DC Medical Malpractice & Patient Safety Blog

The honor system is a fine thing when people are honorable. Not so much if they’re not. A medical example of the latter unfolded recently in Kentucky, where unnecessary heart procedures failed to help the patients, but certainly boosted the bank accounts of the hospital and the surgeons.

As reported last month by the Courier-Journal, a former meat cutter, Edward Marshall had undergone at least two-dozen heart procedures over two decades. They were disabling, and he finally decided in September 2010 to seek treatment by people other than the cardiologists at St. Joseph London hospital.

After consulting a specialist in Lexington, Ky., he was told that an artery in which Dr. Sandesh Patil at St. Joseph had implanted a stent was barely blocked. In other words, there had been no need for the balloon angioplasty procedure, which opens blocked arteries and keeps them that way with the use of a stent, a tiny tube that prevents surrounding tissue from collapsing.

“I would have not carried out this procedure,” the Lexington cardiologist told Marshall in a letter that is included in the court record. Marshall became the first of nearly 400 people to sue the London hospital and 11 cardiologists. The claim is conspiracy to perform unnecessary, risky and often painful heart procedures that served only the purpose of enriching the providers.

The problem in Kentucky is old, sad news. In “Hospital Profit Soars on Wings of Unnecessary Heart Procedures," we wrote about HCA, the largest for-profit hospital chain in the U.S. When the doctor there was performing heart procedures on patients who didn’t need them, the hospital slapped his wrist, fired the nurse who blew the whistle on him and pocketed enough money to run a small country.

Our blog a few years ago, “Baltimore Malpractice Cases Raise Broad Questions About Heart Stents,” concerned a case when a Maryland cardiologist performed more than 1,000 surgeries to implant heart stents. Except that the arteries weren’t blocked, and didn’t require the dangerous, expensive procedure.

The problem common to all of these unfortunate events is that the medical honor system monetarily rewards cardiologists for breaking the rules if they're willing to gamble on not getting caught. These surgeries happen only because one guy says they should. No peer or institutional review. It’s the honor system, and too often, it’s not working.

The Kentucky lawsuits also name the hospital’s parent company, Catholic Health Initiatives (CHI). Two patients died from the alleged unnecessary procedures, and the others must take blood-thinning medications for life. Not only do such drugs carry risks of dangerous side effects, the procedures leave these people at risk of potentially fatal complications.

The hospital’s defense? Exactly as you might imagine. “These were very sick people who needed the interventions, and got them,” its attorney told the Courier-Journal. He called the conspiracy allegations “Alice in Wonderland stuff.”

As the newspaper notes, however, it isn’t only the plaintiffs who are troubled by St. Joseph’s practices:

• The U.S. attorney’s office in Lexington is investigating the medical necessity of its cardiac procedures, and the financial relationship between the St. Joseph system and Patil’s cardiology group.


• A federal criminal health-care fraud investigation focusing on Patil has been launched. The doctor refused to answer 109 questions at a deposition in Marshall’s suit, declining even to confirm that he is a doctor.


• Earlier this year, the Kentucky Medical Licensure Board found that Patil provided substandard care to 4 of 5 patients whose records it examined. It said he used stents without justification in three of them.

Remarkably, however, the board allowed Patil to continue to practice, with monitoring and remedial education. (That’s not oversight, that’s sending someone to bed without dinner.)


• In 2011, the Centers for Medicare & Medicaid Services cited St. Joseph for failing to review the medical necessity of 3,367 cardiac catheterizations performed there in 2010. (That procedure, in which a wire is moved through an artery into the heart, was a problem as well in the HCA case.) This citation noted that one of the hospital’s patients had annual heart procedures (20 in all), never mind that he had no symptoms of heart disease.

The Courier-Journal quoted a researcher at the Kentucky Health Policy Institute who found that St. Joseph performed more angioplasties than either of the state’s major teaching hospitals. After the lawsuits were filed, those numbers declined by one-third.

Patil has not had privileges at St. Joseph London since December 2010, but he’s not the only problem at CHI—it paid $22 million in 2010 to settle allegations in a federal case that its hospital in Towson, Md., made improper payments to a cardiology group, and that doctors regularly performed unnecessary procedures.

