Category: health care

Celiac Experts Make Less Than Zero Sense

Seth Roberts15 Comments

In the 1960s, Edmund Wilson reviewed Vladimir Nabokov’s translation of Eugene Onegin. Wilson barely knew Russian and his review was a travesty. Everything was wrong. Nabokov wondered if it had been written that way to make sense when reflected in a mirror.

I thought of this when I read recent remarks by “celiac experts” in the New York Times. The article, about gluten sensitivity, includes an example of a woman who tried a gluten-free diet:

Kristen Golden Testa could be one of the gluten-sensitive. Although she does not have celiac, she adopted a gluten-free diet last year. She says she has lost weight and her allergies have gone away. “It’s just so marked,” said Ms. Golden Testa, who is health program director in California for the Children’s Partnership, a national nonprofit advocacy group. She did not consult a doctor before making the change, and she also does not know [= is unsure] whether avoiding gluten has helped at all. “This is my speculation,” she said. She also gave up sugar at the same time and made an effort to eat more vegetables and nuts.

Fine. The article goes on to quote several “celiac experts” (all medical doctors) who say deeply bizarre things.

“[A gluten-free diet] is not a healthier diet for those who don’t need it,” Dr. Guandalini [medical director of the University of Chicago’s Celiac Disease Center] said. These people “are following a fad, essentially.” He added, “And that’s my biased opinion.”

Where Testa provides a concrete example of health improvement and refrains from making too much of it, Dr. Guandalini does the opposite (provides no examples, makes extreme claims).

Later, the article says this:

Celiac experts urge people to not do what Ms. Golden Testa did — self-diagnose. Should they actually have celiac, tests to diagnose it become unreliable if one is not eating gluten. They also recommend visiting a doctor before starting on a gluten-free diet.

As someone put it in an email to me, “Don’t follow the example of the person who improved her health without expensive, invasive, inconclusive testing. If you think gluten may be a problem in your diet, you should keep eating it and pay someone to test your blood for unreliable markers and scope your gut for evidence of damage. It’s a much better idea than tracking your symptoms and trying a month without gluten, a month back on, then another month without to see if your health improves.”

Are the celiac experts trying to send a message to Edmund Wilson, who died many years ago?

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Seth Roberts9 Comments

Thanks to Vic Sarjoo.

End-of-Life Medicine: Enormous Lack of Informed Consent

Seth Roberts16 Comments

A few weeks ago I blogged about undisclosed risks of medical treatments. Undisclosed risks are common. They might be the norm. The situation would be even worse — in some sense, much worse — if doctors knew of these risks and failed to tell their patients. It was unclear if doctors knew of the undisclosed risks I wrote about.

Recently Tyler Cowen quoted a newspaper story about Israeli doctors giving birth control injections to Ethiopian women immigrants ”without their knowledge or consent.” Every commenter thought this was repugnant.

The latest RadioLab podcast (“The Bitter End”) is about the dramatic difference between how doctors want to be treated when they are near death (they want no CPR, no ventilator, no dialysis, no surgery, no chemotherapy, no feeding tube, no antibiotics, nothing except pain medicine) and how the general public wants to be treated (most people want CPR, ventilator, dialysis, surgery, chemotherapy, feeding tube, antibiotics, and so on).

The RadioLab guys were puzzled by the difference. Upon investigation, they learned that the big differences exist because all those medical procedures (except pain medicine) have much worse outcomes than the public is told. The doctors know about the bad outcomes. It is better to die, the doctors decide. Unless doctors have less tolerance for being in a vegetative state, having ribs broken, and so on than the rest of us, it is clear that most people agree to these procedures because of ignorance. They fail to know what actually happens because the people who know — doctors — fail to tell them.

In other words, a huge number of sick people are being treated without having given informed consent. Doctors are doing many things to the sick people that benefit the doctors without telling the sick people how bad those things are. If end-of-life doctors told the truth, they would have a lot less work.

The RadioLab podcast hints at the moral retardedness implied by this practice in an interview with a medical student, whom I assume was randomly chosen. Why aren’t people told the truth? the interviewer asks. “I don’t know how to communicate that effectively,” says the student. Then he communicates the truth quite effectively. Why don’t you say that? says the interviewer. People don’t want to hear that, says the student (changing his answer). They don’t want to, but they need to, says the interviewer. The student says it would be “presumptuous” to tell them the truth. Presumptuous. What universe is he in? The absurdities and pathetic justifications given by the medical student to rationalize his behavior suggest that the whole medical profession doesn’t understand there is a big problem.

