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.

Sunday, October 31, 2010

STUDY: Green Tea and Breast Cancer

 
The hypothesis that drinking green tea can prevent breast cancer (and other diseases) has been floating around for years.  Still no definitive evidence for it, though.

The latest in a series of studies (Breast Cancer Research, 29 Oct), attempting to pin down whether compounds found in green tea can prevent cancer, is a fairly decent population-based, prospective assessment of the breast cancer incidence between those Japanese women who drink green tea occasionally and those who drink 5 cups or more a day.

Bottom line:  no difference.

I'm not sure where the hypothesis came from that green tea--and specifically the biologically active catechin present in green tea but not in black tea--can lower the risk of cancer.  I think it was just a simple observation that Japanese women are at less risk for breast cancer, so, what is it they do different?  Well, they drink a lot of green tea.

Ethinic groups differ in hundreds of ways that population genetics or behavioral studies have yet to define.  So it seems a reach to me, implicating green tea...but all such questions are worthy of a look.  Initial studies were pretty bad.  Some showed a protective effect, some didn't.  But they were mostly small and retrospective in design:  a weakness, because you don't know, when looking back in time, whether you're defining the result in advance (remember the Texas Sharpshooter Fallacy?

The strength of this study is that it is prospective.  They took a population from a starting point, defined the result they were looking for, then followed them for years (13).

For Onion Peelers,
Compared with women who drank less than one cup of green tea per week, the adjusted hazard ratio (HR) for women who drank five or more cups per day was 1.12 (95% confidence interval (CI) 0.81 to 1.56; P for trend = 0.60) in the baseline data. Similarly, compared with women who drank less than one cup per week, adjusted HRs for women who drank 10 or more cups per day were 1.02 (95% CI 0.55 to 1.89; P for trend = 0.48) for Sencha and 0.86 (0.34 to 2.17; P for trend = 0.66) for Bancha/Genmaicha [two types of green tea]. No inverse association was found regardless of hormone receptor-defined subtype or menopausal status.

The last sentence is important because there are genetic markers for hormone receptors that indicate higher risk of more aggressive breast cancers.  It's conceivable that green tea could act more (or less) effectively on these subgroups.

You can always criticize the results by suggesting that not enough of the compound (presumably catechin, but nobody's pinned down any particular chemical here) was consumed, even in women who drink a LOT of green tea.

And you won't be surprised to find that the herbal medicine crowd has already made that claim.  Fair enough...but it seems to me that if 10 cups a day doesn't hack it, how much would?  And, if green tea is the magic potion that explains the lower risk in Japanese women, why wouldn't there be a detectable dose relationship at the levels in this study?

Green tea products, and herbal products in general, have little reliable science to show for themselves at this point.

But it's a multi-billion dollar industry.  We can expect hundreds of additional studies.

Doc D
 
 
[Note:  the link to the original study is to a provisional draft.  This link will change at some point.]
 
 

Friday, October 29, 2010

I Refuse To Get Sucked Into The Marijuana Debate

 
Just a quick question.

Isn't smoking marijuana...uh...smoking?

For some reason, the health effects of smoking don't seem to enter the arguments for and against legalization.  And it's astonishing that some people who would have a stroke if a person pulled out a cheroot in a public place, or have severe allergies to smoke of any kind, seem OK with this particular type of smoke.

A quick literature review didn't provide me with any reputable and well-controlled research on the subject.  Oh, yes, there are some studies and they are widely touted by both sides, depending on their political advocacy.

But what research I could find was all poorly designed and inconclusive.  The stumbling blocks to getting a definitive answer are admittedly great:  several decades of observation needed, reluctance to participate in a study, subjective assessment of benefit/harm.

Having to fall back on biological plausibility, it seems unlikely that inhaling a partially combusted botanical that contains hundreds of compounds is without adverse health effects.

But, legitimate science is not going to be a deciding factor for the voters.

This is one of those situations where preconceived belief will resist any evidence to the contrary.

Doc D
 
 

Thursday, October 28, 2010

Got A Health Savings Account? You Now Need A Prescription To Use It...Even For Tylenol

 
Another Poison Pill from HCR.  Congress put in a provision that makes patients get a prescription before they can spend their own money on over-the-counter medicines if they have a Health Savings Account (HSA).

Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA)  have been one of the most successful health care cost control measures in several decades. They are increasingly popular with patients because it diverts some of their spending for insurance into an account they can draw on for health needs.  If they shop wisely and save money, there may be money left over in the account at the end of the year.  Patients routinely save hundreds of dollars on scans, colonoscopy, mammograms, and the like by shopping around.  And there's plenty of consumer info out there to judge quality in the choice.

And guess who gets that extra money?  The employee...  What a concept.  You spend your own money as you see fit, to best meet your health needs, and you get to keep what you save. 

I can't think of a better way to preserve patient choice, and reduce cost.

Except ObamaCare says "No, no...you can't take money out of your account for common medicines that don't require a prescription...unless, uh....you get a prescription for it."  Insane.  You have to get an appointment, go to the doctor, suffer through her/him looking at you like you're crazy, taking the prescription to the pharmacy, waiting for it, and then--at last--you can use your health money to buy the sudafed, motrin, fungal food powder, etc.  (see the Washington Examiner, Oct 27)

This represents the worst form of government regulation.  Supporters of nonsense like this argue that because your HSA is tax-free, you would otherwise be getting a tax break.  In the context of lung transplants and huge costs for procedures and cancer drugs, the amount of tax revenue lost is chump change.  And employer insurance premiums are a tax deduction anyway.

Your $3 dollar cost for a decongestant, which will cheat the government of about thirty cents, now costs $3 plus the loss of work income, plus the co-pay for a doctor visit, gas for your car, annoyance...

That's what I call reform...Not.

Doc D
 
 

Tuesday, October 26, 2010

Nutrition Watch: What Are Baby Carrots?

 
You know they're just "adult" carrots cut smaller, right?

I saw this article (Miami Herald Health, Oct 26).  It never occurred to me that people might think that baby carrots are somehow a different product.  For some vegetables, the less mature product is slightly different in its nutritional content, or taste.  If you've eaten okra (most haven't; it's a Southern affliction), you know that the smallest are edible; the large ones are like wood.  If you eat chinese food, you've had those little corn cobs they put in the stiry fry.  I could go on.

But where carrots are concerned, baby carrots are not immature carrots.  They are fully grown carrots that don't "look" good enough to sell in the store, so they're cut down into short segments and ground into a cylindrical shape.

Voila, babies.  And the industry is allegedly putting $25 million into marketing them.

The only difference is, for the amount of carrot you buy, you're spending three times as much.

It's like the bottled water flim-flam--spending a lot for nothing.  As has been widely reported, most spring waters are just tap water, bottled.

Doc D
 
 

Monday, October 25, 2010

Dragged Kicking And Screaming Into Posting On HCR

 
Against my desires, I'm writing about health care reform again.

I've kept away from this for a while.  The media seems to have (finally) picked up on some of the intended and unintended consequences of the health care reform (HCR) law.  The last time I wrote a Poison Pill post, it was approximately #36 or so.

You hear it every day now.  Plans being cut back or cancelled, holes where certain populations were overlooked in implementing pre-existing illness provisions, rising costs in anticipation of the need to cover all, government regulated benefit packages that will eliminate alternative plans that some people prefer, elimination of retiree drug benefits, the likelihood that young adults who qualify for health exchange subsidies will be dumped into Medicaid, the un-debated costs to the states that must implement the provisions of the subsidies...  The list goes on and one.

Despite all the reassurances over the last 20 months, I'm hard pressed to come up with a single promise that's been kept...in some cases there was blatantly an un-truth, but more often a partial truth (like families with pre-existing illness that can now be covered, but they can't afford it) that ignored consequences.  I discussed most of this back before passage of the law.

As a citizen I'm convinced that we get what we deserve.  It was folly to watch Congressional staffers, lawyers, and academic reform activists draft a hugely complex law.  The whole process was characterized by the absence of input from people who treat people, run clinics, manage hospitals, and have spent a lifetime delivering care to the population.  In other words, the people who know how the system runs, and where it goes off the rails.

