contranemesis

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May 31, 2007

Drugs have risks?

Interesting study highlighted in AMN this week. (Side note, on the website, the June 4 issue is already posted. News is an amazing business.) I don't have access to the journal Health Affairs but apparently the theme of the issue was health risks and benefits. One study by Peter J. Neumann, ScD, discussed mortality risks posed by drugs, work, transportation and recreation. They assessed risk in terms of fatality per 100,000 person-years engaged in that activity. Aspirin use, firefighting and car travel all fall about 10 or 11. Taxi driver and rock-climbing are both 36, with Clozapine at 35. "Helping patients, health care providers and policymakers understand the magnitude of drug risks is crucial to helping them make an informed decision when evaluating the risks and benefits of treatment," said Neumann.

This is certainly helpful information. But like much medical information, it is likely to be misused. First, this is only fatality risk. Evaluating the safety of aspirin involves more than fatality. Bleeding ulcers are (sometimes) painful, always messy affairs, with significant costs. Secondly, the comparisons are for "person-year" of participation. I am not sure how they count rock-climbing for instance. Is that hours spent climbing, or any climbing during that year? Thirdly, though they mention benefits, I wonder if the benefits are subjected to the same analysis. And are the incidences and mortality of the treated diseases dealt with?

Life is inherently risky. Sometimes it is helpful to know what those risks are. Sometimes, it is just background noise. How many people choose office work (0.4) over taxi driving (36) because it is less risky?

Posted by Robert Maddox at 04:48 PM | Comments (0)

May 29, 2007

more on hogberg

More on Hogberg's measures: He goes further than the OECD, narrowing in on a few measures that meet his (admittedly better) criteria. He uses the GUSTO 1 trial in its 5 year extension, to illustrate a good measure.

But GUSTO showed a decrease in mortality at 5 years from 21.4 to 19.6 % (Canada to US). So 1/50 less die in the US than in Canada. This benefit is supposedly from the 43% who received stent or CABG in the US, versus the 15% in Canada. So out of a 1000 people with a heart attack, 196 in the US will be dead in 5 years, and 214 in Canada. But 436 of the US 1000 will have had a major intervention, and only 154 of the Canadians. So "fix" 280 more, and 18 more will do better. GUSTO only proves what every other study on coronary disease intervention proves - no meaningful benefit to intervention.

The COURAGE (Clinical Outcomes Utilizing Revascularization and AGgressive drug Evaluation) concluded that more honestly for people with stable coronary disease. There is NO benefit in mortality to invasive intervention (stent or CABG) and minimal and limited benefit symptomatically. Same with the OAT (Occluded Artery Trial).

Posted by Robert Maddox at 07:42 PM | Comments (0)

Properly evaluating Health care systems

David Hogberg, Ph.D., an analyst for the National Center for Public Policy Research, has an interesting article analyzing the reliability of life expectancy and infant mortality for comparing the US Health Care system to that of other countries.

It is a good analysis, which of course has sparked some debate. In it, he makes this observation: "... a health care system has, at most, minimal impact on longevity." Ignoring the fallacy of asserting the consequent (or its negative), he does provide good support for the assertion from the CEDP's own table. This is Leonard Sagan's claim from the 70's in his book Health of Nations, which was also influential in my education.

He also discusses the question of how we should measure a health care system. Unfortunately, he can only give some general principles. The OECD is working on such measures. However, the measure they appear to be using, such as vaccination rates, cancer screening rates, mortality rates, etc. are of questionable value. They are of value for comparing health systems, granted. And public policy writers may need such. But in the general scheme of life, they are not very meaningful. Rather, they are the hubris bringing nemesis.

Posted by Robert Maddox at 06:30 PM | Comments (0)

Retraction

Sort of. I have just started reading The Rivers North of the Future. It is the last thought of Ivan Illich, written from transcribed conversations, representing his core thinking. In the chapter on health, he comments that iatrogenesis is accepted now as a common occurrence. "If I had to rewrite that book, if I had to say something today, I certainly wouldn't speak anymore about the medical enterprise being the major threat to health. This is now well-known. I would speak rather about the radical change in the attitude of the university-based and university-trained healer during the course of the eighteenth century."

