Full disclosure: Doctors, manufacturers should reveal conflict information - - Modern Medicine
Full disclosure: Doctors, manufacturers should reveal conflict information

Source: Dermatology Times


Key iconKey Points

  • Conflicts of interest between doctors, pharmaceutical companies
  • FDA regulations for investigator disclosures
  • Defining conflict


Karen Nash
At least a third of the new drug marketing applications submitted to the Food and Drug Administration (FDA) don't include conflict of interest information about the investigators involved in the drug studies, according to the finding issued by the Health and Human Services inspector general in January.

Although the FDA technically requires that information, pharmaceutical companies can respond that they requested that data, but if the doctor doesn't respond, the manufacturers aren't compelled to comply.

On Call asked a number of dermatologists around the country if they are comfortable with that process, or if they think the FDA should do more to obtain that information from the investigators.

While not all of the doctors think the compensation — or knowing about the compensation — would make much of a difference in the results or their opinion of the studies, they generally agree that the information should be available to the FDA.

Bruce D. Glassman, M.D., in Alexandria, Va., says not responding to that request makes the studies suspect.

"It makes you wonder if you can believe what you're reading, because the docs could be tainted in some way.

"These should be blinded, non-biased studies, so ultimately, at the end, you can be certain that the information you're reading is true," Dr. Glassman says.

In Charleston, S.C., Brian C. Leach, M.D., shares that point of view.

"Dermatologists have done much better, collectively. The move for disclosure really started taking off during my residency, and every year, there is more willingness and more attention paid at meetings to make those disclosures available.

"We're doing such a good job of making these ties with industry visible, it ought to be equally transparent to the FDA. It's hard for me to believe that if it wasn't being made visible to the FDA, there wasn't some reason for not making it visible," Dr. Leach says.

Barbara D. Garcia, M.D, in San Diego, thinks that if the pharmaceutical companies are sponsoring the study, it can be assumed there are some financial relationships — but that doesn't make her any more comfortable.

"I guess there would be an inherent conflict of interest, but it should still be disclosed. Whenever I read studies, I look for that. If I don't see it, it makes me wonder what's been hidden. I wonder what's being kept from me that might influence the way I interpret the information being presented.

"It should be as important to the FDA as it is to me, when they are interpreting the studies to see if there is any obvious bias that needs to be taken into account in approving drugs that are coming through the pipeline," Dr. Garcia says.

'Simply obvious'

Sheryl Hoyer, M.D., a practitioner in Arlington Heights, Ill., says that it's "simply obvious" data to collect.

"Whenever I read the journals or go to meetings, I look to see whether it says the doctor has a conflict or does not have a conflict of interest. Either way, it doesn't make me not read the study. It's just part of the whole picture. I'll read the article, I'll look at the study. But I want that information to be part of what I've read," Dr. Hoyer says.

Kenneth M. Ellner, M.D., in Atlanta, doesn't really subscribe to the idea that the lack of conflict information is completely innocent.

"When I became president of Atlanta Derm, the pharmaceutical industry was very upset because I worry about conflict of interest. I see it all the time, and it makes me nauseous.

"I was upset when the No. 2 guy at the FDA was not moved up to No. 1, which he was supposed to be. The pharmaceutical industry was too much against him, however. Since when do they have a say in those decisions?" asks Dr. Ellner, assistant clinical professor, Emory University, Atlanta.

For Dr. Ellner, it isn't even the money from doing the study that he wants to know about.

"It's the speakers bureau where they make their money, or the advisory committee. That's the relationship I want to know about," he says.


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Source: Dermatology Times,
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