JAMA refuses to exclude authors who hide financial ties to drug companies

[Trillo]

Emphasis added:

(NewsTarget) The Journal of the American Medical Association (JAMA) said today that it would not ban authors who fail to disclose financial ties to drug companies, because such an action might bring antitrust lawsuits.
....

Though DeAngelis claims antitrust issues would arise if all medical journals banned authors who refuse disclosure, former Federal Trade Commission lawyer and current Penn State law professor Stephen Ross says nothing would prevent JAMA and other journals from sharing the names of authors who have refused disclosure. "They could even jointly observe that particular journals published a certain researcher," Ross says.

"This is classic behavior characteristic of the incestuous relationship between medical journals and drug companies," said Mike Adams, a frequent critic of pharmaceutical industry practices. "With this announcement, the American Medical Association is openly declaring its unwillingness to meet even the most basic standards of journalistic integrity."
....

Critics of JAMA's refusal to ban such authors say that medical journals have failed to abide by fundamental standards of integrity and protect the health of Americans whose lives are affected by allowing such authors to be published. Moreover, simply giving up and allowing such authors to be published -- instead of trying to remedy a serious problem -- indicates how corrupt U.S. medical journals have become.
Read more...
http://www.newstarget.com/019914.html

A journal is cleverly presenting articles as objective when they are nothing more than pharmaceutical corporatist's clandestine advertising?

[katinmn]

1. Most journals are very credible and won't publish something

without full disclosure so I would say this is JAMA setting a dangerous precedent to appease pharmaceutical companies. If all scientific journals uphold the standard of transparency they make it about science and healthcare and not about money. The former editor of JAMA wrote a book about pharma's strong influence over science, the FDA and NIH and it isn't pretty.

[Celebration]

2. according to the article

They won't publish without full disclosure, but when the researchers don't fully disclose their ties, they will not ban them from future publication with the journal, because next time they would use another journal. Their reasoning is that all the journals cannot get together to enforce a ban due to antitrust reasons (IMHO, a legitimate concern). However, they should all individually decide to ban authors who hide their ties to pharma companies. JAMA has had to retroactively disclose ties with some articles, when the authors failed to disclose their ties.

[katinmn]

9. Thanks. I believe that all journals should require disclosure or not

publish the study.

Those journals that don't abide by the standard will quickly lose their credibility in the science community.

It should be an ethical decision, not a business decision.

[KT2000]

3. It is not just authors

Some medical societies depend on contributions from corporations to build new facilities - office buildings and campuses.
The whole thing is rotten to the core. They don't want the depth of influence to be known.

[Trillo]

15. I tend to agree

"They don't want the depth of influence to be known."

The conclusion of anti-competitive or anti-trust corruption seems inescapable.

[Spirit Blooms]

4. Their rationalization makes no sense.

I would think that any anti-trust question lies in the opposite direction, that if they don't disclose financial interests, they're helping further the collusion of business interests in promoting an opinion as objective when it's not. I see a distinct conflict of interest here.

Many TV news shows that cover investing ask those making recommendations to state whether they have any interest in the stock they're discussing. The laws may be different for stocks, but the situational ethics appear the same to me, when one considers the scientific nature of the journal and that good science news reporting requires objectivity.

I wonder if physicians will complain to JAMA about this. I hope so. Don't they rely on it for the latest objective information? Have drug companies now taken over the entire medical establishment? If so I'll have to think twice about even going to a doctor. Do I want to pay to entrust my health to someone who's simply an instrument of a drug company? Their financial motivation to prescribe drugs might be stronger than that to keep me well.

[katinmn]

10. The anti-trust statement does seem very out of place.

[Celebration]

11. on this particular point

Anti Trust laws are strict. No talking with competitors.......about almost anything. But the "requirement" that authors disclose their financial interests is ridiculous when there are no consequences for lying, other than a disclaimer in a future journal. It should be self evident to these publishers that they should not publish the works of liars. They don't need to talk to their competitors to figure out this big "duh."

[trotsky]

5. Gotta love the fear-mongering.

AMA evil, big pharma evil, now you can disregard anything published by the JAMA that you don't like, etc.

