Overtreatment in US Health Care

In April there was a conference in Cambridge, Massachusetts, about how to reduce overtreatment in American health care. Attendees were told:

The first randomised study of coronary artery bypass surgery was not carried out until 16 years after the procedure was first developed, a conference on overtreatment in US healthcare was told last week. When the results were published, they “provided no comfort for those doing the surgery,” as it showed no mortality benefit from surgery for stable coronary patients.

One participant said that overtreatment cost one-third of US health care spending. As far as I can tell, no one said that “evidence-based medicine” underestimates — in the case of tonsillectomies, almost completely ignores — bad effects of treatments. This failure to anticipate and accurately measure bad effects of treatments makes the overall picture worse. Maybe much worse.

Merck’s Vioxx and the American Death Rate

Ron Unz makes a very good point — that just one awful drug (Vioxx) sold by just one awful drug company (Merck) appear to have caused hundreds of thousands of deaths:

The headline of the short article that ran in the April 19, 2005 edition of USA Today was typical: “USA Records Largest Drop in Annual Deaths in at Least 60 Years.” During that one year, American deaths had fallen by 50,000 despite the growth in both the size and the age of the nation’s population. Government health experts were quoted as being greatly “surprised” and “scratching [their] heads” over this strange anomaly, which was led by a sharp drop in fatal heart attacks. . . .

On April 24, 2005, the New York Times ran another of its long stories about the continuing Vioxx controversy, disclosing that Merck officials had knowingly concealed evidence that their drug greatly increased the risk of heart-related fatalities. . . .

A cursory examination of the most recent 15 years worth of national mortality data provided on the Centers for Disease Control and Prevention website offers some intriguing clues to this mystery. We find the largest rise in American mortality rates occurred in 1999, the year Vioxx was introduced, while the largest drop occurred in 2004, the year it was withdrawn. Vioxx was almost entirely marketed to the elderly, and these substantial changes in national death-rate were completely concentrated within the 65-plus population. The FDA studies had proven that use of Vioxx led to deaths from cardiovascular diseases such as heart attacks and strokes, and these were exactly the factors driving the changes in national mortality rates.

The impact of these shifts was not small. After a decade of remaining roughly constant, the overall American death rate began a substantial decline in 2004, soon falling by approximately 5 percent, despite the continued aging of the population. This drop corresponds to roughly 100,000 fewer deaths per year. The age-adjusted decline in death rates was considerably greater.

This illustrates how Merck company executives got away with mass murder on a scale that the Khmer Rouge would be proud of. It also illustrates why I find “evidence-based medicine” as currently practiced so awful. Evidence-based medicine tells doctors to be evidence snobs. As I showed in my Boing Boing article about tonsillectomies, it causes them to ignore evidence of harm — such as heart attacks and strokes caused by Vioxx — because the first evidence of harm does not come from randomized controlled studies, the only evidence they accept. It delays the detection of monumental tragedies like this one.

Interview with Daniel Wolfson of Choosing Wisely

The new Choosing Wisely campaign is centered on lists of “unnecessary” medical tests and procedures. The hope is that these lists will reduce waste in the health care system. I wondered what “unnecessary” meant so I interviewed Daniel Wolfson, who is Executive Vice President and Chief Operating Officer of the American Board of Internal Medicine, located in Philadelphia.

At the heart of my question was: why these procedures and not others? Each list has five items. How were they chosen? Here is how the five items on the American College of Physicians’ list were selected:

The American College of Physicians (ACP) formed a workgroup of eleven experienced internal medicine physicians with specific skills in the assessment of evidence. . . . The group collaboratively identified and narrowed down screening or diagnostic tests commonly used in clinical situations where they are unlikely to provide high value or improve patient outcomes. The results were further reviewed and narrowed by clinically active ACP staff physicians before being placed for review into a randomly selected internal medicine research panel. Representing 1 percent of ACP members, the panel selected five scenarios that represented the greatest potential for overuse or misuse of a diagnostic test leading to low value care.

I said this sounded like a popularity contest. Mr. Wolfson said, no, the recommendations are based on evidence. “Do you know what a randomized trial is?” he asked. What evidence? I said. It’s not on your website.

Yes, it’s there, said Mr. Wolfson. He pointed me to the “sources” at the end of the ACP list. Here is one of those sources:

2011 USPSTF screening for coronary heart disease with electrocardiography (draft) guideline; 2011 AAFP recommendations for preventive services guideline; 2010 ACCF/AHA assessment of cardiovascular risk in asymptomatic adults guideline.

This is evidence? I said. It’s very vague. At this point Mr. Wolfson ended the interview.

