The Doctor You Never Heard Of Who Saved 800,000 Lives

Most New Englanders can recite half the names on the roster of the Super Bowl-bound Patriots. But most  New Englanders, myself included, would be hard-pressed to identify Dr. Mary Ellen Avery. And that is a travesty.

Dr. Avery’s life, and passing, came to my attention several weeks ago in her obituary in The New York Times. Dr. Avery was the first female head of pediatrics at Children’s Hospital in Boston, a distinction that is remarkable enough in itself. But Dr. Avery’s true legacy is as savior of over 800,000 newborns’ lives.

Up until the late 1960s, tens of thousands of babies died each year of respiratory distress syndrome. The newborns would be unable to breath and would foam at their mouths before dying. Autopsies would reveal a glassiness to the babies’ lungs.

Dr. Avery’s research of respiratory distress syndrome led to the discovery that it was caused by an absence of a surfactant which coats the lungs of healthy infants and adults. Dr. Avery then helped to develop a synthetic lung surfactant that could be used to coat the lungs of newborns until their bodies learned to manufacture surfactant of their own.

We should celebrate the accomplishments of researchers like Dr. Avery as much as we celebrate the pigskin feats of people like Rob (“Yo soy fiesta”) Gronkowski.

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If You Believe In Patient Safety, You Need Not Apply For Government Work

Last week, Dr. Donald Berwick resigned as the acting head of the Center for Medicare and Medicaid Services (CMS) after it became obvious that his formal appointment to the position would never be put to a vote in the Senate and, if it were, Senate Republicans would vote him down.

As blogger Harold Pollack points out, Berwick is just one of a string of eminently qualified people whom Republicans in office have prevented from being appointed. Some of the other notable figures whose appointments have been blocked by Senate Republicans include Elizabeth Warren and Peter Diamond.

As blogger/physician Bill Gardner notes in a post entitled “Don Berwick And The Lives Not Saved,” the blocking of Dr. Berwick’s nomination is far more consequential than the kaiboshing of Warren and Diamond’s nominations inasmuch as lives will likely be lost due to the failure to confirm Berwick.

What was Berwick’s crime? Among other things, he has been an outspoken advocate of patient safety. He was a coauthor of the landmark Institute of Medicine report “To Err Is Human,” which estimated that preventable medical errors kill 98,000 Americans each year.

Berwick’s radical program, had he been appointed head of CMS would have included a renewed focus on preventing central line infections, preventing surgical site infections and preventing ventilator-associated pneumonia.

But apparently Berwick’s background and qualifications did not square with the Republican narrative that trial lawyers, rather than doctors, are the problem with medical malpractice and that the “free market” is best method for delivering health care services.

People like Dr. Berwick make tremendous personal sacrifices to involve themselves in the political process, often relocating their family to Washington, D.C., surrendering privacy and the financial and other rewards of work in the private sector. They should be appointed or rejected on the basis of their qualifications, not reduced to being political footballs.

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Intellectually Lazy Or Logically Sound? A Reply To Dr. Donnell On Financial Incentives Affecting Guidelines And Clinical Trials

Dr. Robert Donnell, blogging at KevinMD.com, authored a post over at Kevin.MD the other day entitled, “Judging A Guideline Just By Financial Interest Is Intellectually Lazy.”

The post was in response to recent investigative journalism criticisms centering around the fact that that medical societies responsible for authoring treatment guidelines often have a financial stake in their recommendations. For an introduction to some of the investigative journalism on this topic, you can check out ProPublica’s work here on the financial ties between the National Lipid Association and the pharmaceutical industry.

Dr. Donnell thinks the journalists and others who have attacked guidelines based on the financial interests of research authors, etc., are “intellectually lazy.” Dr. Donnell thinks the criticisms of guidelines that point to the financial interests of medical societies and individual researchers also represent a logical fallacy. Donnell writes that these attacks are, “an ad hominem attack (and therefore fallacious) because virtually all of the criticisms of guidelines that have been written are based not on the science or the [journal articles] referenced in the guidelines but on the company they keep.”

Dr. Donnell may be right that a lot of the investigative journalism pieces may not engage with the science; they may simply point to sinister-seeming associations between drug and medical device companies and the illustrious doctors who promulgate the guidelines.

