Dr. House Was Right

I’m a big fan of the show House, which ran on the Fox TV network for 8 years and is now on Netflix. Gregory House, masterfully played by actor Hugh Laurie, is an brilliant doctor who diagnoses patients whose bewildering symptoms have stymied other doctors. He’s also unbelievably rude: he insults and harrasses his patients and his fellow doctors alike, but they tolerate him - usually - because he’s almost always right.

I doubt that any real doctor is as rude as House. But like any group of professionals, doctors vary widely in their people skills. Recently, though, Medicare has started using patient satisfaction as a component of how it pays hospitals. In response, some doctors now try harder to give patients what they want, rather than what they need, as described last year by Kai Falkenberg at Forbes.  On Medscape recently, William Sonnenberg wrote that “patient satisfaction is overrated” and said of Press Ganey, a company that runs patient satisfaction surveys:

“Press Ganey has become a bigger threat to the practice of good medicine than trial lawyers.”

You can find Medicare's hospital survey online. Dr. House would fail, big time.

What’s wrong with giving patients what they want? It turns out that patient satisfaction is tied to higher costs and, even worse, a higher death rate. A large survey covering 52,000 patients, published by a team led by Joshua Fenton at the University of California-Davis  found that the most satisfied patients not only spent about 9% more than average, but had a 26% higher death rate. From the study: “The most satisfied patients had statistically significantly greater mortality risk compared with the least satisfied patients.”

For patients who think a nice doctor is a good doctor, this might come as very disappointing news. Was the effect due to patients already in poor health, who might be more inclined to like their doctors? No: when the researchers excluded the sickest patients and looked only at the healthier ones, the risk of dying was even higher. (It’s important to note here that this is relative risk; only 3.8% of patients died during the six-year followup to the study.)

Over at The Daily Beast last week, Daniela Drake summarized this trend as “You can’t Yelp your doctor.” (Not that Yelp isn’t useful for finding a good pizza place.) And yet, as Scott Hensley reported on the NPR blog Shots, online ratings of doctors are becoming very popular, even though they don’t measure how good a doctor is at diagnosing and treating illness.

This study has implications for so-called “alternative medicine” as well. Patients who frequent alternative providers such as acupuncturists, homeopaths, and naturopaths often report high levels of satisfaction, as if satisfaction correlated with better care. Now we have a large study showing that this is simply not the case.

It makes sense that patient satisfaction is related to cost: patients often demand treatments that they don’t need, and “Patient requests have also been shown to have a powerful influence on physician prescribing behavior”, as Fenton and colleagues reported. It is less clear why the most satisfied patients died at higher rates.

Obviously, doctors don’t need to act like Dr. House to be effective. But doctors need to be able to tell patients things they don’t want to hear. Just because you want an antibiotic for your sore throat or your child’s ear ache doesn’t mean you should get one.  The UC Davis study demonstrates that using patient satisfaction surveys to adjust reimbursement rates, as Medicare is currently doing, is a recipe for higher costs and lower quality of care.

Given a choice between a friendly doctor who gives me what I want and a brilliant doctor who gives me what I need, I’ll take Dr. House.

Cashing in on fears of autism

Autism has been the subject of much controversy in recent years.  Rates of diagnosis are rising, and many parents-to-be are understandably worried.  Despite the efforts of many good scientists, we still don't have an explanation for most cases, although we do know that vaccines have nothing to do with it. Many unscientific claims are out there, some of them designed to take advantage of vulnerable parents who are desperate for answers. In this climate, any new claim to have found "the" cause of autism ought to be stated very, very carefully, and backed up by solid evidence.

Just recently, scientists at the UC Davis Mind Institute published a study that described 6 antibodies found in the blood of some mothers of autistic children, and much less often found in mothers of normally developing children.  They suggested that these antibodies somehow got into the brains of developing fetuses, causing autism in the children.  They even gave a name to this form of autism: maternal autoantibody-related, or MAR autism.

If true, this study suggests that a test for these antibodies might predict whether or not a child will have autism.

The study seems plausible, and it was published in a respectable journal called Translational Psychiatry.  Unfortunately, though, the study and the way it has been promoted are plagued with problems.