Actually, I am not retracting anything, because I started this study knowing well that iatrogenesis was well-known. And I have been reading a great deal lately about the changes in medicine during the eighteenth (and the nineteenth) century. And I was asked the other day if I had learned anything in the last twenty years about practicing. And my interlocutor commented that he had learned to listen to the patient (which is what Illich says is missing-but which had been partly recovered in Family Practice- though always with the recognition that the patient always lies-okay, maybe not always intentionally).

So as I have begun, so I will continue to explore the nemesis, or really the hubris, of medicine, recognizing that much of this is old hat, but still needs to be eaten.

Posted by Robert Maddox at 05:39 PM | Comments (0)

medical economics

I realize that this is not a profound thought. In thinking about the almost 17% GNP spent on health care, it occurred to me that if that figure decreased significantly (by the 90% iatrogenic or useless stuff, or even by the 50% back to last decade) that would put a significant portion of the population out of work. And that is meaningful significance, not just statistical.

Posted by Robert Maddox at 03:38 PM | Comments (0)

May 22, 2007

mumps outbreak

The mumps outbreaks are confusing the experts. The outbreaks are concentrated in the Midwest. Very few involved unvaccinated people. Almost half had received the two doses of vaccine.

Overall, between 2 and 66/100,000 were affected, usually white college students. The problem, we are told, is that the case definition and reporting forms and systems differ in different states. So at the beginning of outbreaks cases were ignored, and at the peak, cases were overcounted.

How many died? Very few. How many hurt in places they wished they didn't? A few. Less than 6,330 in 2006.

Is this a reason to be immunized against mumps? If you plan to go to college in Kansas or Iowa and haven't had it and don't want it, maybe. Otherwise, what is the point?

Posted by Robert Maddox at 08:19 PM | Comments (0)

Antiemetic suppositories deemed ineffective

The FDA is on a tear. They have apparently decided that there is no evidence for the effectiveness of trimethobenzamide suppositories. We have been using it for decades. Two million prescriptions a year are written for it. Before 1962, drugs only had to be proven safe, not effective.

How much money has been wasted? (At $3 a pop, maybe $60 million a year.)

How many more will get the knife?

How many that are "proven effective" really do not produce meaningful improvement in a patient's health?

Posted by Robert Maddox at 07:52 PM | Comments (0)

Hormone Therapy

Female Hormone Replacement Therapy continues to take a bad rap. The Million Women Study has released a follow-up showing women who use HRT are at increased risk for ovarian cancer. The study has a number of flaws, which the critics are quick to point out.

And there is some clinical iatrogenesis proven, if the flaws are not fatal to the study. But even at its worst, the 20-60% relative risks of cancer or death in varying circumstances are actually much smaller absolute risks of 1/2500 to 1/3300. One or two women out of a thousand die of these cancers in 5 years. (Again, I do not mean to downplay the difficulty of such a condition.)

But the biggest problem is that this is old news. For two or three decades, we have been medicalizing menopause, and then seeking benefits to that medicalization. These drugs (not natural hormones for humans) are foisted on women, not just for symptoms of menopause (where they might be helpful for a short period of time), but for many conditions. There should be no surprise that there is conflicting data, or detrimental effects, when we create disease in order to destroy it.

Posted by Robert Maddox at 07:42 PM | Comments (0)

Walmarting health

Wal-Mart plans to open about 2,000 in-store clinics by 2012. Maybe you don't, but when I go shopping, I fall for the prominently displayed items. And many ED visits are "convenience" driven (because they happened to be in the area, or brought a relative or neighbor, and just figured they would get checked out). How many more unnecessary visits will be generated by these convenience clinics, to the detriment of our health?

Posted by Robert Maddox at 06:54 PM | Comments (0)

Spirituality and Health

Over half of US doctors surveyed report believing that religion and spirituality have a significant influence on health and that a supernatural being intervenes at times. Sloan has tried to debunk the latter of these beliefs, if not the former. (more on that some other time)

What is interesting for the contranemesis is the recognition of cultural iatrogenesis that has occurred. Dr. Curlin, himself a practicing internist as well as ethicist, who has several related studies to his credit, distinguishes between areas where religion is more likely to affect decisions and where is does not.

