The Doritos Locos of Healthcare Epidemics

Last month Health and Human Services (HHS) issued its latest guidance on combatting the opioid epidemic. The first measure proposed within the guidance encourages physicians to begin co-prescribing naloxone (the overdose reversal drug) to all patients receiving opioid prescriptions. This government sponsored union proves that Taco Bell no longer holds the corner market on disturbing co-branding campaigns. For those unfamiliar with the delicacies of Taco Bell, and consequentially the above premise, you can read more on the company’s cobranding initiatives here, here, and here

If the drafters of this guidance set their sights on banking regulations, we might soon see a proposal to combat predatory lending by recommending that institutions found guilty of loan sharking be required to equip loan recipients with fliers for law firms specializing in chapter 13 bankruptcy. And, as will be discussed later, it wouldn’t be a perfect analogy unless the lending institution also owned the law firm.

What follows is a quick recap of the complexities inherent in the effort to combat the opioid crisis. This will be followed by a deeper dive into the problematic naloxone-opioid proposal. Before concluding, the article will briefly review a couple of additional measures that deserve a second look.

Big Business, A Crisis, and Valiant Efforts

Opioids are big business. Big business to the tune of $26.7 billion in 2017. Of that amount, North America constitutes 57% of the market.[i] Unsurprisingly, this is a revenue source that drug manufacturers are reluctant to put aside. As was discussed in the article A Blue Print for a House of Cards, the pharmaceutical industry’s campaign financing and lobbying expenditures have been escalating in the wake of initiatives to lower drug prices and combat the opioid epidemic.

As the social and economic consequences of the US opioid epidemic continue to mount, many regulators have set aside their ties to industry lobbyists in favor of the American people. The Food and Drug Administration (FDA), Centers for Disease Control (CDC) and Health and Human Services (HHS) have all played a critical role in providing guidance and tools to combat the crisis. State level government agencies have also played a substantial role in reversing escalating trends in over prescribing, addiction, and opioid related overdoses and deaths.

The Justice Department has played its part by cracking down on physicians, manufacturers, and pharmacists involved in kickback schemes. The department has also increased punishments for traffickers and illegal online distributors. HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) has taken significant steps in funding cutting edge research and improving access to prevention and treatment services. In some areas the efforts have shown to be effective. The number of prescriptions per capita has been on a downward trend and trends in opioid related deaths appear to be flattening. Nevertheless, the average days supplied per prescription continues on an upward trend[i] as do deaths related to new fully synthetic opioids such fentanyl.[ii] There is clearly a way to go if the opioid epidemic is to be significantly reversed. Despite the efforts taken, there remain a number of glaringly absent policy measures and eyebrow raising guidance that deserves a closer look.

Government Sponsored Co-Branding

It goes without saying that naloxone is an important lifesaving drug that should be readily accessible during this crisis. Nevertheless, the inherent absurdity of prescribing an overdose reversal drug at the same time as the drug itself should raise serious questions as to why the dosage and number of pills are being prescribed in the first place.

When investigating why this piece of guidance made the top of HHS’s list of proposed measures, it is helpful to take a closer look at its origins and most ardent supporters. The FDA recently held an advisory committee meeting where it voted to add labeling language recommending the co-prescription of naloxone for patients being prescribed opioids. Before the vote, several individuals had the opportunity to make their case for and against the decision.

INSYS, a major manufacturer of opioids and soon a naloxone formulary, sent senior director Dr. Dean Mariano to make a case in favor of the dual prescription. Dr. Mariano made his point by emphasizing how this practice will benefit the American public. This message was in no doubt muddied by the fact that the company’s ex-CEO pled guilty last month to an opioid kickback scheme wherein the manufacture bribed doctors to prescribe their opioid formulary and defrauded insurance providers into paying for the drug.

The High Price of Naloxone

Similar to opioids, naloxone has proven to be big business in the United States. Unlike Taco Bell’s Doritos Locos tacos, Cap’n Crunch Delights, and Cinnabon Coffee, the opioid-naloxone co-prescription cannot be found on any sort of value menu.

Even though naloxone has been on the market for decades and in generic form for over 30 years, prices in the United States have skyrocketed in recent years. Kaleo, the manufacturer of the naloxone auto-injector Evzio, recently made headlines as it raised its cost per dose from $575 to $4,100. Price hikes for the drug are in no way limited to Evzio. A recent study[i] found that between 2006 and February 2017 formulations of the Naloxone drug increased in price as follows:

• 2281% for the 0.4 MG single-dose products
• 244% for the 2 MG single-dose products
• 3797% for the 4 MG multi-dose products
• 469% for the 0.4 MG Evzio auto-injector

Some drug companies, like INSYS, have strategically profited from the epidemic by selling both opioids and their antidote. Manufacturers such as Pfizer, Mylan, and Purdue Pharma have all joined in on the government sponsored cross selling strategy.

Cost Implications

With over 200 million opioid prescriptions issued annually in the United States, executed on a large scale this guidance has serious cost implications for government agencies. As HHS’s guidance points out, Medicare and Medicaid will cover at least one formulary of the drug. Furthermore, several state and federal programs exist to subsidize its procurement. Federal funding for these programs have starkly increased as first responders have struggled to foot the increasing bill.