Perhaps the biggest red flag is that the two lead authors, Daniel Braunschweig and Judy Van de Water already have a patent on the proteins described in their paper, and Van de Water is involved with a company, Pediatric Biosciences (PBI), that is already marketing a test to predict autism based on this study.  Van de Water is the Chief Scientific Advisor for the company, which has licensed her patent for this specific test.  The company website claims

"To date, the test has demonstrated 100% accuracy - meaning if a mother or prospective mother has developed the antibodies, then her child will later be diagnosed with AU [autism] or ASD [autism spectrum disorder]."

Wow. This sounds incredibly accurate. This test is apparently the sole product of PBI, and they trumpeted the new study with a press release claiming that

"PBI is developing a diagnostic test based on these findings that will provide physicians with a reliable set of biomarkers for pre-conception … diagnosis of this Maternal Autoantibody-Related (MAR) form of autism."  

PBI is marketing the test to all "women over 30 who are at least 2 times more likely to give birth to an autistic child" as well as other women.

So, with all this hype, and despite the major conflicts of interest of the lead authors, did the study show what they are claiming?  Is this a test that mothers should take?

In a word, no.

First, the study doesn't even answer the right question.  The study looked at antibodies found in the blood of mothers some years after their pregnancy, not during or before pregnancy. Therefore it doesn't tell us whether a test of a pregnant mother will predict anything at all.  Post hoc analyses like this are notoriously inaccurate: for example, it's easy to find factors that predict every presidential election for the past 50 years, but many of them will perform poorly at predicting future elections.  Similarly, finding 6 proteins that distinguish some mothers of autistic children from mothers of normal children, all measured after the fact, tells us nothing about whether we can predict autism in advance.

Second, their striking claim of 100% accuracy is false.  (Their press release only claimed 99%: "A positive result would mean that they have a 99 percent likelihood of having a child with autism if they proceed with a pregnancy.")  But the study provides no such evidence.  What it did show was that 56 mothers (out of 246) had antigens to one of 12 combinations of 3 antigens that they selected.  [Aside: there are many other combinations of antigens that they did not report, and no indication that they properly adjusted their statistics to account for this.] But the study failed to say whether these 56 mothers also had non-autistic children.  If they did, then even the mothers in their own study had a much lower chance than 99% of having an autistic child.  Given that many families with autistic children also have other, non-autistic children, touting an accuracy number like this, without proof, is outrageous.

The study isn't completely worthless: it points to a possible link between antibodies in the blood of the mother and autism in a child.  If Van de Water were truly interested in the welfare of autistic families, she would be focusing on the obvious next step: test a large, randomly sampled collection of pregnant women for the same antibodies.  Then follow them up, over the next few years, to see if the test can predict the likelihood of having an autistic child.  Meanwhile, no one should be selling a test before studies can show that it has some predictive value.

But Van de Water and her friends at Pediatric Biosciences seem far more interested in making money off the fears of prospective parents.  PBI is planning to charge about $800 for their test, which they'll begin selling next year. Stanford University biostatistician Steven Goodman says that they are "peddling false hope that giving birth to autistic kids can be avoided."

A news article in Science last week raised many serious questions about Van de Water's study and its claims.  Several scientists quoted in that article questioned the premise of the study: that antibodies from the mother somehow get into the brain of the developing fetus. Yale scientist George Anderson said the data are too preliminary and the statistics too weak to support a clinical test (essentially the same argument I'm making here).

And what about that 99% claim?  In their interview with Science, Van de Water and Jan D'Alvise (president of PBI) said it

"was not meant to convey likelihood in the statistical sense, but rather the 99% accuracy with which the study demonstrated specificity of the biomarkers for ASD."  

This is unadulterated poppycock. As of this writing, the company website still claims that the test has "100% accuracy--meaning if a mother or prospective mother has developed the antibodies, then her child will later be diagnosed with AU or ASD [autism]."  That claim couldn't be any more clear - or any more wrong.

