unnecessary use of the word "current" in the phrase "[w]ithin our current economic system, that is usually a private company" tells me all I need to know about the good doctor's political leanings, but I expressed and express no opinion on his views. That reminds me, it's time to "express the ferret" as I like to call it. Your offense if forgiven.

Wail away, my babies!
report abuse
vote down
vote up
Votes: -5
...
written by BillyJoe, April 02, 2009
Well, okay, I'll let you win one.
report abuse
vote down
vote up
Votes: -2
Pass 'em to me....
written by DrMatt, April 03, 2009
I'm not a member of AMA. If there's undisclosed conflict of interest or unwarranted conclusions in a paper published in JAMA and JAMA won't promptly publish an admission, then write a short summary with hyperlinks to publicly available evidence and let me know, as I have some web space to host it.

report abuse
vote down
vote up
Votes: +0
Political views
written by rosie, April 03, 2009
This doesn't seem to me to be the right forum to discuss or even mention people's "political views". To a true sceptic, such as we all are, they cannot possibly have any relevance to the matter in hand. Or if they can, then they shouldn't.
report abuse
vote down
vote up
Votes: +1
...
written by Caller X, April 03, 2009
Political views
written by rosie, April 03, 2009
This doesn't seem to me to be the right forum to discuss or even mention people's "political views". To a true sceptic, such as we all are, they cannot possibly have any relevance to the matter in hand. Or if they can, then they shouldn't.


I'm sensing that you're heart is in the right place. I see the letter "J". You've had a family member pass away, right?

Wanting to force teaching of creationism as science in public schools, for example, is a political view. Similarly, isn't it innnnnnteresting that an MD would lament that

"Sometimes it is necessary to work with private companies, though. Even if a drug, vaccine, or tool is developed independently, someone must manufacture and distribute it. Within our current economic system, that is usually a private company."

A reasonable person might construe the word "current" in this contrast implies that there might be a future or preferable system. I simply relayed on which side of the fence I come down on.

Bless your hearts, my babies.
report abuse
vote down
vote up
Votes: -2
Hypocrisy
written by Paul Murray, April 03, 2009
Note that the position "medical journals ought not have a political agenda" is itself a political position.

Of course, it isn't "politics" (or torture, for that matter) when it's us doing it.
report abuse
vote down
vote up
Votes: -1
...
written by Caller X, April 04, 2009
written by Paul Murray, April 03, 2009
Note that the position "medical journals ought not have a political agenda" is itself a political position.

Of course, it isn't "politics" (or torture, for that matter) when it's us doing it.


If it's not torture, you're doing it wrong.
report abuse
vote down
vote up
Votes: +1
x
written by BillyJoe, April 04, 2009
I'm building up a profile on you.
The file will be passed onto the appropriate authorities in due course.
report abuse
vote down
vote up
Votes: -2
You say it best...
written by Human Person Jr, April 05, 2009
when you say nothing at all.

There were some great (and some hilarious) comments regarding this fine piece. The piece has great value, regardless of the political persuasion of the author. I think most were simply pointing out that the piece revealed the doctor's political thinking.

I especially liked the silent comments -- negative 21 votes on my comment above. I laugh, of course, but it's worrisome. A skeptic who would never accept a magical cure for cancer can accept a magical cure for an ailing economic system. Go figure!

Caller X, your sense of humor is great. BillyJoe, you, too. Maybe you other "skeptics" could check out the wisdom of Penn Jillette, skeptic first-class and Libertarian extraordinaire.
report abuse
vote down
vote up
Votes: +2
...
written by tctheunbeliever, April 05, 2009
I really hope you're not comparing x to Penn Jillette. Penn actually has something to say. And he has better jokes than "All Beats".
report abuse
vote down
vote up
Votes: -1
...
written by Caller X, April 07, 2009
You say it best...


Yes I do.

written by Human Person Jr, April 05, 2009
...
There were some great (and some hilarious) comments regarding this fine piece. The piece has great value, regardless of the political persuasion of the author. I think most were simply pointing out that the piece revealed the doctor's political thinking.

I especially liked the silent comments -- negative 21 votes on my comment above. I laugh, of course, but it's worrisome. A skeptic who would never accept a magical cure for cancer can accept a magical cure for an ailing economic system. Go figure!


Politics is fine as long as you don't do it in the street and scare the horses. We can whip the sceptics' eyes and make them sleep and cry.


Caller X, your sense of humor is great. BillyJoe, you, too. Maybe you other "skeptics" could check out the wisdom of Penn Jillette, skeptic first-class and Libertarian extraordinaire.



BTDT. I used to sell him science books in his three-piece suit and reptile-skin boots.



report abuse


If I saw BJ cruising in a panel van would that count?
report abuse
vote down
vote up
Votes: +2
...
written by Steel Rat, April 13, 2009
Wow, I doubt there's been a string of more useless comments anywhere, mine included.
report abuse
vote down
vote up
Votes: -1

Write comment
This content has been locked. You can no longer post any comment.
You must be logged in to post a comment. Please register if you do not have an account yet.

busy