Vol. 74 September 15, 2012 More Surprising Medical Fun Facts

September 15, 2012

An 11 year study of 41,000 adult Spaniards showed no association between consumption of food fried in olive oil or sunflower oil and deaths from heart attacks. (1)

More than 10,000 events of non-trivial bleeding (intestinal bleeding, stroke, nose bleeds, and blood in the urine) occurred in 102,000 study participants who did NOT have heart disease BUT who were taking daily aspirin in hopes of preventing fatal heart attacks. Their death rate from heart attack was NOT reduced. (2)

Eating only organic food made very little difference in the health of individuals according to a Stanford University review of 237 studies (a “Meta-analysis”). Organic produce had a 30% reduction in detectable levels of pesticides compared to standard produce. If uncooked organic meat harbored bacteria, those bacteria were 33% less apt to be resistant to multiple antibiotics compared to uncooked non-organic meat. (3)

More than 6300 reports of serious adverse events associated with vitamins, herbs, and other dietary supplements were filed with the FDA from 2007 to mid-April 2012. (The FDA expects 8,160 to be filed by dietary supplement companies in the next three years.)
The FDA has banned only one ingredient, ephedrine alkaloids (ephedra), used in weight loss supplements and implicated in a number of deaths. That took 10 years to do.
The only ingredient in supplements that requires an FDA warning label about adverse effects is iron, because accidental overdosing in children can be fatal. Labeling of potential adverse side effects and/or interactions with other drugs or supplements is extremely inconsistent.(4)
Check out this website for a guide to over 100 dietary supplements: Consumer Reports-Natural Health.

30% of the water consumed in Singapore is recycled sewage water called NEWater. The public accepted it only after a massive public educational campaign and the decision to release the NEWater only by mixing it in with the water in regular reservoirs. (5) Recycled sewage water may soon by on sale in the U.S. under the name “Porcelain Spring”, using Jack Black as it’s celebrity promoter. For other striking facts about the growing water shortage in Las Vegas, parts of California, and a shrinking Lake Mead behind the Hoover Dam check out the movie, “Last Call at the Oasis.

Factor by which the number of American babies born addicted to opiates has increased since 2000:  3
Number of private U.S. citizens killed in terrorist attacks in 2010:   15
Number of U.S. citizens killed by falling TV sets in 2010:   16    (6)

% change in average retail price for drugs from 2007 to 2012 and 2012 cost per prescription:
Crestor (statin) +91%               $214         generic in 7/2016
Lipitor (statin)  +87%                $237      generic available
Plavix (anticoagulant) +84%   $261      generic available
Boniva (osteporosis)  +102%    $240     generic available
Singulair (asthma)  +72%        $205      generic available
Provigil (sleepiness)  +305%   $1,101   generic available   (7)

The rate of infants born to adolescents aged 15-17 years dropped in 2012 from 20 to 17 per 1000.
The percentage of children under the age of 6 years living in a home with a smoker decreased from 15% in 2005 to 10% in 2012.
The percentage of children living in counties with air pollutants above allowable levels increased from 59% to 67%. (8)

In the mid-60’s each patient discharged alive from Massachusetts General Hospital “cost” about $4,000. In 2002 that “cost” was over $25,000 per patient.
Since 2001 the mortality rate of patients hospitalized at MGH has been stable at about 2% “but the cost per patient has escalated dramatically”. This period seems to be characterized by “diminishing returns with growth in costs far outpacing reductions in inpatient mortality”.(9)

References:
1. BMJ 2012 Jan. 24 :344
2.“Aspirin: To use or not to use?” Arch Intern Med 2012 Feb 13; 172
3. Ann Int Med reported in Bos Glob Sept. 4, 2012
4. Consumer Reports September 2012
5.Wired Sep 2012 p.32
6. Harper’s Index June 2012
7. Consumer Reports on Health Sept. 2012
8. Reported in Journal Watch Pediatrics Sept. 2012 
9. N Engl J Med 366:23 June 7, 2012


Vol. 73 September 1, 2012 Two American Medical Care System Miracles

September 1, 2012

Yesterday a friend told me about his own recent medical care “miracle”.

