Thursday, December 17, 2009

Conflict of interest in continuing medical education

I know I've been on a conflict-of-interest kick lately, and this post will continue in that vein. I have to thank the New England Journal of Medicine for the fodder, which also leads me back to my old assertion: healthcare should NOT be done for profit.

In this week's NEJM, there is a piece from the Office of Inspector General of the US Department of Health and Human Services titled "The Agenda for continuing Medical Education -- Limiting Industry's Influence". In this article Morris and Taitsman lay out the issues and potential solutions. And while the problems are quite apparent, sensible solutions are scarce. The problems may be summarized as the undue influence by the Industry stake holders on the content of physician education. To understand this mouthful, one has to be familiar with the structure of the CME establishment.

The overseeing body for CME accreditation is the Accreditation Council for Continuing Medical Education. ACCME's stated Mission is

...the identification, development, and promotion of standards for quality continuing medical education (CME) utilized by physicians in their maintenance of competence and incorporation of new knowledge to improve quality medical care for patients and their communities.
In their 2008 report the ACCME quantified the total income for the 725 CME providers they accredit to be $2.4 billion. Who are the CME providers? According to the NEJM article, in 2007 they included
...270 physician membership organizations, 150 for-profit medical-education and communication companies, 123 medical schools, 93 hospitals and health care systems, 38 other nonprofit organizations, 15 government entities, 14 insurance and managed-care companies, and 33 providers that were not classified.
It is interesting to note that all of these organizations derive significant revenue from Industry CME funding. While most suspicion of undue influence centers around the for-profit MECCs, it is a fact that MD membership organizations rely heavily on CME funding, in addition to registration fees, to bank-roll their annual congresses. So, the idea is that, since ACCME accredits CME providers and not their programs on the ground, these providers may cater to their Industry clientele by structuring CME programs so as to optimize the chance of being funded. In other words, the relationship between CME providers and Industry is seen as too cozy.

Some solutions are offered by the authors. The one they seem to favor most is a compromise between today's mechanisms of allowing Industry to target specific programs they want to fund and the extreme of removing Industry funding from the CME space altogether: allowing companies to pay dollars into a common pool, which in turn is to be used by a third party to pay for CME programs deemed worthy and without either credit to or input from a company with an interest in the specific area being covered.

So, let's go with this solution. This means that for a private manufacturer the choice now becomes either to play in the common sandbox without any guarantee of a return on their investment (granted, even today the ROI is not supposed to enter into the CME funding calculus), or to get out of the CME funding game and invest elsewhere. If too many manufacturers should choose the latter, the whole CME game will be in trouble, and the physicians will need to pay for their own continuing education. In addition, if you think that meeting registration is expensive now ($400 to $800 in my experience), think what professional societies will have to charge once there is no Industry funding! The whole paradigm as it stands now may tumble.

I personally do not think that this solution is viable. Why not expect the manufacturers to be good corporate citizens and continue to contribute vast sums of money even without direct tangible benefits to them? Well, the answer is surprisingly simple: economic theory. The entire foundation of our capitalist free market theory is the idea of selfish utilities. Simply put, this theory maintains that people will act in their own best interests; this constitutes the rational decision making as promoted by free market economists. The fact that this is a theory that has never been put to a test does not keep our economy, philosophically and pragmatically, from being mired in greed and selfishness. What is the mission of the Boards of Directors of Industry? To generate and maximize profit. Period. Being a good corporate citizen is acceptable only as a by-product of this mission. And this is not a negative judgment of the Industry philosophy; this is the direction backed even by most liberal left-leaning economists in the US today.

OK, then why would we expect Pharma and device manufacturers to "donate" money that will not let them get ahead of their competition? We shouldn't. Having chosen to throw the dice of healthcare on the roulette wheel of free market competition, is it not hypocritical of us to ask that sector to play by different rules? Does it not make more sense to take healthcare out of the for-profit game altogether? I don't know about you, but to me the message is quite clear: by demanding a private industry to give money without an expectation of any ROI is completely at odds with the mission proscribed by free market economic theory. De-profitizing (yes, in fact, it is a neologism; any problem with that?) healthcare is the only solution that I see to remove this dissonance. This is one baby that needs to be thrown out with the bath water.