Marshall’s case is moving slowly through the legal paces. Over the years he claims Patil and others unnecessarily implanted a pacemaker and stents and performed unneeded angioplasties and catheterizations. Unlike many such patients, Marshall said he did question Patil about the need for the procedures, but the doctor would change the subject.

Then, in August 2010, Patil was doing an angioplasty, said that he’d found no blockage in the artery but was going to insert a stent anyway. That’s when Marshall went to the Lexington cardiologist. His report, Marshall told the Courier-Journal, destroyed his faith in doctors.

“It is serious business when someone is fooling with your heart,” he said. “It is just not right what they put people through.”

If you're a patient facing serious heart surgery -- a transplant or a valve replacement, say, anything that requires surgeons to stop the heart from beating while they repair it -- you want the most skilled, experienced hands working inside your chest. All other things being equal, nobody wants a part-time doctor working on them.

But what if you could have "America's Doctor," Mehmet Oz, operate on you?

Before he became a television celebrity, Dr. Oz was an accomplished surgeon at New York-Presbyterian Hospital. He still is. He operates there every Thursday, and recently showed New Yorker writer Michael Specter what the inside of someone's chest looks like when the heart is completely stilled for intricate surgery. It created an arresting scene for Specter's profile of Oz, which he called, "The Operator." (You'll understand why the title is a double entendre when you read the piece, which you can find here.)

The reporter posed a hard question to Eric Rose, the surgeon who trained Oz:

I asked if he would place his confidence in a heart surgeon, no matter how gifted, who operated just once a week, as Oz does. “Well,” he replied, “in general you want a surgeon who lives and breathes his job, somebody who is above all devoted to that.” Again he mentioned Oz’s experience, but when I asked if he would send a patient to Oz for an operation, he looked uncomfortable. “No,” he said. “I wouldn’t. In many respects, Mehmet is now an entertainer. And he’s great at it. People learn a lot, and it can be meaningful in their lives. But that is a different job...."

Celebrity has a magnetic attraction. We all want to be around people who are famous and who dazzle us with their intelligence and personality. But does celebrity mix with surgery, where the surgeon's skills stay up-to-date only with constant practice?

No, it just doesn't.

UPDATE: John McKiggan, a top malpractice lawyer in Halifax, Canada, has written a blog on the same subject, pointing to the research on the number of hours of practice -- typically 10,000 -- that it takes someone in any field to become truly proficient. John says he would also decline Dr. Oz, and he notes that many hospitals have their own version of Dr. Oz, not a TV personality perhaps, but a senior surgeon who has taken on other duties that may have left him or her a bit rusty with the knife.

Bottom line: It pays to know in advance your surgeon's current work load and experience.

The blood-thinning drug Pradaxa has starred in a long-running drama with hundreds of adverse event reports, scores of lawsuits and more than 500 deaths. Introduced in 2010 as an option to Coumadin (warfarin), Pradaxa is under fire for dire side effects including hemorrhage and internal bleeding, as we wrote earlier this year. Unlike older anti-clotting drugs, Pradaxa has no antidote for uncontrolled bleeding.

The latest chapter in this tale was told earlier this month by the New York Times, when the FDA released a report concluding that Pradaxa did not show a higher risk of bleeding than warfarin. As The Times noted, the report did not mention the lack of an antidote.

Medical professionals and patients alike have complained about Pradaxa, expressing concern that the approval process was insufficient, and that such a potentially dangerous drug should not be on the market without a way to reverse its unwanted effects. Pradaxa has made $1 billion for its manufacturer, Boehringer Ingelheim, but critics say it’s exemplary, as The Times puts it, “of what can happen when a drug that performs well in tightly controlled trials is released into the messy world of real-life medicine.”

The FDA report says that bleeding rates associated with Pradaxa don’t appear to be higher than those associated with warfarin. At the American Heart Association Scientific Session a week after the FDA report, Boehringer Ingelheim presented findings that, according to its news release, an antidote in development shows promise, and clinical trials are being initiated.

We have to ask: Didn’t they put the cart so far in front that you can’t even see the horse?

When reports began to surface of bleeding problems, Boehringer Ingelheim recommended dialysis to flush the drug out. Dialysis involves bypassing the kidneys to purify the blood through a machine. But the company, according to The Times, acknowledges that “the amount of data supporting this approach is limited.”