So I continue to think it is a popularity contest. Who knows how the doctors on that “randomly selected internal medicine research panel” made their decisions.

I think the Choosing Wisely campaign is worthwhile, in spite of Mr. Wolfson’s implausible claims (he also said the doctors who created these lists were “courageous”). Here’s what I would say: The items on these lists are things that many doctors in that specialty think are done too often. The lists are like a free second opinion.

 

 

 

The American Dietetics Association Wants No Competition

Michael Ellsberg has an excellent article about the American Dietetic Association’s attempts to make it illegal for anyone they haven’t approved to give nutritional advice. In this document, they are frank that this is their goal. After Ellsberg drew attention to it, it was taken down. I look forward to learning why it was taken down.

The Washington State chapter of the ADA, now called the Washington State Academy of Nutrition and Dietetics, is responsible for taking down the document. The organization has this mission statement:

Empowering the people of Washington to improve health with safe, effective and reliable food and nutrition information.

Our Vision: Optimize the health and well being of Washington State individuals through food & nutrition.

Our Mission: Empower members to be Washington State’s food and nutrition leaders.

Long ago, in the civil rights or suffrage movements, for example, empowerment meant removal of barriers. This organization preaches empowerment by creation of barriers. Their empowerment is someone else’s disempowerment.

What is “Unnecessary” Medicine?

An organization called the American Board of Internal Medicine Foundation has launched a campaign to reduce the cost of health care by reducing “unnecessary” tests, drugs, and procedures. A bare-bones website lists them. For example:

Don’t routinely do diagnostic testing in patients with chronic urticaria [hives].

Here is the explanation of that recommendation:

In the overwhelming majority of patients with chronic urticaria, a definite etiology is not identified. Limited laboratory testing may be warranted to exclude underlying causes. Targeted laboratory testing based on clinical suspicion is appropriate. Routine extensive testing is neither cost effective nor associated with improved clinical outcomes. Skin or serum-specific IgE testing for inhalants or foods is not indicated, unless there is a clear history implicating an allergen as a provoking or perpetuating factor for urticaria.

Not clear. Are they trying to say the tests are useless (“not associated with improved clinical outcomes”)?

My broad question about the campaign is: What does “unnecessary” mean? This is not explained on the website nor in a Washington Post article about the campaign.

A nearby article on the Post website is about “the downside of mammography”. It says:

A study published Monday in the Annals of Internal Medicine adds to a growing body of evidence that the potential risks of routine breast-cancer screening via mammography might in fact outweigh such screening’s benefits.

That’s clearer. It seems to be saying the costs outweigh the benefits. (What are “potential” risks? I thought all risks were potential.) But that doesn’t mean that breast cancer screening is “unnecessary”, it means it is a bad idea.

If the foundation is trying to say that a lot of medicine does more harm than good, then, please, say so. If they are trying to say that a lot of medicine is useless, then, please, say so. Stop being polite.

I contacted the foundation to ask them about this.

Thanks to Bryan Castañeda.

Assorted Links

  • Where are they now? J. S. Boggs, profiled by Lawrence Wechsler in The New Yorker. Boggs made small paintings closely resembling money (e.g., a $100 bill) that he offered in place of real money. He sold surrounding details (e.g., the receipt) to a collector who would try to get the bill Boggs had drawn from the merchant in order to “complete” the work of art.
  • A SLDer (Shangri-La Dieter) loses 80 pounds in 18 months. That’s 1.0 pounds/week.
  • More medicine does not equal better medicine. I agree with every word of this critique by a Glasgow general practitioner named Des Spence. For example, “The prescribing of powerful antipsychotic and potentially addictive stimulant drugs to children is a societal norm. . . . A quarter of US women are taking mental health drugs.” As Spence says, these are signs of a healthcare system biased toward those who make money from it and against everyone else (including children). One way to sum up why this is a mistake: Your health is too important to be left to those who only make money if you are sick.
  • Japan: from rice to wheat to rice.

Thanks to Bryan Castañeda.

Assorted Links

Thanks to Tom George and Mark Griffith.

Genomics Confidential: Iceland Not So Wonderful

Many people think that personal genomics will change medicine. Doctors will choose treatments based on your genome, learning your genome will tell you what diseases you are at high risk of so you can take precautions, and so on. One person who believes this is Eric Topol. In his new book, The Creative Destruction of Medicine, he writes:

The biggest leap came in the first decade of the twenty-first century. The six billion bases of the human genome were sequenced, and this led to the discovery of the underpinnings of over one hundred common diseases, including most cancers, heart disease, diabetes, autoimmune disorders, and neurologic conditions.

