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Dangers of Disclosure

Editors at PLoS Medicine suggest that merely disclosing conflicts of interest is insufficient and possibly even counterproductive.

By | April 25, 2012

image: Dangers of Disclosure Wikimedia Commons, Svilen-milev

WIKIMEDIA COMMONS, SVILEN-MILEV

When a scientist or doctor has a financial conflict of interest, open disclosure in scientific publications might actually backfire and make bias worse, warn the editors of PLoS Medicine in an editorial out today (April 23). Furthermore, disclosure policies in general do nothing to confront the issues of the conflicts of interest themselves, they write. So what can be done?

“The reliance that many of us in the medical and publishing communities have on disclosure policy is problematical,” said Jocalyn Clark, senior magazine editor at PLoS Medicine and one of the authors of the new editorial—“both because it leaves the real question of the conflict of interest unaddressed, but also and more importantly, because…disclosure may actually be worsening the problem.”

Indeed, a study by George Loewenstein of Carnegie Mellon University in Pittsburgh and colleagues suggests that bias may be greater when conflicts of interest are disclosed. This stems from the idea that doctors strategically exaggerate their advice to patients to counteract the possible effect the disclosure might have on patient opinions. Furthermore, simply disclosing their conflicts might make doctors feel that giving biased advice is acceptable, because the patient “has been warned.” The PLoS Medicine editors extrapolate Loewenstein’s suggestion to published articles.

So, said Clark, “we probably have to consider that disclosure alone is not a good enough solution.” In particular, to help minimize bias from medical research and reporting, it may be necessary “to exclude people who have links [to industry] from contributing to the journal,” she added, referring specifically to opinions and commentaries. “Evidence amassed over decades says that any link to a commercial company can create the possibility of bias.”

But a blanket policy of banning any author with industry links from writing commentaries is rather extreme, said Eric Campbell of Harvard Medical School. “[I’m] not sure that is reasonable,” he said. After all, “these relationships are not universally bad and they are not universally good. They have benefits and they have risks.”

Indeed, said Art Caplan of the University of Pennsylvania, “some conflict of interest situations may be highly desirable.” He provided an example from his own experience. “I have a relationship to Johnson & Johnson, which has a terrible problem with a drug that is in short supply because of manufacturing problems, and they want help in terms of figuring out how to allocate the supply of the drug. I’m happy to do it,” he said. It’s a link to a pharmaceutical company and thus technically a conflict of interest, but “that is different from saying I’m giving promotional speeches or I’m on the speaker’s bureau,” he said, referring to the roster of doctors that receive money from a drug company in return for speaking about and promoting that company’s products. The problem with the current disclosure process, he said, is it “doesn’t give you much nuance.” From the readers’ perspective, a conflict of interest is a conflict of interest.

Whether or not journals adopt exclusion policies, Caplan suggests a possible improvement to the disclosure process. “We’ve got the internet. You should put your relationships and what you are doing online and explain what you are up to.”

But even providing such details, while it would certainly give greater insight into individual researchers’ activities, probably won’t fix the bigger problem of  “ritual ignoring of disclosures,” said Campbell.

Ultimately, the conflicts of interests themselves need better management, said Caplan. “University administrators need to come up with coherent generalizable policies for their institutions. Some things are clearly off limits and shouldn’t happen at all, and those should be identified, and then some other things are clearly okay. I think what you do is reason out from the extremes to decide what to do about the middle.”

The good news is this is already happening, said Campbell. “A lot of medical schools have made the decision that speakers bureaus are inappropriate and they have banned them,” he said. “A lot of institutions have said our doctors are not going to take tickets to football games, go out to eat with drug companies, or accept other incentives.”

Dealing with conflicts of interest is only going to get trickier, however, Caplan noted, because of the rising numbers of institutional-level relationships with industry. “The old model was Pfizer hires Joe. The new model is Pfizer hires the entire department of biochemistry… I don’t see that being managed by disclosures of any sort.”

The PLoS Medicine Editors, “Does Conflict of Interest Disclosure Worsen Bias?” PLoS Med, 9(4): e1001210. doi:10.1371/journal.pmed.1001210, 2012.

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Comments

Avatar of: Brian Hanley

Brian Hanley

Posts: 66

April 25, 2012

Disclosure is a red-herring.  What matters is transparency, access to base data so that studies are clean.  The other side of disclosure rules is that when the rewards are so high, they incentivize secret relationships, which are much more problematic.  That ends up penalizing those who do disclose and puts those who don't in the driver's seat.  Improve data transparency and you get at the roots.

