nos-trum. pronunciation: \nos'-trum\. noun. Etymology: Latin, neuter of noster our, ours.
1. a medicine of secret composition recommended by its preparer but usually without scientific proof of its effectiveness.
2. a usually questionable remedy or scheme.
See here for more discussion.

Thursday, March 31, 2011

Despite No Demonstrated Success We're Pressing Ahead With Accountable Care Organizations

 
The head of Medicare appears to say (IMO), "We're pushing ahead with Accountable Care Organizations (ACO) even if it costs more and doesn't improve quality."

Readers who looked closely at my posts on outcomes-oriented and performance-based approaches to health care have seen analyses and research studies that show they don't work...at least the way they are being implemented.

ACO's are another term for these efforts.  They wrap a health care team around financial incentives to be more efficient and reduce cost by paying more when certain standards of quality are met.  In other words, doctor groups that don't improve care or reduce cost will make less.  It's all about incentives...i.e., money.

Unfortunately, as I wrote, the government's demo of this concept under Obamacare provided too little in bonuses to pay for the initial investment over the first three years, and was unlikely to get better into the coming years.  All this, despite the fact that the Demonstration Project under HCR cherry-picked big, successful doctor groups to show how ACO's could work.

Dr Berwick, the President's recess appointment to run Medicare/Medicaid (remember?  it was feared his controversial beliefs would undermine Senate confirmation of the appointment) published a commentary in this week's New England Journal of Medicine (NEJM, Mar 31) that basically says, "Don't sweat the fact that the companies lost money:"
"What can we reasonably expect of the coming wave of ACOs? We know that not all previous efforts at developing a model of shared savings have met expectations."
But we're pressing ahead because it's the best "right" thing that we haven't figured out how to make work or achieve it's stated goals.

In the commentary, Dr. Berwick's nod to the demonstration product as having only achieved "modest" savings is Political Speak.  It means, "Yes, it didn't work, but we think it still will, despite the fact that we picked the doctor practices that we thought would surely succeed and even they can't recoup their investment in the ACO process."  For us simple folk, the businesses lost money.

I've written about Dr. Berwick's organization (The Institute for Healthcare Improvement) and it's Patient-Centered Care concept before.  See here for a criticism of what that means to the patient's ability to choose the care they need and want.

Several months after writing about it, I still think that Americans don't want Patient-Centered Care.  They want Patient-Directed Care.

Doc D
 

Tuesday, March 29, 2011

Accountable Care: Another Performance-Based Flop

 
Accountable Care Organizations (ACOs), the latest brain child to improve quality and lower cost, fail at both.

A short time back I wrote about a large scale study in Great Britain that looked at whether switching to a Pay For Performance (PFP) method of reimbursing health care would be an incentive for doctors and other providers to give better care in treating people with high blood pressure.

Economists are always trying to work incentives.  In this case it's simple:  your patients do better and you get paid; if they don't, you receive a bite out of your wallet.  The GB study looked at 500,000 patients over a six-year period:  three years before PFP, then three years after PFP.

PFP had no impact on how well blood pressure was controlled or whether the patients had complications of the disease.  Not a bad study, and a real kick in the rear for those who think quality can be engineered by dangling payment or not-payment as an incentive.

The study looked only at whether PFP had an impact on the quality of health care, not cost....the other Great Benefit that performance and outcome-based payment systems are supposed to bring about.

Now comes an analysis of cost in a similar setup, resulting from the PPACA (Patient Protection and Affordable Care Act)--i.e., the health care reform law, or Obamacare, take your pick.

The government selected a group of large, well-financed practice groups--Physician Group Practices, or PGPs)--to test the ACO concept (ones that could absorb a loss and still look OK).  The group practices were offered standard Medicare rates, plus the chance to earn more by meeting certain performance standards.  These extra payments were referred to as Shared Savings.

Writing in the New England Journal of Medicine (Mar 23), the authors looked at whether the selected groups were able to recover the initial investment in an ACO (~$1.7M on avg) over the first three years.


The answer was NO.
"The available data indicate that 8 of the 10 PGPs in the demonstration did not receive any shared savings payments in year 1. In the second year, 6 of the 10 practices did not receive such payments, and in the third year, half the participants were still not eligible for any shared savings to offset their initial investment. Given that the percentage of shared savings in the first 3 years was so low for experienced, integrated physician practices, it seems highly unlikely that newly established, independent practices would be able to average the necessary 20% return on their investment."
Both your clinics and mine, plus the insurance industry, are looking closely at moving toward such methods for improving health care quality and reducing cost.  Billions are being spent pushing the idea by thinktanks and the government.  The authors make a great point about testing assumptions FIRST, before adopting policy changes that implement them.
"For policymakers, the urge to do something must be tempered by the risk of disrupting the entire value-based–purchasing movement. We are concerned that physicians and providers may unwittingly undermine future value-based–purchasing efforts if the ACO model fails to live up to the high expectations that do not comport with the data."
This is another pernicious result of Health Care Reform, not unexpected under a major overhaul that was rushed through by incompetents to score an ideological victory.  See my Poison Pill series for more examples.


The politicians get re-elected, the government bureaucrats find more make-work for themselves, costs continue to climb, and care doesn't get any better.

What more could the sick and injured ask for?

Doc D
 
 

Monday, March 28, 2011

Antibiotics For Cough And Phlegm

 
A European study says that patients who come in with a cough and phlegm from a "lower respiratory" illness don't do any better with antibiotics.

But medical practitioners typically give antibiotics for yellow or green phlegm.  The thinking has been that if there is a purulent (pus-like) phlegm then the disease is bacterial.  Ergo, you give antibiotics.  Many health care providers think that clear or white phlegm is due to allergy or viruses...for which antibiotics are useless, and if prescribed, risk adverse reactions.  For a news article, go here.

If I remember the research from decades ago, the theory that the character of the phlegm provides treatment guidance was shown to be false.  That is, coughing up a gross-looking phlegm could still be viral...or represent bacterial colonization that wasn't related to the illness.

However, it's not as easy (particularly in the US) to convince patients that without any treatment they are going to get well just as fast.  Psychologically, people want an "action taken," and it's hard to make the case that doing nothing is best.

The researchers say that the severity and duration of symptoms doesn't change when antibiotics are used.