So what does the science say? Is there any scientific, empirical basis for finding a research study or clinical trial to be less trustworthy based on the fact that it was financed by a drug company? The answer is: YES.

For a great starting point, check out an article published by the prestigious British Medical Journal entitled, “Pharmaceutical Industry Sponsorship And Research Outcome And Quality:  A Systematic Overview,” which you can check out here. The authors of the BMJ article found that studies funded by a pharmaceutical company were four hundred percent more likely to give results that were favorable to the drug company than independent studies.

Oftentimes it’s difficult to discern how drug industry funding is influencing the methodology or results of scientific studies. You can read the “primary sources,” as Dr. Donnell, argues and engage with the science on its own merits and still not uncover anything askew, anything scientifically unsound. But nevertheless, there’s no getting around a brute empirical fact:  Scientific research funded by Big Pharma, for whatever reason, produces results that are biased in favor of the drug companies.That’s not ad hominem attack, that’s not casting aspersions on anyone’s integrity — that’s a scientific fact.

Examples of the empirical tendency for drug company-funded research to favor the drug companies’ own product abound. One fascinating meta-analysis compared the results of fifty-six different drug company-funded studies of painkillers. In each of the fifty-six studies, the painkiller marketed by the Big Pharma sponsor funding the study came in first place. How can all of fifty-six different drugs be better than each other? Answer: They can’t. The study authors’ financial ties presumably influenced their work. (You can engage with the science of that study by clicking here).

(For a wonderfully fun tour of drug company research shenanigans, check out Dr. Ben Goldacre’s wonderful book, “Bad Science:  Quack’s, Hacks and Big Pharma Flacks”).

Rather than being illogical or ignorant, assuming that someone’s financial incentives influence his actions is a basic principle of social science. Rule Number 4 of Harvard Professor Gregory Mankiw’s “Ten Principles of Economics” is “People respond to incentives.” Automatically discounting (to a certain degree) the findings of research studies, where the study has a financial motive is a sensible and reliable heuristic device for people who don’t have the time or the abilities to dive into the research firsthand.

Should you engage with the research studies firsthand if you are able to do so? By all means. But as some of the studies cited above illustrate, there are scientific reasons for viewing their results skeptically.

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Medicare Has The Right Idea

As we’re fond of reminding you here, the costs of medical malpractice don’t amount to a hill of beans when it comes to our health care spending. The legal fees and payouts from medical malpractice amount to 0.5% of our health care spending.

It would be a great thing for the tens of thousands of Americans killed each year by medical malpractice if we succeeded in reducing the incidence of medical malpractice (which we can) but it would not help us bend the curve of health care spending.

To get control of health care spending, we need to get a handle on what most experts consider the biggest driver of health care costs: fee-for-service medicine. Under our fee-for-service model, doctors and hospitals get paid according to how many procedures, tests and other services they perform and not according to how healthy they keep their patients. This gives doctors and hospitals an incentive to run up the bill by ordering unnecessary therapies, instead of focusing on the long-term health of the patient.

So it is a good thing that, starting next year, Medicare will cut reimbursement rates to hospitals with high levels of patient readmission. Part of the impetus for this move is a recent study from Dartmouth school of medicine, showing that the rate of Medicare patients being readmitted to a hospital within thirty days has increased over the past decade.

Let’s hope this precipitates a broader move to a focus on patients’ long-term health.

Private insurance companies also bear part of the blame here. They will pay top dollar for a cutting-edge surgery but are misers when it comes for paying for recuperative stays after a surgery. But if paying for that extra day of recovery time reduces the risk of complications and, thereby, the rate of readmission, it’s worth paying for.

