The BIL:PIL unconference: Challenges and opportunities

Yesterday and today I have been privileged to attend the BIL:PIL "unconference" in San Diego, organized by Jonathan Sheffi and colleagues. Yesterday was awesome with amazing speakers and brilliant ideas. For someone who is used to hard data presentations to and from physicians and scientists, it is great to get out of that silo and see what the rest of the world is thinking about the challenging state of healthcare. Some of the speakers dazzled us with new more efficient approaches to drug development, while others took us on futuristic voyages of the brain's dark matter, artificial intelligence and the promise of stem cells. I cannot wait to hear today's presentations -- tickles my brain just to think of all the new stuff I am learning! It is also neat to meet and rub elbows with such luminaries as Val Jones (speaking today at noon PST) and Gregg Masters, who are not just smart and eloquent, but also really delightful people.

Today I get to give my "untalk". Just by way of a preview, very little of what I will be talking about is new. In fact, when I was putting it together, I tried to look up the antonym of "innovation". Guess what? There is not one in the English language. So, I will have to call myself something else, since, though creative, I certainly do not rise to the ranks of the brilliant innovators I stand beside. At the same time, I believe my approach will bring something valuable to the table. Perhaps I need to come up with an adequate moniker that describes my philosophy. Wait, I think I've got it! But I think I'll wait to unveil it during my talk. It is at 3:00 PM PST and you can see the live stream here. See you at BIL:PIL!

Twitter and information accuracy

I am going out on a limb: I do not wish to offend anyone, particularly those for whom I have a great deal of respect. However, this is potentially a moment where opinions need to be exchanged in the name of improved mutual understanding.

The other day I re-tweeted a tweet from someone whose Twitter activity I enjoy very much.  I like where his links take me, and I appreciate the intellectual and emotional honesty of his own writing. The message I re-tweeted was about Gardasil, Merck’s HPV vaccine marketed in the US. Diane Harper of the University of Missouri is a prominent researcher who was heavily involved in the Gardasil development program. Over the last several months she has cast serious doubt on both the cost-effectiveness and the risk-benefit profile of the vaccine. One of the facts she pointed out at the recent 4th International Public Conference on Vaccination in VA was that, though the drug is marketed to girls as young as 11 years old, the vaccine has never been formally evaluated in girls under the age of 16 years. Neither its safety nor efficacy, let alone effectiveness, is known in the younger population.

A link in the re-tweeted message took me to a newspaper article summarizing Dr. Harper’s objections to the wide-spread use of Gardasil in the US. As luck would have it, shortly following the first tweet, the author re-tweeted another message. This one directed one to a blog post by a British EBM celebrity railing against a deliberate fabrication of information by anti-vaccination ideologue reporters to cast doubt on GSK’s Cervarix in a story published in the British tabloid Sunday Express. In this blatantly sensationalist anti-vaccination article, the journalists were allegedly quoting Dr. Harper’s objections to Cervarix, objections that seemed identical to those she has voiced with regard to Gardasil. Being dubious of the veracity of such claims, the blogger diligently fact-checked with Dr. Harper directly, who promptly denied ever making any claims, or indeed having more than superficial familiarity with the data on Cervarix. In fact, the journal has removed the story from its web site. So, the blog recounted a necessary he-said she-said anatomy of distorting facts in service of the tabloid rag's sales. Perhaps in the UK these disreputable pseudo-news outlets have wider credibility than in the US. But I do not see that I need to get involved in further discrediting a source that would just as likely put news of alien abductions on its front page as the lies about a vaccine.

Since I have been following the Gardasil saga, I was interested in Diane Harper’s views of the data in the context of the epidemiology of both HPV infection and cervical cancer. Additionally, being a health services researcher, the cost-effectiveness questions also caught my eye. Not to mention the information about the age thresholds in the trials. For these reasons I re-tweeted the story. And while the debunking of the anti-Cervarix rhetoric was interesting, it did not add to my knowledge base, other than to trust all tabloids even less, if that is even possible. The blog post thus made the point that there is no evidence to date for any of the dire events that the reporters in their anti-vaccination zeal had made up. This does not excite me: as I keep pointing out, the absence of evidence does not mean that there is evidence of absence. The best we can say is that the vaccine proved safe enough in trials to be approved, and to date we have not seen any red flags. No new information here, other than confirmation of the lies, though, given the source, no big surprise. So, the post being simply more of voyeuristic than scientific interest to me, I chose not to re-tweet the second tweet. Particularly since this is a “controversy” I had not been following closely.

Shockingly, when I got back on Twitter a few hours later, I had a polite but insistent request from the author of the tweet to re-tweet his second, Cervarix, tweet. Now, because I respect this person, and because I am confident that, being an accomplished journalist, he was simply seeking balanced information, I complied without further ado. After all, this was harmless enough. However, I got to thinking about when it might be OK for a tweeter to insist that a particular tweet get re-tweeted. Journalists seek balance in reporting. Scientists seek balance when summarizing evidence. Both are averse to cherry picking. I am sure that my esteemed colleague felt that I was cherry picking the information to fit my point of view. In fact, I wish to assure him that I was cherry picking simply on the basis of what advanced my knowledge on the subject: a story about an important public meeting on vaccination vs. a recount of a tabloid inaccuracy. And even if my intentions had been nefarious, Twitter is neither a responsible journalism vehicle nor a peer-reviewed publication. The cynical view is that information chaos reigns, and while we should all strive for responsible diffusion of information, there is no contract to this effect. The less cynical way to look at it is that Twitter is an egalitarian vehicle, where individuals can make up their own minds as to what they deem important.