Here is the founder of a company that makes sequencers: ““I believe that the impact on the medical community of whole human genome sequencing at a cost comparable to a comprehensive blood test will be profound.”

I disagree. I have seen nothing that suggests genes make a big difference in any common disease and plenty that suggests environment makes a big difference. My self-experimentation led me to one powerful environmental factor after another, for example. Biologists have invested heavily in the study of genes for reasons that have nothing to do with practical applications, as Thorstein Veblen would be the first to point out.

In 1999, New Yorker staff writer Michael Specter wrote an admiring article about a neurology professor named Kari Stefansson. Stefansson had returned to his native Iceland to take advantage of Iceland’s genetic homogeneity to find genes for common diseases. “In the past, drugs were discovered almost by chance,” Specter wrote, as if this would soon change. The wishful thinking involved is indicated by passages like this:

[Stefansson] and Gulcher selected the five per cent of Icelanders among the hundreds of thousands in their genealogical database who had lived the longest— most of them over ninety. The database allowed the two scientists to seek an answer to a simple question: Are these people who live so long related to each other more often than the average in Iceland? The answer quickly became apparent. People over ninety are much more closely related to each other than people in the general population are, and their children are more likely to live longer than the children of others. That provides strong evidence that the trait is inherited.

“Strong” evidence? The “people over ninety” observation is strong evidence that longevity is inherited only if relatives share nothing but genes. The “their children are more likely” observation is strong evidence of genetic control only if parents pass on to their children only genes. Both assumptions are highly unlikely. For example, surely an Icelandic person lives closer to his relatives than to randomly selected Icelanders.

The article quotes no one with my view (geneticists are overstating the practical value of their work), but it does say that “Stefansson set out to raise capital at a time [1996] when investors had become skeptical about the many unfulfilled promises made by companies claiming that genetic research would solve the ills of humanity.”

Will reality overtake hype? Here is an indication this is happening:

Kari [Stefansson], a neurologist, was a Harvard professor when he co-founded deCODE in 1996. Two years later, Iceland’s parliament gave deCODE access to one of the country’s unique resources—health records of the genetically homogenous population. DeCODE debuted on the NASDAQ stock exchange in 2000, and it made dramatic discoveries of genetic factors associated with cancer, heart disease and other conditions. But the company never turned a profit and filed for bankruptcy protection in 2009.

 

An Example of Predatory Medicine

I recently posted about how doctors act like predators, in the sense of having what Jane Jacobs called “guardian values” (e.g., loyalty to other doctors is more important than honesty to patients). Here is an example of medical behavior that coming from an ordinary business would be shocking:

On February 21 [2012], I had my evaluation for a kidney transplant at a university-affiliated medical center about 100 miles from where I live. The way this institution operates, it takes about 8 months to get from initial referral to evaluation and there are all kinds of diagnostic tests in between (see previous blogs for more details). Once you are an approved transplant candidate and an organ becomes available, you go to the hospital and have surgery. The average stay for a kidney transplant is about 3 days and then you are discharged to a local hotel for 5-7 days. During that time, you return to the hospital every day for blood work, monitoring of the immunosuppressive medications and patient education. Also, you must have a full-time caregiver. That can be a friend, family member, stranger off the street corner, but they must be with you at all times to ensure that you are eating, taking meds, bathing, etc. Also, driving is prohibited until about six weeks post-transplant so the caregiver is also a chauffeur and attends the educational activities as a back-up in case the patient becomes incapacitated or symptoms of rejection appear.

In short, your caregiver must be able to put their own life on hold for about two weeks with as little as two hours notice. When you think about it, that’s a pretty tall order to fill. I have a caregiver, he happens to be a member of this forum. He is a dear, dear friend and always will be if only for the fact that he is willing to undertake this role with only the merest of acquaintance. He is more than willing to put himself and his home at my disposal if necessary. I won’t call him out by name, he obviously knows of whom I speak, but I truly feel as though Karma has smiled on me since our paths have crossed.

So the evaluation finally rolls around. Caregivers must be present during the evaluation. We check in at the medical center and are shown to an exam room. We are seen by a barrage of clinicians; dietician, nephrology resident, nephrology attending (the doctor in overall charge of my medical care while at the transplant unit), and the transplant surgeon. There are physical exams (kind of interesting since my caregiver knows me pretty well, but not THAT well), an EKG and a side trip to the lab. At the lab, the phlebotomist doesn’t pay any attention to my advice about using a butterfly catheter and proceeds to draw 20 (count ‘em, 20) vials of blood for type, cross match, antigen levels, etc, etc through a Vaccutainer. About halfway through, my vein collapses and she has to switch to the other arm, this time with a butterfly. After that, a chest x-ray. Back up to the 9th floor for our final meeting of the day; the social worker.

