Stupak shtup

Did Stupak finally shtup himself instead of millions of poor Americans, as he had intended to? I think so, and with the Catholic nuns, no less. The man who has been living up to his unfortunate name by trying to derail the healthcare bill because of the non-existent threat of public money funding abortions is now turning on himself, apparently. In a MSNBC interview, as reported here in the NYT, he evidently disparaged the importance of a large and influential group:

"With all due respect to the nuns, when I deal or am working on right-to-life issues, we don’t call the nuns."

Can we hear this again? You don't call the nuns?!!! I think what he meant to say is that we don't call on WOMEN! I for one, though not Catholic, am taking this very personally. I truly believe that it has to do with disparaging the opinions of those who do not hold economic power, particularly the poor women of our nation. "We do not need to listen to them because they are not the ones electing us" is the implication of this stupid stupid remark.

Well, Bart, I do hope that you enjoy the self-stupping that this represents. With this remark, more than any other in the previous few weeks or months, you have shown your true colors. Go back to where you came from and enjoy the fall-out!

Lies, big lies and... epidemiology?

Now, as you know, I am a big fan of epidemiology. I do not believe that a randomized controlled trial is the be-all-and-end-all in evidence generation, and a well done observational study can add to our reservoir of knowledge much more efficiently. Of course, I, as many others, acknowledge certain limitations of epidemiologic design. However, many of them can be overcome with careful design and analysis.

I have to confess, though, that over the last week I have bumped into two news stories that have made me cringe. The first, reported a couple of days ago and based on a Kaiser study, showed that people

drinking at least four cups of coffee a day were 18 percent less likely to be admitted with a heart rhythm disturbance than those who drank no coffee at all.

So, great, the public may take away the message that drinking coffee prevents a-fib. Well, I have to say that the reporting of this was measured and tried to avoid this unfortunate inference of causality. Yet, it left enough room to imply that yes, perhaps there is a causal link. So, what's wrong with that?

Bear with me while I bring in the second example of a study that bugged me this week, based on the Women's Health Initiative. You may recall that the WHI is the large NIH-sponsored study that a few years ago turned hormone replacement therapy on its head. The study had a randomized component and an observational component. So, the newest analysis shows that women

who drank the equivalent of one to two drinks a day -- be it beer, wine, or liquor -- were 30% less likely than non-drinkers to become overweight or obese.

 Do you see the similarities? So why am I bothered? To me this is the classic case of a high potential for confounding by indication. What's that you say? That is a situation in which a subject that has the exposure in question (in these two cases coffee and alcohol) is inherently different from one who does not, and this difference is what determines the probability of the exposure itself. Why should this present a problem in a study where the authors carefully adjusted for confounding, which is true for both of the studies? It is a problem because the kind of confounding that this represents is impossible to tease out without real-time attention to the subject.

Here is how it would work in the case of coffee study. Say I am a person with paroxysmal (occasional) a-fib, and I have noticed that if I drink so many cups of coffee per day, I get into brief episodes of palpitations. Not enough to send me to the doctor's office or the hospital, but enough to start thinking about cutting out caffeine. So, I stop drinking caffeine, and continue with my baseline frequency of a-fib attacks. You see the problem? Is it possible (or even probable) that those people who drink four or more cups of coffee per day somehow have an inherently higher threshold for slipping into their a-fib than those who do not? And if the answer is "yes", then the four cups become a marker for someone who can tolerate them, rather than the cure for a-fib. You can construct a similar explanation with the two drinks and weight.

So, while I love epidemiology and its methods, I am wary of hanging my hat on associations that may likely be explained by confounding by indication. And although the stories were reported with many caveats, human nature may prevent us from hearing the nuance. It is clear that in both these instances the burden of proof is on the researchers to show me that I am wrong.      

 

  

Republican healthcare paradox

Reading the transcript in the WSJ of the remarks at the President's Healthcare Summit by Paul Ryan, the ranking Republican on the House Budget Committee reminded me of an occasional altercation during my childhood. When a friend would break a favorite toy, the temptation was to ask for the impossible: I want it back exactly the way it was, right now! Over the years this kind of a debating style thankfully dwindled in favor of more reasonable and logical solutions. How is it that our political discourse has spiraled into the childish domain of the unreasonable?