So based on this experience, let me respectfully suggest an alternative course of action around similar future situations, should they arise. Rather than emphatically asking to re-tweet a specific post, why not inquire why the person chose not to in the first place. And though it may be challenging to give a full explanation in 140 characters, it is worth a shot, as it is guaranteed to advance our mutual understanding and to build better relationships.

Fellow consumers: we cannot escape history

The consumerist takeover of the US psyche which began in the 1950s is complete: While we have been in our gluttonous torpor, our citizenship title has been revoked in favor of "consumer". Appropriately enough, this blessed event took place yesterday in a location bearing the hopeful name of Sunrise, FL, where, in an Orwellian concession to the fans of "Going Rogue", the Speaker of the House of Representatives of the United States of America dropped the objectionable "Public Option" and replaced it with the promise of "Consumer Option".

Yes, ladies and gentlemen, we are no longer the public, we are merely consumers. Whodda thunk it? In the nation built upon the principles of life, liberty and the pursuit of happiness, we are officially empowered to pursue only STUFF. Of course, it was a matter of time. The success of the marketing enterprise over the last 50 years is astounding. What? You think this happened by accident? Ever heard of Victor Lebow? As an economist in the 1950s, he is credited with the following words:

Our enormously productive economy demands that we make consumption our way of life, that we convert the buying and use of goods into rituals, that we seek our spiritual satisfactions, our ego satisfactions, in consumption. The measure of social status, of social acceptance, of prestige, is now to be found in our consumptive patterns. The very meaning and significance of our lives today expressed in consumptive terms. The greater the pressures upon the individual to conform to safe and accepted social standards, the more does he tend to express his aspirations and his individuality in terms of what he wears, drives, eats- his home, his car, his pattern of food serving, his hobbies.

These commodities and services must be offered to the consumer with a special urgency. We require not only “forced draft” consumption, but “expensive” consumption as well. We need things consumed, burned up, worn out, replaced, and discarded at an ever increasing pace. We need to have people eat, drink, dress, ride, live, with ever more complicated and, therefore, constantly more expensive consumption. The home power tools and the whole “do-it-yourself” movement are excellent examples of “expensive” consumption.

Really! In broad daylight and with complete seriousness. Are you awake? We have been manipulated for 5 decades. We have generated tremendous wealth for a few, we have decimated our environment, and we are less healthy and happy now than we have been in the last 30 years! So, of course, what we need is more consumerist rhetoric; thanks, Nancy for doing the right thing.

What will it take to break us out of this hypnotic state? What will it take to alter this mystical-magical thinking that the next purchase is going to make our lives everything we had imagined? Stop pressing the lever, get off the spinning wheel, take your own pulse and a deep breath: we have hit the wall.

[Hat tip @ivanoransky, @epatientDave, @paulroemer]

Thomson Reuters: $700 billion in wasted healthcare costs annually -- UPDATED

Another report quantifying the staggering waste in our US healthcare system, "the best in the world". This one is from Thomson Reuters, and is awfully similar to that from PwC. They estimate that the waste is between $505 and $850 billion annually.

Because a picture is worth a thousand words, I created this graph based on their estimates. Enjoy!

Silly me, cannot upload an Excel graph into the blog, so here are the numbers:

Paper record/test duplication	6%
Overuse	37%
Fraud	22%
Administrative inefficiency	18%
Medical errors	11%
Preventable conditions	6%

Bohemian Bankruptcy, by Drag Queen

Oh, my God! This is scary great on so many levels! (hat tip to @Nika7k)

Are 37 minutes of sleep worth $800,000,000?

It seems appropriate to repost my blog from July 29, 2009, in view of this excellent article from Lisa Schwartz and Steve Woloshin from Dartmouth in the current NEJM -- it is a must read. You will not believe what some of the effectiveness claims in FDA-approved drug labels are based on!

Voodoo Medicine

An excellent post the other day on the Science-Based Medicine blog addressed "Incorporating Placebos into Mainstream Medicine". In it the author, Harriet Hall, rails against complementary and alternative medicine as inherently leveraging the placebo effect. She goes on to ask "What if scientific medicine were to co-opt the CAM movement? We could take these treatments out of the hands of the less ethical practitioners and outright scam artists and place it in the hands of those who are more likely to be altruistic". This mouthful grabbed my attention.