For Onion Peelers,
Patients producing discoloured sputum were prescribed antibiotics more frequently than those not producing sputum (OR: 3.2, 95% CI: [2.1, 5.0]), unlike those producing clear/white sputum (OR: 0.95, 95% CI: [0.61,1.48]). Antibiotic prescribing was not associated with greater rate or magnitude of symptoms score resolution among those who: produced yellow (Coefficient: 0.00, p-value:  0.68) or green sputum (Coefficient: −0.01, p-value: 0.11); reported any of three categories of feeling unwell; produced discoloured sputum and felt generally unwell (Coefficient: −0.01, p-value: 0.19).


It's hard to tell how the patients were selected and the study abstract doesn't say what kind of "lower respiratory" diseases were present.  Clearly, some cases of severe pneumonia or chronic bronchitis require antibiotic treatment, or these patients could succumb.

So it's hard to validate their conclusion without access to the raw data and methods.  We haven't heard the end of this.

While we need to reduce unnecessary drug prescribing in this country, I don't think it's going to change providers' treatment preferences...or patient's expectations.

Doc D

 

Friday, March 25, 2011

STUDY: Cruise Ship Virus, Passengers Got It But The Crew Didn't

 
Interesting piece of research that looked at a norovirus outbreak from a cruise ship in 2009.

This was an epidemiologic study (Clinical Infectious Diseases, Mar 22).  The researchers sent a survey to passengers who had been on board during the outbreak.  They got a great response:  83% returned the survey.

Of those who returned the survey, 15% were classified as meeting the diagnosis for norovirus.  There were 1842 people on board, so guesstimating about those who didn't return the survey that's about 250 total cases.

Some of the findings were what you would expect from a highly contagious disease in a confined population:  greater likelihood of illness if a cabin mate was sick, increased risk from being berthed on the same deck where the outbreak began, etc

But a couple of interesting things:

--There was increased risk of disease if berthed or dining in proximity to a vomiting incident that occurred during boarding.  I assume this constituted the index case, from which the outbreak spread.  It's hard to see how this would occur:  was everyone standing around when somebody threw up?  was the clean-up not sanitizing?  How did oral transmission occur at that point...from helping the ill individual?

--Crewmembers were much less likely to get ill:  less than 1% as opposed to the 15% of passengers.  The authors speculate that separate berthing, dining, and passageways for crew could explain it....or the crew was more likely to be immune from previous illness with the virus.

This disease, and others like it, spreads so rapidly that increased sanitary measures once the outbreak is identified are not often effective.  It's too late to start frequent hand-washing and avoiding ill persons once things have gotten rolling.

There's just no substitute for good sanitation and hygiene as a lifelong habit.

Doc D
 
 

Dr. Oz Stirs The Radiation Hysteria Pot

 
One last stab at dealing with radiation hysteria.

I hope you're as bored as I am at this point with all the news media attention to "detecting" radiation at various points around the globe.

Friends and family have been writing me.  One of these was to inquire about Dr. Oz.  I don't watch these shows, but apparently, the Great and Powerful Oz had a segment on x-rays and increasing risk of thyroid cancer.  There's a shield for the thyroid (like the lead apron) so that the neck is covered during an x-ray.  You can request its use, but a lot of dentists don't use it all the time, only when the patient requests it.

Here's why.  If you want a thyroid shield for a dental x-ray, you should wear the shield when you go to the beach for the day, or when you fly in an airliner.   The radiation dose is about the same.  And it's "cumulative lifetime radiation exposure" that is the real measure of cancer risk.  So if you get 0.001 millisieverts of exposure from a dental x-ray, but your routine background exposure from just living on the planet is 2.4 millisieverts per year (on avg), you can see that the dose is trivial:  the radiation you experience everyday for a year is 2000 times what the dental film delivers.

There's a great Op/Ed piece from yesterday at Forbes.com (here) by climatologist Patrick Michaels.  A couple of quotes:
People stay up at night worrying about the 5% increase in sunburn-causing radiation as a result of stratospheric ozone depletion, and the next morning go to the beach and expose 95% of their skin to the same rays.
and, in regard to the model of exponential decay with distance from an environmental exposure (radiation or pollution, take your pick),
At a 2 mile radius, there's only one-fourth of the concentration there is at one mile. At 10 miles, a hundredth; at a thousand, a millionth--all of which simply proves that there will never be a health effect from Fukushima found in California.
I'm not sure how much more income the news networks can milk out of this false issue, but they'll keep trying as long as people tune in.

Doc D
 
 

Wednesday, March 23, 2011

SUPREME COURT: Cold Remedy Liable For Not Reporting Unproven Adverse Reaction

 
Once again we see a problem arise from categorizing Complementary and Alternative Medications (CAM) as not requiring FDA approval before marketing.

Most people know that Congress gave makers of herbs and complementary medicines a free ticket to market their stuff.  They don't have to go through the drug approval process that every pharmaceutical must weather. The only way a harmful CAM product can be restricted is when enough anecdotal reports of injury or death surfaces by word of mouth.  Then, the FDA can take action.

So when the makers of Zicam, an over-the-counter (OTC) cold remedy that's marketed as a "homeopathic" medicine, learned through customers that a few patients experienced anosmia after using the nasal spray, they were under no regulatory requirement to identify the problem.  Anosmia is the term for losing your sense of smell; something you don't think of as very important until you don't have it.

[BTW, if you used Zicam (no longer sold), know that homeopathic "remedies" consist of serial dilutions of the active ingredient to the point where no, or almost no, molecules of the substance is still present...in this case zinc.  Wikipedia says that "Some of the homeopathic ingredients used in the preparation of Zicam are galphimia glauca, histamine dihydrochloride (homeopathic name, histaminum hydrochloricum), luffa operculata and sulfur.  I haven't a clue what any of these would do to your nose.]

The number of anosmia reports was few and in the opinion of the manufacturer, Matrixx Initiatives, not "statistically significant."

The Supreme Court said (NY Times Health blog, Mar 22) that a lack of statistical significance doesn't let you off the hook as far as liability.  Unusually, the justices were unanimous.

I have mixed feelings about this.  Statistical significance, if properly measured, is very important to determining whether an effect is real...or just a coincidence.

However, I'm not impressed with manufacturers who are not regulated deciding for themselves how and when statistical significance is reached.

