DC Medical Malpractice & Patient Safety Blog

Nearly every week, I hear about a patient who had surgery to relieve terrible chronic back pain and ended up far worse off than before. One of the biggest problems is that money motivates surgeons to talk patients into much bigger and more complex operations than they really need -- and then those surgeries result in predictable complications.

The greed allegation sounds a bit harsh, but it comes straight from the top: The Journal of the American Medical Association, in an editorial by a leading Stanford orthopedic surgeon, Eugene Carragee, and in a study carried out by a group of doctors at Oregon Health and Science University led by Dr. Richard Deyo.

The Oregon study found that the rate of complex surgeries for back pain in Medicare patients jumped by 15-fold over a recent five-year period, but there was nothing in the patient population -- like increasingly complicated back deformities -- to justify the increase.

Joanne Silberner of NPR reported:

Deyo says there's no reason to think people suddenly started developing the spinal deformities that justify the complex surgeries. He offers several possibilities for the upswing. "Many surgeons genuinely believe that the more invasive procedures offer some benefits," he says. "But certainly there are important financial incentives at play as well." Surgical fees for simple decompressions are about $600 to $1,000. The complex surgeries earn surgeons as much as 10 times more. He says another possible factor is the tendency for both doctors and patients to go for a new, more expensive approach just because it sounds better.

The problem is that the more complex surgeries carry at least double the risk of a bad outcome, according to the Deyo study.

Most back pain that isn't relieved effectively with medicines or other non-surgical therapies is caused by disk herniation or spinal stenosis. Spinal stenosis is growth of bone near a nerve coming out of the spinal cord which presses on the nerve root and causes pain to radiate down a leg. The vast majority of patients who need back surgery because of spinal stenosis can be benefited from a fairly simple lumbar decompression. This involves removing bone, ligament and facet joint material which is compressing the nerve root. This operation has a high degree of success as it's been developed over the last 20 years.

According to Dr. Carragee's editorial, if the patient also has some deformity of the spine -- front to back or side to side -- the simple lumbar decompression can result in spine instability with increased deformity, so those patients might need a fusion where adjacent vertebrae are fixed together with bone grafts. But even here, simpler techniques get just as good results than more complex procedures that add metal or other instrumentation into the back.

A very small minority of patients, says Dr. Carragee, have spines that are so collapsed and twisted that the spine is unbalanced and tilted forward and the patient has severe pain and poor quality of life. These are the patients who might qualify for the complex surgeries now being done so commonly. Techniques have improved in the last ten years, but the surgeries in these patients still carry a very high complication rate -- 30 to 40 percent. And a lot more patients are getting the complex, multi-level surgeries than is warranted by the medical evidence, according to Dr. Carragee and other researchers.

Consumer Reports has rated spinal surgery as No. 1 on a list of overused tests and treatments.

As quoted by NPR, Dr. Deyo said he would like his study to alter the practice of medicine. "The effect I would hope it would have is to have surgeons and patients choose the least invasive procedure that would accomplish the surgical aim," he says. But he's pessimistic about it, unless there's a change in the financial incentives.

This is yet another area of medicine where it pays for patients to be skeptical and to get multiple opinions. It fits our natural instincts to think that bigger and more elaborate surgeries have a higher likelihood of success, but the human body proves over and over that it prefers minimal interventions.

Medical researchers are discovering that patients aren't quite as dumb and helpless about making intelligent and informed choices about medical treatments as many doctors have assumed over the years. Case in point: prescription drugs. Patients have proven their ability to make smart choices even in the face of complex pro and con information, as long as the data are presented in a straightforward way.

Click on this link to see a "Drug Facts" box on an important drug: Tamoxifen (nolvadex), which can help lower the risk of breast cancer, but with lots of competing risks and benefits. This is a sample, prepared by researchers at Dartmouth medical school, of the way that information ought to be presented on all prescription drugs. Note the clear presentation of the statistical likelihoods of being helped and harmed by Tamoxifen.