Tuesday, December 15, 2009

$1 million vs. a free pen

Two items have grabbed me so far today: one on your favorite contemporary intellectual (and mine) Sarah Palin, and the other on the "Democratic" senator we love to hate, Joe Lieberman. The common thread is flip-flopping of opinion in favor of ideology.

An editorial in today's Washington Post by Eugene Robinson points out Palin's complete 180-degree turn in her views on climate change. Robinson writes:

Back then, Palin was the governor of a state where "coastal erosion, thawing permafrost, retreating sea ice, record forest fires, and other changes are affecting, and will continue to affect, the lifestyles and livelihoods of Alaskans," as she wrote. Faced with that reality, she sensibly formed the high-level working group to chart a course of action.
This sober view from just one year ago is a complete antithesis to her most recent call in a WaPo op-ed to President Obama to boycott Copenhagen and to deny the "shoddy" science of climate change.

In a similar vein, the New York Times talks about Joe Lieberman's ardent opposition to the Medicare buy-in provision in the Senate healthcare bill, the opposition that now looks to be resulting in complete removal of this provision in order to get the bill passed. What is fascinating about his stance is that just a few years ago, as Al Gore's running mate, Lieberman had proposed exactly the Medicare expansion as the solution to our healthcare woes. In fact, the story contends that even a few months ago the Senator was in favor of this strategy.

So, what has changed for each of these politicians in just a matter of months to make them turn completely away from what they had believed? For Sarah Palin, as Robinson astutely points out, it is clearly her political base:

I predict we'll see more artful dodges of this kind from Palin. She made any number of pragmatic, reasonable, smart decisions as governor -- and now, it seems, will be obliged to renounce them all. Her tea-party legions have one answer -- a shouted "No!" -- for every question.
As for Lieberman, he has his own base to cater to. While the NYT reporter hints at the motivation, the Senator is given full credence in his denial of the accusation:
Campaign finance advocates have attacked Mr. Lieberman as “an insurance industry puppet,” suggesting that he wants to protect private health insurers from competition because he has received more than $1 million insurance company campaign contributions since 1998.
During his 2006 re-election campaign, Mr. Lieberman ranked second in the Senate in insurance industry contributions. Connecticut is a hub of the insurance business, with about 22,000 jobs specifically in health insurance, according to an industry trade group.
In the interview, Mr. Lieberman dismissed assertions that he was doing the industry’s bidding. “It’s hogwash and it’s weak,” he said, noting that he had often sided against the companies. He said he favored a proposal, not included in the health care bill, that would end the insurers’ limited exemption from federal antitrust laws.
Hogwash, really? I am not so sure that I am willing or gullible enough to dismiss $1 million in contributions as hogwash. Again I have to go back to my assertions here and here that it is incumbent upon the person taking the money to disclose any real or potential conflict of interest, and let the public decide whether or how this COI may affect one's stance.

So, is it possible that both Palin and Lieberman are just blowing with their financial winds? Well, if you think that a free pen with a drug's name can alter a physician's prescribing pattern, why is it so difficult to concede that $1 million in contributions and a strong political backing may hold some sway over our politicians?

Grand Rounds is Up!

It's Charlotte's Web over at the Florence dot com blog:
Welcome to this holiday edition of Grand Rounds! It's the time of year when friends and family gather, when stories are told and memories are made. But the winter weather and short days here in the northern hemisphere seem to prompt brevity in our everyday comings and goings. It seems like the right time to combine storytelling and brevity and channel Charlotte, one of the most masterful storytellers I met during a childhood spent with my nose in a book.
Great job and thanks, Barbara!

Monday, December 14, 2009

Tinkering and innovation: You can't have one without the other

Last week I blogged about the empty black box of evidence in medicine. Afterwards I got to thinking about black boxes in other parts of our lives in the 21st century -- seems to me they are everywhere and getting more and more prevalent.

To appreciate their proliferation, we must travel back in time to around the middle of the 19th century. I know, it is a bit anxiety-provoking, what no blogging, no tweeting, no iPhones... And yet, let's persist. The landscape is still dominated by small rural communities with farming as the major industry. Around these farming villages some small local businesses are making a successful run: furniture makers, dress makers, healthcare providers. Schools are also local and classrooms are multi-age and co-ed. School day follows the agrarian cycle, allowing the kids to maximize their farm time in every season. Most goods and services are created locally, if not in the home itself. When a shovel breaks, it is fixed. When socks rip, they are darned. When a child is having trouble with homework, she is helped by her parents and siblings. Evening entertainment is provided in the home by family members' stories and the stars in the sky. OK so far?

