SCOTUS ruling: What would FDR say?

"The liberty of a democracy is not safe if the people tolerate the growth of private power to a point where it becomes stronger than their democratic state itself. That, in its essence, is fascism - ownership of government by an individual, by a group."

                                                ~Franklin Delano Roosevelt

We can argue about the strict definition of "fascism". But if we agree with Roosevelt's usage, then we must thank the SCOTUS for accelerating our transformation from a democratic to a fascist state.

Thank you also, SCOTUS, for equating my first amendment rights with those of a corporation, as if we needed to imbue these juggernauts with even more humanity. Is this confusion or is it a stubborn attempt to make the absurd true? Another Roosevelt quote comes to mind: "Repetition does not transform a lie into a truth".

On the other hand, is this an attempt to direct our human evolution down a certain path? Is the expectation that we humans are to become more like corporations? Goldman-Sachs, AIG, watch out, here I come!

Evidence-based... fashion?

The line between consumerism and obesity is not that difficult to draw, and mechanisms for this relationship are plentiful. Passively sitting in front of screens, consuming sugary drinks and snacks peddled by sponsors, forgoing outdoor activities have all been implicated in our lard problem. On the other hand, when we think of the clothing and fashion industry, we think of the opposite extreme of the eating disorder spectrum: anorexia. At the same time, some have suggested that, in fact, the unattainable thinning of the paragon of womanhood is itself responsible for the paradoxical growth in waistlines.

I think there is another mechanism at play in the fashion paradox. Have you noticed how our clothing sizes have become, shall we way, more forgiving? It seems to me that what is a size 12 waist today probably would have qualified for a size 16-18 two decades ago. Assuming that an inch has not changed that much over the last 20 years, something is wrong. Is there a big conspiracy by the clothing manufacturers to make us feel thinner than we are? This is not altogether inconceivable, since experience dictates that when one feels larger than normal, one may confine her wardrobe expansion to shoes alone and forgo a confrontation with the truth. So, encouragement from numbers may be just what is needed to drive continual clothing sales.

Another uniquely consumerist factor plays into this game: the microscopic half-life of a piece of clothing in the American closet. From where I stand, the American consumer is poised for a nearly 100% turnover of her wardrobe every season. And even if I am somewhat off in my estimate, there seems to be a sense of entitlement to a constant stream of new items. So, if this assumption is correct, it is easy to engage in a frequent deception about size by a constant creep of what is considered size 12, for example. The evidence of stable size we seek from new clothing is, thus, flawed.

So, once again I maintain that, in order to conquer our obesity problem, we need to turn away from consumerist ethic. After all, if I still have my size 12 pants from 4 seasons ago, and I can no longer fit into them, this is grade A evidence that I need to pay the piper.

False prophets and H1N1

Frankly, I am sick of people taking credit for chance events. One such chance event is the less-than-expected severity of the H1N1 pandemic. Several organizations, and even nations, have invoked a broad conspiracy by the WHO, among other agencies, to pad the pockets of Pharma companies with a large stake in this disease. Some are feeling proud and vindicated for their assertions as early as last summer that the threat of the pandemic is overblown. Politically, however, it does not seem enough just to gloat; these clairvoyants want further recognition by spreading stories of malfeasance by people they love to hate.

These conspiratorial concoctions are in line with our national psychology, in my opinion. The Republicans' refrain of the last 30 years that government is not to be trusted has taken root. (Parenthetically, it seems that it is through the very GOP members' efforts that this assertion has been fulfilled famously!) Lumping the WHO and the HHS in this equation is but a small stretch.

But what is the reality? The reality is much less news-worthy. In reality, all of the estimates of havoc that H1N1 was expected to reek were just that, estimates. Those estimates were based on the best data available at the time that decisions had to be made. Those data, by necessity, were limited, and the urgency to prepare precluded further waiting to accumulate more information. So, everyone did the best they could. To assign a malicious motive to these decisions is sophomoric. This self-congratulatory stance has blinded its backers to an obvious flaw in their logic: since pharmaceutical industry is a for-profit business, it is child's play to assign profit as the sole motive to these decisions retrospectively. The logic goes that, since Pharma is interested in the potential profit, there can be no other legitimate motive for declaring this pandemic. Well, it makes about as much sense as saying that the only motivation to treat a heart attack is to make money for the manufacturer. To be sure, there are several motives, one of which, from the perspective of the manufacturer, is profit. Still, I hope that a concern for immediate survival and better health of the patient are the prevailing reasons for treatment.