He and his family were finishing up their last day of a two-week vacation on a remote New Hampshire pond (the one, I believe, where the fish called Walter once resided). He was designated to perform an essential rite of passage at the end of their annual visit, the trip to the dump. The dump, of course, is at the outer limits of their township, more remote than their cabin and out of cell phone range.

When he returned to the cabin from the dump he felt the first chest pains. Over the next few minutes they increased, and he didn’t feel or look well. In response to their 911 call the local ambulance raced out on the dirt road and whisked him off to the hospital in Plymouth, NH.

A few minutes after arriving in the ER he received an intravenous “clot-buster” medication and suffered a cardiac arrest! CPR was started immediately, during which he had a seizure. Resuscitation was successful, and a helicopter was called in from a Manchester, NH regional referral hospital. He barely remembers the helicopter ride, but thinks he heard the helicopter pilot getting “clearance to land in 23 minutes” even though the air space was restricted for President Obama’s visit. My friend is a certified pilot and not a supporter of Obama, so, of course, he WOULD remember that.

In the Manchester hospital an immediate cardiac angiogram showed one coronary artery with two narrowed segments, one after the other with a normal segment in between. A stent spanning the two narrowed segments was inserted via his radial artery.

Five hours after the onset of his chest pain and about four hours after his cardiac arrest, he was sitting up comfortably in his hospital bed, fully awake and hungry with a very sore chest from the CPR.

The next day his echocardiogram was normal, he passed his treadmill stress test with flying colors, and he was discharged home.

A week later his chest was still sore as he humbly showed his “before” and “after” angiograms to close friends and colleagues.

What a marvel of electronic communication, modern transportation, presence of trained clinical personnel, and access to state-of-the-art diagnostic and therapeutic equipment and processes.

What superb medical care.

My friend is over 65 years old and is covered by Medicare. He probably won’t even see a bill.

He is the father of three, the grandfather of five, a founding elder of a community church, the medical director of a clinical research center, a retired general surgeon, a member of several non-profit boards of directors, and a so-so pool player. What is the gain in quality-adjusted life years (QALYs) of this event? How could you even begin to calculate it?

How could anyone be against making this kind of medical care available to all Americans?

I heard this story Sunday night as an “oh, by the way” when my friend called to ask my help in arranging a second opinion with a pediatric neurologist for a visiting family.  Their five-year old child had been evaluated elsewhere for left-sided weakness and incoordination. The parents had his medical records, CT scans, and MRIs in hand, and they were looking for a second opinion about prognosis. The only problem was that they were visiting from the U.K. and were returning there in two days.

During my  phone calls to a pediatric neurologist I knew, the Urgent Appointment clinic for pediatric neurology at Boston Children’s Hospital, and the Pediatric Neurology Department at Boston Children’s hospital, I related the short story behind this request for an “urgent” second opinion, and left a few phone messages.. The best I could get, not surprisingly, was a referral to the International Medical Care office of Boston Children’s Hospital for an intake process and a future “second opinion” appointment in a month or two.

I reported this result to my friend on Monday afternoon and remarked how difficult this request would be to fill on such short notice. Later that day he got a call from the BCH Department of Pediatric Neurology with a request for more clinical details. The caller left her cell phone number to call that night after hours, since the family was not then available. The net result: the family went up tp Boston Tuesday afternoon, and received a thorough, reaffirming, and comforting second opinion about their son’s condition from a senior pediatric neurologist. They left for England the next day.

QED: The second American medical care system “miracle” of the week.


Vol. 72 August 1, 2012 Obamacare and the Olympics

August 1, 2012

The Olympics, like Presidential elections in the U.S., occur every four years. Cities, like candidates, compete fiercely and spend lots of money to be the  winner of the “host” contest. No one really knows how much the hosting, or the Presidential term will cost, and no one is ever sure how it wil be paid for. Both always end up costing more than anticipated. The Olympic games, like our Presidential elections, often reflect the state of our world at the time.

