DC Medical Malpractice & Patient Safety Blog

Last November, the FDA ruled that tobacco manufacturers must include on their packaging graphic depictions of the horrors smoking can wreak. The new packaging was to take effect in autumn 2012.

Five tobacco companies now have taken the FDA to federal court, challenging the regulations. Among other things, they claim that the depictions:

• would unfairly dissuade adults from using a legal product;


• would cost millions;


• violate the First Amendment;


• “do not further any compelling governmental purpose”; and


• “would have few if any benefits.”

“A decade of experience in more than 30 other countries has demonstrated that such graphic warnings lead to an array of public health benefits. The warnings are more likely to be noticed than text-only labels, are viewed as more effective in communicating health risks to smokers and are associated with increased motivation on the part of smokers to quit smoking.”

Dr. Koh is assistant secretary for health in the U.S. Department of Health and Human Services. So he's defending his own decision. But knowing what we know about how tobacco poisons work throughout the human body, is this even a close question?

To see a slide show of the text and images for the new packaging, click here.

And if you want to harken back to the olden days before we had any warnings on cigarette packs, and when the manufacturers liked to use doctors to promote their smoky poisons, check out this tour through nostalgia.

Okay, it might be a touch sarcastic. But this poster is backed by good science. How did it come about?

Read the back story on this cardiology website.

A drug prescribed for smoking cessation is linked to an increased risk of heart problems, according to a study published July 4 in CMAJ (Canadian Medical Association Journal). Varenicline, known by the brand name Chantix, was associated with a 72% increased risk of a serious cardiovascular "event."

That sounds huge, but the scientific number-crunching shakes out a bit differently. Although attention must be paid, many critical minds are not ready to dump the drug. Fifty-two (1.06%) of the participants who took Chantix had serious cardiovascular events compared with 27 (0.82%) of those who took a placebo.

One bottom line for smokers who may want to rationalize continuing to puff: It's always better to stop smoking. No excuses.

When varenicline was launched in 2006, the FDA noted that it could raise the risk of cardiac problems, and the federal agency recently updated the label for Chantix to reflect that risk among smokers with heart disease. And we wrote about the drug a couple of years ago. But the new study's authors said, "These increased risks ... are seen in smokers with or without heart disease."

The irony, of course, is that one major risk of smoking is heart disease.

The Chantix-using subjects of this trial were able to abstain from smoking at a significantly higher rate, an achievement that should potentially confer a cardiovascular benefit. Many members of the medical community believe the drug should remained a valuable treatment option, given the devastating effects of smoking. Apart from heart issues, nicotine and the other ingredients of cigarette smoke, of course, compromise lung function and can lead to lung cancer, and also increase the risk of stroke and diabetes.

The results were based on a review of 14 studies of approximately 8,200 smokers or users of smokeless tobacco. Most had no history of heart disease. They were followed for as long as a year, a comparatively short term that gives many researchers pause. It's possible, for example, that the risk diminishes over time.

Dr. Taylor Hays from the Mayo Clinic opined, "Although these results suggest a measure of caution should be taken in prescribing varenicline for tobacco dependence treatment ... [T]he risk for cardiovascular events is low and is far outweighed by the benefits of diminishing the truly 'heartbreaking' effects of cigarette smoking."

If you're taking Chantix, don't stop without consulting your doctor. If you're unable to stop smoking via other methods, discuss the cost-benefit question of treatment with Chantix.

A study examining outcomes of heart and lung transplant surgery has concluded that patients fare essentially the same whether the transplants are performed during the day or at night. Two smaller previous studies – one on kidney transplants and the other on liver transplants – had indicated that patients tended to fare worse if the operations took place in the middle of the night.

The new study, published in the Journal of the American Medical Association, took into account all of the nearly 30,000 heart and lung transplants performed in the United States over 10 years. Researchers were surprised by the results, which indicated that, contrary to conventional wisdom, patient outcomes had little to do with the time of the operation or the fatigue of the surgeon. Rather, they seemed to hinge on the reliability of the surgical team.

Unlike surgeons in other specialties, cardiothoracic surgeons almost always work in the operating room with the same team of highly specialized anesthesiologists, nurses, physician assistants and technicians. The team’s familiarity with and constant repetition of the same complex steps — placing patients on bypass machines, performing certain intraoperative studies, even executing specific suture sequences — may be the key to ensuring consistent performance, whatever the time of day.

