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.

Monday, October 27, 2008

Tagged, I'm "It"

It would appear that I have been tagged with some infectious, self-propagating idea by Abel Pharmboy.

Well, I've only got five exams this week. Why not take a few minutes to answer some simple questions?

Here are the rules for the game.

1. Link to the person who tagged you.
2. Post the rules on your blog.
3. Write six random things about yourself.
4. Tag six people at the end of your post and link to them.
5. Let each person know they've been tagged and leave a comment on their blog.
6. Let the tagger know when your entry is up.

One and two are done. Six random things? You'll have to settle for six pseudorandom things since I don't feel like making a list of personal traits with more than six elements and generating random numbers to determine which things to include. Yes, settle for pseudorandomness. Settle...and suffer!

1. If you ever need to bribe me with something, I suggest a Japanese dinner. I can't get enough salmon sushi, ever, and will continue to eat the stuff until I explode. Please stop me before then so that the restaurant staff doesn't have to clean up N.B. bits.

2. My university was not my first choice school; my actual first choice was Duke University, which, in retrospect, would've been a terrible idea. Duke has no pharmacy program, so I would've needed to transfer after two years. My reasons for wanting attend Duke despite its lack of a pharmacy program? Like so many other messes guys get into, it was because of a girl. Not the most rational motivation.

3. Over the past four years I have transformed from passionately foofy-doctrineless liberal Christian to skeptic and atheist. My conversion to skepticism is actually a result of my studies of alternative medicine. I was first exposed to altmed two years ago when I inadvertently wound up at the Quackwatch website while doing a research project. Thorough investigation of the subject really improved me as a scientist; I would say that before poking into the innards of altmed that I wasn't thinking like a scientist.

Of course, skepticism in medicine led to me applying skepticism to other areas, and when I was exposed to atheism as "skepticism of religious claims" instead of "disbelief in god--as much a matter of faith as any religion" it hit me that there was no other choice than to turn the skeptical eye in the direction of my religious beliefs. They were predictably destroyed once suitably scrutinized.

4. I own a cat. True to family tradition, I didn't get the cat at a pet store, nor did I adopt her from an animal shelter; I simply picked her up off the street as a kitten (roughly 6-8 months old, by the vet's estimation). After pulling onto my street and nearly hitting the poor thing with my car I stepped out of the driver's side door and there was a tuxedo-print cat mewing at me. I did what any soft-hearted but clueless animal-lover would do and took her inside for a saucer of milk (and, when that seemed insufficient, a can of solid white albacore tuna)--all this despite the fact that my lease specifically prohibited pets. I spent the next two hours thinking "what do I do with this animal now?" until I picked my girlfriend up from the airport and informed her that we needed to stop for cat food. She'd owned cats; I hadn't.

5. I used to live in Dayton, Ohio, the so-called "birthplace of aviation" as it is home to the Wright Brothers.

6. I was a Boy Scout as a teen, but I never achieved a rank higher than First Class. I was the first member of my troop to earn a climbing merit badge; I didn't care about promotions or decorations, I just wanted to go camping. I still can't reliably tie any knots.

Tag six, you're it! Go to!

Cobalt at Secher Nbiw
James McGrath at Exploring Our Matrix
Bad of the Bad Idea Blog
The Bronze Dog of The Bronze Blog
Dana of En Tequila es Verdad
and Greta Christina of the aptly-named Greta Christina's Blog!

Tuesday, October 21, 2008

But Think of the CHILDREN!

You ought to recognize that line as a classic refrain of those in a state of "moral panic."

According to a recently released study, 3% of all children and adolescents in the United States go without health insurance at some point in a given year:

That translates into almost 3 million U.S. children with no medical care at all and no access to prescription drugs over a full year. Slightly more than half of that number qualify for public coverage but aren't enrolled.

Overall, more than 9 million U.S. children are uninsured; some 18 million have a coverage gap at one time or another, according to the study.

But, surprisingly, this includes kids whose parents have coverage:

The authors of the first study looked at data from 2002 to 2005 on children and adolescents under the age of 19 living with at least one parent. The study included more than 39,000 participants.

Their analysis found that 3.3 percent of children and adolescents were uninsured, even though they had at least one insured parent. (emphasis mine)

What about demographic information?

Uninsured children and adolescents were 58 percent more likely to be Hispanic than white non-Hispanic; had double the odds of being from a low-income versus a high-income family; were 48 percent more likely to be from a middle-income rather than high-income family; and twice as likely to come from a single-parent home than a home with two married parents.

...children whose parents had less than a high school education were 44 percent more likely to be uninsured; they were also 64 percent less likely to be insured if their parents had public coverage rather than being privately insured.

