The Solution to Every Healthcare Debate: Access vs. Cost

Two things you need to know about Suboxone (or buprenorphine) this morning highlight the essential elements of all past, present, and future healthcare debates.

First, the manufacturer is being sued by the Attorney General of Illinois (and 35 other AGs) for violation of antitrust statutes.  The states allege that Reckitt Benckiser Pharmaceuticals (now known as Indivior, because someone clearly new to marketing thought that would actually be easier to say) has effectively blocked generic competition for Suboxone by scheming to devise a new formulation (the film, an upgrade from the pill) in order to extend the patent protection of its franchise.  Believing, of course, that they are more sinned against than sinning, Indivior took to their web site to issue a statement that they will vigorously defend themselves against the charges.  I'm not sufficiently informed to weigh in on the merits of the suit.  I'll just point out that the company's actions are fairly typical of pharmaceutical companies and that were this a cholesterol medication instead of a potential addiction mitigation drug, I'm not sure we'd see this much attention paid to it by 36 state attorneys general.

Second, current physician capacity for treating opioid use disorder with Suboxone isn't being utilized.  A research letter published last week in the Journal of the American Medical Association shows that despite initial limits on the number of patients a certified physician may treat at any one time of 30 and subsequent limits (after 1 year of prescribing) of 100 patients, these doctors are treating numbers of patients far below those thresholds.  In the 7 states with the highest number of certified physicians, the monthly median patient census per doctor was found to me as follows:

• California: 7
• Florida: 11
• Massachusetts: 22
• Michigan: 7
• New York: 11
• Pennsylvania: 18
• Texas: 10

Increasing the number of certified prescribers and the number of patients they may treat at any one time is a linchpin of the federal government's response to the prescription opioid epidemic.  So it's somewhat concerning that we're so focused on increasing capacity when we're clearly not even close to utilizing the capacity we have.  

Why is this?  Why the law suit?  Why the lack of utilization of existing capacity?  

Like every other debate in healthcare, when you peel back the onion far enough, you find two competing philosophical concepts that dictate nearly every public policy decision that confronts us: COST and ACCESS.  

The law suit is primarily about COST and secondarily about ACCESS (presumably, if a more affordable - read 'lower COST' - generic were to become available, more patients could potentially ACCESS therapy).  

The JAMA study is about ACCESS and it shows that despite our investment in capacity (which COSTS money), we're still not very good at ACCESS itself.  

Follow the money.  Follow the patients.  The solutions to all healthcare issues rest somewhere in the incentives, structure, and balance of the two.  

Michael 

On Twitter @PRIUM1

Free Speech, FDA, and Short Selling

I was entertained by an article this morning on workcompcentral regarding a drug manufacturer that is suing the FDA for infringing its right to free speech.  Amarin Pharma is upset that it cannot market its fish oil drug for "off-label" uses.  You can't make this stuff up.

A quick refresher (admittedly oversimplified) on the FDA's role as a regulatory body:  A drug manufacturer discovers (or purchases) a chemical entity which they believe has a therapeutic benefit for a particular disease state.  The drug manufacturer runs studies (typically across three phases) to test both the safety and efficacy of the chemical entity for that specified disease state.  Application is made to the FDA and the FDA evaluates all of the evidence.  If the application is approved, the FDA mandates that the drug only be marketed to doctors, patients, and other stakeholders for the specified disease state on which the research and development were conducted.  The FDA does this through the drug's "label" and any marketing for uses not contained on the label (or "off-label" uses) is a violation of federal law.  

So... if you come up with a drug to manage, say, prostate enlargement... and you conduct years worth of studies on the safety and efficacy of the drug for prostate enlargement... and it turns out, after all that, the drug is also causing men with male pattern baldness to grow new hair... you can't simply change your mind and market the drug for male pattern baldness instead of prostate enlargement.  You have to go back through the phase I, II, and III development process (or, at least, recast the data drawn from those studies) to create sufficient evidence for FDA approval to allow you to market the drug for that purpose.  (This actually happened, by the way.  Ever heard of Propecia?)

The argument being made by Amarin is a great example of unintentional comedy: they feel their free speech rights are being infringed because the off-label uses which they'd like to communicate are "truthful" and "non-misleading."  They should be able to market fish oil for off-label usage... because it really works... trust them.

