Showing posts with label pharmacy. Show all posts
Showing posts with label pharmacy. Show all posts

Wednesday, January 14, 2009

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.

Tuesday, October 28, 2008

A Tenuous "Alli"ance

It appears that GlaxoSmithKline has recieved approval to market Alli overseas to our European cousins.

This means the product will now be proposed for final approval by the European Commission and marketing authorisation could be granted in the coming months. On licence grant, orlistat 60 mg would be the first licensed weight loss aid available without prescription throughout Europe.


You hear that? An FDA-approved weight-loss supplement! It's a miracle!

Alli was actually released to US markets last summer as one of the more unusual Rx-to-OTC product conversions that we've seen recently. Popular once prescription-only Zyrtec I expected, but Alli was really out of left field. I actually meant to blog about Alli when it was released, but somehow it got away from me. Now I can do so to commemorate its release across the pond.

What is Alli? Alli contains the same active ingredient as a prescription drug that was developed by the Swiss company Roche Pharmaceuticals--the generic name for it is orlistat. It is the first over-the-counter drug approved as a weight loss aid by the FDA, mostly because there's good clinical data that it's actually effective when used properly.

OTC "diet pills" generally contain high doses of stimulants/caffeine, claim to suppress appetite, or somehow purport to "melt fat" or "block calories." Some stimulant weight-loss supplements contain as much caffeine per capsule as three cups of coffee and have "serving sizes" of two or three caps at a time! Clever wording is usually employed to conceal the simplistic nature of these products--Zantrex-3 refers to its caffeine content as "a proprietary xanthine-based stimulant." Caffeine is part of a chemical family called methylxanthines. Other times numerous herbal ingredients or Latin names for botanicals obscure the true content of the supplements except to the most attentive consumers.

Alli, true to its claims, is different. How does it work?

First, a bit of basic biochemistry. There are three major "macronutrients" required for human nutrition--carbohydrates (sugars), lipids (fats), and proteins. All of these are absorbed through the intestine whenever you eat. Macronutrients are then delivered to the liver or various cells of the body that can use them. Carbohydrates are easy; the body breaks them down into smaller units and uses them to produce ATP, a small molecule that is the primary source of energy for the body at the cellular level.

Proteins and fats cannot be used directly by most cells. Instead, the liver processes them into more readily useful forms. Some proteins can be converted into glucose, the most basic (and preferred) form of fuel for body systems, especially neurons. Fat metabolism is more complicated and involves many steps that ultimately culminate in the release of free fatty acids; these are also usable as fuel by many body systems.

If you eat too much of anything, be it proteins, carbohydrates, or fats, the body is remarkably efficient at storing the excess energy produced. The most energy-dense form of stored energy is fat; fats produce the most energy (in calories) per gram. This fat winds up getting stored throughout the body as a reserve for times when food sources are scarce. Each pound of fat on your body represents a total stored reserve of 3,500 calories. Yum!

I've heard it mistakenly stated that you "can't get fat" eating a high-protein diet because "carbs make you fat" or, more obviously, "fat makes you fat," but this is completely false. Your body can (and will) make fat out of anything the liver can get its...um...lobes on.

What does this have to do with Alli?

Alli is not actually absorbed into the bloodstream. Instead, it floats around in the intestines and binds to fat molecules, preventing those from being absorbed. If your body doesn't absorb the fat molecules, it can't process them--in a sense, it's like you never ate them in the first place. Alli binds an average of 25% of consumed dietary fats, potentially reducing caloric intake from a fatty meal significantly.

Problem: Alli is not magic. It cannot break the laws of physics and destroy matter (and I suspect converting fats to energy in your intestine would have odd effects, were it possible). If you don't absorb the fats, they still have to go somewhere. Since they're already 3/4 of the way through your digestive tract, and getting the whole system to flow in reverse is both very unpleasant and very difficult, I'll let you think about it on your own for a second.

A funny aside: The makers of Alli recommend that you not wear light-colored pants while taking it.

