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, September 30, 2010

Health Care Reform: Do We Hate It Or Love It?...uh...Yes.

Take a look at these separate poll data.  They seem inconsistent, but there's an explanation.

From Datawatch, Kaiser Family Foundation  (Sep 29:

(This graph is getting a lot of press from the MSNBC, Salon, NYT, WaPo crowd)

Then from Rasmussen Reports (Sep 20):
Sixty-one percent (61%) of Likely U.S. Voters now at least somewhat favor repeal of the new national health care law, including 50% who Strongly Favor it. That’s up eight points from a week ago and the highest level of opposition measured since late May.
A new Rasmussen Reports national telephone survey finds that 33% of Likely Voters oppose repeal. Since the passage of the bill in late March, a majority of voters have consistently favored repeal of the new law, with support ranging from a low of 53% to a high of 63%.

Doesn't seem to match up does it?  If you watch MSNBC then you probably hear the first story.  If you watch FoxNews you hear the second.

While both sets of data seem to be talking about the same subject, Health Care Reform-and specifically the new law--they aren't asking people the same thing about it.

The first asks about "favorability" and the second is asking about "repeal."

Why should that make a difference?  The first is a "thumbs up" and the second is a "thumbs down" on the new law, right?

The explanation lies in which words you use, and how you phrase the question.  When you ask about health care reform favorability, most Americans are for it.  When you ask specifically about doing away with the current version of reform, they are for that, too.

It's not that the people are inconsistent.  It's that the pollsters design their questions to get the answer they're looking for (cynically speaking) or they phrase the question in a way that their customers or audience would like to hear an answer (diplomatically speaking).

As reform unfolds, and particularly as we approach the mid-term elections, expect to see a lot of spinning of poll data to show one side or the other has the advantage.  As an intelligent reader, though, you can get behind the data, see how they structured the question, how they set the stage for the types of answers they are seeking, and what population they ask the question of (note that the negative poll is "Likely voters."  The positive poll is "Adults.")

Nostrums readers know how to fact-check the data for selection bias and inadequate statistical power.

Doc D

Genetics Of Knee Injuries: Will The Sci-Fi Movie Gattaca Become A Reality?

New genetic studies show a correlation between certain genes (that govern cartilage and knee structure) and knee injuries, suggesting we may be closing in on predicting the likelihood of illness and injury later in life.

It sounds like the scenario played out in the sci-fi classic Gattaca could become a reality:
In the not-too-distant future, a less than perfect man wants to travel to the stars. Society has categorized Vincent Freeman as less than suitable given his genetic make-up and he has become one of the underclass of humans that are only useful for menial jobs. To move ahead, he assumes the identity of Jerome Morrow, a perfect genetic specimen who is a paraplegic as a result of a fall. With some professional advice, Vincent learns to deceive DNA and urine sample testing (IMDB)
The study that appeared recently in the British Journal of Sports Medicine (Sep, 2010), showed that fraternal twin girls experienced the same ligament tear due to sports injury, and an analysis of their knees showed they had similar knee structure and increased laxness in the joint.  The referenced study, and others discussed by the New York Times Well blog (Sep 29), link together to suggest that we can identify specific genes that regulate joint structure and the strength of cartilage.  Taken together the knowledge can combine to tell us whether close genetic relatives are more likely to experience the same kind of injury.

If we discover the genes that predispose to later injury, we could do positive things like develop prevention or correction efforts.  Or, on the bad side, we could use it to eliminate people from sports opportunities, career choices, or military service.  Why sign up a pro football player if he has a predisposition to injury, lost time from play, and long rehabilitation...but is still prone to re-injury?

The bad side of this knowledge is what's explored in Gattaca, one of my favorite movies.  In the movie, the profiling of humans into those who "can"  and those who 'can't" is one aspect of the movie's exploration of the philosophical cocept of personal identity:  what does it mean to be me?  Highly recommended.

This is not to say that we don't need this knowledge of genetic weaknesses.  Ideally, we would be able to prevent the adverse impact of genetic predispositions that are built into our future.

Which way we go--remove limitations or give opportunities only to the select few--will depend not only on the technology that's available, but also on our view of human freedom and responsibility.

Doc D

Tuesday, September 28, 2010

Crazy Weirdness: The Birth Control Pill With Built-In Pregnancy Support...Just In Case

Bayer (the aspirin people) now has FDA approval to market their birth control pill (BCP) with added case the "control" part doesn't work.

You gotta hand it to marketers.  If your product doesn't work, put stuff in it that makes it OK to fail.

In a report by NPR's Health Blog (Sep 27) you can find the FDA's decision to let Bayer put folic acid in it's birth control pill, Yaz.

Mothers who have low folic acid are more likely to give birth to babies with birth defects (specifically spina bifida).

Soooo....In Beyaz, the new Bayer drug, if the "birth control" part doesn't work out like you want it, then you're all set with the folic acid that will protect the fetus  (assuming you don't choose abortion).

I mean, it's logical....and hilarious.

It's like carrying a ready-to-file lawsuit in your glove compartment in case your seatbelt doesn't work.  You're primed to sue in advance.

I suggest (sarcastically) that Bayer add a cholesterol-lowering agent to the pill, too.  That way when  the BCP fails, and the folic acid kicks in, you'll be less likely to have a heart attack before paying for the kid's college education.

Doc D

Monday, September 27, 2010

Poison Pill #30-Something (I've Lost Count): College Health Plans Uncertain

Will the federal government require college health plans to cover abortion?  Will insurers offer plans that meet fed standards, but students don't need?

Apparently this is something else Congress didn't consider.  Many of you may remember the medical policies that your university required.  Students paid a comparatively small premium that would cover them for the period of the school year, at a rate of a few hundred dollars per semester.  Well, it's higher now, but still a bargain compared to a regular policy.

[the "requirement" to pay as a part of enrollment, and whether it should ever have existed, is another question.]

Also, the universities could taylor their policies to what students needed:  a defined term of coverage (the school year) for primarily catastrophic care (most colleges ran an outpatient clinic).  It was not intended to have a lot of preventive medicine provisions; they aren't needed by 20 year olds.

Now that the federal HCR mandate says that policies have to meet federal standards for coverage, it's not clear whether universities by law can offer plans that are at odds with the more comprehensive and longer term requirements of the new reform law.

duh...  Another high-water mark in Congressional incompetence.  To date, HHS has failed to clarify for the universities what they can do--despite written requests for guidance.  It's expected that politics will enter, as the Democrats will not want to give a waiver to colleges....undermining their goal of "the healthy pay for the sick, and everybody has to contribute."

Anticipating a financially unrewarding political answer, the insurance companies in some states are cancelling plans to sell policies to the schools.  In particular, Washington state is having trouble finding any takers for its schools.