With all the controversy over the causes of autism, and with the medical community still struggling to correct the tremendous damage caused by Andrew Wakefield's fraudulent study linking vaccines to autism, the last thing we need is an erroneous claim that someone has found the cause of autism.  And it's far too soon to start offering moms a test that tells them they're going to have an autistic child.

UC Davis muzzles professor for speaking out about excessive PSA testing

When UC Davis announced a seminar on men's health back in October 2010, it sounded like a typical educational event.  But UC David professor Michael Wilkes investigated and learned that the seminar was primarily a sales pitch about the prostate specific antigen (PSA) test, and that its main message was that men should get tested regularly beginning at age 40.  However, the weight of scientific evidence suggests that regular PSA testing is not a good idea, and it may do more harm than good, as I wrote recently.  In a major report issued earlier this year, the U.S. Preventive Services Task Force recommended that men should not get routine PSA screening for prostate cancer, stating explicitly that

"the benefits of PSA-based screening for prostate cancer do not outweigh the harms." 

Prof. Wilkes, an expert on prostate cancer screening, came to the same conclusion almost two years ago.  In response to the UC Davis seminar, he and USC professor Jerome Hoffman wrote an opinion article for the San Francisco Chronicle.  They made basically the same argument that the USPSTF made in their lengthy, thoroughly researched report: that the PSA test often does more harm than good.

The story would end there, if not for what UC Davis then did to Prof. Wilkes.  Within a few hours of the publication of the newspaper article, the Executive Associate Dean at the UC Davis medical school informed Wilkes that he would be punished in two ways.  First, he would lose his position in the doctoring program, and second, he would lose the funding support for a Hungarian student exchange program that he organized.  Dr. Wilkes, it is worth noting, was recruited to UC Davis from UCLA because of the innovative program in doctoring (how to be a doctor) that he developed.

Apparently the Executive Associate Dean (where do they get these titles?) was angry over what Dr. Wilkes wrote in the newspaper.  He later admitted that he read Dr. Wilkes' article just before he wrote his threatening email.  All of this is documented in a report issued this past May by the UC Davis faculty Committee on Academic Freedom and Responsibility (CAFR).  Many additional details were reported on UC Davis Professor Jonathan Eisen's blog in June.

When challenged about these threats, the university lawyer David Levine said, in essence, what threats?  My goodness, he said in a letter to Wilkes, I'm just giving you a few helpful facts:

"I am simply pointing out that there are numerous errors of fact in your article, that they were injurious to the University interests and reputation and thus potentially actionable under the law of defamation."

But heavens no, we're not threatening to sue you or anything like that.  Just pointing out some things that we're sure you will want to know.  The university's lawyer's explained further, in a letter to CAFR this past February, that

"The administrative action … was simply to provide information to Dr. Wilkes regarding … the potential legal exposure for broadcasting false information that is injurious to reputation."

I'm sure that Dr. Wilkes found all of this information very helpful.

This summer, the UC Davis faculty senate voted 52-0 that the university had violated Prof. Wilkes' academic freedom, and called for the university to apologize and withdraw its threats, which UC Davis has not yet done.  An academic freedom watchdog group, FIRE, wrote to UC Davis chancellor Linda Katehi with the same requests.  Chancellor Katehi replied in a letter, dated July 17, that she and Provost Ralph Hexter have "assembled a small team of independent subject-matter experts" to review the case, and that they will have more to say by August 31.

What the heck do you need a committee of experts for?  Even if Prof. Wilkes' article was wrong (and it's not - he is spot-on accurate), he has every right to express his opinions.  So it doesn't really matter if PSA testing is good for you or not.  Yet after almost two years, UC Davis still has not withdrawn the threats made by its lawyers and by its Executive Associate Dean against Prof. Wilkes, and by extension against any other professor who might disagree with something the university is doing.

At this point, merely withdrawing the threats is not enough.  Chancellor Katehi should clearly and unambiguously affirm Prof. Wilkes' right to speak his mind, and she should also punish the Executive Associate Dean, the university counsel, and any other administrators who have been involved in this outrageous assault on free speech and academic freedom.  Otherwise they or others might very well just do it again, the next time they read an Op-Ed piece that annoys them.