As expected, prognostication that the public would like the law once passed have not come true.  We see politicians who supported the law and voted for it neglecting to mention it in their campaigns,  or saying it now needs to be "fixed."  In one case, (Manchin, West Va), a candidate who campaigned for the law during its passage now has the gall to say he wouldn't have voted for it "if he had read it."  Unbelievable.

Allegations that opponents of the law didn't offer alternatives are laughable, but I suppose some will buy into that theme.  There were six comprehensive alternatives offered to Congressional committees during the period of the law's development.  They were unrecognized because nobody mentioned that under our system of party dominance, all committee chairpersons come from the ruling party.  Those Chairs have ultimate control of the committee agenda, so no alternatives saw the light of day.

In summary, when Congress and the President had an opportunity to preserve what's best in our health care system (I've refuted claims to lack of quality in previous posts, here and here), and create the kind of umbrella we wanted over our health care, while creating incentives to reduce cost...one that is quintessentially American and in line with our culture of opportunity and growth...they chose instead a top-down, managed care mechanism that created up to 150 new government activities, increased cost, and overlooked patient needs and desires.  A solution that placed ideology over individual patients.

All along there was enough money in the system that could be recouped to accomplish the entire overhaul.  No significant provisions were included to leverage those resources (fraud, tort reform, cross-state insurance plan competition...to name just a few).

If all that's too long a summary, try this:  the problem with the new law is incompetence. 

Doc D
 
 

Sunday, October 24, 2010

Medical Monitoring At Home A Trend Or False Promise?

 
It's possible for patients on blood-thinning agents to test their blood at home, but a first look says there's no benefit.

Home testing has arrived and new tests are developed every year.  From pregnancy to genetic defects, an affordable and increasingly simple test is available.  Some visionaries see a time when all patients can care for themselves at home using a Star Trek-type medical scanner. 

Beaming ourselves back up, there's a new study in the New England Journal of Medicine (Oct 21) on the effect of home testing to assess whether blood thinning agents are working properly--to reduce the propensity of blood to form clots in those patients who are at risk for complications.  For example, patients who have mechanical heart valves or atrial fibrillation (a rhythm disturbance that can increase risk of "throwing" clots).

Normally, the patient will come to the clinic or go to a lab to get tested on a regular basis.  Whether in the lab or at home, why is this needed?  It's one of those situations where both too much and too little are dangerous.  If the blood is not thinned enough, clots will form.  If the blood is too thin, then excessive (and potentially lethal) bleeding can occur.

Similar home testing is available  for blood glucose in diabetes.  For most patients home testing can help monitor blood sugar.  The patient can respond to a too-low or too-high blood sugar by adjusting insulin or food intake.  There is consensus that where patients are able to conduct and interpret the testing, this home testing can reduce hypoglycemia and it's opposite, diabetic coma.

For blood thinners, home testing could likewise avert dangerous situations...nip them in the bud before they become a problem.  And reduce wait time and the expense of getting tested elsewhere.

Another plus: for both situations, home testing would be much more convenient.

But whether blood thinners would reduce the complications (excessive bleeding on the one hand, or strokes due to clotting on the other) seems less likely.  Here's part of the data--on mortality.




There's clearly a lack of statistical significance between getting tested in a clinic versus doing it yourself at home (p-value = 0.41).  None of the other markers showed a significant difference (time to stroke, bleeding).  This raises the question of whether home testing is useful for some--or all--conditions for which it could be made available.

Or do we take the opposite tack and say, "It's more convenient, but no worse to test at home, so we should do it"?

The answer is...it depends.  And we don't need a definitive answer to proceed with caution.  Still, I'm bothered that we don't yet have a breakdown by patient subgroups.  It may be that certain patients do improve their lot, while others do more poorly.  That could cause the improvement for some to be hidden in the overall impact.  It's going to take more research.

At this point, I would consider using home testing for that patient who understands the way thinners work, how clotting is a risk, the time frame over which the drugs act, the testing procedure, and when to seek medical attention.

For some patients that's not overwhelming; for others, it could be.

Doc D
 
 

Friday, October 22, 2010

Feds Make War On Spuds

 
Another dopey dietary regulation, telling you what you can and can't eat.

[I intentionally tried to mimic the media's hyperbolic way of inventing titles for their articles.  Pretty good, huh?]

The Institute of Medicine (IOM) has recommended that the US Department of Agriculture remove the common potato from it's list of foods approved under the Women, Infants, and Children (WIC) Program...the program that assists the poor to buy food. (Assoc Press, Oct 20)

No, I'm not kidding.  If you're a meat-and-potatoes kinda person, you have to adapt.  Become a meat-and-celery person.

The IOM also recommended that USDA reduce potato use in school lunchrooms.  Potato farmers ain't happy.

Note that we're talking about the fresh, unvarnished, dug-out-of-the-earth potato here.

Not the cheesey-chili fries, or the hash browns fried in grease...the real dietary problem.

And even if we were talking about the gut-bombs, is there any evidence these programs work?  We already know that people trade their food stamps for cash so they can buy alcohol.  Humans aren't dumb, but they are stubborn.

My prediction:  the diet regulations will grow, the amount of money we pour into these programs will increase, and people will find ways to eat what they damn well please.

Another example of your government, bringing you what's good for you...according to them.

Doc D
 
 

Health Care For Terrorists: "Osama"Care's Death Panels

 
Apparently, the terrorists have long been into rationing health care.

This is too ironic to pass up.

From the New York Post via Best Of The Web Today, comes the startling news that accused terrorist Ahmed Ghailani appeared upset on the witness stand that al Qaeda "refused to pay the $500 cost of his wife's C-section."

According to Ghailani, when al Qaeda had to re-locate to the Sudan in the late 90's, they suffered a financial crisis and had to cut back on costs.

Maybe he didn't sign up for the Cadillac Plan.  Or maybe an independent al Qaeda medical advisory board had recommended that C-section was not cost-effective.

[Despite my making fun of this, the real tragedy would be if the wife didn't receive timely care.  I assume she did.]

Doc D
 
 

Another Supplement Claim Bites The Dust - Folic Acid

  
Folic acid is prescribed for pregnant women.  Convincing evidence exists that it prevents a certain birth defect in the fetus.  However, claims that folic acid prevents cancer or heart disease look like a wash.

USA Today (Oct 18) points the way to a new study of folic acid, published in the Archives of Internal Medicine, was a meta-analysis.  I've talked about this before:  meta-analyses gain their power from combining multiple published studies into one, increasing the data available on a given question.  Their weakness is that no two studies are ever exactly the same; either the researchers didn't use the same population, or a different dose, or they didn't study the effect for the same period of time, etc.  It's a challenge for scientists to take studies with minor differences and decide how to select the data that can be meaningfully compared, even if the broad question is the same.  In some cases they have to exclude studies because they are just too different.

Folic acid is a vitamin that is prescribed specifically in pregnancy to prevent spina bifida, but is present in most multi-vitamins as a part of the "shotgun" approach to making sure you aren't "vitamin deficient."

[Don't get me started on the concept of vitamin deficiency.  Unless you have some disease or other physiologic abnormality (like starvation or alcoholism) it's very hard to be deficient in a vitamin.  All the claims that processed foods destroy vitamins to such an extent that we don't get enough have never been substantiated.]

You might ask how researchers could suspect that folic acid could help heart disease and cancer.  Here's the logic:  a protein building block (amino acid) named homocysteine--found in the blood--has been measured at higher levels in those patients who are at risk for heart and other problems.  Taking folic acid lowers the level of homocysteine.  Therefore, maybe taking folic acid will lower the risk of disease.

I've written several times about the danger of seeing things too simply.  The fact that homocysteine is higher in those at risk doesn't mean it's the cause of the risk.  It may just be a coincidence.

The study in question here followed 37,000 people for five years, with and without folic acid.  There were no differences in the rates of heart disease, diabetes, or cancer.

Now, you can argue that we should study the impact for 10 or 20 years.  For cancer, it's conceivable that a longer "incubation" period could bring about a measurable effect.  For example, cigarette smoking doesn't cause cancer in five years.  But for heart disease, if you don't see some kind of population impact after five years, it's very unlikely that going longer will show anything different.

