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.