The Problem Is Profit (At Least in Healthcare)

If the vagaries of the medical system has you frustrated, look no further than today's New York Times opinion page for a little shot of optimism to your system. There you will find some government/academia heavy hitters (Ezekiel Emanuel and Jeffrey Liebman, both former advisers to the Obama administration) explaining how wunnerful healthcare is gonna be due to the impending extinction of health insurance companies. How's that possible, you ask? Well, the details are complicated, but the gist is that due to the changes wrought by the health care bill so stupidly referred to as "Obamacare" by the vast majority of Americans, a new system of apportioning dollars for healthcare will come into being in the next few years. This new system will have organizations known as "accountable care organizations", or ACOs, which "will increase coordination of patient’s care and shift the focus of medicine away from treating sickness and toward keeping people healthy". And, the authors contend, it's going to make everything better.

How that will take place is explained in two terse grafs midway through the article:

Because most physicians and hospitals today are paid on a fee-for-service basis, medical care is organized around treating a specific episode of illness rather than the whole patient. This system encourages overtreatment and leads to mistakes and miscommunication when patients are sent between their primary care doctors, specialists and hospitals. Indeed, under today’s payment system, investments in providing better care are doubly penalized. If a hospital hires a nurse to follow up with patients after they are discharged in order to reduce readmissions — for example, to help patients with diabetes improve blood sugar control — it must pay for the nurse, which is typically not reimbursed by insurance companies or Medicare, and it loses revenue by preventing the readmission.

In contrast, accountable care organizations will typically be paid a fixed amount per patient, along with bonuses for achieving quality targets. The organizations will make money by keeping their patients healthy and out of the hospital and by avoiding unnecessary tests, drugs and procedures. Thus, they will actually have a financial incentive to hire that nurse for follow-ups.

To give some context, a major chunk of Zeke Emanuel's career has been defined by paying attention to the issue of "overutilization"--the overuse of extremely expensive resources by physicians and hospitals--and ACOs appear to constitute a solution to this problem. Stop overutilization, you drive costs down because you stop needless testing. Create incentives to limit spending, you stop overutilization. QED. Thus, the new rules of the healthcare act will massage this new model into place.

Now that all sounds very nice and well, but color me dubious for the most part. I don't dispute Emanuel's contention that we spend too much on healthcare (we spend twice the amount of any other country per capita), and I agree with much of his analysis of the root causes of overutilization. But Emmanuel and Liebman appear to think that the private sector is up to the task of doing this, and on this point I am skeptical. Oh, we'll have changes with this ACO model, I'm pretty confident, but several of them are going to take a system that already has huge problems and make at least some of them worse.

The problem is profit. Healthcare companies are like any other capitalist venture: the bottom line is that they are in business to make money, and make a lot of it. Companies exist to make shareholders wealthy, and they will engage in whatever practices are legal in order to do so. In healthcare, this means, on the whole, that corporations wishing to make money have to increase production (having doctors see more patients, not by having more sick people) and/or reduce costs (either by making people healthier, which is easier said than done, or by decreasing overutilization, or by having cheaper labor than doctors see patients, or just paying doctors less).

I'll let the economists wax eloquent on how this makes the world a better place in theoretical terms, but I want to give you some idea of what this means in the real world. Let's take Your Local Little Hospital. If you go there nowadays, you're as likely as not to be cared for by something called a "hospitalist", which is an internal medicine doctor whose sole job is to care for hospitalized patients, and thus this doctor has no "practice" in the traditional sense of having a group of patients for whom he or she cares for an extended period. These hospitalists often work for either the hospitals themselves, or for corporations involved in the profit business.

If you go to Your Local Little Hospital and your hospitalist works for a corporation, that corporation likely is putting an enormous pressure on Dr. Hospitalist to see as many patients as they possibly can in one day, upwards of 20 to 25 patients. If you have ever spent time in a hospital or been with a loved one or friend, you'll know that face-time with the doc can (one hopes at any rate) be a huge factor in understanding what's going on. Suppose a conversation with a doc takes just five minutes; most people would want more, especially if they're sick, but let's just be conservative for the sake of the numbers to make a point. If that doc spends just five minutes talking with each patient and/or family of the patient, the doc with a census of 25 would spend about two hours each day just doing that task. That leaves the tasks of reviewing data, interpreting the data, writing a note, calling consultants, examining the patient, placing orders, and then reviewing the new data from that day's tests and making plans as necessary. It takes a lot of time to take care of a patient, about an hour each day by my estimation, so you can see what happens when you have 25 patients on your census.

The difference between this world and the one where the hospitalist is employed by Your Local Little Hospital is that the hospital--assuming it is a non-profit hospital--is not driven to quite the same extent by raw money. Of course, even non-profit hospitals need to keep a positive cash flow, but they don't have to worry about creating huge amounts of cash so that their CEO and major shareholders can afford lovely getaway ski chalets. Their only real bottom line is to stay in business, so they can afford to let their hospitalists see, say, 12 to 15 patients a day--considered by most in the biz to be an entirely reasonable number and still do good medicine. That's nearly half the workload of the hypothetical hospitalist in the graf above, and while this is all hypothetical, it really is happening out there right now.

