Albuterol and Political Correctness

Nobody get all prescriptive versus descriptive linguistics on me, but I'm noting a bizarre thing lately. It may not be new, but there's this odd tendency for people to call decisions or acts that they disagree with that they think are clearly done to please somebody not them "politically correct."

There's a fair deal of politics in this post, but I swear it's about a pharmacy-related issue.

Political correctness, PC-ness or PC-ism is a term mostly associated with liberals and liberal thinking. The basic gist of PC-ness is the idea that you shouldn't offend people, but it extends beyond that; you shouldn't do things that might offend people. Furthermore, everything you do is potentially offensive to someone, no matter how mundane it seems to you. Taken to its extreme, PC-ness is "left-wing censorship." It is frequently assumed within the context of PC that white males are not really offended by anything, but that women, racial minorities, and religious minority groups are "sensitive" to "careless speech." Women in particular are used as an example, partly because some feminist groups really do go way too far, insisting that the word "human" is offensive because it contains the word "man" and that alternative terminology needs to be developed.

The idea of what is and is not offensive is highly affected by cultural and subcultural norms, so I'm not even going to go into that. You could write a book on the subject. I'm sure someone has.

What I'm going to take issue with is the use of the phrase PC being grossly misapplied and my understanding of why it happens. The most recent example of this that I've seen was when I, out of morbid curiosity, clicked a link to "saveCFCinhalers.org" (I'm not going to link them because I don't want to boost their google ranking).

Summary: CFCs, or chlorofluorocarbons, are compounds that have been used as aerosol propellants and refrigerants for roughly the past century. CFCs react with ozone in the upper atmosphere and catalyze its destruction. Because CFCs are a catalyst, they are not used up in the reaction, so a single CFC molecule may destroy a number of ozone molecules, converting them to oxygen. Ozone blocks ultraviolet radiation, specifically UVB rays. It is well-established that CFCs deplete ozone and that this will increase the amount of UVB rays that reach the earth's surface. CFCs were phased out of aerosol paints and other products during the last decade. 2008 was the last year that CFCs could be included in metered-dose inhalers (MDIs, or "puffers").

MDIs containing a different, non-CFC propellant (HFA inhalers) have been on the market since 1996. As of December 31st, 2008, CFC inhalers may no longer be sold and supplies have basically been exhausted anyway since nobody has been making them for a while. The most commonly used MDIs are albuterol "rescue inhalers" that expand the passageways in the lungs. This is a big deal drug--if you want to know what it's like to have an asthma attack, go get a straw. Put it in your mouth. Breathe only through the straw without opening your mouth wider or using your nose.

Anyway, the old inhalers have been replaced with environmentally-friendly versions. Same drug, same dose, same efficacy. Some people are throwing a fit about this.

There are a few big complaints.

1. The HFA inhalers cost a little more. The old albuterol generic was about $25, less if insurance picked up part of the tab. The new inhalers are about $35-40 and insurance pays less since they're generally "brand name" products now. The whole insurance payment thing might change soon if enough people complain about it.

2. The HFA inhalers don't "feel" the same when sprayed--they're a bit less "forceful," which leads people to think that they don't work.

3. The propellant contains a very tiny amount of ethanol, which might leave a bad taste in the user's mouth. It is not enough to get you drunk by any stretch of the imagination.

The websites railing against HFA inhalers are full of comments that basically tell the same story. My inhaler doesn't work anymore. My daughter changed to an HFA inhaler and she died of an asthma attack a few months later. I changed to an HFA inhaler and now I have a huge long list of health problems I didn't have before. The government and the FDA are ripping us off and lying about the safety and efficacy of HFA inhalers. Here's a list of doctors that don't believe the HFA inhalers work as well. The American Lung Association is full of shit. Etc. I actually got into an "argument" of sorts with a coworker over this one day--not someone that works in the pharmacy. He was convinced that albuterol had been taken off the market completely and that you simply couldn't get it anymore, and when I informed him otherwise he seemed incredulous--but I didn't get an opportunity to talk to him about it further.

The comment that piqued my interest (and inspired this entry) was the complaint that CFCs had been removed from inhalers to "be politically correct."

I don't know exactly what train of thought the commentor used to get to that point, but here's how I see it. Before anyone accuses me of straw-manning anybody, I'm quoting statements made by my incensed coworker. While his thoughts may not be echoed by everyone who opposes this particular bit of regulation, this is the only dialogue I've had with someone who had a problem with the banning of CFCs on principle rather than because of some specific complaint (such as the new inhalers costing more).

1. Some people ("environmentalists") think that CFCs damage the ozone layer.
2. People who want to be "environmentally-friendly" by using CFC-free products should have the right to buy them; let the market decide.
3. I'm not convinced that CFCs damage the ozone layer.
4. Not letting me choose which product to buy is an unfair limitation of my personal freedom.
5. Therefore, a CFC ban limits my personal freedom.

This train of thought hinges on one particular premise, which, again, lest you think I'm constructing a straw man, was basically the crux of my coworker's entire argument: I'm not convinced that CFCs damage the ozone layer.

Let's go with the "free market" approach. In order to make an informed decision about which product is best, you have to understand several things. First, you have to know what the ozone layer is. Second, you have to know that CFCs damage the ozone layer. Third, you have to know the consequences of damaging the ozone layer. Once you have all of that information, you can make a choice: Do I care whether or not the ozone layer is damaged by the products that I use?

Here's the problem. This isn't a personal choice that's (primarily) going to affect only you, like what color to paint your shutters or whether or not to snort cocaine. Your decision is going to affect everyone living on the Earth for at least the next 50 years, which is how long an individual CFC molecule can remain in the atmosphere destroying ozone molecules. You are contributing to an increase in UVB radiation reaching the planet's surface during your lifetime, much of your children's lifetime, and at least part of their children's lifetime. You are increasing the risk of skin cancer for everyone alive now and everyone who will be born over the next several decades.

Frankly, I don't think you should be allowed to make that decision any more than you should be allowed to shoot me and take my wallet or dump sewage on my property, and the fact that you're too short-sighted to see the consequences of your actions shouldn't affect my personal health. I have rights too, you know.

(Incidentally, to preempt the slippery slope, I don't favor smoking bans because if second-hand smoke bothers you, don't go where people are smoking. If the owner of a particular piece of property opts to ban smoking for the comfort of their non-smoking patrons, that's their call, but nobody should be able to tell you you can't smoke outside or in your own car--though exposing your kids to second-hand smoke is certainly irresponsible and I have mixed feelings about it.)

What does any of this have to do with PC-ness?

Well, PC-ness is about not offending people. One of the things that I've heard said several times, more by conservatives than by liberals, is that "you don't have a right to never be offended," and I agree. Sometimes, people are going to do or say offensive things, and unless they're hurting you or there's a specific rule against whatever they're doing (sexual harassment at work, for example), you just have to get over it and move on. That doesn't mean you have to like it, and you can certainly say you don't like it, because criticism is not the same thing as censorship. Plus, some things are just socially unacceptable within a specific culture because enough people have decided that they don't like thing X that doing or saying thing X will get you publically ostracized (being openly racist in many circles in the US is a good example).

At this point, environmentalists become a minority group identified by a set of opinions or beliefs. If you don't accept the whole CFC-ozone layer thing, you might call it an "environmentalist belief," which puts it on par with any other faith-based assumption that you don't share. At that point, the government banning CFCs does seem like a "PC thing." They're doing it to appease some minority's feelings.

Which means that you're treating the CFC-ozone "belief" kind of like the beliefs of religious groups that are not your own. It's like if the government banned pork products because Muslims consider them unclean. You don't care what Muslims believe if you aren't one. Why should the "belief" of a minority group infringe upon the rights of the majority? Stupid political correctness!

This is why calling something PC in this context is just an empty smear--we're not talking about offending people here. We're talking about reducing the risk of skin cancer for human beings all over the world. There is a concrete reason for banning CFCs that has nothing to do with anyone's feelings. The EPA, NASA, National Weather Service and National Oceanic and Atmospheric Administration all concur. So do independent researchers at Manchester Metropolitan University in the UK and scientists from Germany, Belgium, Denmark, Norway, Spain, Switzerland, Finland, Canada, and Greece. Some very compelling evidence would be necessary to invalidate current theories.

Here's the part of all this that I don't entirely comprehend. Conservatives are generally very black-and-white--things are true, or they aren't. They pride themselves on being practical thinkers and denounce liberals as naïve idealists. The reason I think that this is funny is because calling evidence-based environmentally-friendly legislature "PC" is essentially invoking a kind of relativism. "You and I believe different things. Neither one of us can produce proof that will convince the other, so let's just agree to disagree." Except that you can't do that, because whether or not CFCs affect the ozone layer (for example) isn't a matter of opinion. It's either true or it isn't. And if we're talking about laws, something is either a law or it isn't; we have to decide. To "agree to disagree" in that context is to suggest shutting down dialogue on the subject--therefore, nothing is changed and the conservative viewpoint "wins" by default.

Inappropriate use of relativism regarding what is valid knowledge--which I see on both the far left and far right--is actually an interesting enough topic to warrant its own post, and I might have to make one later.