There's this big book--so big it's almost unusable--that all doctors have, called the PDR...which stands for Physicians Desk Reference.  It includes every possible side effect and adverse reaction for every pharmaceutical that's marketed in the US.  If it was a list of only those things that are connected to taking the medicine, then it would be useful.  However, drug manufacturers use it as a CYA (cover your you-know-what) document, and include every single thing that any patient has ever reported.

So the book ends up having a list of adverse reactions a mile long for the most innocuous drugs.  Most of the reactions don't have anything to do with the drug, but the manufacturer--if he's ever sued--can say, "It's in the PDR and your doctor was informed."

For an (exaggerated) example, it's important to know that blood pressure medicine X can cause low blood pressure when taken with certain other medications.  But if somebody reports getting belly button lint after taking it...it will be listed  in the PDR.  We just ignore most of the junk like this.

The funny thing about this Supreme Court case is that the anecdotal reports of anosmia surfaced, and patients were warned about it.  The plaintiff in the case is not a patient, but an investor who lost money when the warning about anosmia was issued, and lost money.  The plaintiff filed suit not for product safety, but for securities fraud.  Crazy in America.

Justice Sotomayor wrote
“Given that medical professionals and regulators act on the basis of evidence of causation that is not statistically significant...it stands to reason that in certain cases reasonable investors would as well.” 
So Matrixx Initiatives, who alleged that since the reports of anosmia--which they had known about but not revealed--were not significant, they weren't obligated by law to report them, took it in the shorts.

If Complementary and Alternatives Medicines (CAM) had a regulatory process parallel to pharmaceuticals and medical devices, none of this--neither securities fraud nor product safety issues--would have arisen.

Another Poison Pill from our country's approach to CAM.

Doc D
 

Monday, March 21, 2011

Comparing Health Risks Requires Understanding Of Biology

 
This is a Food-For-Thought post about judging potentially harmful health effects.

Suppose I tell you that exposure to something carries a negligible risk of serious harm, one in a million, say.  Now I tell you that 100 million people are going to be exposed to that risk.  Does it make a difference to our perception of risk--that is, do we take action to prevent it--because now there are, on average, 100 people in that 100 million who will experience that harm?

If you look at the question from the point of view of yourself, as an individual, and realize that there are thousands of things you are routinely exposed to every day with orders of magnitude greater risk (1 in 100,00 for instance...which is close to the risk of a dying in a car accident), the risk is non-existent because it's so small...to yourself...and in the larger scheme of total risk.

If you look at the big picture of those 100 in the total of 100 million and think, "This is a measurable level of risk to individuals that is morally wrong to tolerate,"  and assuming that something can be done to remediate it, you would want to eliminate the risk.

What makes one person see a given risk as not worth considering, and another person as a risk to correct?

Before concluding that this is an unrealistic hypothetical, consider that the body scanner at the airport delivers a very small dose of ionizing radiation.  The measure used is "sieverts" (the parallel of "meters" for length and "grams" for weight).  Radiation exposure is a lifelong cumulative risk; a single exposure isn't a causative event, it's the total amount you recieve over a lifetime that increases the risk.  You receive about 0.0001 millisieverts from a body scanner (one ten-thousandth of a millisievert)

--You receive about the same dose from flying at 30,000 feet in an airplane for two minutes.

--You receive about 2.4 millisieverts a year, just from living on the planet due to bombardment of the earth with radiation...called background radiation.  This can vary from 1 to 10 millisieverts a year depending on where you live.  Background radiation alone will cause 1 in 100 to dies of cancer (the cumulative effect of going to the beach, flying, and just being on the earth) according to one expert.  See here for a discussion.

--You receive about 10 millisieverts from a CT scan to detect cancer.

--People living in Tokyo are being exposed to 0.001 millisieverts.  That's one-thousandth of a millisievert, again, for clarity).  Note that this is 150 miles away from the affected reactors.

Now, back to my hypothetical.  The risk of cancer from an airport body scanner is about 1 in 80 million...even lower than my example of 100 in 100 million.  Given the magnitude of routine exposures above, and the cumulative nature of radiation exposure risk, does an airport scan worry you?

Yep, it adds a miniscule amount to the lifetime total.  But you could get body scanned a hundred times and not reach the dose obtained by a day at the beach.  A CT scan is the equivalent of four days living on the earth.

[By the way, there are alternative airport scanners that use millimeter wave scanners--using radio waves--to scan the body instead of ionizing radiation.  The two types of scanners cost about the same]

To carry this further, are you worried about radiation from Japan?  By the way, the half-life of radioactive iodine is about eight days.  Most of what leaked from the core container has already decayed.

My theory is that so few people understand the biology of how radiation affects our bodies that it becomes a boogey man, something to panic over.  The less we understand, the greater our belief that it's deadly.  The philosopher Montaigne once said,
"Nothing is so firmly believed as that about which we know the least."
Radiation is a real hazard, but only if you're standing near the leaking core container in Japan.  Conflating that hazard with radiation hazard from medical treatments and airport scanners is comparing (in size) a grain of sand to Mt Everest.

Doc D
 

Saturday, March 19, 2011

Medical Quotes Of The Day - 19 Mar 11

 
Here's a few of those "A _____(fill in the blank) a day, ...."  sayings:


--A pill a day keeps the stork away.


--If a smile a day will keep the doctor away... Here`s Mine!

--A condom a day keeps AIDS away.

--An apple a day makes 365 apples a year.

 
 
Doc D
 
 

Friday, March 18, 2011

Idiotically Unnecessary Guidance: WHO Says People Arriving From Japan Are Not A Radiation Risk To Others

 
I started to write a short note on just how weird and panicked you have to be to think that someone who has been in Japan would bring back some radiation that could affect their neighbors.  See here.

Where would it come from? Their luggage? On their breath?  In their pocket?

Anyway, I'm speechless.  So, I'll let it go at that.

Doc D
 
 

Media Goes Nuts Over "Pear" Versus "Apple" Body Fat

 
Almost every news outlet today is breathlessly touting a study that just appeared showing that it doesn't make any difference whether your body is apple-shaped or pear-shaped in regard to risk of heart disease.

This flies in the face of years of studies that showed, if you're apple-shaped--body fat centering in the abdomen instead of the thighs--you're toast.  See here for a news article that's typical of the now-contested guidance.

Remember the Peter, Paul, and Mary song, A'Soaling?

Apple, a pear, a plum, a cherry
Any good thing to make us all merry.