Also, based on North Carolina's Board of Regents decision to require schools to meet federal standards, it's not clear whether those colleges have to support abortion coverage (as part of an exchange), requiring every student to pay premiums that provide that coverage.  Again, no answer yet.  But, I expect they will find a way to get around this conundrum.

Good old healthcare reform.  It always comes back to the costs and competence:  unsustainable on the former, and absent the latter.

Congress and HHS don't seem up to task of doing a good job.

Doc D

STUDY: How Smoking Increases Risk Of Ectopic Pregnancy...Maybe

This study is a good example of how science progresses in small steps.  Much smaller than the press would have you believe.

For NOSTRUMS, that's a no-no.

So here's the title of the article in BBC News (Sep 27):  "Smoking link to ectopic pregnancy"

To refresh your knowledge, ectopic pregnancy (EP) is a condtion where the egg implants somewhere else than the womb, most commonly in the tube that runs from the ovary to the uterus (the Fallopian tube--FT).  This is bad, because unlike the uterus, the FT can't expand as the fetus grows and at some point a potentially lethal rupture can occur, requiring emergency surgery.

So, anything that increases the risk of EP is to be avoided.  We have known for some time that women who smoke are more likely to have an ectopic.  But why?

The news article says this: 
"Research from experts at Edinburgh University said Cotinine [a chemical in cigarette smoke] triggered a reaction which increased a protein in the Fallopian tubes.  They said the protein, called PROKR1, raised the risk of an egg implanting outside the womb."
Not really.  The link is more tenuous than that.

The researchers themselves were more circumspect (American Journal of Pathology, Sep 23, 2010).  They "hypothesized" a mechanism for one chemical in smoke that modified the protein PROKR1, which is a receptor for other proteins that impact muscle activity in the FT.

If it sounds like I'm splitting hairs, then let's lay it out.  They think the following occurs:  smoking -> cotinine in the bloodstream -> modification of the PROKR1 receptor -> changes in the protein that impacts smooth muscle -> altered muscle activity in the FT -> differences in the movement of the egg down the tube to the uterus -> some eggs not making it all the way and implanting in the FT. (substitute the words "leads to" for my little symbol "->")

Given the hypothesis, they took 21 specimens from hysterectomy and exposed them to cotinine.  They then measured the level of the receptor PROKR1.  It was higher than if cotinine was blocked.

For Onion Peelers, (this one is difficult to decipher, so skip to the next paragraph if you like),
Sera/FT were collected at hysterectomy (n = 21). Serum levels of the smoking metabolite, cotinine, were measured by enzyme-linked immunosorbent assay. FT explants (n = 4) and oviductal epithelial cells (cell line OE-E6/E7) were treated with cotinine and an ...antagonist. PROKR1 transcription was higher in FTs from smokers (P < 0.01). ... Cotinine treatment of FT explants and OE-E6/E7 cells increased PROKR1 expression (P < 0.05), which was negated by cotreatment with antagonist.

So given all that, they showed that if you exposed Fallopian tubes to one of the hundreds of smoking chemicals, you get more of a protein that is involved in muscle activity (they didn't claim to observe any muscle activity changes directly), possibly affecting the FT function.

It's a good hypothesis to explain how smoking can increase risk of EP.  But looking back at my "leads to" sequence, you can see that some of the pieces are still missing.  Pieces that they need to fill in, in order to justify the BBC's characterization as having found a "link" to ectopic pregnancy.

Smoking is bad in ways we haven't even begun to define yet.  And this may be another one.  As one of the authors said,
"While it may be easy to understand why inhalation of smoke affects the lungs, this shows that components of cigarette smoke also enter the blood stream and affect seemingly unconnected parts of the body like the reproductive tract."
That's a good point, but not the end of this particular story.

Doc D

Sunday, September 26, 2010

Healthcare Costs Accelerating? Well...No.

Contrary to popular belief the cost of health care, which, like everything else, is rising, is not growing faster than before.

I got this graph from the Kaiser Family Foundation.  Despite a bent toward universal health care, they are something of a gold standard for quality in their research.  They were the first to point out that of the 47 million uninsured, a significant percentage were already eligible under Medicaid but hadn't signed up, that another chunk were illegals, and that several million were wealthy and don't use insurance.

In any case,  here's the percentage rise in national costs for selected expenditures between 1996 and 2008 (the last year for which complete data are available).  NOTE:  these are percentage increases.  As you can see, the rate of increase has been falling for some years.

Benjamin Disraeli (I think) once said something to the effect that "by the time a crisis becomes apparent to the general public the concern has already peaked and is no longer critical."  (I'm paraphrasing greatly)

It goes without saying that this is all pre-healthcare reform.  Analysts are now saying the rate of increase will go up.  Makes sense when you add 30 million people to the system.
Doc D

Saturday, September 25, 2010

Diabetes Drug Restricted: An Example Of Balancing Safety And Effectiveness

Maybe many of you have a friend or family member with diabetes.  The reputation of the blockbuster diabetes drug Avandia has been tarnished by data suggesting heart complications.

But the data is not yet clear.  I wrote a long piece that appeared in Science-Based Medicine two months ago that looked at the data.  While it was written for Onion Peelers, and included a lot of data, it was a fascinating case of looking at the question of drug safety.  It also showed how the FDA goes about judging safety in the context of politics and lawsuits.

The FDA has now rendered a final opinion, which puts the drug into a category where there are major restrictions on its use.

If a diabetic is already taking the medicine and has no complications, they can continue.  But if a new patient requires treatment, and other drugs don't do the job, the physician has to meet a number of requirements in order to prescribe the drug and meet standards of care.

You can read more about the FDA's opinion here

In the opinion of some, even though the hazard is not well established, the drug should have been banned.  Europe has decided to do so.  But if we adopt an absolute standard for safety, then almost all drugs will need to be banned.  I am not aware of any approved drug that has not caused harm under some circumstances.

Even Tylenol (acetaminophen) can cause death in children if given continually in too high a dose.

So, what's a good standard for safety, when there is no certainty from the scientific data?

Consider also, the prospects for diabetes control when the other alternatives for treatment of diabetes are less effective?  Most of the older drugs have significant side effects.

Or, what happens i fpatients find they are allergic to effective alternatives?  Avandia has only one modern competitor, Actos. 

And Avandia is without risk to almost all diabetics when taken properly and monitored.

Shouldn't we keep some medicines around, even though they have cautions and restrictions, for those occasions when alternatives don't do the job?

Ultimately, I think the FDA did a good job of trying to assess the data we have, and made a decision that balanced the needs of diabetics against safety.

Doc D

Thursday, September 23, 2010

Weight Loss Surgery For Teenagers...Not A Great Idea

Gastric banding is exploding among overweight adolescents...and accomplishes what, exactly?