I personally like to think of Alli as "negative reinforcement." Operant conditioning is basic psychology. Continuously eat fatty meals on Alli and you're going to suffer chronically oily stools. You're either going to learn to control your dietary fat intake or you're going to throw away your Alli.

This isn't to say that Alli is bad. As part of a comprehensive diet and exercise plan, it will help you lose more weight, even if it's only a few extra pounds. But the reason Alli can get FDA approval, aside from the fact that it's been subjected to more rigorous clinical trials, is that Alli doesn't claim to be magic. "Eat all you want and still lose weight!" "Melt fat away while you sleep!" Due to loose regulations, dietary supplement manufacturers make these kinds of claims all the time. But the makers of Alli had to be realistic about the potential benefits of their drug to get it approved. This isn't a bad thing. It's what we should expect from all drug and supplement manufacturers--indeed, it's what should be legally required.

Anyway. Now Europeans can experience the thrill of Alli without a doctor's prescription!

...just remember to wear dark pants.

Friday, October 10, 2008

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.

Wednesday, October 8, 2008

One More Thing to Write your Congressman About

PalMD has pointed out yet another area of healthcare that is clearly lacking and potentially in need of intervention.

In order to know how much short-acting insulin to take, a diabetic has to insert a test strip into their glucometer, prick their finger with a small needle, and touch the drop of blood to the test strip. This is usually done (at least) on waking, before every meal, and at bedtime---at least four times per day. Thankfully, blood glucose monitors are quite inexpensive and last a long time. Test strips, however, are expensive and disposable. How expensive? Depending on the brand of meter being used, and how many times you need to test, $30-$200 per month. These strips are usually not covered by insurance.

To give a comparison, good medical treatment for coronary heart disease, which usually requires about four medications, costs around $16/month. Older forms of insulin are also rather inexpensive (but the newer ones are costly). Without insulin, diabetics die---fast. Without test strips, diabetics don't know how much insulin to use.


He's absolutely right--and this is an absurd situation. Why don't insurance companies generally pay for something that is at least as necessary as insulin itself?

So...do something about it! Write, using this link. Or perhaps this one. Do both. The first is for the House and the second the Senate.

Don't know what to say? Try starting with what Pal suggested:

Diabetes is a serious disease affecting more than 20 million Americans. Part of the treatment of diabetes is the regular testing of blood glucose levels. In order to do this, diabetics must purchase glucometer test strips, which cost around a dollar a piece, and are usually not covered by insurance. For diabetics, especially those who have financial difficulties, the cost of test strips, which can be up to hundreds of dollars per month, makes diabetic treatment impossible.

I respectfully request that you look into potential solutions for this very serious problem, and bring this to the attention of your colleagues.

Sincerely...

Monday, October 6, 2008

Generics and Allergies Redux

I've covered generic drugs and their supposed inferiority to brand-name drugs before. But something came up at work the other day that made me want to take a second look at the topic.

Scenario: Male patient, age I forget, military (so he has Tricare insurance, which pays for everything except for the things that it doesn't). A middle-aged woman is driving him around and apparently in charge of his care (wife? mother? again, I forget the guy's age).

Four new prescriptions. Metoprolol XL (beta-blocker), raniditine (antacid), warfarin (Coumadin, anticoagulant/"blood thinner"), furosemide (diuretic/fluid mobilizer). All new meds for him. I guessed post-heart attack or maybe heart failure, but didn't actually ask what was wrong.

Doctor signed the Coumadin script dispense as written. Tricare won't pay for brand-name Coumadin for this patient. Other three drugs come back $0. Zero, zip, nothing, free. Coumadin comes back $55. The patient has two options: Wait for someone to call the doc tomorrow and get authorization to dispense generic or pay for the brand. For $55, I'll tell you what I'd do. He didn't; he paid the $55. Why?

"His doctor is very particular, and he has a lot of allergies, so he's going to go with the brand name. He might be allergic to one of the fillers in the generic, you know."