So, they were wrong.  Fruits, at least in regard to their shape, don't make us merry.

Now I'm confused and it really puts a wrinkle in my efforts to transfer my abdominal...uh...girth...to my thighs.  I've been massaging downward for years (to little effect, I might add).

What does the actual study (The Lancet, Mar 11) say?  First of all, they controlled for a lot of other variables like age, sex, smoking status, high blood pressure, diabetes, high cholesterol.

For Onion peelers,
Serial adiposity assessments were made in up to 63,821 people (mean interval 5·7 years [SD 3·9])...Addition of information on BMI, waist circumference, or waist-to-hip ratio to a cardiovascular disease risk prediction model containing conventional risk factors did not importantly improve risk discrimination (C-index changes of −0·0001, −0·0001, and 0·0008, respectively), nor classification of participants to categories of predicted 10-year risk (net reclassification improvement −0·19%, −0·05%, and −0·05%, respectively).

That's a lot of measurements in a lot of people, and not one jot of difference.  But this won't settle the question; one study does not the truth make.

For now, though, I'm pushing "fat location" to the back of my risk-filled dinner plate...so to speak.

Doc D
 

Thursday, March 17, 2011

Record-breaking Longevity In The US. 78 Years And 2 Months

 
Great news, if you were born last year.

Lots of news stories today about the CDC's just-released report on life expectancy in the US.  Most articles mention that the new record for average length of life applies only to those born in 2009.

Be that as it may, there is a gold mine of information in the preliminary report.  For instance:

1.  The usual gender and ethnic gaps are still there:  you still have an advantage if female and white.

2.  Suicide made it into the Top Ten causes of death, which aced out septicemia for the 10th spot.  Living longer, but not happier, I guess.

3.  Death rates for 10 of the top 15 causes dropped.  The biggest decreases were in heart, lung, and stroke.

4.  Fewer overall deaths by 2.2%, but fewer births overall by 3.1%.  As an exercise, figure out why this alone doesn't mean that population growth will slow.

5.  Infant death rates from maternal complications and accidents went down, 7.5% and 8.5% respectively.  The overall infant death rate has fluctuated over the last 10 years.  The top three causes remain the same:  malformations, prematurity, and SIDS.

None of this data takes into consideration innovation or breakthroughs in treatment or prevention.

Just imagine what could happen if the following developments--already in the works--should prove effective:  a vaccine for all strains of influenza (#8 cause of death), pancreatic stem cell replacement for diabetics (#6), a gene therapy that reverses the symptoms of Parkinson's disease (#14).

The planet's gonna get awful crowded.

Doc D
 

Wednesday, March 16, 2011

Are Americans Getting Fatter Or Not?

 
Well, yes and no.  This is confusing.

My Just-Arrived-In-The-Mail issue of the New England Journal of Medicine has a commentary on what's going on with obesity in this country (not yet available online).

Consider the following quotations from that article:
"state-and national-level data from the 2009 Behavioral Risk Factor Surveillance System...showed increases between 2007 and 2009 in the reported prevalence of obesity among adults--a 1.1% increase nationally, or an additional 2.4 million or so obese adults."

"Results from the CDC's 2007-2008 National Health and Nutrition Examination Survey suggest that the prevalence of obesity among women (35.5%) and children 2 to 19 years of age (16.9%) has remained stable over the past 10 years and that the prevalence among men (32.2%) has not changed significantly since 2003."
You can see the confusion.  I've written before that maybe we've "peaked out" on weight gain in those who are susceptible, or that the obese are getting more obese, but those who are not susceptible are keeping weight gain in check...but it's just speculation. 

While the authors mention this, there are other likely explanations.  Some are methodological:  one set of results is from measurements (the second) and the other is from self-reporting (the first).  Self-reporting is frequently distorted, particularly if some opprobrium attaches to a positive self-assessment.  Some are congratulatory:  our efforts to reduce obesity are having some impact.  I don't believe it.

Apparently it's not in doubt that the obese are getting "up there."  The fraction of obese people who are grossly so--350 pounds and up--is growing.

We don't need to get distracted by seemingly contradictory data reporting.  The fact is, this is a critical public health problem and we don't have a good way to address it.  I've written that IMO, dietary laws are futile (here, here, and here).

From a preventive medicine specialist's perspective it's the most frustrating problem of all.  There's no pill to take (there are some, but I dispute the wisdom of these treatments), the surgeries work for only a while (same dispute with the wisdom).

And there ain't no vaccine.

Doc D
 
 

Peope In CA Taking Potassium Iodide To Prevent Radioactive Iodine-Induced Cancer From Japanese Nuclear Accident

 
You've GOT to be kidding.  How many thousands of miles is it to Japan?

At first, I thought this was a joke, but then I saw an article on Kevin MD from Kevin himself.  He reports that pharmacies in California are running out of potassium iodide pills.

Guess what? The kind of radioactive particles that leak from reactors don't zap with the speed of light into the far reaches of the galaxy instantaneously.  They mostly fall to earth near by.

Worse, the media has jumped on the Panic Bandwagon and USA Today is telling people that they have to begin taking iodine several weeks before exposure to radioactive iodine in order for the radiation-induced cancer to be prevented.

I'm still astonished at the degree to which we--as a species--panic about things.

Let's review our past.  Some of these things seem laughable now.

1.  In the Fifties, families dug atomic bomb shelters in their back yard and stocked them with months supply of food.

2.  After the Three Mile Island reactor leak, measurements were taken of radioactive material in the vicinity of the reactor.  Only trace--and harmless--readings could be detected within a quarter-mile radius of the faciilty.

3.  In the early years of AIDS, an orthopedic surgeon was quoted as saying, "It's not a question of IF I get the disease, it's WHEN I will get it," predicting that everyone who touches someone with the disease would contract it.

4.  In the 1970's after several decades of a reversal of global warming, scientists were speculating that we were entering a new Ice Age.  It only took 30 years for them to "do a one-eighty."

5.  When Saddam lit the oil fires during Desert Storm, predictions were that the enormous smoke cloud would drift over Europe and change the climate for decades.  By the following year, there was no trace that the fires had ever occurred.

6.  When five people were killed in an anthrax attack some years ago--carried through the mail and confined to a single chain of mail handling--tens of thousands of people across the country wanted their doctors to prescribe the antibiotic Cipro, so they could take it...just in case.