Drug companies have taken it a step further and lobbied government agencies for legislation supporting increased prescriptions and preferred status among federal agencies. Kaleo and Adapt, two major players in the naloxone industry reported spending $300,000 and $475,000 in lobbying for legislation in 2018 alone.[i] Alkermes, a major player in the opioid addiction industry, has been brought under investigation for its lobbying efforts related to its opioid overdose prevention formulary Vivitrol. The company was under scrutiny for its inappropriate lobbying of government agencies and its propagation of misconceptions related to other drug alternatives. The company’s efforts boosted sales as it won over judges and correction officials to exclusively prescribe its formulary over other brands with higher efficacy rates.[ii] At over $1,000 per dose, Alkermes profits substantially from the deal.

Cut Rate Solutions

If the primary argument for the guidance is truly to increase consumer access to naloxone, the word access once again needs to be reevaluated. Having a prescription is not the same as having access to a life saving drug. As has been addressed in prior articles, accessibility of medication in the United States is more about affordability than proximity. Assuming again that the primary goal of this legislation is to increase access to a drug, there are far more cost effective measures that could be taken by legislators.

1. Regulators could allow an exception to the law prohibiting retailers, first responders, and consumers from importing the drug from countries where it is sold far less expensively than it is in the United States.
2. The FDA could, on a federal level, switch naloxone’s status from being prescription-only to over-the-counter. While many states have taken actions to make the drug available without a prescription, the widespread adoption by pharmacies has been low. Switching the drug’s status on a federal level would also enable new low-cost entrants to come to market more quickly as FDA authorization for over-the-counter drugs is relatively easy compared to prescription-only formularies.
3. Alternatively, federal law section 1498 specifically provides for such emergencies by allowing the government to circumvent patents and produce a low-cost generic of a drug. While I am in no means a proponent of governments seizing patents, given the state of emergency and escalating healthcare costs, if access to naloxone is the key issue, this seems like the most immediate solution.

Other Eye-Brow Raising Proposals

Beyond the naloxone-opioid guidance discussed above, the guidance went on to establish a myriad of additional proposals that deserve a second look.

Conflicts of Interest

Also included in the guidance were clear conflicts of interest. One such piece of guidance recommended that doctors attend Opioid Analgesic Risk Evaluation and Mitigation Strategy courses. Education is certainly crucial to involving physicians in the fight against opioid addiction. However, such education is only useful to the extent it is unbiased and designed to teach practices that will reduce opioid dependency and implement more effective alternatives. Unfortunately these educational courses are funded by drug companies with approved opioid drugs on the market.[iii] According to the manufacturers themselves, they are actively “collaborating to operationalize this complex national program.”[iv]

Unnecessary, Yet Apparently Necessary Advice

The published guidance also included several recommendations you would hope would be unnecessary but likely speak to more fundamental issues in the American healthcare system. One recommendation encourages the consistent use of established state-run Prescription Drug Monitoring data bases. These databases are crucial to cracking down on “doctor shopping” and cases of abuse and illegal distribution.

A few issues stand out. First, these databases should not be optional. While 49 states have made these databases available, only 39 require prescriber use. Second, the American Medical Association (AMA) has continued to report that compliance rates among Veteran Health Administration (VHA) pharmacies remain disturbingly low. Finally, the poor technological underpinnings of the databases have lead to continued complaints about reporting delays, indecipherable data, and time consuming entry.

A follow up recommendation encouraged doctors to more closely evaluate decisions to continue opioid prescriptions for patients that experience non-fatal overdoses. While this may seem obvious, the guidance quotes a recent study on the subject that found opioids were prescribed to 91% of patients after a non-fatal overdose.[v] In a system where access to preventative care is limited and doctor’s relationships tend to be more episodic than long term, lasting solutions to chronic pain are often not the default solution. Too many patients in the US healthcare system lack consistent access to a primary care physician, and even fewer have insurance plans that cover therapeutic services like physical therapy.

Summing it Up

The opioid epidemic represents a major challenge to those in a position to influence healthcare policy in the United States. The pharmaceutical industry has proven a more than worthy opponent for those wanting to orchestrate real change in the American healthcare sector. However, in the face of an epidemic with serious social and economic ramifications, it is vital that those in a position to make a difference operate without bias. Many groups and individuals, driven by a common purpose, have made it their mission to study the issue and develop new policies and methods to addressing the crisis. It is vital that such work is supported and that drug manufacturers’ interests are never put above the American public.

[i] https://www.statnews.com/2018/03/13/naloxone-study-access/

[ii] https://www.harris.senate.gov/news/press-releases/senator-harris-launches-investigation-into-pharmaceutical-manufacturer-alkermes-regarding-opioid-addiction-treatment-manipulation

[iii] https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm

[iv] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5283702/

[v] https://www.drugabuse.gov/publications/improving-opioid-prescribing/improving-opioid-prescribing

[i] https://www.sciencedirect.com/science/article/abs/pii/S0306460318304696

[i] https://www.cdc.gov/drugoverdose/pdf/pubs/2018-cdc-drug-surveillance-report.pdf#PDO%20Surveillance%20Report_2018_F.indd%3A.88319%3A813

[ii] https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates

[i] https://www.mordorintelligence.com/industry-reports/opioids-market

Originally published at termsofagreement.com on January 19, 2019.