Wake up, CDC! Your pandemic is here!

We are 2 months into the outbreak with H1N1 (swine) influenza, a variant not previously identified in humans. However, data suggest it was circulating unnoticed in pigs for years. It has two characteristics of concern: it spreads from person to person a bit more readily than older flu strains, and it seems to keep on spreading through the warmer months. This is likely due to the large number of susceptible people in the population, since it seems that younger people have little "crossover" immunity from exposure to previous flu strains, while the oldies appear to have partial immunity, based on the pattern of spread. These features might be seen with any strain arising de novo (not derived from recently circulating human strains).

Recent research suggests that, in terms of a repeat of the 1918 flu, we have less to be worried about than has been thought. These studies note that an estimated 95% of deaths from the 1918 pandemic occurred as a result of complicating, secondary illnesses that developed in people weakened by the flu, rather than by the flu itself. Furthermore, this analysis suggests that by preventing and/or treating such secondary illnesses, many lives could be saved.

Brundage et al.'s abstract notes that this "hypothesis suggests opportunities for prevention and treatment during the next pandemic (e.g., with bacterial vaccines and antimicrobial drugs [antibiotics]), particularly if a pandemic strain-specific vaccine is unavailable or inaccessible to isolated, crowded, or medically underserved populations."

CDC posts an H1N1 Flu Situation Update at least weekly. As of June 19, there were 21,449 "confirmed or probable" cases in the US and 87 deaths, or 1 death per 250 cases. It is great that CDC is keeping such close track of things. But what are they doing with this information, in terms of analyzing how many people died from secondary infections, what complications might lead to death, and which patients are most at risk and need special care. Most importantly, what do the data tell me can be done to prevent my patients from dying?

Unfortunately, the expert advice needed is MIA. CDC's "Interim Guidance for Clinicians on Identifying and Caring for Patients" with H1N1 flu was written on May 4, when there were just a few cases in the US. CDC has yet to update it with information from the 20,000 cases diagnosed since then. Instead, the (old) website says, "There is insufficient information to date about clinical complications of this novel influenza A (H1N1)..."

The only treatments and preventives recommended are Tamiflu and Relenza, even though CDC still fails to provide any information on how well or poorly they affect the clinical course of the illness. Meantime, CDC suggests that longstanding guidelines for the treatment of community acquired pneumonias could be followed for secondary infections. The link they provide did not work for me. And anyway, I know the guidelines. What I need to know is whether this advice is the best possible in patients with H1N1 flu.

On May 17, Australia moved to a new national health alert level, called “protect,” to focus on the early treatment of those vulnerable to [severe illness from] the flu, including pregnant women, people with respiratory disease, heart disease, diabetes and obesity. And on July 2, Australia's Health Minister, Nicola Roxon, reassured parents that swine flu does not pose a greater danger to children than seasonal flu.

CDC, wake up!

Do you really want to improve healthcare? You do it as a doctor by not settling for anything but the best outcome

Atul Gawande wrote a 2004 article in the New Yorker that was a stunner. I thought cystic fibrosis patients died around thirty years of age. Turns out they don't have to. At one cystic fibrosis clinic in Minnesota, patients hardly ever die. How was this achieved? It took a doctor who was absolutely compulsive about getting the very best outcomes. He just kept trying things and working harder and pushing everyone else harder too. He didn't just keeps repeating the practices in the textbooks.

Medical culture is one of complacency and uniformity. Malpractice laws require that we practice according to a local standard. You want to try something different? Stepping outside the mainstream makes you more susceptible to losing a malpractice suit. It usually makes your colleagues uncomfortable, too. If the local standard amounts to doing every test and procedure in the book---well, that is what you are expected to do, actually it is what you are legally required to do.

But if we want stellar outcomes, not to mention cost savings, that is absolutely the wrong way to get them. Gawande's articles are game-changers.

What we need is a paradigm shift. We have to make sure everything we do, for every patient we see, uses every arrow in our quiver to aim for that perfect outcome. And we have to use data and science a lot more, to make sure we know what works to achieve those results. We have to train docs to think differently.

The demand that doctors practice at the level of a local standard probably makes sense as a legal doctrine. But it sets the bar for healing way too low. It's basically a race to the bottom.

Gawande shows us exactly the kind of cultural shift that could truly achieve the world's best healthcare system. If you read nothing else on improving healthcare, READ THIS ARTICLE.