In the brave new world of ACOs, all of these numbers may eventually seem quaint. Here's an op-ed--from the CEO of the Society of Hospital Medicine, mind you--that blithely chirps about "new paradigms" in which a hospitalist can see up to forty patients in a day! I have no understanding of what such a new paradigm could be except for one in which mistakes will be made and families and patients will wonder who the hell is in charge of their care.

So when people write feel-good phrases like "the new system will encourage treatment of the whole patient instead of being organized around treating a specific episode of illness", and that the remedy for such problems is by bringing the magic of market-based solutions to bear on them, I think that such people have learned the high art of euphemism because they either don't understand, or don't care about, the realities of what caring for patients actually means. (Though Zeke Emanuel must--he's a doc himself! What happened to his rhetoric I can only guess.)

I make good money as a doc, but I'll never be CEO-rich doing it, which is fine with me since becoming rich wasn't my priority in going into medicine. Most of the docs I know could be described similarly. But for us, profit wasn't the primary motivation. It's true that most of us make enough for the occasional nice bottle of Cabernet, but for people who want to be rolling in it, being a doc is not the right way to go, as there are easier ways of making a buck. The same should be true, by and large, for the entire biz of healthcare as well.
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Taking the Right (Though Small) Steps in Conflict of Interest

Amidst the braying and screeching of the Republican Presidential candidates in South Carolina came a small news bit that the Obama administration will institute new requirements that drug companies must disclose their payments to physicians for speaking, consulting, and research activities. As noted here, this has been backed in large measure by Republican Senator Chuck Grassley and Democratic Senator Herb Kohl, who have been at the forefront of conflict-of-interest issues in medicine for the past several years.

Two facts in the articles bear repeating: a) that physicians can be mightily influenced by the largesse of drug companies; and b) that "about a quarter of all doctors take some cash payments from drug or device makers and nearly two-thirds accept meals or food gifts" [my emphasis]. As you can find on the ProPublica website in the above link, companies invest millions of dollars in these little gifts. If you think that doctors can go to a fancy dinner sponsored by Drug Company X and not have their subsequent prescription patterns influenced in favor of Drug Company X, then you would wonder why the industry invests such resources in the first place.

Disclosure is a nice gesture, but it is mostly only a gesture. Like the disclosure of nutrition facts for food producers (something that industry likewise fought against tooth and nail), it is utilized only by a very small group of people. Similarly, the vast majority of patients won't have the determination and persistence to track down the disclosure information. And besides, when two-thirds of docs are on the take, what difference does the research make, anyway?

The only legitimate long-term solution is to tighten existing rules about doc-industry relationships. There are a few areas where docs have to work hand-in-hand with industry (surgical subspecialties are the main ones that leap to mind) and would need to be carefully thought out, but otherwise it's really not that difficult to create rules by which docs are supposed to operate with respect to drug companies. We already have such rules for scientific ethics in research; why there can't be a similar arrangement for the daily business of doctoring is quite beyond my understanding. In the meantime, the standards we have now would be regarded as appalling by most people if they understood the situation.
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One Patient, One Hour

If the American principle of voting can best be described as "one man, one vote" (leaving aside that it ain't just men), I'd say there's a similar, though less well defined and understood, principle that applies to hospital medicine: one patient, one hour. That is, to do good medicine in a hospital-based setting, it takes a general internist, on average, about one hour to take care of a patient.

This may come as a surprise to anyone who has been hospitalized and seen a doc for about five minutes each day, but that hour applies to all the tasks required in caring for that patient. A doc's gotta review the vital signs, the med sheets, the nursing notes, the social worker and physical therapist's assessments, look up the daily labs, check the consultants' notes, and then come before the patient, examine them, answer their questions, talk to family members, set up a plan for them, and then write a note in the chart. Of course, individual styles may vary: I tend to enjoy spending time talking with patients and their families, but that slows me down, and I'm not highly efficient to begin with. Moreover, not every patient every day requires an hour, as the patient with uncomplicated cellulitis needs IV antibiotics, not a huge re-evaluation on a daily basis. But based on my experience and discussions with lots of hospital docs, the one-hour-one-patient "rule" is a pretty good predictor of the quality of medicine. Cut that amount substantially, and sooner or later a doc will make a mistake, whether it's an oversight in drug-drug interactions, a missed lab value, or a misunderstanding with a family about prognosis because a meeting between doc and family didn't take place.

So this past weekend, when I took to covering the "floor" patients as part of a moonlighting gig at a local community hospital, I was given a list of 14 patients at 7 am. I wasn't surprised very much when I left the hospital almost exactly 14 hours later. It took about a half-hour to divvy up the patients initially, and I took about ten minutes to wolf down a lunch, but the average time I spent was just under an hour for each patient, and by the time I headed home I felt I had a decent handle on what was going on with them.