In many cases, Curlin emphasizes, religion does not affect medical decisions. All emergency-room physicians treat broken legs and acute pneumonia using standard protocols. Religion comes into play at what he calls the “margins,” areas that until 50 or 60 years ago were not considered part of the medical profession: end-of-life issues, sexual and reproductive health, and mental health. As long as medicine continues to reach beyond broken bones and acute disease into “areas in which people disagree,” physicians will, he argues, make moral judgments. And those judgments will be colored by religious, spiritual, or secular beliefs.

The "margins" are areas that were "medicalized" by the hubris.

Posted by Robert Maddox at 06:42 PM | Comments (0)

Wasting more money

President Bush as agreed to extend an early detection program for breast and cervical cancer. We looked at the relative uselessness of Pap smears. Mammograms are subject to the same analysis. Now the funding for the NBCCEDP will increase to $275 million by 2012.

About 341,000 women were screened for cervical cancer through the program, and almost 5000 cervical lesions were found. Interpret this information correctly. Ask how many of these women actually had cancer and how many would have regressed to normal. Ask how many needless procedures were done on these histological lesions with no meaningful significance. Ask how many women were harmed by this pogrom.

Continue reading "Wasting more money"

Posted by Robert Maddox at 05:12 PM | Comments (0)

May 15, 2007

the FUTURE of HPV

Wow. Speaking of great study names, the NEJM published reports on two large ongoing trials on the HPV vaccine. Females United to Unilaterally Reduce Endo/Ectocervical Disease I and II (which they call FUTURE I and II). They are looking at meaningless histological endpoints again, but include adenocarcinoma in situ. Looking at the higher grades there is no benefit so far to the vaccine (which is not their conclusion). To what I wrote earlier, I will add this.

The findings of the FUTURE, even interpreted in the most favorable light, pale when set against the risks and harms. It is projected that about 11,000 US women will be diagnosed with invasive cervical cancer this year. Of these about a third will die.

So to find the 1/10,000, it is urged that every woman receive an annual Pap smear. This obviously ignores that only women with high-risk HPV types are even at risk. It also ignores that it takes ten to twenty years for the cancer to develop. Even worse, it ignores the number of false positives that are found and must have follow-up testing, at a huge psychological cost (of thinking she is dying of cancer for the weeks or months the follow-up takes) and financial and physical and social costs. And what of the harm of the LEEP or cryo or other modality? These obscure further testing, and create harm of their own.

"Annually in the US, about 50 million women undergo screening; about 3.5 m (7%) will be referred for further evaluation. Of these, more than 2 million will be referred for further evaluation of ASCUS.� 2 million unnecessary colposcopies? Or cryotherapy, which is associated with PID & cervical stenosis, and which makes subsequent colposcopy inadequate. A complication rate of 5-20% means 25-100,000 unnecessary complications to prevent a few deaths. Or even up to 11,000.

Then there is the accuracy issue. Estimates vary, but using higher grade lesions PAP has a sensitivity of 70-80% and specificity of 95%. (68 and 75 more realistically). With a prevalence of 6/10000 CIN3, the Positive predictive value of the PAP is 1%.

So we scare everyone into getting a test that is only right 1/100 times when it's positive, to send 2 million women for further testing, which harms 200,000 of them, to prevent potential cancer two decades later in maybe 11,000 (though the nonvaccine oncogenic types will undoubtedly increase in significance). Have we gone mad?

Posted by Robert Maddox at 05:24 PM | Comments (1)

May 14, 2007

Who can change the Future

Back in March, business professors from Harvard and UVA wrote a special communication in JAMA (March 14, 2007) basically summarizing their book, Redefining Health Care, which I am hoping to obtain so I can examine their thesis more closely. The article was entitled, How Physicians Can Change the Future of Health Care. They are very thoughtful and well-spoken professors who make the point that health care is not only a poor value for the money, but the system is fatally flawed, preventing any increase in value. They address the increasing value in telecommunications, for instance. No one complains about the cost of a cellphone because of the ever-increasing value purchased. Medicine is a zero-sum, cost-shifting competition. Their criticism is right on the mark. But their solution is reorganizing practice around medical conditions and care cycles, with risk-adjusted outcomes and costs carefully measured for comparison.