A recent study in Pediatrics shows that--although not approved for those under 18--laparoscopic adjustable gastric banding (LAGB), is growing rapidly in obese teens.  The procedure applies a band around the upper part of the stomach,  that can be adjusted:
The pouch fills with food quickly, and the band slows the passage of food from the pouch to the lower part of the stomach.  As the upper part of the stomach registers as full, the message to the brain is that the entire stomach is full, and this sensation helps the person to be hungry less often, feel full more quickly and for a longer period of time, eat smaller portions, and lose weight over time (Wikipedia)

Classic gastric bypass surgery is more extensive.  In the bypass operation, the stomach is sewn to a lower part of the intestine so all food "bypasses" that part of the gut.

Banding is much more simply done.  The research article shows that there were no deaths among the ~600 patients (including both types of surgery), and complications were uncommon.

For Onion Peelers,
Overall, 590 adolescents (aged 13–20 years). Rates of laparoscopic adjustable gastric banding (LAGB) increased 6.9-fold from 0.3 to 1.5 per 100 000 population (P < .01), whereas laparoscopic Roux-en-Y gastric bypass (LRYGB) rates decreased from 3.8 to 2.7 per 100 000 population (P < .01).  The rate of major in-hospital complication was 1%, and no deaths were reported. Of the patients who received LAGB, 4.7% had band revision/removal. In contrast, 2.9% of those who received LRYGB required reoperations.

I grant that in the short term this procedure forces the individual to lose weight, but unless the idea is to keep the band in place for a lifetime, once it's removed, the problem recurs most of the time.  So, you spend about $20,000 to get thin for a couple of years, then go back to being overweight (recurrence rate is really high).

Some experts say you should combine the surgery with behavioral modification to get better results.  But if that's the case, why do the surgery part?  Just do the therapy.

I've written several times about the global problem of obesity.  Quick fixes waste a lot of resources and don't get at the root of the problem.

The real problem is the efficiency of our physiology.  As humans we adapted in the pre-historic environment to a subsistence level of existence where our bodies had to be able to use every calorie, from berries to carrion to tree bark.  Contrarily, those people who are naturally thin today would have been the first to die back then, in times of starvation.

Modern humanity has no defense against nutritional plenty.  Chemical messages sent to the brain that we've eaten enough are not instantaneous, and we keep eating until they arrive, shutting off the impulse to consume.  Combined with sedentary habits, we don't burn off the calories. 

[When I was active duty military I once had a recruit answer a health information form on "what kind of physical activity do you engage in regularly?" with the answer "video games."]

I once read an article that said pre-history humankind spent more time running than walking.  Maybe it's not true but you get the picture.  Our bodies are marvelous at storing calories and were adapted to being physically very active most of the time.

You can't fix that with gastric bands, and dietary laws.

What you can do for kids is get them active.  Most schools no longer spend any time doing physical training (about 20-30% do).  I'll bet an hour a day of physical exercise, games, training, etc would drop more pounds--and develop a habit of activity--than all the nutrition lectures, menu labelling, and medical treatments ever could.

Doc D

Not Really Medical Cartoonville - 23 Sep 10

This was meant to be humorous, but isn't really a cartoon.

That being said, I think the data is accurate, p-value = 0.001


Wednesday, September 22, 2010

Medical Cartoonville - 22 Sep 10

Why didn't I ever think of this?


Genetically Modified Food: Salmon Isn't The First

A lot of attention in the media to an FDA panel looking at a modified salmon that grows faster.

No decision yet.  To be considered:  food safety and environmental safety.

More to come on that.  For a quick discussion of the issues go to USA Today Health & Behavior blog (Sep 21).

But if you're not that interested, I thought you might like a peek at how much of your current food products are genetically modified.  The same article has a nice graph:

These are big ticket items, and many (or most) are modified genetically.

But grains are one thing, fish is another.

Doc D

Tuesday, September 21, 2010

Emergency Surgery Not Always Needed For Appendicitis?

The headline in the media is misleading.  It sounds like you can get away with not doing surgery.

There's an article in the USA Today Health & Behavior blog (Sep 20) that implies just that.  Here's the title:  "Some appendicitis cases may not require 'emergency' surgery."  The key word, which they were smart enough to put in quotes, is "emergency."

The research that led to the news article is in the Archives of Surgery (Sep 2010).

The method used to document the outcomes of delaying the surgery can be criticized.  They didn't look at whether the surgeons were "sure" (as far as you can be) that the patient had appendicitis before operating, and didn't account for cases where the diagnosis was uncertain until further observation showed that the appendix was getting more inflamed.  They just abstracted data from the medical record, classifying patients into one of three groups--whether the patient had an appendectomy in less than six hours, 6-12 hours, or more than 12 hours from admission to the hospital.

They found no difference in outcomes among the three groups (but they all had their appendix out...)

For Onion Peelers,
Of 32 782 patients, 24 647 (75.2%) underwent operations within 6 hours of surgical admission, 4934 (15.1%) underwent operations more than 6 through 12 hours, and 3201 (9.8%) underwent operations more than 12 hours after surgical admission.  No significant differences were found in adjusted overall morbidity (5.5%, 5.4%, and 6.1%, respectively; P = .33) or serious morbidity/mortality (3.0%, 3.6%, and 3.0%, respectively; P = .17).

The description of the study above shows you what they mean by "emergency" surgery.  They mean operating as soon as possible after you walk in the door, rather than as soon as poosible after the diagnosis is certain enough to operate.

You can debate whether an operation 24 hours later--when the uncertainty over the diagnosis has been clarified as the patient gets worse and the appendix becomes clearly inflamed--is not really an "emergency."

In my book, it is an emergency.  Because, you're doing "watchful waiting" until a decision can be made, and then proceeding in an emergent fashion.


The bottom line is, appendicitis needs an appendectomy.  Nobody (except me, of course.  see here) should mess around with severe abdomenal pain that suggests appendicitis.  To do so is foolish and lethal.

Yes, there have been extremely rare cases in which patients "appear" to have resolved their appendicits. But it's not clear that they actually had the diagnosis in the first place.

And I'm not betting my life on a miracle.

Doc D

Monday, September 20, 2010

Media Hypes Virus As Cause Of Childhood Obesity

The new research, while interesting, makes no case for causation.

I predict you're going to see a lot about this in the media.  Everybody wants an external explanation for bad things that happen to them.  "If I'm fat, it's not because I eat a lot.  It's because I caught a virus"  (i.e., not my fault).

You can read one of the news articles here (from the Wash Po Health Blog, Sep 20), or the journal article in Pediatrics here.

The authors of the research, unlike the newspaper (who titled their article, "Could a childhood infection trigger obesity?"), are careful to say that there appears to be an "association" of antibodies to Adenovirus 36 (a common cause of minor illness) and being overweight, in children.

You see the issue, right?  Is the association a coincidence?  Why don't the other 100 million kids who get AD36 become obese?  Are obese kids just more prone to AD36, instead of the other way around?