To the credit of the woman managing his care, she was actually pretty smart. She asked a lot of good questions and knew a thing or two about the medicines she and some of her family members were on. Best kind of patient. But here was an example of what she knew getting her in trouble, and she wouldn't be talked out of it. I had previously explained to her that it didn't matter whether he went brand or generic as long as he stuck with his choice (warfarin is a fickle mistress, and you want to be consistent).

I'd heard this line of reasoning before--once from a patient and once from a tech I used to work with. "I might be allergic to the fillers in the generic."

News flash. You might be allergic to the fillers (excipients) in the brand, too. There are probably only about two dozen different ingredients that you can put into tablets and have them still do what they're supposed to do. The brand and the generic probably differ by only one or two excipients. If you've never taken either one, you are just as likely to be allergic to a component of the brand as the generic. Generic drugs are not made with ingredients that are somehow more likely to be immunogenic.

So. Unless you know you're allergic to something (a dye, for example) and you know the brand or generic version of a particular drug contains that something there's no reason to assume you are "less likely" to be allergic to something in the brand name drug.

Another day, another victory. Generics are still the way to go, 99.999% of the time.

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.

Friday, September 26, 2008

But Doctor, I NEED Antibiotics!

How often do you go to the doctor? What prompts you to seek care?

For many people, the answer to that question is "at least once a year" and the reason is upper respiratory tract infection (URTI). Because of the amount of time and effort involved in isolating precisely what is causing an upper respiratory tract infection, doctors quite frequently prescribe unneeded antibiotics:

Various bacterial respiratory infections were diagnosed during 6.5% of physician office visits in 1999. One or more antibiotics were prescribed during 51.0% of those visits. The probabilities of resistance to the most frequently prescribed antibiotics varied from 20% to 40% and showed a weak positive correlation with the frequencies of antibiotic prescriptions.

It is a well-established fact that a huge percentage of antibiotic prescriptions are dispensed for conditions where they will have no effect, such as the common cold, simply because doctors feel that they have some obligation to write patients a prescription--or because the patients pressure the doctor and insist that they need an antibiotic.

But statistics released in this month's Pharmacist's Letter make the issue very clear. Overtreating with antibiotics does more harm than good.

There's only a 1 in 4000 chance that an antibiotic will help most acute upper respiratory infections.

But there's a 1 in 4 chance of diarrhea...a 1 in 50 chance of a skin reaction...and a 1 in 1000 chance it'll cause an ER visit.

...antibiotics [overuse] can also lead to more resistant infections that are harder to treat.

Now, as always, I encourage readers who believe that they might be suffering from any illness to consult their physicians. But think about those numbers for a second. There's only a 0.025% chance that it's going to do you any good to beg your doctor for an antibiotic prescription. The odds that you will wind up in the ER because of a bad antibiotic reaction are higher than the odds that the antibiotic is going to do you any good.

This does not mean that you should avoid antibiotics at all costs, believing that the risks always outweigh the benefits, because that is patently untrue. Keep in mind that these numbers only pertain to (generally non life-threatening) respiratory infections. What this really mean is that you should ask your doctor to be straight with you, especially if you are going to the doctor because you're coughing up phlegm or have a stuffy head. "Do you really think I need an antibiotic?" Make it very clear that you will take no for an answer if it is that physician's professional opinion that you don't need one. They didn't go to school for nothing.

Monday, September 22, 2008

Like Decaf Coffee, but More Dishonesty

I got a kick out of this article about a "new" dietary supplement that supposedly contains the FDA-banned stimulant ephedra while still being legal through various loopholes:

Garza, a bodybuilder who nearly won the Mr. USA competition in 2004, said XP2G is manufactured for his store by a private lab.

He said his pills are made from the same plants used to make traditional ephedra products but lack the ephedrine alkaloid chemicals named in the bans.

Garza said because XP2G lacks those particular chemicals, it does not present the same risk of side effects as traditional ephedra products, and it is not in violation of the bans.