So, let's not distract from other important issues of our day by creating false controversies. Although for the moment it looks like many of our predictions were much graver than what is coming to pass, it is counter-productive to spread rumors of a conspiracy, when the evidence used to generate the projections is there for examination. On the other hand, I am glad that we can continue to engage in this pointless blame game, rather than having to clean up from what could have been.           

Evidence-based airport security?

Backscatter scanners cost $150,000-$180,000 a piece. Congress has appropriated funding for 450 scanners to be placed in the US airports. By my simple back-of-the-envelope calculation we are talking $67,500,000-$81,000,000 of our taxpayer dollars. How do we wrap our brains around the value proposition of this investment?

Well, in order to do this we need to know something about what outcome we are trying to affect and the impact of this machine on this outcome of interest. Seems like the most sensible outcome of interest is deaths averted due to airplane-related terrorist activity. According to Nate Silver at fivethirtyeight.com, in the first decade of the 21st century, factoring out the 9/11 fatalities, there were about 200 deaths related to violent incidents on board of commercial aircraft in the entire decade. So, assuming that the scanners' effectiveness is 100% (that is that it can prevent any violent act aboard an airplane that would result in any number of deaths), the cost to avert one death is $337,500-$405,000 over 10 years (this is not taking into account either inflation or discounting for future events).

If we had a medical technology with the same cost-effectiveness profile, would we think it reasonable to pay for it? More importantly, would we get congressional appropriations to pay for it even in the absence of any effectiveness data? What we know and what we think we know about this are widely divergent. What we know is that the scans can detect certain culprits of potential acts of terrorism. What we do not know is whether this level of detection will indeed result in aversion of death. After all, had we not detected prior to the Detroit flight that Umar Farouk Abdumutallab was a potential threat to US citizens? We had, but the information was not acted upon. Similarly with the scanners, they may have efficacy in detecting the threat, but how this information is utilized is sure to impact their effectiveness as far as the endpoint of interest: death prevention. So, reaching for a new expensive and potentially more invasive technology in this case is a bit like blaming one's failure to treat a cancer detected on a mammogram on unavailability of the more sensitive MRI technology.

There seem to many points of faulty logic in this undertaking of heightened airport security. Not only do we need to re-examine critically our assumptions, but also we have to assess soberly whether the investments we have made to date are in the right places. Remember the cold war? It was all about getting a leg up in the nuclear arms race. "You build a better missile, we will build a missile shield. Then you will build an even better missile that will penetrate the shield." And so on, and so on. It is much like laws, upon which clever corporate lawyers rely for loop holes in favor of their clients' misdeeds.

As much as anyone, I would like international terrorism, just like ventilator-associated pneumonia and other hospital-acquired complications, to become a "zero event". Unfortunately, I am all too keenly aware that wishing something to be true only makes it so in fairy tales. The dearth of evidence to support many of the expensive anti-terrorism interventions is concerning. Poor logic, erroneous assumptions and unjustified inferences have been driving our decisions for too long. The public should demand the same level of evidentiary support for astronomical "anti-terrorism" appropriations that we do for healthcare.

The FDA and drug costs: A health services researcher's epiphany

Happy New Year to everyone, and apologies for not posting for some time. You probably thought I was on vacation, but in fact a family illness has kept me from writing. For reasons of confidentiality, I will not be disclosing the details of it for the moment, but will share certain salient points this experience is clarifying for me.

Take expensive medications, for example. In the last few weeks, the anonymous cost-effectiveness equation of certain interventions has taken on a uniquely personal dimension. Thinking about using a prohibitively expensive medication with limited effectiveness in the abstract derives a much clearer answer than in the case of a loved one. What is a couple of extra months of life and functionality worth to you? And what if it is indeed more than a couple of months, since there are many individual exceptions to average values? Who am I to dissuade my family member from accepting this treatment course, even though I am keenly aware of its fiscal and clinical ramifications?

Here is what I am beginning to think. If even someone as close to health economics as I am cannot say "no", when put in the situation personally, to a therapy that I would academically consider cost-ineffective, how can a lay person faced with such a choice say "no"? If they cannot be expected to say "no", who should? In the spirit of patient empowerment I would certainly not advocate substituted judgment; that is, I would not advise the physician to make this decision unilaterally. And truly, although everyone is interested these days in having MDs take economic aspects into consideration, there is a potential conflict of this stance with the "do no harm" priority.