Here is the disconnect: on the one hand, as Mr. Ryan points out, the Obama-supported healthcare bills may bend the cost curve in the wrong direction, increasing drastically the deficits and creating empty promises for the future generations. This is clearly undesirable. But where was Mr. Ryan when Sarah, Michelle and the tea baggers were crying "death panels" and government sanctioned euthanasia when the talk came around to curbing the potentially unnecessary and marginally effective care that ravages our healthcare system? How can we have it both ways? Is it not obvious that if tthe amount of healthcare delivery continues its upward trajectory, the bill accompanying it can do nothing but continue to go up as well?

The Republicans insist that they merely object to governmental intervention in the healthcare market, and they would be delighted to craft legislation that promotes free market solutions to this mammoth that is killing America. Really? When was the last time any congressional legislation promoting "free markets" helped the people who are struggling? If the fact that in 2004 the top 0.01% of the US population controlled 6% of the nation's wealth is any reflection of the success of such legislative efforts, well...

This spin machine has got to stop. We need to demand that our legislators speak honestly and rationally about this complex multifaceted issue. The reality is that all Americans need to do some soul-searching in order to make the adult decisions that need to be made. What are we willing to give up and what are the trade-offs we are willing to accept? As difficult and as unusual it is for us to think of giving something up, make no mistake about it: we must give some things up.

So, no more sound bites! Give us the respect of an informed and cordial debate without leaving out critical pieces. Stop running for office and govern!

Would you spend your entire paycheck on healthcare?

It is an absurd question, right? Well, not really. Bear with me for a bit.

As I half-listened to the White House healthcare summit yesterday, I was feeling the familiar sensation of nausea rising in response to the usual excuses and talking points from both sides. Talking at each other, parroting old memorized lines about the process rather than the substance, the illustrious group came away with no consensus. Nevertheless, this lack of results seems to be pushing the Democrats to plow through the opposition and unilaterally pass the legislation through the process of reconciliation. But will it be done well? This has always been the question.

I think this WSJ article from today has called our attention explicitly to something that has been hampering any sensible approach to the reform, the selfish blame game:

Insurers contend that they must pass on ever-higher bills from hospitals and doctors. Hospitals say they are struggling with more uninsured patients, demands by doctors for top salaries, and underpayments from Medicare and Medicaid.

And doctors say they are strong-armed by insurance monopolies and hampered by medical malpractice costs.

This is the ultimate case of missing the forest for the trees. Let's think about this in slightly different terms. You are noticing that your food bill is growing out of pace with your income, the growth of your family and the growth of the national inflation rates. Do you not stop and ask what is going on? And if the answer is that, without any other changes, your family is now consuming 20 pounds of potatoes per week, while 6 months ago you made do with 4 pounds, do you not stop and ask why? And if on top of that observation you have also noticed that your family is becoming obese, do you not stop and rethink what is going on? And if as you stop and think you notice that your obese family members are in fact making even more frequent trips to the kitchen to feed their increased hunger, do you not want to break the cycle?

Well, we are "eating" a lot more healthcare than we did 10 years ago, and in the next 10 years we are likely to be "eating"even more. If healthcare continue to grow at the current pace, we will be spending 100% of our income on healthcare before we know it; and on healthcare that continues to fall short of meeting our needs to boot. The levels of chronic disease in our society have never been higher, and the number of diseases that "require" treatment has never been more vast (think mild depression, erectile dysfunction, lactose intolerance, and many other marginal human woes, most best addressed by introspection and lifestyle modification). Reflecting this growth, our preoccupation with health and disease seems to be edging out other, far healthier pursuits. And the rhetoric of "best healthcare system in the world", emanating from the Republican opposition yesterday, is not only disingenuous, it is just stupid, especially coming from someone, in fact many someones, who should know better.