You don't see these Drug Facts boxes anywhere now. Instead, what we have now are ads to consumers that first show happy, healthy, bouncy people, presumably after they've taken the drug, along with a few simplistic sentences pushing the drug's benefits, but next these same ads show acres of fine print with all the downsides of the drug. The subliminal message is that all patients need to do is "ask your doctor" if Drug X is right for you. Meantime, your doctor has been sold a message on Drug X -- usually by a well-tailored, attractive sales rep -- that is only slightly less simplistic than the one in the "direct to consumer" advertisement.

So really, both patients AND doctors could benefit from a requirement that the drug information be reorganized and presented in an intelligible way. The FDA is now considering such a rule.

The Dartmouth researchers -- Lisa M. Schwartz, MD, Steven Woloshin, MD, and H. Gilbert Welch, MD, MPH -- have published a study proving that consumers presented the Drug Facts boxes for two competing drugs for prevention of heartburn, one of which was a lot more effective than the other, were a lot more likely to pick the correct drug when the information was presented more clearly. They also found that the consumers presented the standard advertisement tended to over-estimate the drugs' benefits in preventing disease -- no surprise there -- and that the Drug Facts box helped set them straight.

I've written before in this blog about tamoxifen. There was an interesting study that found that very few women chose to take tamoxifen once the pros and cons were fully laid out in an understandable way. In that study, and in my blog piece, the numbers were presented a little differently than the Drug Facts sample box. I used the "count the people" technique which is detailed in my book, "The Life You Save." This can make the numbers more graspable than the usual "percentages."

For example, if we consider a hypothetical 52-year-old woman who had her first baby after age 30 and whose mother had breast cancer, she has about a 1.9% risk of developing breast cancer over the next five years. (The risks of breast cancer vary with age, family history, and age of first childbirth.)

So if 1,000 women just like this 52-year-old took tamoxifen over those five years, the research says that here is what would happen:

* Of the nineteen women (same as 1.9%) who otherwise would have developed breast cancer, nine will not develop breast cancer.

* Thirteen women would avoid broken bones from osteoporosis, another benefit of tamoxifen.

* Twenty-one women would develop endometrial cancer (typically more treatable and less deadly than breast cancer if caught early).

* Twenty-one women would develop blood clots.

* Thirty-one women would develop cataracts.

* Twelve women would experience sexual problems.

* One hundred twenty extra women would get hot flashes and other menopausal symptoms (in addition to those who would get such symptoms anyway).

The researchers who wrote the study bemoaned this as an example of patients being unreasonably scared about shifting off their status quo (not taking the drug), but as I noted in my blog, a lot of patients who read the data in the New York Times and wrote comments on the Times' "Well" blog concluded that the women in the study who declined tamoxifen were just making reasonable choices for themselves.

The point is: There is no right or wrong answer when it comes to taking a drug over the long haul to prevent a disease. For some patients, it will be worth the downside of the drug. For others, it won't. But each of us is entitled to make an intelligent and informed choice, and that's why we need more clearly presented information than we're currently getting from the drug manufacturers.

The scandal of Dr. Mark Midei, the cardiologist at St. Joseph's Medical Center in the Baltimore suburb of Towson, Maryland, is scaling new heights in the number of victims counted. The hospital mailed letters to 585 Midei patients informing them that an independent review shows they may have received heart stents unnecessarily for artery narrowing that Midei grossly exaggerated. But now, according to the Baltimore Sun, many more patients are coming forward whose procedures were done outside the two-year arbitrary time limit the hospital set for its own review. It appears now that the total number of cases of unnecessary heart stents could easily exceed one thousand.

Read more here.

Hundreds of patients appear to have received cardiac stents that they didn't need from Dr. Mark Midei, a cardiologist at St. Joseph's Hospital in Towson, Maryland. So why did no one at the hospital blow the whistle? And why did the patients not realize that Midei was rushing them into unwise and risky surgery?

Heart surgery is highly profitable, and there are no incentives for doctors or hospital administrators to rock the boat by raising questions when one cardiologist is putting stents into far more patients than his colleagues.

As for the patients, we Americans have a bias toward dramatic action. If one doctor tells us we need a stent to prop open the coronary arteries in the heart, and another doctor says all we need to do is take a pill every day, most of us will tilt toward the big intervention. Which can be a big mistake, because we then get a piece of metal permanently implanted in a blood vessel, and we have to take medicines anyway for the rest of our life to avoid getting blood clots from the metal that could cause a devastating stroke or more heart damage.