Here is what bothered me. The traditional healthcare providers believe that they are practicing scientific medicine. And why wouldn't they? The clinical research establishment (of which I am a part, mind you) is constantly touting new breakthrough results, and the FDA after all only approves therapies that are proven to be effective! Well, not so fast; there are an awful lot of assumptions in this statement. First, how much of the research out there is of high quality and how much is bovine excrement? Next, even the best of studies that find statistical advantages to one course of action over another show minute, potentially inconsequential differences that a lot of the time translate into zero benefit outside the laboratory of clinical trials. And as for the FDA, they are paid by the manufacturers to review and approve drugs and devices. And even though I trust in their earnestness, most of the time they require only statistically significant differences (microscopic ones can still emerge given a large enough study size) in outcomes that are not all that meaningful to one's well-being (e.g., drop in cholesterol as a surrogate for a reduced risk of death from cardiovascular disease, a less straight-forward relationship than you might suspect).

So, there is the science bit. As for ethics, I will give Dr. Hall that for the most part MDs do try to practice what is commonly accepted as scientific medicine. The key here is "for the most part". Remember Gawande's story of McAllen, TX? And lo' and behold, just a few hours ago Reuters reported a bust of a large Medicare fraud scheme, where, believe it or not, docs were charging $3,000 to $4,000 for simple knee and shoulder braces and heating pads, calling them "arthritis kits". And while I do not question the ethics of the majority of my brethren, this incident sure underscores that, just as CAM practitioners, the house we live in is also made out of glass.

We have a long way to go to achieve good health in this country. Our culture has become over-reliant on experts in everything, including healthcare and evidence, to slap our wrists when we have been "bad" and to give us marginally useful advice on how to cure our ills. We must question our assumptions. I agree with Dr. Hall, nothing replaces a combination of evidence and experience. Or the placebo effect.

Civic involvement: a communist plot?

Absurd, you say? Not at all!

That paragon of intellectual reasoning, Glenn Beck, has been conjecturing that the new call to volunteerism by the Entertainment Industry Foundation is a giant mind control experiment by Obama aimed at fostering zombie-like agreement from unquestioning public. Really? He is worried that we will soon find ourselves in Mao's China. Hmmm, very interesting.

Coincidentally, a recent study from the University of Massachusetts, Amherst, showed that in a large cohort of baby boomers, what determined happiness and fulfillment was not the relentless pursuit of money, but... you guessed it, giving back to the society through such activities as volunteerism!

So, why does Glenn, being an authority on everything, from politics to science to history, worry about rampant volunteerism promoting a totalitarian system? Well, the answer is he is not. That's right, he is not. These are the same tactics traditionally used to derail healthcare reform. Remember Reagan's ads in the Truman era equating socializing medicine to a descent into the Nazi Germany and Communist Russia? These are blatant lies, but they strike at the core of our national fears. This is exactly what Glenn and his cohorts are doing -- fanning the flames of the cold war left-overs. Why? The answer to this is surprisingly simple: to keep us down.

The message of the UMass study is very clear: single-minded pursuit of money leaves a spiritual void that can be filled only by civic engagement. This thought is subversive: if the population is fulfilled, they are potentially less prone to manipulations of consumerist marketplace, and they may even see through the deception of the wealth myth (work harder to make more has not been the case in the last 30 years for 80% of the American workers). Such mass epiphany would threaten the stranglehold that conglomerates such as Rupert Murdoch's has on our national consciousness. Simply put, Glenn and other minions are terrified by these developments because their message machine will become impotent and unable to sell us the bill of goods that has so successfully kept them in style and the rest of us in painful conflict.

So, be afraid, Glenn, be very afraid! Civic involvement builds communities. Strong communities can in turn guard from yours and other media propaganda. Strong communities create healthy and caring individuals, the best antidote to your cynical attempts to keep us isolated and unhappy and unsuccessfully filling the void with plasma screen TVs, new cars, in need of ever-increasing fixes of these false gods. Strong communities are anathema to anti-healthcare reform rhetoric: if we know and care about our neighbors, the impersonal healthcare disaster stories we hear today gain a very personal dimension. In strong communities your media noise is replaced with family conversations, and children learn to respect others and themselves. This is exactly why your fears are justified, Glenn (and Rupert). In a nation starved for real values and happiness, civic involvement will prevail, and your empire of cards is sure to collapse. Good riddance!

Will more healthcare bring better health?

An awful lot of time and energy is being spent on finding solutions to our broken healthcare system. This  is justified, of course, given the unprecedented 16.2% of the GDP that it eats up, while virtually excluding 46 million people from participating through lack of insurance, and harming many through poor and defensive practices. But will focusing on these unquestionably important trees improve the forest of the nation's health? A nation that boasts unprecedented rates of obesity, diabetes and other chronic diseases? A nation 40% of whose citizens suffer from a chronic disease? A nation where 80% of the adult population pops at least one pill every day?

I am skeptical. And here is why. The Rand Corporation created this very interesting pie chart, quantifying the influences of factors responsible for premature death in the US.

Based on this chart, only 10% of all premature deaths will be avoided if we fix the access to and quality of our healthcare system. If we posit that avoiding premature death is our primary goal, then perhaps we need to be exploring other risks that compete with the medical care short falls. This scheme suggests that of the 70% of the causes that are modifiable (we cannot change our genes yet), 86% can be attributed to our social status, the environment around us and our behavioral patterns. Let's examine each one separately and see what conclusions we might draw.

