A number of experts pointed out the risks associated with a dramatic increase in opioid prescribing. They were ignored in favor of others who downplayed those risks.

We sometimes lose sight of how big a role politics plays in healthcare. Not just in finance, either. An example you’re already familiar with: a seemingly innocent change in policy that contributed to the onset of the opioid epidemic.

“Enduring pain: how a 1996 opioid policy change had long-lasting effects”

The research behind the campaign to declare pain the “Fifth Vital Sign” was never strong, and time has shown it to have been even weaker than suspected. The real motivation came from advocates– ┬ápain patients and pain physicians, aided by elements within Big Pharma looking to market their products. A number of experts pointed out the risks associated with a dramatic increase in opioid prescribing. They were ignored in favor of others who downplayed those risks.

A lobbyist representing a pharmaceutical firm with a product to sell isn’t necessarily interested in a true scientific consensus. They seek out experts willing to support the company’s position. If problems with the drug emerge, they work hard to minimize the adverse effect on the company’s reputation. They may urge the client to quickly settle claims that might otherwise alert the public. It’s all in the service of that bottom line. That’s what they’re paid to do.

I’m wondering if something comparable went on in a more recent case, involving quetiapine, brand name Seroquel. This enormously popular medication was initially approved for use with victims of schizophrenia. But physicians, including nonpsychiatrists, began to prescribe it for a host of other ailments. This is known as ‘off-label’ use, meaning other than as approved by the FDA. It’s a common practice and not against the law. It can and has created problems. Here’s an account from the Washington Post.

To quote from the article, by the beginning of 2012 the drug’s maker had already paid out over $1 billion in claims involving

“…about 20,000 cases where Seroquel or its generic equivalent, quetiapine, was listed as the primary or secondary suspect in an adverse event. That included 1,754 deaths in which they were the primary suspect plus 2,309 deaths in which they were a secondary suspect. Overall, 93 percent were apparently the result of off-label prescribing of the drug. Earlier data… looked at adverse events by category of quetiapine use and found that off-label prescribing accounted for more than a quarter of 5,657 cases from 2004 through September 2010. More than half of the off-label cases were for insomnia and sleep disorders.”

(Earlier data: “How Seroquel, A Risky Anti-Psychotic, Became a General Mental-Health Drug“)

This is the sort of aggressive settlement policy we’ve seen elsewhere when a corporation is anxious to avoid damage to their reputation. Remember the fast food franchise that served coffee heated to the point it actually scalded customers? The corporation allegedly decided it was better (cheaper?) to pay off burn victims than lower the temp on their product, and risk losing customers to the competition.

There was a great deal of money involved, after all. And for many corporations, revenue trumps all.


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