The questions are endless.  And, the study included only 124 kids; that's very small.  Also, some non-obese kids had antibodies to AD36.

To be fair, the "association" was strong.  If you separate out just the overweight kids 3/4 had positive antibodies (but remember, I said this was a very common causes colds and stomach's going to be around all the time).

For Onion Peelers,
Of the 124 children, 46% were nonobese and 54% were obese. AD36 positivity was present in 19 children (15%). The majority of children found to be AD36-positive were obese (15 [78%] of 19 children). AD36 positivity was significantly (P < .05) more frequent in obese children (15 [22%] of 67 children) than nonobese children (4 [7%] of 57 children).

File this away as interesting, and worth following up.  Any takers for a bet that we will uncover a number of other factors at work here?

Doc D

Switzerland Tired Of Being The "In" Place For Assisted Suicide.

"Suicide tourism" is a new one on me.

The Swiss government rejected a request for a ban on assisted suicide, but did agree to re-look at their laws with a view to tightening up the requirements, according to the Assoc Press (Sep 17).

The AP goes on to say that in Switzerland the only requirement is that the suicide "helper" must not benefit from the death (nothing about qualifications?)

This has made the country a great place to go if you want to die...a process that has been called "suicide tourism."  This doesn't sit well with the government;  it's not the picture you want to paint of Swiss attractions.

I guess it's not much of a boost to the economy when the tourists "check out" as soon as they arrive.

Doc D

Sunday, September 19, 2010

What's The Difference Between Lice And Bed Bugs?

Some people think they're the same.  Not so.

I know, your favorite Sunday conversational item, but the US is experiencing a sharp increase in bed bug infestations.  And treatment for one is not the same as treatment for the other.

Biologically, they are from different insect classes:  Lice are Phthiraptera and bedbugs are Hemiptera. 
As you might expect from the classification, they are very different in their habits and the problems they cause.

Lice are obligate parasites of mammals, scavengers that feed off of dead skin and other debris.  By themselves, they are an annoying infestation, although they can transmit typhus.  They cling to body hair.  Treatments are fairly straightforward, if not always 100% effective:  lice combs, and over-the-counter treatments, shaving, etc.

Bedbugs, at least the human type, are blood feeders, piercing the skin with feeding tubes.  The name comes from their habitat around the home, and their mostly nocturnal feeding pattern...hence the "bed" part.  Outbreaks and prevalence have been increasing since 1995 or so.  As blood feeders, they cause other infections, and allergic reactions, sometimes severe.

The problem with bedbugs is, they are becoming increasingly resistant.  Historically, DDT almost brought about eradication, but with banning of that and a reluctance by the FDA to approve other chemicals that have some long-term negative health consequences--combined with increasing resistance to DDT and other agents--the parasite will continue to spread.

In apartment complexes, if brought into one apartment, it can spread to other units.

Given the public health consequences of inaction, a search for more safe and effective therapies is underway.  FDA may be forced to re-look at some of their decisions to disapprove effective chemicals.

Without any clear path ahead, I expect this to become a growing concern.

Doc D

Saturday, September 18, 2010

How Valuable Are Medical Articles In Newspapers? Not Very.

What medical writing/reporting can you rely on?

An article in PLoS Medicine Journal (Sep 14) talks about the value of specialized reporting on issues of health.

The thing that motivated me most in setting up Nostrums was the distortion or hype I saw in the media about medical topics.  I found it infuriating that reporting that reached mass audiences would advocated breakthroughs that weren't, and derided proven treatments as obsolete...when they weren't.  The harm that can come from uninformed advice is particularly severe in  the field of medicine.  It's true there are wacko doctors out there, but fortunately they are rare.  And there are a few who don't keep up with current standards (that aint easy, let me tell you).  BUT, no other source than a physician, or other credentialled provider, is reliable.

Unfortunately, targeted and accurate medical advice doesn't reach the same audience.  A hyped article in the New York Times reaches millions, while each patient must talk one-on-one with their doctor to make good decisions.

In turns out that journalism researchers know that there are pernicious elements to their efforts:
1.  authors don't understand science.  Very common
2.  Editors who want to follow a "marketable" narrative rather than a sober assessment of the facts.

I recommend that media articles be taken with a grain of salt.  A few of them have some background in science, but most don't.  About the best magazine I've seen for science news is ....Science News.  The writers all specialize in their fields, the articles are shorta and to the point.  Priceless weekly newsletter, about 20 pages long.

Doc D

Thursday, September 16, 2010

Fewer People Smoke. Great. But It's Caused More Obesity. Not So Great.

The research community has known for decades that people who quit smoking are likely to gain weight.

Suggested Article Title:  The Unintended Consequences of One-Dimensional Public Policy

An opinion piece in the Wall Street Journal (Sep 7)  talks about broad public policy consequences.  If government and commercial organizations address unequal pay for women by promoting opportunities and education about the workplance and pitfalls in career management, things happen.  I've read several articles recently about (1) average higher incomes in over 30 single females than over 30 single males, (2) college enrollment and graduation rates higher in women than in men, and (3) more PhD's in 2009 in women than in men.  Many medical schools now have more women than men students.  My undergraduate college is approaching 60% women.

None of which is necessarily bad, but it was not the original intent of the policies to reach beyond equity.

The unintended consequences of public policy emerge routinely in many fields:  illegal immigration, which everybody is upset about, has been falling for the last two years.  Why?  Well, the economy stinks; why would they want to?  No jobs.

But this is a medical blog.  And public health policy has  unintended consequences, too.  As the op-ed says,
And then there is the anti-smoking effort that has become something of a national norm. Smoking is now banned in most public places, especially the workplace. A Chinese researcher has found that during the period from 1998 to 2006 such policies on the job have led to more in obesity among workers. 
Feng Liu of Shanighai University of Finance and Economics studied responses from 227,000 American workers and found that on average, nonsmokers had a Body Mass Index 1.8 points higher than smokers and a probability of obesity almost 10% higher. The study also reported that smokers had a BMI 3.6 points lower and were almost 20% less likely to be obese.
Smoking causes an estimated 443,000 deaths a year in the U.S. through increased likelihood of heart and lung diseases and cancer. Obesity is thought to be a large cause of heart disease, diabetes and some cancers, although the research has not been as developed in associating it with an estimated number of deaths.

I'm not surprised by these results.  You can criticize the study's method (self-reporting), but in my clinical experience, most quitters gain anywhere from a few pounds to several dozen pounds. 

Single-focus public policy always overlooks human nature: that we are dealing with a complex interplay of motivations and incentives.

Does this mean we should back off on smoking regulations?  Of course not, but improving that public health hazard has led to worsening of another.  Hence, we are seeing policy efforts to deal with obesity by calorie labelling, restrictions on fast food restaurants, school menu changes, promotion of fruit and vegetable consumption, etc. 

