This Is Not The Time To Suck It Up

inhalermugging2.jpg[UPDATE - Angry? Frustrated? Read the Doc Gurley post http://www.docgurley.com/2008/05/30/im-not-going-to-suck-it-up/ for information on how you can make a difference. ]

Are you inhaling a low-flow toilet? Have you been Blackwatered by the FDA?

If the answer to both those questions is no, well, prepare yourself—you will be soon. For many of you readers, however, this tragedy has already been inflicted on you, and, as a physician and concerned fellow citizen, I’d like to express my deepest sympathies.

All across America, with increasing frequency, each of the 17 million people with asthma will wander into sweet, innocent looking drugstores with cheery slogans and holiday displays, only to be mugged at the counter.

Here’s the scenario:

You’re twenty-eight years old. You earn $30,000 a year teaching at a private school. You live in the San Franciso Bay Area, which means that, after taxes, it’s a big splurge for you to get a burrito. You go to an unnamed drugstore, cough*Longs*cough, to pick up your monthly $26 generic inhaler and they say, with a smile, “That’ll be $46.”

Are they kidding? That would mean you just lost your two pathetic burrito nights out this month! There must be a mistake. But the pharmacist says, no, the price of inhalers went up–everywhere.

Nationwide?

Yes, nationwide—internet and everything. There are no other options. In fact, many places are charging $60 or more for the same inhaler.

My God, you think, that’s over double the old price. In your mind you see calendar pages flipping and red X’s appearing. Every burrito night with friends for the next year is now cancelled.

It’s not like you can stop using your inhaler. You’re not a doctor, but breathing seems kind of, well, important. Then the realization hits you–what if they jack the price even more? What would stop them from going higher and higher? You feel like hyperventilating at the thought, in fact you feel like you might pass out, but then you realize you can’t afford a 911 call.

Your roommate finds you lying in the middle of aisle 6A, between the Santa hats and the cardboard turkeys.

What just happened?

Pop Quiz: (what, you thought you’d get to read a whole article by someone who was pre-med and NOT have to take a pop quiz?)

Choose the most plausible explanation for your drugstore experience:

a) You idiot. You should never eat cookies during snack-time that Blake, the seven-year-old psychopath, says his mom made for you. Clearly you’ve just had a bad acid trip.

b) After ammonia salts and being slapped around by your roommate, you come to, and realize the pharmacist made a classic medication error. Sure, Viagra pills (two for $46) can be mistaken for an inhaler. Happens all the time. You console yourself with the thought that Viagra, at least, might give you as much entertainment as burrito night (insert your own burrito-Viagra joke here________).

Or,

c) The FDA handed three pharmaceutical companies a group-monopoly on your medication. In fact, the FDA revoked the generic status of your inhaler and issued a new patent on it, despite the fact that it is the same drug, the same dose, and the same way of administering it. The FDA justifies handing over an extra $1.3 billion (yes, billion dollars) of your money each year to these three companies by saying it was important to the environment. In other words, congratulations. You are now inhaling the drug equivalent of a low-flow toilet (and yes! your expensive new inhaler, unlike the old kind, now clogs with the frequency of a low-flow toilet too!).

Answer: Trick question. The most plausible answer, clearly, is a. However, the truth is c.

What you have just experienced is pharmaceutical extortion. You want to breathe? Give us as much money as we feel like charging. And, like Blackwater in Iraq, our government has handed a private company unfettered access. This time, to you. The only limiting factor is public outrage.

See, the $1.3 billion a year total is only an estimate from a New England Journal of Medicine article, based on what is being charged until the end of this year for these inhalers—all other generics and competitors are banned, starting with the effective date of the FDA ruling, December 31, 2008. From the FDA’s own decision, here’s the FDA’s lying overly-optimistic assessment of what happens when you hand new patents and monopolies/oligopoly to three drug companies (GlaxoSmithKlein, Schering-Plough, and IVAX):

“A few comments suggested that prices for albuterol HFA MDIs would increase after the [FDA] rulemaking. A GSK spokesperson at the PADAC meeting said that GSK had committed to a price freeze on VENTOLIN HFA until December 31, 2007. The commitment was repeated in GSK’s subsequent written comments. We believe that GSK’s price freeze will be effective in keeping prices at the current level through much of the transitions period before the effective date of this rule.” [Doc Gurley comment: Yeah, right. Then what?] “Although Schering-Plough has not made a similar commitment, it seems unlikely that they will raise their prices knowing that one of their two competitors is committed to a price freeze.” [Doc Gurley comment: unprintable]

This is not a fringe issue. Albuterol inhalers are the seventh most common prescription in America. Think of the number of people affected by this decision—especially those in the middle classes. If you want to feel your blood pressure rise to the exploding point (hey, how long until they revoke generics on blood pressure meds?) you can read the entire justification by the FDA for their decision here.