None of this should be a surprise. Poor kids don't have adequate health care coverage. Middle-class kids are less likely to be insured than kids from richer families; kids whose parents make between $38k and $72k a year are just as likely to be uninsured as their poorer counterparts. Kids with parents who have limited education are less likely to be insured, probably because the parents are less likely to have jobs that offer comprehensive family healthcare plans.

Why haven't we passed legislature to provide all children with health care coverage? Remember, the people who typically vote against candidates daring to propose universal health care are also the people who are most opposed to family planning.

"But N.B.," say some members of the audience, "the article says that over half the kids involved qualify for public assistance but aren't signed up. That's the fault of parents, not the government."

You're right. But not providing health care for children is sheer negligence, and we punish people for child neglect already. The definition of child neglect is "any recent act or failure to act on the part of a parent or caretaker which results in death, serious physical or emotional harm, sexual abuse or exploitation." It is considered neglect to fail to provide for a child's basic needs, and medical care is included among them.

About half of U.S. children without health insurance had to go without medical care or prescription medications while they were uninsured, said researchers from the University of Rochester Medical Center. Even more children went without preventive care, including receiving necessary vaccinations.

If you don't see why this is a problem, you're part of it. And if you don't see why there need to be laws mandating health coverage for children (and adequate government assistance for those who need it), you're still part of the problem. Until there are laws mandating health care coverage for all children, we're losing a battle. There are kids out there who don't get treatment for the most basic illnesses because they lack health care coverage. Maybe one of them is yours.

"Children are like flowers," they say. "You can never have too many."

If you aren't watering your garden and your flowers are dying, maybe you should rethink that assertion.

So...please! Think of the children!

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.


Tuesday, October 7, 2008

Selected Conversation of the Evening

From tonight's work shift. This phone call left me thinking.

"Hello, thank you for calling CorpoPharmacy, this is N.B., how can I help you?"

[shrill old woman's voice] "What's the name of that disease that's going around, it's killing lots of people and everyone is getting it?"


"You know! It's that disease, everyone has it..."

"Do you...er..."

"Why can't you just tell me what it is!?"

"Ma'am, you're being very vague. I don't actually know what you're asking."

"Everyone's getting it!"

"...do you have some idea as to what causes it?"

"NO! Nobody knows what causes it!"

"Er, no, I meant...how does it spread? Animal bites..."

[she cuts me off] "NO! You get it, it's spreading, it affects your brain, and you forget things!"


"YES!" *click*

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, October 3, 2008

Thought Experiment

What if more things worked like health insurance?


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.

Wednesday, October 1, 2008

Student Finds Classical Reporting on "Holistic" Medicine Still Lacking Critical Rigor

The rise of "alternative medicine," if you can claim that it has risen at all, has mostly been due to word of mouth and unwarranted exposure by an uncritical press. Seeing as how CAM itself never actually changes, it should be no surprise to anyone that neither does reporting on it. We hear the same fallacies, the same appeals to authority and tradition, and the same overweighting of anecdotal evidence over and over again.

So I wasn't even a little shocked at this typical article on the common cold.

ABCNews.com asked four holistically minded doctors what they do when they feel under the weather. Their prevention and treatment advice might help you dodge or short-circuit the next bug that comes your way.

I'm not even entirely sure where to begin. "Holistically-minded doctors?" What does that even mean? Proponents are going to spout some gibberish about doctors that "treat the whole person, not just their symptoms," but let's see what these doctors recommend to "treat the whole person."

Let's start with Dr. David Rakel, MD.

There's no firm evidence that any medication or herb will prevent the common cold, said Rakel.

Hey, cool, he's actually concerned with whether or not there's evidence for the stuff he suggests!

At the first sign of symptoms, the goal is to attack the virus early because it replicates the most within the first 48 hours, pointed out Rakel. He might drink more green tea, which appears to have antiviral and antibacterial properties. And he would also drink three big glasses of orange juice to get more vitamin C...

...besides consuming more liquids, Rakel might take 20 to 30 milligrams of zinc acetate lozenges twice a day to improve his immunity. He takes zinc only for the first two or three days of a cold, when he feels it's most effective. He might add andrographis, an herb that's sometimes called "Indian echinacea." He would take 400 milligrams of this immune-stimulating herb three times a day.

That's why when it comes to his own health he takes a shotgun approach and tries everything that has ever been suggested for treating the common cold. Vitamin C, zinc, green tea (antioxidants), and "Indian echinacea," which must be better than "Western echinacea."

At least Dr. Rakel gets an annual flu shot, but he bemoans the presence of thimerosal in flu shots. I guess the fact that thimerosal-free flu shots is not important to him, or maybe he just thinks the CDC has it all wrong.

Strike one, MD's out. Who's next? Lynne Shinto, ND. You can probably guess where this is going.