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Should Your Doctor Be Taking “Smart Drugs” And Other Medical Malpractice Hypotheticals

smart drugs.jpgIn this week’s news were a couple of stories that I thought made neat medical malpractice hypotheticals.
The first comes from a new research study showing that doctors who take so-called “smart drugs” (drugs that improve focus and concentration like ADHD drugs and anti-narcoleptic drug Modafinil) perform better than doctors who don’t. The study prompted Instapundit’s Glenn Reynolds to ask, “If ‘smart drugs’ improve doctors’ performance, is it malpractice not to take them?” The answer is “Certainly not,” for reasons explained in this earlier blog post of mine. But perhaps medical malpractice law should move in the direction of sanctioning sleep-deprived doctors, as I argued in this post.
The week’s other interesting (to me at least) med mal hypothetical comes to us courtesy of Spencer v. Roche, a case decided this week by the First Circuit Court of Appeals. Spencer was a case in which the plaintiff sued for alleged violations of his right to be free from unreasonable search and seizure under both the US Constitution and Massachusetts Declaration of Rights. In 2005, the Plaintiff, Spencer, was stopped by police for driving without a license. Upon learning from a confidential informant (CI) that Spencer had supposedly placed a bag of cocaine into his rectum a short time before, police arrested Spencer and obtained a search warrant to search his anal cavity.
Police then transported Spencer to Saint Vincent’s hospital, where a doctor took a KUB x-ray of Spencer’s anal cavity and stomach area against Spencer’s will and apparently while Spencer was handcuffed. Lo and behold, the ultra-reliable criminal snitch was wrong and no drugs were found on Spencer. He was released and sued under 42 USC 1983 and the Massachusetts Civil Rights Act for violations of his Fourth Amendment and Article XIV rights to be free from unreasonable search and seizure. This week, the First Circuit Court of Appeals ruled against Spencer, holding that the search was reasonable under the federal and Massachusetts constitutions.
The Spencer case raises the question of whether any medical malpractice claims would have succeeded. One element of a medical malpractice case is the existence of a doctor-patient relationship and, while that element would be problematic here, let’s assume for the moment we pass that threshold. At that point, issues of informed consent would come into play.
A couple of years ago, American Medical News reported on a medical malpractice lawsuit against a Texas surgeon who performed surgery on a patient, evidently against his will, in order to recover a bullet that implicated the patient in the commission of a crime. As the article noted, “According to American Medical Association policy, physicians should honor informed consent policy, both in ethics and law, “unless the patient is unconscious or otherwise incapable of consenting and harm from failure to treat is imminent.” The article suggested that the doctor might rely on Rule E-2.065 of the American Medical Association’s ethical guidelines, which pertains to “Court-Initiated Medical Treatments In Criminal Cases.” But it seems plain, from reading the rule, that it is meant to apply in cases where, for example, the court orders forceful medication of a mentally ill criminal.
British medical ethics are much clearer. It seems clear under the British Medical Association’s guidelines for “Intimate Body Searches,” which state that, “no medical practitioner should take part in an intimate body search of a subject without that subject’s consent.”
Overall, a week’s worth of interesting tort news.

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The Worst Medical Malpractice Is The Surgery You Did Not Need In The First Place

spinal surgery medical malpractice.jpgLast week, The Wall Street Journal ran a chilling story on the prevalence of doctor-owned medical device companies and the conflicts of interest that arise when doctors are implanting medical devices whose sales they profit from.
The heart of the story involved a 48-year old Baptist preacher named Gary Steven Moore. Moore died on the operating room table in the midst of a 360-degree spinal fusion surgery. Medically speaking, Moore was a poor candidate for spinal fusion surgery because he had had 11 previous bowel surgeries and suffered from diabetes and heart disease.
But Moore’s surgeon, Dr. Adam Lewis, recommended the surgery to Moore, never disclosing that he was part owner of a company named Spinal USA, whose hardware would be implanted during the surgery. On this single surgery, Spinal USA would earn tens of thousands of dollars for its hardware.
Unfortunately, the specter of doctors profiting from the medical hardware they use during surgery is not an uncommon one. Doctors are able to get around anti-kickback laws by starting small medical device companies of their own. And the FDA’s 510(k) loophole, which allows medical device makers to market products without FDA approval if they resemble devices already on the market, means that it is cheap for doctors to do so.
As The Wall Street Journal story noted:

Critics of such arrangements say they give surgeons an incentive to do more operations, and that the conflict of interest has led to a spate of unnecessary back surgeries that waste health-care dollars and often do patients more harm than good. “Patients are having huge operations that are un-indicated because of this,” says Scott Lederhaus, a neurosurgeon in Pomona, Calif., and member of the Association for Medical Ethics, an organization of doctors that focuses on conflicts of interest.