So, humanistically speaking, who should make this judgment? As you know, I do not believe that we can let the market drive these choices, unless down the road we are willing to spend 100% of our GDP on healthcare! This means that someone does have to say "no". Following the chain of development and marketing of technologies, since neither the MDs nor the patients (or their surrogates) are in a great position to do this, the decision must reside upstream. The most proximate upstream entity is the payor, but look at the political maelstrom that a discussion of limiting payment for existing interventions has precipitated in the US. The FDA is the next stop in this space-time continuum, second only to the manufacturer. This to me seems to be the logical final stop for the decision bus. Beyond the manufacturers themselves, who would be well-served not to invest untold dollars into bringing to market marginally effective exorbitantly priced technologies, the agency is probably the most sensible point in the pathway to close the door to products with questionable value. Today, the FDA is not empowered to consider the value proposition; this role is left to the payor. The FDA can only make judgments on efficacy and safety of technologies under evaluation. Could we change that? Would we want to? Is this the right solution?

In the meantime, we will do the trial of this expensive therapy and see what happens. Maybe it will buy more time than we think. Then again, maybe not.

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.

$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!

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!              

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

  

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.      

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.  

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.        

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.    

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.

Differential diagnosis of climate change

When I was in medical school, I learned that the differential diagnosis was the cornerstone of any medical encounter. Differential diagnosis involves taking a detailed history of the patient's complaint, followed by a physical exam, to arrive at a few possible reasons for the person's symptoms. Once developed, this list of potential etiologies guides the doctor's further testing, so that there is little excuse for a shot-gun approach where every conceivable test is ordered.

Through training and practice I honed my differential diagnosis skills. I developed a risk stratification approach, where I had in mind about top 5 things that could likely underlie the patient's presentation, but also included 2-3 other possibilities that, if unaddressed promptly, could prove deadly. This list would serve as the roadmap for my investigation.

I am reminded of this approach as I read the developing story of the climate debate e-mails in the mainstream press. The manufactured magnitude of the furor is certainly good for news as entertainment. It is also prompting climate change skeptics to cry vindication. What has been missing from this coverage is the weight of the evidence that supports this as our current reality. While we can argue all we want about what our earth will look like in 50-100 years, what is clear is that the temperatures are on an overall rising trajectory, the glaciers are melting, and the green house gas emissions are accelerating. Put together, these facts beg the development of a sober differential diagnosis for what is causing this presentation. I would argue that in this list we need to include not only the most likely culprits, but also those that, if not stopped promptly, will result in irreversible and deadly changes in the near future. So, even if one is willing to ignore the broad scientific agreement with regard to the future of climate change or the likelihood that human activity is driving it, common sense of safeguarding against the worst case scenario demands we nevertheless do something about these factors.

And here is the contradiction of our human psyche. Take the mammography recommendations maelstrom and compare it to our attitude toward climate change. The outraged reactions to the new evidence-based recommendations are a reflection of our better-safe-than-sorry attitude toward a deadly disease, no matter what the cost to the individual or the society. So, why do we not adopt the same stance when it comes to climate change? Why not open our eyes to the possibility that, despite the poor judgment of the scientists involved in the e-mail scandal, there is a very real possibility that our climate is changing. Once this becomes a possibility, it matters little whether it is human activity that is driving it or just the natural order of things: the only modifiable risk factor that can affect this trajectory is human activity.

So, the debate becomes simply about two choices. First is to consider the idea of climate change honestly in the context of what we know to be the truth. Second is to keep our blinders on and continue to be condescended to by those whose financial interests would be affected by the resulting societal behavior change. The right choice is obvious.      

When an information disconnect does not create cognitive dissonance

Just posted this on the BMJ's doc2doc blog  

Is it rare for an information disconnect to be accompanied by a complete absence of cognitive dissonance? And does such an absence signal mere ignorance or deliberate intellectual dishonesty? There is such a gap present in our healthcare debate.

Think about this. The Republican Party has always touted itself as a fiscally responsible party. Under this banner they like to cut taxes and minimize what they call "entitlement" programs (these of course are just the programs that provide a modicum of support for those left out of our consumerist equation). So, given this as a top priority in the hierarchy of their agenda, there is no contradiction in their stance against public coverage of healthcare in the US. OK so far?