The comments on the RadioLab podcast at the website also suggest that doctors fail to grasp there is a big problem. Many commenters are doctors. Some agree with the facts in the program. None expresses even discomfort with the situation. One commenter is Joseph Gallo, the Johns Hopkins medical school professor who runs the study that revealed the enormous difference between what doctors want and what the general public wants. “I second the sentiments about nurses being great,” wrote Gallo. “I would add that studies that have asked nurses about their end-of-life preferences have found similar desire to limit care.” The two sentences contradict each other. There is nothing “great” about anyone who sees this happening and does nothing.

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Seth Roberts15 Comments

Personal Science = Insourcing Your Health

Seth Roberts3 Comments

I recently blogged about undisclosed risks of medical treatments. For example, sleeping pills are associated with a big increase in death rate. Patients are rarely (never?) told this. One reason risks are undisclosed is ignorance: Your doctor doesn’t know about them. Another likely reason is that you and your doctor have different goals. If a treatment harms you, your doctor is not harmed, in all but a few cases. If you refuse a treatment (such as a surgery), your doctor may make less money. This pushes doctors to overstate benefits and understate costs.

This is the simplest case for personal science: You care more about your health than any expert ever will. The experts have advantages, too (such as more experience with your problem) so it is not obvious that personal science will be better than expert advice — you have to try it and find out. When I started to study my acne, I was stunned how easy it was to improve on what my dermatologist had told me.

A recent article in The Atlantic (“The Insourcing Boom”) describes a similar revelation at General Electric. GE executives wondered if they could build a certain water heater (the Geospring) just as profitably in America as in China. They looked at it carefully:

The GeoSpring in particular, Nolan says, has “a lot of copper tubing in the top.” Assembly-line workers “have to route the tubes, and they have to braze them—weld them—to seal the joints. How that tubing is designed really affects how hard or easy it is to solder the joints. And how hard or easy it is to do the soldering affects the quality, of course. And the quality of those welds is literally the quality of the hot-water heater.” Although the GeoSpring had been conceived, designed, marketed, and managed from Louisville, it was made in China, and, Nolan says, “We really had zero communications into the assembly line there.”

To get ready to make the GeoSpring at Appliance Park, in January 2010 GE set up a space on the factory floor of Building 2 to design the new assembly line. No products had been manufactured in Building 2 since 1998. . . .

“We got the water heater into the room, and the first thing [the group] said to us was ‘This is just a mess,’ ” Nolan recalls. . . . “In terms of manufacturability, it was terrible.” . . . It was so hard to assemble that no one in the big room wanted to make it. Instead they redesigned it. The team eliminated 1 out of every 5 parts. It cut the cost of the materials by 25 percent. It eliminated the tangle of tubing that couldn’t be easily welded. By considering the workers who would have to put the water heater together—in fact, by having those workers right at the table, looking at the design as it was drawn—the team cut the work hours necessary to assemble the water heater from 10 hours in China to two hours in Louisville.

In the end, says Nolan, not one part was the same.

So a funny thing happened to the GeoSpring on the way from the cheap Chinese factory to the expensive Kentucky factory: The material cost went down. The labor required to make it went down. The quality went up. Even the energy efficiency went up. . . . The China-made GeoSpring retailed for $1,599. The Louisville-made GeoSpring retails for $1,299.

That’s what happened when designers and manufacturers were no longer so far apart. As far as I can tell, the designers at GE had no idea such big improvements were possible, just as I was shocked how easy it was to do better than my dermatologist.

There are dozens of ways to bring the incentives of doctor and patient closer together but that would be like trying to bring the Chinese workers and GE designers closer together. Personal science is much easier. No one besides you needs to change. It corresponds to insourcing: insourcing responsibility for your health.

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Seth Roberts8 Comments

 

What Should Your Cholesterol Be?

Seth Roberts9 Comments

According to the Mayo Clinic website, lower levels of cholesterol are better. For total cholesterol, says the Mayo Clinic, below 5.2 mmol/L (= 200 mg/dL) is “desirable”. A level from 5.2 to 6.2 mmol/L is “borderline high”, and above 6.2 mmol/L (= 240 mg/dL) is “high”.

