Two months ago, it was reported that six US states filed lawsuits against Connecticut-based Purdue Pharma, accusing the company of “…fueling a national opioid epidemic by deceptively marketing its prescription painkillers…”
This is in addition to the 400+ additional lawsuits by US cities and counties, which have now been consolidated in Federal court.
Other defendants in that consolidated lawsuit include both pharma companies and wholesalers, such as J&J, Teva, Endo, Cardinal Health, and others.
This is not the first time that a government has singled out Purdue Pharma. The US Federal government brought criminal charges against Purdue over ten years ago, resulting in a guilty plea and millions pain in criminal and civil fines.
We’re not attorneys, and we have not reviewed the details of these lawsuits. So we will leave that to others more qualified to do so.
Part of Purdue’s response was to stop using their sales reps from promoting OxyContin to physicians, though it is unclear to us if this will result in lost jobs.
While the lawsuits continue, this is becoming a problem that extends even beyond the 40,000+ deaths per year attributed to opioid abuse and misuse.
For example, a black market is now rapidly growing, especially for potent and high-value drugs like fentanyl, partly to serve the market of legitimate users who cannot obtain enough medication legitimately.
Why is this happening?
One paradoxical reason is because many physicians are becoming increasingly shy about prescribing these medications, and now some pharmacies are carrying very limited supplies (if any), with the latter bearing the additional safety and related concerns associated with the potential theft of opioids. The latest statistics suggest that ~4,000 armed pharmacy robberies occur per year in the US.
So are physicians to blame?
Naturally, we do not foresee a day when governments start suing prescribers when it’s the companies that have (supposedly) the pools of cash. But should the prescriber community bear some of the blame?
It’s an interesting question.
On the one hand, more prescriptions means more opioids making their way from pharmacies into the general population where they can be abused and/or diverted.
But on the other hand, it is not fair to blame the physician who has no control over what happens to the drug product once the prescription is filled. Indeed, the physician has no control over where the prescription is filled.
Indeed, physicians are, for the most part, prescribing fewer opioids, or prescribing them in much smaller quantities. But fewer prescriptions means less supply in the wild, potentially resulting in more armed robberies in pharmacies where the supply is being stored.
So now we have this incredible paradox, where fewer, smaller prescriptions are being written and filled, resulting in less supply out in the community. This, in turn, is causing an increase in pharmacy robberies, because that is where the supply is.
So pharmacies are now carrying little to no opioids, and making it known to their customers/patients that they do not carry opioids anymore…making it more difficult for some patients to legitimately get the medications they need…and so it goes.
So who wins?
Nobody.
If anything, patients lose on several fronts.
First, patients with legitimate pain management needs have fewer options: fewer physicians willing to prescribe opioids legitimately, to be filled at fewer pharmacies willing to maintain an opioid inventory.
Second, this legal entanglement, coupled with unfavorable reimbursement, means less and less research and licensing in the pain management space, even when a number of very interesting non-opioid pain relievers are in development and available for licensing.
Pharma companies? Yes, they lose as well. Companies are now spending time and money fighting lawsuits, when instead that money can be used for research or in-licensing in a therapeutic area with clear unmet medical needs.
You can make the case that pharma companies have the flexibility to shift their portfolio strategy away from pain towards anything else they choose (oncology being a popular choice these days). So they can’t lose in the sense that they can shift their strategy away from the problem.
Prescribers? You bet.
Many are shifting their practices in order to limit or entirely avoid patients who may require serious, legitimate pain relief. Recent data suggest that the number of opioid prescriptions has dropped over 20% over the past 4-5 years.
Fewer opioids may mean less illegitimate use and abuse, but potentially more robberies. So this trend, while helpful, is not the entire solution to the problem.
Payers? They’re not winning either. Opioid abuse leads to more emergency department visits and hospitalizations, which as a payer is the last thing you want.
Local governments are stuck with the management of a tremendous problem that is not of their making. The current administration is making some limited moves to help state and local governments deal with the problem. But clearly a broader series of solutions is needed.
How can we turn this around?
What’s abundantly clear is that there is no quick fix for this problem. It will take an unbelievable array of solutions, coming from a wide array of constituents, to manage this problem.
Here’s a quick list…and one which is likely incomplete:
> Fewer opioid prescriptions…continued messaging to prescriber community from FDA, CDC, etc.
> Lower quantities per opioid prescription…as above
> Increased use of non-opioid pain relievers where appropriate…as above…great opportunity for pharma companies with these products to demonstrate their value
> Better, real-time tracking of prescription filling and refilling…states already track opioid prescriptions, but real-time/just-in-time prescribing may help curb overprescribing and inappropriate prescribing.
> Grants and other incentives to accelerate development of non-opioid pain relievers…Federal grant issuing agencies…advocacy groups…
> Greater access to medical cannabis…a glorious opportunity for the FDA and individual states to make a major impact
> Greater support by Federal to State, and by State to Local governments for various programs, services, and enhanced law enforcement…DEA? Department of Justice? FBI? Other agencies?
Conclusion
Obviously, this is a problem that will not go away easily. But the bits and pieces to tackle this problem along different vectors are in place. And there may be additional approaches which we have not mentioned.
What is clear, however, is that the sooner “we” address this problem the better.
Unfortunately, there are a number of different “we’s” involved here, and this is ultimately the bigger problem which transcends election cycles and political trends.
And that is what worries us the most about this problem.