The British opened their Olympic Games with a stupendous show that included a celebration of their National Heath Service! It must have been a Socialist conspiracy, something we would expect from China. Can you imagine that ever happening in America!? Medicare is almost as old  as the NHS (born in 1965 rather than 1948), is a great comfort to those over 65, and politicians attack its benefits at their own peril, BUT a celebration of Medicare during the Super Bowl halftime? I don’t think so! Maybe in twenty years.

America does have the best medical care in the world for most people, but I think that we are so busy explaining why it is so expensive and why not everyone has access to it that we never get around to celebrating it. Now that the constitutional fight over ACA has been resolved by the Supreme Court maybe we can begin to celebrate some of its positive aspects.

The extension of coverage on family policies to children up to the age of 26 proved to be so popular that most insurance companies announced that they would provide that coverage even if the court struck down the act. Likewise, providing coverage for pre-existing conditions.

Whether the penalty for not obtaining insurance coverage is a tax or not is still a political football, but the tax (according to the Supreme Court) will amount to about $95 a year in 2014. 26 cents a day seems to be a ridiculously small price to pay for counting on other tax payers to cover your medical bills if you lose life or limb.

Micheal Phelps did not win his record-breaking gold medal in the solo medley event, but did so in the four man relay. His solo event fourth-place finish should remind us all that despite supreme conditioning, a dedicated will, and a stellar record, the body does age and performance decreases. We will all be eligible for Medicare some day. Why not sooner than later if current Medicare subscribers think it so great?. Phelp’s team win reaffirms how performance can improve with the help of trained colleagues. The ACA incentivizes the formation of “Medical Homes” of primary care physicians, nurse practitioners, physician assistants, social workers, and others organized together to deliver patient-centered care. We will need such organizations of physicians and physician extenders.  A significant “unintended consequence” of the ACA, now just being discussed, will be the shortage of primary care physicians to provide the care for the newly insured under ACA.

What about that 5 foot weight-lifter 123 pound that no one ever heard of stepping up and lifting over three times his own weight?! Not much has been said about the Center for Effectiveness Research established by the ACA. It is no five-footer, but is one of those “sleepers” in the Act that could profoundly effect our health care by system by evaluating and publicising the benefits ( and costs) of new technology. Another “small item” in the ACA which may eventually become perceived as a giant is insurance coverage for mental health services, a first.

The Queen’s granddaughter’s equine competition has at least knocked the stories about Romney’s Dressage horse off the TV. Maybe Obama’s grandchildren will compete  in a future Olympics (women’s basketball?). Better yet, the opening show, like this year’s scene of the Queen greeting Mr. Bond, could feature the then-President turning in his chair and greeting his visitor with, “Welcome back, Dr. Berwick”.

By then we may know if Olympic athletes are genetically superior to us mere mortals. I am sure that we will be screening them for “gene therapy”. As Dr. David Jones states in his NEJM article on the medical history of the Olympics, “What’s the limit of human performance? We still don’t know”.

I say ditto for the ACA.


Vol. 71 July 15, 2012 When “Yes” Becomes “No” in Medicine

July 18, 2012

 

“PRIMUM NON NOCERE” – First, do no harm.

This quotation is considered to be the first rule for physicians, but it has a somewhat uncertain origin and a changing definition. The original definition of “harm” became more complicated and variable as medicine accepted the concepts of “risk vs. benefit” and “cost benefit analysis”. Since the values in these concepts are variable, the definition of “harm” has become more variable, more complex, and sometimes more relective of the bias of the definer.

Medicine is both an art and a science, and science, as we know, considers all of its “truths” as tentative. As new data is obtained these truths can change. Here are some recent examples of changes in medical recommendations based on new data AND new elements in“”cost benefit analysis” AND possible bias of the maker of the recommendation.