A 2011 study from Norway, based on 500,000 person-years of observation, found drastically different results. For both men and women, the lowest levels of total cholesterol (below 5.0 mmol/L) were associated with the most death. For men, the best level was intermediate — what the Mayo Clinic calls “borderline high”. For women, the safest levels were the highest.

If high cholesterol causes heart disease, as we are so often told, the pattern for women makes no sense. For a long time, experts have told us to limit egg consumption because eggs are high in cholesterol. However, a new study shows that egg consumption has no association with heart disease risk.

Via Malcolm Kendrick. I also like his post about whether statins cause muscle pain.

Hard to Say Whether Medicine Does More Good Than Harm

Seth Roberts6 Comments

A draft article by Spyros Makridakis about blood pressure and iatrogenics takes issue with the statement that “The treatment of hypertension has been one of medicine’s major successes of the past half-century.” Over the last half-century, the article says, the death rate for people with high blood pressure decreased by almost exactly the same amount as the death rate for people without high blood pressure. Apparently “one of medicine’s major successes” is a case where the health benefit no more than equaled the health cost — leaving aside what the treatment cost in time and money.

Because very high blood pressure (systolic > 180 mm Hg) is quite dangerous and blood pressure drugs really work, this is a surprising outcome. Makridakis points out that doctors start treating high blood pressure when it rises above systolic = 140 mm Hg, a point when there is little or no increase in death rate. This article tells doctors to immediately prescribe drugs when systolic blood pressure is above 160. Yet death rate clearly increases only when systolic blood pressure is above 180. Makridakis concludes (as do I) that blood pressure drugs have significant health costs as well as benefits. The drugs are so often prescribed when they do no good and the costs are so high that the overall health costs of blood pressure treatment have managed to be as high as the overall benefits. Even when handed a relatively easy-to-measure problem (high blood pressure) and a relatively simple solution (blood pressure drugs), our health care system managed to achieve no clear gain. If this is “one of medicine’s major successes”, medicine is in bad shape.

The last paragraph of Makridakis’s article makes a surprising statement: “We strongly believe that medicine is extremely useful.” It does not explain this belief, which is contradicted by the rest of the article. I was puzzled. I wrote to the author:

I recently read your paper on “High blood pressure and iatrogenics”. The main part makes good sense. Then it ends with something quite puzzling: “We strongly believe that medicine is extremely useful.” No doubt a few areas of medicine are extremely useful. For large chunks of medicine, it is hard to tell whether they do more good than harm, because so many drugs and other treatments have undisclosed or unnoticed bad effects.

For example, tonsillectomies — for a long time the most common operation — is associated with a 50% increase in mortality in one study. The notion that cutting off part of the immune system is a good idea makes as much sense as the idea that cutting out part of the brain is a good idea. Another example is sleeping pills. They are associated with a three-fold increase in death rate soon after they begin to be taken. I am not saying that medicine overall does more harm than good. I am saying that a strong belief about the outcome of such an assessment (does medicine overall do more good than harm?) doesn’t make sense.

Makridakis replied:

Thank you for your email. The paper you mention is a draft posted for comments. I agree with you that my statement is wrong. It should have read: : “We strongly believe that medicine can be extremely useful”. For instance, this could be the case in treating heart attacks, strokes, traumas from car accidents or bullet shots. But in most other cases the harm from treatment can be greater than the benefits. In addition, the harm from preventive medicine can exceed its value. Thank you for pointing out this mistake to me.

Puzzle resolved.

Sleeping Pills are Very Dangerous

Seth Roberts8 Comments

Do you know how dangerous prescription sleeping pills are? I didn’t, and I do sleep research.

I came across Dr. Daniel Kripke’s book Dark Side of Sleeping Pills while finishing yesterday’s post on undisclosed risks of medical treatments. I had written an almost-complete draft a year ago. One line in the draft said “undisclosed risks of sleeping pills” with no additional information. I couldn’t remember why I’d written that so I googled “dangers of sleeping pills” and found Dr. Kripke’s book. I was unaware the evidence was so strong. I asked Dr. Kripke to tell the story of how he came to write it. He replied:

It is almost a life-long story.

