On May 16th my Post Script blog addressed the “Prescription Opioid Abuse Epidemic” going on in the United States. Seemed like something good was happening. An FDA Advisory Panel had just voted unanimously to REQUIRE expanded education and training of providers to reduce the abuse and misuse of prescription opioids. At virtually the same time, the CDC issued new clinical guidelines to providers regarding prescription opioids. The most significant of these was that, due to a lack of supporting evidence, opioids should not be used as first line therapy for non-cancer chronic pain.

Sadly, these recommendations failed to understand the nature of America’s true addiction.

In college I participated in intercollegiate debate. It’s an ugly and weird little exercise, but there are rules. To win your case, there are certain things that the Affirmative team must prove. The case had to be topical, the problem significant, and the plan to correct it both workable and without counterbalancing disadvantages. Most importantly, there must be an inherent reason why the problem will not be solved without the Affirmative plan.

Inherency can be proven in a variety of ways. Sometimes there is a law that needs to be repealed, sometimes it’s a judicial precedent, sometimes there are pragmatic, attitudinal or religious reasons a proposed change will not happen without adopting the Affirmative plan. But of all the inherent reasons why something positive will not be done, the most powerful is profit-motive.

America’s most powerful and dangerous addiction is not to long-acting prescription opioids. America’s real addiction is to profit.

The Monday paper had a B-section story that left me speechless. The story announced the recent FDA approval of Probuphine from Braeburn Pharmaceuticals for chronic pain management. Probuphine is a surgical implant placed under the skin of the upper arm which administers portioned levels of an opioid for at least 6 months before the patient needs a refill. It is being touted as the next big advance in our efforts to “fight addiction.”

Let me repeat that, and this will require a good bit of cognitive dissonance. Probuphine is our “next big advance in our efforts to fight addiction.” Once more, for what I hope is unneeded emphasis. Burying a six-month supply of slow release opioid in your upper arm flab is the next big advance in fighting addiction.

Despite the good intentions of their publicity releases last month, the FDA and CDC forgot who they were dealing with. Like the Wall Street banks, Big Pharma is “too big to fail.” In South Carolina alone, more than 291 million opioid pills were prescribed between July 2014 and June 2015. Among those were 14.5 million in Charleston County, 10.5 million in Berkeley County and 7.9 million in Dorchester County. That works out to just over 60 narcotic tablets for every man, woman, child and fetus in the state.

At least, the FDA would be forced to”reach” harder to justify their inherent support of Big Pharma. Among the several “pluses” of Probuphine, the implant allows patients to bypass monthly appointments in favor of a 6-month re-load. A bit of a shame since the CDC had just endorsed monthly counseling and psychological support as elements of a non-narcotic alternative approach to non-cancer chronic pain. The rural card was also played, pointing out that residents in rural areas would not have to drive so far for monthly doctor’s visits to refill their medications. There’s a nice perk.

The FDA also noted that the implant would help prevent drug diversion. By administering the drug via implant the Pronuphine will not be subject to becoming lost, stolen, misused or re-sold. Makes sense, Big Pharma doesn’t want anyone else muscling in on their profits. Me, I think the FDA has woefully underestimated the underground prescription opioid industry. If you can take out kidneys in an old, cracked porcelain bath tub on ice, I don’t think it will be that tough to dig a reservoir out of some bingo wings.

Last, but certainly not least, the final plus is that Pronuphine is now available at the new rock bottom price of $825/ month which sounds better than the real price of $4,950 which covers the entire 6 month depot. Being cheaper than daily oral pills and having the added benefit of cutting out those pesky physician office visits brings Big Pharma together with Big Insurance and brings the FDA to its knees.

Okay, so maybe the above is a bit heavy handed. I’ll cop to that charge. But first, in the immortal words of Deep Throat, let’s “follow the money.”

Twenty years ago, when Purdue Pharma and other Pharma companies began to aggressively market Oxycontin and other long-acting opioids they promised providers that the long-acting opioids were not addictive and there was no legitimate reason to restrict their use to post-surgical pain, trauma, cancer or other terminal pain conditions. Big Pharma undertook a multi-million dollar campaign to paint chronic and other non-malignant musculo-skeletal pains as requiring opioids despite the lack of any evidence that was true.

Between 1996 and 2002, Purdue Pharma funded more than 20,000 pain-related educational programs ( I attended and got some nice golf balls) through direct sponsorship and financial grants to encouraged long-acting opioids for chronic non-cancer pain. Significant financial support was provided to the American Pain Society, American Academy of Pain Management, Federation of State Medical Boards, the Joint Commission, and other organizations such as the American Geriatric Society (AGS).

In 2009, the AGS changed its guidelines to recommend opioid painkillers for “all patients with moderate to severe pain” in preference to over-the-counter NSAIDs. A pain guide published by the AGS and funded by Janssen (Duragesic, Ultram ER, and Nucynta) states that opioids “allow people with chronic pain to get back to work, run and play sports,” and describes as a “myth” that patients will require increasing doses of opioids over time.

The guide highlights the relationship of NSAIDs to gastric irritation and bleeding, but found no need to mention the constipation, diminished immune response, reduced libido, fracture risk, liver function abnormalities, pulmonary and congestive heart failure issues, sleep apnea, reduced mental capacity and potential overdose associated with opioid painkillers.

Purdue Pharma was preparing for the day when it’s other big earner- MS Contin lost its patent protection. Oxycontin would not only replace MS Contin as an even longer-acting painkiller, but would also widen the market to non-cancer usage. It was a successful marketing strategy that has earned Purdue at least $31 billion. Twenty years ago, none of the pain conditions currently presented as requiring opiods would have been presented that way. Then again, 40-50 people were not dying from opioid overdoses each day.

However, Big Pharma could not accomplish all this alone. While the approval of an extended release subcutaneous opioid implant to “fight addiction” might be particularly tone deaf in the face of a national epidemic, it’s not the first time that the FDA has stepped up when the deep-pocketed Big Pharma and massive chain pharmacies have called. On the same day in 2013, that the FDA announced restrictions on Vicodin it also approved long-acting Zohydro (hydrocodone bitartrate) over the objections of both medical and public health groups as well as its own Advisory Committee. Zohydro is estimated to have 5 to 10 times the abuse potential of Oxycontin.

In 2014, the FDA approved Tarrginiq ER, acknowledging that it was capable of causing euphoria, overdose and death. In 2015, the FDA approved opioids for children as young as 11. The market has further expanded with approval of drugs like Suboxone designed to be an even longer acting opioid treatment for long-acting opioid addiction. Do you feel like you’re falling through the looking glass yet?.

Just to add that last little bit of Looking Glass absurdity to this issue, remember that American’s never miss a chance to make a buck. Acadia Healthcare is a national chain of addiction treatment centers and behavioral health companies. In 2010, Acadia owned 6 facilities. By 2016, Acadia owns 587 facilities in the US and UK. At a recent investor conference, Acadia’s CEO Joey Jacobs discussed the impact of the Affordable Care Act to expand insurance coverage to so many more poor people and, especially, allows young people up to age 26 (peak age of opioid and heroin addiction) to stay on their parent’s insurance plans.

In his slide show, Jacobs referred to the rising use of heroin (in his excitement he forgot prescription opioids, but we forgive) as a “favorable industry tailwind” and predicted that profits would continue to grow.

And yet, as a country, we are unable (it’s financially impossible!!) to find the money to improve our public schools, provide universal healthcare coverage or insure a college or technical school education opportunity to everyone who qualifies. In debate, we’d argue that there is no profit-motive for any of those things to happen.

 

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