For Onion Peelers,
Folic acid allocation yielded an average 25% reduction in homocysteine levels. During a median follow-up of 5 years, folic acid allocation had no significant effects on vascular outcomes, with rate ratios (95% confidence intervals) of 1.01 (0.97-1.05) for major vascular events, 1.03 (0.97-1.10) for major coronary events, and 0.96 (0.87-1.06) for stroke... There was no significant effect on the rate ratios (95% confidence intervals) for overall cancer incidence (1.05 [0.98-1.13]), cancer mortality (1.00 [0.85-1.18]) or all-cause mortality (1.02 [0.97-1.08]) during the whole scheduled treatment period.

And as a final warning, one author, Dr. Jeffrey A. Tice,
suggested that consumers be cautious about high-dose supplements. "High doses of other vitamins with a strong scientific rationale for long-term health benefits, such as the antioxidants vitamin E and beta carotene, are now known to be harmful," Tice said.  "Be wary of the current enthusiasm for vitamin D and omega-3 fatty acids until large randomized studies are completed," he added. "The best way to optimize your health is to exercise regularly, eat a nutritious diet, avoid smoking and maintain a healthy weight." (USA Today)
That says it all.

Doc D
 
 

Thursday, October 21, 2010

Feeble Attempt At Posting Something...Cough, Cough

 
I've been under the weather.

Despite my decades-long attention to sanitation and hygiene, some scurrilous knave managed to pass along their respiratory infection.

While I whimper and whine about that, consider the following headlines (reading is about all I can get myself to do right now):

Too Much Information:

"Malaria No More Uses Humor to Show Malaria Is No Joke"
                                                                                 --NonprofitMarketingBlog, Oct. 19

"Do Women Sweat Differently Than Men?"
--New York Times website, Oct. 20


"Man Arrested for Sexually Assaulting Horse"
--Connecticut Post (Bridgeport), Oct. 19


If you doubt this drivel really exists, feel free to click on the links.

People who write this stuff need to get a real job.
(h/t to Best Of The Web).

Doc D
 
 










Tuesday, October 19, 2010

B-12 And Alzheimer's Link: Almost Certainly A Meaningless Association

 
Just because something (drinking coffee, say) is associated with something else (less risk of Parkinson's disease) doesn't mean we need to do anything about it.

I was reading an article in BBC News Health (Oct 18) about a new study that links Vitamin B12 to Alzheimer's disease, one of the forms of dementia.  I didn't read the real study, just the news article.  Apparently, the study shows that people with the highest levels of B-12 are least likely to be diagnosed with dementia...at least, if you think looking at 271 people from Finland counts as a good study.

But this is what caught my attention:
"A recent trial found that "brain shrinkage", which has been associated with Alzheimer's, was slowed in older people taking high doses of vitamins, including B12."
And?

The implication is, if less brain shrinkage, then less Alzheimer's, so take B-12.

But we get fooled by this kind of thing all the time. 

It's typical that when we go further and study this association we find that taking B-12 does decrease the shrinking, but the Alzheimer's still occurs...you just have a less shrunken brain accompanying your dementia.

You can't take a complex physiologic environment with thousands of interacting variables and isolate a simple phenomenon of cause and effect.

The classic story for how we are fooled into thinking we're measuring something that really matters is the case of heart rhythm abnormalities (arrhythmias) after a heart attack (or myocardial infarction, MI).  Studies showed that people who have irregular heart beats after an MI were less likely to survive. 

Along came a new group of drugs to control heart rhythm, reducing the irregular beating.  So doctors charged in, giving the new drug to MI patients who showed a tendency to arrhythmias, and...behold...their hearts beat regularly.

But, after some years of experience with the drugs it was learned that these same folks who showed a tendency to irregular rhythms--but had their rhythms controlled by the drugs--were still more likely to die.  And in some cases the drugs themselves caused adverse reactions...occasionally, lethal ones.

There's an old adage in we get taught in medical school:  "Don't treat the test result, treat the patient."  We shouldn't have assumed that just because the finding was present (irregular heart rhythm) in those who were at increased risk of dying, that it was the important factor in raising that risk.  It wasn't; something else is.

Today's post is a cautionary tale about stories like the above on B-12.  We need to disregard pretty much all of them...they're almost always meaningless.

One last thought.  A study was done some years ago that showed lap dancers who weren't on birth control pills (i.e., they were fertile) got more tips.  The researchers concluded that men were more attracted to fertile women.

Given this discussion above of "associations" between things, does that conclusion make any sense to you?

Doc D
 

Monday, October 18, 2010

The Miracles Of Genomic Medicine...Someday: The Example Of Predicting Human Height

 
Not a day goes by that some research doesn't identify a new gene that's associated with some disease.  But we are light years away from making any use of it.
 
I was reading David H. Freedman's book Wrong:  Why experts* keep failing us...and how to know when not to trust them.  Very readable, and it give great examples of the themes I keep harping on in Nostrums.

I came across a reference to an article in the European Journal of Human Genetics (Feb 2009) called "Predicting human height by Victorian and genomic methods."

Everybody wants their kids to grow up tall.  [Remember that Randy Newman song "Short People (got no reason to live)"?]

So parents would reeaally like to know what genes would give you tall children.

The researchers looked at the 54 genes they found to be common among tall people and developed a formula to predict a person's height.

They then applied the formula to 5,748 people. 

Results:  Their genomic prediction was only one-tenth as accurate as the tried-and-true method that has been used for over a hundred years:  take the average of the parents' height and correct for gender.

For Onion Peelers,
In a population-based study of 5748 people, we find that a 54-loci genomic profile explained 4–6% of the sex- and age-adjusted height variance, and had limited ability to discriminate tall/short people, as characterized by the area under the receiver-operating characteristic curve (AUC). In a family-based study of 550 people, with both parents having height measurements, we find that the Galtonian mid-parental prediction method explained 40% of the sex- and age-adjusted height variance, and showed high discriminative accuracy

I guess we can throw out all those DNA-analyzing machines that cost millions and get a tape measure instead.
Doc D
 
 

Changes To CPR...But Change To Do What?

 
First we hear to cancel the breathing part, now we switch the order to first give breaths, then compressions.  Confused?

I wrote sometime back that a new study showed that bystander cardiopulmonary resuscitation (CPR) is more successful when people just do the chest compressions.  Patly because people are more likely to help if they don't have to put their mouth over someone else's.

Now the American Heart Assocation is changing their recommendation to support that research.  No longer should the rescuer open the airway and give two breaths first--followed by chest compressions.
Under the revised guidelines, rescuers using traditional CPR, or cardiopulmonary resuscitation, should start chest compressions immediately - 30 chest presses, then two breaths. The change applies to adults and children, but not newborns. (Assoc Press, Oct 18).
But, according to the USA Today (Oct 18) report,
The new guidelines dictate that a bystander should compress the victim's chest 100 times a minute to a depth of about 2 inches. That keeps blood and oxygen flowing to the brain, sustaining it until help arrives. Stopping for rescue breaths can interrupt blood flow.

Uh...isn't that inconsistent?

I suspect somebody reported it wrong, or we're talking about different groups of situations (people who arrest due to oxygen deprivation versus those who are having a heart attack, for instance).  But how can we tell from the reporting?
If we begin to confuse potential rescuers ("Should I breathe, then compress, or compress first...or only compress?") then the result--patient survival--could be worse.

Ever wonder why we can't get research results right?  A series of research studies over the last dozen years have shown the following:  Vitamin D prevents cancer; no it doesn't; yes, it does; no, it doesn't.

Until the science works its way through all the variables involved, there is no answer.

But for public policy, as opposed to research results, we need to be crystal clear ("How clear?" "Crystal") about what's recommended before putting it on the street, or reporting on it.
Doc D
 
 

Saturday, October 16, 2010

Questions Best Unanswered - 16 Oct

 
 

"Scientists Learn Why Sex Beats Cloning"
--MSNBC.com, Oct 13
 
 
 



How Many Lives Are Saved When The Uninsured Are Covered?

 
There are several studies on this issue.  The Institute of Medicine estimated it at 18,000 per year.  But, no study (so far) accounts for all the factors involved.

A few days ago I was reading a transcript of the election debate between Senator Barbara Boxer of California and her challenger.  She was touting the potential of health care reform, and blithely said, "No longer will thousands of people die every day for lack of insurance coverage."

I was stunned at the exaggeration, and doubly so because nobody followed up to challenge it.  If you do the math, she's claiming about a million people a year die because they have no health insurance.  (Say, 2,000 x 365 days).

The highest estimate from the few available studies is 40K, and the lowest is zero.  The question gets complex because it's hard to estimate the impact of a subjective decision that may be in someone's mind ("should I go to the doctor?") and the data on mortality.  Note:  We're not talking about the health or well-being of the uninsured, only those who die.

This year's winner of  the John M. Eisenberg Article-of-the-Year Award, was published last year in the journal Health Services Research (21 Apr 2009).  The study did a fairly decent job of controlling for external variables and found the risk of dying due to lack of insurance coverage was no different than that for those who have coverage.

For Onion Peelers (the description is so well written, I'm just going to quote the results):
"National Health Interview Survey from 1986 to 2000 were followed prospectively for mortality from initial interview through 2002. Baseline information was obtained on 672,526 respondents, age 18–64 at the time of the interview. Follow-up information on vital status was obtained for 643,001 (96 percent) of these respondents, with approximately 5.4 million person-years of follow-up... Adjusted for demographic, health status, and health behavior characteristics, the risk of subsequent mortality is no different for uninsured respondents than for those covered by employer-sponsored group insurance at baseline (hazard ratio 1.03, 95 percent confidence interval [CI], 0.95–1.12

Note that if you don't correct for obesity, smoking and health status there is a slighly increased hazard ratio (1.1 to 1.2).  They wanted to stick to an apples-to-apples comparison group.


US hospitals are required by law to not turn away patients who present for care, whether they have insurance or not.  So all who have an urgent need for medical care can get it.

This study challenges our assumptions.  We need more work in this area to understand the impact of health care availability.

In my clinical experience denial of symptoms is a bigger killer than lack of insurance.
 
Doc D
 
 

STUDY: Eliminating Insurance Deductibles Results In More Prevention Screening...By Just A Smidgeon

 
If prevention was free, would more people obtain age-appropriate screening tests?  Not so much, apparently.

This is just a reminder that health care cost is not the only factor determining health-seeking behavior.

A study (reviewed in the WSJ Health Blog, Oct 15) looked at what happens when you remove the health plan deductible payment.  I'm sure all of you have pesonal experience of this:  every year--in many plans--you must spend a certain amount before your insurance kicks in.  Some people, most government plans in particular, don't have this; theircoverage begins with the first dollar.

Once you meet your deductible, insurance starts to pay...anywhere from 100% (so-called Cadillac plans) down to 70% or less.  And certain types of treatment may be covered for even less.  Braces for your kids, for instance.  You pay the rest (the co-pay).

In any case, the researchers wanted to see whether removing the deductible caused a rise in how many people would get preventive health exams and testing performed.  Note that they didn't remove the co-pay--that remained the same as for any visit for health care.

The results?  Less than one percent increase in prevention seeking.
They analyzed data covering three different groups: people in high- and low-deductible plans, before and after the preventive care deductible was eliminated; and a control group from another employer where the deductible for preventive care didn’t change. ...Scrapping the deductible “modestly” improved screening rates for blood-cholesterol tests, Pap smears, mammograms and fecal-occult blood tests, the researchers conclude. After adjusting for demographics and the overall trend of the test’s use, “there were between 23 and 78 additional uses per 1,000 eligible patients of covered preventive screens.”  (WSJ Health Blog)
[Note:  I couldn't find the original study.  So, a caveat...]

Interesting, but maybe predictable, was the finding that people with "high-deductible" plans were least influenced.  The authors speculate that these are the people who are the least "risk-averse."  That is, they buy coverage just for big costs or catastrophic needs, and therefore, don't see their own health risk as high enough priority to warrant investment in a costlier plan.  Further, because they seek risk this way, they will be less likely to respond to a prevention incentive, even if the cost is reduced. [Alternatively, people with catastrophic coverage may choose these plans because they can't afford more, even if the deductible is eliminated.  There's not data to support either explanation.]

Repeat note:  I've written about this before.  Prevention is good medicine, but it doesn't often lower lifetime healthcare costs.  See my post, or just think about it:  which generates more cost?  someone who dies young, or someone who lives much longer?  Claims (notably by the President) that prevention lowers cost are misleading.

The point is, people are complex and are likewise complex in how they are motivated.  Just reducing or eliminating cost isn't even close to the whole answer  [Also, see this for how income and insurance don't explain racial disparities in breast cancer care.].

In a related vein, take a look at the article written by a nurse practitioner explaining why she doesn't get screening mammography despite a family history of breast cancer.  It's a reasoned and understandable decision, if not the one I would recommend to patients.

I'm male, so I can't relate completely.  However, similar reasoning applied to prostate cancer (the level of risk is about the same, statistically.  And, my Dad had it), leads me to the decision to get screened.  My sense of well-being is disturbed by the existence of unexplored risk, and I will act aggressively to reduce it...despite the fact that there's a similar level of complications from un-needed prostate treatment as there are for un-needed breast mass treatment.

I have no problem with people making informed choices, even if I don't agree with them.  We should be in charge of our bodies, and nobody else.

Doc D
 
PS:  "Smidgeon"  is a highly technical medical term that indicates a quantity somewhere between "it's there when look close" and a "pinch."
 
 
 

Friday, October 15, 2010

Proposed Nostrums Change

 
I'm considering using the following badge to announce posts with research data ("onion peeling").




 
 
Doc D

Thursday, October 14, 2010

A New Approach To Degenerative Arthritis. Promising, But Nowhere Near Practical Yet

 
For those of us who have chronic joint pain, a potential treatment using a monoclonal antibody to inhibit pain generators. 


A study in the New England Journal of Medicine (Oct 14) looks at using an antibody to reduce knee pain for those who have osteoarthritis (the degenerative type of arthritis; i.e., due to wear-and-tear).

The pathology goes like this:  over time, the inner surfaces of our joints become worn down by rubbing together for years, or due to imbalances (or increased weight) that create increased pressure, or by scarring from trauma.  Once the cushioning and protective surfaces are gone, then bone begins to grind against bone, and we get inflammation and pain.  The process continues and we are treated with Motrin-type drugs to reduce inflammation and therefore lower the pain.  But as long as mechanism that started the problem continues, the condition worsens.  In severe cases, the answer is replacement of the joint with an artificial unit (definitely not minor surgery).

[Note:  the other types of arthitis, like rheumatoid arthritis, are caused by different mechanisms...and treatment is likewise different]

It would be great if you could reduce the pain, and increase patients' mobility without the need to take non-steroidal anti-inflammatory drugs (Motrin, Celebrex, etc), that only last for hours and can occasionally cause GI bleeding.

It turns out tha,t in inflamed joints, there's a protein called nerve growth factor (NGF) that acts on the pain nerve fibers to increase the sensitivity of these pain nerves, leading to increased pain.

The hypothesis is, if you inhibit NGF, you will decrease the pain.

The study referenced above gave an inhibitor of NGF called tanezumab or placebo to 460 patients with moderate to severe knee pain.  It was given by two injection--at increasing doses--two months apart, while monitoring pain (using standard survey measurements).

The results were pretty good.




The upper graph is reduction in pain, the lower is how good the response was.  There was also a trend toward a better response with higher doses.

Conversely, adverse reactions increased with dose.  About 6% dropped out of the study due to reactions.  Most common was headache after injection.

Caveats:
1.  Intermittent injections are more prone to safety concerns and practical considerations.  A better route of administration would be good.  Every two months is not bad, but...
2.  Safety in the long run is not addressed here.  More work to be done.
3.  No evidence that this slows the progression of the arthritis...it just reduces the pain (which is good in itself)
4.  No comparison to the relief of pain using other drugs.

For Onion Peelers,
Mean reductions from baseline in knee pain while walking ranged from 45 to 62% with various doses of tanezumab, as compared with 22% with placebo (P-value <0.001). Tanezumab, as compared with placebo, was also associated with significantly greater improvements in the response to therapy as assessed with the use of the patients' global assessment measure (mean increases in score of 29 to 47% with various doses of tanezumab, as compared with 19% with placebo; P-value ≤0.001).

Unlike chemical agents, which can have broad effects throughout the body, antibodies are targeted to specific agents of disease and symptoms.  On the other hand they are more complicated compounds and can cause immune reactions themselves, sometimes.

Still, this line of research is very interesting and worth exploring further.

Doc D
 
 

Wednesday, October 13, 2010

Supreme Court Vaccine Case: If You Can't Show Cause, Can You Sue Anyway?

 
A new vaccine case before the Supreme Court is being characterized as a "product liability" issue.  But the problem is that the plaintiff has never shown that the vaccine caused the problem.

This is an interesting twist, both in the law and in the science.  The facts are these (quotation from the Washington Post (Oct 13) :
"We are talking about trying to eliminate some of the most horrifying and horrible incidents of injury to vaccines that we compel children to take," said David C. Frederick, a Washington lawyer.  He represents the parents of Hannah Bruesewitz, 18, who began to have seizures as an infant after receiving the third of five scheduled doses of Wyeth's Tri-Immunol diphtheria-pertussis-tetanus vaccine. The company, now owned by Pfizer, has taken the drug off the market.  ...The National Childhood Vaccine Injury Act of 1986 said all such claims must first go to a special tribunal commonly called the "Vaccine Court." The tribunal ruled against the Bruesewitzes, saying they had not proved that the vaccine caused Hannah's problems. The couple then sued under Pennsylvania tort law. But federal courts said the suit could not proceed, because federal law prohibits claims against "design defects" in vaccines.  The question before the Supreme Court is whether that is correct, or whether Congress left some remedy for those who say injury or death could have been avoided if the manufacturer had offered a safer vaccine [my note:  say what?  how did we go from "didn't cause" to "injury could have been avoided"?]
Note that while the case is about remedies for a product that was later replaced by a different vaccine, the parents have never shown in their suits that the daughter's seizure disorder was caused by the vaccine.

Where did the issue get transformed?  

I have a problem with suing for treatments that have been superseded.  It reminds me of the heart valve replacement suit a couple of years ago.  Prior to the 1960's people with bad heart valves mostly just...died.  Then a hardware device came along that allowed replacement of the valve, extending doomed patients' lives.  It worked like a ping pong ball in a small birdcage; the flow of blood out of the heart would push the ball away from the base of the cage allowing blood to flow.  The ping pong ball would then be pushed back to the bottom of the cage, plugging the hole and stopping blood from flowing back into the heart.  Anybody who knows about back-flow valves in plumbing can see how it works.  (My description is way over-simplified, but you get the idea.)  Not elegant, but it did the job.  After more than two decades, the frame of the cage, after about a billion heart beats pounding it, began to crack in some cases.

So, these folks, who got an extra couple of decades of life, sued...alleging a product defect.

The point is, you get the best available at the time...and if better comes along later, should you be able to sue retroactively? (This is risky surgery, you don't just replace an artificial valve like buying a new car)

The vaccine suit is similar (but, still, it shouldn't even be credited, since there's no proof of harm).  The vaccine in question was superseded by a vaccine that's less likely to cause febrile seizures.  The new product had been introduced at the time of this child's birth (if I understand the facts correctly), but the data was not yet complete on whether it was safer or not, and the old vaccine was still available. 

Why no proof of harm?  Many vaccines cause fever.  About 15% of kids are vulnerable to seizures from fever.  These are almost always harmless, and they grow out of that vulnerability.  And any febrile illness can cause these seizure episodes, not just vaccines.  But there's little evidence that they precipitate a lifelong seizure disorder.  And many children have lifelong seizure disorders, caused by neurological problems, birth defects, etc...nothing to do with vaccines.

This is what the parents failed to show in their previous suits.  And, by the way, the issue of "forcing" vaccines on people was decided in the courts a hundred years ago; yes, the government has an obligation to protect the public by not allowing people to spread contagion.

I guess ultimately this case is about sympathy.  Sympathy for the child and their family:  "Can't we find a way to compensate them for this tragedy?"  Because it is a tragedy:  the daughter requires extended care, medication, and support...the kind of situation that can financially break even the wealthiest.

One final consideration.  The 1986 law that shielded vaccine manufacturers from liability, and set up a vaccine court to decide compensation, was an effort by Congress to stem the tide of companies who were cancelling vaccine production because they were getting sued all the time.  That court has worked; it has compensated many thousands of people, awarding millions.  At the same time, it cuts out the frivolous and unproved cases.

So, should we overturn a mechanism that compensates those who are truly harmed, and protects vaccine production?  Shortages have occurred in the past for exactly the reason that the law was written.

The media article seems to think the justices have mixed feelings.  But if we go back to the pre-1986 situation, there may be consequences we don't want.

Doc D
 
 

Monday, October 11, 2010

Trends: More Drug Companies Data Mining Your Durg Usage, Compliance, Diseases

 
Your pharmacy benefit managers are starting to look at whether you take your medicines as you should, and how much you are at risk of developing diseases.

It sounds confusing, but a pharmacy benefit manager (PBM) can look up whether you refilled your required daily medicine every 90 days.  If it took you longer than that, maybe you didn't take it every day like you were supposed to.  Or maybe you quit taking your meds entirely: if you are hypertensive, you're more likely to have a stroke, and need expensive care...costing the insurance plan more.

Also, PBM's can see when you became diabetic, say, and look back at your other medical and prescribing history to see whether you were at increased risk for diabetes.  That way they can design models for customers that will predict when someone with certain characteristics will be more likely to be sicker, or need more expensive medicines in the future....and cost the insurance plan more.

There's a positive side to this:  your  PBM can call and encourage you to stay on your meds, or offer an easier way to obtain the drugs (by mail, say).

That sounds good, but minimally helpful.  I think it's mostly about cost:  are you gonna be a drag on profits, to the employer plan or the government, depending on who pays the bill.

Other efforts are underway, according to the WSJ Health Blog (Oct 11),
"UnitedHealth’s Ingenix unit sells a diabetes-prediction service; among other things, it uses mole-removal stats to pinpoint people who spend time outdoors and therefore who aren’t likely sedentary."
I can think of other reasons why mole-removal might be high that have nothing to do with exercise and fresh air.

Some people will see this as anonymous information that can help design better patient compliance and assist people in stay on track with their health.

Others are going to see this as another way our personal lives are being monitored and regulated. 

You know the old saying, "If you don't have the freedom to choose poorly, you don't have freedom."

Doc D
 
 

Just When You Thought HCR Was Safe From More Poison Pills

 
How often do you run across a situation where two goods make a bad?

I didn't put this together either, but it's right there in the law, and I should have picked up on it.

Take two positive elements in our healthcare system:
1.  Most retirees have employer-based healthcare plans that provide good coverage and low deductible/co-pays = Good.
2.  The new HCR law requires health plans to cover dependent children up to age 26  = Good, also.

[Wait, you say...how many retirees have under-26 children?  Don't people stop having children long before they retire?  Actually...no:   foster children, adoptees, late-bearing...]

So, put the two together:  retiree with a health plan and dependent child under 26...covered?  NO.

There's a provision in the law that exempts retiree plans from the 26-year old requirement.  Sorry, Charlie.

From the Wall Street Journal, "Health Overhaul Overlooks Retirees" (Oct 9)
"Glenn Franco, a retired community-college instructor in Michigan, tried to get his 24-year-old daughter on his health plan—and was turned away. ... Many large employers are telling retirees the same thing. They include Alcatel-Lucent and Verizon Communications Inc., as well as state and federal government plans and those for military families and unions. Thanks to a little-noticed clause in a 1996 law, retiree-only health plans are exempt from the Patient Protection and Affordable Care Act that went into effect last month."  A retiree health plan is one that provides coverage until age 65, after which it either phases out or acts as a supplement to Medicare. ... Employers say they might drop retiree coverage altogether if Congress were to force them to extend dependent coverage and comply with other provisions under HIPAA and the ACA.
Poison Pill. 

The consequences of passing un-read legislation.  And I don't care whether this exemption was a Dem or a Rep idea, it's incompetent.

Here's another question:  what about dependent grand-children under the age of 26 who are living with their covered, retiree grandparents and whose parents are not available or capable?  (drugs, prison, etc).  Are they covered?

Doc D
 
 

Sunday, October 10, 2010

Medical Cartoonville - 10-10-10 (Yep, Oct 10, 2010)

 
(Incredibly slow day for Nostrums material.)

I love this cartoon.


 

Saturday, October 9, 2010

FDA Withdraws Obesity Drug: Thoughts On 30 Years Treating Overweight Patients

 
The FDA decided that, on balance, the modest weight reduction didn't justify the low incidence of heart risk.