Laboratory Says Security Is Tighter, but Earlier Count Missed Dangerous Vials/ Wash Post

Over 9,000 undocumented microbial samples turned up in Fort Detrick's three-month long inventory, completed last month. But that doesn't mean we have a problem with biosecurity at the Army labs, does it? Nor does it suggest a similar problem might exist at the many labs that have sprung up since 9/11 in the US Government-sponsored biosecurity cottage industry, does it? And why should Obama's nomination for the Department of Homeland Security bioterrorism czar worry about biosecurity at these labs?

I should have directed readers to Lew Weinstein's blog on the anthrax letters case and the subject of biosecurity long before. Lots of interesting material there.

Rationing is Not a 4-Letter Word

Finally a mainstream article (in the NY Times, no less) redefines the misunderstood notion of rationing and healthcare reform.

David Leonhardt's timely and important article deconstructs (I love that word; here's one definition of it: textual analysis that can reveal hidden ideological assumptions) rationing. Here is a definition of rationing: the controlled distribution of resources and scarce goods or services.

Most Americans do not feel they get sufficient time and attention from their medical providers. They find the prices of drugs (or even their fractional co-payments) too high. They do not get enough information on wellness and prevention. Hello. Those problems are the result of an unacknowledged system of rationing. And the current rationing system works to prevent doctors conversing together about your medical problems, to prevent doctors reviewing your old medical records, to prevent doctors educating you about wellness. That is because the current system rations those services by failing to pay for them.

Oh, and by the way--don't you dare come down with an illness that cannot be successfully treated with a drug or operation, because other forms of treatment are highly rationed in the current system.

Most Americans put up with long waits for care, too-short visits, too many tests and not enough face time, because they have been led to believe they have the best healthcare system in the world. If best is costliest, with the most varied and numerous medical devices, procedures, and specialists, then we do have the best system. But if best is measured by outcomes, then we aren't doing very well.

What we really need is rational rationing. Not decided by medicare bureaucrats or by default, but by the stakeholders. We have got to get the price of healthcare down, and that will take rationing. Let's do it in ways that enhance health, longevity and safety. (I could name hundreds of ways to save that would yield better results.) Hello.

Anyway, Leonhardt makes these points so much better than I can. Read his short piece. Uwe Reinhardt discusses the misunderstood concept of healthcare rationing in another excellent article.

Barriers to an Improved and more Cost-Effective Medical System

Health care per capita in the United States costs at least double nearly every other country on earth. Yet our longevity, infant mortality, and other health indices lag behind the rest of the industrial world. What's not to change about such a system? Think of it: we do the same tests and radiology studies as other countries, use the same drugs, and I get paid about the same (as a primary care doctor) as if I lived in western Europe, Canada or Australia. But healthcare costs twice as much over here, because we do more or different things than we need to do for patients, our drugs cost more, our equipment costs more, and there is an enormous amount of "fat" everywhere you squeeze the system.

Egregious financial conflicts of interest can be found under every stone you care to turn up in the healthcare garden.

Profit margins have been reliably above 10% per year for most healthcare companies. No wonder members of Congress and the administration have invested in them. However, those investments are anchors, preventing the US from turning around the ship of state when it comes to healthcare. Shouldn't our legislators recuse themselves from a role in healthcare policy reform while hamstrung by personal investments?

We administer more in the US. A lot of the administration is not designed to reduce procedures or cut costs. Instead, it redirects resources. For example, insurer A contracts with Pharmacy Benefits Manager (PBM) B to supply medications to its customers. Drug manufacturers or wholesalers make deals with the PBM to sell only certain drugs, and to shift prescribed drugs to others in the same class. This is done through the mechanism of the Formulary, a fancy name for limiting the selection of available drugs. But every year the formulary (or pricing pattern of available drugs) changes, so patients (and hospitals) have to frequently change the drugs they have available, or pay through the nose. This is one of many wasteful situations in healthcare, in which the beneficiary of the change (the PBM) shifts the costs of the change onto consumers, hospitals and pharmacies. It is a shell game.

Here is another example of crazy healthcare economics. I see a patient on referral. Another doctor thought I had some expertise to offer this patient. I do a complete evaluation, and give the patient and referring doctor my advice. I bill the patient's insurance company, which decides how much it wants to pay me for the service. I never know what I will receive, how long it will take to arrive, and I frequently receive nothing. I can write letters, make phone calls, and sometimes some money will arrive late, but it is entirely unpredictable. Can you name any other industry in which the price that will be paid for a service (if any) is kept a secret by the payer until after the service is rendered, and often bears little relationship to the time spent or complexity of the service?

Since billing rules are constantly changing (another version of the shell game) billing cannot be done cost-effectively in a small office, for you cannot keep up with the changing regulations and software needed.