Avatar of: jvkohl

jvkohl

Posts: 53

April 25, 2012

Disclosure of Pheromones.com as my domain for information dissemination about human pheromones and the purchase of pheromone-enhanced products continues to be a thorn in my side when I expect interest in my published works, such as Human pheromones and food odors: epigenetic influences on the socioaffective nature of evolved behaviors. Socioaffective Neuroscience & Psychology, 2: 17338. http://dx.doi.org/10.3402/snp....

Nevertheless, the epigenetic effects of nutrient chemicals and pheromones that I detailed have since been indicated in reports of pre-existing genetic variations responsible for adaptive evolution, as compared to random mutations, which apparently are not involved in adaptive evolution. See: Evidence of non-random mutation rates suggests an evolutionary risk management strategy. http://dx.doi.org/10.1038/natu...

Taken together these two publications might be considered "game changers" that force evolutionary theorists and molecular biologists alike to reconsider whatever model they are using for therapeutic drug development, or whatever else they are doing. Clearly, epigenetic effects on the gene, cell, tissue, organ, organ system pathway must at least be considered before scientific progress can best be ensured. But when the most important of these epigenetic effects appear to come from nutrient chemicals and their metabolism to pheromones instead of from "random mutations," the fact that so many people have "known that all along" may reflect badly on researchers who have not considered the facts, and who will therefore not respond favorably to disclosure or non-disclosure of my commercial interests.  

Avatar of: edfru

edfru

Posts: 2

April 25, 2012

as long as the bottom line is king this problem wont be solved & wont go away.in all walks of life,personal ethics & behavior is cannot be separated from personal finance.

Avatar of: Jerry SCHNEIR

Jerry SCHNEIR

Posts: 2

April 25, 2012

It sounds like some doctors want to have conflicts of interest since it means they make money at both ends of the street. It reminds me of some people at the FDA who wanted to be on pharmaceutical payrolls while approving their drugs. Patients have the need and the right to know that their doctor has other interest rather than just their best interest in mind. And patients should question the wisdom of taking any drug or treatment when a doctor discloses some conflict of interest.

Avatar of:

Posts: 0

April 25, 2012

Disclosure is a red-herring.  What matters is transparency, access to base data so that studies are clean.  The other side of disclosure rules is that when the rewards are so high, they incentivize secret relationships, which are much more problematic.  That ends up penalizing those who do disclose and puts those who don't in the driver's seat.  Improve data transparency and you get at the roots.

Avatar of:

Posts: 0

April 25, 2012

Disclosure of Pheromones.com as my domain for information dissemination about human pheromones and the purchase of pheromone-enhanced products continues to be a thorn in my side when I expect interest in my published works, such as Human pheromones and food odors: epigenetic influences on the socioaffective nature of evolved behaviors. Socioaffective Neuroscience & Psychology, 2: 17338. http://dx.doi.org/10.3402/snp....

Nevertheless, the epigenetic effects of nutrient chemicals and pheromones that I detailed have since been indicated in reports of pre-existing genetic variations responsible for adaptive evolution, as compared to random mutations, which apparently are not involved in adaptive evolution. See: Evidence of non-random mutation rates suggests an evolutionary risk management strategy. http://dx.doi.org/10.1038/natu...

Taken together these two publications might be considered "game changers" that force evolutionary theorists and molecular biologists alike to reconsider whatever model they are using for therapeutic drug development, or whatever else they are doing. Clearly, epigenetic effects on the gene, cell, tissue, organ, organ system pathway must at least be considered before scientific progress can best be ensured. But when the most important of these epigenetic effects appear to come from nutrient chemicals and their metabolism to pheromones instead of from "random mutations," the fact that so many people have "known that all along" may reflect badly on researchers who have not considered the facts, and who will therefore not respond favorably to disclosure or non-disclosure of my commercial interests.  

Avatar of:

Posts: 0

April 25, 2012

as long as the bottom line is king this problem wont be solved & wont go away.in all walks of life,personal ethics & behavior is cannot be separated from personal finance.

Avatar of:

Posts: 0

April 25, 2012

It sounds like some doctors want to have conflicts of interest since it means they make money at both ends of the street. It reminds me of some people at the FDA who wanted to be on pharmaceutical payrolls while approving their drugs. Patients have the need and the right to know that their doctor has other interest rather than just their best interest in mind. And patients should question the wisdom of taking any drug or treatment when a doctor discloses some conflict of interest.

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