So. Here's the tl;dr summary: You can't criticize someone for being "PC" when what they're doing is not about avoiding offending people but about responding to objective, measurable conditions. This is true even if you think that the thing being done is intended to appeal to a "minority group" because you don't care about the issue at hand. Using the phrase PC doesn't make a damned bit of sense--but as with all language, you're free to use the phrase to mean whatever you want. You just shouldn't expect your listener to interpret what you're saying properly.

Five "Myths" about Socialized Health Care

A friend of mine and I were having a discussion about "socialized medicine" the other night. After a lot of verbal parrying and thrusting we concluded at about 3:30 AM. When I woke up, I found that he had left me a message--a link to an article called "five myths about socialized health care." Here's the article. It's written by a "John Goodman."

Here's what I think about each of Goodman's "myths" and his ultimate conclusion.

Myth: "Socialized medicine gives you a right to health care."

Goodman argues that socialized medicine does not REALLY give you a right to care. In Canada, he claims, you don't have a right to heart surgery. You don't even have a right to a place in line.

In a sense, Goodman is correct. Just because the government provides single-payor insurance doese not mean that all people have the right to care automatically. That's why single-payor insurance/health care coverage is necessary but not sufficient. We need both single-payor health care AND a government declaration or law stating that citizens have a right to health care.

This argument is fallacious because it has inverted cause and effect. People aren't saying they want socialized medicine because it gives them a right to care. People are simply asserting that they have a right to care. People don't have a right to care under the current "free market" system, either.

Goodman claims that the market provides a means for people who need care more to get it--by paying more for it. He asserts that patients "waiting for care" in socialized systems are suffering. This is completely ridiculous. Hospitals in single-payor systems rank patients based on priority. The patients who are in most urgent need of care get it first. Care costs money; what Goodman is saying is that someone who really, really needs to get to "the front of the line" will magically produce as much money as it takes to get there. Where does this model account for people who really, really need to get to the front of the line but have no money for care?

Furthermore, many people are already sitting around and suffering because they can't afford medical care. Right now we are rationing care based on people's ability to pay rather than the severity of their illness. From a medical perspective, this makes absolutely no sense. You should treat the sickest patients first, not the wealthiest patients.

Myth: "Socialized medicine gives people higher-quality care."

Goodman claims that patients in Canada and the UK get worse care based on the number of patients in chronic renal failure who get dialysis or the number of patients who get coronary artery bypass surgeries. He also asserts that British doctors spend less time with their patients than American doctors.

In one study done in America (Ohio to be precise) physicians spent an average of 17.5 minutes with each patient. And it's true that physicians in Britain spent, on average, just under 10 minutes. But Goodman is exaggerating when he says that the physician barely has time to take the patient's temperature. Routine examination tasks like checking temperature and blood pressure are now relegated to nurses; doctors almost never do these things themselves.

If a patient is complaining of "coughing up yellow gunk" and "sinus congestion" and similar symptoms it generally takes about five minutes for the physician to listen to the patient's lungs and diagnose the problem appropriately because he's seen the same presentation of symptoms ten thousand times. The mean visitation time is likely skewed downward by the fact that some illnesses honestly don't take that much time to diagnose. Medical professionals report a prevalence of 62 million cases per year for the common cold; you can't really expect them to spend 20 minutes explaining proper treatment for that sort of thing.

Dialysis and coronary bypasses are strange endpoints. Dialysis is only actually medically necessary when kidney function declines to about 10%. 485,000 patients in America are estimated to have end-stage kidney disease requring dialysis or transplant; in 2005, 341,000 patients recieved dialysis, or 70% of patients with ESRD. 17,429 kidney transplants were performed, so 3.5% of patients recieved a new kidney instead (which is better).

In 2005 there were 32,375 Canadians requiring renal replacement therapy. Of these, 19,721 recieved dialysis, or 61%. It's true; this number is lower. But 12,654 patients recieved a functioning kidney transplant. So 33% of Canadians who needed a new kidney got one. That's TEN TIMES more people who recieved a new kidney, which is infinitely better than dialysis as far as patient quality of life and outcomes.

Also, we shouldn't brag about how many coronary artery bypass surgeries we're doing. The fact that people need bypasses means that preventative measures have failed. Ideally we'd do fewer bypasses because fewer people would need them because we provided better preventative care.

Myth: "Socialized medicine gives people more per dollar in terms of care."

Goodman claims that Americans don't get more care despite spending more money. He asserts that life expectancy is the primary measure used to judge "health care quality."

The WHO created a scale to assess health care quality in different countries based on five criteria:

-Overall level of population health
-Health inequalities (or disparities) within the population
-Overall level of health system responsiveness (a combination of patient satisfaction and how well the system acts)
-Distribution of responsiveness within the population (how well people of varying economic status find that they are served by the health system)
-Distribution of the health system's financial burden within the population (who pays the costs)

So no, no one is claiming that life expectancy is the primary criterion for evaluating health care quality.

Goodman also claims that more people who get breast cancer or prostate cancer in the US survive than those who develop these conditions in other countries.

See page 4 of this document.

It is true that the US outranks Canada and England in terms of breast cancer survival rates (in fact, it is 14% higher). But the survival rates for colorectal cancer are better in the UK and Canada. Childhood leukemia survival rates are better in Canada than the US. So are kidney transplant rates, as I already pointed out. So are liver transplant rates (about 20% higher, in fact).

Cherry-picking breast and prostate cancer is dishonest. Disease survival rates, incidences, and other statistics vary from country to country. Choosing two examples where the US outperforms other countries does not prove anything in the grand scheme of things.

Myth: "Socialized medicine gives people equal access to health care."

Goodman claims that care in countries with socialized medical programs does not really offer equal access because minorities still get less care. That's a terrible thing, but it doesn't really help his point. It isn't damning that socialized medicine isn't perfect.

Goodman then cites a survey of the elderly. According to the results, the elderly think that it is easier to get care in America, that they have shorter wait times, and that services are better.

This survey doesn't prove jack the way he's citing it. It's terribly misleading because as the author is presenting it he's basically saying "more elderly people think health care is good in America, so it is!"

I found the actual study cited--"The Elderly's Experiences with Health care in Five Nations" by Cathy Schoen et al., published May 2000. Let's see what it says.

12% of polled US elderly said it was "very difficult" to get care. 15% said the same in the UK; not a huge difference, and potentially attributable to randomness. 13% of Canadians said it was very difficult to get care--again, not terribly significant. Only 6% of Australians and 9% of New Zealanders thought it was very difficult to get care.

7% of those polled in the US said they had to wait five weeks or more for nonemergency surgery compared to 51% in the UK. So? That's the point--it's "nonemergency surgery." There's less rush to get it done. Having to wait to get an appointment to remove a mole or get a vasectomy is not a serious problem.

32% of those polled in the US rated their health care as "excellent." It is true that only 25% of those in the UK did the same, but New Zealanders had the highest rate at 39%. And again, 40% of US respondants reported "excellent care from their doctors," whereas 51% of New Zealanders did.

27% of respondants in the US described their most recent hospital stay as "excellent" compared to 39% in New Zealand.

9% of US respondants complained that their hospital stay was "too short." What in the world is this about? I think a team of medical professionals is in a better position to judge when you're well enough to go home than you are, especially since the longer you have to stay in the hospital the more it costs (both you and them).

I'm not going to go into the part of the study about prescription drugs because this study was released before Medicare Part D, and I'm sure that things have changed significantly.

As far as "younger patients preferentially getting care," which makes more sense--a liver transplant for a 30-year-old or a liver transplant for an 80-year-old? Who will ultimately benefit more?

In short, the US is somewhere in the middle of the pack. We do better than the UK and Canada on some issues but are vastly outperformed in most categories by New Zealand and Australia (and they have socialized medicine there, too). All this means is that if we institute universal health coverage we should learn from the flaws of the UK and Canadian system and emulate the good parts of systems from countries like New Zealand.

Myth: "National health insurance is an efficient way to deliver care."

Goodman says that the US health system is more efficient than other systems. He first asserts that this is true because the US has shorter hospital stays than anyone else. But he just cited a study where respondants complained that their hospital stays were "too short!"

What he says is true, to a point:

A 2006 survey says that in England the average length of stay was 6.3 days whereas in America it was 4.8 days (average of all diagnoses). One day's difference, really. That's not terribly significant in the long run. And hospital length of stay is not really an appropriate sole measure of the efficiency of health care systems.

Goodman continually uses the UK as an example of a poorly-run socialized health care system. What he fails to take into account is that the UK is not the only country with socialized medicine, and it does not have the best system by any stretch of the imagination. Saying that Britain's health care system is socialized but not as good as ours in terms of efficiency does not prove socialized health care is bad, it proves that Britain's health care system is less efficient. We would have to compare America to more than one country. Furthermore, if the British model is bad, we can choose to do things differently than they do, taking examples from what works in other countries and throwing out whatever doesn't.

Goodman also asserts that when you incorporate the cost to hospitals and doctors that Medicare and Medicaid are inefficient, but he doesn't provide numbers to back his assertion.

Cato: "Capitalism will fix the problem."

No it won't.