The boneheaded dialysis advice was described perfectly by one doctor in The Times’ story: “People that are bleeding to death aren’t going to tolerate being put on dialysis.”

The problem is compounded, according to The Times, if doctors prescribe the drug to the wrong patients. Older people and people with kidney problems are not good candidates for Pradaxa—their bleeding risks are higher than for other people. Boehringer Ingelheim advises testing a patient’s kidney function before prescribing Pradaxa, and notes that the risk of bleeding increases with age.

“The problem is that the people that prescribe this, as a general rule, are cardiologists and family practitioners,” Dr. Mark L. Mosley, director of the emergency room at Wesley Medical Center in Wichita, Kan., told The Times. “The people that see the harm are your E.R. docs and your trauma docs.”

When Pradaxa was approved, its lower maintenance seemed superior to the nearly 60-year-old warfarin (Coumadin) for preventing prevent strokes in people with atrial fibrillation (a heart-rhythm disorder commonly called A-fib). Warfarin patients must be carefully monitored for diet and drugs, and must have frequent blood tests. Not so for Pradaxa patients.

In little more than a year, The Times reports, 17 in 100 a-fib patients got Pradaxa; 44 in 100 got warfarin. The FDA estimates that in the U.S., about 725,000 patients have taken Pradaxa.

But in 2011, according to The Times, Pradaxa “was linked to more reports of injury or death than any of the more than 800 drugs regularly monitored by the Institute for Safe Medication Practices.”

Other new drugs intended as an option to warfarin (Xarelto, which has been approved to treat blot clots, and Eliquis, for which FDA approval is pending) also lack antidotes, but they haven’t shown the same bleeding-death risk as Pradaxa.

All medicine carries a risk of side effects; some can be life-threatening. Sometimes, the risk is worth it, which is the position adopted by medical professionals who believe in Pradaxa. The Times referred to a recent study showing that about 4 in 10 people with atrial fibrillation don’t take any drugs, leaving them at risk for strokes. Many cardiologists say the risk of stroke is more dangerous than the risk of bleeding complications.

Maybe. But if you’re an A-fib patient whose doctor recommends Pradaxa, find out why he or she prefers it to warfarin, which also can cause a host of side effects, some of them serious. If you’re older or have a history of kidney problems, beware, and seek a second opinion.

In antiquity, people chewed willow bark for its analgesic properties. Willow is rich in salicylate, the precursor to acetylsalicylic acid, the compound delivered today by common aspirin. It not only relieves pain, it reduces inflammation and fever. And within the last generation, aspirin has become the only over-the-counter analgesic that some health professionals have recommended to lower the risk of heart disease and stroke.

But the October issue of Harvard Men’s Health Watch suggests it might be wise to reconsider the regular use of aspirin for what it calls “primary prevention” of cardiovascular disease—that is, taking it an aspirin once a day when you don’t have heart disease but hope to prevent it.

Millions of Americans take a daily aspirin not for headaches but to hedge their heart health bets. They leave themselves at risk, according to Health Watch, for bleeding in the upper gastrointestinal (GI) region -- i.e., stomach and esophagus -- and the brain.

When blood vessels are constricted or obstructed, blood flow is reduced. Blocked arteries can cause heart attacks and strokes, so some people take aspirin because it suppresses the ability of blood to clot by making platelets less "sticky." The same trait raises the risk for bleeding in the gut and brain. “The critical question,” Health Watch says, “is whether your risk of cardiovascular disease outweighs the risk of bleeding. Right now, the answer is not simple.”

See our blog from last year about the danger of taking aspirin along with other pain relievers.

The risks are not the same for someone taking low-dose aspirin for “secondary prevention,” or those who have had a heart attack, certain kinds of stork or other cardiovascular disease. They have a high risk of additional problems, so the question of balance is clear: Aspirin is their friend (unless they are allergic to it or have a major bleeding issue).

Out of 10,000 people with a heart problem history, aspirin can prevent 250 cardiovascular events (heart attacks, strokes and sudden death). That same group will experience 40 cases of serious bleeding. For every six people helped, one will be harmed. “That's little consolation if you're sent to the hospital with internal bleeding,” Health Watch says, “but as a public health policy this risk equation is acceptable.”