I'm OK with health education efforts, but think laws and regulations to restrict choice will fail (remember Prohibition?)

Ask yourself this:  what unintended consequences will be created when we begin to lower obesity?  Are we just playing Whack-A-Mole?

Doc D

Wednesday, September 15, 2010

Cancer Study: Kill The Tumor But Cancer Sometimes Recurs, And Why.

If you kill all the cancer cells, can the cancer still come back?  Yeah, and not because a new cancer has arisen.

A study in the New England Journal of Medicine (Sep 9), looks at myelodysplastic syndrome (MDS).  I won't define the condition further than to say it means a pre-cancerous condition where blood cells are formed that are infeffective or abnormal.  The condition used to be called "pre-leukemia:"   there is the risk that this syndrome will progress to leukemia.

So, the difference is that MDS makes bad cells, leukemia is really bad cells multiplying out of control.  No hematologist would agree with that;  it's much more complicated.  This half-baked definition just works for my purposes.

Because the jist of the article is, "OK, we can treat MDS with a drug that kills all the bad cells to the point where they are in remission and we can't find any of those cells.  How come some of these patients have a recurrence?" 

The simplistic answer is that the researchers found that stem cells which have a chromosomal abnormality that puts them at risk of producing ineffective MDS cells still exist in the body, and show a resistance to the drug.

For Onion Peelers,
Although lenalidomide [the cancer drug] efficiently reduced [stem cells that lead to MDS] in patients in complete remission, a larger fraction of the minor stem cells as well as functionally defined chromosomally abnormal  stem cells remained distinctly resistant to lenalidomide. Over time, lenalidomide resistance developed in most of the patients in partial and complete remission, with recurrence or expansion of the resistant cell lines and clinical and cytogenetic progression.

You can see why knowing this is important.  As the authors describe it,
The present findings have clinical implications, since the identification of distinct stem cells in myelodysplastic syndrome may provide a sensitive tool for surveillance during therapeutic targeting. The ability to pinpoint and purify minor cancer stem-cell populations, before as well as during treatment, might be useful in monitoring clonal evolution and in identifying molecular targets that are distinct from those identified in the bulk of the tumor.
If we can identify the troublesome stem cell lines that lead to MDS, then they can be a marker and a target for therapy that could lead to more remissions and less recurrences.

The lesson to be learned is that treatment has to look beyond the immediate abnormal state to higher-order, or predisposing, elements in order to be successful.  We're pretty good at killing tumor cells; we need to get better at dealing with the cells or conditions that lead to tumor cells

An interesting piece of work.

Monday, September 13, 2010

Note To Readers - Sep 13

I 'm on the road.  See you Wednesday.

Doc D

Sunday, September 12, 2010

Has It Come To This In The Age Of Science? Oxygen Facials?

So all those high altitude pilots, who breath pressurized 100% oxygen should have the best facial skin on the planet (at least the part that's under their masks).

I read this article in the Miami Herald Health page (Sep 8) about oxygen facials. This has to be a joke, right?  A device blows oxygen on your face, and it improves your complexion?  After millions of years, we find that the 20% O2 in the air is insufficient?

The author says she has heard of no studies to validate this effect.  Me neither.  She says, "The biggest negative is that the treatment can activate damaging free radicals, which can cause cell and DNA damage that can result in wrinkles and even skin cancer."  That's too much of a stretch, because there are no studies to show that either.  For me it's just a waste of money on pipe dreams.

And to put the icing on the cake, the FDA has no jurisdiction to investigate or regulate doing this treatment because the company who manufactures the (expensive) machine, and markets it, makes no claim that it is a medical treatment.  It's like using Dove bath what?

But what the heck, Professor Madonna says it works wonders with her facial skin appearance (but only on HD television, apparently, not regular digital--so you have to buy a HD TV and watch yourself on it to see the great result).

This is more laughable than beliefs in invisible energies that control our lives and health.

By all means, if you have the money to spend on an iPad and a couple of mocha lattes, go ahead and oxygenate.

Doc D

Saturday, September 11, 2010

Cheaper Drugs From Other Countries: Also Sometimes Counterfeit, Diluted, Or Adulterated

This is for those who think buying drugs abroad is a simple fix for the high cost of drugs.

From the Washington Post Health blog (Sep 11):
India, the world's largest manufacturer of generic drugs, has become a busy center for counterfeit and substandard medicines. Stuffed in slick packaging and often labeled with the names of such legitimate companies as GlaxoSmithKline, Pfizer and Novartis, the fake drugs are passed off to Indian consumers and sold in developing nations around the world.  Experts say the global fake-drug industry, worth about $90 billion, causes the deaths of almost 1 million people a year and is contributing to a rise in drug resistance.
Drug prices are a function of development costs, regulatory costs, marketing costs, the need to recoup investment while protected by branding, and of course, profit margin to grow the company (which they will maximize; that's how captialism works).

[The other side of the story on high profits for certain drugs is (1) only 1 in 300 drugs actually becomes a big moneymaker...the others are business losses, and (2) after the drug becomes generic, the profit becomes very small...if the company has not made back its costs by then, the drug is an overall loser.]

Given the temptation to counterfeit, and huge potential revenue, it's no wonder that a lot of what's on the market in other countries is harmful or worthless.  Some governments enforce product laws better than others.  People who buy online are particularly vulnerable to this kind of scam.

Even if the drugs contain the actual drug, in some countries there are few quality control measures that are enforced.  A product that is supposed to be the equivalent of, say, Lipitor (atorvastatin)--a common cholesterol drug--may actually contain little of the actual drug....just enough to pass a quick test by auditors that just checks whether the compound is there, not how much.

The companies who offer all these cheap drugs know all the dodges.  And there is no assurance that you are getting the right thing, in the right amounts, and nothing else (some unscrupulous companies add filler and other chemicals that may be harmful).

In fairness, there are countries who do a fairly good job of enforcing drug quality.  However, how do you tell whether a retailer in that country isn't just a shell for some other country's manufacturer?  Canada is a good example; you can get drugs cheaper from Canada.  The Canadian government does this by essentially blackmailing the drug companies; they legislate prices they will pay, and the drug companies have to go along (forcing US prices higher).

I've talked to people who say they can tell the difference between a good product and a bad one by how the website looks and the testimonials of previous customers.  Neither of these approaches are reliable.  Companies hire people to give testimonials, and web developers steal logos and content from legitimate companies. 

The classic story for bad drugs was the Fen-phen debacle.  Much of that product was produced overseas and bought cheaply by people who wanted to lose weight.   Result:  heart valve damage.

Doc D

Friday, September 10, 2010

Being Your Own Health Care Decision-Maker: Using Online Quality Data

If you could see data on how well your hospital/doctor stacks up in quality terms, could you decipher it, or take the time to learn how?