How did this happen? Well, the whole story is long and ugly. It begins with the realization, almost exactly thirty years ago, that the propellants used by inhalers (CFCs), were bad for the ozone layer. Truly, they are. In 1978 CFCs were banned from use in aerosols, but no one did anything about inhalers. There are over 52 million inhalers dispensed a year. That’s a lot of CFCs, both inhaled and then exhaled into the environment. Bad for everybody.

However, these propellants are, like DDT, very cheap.

So, none of the drug companies wanted to change. In 1987, as part of the Montreal Protocol, there was a “critical use” exemption made for inhalers, when it looked like someone might crack down and ask drug companies to use something else (read: reduce their profit margin).

Inside the medical community, doctors have known about the propellant issue for years, and, at least in my circles, griped about why the drug companies wouldn’t do something about the formulation. There was foot dragging and more foot dragging. To make things even more infuriating, Canada, Australia, Japan and all of Europe have managed years ago to make the transition to more earth-friendly propellants (called hydroflouroalkanes, or HFAs)—without major price gouging. So when the FDA claims that the cash-cow handed to these three companies was necessary because of “innovation,” don’t believe it—the newer inhalers have been used in other countries for a while.

In 2005, the FDA announced that the exemption for inhalers would end on December 31, 2007. From 2005 to now, my guess is that the back-room deals were hammered out. You might argue that these companies have made mega-profits for 30 years off the environment and ought to clean it up. Instead, existing competition was eliminated–actually banned. Generics were revoked. New patents were issued for the old drug. Three companies now are allowed to charge what they want. If you’re a free-market advocate, you ought to be more enraged than anyone else.

The only concession to ameliorate the price increase that the FDA listed in their decision was a plan offered by GlaxoSmithKlein (no details were given by the other two companies) for a one-time only handout of 2 million free inhaler samples (less than 4% of the yearly number of inhalers bought), and some unspecified number of one-time only coupons for $10 off the price of one inhaler (keep in mind the average price increase was estimated to start at $20). As a physician, I thought I’d use my mystical, enormous insider influence to get one of these coupons or samples. I spent four hours on the phone. I called all three companies. I logged onto patient information and provider information sites on-line. Here’s what I got:

Doc Gurley’s Albuterol Patient Assistance Report Card: (I’m not grading on a curve–you thought I was joking about being pre-med, didn’t you?)

IVAX–D-. IVAX has the decency to use a real person to answer the phones. They’re very nice, they just don’t have any programs to help you. No inhalers or discounts.

Schering-Plough—F. Call their numbers and all you get is a short recorded, useless message—go ahead, try the “press 2 if you’re a prescribing physician” option. It doesn’t matter who you are, you’re out of luck. Despite their extra $1.3 billion a year, they’re not upgrading to humans on the phones. No albuterol samples, no freebies, no discounts.

GlaxoSmithKlein—Suspension. I called seven times over two days. No answer or busy each time. Online, the patient and provider sites for the much-touted samples/discounts are all links to existing, long-time drug-assistance programs that have very little to do with GSK. There’s nothing specific to albuterol or asthma, nothing to help anyone in a hurry who can’t afford their medicine (or breathe!). Big liars.

So, if you don’t have asthma or emphysema—if you, personally, don’t have to buy an inhaler–why should you complain? Well, based on my extensive years of clinical experience as a physician, I would say it’s generally more difficult for people to march or shout effectively, when they can’t breathe. Little help over here, people? Would ya?

Second, here’s why you ought to be very worried, even if you personally haven’t been mugged by the FDA (yet). The greatest talent of the pharmaceutical industry today is that of finding new, expensive ways to do the exact same thing, over and over (commonly called “me too” drugs). Once a trick has been found, they excel at applying that same approach to every possible other situation. Kind of the opposite of innovation. That means you can expect this type of extortion to be expanded to other drugs and other diseases. Especially after having such a resounding success this time around. As Avery Johnson reported in the Wall Street Journal when discussing the market for inhaled insulin (10/19/2007), “Pharmaceutical makers are desperate to replace chemical-based medicines whose patent protections are expiring. Lacking new drugs, they are making big investments in fancy ways to deliver existing ones…”

How long do you think it’s going to be before drug companies start to find “environmental” reasons for why birth control pills, or antibiotics need to be “reformulated”–possibly with new, inert ingredients, or a special biodegradable bottle? How long until there are more justifications for revoking generics and re-issuing new patents for drugs that already exist?

If you ever take, or might need, a prescription medication, you might be getting a tickly feeling between your shoulder blades from reading this article. Let’s just say that feeling is a warning signal your body is trying to give you—because you’re now standing in the crosshairs of the pharmaceutical industry’s big Blackwater-profit guns.

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