DC Medical Malpractice & Patient Safety Blog

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."

When a 44-year-old male friend dropped dead the other day from a massive heart attack -- no prior symptoms, no warning of any kind -- I wondered if modern medicine could have done anything to prevent the tragedy. The answer I learned is that low-tech still beats high-tech hands down in preventing America's No. 1 killer.

Low-tech means getting regular exercise, eating right and paying attention to cholesterol, blood pressure and the other risk factors for heart disease, and it also means moving fast to get to a medical facility with any symptoms whatsoever that might be signaling heart attack. Those are the proven ways to lengthen your life span and avoid early death.

But my friend didn't have any symptoms or risk factors. What could he have done? That's where high tech comes in, but the answers are not encouraging. The available treatments are expensive and not very effective for people without symptoms.

He could have had the gold-standard test for narrowed arteries in the heart: an angiogram. That's an X-ray movie of the arteries that involves putting a tube into the groin, threading it up to the surface of the heart, and squirting dye through the tube to outline the inside of the blood vessels as high-speed multiple X-rays are taken. I've watched these movies for some of my medical malpractice lawsuits, and they are eerily fascinating: the dye looks like smoke as it pushes out of the tube and mingles with the blood in the arteries, which suddenly light up as if a switch has been turned on, with the heart quivering all the while behind the arteries.

The problem is that most of the time, angiograms on people without chest pain symptoms show nothing. Even when there are some symptoms, the angiogram is just as likely to turn up clean as a whistle, or with only minor narrowing, as it is to show serious disease.

A new study in the New England Journal of Medicine of 400,000 patients found that the odds of finding operation-worthy heart disease in patients getting a first-time angiogram without any known heart disease was only four in ten -- which means that the $2,500 procedure was wasted on six of every ten patients.

Now, you might think that the angiogram can still be worthwhile if it shows some blockages that can be cleaned out. But that's true ONLY IF those blockages are causing symptoms. The usual technique to unblock arteries -- with a balloon and a wire scaffolding (stent) to hold open the artery -- has been shown to work to relieve symptoms of chest pain, but it does NOT extend life in symptom-free patients. In those patients, it's thought that the heart has already learned how to deal with the blockage by shifting blood from another supply.

Here is a very good article from Harvard Medical School on who should get the balloon treatment -- called angioplasty -- and who shouldn't.

The bottom line: Angioplasty can save your life during a heart attack if it can be done fast enough to open the artery before permanent damage is caused to the heart muscle. But for symptom-free patients, angioplasty is worthless and exposes patients to the risk of dying from a complication of having wires and tubes poked into your heart. And for patients with non-debilitating chest pain, angioplasty doesn't work any better than taking drugs and making lifestyle changes.

People who get chest pain and learn they have heart disease should think of the pain as a gift from on high: It's given them a chance for a new lease on life. But for people like my friend whose first symptom is a fatal heart attack, there's not much that medicine can do. We're all fated to die at some time, and we haven't learned how to defeat fate. We can and should pay close heed to getting plenty of exercise, eating right and doing other things to lower our risk. But the risk will always be there.

Actor James Woods' brother Michael died of a heart attack three years ago in an emergency room hallway in Rhode Island because no one was paying attention. Now, something good will come from Michael Woods' death, thanks to a settlement reached between the Woods family and Kent Hospital in the middle of a jury trial.

The settlement creates a new institute to help teach hospital staff how to pay better attention to patients and develop a more "human-centered" standard of care.

An impasse between the two sides in the trial was broken when the president of the hospital, Sandra Coletta, called James Woods the night before the actor was going to testify about his brother's death. As reported in the Providence Journal:

In that call, he said he heard something he’d never heard from Kent Hospital before, someone saying she was sorry for his family’s loss. ... Woods said the family’s peace of mind about the agreement was helped when Coletta met his mother, Martha.

“Sandra and my mother had a very personal moment, a mother-to-mother conversation,” Woods said, calling it a “sweet and dear way to express sorrow.”

“It was all I ever needed to see in my life,” Woods said, “one human being saying to another human being ‘I’m sorry for your loss.’ ”

In announcing the new Michael J. Woods Institute, which will be funded by $1.25 million of the hospital's money, hospital president Coletta said:

"We know we're not perfect at Kent Hospital. Mistakes were made. We can do better. The Michael J. Woods Institute will help establish a leadership role in promoting patient safety and developing new ways to improve the patient experience and clinical outcomes."