7.  When the Gulf Oil Spill occurred last year, experts predicted untold damage to the ocean environment, until researchers discovered a bacteria in the depths of the sea that eats oil.  Oh yeah, we forgot that oil has been spilling into the ocean for hundreds of millions of years from earthquakes and the like.

There are many more.  The book to read is, Extraordinary Popular Delusions & the Madness of Crowds, by Charles Mackay, first published in 1841.

And, by the way, if I see another news story in the media explaining reactors and radiation effects, I'm going to commit seppuku.

Let's all take a deep breath, calm down, and use common sense.  The Japanese people have a definite public health problem to prepare for.  But we here in the US should probably spend our time looking at OUR reactors near the coast line (if we have them) for vulnerability to damage.  That would be more helpful than wasting money on iodine.

And, as the Kevin MD article says about taking potassium iodide without a clinical need, "there are side effects as well, including inflammation of the salivary gland, allergic reactions, and gastrointestinal side effects."

So, if you're worried about radiation effects, and want to take a pill, don't take iodine, take a Valium.*

Doc D
 
 
*Note.  For the litigious:  this is not a medical recommendation...it's sarcasm.
 
 

Tuesday, March 15, 2011

CITATION: Some "Healthy" Foods Aren't

 
This is just a quick note referencing another article on how we develop a false black-or-white view of nutrition.

Some foods are bad for you; some are good.  But mostly they all have their good and bad points.  The OC Register Healthy Living blog (Mar 15)  talks about some of the ones we think are healthy...and for which we need an attitude adjustment.

Please go here and read the article for explanations.  But these are the "5 healthy foods (and a water) that aren’t so healthy."

1. veggie chips
2. granola cereal
3. turkey hot dogs
4. vitamin-infused waters
5. wrapped sandwiches
6. couscous

The original source for the nutritional information is Consumer Reports.

You can eat these things and it's not going to kill you.  The "killer" is a fanatic belief in the virtue of any rigid approach to nutrition.

Doc D
 
 

Monday, March 14, 2011

Top Five Posts - March Edition

 
The Top Five Posts Over The Last Two Months.

In rank order:

1. Narcissists No Longer Have A Narcississtic Personality (?) (30 Nov 2010) --a repeat Top Five.

2. Fears Of Radiation From Electrical Utilities "Smart Meters:"  You Have Just Entered The Twilight Zone (2 Feb 2011) --classic woo.

3. Doctors Get Sick, Too...My Appendicitis Story (29 Jun 2010)  --This post has been in the top five since day one.

4. Harvard Prof To Explain HCR In A Comic Book...Huh? (9 Feb 2011) --glad I didn't go there.

5. What's The Difference Between Lice And Bed Bugs? (19 Sep 2010)  --a multiple-month winner, probably due to the yuck photos.


As ever, thanks.

Doc D
 
 

Why People Disbelieve The Science...Often Strongly So.

 
Beliefs about issues like vaccination are driven by cultural values not scientific evidence.

Such is the theory of risk proposed by researchers like Dan M. Kahan, of Yale Law School, who has written on the conflict that develops when all the scientific experts agree but some members of the public do not (and vehemently so).

This came up in an article in the Wall Street Journal Health Blog two days ago (Mar 12).  The original article concerned the "clash" between patients and scientists over a suspected viral cause for chronic fatigue syndrome (CFS).  Almost everyone has heard of CFS:  a debilitating and chronic syndrome, the etiology for which doctors and scientists have been speculating and experimenting for decades.  The literature, advocacy groups, and blogs are littered with ideas, allegations, hypotheses, and claims.

Desperate for a cause and a treatment, patients have alleged conspiracies to cover up evidence that the syndrome is a definable disease with a specific cause, and at the same time have suffered the ignominy of disbelief and disparagement by the public...and sometimes, doctors.

Along the way, quacks with remedies and healthy people who want to jump on the bandwagon to explain their life stress have muddied the waters and confused patients and public alike.

Desperate people are the most vulnerable to quackery.

The fact that XMRV--the suspected virus--has only been associated with CFS in one or two small studies, but other investigators have not been able to reproduce those results, drives the desperate to want an answer NOW.  Scientists, knowing that initial studies are often a red herring, want to be deliberate and systematic.

See the blog for more detail on CFS.  At one point the article branches off into why people sometimes strongly disbelieve the empirical data (as in the autism-vaccine debacle).  One theory, and a good one to explore, is that people develop belief that accords with their values over the evidence.  From one of Kahan's papers (on the controversy over requiring adolescents to take the Human Papilloma Virus--HPV--vaccine) found here (on SSRN):
"The cultural theory of risk asserts that individuals selectively attend to risks and related facts in a way that reflects and reinforces their "cultural worldviews," or preferences about how society should be organized (citations).  If this process is at work in the HPV vaccine debate, those on both sides are advancing the positions that they honestly believe promote the health of girls and young women. Yet the reason that they hold those particular beliefs is the congeniality of one or another set of risk perceptions to their preferred vision of the good society."

The science is clear that HPV vaccine is safe and effective against several strains of the virus that can lead to cervical cancer, that HPV infection is spread as an STD, and that the vaccine can interrupt the chain of transmission in many cases.

Kahan relates the HPV story to other controversies such as gun control, and links the resulting conflicts to the cultural theory of risk.

Both the blog article and the paper referenced are recommended reading.

Doc D
 
 

Sunday, March 13, 2011

Taking Meds For Hair Loss And Feeling Limp?

 
A quick note for males in the audience.

I noticed this article in USA Today"s Health blog (Mar 12).

Avodart, Proscar, and Propecia are drugs in a single group called 5-alpha reductase inhibitors.  They are used to treat difficulty urinating due to prostate enlargement....and hair loss.

The review referred to in the blog article can be found here.  The pertinent result (quotation is from the blog link above) was:
"About 8% of men taking the drugs reported erectile dysfunction, and 4.2% reported reduced libido, they found, compared with 4% and 1.8% of men receiving placebo, respectively.  Reduced ejaculation and semen volume and depression were also reported by some men, the researchers note."
The point is, there are almost no beneficial medications that do not have other, often unwanted effects.

Therapy, particularly for esthetic reasons--like hair loss--should be approached with caution (see my post on the German celebrity who died from her sixth breast augmentation.)

Sometimes accepting nature's cruel blow is the better course.

Doc D
 
 

Who's In Charge In Congress? The Staffers?

