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What If The Figure That Justifies Zohydro's Existence Is Fake?

This article is more than 9 years old.

When the Food and Drug Administration defended its decision to approve Zohydro, a narcotic pill made by Zogenix that, unlike competitors, is not abuse resistant, it fell back on a number from the prestigious Institute of Medicine: 100 million people suffer from chronic pain. The need for painkillers that are less likely to lead to addiction must be balanced against the needs of those people.

But what if that 100 million figure is, essentially, cut from whole cloth? That's the argument being made by John Fauber, an investigative journalist for the Milwaukee Journal Sentinel and MedPage Today, a popular site that serves physicians.

Fauber's argument is two-fold. First, he points to numerous conflicts of interest among physicians on the Institute of Medicine panel. Fauber finds that nine of the 19 experts on the panel had connections to companies that manufacture narcotic painkillers, including  at the time or in the 3 years prior to their work on the report. These conflicts, Fauber writes, were not disclosed.

The Journal Sentinel/MedPage Today investigation revealed a series of links, starting with the panel’s chairman — [Philip] Pizzo, the dean of Stanford’s medical school.

In January, 2010 — 10 months before the pain panel began meeting — Pfizer gave Stanford a $3 million, 3-year grant to fund medical education. Stanford said the grant came with no conditions and Pfizer would not be involved in developing the curriculum.

Pfizer makes several pain-related drugs. In addition, other companies that make pain treatments have provided thousand of dollars in research and other funding to Stanford, according to the ProPublica “Dollars for Docs” data base.

In an email and an interview, Pizzo defended his work and the committee members.

“At no point in the process or since have I ever felt that any of our committee members operated with anything other than integrity and commitment to an incredibly important national health issue — pain in America,” he wrote.

That's the weaker part of Fauber's case. Fauber also finds that two experts connected with the report questioned the finding at a meeting held by National Institutes of Health.  “If we are concerned about the message we are sending, we shouldn’t exaggerate the message because the eyeballs start to roll,” said Allan Basbaum, a pain expert and professor of anatomy at the University of California, San Francisco, said at the meeting. “The message will be more powerful if people can believe it.” Then Michael Von Korff, an investigator with Group Health Research Institute in Seattle, said that nobody had asked him about a key piece of data used in coming up with the estimate. Korff said that only about half those with chronic pain are substantially disabled and half of those have substantial work disability. “The 100 million number, I don’t like it because I think it is a little misleading,” he added.

In the article, Pizzo makes the argument that it doesn't really matter whether there are 100 million people with chronic pain, or 60 million, or 40 million. But it does. Because we know that 16,651 people died in 2010 because of overdoses of narcotic painkillers. From a public health standpoint, this is a question of risk and benefit.

Go read the whole article.