For the other side of things,
http://jama.ama-assn.org/cgi/content/full/296.8.jed60051

It would be an understatement to say that I have been disappointed by the reaction of several would-be pundits to our initiative to increase transparency around the issue of disclosure of financial interests. They have misinterpreted, misrepresented, or misunderstood the meaning and results of our policy and our ability to manage the problem of authors' failure to disclose. Specifically, failure of the authors to fully disclose their financial ties does not automatically translate to the article being flawed. For example, the JAMA articles cited in this editorial as examples of authors' nondisclosure were all peer reviewed and editorially evaluated and no one has questioned their validity. Moreover, publication of our updated policy and editorial was not a reaction to any published newspaper articles as has been insinuated; the policy and editorial had been prepared weeks before any such media reports appeared.

Most important, there simply is no way to guarantee that all financial relationships and arrangements of all authors are disclosed. It is not feasible to independently investigate the financial relationships of every author, as no comprehensive, up-to-date source of this information exists. Calling every author (for JAMA, that involves thousands of individuals annually) offers no advantage over our current requirement that every author sign a document attesting to his or her financial relationships or lack thereof. Misrepresentation of or failure to completely disclose financial interests on the telephone or in person is not much different than doing so in writing—in fact, one might argue that requiring a signature better encourages honesty.

<snip>

...Like these deans, I have also tried to enhance the education of authors via JAMA's expanded disclosure rules. As part of this process, we have made no attempt to conceal the episodes of failure to disclose in a simple correction published in JAMA, and we will continue this approach until it becomes unnecessary. Although our efforts to educate authors about the importance of full disclosure of relevant conflicts of interest and to enforce compliance with tightened rules have not always been received as we might hope, we do see a silver lining—even in the harshest scrutiny. The intensity of public discussion is invaluable, not only for raising the visibility of JAMA's requirements, but also for increasing awareness of the potential influence of money in science as well as for increasing appreciation for the role that full disclosure of potential conflicts of interest plays in ensuring that physicians and patients can properly interpret, and more importantly trust, what they read in JAMA.

[Celebration]

6. A few points

A study may be valid and completely okay notwithstanding a researcher's ties to a pharmaceutical company. Howevever, there is certainly a reason to go over the results and methods with a fine tooth comb. At the very least there is a motivation for skewing the results. Speaking for myself, I am much more interested in the safety issues. Any data that is thrown out, or stopped early, or whatever, is suspect. Also conclusions drawn may be overly broad. Suffice it to say that there are various ways, subtle and not so subtle, that a study may not reflect the reality of the situation. Therefore, it is IMPERITIVE that we know the financial ties of the researchers.

JAMA and others DO publish the financial ties. That is a step forward. Researchers are required to disclose their financial ties. However, there is now NO MEAT behind this. If researchers choose to lie, and not disclose their financial ties, other than pulishing them in a later edition, THERE ARE NO CONSEQUENCES.

Do you get that?

There are no consequences for the researchers lying and saying there are no financial ties when there actually are.

Do you ACTUALLY TRUST a study done by researchers that LIE about their financial ties?

Wouldn't it be much better if JAMA and other journals would refuse to publish the studies done by proven liars? That is the whole point.

[trotsky]

7. Of course I'm concerned.

But the JAMA also requires an independent, academic statistician to review ALL calculations before submittal. This does tend to discover any outright statistical manipulations or lies. Because you know, a researcher that works for or is funded by a company CAN run a real experiment and get real data that truly does support what the company wants to find.

You seem to want to apply a different set of standards, here. Any person working in the allopathic arena is suspect because of profit motive. Yet the people working in the "alternative" fields seem immune from criticism - FOR THE SAME MOTIVE. They want to make money too, you know. The difference is that people published in JAMA still, despite who they say they're taking money from, have to back up what they say with sound science. Alties have no such oversight whatsoever.

I think you completely missed the point of the editor's piece.

[Celebration]

8. Have no idea what you are talking about

If someone submits an article to JAMA and the aloe growers pay for the study it should be DISCLOSED. If they lie and do not disclose their ties to the aloe vera industry, then JAMA and other journals should not publish their studies in the future, because they are liars.

That is very consistent.

This goes above and beyond peer review, which is always done of course.