Men should not be screened for elevated PSA (Prostate Specific Antigen)
The initial excitement about this test for the early (“before symptoms appeared”) diagnosis of prostate cancer has been dissipated by data showing that positive tests (elevated levels of PSA) led to lots of referrals to urologist specialists, lots of biopsies, and lots of invasive surgical and radiation treatment which did NOT result in a reduced death rate or lessened disease burden from prostate cancer. Also, the interventions were associated with a bunch of serious complications.

Prostate cancer is usually an indolent disease. If a man lives long enough it will eventually appear in his body, but will rarely cause death or a heavy disease burden. PSA screening of asymptomatic men who have a normal digital (digital, as in finger) rectal exam and a negative test for occult fecal blood is now considered to cost more (in money, patient inconvenience, and medical complications) than its benefits. The PSA does not identify the less common case of aggressive prostatic cancer at a time that makes earlier treatment more effective.

Women under 50 don’t have to get an annual mammogram.
This 2009 recommendation caused a great deal of controversy because of the long term investments of several “stakeholders” in the mantra “get an annual mammogram to save your life.” But, by 2009, data conclusively showed that in order to save the life of one woman in her 40s from breast cancer, 1,904 women would have to be screened every year for up to 20 years. Because the U.S. Preventive Services Task Force judged that the risks of harm from false positives mammograms, subsequent biopsies, and overly aggressive treatment of indolent lesions that resulted from annual screening outweighed its benefits. Hence, the USPSTF panel’s recommendation that most women ages 40 to 49 need NOT get a routine annual mammogram.

Statins do not prevent fatal heart attacks in healthy people.
Studies in 1999 indicated that lowering cholesterol by taking statins (Lipitor, Zocor, etc.) in people who had had a heart attack reduced subsequent cardiac deaths in those people by 30% and reduced subsequent symptomatic coronary artery disease by 25-60%. This dramatic protective effect of statins in these high-risk patients was extrapolated to people without heart disease or risk factors and by 2008 half of U.S. men between the ages of 65-74 were taking statins. Last year a meta-analysis (a research analysis of a large number of studies) failed to show a reduction of death rates in healthy people taking statins.  “Only limited evidence showed that primary prevention with statins may be cost effective and improve patient quality of life.” (1)  More recent studies documenting the complications and side effects of statin use have also contributed to the change in this recommendation.

Colonoscopy for the prevention of death from colon cancer is no better than, and may be inferior to, flexible sigmoidoscopy.
Not so many years ago your primary physician would perform a screening examination of your lower colon with a flexible sigmoidoscope in his/her office, with just light sedation, no biopsy, and no annoying, rigorous bowel preparation. The reimbursement was modest. Since then, the norm for screening for colon cancer has become a colonoscopy, performed by a gastroenterologist or general surgeon in a hospital or an ambulatory surgical center with sedation heavy enough to warrant the presence of an anthesiologist and associated with an interpretation of the inevitable biopsy by a pathologist. The reimbursement all around is much more substantial.

Both procedures reduce the incidence and mortality of colon cancer, but “as reimbursement moves from fee-for-service to bundled payments for episodes of care, there will be a renewed focus on delivering evidence-based interventions in a manner that optimizes resource use.” (2)

Daily low-dose aspirin does not reduce cardiovascular deaths in healthy people.
Use of aspirin to prevent a subsequent heart attack in people who have already had one DOES reduce their death rate from another heart attack. Extrapolation of this widely accepted fact has prompted many  healthy people with no history of heart disease to take low dose aspirin daily. In yet another meta-analysis of over 100,000 people “at risk for” but not having coronary artery disease, daily aspirin did NOT lower the rate of fatal heart attacks. The rate of non-fatal heart attacks was reduced by 20%, but more importantly the use of aspirin INCREASED the rate of non-trivial bleeding (GI bleeding, stroke, hematuria, and nose bleeding) by 31%, ie. the risks of daily aspirin use outweighed its benefits.
SPOILER ALERT: The study recommends that physicians and patients should decide on a case-by-case basis about whether to continue daily aspirin if you are already taking it. My own physician noted that in several of the international studies in this meta-analysis the dose of aspirin was up to 300 mg a day (one adult aspirin) but that in the U.S. the usual recommended aspirin “low” dose is 81 mg. ( a baby aspirin) daily The higher the dose of aspirin the more likely it is to cause bleeding.