Hmm. So it contains "ephedra" but it doesn't contain ephedra. Do you follow?

Ephedra is actually the name for a genus of plants. Extracts from the Ephedra sinica plant, known in Chinese medicine as ma huang, contain the stimulants ephedrine and pseudoephedrine (yes, the same stuff that's in Sudafed). The popularity of ephedra stems from its so-called "thermogenic" properties--it increases heart rate and blood pressure and raises blood sugar by stimulating the sympathetic nervous system. Most people know the sympathetic nervous system as the system responsible for the "fight-or-flight" response. Essentially, ephedrine acts on the same cellular receptors that epinephrine does. Epinephrine, if you aren't aware, is the same thing as adrenaline; they're just different names for the same chemical.

So what Garza is claiming that his proprietary formula contains parts from ephedra--the plant--but not the alkaloid stimulants that make ephedra "worth" adding to diet pills in the first place.

Why would you do this? Well, because, as I've previously stated, most people don't read anything beyond the front of the bottle when they're buying drugs or supplements. By being able to put "new and improved! Totally contains ephedra!" on the packaging, Garza will sell more product, especially to consumers who liked the old ephedra products that are now subject to FDA ban. What those consumers probably won't realize is that they're being scammed even worse than they were before; the manufacturer is using some loophole to claim the formulation contains ephedra when it doesn't contain the chemicals that make ephedra desirable. It's a bit like selling "coffee" to caffine junkies on the basis that your product "contains real coffee extracts!" without letting on that your product is actually decaf.

More troubling is the fact that Garza may, as they say in France, be totally full of merde:

University of Maryland professor Dr. Fermin Barrueto said legal ephedra is only a marketing gimmick. He said the only way to remove banned chemicals from ephedra is through a complicated extraction process that manufacturers are unlikely to perform.


Which means one of two things: The manufacturer is lying about including ephedra (and not including it, but listing it on the label anyway), or the manufacturer is lying about lying about including ephedra (including it despite it containing the banned alkaloids).

As they said in Smash TV: Big money! Big prizes! I love it!

It's Ozone Action Day: Don't Use Your Inhaler

Do you remember the CFC reduction efforts that went into effect in the latter half of the 20th century? CFCs, or chlorofluorocarbons, are a class of compounds that were traditionally used as refrigerants, solvents, or propellants in aerosol spray cans. When scientists determined that CFCs were contributing to the hole in the ozone layer. CFCs participate in a reaction with ozone where they act as a catalyst--i.e., they are not used up--that breaks ozone down into oxygen gas. Because individual CFC molecules are not used up in the reaction, a single CFC molecule may continue to break down thousands of ozone molecules over its lifetime.

What does this have to do with inhalers? By the end of 2008, CFC-containing inhalers will no longer be sold.

Traditional inhalers used to treat respiratory diseases like asthma used CFC-based propellants to deliver an aerosolized spray of medication directly to the lungs. But the time has come to phase out the old inhalers and replace them with new, more environmentally-friendly alternatives. The replacements, HFA inhalers, are just as effective as the old standbys without causing damage to the ozone layer or contributing to greenhouse gas production. The switch is a good thing, on the whole.

For once, Pharma is releasing a bunch of variations on their old products that aren't just a scam to extend their patents. They're actually doing something to help the environment. Y'know, aside from the fact that they're doing so because of Federal mandate.

There are a few minor issues that must be addressed. The new inhalers are just as good as the old ones, but FDA regulations consider them to be different, non-equivalent drug formulations. This means that you can't simply switch back and forth from CFC to HFA--in most states, the physician who writes the prescription must specify that the inhaler to be dispensed is an HFA inhaler. HFA inhalers are also going to cost slightly more--about $50 versus $30 for the old inhalers. But many manufacturers are distributing coupons that might help reduce costs for patients making the switch.

So if you use an inhaler, be prepared--you're going to have to switch, and soon. But the sooner the better, really. With every puff you're taking on an HFA inhaler instead of a CFC inhaler, you're contributing to the efforts to repair the ozone layer. That's like saving the world, one inhalation at at time.