She says she thinks that too much sugar can weaken immunity...when she gets a cold, her philosophy is to let it run its course. She'll turn to the usual suspects: bed rest, more fluids and chicken soup -- or because she's Japanese-American -- miso soup with shiitake mushrooms, fungi known for their immune-strengthening compounds.

Go Lynne! You strengthen that immune system! Is that the humoral or cellularly-mediated immune system? What do you mean you don't know? You're just sure it works? Well, as long as you're treating the real cause of disease instead of just addressing symptoms, like a good holistic doctor.

These approaches may make the symptoms feel better, she admits, but they likely won't make a cold go away faster.

Oops. I guess not. So you fail at both science and pseudoscience.

If Shinto's sinuses are congested, she turns to an "old naturopathic therapy" thought to stimulate the immune system. Called hydrotherapy, she might stick her bare feet in hot water for three minutes then in ice-cold water for 30 seconds, and she repeats this hot-cold sequence three times.

This is a fantastically plausible treatment for nasal congestion. Maybe the alternating peripheral vasoconstriction and vasodilation...no, this really is so implausible as to not warrant investigation.

What about another MD's perspective? Surely a second opinion is worthwhile. Dr. Kevin Barrows?

He's a big believer in meditation and has found this mind-body approach helps increase his awareness of subtle body shifts, a tip-off that he may be getting sick. For him, a sore throat is his early warning sign of a cold, his cue to start taking echinacea.

That's great, doc. I'm glad that you can recognize one of the most common symptoms of the common cold as...indicative of the common cold. But he didn't learn that in medical school. No, he figured it out through meditation! Once he determines that his chakras--er, his throat hurts--he knows it's time to start taking echinacea, the herb that a Cochrane review states "shows inconsistent benefit."

Sixteen trials including a total of 22 comparisons of Echinacea preparations and a control group (19 placebo, 2 no treatment, 1 another herbal preparation) met the inclusion criteria. All trials except one were double-blinded. The majority had reasonable to good methodological quality. Three comparisons investigated prevention; 19 comparisons investigated treatment of colds. A variety of different Echinacea preparations were used...

...there is some evidence that preparations based on the aerial parts of E. purpurea might be effective for the early treatment of colds in adults but the results are not fully consistent.

I know that whenever I have a problem, I'm willing to rush out and spend money on things that "might work."

Outside of a mental health context, I know that if I ever had a doctor who suggested "meditation" as a serious method for identifying or treating any illness I'd pull up my pants and walk out the door. Three doctors I'd never want to visit--assuming that their beliefs are being accurately portrayed in this article. Well, what about Dr. David Leopold, our fourth contestant?

At the first sign of a cold, Leopold treats his symptoms extremely aggressively. His goal is to support his immune system so that it helps clear the virus and slows down the spread of symptoms.

He takes zinc gluconate lozenges, drinks plenty of herbal tea and also uses a liquid tincture of echinacea. Despite research that questioned the herbs' benefits, "I'm convinced that most of the well-done studies of echinacea suggest it seems to be effective for reducing the severity and duration of a cold."

Just what I need, a doctor who flunked both statistics and immunology. No thanks.

The thing is, I'm not entirely sure that the blame is entirely on the doctors being quoted here. Now, granted, I don't think that their words (or positions) are being fabricated; I'm sure that, when interviewed about their "holistic medicine" use, all of these doctors (and the naturopath) volunteered honest information.

But here's the problem. This "sound-bite medicine" doesn't actually leave room for--or invite--serious discussion of anything beyond "some doctor said you should try this." And, in the interest of "unbiased journalism," the reporter behind this story didn't bother to fact-check any of the claims made by the doctors. After all, they're just harmless claims; the article isn't about "what is good medicine" but rather opts to provide some opinions by licensed medical practitioners.

Unfortunately, this approach is seriously misguided. Most people think of physicians of all stripes as having a good, solid understanding of medicine, and this implicit trust that doctors know what they're talking about is crucial. If patients think doctors are idiots, why would they ever solicit one for an opinion? The drawback to this is that off-the-cuff "opinions" about vitamin C, echinacea, or other various treatments that don't stand up as effective under serious scrutiny reinforce the misconception that these treatments actually work. Just try telling a patient whose doctor takes vitamin C that vitamin C doesn't treat or prevent colds. "If it doesn't work, why does my doctor do it?" What surprised me about this article is that it didn't even contain the "token skeptic" interview, but then, the article is subtitled "what alternative medicine experts do when they get sick."

Physicians who succumb to non-evidence-based thinking do more than harm themselves. They drag down patients with them, even patients they'll never meet, because their endorsement of unproven remedies assures that these treatments will never die out despite the immense evidence against their efficacy. As long as there are doctors promoting these remedies, no amount of double-blinded, well-controlled, properly randomized research is going to convince the public that they aren't effective--because their doctors, expected to be the gatekeepers of knowledge, are ignoring it.