Well, here comes the disconnect (no pun intended): they do not wish to limit any and all existing and future healthcare interventions for our public, including the Medicare population. They have made up rows of dying grandmas whose ventilator access is rationed by the government death panels, and have equated the proponents of rational rationing with the Nazis. So, where is the disconnect? Well, given that Medicare expenditures have been growing at rates far outpacing the US annual inflation (up to 12% in some years), how do we propose to pay for this escalation if we are unwilling to limit care? Well, one way is by raising taxes. This thought, of course, sends the Republicans sobbing into their hankies -- such a solution is anathema to their pseudo-science of supply-side economics. In the meantime, a few years ago they added to the Medicare bill by creating Medicare Part D, or prescription drug coverage. In and of itself, this coverage is a good idea. Unfortunately, Medicare is not empowered to deny coverage based on cost or cost-effectiveness, and it is further prohibited from negotiating drug prices. Well, in 2006 this program cost Medicare over $40 billion. And George W. Bush insisted on lowering taxes at the same time. And he started two expensive wars, too. So, am I just dense because I cannot get these numbers to add up? Am I missing something that is indeed fiscally responsible about the Republican stance? Why does this disconnect not create any visible cognitive dissonance for them?

I think I know why. They are not the party of fiscal responsibility, but the party of survival of the fittest consumer. An entitlement program creating corporate profit is good, while one geared at improving our society is a manifestation of the Nanny state. In fact, the Nanny state has run rampant in the last 30 years wiping noses of our corporate giants with their supply-side religion, while shaking off the needs of the public as socialist propaganda. There is no fiscal responsibility here, only the single-minded pursuit of more for less. The US currently has a $12 trillion (this is worth writing out just for its shock value: $12,000,000,000,000) debt on the books. This does not take into account what is already committed to future debt, which by some accounts exceeds utterly unimaginable $60 trillion. In fact, by 2019 the US government's annual interest on its debt will be $500 billion more than it is today, going from $200 to $700 billion! Just the interest, folks!

So, while I can almost intellectualize the Republicans' selfish desire to keep 46 million people in the US from availing themselves of healthcare, I deplore their dishonesty in hiding behind the aegis of fiscal responsibility. The last time our budget was balanced, a Democrat was in the White House. A Republican started an ill-conceived war and cut taxes at the same time -- this is living in a fantasy of a most destructive kind! So, don't make the healthcare bill about anything other than what it is about: the potential profit to be made from keeping healthcare status quo on the backs of growing numbers of citizens of our nation. It makes you look not only hypocritical, but also supremely stupid!                  

The century of unintended consequences

Where to begin? The phrase "unintended consequences" has been making rounds in healthcare, politics, and other venues of late. It appears most pronounced in healthcare, and has been clearly brought out by the cancer screening debate last week: while taking for gospel that early detection saves lives, we have been subjecting countless people to unnecessary, invasive and sometimes deadly interventions. Oooops, we say, an unintended consequence of our good intentions. You do not have to look far to see others. The mounting problem of antimicrobial resistance due to egregious overuse of antibiotics, mounting data on the downsides of the widespread use of proton pump inhibitors, manifest as an increased risk for C diff diarrhea, pneumonia, and most recently, because of heretofore unappreciated interaction with Plavix, strokes and heart attacks.

Unintended consequences can also be seen in other areas of our lives. The thoughtless experiment of mortgage-backed derivatives and their implosion, the nearly irreversible effects our thirst for fossil fuels on the environment can on the one hand be attributed as unintended consequences. But I have to say, I am not buying it. Letting us all off the hook with this innocent statement is as simplistic as it is dishonest. It is like letting your kid off the hook for stealing a candy from the store because he did not foresee being caught. In fact, even the expression itself, "unintended consequences", is seemingly designed to demonstrate our sudden passive and victim-like situation. "But I did not intend for this to happen, so I am an innocent victim here". Pshaw! Much of what we call unintended could have been foreseen, if we had the will to plan ahead. The issue is that we are not, and are steamrolling ahead from moment to moment with no thought given to long-term consequences.

It is a fact that Nobel laureate Joshua Lederberg predicted in the 1970s that bugs would evolve resistance in response to our antibiotic warfare on them; even then he cautioned against overusing these agents. It is a fact that you cannot keep building a house of cards with imaginary assets without having it collapse. It is a fact that you cannot expect to keep drilling and emitting with one hand, while with the other eliminating vast carbon sinks, without noticeable climate change. It is also absurd to call our lack of viable fossil fuel alternative an unintended consequence: in what closed system can a resource be infinite? And once this resource is inevitably exhausted, what then?