Friday, September 19, 2008

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?"

Wednesday, September 17, 2008

Doing One's Duty

Most people have heard of the Hippocratic oath. Physicians traditionally took the oath upon graduation. Some parts of the oath are less applicable today; I think a lot of people would object to swearing in the name of a bunch of Greek gods. And while some doctors may not want to perform abortions, I think that it's unlikely that anyone is going to prescribe insertion of a silicone ring as a method of doing so. You get the idea.

But did you know that there's a pharmacist's oath? And a written code of ethics?

The oath is pretty brief. But that's good. It's concise. Here's what it comes down to: You, as a pharmacist, have obligated yourself to serve people. You're going to do this by knowing lots of stuff about drugs.

Likewise, the code of ethics is pretty to the point. You're going to serve patients, and you're going to do your best to be fair about it. You're going to respect and utilize the knowledge of other professionals. And you're going to respect your patients' autonomy.

So why do so many pharmacists think that it's somehow acceptable to refuse to dispense contraceptives?

Now, what I think this guy (Koelzer) is doing is stupid. But in one sense, he's doing this the right way. He's started his own pharmacy. He is not asking businesses that he does not own to make a special exception for his religious beliefs. If people want to patronize a pharmacy that refuses to stock contraceptives, it deserves to stay open as much as a pizza parlor that won't stock non-Kosher toppings. It would be an unfair imposition to tell Koelzer that he has to shut down his pharmacy, because he has the right to run whatever kind of business he wants. It would be wrong.

Koelzer might be a good business owner. But is Koelzer a good pharmacist?

I don't think so, because he's violating the pharmacist's code of ethics. He's violating his oath. He swore to make patient care his first priority--and he isn't. Guaranteeing women control over their own reproduction is patient care. It's not some kind of luxury. Koelzer might say that if women want to control their reproduction that they should refuse sex. But that's not respecting his patient's autonomy, either. His patients in search of contraceptives have clearly decided that they would like to have sex. A lot of people who use contraceptives are married, so this isn't just about sinful, blasphemous fornicators.

So if you want contraceptives, you won't go to his pharmacy. He owns his own business. It's his right not to offer them, and it's your right to shop somewhere else.

But he's still a bad pharmacist.

Saturday, September 13, 2008

Yes, We Have No Tobacco

There's an old joke of sorts that goes something like this:

Why do sick people have to walk all the way to the back of the pharmacy to buy medicine when healthy people can get cigarettes in the front?

Legislature passed in San Francisco in July might make this joke completely unintelligible to the next generation. But drugstore giant Walgreens is throwing a fit.

The ban, which is scheduled to take effect Oct. 1, doesn't extend to grocery stores or big-box stores that also have pharmacies. That's why the company wants the plan stopped, said Walgreens spokeswoman Tiffani Bruce.

In short, Walgreens thinks it's unfair for Meijer, Wal-Mart, Target, and various other grocery store chains that have tacked pharmacies onto their business in recent years to continue selling cigarettes if they can't.

The reasoning here gets kind of weird. Walgreens is claiming that somehow it's more appropriate for cigarettes to be sold at pharmacies than at grocery stores because pharmacies offer a greater opportunity for patient contact with pharmacists. Pharmacists, as they continually remind us in school, are as responsible for public health as any other health care professional. The logic is apparently that a patient buying cigs at Walgreens, Rite-Aid, or CVS is more likely to have an encounter with their pharmacist during the same trip. During this encounter, the pharmacist is expected to "do the right thing" and encourage the patient to quit if given the opportunity.

Huge logical flaw: I would wager that only a small percentage of customers at my workplace who are buying cigarettes are also there to talk to a pharmacist. It's true that sometimes customers come in to pick up both meds and smokes, but the items are sold at different check-out counters, which means that a great number of cigarette purchasers never speak to a pharmacist. And even buying your smokes at the pharmacy check-out doesn't guarantee you're going to talk to a pharmacist. He or she is probably too busy making sure Mrs. Johnson isn't going to inadvertently get a lethal dose of digoxin or calling some doctor who forgot to write an actual dosage on Mr. Smith's prescription.