Recently in this blog, I pointed readers toward an excellent review by the Harvard Medical School of the scientific evidence on who should -- and shouldn't -- get the balloon and stent treatment for opening their heart arteries. Many studies have found that unless a patient is having repeated symptoms, the stent treatment does nothing to extend his or her life, even if an artery looks dramatically narrowed.

In the case of Dr. Midei, it appears that outright fraud might have been involved. You have to have a significant narrowing of the artery, 70 percent or more, to even start to qualify for stent treatment, and Midei aggressively over-read his own X-ray studies of the heart's blood vessels to make it seem that patients had much worse narrowing than they really did, according to the published allegations about his practice.

This raises a Fox/Henhouse issue: How is it that a cardiologist can do his own testing to see if someone needs treatment, and then be the one to profit mightily if the decision is yes, they need it? Should second opinions be mandatory on any patient with blood vessel narrowing?

Dr. Bob Wachter, a patient safety pioneer at UCSF medical school in San Francisco, wrote a thoughtful blog on this topic. I'm reprinting part of it below, and urge readers to read the whole article here.

Dr. Wachter writes:

Obviously, the Mideis of the world could be caught by requiring that every cath [blood vessel X-ray] undergo an independent second reading. Some insurers in New Jersey now require such readings before they authorize a stent, and at least one SoCal Kaiser hospital mandates that each cath be presented at a conference before a treatment decision is rendered, analogous to what many tumor boards do for cancers.

Such required peer review might have benefits beyond simply preventing the rare case of fraud. If done well, it might also ensure that other conflicts of interest and non-evidence-based decisions are avoided to the degree possible. For example, a meta-analysis in last month’s Annals of Internal Medicine illustrates the limited value of percutaneous coronary interventions – whereas older studies found that PCI was more effective than medical therapy in treating angina, more recent studies show that these differences have narrowed or even vanished. I’d guess that, when recommending a treatment for a patient with mild angina and a 60% LAD lesion, a peer review group is more likely to pay attention to this kind of evidence than the average cath jock – who may not only be staring at his kid’s private school tuition bill but also at a patient whose bias is to see a stent as a more intuitively satisfying solution than “just medications.”

Some will argue that mandating second opinions for every cath is the equivalent of hitting a nail with a sledgehammer, and they might well be right. However, I do favor at least random over-reads of a sample of catheterization studies. Something like this already happens in a few specialties. In many teaching hospitals, a random sample of pathology studies is reviewed by a second provider. In a few forward-thinking practices, radiologists re-read a sample of x-rays, looking for discrepancies. In response to this case, in fact, St. Joseph’s now requires that 5% of its cath cases undergo a random and blinded re-review. Random audits won’t catch every case of fraud, any more than IRS audits catch every tax scofflaw. But they do help keep people honest, particularly if the audits are coupled with a culture in which the docs welcome feedback and strive for continuous improvement.

Speaking of which, the Midei case made me wonder about the institutional culture at St. Joseph’s. Was Midei a rogue interventionalist working in isolation? Perhaps so – it's common for no other doc to be looking over the shoulder of a cardiologist and his cath readings. But cardiologists don’t perform caths on desert islands – they are assisted by cath techs and nurses. In my experience, these folks become as adept at reading cath films as any physician. If the allegations against Midei are true, it strains credibility to think that no one in the lab knew that inconsequential lesions were being read as tight stenoses and treated with stents.

And what about the hospital administrators? Stents are big business. When Johnson & Johnson first launched their drug coated Cypher stent in 2003, Dr. Midei told the Baltimore Sun, “This is the hottest thing in cardiology in years.” And it was: Maryland hospitals chalked up nearly $250 million in stent business in 2009, and St. Joseph’s stent revenues were $38 million, up more than 50% in 5 years. Before the case broke, St. Joseph’s advertised itself as the busiest cath hospital in Maryland, averaging nearly 20 interventional cases daily. While it is possible that no St. Joe’s leader knew precisely what was happening, I'm guessing that some did but chose to look the other way: the pressure to steer clear of the golden-egg-laying goose must have been intense. Perhaps the fact that the hospital’s CEO and two other senior executives resigned after the case broke provides a clue as to who knew what when.

