Orthopedists Due Major Blame for Opioid Crisis? – PART II

Digging past the headlines, it’s difficult, if not impossible, to establish a direct correlation between legitimate short-term opioid prescriptions for acute or post-operative pain from orthopedic interventions and illicit trafficking.

The legal and regulatory focus on orthopedic prescriptions has fueled a number of legal and policy changes as well as several unintended consequences.

In Part I, we listed the first three of those changes. In Part II, we pick up the narrative with the Drug Enforcement Administration’s (DEA) slow and apparently misguided attempt to slow the trafficking in illicit opioid drugs.

4. Was upper management of the DEA protecting drug companies from harsh action to stop the illicit pill trade? DEA field agents think so, but maybe that’s changing.

A fundamental question in the opioid crisis is how hundreds of millions of pills have gotten into illicit circulation.

In the early 2000s, DEA field agents began cracking down on major drug companies and distributors for selling opioid pills to Internet pharmacies and other pharmacies ordering illogically huge batches. In all, 13 companies, representing 85% of the prescription opioid business, were charged with at the very least looking the other way.

McKesson in 2008 paid $11.3 million to settle a case in which three of its warehouses were accused of failing to report hundreds of suspicious orders. (“How drugs intended for patients ended up in the hands of illegal users: ‘No one was doing their job’,” Washington Post, 10/22/2016).

In the settlement, McKesson agreed to closely monitor its warehouses.

Cardinal Health paid a $34 million settlement in 2008 for similar failures. Then, in 2017, Cardinal agreed to pay $44 million for failures to alert the DEA to suspicious orders from its Lakeland, Florida warehouse from 2009 to 2012 (“Cardinal Health fined $44 million for opioid reporting violations,” Washington Post, January 11, 2017).

Then, agents in the field thought they’d discovered the mother lode of cases: McKesson again, according to Washington Post and other news stories.

Field agents thought the case was so big and solid that they wanted a billion-dollar fine, immediate shutdowns of more than one McKesson warehouse, and criminal charges against unnamed executives, given that this was a repeat violation.

McKesson had never bothered to monitor its warehouses after the 2008 settlement, claims an October 2017 stockholder lawsuit (“McKesson Records Show Failed Opioid Oversight, Lawsuit Says” – Bloomberg News, December 8, 2017.

McKesson says the claims in the lawsuit are just unproven claims.

However, McKesson settled the second case for $150 million in January 2017—but with no immediate suspensions of opioid sales and no criminal charges. At least three senior DEA agents in Denver and Detroit, with 29, 30, and 43 years’ experience, were so upset that they retired.

A $150 million fine seems gigantic to most of us. However, it’s just 1.5 times what McKesson’s chief executive made that year.

And then things got worse

In the Post stories, agents described foot-dragging by superiors on cases against distributers from around 2012 to mid-2016, as the crisis hit new peaks every year. DEA headquarters (HQ) stopped using the agency’s most powerful weapon—immediate suspension of the license and shutdown of warehouses of a distributor caught selling large quantities to suspect pharmacies.

Why did DEA HQ seem to go easy on McKesson and others? A DEA investigator told the Post that his superiors said McKesson had been treated lightly because it has hordes of Ivy League lawyers.

Then, investigators’ jobs were made even more difficult.

In April 2016, with the crisis spiraling out of control, Republicans pushed through Congress, and President Obama signed, a law with an innocent-sounding name, “The Patient Access And Effective Drug Enforcement Act.”

This law made it much more difficult for field agents to immediately suspend illicit opioid sales. It passed Congress by unanimous consent, which means every member of Congress in both political parties went along rather than demand a vote.

The House sponsor of the bill, who had pushed it for years, was Rep. Tom Marino (R-Pa.), whom President Trump subsequently nominated to head the Office of National Drug Control Policy, a job informally called the nation’s drug czar. Marino received $100,000 in campaign funding from drug companies.