DEET insect repellent is safe to use on anyone over the age of two months.
“The American Academy of Pediatrics states that insect repellents with DEET are safe to use on children as young as two months old.” Apply only once a day, but you can use any concentration from 7% to 25%. The higher concentration isn’t any more effective, but its protection lasts longer. DEET protects against tick bites too.

Statistics NEVER lie, … or can they?
Published medical research produces data that meets statistical standards of “significance” which reassures the reader that the findings are “true”. Meta-analysis studies ( a technique of comparing data results from different studies and treating them as if they are all from the same study) are the current epitome of statistical correlations. The interpretation of statistics, however, is not standardized, and epidemiology (the science of statistics applied to large populations) has been called by some cynics as “the art of lying on a grand scale.”  Here’s an example of the potential pitfalls in interpreting statistics:

700,000 physicians “cause” 120,000 accidental deaths per year for a rate of
.171% accidental deaths per physician per year

There are 1,500 accidental gun deaths per year and 80 million (yes, million) U.S. gun owners for a rate of .0000188% accidental gun deaths per gun owner per year.

THEREFORE, statistically, doctors are approximately
9,000 times more dangerous than gun owners.

We withheld the statistics on ….Lawyers !
for fear the shock would cause people to panic and seek medical attention! (3)

References:
1. Arch Int Med June 2010:170:1024
2. NEJM 366;25 June 21, 2012, pg. 2421
3.  thanks to Bob Harrington for picking this pearl off the web
4. Overdiagnosed: Making People Sick in the Pursuit of Health
H. Gilbert Welch, MD, Lisa M. Schwartz, MD, Steven Woloshin, MD

http://www.beacon.org/


Vol. 70 July 1, 2012 There’s a New “F” Word in Town

July 1, 2012

Care is never futile, but medical interventions sometimes are. (1)

Ten years ago our community hospital’s Ethics Committee spent a lot of time trying to reach a consensus on the meaning and implications of the “F” word. Our context almost always was the ethical dilemmas of end-of-life decisions, renal dialysis, continued ICU care, and mechanical ventilation support. Was it ethical to continue renal dialysis on the Jamaican woman when we considered dialysis to be a medically futile treatment or should we send her back to her country as she requested where it ws not avialable?  Should the young man comatose after being struck by lightening be continued on ventilation support when any further treatment appeared to be futile?

At that time our futility discussions focused primarily on patient or family “demands” to continue expensive therapy with little hope of real benefit to the patient. Our discussions closely mirrored articles in the medical and popular literature at the time, and, likewise, did not result in a consensus of the definition of futility. At a 2003 meeting our Ethics Committee reviewed four different kinds of failed attempts to define futility, 1) by reaching a medical consensus, 2) by using empirical data, 3) accepting patient-defined futility, and 4) accepting physician-defined futility. We could only conclude that sometimes all we could say was, “We feel that further care is futile.” There are three “F” words in that simple sentence. Our attremptd emphasis on feelings never really helped in making the message any easier to deliver, understand, or accept. Trying to substitute one “F” word for another never really stuck to the wall.

With the passage of the Affordable Care Act the context of “futility” discussions has broadened considerably as legislators, insurance companies, and providers struggle with the central problem of how to pay for universal access to all kinds of medical care without using the “R” word.  The most recent example of that changing context is an essay by a MD lawyer advocating the new “F” word of “Frugality” (2).