Socioeconomic status (SES) is known to be the single most important determinant of health. SES determines not only where we live, but also what we eat, how much activity we engage in, and our educational opportunities. It is well appreciated that obesity rates are higher in poorer communities. Most shocking, however, was a report a little over a year ago indicating that, in the face of ever-increasing life expectancy in the overall population, life expectancy in the poorest parts of the US is declining. At the same time, the economic gap in the US is widening, with an unprecedented 6% of the wealth concentrated in the top 0.01% of the population. Further, since the mid-1970s, the real wages for the bottom 80% of earners have remained constant, while productivity has enjoyed exponential growth. And are we doing anything about this driver of health? We are continuing to outsource jobs, we continue to tolerate astronomical bonuses on Wall Street, all with the blind belief in economic growth, but in reality at great expense to the majority's welfare.

Environment is next. We have not only passed Hubbert's peak in oil consumption, but we have gone beyond the level of CO2 production, 350 parts per million, beyond which we threaten the planet with temperature increases that will not only alter our geopolitical balance, but also potentially bring us to the brink of extinction. Yet, much like the tobacco "debate" played out in the decades of the 20th century, we continue to drag our feet on climate change. Furthermore, we use tobacco tactics to cast doubt on the potential links between other man-made environmental contaminants and disease, confusing absence of evidence with evidence of absence of such a causal link.

And what about behavior? In the 21st century we are not talking about sex and substance abuse. In the 21st century the addiction of choice is the media. Children spend on average 7 hours per day glued to a screen, being unabashedly marketed to even while in school. Three major corporate conglomerates control the content of TV programming, telling stories not in order to promote responsible citizenship, but so as to create the perception of need where none exists, to drive consumerism and finally to generate the next generation of corporate drones with the single aim of ever-increasing productivity.

If it seems that we live in the Brave New World, it is because we do. The healthcare reform discussion, though necessary, is taking a lot of air away from other, equally as or potentially even more urgent concerns. The lather stirred by the opposition to healthcare reform is an effort to imbue this almost no-brainer populist need with a false controversy in the hopes that the hot air will distract the already apathetic nation from the worsening crimes of Wall Street against Main Street.

So, no, I do not believe that solving our healthcare problem will resolve out health disaster. The latter will need a more global approach to our runaway societal woes. A few posts ago I indicated that the market model of healthcare was a miserable failure. Today I have to conclude that unopposed market forces have promoted the failure of many, the success of a few, and have sold our Democracy to the highest bidder. Only by injecting humanist values into our society can we hope to get this ship back on course. If we don't, we are simply enjoying our final days of debauchery on board of this titanic.

The cost-effectiveness of patient empowerment

I think by now there is not a person in the US who cannot quote at least approximately how much we spend annually on healthcare. Fewer people appreciate that nearly 1/3 of this $2.2 trillion bill is eaten by hospitalizations, amounting to about $680 billion. Although the data in the diagram below represent a single year, the overall distribution of expenses is remarkably constant over time.

Of this staggering amount of money, no less staggering is the ICU expenditure, quantified at nearly $60 billion in 2000.

The role of the ICU is to support a patient through his/her critical illness. The reason ICUs exist is that these patients require more intense human and technological interventions, and this geographic segregation allows for more efficiently concentrated care. The philosophy behind putting a patients in the ICU is that of a therapeutic trial. In other words, no one knows for sure a priori whether the ICU intervention will make any difference in the individual patient's outcome. What we have to go by is evidence from studies of similar patients that tells us what on average the expected outcome may be.

Until about a decade ago we never had the luxury of inquiring about what an ICU survivor might be doing a year later: we were fixated only on getting the patient through the acute illness. In fact, about 10 years ago, when I had the chance to ask a very well known and respected academic intensivist whether he cared about what happened to the patient once the ICU doors closed behind him, he, like so many of his peers, gave a resounding "no". Well, we have learned a lot over the last two decades about how to improve ICU outcomes -- more patients are surviving to leave the ICU. So now we have started to be concerned about their longer-term outcomes. After all, surviving an ordeal today just to die or, even worse, wish you were dead, tomorrow is not the kind of a victory anyone would want to claim. Unfortunately, what we are learning is that their long-term outcomes are not particularly encouraging. More than half of those patients who survive a prolonged critical illness die within the subsequent year. Even more discouraging is that fewer than 10% are actually at home living independently. So, when starting a therapeutic trial of an ICU, both the clinician and the family of the patient need to have a clear end in mind, so as to minimize pain and suffering for both, the patient and the family. And a byproduct of this conscious minimization of suffering through inappropriate care is potential avoidance of economic ruin.

What triggered this rumination for me is the paper published in this week's New England Journal of Medicine looking at the clinical course and outcomes of nursing home residents with advanced dementia.
In this prospective study following 323 patients, more than one-half were dead by 18 months. This is not in and of itself surprising. What should, however, shock an uninitiated reader is that 4 out of 10 of these unfortunate patients undergo at least one burdensome intervention, including a hospitalization or an ED visit, in the last 3 months of life. Although as a former clinician I have no trouble believing this number, as a member of the human species I am absolutely appalled! Is there really ever a point to such torment knowing that any potential postponement of death is at best temporary and at worst painful for the patient?