Two particulars about this experience bear mention, however.

First is that a "census" of 14 is, based on what the full-time floor docs tell me, on the lower end of the spectrum, with typical numbers in the 18-20 range, sometimes higher. The reason for this is money, money, money. The docs at this particular hospital work for a for-profit company (as do I when I moonlight for them), a company whose stock is publicly traded and for whom profits are by definition their lifeblood. While I'm not making any comments on how the company is run and how they try to maximize profits and simultaneously provide high-quality care, I can give you an idea about the numbers.

In the northeast, where I work and where salaries are a little higher than in other parts of the country, a typical hospitalist (i.e. a hospital-based doc, though more on "doc" anon) costs a company around $250K per year when you add benefits, malpractice insurance, and administrative costs to the salary, which at least where I work is a touch under $200K. When you factor in reimbursements from patient care, all it takes is an accountant to figure out how many staff are needed to see so many patients on average and estimate the census size required for the company to make a profit at a given hospital. Since the company's reason for existence is profits, they are always trying to push the envelope with patient census, and shooting for a census of 20 (or higher!) keeps the company in the black. This article from KevinMD features the musings of a doc who once routinely had to care for forty patients a day--and he casually notes that he currently has a daily census of "maybe around 20".

Now, a non-profit hospital running its own hospitalist program also has a bottom line and still has to think about having its revenue stream cover its costs. But there's one difference, and it's a huge one: the need for profit. I haven't done a lit search to see if there are any articles looking at this, but I'd be willing to bet more than $5 that if you surveyed the average patient census of hospitalists working for non-profit hospitals versus for-profit companies, you would find a statistically significant larger census in the latter group. By how much, I don't know. But what I do know is that if you move an average census above 12-14, and if you ever move it above 18, you simply can't be a decent doctor. It can't be done.

(As this piece notes, two studies have shown that as census numbers increase, face-to-face patient time does not decrease, but the critical behind-the-scenes work of "documentation, writing order, and communicating with nurses and primary care physicians" does. For those interested in reading the primary academic literature on staffing requirements, you can see this article from 1999--it assumed an average census of about ten in making its calculations.)

The second item of note is that, while I was slogging away seeing my patients, I saw a brief verbal altercation between two of the younger hospitalists, neither of whom I knew. I ran this past one of the hospitalists with whom I've worked for many years and he shrugged. "Oh, X is mad because Y just left yesterday at noon and turned her pager off," he said. "Noon?!" I responded. To leave at noon, this doc saw fifteen patients in around five hours. That's twenty minutes per patient--and she was meeting all of these patients for the first time. That means she looked through the chart, reviewed the medications, saw the patient, wrote a note, and (a theoretical conjecture--I doubt it really happened) communicated with family members...all that in less than the length of a sitcom. Which is an appropriate comparison, since all one can do when confronted with such negligence is laugh. My heart goes out to this doc's patients and families. I hope she remains the exception in our profession.
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Is HuffPo Changing Its Science and Medicine Editorial Policy?

Yesterday the Huffington Post ran a fascinating column in its Science section. Seth Mnookin, a science journalist and author of the book The Panic Virus (required reading for anyone looking for an introduction to the flim-flammy methods of the vaccine-causes-autism cult), commented on the role that responsible journalism has to play in educating its readers on science and medicine. "The fact that a specific story is controversial (or that it is promoted by a particularly outspoken celebrity) does not mean it deserves the oxygen it needs to survive", Mnookin wrote.

Such sentiments have been expressed before by Mnookin as well as other journalists and scientists. What made his dispatch so singularly stunning is that HuffPo has heretofore provided an electronic safe harbor for most well-known anti-vaccine cranks for the past several years. The website has granted a platform to an ongoing campaign of misdirection and misinformation about vaccines and its alleged link to autism, of which this article by Robert F. Kennedy Jr. is but one odious example.

As a consequence of this policy, Mnookin has, entirely appropriately, devoted much of his energy in recent years to hammering HuffPo for its irresponsibility and harm-inducing potential. (A terse encapsulation of his thoughts can be found in a brief blog entry where he notes, "Let me state very simply: HuffPo publishes dangerously ignorant dreck", and similar thoughts can be found here and here.) Thus, inviting Mnookin to hold forth on...well, basically anything constitutes a very profound shift in attitude.

Will this lead to wholesale changes at HuffPo? Hard to say. "It'll be interesting to see how this all plays out", says Mnookin, wondering if he was being played by the editors who could then claim that they were being "balanced" in their approach. If they are sincere, a good place to start would be to issue some form of retraction, as Salon did in its removal of a Kennedy-authored vaccine/autism piece, co-published with Rolling Stone, entitled Deadly Immunity. (Rolling Stone removed the story as well, but as noted here, they have not been as forthright in dealing with the criticism of their decision to publish Deadly Immunity as Salon.) We'll see what comes of it.