In other words, your chances that a pharmacist is going to swoop in like Superman and rescue you from yourself are very slim. So much for the idea that it's somehow healthier to have cigarettes in pharmacies than in grocery stores.

I don't know what message Walgreens' lawyers are trying to send, but here's how I read it: We all know cigarettes are unsafe, but if you're going to buy them, you should at least buy them somewhere where someone might try to talk you out of it. So they carry cigarettes in hopes that you will encouraged to quit buying cigarettes. What? Do they really expect us to believe that?

I think the ban sends precisely the right message. Why? It's all about public perception.

Most customers at your typical big-box store will never use its pharmacy component. The pharmacy is an afterthought; the stores were not built to be pharmacies, they simply contain pharmacies, much the way that they occasionally contain lawn and garden sections or automotive departments. The pharmacy is there to complete the one-stop-shop set. Business moves like Wal-Mart's $4 generic initiative make it pretty clear that the big-boxes don't actually expect to make a lot of money running pharmacies. The pharmacy is a way to get you to do your other shopping at their store. It is a lure, like the dangling light of an angler fish.

There's nothing inherently altruistic about today's corner drugstore, but I'd wager that there's a reason the big-boxes have had to resort to bargain-basement prices to get people to use their pharmacy services--the corner drugstore just "feels" better to the consumer. They're smaller and feel more focused. The message from the corner drugstore is that pharmacy is the purpose of their existence. The drink case, the cigarettes, and the greeting cards are for your convenience. It's more like the store is attached to the pharmacy than the pharmacy is attached to the store. (This isn't exactly true, given the history of corner drugstores in America, but we're talking about consumer perceptions, not truth.)

So if you take the cigarettes out of grocery stores, people are going to throw a bloody fit. They'll spew all kinds of vitriol about the nanny state and freedom of choice. And, to some degree or another, they'd be right. No, you don't have an inherent "right" to buy cigarettes, but cigarettes are sold, and a broad ban on cigarette sales would provoke a lot of rage. Even most non-smokers would say that the government had gone too far.

Conversely, if you take cigarettes out of drugstores, a few people are going to complain about the inconvenience--smokers, of course--but everyone else is likely to congratulate you for reinforcing the notion that the drugstore is a place where medicine and health care are the number one priorities. Can you imagine a doctor's office with a cigarette vending machine in the lobby? Nevermind the fact that cigarette vending machines have gone the way of the dinosaurs--most people would find the notion appalling these days. (This is, of course, a product of changing culture. It wasn't long ago that doctors had no problem endorsing their favorite brands, and pharmacists were no less guilty of "promoting" smoking.)

The corner drugstore isn't what it used to be. Gone are the days of pharmacists doing double duty as soda jerks. The modern pharmacy is trying to become an arm of the healthcare system, not just "a store"--and eliminating cigarette sales goes a long way toward reinforcing that idea.

Sunday, September 7, 2008

Bizarro Health Savings Account

So the company I work for automatically lists items as "FSA eligible" if they are commonly covered by a flexible spending account for health purchases, sometimes known as an HSA. An HSA, if you're not familiar with the concept, is essentially a "bank" of money that you pay into (often with each paycheck). This money is tax-free, but you can only use it to pay for your medical expenses. Some plans allow your unspent dollars to roll-over at the end of the year, whereas others do not, leading to a last-minute spending frenzy. Most HSA plans allow you to spend the dollars you have on any health-related purchase, but there are always exceptions. As a general rule, it's safe to assume that standard over-the-counter products are probably covered, so those last-minute spending frenzies usually turn into people buying more aspirin and bandages than they are ever going to use just so that the money doesn't disappear unspent.