In truth, the entire 20th century has been a cruel experiment in consumerism. Decisions made in the 1920s and the 1950s about converting the US citizens into a race of single-minded consumers were deliberate and well planned. And of course, the intention was clear: to increase the wealth of the few. I am confident that no one explicitly intended for this accumulation of wealth in a few hands to result in an ever-widening gap between the haves and have-nots. But is it so difficult to imagine that this is a not unexpected result of single-minded pursuit of wealth? Over the decades of industrialization, farmers and small-scale merchants, able until then to support themselves independently, abandoned their country seats and their communities to move to the cities to fulfill the shining promise of wealth and happiness unscrupulously promulgated in the name of this relentless pursuit of wealth. When the internal combustion engine became a reality, and as the city populations expanded, the suburban dream was born, isolating people further into their cookie-cutter homes away from organic communities of their ancestors. The last 30 years of the 20th century brought with them the proliferation of technology that has allowed us to work 24/7, be connected (only virtually), and, more importantly, to buy stuff any time of day and night from anywhere in the world. This American dream has left 80% of the US population behind economically, our main fuel source on the brink of disappearance, and American society more unhappy and fractious than any other time in the past century. Our politicians and business leaders unabashedly preach selfishness, greed and lies. All in the name of money and power. Unintended consequences? I think not.

Today, when divisive politics are playing out on Capitol Hill for all the world to see unequivocally our degraded values around social support and responsibility, it is worth pausing to contemplate what we are undertaking today that will result in "unintended consequences" tomorrow. Is it honest to say that the poverty, crime, disease and deprivations in migrant worker shanty towns in Mumbai and Namibia and China and countless other places in the third world, migrants who abandon their rural communities in search of the Western promise, are all truly unintended consequences? Or are they really collateral damage of our sick zero-sum economic game? And just because these consequences were not our primary intent, we cannot wrap up in their cloak of innocence: these consequences were and are entirely foreseeable, convenient or not. We are guilty!

So, while we in-fight about who should have access to healthcare, whether abortion or gay marriage is morally tenable, and what Jesus would do, we have been made accessory to the real catastrophic atrocities -- a growing local and global economic apartheid in the service to our corporate masters. The ones that are bleeding are we and our children. But of course, these are just unintended consequences.

The good news is that we can each do something to mitigate this overwhelming disaster: stop buying crap you do not need! Stop buying it because it is on sale -- you already have enough crap. Think about it: some of the sale prices are not even enough to pay for the fuel it takes to run the machines that made the piece of crap in the first place. And it will probably end up in your trash within the next 12 months anyway. How is this living with the future in mind? Really, before you make your next purchase of anything, think hard: there is no such thing as a free lunch. Chances are, your purchase will only better the bank account of a small minority of people who have produced the item, and in the process contribute to the environmental and spiritual devastation for many. Stop being helpless, stop pressing the lever and stop being a cooperative slave to this insidious juggernaut of consumerism. You will feel better if you can claim intentionality in building a better and more lasting world.                                        

Mammography and conflict of interest disclosure

I don't know about you, but I am really struck by the lack of support for the new USPSTF evidence-based recommendations for mammography screening by the heavy-weights in this area -- American Cancer Society, American College of Radiology, and several institutions that are known bellwethers for clinical practice. But why should I be surprised?

A couple of weeks ago I posted about conflict of interest in healthcare research here. There is a veritable witch hunt by professional organizations and peer-reviewed journals to rout out any appearance of a conflict of interest, but pretty much only as it applies to private research funding. What about mammography screening and the loud chorus of dissent with the recommendation? Well, consider the sources. Does it seem that their opinions may be somewhat tainted by their tremendous financial interest in maintaining and even extending the status quo?

I do not wish to accuse anyone of nefarious motives; I believe Hannah Arendt's considered assertion that evil is banal -- we do not plan it, we just slip into it. In fact I am not even willing to call the dissenters evil. I just want the conflict of interest disclosures to apply to everyone equally. The public relies on our healthcare institutions to promulgate policies with our health and not their financial advancement as the primary goal. As a researcher who takes research and consulting dollars from private industry I am expected to disclose meticulously all of my financial interest in a manuscript that I submit for publication or a talk I give. In the same spirit of full transparency, I call on all organizations voicing an opinion on the subject to disclose their financial stake in the mammography enterprise and how much revenue they stand to lose from adoption of the current USPSTF recommendations. Explicit disclosure of such conflicts of interest is an important step in helping the public understand the implications of the skirmish around this evidence.