In comes industrialization. Furniture and dress making are automated, farmers begin to move into cities and schools become more regionalized and no longer need to observe the constraints of the agrarian lifestyle. The second half of the 20th century ushers in unprecedented advances in technology. Instead of fixing our broken shovels, we chuck them and buy new ones. Ditto for socks, cars, computers, couches. We used to be able to look under the hood of our 1967 Dodge Dart and fix the strange rattling noise. We used to bring our shoes to a shoe repair shop to re-sole when necessary. Today we discard the old and buy the new model.

I know what you are thinking: there she goes again railing against consumerism! Well, yes, but that is not where I am going with this. A byproduct of our rampant consumerism is the loss of the art of tinkering. Tinkering is our legacy. What were Thomas Edison and Ben Franklin if not tinkerers? How about Steve Jobs and Michael Dell? How many of us can build or fix a transistor radio? What about next generation life-altering technologies we cannot even conceive of yet?

Along with this loss of tinkering came the ceding of expertise. What I mean is that, since everything today seems infinitely more complicated, the public defers to the expert class, built around the black boxes clearly inaccessible to mere mortals. And guess what is the biggest black box... If you guessed our educational system itself, you are correct. Reading, math and social studies have been taught in the home, then in small school houses, for centuries. (And if you think that farmers did not learn math, think again: you cannot get around a farm without being facile with things mathematical.) Parents used to know how to help their children learn. Now, we defer our children's education to "experts" behind closed doors, who are likely to recommend pharmacologic solutions where individualized approach is needed. And what has this gigantic black box yielded? If you read award-winning secondary school teacher John Taylor Gatto's angry diatribe against our educations system, "Weapons of Mass Instruction", aside from a big headache, you will walk away with the understanding that we are now, as a nation, more cynical and dumber than we were 80, 50, and even 30 years ago. Thanks to experts.

So, we in effect have given away transparency and control over most of our daily lives. Distant industrial farms provide what passes for our food, distant manufacturing plants in China deliver our clothes, furniture, computers. Locked down institutions beyond our inquiry and constructive criticism have a hold on our children for 8 hours each day, and wish to prolong this hold by contracting vacation time to do what? Produce even more pervasive boredom, cynicism and ignorance? Even our entertainment has passed into the black box realm: distant producers selling their advertisers' wares by creating inane and irrelevant "entertainment" for the masses.

People, we are no better informed than our ancestors banging their drums to ward off solar eclipse. Our fancy gadgets separating us from what's under the hood of reality give us a false sense of complacency. If we want true innovation, we need to get back to our tinkering roots. Learn to darn your socks, help your child to read and teach her to tinker, so that she can stay curious. Question "experts": most of the time the mountains of complexity behind their concepts are useless or unnecessary, or created for the purpose of exclusion by obfuscation. Throw open these black boxes and shine a light in them. Play with stuff. Play with ideas. Tinker!              

Thursday, December 10, 2009

When the black box of evidence is empty

A close friend of mine gave birth a few days ago to her second child. My friend is a slight woman whose infant came out at 6 lb 9 oz, even though she was calculated to be at 36 weeks' gestation. The infant and the mom have done great with absolutely no complications.

This is why, when I was talking to the Dad this morning, I was shocked to hear that the baby had to undergo a test I had never heard of: something to do with putting the child in its car seat and monitoring its heart rate and oxygen saturation for one hour. Mind you, my youngest is 9 years old, and I had never hear of this test, so I looked it up.

Turns out, this is a test formally known as a "pre-discharge car seat challenge". I went to the American Academy of Pediatrics web site to look for their take on it, and here it is:
Hospitals should develop a policy to ensure provision of a period of observation in a car safety seat before hospital discharge for each infant born at <37 weeks' gestation to monitor for possible apnea, bradycardia, or oxygen desaturation.
I went on a circuitous journey to trace the origin of this recommendation. Turns out, it is based on a consensus statement from an APP committee from 1996, the reference for which is this paper from 1993 about implementation of the 1990 AAP recommendations. Looking at the 1990 version, however, does not help in the least, as there is no mention at all of the test in question, or anything to do with infants under 37 weeks' gestation. So, this is where the dubious evidence trail ends. Period. No evidence near as I can see. [If someone knows of a more complete statement that does include the information I am interested in, please, point me to it].

