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Does a Financial Conflict of Interest Ever Expire?

Does a Financial Conflict of Interest Ever Expire?

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Several weeks ago, I wrote about the silliness of the war between primary care societies and cardiology organizations about the new hypertension guideline.

Here’s the story thus far. Cardiology specialty organizations announced that the new cutoff for hypertension would now be a systolic blood pressure greater than 130 mm Hg. Primary care societies had announced earlier in the year that the appropriate cutoff was greater than 150 mm Hg in most patients.

The American Academy of Family Physicians and the American College of Physicians denounced the new cardiology-led guidelines. The American Heart Association and the American College of Cardiology countered with a publicity campaign to support their position.

I called it a “fake” war, because it made no scientific sense. Larry Husten, in his most recent CardioBrief post, corrected me, stating that the war was quite real.

On Feb. 5, 2018, the Baltimore Sun published an article by a family physician (Dr. Max Romano), who accused the cardiology guidelines committee for undisclosed financial conflicts of interest.

He wrote that certain members of the guideline committee had financial relationships dating back to 2013-2014, which had not been disclosed in the guidelines publication. He assumed that these 4-year-old relationships (regardless of the amounts or purposes) led the members of the guideline committee to dramatically widen the use of antihypertensive drugs, simply to promote the profits of the pharmaceutical companies that had previously funded them.

The attack by Dr. Romano may have been well-intentioned, but it was ill-informed for several reasons.

First, the Open Payments website contains only information about payments that are reported using specified definitions. The site reports the date when payments were made, which may not correspond to the dates that the relationship took place. (Payments may be delayed for months or years after a contract is completed.)

Second, nearly all antihypertensive drugs are now generic and very inexpensive. Hypertension is neither a source of revenue growth nor an area of innovation. The companies that will primarily profit from the change in the diagnostic criteria or treatment targets for hypertension are not those that were identified by Dr. Romano.

Third, the Open Payments system only reports recent financial relationships. It does not report relationships that occurred in 2009, 2004, 2001, 1998. If it did, Dr. Romano’s article would undoubtedly have been much longer.

Suppose that Dr. Romano could go back 5, 10 or 15 years. Are these older financial relationships relevant to his argument?

Some might say yes, that any payment of any type for any reason — even one that was 30 years old — creates a bias that should disqualify someone from serving on a guidelines committee.

Really?

Does any prior financial interaction, regardless of amount or purpose and regardless of the time period, disqualify someone?

All organizations that worry about conflicts of interests have a “sunset” provision. It is the identification of date before which the influence of a prior relationship is deemed to be irrelevant. You can argue about whether it should be 1, 3, 5 or 20 years. But at some point in time, the influence of that relationship becomes negligible.

I am sure that some will disagree. Some may propose that we should populate our guidelines committee only with people who have been placed in a hermetically sealed container since birth, which has shielded them from all microbes that could influence their cerebral development.

I guess we could do that, but how would these highly protected individuals ever know what the real world was like? How would they ever make informed judgments? Doesn’t one need to interact with the world to understand its limitations?

I certainly do not want to hear advice from people who don’t know what the world is really like. I certainly do not want to hear people analyze trials that have been supported by industry if they have never been involved in an industry-supported trial. How would they ever know what they are talking about?

Trust should be based on the integrity of individuals, not on their ability to pass some arbitrary test of “purity.”

Using a litmus test of “purity” means that you don’t need to do any work to figure out if someone is being intellectually honest. It is so much easier simply to create a stereotype. If you think about it, that process actually has a name — it is called “profiling,” and it is really bad news.

Interestingly, those who would routinely condemn “profiling” behavior in others have no qualms about doing it themselves. Welcome to today’s world.

Packer recently consulted for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cardiorentis, Daiichi Sankyo, Gilead, Novo Nordisk, Relypsa, Sanofi, Takeda, and ZS Pharma. He chairs the EMPEROR Executive Committee for trials of empagliflozin for the treatment of heart failure. He was previously the co-PI of the PARADIGM-HF trial and serves on the Steering Committee of the PARAGON-HF trial, but has no financial relationship with Novartis.

2018-02-14T10:30:00-0500

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