Another interesting point in this study is that what reduced the likelihood of this infliction of pain was a clear understanding by the patients' loved ones of their dismal prognosis. So, although some of the less informed yet loud and disingenuous voices tout them as government-sponsored death panels, the reality is that end-of-life discussions are not intended to limit necessary care. Rather, their intent is to create an honest and transparent dialogue between the clinicians and the patient and his/her family, thus empowering them to make the right choices according to their values. Perhaps the fear-mongers in their torrent of feverish activity have been too busy to notice that the age of paternalistic medicine is over. In the 21st century patient empowerment is the mantra. End of life discussions are just that, empowering.

If I were a politician driving a message, I would stop here. I would not connect this message of empowerment to dollars. But I am an outcomes researcher, so I must. There are examples in corporate America who say that if you do the right thing for the customer, the money will follow. To me this is simply an extension of the golden rule. Call it karma, call it what you will, but doing what is right is often contagious and causes a domino effect. And yes, in the case of spending the necessary time with the patient and the family to discuss the best course of action, the desired byproduct may be to help curb the waste of Medicare dollars on useless interventions, thus ensuring not only the best for the patient, but also the program's sustainability.

Our PLoS H1N1 predictions: right so far (UPDATED)

In August we published a knol in PLoS Currents: Influenza, where, based on the data to date, we modeled hospitalization, respiratory failure and death rates from H1N1. Because "preditions are hard, especially about the future", we could not be sure that we got the numbers right, especially since they were quite staggering.

Well, yesterday, the CDC and ANZIC published the US experience with the first 272 hospitalized patients and the winter flu season Australian-New Zealand ICU experience with H1N1. Here is a table that compares our predictions to what the CDC they found:

	Zilberberg knol (base case)	CDC NEJM study	ANZIC study
ICU admission		25%
ARF (relative to ICU)			65%
Acute Respiratory Failure rate [ARF] (relative to hospitalization)	12%	25% x 63% = 16%
Mortality rate (relative to ARF)	58%	Not reported	17%/65% =26%*
Mortality rate (relative to ICU)			17%
Mortality rate (relative to hospitalization)	12% x 58% = 7%	7%

*Based on assumption that all deaths occurred in ICU patients
Clearly, we got it right at least partly right -- totally consistent with the CDC numbers, and slightly higher on mortality than ANZIC. Also of interest in the CDC study is the data on antibiotics use:

Of 260 patients for whom data were available regarding antibiotic therapy, 206 (79%) received antibiotics. Of 198 patients for whom the date of initiation of antibiotics was available, such therapy was started before admission in 30 patients (15%), on admission in 117 patients (59%), within 48 hours after admission in 44 patients (22%), and more than 48 hours after admission in 7 patients (4%). Patients received a median of two antibiotics (range, one to seven); 70% of the patients received more than one antibiotic. Commonly used antibiotics included ceftriaxone (in 94 patients), azithromycin (in 84 patients), vancomycin (in 56 patients), and levofloxacin (in 47 patients). Seventy-threepercent of patients who had radiographic findings that were consistent with pneumonia were treated with antiviral drugs, and 97% were treated with antibiotics.

It is not surprising that there was such a high rate if antibiotics use, as these patients represent a group with very high severity of illness, where you throw everything at them up front and ask questions later. The rate is also similar to what was reported in the Spanish study, though those patients might have been even sicker since they were all in the ICU.

What concerns me more, however, is the 15% rate of use of outpatient antibiotics in the setting of this viral illness. I am not pointing any fingers here, as it is a decision that has to be made individually in the office by the doctor and patient. But, as I have done in the past, I do want to caution about what indiscriminate use of antibiotics could do to the incidence of C. diff and other resistant infections. We need to be very judicious in our use of these therapies as the onslaught of the H1N1 pandemic continues.

An extraordinary video

Today I am celebrating President Obama's Nobel Peace Prize by posting a video that has nothing to do with healthcare. This is an amazing piece of visual and performance art hailing from my old homeland. Warning: If you have even a drop of Eastern European blood in you, grab a box of tissues.

The lost art of evidence-based debate

When people first find out that I was not born in the US (that's right, there go my presidential aspirations!), their question is about culture shock. They want to know what I perceived to be the biggest differences in cultures in the old vs. the new country. Over the nearly 35 years that I have spent in the US my thinking on this has evolved. Initially I was flabbergasted that teachers in high school tolerated students' putting their feet up on the desks. In my old country such behavior would have been punished corporally.