Why did I go after this piece of information? Well it seemed to me to arise out of the "more is better" fallacy, and I wanted to understand a) the evidence that led to the recommendation, b) how the test alters practice, and finally, and most importantly, c) does this practice impact the desired outcomes (i.e., prevent something bad).

So, I went to one of the most trusted sources in evidence synthesis, the Cochrane Collaborative, to see if they have examined this issue. Lo' and behold, I found this 2006 review, whose findings were summarized thusly:
There is no evidence that undertaking a pre-discharge "car seat challenge" benefits preterm infants. The "car seat challenge" assesses whether preterm infants who are ready for discharge home are prone to episodes of apnoea (stopping breathing), bradycardia (slow heart rate), or desaturation (low oxygen levels) when seated in their car seat. However, it is not clear whether the level of oxygen desaturation, apnoea, or bradycardia detected in the car seat challenge is actually harmful for preterm infants. Additionally there is concern that the use of the car seat challenge may cause undue parental anxiety about the safety of transporting their infant in a car seat. Despite these uncertainties, and despite the widespread use of the test, we have not identified any randomised controlled trials that assessed whether undertaking a car seat challenge is beneficial or harmful to preterm infants.
So, here is a kid, born at supposedly 36 weeks gestation, but looking and acting like a full-term infant, having to sit in her car seat for 1 hour to undergo monitoring that has absolutely no evidence behind it. Putting aside the inconvenience, the false positives, the parental anxiety, let's think about the costs. I could not find published reimbursement rates for this useless test. However, if you think about the person-power, the equipment used, and the potential prolongation of hospitalization that it may induce, the price tag is likely not trivial.

This case is instructive to me. As I have said before, a pitiful minority of medical practice has good evidence behind it. It is precisely this type of testing, done to comply with what looks to be a self-propagating yet outdated recommendation, that healthcare reformers in Washington need to be addressing. Furthermore, when evidence is kept in a black box, we are likely to find that the box is indeed empty.a,
bradycardia, or oxygen desaturation. An appropriate
hospital staff person should conduct the observation.
Hospitals should develop policies to

Wednesday, December 9, 2009

Evidence-based free-market economics?

Seeing as I am an outcomes researcher, I thought I'd float this question to all the zealots of free market economic theories: Have their outcomes ever been examined in an evidence-based manner? Here is what I mean.

In medicine, the highest quality evidence comes from randomized controlled trials (RCT). In these deliberately and painstakingly planned and executed studies subjects are enrolled randomly into either a treatment group or a placebo (or standard of care) group, and certain relevant outcomes over time are compared between the two groups. This design works well for drug trials, for example, but not so well for something like environmental exposure studies. Thus, in order to understand the adverse effects of smoking on health, no RCT could be performed ethically, so these data come to us from epidemiologic studies. Though deemed by the EBM community to be somewhat inferior to an RCT, they have their advantages: they can enroll more and varied patients, they are cheaper, they are more feasible to do over long periods of time, and they do not require alterations in naturalistic practice. The flip side is that we have to be more careful about introducing such inaccuracies as bias, misclassification and others, though their most important limitation as cited by some is their inability to prove cause and effect.

Putting the limitations of epidemiologic methods aside, their practicality makes them attractive and ubiquitous in helping us understand healthcare. One of the most important issues we face in EBM is understanding the risk-benefit profile of what we do. To get at this, our studies have to be planned carefully to incorporate not only the important exposures, but also the relevant, valid and complete endpoints (or outcomes). Thus, it is not enough to pat ourselves on the back by saying that a drug decreases the risk of a clot; we also have to show that this benefit outweighs the attendant risk of bleeding in the specific population of patients.

Let's apply these principles to the free-market theory. Have its advocates examined its risk-benefit profile in a scientifically rigorous manner? According to Harvard's Stephen Marglin, they have not. In his book "The Dismal Science" he makes a strong argument that economists, by pushing their free market theories with religious fervor, have undermined the very structures of our communities. Furthermore, this noted professor of Economics maintains that free market theories have never been impartially evaluated. So, there you have it: the single unifying thread of the entire Western civilization today is just as faith-based as a rain dance around a fire. So, when we talk about evidence for climate change and peak oil and how a concerted effort to mitigate these phenomena would affect our economy, let's not fool ourselves: the evidentiary standards we demand for free market's detrimental effects are much more stringent than those for its benefits, which we have essentially swallowed on faith. Hook, line and sinker.      