So their solution appears to be more of the same social iatrogenesis, compounded and re-organized. Any solution based on increased data will certainly improve results on an individual level, if the data is more accurate and applicable. But as clinical iatrogenesis improves, unless there is increased focus on the individual person's autonomy (according to Illich), social iatrogenesis will increase. And I would add to Illich that not only must the patient's autonomy increase, but the relationship between the doctor (teacher/advisor) and the patient must intensify. Porter's proposal speaks of value for "patients" but the focus shifts from the individual patient to "conditions and care cycles," the very shift started by Sydenham and intensified by Descartes. And the shift from individual to "disease" must be a shift of decreasing value for the patient, ultimately.

Posted by Robert Maddox at 11:55 AM | Comments (0)

May 10, 2007

Meteor and asteroid

Don't you love the names of these studies? Decades ago, it was the rare trial that had a memorable name. Now they all have these great acronyms. METEOR -- Measuring Effects on Intima-Media Thickness: an Evaluation of Rosuvastatin -- looked at a surrogate end-point (the thickness of one layer in the carotid artery) for risk from subclinical (no symptoms) atherosclerosis. They measured the progression of this thickness over two years with a statin and placebo. They found statistically significant reduction in the rate of progression with the statin.

Great but useless. Ever since we learned to measure things medical, like specific gravity (of urine) and temperature, we have made measurement more important than life. Even the JAMA editorial recognizes the minimal value of surrogate end points (looking at some measurement other than the clinically important one). As Dr. Lauer points out, numerous agents which improved surrogate endpoints "were even found to cause harm when tested for their ability to prevent clinical events."

Statins may improve even certain clinical events (heart attack or stroke) under the right controlled conditions. But the evidence does not exist for a meaningful reduction in all cause mortality. In other words, they might prevent a heart attack but you still die in the same time of something else. But METEOR showed that the progression was not reversed by the statin. So maybe if all the low risk people are started on it soon enough, it would help. That is 50% of 50 year old men and 40 % of 50 year old women. Treat half the population to slow down an unproven connection in a handful. Is this clinical, social or cultural iatrogenesis? They are blurring now.

Posted by Robert Maddox at 10:02 PM | Comments (1)

epoetin misuse

An editorial in JAMA April 18 exposes what appears to be a for profit scam on the drug used to combat anemia in dialysis patients. Actually, the study published by Thamer et al provides the evidence and Dr. Coyne draws the obvious conclusions. Basically, for-profit dialysis centers are unnecessarily aiming for much higher hemoglobin levels, based on misinterpreted evidence. in this way, they make $1700/yr per patient from the government reimbursement. At 309,000 patients on dialysis (2004 figures), that is much waste.

There is no survival benefit to this extra treatment. There may even be an increase in mortality (demonstrated by the CREATE and CHOIR trials ironically, as well as some others showing increased strokes).

Amgen, the company manufacturing this, of course bears no culpability. And the doctors prescribing it surely don't know any better. And the centers profiting from this aren't actually prescribing it. The perfect crime.

Posted by Robert Maddox at 06:45 PM | Comments (0)

Gattaca revisited

A study in JAMA April 11, 2007 (which I cannot link because it is subscription only) by Thomas Morgan, et al, entitled, Nonvalidation of Reported Genetic Risk Factors for Acute Coronary Syndrome in a Large-Scale Replication Study, had an unexpected result. The supposition is that we should be able to find the genetic defects that lead to heart disease (specifically that lump term ACS-which includes heart attacks that do and don't show on EKG, as well as chest pain thought to be from the heart and worse than your regular angina). This study attempted to validate the 85 genetic variants that previous studies have indicated may be associated with ACS.

They could not confirm any of them. The problem culturally, as the film Gattaca explored, is that many of these genetic variants can be tested for now, and that puts people with those variants in danger of social repercussions. It is ironic that this study focussed on the disease highlighted in Gattaca.