When performing a transplant, “the surgeon isn’t doing a complicated operation in the middle of the night with an anesthesiologist who usually staffs gynecology procedures and a nurse who works in the orthopedic operating rooms during the day,” says Dr. Ashish Shah, a co-author of the study and assistant professor of surgery at the Johns Hopkins University School of Medicine. “We need to think about doctors less like airline pilots and more like a part of a special forces military team. Those teams carry out complex tasks at a very high level and under less than ideal physiologic or environmental conditions.”

Source: The New York Times

You can read an abstract of the study here.

Diabetes medication Avandia will be pulled from pharmacy shelves in November because it poses a major risk of heart attack, the Food and Drug Administration has announced.

Under a new program effective Nov. 18, 2011, only certified physicians will be allowed to prescribe the drug, and then only to patients who've been informed of the risks and who will fill their prescriptions by mail order through specific pharmacies.

The new FDA guidelines limit the drug to patients already successfully treated with it or to those for whom it's pretty much a last-ditch effort to control blood glucose medically. In addition, healthcare providers and patients have to enroll in the Avandia-Rosiglitazone Medicines Access Program to prescribe and receive rosiglitazone medicines.

The restrictions to access are so tough that virtually no one will be able to obtain the drug, says Dr. Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic, who has long advocated more restrictions on the use of rosiglitazone (Avandia's generic name).

Avandia is also sold as a component in the combination drugs Avandamet and Avandaryl. It was approved in 1999 to lower blood-sugar levels in patients with type 2 diabetes. In 2007, Nissen published an analysis showing that the drug increased heart attack risk by about 40% in people with type 2 diabetes, who are already much more prone to heart attacks than people without the disease.

Subsequent studies confirmed the greater heart attack risk. In June 2010, more than half of the members of an FDA advisory committee recommended pulling Avandia from the market or tightening restrictions on its use, and in September, the FDA decided to impose restrictions.

Source: TheHeart.org

You can read the FDA’s decision here.

A new Texas law that mandates insurance coverage for coronary artery calcium scanning and carotid artery ultrasound was “premature” and will have major ramifications for public health, a noted Texas cardiologist says.

In a commentary published in the Archives of Internal Medicine, Dr. Amit Khera, a cardiologist at the University of Texas Southwestern Medical Center in Dallas, says that although some of these tests may be right for some patients, mandating their use via legislation goes far beyond what the evidence to date supports.

"I'm not against this technology – I use it myself," Khera says. "But when you go from an individual doctor and a patient making a decision about a test to a statement like 'we should apply this to an entire population, and the evidence is so strong that we need a law,' I think then you need a much higher level of evidence and a more detailed look at all the ramifications."

Neither screening test has been proven in adequately powered trials to lead to diagnoses or preventive measures that translate into reduced adverse cardiovascular events. There is also no real consensus as to which patients might benefit from screening, what level of baseline risk would warrant further screening or what steps should be taken as a result of any given finding.

In terms of calcium screenings alone, Khera calculates that approximately 285,000 individuals in Texas who would be eligible for insurance coverage of screening based on criteria set out in the bill would be found to have calcium scores over 400, and many of these people would already have another indication for taking statin therapy. And, he notes, a one-time screen could be expected to result in 190 new cancers and find 190,000 incidental findings of "minimal consequence" that would inevitably be followed with further, possibly unnecessary tests.

In an editorial note accompanying Dr. Khera’s commentary, Archives editor Dr Rita Redberg commented that “at a time when states are facing crises in health insurance spending and cutting lifesaving treatments, and when Texas leads the nation in the percentage of residents without health insurance, it is remarkable that Texas has chosen this path."

A new bill modeled on the Texas legislation is also set for consideration in Florida.

Source: TheHeart.org

You can read an extract of Dr. Khera's original commentary in the Archives of Internal Medicine here.

The news this week from the Centers for Disease Control and Prevention that as many as 48 million U.S. adults have high levels of bad cholesterol, and aren’t doing enough to control it, left out one conspicuous controversy: Should lots more Americans be taking statin drugs, or would it be a huge waste of money?

Statins like Crestor and Lipitor lower cholesterol in the blood by decreasing cholesterol synthesis in the liver. Since plaques in coronary arteries are mostly composed of cholesterol, lowering cholesterol cuts the rate of formation of plaque, and in some cases, even shrinks it.