The free market won't fix health care because as far as the "free market" is concerned there is no problem. People who can't pay for goods and services in a free market economy don't get them. Ability to pay is the primary rationing mechanism. This means that it's okay if people don't get medical care if they can't pay for it because you only deserve things you can pay for.

What medical insurance does is not provide you with health care--it protects you against the astronomical cost of health care. Insurance works by spreading out the risk of illness over many people. This is why it's cheaper to insure a whole company, where the risk is distributed over a larger group, than it is to buy private insurance. Health care is not going to get cheaper. As we develop more advanced technology it requires more specialized knowledge to be a doctor or nurse. This means doctors and nurses require more expertise and education. This translates into increased costs.

To quote someone else's words on the subject:

For most Americans, providing health care ought to be different from selling soap; they won't tolerate doctors acting like commissioned salesmen and investment bankers. And if that means having less market competition and more regulation in the health care system, it seems to be a trade-off they're willing to make.

The free market is fantastic for regulating the price of most goods. Grecian urns? They're worth whatever someone is willing to pay. Luxury cars? Caviar? Designer clothing? Pepsi versus Coke? Price is a good rationing factor for all of these things. If people won't buy Pepsi because it costs more than Coke, Pepsi can lower their prices and see if people change their minds.

If you have a heart attack you don't have time to comparison shop. There is no incentive for hospitals to charge less. If you need a drug and there are no other drugs on the market that are just as good because the only drug that treats your illness is too expensive for you to afford, why should drug companies lower their prices to accomodate you? Medicine isn't a luxury, it's a basic human need. It cannot be subjected to the whims of the market. It cannot be treated like "just another service." There is no other industry where "buy" or "don't buy" is literally a decision between life or death.

Seriously. Every choice you make regarding health care directly impacts your chance of survival. We as a society, if we value the lives of our members, cannot afford to permit people to make the wrong choices. This doesn't mean people should be treated against their will. It means that people who want care should be provided with the best care available.

Patients often have no idea how to choose which care is best--that's why they go to doctors. If you develop an infection, do you know which antibiotic to use to treat it? In a true "free market" scenario drug companies would advertise their antibiotics directly to consumers and let them choose which one to use. This would be an absolute disaster; patients would wind up choosing antibiotics based on who connected with them through advertising rather than which antibiotic would actually treat the infection. If you have trouble believing this, consider the fact that 75% of consumers purchase brand-name drugs when buying over-the-counter medications despite the fact that on average generics cost about 2/3 as much and are equivalent products. They choose the more expensive product even though it is no better than the cheaper product. They do this because of brand recognition, faith in companies that produce brand name drugs, misconceptions about generic drugs, and many other reasons.

I have a hard time with the idea that patients who won't buy generic acetaminophen because they like Tylenol better will choose the right therapy for complicated illnesses. Which insulin should a diabetic use? Which ACE inhibitors have the best data to prevent strokes and heart attacks? What chemotherapy regimen is best? Giving patients full control over these choices is a mistake because they typically do not have the information necessary to make them--and most people overestimate their ability to make the right choice. If I had a dollar for every time a patient told me they should be able to get antibiotics whenever they wanted (and pick the ones they should get) because "I know when I'm sick" I would be a millionaire.

And that's what I think.

Retail Pharmacy: Bringing Home the Bacon

I'm afraid that I must both simultaneously agree and disagree with a recent post by The Angry Pharmacist about an issue that hits fairly close to home.

Pharmacy professors wield the term "patient care" to their students like its what brings home the bacon every pay-period. Hate to break it to you kiddies, but they are full of shit.

You know what makes the store money? Filling prescriptions. Like it or leave it, filling an Rx fills your paycheck. This precious 'patient care' where you go out front and waste your time consult Mrs Smith on how to take her atenolol for the 4th time this month ends up costing the store money in the long run because you are not filling prescriptions. Spending hours with patients may make you feel warm and fuzzy, but getting off your ass and filling Rx's is what keeps your paychecks from bouncing.

As one of those ignorant pharmacy students, I'm sure my opinion is worthless, but I think that this sort of thinking is both immensely practical and startlingly backwards.

When I settled on pharmacy as a career I was 16. No one in my family was a pharmacist. No one in my family was a healthcare professional of any sort, for that matter. What initially appealed to me was medicinal chemistry. I wanted to research the next generation of drugs, develop treatments or cures for man's most devastating illnesses, and spend most of my life in a lab surrounded by bubbling beakers.

Once I actually got into heavy lab science (analytical chemistry) I decided I hated it. I made some phone calls and arranged for a summer job at a pharmacy in my hometown. After about three weeks of working there I was solid enough on all the mundanities of the job (register duty, cleaning and organization, data entry, etc.) that I was able to start dedicating my "brain time" at work to learning about drugs.

I started learning drugs in the most disorganized fashion possible, which is probably good because my mind wraps itself around trivia and traps it forever. I asked questions of the pharmacists on duty. I pulled package inserts off bottles while I worked and read eagerly. I was lucky to have preceptors that were willing to take the time to answer my inquiries and who encouraged me to continue trying to soak up as much knowledge as I could. The "big secret" that helped everything fall into place was the pharmacist who told me that drugs in the same class have similar names (like all ACE inhibitors ending in "-pril"). Suddenly I realized that I could generalize my knowledge about some specific drugs.

What was the point of that long story?

I started out thinking I wanted absolutely nothing to do with patients because I hated dealing with people and loved chemistry. Loving chemistry translated into loving drugs. I started studying drugs in a vacuum, practically absent of other knowledge about the human body. I learned about the functions of the body based on the activity of drugs, not the other way around. This is probably the most detached-from-reality way to go about the process. The people involved were irrelevant. The drugs were cool. They weren't.

Four years later I live for patient care. Not because I necessarily like patients more, although I did discover that I'm not as misanthropic as I thought. No, I live for patient care because patient care is when I'm getting the most out of the effort I've put into learning things. Not being able to do patient care would be like telling a carpenter that he needed six years of school to get licensed but that on the job all he'd be allowed to do is hold the toolbox and make sure that the boss was using the right tools.

But N.B., you're thinking, TAP didn't say patient care was unimportant or bad. He said it wasn't profitable. "Patient care" doesn't pay the bills. Dispensing prescriptions does.

I agree that somebody does need to be paying attention to whether or not a business is making money. I don't ever want to be that person. That's why I would never start my own pharmacy, although I considered it at one point (it's also business suicide in today's climate, but whatever). I want to take care of patients without being worried about whether or not I'm filling enough scripts per week to pay my overhead, and if that makes me an empty-headed pharmacy student, so be it. Because if script volume is the most important indicator of whether or not I'm doing a good job then I am not a clinician, I'm a salesman.

Modern big-box stores and corner pharmacies are taking a loss on operating their pharmacy departments. It's the honest truth. The money is made elsewhere. How else could the big-boxes justify giving away generics at $4 or select antibiotics for free? They know the pharmacy doesn't make money; the pharmacy attracts customers. The pharmacy is not making money no matter what. What you are doing by filling more scripts is not making money, it is losing less money.

TAP's opinion on this subject is that the solution is to target the PBMs, or pharmacy benefits managers, that screw pharmacists over by reimbursing them considerably less than what they deserve. A business cannot operate by selling its product at a loss, but the PBMs essentially say something like this: "Well, you collected the patient's $10 copay and you charge uninsured patients $150 for the drug? It costs you $120 to order the drug? Yeah, we'll give you $90 + $3.50 for the dispensing fee, take it or leave it." Fix the industry regulations that let the PBMs get away with robbery and we're all good.

Because I'm young and naïve, I'm too stupid to know my ideas are bad. So here's mine. Pitch out the idea that pharmacy is a business altogether. Fuck pharmacy entrepreneurship. Stop assuming that pharmacies should operate as "drug sellers" and start thinking of them as "drug providers." The old business model doesn't work anymore. No longer does Joe the Pharmacist open his own shoppe on the corner and grind powders with a mortar and pestle all day so that he can punch capsules or roll pills. Nobody sells patent medicines anymore (unless you count the altmed scammers). Pharmacy is now ruled by giants, not Joes.

We should turn pharmacy over to the ultimate giant--the Feds. No more corpo-pharma. Pharmacists become government-salaried employees. Prescription drugs (not OTCs), patient care, whatever, they all become services funded by your tax dollars, free or practically free depending on your income level. Pharmacists already counsel for free. They're already giving away their services without collecting a dime--because it's viewed as a professional responsibility. The only thing stopping them from giving away the drugs is the perception that it's necessary to make a profit because no one will keep you afloat otherwise. Currently, that's true. But it doesn't have to be.

Laugh if you want, call me a socialist (the ultimate bad word), whatever, but at least have the courtesy to tell me why you think it wouldn't work. Spain has a system sort of like this. Germany has its own version. A lot of European countries have variations on this model; even if the pharmacies aren't government-owned, public healthcare provisions cover the cost of patient care. Clearly the government is not expecting pharmacies to "operate at a loss." If it did, the pharmacies would go out of business and there would be be no more pharmacies, which is a rather self-defeating model if the purpose of having universal health coverage is to make sure people have access to care.