Is it acceptable for you? Probably not if you’re taking it to prevent a heart “event.”

On average, for every 10,000 people taking low-dose aspirin, seven people will be helped (mostly by preventing heart attacks) and four will be harmed. Individual risk, of course, varies depending on your health profile and lifestyle choices. The benefit of aspirin rises with age, being overweight, smoking and having high cholesterol. The risk of bleeding also rises with age, but so does the risk of heart attacks and strokes, and, therefore, the potential benefit of taking aspirin.

A study in the Journal of the American Medical Association (JAMA) added fuel to the prophylactic aspirin fire. Analyzing health records in the Italian National Health Service, researchers concluded that the study “demonstrated that the incidence of major bleeding events is much higher than that recorded in randomized, prospective clinical trials. …[W]e found a 5-time higher incidence of major bleeding leading to hospitalization among both aspirin users and those without aspirin use.”

That study involved a wide range of patients; Health Watch says some probably would have had a higher risk of bleeding than the previous trial patients, which could explain the higher incidence of bleeding. That study also didn’t define the benefits of aspirin, which could have been significant.

For now, the science remains uncertain and experts disagree about who should take aspirin to prevent a first heart attack or stroke. European cardiology guidelines don’t recommend aspirin for primary prevention. In the U.S., the FDA has not approved aspirin labels touting cardiovascular disease prevention.

That could change if better primary prevention trial results indicate they should. But unless and until that happens, what should you do? The advice from the Harvard Men’s Health Watch is sensible: First, know your medical history and health profile. In other words, know as much as you can about your risk for developing heart problems. You can’t weigh potential harm against potential benefit without this information. And if you already take low-dose aspirin to head off cardiovascular disease, discuss the wisdom of this practice with your doctor.

NOTE TO READERS: The Harvard Men’s Health Watch newsletter was the major source for this piece.

Some states require health-care providers to report outcomes about certain heart procedures, and some states don’t. A recent study in Journal of the American Medical Association (JAMA) of nearly 100,000 Medicare patients in 10 states showed that doctors in mandatory reporting states perform the procedures less often than doctors in states with no reporting requirement. But, it’s interesting to note, these differences don’t seem to have affected patient survival rates.

For background information on heart attacks, see our newsletter.

As reported in the Los Angeles Times, the analysis reflects a national interest in greater transparency about how health-care providers compare. This month, for example, marks the beginning of the Centers for Medicare & Medicaid Services’ imposition of financial penalties on hospitals that fall short of standards for readmission rates (also known as "bounce backs," where the patient returns to the hospital fewer than 30 days after being sent home).

Many heart attack patients arriving at the ER are in acute distress and not likely to survive, no matter the intervention. Determining if any intervention would be likely to save the patient or be a futile effort can be tricky.

The most common procedure to clear blocked arteries is angioplasty. It involves threading a catheter through the artery to inflate a tiny balloon at the blockage site; often, a stent is installed to keep the artery open.

The JAMA study reviewed nine years of Medicare data about patients 65 and older who had suffered acute heart attacks. Thirty-eight percent of patients in the three states that require public reporting received an artery-opening procedure; 43 percent in seven states without the requirement got one. For patients with full blockages, the numbers were 62 percent versus 68 percent.

Thirty days after the patients presented, the overall death rates for both groups were about 12 in 100. Among patients with full blockages, the death rate in reporting states was 13.5 percent versus 11 percent in nonreporting states — a slight but statistically significant difference.

Many health policy professionals favor making performance data public to enable patients to make informed decisions about where they get care and to promote accountability among providers. If sunshine doesn’t always improve outcomes, some observers say it can backfire.

One cardiologist not involved in the study suggested that some extremely sick patients were being denied care because doctors were under pressure to keep their success rates high. Losing a patient would make them look bad, even if survival was doubtful from the get-go. If you’re forced to report outcomes, he said, some doctors just don’t do the procedures in hopeless cases.

The results of transplant surgery have long been made public in order to ensure that scarce organs aren’t wasted (see our recent blog post, “Why Organs Are Wasted, Not Transplanted.”) And Medicare’s Hospital Compare site publishes information about hospital performance.