Further, it appears to call into question the whole "cure by genetics" approach that is becoming very popular since the Genome Projects. One of the major risk factors for heart disease is family history. But with all our recent hubris, we have not identified the genes responsible. Apparently there are many more factors involved. "There is no gene for the human spirit."

Posted by Robert Maddox at 05:33 PM | Comments (0)

May 09, 2007

tidbit

For any med students that might join us, that April 25 JAMA has the best and clearest explanation of pulsus paradoxus I have ever seen.

Posted by Robert Maddox at 01:01 AM | Comments (0)

Pneumococcal vaccine

I haven't dealt with vaccines in general yet, nor many of the specifics. But this tidbit from JAMA April 25 is too good to pass up.

"The vaccines against Hib and pneumococcus seem like a good idea. Those germs are the cause of much childhood disease. Hib (a bacteria) was the most common cause of meningitis, as well as a major cause of epiglotitis, cellulitis, pneumonia, and a host of other infections. Some of these carried a high mortality rate. It seems to make good sense to vaccinate against such a killer. Maybe the death rate has been reduced from 1/5000, or 10,000 to maybe 1/100,000. (I am guessing at those figures.) But it seems to me that other organisms have just risen to take its place." I wrote a few weeks ago.

Now this from JAMA on pneumococcus. The vaccine was 7-valent (it had 7 types mixed together). The incidence of invasive pneumococcal disease caused by these types decreased, as hoped. But other types have increased and are causing almost as high an incidence as pre-vaccine. What else would we expect? Do we really think we can conquer all disease? Won't the death rate still be one a piece?

Posted by Robert Maddox at 12:53 AM | Comments (0)

Epidural for Back pain

JAMA april 25 had a perspective on epidural steroid injections for back pain. Out of about $90 Billion spent on back pain, nearly $50 million is spent on these injections, for which little evidence can be found. There was improvement between 2 to 6 weeks, but not much at first or long-term. So it is not useless.

The big question is, how is the other $90 Billion spent and is there any evidence for it?

Posted by Robert Maddox at 12:35 AM | Comments (1)

May 08, 2007

tetanus

To start on vaccines (remember, I am not giving specific medical advice, but discussing general principles): Let’s take the one that elicits the most frequent fear response, tetanus. Tetanus is a horrible disease, causing a horrible death. The lockjaw, then generalized tetany, has been known from antiquity. The organism was isolated in 1889. The concept of protection by transferred antitoxin was demonstrated in 1897. The toxoid, a formaldehyde-treated toxin, was developed in 1924, and by WWII was in wide use. By the late 1940’s, tetanus was introduced into routine childhood immunization.

Remember that there was a significant steady decrease in deaths from tetanus from the mid-1800’s, when records were first kept. Even the CDC's Pink book states, “A marked decrease in mortality from tetanus occurred from the early 1900’s to the late 1940’s.” At that time, the late 40’s, there were about 0.4 cases/100,000 (or 500) per year. About 30% of the cases were dying. Now less than 10% of people with tetanus die, and we are down to about 20 per year, or less than 0.01/100,000 (1/15 million).

Perhaps the vaccine can be credited with decreasing both the mortality and incidence of tetanus. The rate of decline doesn’t support that, but it is still possible. Even if the vaccine is responsible for that decrease, it is still only a few hundred people out of 300 million. Remember our lightning death rate is exactly the same. Dying of tetanus, even without the shot, is a 1/million chance, the quintessential act of God. Yet to prevent that, we go crazy, spending precious time, energy, and care to race around to get a tetanus shot. Puncture wounds account for half of tetanus cases, so maybe stepping on a nail is a good reason to make the effort for a shot. But self-piercing and tatooing account for a fair number also. So avoid those.

Posted by Robert Maddox at 11:12 PM | Comments (2)

marriage

Marriage is contranemesis. I haven't accumulated all the evidence. But it is pretty clear that marriage is healthier than singleness, and certainly the case that marriage is healthier than divorce. A married man with heart problems can expect to live 4 years longer than an unmarried healthy man. And a smoker is as well off married than a non-smoking divorcee.