Also in the same vein, it appears that one of the main peddlers of nonsense about the vaccine-autism link, the now-thoroughly-discredited Andrew Wakefield, has decided to file a libel lawsuit in Texas against the authors of a British Medical Journal article published last year in which Wakefield was described as a "fraud". A similar type of lawsuit filed by Wakefield in the UK in 2005; Wakefield dropped the suit after the judge suggested that Wakefield was using the proceedings "for public relations purposes". As the linked article notes, a new law in Texas is supposed to discourage frivolous libel suits by placing a higher burden on the plaintiff than in years past, so the Wakefield suit should become something of a test case.
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Billy Rubin Blog Hero & Villain Of The Year (and Year-End Book Review)

"It's an honor just to be nominated," crowed sex columnist Dan Savage in response to Andrew Sullivan's listing of Savage in his poll for the "Moore Award". Sullivan, in his Daily Beast blog "The Dish", has a variety of year-end awards, and his "Moore" award (named after the lefty agitpropster filmmaker Michael Moore) is for "divisive, bitter and intemperate left-wing rhetoric". Savage garnered a nomination this year, and has thus far worn that nomination like a badge. As of this writing, with just under 10,000 votes cast, Savage is comfortably in the lead with more than 58 percent of the vote in a field of ten candidates--a sum that Mitt Romney dreams about even more than Sugar Plum Fairies as we close in on the Iowa Caucuses. (What Simon Winchester, whose entire collected works I have nearly finished over the past few years, has said or written to be included in this group is unknown to me, but it must have been a doozy, since under normal circumstances one would not describe his utterances as remotely extreme.)

Savage's nomination came as a result of a dustup between him and soon-to-be-former-candidate-for-President Representative Michele Bachmann back in September during the Republican Presidential debates. At that time, Bachmann was indulging in one of her favorite political tactics in order to separate herself from her rivals and recover some of the mojo she had lost over the summer when she had been the darling of the party and led in the polls.

That tactic would involve departing entirely from reality and making up whatever stuff she deemed suitable to rile up sufficiently nitwitted partisans, as she did earlier in the campaign when she attacked Michelle Obama for advocating breastfeeding by supporting a tax break for breast pumps, turning the tax break into a right-wing fantasy that the government was "going out to buy my breast pump". In the September debate, Bachmann had decided to stake out the anti-vaccine territory to stick it to Texas Governor Rick Perry, who was then leading in the polls. In 2007, Perry had admirably issued an executive order mandating that Texas girls receive access to the HPV vaccine, a major cause of cervical cancer as well as other maladies. That order was later overturned by the Texas legislature, causing Perry to quip--correctly--that the bill's supporters were effectively killing women who would needlessly die from the cancer.

Not that he said it that bluntly, but he came close: "no lost lives will occupy the confines of their conscience, sacrificed on the altar of political expediency", was his rather eloquent retort at the time. Unfortunately, he may have wished he never uttered those words, as the HPV order came back to bite him rather fiercely as the primary season got more contentious and governmentophobic conservatives took a dim view of his actions. Bachmann, though, decided to go for the jugular, and took the almost-reasonable sounding "there are limits to government" argument and pushed much deeper into the Twilight Zone. At the debate, she merely parroted the usual lines about governments forcing people to do things against their will, but the following day, in an interview with the Today show's Matt Lauer, Bachmann noted that she had been approached by a mother who claimed that her daughter had "developed mental retardation" after receiving the vaccine, and asked the viewers to draw conclusions for themselves.

In response to this perceived bit of a politician's own mental retardation, advocacy groups rose up in unison to denounce Bachmann's position. "There is absolutely no scientific validity to this statement", wrote Dr. O. Marion Burton of the American Academy of Pediatrics. Doctors blogging on the subject blasted her, including one who chided Bachman for her "anti-vaccine porn". And a few bioethicists offered thousands of dollars to review the records searching for proof of the vaccine's harm. Bachmann, in the days to come, would disingenuously backtrack on the claim, noting that she herself never made a claim about the vaccine's harm, only that someone else had done so, in language and reasoning so slippery it invites comparison to any number of reptiles.

Enter Dan Savage.

Within two days of the blowup, Savage wrote a brief dispatch on the matter, noting that her "comments" on the HPV vaccine were much more accurately described as "lies". Then he let his savage pen loose, noting the following:

Bachmann and her ilk believe that woman [sic] who have sex—along with men who fail to purchase health insurance—deserve to die horrible deaths. That's why they hate the HPV vaccine, that's why they fought its introduction, that's why they tell lies about it now. Because they want women to die.

Presumably, Savage meant something more along the lines of "women who have premarital or extramarital sex". Regardless, Savage's characterization of Bachmann was unquestionably intemperate. It was obviously divisive. It was unambigously bitter. Thus, by Andrew Sullivan's criteria, an ideal nominee for his award!

