Opinion

Avoiding the Second Best and the Almost Brightest

During my tenure at the FDA I was the senior official in charge of advisory committee oversight and the final decision-maker on who got a Conflict of Interest waiver and who did not. Many did not — but those who did received their waivers because FDA professional career staff made a strong case that these people weren’t just important to the advisory committee — but critical.

And we should all pay attention to the nomenclature.  It’s not about “conflict of interest” – it’s about “interest.”  And having an “interest” is not necessarily a bad thing – as long as you’re transparent about it.

If we allow FDA ad comms to become the realm of the second best and the almost brightest –what have we done to the advancement of America’s health? The answer is a significant disservice.

Worse — who would want to serve on an advisory committee when you’re viewed as a potential criminal before the ink on your appointment is even dry? Independent-thinking advisory committee members will feel threatened and suffocated by the unspoken threat of federal investigators knocking at their clinic doors. Such legislation amounts to advisory committee lettres de cachet for folks like the CSPI, posturing politicians and Page One hungry reporters.

In the February 7, 2010 edition of The Lancet, Richard Horton pointed out that the battle lines being drawn and between clinician, medical research and the pharmaceutical industry are artificial at best — and dangerous at worst. Dangerous, because all three constituencies are working towards the same goal — improved patient outcomes.

Horton’s main point is that we must dismantle the battlements and embrace of philosophy of “symbiosis not schism”.  It’s what’s in the best interest of the patient.

Consider an analysis published in The International Journal of Obesity and financed not by industry but by the National Institutes of Health.

After analyzing weight-loss research conducted over four decades, they’ve found that the quality of data reporting in industry-sponsored research does indeed seem to be different from that in other research: It’s better.

The researchers found that the quality of data was significantly better in industry-supported research than in non-industry-supported research, particularly in studies involving drug treatments.

According to the New York Times, “This suggests that, while continued efforts to improve reporting quality are warranted, such efforts should be directed at non-industry-funded research at least as much as at industry-funded research.”

The Sunshine Act with all of its high-minded language about transparency is really just about slamming the pharmaceutical industry.

That’s politics trumping the public health.

Why isn’t anyone concerned about the payments physicians get from insurance companies to switch patients from brand name to generic medicines, or from trial lawyers to be expert witnesses?

If physicians and academicians are paid by industry for their medical expertise – and those payments are important to disclose – why aren’t payments for that same expertise important to disclose when they’re being used by insurance companies and lawyers?

When is a conflict not a conflict?  The answer, it seems – it when it’s convenient to the Brotherhood of the Conflict of Interest Priesthood, the COI Polloi.

Who’s pure and who isn’t?  Here’s the answer – nobody is 100% pure.  Not even Ivory Soap is 100% pure – and it floats!  And politicians are certainly not 100% pure.

“The best interest of the patient is the only interest to be considered.”
William Mayo, MD

 

Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest and an Executive Partner at YourEncore

 

 

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