But many doctors are opposed to public reporting, and point to studies such as JAMA’s as justification. If sunshine doesn’t always cultivate improvement, does that mean performance should remain cloudy? Many health professionals, according to The Times, believe these studies and their results reinforce the need for improved performance measures that examine the differences among patients and promote valid comparisons. And, one hopes, offer ideas about how to refine care so people get what they need and resources are used wisely.

Another cardiologist who helped develop the outcome measures used by Medicare said the next steps were to determine why some providers did better than others, and then to spread the best practices throughout the healthcare system.

"Just putting the data online is not enough," he told The Times.

One of the strongest risks for heart attack and stroke is hypertension, or high blood pressure, which is a measure of how hard the heart is working to pump blood.

The medical establishment has been aggressive in addressing hypertension with prescription drugs. But a new study in BMJ (British Medical Journal) concludes that treating patients with stage 1, or mild, hypertension with drugs has no benefit.

Study results indicated that drug treatment did not reduce total mortality risk, coronary heart disease or stroke.

Blood pressure (BP) is read via two numbers, systolic (top number) and diastolic (bottom number. Systolic reflects the maximum pressure exerted as the heart contracts, and diastolic reflects the heart at rest, or the time elapsed between beats.

BP readings generally are defined by four levels:

• normal (below 120/80);


• prehypertension (120-139/80-89);


• stage 1 hypertension (140-159/90-99);


• stage 2 hypertension (160+/100+).

Sometimes the two values fall into different categories; the correct reading in that case is the high, or riskier, level.

The BMJ study results were drawn from controlled, randomized trials of more than 8,900 patients with stage 1 hypertension. They were treated for four to five years. People with pre-existing cardiovascular disease were excluded.

Drugs prescribed to treat hypertension fall into several categories, including diuretics (Lasix, Bumex, etc.), ACE inhibitors (Vasotek, Prinivil, Mavik, etc.), beta blockers (Lopressor, Levatol, Inderol, etc.) and others.

Side effects of blood pressure drugs can be significant. They vary depending on the class of drug taken, and include:

• irregular or rapid heartbeat;


• erectile dysfunction;


• dizziness;


• headaches;


• weakness, fatigue;


• leg cramps;


• intense, sudden foot pain;


• depression;


• insomnia;


• dry cough;


• skin rash;


• loss of sense of taste;


• constipation;


• swollen ankles;


• dry mouth;


• diarrhea;


• heartburn;


• fluid retention;


• joint pain.

One reviewer of the BMJ research said that the analysis should lead to dramatic changes in the way doctors treat mild hypertension; that behavioral changes—exercise, smoking cessation and improved diet—should take precedence over blood pressure pills.

Dr. Julian Tudor Hart responded to the research with particular insight. “Why has it taken more than 30 years to reach this conclusion,” he wrote, “when it was already evident from any careful and critical reading of the trials claimed originally to justify interventions in the diastolic range 90-100 mm Hg? And what should we do now to get practice onto a more rational footing?”

Hart has long believed that controlling blood pressure with what he calls a “whole community,” or less pharmaceutical, approach is possible and effective. But the medical establishment had been steadfast in finding the 90 mm Hg (millimeters of mercury, the silver element visible in the BP gauge) as the threshold for drug intervention.

After a series of symposia on mild hypertension sponsored by the World Health Organization decades ago, Hart refused to support this advice. The WHO organizer, he writes, “appealed to me to do what all other participants had done, and sign the statement, reminding me that three transnational pharmaceutical companies were sponsoring all three symposia and had a right to expect results. I still refused.”

Really, is anyone surprised that Big Pharma is happy when the medical establishment opts for scorched-earth treatment when a drug-free approach might work better?

After a nasty, profane exchange with other medical professionals, Hart relented and signed the statement supporting drug intervention for mild hypertension. “I thought I had reached the limit of what a mere GP could do without becoming hopelessly isolated,” he explains, but, “… I was never convinced that the very small reductions in cardiovascular and cerebrovascular event rates justified the conclusion, except in diabetics.”

Another researcher at the symposium told of the pressure he had felt to find positive results in large scale studies or risk losing funding for future research. That man, Hart, says, “concluded that, realistically, medical scientists might have to accept that some degree of ‘quasi-science’ was inevitable and therefore justifiable, for obtaining necessary state funding. Conclusions must sometimes be bent to our market.”