It sailed through the Senate on the reputation of Sen. Orrin Hatch (R-UT), who still defends it.

Headlines on the anger of DEA field officials over the foot-dragging and then this law put DEA headquarters under a harsh spotlight. Personnel changed, and now, attitudes seem to have changed. Marino was out as the drug czar nominee.

On May 4, 2018, the DEA issued its first immediate suspension of a drug wholesaler since 2012.

The DEA alleges that this wholesaler, Morris & Dickson of Shreveport, Louisiana, “failed to properly identify large suspicious orders for controlled substances sold to independent pharmacies with questionable need for the drugs…primarily purchases of Oxycodone and Hydrocodone…in some cases, pharmacies were allowed to purchase as much as six times the quantity of narcotics the pharmacy would normally order…[and] failed to identify these large suspicious orders resulting in millions of dosage units of Oxycodone and Hydrocodone being distributed in violation of the law,” according to a DEA May 4, 2018 press release.

The independent pharmacies “were purchasing more narcotics than several of the largest chain pharmacies combined within the same zip code,” the DEA said.

The company said in a statement that it had done nothing wrong, and that the DEA was mistaken about the impropriety of the orders.

No one knows the total numbers of opioid pills diverted to the black market through “pill mill” physicians and pharmacies and the dozens of Internet “pharmacies” to which the manufacturers and distributors sent big-batch orders of pills without asking questions. However, the numbers in the Washington Post stories alone add up to many tens of millions of pills (20.8 million pills to two pharmacies in West Virginia alone).

5. Drug company publicists blame physicians.

Despite the numbers, a prescription drug manufacturers’ trade association, the “Healthcare Distribution Alliance,” put up a web page in June titled; “Fact Check: Where 60 Minutes Got it Wrong on the Opioid Crisis” disputing the findings of Washington Post-60 Minutes reports.

It says: “FACT: There is broad recognition among leading public health authorities that opioids have been over-prescribed—a trend that began in the 1990s and has only recently received the attention it deserves.”

This bold piece of propaganda, just a few weeks ago, comes despite the 22% decline in the total of opioid prescriptions written from 2012 to 2016, while the use and availability of illicit pills has continued to rise.

6. Expect new, alternative pain medications – several years from now.

A 2016 law signed by President Obama directed the National Institutes of Health (NIH) to fund research on alternatives to opioids for pain medication.

NIH announced in April 2018 that it will be offering grant money for that research. So, eight or ten years down the road, given the time it takes for testing and clinical trials, there might be new, affordable, effective alternatives to opioids for pain. Or maybe not. If there are, the next question is whether their costs will be covered by Medicare, Medicaid, and private insurance (or whatever sort of a health system we’ll have then).

Most of the current, effective alternatives for chronic pain (other than NSAIDs) require physician intervention, and are therefore costlier, and they may or may not be covered by health insurance.

The wording of the 2016 legislation and the NIH announcement appear to be aimed at finding cheap and easy treatments—that is, non-addictive pills which would work better than NSAIDs.

7. Will effective treatments for opioid abuse be covered by insurance, Medicaid, and Medicare? And will drug prices be capped?

Treating opioid abuse or overdoses isn’t generally part of the orthopedic specialty, except to the extent that drugs which reduce the risk of addiction or overdose are sometimes prescribed along with opioids to prevent opioid use disorder (OUD) these days—a new regimen in the past couple of years.

Effective treatments which reduce the risk of either fatal overdoses or long-term dependency are available. They’re called medically assisted treatments (MAT). The issues are, as they have ever been, whether they’ll be covered by insurers or not.

The price of an overdose treatment, a ready-made injector called Evizio, which is similar to an Epipen, went from $690 per 2-dose pack in 2014 to $4,500 in 2016. A nasal inhaler of the same drug (Naxolone) costs $150. And multiple treatments might be needed. Naxolone itself is fairly cheap, and in some states, it’s available in a kit at pharmacies without a prescription.