As we learn more and more about drugs we are able to better define "benefit" and uncover one-in-a-million level "risk."  I predict we'll see more and more of these complex situations where there is no black-and-white solution.

But the request to Abbott (the manufacturer) by the FDA to stop marketing the anti-obesity drug, Meridia, culminates a long battle over this drug, and illustrates one aspect of our search for a reliable, long-lasting, and safe treatment for obesity.  We aint got one.

Over the last 3 decades of clinical practice, I've found obesity to be one of the most difficult conditions to treat....actually, "treatment" is not the term, maybe "influence" is the right word.  If I could influence the development or persistence of obesity, I would be happy.

But I admit it's been a losing battle.  Every modality has been tried, and most are still going strong:  (1) drugs, (2) liposuction, (3) bariatric surgery (banding the stomach), (4) psychotherapy, (5) behavioral conditioning, (6) diets (Lord...the diets), (7) calorie labelling, (8) restricting foods in schools, (9) dietary laws (10) nurtritional counselling, (11) herbals (all crap)....and on and on.

The percentage of overweight citizens continues to grow.  In medical school we were taught that the "cure rate" for obesity was lower than that for cancer; in a sense thats true.

I almost never used drugs for my patients.  When Meridia came out, I prescribed it a handful of times, then quit.  I think the approach is wrong, even as a "stimulus" or "kick start" to further behavioral change.  There were too many side effects (blurred vision was most common in my experience), and any weight loss didn't persist.

Our bodies were engineered to survive with a subsistence diet.  We never adapted to abundance.  So, there's a physiological roadblock to success in weight loss.

Psychologically--in my experience--my overweight patients were stressed, or depressed, or unhappy, or trapped, or had lost faith.  In a word, it was a loss of well-being.  Without waxing philosophical, there was always an element of "what's the point?" to their struggles.  They were desperate to find an external fix to an internal problem.

By contrast, those rare successful cases (I mean keep it off for the rest of their life) all had a sense of purpose, self-direction, and optimism.  They couldn't be diverted to comfort food, or pleasure-eating, because their lives were filled with other engaging and fulfilling things.

That's why I don't think all those diets and pills and surgery will ever really succeed.

It's about building a life that means something.

Doc D
 

UPDATE:  You understand, of course, that I'm not talking about people who have another disease that causes obesity, or a genetic defect, one component of which is obesity.  I'm talking about garden variety overweight.
 
 

Friday, October 8, 2010

Why Your Doctor Won't Answer Email. A Personal View

 
A new survey says only 6.7% of doctors engage in email with patients.

The report, put out by the Center for Studying Health System Change (CSHSC), didn't look at why more docs don't use a modern tool to facilitate the exchange of information and guidance between doctor and patient.

The Center, which sounds like a part of the government, is actually a private think tank with financial ties to the unions and other progressive philanthropic organizations.  They try to be non-partisan but their results usually lean to the left a bit.

Back to emailing your physician:  there are a number of reasons why doctors don't do this.  There's an article in the Wall Street Journal Health blog (Oct 7) that talks about most of them:
This survey didn’t ask non-emailing physicians why they weren’t trading LOLs and emoticons with their patients, but the CSHSC brief has a host of previously cited reasons: “lack of reimbursement, the potential for increased workload, maintaining data privacy and security, avoiding increased medical liability and the uncertain impact on care quality.” (Given that list, it’s hard to figure out why any physician would choose to email patients.)
All of these things are certainly dis-incentives to use the printed word, I guess.

I don't practice by email.  That's not to say that I don't answer a quick question or deliver a result that doesn't need further inquiry ("Mr. Smith, your cholesterol is down to 180; keep up the good work.").  But anything further than that limits my ability to do the job.

For me, it has to do with the very personal, face-to-face, intimate nature of health care.  I can't see your face or your body movements when I ask a question or give information.  I can't see a question on your face, that says I'm not meeting your needs.  I worry that the words I use may be mis-construed in print (happens all the time with email), and I can't tell how you receive them.  If a question comes up, you aren't there so I can go back and physically examine the problem.  I can't see skin textue, swelling, clues to psychological status, etc.  I could go on and on, but the bottom line is, your bodily absence makes my job impossible.

Even a web video call doesn't cut it.

So, I'll use email for administrative things, but not for clinical practice.

Doc D
 
 

Thursday, October 7, 2010

Top Five Posts Over The Last Six Months - 7 Oct 10

 
For your interest, these are the five posts that were most popular, highest pageviews first.

1.  Doctors Get Sick Too -  My Appendicitis Story  I'm hoping this was interesting from a clinical point of view, not as a soap opera.

2.  Commonwealth Fund Blasts US Health Care:  Helpful But Subject To Criticism  Like most organizations who are activists for or against HCR, they use selected data to support their cause.

3.  Doctors Fleeing Medicare In Texas, Fed Up (Pun Intended)  The rate of non-participation has grown several fold this year.

4.  Healthcare Reform:  Focusing On The Goals And The Dialogue  My grand scheme for reform (pre HCR law passage):  Cost, Access, Coverage, Quality.

5.  Should Nurse Anesthetists Work Unsupervised By Doctors?  There's a reasonable middle ground


Actually, there was one cartoon that would have made it into the top 10:

Medical Cartoonville - 7 July 10


Doc D
 
 

Another Flu Vaccine Myth Bites The Dust

 
The media went nuts a few months ago about Sweden looking into cases of narcolepsy after taking the H1N1 vaccine.

Narcolepsy is a chronic sleep disorder.  The most common symptom is excessive daytime sleepiness, in which a person experiences extreme fatigue and possibly falls asleep at inappropriate times, such as while at work or at school.  It's a complex problem with other features we don't need to go into:  cataplexy, hypnagogic hallucinations, etc, even insomnia.  We understand the syndrome poorly, but there's evidence for a genetic component, and some type of autoimmune phenomenon.

Once announced, the vaccine alarm spread throughout Europe, with some countries suspending one particular product.  Just Google "vaccine" and "narcolepsy" to see the dozens of articles about it.

Now comes word that although there were a handful of cases of narcolepsy diagnosed in people who had taken the vaccine, there were just as many who were diagnosed with the disease that had not received the shot.

For Onion Peelers,
Turns out that Sweden gave 6 million doses to its population of 9.3 million.  There were six cases of narcolepsy diagnosed in children; in that group only two had received the vaccine.  Of 10 adult cases of narcolepsy, half had taken the shot, half had not.  Ergo, what you might expect from chance alone.

This is a classic case of the Texas Sharpshooter fallacy, and one commonly at work when people falsely perceive an increase in some adverse event.

The fallacy goes like this:  our crafty Texan fires a number of shots at the side of a barn, then goes up and paints a bullseye around all the bullet holes, and claims to have scored a bullseye with every shot...and therefore is a sharpshooter.

Explained like this, everyone can say "Well, sure, that's fallacious reasoning."  But then, when several people with an unusual illness or adverse reaction pop up in a location, most of us forget all about the fallacy and assume that there's an outbreak ("danger, Will Robinson.")

In Sweden, somebody happened to notice a couple of cases of childhood narcolepsy in vaccinated children, and isolated that data from the total environment (in the same way the  sharpshooter drew his bullseye).  Once the statistics were in, people could see that there were just as many cases, or more, of narcolepsy without the vaccine than in association with it.

Investigating isolated observations of disease occurrence is a good thing.  Ignoring input is foolhardy.  Rarely, it leads to useful information of a real outbreak...like food poisoning from a widely atttended picnic.  Most often it's a red herring.  But you have to ask yourself about plausibility:  is there a conceivable link between vaccines and narcolepsy?  Well it's "conceivable" (as is the existence of martians), but not a known connection for any other vaccine.  And even if conceivable, how much faith should we put into an analysis of two or three cases of a rare disease?

This fallacy is a weakness built into human reasoning that probably had some survival value in the pre-historic period when individuals had no idea how or why things happened to them.  An integral part of the fight-or-flight reaction, maybe:  better to assume the worst and think it through later.

The epidemiology literature is littered with examples of panic over episodes like this.

If you hear of unlikely associations, it's best not to don your 10 gallon hat, grab a rifle and head for the barn.

Doc D
 

Wednesday, October 6, 2010

Diagnosing Unscientific Claims...Some History

 
Looking back on scientific nonsense.

