Heart Emergencies by Appointment at Mt. Sinai Hospital

A recent Bloomberg News article looked into why Mt. Sinai Hospital in New York did a very large number of heart procedures, making its cardiologists very well-paid. One reason, the journalists discovered, is that patients had been told to lie:

On a pair of representative Sundays in 2012, 10 patients told ER workers they’d been instructed to arrive there before their cath-lab appointments, according to internal hospital correspondence. Two of them said they’d been coached to say they were having acute symptoms of heart disease, according to the exchanges.

Even more remarkable, the journalists found, was that many patients had cardiology appointments before they showed up at the emergency room:

Certain patients who showed up at Mount Sinai Hospital’s emergency room on Sunday mornings stood out [because] they already had appointments. Each was scheduled for a procedure at Mount Sinai’s catheterization lab, where cardiologists thread wires and tubes into blood vessels to detect disease and insert cardiac stents. The New York hospital’s cath lab has regularly scheduled such emergencies-by-appointment, according to three doctors and another medical professional, all of whom said they had direct knowledge of the practice.

Larry Husten, a medical columnist at Forbes, argues that this is an example of a widespread problem.

Man Beats Prostate Cancer Without Surgery

This story by investment blogger Mish Shedlock about a prostate cancer diagnosis illustrates the bias of doctors toward dangerous expensive treatments:

The biopsy showed I had cancer. My “Gleason Score” was 6. The surgeon who performed the biopsy strongly recommended surgery. He gave me a cost of $20,000.

Bad recommendation. Shedlock got rid of his cancer, as measured by PSA (Prostate Specific Antigen) tests, without surgery or any other expensive or dangerous treatment.

The surgeon said something else also highly misleading. He told Shedlock he was “10% cancerous”. When Shedlock repeated this to his oncologist,

The oncologist replied “That’s not correct. Of the 12 samples, only one had cancer and one was questionable. The cancerous sample was 10% cancerous.” Now that is a hell of a lot different than being 10% overall cancerous.

His oncologist seemed unfamiliar with data:

I informed the oncologist that I was going to have a PSA test every month. He commented something along the lines of “Why do you want to do that? Every six months is sufficient. The tests are not that reliable.”  . . . [I thought:] The more unreliable a test is, the more tests one should take to weed out erroneous outlier results.

This reminds me of the dermatologist I had in graduate school. After I tested the two medicines he had prescribed for my acne, and found that one of them didn’t work, and told him this, he said, “Why did you do that?” Haha.

The oncologist predicted that the cocktail that cured Shedlock “would not do [him] any good”.

I am sorry Shedlock does not name the doctors involved, as I did in a similar situation. I too avoided recommended surgery and my surgeon made highly misleading statements. Shedlock wrote about bad health care more generally here.

Thanks to Steve Hansen.

Missing Data in Clinical Trials: FDA Officials Refuse to Set Limits

People who believe in “evidence-based medicine” say that double-blind clinical trials are the best form of evidence. Generally this is said by people who know very little about double-blind clinical trials. One reason they are not always the best form of evidence is that data may be missing. Nowadays more data is missing than in the past:

By [missing data] he [Thomas Marciniak] means participants who withdrew their consent to continue participating in the trial or went “missing” from the dataset and were not followed up to see what happened to them. Marciniak says that this has been getting worse in his 13 years as an FDA drug reviewer and is something that he has repeatedly clashed with his bosses about.

“They [his bosses] appear to believe that they can ignore missing and bad data, not mention them in the labels, and interpret the results just as if there was no missing or bad data,” he says, adding: “I have repeatedly asked them how much missing or bad data would lead them to distrust the results and they have consistently refused to answer that question.”

In one FDA presentation, he charted an increase in missing data in trials set up to measure cardiovascular outcomes.

“I actually plotted out what the missing data rates were in the various trials from 2001 on,” he adds. “It’s virtually an exponential curve.”

Another sort of missing data involves what is measured. In one study of whether a certain drug (losartan) increased cancer, lung cancer wasn’t counted as cancer. In another case, involving Avandia, a diabetes drug, “serious heart problems . . . were not counted in the study’s tally of adverse events.”

Here is a presentation by Marciniak. At one point, he asks the audience, Why should you believe me rather than the drug company (GSK)? His answer: “Neither my job nor (for me) $100,000,000’s are riding on the results.” It’s horrible, but true: Our health care system is almost entirely run by people who make more money (or make the same amount of money for less work) if they exaggerate its value — if they ignore missing data and bad side effects, for example. Why the rest of us put up with this in the face of overwhelming evidence of exaggeration (for example, tonsillectomies) is an interesting question.