The author argues that even if and when we reduce medical care costs by eliminating the estimated 30% spent on “wasted or ineffective measures” (3) we will still be facing the apparently inexorable annual rise of medical care costs “unless we start saying no to some beneficial care”. He does not think that the Independent Payment Advisory Board (IPAB) with the authority to change Medicare payment policies, or the Medicare “luxury tax” on Cadillac employment-based health insurance, or the current incentives for new Accountable Care Organizations and insurance companies will be enough to slow the rise of medical care costs. The new “Frugality” will only be achieved by more selective adoption of new technology. This means that after we say “no” to non-beneficial technology “we will need to say ‘no’ to some potentially beneficial new technologies because of imperfect data about clinical effectiveness”.

Daniel Callahan, President Emeritus of the Hasting Centers and one of our most respected Medical Ethics gurus, made the same argument in his 2009 book, Taming the Beloved Beast: How Medical Technology Costs are Destroying Our Health Care System (4) His opinion is that multiple studies in the 1980s-1900s comparing the cost reduction effects of regulation vs. competition are inconclusive, and that there is little evidence that the “business model” of competition works in health care. His solution to reducing medical care costs is to restrict the unbridled introduction of new technology. In his view new technology often raises the cost of medical care without improving health. The answer is rigorous assessment of new technology (both drugs and devices). “Technology assessment must COMMAND, not just COMMEND.”

“Futility” is such a negative, dead-end word. It is the end. “There is nothing more we can do.” It is colored by end-of-life issues, discussion of which are necessary and important, but which have become politicized.

“Frugality” implies a positive value, a process. “Thrifty” made it to the Boy Scout pledge, but it could have been “frugality” just as easily.
Lets hope that “frugality” sticks to the wall.
We shall see.

References:
1.Poncy M. Ethics and futile care. Program and abstracts of the National Conference of Gerontological Nurse Practitioners 25th Annual Meeting; September 27-October 1, 2006; Ponte Vedra Beach, Florida.
2. Beyond the “R Word”? Medicine’s New Frugality, NEJM 366;21, G. Bloche, pg. 1951
3. Implications of Regional Variations in Medicare Spending, Ann Int Med 2003;138, Winneberg, et al., pg. 288-298
4. Princeton University Press, 267 pages


Vol. 69 June 15, 2012 How to Avoid the “R” Word.

June 15, 2012


“We make those decisions all the time. The decision is not whether or not we will ration care — the decision is whether we will ration with our eyes open.” –Donald Berwick, MD

When infinite demand exists for finite resources certain decisions have to be made by those responsible for distribution of the resources. It is called “rationing“.  And that is what is causing all the palaver about reducing medical care costs. Who decides, how do they decide, and how do the decisions get implemented? “Rationing” has become the political lighting rod of that discussion and any politician or candidate (or even Director-designee of CMS) that does not successfully avoid its use is at great political peril.

A recent thoughtful essay in the NEJM advances the case for substituting “avoidance of waste” for the “R” word. (1) Since 30% of our medical care costs go to tests, treatments, drugs, and medical devices that in truth result in no patient benefit (2), the author argues that, at least, we should first eliminate the non-beneficial expenses. Consumer Reports in cooperation with American Board of Internal Medicine and 16 other medical specialty societies has recently published its list of non-beneficial medical activities for us to avoid. They call the campaign “Choosing Wisely”.

Since many very expensive items can be categorized as new technology, the author also argues for a more rigorous standard for the approval of new technology. New technology currently needs ONLY to prove that is safe and that is better than a placebo. There is NO requirement that it show that it has better outcomes than existing technology. This is true for drugs, PET scanners, linear accelerators, organ and bone marrow transplants, cardiac surgery, and all the different kinds of heart vessel stents. Highly technical, complex, and expensive gene treatment (“personalized medical therapy”) is just now peeking at us around the corner.

If a standard of improved outcome for new technology were in place, how would it be implemented? The ACA established the Center for Comparative Effectiveness Research within CMS to gather comparative outcome data and make recommendations, but the ACA also explicitly denies the CMS the authority to use such recommendations in setting Medicare reimbursement rates!

