Medicare Set-Aside Blog on January 2, 2013
Posted by

While I’m guessing I should be anxiously awaiting the president’s signature on H.R. 1845, I am much more excited about starting off the new year with finally finding an appropriate moniker for our nation’s opioid problem. In an excellent article published by the Washington Post this week, it was noted that the small town of Portsmouth, near the borders of Ohio, West Virginia and Tennessee (population: 80,000) is served by nine pill mills, and it refers to opioid addiction as “pharamageddon.” In a town where more than 100 doses of opioids are annually prescribed and dispensed per capita and 10% of babies are born addicted, about 20 people per year die of overdoses.

The general consensus of the article is that Purdue Pharma is primarily responsible for the opioid problem in this country. While I don’t disagree with that concept totally, the article sadly does this in a manner that somewhat forgives our entire medical and scientific community, as well as regulators, for turning a blind eye for so long. The FDA approved the drug with a label that permitted Purdue to state that the risks of addiction were reported to be small. The New England Journal of Medicine, the nation’s most respected medical publication, reported in 2003 that such painkillers pose a minimal risk of addiction (an article that Purdue reprinted 10,000 times). Based primarily upon these two factors, state medical boards made prescribing rules for opioids more liberal and doctors started prescribing for chronic pain more freely. So how did so many people get it so wrong?

Well, first we blame big pharma in general. If the information spoon-fed to the public wasn’t funded and/or manipulated by the pharmaceutical companies, individuals financially tied to those companies were involved. Of sixteen key clinical trials, five were funded by Purdue and an OxyContin distributor, two were co-authored by Purdue employees, and two were sponsored by other drug companies making different opioids. One of the key published studies sponsored by Purdue (the one reprinted 10,000 times) omitted suspected cases of withdrawal symptoms. When the FDA attempted to refine its policy on opioids in 2002, it solicited ten outside experts for advice. Five of them reported having served as speakers or investigators for Purdue and three others reported working as speakers for or as advisers and consultants to other pharmaceutical companies. An ex-FDA adviser admitted in a 2010 interview that, at the time, the goal was to destigmatize opioids; therefore, they often left evidence out. They were trying to make the primary care audience feel more comfortable about opioids. Well, mission accomplished.

But this still doesn’t explain how all of the medical professionals got it so wrong for over 20 years. Even the FDA admits that it relied on industry experts for advice. Unfortunately, they all appear to have had ties to big pharma. Of course a spokesman for Purdue says that “[t]heir past work with industry should not preclude them from sharing their expertise with government agencies or their peers in the medical community.”

The FDA also relied upon a number of other trials and articles all suggesting little reason to worry about addiction. Turns out that many authors of these studies now admit that Purdue gave them the data upon which they relied. In information disclosed during discovery in 2007 when Purdue was being prosecuted for misbranding, it was discovered that many indications of withdrawal had been left out.

That still doesn’t forgive the current situation. Why did it take so long to admit that perhaps accepting this data at face value may not have been appropriate? The article quoted the director of the Ohio Department of Alcohol and Drug Addiction Services as saying that “[a] pharmaceutical company that has a vested interest in promoting their product should not be seen as a reliable source of safety information.” Why did no one else possess this bit of common sense during the 90s?

The article unfortunately only tells the sad tale and does not mention any solutions in the works. That is likely because there still are none. 2012 was was a year of raising awareness of the problem and apparently looking for the reasons behind it, if this article is any indication. On this first day of the new year, let us hope that 2013 will bring us some solutions. While there is no easy way to deal with the existing addicts, we must for their safety and wellbeing. But more importantly, we need to get the wanton prescribing under control to prevent creation of new addicts. Just as the medical community was so effectively brainwashed into believing that opioids were harmless, they need to understand just how destructive they truly are. And when that finally happens, not only will people stop dying, but we lower our insurance costs as well and everyone wins. Oh, well, maybe not big pharma…

Click here for the original article..