Science, Hart admonishes, “cannot include a market for medication accepting all the plausible mythologies lobbyists can maintain among the lay public, media editors and politicians.” The body of knowledge is advanced not only “by showing that new methods are useful, but equally by showing that they are no better than old methods, or perhaps don't work at all. All three outcomes represent worthwhile gains in knowledge.”

Although not all causes of high blood pressure are known, several factors contribute, many of which individuals can address without drugs:

• smoking;


• being overweight or obese;


• lack of physical activity;


• too much salt in the diet;


• excessive alcohol consumption;


• stress;


• advancing age;


• genetics;


• family history of high blood pressure;


• chronic kidney disease;


• adrenal and thyroid disorders.

If your hypertension is mild, and you do not have other, complicating disorders (diabetes, kidney disease, etc.), do not accept a prescription for blood-pressure medicine without discussing lifestyle changes first. If your doctor is unwilling to have this conversation, or to see beyond the pill fix, it’s time for a second opinion.

Heart disease is the No. 1 killer in the U.S. for both men and women—more than 600,000 deaths every year. The estimated annual cost of heart disease in the U.S. is more than $316 billion for health-care services, medications and lost productivity, according to the Centers for Disease Control and Prevention (CDC).

You’d have to be a recent transplant from Saturn not to know that diet plays an important role in heart health. Eating too much of certain kinds of fat can boost blood cholesterol levels and the possibility of atherosclerosis (blocked arteries), which can cause a stroke as well as heart attack. Eating too much sugar and processed foods packs on the calories, and often the pounds. Too much weight, again, puts your heart at risk. Eating too much sodium (salt) can increase your blood pressure and your risk for a heart attack and stroke.

So what in the world was the American Heart Association (AHA) thinking when it sold Frito-Lay the right to distribute its highly processed, salty snack food at the AHA Dallas Heart Walk?

The question, posed on WeightyMatters.ca, which raises consciousness about healthful eating and Big Agri, makes you wonder if nothing, not even your core message, is more important than exploiting a money-making opportunity.

The walk, like similar events all over the country, raises money to fund heart disease research. According to WeightyMatters, it raised more than $4 million this year, and drew a huge crowd.

In exchange for its “generous” donation of Cheetos to the assembled masses, Frito-Lay got to:

• Tie their brand to the positive emotions of the walk—joy, hope, charity, community spirit. Never mind that a heart attack is the last thing that would make you happy.


• Target their marketing to the large contingent of youngsters in attendance (who got to meet and greet Cheetos mascot Chester the Cheetah) in hopes of converting them into brand-loyal consumers.


• Promote the idea of junk food as a part of daily life that has the blessing of the American Heart Association.

An organization devoted to healthful behavior and saving life should be ashamed for betraying its message for 30 pieces of silver.

Sadly, it’s the American way. Remember our blog earlier this year about the breast cancer foundation’s unholy alliance with a firearm vendor? And, as one person who commented on the WeightyMatters site put it, “[M]y kids came home outraged last year after the Heart & Stroke Foundation came to their school to launch the Hoops for Heart program. Apparently the kids had been told, among other things, to watch less TV & play fewer computer games. The big prize for the kid raising the most money? An Xbox.”

If you’re more interested in doing the right thing, see our recent newsletter, “A Healthy Heart: Unlocking the Key to Long Life.” And to learn more about a heart-healthy diet, see this backgrounder from the CDC.

Our August newsletter about dietary supplements included some cautionary advice about some so-called “natural” supplements that can cause significant harm. One was Reumofan, a product manufactured in Mexico and marketed as a remedy for pain.

The FDA had issued a warning earlier this year about it after receiving several adverse event reports, including stroke, gastrointestinal bleeding, liver problems and worsening glucose control.

Last week, the feds raised the volume of concern about Reumofan after additional reports of bleeding, strokes and even death, according to AboutLawsuits.com.

The warning, “FDA issues new safety alert on Reumofan Plus and Reumofan Plus Premium,” says that these products contain drugs that are not declared on the labels. They’re also illicit.

The worrisome active ingredients are dexamethasone, diclofenac, and methocarbamol, a combination whose risk factors include severe injury or death, according to the regulators. Dexamethasone, a corticosteroid, is so powerful that the FDA advises people taking Reumofan products to consult their doctor before they stop using it. It must be discontinued under medical supervision because of a risk of withdrawal syndrome.