Today I consider myself to be a more sophisticated judge of cultural differences. I have come to appreciate that the US is not a monoculture, but a conglomeration of many different philosophies. And I do not mean just based on race, ethnicity and other obvious cultural drivers. Take for example politics as a profession: its culture is quite distinct from many others. Social scientists tell us that successful politicians are necessarily narcissistic, which is a blessing and a curse. This makes them not only über confident and decisive, but also prone to philandering and other forms of deception. I am also struck by how well they have perfected the art of not responding to questions by taking every opportunity to drive their talking points. Particularly astonishing is their ability, derived from Karl Rove's playbook, to turn a complete fabrication into what is accepted as reality by some. Just look at the death panels rhetoric.

I have to say that over the years I have cynically come to expect this and other bad behaviors from politicians. What is concerning to me is the pervasiveness of the same Rovian tactics in other sectors. Remember the recent E. coli outbreaks linked variously to Mexican peppers, tomatoes and spinach? Well, keeping this in mind, let's consider the work by the Center for Science in the Public Interest on FDA-regulated foods that have been implicated in E. coli outbreaks. This work, citing such seemingly innocuous and even desirable foods as lettuce, tuna and potatoes, has apparently incensed some of the corporate food lobby. Indeed, the Chicago Tribune reports that

...the Produce Marketing Association disagrees with putting them on the list, saying it is committed to providing safe produce and is working with the FDA and CDC to create "food safety solutions to help safeguard public health" and that "fruits and vegetables are necessary for better health."

All points well taken. But how does this address the issue at hand? Take back your data because we are committed and working on doing better? Why this is like a doctor saying "take this malpractice suit off my record because I am committed and working on doing better". Absurd logic? I think so.

The article further cites objections from the tuna organizations thusly:

But the National Fisheries Institute was even more scathing the study (sic) in their statement, saying "Seafood is a safe and healthy product that is an essential part of the American diet. CSPI has a history of attempting to scare consumers by playing fast and loose with definitions that might lead the casual reader to think people are getting sick left and right from seafood...Consumers should take this report with a grain of salt and a heaping helping of perspective."

Scare? Fast and loose? Have they ever heard of scombroid? No, it is not fatal, just unpleasant, but it happens despite the FDA regulation to gut and stuff the fish with ice immediately upon catching. Instead of addressing the evidence, they are quick to deny the allegation by casting doubt on the source.

And this brings me to my central point. Do these tactics of killing the messenger originate in relentless pursuit of market share even at the expense of public's health? Or is this just ignorance of how to debate a legitimate point? Is it possible that these executives and lobbyists do not have the skills to structure a logical evidence-based argument? Perhaps our educational institutions have lost sight of this critical skill as well. My guess is that it is a little bit of the latter and a lot of the former. Seems like public debate continues to deteriorate into voyeuristic entertainment, aided by shallow reporting.

But it does not have to be this way. The public needs to be empowered to make their own decisions based on a critical look at the evidence presented by both sides. If we can vet this evidence ourselves, there will be no room for corporate deception. Their antics will take their rightful place in the comics section of the paper.  

Shaky evidence for flu vaccination policies

This in the British Medical Journal from a Cochrane Center -- evidence for policies is shaky at best.

BMJ  2006;333:912-915 (28 October), doi:10.1136/bmj.38995.531701.80

Analysis and comment

Public health

Influenza vaccination: policy versus evidence

Tom Jefferson, coordinator^{1
1 Cochrane Vaccines Field, Anguillara Sabazia, Roma 00061, Italyjefferson.tom@gmail.com}


QUOTING:
Summary points

Public policy worldwide recommends the use of inactivated influenza vaccines to prevent seasonal outbreaks

Because viral circulation and antigenic match vary each year and non-randomised studies predominate, systematic reviews of large datasets from several decades provide the best information on vaccine performance

Evidence from systematic reviews shows that inactivated vaccines havelittle or no effect on the effects measured

Most studies are of poor methodological quality and the impact of confounders is high

Little comparative evidence exists on the safety of these vaccines

Reasons for the current gap between policy and evidence are unclear, but given the huge resources involved, a re-evaluation should be urgently undertaken

(A hat tip to @cebmblog)

H1N1 vaccine and the burden of proof

I am following with great interest all of the reports, both scientific and popular, on the reluctance to subject oneself to the H1N1 vaccine. Yesterday's WaPo reported that

A nationally representative poll of 1,042 adults released Friday by the Harvard School of Public Health found that only 40 percent were sure they would receive the vaccine and that about half were certain their children would. Recent research by the University of Michigan and by Consumer Reports yielded similar results.

Similarly, a CBS story reported that

Outside New York 's capitol building, health care workers - shouting "Give me liberty!" - vowed to fight an unprecedented order from state health officials: a requirement for every health care worker to get seasonal and H1N1 flu shots or face the possibility of being fired.

By some strange coincidence, the CBS story reports that, in any given year, the rate of voluntary vaccination against seasonal flu among healthcare workers is 40%. This begs the question: What is it about flu vaccination that engenders skepticism in over one-half of the population, whether healthcare professionals or lay people? And further, upon whom does the burden of proof in this argument fall? That is, does the government, who is mandating universal vaccination among NY healthcare providers, need to prove safety and efficacy to the satisfaction of the people or do the protesters need to prove to the government that their concerns are legitimate?