This is one often-overlooked benefit of the civil justice system: producing positive safety reforms to try to reduce the toll of medical error. An actor's celebrity helped make that a reality in Rhode Island. On a quieter level, similar positive events happen at the end of many lawsuits, where families who have lost a loved one insist that part of the settlement go toward education and system reforms to make hospitals safer places. Patient safety advocates like me believe this is one of our highest callings.

Every hospital patient needs someone with them at all times to help prevent medical errors and keep them safe. That's a mantra I have advocated for years, and another example of why it's good advice comes with a riveting story in the Washington Post by health writer Sandra Boodman.

Ms. Boodman's article tells how a Washington area woman's advocacy in the emergency room and hospital helped lead to a correct diagnosis of baffling symptoms, and likely saved her sick daughter from harm. The article interviews Patricia Dawn about her 4-year-old daughter Brooke's illness, that was eventually discovered to be Kawasaki disease, an unusual heart condition.

Brooke got the right treatment in time, but only because of her mother's persistence. Mrs. Dawn refused the recommendation of the emergency room doctors to take her daughter home at 2 a.m. when she wasn't feeling any better but they had run out of things to do. At her insistence, her daughter was hospitalized, and an infectious disease specialist eventually figured out that the red lips, red eyes, fever longer than five days, and swollen lymph node in the neck all were signs of Kawasaki, which affects about 2,000 American children a year.

It was also at the family's suggestion that the infectious disease doctor was brought in who made the correct diagnosis.

The story underlines the importance of having a good advocate present at all times with a patient in the hospital. Even a lay advocate can see when symptoms aren't improving and can insist on action.

I discuss this subject in depth in Chapter 12 of my book, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst."

"Amenable mortality" is a body count of unnecessary deaths due to lack of preventive health care. The latest measure is not flattering to the American health care system.

Researchers count these deaths by looking at premature deaths in areas like these:

* Adults who die from breast or colon cancer before age 75, indicating lack of timely mammograms or colon screens or care. * Children who die before age 14 from vaccine-preventable or easily treatable illnesses such as coughs, measles, asthma, and other respiratory problems. * Diabetics who die before age 50 from complications that could easily have been prevented with proper medical management. * People who die from infections or hypertension before age 75, a symptom of lack of preventative and appropriate care, including blood pressure control.

In the mid-1990s, the U.S. ranked 15th out of 19 industrialized nations in its death rate from "amenable mortality." Now the figures have been updated, and America is in last place -- 19th out of the same 19.

France, Japan and Australia do the best in this ranking. The United Kingdom used to be worse than the U.S. but has gotten a lot better.

Consumer Reports has a chart of the latest data here.

Nobody wants to go home from the hospital only to be readmitted within a few weeks. But that revolving door is very common in conditions like heart failure, where the patient's heart muscle doesn't pump effectively after it has been weakened by heart attack or other heart disease.

The open secret of the hospital industry is that the financial incentives of Medicare and private insurers are tilted toward keeping that revolving door going. Hospitals that actually invest money in following patients after they leave the hospital to try to keep them healthy find that they lose money on this follow-up care. Reed Abelson of the New York Times wrote a report describing how progressive hospitals that have tried to keep their patients from readmission have lost millions of dollars in the process. Those include the Park Nicollet Health Services in Minnesota and Catholic Healthcare Partners in Cincinnati.

One lesson from this story is that patients don't have to wait for medical payment reform to get better care and avoid the revolving door. If you or someone in your family has heart failure, here are the early warning signs that symptoms may be worsening and a doctor or nurse should be called:

* Weight gain. Patients need to weigh themselves every day. Sudden weight gain often means a buildup of fluids caused by the heart not pumping effectively.

* Shortness of breath. Fluid buildup often is most apparent in the lungs and is signaled by being out of breath.

* Ankle swelling. Another place where fluid buildup can be spotted early.

A phone call to the nurse can result in an adjustment of medication that may ease the problem. If that doesn't work, a visit to the doctor's office might be in order. The goal is to intervene before a crisis develops and you have to be rushed to the hospital in an ambulance.

If your doctor already has a system in place that helps you monitor yourself at home, that means you have a top-quality doctor. If you have a hard time getting such a monitoring system going with your doctor, then it might be time to switch to someone who is more responsive.

Patrick Malone discusses how to find a top primary care doctor in his new book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst