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(A.K.A. Non-Original Rants)

–Co-opting good stuff from all over the ‘Net and maybe some original thoughts—ΜΟΛΩΝ ΛΑΒE

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Fed.gov doesn’t seem to understand the term ‘conflict of interest’

I knew it was bad, but damn….

The new FDA chief is kicking Big Pharma off of advisory panels.

“That’s why today we are announcing we’re removing industry members, pharma members, from FDA advisory committees,” Makary said. “I was shocked when I learned that employees of big pharma companies sit on FDA advisory committees as members of those committees.”

“So we’re going to be replacing them, whenever statutorily possible, with patients and family caregivers,” he added. “We’re going to be inviting pharma companies to send representatives to the advisory committees, but they can sit with the rest of the public and watch and pose questions as the rest of the American public can… the idea is that there should not be a cozy relationship.”

And…

Why is the FDA taking private funds for drug reviews? And the revolving door between regulators and industry has to stop. Regular industry utilizes non-competes. Why not a modified version for government employees?

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Midwest Chick

7 responses to “Fed.gov doesn’t seem to understand the term ‘conflict of interest’”

  1. doc Avatar
    doc

    Speaking as a (retired) member of the pharma world – both academic and industrial: having scientists from industry is not, necessarily, a bad thing. Some of us are vastly more expert than anyone at FDA, having created the field or invented the drug. There is certainly opportunity for a conflict of interest, BUT I never saw it happen at the advisory panel level. Industry people were KNOWN TO BE industry, and in general tried hard to act in what they saw as the best science. Now, at the FDA highest political/leadership level? Yep, THAT’s a problem. Just like with the military. So: recognize where the problem IS a problem, and where it is not.

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  2. Unferth Avatar
    Unferth

    I’m not sure I see a problem with charging Big Pharma for testing drugs — perhaps plow those funds back into the general fund versus earmarking them for the FDA.

    The problem is when individuals in the approval process have a conflict of interest via holding Big Pharma equities or past/future employment. Fixing this is a two-edged sword, and I don’t think there is a good answer. If you want a career where you learn about drugs, enough to make a decision on effectivity and safety, odds are you have to work for Big Pharma (especially if you’re hoping for a paycheck).

    The conflict of interest that brings to the table is painfully obvious and can have devastating effects.

    Covid certainly made this problem front-and-center with the FDA. I’m willing to bet that there are a lot of departments and agencies in the US government that suffer from the same fate. IIRC, Secretary of Defense Lloyd Austin had been an executive with Raytheon — congress had to waive a restriction or two so that he could serve.

    And let’s not get started on Fauci’s wife overseeing him for ethics issues.

    I think long gone are the days of the idealistic bureaucrat doing what’s right for the people and the country. It may have been that way in the ’50s and ’60s, but it certainly died out before the ’00s.

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  3. Midwest Chick Avatar
    Midwest Chick

    doc–Maybe I’m cynical, but I can’t imagine the creators of anything would want to have it picked apart (like calling someone’s baby ugly). So any advisory capacity would be colored by sheer human nature, especially when they are there to have something approved. They are going to show it in the best light. On the flip side, it’s up to the FDA to ask the hard questions so if they don’t have the chops or data to do so, then they aren’t capable of doing their jobs.

    Unferth–Excellent points and better said than I could. I’m betting the co-option happened earlier than the 00’s though.

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  4. Nemo Avatar
    Nemo

    @Unferth

    “The problem is when individuals in the approval process have a conflict of interest via holding Big Pharma equities or past/future employment.” and patents for the very medicines they’re reviewing.

    Fauci was/is receiving monthly compensation for the patents he licensed to Pharma during his 40+ years as Director of NIAID.

    Just look at the deaths caused by two drug treatments he holds patents on, one for AIDS, AZT, and one for Covid, Remdesivir. He approved them, despite clinical trial data indicating that either more study was needed or they should NOT have been approved at all.

    What happens when a company funds a study to determine what ever about some question? The study, usually finds on the side of the outcome desired by the company.

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  5. Gerry Avatar
    Gerry

    I with Doc on this.

    I was asked to be on a committee by someone at EPA that wrote international pollution monitoring standards for OIML. The reason was the bureaucrats and academics kept writing standards that were not technologically feasible. Writing detection limits that were off by an order of magnitude or more was common.

    As for fees, not a problem as long as it is a real review and not a rubber stamp.

    As for people jumping from .Gov to the industry the regulated or contracted, I am in 100% agreement. DOD is even worse than HHS or EPA.

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  6. Matthew W Avatar
    Matthew W

    EVERYTHING with the government is part of a scam…………….

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  7. Old NFO Avatar
    Old NFO

    Conflict of interest and ethics issues… Why is anyone surprised???

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