Thanks to Alex Chernavsky.

Speech Pathology Confidential

Bryan Castañeda told me the following:

I was talking to a good friend of mine who’s a speech pathologist. He works for a woman who runs a private practice in Connecticut. Says that a third of his patients require the amount of treatment his boss recommends, a third require treatment but less than she recommends, and a third require no treatment at all. But his boss is skilled at preying on parents’ insecurities (and their clientele has a lot of money), so she makes a killing. He agreed with your advice that people should be more skeptical of the claims of medical professionals and do their own research to evaluate to those claims.

The woman who runs the practice has a Master’s in speech pathology, same as Bryan’s friend. I asked about the treatments. Bryan’s friend replied:

It depends on the diagnosis. If it’s a speech disorder, we do articulation therapy. Articulation therapy usually consists of drills, correcting erred sounds by shaping the articulators appropriately and then having the client produce the sound in isolation, at the word, phrase, and sentence levels, and then in reading aloud and in conversation until they’ve reached 100% or close to 100% accuracy.

If it’s a language disorder, we do language therapy. Language therapy is a little more complicated. We target specific language areas based on the results of previous testing. It can vary a lot, but some of the more common things I do is read passages and have the client answer questions about it, teach grammar, work on formulating sentences appropriately, teach vocabulary, and word classification activities. A lot of worksheets and games too — materials that my boss writes off at tax time. We bill by the hour, so more hours certainly equals more pay for her,” he says. “We are all salaried, so the tighter she crams our schedules the more she gets to keep at the end of the day.

At least the unhelpful treatments are harmless, in contrast to a large fraction of mainstream medicine, where children have their tonsils removed, and so on.

Bitter Pill: Why Medical Costs Are Killing Us by Steven Brill

Steven Brill has a great article in Time called Bitter Pill: Why Medical Costs are Killing Us. I found it nauseating and terrifying — and I have health insurance. It is nauseating that helpless sick people are billed huge amounts of money that bear little relation to costs. It is terrifying that our government has failed to protect us from this.

Brill’s article is about the details of health care costs in America, especially hospital costs. Markups are huge. One example is a test strip for measuring blood sugar. The patient was charged $18 for each strip. On Amazon, the strips cost $0.50 each. The patient had no choice and was not told the wildly-inflated price. Brill gives many examples of similar markups. Hospitals, including nonprofit hospitals, are large prosperous businesses with very well paid CEO’s (e.g., $1 million/year). Yet Americans pay far more for health care than people in any other country and, judged by life expectancy, get worse results than people in about 40 countries. Brill’s article begins to explain the discrepancy.

Asked to explain their prices, many hospitals refused. One of them, MD Andersen in Houston, gave a statement that Brill quotes in part:

The issues related to health care finance are complex for patients, health care providers, payers and government entities alike . . . MD Anderson’s clinical billing and collection practices are similar to those of other major hospitals and academic medical centers.

Judging from the widespread refusals to explain and answers like this (“everyone does it”), the prices are indefensible.

The term stagnation — America is in the grip of profound stagnation — may be misleading because it makes it sound like things are staying the same. People point to a lack of increase in the median income over the last 30 years as indicating “stagnation”. Beneath stagnation is problems stacking up unsolved. (When they are solved, spread of the solutions produces an increase in income.) The problems aren’t staying the same: They’re getting worse. Health care costs are a good example. Health care costs have gone up faster than inflation for a long time, with plenty of signs that the American excess (the difference between what Americans pay and what everyone else pays) is completely wasted. (Or worse, given the many bad effects of drugs, surgery, and other high-tech medicine.) The American excess isn’t trivial, so median income, adjusted for it, has been going down for a long time, over the same period of time that median income in almost every other country has gone up. Quite a comment on the quality of our government.

As Brill says, the health care debate has been about who will pay? The question are prices too high? has been ignored.  Jon Stewart said, “This should be a Silent Spring moment.”

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.

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

  • All about kefir
  • Fraud and waste at a New York hospital. From the comments you can see that the problems have lasted decades.  If someone is always sick, year after year, it means there is something about their sickness (about health in general, actually) we do not understand. Likewise, the decades-long persistence of huge problems at this hospital suggests there is something fundamental about regulation (and perhaps health care) we do not understand.
  • This paper about how well blood uric acid level predicts mortality, which appeared in 2004, did not get nearly the attention it deserves. I was shocked by its existence — American medical school professors are almost incapable of good research. Well, it’s from Finland.
  • David Healy’s new blog.