(And this is a completely separate issue from whether or not I decide to use some extra oregano in my diet when I have a cold--whether by sprinkling in my chicken soup or encapsulated).

[trotsky]

12. Just read the JAMA editor's piece.

Please.

[Celebration]

13. I did

Here is the controversial part--

"Leveling sanctions against an author who fails to disclose financial interests by banning publication of his or her articles for some time period would only encourage that author to send his or her articles to another journal; it cleans our house by messing others. So what about all editors, or at least a group, such as the International Committee of Medical Journal Editors, agreeing to share the information and jointly to ban the offending authors? Those who suggest this approach have not considered the risk of an antitrust suit."

Copout. All they would need to do is make it crystal clear that any failure to disclose ties will be prominently displayed in further issues, and they will no longer be considered for publication in JAMA. They should go further and state that as of a certain date (the sooner the better) they will no longer publish anyone who lies to another medical journal either. Other medical journals should do the same. They wouldn't need to talk to each other about this. And their statement is pretty self serving. JAMA may have no control on what other journals do, but every journal should set their own highest ethical standards, and call the other journals on it in public when they fail to do the same.

I do agree that this probably should not be retroactive. There is a chance that some of the researchers were not being intentionally fraudulent and were getting used to the new regulations. I think the sanctions are necessary now, though, given the non-complaince.

[trotsky]

14. You're not understanding what's being said.

OK, so the JAMA bans the author. He goes somewhere else & a journal with less stringent requirements publishes him. Did you solve any problems? As seen right in this forum, people will go and pull articles from even the silliest of "official" journals.

Even IF there was a way to get all journals on board and they could create a blacklist, those journals then indeed DO run the risk of antitrust. How long should a researcher be blacklisted? If they perform research for different industries, should they only be blacklisted for the one(s) they failed to disclose? All of them?

The system is not perfect, but if that's what you want, you'll never get it. You've got to strike a balance between censoring good science and preventing the crap science, and at least JAMA is trying.

This to me just smacks of the same attitude that if one flaw can be found in "traditional" medicine, then the whole system is hopelessly corrupt and nothing it produces can be trusted. And of course, the flipside, people in "alternative" medicine can invariably be trusted, even when they make claims they can't support.

[Celebration]

16. oh baloney

Sure you solve some problems. JAMA solves their own problem (enabling liars getting published in their own journal is a big problem). Then they could flaunt the moral high ground to any other journals that publish them (without a conspiracy or talking to them). You wouldn't really think this should be such a big problem, would you? You would think researchers would tell the truth, wouldn't you? Doesn't it disturb you at all that medical researchers at Harvard have not been able to follow basic instructions on answering questions about their financial ties? It should. If they cannot answer those questions truthfully, then future research by them should be suspect. Again, since this is all fairly new, I probably would not make it retroactive--but going forward lying about financial ties should have consequences, whether those ties are to pharmaceutical companies or to aloe vera growers.

Is it to much to expect people to tell the truth?

And the WHOLE POINT of this it to try to make us have MORE confidence in the system. Don't you agree? When people flaunt breaking of the rules, and get away with it, it erodes our confidence further. That should be crystal clear. Do I trust journals that publish the academic studies of known liars? Should I?

[trotsky]

18. *sigh*

It's a problem because right now, the lion's share of the money for research comes from... yup, the private sector. You can badmouth it all you want, and nitpick and cry about it until you're blue in the face, but the fact remains, even the few articles from JAMA that this pertains to have not been shown to be false. Whoever paid for the research, let the science speak for itself. That's what should be first and foremost.

And I implore you, please turn as much outrage to ALL sources that aren't up front about their backers and connections, or who have lied. It would be the most honest thing to do.

[Celebration]

19. Good grief, I DID

This applies to ALL funders and the researchers that they sponsor.

And history shows that there have been problems with articles--look at Vioxx. That's why these rules were enacted to begin with. All I am saying is get some teeth behind them.

[katinmn]

17. If journals want to maintain integrity, they require disclosure

across the board. You can't make exceptions otherwise no one would disclose.

I think it's pretty obvious why we have disclosure rules. Now the challenge is to find a way to educate people within medical schools, research universities and corporations. Set a timeline and and enforce the rule.