For example, in the very same issue of the NEJM there is an elegant multi-center study that leads to the implementation questions for a less dramatic, not-quite-so-emotionally-laden, but much more common condition than heart transplants and exotic “savior” cancer drugs; urinary incontinence in women. This study showed beyond a doubt that urodynamic testing results on women who go to a urologist because of urinary stress incontinence had no effect on the outcome of the surgery. The surgery is successful 69-72% of the time whether the urodynamic testing is done or NOT. In other words, the clinical judgement of the urologist in the office is enough to indicate who is likely to benefit from the surgery.

The urodynamic testing, with it’s charge in the U.S. of $640-$1503 depending on the insurance company and region, adds no benefit. The article’s authors (all 34 of them) flatly state that urodynamic testing for women presenting with stress incontinence should not be done. (the same conclusion made by NICE, National Institute for Health and Clinical Excellence, in the U.K. in 2006). The article does list four specific instances where urodynamic testing might prove helpful; 1) patients with previous surgery for incontinence, 2) presence of neurological disease, 3) patients planning more extensive pelvic-organ relapse corrective surgery, and 4) urge-predominant incontinence rather than stress-incontinence. All of these definable situations can be documented in the medical record for the few patients who have them.

How could such a reasonable, well-founded recommendation to reduce costs without compromising quality be implemented?

1) Medicare could refuse to reimburse for urodynamic tests in uncomplicated stress incontinence patients. This is without doubt the most direct way to save these costs. Private insurance would soon follow suit after the political and medical backlash quieted down (urodynamic studies are almost always done in the urologist’s office and can represent a significant revenue stream to the office). Current ACA language explicitly prohibits this action.

2) ACO’s could implement a practice guideline recommending avoidance of urodynamic testing before usual stress continence surgery. Any resulting cost savings could be shared by all the physicians in that ACO. Urologists would receive a portion of the savings to offset their revenue loss, and they in turn could ask the other specialties in the ACO, “What have you done for us lately, so that we can share in some of your cost savings”.

3) Physician leaders in the urological specialty and academic centers could support educational efforts to inform their members of the non-benefits of urodynamic testing for most patients and wait for its use to fade away under the weight of replicating, confirming studies, and editorial comments.

This third option is often how our practice patterns currently change, but it is a slow process as shown by our continued discussions of the comparative benefits of open heart surgery or various vascular stents. That this “revelation” about the non-benefits of urodynamic testing has been around since 2006, but still warrants an article published in a 2012 NEJM is another clue about the pace of change. Given the inevitability of rationing and the moral repugnance of doing so with broad-brush budget caps monitored by bureaucrats, arbitrary decisions by non-accountable insurance companies, price-based decisions by for-profit drug companies, age-based discrimination, or by economic or social class classifications, we can only hope that we can find a better way.

Comparative Effectiveness Research under the ACA could develop evidence-based standards to be implemented by ACOs of high quality, cost-conscious physicians who would then share in the savings resulting from their hard work of changing practice patterns appropriately. Otherwise, we may have to settle with our current system of “muddling through” and try to be patient with the plodding pace of change as we watch the treasury run dry.

It might help if we did replace “rationing” with “avoidance of waste”, but I don’t hold out too much hope for that. It will take more than one article and a less insipid term to capture our imagination.

In my next blog on July 1, I will describe how to avoid the “F” word.

Refererces:
1. “From an Ethics of Rationing to an Ethics of Waste Avoidance”, Howard Brody, M.D.,Ph.D; NEJM 366;21 May 24, 2012: p. 1949
2. “The Implications fo Regional Variations in Medicare Spending”, Wenneberg et al., Ann Intern Med 2003;138: p. 288
3. “A Randomized Trial of Urodynamic Testing before Stress-Incontinence Surgery”, Nager et al., NEJM 366;21 May 24, 2012: p.1987


Vol. 68 June 1, 2012 ECMO or Elmo for your child?