Thanks to Bruce Charlton, Jazi Zilber, Melissa McEwen and Alex Chernavsky.

Assorted Links

Thanks to Tom George and Mark Griffith.

Assorted Links

How Accurate are the QuackWatchers? Mercury Amalgam Fillings

From Amalgam Myths and Facts (amalgam here means mercury-containing amalgams used by dentists):

Myth 10: Amalgam has been banned in Germany and Sweden and therefore should be banned in the United States.

Fact 10: Dental amalgam has not been banned in any country in the European Union.

From a 2009 press release:

The [Swedish] Government today decided to introduce a blanket ban on mercury. The ban means that the use of dental amalgam in fillings will cease.

In response to the Swedish ban, the American Dental Association put out a press release that said such a ban was “not necessary” in America because dentists do such a good job recycling the amalgam that doesn’t go into your mouth. Moreover, “a recent economic impact study published in the journal Public Health Reports indicates dental care costs in the U.S. would increase up to $8.2 billion in the first year alone if amalgam use was discontinued.” I don’t know what “up to” means. Perhaps it means that dental care costs would increase by a trivial amount “up to” $8.2 billion. Mercury-containing amalgam fillings are about half mercury.

Soon after I had two mercury fillings removed, I slowly became faster at arithmetic.

Assorted Links

Thanks to Hal Pashler and Anne Weiss.

Assorted Links

Thanks to Tim Beneke.

Assorted Links

Thanks to Robin Barooah and Mike Bowerman.

Chinese Medicine As Now Practiced

In America, I often hear praise for “Chinese Medicine”. By this they mean Traditional Chinese Medicine, which includes acupuncture and techniques that harness hormesis. I tend to agree. Medicine as now practiced in China is a different story.

Last night, I had dinner with some of my students. I asked them what their parents thought of their decision to major in psychology. One of them had a surprising answer. Her mom was happy that she was majoring in psychology because among the required courses was a human anatomy and physiology class. If her daughter took this class, her mom believed, it would be harder for doctors to cheat us.

Chinese doctors “cheating” patients is a big problem, in other words. They prescribe drugs that don’t work, said my student, and perform useless surgeries. Little different than Western medicine, except perhaps the drugs are less dangerous. Just as in Western medicine, drug reps try to bribe doctors to request their drugs. Unlike Western medicine, doctors steal the drugs of hospitalized patients, my student said, which they then sell. After a friend of mine was badly burned, she had (wisely) turned down the recommendation of a skin transplant. This angered her doctor, who would have made money from the operation. Later, when he changed her bandages, he did so roughly, which was very painful. Revenge.

“Don’t see the doctors at Tsinghua hospital [the campus hospital],” said my student. She had had a bad experience. She had gotten injured and gone to the hospital. She had had to wait half an hour to see a doctor; who had taken a mere 30 seconds to prescribe a cream that did almost nothing. That evening I watched The Poseidon Adventure. A doctor visits a sick woman in bed in her cabin. After a long wait, he gives her cursory treatment.

HUSBAND (to doctor) Hold it, hold it. You mean to tell me we had to wait all this time just for you to come in here and kiss her off with a couple of pills and some crap about staying in bed? How do you know she’s just seasick? Look at her! It could be something else! You didn’t even examine her.

Same complaint.

Harvard Psychiatrist Joseph Biederman and Parents: “Should Be Left in a Room Together”

Joseph Biederman is a professor of psychiatry at Harvard. He recently received a far-too-mild sanction for behavior that included this:

Biederman was then placed in charge of the institute and began a study of 40 children between 4 and 6 years old who were given Risperdal [made by Johnson & Johnson] and Lilly’s Zyprexa, another antipsychotic. At the time, Harvard and MGH [Massachusetts General Hospital] rules forbid researchers from running trials with [drugs] if they receive more than $10,000 from a company that makes the drug.

It was eventually revealed that Biederman had received at least $1.6 million from drug companies, including far more than $10,000 from Johnson & Johnson and far more than $10,000 from Lilly. One comment on the quoted article made the excellent point that bipolar disorder had a usual onset age of onset of 18 years or more and had never been found in young teenagers (e.g., 14-year-olds). Yet Biederman suddenly claimed it appeared in 6-year-olds. In a good expression of how I feel about Biederman’s behavior, another comment said he should “be left alone in a room with the parents of the children [he] treated”.