For people with diagnosed heart disease, statins are mainstream, non-controversial medical treatment. But for patients who just have high cholesterol, but no known heart disease yet, the drugs have modest if any benefit. And this is the group that is the main target of drug manufacturers for expanding sales of statins.

A cautionary statement about the questionable role of statin drugs in "primary prevention" of heart disease was recently released by the British-based Cochrane Collaboration, which conducts rigorous reviews of medical studies to see how the evidence measures up.

The authors of the new Cochrane review criticized much of the studies sponsored by drug manufacturers for leaving out key data. They concluded:

Only limited evidence showed that primary prevention with statins may be cost effective and improve patient quality of life. Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.

Doctors who are slow to turn healthy people into medical patients are careful about whom they prescribe statins for. For example, Dr. Robert Lemmon, a South Carolina family practice doctor and medical blogger, wrote an analysis of the published studies and concluded that statins were "overrated" and did not much help people who don't have heart disease. Noting that other cautious reviewers had reached the same conclusion, even though it cuts against drug manufacturer hype, he wrote: "This post is blasphemy. Fortunately I am in good company."

The CDC report also talks about improving diet and exercise habits as strategies to cut cholesterol. That can work in individuals very well, but as a public health strategy, education campaigns also fall short in making any notable impact. That's why public health advocates reach for systemic changes that would expose people to less temptation by strategies such as bans on use of certain bad fats in restaurants and fast food manufacturers. A provocative article on this topic was published in PLoS Medicine.

Article first published as Government Reports Millions of Americans Have Untreated High Cholesterol — But What Treatment Works? on Technorati.

Merrill Goozner has an excellent blog on the medical industry. Here's his take on the cardiac stent "mill" in Baltimore, and how it has come to light and reached some measure of accountability.

He writes on his "Gooznews" blog:

... let us point out a few interesting aspects of this still evolving story.

First, it was officials with access to patient billing records at the Centers for Medicare and Medicaid Services who launched the investigation. Yet we read this morning in the Washington Post a story by Kaiser Health News about pushback from the American Civil Liberties Union and others against the creation of comprehensive electronic database containing records from the Federal Employees Health Benefits Program, which covers millions of federal workers. One of the purposes of such a database would be to conduct investigations like the one carried out by CMS.

Second, it was local reporters at the Baltimore Sun, after learning about letters sent from the hospital to patients advising them about their possibly unnecessary operations, who brought the story to light. Individual cases highlighted in today’s New York Times story on the Senate report came from trial lawyers suing the hospital on behalf of those patients.

There’s talk these days about cutting Medicare budgets by making seniors pick up more of the tab. Having “more skin in the game” will lead consumers to think twice before buying unnecessary medical services. There is also a lot of talk about limiting patients’ right to sue in order to stop physicians from practicing defensive medicine.

Can individuals without legal rights whose every second opinion will require another payment out of pocket be able to stop rogue physicians from practicing money-driven medical practices like those at the Baltimore hospital? ...

Not much of a chance that that will happen, Merrill.

Here's our report on the consumer groups pushing back on the deficit commission proposals to save money on medical care by wiping out patients' rights to get legal accountability when they are injured by poor medical care.

With lucrative fees for doctors, little oversight, and much disagreement about who needs stents in their heart arteries, it was perhaps inevitable that malpractice allegations of unnecessary surgery would explode into hundreds of lawsuits against a single cardiologist in Baltimore.

But now a new report from the U.S. Senate Finance Committee, which oversees the federal Medicare program, says the Maryland cases against Dr. Mark Midei may be only the tip of a very large iceberg.

Medicare spends $3.5 billion a year on cardiac stents, the tiny wire mesh tubes that are intended to prop open clogged arteries feeding the heart muscle.

In a long story in the New York Times, Dr. Steven Nissen, chief of heart medicine at the Cleveland Clinic, said:

"What was going on in Baltimore is going on right now in every city in America. We’re spending a fortune as a country on procedures that people don’t need.”

Dr. Nissen said he routinely treats patients who have been given multiple unneeded stents by other doctors.

I wrote about unnecessary cardiac procedures in my patient safety newsletter last summer. You can read it here.

A good resource for readers is the Harvard Medical School newsletter on cardiac care. The bottom line for most patients, the Harvard doctors say, is that if you're not having symptoms, you should be very wary about anyone proposing to put stents in your heart.