I know I'm committing the error of "is versus ought" here, saying all this. But that's okay. The current fight in pharmacy is trying to keep pharmacy a working "business" under the present model. We'll never win. Pharmacy is too big now for Joe pharmacist to contain its girth. The business end of pharmacy needs to be abandoned altogther in favor of a patient-focused model.

Here's the bottom line. If you operate a pharmacy (or a doctor's office, for that matter) like a business, profit must trump patients. This is contradictory to every code of medical ethics in existence. It's true, you might take some patients at a loss in "real" practice. But there still exists a conflict of interests; as long as pharmacists are concerned about keeping a roof over their heads and worried about "the bottom line" they will never be giving 100% to the patients they serve. Healthcare is a service field. It is lucrative for many people. But ideally the point of being a doctor or pharmacist is not to get rich. It is to help people--and be sufficiently compensated so that one can live comfortably during his "off hours."

Don't recoil reflexively when someone says "socialist" or "government-subsidized." Abandon the idea that individualism--i.e., capitalism--is the best solution. You can't even start your own pharmacy anymore and have it survive; claiming that starting a pharmacy is a sound business idea at this point is utterly foolish. Quit thinking about you and how you want to run your own business which is the American dream. Stop being a selfish prick and put your patients first!

And if that's not why you went into healthcare, leave. Because we don't want you here.

Thought Experiment

What if more things worked like health insurance?

INT. A FIREHOUSE AT NIGHT.

DISPATCHER sits over a bank of computer terminals, nervously adjusting his headset. He reaches for a volume dial. CHIEF sits at a table in the background behind Dispatcher, nursing a cup of coffee.

DISPATCHER: Chief, we're getting a call. It's the Taylor house on 38th.

CHIEF: Mmm. That's too bad. Nice place. How's their coverage?

DISPATCHER: They don't have any, sir. Their policy was cancelled two months ago when Mr. Taylor was laid off.

CHIEF: What!? They didn't bother to get private coverage? How irresponsible can Mr. Taylor be?

DISPATCHER: Well, they said they couldn't afford the premiums. And Mr. Taylor is a smoker. You know what that does to rates. Besides, with the deductibles on the private plans, they'd have to burn down two houses before we picked up anything.

CHIEF: Yeah, you're probably right. Well, that settles it. We can't afford to respond. The risk of not receiving payment is too high. We can't operate a business like that.

DISPATCHER: Too true, sir. Actuaries are in full agreement. And the initial assessment is sound. The house is too far away from neighboring property for the fire to be contagious. It'll burn itself out without any trouble.

CHIEF: Oh, good. No worries about liability. I'll take the call. (dispatcher presses a button on the console) Mrs. Taylor? I'm sorry, but we're just going to have to let your house burn down.

MRS. TAYLOR's voice breaks in over the intercom.

MRS. TAYLOR: (clearly distressed) But...my baby is in there! You have to save my baby!

CHIEF: I'm sorry, ma'am, but we just can't help you. Why don't you call the emergency fire department? They're required by law to come help, even if you don't have coverage.

MRS. TAYLOR: But everyone's calling the emergency fire department lately! It could take them hours to get here!

CHIEF: Well, Mrs. Taylor, I'm sorry to say this, but we wouldn't have that problem if people would just be responsible and make sure they always had fire insurance. This is America, and people have to be willing to be accountable for their own bad decisions. We can't make the taxpayers bear the burden of a few careless people whose houses catch on fire. (he coughs) Especially smokers like your husband. It's just a disaster waiting to happen.

Mrs. Taylor continues to weep in the background. The Dispatcher and Chief exchange glances, shrug, and terminate the connection.

DISPATCHER: I really think that the free market has done wonders for the firefighting industry. We spend so much less time answering unnecessary calls.

CHIEF: It's like my father always said. There's nothing that can't be improved by privatization. Who wants the government interfering with our lives?

DISPATCHER: Yep. Besides, there's no "right to firefighter services" listed anywhere in the Constitution. America really has become a nation of whiners.

CHIEF: You said it. You want a cup of coffee?

DISPATCHER: Cream and two sugars, please.

Caveat Emptor: Drugs and the Free Market

First reported (within my circle of sources and reading material) by PalMD of denialism blog, the FDA is cracking down on the sale of many unapproved "cancer cures" being sold online and elsewhere. This, in itself, is excellent.

It is also a fantastic example why trusting the free market to solve all problems is a completely bogus idea.

I always come back to healthcare whenever I want to talk about the free market. This is partly because healthcare is what I know; I am much more capable of talking about the prices of drugs (in particular) and medical services than I am talking about the prices of various other products because I'm surrounded by them. But, more importantly, the healthcare "market" is a spectacular example of an area where "natural market forces" are completely insufficient regulation.

The short answer for why this is is that the costs of healthcare services are not always clear up front, so there's no way to "comparison shop." You usually get treated and worry about how much it will cost later, especially in an emergency situation. The capitalist model of self-regulation requires consumers to be able to discern the cost of services in order for it to make any sense. How can you be an informed consumer if you can't evaluate the cost or the utility (worth) of goods?

Sure, this is true on some massive scale when we talk about hospital stays and surgeries, but the problem with those is that the only consumers who actually know what they cost are already bankrupt because of them (everyone else is insulated from the scary truth of the real costs thanks to insurance companies). But those are the big-ticket items of the healthcare world. And you might argue that in some cases that they're often essential to the point where price is no object, because most people would rather pay any amount of money than die. (They might regret this decision later when they're being suffocated by hospital bills, but few rational people are going to say "nah, let me die, saving my life will cost too much.")

So let's talk about small out-of-pocket expenses of non-urgent matters.

Buying drugs is, in many cases, like buying any other good. There exists genuine competition in the market, especially when we're talking about non-prescription items. Should I buy Alavert or Claritin? Benadryl or the "store brand?" Which pain reliever do I choose? The fact of the matter is that 99.9% of the time all of these goods are equal. It doesn't matter, from a medical perspective, whether you buy Claritin or Alavert. They're the same drug. The only reason consumers might prefer one over the other is because of advertising and brand recognition--this is a "Coke or Pepsi" scenario.

Most consumers know that Coke and Pepsi are equivalent products (more or less). Sure, they might have a preference for one over the other, and that preference might even stand up to blind taste-tests. But how many consumers really know that the "store brand" is as good as the brand name when it comes to drugs?

If marketing research is any indication, the answer is not many. In 2005, generic versions of OTC drugs made up only 23.4% of the market share. Conversely, generic prescription drugs made up over 75% of the market share. Hmm. Why might this be?

When filling a prescription, most pharmacies will automatically substitute the generic if one is available as long as the physician has indicated that such a substitution is acceptable. Some states (Massachusetts, for example) actually mandate substitution unless the physician indicates otherwise. It's easy to see why generic prescription drugs predominate the market. Many commonly prescribed drugs are more or less only available as generics; the brand names are no longer made or no longer carried by pharmacies (how many people really care about getting brand name Amoxil?). I think it is safe to say that one major reason generic drugs predominate in the prescription drug market is that patients are not actively involved in the brand versus generic decision. They are leaving the decision to someone who is more educated about the product they are buying. The doctor and the pharmacist both know (and will reassure the patient if necessary) that the generic is just as good as the brand for a fraction of the cost.

Letting your pharmacist substitute a generic to save you money is kind of like getting insider information on stocks or letting your broker decide where to invest your money. You're not stupid for consulting your broker. You're smart. You're using your broker's expertise to your advantage. He probably knows a lot more about the stock market than you do, and you will make more money if you let him help you.

There's also the fact that the price difference between brand and generic in the prescription drug market is pretty large. Consider lisinopril, a drug used to lower blood pressure, prevent recurrent strokes, and protect the kidneys of diabetics. Generic lisinopril costs about 50 cents a tablet. The branded product costs twice as much. Cholesterol-lowering simvastatin's (Zocor) generic is about $2 per dose. The brand is about $5. Does it really make sense to pay twice as much for something if you don't have to? Of course not. Consumers aren't stupid.

The short story is that about 75% of consumers, given what amounts to "expert advice," will pick the cheaper prescription drug product. So why do only 25% of consumers pick the cheaper generic when making an OTC drug purchase?

The same reasons why they would choose a branded drug if there weren't a pharmacist between them and their prescriptions.

Brand reputation. Perception of generics as inferior products--misconceptions about quality, purity, and efficacy. Prior "bad experiences" with a generic drug. Inability to pronounce the generic drug's name (yes, I'm serious). And people are suspicious about the origins of "store brand" drugs. I'm not sure where people think they come from--they're made in the same factories and held to the same manufacturing standards as the brands.

There's limited standardization in naming generic OTC drugs. Because drug chains can't rely on brand recognition the same way ("Claritin is for allergies, I saw it on TV") most generic OTCs have very...generic...names. "Non-drowsy allergy relief." "Non-aspirin pain reliever." "Stomach acid relief." I kid you not when I say that there are probably half a dozen products on a given pharmacy shelf that have some variation on the phrase "cold symptom relief" as their only name, leaving the consumer to decide which product to purchase.