Let's take safety and efficacy. The mere fact that the vaccine has been approved by the FDA (and other regulatory bodies around the globe) should give us some comfort about its profile. Of course, we are all too aware of the recent debacles of removal of medications from the market due to safety signals, Vioxx being the most memorable of all. This drug, having undergone the FDA's scrutiny, was approved and then pulled because of an unacceptably high rate of cardiac events detected in treated patients in post-marketing studies. This has unquestionably colored the public's attitude toward drugs, even those receiving the FDA's blessing.

But is there something special about vaccines? From where I stand, vaccines are subject to an exaggerated suspicion on the part of the public, more so than other therapies. Well, my guess is that because most of the time the population for these injections consists of young and healthy individuals, the risk-benefit balance has to be much more weighted to the benefit side. What I mean is that the more seriously ill the person is, the more risk we are willing to accept for a small incremental benefit. Take cancer chemotherapy: when the alternative is certain death without a drug, the often severe side effects of that drug are acceptable given that it improves one's survival odds. Not so among the young and healthy. It would be absurd to accept the same risk profile from a vaccine that we would in a chemotherapy drug. OK, so there is the risk-benefit profile.

One important question that goes mostly unaddressed in safety discussions is that of time. That is, risk-benefit over what period of time? The flu vaccines, whether seasonal or H1N1, are developed annually and over a fairly contracted timeline. Can we possibly fathom the potential long-term risks of these vaccines in someone who is 20 years old today? Our drug approval process gives us a false comfort in that it only examines drug profiles in the short term. However, the human body is a complex network, and an exposure today may not make itself known until 20 or 30 years from now -- look at cigarettes and cancer. Further complicating this issue are several factors. First, we do not have a great system in the US for tracking adverse events, be it from drugs or from vaccines. The systems are voluntary, and for this reason incomplete and fraught with bias. Second, the task of connecting the potential exposure to an outcome separated by 20 or 30 years is a highly complex cognitive exercise. This task is made even more challenging if the exposure rate to the agent in question, here the vaccine, is very high. Under these circumstances, it may be difficult or impossible to connect the outcome to the exposure causally.

So, where does the burden of proof lie? The fact that even healthcare professionals have a hard time understanding this balance speaks to the complexity of the issue. As for the H1N1 mandatory vaccination of the healthcare workers, the added potential risk to the society may make the explicit risk-benefit balance easier to derive, given the immediacy of the outcomes. Nonetheless, I go back to my previous assertion that there is a dire need for better individual risk-benefit communication -- decision scientists and behavioral economists need to be recruited in droves to help with these dilemmas; we have the technology! In the long term, however, nothing will replace an educated consumer who is empowered to participate in this nuanced exercise.      

 

Ignorance vs. cynicism in the campaign of lies

It is staggering to me how out of touch some influential people can be. Or is it just more smoke in mirrors? Take the Op-Ed piece in today's WSJ by 3 former presidents of the American Medical Association Donald Palmisano, William Plested and Daniel Johnson. The first sentence of the second paragraph proclaims:

The United States has the best health care in the world today, and thanks to the ever-expanding frontiers of science and medical innovation the brightest days are ahead.

Really? Have they not heard of the nearly 100,000 potentially preventable deaths in the US hospitals exposed by the obscure body known as the Institute of Medicine in their report "To Err is Human"? What about the nearly 100,000 fatalities due to healthcare-associated infections? And since they threw down the gauntlet of comparison, what about our crappy standing among the developed nations with respect to infant mortality and life expectancy? What do these facts say about our healthcare?

They go on to concede that

It is true that there are Americans who fall through the cracks of our medical system every day

Must be some cracks, if they can accommodate nearly 50 million citizens! No, these are not cracks, they are crevasses, they are canyons, they are craters! And as for innovation, have they checked lately where that stands? And where innovation originates? Probably not. Had they done their homework, they would have realized that much innovation comes from within the walls of institutions of higher learning and is funded with -- yes, you guessed it -- our tax dollars.

Coincidentally, another story, this one in today's WaPo, brings to light a less rosy picture of our healthcare system, and particularly how it is viewed by the people. In seeking the reasons for why so many Americans are skeptical of the H1N1 vaccine, Rob Stein states

...the vaccine campaign is being buffeted by political and social currents: wariness of mainstream medicine combined with suspicion of big government and a general unease and complacency about vaccines. [emphasis mine]

So, if we really did have the "best health care in the world", why would there be such wariness?

The good doctors should stop the self-pity fest for not being invited by President Obama to the Rose Garden event today, where supporters of healthcare reform will help the President push for meaningful change. Seems to me this is not about being left out for disagreeing with the President. This is about the obliviousness to the reality among people who should be most in touch with it. Or is this just another installment in the campaign of lies by the opposition, this time wearing a mask of respectability through the sources? Could they really be that cynical?    

 

Whores, psychopaths and newsmen

Prostitution is legal in Las Vegas. Before antibiotics, people with tertiary (or neuro-) syphilis were considered to be pleasantly demented. Fitting neither of these criteria, fringe politics today is nevertheless mercenary and surreal. And loud. What we have is malicious fabrication rammed down the public's throat by a bunch of whores and psychopaths.