Cases like this one are terribly troubling, not just because they harm individual patients but because they do violence to the trust that is so fundamental to the physician-patient relationship. Part of the solution must be more robust oversight procedures, such as mandatory second readings of randomly selected cath films.

But these cases also force us to consider the kind of culture that could allow such a fraud to take root and go on for years – a culture that likely prized the hospitals’ and physicians’ financial health over the clinical health of their patients. If the allegations are true, the penalties should be severe, not only for Dr. Midei but also for leaders who knew – or should have known – what was going on, yet remained silent.

Patients need to know that this is not just an issue of a few rogue bad apples. Medicine's fee-for-service payment system pushes doctors toward advocating for more aggressive and profitable interventions. The only way to find out what your body really needs is to shop for second and third opinions, every time. I have more on this subject in chapter 9 of my book, "The Life You Save."

The chapter title says it all: "The Second Opinion: Always Your First Choice."

Nurses are the front-line protectors of patient safety in hospitals, nursing homes and anywhere patients are treated. So to avoid patients being hurt by medical malpractice, it's important to protect nurses from being fired if they speak up when they see dangerous care. The Maryland Court of Appeals has just recognized this important principle of public policy in a decision reinstating a nurse's wrongful termination lawsuit against Montgomery Hospice Inc.

The case of the nurse, Susan Lark, was thrown out by a trial judge in Montgomery County, Maryland, because Ms. Lark had only complained to her supervisor about the dangerous practices she saw at the hospice. The trial judge said that to be protected by Maryland's health care whistleblower statute, Ms. Lark should have also complained to an outside agency like the State Board of Nursing.

The Court of Appeals, Maryland's highest court, said the trial judge was wrong. As long as the employee has reported in writing the dangerous practices to a supervisor or administrator at her workplace, that employee is protected from being fired.

Susan Lark's lawsuit contended she was discharged for making complaints about serious errors in handling narcotic drugs, such as giving narcotic "starter packets" to numerous patients, including children, without a written doctor's order.

You can read the Maryland court's decision on its website by clicking here.

In other nurse whistleblower news: A lawsuit on behalf of two nurses in Winkler County, Texas, who were fired for reporting a dangerous doctor to the state medical board, is proceeding. The nurses were vindicated in criminal court earlier this year. Now their case against the hospital that fired them and the authorities who wrongly prosecuted them criminally is set for trial in November 2010. Read more on the Texas Nurses Association website.

Food allergies are frequently overdiagnosed because the two tests commonly used have less than a 50% accuracy rate, according to a new authoritative study. As a result, whereas three in ten adult Americans think they have one or another food allergy, the actual number is more on the order of one in twenty (5%) adults, and a little higher for children (8%).

The new study was sponsored by the National Institute of Allergy and Infectious Diseases, a branch of the NIH, and was reported in the Journal of the American Medical Association.

The skin prick test and the antibody test are the two main tests done for food allergies, but the only real way to know if someone has a true food allergy is to challenge their body by slipping them a small amount of the food and seeing if a rash or even bigger reaction results. That's a scary prospect for many patients, so the food challenge test is seldom done.

Another issue is that many people have a food intolerance -- like lactose intolerance due to a missing enzyme that breaks down sugar in milk -- but that is not the same as a food allergy, which happens when the person's immune system goes haywire in response to an allergen.

Read more in Gina Kolata's article in the New York Times and Katherine Hobson's WSJ blog article.

This study reinforces advice I give in my book, "The Life You Save." I don't think anyone should make major changes in their life based on one or two test results without making really sure that they have the condition. That can mean confirmatory testing, a second opinion, or just plain education so that you understand that no test result is 100%.

One routine piece of advice that many of us patient advocates give about scouting a new doctor is to make sure the doctor is certified by one of the boards under the umbrella of the American Board of Medical Specialties. But there's a "grandfather" issue that patients need to know about even with these boards. Doctors who were certified before 1990 have a lifetime certificate, and it's strictly voluntary whether they stay up-to-date by taking the re-certification exam every ten years.