The cost issues for addiction treatment are different. Medically assisted treatment (MAT) requires therapy, lab testing, and lengthy prescriptions for long-acting drugs which prevent euphoria and allow for gradual withdrawal (a buprenorphine/naloxone combination or extended-release naltrexone, according to a National Institute on Drug Abuse (NIDA) study).

It’s expensive, but it works. The NIDA said that after buprenorphine was made available in Baltimore, overdose deaths fell 37%. An interesting fact about buprenorphine, the NIDA says on its website, is that it is sometimes illegally diverted—to drug abusers trying to heal their addiction.

Fewer than half of all the substance abuse treatment centers in the U.S. use MAT, and of those, only a third of opioid addicts are receiving MAT. – “Effective Treatments for Opioid Addiction.”

The much-criticized 2017 New Jersey law with the infamous “toughest in the nation” five-day limit for opioid prescriptions also included a beneficial (unless you’re an insurance company) provision which drew less attention: insurance companies in the state are required to cover inpatient or outpatient MAT for opioid abuse for up to six months. Federally regulated coverage, including Medicare, Medicaid, ERISA, DOD, and VA health systems are outside the state’s jurisdiction, but it sets a precedent.

Will the federal government do the same?

For Medicare, maybe. For Medicaid, which already covers substance abuse, nothing new, except for a proposed 42-month test in five states in the House opioid bill, S6. And current coverage is at political risk.

Medicare: the June 22 House opioid bill would require Medicare to make bundled payments for MAT to opioid treatment programs which could reach up to 3,000 Medicare beneficiaries not currently being treated for substance abuse. For people with Medicare Advantage 8 plans, the House bill proposes spending $1 million to study whether patients with Medicare Advantage have sufficient access to MAT.

Medicaid: MAT is already covered in every state, says a January 2018 Kaiser Family Foundation report, “Medicaid’s Role in Addressing the Opioid Epidemic.” Of the approximately two million Americans under age 65 with OUD, 38% have Medicaid, 37% have private insurance, 17% have no insurance, and 8% are listed as “unknown.”

However, that Medicaid coverage is under the Affordable Care Act, which Republicans have been vowing to kill off since it was enacted a decade ago. The future of Medicaid funding for opioid abuse is in doubt under the Trump administration and current Congress.

The House bill would also require state Children’s Health Insurance Programs (CHIPs) to cover opioid abuse.

The Senate is expected to take up the House bill in November.

8. West Virginia, state attorneys general, and lawsuits by OUD sufferers.

A new trend: sue drug makers and distributors.

West Virginia’s attorney general on June 28 became the latest to sue Purdue Pharmaceuticals for allegedly falsely advertising that OxyContin was safe and minimizing the risk of addiction.

As of June 18, more than 600 state, county and city governments had filed lawsuits against drug makers over opioids, according to a website, https://www.consumersafety.org/legal/opioid-lawsuits/

Migrating Lawsuits

Most of the lawsuits are based on claims of drug company false advertising. However, the lawsuit trend could hit physicians if a West Virginia Supreme Court of Appeals decision were to spread to other states.

The drug companies thought they were immune to lawsuits from individuals with OUD on the legal grounds that a perpetrator of her or his own harm can’t sue any other contributor to it.

However, in West Virginia, the highest court ruled in 2015 that OUD sufferers may indeed sue parties in the prescription distribution chain on the legal principle of “comparative negligence” (Case 2015-14-0144). That is, even though the addicts harmed themselves with illegal activity, others’ negligence, if any, isn’t excused. They sued physicians as well as the manufacturers, distributors, and pharmacies.

The case itself hasn’t been decided yet.

If they win, it seems likely that others will try to use this “comparative negligence” theory against everyone in the chain of distribution, potentially including physicians.

And with that, we’re back to where we began.

Blaming the orthopedist for doing their job.