According to a recent report by the Department of Health and Human Services’ Inspector General, at least twenty states are home to surgeon-owned medical device companies. And these companies are branching out, from spine surgery to hip, knee and cardiac surgery.
It’s bad enough to be a victim of medical malpractice. But when the surgery was unnecessary in the first place — that’s the worst kind of medical malpractice.

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The Problem With Doctors Complaining About Medical Malpractice Law

law books medical malpractice.jpgToday I was reading a great blog post over at KevinMD.com. Much of it had me nodding in agreement with the physician-blogger who wrote it.
The blog post’s title was “Lawsuits Are More Of An Emotional Issue Than A Financial Issue” and the author made many sound points. As the author pointed out, it makes little sense to cap damages on doctors as part of an effort to lower medical malpractice insurance premiums when Medicare and Medicaid already price the cost of malpractice insurance into what they reimburse a doctor in a given state. Tort reform therefore constitutes a windfall for most doctors.
But then the blog post began to lose me. The author posed a hypothetical wherein an otherwise healthy thirty-six year old woman goes to the doctor’s office complaining of chest pains that have lasted two days. The doctor does not run every expensive diagnostic test in the book but concludes that the patient’s chest pains are unrelated to a blockage and is subsequently sued for malpractice when the patient is discharged and dies of a heart attack.
The hypothetical reminded me of one of the main problems with doctor-led discussion of medical malpractice law: they don’t understand medical malpractice law anymore than I do the ins-and-outs of their subspecialty.
In order to prove medical malpractice, a patient has to prove a whole heckuva lot more than, “There was some expensive test that could’ve been run that would’ve prevented my injury.”
The plaintiff has to show that the standard of care in the medical profession would have dictated that the doctor run the tests. In effect, the doctor is judged by what the average doctor would do, rather than by some superhuman standard.
There’s a world of difference between the two.
If more doctors understood the standard that applies to medical malpractice, there would probably be a lot fewer cries for tort reform.

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Could Your Doctor Use A Coach?

medical malpractice coach.jpgDr, Atul Gawande, one of the heroes of this blog, has a great new article in The New Yorker on the importance of coaches in improving performance.
As Dr. Gawande notes in his article, for the first several years after becoming a surgeon, the rate of complication in operations he performed declined — until he was beating national averages. But then his performance plateaued. His rate of complications continued to be exemplary but it was not falling anymore.
Then Dr. Gawande took a single lesson with a tennis coach that really improved his game. Soon afterward, Dr. Gawande was watching a tennis tournament and the camera panned to Rafael Nadel’s coach. A thought occurred to Dr. Gawande that has occurred to few others in medicine: If Rafael Nadel, who’s the best in the world at what he does, can benefit from coaching why can’t doctors and surgeons?
We tend to think doctors and surgeons don’t need coaching because they’ve already acquired all the knowledge and mastered all the techniques that are necessary to do their job. Very often, wrapped up in our whole notion of professionalism is the idea that a professional is someone who is done with education, someone who does not need to be taught anything further. But in certain fields, the most elite practitioners continue to receiving coaching and tutelage.
The dichotomy exists in music. Most instrumentalists don’t have coaches; they graduate from music school and are thought to have received all the coaching that they need. (Yitzhak Perlman is a rare and notable exception; he attributes much of his success to the coaching of his wife, a concert-level violinist herself). But vocalists differ: all of the world’s best vocalists have voice coaches. Rather than reflecting some underlying difference in the complexity of playing an instrument and singing, the differing attitudes toward coaching appears to be a historical contingency, a quirk.
Gawande convinced one of his former professors, Dr. Robert Osteen, to come out of retirement and coach him in the operating room. The first operation that Dr. Osteen coached – a thyroidectomy – was not one that Osteen had performed a lot in his career. But after the operation was over, Dr. Osteen had some great coaching tips for Dr. Gawande. Dr. Osteen noticed that the way Dr. Gawande had draped the patient, while perfect from the standpoint of maintaining a sterile environment, interfered with the movement of the surgical assistant and the resident. Dr. Osteen gave Gawande a list of other equally astute coaching tips.
Since taking on a coach, Dr. Gawande’s complication rate has gone down. The sample size is, at present, too small to declare the coaching to have been a statistically significant contributor to the decreased rate of complications, but Dr. Gawande believes that the coaching will prove to be important.
Dr. Gawande closes the article with an anecdote of one patient in the operating room who, prior to being put under anesthesia, asks who Dr. Osteen is. When Dr. Gawande explains to the patient that Osteen is in effect a coach, the patient gives him an uneasy look.
If your doctor ever tells you that she has a coach, perhaps you should count yourself lucky instead of sharing that patient’s unease.