Only one matter bears mention: Savage was almost certainly correct. And for that we name one of our favorite columnists, Dan Savage, for the Billy Rubin Blog Hero Of The Year, and his public foil, soon-to-be-just-Representative Michele Bachmann, for the Billy Rubin Blog Villain Of The Year. Happy 2011, y'all.
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PS--In other news, we've been catching up on our reading around here and want to give a special shout-out to the following books, most of which came out in 2010, but we're almost never that up to date on our reading until someone actually pays us to write this blog. Besides, these books will have a shelf life to come, so please do consider them if you want to read excellent books on medicine:

The Emperor of All Maladies--Siddhartha Mukherjee's phenomenal "biography" of cancer. Though the subject matter may seem intimidating and depressing, Mukherjee takes the reader along on a ride that is suffused with the insight of a great clinician, the wonder of a thoughtful scientist, and the humanity of a fine writer. For his work he won the Pulitzer Prize for general nonfiction, and appropriately so. (Readers wanting to delve further into cancer literature might consider watching a Japanese film that received almost zero attention in the US, 1778 Stories of Me and My Wife, detailing the struggles of a writer and his cancer-stricken spouse. Be forewarned, however, that it makes the phrase "gut-wrenching" seem inadequate. I watched it on a flight from Europe to the US, and by they end the Dutch people around me practically had to carry my sobbing ass out on a litter.)

The Panic Virus--Seth Mnookin's book about the vaccine-causes-autism movement. An excellent primer on vaccine hysteria, narrower in scope than Arthur Allen's Vaccine but no less important or readable.

Anatomy of an Epidemic--Robert Whittaker's compelling analysis of modern psychiatry, which I've written about before here.

Lipitor Goes Generic, and Everyone Wins...Theoretically

I like to play a game with my med students, residents, and fellows--although really the game can only be played with residents and fellows as the students don't have enough medical mileage under their belts to fare well. I ask them this question: what do they think are the five greatest drugs of all time? After all, people routinely debate the greatest baseball player--I'm partial to Willie Mays--the greatest writer in the English language, the greatest movie, and the list goes on. Why not have a discussion about what makes a drug great?

So we talk about how drugs are used and what makes them good or not. I do this exercise to get them thinking about qualities that define particular drugs or entire classes of them, and why some may be preferable to others. Such qualities include "applicability" (i.e. how many people would benefit from its use, as Tysabri™ is an incredible drug that preserves quality of life, but only does so for people with advanced multiple sclerosis, a very small group), the magnitude of benefit (a drug that saves a life is more important than one that eases wrinkles, such as Botox™), ease of use, minimal side effects, and a proven track record (drugs that are new to the market often appear miraculous; most don't last, as the brief life of Xigris™ shows) among other things.

Lively debates ensue, but what I find most interesting is that the drugs that most housestaff end up agreeing on are ones that have been around a very long time and weren't developed by recent pharmaceutical company R&D programs. And by "recent" I mean the past 30 to 40 years. Aspirin may be the greatest drug of all, and has been around in its current form since the mid-19th century (and the active ingredient was found in folk remedies long before that); morphine and its narcotic siblings are likewise more than a century old; penicillin-class and sulfa antibiotics were developed before World War II; insulin was first used in the 1920's after decades of research; and beta-blockers were first developed in the 1960's.

That said, one class--relative teenagers compared to these elders--stands out, and one drug from that class stands out in particular.

The class of drugs are known as "statins", and the drug is Lipitor™, the signature product of Pfizer. Since its introduction in 1996, Lipitor has not only gone on to become a blockbuster drug--its total estimated gross is $100 billion--but has by any measure been proven to meet the definition of a wonder drug. It is reasonably safe, most people tolerate it, lots of people require it, and it saves lives. Lots of lives. It's usefulness has been proven over and over again in well-designed trials. Unlike so many other drugs, its initial promise has not begun to fade.

The biochemical pathway in which Lipitor and its fellow statins work disrupts cholesterol synthesis, but we're still learning about how it works its magic: other medications that lower cholesterol in different ways, such as ezetimibe (trade name of Zetia™), seem not to have the same benefit in terms of preventing heart attacks and death that the statins do. Moreover, while Lipitor wasn't the first statin to market, and there are six other members of the statin class, Lipitor has reigned supreme. This is due in part to a more profound reduction in "bad cholesterol" LDL and an elevation in "good cholesterol" HDL than others in the class, but also its "gentleness", as for instance rosuvastatin, whose trade name is Crestor™, lowers the LDL the most of any in the class, but does at the cost of more serious and more frequent side effects. (A useful consumer review on statins from Consumer Reports can be found here.)