Now there are many factors here that bear examination. And RAND is attempting to do that.

Posted by Robert Maddox at 02:48 PM | Comments (1)

Antibiotic soap?

Is the use of antibiotic soap and its causative link to increasing antibiotic resistance an example of clinical or social iatrogenesis? Illich writes, ”When medical damage to individual health is produced by a sociopolitical mode of transmission, I will speak of ‘social iatrogenesis,’ a term designating all impairments to health that are due precisely to those socio-economic transformations which have been made attractive, possible, or necessary by the institutional shape health care has taken. Social iatrogenesis designates a category of etiology that encompasses many forms. It obtains when medical bureaucracy creates ill-health by increasing stress, by multiplying disabling dependence, by generating new painful needs, by lowering the levels of tolerance for discomfort or pain, by reducing the leeway that people are wont to concede to an individual when he suffers, and by abolishing even the right to self-care.”

Antibiotic soap (can you buy any other kind) is a result of social pressure, perhaps even political pressure, on the industry and on the public. The whole phobia of germs has led to this use of germ-killing (or attenuating) soap, which appears to lead to individual harm, in the form of MRSA and other resistant strains. This is iatrogenesis produced by a sociopolitical mode of transmission.

Posted by Robert Maddox at 09:54 AM | Comments (0)

May 04, 2007

Ear infections

Ear infections are always a great concern of parents, who don't want to see their children suffer, and would do almost anything to help them. An old review, updated recently by Prof. Del Mar for BMJ, gives a picture not commonly understood by even most doctors.

Middle ear infections ( known as AOM-Acute Otitis Media) always get better, with or without treatment. There are few complications from AOM anymore (for whatever reasons), and antibiotics do not prevent them anyhow.

80% of children are better (at least out of pain) by the next day, regardless of treatment or not.

Starting an antibiotic early in the course would reduce the chance of pain by a third. IOW, from 20% to 14% (there's that relative risk reduction again). This means that 100 children would have to be treated to benefit 6, for a NNT (number needed to treat) of 17 for 1 to benefit by less pain days 2-7.

And if that were the whole story, we might all conclude that the cost and trouble of taking an unnecessary antibiotic would be worth it.

But what about the harm of antibiotics? The diarrhea, the abdominal pain, the rash? 30% So 5 of our 17 will be harmed in some way by the unnecessary antibiotic. To help one with pain, we harm five. Is that worth it? Some parents and doctors still think so. This concept is still just too foreign to most that it may not be worth the fight.

Posted by Robert Maddox at 10:20 AM | Comments (3)

May 03, 2007

MICU misdiagnosis

One does not have to search far for examples of clinical iatrogenesis. But one must also be careful of accepting every report of misdiagnosis and error. A study published in Chest in 2001 looked at records of 1800 admissions to a MICU. Of the 401 patients that died, 91 had autopsies. Eighteen of those had a different diagnosis from that which was made clinically. Eight of those were considered major, with a direct impact on therapy. The other ten patients had an unexpected major finding, but would not have changed therapy. So is the conclusion that one in five ICU deaths are misdiagnosed? (18/91)

Continue reading "MICU misdiagnosis"

Posted by Robert Maddox at 10:23 PM | Comments (0)

May 02, 2007

Why is Medical Care so Expensive?

Cleaning out piles of articles, I ran across this piece on the cost of medical care. This topic is naturally one I am forced to think about every day. And a friend just asked about a particular bill he had unnecessarily and unwittingly incurred. One of the social costs of our current medical model is this defensive medicine. In this case, a skin tag was sent off for biopsy, even though the dermatologist was fairly certain it was not cancer. No one takes responsibility for the action. "It is the law."

I suppose this is an example of what Illich calls "specific counterproductivity." It is the "frustrating overproduction" that results from industrialization of medicine. He distinquishes it from direct costs (which some might see this example as) and from negative externality (social costs not included in the monetary price). The intended result (improved health) is actually subverted.

This is one way, indirectly, that government programs (Medicaid and Medicare),

Continue reading "Why is Medical Care so Expensive?"

Posted by Robert Maddox at 12:06 PM | Comments (0)