Here is a guest column on this topic by John James, a patient safety advocate from Houston. I'm reprinting this with John's permission. John James is a NASA Ph.D. scientist who lost his son Alex to medical malpractice. Dr. James wrote a book: "A Sea of Broken Hearts -- Patient Rights in a Dangerous, Profit-Driven Health Care System." His description of the book:

This is the story of a father's journey through the healthcare that resulted in the death of his 19-year old son, and the incredible coverups of mistakes that were made. The reader is taught a little basic cardiology, and then invited to use those skills to solve "medical mysteries" that were missed by the boy's cardiologists. Chapters are devoted to understanding how physicians are educated and why current medical care is infested with errors - many of them lethal. The last chapter is a patient bill of rights that would enable patients to protect themselves from healthcare that is centered on making money and not patient safety.

The book is available from several on-line sources. Please go to http://PatientSafetyAmerica.com to read short reviews and learn about the sources.

And here is John James' column:

Does your Doctor Know?

Keeping up with new medical discoveries and applying them effectively to patients is a daunting task. One might suppose that physicians have developed an efficient and comprehensive way to capture new medical discoveries and disseminate these into the clinician community.

You would be wrong, perhaps dead wrong.

In a series of opinions from physicians published in the New England Journal of Medicine the woefully inadequate way physicians continue to learn is inadvertently revealed. That is not the intention of the opinions, but a little inspection discloses the problems. Besides their ongoing experience base, there are two major ways doctors can acquire new knowledge. The first of these is state-mandated continuing medical education (CME). Among the states, the mandated number of hours per year ranges from zero to fifty, but none is specifically required in the physician’s declared specialty. Is it any wonder that one of the articles, citing three studies, observes that CME does not improve physician performance or knowledge.5

The second way that physicians acquire new knowledge outside their practice experience is through board certification and periodic recertification. Surprisingly, a physician does not have to be board certified to represent himself as a specialist to the public. In addition, there are many second-rate board certifications appearing that are generally regarded as unable to give any assurance of competency.

What about the traditional and well-respected boards, such as those under the purview of the American Board of Medical Specialties. Can certification by these boards assure physician competency? There are two cases. One applies to physicians given limited certificates after 1990. They must periodically recertify. For example, internists must recertify every decade. Unfortunately, medical knowledge grows so quickly that information more than 5 years old may be well out of date. This approach is better than nothing, but it is clearly inadequate to ensure that your internist is up to speed on the latest findings.

Physicians that were board certified before 1990 trouble me most as a patient. These physicians were given lifetime certificates. This means that they do not have to recertify to continue to represent themselves to the public as board certified. However, these specialists can choose to voluntarily participate in maintenance of certification (MOC). This choice prompted the series I am reviewing here.

Two MDs make the case that internists with lifetime certificates should voluntarily recertify.5 They view MOC as a superior process to CME and cite several studies linking MOC to better physician performance. They note that physicians’ ability to self assess their learning needs is poor. Barriers to voluntary participation include costs and time. Of course, the fear of failure is another barrier. They note that there are flaws in the testing, but that these can be reduced by feedback from participants.

Three other MDs argue that a physician with lifetime certification should not voluntarily recertify.6 They note that very few physicians choose to recertify, which they interpret to mean that the specialists think the process is irrelevant to their practice. I would argue that it is more likely the cost, time, and fear-of-failure that limit voluntary MOC. They argue that there is not “definitive evidence” that recertification benefits patient care. They further argue that the recall of facts on the closed examination does not make an improvement in patient care.

As a patient I feel that physicians should demonstrate some level of competency through recertification or be required to disclose to all their patients when the last time was that they were subjected to a competency assessment. You might like to know that almost ¾ of cardiologists in a national survey admitted that they had not been evaluated for competency in the past 3 years.7

Citations:
5) Levinson, W and TE King, Jr. Enroll in the MOC program as currently configured. N Engl J Med 362:949-950, 2010

6) Goldman, L, AH Goroll, and B Kessler. Do not enroll in the current MOC program. N Engl J Med 362:950-952, 2010

7) Campbell, EG, S Regan, RL Gruen, et al. Professionalism in medicine: Results of a national survey of physicians. Ann Intern Med 147:795-802, 2007

If you would like to subscribe to John James' Patient Safety America Newsletter, send him an email at john.t.james@earthlink.net. I'm a subscriber, because John regularly provides valuable information about our broken health care system.