So, let's look at the big picture, folks. Let's walk away from the divisiveness of the blame game and get back to the basics. We are not the best, we are least accessible, and we are most expensive. In the world! Yes, we are special, we are Americans. But it is time to exercise that specialness by admitting the abject failure of this market experiment, get off our high horse of individuality and look to other nations and systems for a sensible solution. I for one am not willing to spend all of my time or money obsessing about my health. How about you?  

 

Does lactose intolerance really need a NIH panel?

I will go out on a limb: I think that lactose intolerance should not be medicalized.

I stumbled upon this story on WebMD discussing the NIH panel on lactose intolerance. First of all I was shocked that my tax dollars are even spent on a NIH panel on lactose intolerance. Reading the rest of the story provided ample opportunity for further shock. 

For example, did you know that we do not have an idea of what the prevalence of this scourge is? So, clearly, we need large representative studies to establish this. OK, so gathering evidence is never a bad idea. But in an odd juxtaposition to the call for evidence was this statement:

"The numbers may be elusive, but outcomes of a dairy-poor diet are easy to predict."

Really? Is this statement evidence-based, or is it setting up the argument that some associations are just too obvious to need evidence behind them? Because if it is the latter, I for one do not appreciate the double standard. In fact, the statement, though not ostensibly a direct quote from an "expert", seems rather irresponsible to me, implying that we should feel free to apply opinion-based and consensus-based principles to this question.

My final outrage came when reading that (I paraphrase) for a bona fide diagnosis one should really undergo a breath test, and other (by implication) more serious conditions need to be ruled out, such as irritable bowel syndrome and celiac disease.

Why, you might wonder, does this engender such a visceral reaction from me? Surely it is not because I do not feel compassion for those people who suffer these conditions. And it is not because I do not want to learn more about them. What worries me is that having a diagnosis requires treatment, usually with a drug directed at the symptom. I am very concerned that, instead of understanding and dealing with the underlying causes of, say lactose intolerance symptoms, we will slap the band-aid of a pill, a course much more expedient, though potentially far more detrimental, than looking for a preventive solution. In the case of lactose intolerance, the non-pharmacologic solution may have something to do with the way our milk is produced and processed: our terror of things microbial has driven us literally to sterilize milk prior to consumption. Some people feel that this "deadness", lack of organisms that through their own lactase production may potentially help us digest it, exacerbates the symptoms of the intolerance.

But this answer would be neither simple nor politically palatable. Who would support this type of research? Milk manufacturers, who would have to overhaul their operations completely? The government whose regulations drive our milk production? The small community of committed farmers who produce raw milk, but do not have corporate muscle behind them? Not likely. And what about public opinion, so durably skewed by the establishment to fear all microorganisms?

So, when a NIH panel begins looking at an issue like this, I naturally worry. And while I do want to know more about it, I am skeptical of the end-result. Are we going in the direction of 100% prevalence of chronic disease requiring 100% penetration of prescription drugs in the US?

Buddhism and antibiotic resistance

There is a concept called "samatha" in Buddhist meditation. It has to do with sitting quietly, doing nothing. The opposite of mindless action, samatha is the cornerstone of the mindfulness practice. But what does it have to do with antibiotic resistance?

Well, I came across this interesting slide presentation by Dick Zoutman from Canada. Starting at the top of page 5, the talk goes into several fascinating surveys about what influences antibiotic prescribing for upper respiratory tract infections (URTIs). The first survey was of 316 family MDs in Ontario, which, among other factors, determined "physician's desire to act" as a risk factor for prescribing an antibiotic. The next survey of 313 patients identified patient expectation to receive antibiotic as the most important driver of prescribing behavior. The latter can be interpreted as a). the patient's preference for some kind of an action or b). the patient's expectation of action on the part of the MD. Either way, "action" is the operative word.

So, what does this mean? Well, at the simplest, most immediate level, this finding confirms that education of both physicians and patients is a potentially fruitful target for antibiotic stewardship programs. But at a deeper level, perhaps something as fundamental as a re-evaluation of our approach to life is what is needed. Antibiotic overprescribing is a clear example where the philosophy that doing something is better than doing nothing is not just wrong, but threatens to send us back to the dark age of pre-antibiotic era.