June 1, 2012

Nellie is a girl, a twin born 2 weeks prematurely in our pediatric practice. She weighed a beautiful 4 lbs. 10 oz at birth and was very healthly. At her two-month well baby visit she and her brother were clearly thriving in a loving, attentive family. She got her routine DTaP immunization (Diptheria/Tetanus/Pertussis) then. Thirty seven days later she came back to our office after vomiting three times the night before. Both twins were a bit fussy. We determined that the vomiting actually followed and was associated with several coughing spells. Her exam was normal, her lungs were clear, and she did not appear sick in any way.

The next day she returned to the office with difficulty breathing, had signs of pnemonia in her right lung, and was immediately admitted to our community hospital. Overnight in the hospital she developed pneumonia in the other lung and began to drop the oxygen level in her blood. She was transferred to a children’s hospital because she  now required a ventilator to be able to breathe.  The very next day she suffered almost complete cardiac-respiratory  collapse. Her lungs would not work at all. That is when they put her on the ECMO machine (Extra Corporeal Membrane Oxygenator, aka the “artificial lung”). Like a heart bypass machine the ECMO takes blood from the patient, circulates it through membranes with oxygen, and returns the oxygenated blood to the patient. Without that oxygen,of course, the brain and other vital organs begin to die. Her lungs had failed from an infection with pertussis, whooping cough.

Vaccinations nearly wiped out whooping cough more than 30 years ago, but it has made a vengeful comeback in California, Washington, and other states.

Cases of pertussis declined rapidly in the 1940s. The all-time low was in 1976, with only 75 cases reported in the United States. Since the early 1980s, there has been an increase in reported cases of whooping cough.

Why this resurgence?

Vaccination rates are decreasing as more parents refuse to have their children immunized against a number of preventable diseases.

But, that is not the whole story. Most of the new cases in California are in infants under two months of age, too young to be fully immunized (like Nellie). We also know that even with a full series of three to four pertussis immunizations only 85% of the children develop a level of immunity high enough to protect them. There is also recent speculation that the new pertussis cases are caused by a more virulent, mutant strain of the bacteria that can cause whooping cough even in those receiving our current vaccine. Studies have been launched to test that hypothesis.

One thing is clear. “Herd immunity”, protection of an individual infant by immunizing all the surrounding children in the community, is not enough for pertussis. Some states have refined the herd (community-wide) immunity  concept with a more focussed family-wide immunity concept, “cocooning”. Cocooning seeks to reimmunize for pertussis any adult caretakers of the infant, including the pregnant mother and all other adults surrounding the infant. The objective is too avoid any exposure of the infant to the pertussis germ in the first six months of life, or until the pertussis vaccination series can be completed. The easiest thing for adults to do is to get a Tdap (Tetanus/diptheria/pertussis) instead of their next regular tetanus booster—the Td shot – that is recommended for adults every 10 years.

THE OTHER EASIEST THING TO DO IS MAKE SURE YOUR CHILD OR GRANDCHILD GETS IMMUNIZED AGAINST PERTUSSIS STARTING AT TWO MONTHS OF AGE.

Currently there are 17 preventable diseases for which we give immunizations in the first two years of life. In 1980 we only had 7 vaccines. Those 7 vaccines contained over 3000 proteins (aka “foreign protein” by anti-vaccine advocates). In 2012 our more purified vaccines, including acellular pertussis vaccine (the “ap” of Tdap) with only 2 proteins, contain a total of  less than 200 proteins in all 17 vaccines.

Ellie was on ECMO for three weeks. Every attempt to remove her from the artificial lung resulted in a dramatic drop in blood oxygen and ECMO treatment was continued. Her kidneys , heart, and lungs were stressed to the failing point. Finally, her lungs began to recover from the pertussis infection. Yesterday they put her twin in the ICU bassinet with her, and her vital signs calmed right down and became even more stable. The two looked like they just “chilled out together” as twins do. Today she will have her breathing tube removed. We antiicpate that she will breathe on her own and continue to improve. We all wonder how her brain fared during all this stress. We shall see.  Some of us wonder what all this intensive care cost?

Make sure you do everything you can so your children to get to know Elmo rather than ECMO.

Let them have their immunizations!


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