This comes down to a fundamental question of regulatory oversight:  "Truthful" and "non-misleading" according to whom?  

This is why the FDA exists.  I have been a vociferous critic of the agency for its lack of consistency, its approval of questionable medications, and its lack of emphasis on the public health effects of its approval process.  But I have never questioned the necessity of a third party regulatory agency intended to protect Americans from potentially delusional and dangerous claims of safety and efficacy from the pharmaceutical industry.

By the way, Amarin is publicly traded (NASDAQ: AMRN.)  My investment advice is worth exactly what you're paying for it... but I might think about a short position on any company willing to waste money on this kind of frivolous lawsuit.

Michael  

The Fight Comes to My Own Back Yard

Fulton County, Georgia has filed a lawsuit against several of the major drug distribution companies (McKesson, Cardinal, etc.) seeking damages related to the prescription drug abuse epidemic.  I haven't read the full court filing, but it appears this action is similar to West Virginia's approach (i.e., to sue the distributors and not the manufacturers, as the City of Chicago and Orange/Santa Clara Counties in California chose to do).

This suit is interesting for two reasons:

1) It's politically cleaner than the West Virginia law suit.  In that state, the primary law suit left out (at least initially) McKesson and Cardinal, the two largest drug distributors.  Turns out the Attorney General in West Virginia used to be a lobbyist for McKesson and his wife is a lobbyist for Cardinal.  While the legal concept being used by Fulton County of focusing law suits on distributors is similar to West Virginia's, the potential conflicts of interest are absent.

2) I live in Fulton County, Georgia.  I'll have a front row seat for this battle.  My county is a politically, racially, and economically diverse county; but like the rest of America, we have more in common than we have differences.  Among the things residents of Fulton County have in common is that many of us have felt, witnessed, or experienced the impact of prescription drug misuse and abuse.

My community is a lot like yours, probably.  Except that we now have an aggressive and creative legal strategy we're pursuing that may offer a pathway for communities across the country to recoup at least some of the costs we've expended in public health, our judicial system, and our law enforcement agencies.

Or... this could fall flat on its face and prove a waste of taxpayer resources.  I'm not taking a position either way, but I'm fascinated to see how this plays out.

Michael
Follow us on Twitter @PRIUM1

Drug Distribution: Friends in High Places

Here's the simple version: a drug is discovered, researched, and developed by a pharmaceutical company.  The company takes a new chemical compound from the work bench of a scientist through the various stages of animal testing and then through phases I, II, and III (and sometimes IV) trials mandated by the Food and Drug Administration before a drug is approved.  This process is expensive, takes a long time, and is fraught with risk.

But have you ever wondered how a pill gets from the pharmaceutical company to your local pharmacy?  Who handles that part of the value chain?  Turns out this is, by itself, a multi-billion dollar industry called "drug distribution" and it's dominated by two very large firms, McKesson (#15 on the Fortune 500 list with $122 billion in revenue) and Cardinal Health (#22 on the Fortune 500 list with $101 billion in revenue).  

And with the responsibility for drug distribution comes the risk of law suits connected to prescription drug misuse and abuse.  

A judge in West Virginia has just decided to allow a lawsuit against drug distributors to move forward, overruling objections from the companies (thanks to Alix Michel for the tip).  The companies sought to have the suit dismissed on the grounds that, among other things, they hadn't broken any laws in the state of West Virginia.  Boone County Judge William Thompson ruled that the two state agencies bringing the suit, the Department of Health and Human Resources and the Department of Military Affairs, have the right to sue.  The suit alleges that the drug distributors did not have proper diversion-prevention programs in place and turned a blind eye to suspicious orders from local pharmacies for prescription opioids, thus fueling the epidemic of prescription drug misuse and abuse in West Virginia.  

When I got to the list of drug distributors associated with the suit, I scanned the list for McKesson and Cardinal.  They were conspicuous in their absence.  

So I kept reading... 

The state agencies actually asked the West Virginia Attorney General to add McKesson to the law suit.  He declined to do so based on the state's "ongoing investigation" into McKesson.  Cardinal is part of a separate law suit (the article doesn't disclose how it's different).  That seemed odd to me.

So I kept reading... 

Turns out the AG used to be a lobbyist for McKesson in DC and his wife was a lobbyist for... you guessed it... Cardinal. 

You can't make this stuff up.  

Michael
On Twitter @PRIUM1