Up until this time, everything had been encouraging. I can’t say enough good things about the clinical staff, they were all wonderful, professional, warm, willing to answer questions, etc. My transplant surgeon looks like he should be on a TV medical drama, he can unzip me any time! The good vibes ended the minute we sat down with the social worker. She informed me that I would be required to have a second caregiver, a backup so to speak. WTH? People that can call a halt to their lives don’t grow on trees. Talk about hitting a brick wall. Here’s a sample of the conversation:

Social worker: What will you do if you are discharged to home and you can’t take care of yourself?
LadyDoc: Well, if I can’t take care of myself then I guess I shouldn’t be discharged, should I?
Social worker: Well, you could always go into a nursing home.
LadyDoc: Over my dead body.

And there you have it, the standoff. I have looked through every single printed word and email that I have ever gotten from this institution (and I keep very good records) and there is NOT A SINGLE WORD about having a second caregiver. The only family I have in the area is my daughter and she has two little boys under the age of five at home, so I can hardly ask her. My circle of friends is painfully small, many are disabled and not up to the challenge and the others have lives of their own.

The social worker called me a few days later to see if I had changed my mind and it suddenly began to sound like a sales pitch. She was touting all the advantages of this particular institution but I just don’t see it. I am now turning my attention to medical centers where the inpatient stay is closer to 5-7 days and then the patient is discharge directly to home, none of this stay-in-a-hotel stuff. I can’t think of too many places where germs and nastiness run more rampant than a hotel. I am so frustrated, I feel as though the last 7 months of my life have been an utter waste of time. Furthermore, the evaluation day was wasted; if we had met with her first we could have simply gotten up and walked out and said “Thank you for playing, please try again”.

In case you needed any convincing that customers for health care differ from customers for other services. (The difference: they are more desperate.) Think of this example if you are sure that government-run health care must be worse than the current system. You can learn what happened next at the link.

The Parable of the SAMe

SAMe is a drug well known to help depression. For example, “a popular dietary supplement called SAMe may help depressed patients who don’t respond to prescription antidepressant treatment, a new study shows.” But there’s something important few people know about SAMe.

While talking to a Seattle woman about how Vitamin D3 first thing in the morning helped her with depression, she told me the following story:

When I was 47, I just wanted to be healthier. I kept gaining weight. I knew what foods are healthy. I just didn’t seem to eat them. A naturopath suggested SAMe. I tried it — Twin Labs SAMe. That was really fabulous for me. For the first time I got a glimpse of what being not depressed was like. Cravings weren’t there any more. Went from a size 24 to a size 14. Lost 70 pounds. I’m 5′ 8″. I didn’t feel deprived. I was eating plenty of food. going to yoga. Feeling really great.

Then Twin Labs discontinued it. It was made in Japan. I tried every other SAMe out there, eight different brands. None of them worked. I gave each of them a month. I tried different dosages.

I started slipping back into depression. Not being able to cope. I was sleeping more. Sugar cravings returned.

[why did Twin Labs stop making it?]

It wasn’t a good seller for them. So fucking wrong. I wrote letters to try to get them to start making it again. I did a campaign. People found pockets of what was left in the country and sent it to me. But it finally ran out.

The moral(s) of the story? 1. So much for word of mouth. You might have thought it would make the good SAMe sell well, better than the bad SAMe. Apparently not. 2. So much for the placebo effect. 3. Clinical studies (e.g., of SAMe) may higher-quality versions of what they are testing than the versions available to the rest of us. 4. So much for quality control in the supplement industry — except maybe in Japan. There can be substantial quality variation among supplements, undetected by the industry. I have to believe the companies selling the useless SAMe didn’t realize it. Surely they thought that good SAMe would be a better product for them than bad SAMe.

This resembles the Vitamin D3 story I have been telling. Tara Grant said she’d heard countless times that Vitamin D is good. She hadn’t heard once that it must be taken in the morning. I’ve heard countless times that SAMe is good. This was the first time I heard about huge quality control issues. In both cases individual self-observation uncovered a crucial truth that an industry had overlooked. They didn’t want to miss it. The Vitamin D Council didn’t want to miss the time-of-day effect. They just did.

This also resembles what I said about ultrasound machines: A lot of them are broken, unbeknownst to their operators and the people (often pregnant women) being scanned. The countless “experts” (doctors) who recommend ultrasound don’t seem to know this.

Which is why personal science (trusting data, not experts) is more valuable than experts want you to think.