Western medicine in general promotes rapid decision-making as its paradigm. In fact, when I was in practice, there used to be tremendous political capital in the bravado of rapid assessment and planning. But let's not kid ourselves: the majority of treatment decisions made in the outpatient setting do not necessarily need to be rushed in the way that our expectations have driven them to be rushed. So, let's take this sage advice and "don't just do something, sit there". It is time for some samatha in our decision-making as both physicians and patients, lest we continue knee-jerking our way into this escalating resistance catastrophe.    

 

Evidence-based... inquisition?

Remember the trial a couple of years ago that showed that group support participation was associated with prolonged survival among women with metastatic breast cancer? I've thought a lot about that over the years. Isn't it interesting that something as simple as a supportive environment can make a difference in what researchers consider to be the hardest endpoint there is: survival? In our dualistic view of the human organism, we think of support as acting in the realm of the psyche, and not the physical. And yet, here is the evidence of a psychological exposure somehow making a tangible physiologic difference.

Now, how do we do evidence-based medicine? Well, we look for clinical studies that tell us whether and how well a treatment works for a particular condition. For the rabid evidenistas among us the most valid design to provide such evidence is a randomized controlled trial, since it has the most internal validity (i.e., we are in fact likely to be studying what we think we are studying). When we pat ourselves on the back on a randomization well done, we cite the balance in the fairly obvious demographic and clinical characteristics in the two (or more) comparator groups, namely, age, gender, comorbidities, the burden of acute illness, and the like. We rarely bother with their social or psychological milieu; in fact edging up to evaluating that may be viewed by some as engaging in quackery. Well, true, these exposures are ephemeral and somewhat abstract, but look at the breast cancer study... Just because it is difficult to study and we do not have validated tools for them currently, does not mean that we can ignore, or worse yet, disparage, their potential influence. Isn't there a saying to the effect that we cannot discover that which we do not currently have the tools to understand?

And speaking of inadequate tools, a related sticky wicket comes to mind: heterogeneity. I say it is related because we do not even dare look at the underlying non-physiologic heterogeneity as I mentioned above. What may surprise the uninitiated more, however, is the fact that we do not have good tools to identify physiologic heterogeneity. And as most appreciate, heterogeneity demands large numbers of subjects to study to get a detectable effect. In fact, our research enterprise is set up to do mammoth studies for often a miniscule difference (think cardiology trials requiring 20,000 patients to demonstrate a fall in mortality from 0.5% to 0.25%). It is very likely that by using this sledge hammer method to craft the fine jewel of evidence we are missing huge chunks of useful information.

And if this is the case for our Western paradigm of medical treatment, how does it play out in our study of Eastern and other non-traditional modalities? Don't take me wrong; I am not suggesting having blind faith in homeopathy, for example. But I am curious about how cultural psychology may influence responses to such treatments as Ayurvedic medicine, say. Perhaps it only "works" in conjunction with meditation and yoga? An "Eastern bundle" anyone?

The point is I do not know the answers to these questions. What I do know is that with our approach to evidence building we are looking at a vast castle through a key hole: we are only seeing small swaths of reality. My final point is this: because so much remains in the dark, we need to be humble when exploring evidentiary basis for any intervention. A parochial attitude equating gaps in our understanding to lack of effectiveness makes us seem like the Inquisition persecuting Galileo for defining an alternate reality which turned out in the long run to be the truth we live by.  

Kids, schools and superbugs

What do the three have in common, you might wonder? Well, more than we used to think.

This story in today's UK's Telegraph reports on a school child who developed diarrhea and tested positive for C difficile. The alarming thing is that there did not seem to be any explicit risk factors for this. The appalling thing is the mis-information by the story that

Children rarely become ill with C-diff, which normally strikes elderly people in hospital. 

This is how things used to be, before the BI/NAP1/027 bug evolved in the early first decade of the millenium. We and others have shown that kids are not immune from it, and neither are other people previously thought not to possess any risk factors for it. In fact, we have a paper coming out shortly in the CDC's journal Emerging Infectious Diseases showing that in the US the rate of pediatric hospitalizations with C diff rose from 7.2 cases per 10,000 hospitalizations in 1997 to 12.8 cases/10,000 in 2006.