The Food and Drug Administration has issued Class I recalls of Hospira Symbiq One- and Two-Channel infusers and Medtronic Octopus Nuvo tissue stabilizers.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The FDA is recalling Hospira’s infusion pump products due to motor encoder failures in the pumping mechanism that causes the infuser to cease operation. Delay or interruption of therapy may result in serious injury or death in: patients receiving critical therapy, pediatric patients, and neonates. The company mailed an “urgent device field correction” to affected customers and issued a recall notification in February 2010. All the affected units were distributed from Dec. 23, 2006 to January 22, 2010.

Medtronic’s Octopus Nuvo tissue stabilizers were manufactured from February 19, 2010 through August 28, 2010 and distributed from March 8, 2010 through September 7, 2010. The device stabilizes and minimizes the motion of selected areas of the beating heart during minimally invasive cardiac procedures while directly visualizing the heart through a small cut in the chest cavity. The FDA ordered the recall because of the possibility that a component of the device could fracture during use and fragments could fall into the patient’s chest cavity and/or damage the heart tissue, causing serious injury or death. Fortunately, no action from patients is required, since any adverse event related to the device would occur at the time of surgery.

Medtronic sent an “urgent medical device recall notice” to its customers on September 14, requesting that they discontinue use of the device, quarantine all unused devices and return unused devices.

Hospira recall source: Bioscience Technology

To view the FDA ruling on Hospira, click here.

Medtronic recall source: Operating Theatre Journal

To view the FDA ruling on Medtronic, click here.

A diet drug which safety advocates called to be withdrawn from public use eight years ago has finally bit the dust. Under pressure from the Food and Drug Administration, the drug’s manufacturer, Abbott Laboratories, voluntarily pulled the drug from the market due to longstanding concerns that it increased the risk of heart attacks and strokes.

“There was no identifiable population of patients for whom the benefits of Meridia outweighed its risks,” said John Jenkins, MD, director of the office of new drugs at the FDA. “Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke.”

The move was described as “commendable but dangerously too late,” by Sidney Wolfe, MD, a member of the FDA’s Drug Safety and Risk Management Committee and director of the Health Research Group of Public Citizen, a consumer and health advocacy group.

The pressure from the FDA came after results of a clinical trial involving more than 10,000 patients showed that people who took Meridia had a 16% increase in relative risk of heart attacks. The trial also showed that individuals taking Meridia only lost approximately 2.5% more weight than those on placebo and that the weight loss didn't last very long.

Abbott maintained these results weren’t relevant because most of the individuals in the trial had cardiovascular disease and should not have taken the drug in the first place. The company continues to maintaion that for the right patients, the drug is safe.

European regulators took the drug off the market in January 2010. An FDA advisory committee was split on whether to remove the drug, but the ultimately decided to recommend doing so because “there was no identifiable population of patients for whom the benefits of Meridia outweighed its risks,” Jenkins said, adding that he did not believe Meridia users would have any residual increased risk once they stopped taking the drug.

Source: The New York Times

You can view an abstract of the clinical trial that led to the FDA recommendation here.

Until now, it’s been easier to rate appliances and restaurants than surgeons in most parts of the country, but that should change now that surgeons who perform cardiac bypass surgery are being rated on objective quality measures in Consumer Reports magazine.

The consumer magazine recently published ratings of 221 surgical groups in 42 states online. The same ratings will be available in the October print issue. To date, only a few states, such as New York, compile data-based ratings of physicians.

The data Consumer Reports used to rate the physicians was collected the Society of Thoracic Surgeons, which includes more than 90% of cardiothoracic surgeons in the U.S. in its membership. Physician groups, not individual surgeons, were rated either above average, average or below average based on (a) complication and survival rates; (b) the surgical technique used; and (c) the type of medication(s) the patient was sent home with after surgery.

An article in the New England Journal of Medicine called the move to make this data public “a watershed event in health care accountability.”

The 221 groups rated in Consumer Report represent less than a quarter of physician groups that perform bypass surgery in the U.S., as only surgical groups that allowed their information to be published were rated. Of these, only five were rated below average, which is fortunate, because the gap in treatment between a below-average and an above-average surgical group can be extremely wide; for instance, at an above-average hospital, patients had a 92% chance of receiving the recommended medications when leaving the hospital; at one of the below-average hospitals, patients had only a 24% chance of getting the recommended drug.

For now, the information is available only to people who subscribe to Consumer Reports online and print subscribers. However, STS says it will make the ratings freely available on its web site in a few months.

Source: New York Times
Visit the web site of the Society of Thoracic Surgeons (STS) here.

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