As a young psychiatrist, I learned that the American Cancer Society had done a questionnaire survey of a million people which showed mortality related to long and short sleep. [People who sleep less or more than average have higher death rates.] In 1975, I asked if they would collaborate with me on a more complete analysis of the data on sleep length and insomnia. As a control variable, we included analysis of their one question about sleeping pill use. To my surprise, it looked like sleeping pill use was a strong predictor of early death, while insomnia was not (if you controlled for sleeping pill use by insomniacs).

There were many reasons why these results needed further study, so I asked if I could refine the questions for the new Cancer Prevention Study II (CPSII) which the American Cancer Society commenced in 1982 with 1.1 million participants. Imagine my surprise when I observed that sleeping pill use was associated with a comparable mortality hazard ratio as cigarette smoking! These studies, and about 20 more done all over the world with similar results, had two important limitations: in general, the studies did not identify the sleeping pills used and did not measure whether those taking sleeping pills at the start of the study continued the drugs, or whether those who were not taking sleeping pills (the comparison group) started taking them. So another study was needed.

Meanwhile, sleeping pills were never my main scientific concern. I was mainly interested in bright light treatment of depression and trying to understand how light worked. When I saw that patients needed information about light treatment, I wrote a very short book called “Brighten Your Life”, but it wasn’t long enough to publish, so I added information about sleeping pills to make it longer. When we found no publisher for the book, I made the information available at two web sites: www.BrightenYourLife.info and www.DarkSideOfSleepingPills.com. I found that the web site about sleeping pills was more popular than the advice about light treatment–indeed, one of the most popular sources about sleeping pills at Google. Therefore, over the years, I have worked to revise and update both web sites to try to help patients. It costs some money to program and maintain the web sites, but people write me to tell me how they have benefited. I see so much misinformation coming from the drug companies that I want people to have an alternative source.

Five or six years ago, my friend Dr. Bob Langer was working at the Geisinger Health Research Center, which had access to electronic health records about sleeping pill use from a large number of people. It took us five years to plan a study, obtain approval from ethics committees, retrieve the complex data from computer files in anonymized form, and analyze the very complex results. When these were published by the medical journal BMJ Open, the new information became available at https://bmjopen.bmj.com/content/2/1/e000850.full. It is an interesting web site which includes more data in a supplement to the main article and some comments and debate about the article. The interest in the article was world-wide, with stories on the BBC, at Agence France Press, in major newspapers in Japan, India, and China, and even mentions in far-off places like Myanmar and Ruanda. The new data showed that people taking drugs such as zolpidem and temazepam had about 4.6 times the mortality rate of people of the same age and sex who took no sleeping pills. The new data confirm that sleeping pills might cause as much death as cigarettes, and also some cancer, so I feel a big responsibility to make the information available. There may be hundreds of thousands of lives at stake. People need to know that sleeping pills are too risky to use, and I wish I had more help in telling people.

Recently we updated the Dark Side Of Sleeping Pills and Brighten Your Life and made them available together in a Kindle book, which is easy to purchase at Amazon and read off-line. The books have some new information which we have not yet had a chance to put in the web sites.

Even with, now, more than 20 scientific papers showing that taking sleeping pills is associated with more death and more cancer, many people don’t believe it. They imagine there is some other explanation, though nobody has been able to demonstrate an alternative explanation. Of course, statistical association is not quite the same thing as proof of causality, but if it is good enough for the American Cancer Society to advise avoiding cigarettes, it is enough evidence of risk to stay away from sleeping pills, in my opinion. The problem is that the drug companies have never done a controlled trial study large enough to prove one way or another whether the sleeping pills cause death and cancer, and I think they never will. The cigarette companies have never tried to prove that cigarettes are safe, and they know better than to try. It is the same. Whereas the FDA requires the very large studies for heart and diabetes drugs and so forth, the FDA has dropped the ball with sleeping pills. For more information about that, please see the Kindle book. There is, however, a new alternative to large, expensive, and dangerous controlled trials called a Mendelian randomization study, which uses the new genetic methods to determine causality when a genetic variation causes a risk factor such as sleeping pill usage. Since the genetic data already exist to do the Mendelian randomization studies, it is a matter of doing the difficult statistical analyses. I hope scientific colleagues will join in this task, because I can’t do it by myself. It is crucial to determine for sure the risks of sleeping pills. Too many lives are at stake.