Pfizer has seen an enormous windfall from Lipitor, and they have deserved every penny. It is, in other words, an "honest" drug: no ridiculous shenanigans, such as those seen in the marketing of the generally unimpressive drug Neurontin™ by the very same Pfizer corporation, or the introduction of the current #1 drug by sale, Nexium™, which is nothing more than a clever repackaging of Prilosec, whose patent was due to expire and would have deprived its maker Aztra Zeneca of billions of dollars. But today Lipitor is now open to the competition, as its patent expired on Wednesday, so generic atorvastatin can be made and marketed in the US, which should drop the price of atorvastatin considerably. Thus, although I make no claims to be an economist or an intellectual property law expert, it looks like the expiration on the patent of the greatest modern medical drug was a win-win for both consumers and the shareholders who brought the drug to market.

I say "looks like" only because Pfizer, as this article explains, still intends to protect Lipitor's brand name in some ways that defeat the entire purpose of the spirit of patent law. Some of their efforts, like direct mailings of "coupons" for lower copays for Lipitor, seem free-market legit. Others, however, have that unpleasant odor so frequently associated with Big Pharma these days. In particular, Pfizer appears to be cutting deals with so-called "Prescription Benefit Managers" to elbow out the competition. PBMs serve as third-party payers for insurance companies and administer drug formularies. Pfizer's goal in negotiating with the PBMs is to give Lipitor at a discounted price in exchange for the PBM not carrying other companies' generic atorvastatin, effectively cutting them out of large markets.

It is not an illegal practice, although I fail to understand how this benefits consumers tremendously. Nor does the CEO of Watson Pharmaceuticals, Paul Bisaro, who complained about Pfizer's tactics on CNBC's "Squawkbox"--not exactly the kind of haven for socialist ideologues. But the story is still in motion, the deals are taking place in the backrooms and boardrooms away from journalists, so time will have to tell about atorvastatin's future. Today, however, was a good day for medicine, for business, and ultimately, for patients.
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PS--we also note with great enthusiasm that Gary Schweitzer's Health News Review blog has adopted a new look. Go check out the makeover! It is among the most valuable resources on medicine, and comes awfully cheap.

Say It Ain't So, Joe

The breathtaking arrogance of Coach Joe Paterno's statement that he would continue to coach the Nittany Lions football team can only be met with a dropped jaw. While confessing to being "absolutely devastated by the developments in this case", Paterno nevertheless states that he will soldier on as head coach until season's end. Astonishingly, he manages to shoot a specific barb at the Board of Trustees, presuming to offer advice that they "should not spend a single minute discussing my status. They have far more important matters to address."

No, they really don't, and for Paterno to even think to throw his weight around indicates, alas, his complete inability to comprehend the magnitude of his errors. At best a case can be made that Paterno acted within the legal boundaries of behavior when confronted with accusations that his longtime assistant coach, Jerry Sandusky, had forcibly sodomized a ten year-old child on Penn State University grounds. But no legitimate case can be made that Paterno behaved in any way that anyone with a moral compass would regard as humane or decent. How this man could possibly have the nerve to think about taking the sideline against Nebraska this weekend in light of the week's revelations about his appalling role in enabling Sandusky's predatory instincts, words cannot summon the outrage. He should be wearing sackcloth and ashes, begging anyone willing to listen for forgiveness for having allowed a monster to run amok for at least a decade. Instead, he swaddles himself in the cocoon of supporters who appear to think the Kool-Aid tastes quite fine, thanks, as he shoots off press releases without staring the disbelieving in the face.

Regardless of whether Paterno does indeed rally the Happy Valley faithful for one victory lap after having become the winningest college coach, this is an ignominious end for a fine man, one who was arguably the last of a special breed in big-time college football: the coach who saw his mission as shaping and educating the minds of young men as much as winning national titles. To distant admirers--and I count myself in that group--Paterno stood for something that I fear large Universities embody less and less with each passing year, namely, a commitment to principle. When the Jim Tressell scandal at Ohio State broke this year, nobody who had been paying any attention to the corrupt state of college football could really have been surprised, except that the ensnared head coach was one who wore sweaters and projected an image of integrity.

Like the rest of big-time college football, it was only an image, a fig leaf covering a morally bankrupt system. There was more than a hint of wink-wink nudge-nudge in the bouncy collegiate career of Cam Newton, who despite being involved in a cheating scandal at Florida nevertheless managed to finish his career leading the Auburn Tigers to the national championship. Somehow Newton managed to play for three colleges during his NCAA eligibility despite clear evidence to anyone willing to pay attention that he likely deserved expulsion from the first school, and behaved in a manner unbecoming any University in offering up his services to the highest bidder in what has since been called the "pay for play" scandal. (Two scandals for one college athlete--not bad!)

Compare this to the NCAA position thirty years earlier on running back phenom Marcus Dupree, who had left the University of Oklahoma in 1983 in an attempt to break with head coach Barry Switzer. The NCAA ruled him ineligible for two full seasons; Dupree's awkward attempted leap to the pros never panned out, and his claim to fame is being the subject of an ESPN documentary, The Best That Never Was. Such an action today, along with the so-called "death penalty" levied against Southern Methodist University, is inconceivable. Everyone is in on the joke, and most serious college football fans appear not to care terribly much. Even the Miami Hurricanes scandal, along with the shenanigans at Ohio State and the unsavory behavior of Newton, seems not to have made a blip on anyone's ethical radar screen. Yes, they get paid indirectly. Yes, a good chunk of them don't belong in college. So what? Let's talk about the injustice of the BCS rankings instead.