Tuesday, December 8, 2009

An executive articulates the value of his drug

Allos Therapeutics is a small biopharmaceutical company located in Westminster, Colorado, with a single agent on the market. Pralatrexate, brand name Folotyn, is a small molecule therapy for a rare and aggressive hematologic malignancy peripheral T-cell lymphoma. The recently FDA-approved drug is stirring controversy by, you guessed it, pricing itself out of the market. The pricing giants at the company decided that a fair price for the drug, achieving parity with other compounds in the space and helping them recoup their investment, would be $30,000 per month.

In the area of cancer, such a price tag is certainly nothing unusual. Here, fancy and expensive-to-produce biologic therapies can run as high as $100,000 annually to treat such common cancers as those of the lung, breast and colon, even while only prolonging the patient's life by an average of 2 months. But here is the kicker: pralatrexate is not a biologic, but a small molecule, and not even first in class! So, essentially, it is a me-too drug that is not particularly expensive to manufacture.

But let's give the company the benefit of the doubt -- after all, clinical development, especially in a rare cancer, is prolonged, costly and generally resource-intensive. A few more pieces of the puzzle are in order before we can make the final judgment. The drug was approved based on a trial of 115 patients with recurrent PTCL refractory to, on average, 3 prior therapies. The outcome evaluated was a combined endpoint of complete response or complete response unconfirmed or partial response (each indicating degrees of tumor shrinkage). Among the 111 evaluable patients the response rate was 27%, and the median duration of response was 9 months (meaning that one-half of the 29 responders progressed by 9 months). And the median duration of use of the product in the trial was 70 days.  

So, let's do the math here: if 100 patients are prescribed this drug for 70 days (this is being conservative, as the median is usually lower than the mean value in similar distributions) at a cost of $30K per month, we have spent $7,000,000 to get a response in 27 patients that lasts under 1 year, or about $333,000 per year of life saved. So, this may be less reasonable in some books than others. Hmmm...

Well, in case you you have any shred of doubt remaining, look at what James Caruso, the Chief Commercial Officer for the company, is quoted as saying:
Patients, moreover, are likely to use the drug for only a couple of months because the tumor worsens so quickly, he said. So the total cost of using Folotyn will be less than for many other drugs with lower monthly prices.
So, the message is that our expensive drug should be used not because it saves lives, not because it improves quality of life, but because the expense will be limited by the its uselessness? Isn't is a little bit like saying that a gas-guzzling HUM-V is worth the expense because it will break down in two months anyway? I have to admire the manufacturer in speaking the truth this way: if more manufacturers do this, comparative effectiveness concept will become obsolete before it is even legislatively approved.  

Gossip: an untapped renewable energy source

Just out of curiosity I Googled news on "peak oil" and got 3,397 hits. Then, I Googled "Tiger Woods", and got a staggering 57,134 hits! What does this mean?

I have spoken of peak oil before, so will not belabor the issue right at the moment. On the other hand, this is the first time the name Tiger Woods is appearing on this blog. Why? Because a celebrity's personal life is none of my business, it is none of my children's business, and none of my community's business. I prefer to engage in life itself rather than waste my time on voyeuristic destruction of another life (actually several lives).

But here is my question: how can we harness this endless and renewable resource of gossip to power our post-peak lives? Why is the Department of Energy not exploring this abundant energy source? Oh, yeah, you are right, it is toxic to the environment.

Destruction of lives in the name of cheap entertainment has become a staple of "journalism" in America. If news outlets would only focus as much attention on the real issues that we are facing as a society as they do on meaningless infotainment, we might not be a nation of overgrown adolescents habituated to a steady diet of mindless pablum. That would be pretty subversive, would it not? I wonder what it would be like if we just said "No thanks, not today. Not any longer."

The wheels of corporate journalism are lubricated by oil. What would happen if the truth came out? The bottom would fall out of the market, as all of it is inextricably dependent on oil. You can press your nose to the glass of familiar narrative of someone else's fame, fortune and destruction and be content to live in the fairy tale being sold to you. Or you can demand the truth, so that you can make your own decisions within your community. The choice is yours.  