 
The media reports that a Congressional staffer who was a major player in drafting the health care law has admitted privately that the law was not what the Senator (Kennedy) wanted, but "what I wanted."

I doubt most voters know that the staff frequently does what THEY want, not necessarily what their boss, or the people who elected her/him, want.  For the reporting that alleges the claim above see Politico here ("Orrin Hatch: Ted Kennedy wouldn't have wanted health care law")

I remember studying this in my MPH masters program.  There's a great book called The Dance of Legislation: An Insider's Account of the Workings of the United States Senate , by Eric Redman, now considered a classic.  Redman served on the staff of Senator Magnusson (WA) several decades ago.  His book focuses on a single piece of legislation, the 1970 National Health Service Bill (ironically a health care reform effort), and tells the story of
"the maneuvers, plots, counterplots, frustrations, triumphs, and sheer work and dedication involved. He provides a vivid picture of the bureaucratic infighting, political prerogatives, and Congressional courtesies necessary to make something happen on Capitol Hill" (publisher blurb).
If you watched the ugly process we observed in 2009 (the Cornhusker Kickback, and the Louisiana Purchase to mention only two of hundreds), and wondered how all this stuff goes on, this is the book to read.  It's hard to make legislating read like a thriller, but this comes close.

What struck me the hardest in the book is the primary role that the Congressional staff plays.  They do the work of interacting with special interests and lobbyists, negotiate with other members' staff, direct or perform the actual writing of the legislation, and promote the product to the elected member.

It's almost like they are the legislators...and the Congressional members are "front men" (and women) that are the political and vocal "face"... but not the substance of what gets done.

Shocking, really.  The book is still available from online retailers.

It helps to know that staffers begin their career (generally) as young college graduates with little to no experience of the subjects they are charged with managing (taxes, welfare, health care, agriculture, etc).  They usually have a poli sci degree.   The senior staff who've been around for 10 years or more have soaked up knowledge, but what knowledge they have is all linked to the political process they have lived every day.

[A personal anecdote of working with Congressional staffers.  I was involved with physician manning for the military back in the 90's.  We explained to the staff that we were short of orthopedic surgeons.  One young, pimply-faced staffer said, "The answer is simple; we just make all medical graduates go into orthopedic surgery."  This is the quality of thinking that's typical.]

And this partially explains why our government adopts such incompetent policies.

Doc D
 
 

Friday, March 11, 2011

Medical Cartoonville - 11 Mar 2011

   
One of Dr. Val's great cartoons.
 
 
 

Doc D
 
  

Thursday, March 10, 2011

The Health Care Reform Waiver Lottery: Now Entire States Enter The Game

 
The state of Maine received a waiver from a key provision of the HCR law.  Other states have similar requests in the pipeline.

I read in The Hill yesterday that as of last week the Department of Health and Human Services (HHS) has granted 1040 waivers to organizations that say they are unable to meet the minimum coverage requirements.  By contrast only about 50 waiver requests have been denied.  This is another effort to postpone the toxic effects of the law; the last several months have seen numerous efforts to delay requirements until after the 2012 elections to minimize disruption that could cost an election.  See here on the delay in W-2 reporting that was required in the law; and recall the delay announced in shrinking Medicare Advantage programs and HSA accounts.

Maine received a waiver from the requirement that insurers spend almost all their revenue for actual health care services (as opposed to running the business, administrative costs, and--presumably--executive bonuses).

Allegations are that some of the waivers are politically motivated.  That is, the Administration is favoring unions and other political supporters.  I haven't seen any data that supports that yet; although one report said that Service Employees International Union (SEIU) received one of these waivers.  HHS claims that the waivers are primarily going to small insurers, but SEIU is one of the biggest unions in the country.

Recall that SEIU and others who have so-called "Cadillac" health care plans received an exemption under the law (until 2018?) from paying the tax on high-end, covering-everything type plans.

Political maneuvering that favors some groups over others just fuels further disgust with the whole process, and sustains the high disapproval ratings that pollsters continue to see when surveying health care reform.

I read elsewhere today that the number of doctors who are opting out of Medicare in my state (TX) is continuing to grow.  Maybe I should put a couple of counters on the website, so readers can monitor the growth of things like waivers and opt-outs.  I'll think about it.

The other states seeking a minimum coverage waiver are Kentucky, New Hampshire, and Nevada (isn't that Harry Reid's state?)

Doc D
 
 

Wednesday, March 9, 2011

The Mediterranean Diet Works, Of Course...Because There's Nothing New In It

 
A meta-analysis of the health effects of the Mediterranean Diet shows benefit, but that's what we would expect from a collection of common sense advice that we've known for decades.

People talk about the Mediterranean Diet (aka THE DIET) as if there's some magic ingredient, or specialized technique.

Read this description from Science Daily (Mar 7):
The Mediterranean diet is a dietary pattern characterized by high consumption of monounsaturated fatty acids, primarily from olives and olive oils; daily consumption of fruits, vegetables, whole grain cereals, and low-fat dairy products; weekly consumption of fish, poultry, tree nuts, and legumes; a relatively low consumption of red meat; and a moderate daily consumption of alcohol, normally with meals.
Anything you haven't heard about before?  When you take each part of the diet and consider the advice, it's all stuff we've known for a long time.

So why does this diet have a special name?  Or a sacred status:
The Mediterranean Diet is more than a diet. It is a lifelong living style. You have to adopt it, as a religion. Decades ago, it was the natural way of life of many people around the Mediterranean Basin, especially in Spain, Italy and Greece (from Mediterranean Diet.com).
I've got it.  I can be rich and famous by putting together a bunch of common sense and giving it a name.  Here's the Doc D Automotive Safety Prescription:  make sure the key is turned on, establish that there's a brake pedal, glance at the tires to make sure they're inflated, and never try to drive from the back seat.

Do you think it'll become "lifelong living style"  in driving safety?

Anyway, what got me started on this rant, was the Science Daily article referred to above.  So I went to the research at the Journal of the American College of Cardiology (current issue dated Mar 15).  The meta-analysis took 50 previous studies and combined all the data.  This included statistics on approx 500K participants.   The focus of the review was to measure the impact of THE DIET on metabolic syndrome,  the quick and dirty definition of which is:  heart risk due to a combination of insulin resistance, high blood pressure, obesity, clotting factor abnormalities, and predisposition to inflammation.  That's very inexact, so you can go here to read more about it.  It's growing in prevalence.