There are a number of good books on how to judge whether research claims or health care policy proposals have merit.  Books like Snake Oil Science by R. Barker Bausell, and Science Under Siege by Kendrick Frazier, look at the ways we get fooled by bad science or implausible data.

Nostrums follows the same pattern of trying to show when a medical claim or policy proposal doesn't make sense, by looking directly at the data.

But these authors weren't the first to do so.  Enter Irving Langmuir, over fifty years ago.  What follows is my review of his work in diagnosing "Pathological Science."


Langmuir's Pathological Science, A Reappraisal

Irving Langmuir (1881-1957) won the Nobel Prize in Chemistry in 1932. In 1953, he gave a talk during a colloquium at The Knolls Research Laboratory that detailed his experience with “the science of things that aren't so.” During the course of that presentation he listed the symptoms associated with “not-science” under the moniker Pathological Science (Physicist Robert L. Park later developed the Seven Warning Signs of Bogus Science, which overlaps a bit, but contains new signs inspired by the impact of 24/7 media...an influence unknown in Langmuir's time). However, most scientists and authors give Langmuir credit for being among the first to define the common implausibilities of unscientific claims.

Although Dr. Langmuir lived through an era of quackery and nostrums in medicine, his focus was on science-less notions in the physical sciences. At the time of his speech the Great Explosion in alternative medicine had yet to occur--after all, the Sixties were still to come--so it's appropriate to ask if his initial diagnosis is still useful or just an anachronism.

Do his symptoms still tell a tale that applies to alternative therapies? What would he have thought of "testimonial evidence" and all the other Ways of Knowing, that have grown up since his time.  In 1953, the science of "things that aren't so" was confined to legitimate scientists who went off the rails, unwittingly, but used the scientific method.

I thought it was interesting to look back and see Langmuir's pathological symptoms in light of today's medical claims.
Characteristic Symptoms of Pathological Science

Langmuir's list, as transcribed by R. N. Hall, and preserved by Kenneth Steiglitz of Princeton University, is as follows:

1. The maximum effect that is observed is produced by a causative agent of barely detectable
intensity, and the magnitude of the effect is substantially independent of the intensity of the cause.
2. The effect is of a magnitude that remains close to the limit of detectability; or, many measurements are necessary because of the very low statistical significance of the results.
3. Claims of great accuracy.
4. Fantastic theories contrary to experience.
5. Criticisms are met by ad hoc excuses thought up on the spur of the moment.
6. Ratio of supporters to critics rises up to somewhere near 50% and then falls gradually to oblivion.

Note that Langmuir is targeting reputable scientists engaged in false theories. He grants them integrity of method, grounded initially in reputable science, but not the validity of the result. By contrast, today we are confronted not only with invalid claims, but also a rejection of methodological integrity.

In our day, there are undetectable rays, invisible forces, miraculous herbs, supernatural talents, and super vitamins.  As a culture we have gone so far as to reach back to prehistoric animism, yanking primitive man's groping for understanding (shamanism) forward into the age of reason in ways that Enlightenment thinkers would have ridiculed.

The science changes, but human nature doesn't.

Doc D
 
 

Tuesday, October 5, 2010

Don't Miss It...Flu Vaccine Is Here, Coming To A Pharmacy Near You.

 
The flu vaccine has been available for over a month.  If you skip it, you'll regret it.

Here's why:
1.  It can take up to three weeks to become immune.  Wait until people are sick around you...and you messed up.
2.  The more people who are immune, the less the spread, and the fewer the cases.
3.  For you, influenza may not be a lethal threat.  But I assume you have older relatives, someone you know who's pregnant, a friend with a chronic illness?  How would YOU like to be the agent of their death?

As I said some time back, H1N1 is still around.  The data from last year showed that infants were particularly vulnerable, and the virus was more lethal in the first year of life.

The good thing we now knowis that mothers who are pregnant pass on their immunity (if they get the vaccine) to their babies in utero.  Influenza was 40% less likely in infants under the age of six months if their mother got the vaccine while pregnant.  The study is here.

Doc D
 
 

Monday, October 4, 2010

Great Fanfare For Stimulus Medical Research Into MRSA...Un-earthshattering

 
The press is trumpeting an 11 million dollar Stimulus Plan project to deal with severe infections that occur outside the hospital. 

Staphylococcal infections are everyday events.  Almost all of us are colonized with various strains...on the skin, in the mouth, etc.  Methicillin-resistant staphylococcus aureus (MRSA) is a strain that can--in rare cases--cause lethal infections, more commonly from hospital sources but also from community exposure.   Nobody knows why... or what makes that rare person vulnerable.

According to the OC Register Healthy Living blog (Sep 4), the Administration has devoted some cash to test an antiseptic called chlorhexadine as a outside-the-hospital agent to suppress the population of the bacterium.  The logic is, if there's less of it around, fewer people will get infected.  The problem is that the agent they are going to test is the same one that's used in the hospital (Hibiclens), and in oral rinses that are already commerically available.

If it's effective it's not going to be because we found a great new agent against the bacteria.  It means we push people to use it at home.

I predict it will become the MRSA version of bottled water and hand cleansers.  Another costly product that millions will buy to keep from getting a rare condition.  I'm not an investor, but if I were I'd invest in chlorhexadine stock.

At some point a public health statistician will calculate how many millions of dollars we will spend to prevent one case of disease....and we'll be shocked, but keep using it  (pass the Purell, please).

The problem with MRSA infections is finding out in advance what makes a small number of people very vulnerable.  About 2 million people are carriers, but never get very sick with it.  My guess is an immune system defect that keeps the normal immune response from preventing the spread of infection throughout the body.  But, honestly, we don't know.

And the cleanser may "decolonize" individuals, but lead to chlorhexidine-resistant MRSA.  Wouldn't that be ironic?
 
Doc D
 
 

ObamaCare's Great Benefit For Uninsurables With Pre-Existing Illness...Except Few Of Them Want It

 
Great idea, incompetent execution.  It's too expensive, there's a waiting period, and it doesn't cover drugs.

This is not a poison pill, really.  The concept of offering health insurance to those people who can't get coverage because they have other medical problems is a worthy one.  But, unlike the insurance companies who say they can't offer it, the government offers it... but makes it unaffordable.

The Assoc Press (Oct 3) reports on how the program is faring across the country.  California has openings for 20,000 people but fewer than 500 have applied.  Texas has received 200 applications.

Government officials estimated that about 375,000 people would seek coverage this year. Not happening...

According to the report, the problems are these:
-Premiums may be out of reach. In many states, people in their 40s and 50s face monthly premiums ranging from $400 to $600 and higher. "I think there's some sticker shock going on," said Sabrina Corlette, a Georgetown University research professor. "People who may be eligible are finding out that even if they can get the insurance, the price is too high."Pennsylvania, which set a premium of $283 for all ages, has had no problem getting applicants.
-A barrier may include requirements that people be uninsured for at least six months and that people provide documentation that they've been turned down by an insurer. "There are many people who don't meet the criteria for the federal pool, particularly the six months without coverage," said Goldman.
-In states where the federal government runs the program directly, the insurance plan doesn't provide coverage for prescription drugs until people have met a $2,500 annual deductible. "Applying this high ... deductible to the pharmacy benefit is a real barrier to consumer access to medications," Steven Browning, a Texas official, wrote HHS last week.
Government officials are now saying "it's going to take time" for people to avail themselves of this great program.  But you'd think if people were desperate for coverage due to illnesses, they would jump at it.

It's tempting to call this great benefit a pig-in-a-poke, but time will tell.

Doc D
 
 

Saturday, October 2, 2010

Medical Cartoonville - 2 Oct 10

 


 
 
This is an advertisement for a very funny book:  Suture Self, by Leo Cullum.  A book of medical cartoons, you can find it at book stores or Amazon here.
  
  

Is It Ethical For Physicians To Stand Mute On Unproven Alternative Medicine? A Personal View.

 
Is it unethical for physicians to acquiesce in unproven therapy...in particular, alternative medicine?

This post needs an introduction.  I originally wrote what follows for publication in an online journal.  While blogs tend to have more opinion content, I occasionally do more technical pieces for different venues.