The unpredictable payment system led many doctors to sell their practices and take a salary, swapping autonomy for income stability. (I gave away my practice in 2002, and was mighty glad to relinquish captivity to an incomprehensible system of reimbursement.)

There has been a revolving door at FDA for employees or consultants to drug and device manufacturers, who become regulators for awhile. Maybe that is why the rules for scrutinizing new medical devices have been so weak. Attorney Daniel Troy was the top attorney and enfant terrible at FDA, appointed by Bush to gut public health protections. He is infamous for creating the legal doctrine of "preemption": if FDA approved it, no state courts can hear challenges to the safety or efficacy of the product. Now he has returned to the pharma industry as senior VP at Glaxo.

Let's talk pricing. Competition controls prices, right? But FDA approval gives manufacturers a license to steal, since no one else can sell your drug while it is on patent, and no one can tell the manufacturer how to price it. Is the drug used for cancer, a heart attack or stroke? Then it is worth thousands of dollars a dose. (You heard me right. Thousands. No wonder the drug companies focus on drugs for the final year of life.) Because most patients are shielded from the full cost by insurers, there is no outcry. Those not shielded may go bankrupt trying to pay.

Need I go on? An army of hardworking, well-intentioned health professionals puts a good face on a heathcare industry replete with dirt. And given the nutty payment system, healthcare institutions are practically forced to steal from Peter (i.e., overcharge) to pay Paul, a very unsatisfactory situation that currently is a requirement for hospitals (and healthcare professionals like me) to stay in business.

Our nation is desperate for an accounting of where the healthcare dollars are going; for accountability for quality outcomes; and to develop a system in which excellent health indices, broad preventive services, and enhanced provider communications occur -- one for which we can all be proud, and healthier!

The Cost Conundrum: What a Texas town can teach us about health care

Atul Gawande is a marvelous writer, as well as a surgeon. In an article in today's New Yorker, Gawande proves himself to be in the first rank of health care pundits, as well. His extraordinary article is a joy to read, but also extremely important. For example, it identifies and explores the reasons a negative correlation between healthcare costs and quality of care exists.

"Two economists working at Dartmouth, Katherine Baicker and Amitabh Chandra, found that the more money Medicare spent per person in a given state the lower that state’s quality ranking tended to be. In fact, the four states with the highest levels of spending—Louisiana, Texas, California, and Florida—were near the bottom of the national rankings on the quality of patient care."

Gawande travelled to McAllen, Texas, to investigate why per capita healthcare costs (paid by medicare) were higher there than almost anywhere else in the country. Many theories that might explain this were examined, but eventually had to be rejected. Finally, it became clear that in McAllen, many of the doctors had learned how to game the system for maximal financial benefit. The medical culture had evolved to one in which "financial considerations drove the decisions doctors made for patients."

McAllen's patients got an overabundance of illness care. However, preventive care was lacking, and people were no healthier than in markets where health care costs were 50% less. "So here, along the banks of the Rio Grande, in the Square Dance Capital of the World, a medical community came to treat patients the way subprime-mortgage lenders treated home buyers: as profit centers."

Things were McAllen's mirror image at the Mayo Clinic in Rochester, Minnesota. "Among the things that stand out from that visit was how much time the doctors spent with patients," Atul noted. Yet costs were among the nation's lowest at Mayo. Mayo doctors were salaried, and primarily focused on improving the quality of care.

“When doctors put their heads together in a room, when they share expertise, you get more thinking and less testing,” Denis Cortese, Mayo's CEO, told Atul.

Colorado had an interesting model. "Grand Junction’s medical community was not following anyone else’s recipe. But, like Mayo, it created what Elliott Fisher, of Dartmouth, calls an accountable-care organization. The leading doctors and the hospital system adopted measures to blunt harmful financial incentives, and they took collective responsibility for improving the sum total of patient care."

"When you look across the spectrum from Grand Junction to McAllen—and the almost threefold difference in the costs of care—you come to realize that we are witnessing a battle for the soul of American medicine."

Gawande questions whether the doctor--any doctor-- "is set up to meet the needs of the patient, first and foremost, or to maximize revenue. There is no insurance system that will make the two aims match perfectly. But having a system that does so much to misalign them has proved disastrous. . . Every incentive in the system is an invitation to go the way McAllen has gone. "

Gawande concludes, "As America struggles to extend health-care coverage while curbing health-care costs, we face a decision that is more important than whether we have a public-insurance option, more important than whether we will have a single-payer system in the long run or a mixture of public and private insurance, as we do now. The decision is whether we are going to reward the leaders who are trying to build a new generation of Mayos and Grand Junctions. If we don’t, McAllen won’t be an outlier. It will be our future."