Anyway, at my store, both the register and the customer's receipt specifically note items that are eligible purchases; the customer can keep the receipt in the event that there is a dispute with the insurance company. This also allows the customer to just swipe their HSA card and have eligible items paid for while ineligible items remain unpaid. This saves the cashier from having to ring the items up separately if the customer wants to pay for some items that are eligible and some that are not.

There used to be an occasional problem where ineligible items would get rung up with an HSA debit card by mistake. Ultimately the consumer would get an audit from their insurance company bitching at them about trying to use their HSA to pay for bread and greeting cards. A recent update to the system actually prevents the register from accepting an HSA card for items that the register does not recognize as eligible; the cashier will get an error message saying that the customer needs to use a different form of payment.

So imagine my surprise today when Mucinex and Benadryl didn't ring up as FSA-eligible items. That was odd, and potentially noteworthy, but not that strange. It was conceivable that recent policies had changed to prohibit consumers from buying OTC items without a prescription.

Then Oscillococcinum rang up as FSA-eligible and I stared at the register screen in disbelief.

To make a long story short, "Oscillo" is a homeopathically-prepared dilution of the organs of a muscovy duck. It is a "200C" dilution, which is impressive even by homeopathic standards; the original formula has been successively diluted in a 1/100 ratio 200 times, meaning that the ultimate concentration of duck organ solution is 1 with 400 zeroes following it. This is four times the estimated number of molecules in the known universe, so the probability that the resulting solution contains any of the original "duck molecules" is basically nil unless somehow we have an entire universe filled with "Oscillo." Not that that's a problem for devoted believers in homeopathy. The preparation is touted by its manufacturer as a remedy for "the flu." You know, an illness that actually kills people from time to time.

So let's get this straight. According to the computer system at work, your insurance company is more likely to let you spend your tax-free savings on fake medicine than real medicine. In fact, the register would not let me charge a box of Benadryl to this guy's HSA because it considered the drug "an ineligible purchase."

See why I used the word "bizarro" in the post title?

Monday, May 12, 2008

The Price of Potency

Male readers, would you risk your life for an erection?

It seems like a bizarre (and personal) question, but there are patients that are more than willing to do it. They are so willing, in fact, that they will lie to both doctors and pharmacists to get their hands on little blue pills when it's the little white ones that are keeping their heart supplied with oxygen.

Viagra, Cialis, and Levitra belong to a class of drugs called PDE-5 inhibitors. PDE-5, otherwise known as phosphodiesterase isoform 5, is an enzyme indirectly responsible for maintaining the amount of free nitric oxide, or NO, in certain parts of the body. PDE-5's claim to fame is that it decreases the amount of NO in the vasculature of the penis in an area called the corpus cavernosum. NO causes blood vessels to expand, which in turn causes an erection. By blocking PDE-5, the overall concentration of NO goes up, making it easier to achieve erection--but not in the absence of sexual stimulus (typically, anyway). If you want some good anatomical diagrams, try this link, which coincidentally explains more or less exactly how these drugs work in more detail.

Nitroglycerin and other nitrates work on the NO system, too. All of these drugs either directly degrade into NO or indirectly release NO via metabolism in the bloodstream. Angina pectoris (chest pain) is caused by the heart receiving insufficient oxygen. In the treatment of angina, NO causing expansion of blood vessels allows more blood to flow to the heart. It also decreases the pressure in other vessels, making it easier for the heart to pump blood; because the heart is not working as hard, it needs less oxygen. The result is a reduction in angina symptoms.

Both of these drugs increase NO levels. NO dilates blood vessels. Can you see where this is going?

Yes, combining nitrates with PDE-5 inhibitors can result in so much dilation of blood vessels that blood pressure drops to dangerous levels. If pressure drops too low, vital organs (such as the brain) can become starved of blood--which means that they are also starved of oxygen.

This drug combination is therefore contraindicated, i.e., a totally bad idea--and the kind of thing that a doctor (or more likely a pharmacist) could get sued for prescribing/dispensing. Giving a patient on nitrates a drug for ED is putting the patient at serious risk. But I've encountered patients who were willing to lie to everyone within a five-mile radius--doctors, nurses, technicians, pharmacists--to get their hands on the blue pills (or yellow ones, depending on their preferred drug).