All of which is lamentable, but the Paterno scandal is different, as the look-the-other-way behavior (or, in the case of two senior Penn State officials, outright perjury) didn't enable some coddled athletes but instead led to little boys being raped. Several little boys--the count stands at nine who have come forward, and it seems reasonable to suppose that these are not the only nine. According to the Grand Jury report, Paterno had been told the explicit details of the rape of "Victim #2" when informed by grad student Mike McQueary in 2002. Moreover, one thinks that the Coach must have heard, at the least, rumors of some odd behavior of Sandusky in 1998 involving showering with a child. As Andrew Rosenthal notes while scratching his head, these are not the actions of a man who should be allowed to script his own exit, whatever sterling reputation he may have had previous to November 2011.

The ESPN columnist Rick Reilly argues that this story isn't really about Paterno, but I would beg to differ. Stories of pedophiles being caught, however grotesque, are not centrally important to the national news of the United States. But when powerful people in a revered institution give a free pass to a pedophile due to whatever inexplicable reasons tied to the success of a football team, that is a statement about not only the abuse of power by those people, but also the screwed-up priorities that gave such people that kind of power in the first place.
--br

PSA and the Embattled US Preventive Services Task Force

The US Preventive Services Task Force is a teeny tiny little group of researchers, physicians and epidemiologists who can claim the privilege of issuing recommendations on a variety of health-related issues such as screening, counseling, and preventive medication use. They're meant to be independent of the Department of Health and Human Services so as to be as far from the taint of Washington politics as possible, but alas, they've had a habit of getting themselves into the spotlight in the past few years, most recently this past week with some new recommendations on the blood test that screens for prostate cancer known as the PSA (for "Prostate Specific Antigen").

I'm not blaming them for stirring the pot so much, mind you--the USPSTF's job is to evaluate the evidence for a given current health practice and decide whether that practice makes any sense. While that concept sounds simple in theory, it becomes exquisitely difficult to accomplish without wading into dangerous political waters in practice. It was just about two years ago that the USPSTF issued recommendations about mammography as a screening test for breast cancer: they advised that women between ages 50-74 should have mammograms every other year (unlike the then-current annual recommendation) and that women under 50 shouldn't have mammograms at all unless they were in a particularly high-risk group. This fairly understated document generated an enormous backlash (which I've described before here) and caught members of the Task Force by surprise.

But when you look at the numbers, the actual data that formed the basis of the recs, it's not hard to see that the Task Force was if anything being generous about mammography. I don't have the time to review all the data here but one stat may suffice. One typical mathematical model was used by the Task Force to estimate the number of lives saved versus the number of those who would go on to be diagnosed with possible breast cancer based on an erroneous read from a mammogram (these are known as "false positives"). In the model, if you annually screened 1000 women starting at age 40 and did so for 30 years, you would save eight lives. This came at the cost of one hundred fifty-eight false positive diagnoses, at least a group of which, presumably, would progress all the way to mastectomy and possibly even radiation or chemotherapy. If, however, you started the annual screen at age 50, you would save seven lives instead of eight, but you'd reduce the number of false positive mammograms from 158 to 95..."only" 95. (Again, the USPSTF advised against annual screens for women 50-74, and there are data that can be used showing a similar effect in the every-other-year scenario, but I thought these numbers were revealing.)

So when news came this past week of the new recommendations on the PSA screen, I wasn't completely surprised to learn that the panel--which, incidentally, is a different group of doctors than those who issued the mammography guidelines--advised against its use entirely. The evidence has been mounting for several years that PSA is a less than stellar test, and its interpretation can be especially slippery when the value of the test hovers just above the normal range. This leads to many false positive diagnoses with precisely the same problems found in the mammogram. Men with false positives sometimes undergo radical prostatectomy, a surgery that can leave one not only sexually debilitated but incontinent. The test works entirely differently than a mammogram but the principle of test interpretation and the problems of overdiagnosis remain the same.

Likewise I wasn't surprised to hear of a similar backlash against the Task Force and the exchanging of academic insult followed by counterinsult, or more heated comments outside the ivory tower walls. (One advocate for the PSA, the urologist Dr. James Mohler, described the chief medical officer of the American Cancer Society Dr. Otis Webb Brawley, a PSA skeptic, like this: "I have known Otis for over 20 years. He doesn't come off as being ignorant or stupid, but when it comes to prostate-cancer screening, he must not be as intelligent as he seems." That's about as close as one can get to saying, "hey, asshole, fuck you" in the subdued world of academia without actually doing so.) At the blog db's Medical Rants, a fairly innocuous post by db was met with at least one howl of indignation, with commenter Scott Orwig accusing db of being "irresponsible, unprofessional, and unethical". (db's follow-up post is here.)