If the consumer does not first consult an "expert" (the pharmacist), they is left using the same reasoning tools that affect their decision about brand-name drugs. Anecdotally, I would say that most consumers don't know the active ingredients in their preferred OTC cocktails. They know the color of the box. They know what the product is called. And, most important to the consumer, they know what worked last time they were sick. They want that again, whatever it was, even if it's the wrong drug for the symptoms they have this time.

(Walgreens is brilliant in this regard by shoving the "Wal-" prefix in front of all their generic names. I get a lot of people who ask me for Wal-itin. I don't work for Walgreens. Our Claritin generic is obviously called something else. Many of them don't even seem to realize that Wal-itin is Walgreen's name for their Claritin generic--they think Wal-itin is its own unique drug, brewed in some secret Walgreens facility.)

The price difference between brand and generic OTC drugs seems smaller, which is another major factor. A box of 50 Tylenol costs $6.50 at Walgreens. A box of the generic costs $4.50, $2 less. Normally, when someone offers you the same product at a lower price, you take it. The generic market should be totally destroying Tylenol sales, but McNeil Consumer Healthcare still sold $129 million worth of their flagship product, "extra-strength Tylenol tablets," in 2003. That doesn't include sales of the popular Tylenol PM, Tylenol Cold, or liquid Children's Tylenol. The sum for all these product lines from 2003 is about $242 million.

Think about that for a second. Consumers spent an average of $2 more per purchase to buy products with the Tylenol brand name so frequently that McNeil made $242 million dollars. And they did it for the reasons I've already mentioned above--or perhaps others. Marketing experts spend their whole careers trying to understand and capitalize on this stuff; my understanding of it is very basic.

This isn't like buying generic foods, where you might get something you don't like as much as the brand product. The generic drug industry is tightly-regulated by the FDA. You can't sell generic drugs that are inferior to the brand names, unless your definition of "inferior" is different from the FDA's. The drugs have to work just as well.

You could argue that consumers might be buying the brands over the generics because of factors other than how well they work as drugs. Sometimes brand name drug tablets have coatings or flavorings that make them taste better than their generic counterparts. Maybe the packaging is easier to open. Some people are legitimately allergic to certain dyes or additives that might be present in the generic that aren't in the brand (but this is extremely rare). But this probably wouldn't account for 75% of consumers choosing brands over generics.

No, the short answer to why consumers choose branded products when buying OTC drugs is that they don't actually have all the knowledge necessary to make an informed purchase.

Man, that was long-winded. Let's come back to the original point of the entry.

If consumers aren't making informed decisions about whether to buy brands or generics when making OTC purchases, who the hell thinks that consumers will be able to make informed decisions about how to treat their own cancer?

I'm not talking about violating patient autonomy here. Patients should never be forced to accept treatments against their will. Patients should talk with their physicians and discuss treatment options, then choose whatever they feel is most acceptable. But it is up to the doctor--who has many more years of education on the subject--to lay out the options. If the patient believes that there is an option that the physician has not mentioned, he or she should certainly bring it up.

But when physicians say "no, I don't think that's a good idea," the answer is not to go ahead and do it anyway. By all means, ask for a second opinion. You're entitled to one. But do not decide that somehow you are more qualified than a trained oncologist to choose your own cancer treatment. You are not. Ignoring the advice of experts to pursue the beat of a different drum to your own detriment isn't individuality. It's idiocy.

This is why holding up "freedom of choice" when talking about unproven (and often highly suspect) treatments for cancer or any other disease is a bullshit move intended to distract from the real issue at hand. Your doctor telling you that herbal tea will not cure your cancer is not oppression. Shutting down salesmen who commit fraud isn't oppression, either.

But in the worldview of the champions of truly deregulated free-market medicine, the consumer is granted a delicious variety false empowerment. You have the right to choose any treatment you want--even those that don't work. And if you choose treatments that don't work instead of those that do, well, caveat emptor. May the buyer beware. All sales are final and non-refundable. The only person you have to blame for getting scammed is yourself. And this is disgusting.

So go ahead. Fight for your freedom to get ripped off. The primary characteristic of the free-market is that it's self-correcting, right? Frauds will eventually be exposed and people will stop buying their products.

But how many people should be allowed to die before we say "enough is enough?"

Advertising in Bizarro World

The other day I picked up a new copy of everyone's favorite pharmacy publication, DrugTopics. I generally like DrugTopics, except when they're running Zicam ads or otherwise uncritically promoting unproven treatments because the manufacturers were willing to pay for a page. The Zicam ads are annoying because they attempt to lend legitimacy to a product that has done everything conceivable to skirt FDA regulation--like calling itself homeopathic when in fact it contains measurable amounts of zinc. At a "1X" and "2X" dilution, a "recommended daily dose" of oral Zicam "cold remedy" tablets contains 80 mg of zinc. That's nearly eight times the typical dietary intake, and your average multivitamin contains about 10 mg as well. In essence, Zicam is about as homeopathic as Prozac, except that Prozac required FDA approval and Zicam didn't. Way to go, guys.

But this post isn't about Zicam. No, another advertisement caught my eye this time around--it was an ad for Luvox CR.

Luvox CR is a new formulation of fluvoxamine, a drug used to treat depression and obsessive-compulsive disorder. It's in the same general family as all the other SSRIs--Prozac, Zoloft, Paxil, Lexapro, et cetera. Granted, there are subtle differences between all of these drugs, but it's fair to say that fluxovamine (more or less) doesn't do anything spectacular by comparison; it is, in fact, one of the oldest SSRIs on the market.

Luvox CR, like many other drugs, is a follow-on drug intended to extend the patent life of a drug entity. Of course, follow-on drugs typically tend to come out a few years before a patent expires as opposed to a decade later, so Luvox CR is kinda missing the boat, but they're trying. All of this is acceptable, if shady, given the tendency of drug reps to push follow-on drugs like they're the greatest thing since sliced bread (and, of course, are totally worth paying $5 a dose for as opposed to the 50 cents the generic version of the old drug might cost).

Here's why I'm making the bizarro world reference. The advertisement's tagline was, and I quote: "NEW LUVOX CR: AN ANTIDEPRESSANT WITH NO GENERIC EQUIVALENT!"

I blinked in curiosity after reading these words. Was this supposed to be a good thing? Are reps supposed to approach psychiatrists, talk them up about the wonders of their new product, and wow them at the end with a concluding "best of all, this drug is going to cost your patients a fortune?" Who is this supposed to impress? I'm pretty sure the only people who think that "no generic equivalent" is a merit are the drug companies.

Or maybe these sorts of advertisements aren't ads at all--they're a warning to uppity pharmacists not to try doing stuff like "saving patients money" by "requesting lower-cost alternatives" and "cutting into pharma's profits."

Did I publish that where it was publicly viewable? Oooops.

Seriously. This is my biggest gripe about the pharmaceutical companies and their method of advertising. I can deal with them buying filet mignon for doctors. I can tolerate the magazine ads and even the occasional television spot, even if I think direct-to-consumer advertising does a lot more harm than good (no statistics, just impressions). What I can't stand is pharma advertising flaws as merits. "Our product costs ten times as much as our competitor's!" is something you would never hear touted as a positive in any other industry.

But hey, I'd much rather pharma play fast and loose with patent laws to try to squeeze a few more good years out of drugs that the FDA has thoroughly reviewed than "big woo" (sometimes the same companies, for that matter) play the get-out-of-jail-free "it's alternative medicine" card. After all, big woo has to slap the quack Miranda warning on all their products.

It's a strange day and age when "costs more!" and "isn't proven to work!" are somehow twisted to be signs of a good product.

Rx Essentials: Are They Really?

You may have seen a product line on the shelves recently called RxEssentials. The marketing for these new vitamin supplements is actually pretty slick; Nature Made is a big company, and they do produce some quality products. A lot of their supplements are USP Verified, which means that the United States Pharmacopoeia has verified that what's on the label is what's in the bottle. Always a good thing. I have to commend them for going the extra mile to meet those standards.

RxEssentials, on the other hand, is a clever way to get you to pay more for your vitamins than you would otherwise.

The basic claim behind RxEssentials is that each formulation supplies key nutrients for people taking specific medications. Sometimes this is the case because the drug blocks or reduces nutrient absorption; in other cases, the manufacturers seem to be taking a page out of Pauling's orthomolecular medicine, which posits that nutritional deficiencies (or, for extra woo flavoring, "imbalances") are the root cause of basically every disease ever. There's a little bit of truth to some of this reasoning. Some drugs do reduce absorption of specific vitamins or minerals. Isoniazid, which is used to treat tuberculosis, can reduce vitamin B6 levels to the point where patients may actually suffer neurological problems if they fail to supplement. And methotrexate, an immune system modifying drug, is usually given with folic acid to prevent deficiency--methotrexate actually works by inhibiting the conversion of folic acid to its active form, tetrahydrofolate.

So let's look closely at RxEssentials. What do they offer that your basic multivitamin might not? They cost, on average, about $10 a bottle for 60 tablets, a two-month supply.