Monday, December 7, 2009

Can US agriculture reform inform the healthcare debate?

A rather shocking analysis by an otherwise astute observer of American history Athul Gawande, MD, in the New Yorker has sent me reeling from its short-sightedness. In his article Gawande argues that the Senate healthcare reform bill is on the right track by not demanding wholesale budget controls, but rather instituting small pilot programs to see what works best. Although pilot programs may not be a bad idea, Gawande's argument is deeply flawed. It relies on the theory that the changes in agriculture and food production in the beginning of the 20th century were also characterized by small pilot programs that eventually took over the nation, bringing our food budget under control and, by reducing drastically the proportion of population engaged in farming, provided a productive work force for manufacturing and growing the economy.

Indeed, the changes in the way we produce our food that took place in the first decades of the last century are remarkable, and one can stand breathless before this edifice of modern science with unabashed awe... but only if one truly believes that this movement has been a success. And clearly, Gawande subscribes to this opinion:
The history of American agriculture suggests that you can have transformation without a master plan...
I would beg to differ, and so would many who worry about our current agricultural practices. We raise corn and soy beans as monocultures, and douse them with petroleum-based fertilizer to make them grow. The humus that Gawande talks about in his article is not considered at all in today's industrial agriculture, and the level of the destruction of the topsoil in these gigantic swaths of potentially fertile land is unprecedented. Similarly, food animals are grown in inhumane, crowded, disease-laden conditions in so-called Concentrated Animal Feeding Operations, or CAFOs, where cows are fed corn and corn byproducts. Instead of grazing in pasture and putting their rich manure back as fertilizer, thus ensuring the sustainability of the humus, their effluent now contaminates water supplies. It was only a little over 20 years ago that the world was shocked by the revelation that these ruminants were in effect made into cannibals by being given parts of other cows in their feed, resulting in the emergence of the Mad Cow Disease. I doubt that I even need to mention that because of the unhealthy conditions of the CAFOs, animals are actually routinely given antibiotics to keep them from contracting infections, a practice that scientists agree is driving the evolution of a class of superbugs that are now threatening our species.

A couple of other effects of our wildly "successful" farming apparatus are the obesity epidemic, the combined contributions of deforestation for the sake of pasture and the exorbitant amount of methane gas produced on these farms to climate change. There are also the effects of the continuing fallout of the displacement of family farmers from their communities and their connection to ancestral ways to the impersonal and demoralizing widget-making in the cities. All in the name of the economy!

So, dear Dr. Gawande, forgive me if I disagree with you on each and every point about how industrialization of agriculture has been a wonderful thing for America. I believe you, much like most pundits, are confusing the almighty American Economy with the American citizens, who certainly fade in comparison to the riches derived on their backs.

I am not fundamentally opposed to pilot programs -- they may be the way to tweak incremental changes in how we do medicine. But to rely on them as the sole fundamental tool in the reform is a big mistake. In fact, the history of the American agricultural revolution is the strongest argument there is against a transformation without a master plan. It would be tragic to be lulled into the complacency of "act now think later" at this critical cross-roads of our time.        

Wednesday, December 2, 2009

Why medicine is not like a parachute

At the recent meeting of the American College of Chest Physicians I went to a session on hospital rapid response teams. This was a talk given by a senior and respected member of the Pulmonary and Critical Care academic community, well published and known. Now, if you are wondering what the heck is a rapid response team, I will tell you: it is a team composed variously of an ICU physician (or a hospitalist, depending on local patterns), a nurse or two, a pharmacist and sometimes other ancillary personnel. The role of this team is to be at the beck and call of the ward nursing staff to evaluate urgently any floor patient whose clinical condition may appear to be deteriorating. The ultimate goal, of course, is to avert a catasprophic emergency called a code, where the patient deteriorates to the point of needing emergent resuscitation.

While such a team makes a lot of sense, no study has convincingly shown that it does what it is meant to do -- either prevent codes or save lives. The presenter, a man quite invested in the sensibility of such teams, was making the point that perhaps we just have not focused on the correct outcomes to measure for this intervention. Ultimately, he said, we should continue to support such teams because of our gestalt that they work. After all, he went on, nobody has tested the effectiveness of the parachute in a randomized controlled trial.