Caveat emptor: I have not yet read the Task Force report so I don't want to take sides in this post. What I can say is that slogans impress me less than an explanation of complex data, and while the latter is less sexy and the former more emotionally comforting, it's usually an indicator of which argument is more likely to be right. In all the articles I've read so far, all I'm hearing from the advocates are slogans.
--br

When a Microbe "Eats" a Human

There they go again. My guess is that the science & health "editors" at the major television media outlets felt a frisson of excitement when they heard of the deaths of some teenage kids exposed to pond or lakewater from an extremely rare amoeba known as Nagleria fowleri. Why? That's lot's of eyes of worried parents zooming in to their website and passing it along to other worried parents. It's good for the news business. ABC News's piece is here; CBS's story, with a link to a piece giving tips on staying safe, is here; MSNBC's take is here. Of the majors, only CNN appears to have taken a pass at the time I write this; at Fair & Balanced, the story is buried in the "Children's Health" tab here.

That the media Bigs love a good scare story, particularly with respect to some spooky infection, isn't saying anything new (and is discussed thoroughly in Marc Siegel's great book False Alarm: The Truth About the Epidemic of Fear). Suffice it to say that, depending on how you slice the numbers, thousands of American children die every year and that the three deaths so far due to Nagleria hardly indicates that we need to take all of our children out of the lake. Indeed, about a thousand kids die annually due to drowning, but this substantially larger problem isn't grabbing headlines and isn't even being mentioned as a comparison in the Nagleria stories to give some sense of proportion. Yes, lakes can be dangerous places: but mostly because teenagers drink alcohol and do stupid things on boats, not because a microscopic beast lurks underwater.

Which is actually what the Rubin blog is preoccupied with at the moment: the description of Nagleria. "Microscopic beast" is something of a contradiction in terms, right? Nagleria is smaller than a speck of dust and almost pretty to look at under a microscope. Beasts, by contrast, are big. They look scary! They have big, giant...teeth. And with those teeth, they eat. No surprise then, that a sensationalistic news item indulges in a little sensationalist imagery, as every one of the news stories above refer to Nagleria as a brain-eating amoeba.

But it's nonsense for the most part. Humans are, for Nagleria, what we call an accidental host: it makes its living by hanging out in the water feeding on tiny little bacteria. Yes, it does consume brain cells once it finds itself inside a human head, but to call it "brain-eating" just amps up the raise-the-hair-on-the-back-of-your-neck factor. Why not just call it "lethal", as it is almost universally so?

While we're on the subject, "flesh-eating bacteria" is--are you at all surprised?--likewise a misnomer. There is no particular species of flesh-eating bacteria, as it could be any number of bacteria. The most common bug to cause the condition of necrotizing fasciitis (the phenomenon that is caused by so-called flesh-eating bacteria) is from the family streptococcus, which lives harmlessly in the nasal passages, mouth and gut of humans. The problem isn't the bacteria per se; the real problem is when the bacteria manage to get deep into the soft tissues of the body (usually the legs, sometimes the arms, less commonly the trunk or face). In the upper layers toward the skin, bacteria have lots of physical impediments in their way to cause infection, and by the time they've lumbered along to a new patch of tissue, the immune system usually kicks in and clears the infection. We call that cellulitis.

In rare cases, though, these bacteria can dive deep and get down to an area called the fascia. Once there, there are no physical impediments, and the bacteria can move rapidly and make people incredibly sick very quickly, and typically the only "cure" is to filet the person's limb, take out the dead tissue, and hope that they survive. Often the affected limb needs to be amputated, and there's a high mortality rate. But there's nothing special about the bacteria themselves, although you wouldn't know that from seeing the news stories put out by the august organizations noted above.
--br

Media Overstatement on a Slow News Day

Right now one of the lead stories at the NY Times website deals with a potential new "miracle drug" called SRT-1720. With heavy emphasis on the scare-quotes. The article's title, "Drug Is Found to Extend Lives of Obese Mice," might be generating a huge buzz on the obese mouse circuit, but beyond this, I'm puzzled as to why this story is given such prominence in the Paper of Record. You could even argue that the story is barely worth running at all, even if placed deep in the science section of the website.

Bottom line is that this is a very preliminary study of an experimental drug. Studies like this are a dime a dozen, and it turns out that lots of fascinating things can be done in mice, but most of the time those fascinating things either don't work in humans, or end up having unacceptable risks compared to the benefits. I don't mean to belittle the experiment--it sounds very exciting--but I'm not sure that it's ready for primetime among laypeople just yet. Could it be part of a bigger article talking about strides that science is making in the field of aging? Sure: that's what the TV show NOVA is about, among other forms of popular science media. But there ain't no miracle drug coming down the pike that's going to extend the lives of obese people by 44 percent. So time to bury the story.

I can't wait to see what Gary Schweitzer is going to do to this story in his HealthNewsReview Blog. Go get 'em!
--br