The current issue of the New England Journal of Medicine (Sep 7) has an article about publishing cardiovascular surgery (CVS) results online for patients to review.  In principle, I'm all for transparency of quality measures in medicine. There are some limitations that have to be recognized, though.

This particular effort, while groundbreaking, included only 20% of the total number of cardiovascular surgery programs in the nation.  About 90% of the programs contribute their data to the quality database that's maintained by the Society of Thoracic Surgeons (STS). This means that only a fifth of the programs allowed their data to be published.  Furthermore, the programs that have allowed their data to be viewed publicly are those that are probably in pretty good shape (human nature being what it is, they probably see it as a positive advertisement for their program).  Of the 55 programs in the published data, 50 are in the highest category, earning three stars out of three.  Only five earned the lowest category rating, which is one star.

The list of the CVS quality measures are good ones. They look at infection rates, complication rates, readmissions, mortality, etc.   This is the (semi-readable) list of the quality measures:

All of these are pretty scary.  But if you need heart surgery, you're already in the hurt locker.  In addition to the star rating, patients can see actual performance data that generate the rating:  for instance, whether “patients have an 89% chance of avoiding all five of the major complications,” and the like.
What doesn't appear in the data are the characteristics of the patient population that underwent surgery at each institution (as far as I can tell).  A surgery program that tends to care for patients that are sicker will do less well than one that takes care of patients that are more healthy. Hospitals that have more elderly or socioeconomically disadvantaged patients would fall into the poorer results category. This is just a fact of life and shouldn’t be a ding on the program.

Another thing critics will point out: the data are not presented by surgeon, only by facility (or program).

Efforts like these can be picked to pieces and doctors sometimes are very nervous that their efforts will be mischaracterized, or their results erroneously reported. But this is a great step forward in giving patients the transparency they need to make health care decisions. And, as the authors of the article point out, there will be now be increased pressure on other programs to allow their data to be seen.

You can read the article at the New England Journal here.

A different question is whether the patient population has the ability to look at certain very specific and medically complex criteria and make a reasonable decision.  In my opinion, most people are capable of interpreting results such as these, but it's just going to take them time and effort. If they accept the authority that's given to them to make a reasonable decision, and put in the effort to learn how to judge what is good, and what is not so good, then they will retain control of their own medical care.  The alternatives are (1) to accept what you get, or (2) let Big Brother do it for you.

It remains to be seen whether patients are willing to make the effort.

Doc D

Health Care Reform Poison Pill Redux: Cancelled Policies

"You can keep your health insurance"...unless they cancel it.

From the Dallas Morning News (Sep 9):
Two months ago, Al and Jill Alcantara, both 63, of McKinney, got a letter from their health insurer saying their policy would not be renewed.  Al and Jill Alcantara's insurer has canceled their policy effective Feb 1...It blamed its decision on the company's inability to meet requirements of the health care overhaul signed into law this year...The Alcantaras now plan to join the Texas High Risk Insurance Pool. The plans available range from a $2,500 deductible with $1,025 monthly premium to a $7,000 deductible with a $662 monthly premium. Jill Alcantara acknowledges that's expensive.
Is this what you had in mind from health care reform?  $12,300 premium with $2,500 deductible?

An anecdote, surely...and not data.   But others will have the same experience.  The government says it's not their fault, which is surely weird.   However, in fairness, some small insurance companies enter and leave the health care business on a regular basis.  Whether this is a trend or not, time will tell.

But based on multiple reports and analyses:  free health care (for some) costs a lot (for others).

Doc D

Thursday, September 9, 2010

Whooping Cough Outbreak In California: Update

Public health officials blaming doctors for missing cases of whooping cough.  Maybe we should send our docs to 3d world countries to experience cases of disease that have become rare in countries who actually vaccinate.

I saw a couple of case of pertussis (whooping cough) back in my early years, but not much since...BECAUSE THERE'S A VACCINE. 

Which California has decided is a personal "decision of conscience" for parents, instead of a public health requirement.  The percentage of immune children has been falling due to influx of non-immune Hispanics and New Age parental refusal.

So, as of this week, the pertuss outbreak in California has quadrupled the number of cases (so far), and eight children have died (NBC San Diego, Sep 7).  And it aint over yet.

If doctors don't see cases of a disease very often (like the plague) they are less likely to recognize the rare case. (except now it's less rare in CA; the good news--if there is any--is more docs will have experience with it). They should get out the textbooks and refresh their knowledge.

But it's worth publishing a graph from a very old post of mine.  It's a CDC graphic about "The Life Cycle of a Vaccine."  Red is the disease line; blue is the vaccine rate.   It's either a short attention-span problem, or humanity's inability to learn from history.  Vaccines make diseases rare, so people don't want to take it, and the disease comes back.  See that post for more information:

Doc D

Tort Reform Savings: You Say "To-may-to," I Say "To-mah-to." It's Not The Cost.

Lots of media attention to a study that claims tort reform will "only" save $56 billion.  Uh...that's enough to cover the uninsured without HCR.

There's a new study in Health Affairs (Sep, 2010) that provides a lowball figure for the monetary savings from tort reform. 

I'm not going to say much about money.  It's not the main reason for tort reform.  And the authors of the article caution that estimates of defensive medicine costs are unreliable, because it's hard to define what is, and what is not, a "defensive" cost.

So, I don't believe the high cost estimates (hundreds of billions) or this lowest estimate ($56B).  It's probably somewhere in the $100B range.

More important to consider is how tort reform affects the whole system.  I live in Texas, where we have had tort reform since 2003.  Here's what matters.
1.  In 2003, malpractice costs and lawsuits had been skyrocketing for several years. 
2.  The number of successful suits had not changed much, but the number of frivolous ones had grown.
3.  Insurance companies, faced with costs of defending frivolous suits, were becoming more liable to settle rather than fight.
4.  The number of doctors applying to practice in Texas (particularly specialists) was falling.
5.  Studies showed that somewhere between 50% and as high as 85% of malpractice awards were going to the lawyers instead of the patients who were harmed.  This created a huge incentive for lawyers to take up dubious cases.
6.  Awards for harm are divided into two basic parts:  economic harm (loss of income, disability, career, etc) and "pain and suffering."  The first, economic component is calculated based on things like age, earning ability, and the tends to be tied to some rational formula.  The pain-and-suffering award is largely unlimited.
7.  Juries, who recommend or direct the award, would look at how much the patient would receive, and increase the total in order to keep the lawyers from getting a lot, and the patient a little.  That is, if a lawyer gets 60%, for the patient to get $4 million, they had to award $10 million (these are very high examples, to highlight the impact).
8.  Lastly, it fosters distrust between doctors and patients, in one of the situations in life where it's critical.