The arthritis formula is recommended for anyone taking ibuprofen, naproxen, or aspirin to relieve arthritis pain. It contains vitamin C, vitamin D, and folic acid. Fail. None of these drugs are going to significantly impair absorption of these nutrients, and most of that 500 mg of vitamin C is going to end up excreted in the urine. Vitamin C is abundant in the diet, and vitamin C tablets are dirt cheap ($6 for 250 tablets is pretty common). The most valuable component of the formula might be the vitamin D; most people with arthritis are older, and most older people get insufficient vitamin D. But vitamin D isn't expensive, either. An inexpensive multivitamin a day is going to cover everything.

The cholesterol formula is designed for patients on statin drugs--Lipitor, Zocor, or their close cousins. As expected, it contains CoQ10. Oh, and B-vitamins, but those are in everything, including bread. CoQ10, or coenzyme Q10, is commenly touted as a means of preventing muscle damage due to statin use. Unfortunately, the evidence doesn't hold up. Some studies show benefit; others don't. One study using 200 mg of CoQ10 daily showed no benefit but noted that patients might respond due to the placebo effect. Another showed some benefit with a 100 mg dose. The evidence is inconclusive. CoQ10 is also kind of expensive, as much as $20 for a bottle of 30 softgels containing 100 mg each. RxEssentials might actually be the better buy if you're dying to try CoQ10, but that's not saying much.

I have to admit that I find the depression formula particularly lacking. B-vitamins, folic acid (maybe for pregnant, depressed women?) and vitamin D. Yes, it's the old "depression is caused by vitamin deficiencies" gambit, except that they're telling you to stay on your Zoloft or Prozac and "supplement." More orthomolecular medicine at work. B-vitamins are important cofactors in energy production; the idea is that a lack of B-vitamins results in "decreased energy," which somehow translates into "depressed mood," "sleep disturbances," "loss of pleasure in daily activities," and, my personal favorite, "suicidal ideations." There is no evidence whatsoever that nutrient deficiency is a primary cause of depression; B-vitamin deficiencies can cause neurological problems, but B-vitamins are so prevalent in the diet that hardly anyone has a problem meeting their needs. You're going to get all this stuff in your (much cheaper) multivitamin. Vitamin D is great for bone health, but store brands are generally cheaper. The manufacturers are clearly assuming depressed people don't get enough sun.

I was really hoping that they'd get their heartburn formula right. An acidic environment is important for the absorption of iron, and chronic acid-suppression therapy coupled with low iron intake creates a situation where deficiency is a very real possibility. Except that there's no iron in the supplement! None! Instead, they're pushing B-vitamins again. B-vitamins are a very necessary component of nutrition. They aren't worth paying a lot of money for; they're in everything, including enriched flour, grains, vegetables, bananas, and even beer (although alcoholic beverages are not a good source of nutrients and chronic alcohol consumption, in excess, can cause other problems). Oh, and they throw in some calcium, but only 120 mg per dose. For reference, most people need 1200 to 1500 mg of calcium per day in divided doses (you can only absorb 500 mg "at a time"). It would've been easy to formulate an iron-replacement regimen for patients with acid reflux; I can't believe they blew this one.

Finally, we have the diabetes formula. In case you hadn't guessed by now, their supplement for diabetics includes--yeah, it really should've been obvious--B-vitamins! Oh, and folic acid. We wouldn't want anyone giving birth to babies with neural tube defects. Except that, of course, that's not why the manufacturers chose to include folic acid in the supplement; it's to "maintain energy." Argh! Yes, patients with diabetes have problems with "energy" metabolism; they can't properly utilize glucose to fuel cells because they produce insufficient insulin. But taking extra B-vitamins doesn't help the body utilize glucose any better, unlike oral diabetes medications or insulin injections.

To summarize, RxEssentials gets the big thumbs-down. The manufacturers claim that RxEssentials "provide specially selected nutrients." But as you can see, most of the products contain the same ingredients: B-vitamins and folic acid. At least they're being responsible and telling people that RxEssentials are not a replacement for their prescription drugs.

There are therapeutic precedents for taking specific nutrient supplements for various conditions or with particular medications. I already mentioned a few. But any responsible physician is going to prescribe those nutrients alongside the medication--especially if serious harm will result from not having them. Note that none of these products are for people on methotrexate! Arbitrarily deciding you need to supplement is a waste of time and money.

So what should you do if you think you have a nutritional deficiency? Talk to your doctor. Evaluate your diet with information from appropriate food guides. Nutritional deficiencies have a set of clear diagnostic criteria; less-specific concerns like "I feel tired sometimes" or "I get a lot of colds" are generally not indicative of a problem. Everyone feels tired sometimes. B-vitamins are not effective in reducing the effects of "stress" or a replacement for a good night's sleep. You probably don't need RxEssentials. And even if you did, a cheaper multivitamin would offer the same benefits.

Like most dietary supplements, RxEssentials relies on good marketing to make sales. It's too bad that marketing is all they have.

Seeing the Forest for the Trees

I have mentioned my aggravation with Forest Pharmaceuticals before in the context of their excessive promotion of Namenda, a drug to "delay the progression" of Alzheimer's disease. While Namenda is effective, the drug reps I've talked to have a tendency to really push it as being significantly better than it actually is, especially since we're looking at doubling the cost per patient and increasing "pill burden" for patients or their caretakers. There's nothing more depressing to me than seeing families spending a fortune on medications for Alzheimer's while watching their loved ones deteriorate despite treatment.

On the other hand, Forest's Lexapro is a follow-on drug that's actually been demonstrated to be better than its parent. So maybe they aren't all bad.

Then they released Bystolic.

Bystolic is a beta-blocker. The market is positively overflowing with beta-blockers. Metaprolol, atenolol, propranolol...a dozen or more drugs. Granted, they have subtle differences, but Bystolic doesn't bring anything new to the table.

Beta-blockers reduce adrenergic (adrenaline-mediated) stimulation of the heart and blood vessels, slowing heart rate and dilating arterioles to decrease blood pressure. B-blockers aren't as good at lowering BP directly as some other drugs, but they are quite useful in preventing further damage to the heart after a myocardial infarction (heart attack) and in treating irregular heartbeats. Intriguingly, propranolol can even be used to prevent migraines, though the precise mechanism of action is not well-understood.

Bystolic is only approved to lower high blood pressure, but Forest is hoping to get it approved for patients with heart failure as well. Unfortunately for Forest, we already have a great cousin drug that has both indications--carvedilol--and it's available generically as of last year.

I realize that sometimes drugs get stuck in the research pipeline and the company gets so far into development that not releasing the drug is a bad financial move even if the drug is not likely to "sell." But Forest has likely spent enough money producing Bystolic that they must find a way to get physicians to prescribe it despite the fact that Bystolic is a "useless" drug. Sure, it works, but no sane clinician is going to prescribe it given a myriad of equally effective alternatives that cost one-fourth as much.

Unless, of course, Forest sends out their reps to promote it. Which means that it's a safe bet that Forest is going to spend a lot of money to advertise a drug that you'd have to be incredibly foolish to prescribe. Drug research and development costs are very high, but pharmaceutical advertising inflates prices beyond what is reasonable. And if given a sufficiently convincing sales pitch, many physicians might prescribe the drug anyway. Many doctors just don't know how much drugs cost. I have personal experience in the matter; I make a lot of phone calls when I'm working to ask physicians to switch to cheaper alternatives or to permit generic substitution when they've signed something "dispense as written" for no good reason (dermatologists, I'm looking at you).

Come on, Forest. You can do better than this. I know I saw your vague, almost viral ads in pharmacy magazines and got a little excited about your "new development in the treatment of hypertension." At least throw us another direct renin inhibitor instead of trying to pass off a totally underwhelming drug as the next big thing.

The Appropriateness of Chronic Self-care

A lot of over-the-counter products, many of them derived from herbal sources and others as specially-formulated multivitamin supplements, are advertised to treat (or help treat) various chronic disease states. AmealBP is a new product for patients with high blood pressure. Saw palmetto shows great promise in relieving symptoms of benign prostatic hyperplasia, or BPH (non-cancerous enlargement of the prostate), and it may have similar efficacy to finasteride, a prescription drug used for the same purpose--but with fewer reported side-effects (though that doesn't necessarily mean it actually has fewer side-effects). And though trials have generally shown that it is ineffective for the purpose, black cohosh has gotten a lot of press for reducing symptoms of menopause, namely hot flashes.

Let's momentarily ignore the issue of efficacy for all of these products and assume that they work as advertised with minimal risks or side-effects. Would that make them good products?

There are many pros to self-care, or therapy with over-the-counter products without the intervention of a physician. Self-care helps reduce healthcare costs, largely because physician's office visits are expensive. The convenience and ease of access to self-care promotes the seeking of treatment by patients who might otherwise do nothing. And symptomatic relief of common ailments, such as colds, helps reduce the number of sick days taken by employees, increasing workplace productivity. Some do-it-yourselfers love the idea of treating all their ailments via Google diagnosis and OTC purchases.

The question is whether or not these are really illnesses that should be self-treated. Is BPH really an illness that should be self-diagnosed and self-treated? The major symptoms of BPH are related to urination. But there are many problems that might cause difficulty urinating or "leakage" in men, including the anticholinergic effects of many medications, especially since BPH is a problem of old age and older people are more susceptable to these side-effects. And while BPH is a "wait and see" illness, not typically requiring a biopsy, BPH may not be BPH--it may be cancer. Which means that these medications are likely best used under the supervision of a doctor, significantly reducing the monetary savings of self-treatment.