In this case, I asked myself the question in bold above.  Physicians often have patients who want to try therapies or herbals for which we have no solid evidence of benefit, and in some cases, whether they are truly harmless.  Is it ethical to say nothing, not dissuade, or avoid pointing out that--at this point--there is no verifiable benefit?  In summary, is it ethical to permit unproven therapy?

Ten years back, I did graduate study in philosophy and taught medical ethics.  It occurred to me that the same ethical arguments that were effective against the use of placebo (which is also of no known utility) might also apply to alternative therapies.  What emerged is not a knock-down argument against physicians allowing patients to pursue homeopathy, naturopathy, and the like...but I think it's a worthy attempt.

Hence, the somewhat long, if (I hope) interesting, post that follows.  Reader warning:  it's different from what you usually see on Nostrums.
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The Ethics of Permitting Unproven Therapy



I just finished R. Barker Bausell's excellent book Snake Oil Science. Bausell makes the case that the placebo phenomenon “holds the key to answering this book's pivotal question: whether or not CAM therapies work;” i.e., the placebo effect just is the genesis of symptom relief from complementary and alternative medicine (CAM)...and other therapies I'll lump together as “unproven.” I won't follow his argument in detail in this post (Chapter 8 of the book is compelling, and worth the price of the book); it's enough for my purposes that there be a close enough relationship between why both seem to work, and that both share a lack of scientific evidence for a disease-specific causal relationship to the benefit they offer. I'll explore in this post whether these shared features create an ethical problem for the physician who thinks placebos should not be used but will permit--or acquiesce in--patients using CAM.

What follows won't offer a firm conclusion, but it makes some assumptions. (1) There is no definitive randomized double-blinded placebo-controlled study of CAM demonstrating positive results. (2) The benefit of CAM is indistinguishable from that of placebo. (3) Intentional uninformed use of placebo is harmful and unethical. (4) There is little distinction between intending harm and permitting harm.

While many would agree with all four, each could be argued.

As a clinician,my experience of placebo is its use in well-controlled studies. I can't recall intentionally prescribing a useless treatment deceitfully with the hope of gaining ground against a medical condition for which other active therapies had proven ineffective. I have engaged in “empiric” antibiotic use, but for the last two decades have rarely been tempted to risk adverse drug reactions or treatment failure when it was likely that giving an antibiotic would serve only the placebo effect of giving the patient a sense of having been treated with something powerful.

However, this type of placebo effect is not my concern here. I want to focus on the use of so-called harmless substances where the physician has no good options for active therapeutic benefit...that is, the sugar pill, or the inert capsule. This use of placebo has a long history. For most of the last 2,000 years the use of substances that had no active ingredient was unintentional, because physicians had no evidence that nostrums and potions were not working. But the intentional use of a substance known to lack specific pharmacological effect lasted well into the modern era... until some began to question whether using placebos, despite providing measurable symptom relief, was ethical. Due in no small part to an article by philosopher Sissela Bok, (“The Ethics of Giving Placebos,” Scientific American 231, 1974: 17-23), the practice has largely disappeared. The AMA's code of ethics states that
In the clinical setting, the use of a placebo without the patient’s knowledge may undermine trust, compromise the patient-physician relationship, and result in medical harm to the patient.
With that introduction, I want to ask this question: if prescribing a placebo is unethical, how is it ethical to permit a patient--uninformed by evidence--to engage in an unproven CAM therapy? In what way is that less of a moral deceit than prescribing a sugar pill? When we acquiesce in our patients' adoption of cleansing diets and homeopathy, are we doing anything less deceitful? Many clinicians have tried to adopt a middle way, an open-mindedness to patient's needs that avoids the extreme of being “so open-minded your brains fall out.” In the words of one practitioner (link) who reflected on this:
When it comes to CAM , I’ve learned to support my patients in their choices while tempering their enthusiasm from time to time with evidence of harm or sometimes just plain old common sense. For Jenny, since she wasn’t on any medications or recreational drugs and was careful to follow a healthy diet, I told her that as long as she didn’t overdo it, a little taste of her own fresh urine every morning wasn’t likely to cause her any harm. I’ve adjusted to the new climate in healthcare, and my mind is open but balanced — without any need to pick my brain up off the floor. http://www.physicianspractice.com/index/fuseaction/articles.details/articleID/1455.htm)
I suspect many of us don't try to “talk patients out of it.” Patients who sing the praises of chiropractic get no advice from me, unless they ask what I think. This middle way may be our best ethical approach, but it leaves the question unanswered: if you accept the parallel operation and impact of placebo therapy and CAM, why is the first unethical, and not the second?

Whatever your instinct at this point, Dr. Bok's comments shed more light on the comparison.
The common practice of prescribing placebos to unwitting patients illustrates the two miscalculations so common to minor forms of deceit: ignoring possible harm and failing to see how gestures assumed to be trivial build up into collectively undesirable practices. (from Lying:Moral Choice in Public and Private Life, pg 61-68)
Take ignoring possible harm first. Bok says (paraphrasing for CAM), to the extent that the evidence-based physician allows a patient to engage in unproven therapy--without first ascertaining the underlying problem--significant disease can be overlooked. In practice, directly overlooking a disease is uncommon. More common would be a failure to understand the underlying reason a patient would consider an unproven therapy; understanding that need could be invaluable to future treatment.

Further, as Bok goes on to point out for placebos, the beneficial effect of CAM can be short-lived, and the patient may lurch from one New Age therapy to another as each loses its impact. Finally, as Bausell points out in his book, the natural history of chronic disease-- which promotes treatment-seeking behavior when symptoms are worst, but would have improved soon anyway--is indistinguishable from therapeutic benefit to the patient. This clouds the perceived benefit from the useless--and invariably expensive—CAM treatment. Patients are left believing the CAM therapy (that operates like placebo) has worked.

As regards Bok's second miscalculation, the growth of “collectively undesirable practices,” we're there. Every day a new therapy appears in print, based on some object's imagined influence on health. If the new therapy survives allegations of acute injury, then it graduates to full CAM adoption without further inquiry.

My current favorite is Earthing: the Most Important Health Discovery Ever? It's #4 on Amazon's CAM bestseller list. The publisher's blurb says
Few people know it, but the ground provides a subtle electric signal that maintains health and governs the intricate mechanisms that make our bodies work-just like plugging a lamp into a power socket makes it light up. Modern lifestyle, including the widespread use of insulative rubber or plastic-soled shoes, has disconnected us from this energy and, of course, we no longer sleep on the ground as we did in times past.
The number of fantastic therapies is growing faster than patients can launch into them, lose interest, and drive on to the next. In the minds of some, physician acceptance that there can be other non-evidence-based alternatives is instrumental to that growth. Others have written that the promise of modern medicine was its own worst enemy; as the diseases that historically plagued humanity were conquered, people came to expect the same success with the chronic diseases of a longer-lived population. And that promise has not been fulfilled. Chronic disease is mitigated, temporarily, at best by science-based medicine. In common sense language, the more we promote magic pills, the more the public comes to expect them, and if they can't get them from us, they'll try elsewhere.

In summary, CAM does harm for the same reasons that placebos do harm.

I think applying Bok's reasoning regarding placebo forms a moral basis for actively resisting CAM therapies. Absent this resistance, the number of these counter-intuitive and implausible treatment modalities will grow unimpeded by critical review.

I've left to last an important distinction between placebo and CAM that some would argue undermines the clinical parallel between placebo and CAM. In the placebo effect, there is direct physician intent to deceive, however worthy the motive. In CAM, the patient intends the activity and the physician's role is passive acquiescence. Is there an ethical distinction here? Two influential works that argue “no” are Shelly Kagan's The Limits of Morality (1991), and Samuel Scheffler's The Rejection of Consequentialism (1994).

Philosophers have argued about moral duty of this type for ages. Rather than this become a lecture on ethical theory, my dumbed-down version is this: some would argue that “intent” is the more important part of an act with moral content. Others would say that the “outcome” is more important. That's my mickey mouse distinction between deontologic and utilitarian theory.

My reading of Bausell and Bok is that, like with placebo, permitting unproven therapy is a form of deceit; an abdication of responsibility to truthfulness that could undermine trust and lead to harm, either by overlooking an underlying medical issue or by contributing to new, collectively undesirable practices. In practice this would mean clinicians should intervene even in those situations where the patient chooses the harmless “sugar pill” variety of CAM.

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Doc D
 

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