Tort reform in Texas did the following:
1.  Lawsuits fell by 30%.  The number of successful suits stayed relatively constant.
2.  Pain-and-suffering awards were limited to $750K.  Economic awards were not limited by law.
3.  Malpractice insurance premiums for doctors fell by 35%.
4.  Savings from malpractice insurance funded a free clinic in Corpus Christi.
5.  Insurance premium savings allowed the Kelsey-Seybold clinic in Houston to build a new clinic service.
6.  Applications from doctors wanting to practice in Texas rose from 1000 to 3000 a year.
7.  Many areas of Texas now have sub-specialists that didn't have them before.
8.  29 counties who had no obstetrician now have one.
9.  Hospitals were able to plough insurance savings back into facility improvements.

Back when I was in practice in Emergency Medicine, I did radiologic imaging on about 10% of head injury cases.  Over a 5-year period I had no adverse consequences or missed diagnoses.  Now, ER docs have a saying, "Every bump on the head gets a scan."  Can you guess why?  But try to define, in a subjective clinical environment, whether a scan is ordered for defensive reasons:  the doc is looking at the patient, the family, the level of trust, the stress and worry...and a hundred other things that come together in her/his mind to decide whether to do a test.  How do you measure that impact?

The media will snipe at each other over this study:  "we don't need tort reform", "yes, we do."   But the money is just one small part of the overall problem of defensive medicine.

It's the impact on the whole system that's toxic.

Doc D

Tuesday, September 7, 2010

Great Article On Medical Research Jargon

Readers know I dig into research studies directly.  A lot of the time I assume that terms like "double-blinded" and "meta-analysis" are understood.  If not, Forbes published a quick and dirty guide.

From the Forbes Consumer Health Blog, Aug 23, comes a glossary to all the different kinds of research studies ("Medical Terms You Need to Know"), why some are give stronger evidence than others, how the study is conducted, and how the end results are evaluated.  A great resource.  Bookmark this article, so when you read a journal article (or a Nostrums post) on a "case study" you know why it doesn't tell us much that's immediately useful.

You'll also know the strengths and weaknesses of "clinical trials" that follow a group of patients under a specific treatment to see if they get better...and much more.

It may even help you to deconstruct the hype that accompanies almost every media report of an interesting study.

For the inquiring mind, it doesn't get any better than this.

Doc D

Monday, September 6, 2010

Most Employers Don't Address Quality In Choosing Health Plans.

This is what happens when others make healthcare insurance decisions for you...and you don't take charge of your medical care.

Assume your employer looks at quality in choosing a health plan?  The data from a survey by the Kaiser Family Foundation shows that more often than not they don't:
Just 34% of firms employing at least 200 people and 5% of firms employing between 3 and 199 people reported reviewing performance indicators of plans’ clinical and service quality.  And of those that did so, 49% said the info was at least somewhat influential on their plan selection. (WSJ Health Blog, Sep 3)
It's not clear why this is the case, or what other factors were important.  But, you can bet that price played an important role.

Nostrums has always been dubious of healthcare decision-making that isn't conducted by the recipient themselves.  Who better knows the unique needs and desires of the individual...than the individual themselves?

There are mechanisms to check on the quality of your healthcare.  You don't have to rely on your employer, or Congress for that matter.  These organizations look for a uniform answer; one that may not be your answer, trusting that the company or political process will be their advocate.

Where can you the patient look to judge quality?  There are online databases.  One option: the National Committee for Quality Assurance health plan report card.  The Agency For Healthcare Research and Quality publishes data and surveys on quality.  Your insurer may have a website that includes data on customer satisfaction and a report card.  Check out WhyNotTheBest  from the Commonwealth Fund.  Medicare runs a website called Hospital Compare.  Consumer Reports and Angie's List have entered the field with feedback from patients on individual doctors and hospitals; some of their work is useful.  Some is unfiltered, and has the same utility as blog comments.  But expect these to get better.

Transparency is key, and the opportunities to make your own decision on quality are expanding all the time.  The alternative is to accept somebody else's idea of what you want.

For some reason, everybody understands that when you buy a car or a refrigerator you need to be a smart consumer, but with healthcare you have to just take it as it comes. 

Not true.  You can be an advocate for yourself.

Doc D

Sunday, September 5, 2010

Nostrums Is On A Critical Mission

We are taking care of grandkids (age 2 and 4) while my daughter and her husband (active duty military) are both deployed. 

Posts may be erratic for a couple of days, until we get settled in...or commit seppuku.

Just kidding...they're cute as can be, and quite loud.

Doc D

Saturday, September 4, 2010

Vaccine Deniers Please Move To Another Planet So You Won't Kill The Rest Of Us.

It's that time of year.  The flu vaccine is here.  I got mine yesterday.  Don't mess around.

This year's vaccine covers three viral strains:  the pandemic H1N1 (it's still around), an influenza B strain (most of human cases are influenza A types, but this one is expected to be a factor this year), and an H3N2 virus that's cruising the globe.  Every year WHO and the CDC make a "best guess" combination.  This strategy usually works fairly well. 

Even if you don't think influenza is serious for you, it will be for the person you transmit it to...who may be frail, elderly, or have other health problems.

The higher the percentage of immunes, the less transmission.  That's the path to control.

Doc D

Friday, September 3, 2010

Drugs For Osteoporosis: Dueling Research About Risk Of Esophageal Cancer

Very important research to watch as it develops, for those women who take drugs for low calcium in their bones.  But, the worst case scenario  is that the risk of cancer is still low.

This is typical for how science advances: studies will give opposite results, and sometimes there is a clue to the real answer in the methodological differences.

Disorders of bone metabolism, particularly in ageing, and most particularly in women, are disabling and potentially life threatening.  Collapsed spinal column structures, easily fractured bones...all are very serious.  So medicines that will preserve calcium, and hence bone strength are critical for some patients.  Many patients take these medications, called "bisphosphonates."

To see the study that shows no effect on risk of throat cancer from bisphosphonates (Fosamax, Actonel, Boniva, and others) go here.

For the study that show an increased risk of throat cancer go here.

The fascinating thing about these studies is...they both used the same patient database.

So, why the different result?  Well, in the second (increased risk) study, the patients had been on the drugs longer.  Maybe that's it.  Too soon to tell.

For Onion Peelers:
1.  Here's the data on the "no increased risk" study.
Mean follow-up time was 4.5 and 4.4 years in the bisphosphonate and control cohorts, respectively. One hundred sixteen esophageal or gastric cancers (79 esophageal) occurred in the bisphosphonate cohort and 115 (72 esophageal) in the control cohort. ..the incidence of esophageal cancer alone in the bisphosphonate and control cohorts was 0.48 and 0.44 per 1000 person-years of risk, respectively. ...(adjusted hazard ratio, 1.07 [95% confidence interval, 0.77-1.49]).