So why is this happening? Well, there are a couple of ways to answer this question. The proximal answer is that the new bug is better equipped to propagate. Its spore possesses greater stickiness than the old pathogenic version which we all knew and loved in the '90s, and thus is more difficult to eradicate from fomites and anatomic surfaces. It also produces on the order of 20-times more of the toxins responsible for wreaking havoc in the colon. So, clearly, this is a bug for the new millenium.

But here is the real reason for this, albeit a little more removed: antibiotic overuse. All physicians are aware of this, and we all get the connection. The way this works is that C diff is impervious to many of the antibiotics employed to treat other infections, while its neighbors in the gut are decimated. Thus, C diff proliferates to fill the void and takes a firm hold under the right circumstances. The new superbug is, of course, very likely the result of the all-too-familiar saga of resistance evolution.

Here is the frightening part: we are still overusing antibiotics! I frequently hear from my friends that their MDs offered antibiotics for something that to me is clearly a non-bacterial issue. The most frustrating situation is when I am convinced that the friend has a post-viral reactive airways cough and needs an inhaler, but instead comes home with a handful of antibacterial pills. And no one wants to take the chance. We are so risk averse that even when we are well educated about the perils of antibiotic overuse, we are still likely to take them if our doctor prescribes them. And for a doctor, with the shrinking appointment times, what is the most expedient course, particularly with a patient with an entitled attitude? You guessed it, antibiotics!

So, what do we do? My feeling is that the action has to be multi-pronged. Yes, physicians need to be held accountable for their treatment choices, but so do patients. We need to do a much better job educating the public about the dark underbelly of antibiotics, so that they can be partners in these decision. In my opinion, this may be the most critical healthcare issue of our time, given the concerns raised by both the WHO and the FDA that, if resistance emergence continues at this pace, we will be back to the dark ages of pre-antibiotic era.

To this end, The Surgeon General should pick up the banner of antibiotic education. In fact, I recently sent her a letter outlining why she might want to make this a part of her Public Health agenda. If anyone is interested in making it a more public effort, I am happy to share it and resend with more signatures than just my own. She after all puts the "Public" into Public Health.

We have got to start talking to the people about this. The resistance train needs to reverse direction. And now!        

  

HEOR as a non-clinical option

Read my post on HEOR as an option for former clinicians at the Non-Clinical Healthcare Professionals ning network blog here.

Health Economics and Outcomes Research: Too little too late?

So I went to this meeting in Washington, DC, last week, to be a part of the conversation on the value of HEOR in the industry. It was a great meeting, with about 50 attendees, most of whom are intimately involved in HEOR in their every-day lives. It was also somewhat spooky. None of the presenters had shared thoughts prior to the meeting. Yet everyone's message was oddly aligned: we need more quality HEOR studies earlier in technology development.

There was broad consensus that most companies do not have a good understanding of the role, methodologies, or value of HEOR within their development programs. And while clinical trialists are a well accepted asset to the industry, HEOR groups still tend to be the red-headed step children. They have little buy-in from other departments and minimal support from the leadership, and their output is viewed with suspicion. To be sure, there are companies who understand the role of HEOR, and these are the success stories. But majority are still in the dark.

This situation must change, and here are some of the compelling reasons why. While 20 years ago all of the emphasis in drug development was on the FDA approval, today, in our economically constrained healthcare system, no approved technology can succeed without understanding what value it brings to the table over what is already available on the market. No longer can marketers employ smoke and mirrors to develop the "winning" proposition. I would argue that, in general, the industry cannot afford to lag in its understanding of economic arguments behind the payor community.

I have always argued that manufacturers need to be the biggest experts on the diseases they are pursuing and their treatments. This by necessity must include the value proposition of their technologies beyond the statistically significant improvements over placebo required by the FDA for approval. We must develop objective milestones by which to judge worthiness of technologies in development at every point in the development process. Those who do, will adapt to and succeed in this atmosphere of cost controls. Those who do not do so at their own peril. As scientists, citizens, consumers and investors, we should make sure that manufacturers are engaging in this ongoing evaluation of their wares with a critical eye to what value they intend to bring to the society.

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