So they found that THE DIET reduced the risk of metabolic syndrome (MS).

For Onion Peelers,
...Adherence to the Mediterranean diet was associated with reduced risk of MS (log hazard ratio: –0.69, 95% confidence interval [CI]: –1.24 to –1.16). Additionally, results from clinical studies (mean difference, 95% CI) revealed the protective role of the Mediterranean diet on components of MS, like waist circumference (–0.42 cm, 95% CI: –0.82 to –0.02), high-density lipoprotein cholesterol (1.17 mg/dl, 95% CI: 0.38 to 1.96), triglycerides (–6.14 mg/dl, 95% CI: –10.35 to –1.93), systolic (–2.35 mm Hg, 95% CI: –3.51 to –1.18) and diastolic blood pressure (–1.58 mm Hg, 95% CI: –2.02 to –1.13), and glucose (–3.89 mg/dl, 95% CI:–5.84 to –1.95)

If you look at the statistics closely you can see that the individual differences are not that great, and the confidence intervals are large, but taken together the health impact can be substantive.

That's all for today.  I have to go work on my DRIVING SAFETY program.

Doc D
 

Tuesday, March 8, 2011

STUDY: Nicotine Measured From Toenail Clippings Predicts Risk Of Lung Cancer

   
Wouldn't it be easier just to ask whether a person smokes, how much, and for long?

This dubious research was done at the Univ of San Diego (see here for the media report).  I hope we taxpayers didn't fund it.

What could possibly have led these scientists to analyze toenails for nicotine?

One comment in the media article said that some of the men with the highest levels of nicotine in their toenails were non-smokers, and speculated that they were exposed to second-hand smoke.  Does that make sense?  That some people are nicotine magnets?

On the contrary, such a finding would make me question whether the measurement was accurate or meaningful.

Doc D
 
 

Sunday, March 6, 2011

STUDY: Psychosis Symptoms More Likely In Marijuana Users

 
Two studies this year showed increased risk of symptoms of psychosis after adolescent marijuana use.  The most recent was a better study, but not definitive.

Although the legalization crowd will criticize the studies, and their opponents will trumpet them, we haven't heard the last word on whether marijuana use among teenagers has anything to do with mental health, except as an "association" between two variables.  Previous studies, showing increased rates of schizophrenia and other mental health issues, have been criticized for being poorly controlled.

This week's study, appearing in the British Medical Journal, enrolled subjects age 14-24 who had not used marijuana before (first caveat:  "self-reported" non-use), and followed them for 10 years.  Those who subsequently became users had higher incidence of psychotic symptoms. [see here for an editorial on recent studies.]

As Nostrums readers know, the association of an exposure (marijuana) and symptoms (psychosis-type) doesn't mean that one caused the other.  It could just as likely be explained by an unknown variable shared by those at risk, or simply that people who are likely to develop psychotic symptoms are more likely to start using marijuana.

In designing the experiment, it was left up to enrolled subjects whether they initiated substance use or not.  From the perspective of experimental design, clearly this isn't random, or blinded.  And I can't think of a way to make it so.

That the risk of symptoms of psychosis increased the longer the person smoked is interesting, but doesn't necessarily imply a dose-effect (i.e., the more you inhale the worse you get). 

But you have to give the researchers some credit.  They compared users and non-users for differences in gender, socio-economic group, age, other drugs, and other health problems.  No differences were found.  This means the higher risk of symptoms of psychosis can't be explained by being poor, or male/female, or older, etc., the usual confounding variables.

I'm not a fan of substance use of any kind.  And smoking any plant probably entails similar lung risks (I'm not aware of any useful research that looks at lung cancer or emphysema risk in marijuana smokers).   But the science isn't complete.

The fur will fly over this research, and we are marginally closer to defining harmful effects, but the fat lady hasn't sung.

Doc D
 
 

Friday, March 4, 2011

HCR Expert Says, "Yeah, You Have To Buy Broccoli"

 
According to Harvard professor and HCR supporter, the Constitution does allow the government to make you buy broccoli.

There were a lot of horse laughs at Judge Vinson's comparison between the individual mandate under the new health care reform law and the government forcing you to buy broccoli.  Recall that this is the judge in the 26-state suit claiming that the requirement to buy health insurance is unconstitutional.  Vinson said, "Yep, it's unconstitutional,"  and wrote a long opinion as to why.  In that opinion he made the statement that if not buying something comes under the government's power to control or coerce, then you could be forced to buy this tasteless vegetable.

I think the judge chose broccoli as a humorous exaggeration...not many people eat broccoli.  But some tried to ridicule the comparison by taking it seriously.

Now, former Solicitor General and Harvard professor Charles Fried, one of the experts testifying before Congress that the mandate is constitutional, admitted that...well, yes...the government could force you to buy broccoli.  See here.

All this talk of broccoli is beside the point.

I think what's at stake here is whether Congress has the authority to pass laws that compel persons to purchase a specific product.

A more realistic example would be for the government to compel purchasing an American-made product because a large company that makes that product is failing, and people would be laid off.  One example others have used is automobiles.  Suppose a US car company is about to go under, unable to compete with foreign makers or with their competitors in the US.  Interpreting Professor Fried, the Congress could compel you to purchase one of their cars, as being in the best interest of the country.  Note that I don't mean compelling people who are already in the market for a new car, but people who don't want a new car.

I think Congress would have been better advised to write the law in such a way that defined health care as a special case.  That is, it's not like any other industry.  This would have carved out a limitation:  that is, the government can make you get health care insurance, but they can't make you buy other things you don't want.

Had they done that, there wouldn't be a "slippery slope" argument that risks the Supreme Court saying, "The government did not define a constitutional limit on what it can compel citizens to purchase, a vagueness that we are unable to rule in favor of."

But they didn't choose this route.  That would have started a different legal battle, but it's one that doesn't involve expanding the scope of the US constitution in an unprecedented manner.  Even the judges who have ruled the mandate constitutional (so far) have admitted that their interpretation of a decision not to buy something as "economic activity"  and, therefore, covered by the Commerce clause of the Constitution, has no legal precedence. 

In any case, Congress decided to write the law in such a way that "mental activity" (the thinking you do about whether to buy something) is "economic" and therefore, commerce.

Go figure.