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Another Hospital Death Due To “Alarm Fatigue”

alarm clock.jpgLast summer, a 60-year old man died at UMass Memorial Hospital. Apparently, for an hour before the man’s death, alarm bells were ringing indicating that the patient had a fast heart rate and potential breathing problems. But the alarms went unanswered.
The incident was only reported to state officials this spring and, according to The Boston Globe, the man’s death is being investigated as another case of “alarm fatigue.”
“Alarm fatigue” is a catchall term for a growing phenomenon in hospitals. It can describe situations where doctors and nurses shut off an incessantly ringing monitor to avoid its unpleasant sound, as well as situations where an alarm goes off audibly but it is either consciously or unconsciously ignored by health care providers who have become desensitized to its tone.

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Massachusetts Think Tank Issues Hackneyed White Paper On Tort Reform

think-tank.jpgLast week, The Pioneer Institute, a Massachusetts think tank, issued a white paper dubiously entitled, “Innovative Medical Liability Reform: Traditional and Non-Traditional Methods,” in an effort to persuade Beacon Hill to adopt tort reform measures that include caps on non-economic damages and protections for medical malpractice insurers that would enable the insurers to pay out medical malpractice settlements and verdicts over time, rather than in lumpsums. The paper is notable not for its contributions to the debate over health care reform, but for the way it parrots the canards of the tort reform movement and shifts focus from the core of health care spending.
Interestingly, nowhere in the white paper is there any mention of the fact that several thousand Massachusetts residents are killed annually by preventable medical errors. It doesn’t really help your crusade to protect doctors and insurance companies when you point out that doctors kill more than 100,000 Americans annually through medical malpractice. Nor does the paper discuss the fact that many deaths due to medical malpractice are preventable. For example, the use of a 19-step surgical checklist has been shown by to reduce medical malpractice by forty-seven percent but only one-fifth of hospitals require the use of such a checklist.
The stated goal of the Pioneer Institute’s Health Care Initiative is “cost containment” and reduction in health care costs. But, as any regular reader of this blog knows, trying to reduce health care costs by changing medical malpractice law is a doomed project since the insurance payouts and legal costs associated with medical malpractice lawsuits amount to one-half of one percent (0.5%) of our total health care spending. When you throw in a generous estimate of the costs of so-called “defensive medicine,” the total cost expended on medical malpractice amounts to $45.6 billion. $45.6 billion sounds like a big number, but when you consider that we spend 16 percent of our $14 trillion GDP on health care costs, you realize that it’s a relative drop in the bucket. And a lot of that spending on medical malpractice is necessary — to compensate the patients who have been maimed by medical malpractice and the families of those who have been killed by it.
The white paper claims, “There is widespread agreement that the majority of tort systems across the country are driving up the cost of health care….by increasing the cost of medical malpractice premiums.” But the cost of medical malpractice premiums are included in the $45.6 billion price tag recently published in the journal Health Affairs. And numerous studies have shown that medical malpractice premiums have not fallen in states that have enacted medical malpractice tort “reform.” This is paradoxical, but the price of medical malpractice premiums, like most insurance premiums, is driven primarily by the investment performance of insurance companies, not payouts on losses. Furthermore, the medical malpractice industry is hardly some shining example of perfect competition, as many states only have several firms issuing policies.
If you were serious about bringing down the cost of health care, you would focus on something other than medical malpractice, such as the fee-for-service model of our health care system that gives hospitals a financial incentive to conduct wasteful tests and procedures.
Medical malpractice “reforms,” like caps on damages, will compound the injury suffered by the victims of medical malpractice. And doctors will not see savings in malpractice insurance costs. The only ones who will benefit will be the insurance companies.
Medical malpractice “reform” is a perennial topic on Beacon Hill. Let’s hope that our legislators don’t buy the snake oil this session.

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