Mevacor, otherwise known as lovastatin, has been considered as an over-the-counter or perhaps a "behind-the-counter" drug. Lovastatin is a "statin," used to lower cholesterol and a member of a class of drugs that is estimated to have saved 83,000 lives since the '80s. Like low-dose aspirin, statins are clearly a life-saving therapy for patients at risk for cardiovascular disease. Wouldn't improving patient access to statins--by making them over-the-counter, or perhaps behind-the-counter--save lives as well? Maybe. Maybe not. Statins are effective, but must be used judiciously. And because statins can cause both liver damage and rhabdomyolysis, or breakdown of muscle tissue, patients on statins need to have regular lab tests and monitoring. So OTC statins don't save patients from regular doctor visits--one at the initiation of therapy to establish a baseline for liver enzymes and follow-up monitoring every three to six months depending on the patient, not to mention lipid panels to confirm that the therapy is actually working. The drug may be more accessible if moved out of the pharmacy, but will it really be any more convenient? And how many patients are going to cut corners, putting off lab tests and appointments they don't think they need in order to save time and money? I really don't think OTC statins are a terribly good idea.

If lovastatin shouldn't be OTC, why should saw palmetto or AmealBP? All three are intended to be used to treat chronic conditions that require monitoring by a primary care physician. The only reason the latter two escape scrutiny is the DSHEA. Putting aside questions of efficacy--and even safety, at least in the sense of drug side-effects--is it really a good idea for patients to be treating these conditions without the intervention of a professional? And don't even get me started on the notion of these products as "complementary" therapies; saw palmetto is theorized to work via the same mechanism as finasteride, which is the blockade of enzymatic conversion of testosterone to the more potent dihydrotestosterone. No sane physician would prescribe finasteride and dutasteride simultaneously, as they have the same mechanism of action. Why take saw palmetto alongside finasteride? Patients may unknowingly do so, especially if they do not discuss the herbal supplements that they use with their physician.

I apologize in advance to the do-it-yourselfers, but some things just aren't conducive to that kind of attitude, and healthcare is frequently one of them.

Pharmacists as Triage

Jim Plagakis is hard-hitting and frequently acerbic, but that's what makes bloggers like P.Z. Myers the moguls that they are. Jim's most recent entry on pharmacists as the ultimate kings and queens of triage is a rather interesting read, and I really couldn't agree with him more.

I don't have a lot of the bitterness Jim does, likely because the system hasn't chewed on me for quite as long. Jim still remembers the days when it was illegal for pharmacists to discuss medication with patients. Nowadays, many physicians are starting to recognize the value of good pharmacists in the healthcare network. Not just the pharmacists that work in their hospitals, mind you, but the pharmacists manning drugstore counters at retail outlets.

The healthcare system is dramatically inefficient; the Buckeye Surgeon recently related a case that was an appalling waste of resources. You can't possibly appreciate the number of people who use their drugstore pharmacist as a first resource for medical advice unless you've worked in a community pharmacy. Pharmacists are accessible, abundant, and best of all from the public's point of view, free. There's no office fee, no receptionist, and no paperwork. Pharmacists are available at all hours. Your pharmacy may not be open 24/7, but in all likelihood there is another pharmacy that is within 20 minutes' driving distance. And distance is arguably irrelevant with the telephone; pharmacies recieve calls at all hours of the night. Getting a phone call at 9:30 from a concerned mother or a constipated senior is a regular part of the job.

But if pharmacists are going go wind up being a major point-of-triage by default, we must ask if they're doing a good job. Most of the pharmacists I've known have been good medical professionals on this point. They know what they can and cannot handle. Being a community pharmacist is really all about knowing what illnesses are self-treatable and being willing to take a thorough history to rule out cases that are inappropriate for self-care. We refer many patients to their physicians or even to the hospital, but we save many more from trips to the ED over upset stomachs. The problem is that from a documentation and communication standpoint, this absolutely sucks. In 99% of cases, the only surviving record of care provided by a pharmacist is in both parties' short-term memory. Patients, then, have to pass on care that a pharmacist has suggested verbally. Many of them will forget to do so, leaving gaps in the patient's medical history.

Granted, it isn't necessary for patient records to be bogged down by entries like "on November 14th I had a headache and the pharmacist recommended Excedrin." But wouldn't it be wonderful if pharmacists had a way to keep accurate records of patient self-treatment? When hospitals perform medication reconciliation for recently admitted patients, they call pharmacies to confirm records. If only there were a mechanism for pharmacists to store more detailed information about a patient's history of illness and attempted therapy! It would be particularly handy for pharmacies to have a record of patients who take supplements or herbal products. A counseling record wouldn't have to be particularly complicated or long to be useful; most records would be the result of about 5 minutes' worth of conversation.

"Patient reported to pharmacy on [date] with [chief complaint]. Reports [symptoms]. Medical history includes [x and y]. Recommended [course of action]. Known action taken by patient includes [z]." These records could be passed on to the patient's primary care physician. This is the 21st century! We have the technology!

Of course, in accordance with privacy laws and to keep everything easily retrievable, computerized data is the way to go. The problem is that this could get ugly; patients new to the particular pharmacy would not have established records, and the process of setting up a patient profile is a time-consuming task for staff. In reality, most pharmacies can collect information for a full patient profile in minutes, but this assumes adequate staffing--and most busy pharmacies are not adequately staffed. "Having time to do thorough and appropriate patient counseling" already feels like a pipe dream for many pharmacists, and adding an additional step to the process would require time that numbers-obsessed retail giants are not willing to spare. And then there are the patients are talking to pharmacists specifically because they want to avoid drawn-out meetings or filling out paperwork. In today's drive-through society, the idea of having to wait for anything just sets some people's pants on fire. Would patients be willing to take an extra 3-5 minutes to improve the quality of their healthcare by getting proper advice and attention from their pharmacist?

An oddity of this whole situation is that patients want more counseling but that they're unwilling to pay for it. Cost is apparently the number one factor in choosing a pharmacy. Hm. But costs being equal, patients prefer pharmacies where they feel that the pharmacist is involved in their health. They want a rapport with their pharmacist. Many patients at my store actually bypass closer retail outlet locations because they like our staff better--and they say so.

Pharmacists are becoming a bigger part of the healthcare team every day. How can they possibly cope with this increased responsibility or use their knowledge effectively if they neither have access to patient medical records nor have a means to communicate patient information with PCPs? As it stands, pharmacists are huge contributors to patient well-being but are effectively severed from the main body of patient information. They are an island, and messages are neither recieved nor sent, creating a black space where pharmacists are forced to grope around in the dark and hope patients have all the information they need to do their jobs.

I had a man approach me the other day saying he wanted to purchase a particular product. Before simply directing him to the product, I wanted to make sure his decision was sound, so I inquired as to his symptoms and his medical history. He said he was in good health and taking no other medication, so I agreed that the product was a good choice and sold it to him. He came back some three hours later saying he wanted to return the (unopened) product because he had read on the label that it should not be used by patients with thyroid disease--and he apparently had some manner of thyroid disease. Apparently thyroid disease doesn't count as an "existing medical problem." Maybe he was ignoring me, or he could've somehow forgotten. No harm came to the patient, but the case illustrates my point. Universal patient records would've prevented this problem in entirety, and it would also safeguard against more serious ones.

Patients are fallible. Doctors and pharmacists are fallible, too. We would be able to prevent more mistakes and provide a higher standard of care if we could improve communication and implemented a system for pharmacists to keep detailed records of patient counseling sessions. The biggest cost would be in time--in the long run, the prevention of errors and the streamlining of pharmacists as triage agents would ultimately save the medical system a great deal of money. So why aren't we doing it already?

Zyrtechnicality

Near the beginning of the month, the FDA approved Zyrtec-D for over-the-counter sale in the U.S.

Rx-to-OTC conversions are always a matter of great interest for pharmacists and patients alike. Prilosec OTC floated around the FDA for a long time because the FDA was uncertain as how to to label it for patient use, eventually settling on the current information. And one of the other big non-drowsy antihistamines on the market, Claritin, was actually moved to OTC as a result of a petition by insurance company WellPoint; apparently, they got tired of paying for it. Prescription antihistamines are a huge portion of the pharmaceutical market share, totaling over $4.3 billion in 2001.The price of Claritin dropped over 70% after becoming OTC, and generic versions soon followed. Zyrtec's patent supposedly expires this December, so we may see generic versions sometime soon.

So what's the big deal?

First, for what it's worth, the U.S. is kind of behind the curve on this. OTC Zyrtec has been available in Canada for a while now under the brand name Reactine.

Second, most comparative studies suggest there is no clinical difference between newer antihistamines, though side-effects may vary somewhat. Some other studies say one or the other is better; many patients I talk to swear that Claritin is ineffective but that Zyrtec or Allergra works wonders. Aside from patient preference, the only major difference between these drugs is cost. And while the availability of Zyrtec as a competitor might drive down the cost of Claritin, generics have already done that considerably. I purchased 240 generic loratadine (Claritin) tablets last spring for about $30, which is what my insurance company wanted me to pay for prescription Zyrtec each month (retail price being something like $74). Eight months of therapy for the price of one. Not bad.