Welcome to the Sausage Factory: Multiple Fraud in a Paxil Study

Dr. Jay Amsterdam, a professor of psychiatry at the University of Pennsylvania, recently lodged a very interesting complaint against five authors of a 2001 study that compared Paxil to another drug and placebo for treatment of bipolar disorder. The paper reports research paid for by SmithGlaxoKline, the makers of Paxil.  For a subgroup of patients, it says, Paxil worked better than the other drug and better than placebo. Paxil supposedly had fewer side effects than the comparison drug. Amsterdam accuses the five academic authors of plagiarism — meaning they put their names on a paper they didn’t write (like a student who buys a paper). He also says the paper grossly misrepresents the results (because the subgroup analysis was completely ad hoc and the side effects description utterly wrong). So if they did write it . . .

The paper has been cited hundreds of times.  Given the actual results — Paxil had worse side effects than the other drug, and the subgroup result means little — this is no small matter.

As Spy magazine has said, if you cheat your customers, don’t fire anyone. Email included with Amsterdam’s complaint suggests he was upset because he was not an author on the paper. Why? Well, the study was done at many sites and there could be only one author per site — according perhaps to SmithGlaxoKline. At Penn, the work (enrolling subjects) was first given to a junior faculty member named Laszlo Gyulai. However, Gyulai couldn’t enroll enough subjects. Amsterdam was asked to help and paid for doing so. He ended up enrolling more subjects (12) than Gyulai (7). Yet Gyulai was an author and he was not! This greatly bothered him. He considered it  “misappropriation” of his data, said Gyulai had engaged in “the theft and publication of a professor’s data”, and wanted Gyulai censured. Perhaps Gyulai had considered Amsterdam’s non-authorship okay because many professors who contributed subjects were not authors. Whatever the reason, it appears that authorship was determined by the firm that did the ghostwriting, Scientific Therapeutics Information, presumably following orders from SmithGlaxoKline.

I don’t know why Amsterdam waited ten years to complain. Since 2001, however, the ghostwriting problem has become much clearer. In 2001, Amsterdam complained to his department chair, Dr. Dwight Evans, about the situation. In 2010, Amsterdam learned that Evans had benefited from ghostwriting. That’s how common it was.

There’s also this:

POGO [Project on Government Oversight], in a letter to President Obama [related to Amsterdam’s complaint], asked that he remove Amy Gutmann, president of the University of Pennsylvania, from her position as chairman of the Presidential Commission for the Study of Bioethical Issues, until the two cases involving Dr. Evans are fully investigated and resolved.

Chairman! Another indication how common and tolerated ghostwriting is. It is as if an obesity expert, appointed head of the most important obesity committee in the country, charged with recommending how to stop the obesity epidemic . . . is fat.

Perhaps British journalistic phone-hacking has been more common than misrepresentation of results by med school professors but the latter, I’m sure, has done more damage.

Attachments to the Amsterdam complaint. Pharmalot weighs in. Some of the accused defend themselves.

Worse Than Placebo? Forest Laboratories’s Shameful Marketing

While Forest [Laboratories] applied to the FDA for pediatric use of Celexa [the anti-depressant] and was eventually denied, the company admitted it had marketed the drug to doctors by hiring speakers to tout its benefits for young patients. Forest also admitted it had suppressed the negative results of research in Europe that found Celexa was no more effective in treating depressed children and adolescents than a sugar pill. Fourteen young patients in that study attempted suicide or contemplated suicide, compared with five in the placebo group, court records show.

From this article. Is Forest Laboratories worse than other big drug companies? Probably not. What’s horrible is how this sort of thing — suppression of negative results — keeps happening. It suggests that the evaluation of drugs should be taken entirely out of the hands of drug companies.

The Medtronic Scandal

In August 2010, John Farber, a reporter at the Milwaukee Journal Sentinel, wrote an article about how a medical device called Infuse, used for spinal surgeries, “went from revolutionary advance [2002] to public health alert [2008].” Bad side effects were common when Infuse was used, far more common than when it wasn’t used. Infuse is a hugely profitable product of Medtronic, the largest medical device company in the United States.

How did the high rate of bad side effects go unnoticed? Farber went on to find that there were unreported conflicts of interest in the journal articles about Infuse. The authors of the articles had received (before and after publication of the articles) large payments from Medtronic, on the order of $5 million per person. The articles themselves greatly underreported side effects. Moreover,

Evidence has accumulated suggesting that the superior clinical results reported by doctors with financial ties to Medtronic have not been replicated when the device was used by doctors who receive no payments from Medtronic.

A whole issue of The Spine Journal has been devoted to the problem and a Senate committee is investigating.

Thanks to Zachary Hamaker.