2.  Here's the data on the increased risk study:
The incidence of oesophageal cancer was increased in people with one or more previous prescriptions for oral bisphosphonates compared with those with no such prescriptions (relative risk 1.30, 95% confidence interval 1.02 to1.66; P=0.02). Risk of oesophageal cancer was significantly higher for 10 or more prescriptions (1.93, 1.37 to 2.70) than for one to nine prescriptions (0.93, 0.66 to 1.31) (P for heterogeneity=0.002), and for use for over 3 years (on average, about 5 years: relative risk v no prescription, 2.24, 1.47 to 3.43).

If you slogged your way through all of that, you might be asking yourself, "why can't these people study things using the exact same way of analyzing the data, so we don't have to puzzle it out?"  I can't answer that.

What's not easy to see that having "10 or more prescriptions" is one way of saying how long somebody has been taking the medicine (maybe the British like that way of putting it...this was a UK study.)

Finally, let's sweep away all the detail, and just assume that the "increased risk" study is true.  If you do some other analysis, what we're talking about here is going from approximately 1 in 1000 risk to 2 in 1000 risk by taking the bisphosphonates.

By comparison, for the elederly who have severe bone loss and suffer a hip fracture, the fatality rate is about 50%.

So, take your choice.  Patients shouldn't rush to judgment yet.  Talk to your doctor.

Doc D

What Would Ann Landers Say About Women Getting Tattoo's?

This quote from Matt Labash's column went viral, but I couldn't help repeating it. 

As a doctor I really dislike tattoo's.  They cause all kinds of medical problems:  getting them, having them, and getting rid of them.  For the whole, hilarious article go here.  (With a hat tip to GruntDoc)
Here’s a tattoo rule of thumb: Only get one if your job entails shooting people, if you’re an ultimate fighter, or as a safety issue, if you find yourself wrongly incarcerated, and displaying your affiliation with the Aryan Brotherhood will help make prison showers less eventful.
--Matt Labash, The Daily Caller, Aug 31.

Thursday, September 2, 2010

I Can't Think Of A Title For This

The world is insane.  I have no other comment than the excerpt below.

BAKERSFIELD, Calif. (AP) - A doctor involved in an "on-again, off-again" relationship apparently tried to force her way into her boyfriend's home by sliding down the chimney, police said Tuesday. Her decomposing body was found there three days later.  (, Aug 31)


Doc D

A Doctor Talks About What It Feels Like To Be Sued

Most patients could care less about standing in their doctor's shoes, but sometimes it helps.  Other things go on in your doctor's mind that have nothing to do with diagnosis and treatment.

The Washington Post Health blog (Aug 31) has a great post from an infectious disease specialist who is handed a letter that says he's being sued.  The subsequent panic, review of his treatment, and relief that follows (when he realizes that although the patient in question died, his medical care was unreproachable), is very accurate.  I've never been sued in 35 years, but I know that cold sweat that comes from the internal dialogue, "Please, God, tell me I did everything I should have." 

Studies show that only 17% of malpractice lawsuits correspond to actual medical negligence.  I'm happy the real instances were pursued, but I'm bothered by the 83% of suits that don't involve any negligence.

The really interesting part in this doctor's story comes later when he talks about the impact of going through this process. 
The next day, I was considering whether to order a CT scan for a hospital patient experiencing abdominal pain. On the one hand, I did not think the scan would reveal anything significant, and I try to avoid ordering unnecessary tests. But then I thought about a potential lawsuit. What if I missed a cancer or an abscess by not ordering a CT? How would I defend myself? It was easy enough to pen "CT abdomen to rule out abscess" -- something that could be identified and treated if found through this extra test.

The fear of a lawsuit trumped all other thinking: I ordered the scan; it was negative.
Good luck with changing that very human reaction by using policy or regulatory dis-incentives.  Yes, if we all stood firm in our convictions every time false accusations arise, then maybe the number of these would go down.  But, maybe not; money drives the tort system. 

And, for me and most doctors, it's very personal...not just a policy phenomenon.

Doc D

Wednesday, September 1, 2010

STUDY: Supplement Can Improve Treatment Of Depression...We Hope

There's some media interest in a study that shows S-adenosyl methionine may be useful in the treatment of major depression.

But notice the sentence in the NY Times Well Blog (Aug 31):
A popular dietary supplement called SAMe may help depressed patients who don’t respond to prescription antidepressant treatment, a new study shows.
Actually that's not what the study shows.  Let's look at the real study. in the American Journal of Psychiatry, July 2010.

But first some background.  S-adenosyl methionine (SAM-e for short) is a compound found normally in our bodies.  It's involved in regulating the synthesis of some brain chemicals, among other things.  If you measure the amount of the compund in the spinal fluid of severely depressed patients, it's very low.  If you treat depressed patients with other medicines, it raises the level of SAM-e.

These and other studies show that something's going on with this compound that involves depression.  What, we're not sure.  However, a beginning hypothesis could be that limited amounts of SAM-e can either be the cause of, or result of, depression.

So, why not try giving it to people and see if they improve?  There have been a number of studies to look at this, but they all suffer from some limitations:  either the compound had to be given by shot, or the study period was not long enough, or too few patients, or investigations couldn't document that different commercial formulations had the same amount of the compound in them, yada yada yada.....  And finally, the benefit could not be distinguished from that of least convincingly.  If you follow Nostrums, you know these are common occurrences and they make for caution in claiming great things for new treatments.

So, what was wrong with the NY Times statement?  Here's what they didn't say:
1.  The study had only 73 people in it altogether, and the study period was only 6 weeks.  If I was despressed, 6 weeks of improvement would be great, but what about the next 30 years?
2.  The SAM-e was used as an "adjunct."  For those not used to the term, this means it was an "add-on" drug.  The patients were still getting their SRI (Prozac or whatever) along with the supplement.
3.  The study participants were people with "major depressioin."  This is different as night and day from garden variety being down, depressed, and havin' the Blues.  Major depression is "characterized by marked functional impairment, morbid preoccupation with worthlessness, suicidal ideation, psychotic symptoms, or psychomotor retardation."   So nothing has been shown about other depression categories.
4.  Different commercial preparations make it not possible to know whether the dose used in this study is the good, bad, or indifferent.

All of the above sounds like I'm down on the idea that this supplement can work.  I'm not.   This was a double blind controlled trial.  But there is more work to be done, and NYT didn't get the story straight.

For Onion Peelers, here's what I know (The abstract didn't give p-values, CI's, etc.):
The Hamilton Depression Rating Scale response [a tool to measure level of depression] and remission rates were higher for patients treated with adjunctive SAMe (36.1% and 25.8%, respectively) than adjunctive placebo (17.6% versus 11.7%, respectively). The number needed to treat for response and remission was approximately one in six and one in seven, respectively.

Recommendation:  Not ready for primetime, yet...but some promise shown.

If you still want to run out and buy this, there's a leeeetle problem:  expense.  $140 a month is in the range.

And it ain't covered by insurance.

Doc D


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