When I heard this, I realized that I had been hearing this comparison a lot lately, of medical interventions to parachutes. And since his statement seemed somehow wrong to me, I started to think about why such an analogy is completely fallacious. And here is the startlingly obvious answer: the number needed to treat (NNT) for a parachute is 1! What this means is that one only needs to "treat" one person with a parachute (or strap it on before jumping out of a plane) to save one life. Now, is there really anything that we do in medicine whose margin of effectiveness comes even close? Last week we argued about a screening test with the NNT of 2,000. And we also talked about a therapy with a NNT of 16 which is not being utilized because of high costs.

So, let's not be intellectually lazy and let's not resort to comparing anything we do in medicine to a parachute. The parachute is made to mitigate the laws of physics, which are inherently more predictable, stable and generalizable than the laws of biology. Instituting a rapid response team may feel good to us, but, in addition to lending no measurable improvements to patient care, it may have the "unintended consequences" of abandoning patients who really need our attention at that moment to better their outcomes.

A similar argument can be made about many interventions whose mere face validity we take as God's own word. We and others have cautioned against such gullibility, particularly in a world that runs with half-truths and misinformation under the banner of quality measures. None of us has the cause to be so self-congratulatory as to compare our wares to the parachute. Now more than ever, experts need to think and present critically, soberly and objectively, lest we continue the trend of parochialism in our out-of-control disease care system.    

Tuesday, December 1, 2009

USPSTF recommendations: Demanding manipulation from science

The recent uproar over the new screening mammography recommendations got me thinking about a lot of stuff. One of the lessons cited by some journalists and pundits is on how potentially volatile information should be presented to the public. The USPSTF was excoriated by critics not only for what it said, but how it said it. While the objections over the former can be dismissed as ravings of loud and poorly informed voices deliberately trying to hijack public opinion, the latter criticism is more insidious.

Some intelligent and balanced observers noted that the USPSTF really should have foreseen the fallout and laid the groundwork to make the sting of the recommendation less pronounced. In the corporate world this is called "making the rounds". This means that, when you have an idea, it is not enough just to present it on its merits in a group forum. Indeed, you must go around to those whose opinions matter and get them to sign on to your idea before you make it public. In this way, by furthering your relationships, you manipulate the outcome in your favor. This can take countless hours, but this is how things generally get done in the world of business.

The world of politics is similar, in that many reforms and decisions are dependent on behind-the-scenes deal-making between politicians. These clandestine transactions, the theory goes, assure the appearance of a successful outcome in the light of day. And a victory necessarily begets other victories.

Well, to be sure, science and academia are not immune from such politicking and manipulation. In fact, I have heard some assert that our academic institutions are the most politically charged enterprises, even more so than business and politics. So, in that respect, it is not unreasonable to expect some round-making prior to spilling the mammography beans. But what if we question this premise? What if we insist that science remain the last frontier shielded from political influences? I would argue that this should be our only stance on science, be it climate science or medicine. Science should be judged on its merit only, and not on its political ramifications.

In a society where business and political message machines spend countless dollars on market research surveys to package their manipulations to get us to follow their political and consumerist directions, the public is now angry that the USPSTF, a scientific body, did not take the time to effect an elaborate manipulation scheme to get the loud dissenters, and the rest of us, on board with their recommendations. Is it not outrageous that we, American adults, expect, and even demand, such manipulation instead of the straight unadulterated truth?

This is a sad reality of our time, following decades of indoctrination by marketers, educators and other "experts", to become compliant little consumers that we are today. How easily we are stirred into a rage by callous reporting and special interest demagoguery is telling. We are a mirror-mirror-on-the-wall society: we will not tolerate any truth that does not fit our conveniently preconceived notions of specialness and entitlement. And while this attitude gives us a peaceful soporific feeling one gets following a psychotic rage, it will make it that much more painful when this consumerist fog is replaced by the reality of shortages, as our cheap energy supply dwindles. Unfortunately, by then, it will be too late for the truth to set us free.

There is still time, though! Turn off the television, stop listening to and reading mass-produced messages designed to make you a quiet lemming on its way off the cliff. Focus closer to home, build your local community. And, yes, talk to your doctor about your mammography concerns -- you will surely walk away with a more satisfying conclusion and a feeling of self-determination.