Sleeping pills are astonishingly dangerous for something that is treated as more or less safe. In some cases, they are associated with a five-fold increase in death rate after only a few years of use. Cigarette smoking is associated with only a two- or three-fold increase in death rate after long use. And doctors don’t prescribe cigarettes. Is there anything else treated as safe that is associated with such a large increase in death rate? I can’t think of anything.

Undisclosed Risks of Common Medical Treatments

Seth Roberts10 Comments

Millions of tonsillectomies have been done, mostly to children. Were any of their parents told that tonsils are part of the immune system (taught in high school biology and known since the 1960s)? A Cochrane Review of tonsillectomies (the “highest standard” in evidence-based medicine) fails to mention that tonsils are part of the immune system. A recent study found tonsillectomies associated with a 50% increase in heart attacks. (I write about tonsillectomies here.)

Are tonsillectomies unusual? Several recent news stories suggest no, they aren’t. Failure to tell patients the full risks of medical treatment may be common:

1. Undisclosed risks of hernia surgery. From the Wall Street Journal: “More than 30% of patients may suffer from long-term chronic pain and restricted movement after surgery to fix a hernia . . . studies show.” The article says “many patients don’t consider” this risk — meaning they don’t know about it. A Berkeley surgeon named Eileen Consorti told me I should have surgery for a hernia I could not detect. I have previously written about her claim that evidence supported her recommendation when no such evidence existed — or, at least, no one including her has ever found it. I said I wanted to see the evidence because there were risks to surgery. She replied that none of her patients had died. I was shocked by the incompleteness of her answer. There are plenty of bad outcomes besides death — as the Wall Street Journal article shows.

2. Undisclosed risks of sleeping pills. A book called The Dark Side of Sleeping Pills by Daniel Kripke, a professor of psychiatry at UC San Diego, goes into great detail about risks of sleeping pills that few doctors tell their patients. For example, one study found that “patients who took sleeping pills died 4.6 times as often during follow-ups averaging 2.5 years [than matched patients who did not take sleeping pills]. Patients who took higher doses (averaging over 132 pills per year) died 5.3 times as often.” Insomnia alone was not associated with higher mortality. Tomorrow I will post Dr. Kripke’s answer to the question “why did you write this book?” Here is a website about the dangers of Ambien.

3. Undisclosed risks of anticholinergic drugs. From the NY Times: “After following more than 13,000 British men and women 65 or older for two years, researchers found that those taking more than one anticholinergic drug scored lower on tests of cognitive function than those who were not using any such drugs, and that the death rate for the heavy users during the course of the study was 68 percent higher. That finding, reported last July in The Journal of the American Geriatrics Society, stunned the investigators.” Anticholinergics are “very very common” said a researcher. They include many over-the-counter drugs, such as “allergy medications, antihistamines and Tylenol PM”.

4. Undisclosed risks of statins. A recent NY Times story says “the Food and Drug Administration has officially linked statin use with cognitive problems like forgetfulness and confusion, although some patients have reported such problems for years. Among the drugs affected are huge sellers like Lipitor, Zocor, Crestor and Vytorin.” Prior to this official linkage, the reports of forgetfulness and confusion were mere anecdotes that evidence-based medicine proponents ignore and tell the rest of us to ignore.

5. Undisclosed risks of metal-on-metal hip replacements. They leak dangerous amounts of metal (e.g., cobalt) into the rest of the body. “Despite the fact that these risks have been known and well documented for decades, patients have been kept in the dark,” says a recent article in the BMJ. By 2007, the danger was so clear that a British regulatory committee said that patients must sign a form saying they’ve been warned. This didn’t happen — a surgeon told the BMJ that “surgeons were unaware of these discussions.” Other materials could have been used.

These six treatments (tonsillectomy, hernia surgery, sleeping pills, anticholinergic drugs, statins, and hip replacement) are so common they raise a scary question: What fraction of the risks are patients usually told?

The surgeon or drug company gets paid no matter what happens to you. Malpractice lawsuits are very rare on a per-patient basis — and no one will be sued for performing a tonsillectomy on a child who gets a lot of colds or prescribing sleeping pills to someone who has trouble sleeping. In a Freakonomics podcast, Steve Levitt said that doctors terrify him. And his father is a doctor. Given the undisclosed risks of common treatments, he is right to be terrified.

Thanks to Allan Jackson, Alex Chernavsky and Tim Beneke.