The whole scenario raises some interesting questions. Why are male patients willing to lie to their healthcare providers? Perhaps they don't really understand the risk. Perhaps they think they understand the risk, but they don't care. Perhaps they're being fed all kinds of mass-marketing and commercial nonsense about how they'll never be able to satisfy their lovers without Big Pharma's magic erection pills. ED is a serious quality of life issue for a lot of patients--those with diabetes are among the most commonly affected. But when we as a society are putting pressure on men to the point where they are willing to risk their lives to get a hard-on, something is wrong. And this pressure isn't new--the search for aphrodisiacs has been on ever since the start of recorded history. A biological imperative? A product of culture? Who can say for sure?

Tuesday, May 6, 2008

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.

Monday, May 5, 2008

A Brief Personal Update: Plus, Insulin By Mouth? (Kinda)

After several panic-filled weeks of last-minute cramming for final exams, N.B. is finally "free" for the summer (aside from all those lick-and-stick hours at the local pharmacy where he earns his keep). The goal at this point is to finally find things I enjoy doing--like blogging--instead of shoving medicinal chemistry into my head so that I can pass the semester-end exam.

It also gives me time to do less academic (but arguably no less cerebral) things to do, like finally beating Metal Gear Solid 2 on the "extreme" difficulty. Preferably without using hundreds of continues. No, I haven't done it yet, but it's a by-end-of-summer goal.

In any case.

This particular story apparently isn't breaking news--and if you've been following it, it's a saga that has dragged on for several years, reportedly with the intervention of Big Pharma trying to shut down Little Biotech, or at least buy them out. But here's the exciting news for patients and investors alike. An oral insulin spray is still in development and has apparently performed well in trials. The medication is approved for use in Ecuador and India, and it is currently undergoing phase III trials in the U.S., suggesting that we may see some sort of release in the states in the next one or two years.

Buccal administration is a complicated-sounding way of giving medicine by having it absorb through the cheek. The cheeks and area underneath the tongue have a rich blood supply and fairly thin barriers between the bloodstream and the outside world, permitting specially-formulated drugs to cross easily. While a lot of buccal drugs are used for their local effect (like anesthetics), some are intended to effect the whole body, like the opioid pain-reliever fentanyl, which is available as what amounts to a sucker.

Another major advantage of buccal administration is that it bypasses both the stomach and the liver, preventing the drug from being broken down before it enters the bloodstream (in the case of the liver, this is called first-pass metabolism). Protein drugs, such as insulin, cannot normally be taken by mouth because the stomach and intestine will digest them like any other protein, rendering them inactive. To prevent insulin from being reduced to useless amino acid bits, it must normally be given by injection.

The reason inhalation was considered as a route of administration for insulin was because it, too, bypasses the breakdown that takes place in the stomach. Theoretically, the rectal route partially bypasses first-pass metabolism (it actually depends how far up you insert the suppository), but I can't imagine rectal insulin would be very popular, and there are other complications.

For the pharmacologists in the audience, now I'm trying to imagine what sort of formulation barriers might exist to insulin suppositories. Base incompatibility? Temperature/storage problems? I've never even heard of a protein drug being given by that route. But I digress.

The product that the article I linked is talking about is a spray--think something like breath spray--that is applied to the inside of the cheek. The spray would be metered to provide a precise dose, but fine-tuning might be difficult unless the spray can be "dialed" to spray different amounts of insulin. The details are still fuzzy, but the research is still very exciting.

Patient compliance--the ability and willingness of a patient to properly use his or her medications--is a huge obstacle for patients with diabetes. Anything that makes administration of insulin easier for adults and children alike is definitely a good idea, assuming of course that there are no long-term drawbacks and that the system is practical (inhaled insulin turned out not to be). I'm looking forward to seeing where this research goes.