Serious Transparency Loophole Is Impacting 'Good Medicine'

Medicine How Big Pharma is Taking Advantage of a Transparency Loophole

If a well-meaning law leaves a hole, lots unsavory tactics can be used to make it a loophole. That appears to be what’s happening regarding a transparency loophole that was supposed to be regulating big pharma. According to an article by The Pharmlot View, a 4-year-old law that requires drug makers to keep track of and report meals they buy for doctors, speaking and consulting fees, as well as running clinical trials, is being circumvented.

The Loophole

The article says that while the law has highlighted some influential practices that may influence the medical community, the thwarted scandals are not the norm. Most times it seems a transparency loophole is being exploited. The problem seems to be that pharmaceutical companies are not required to report fees related to a medicine that may not yet be approved by the FDA. The Pharmlot View article shines a light on how this practice is leading to the influence of physicians.

Consider the scenario laid out by the article: a small company contacts a doctor about an up and coming drug not yet approved by the Food and Drug Administration. While that doctor may not drastically alter a course of treatment for patients now, they may be more likely to use the drug once it is approved by the FDA. All the while, the pharmaceutical company need not report on the tactics it used to introduce that doctor to the drug in the first place.

Paul Thacker, a former staffer at the Senate Finance Committee says, “This is not what Congress intended.” His committee investigated the possible conflicts of interest between pharma companies and doctors. He actually helped draft the law that led to the creation of the OpenPayments database. Now the law he helped draft is being exploited.

Damning Example

In one, particular damning example, the transparency loophole was used as a selling point. AveXis is a small biotech company that uses gene therapy research. This research had not yet led to a drug that was on the market, so the company was able to align with doctors and medical experts in secret. They were able to pay fees and provide travel and lodging, all without reporting the interactions.

AveXis basically used the loophole as a way to get “expert” advice on how to infiltrate the hospital market. They used tactics that would have to be noted in the database IF their drug was approved by the FDA. This example has led many to believe that companies are aware of the transparency loophole and are using it for their benefit.

Why it Continues

If the transparency loophole is there and being exploited, then why hasn’t anyone moved to close it? Well, that has to do with the original backlash from the law itself.

Back in 2013, many doctors were downright insulted that anyone would insinuate they were being influenced by big pharma. They complained that the databased was worthless because their judgment had not been influenced one way or another. While those complaints have slowly stopped trickling in, some experts think that requiring small pharmaceutical companies to report pre-market interactions could be too expensive and time-consuming. The argument is that investments in possibly life-saving drugs could be compromised.

According to the article, there is a fair amount of pushback against this loophole. Dr. Aaron Kesselheim is a Harvard Medical School professor who also heads the program on regulation at Brigham and Women’s Hospital. She says the loophole is easy to exploit, “I don’t think it’s hard to imagine that payments made prior to [FDA] approval may still influence a person later.”

In other words, the law is being taken advantage of and is not being used at it was intended. What happens next is up to Congress.

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