Doc D
 
 

Thursday, March 3, 2011

Supreme Court Rules "No Suits Against Vaccine Makers"

 
The decision wasn't even close (6-2).  For some, this result doesn't make sense...but it does.

Here's how the Des Moines Register (Mar 2) described the case:
"Last month the U.S. Supreme Court sent a message to American parents: If you think a vaccine harmed your child, don't turn to the local courthouse. In a 6-2 ruling, the court affirmed federal law that prevents vaccine makers from being sued in state courts and protects them from civil liability in "damages arising from a vaccine-related injury or death."
Before we hear from those who would argue for the parents and their children, consider this:

1.  The vaccines in question have been approved safe and effective by the FDA.  We're not talking about experiemental or unlicensed use.
2.  Back when vaccine makers feared constant lawsuits over their products, the industry was bailing out of making them.  This created several crises, resulting in vaccine shortages.
3.  As a result, Congress set up a vaccine court to hear all cases of harm to children, a "no fault" alternative to suing companies who make quality products, but can't guarantee that no one will have a reaction to the vaccine.  Even the safest of our vaccines, while saving millions of lives, cause adverse reactions to somebody.

The vaccine court's responsibility is to establish whether the vaccine caused the harm, then award compensation from a federal fund established for that purpose.  Establishing cause and effect allows the science to eliminate the litigous, ambulance chasers, and those whose claim is without merit  (there are a lot of these).

[This Supreme Court case was one of the latter.  There was no link between the injury and vaccine, so the parents and their lawyers went after the company.]

The National Vaccine Compensation Program (that set up the vaccine court) has been a success.  Vaccine companies have continued to, and in some cases re-started, making vaccines, and those who are innocently harmed have an avenue to seek redress.

Had the Supreme Court ruled otherwise, vaccine makers would have to increase the cost to cover liability, and lawyers would have a deep pocket to bring cases against.  Parents who misapprehend what caused their child's problem would have had a way to pursue a baseless claim to jurors who might be swayed by the tragedy alone.

As the world's leader in lawsuits, the US doesn't need to fabricate more.

Doc D
 
 

Wednesday, March 2, 2011

CIty Funds Brain Cancer Scans For The Healthy

 
Unnecessary screening leads to unnecessary treatment.

I ran across this article in the Wall Street Journal Health blog (Mar 2): 

"NYC City Council Funds Unproven Cancer-Screening Program"

Apparently the city funds a scanner to the tune of about $2 million to go around the city scanning normal people for brain cancer.

The article rightly points out that there are situations where screening is at least prudent (both your parents are diabetic, and you get a fasting blood sugar).  But this is one of those situations where it's not.

Brain cancer is very uncommon.  I'm not sure how many people you have to screen to find a "real" brain cancer, but I bet it's in the thousands.  From that same population you will find hundreds with other "findings" that may suggest they need to be treated, but more likely you're better off without treating...and without knowing.

The prostate cancer blood test, prostate specific antigen (PSA), is a case in point:
"The PSA test, the benefits of which still aren’t clear, has become the poster child for this controversy. (One analysis found that for every life saved by the PSA, 47 men received unnecessary treatment and risked side effects like incontinence.)"
Epidemiologic data, the sensitivity and specificity of the screening test, and (most importantly) the risk factors of the patient,  need to be guiding factors in screening for medical diagnoses.

There's an old saying among doctors, "Test enough and you'll find something."

That's not preventive health care, it's fishing.

Doc D
 
 

Tuesday, March 1, 2011

Ethics... And Evaluating New Treatments For Serious Diseases

 
A new approach to gene therapy for AIDS is promising, but...

We've known for decades that a few people are resistant to HIV--on the order of 1 in 100.  They can be shown to be infected, but don't get sick (so far) and don't need to take medicine.

There's a receptor (CCR5) on the surface of the immune cells that HIV attaches to, in order to infect the cell.   These rare individuals seem to lack that receptor, and the gene that produces it.  No receptor, no virus attachment, no infection of the cell....get on with your life.

Researchers have discovered a way to take immune cells from someone who has the disease and snip out the genetic code repsonsible for this receptor, then grow a whole bunch of these cells and give them back to the patient.  For a decent summary of the research go here (Assoc Press, Feb 28).

The modified cells appear to survive when put back in the host.  The hypothesis is that they are resistant to infection with the virus and can continue to do their job in the immune system.

It's exciting, but reading the news article, I asked myself why we have this receptor, and what does it mean if we don't have it?  We don't know.  The reseachers realize this, and know that before we go modifying every patient's cells, we need to understand the function of this gene.

The few people who have been treated so far with modified cells have shown some improvement, but it's not a cure.

Ethical question for the day:   How do you balance our limited knowledge of the safety of a new treatment against the harmful effects of not giving the treatment?  Assume that three years from now, we can't find any reason to justify not removing this CCR5 receptor from the immune cells of patients who are ill with HIV, and on several medicines a day to keep the disease at bay.  What if you could read the future and knew that it would take us 20 years to find out that CCR5 becomes essential to the immune system later in life?  Treatment with treated cells would help now, but create a new problem later.  If long-term studies show that people treated with the modified cells are harmed by the treatment, even though they benefited in the short run, can they sue?

Far-f;etched?  A little, but this happened with the early hearrt valves.  Until the first artificial valves were invented most people died of their leaky valves.  After getting a new lease on life for 20-30 years, the valves began to crack from the constant pounding they took from pulsating blood flow.

The patients sued:  defective product.

I don't have a good answer to questions like these.  I suspect that all new treatments and devices are vulnerable.  Political pressure will be put on the FDA to approve quickly, and then they will be criticized later if long-term studies show problems that could have been avoided if there had been more research.

We saw this last week, when it was reported that medical devices approved quickly were recalled more often.  I doubt that this occurred because the devices were shoddy workmanship.  More likely the devices needed more time to be studied before approval.  This is the Monday Morning Quarterback phenomenon:  "We shoulda known..."

For something like HIV, any investigational therapy will undergo the same push to get it out quickly.  Particularly if the media hails it as a "breakthrough" even while the therapy is still in the developmental stages.

How many times have we heard about breakthroughs?  Some recent research suggests that most of these new and exciting ideas never see the light of day because the research was faulty or we find a problem ("the operation was a success but the patient died").

Experience suggests that almost all "breakthroughs"  never break through.

Doc D
 
 

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