Gasping in an airless system

As I’m sure comes as no surprise, I prescribe a lot of medications.  While I try to err on the side of avoiding unnecessary prescriptions if doing so seems clinically appropriate, of course there are all manner of ailments and injuries for which some kind of pharmaceutical is the clearly-indicated treatment.  As we enter cold and flu season, I suspect I’ll be doling out a fair amount of antibiotics for ear infections and oral steroids for croup.  Determining whether a drug is going to be helpful and which one would be best is among the most important aspects of my job.

One medication I prescribe with great frequency is albuterol, a bronchodilator.  Asthma is a very common childhood illness, and one that primary care providers can often manage without consulting subspecialists.  For patients with asthma, albuterol is the most commonly-used “rescue” inhaler for when their airways constrict, which causes wheezing and prevents them from breathing well.  For younger patients I usually prescribe it to be administered via nebulizer, a somewhat cumbersome machine that creates a medicated mist for patients to inhale through a mask or mouthpiece.  However, for patients old enough to use a metered-dose inhaler (MDI) properly, it’s a far more convenient and portable way of delivering the same medication.

If albuterol isn’t the most common medication I prescribe (amoxicillin probably claims that title), it’s certainly among the top few.  Some drugs my patients take they can live without if they really must.  While ADHD can have a really negative impact on quality of life, a kid can survive without Concerta.  Asthmatic kids, however, simply cannot do without albuterol.  Should they suffer an exacerbation of their illness, having the medication is quite simply the difference between being able to breathe and not.

So I prescribe a lot of albuterol MDIs.  Or rather, I would if they existed.  Unfortunately, albuterol inhalers per se are not currently on the market.  What my patients really get are prescriptions for Proventil or Ventolin or Proair.  There are, at this time, precisely zero generic albuterol MDIs on the market.

The reason why there are none on the market and thus patients (or their insurance companies, if they are blessed with good coverage) are forced to pay for the name brands is contained in this horrifying and infuriating article about pharmaceutical pricing in the New York Times.  If it does not make your blood boil, then I congratulate you for having a more even temperament than I.

[I]n the United States, even people with insurance coverage struggle. Lisa Solod, 57, a freelance writer in Georgia, uses her inhaler once a day, instead of twice, as usually prescribed, since her insurance does not cover her asthma medicines. John Aravosis, 49, a political blogger in Washington, buys a few Advair inhalers at $45 each during vacations in Paris, since his insurance caps prescription coverage at $1,500 per year. Sharon Bondroff, 68, an antiques dealer in Maine on Medicare, scrounges samples of Advair from local doctors. Ms. Bondroff remembers a time, not so long ago, when inhalers “were really cheap.” The sticker shock for asthma patients began several years back when the federal government announced that it would require manufacturers of spray products to remove chlorofluorocarbon propellants because they harmed the environment. That meant new inhaler designs. And new patents. And skyrocketing prices. [emphasis mine]

I learned of this revolting turn of events a couple of years ago when a mother asked if there were an alternative I could prescribe for her child’s Flovent.  Inhaled fluticasone is one of the most commonly-used medications for patients with persistent asthma, a low-dose steroid that calms the chronic inflammation that predisposes these patients’ airways to spasm.  Generic fluticasone was the medication I intended to prescribe (or, rather, renew) to keep this particular patient’s asthma in good control, thereby obviating the risk that she would have worsening of her illness and possibly end up hospitalized.  She had no option to do without it.

“Why would she be getting Flovent?” I asked.  “Fluticasone has been around for a million years.  I’m sure it’s available as a generic.”

No.  Because of the requirement that CFCs no longer be used as propellants, all inhalers are shiny new hydrofluoroalkane (HFA) products.  Which meant new patents and much, much higher prices.  For the exact same medication.

There is a word for hiking up prices on items that consumers cannot do without.  It’s called “gouging.”  And as the Times article makes very clear, the utter lack of cost control and patent regulation on these life-saving medications means pharmaceutical companies gouge my patients to their heart’s content.  Because they can.  Indeed, their stampede toward every last dollar they can stomp out of American customers yields products that would be hilarious if the situation weren’t so egregious.

For its part, the United States patent office grants new protections for tweaks to drugs without weighing the financial impact on patients.

For example, with the patent for the older oral contraceptive Loestrin 24Fe about to expire, the company Warner Chilcott stopped making the pill this year and introduced a chewable version — with a new patent and an expensive promotional campaign urging patients and doctors to switch. While many insurance plans covered the popular older drug with little or no co-payment, they often exclude the new pills, leaving patients covering the full monthly cost of about $100. Patients complained that the new pills tasted awful and were confused about whether they could just be swallowed.

I cannot wait for Warner Chilcott to introduce some other product that absolutely nobody wants.  Perhaps a flashlight that requires sunlight to run?  Of the hundreds of prescriptions for birth control pills I’ve written, a grand total of zero patients has ever asked if they were available in chewable form.  Thankfully there are plenty of other generic OCPs that one might select as an alternative to this preposterous answer to a question nobody asked, though switching from one pill to another will mean some women will experience side effects making the transition for no good clinical reason whatsoever.

The entire article is well-worth reading, and I highly recommend it.  It describes in hypertension-inducing detail how Big Pharma retains patents on old medications, pays manufacturers of generic versions to keep them off the market, and thereby sticks American consumers with price tags several times higher than patients in other countries pay for the same drugs.  If ever an industry veritably begged to be regulated differently, it is this one.

I look forward to reading Tod’s continuing series on healthcare costs.  I certainly agree that the Affordable Care Act, for all the good I believe it may do, does precious little to keep healthcare costs from digesting more and more of the GDP.  I do not know what solutions he plans to present, but I will tell you now that nothing will contain costs without a significant change in how much Americans pay for medications.

So long as pharmaceutical companies can play a shell game with their products and strangle competing products before they ever come to market by colluding with their “competitors,” the “market solution” to this problem will remain elusive.  If a patient who cannot afford Flovent goes without and lands in the hospital with an oxygen saturation somewhere in the mid-80s, it won’t be GlaxoSmithKline who bears the cost of her preventable ED visit and inpatient stay.  It will be her or her insurance company (or, under so-called “global payment models,” quite possibly her physician), creating an expense we will all eventually share.

Having no option and none on the horizon, I will continue to prescribe Proventil and Flovent and the like.  My patients will, after all, continue to need them.  And so long as the companies that sell the medications without which these patients cannot live (or live well) exploit that need, there will be no real exit from the morass that mires us deeper every year.