Consider Rush. A tool of the extremist right, he spews hatred day in and day out. Take Beck. With an actor's flair he incites his adoring public to the heights of fanatic hatred worthy of an Orwell novel. Taken together, their sociopathic rhetoric is validating and mainstreaming the psychotic margin that has always existed in our nation. And people listen, get worked up into lather and start Facebook discussions about presidential assassination. They are actors in well financed sinister entertainment masquerading as political commentary.

Some politicians seem to follow. Take Bachmann and Wilson and Franks. Bachmann, who advocates a hunger strike to make sure that we fail to reform and provide access to healthcare for all citizens. A Christian stance? I do not think so. Then, the illustrious Wilson calling the President a liar? In the Congressional chamber? Absurd! Finally, Franks referring to the leader of the free world as "the enemy of humanity". Is this not madness?

David Brooks in an editorial in the NYT today reminds us of the impotence of these "spittle-flecked" Quasimodos. Much like I said before, he contends that their claims of vast followings of Republican armies are simple delusions. I hope so. Nevertheless, their noise is giving me a headache. Let's use the power button. Off.

Are vaccines safe?

The H1N1 pandemic is bringing into focus not only the world's vulnerabilities vis a vis the spread of an infectious disease, but also our complete lack of a framework in which to make rational choices about prevention. The cornerstone of preventive efforts for any significant infectious disease is vaccination of a large swath of the population. The rapid development and approval of the H1N1 vaccines is both a blessing and a curse, given the sophomoric level of discussion about its risks and benefits. By coincidence this discussion has extended into the world of HPV vaccination, with a high profile death of a 14-year-old girl in the UK one hour following inoculation with Cervarix, the GSK's HPV shot. Though upon a post-mortem examination it is clear that the girl's death was a result of a malignant tumor invading her chest and not of Cervarix, the level of panic and skepticism about the vaccine is illustrative of the polarization of public opinion on the very philosophy of vaccination itself.

Why do we even have vaccines? To put it simply, vaccines are there to prevent highly infectious agents from causing mass morbidity and mortality. In the US, states mandate that children undergo certain vaccinations as a prerequisite for attending school. In fact, save for a handful of states where parents can express intellectual objections to some vaccines, in most states, including my own, the only acceptable reason for not vaccinating a child is a religious objection. And this is an all-or-nothing situation, where you are forced to either get the entire panel of shots or nothing. These laws, written decades ago, have taken individual decision making out of the public's hands. They leave no room for engaging in an educated risk-benefit analysis for the individual situation.

Rabid vaccine advocates would argue that there is never a need to make individual decisions in diseases where a vaccine is available. Well, let's take the chicken pox vaccine. Here is a childhood disease that is indeed highly contagious, but only causes a self-limited nuisance illness with a very low risk of complications in the pediatric age group without underlying conditions. In the US the disease was associated with ~10,000 hospitalizations and on average 105 deaths annually in the pre-vaccine era. So, is this really a big deal? Well, yes, from the perspective of those families suffering the 105 fatalities. But what about the societal concern? This is well summarized in the recommendation rationale from the American Academy of Family Physicians: 

Because chickenpox is so contagious, a child with chickenpox shouldn't go to school or day care until all the sores have dried or crusted. Many parents miss work during the time their child has chickenpox. Because of the lost time from work, chickenpox can be a significant cost to parents of children who get the illness. [emphasis mine]

So, there is clearly an economic risk that drives at least some of the rationale for requiring this vaccine. This then begs the question: should economic considerations ever drive a government mandate for vaccination? Note, economic considerations do not fall into what I put forth as the rationale to vaccinate: to prevent spread of highly contagious disease that causes wide-spread morbidity and mortality. Now it becomes about the money. So, does it not stand to reason that I as a parent should be able to take into account my personal situation with respect my aversion to missing work days to stay home with a sick child and make this vaccination decision myself?

Unfortunately, I do not believe that most citizens are equipped with the skills to make these informed choices. Since we have broadly accepted the government's judgment as to who should get vaccinated with what, we have not been taught systematically to make these choices rationally. And here we are, in 2009, faced with the swine flu and HPV choices: to vaccinate or not?

Ignorance is fertile ground for breeding fear. Hysterical rhetoric on both sides, anti-vaxers and vaccine apologists, is promoting a climate of confusion. When a radio program polls its listeners on whether or not they believe the H1N1 vaccine is safe, what are they looking to accomplish? As scientists we know that the concept of safety does not exist in a vacuum. How do you define safe? Safe for whom? Is there a gradient of safety? And what do the loud and often non-sensical caller responses accomplish but to create more noise at the margins?

A more constructive approach in the short-term would be to present the populace with facts -- both risks and benefits of both the diseases and the vaccines against them. (And yes, the reality is that diseases AND vaccines will have risk-benefit profiles that differ for different people.) But this short-term tactic will not solve our general inability to make rational choices when faced with complex ideas. This shortcoming needs to be addressed in our educational institutions. This knowledge will serve us in far more ways than just deciding whether or not to vaccinate our kids against chicken pox.