As an aside, it's kind of weird that only Zyrtec-D is going over the counter. Zyrtec-D, like its cousin Claritin-D, contains both an antihistamine (cetirizine, the generic name for Zyrtec) and the popular decongestant pseudoephedrine (PSE), well-known as being the primary ingredient in methamphetamine production. I expect "plain" Zyrtec to follow eventually, and this has little significance, but it's just an observation. Strictly speaking, all the studies I've cited were done with antihistamines alone, but since both products are available in combination with PSE, the comparisons are still valid. While both antihistamines may offer better relief to stuffy nose sufferers across the world when combined with PSE, the effect of PSE isn't going to change significantly by being paired with an antihistamine, so comparing the antihistamines directly should be sufficient. It is worth noting that Zyrtec theoretically causes slightly more drowsiness than Claritin, but it's conceivable that the mild stimulant effects of PSE will counteract that. Maybe that's the reason plain Zyrtec isn't going OTC yet. Who knows.

One of the pharmacoeconomic impacts of insurance companies pushing Claritin OTC back in 2002 is that many state Medicaid programs stopped paying for non-sedating antihistamines because patients could now get them over-the-counter. Medicaid patients who found Claritin ineffective or whose physicians prescribed other drugs were frequently out of luck, and at least a few patients were probably still unable to afford Claritin, leaving them totally out to dry. It's actually pretty likely that, at least initially, consumers will pay more for Zyrtec-D when it goes over-the-counter than they do now. Insurance companies, conversely, will save money by not reimbursing patient costs for the drug. The price for uninsured patients should drop sharply, though this doesn't necessarily mean Zyrtec-D will be the best deal available. Practically speaking, Rx-to-OTC switches tend to make self-treatment more convenient and increase patient access to medication at the drawback of increased costs for all but the uninsured. Where is that money going? Insurance premiums are still on the rise; I'll believe that making Zyrtec OTC will reduce premiums by lowering the expenses of insurance companies when I see it happen with my own eyes.

Expect to see a lot of advertising for "new" Zyrtec-D, now available OTC. Don't expect it to revolutionize the self-treatment of allergies. At best, maybe the "antihistamine wars" will make it cheaper for all of us to keep from sneezing around cats.

Irrational Exuberance

Alan Greenspan, former Federal Reserve Chairman, used the phrase "irrational exuberance" to refer to a kind of overenthusiasm for the market during an economic boom; notably, he only used it once, and there was a worldwide plummet in stock prices following that speech, but I think it's an appropriate term to refer to something that I've thought about quite a bit.

I love the drug companies. I really do. We've come a long way in the past 50 years in terms of effective pharmacological treatments for illnesses across a broad spectrum because of dedicated scientists and researchers working to develop the next blockbuster drug. These companies really are doing the public a great service. Just to throw out an example, cholesterol-lowering statin drugs are estimated to have saved 83,000 lives in the last 20 years. Most people nowadays die of heart disease or cancer instead of typhoid and diphtheria, and the death rate due to coronary artery disease in the U.S. has dropped 25% since 1994.

The drug companies are providing a valuable service. And like any other service, we have to pay for it. I don't think that's wrong, really, because pharmaceutical research companies have to make money too. It's not a crime to want to make money, especially if you've invented or discovered something useful, whether it's a rubber O-ring that holds together mechanical parts better than existing joint fasteners or a tiny carbon-based compound that relieves migraines. Of course pharma is "in it for the money." They have to eat, too. If I didn't get paid to do my job, I'd quit. I sincerely doubt you can find anyone who's willing to work for free full-time, no matter what field we're talking about.

What I don't like is when they're being dishonest about it.

I don't mean dishonesty that they're trying to hide. I can't do anything if Lilly or Glaxo or Roche or whoever is committing tax fraud or exploiting weird financial loopholes to widen their profit margins, and while I do care about it, it's outside my area of expertise. I'll leaave that to the lawyers and the accountants to scrutinize. No, what drives me nuts is when pharma is talking about their latest product like it's the greatest invention since the wheel when in fact it's about as useful as most of the gadgets you see on late-night infomercials.

Usually this sort of thing comes up when a company is about to lose their patent on a drug, at which point they attempt to extend the life of their branded drug entity by rolling out products with new release mechanisms (Coreg vs. Coreg CR, for example) or "follow-on" drugs that are actually derivatives of the original drug molecule. The drug Celexa is a great example--Celexa's generic name is "citalopram." It's an antidepressant. Like many drugs, its structure is complex enough that the "mirror image" of that structure is not the same compound. Essentially, at least one set of chemical functional groups is "reversed" in its rotational arrangement in three-dimensional space. This is really kind of complicated, so here's a way better link to explain what I'm takling about:

Someone else can teach you organic chemistry.

Usually, the left-rotating and right-rotating compounds get designated as L (levo, or left) or D (dextro, or right) enantiomers of a substance. Sometimes the letter S is used, for the Latin word for left ("sinister").

Anyway, Celexa as a drug is a 50/50 mixture of both S-citalopram and R-citalopram. Some pharmaceutical chemists playing around in the lab figured out that the S-citalopram is the part that's doing the real work, so some time later they decided to develop a way to just synthesize the pure S-form (which is harder, incidentally) and marketed the new drug as "escitalopram." Say it aloud. Cute name, no?

Escitalopram is available in dosages that are half of what Celexa comes in--Celexa tablets come 10, 20, and 40 mg. Escitalopram tablets are 5, 10, and 20 mg. The theory is that by getting rid of that R-form and dosing the patient with only the pure S-form you end up with fewer side-effects or better efficacy. Sometimes that's true. Sometimes it isn't.

Escitalopram, for the curious, is the popular antidepressant Lexapro. By purifying the S-form from what chemists call the "racemic mixture" (the 50/50 mix of both forms), Forest Pharmaceuticals gets to call what they've cooked up a "new drug" and has an exclusive patent on their creation for about the next 20 years. Joy! Studies do suggest that Lexapro works a little better than Celexa, and that it's slightly better tolerated, but it's also pricier because it's currently brand-name-only: $80.31 for 30 tablets of the 10 mg strength vs $39.99 for the roughly equivalent generic citalopram 20 mg tablets. It might be worth the difference. It might not. The drug companies really want you to think it is, and they tell doctors that Lexapro is way, way better than Celexa, because it's about twice as expensive. They tell pharmacists that it's better, too, and occasionally bother to produce the graphs that prove it. And pharma is really big on phrases like "not equivalent" when they're comparing their new drugs or dosage forms to old drugs or dosage forms. They insist very strongly that the drugs are not the same, and woe to any pharmacist who dares suggest the older drug is just as good as the new one. Some patients will ultimately try both and like one or the other better. That's cool for them.

I don't appreciate pharma sending a rep into our store to talk about how Lexapro is so much better than generic citalopram that any effort to inform patients that yes, there are generic antidepressants that are cheaper (if you would like to save money) is tantamount to blasphemy. How dare you compare their superior product to the clearly inferior generic products on the market, even those that their company also makes! Their newest branded product is a bargain at ten times the price, even if it's only 5% better than the generic!

The Forest Pharmaceuticals rep who came into our store gave us the schpiel about Lexapro being awesome, but that bothered me a lot less than his pitch for Namenda. He vehemently expressed his opinion that Namenda was the coolest thing in the entire world because "the evidence is so strong for it. I always ask all the doctors who I talk to if they would want the opportunity to add Namenda to their drug regimen if they had Alzheimer's, and they always say, 'well, yes, I would.'"

Background. Namenda is a drug to treat Alzheimer's disease. Wait, I take that back. It's a drug to prevent Alzheimer's disease from getting worse. Wait, no, that's not really true either. It's a drug to make Alzheimer's disease get worse more slowly. That's about right.

The other big drug on the market for Alzheimer's management is called Aricept. You start a patient on Aricept as soon as you suspect they have Alzheimer's, because it works best in mild to moderate cases, but if you don't catch it for some reason, it can work in more severe cases. One study showed an improvement or stabilization of cognitive function in 63% of patients taking it (versus 39% on placebo, not terrible). It's worth a shot to put a patient on Aricept because it's about the best we can do right now.

However, the rep was trying to convince us that Aricept plus Namenda was vastly superior to Aricept alone, saying that there was a whole wealth of evidence available.

The information I've found suggests that the gains on cognitive function scales for treatment with Namenda are roughly a 5% absolute increase. OH MAN. We're still looking at only marginal improvement no matter how we approach drug therapy for Alzheimer's disease. This is totally worth spending an extra $1600 in prescription drug costs a year, considering that Aricept costs about $1700 a year by itself, excluding medical insurance. Behold the power of sarcasm.

Don't come to me and tell me how awesome your drug is unless you're prepared to prove it. And if your drug really isn't all that awesome, quit telling me how awesome it is. The FDA may have approved it because you demonstrated it was better than placebo with studies that showed statististical significance, but don't hype it up when we're talking about 5% absolute gains. I realize that it's the job of people who do marketing to get way more excited about their products than is rational, but this is medicine. That just won't do here.