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID); methocarbamol is a muscle relaxant. The former can increase the risk of heart attack, stroke and gastrointestinal problems, and the latter can cause dizziness, low blood pressure and compromised mental and physical activity.

It is illegal for products billed as dietary supplements, which are not subject to the same regulatory scrutiny as drugs, to contain FDA-controlled medications.

If you use or recently used any Reumofan product, contact your doctor immediately. If you had a problem after taking Reumofan, contact MedWatch, the FDA’s adverse event reporting program, at (800) 332-1088 or online here.

A disturbing story published last week in the New York Times raised anew questions about how profit sometimes is the primary consideration in performing medical procedures. Following a major hospital chain’s paper trail, The Times told a story of widespread overuse of cardiology resources with serious implications for patient safety.

In 2010, Stephen Johnson, the chief ethics officer of HCA, the largest for-profit hospital chain in the U.S, received a letter from a former nurse at a Florida hospital claiming that a doctor there was performing heart procedures on patients who didn’t need them. A two-month internal investigation confirmed the charge in a confidential memo by Johnson. The doctor was slapped on the wrist, but the nurse lost his job. That decision, Johnson said in the memo, was because he blew the whistle on the cardiologist.

“But the nurse’s complaint,” The Times reported, “was far from the only evidence that unnecessary — even dangerous — procedures were taking place at some HCA hospitals, driving up costs and increasing profits.”

According to The Times, Medicare reimburses hospitals about $10,000 for a cardiac stent—a tiny tube that holds an artery open. But recently, doctors have been less eager to implant stents, preferring drugs to treat blockages.

Another invasive test, cardiac catheterization, which Medicare reimburses at about $3,000, is used to diagnose blocked arteries. A long, thin, flexible tube (the catheter) is inserted into a blood vessel in the arm, groin, or neck and threaded to the heart, where it is used to inject dye into the heart's blood vessels to take x-ray pictures.

Even if necessary, these procedures pose a range of risks from infection, nerve damage, pain to death. Cardiologists generally don’t operate on coronary arteries unless they show at least 70 percent blockage. (See our story about unnecessary surgery here.)

Although The Times’ story focused only on HCA, a story published last week by ProPublica, an independent investigative organization, said that the practice of inflating the need for cardiac procedures is widespread.

ProPublica referred to a study published last year in the Journal of the American Medical Association that found that only half of 144,000 nonemergency heart catheterizations were appropriate.

"It's presented in the media as if it's an aberrancy, when actually it's the rule," Dr. David Brown, an interventional cardiologist and professor of medicine at SUNY-Stony Brook School of Medicine told ProPublica. "The medical system is addicted to the revenues that it generates."

Last year, Medicare spent nearly $1 billion on the procedures that boost revenues for doctors and hospitals but cost taxpayers, raise insurance premiums and put patients at risk—about 3 in 100 patients experience serious complication.

Since 2002, HCA itself had uncovered evidence that some cardiologists at several of its Florida hospitals were unable to prove the need for many of the procedures they were performing. To justify them, according to internal HCA documents, doctors wrote inflated medical reports to make it seem as though they were necessary.

Approximately half of one HCA hospital’s cardiac catheterizations—about 1,200—were deemed to have been performed on patients without significant heart disease, according to a 2010 confidential review.

At one hospital, a 44-year-old man who came to the emergency room complaining of chest pain suffered a punctured blood vessel and a near-fatal irregular heartbeat after a doctor performed a procedure that an outside expert later suggested might have been unnecessary. The patient had to be revived.

In another incident at the same hospital, a woman with no significant heart disease went into cardiac arrest after a vessel was cut when a cardiologist inserted a stent. She was hospitalized for several days.

Last month, the U.S. attorney’s office requested information on reviews assessing the medical necessity of interventional cardiology services provided at 10 of HCA’s hospitals. The Justice Department, according to the Associated Press, also will review billing and medical records at 95 HCA hospitals.

HCA declined to provide evidence that it had alerted Medicare, Medicaid or private insurance companies of its findings, or that it reimbursed them for any procedures the company determined had been unnecessary, never mind that such action is required by law.

HCA told The Times that it took the steps necessary to improve patient care, and that “significant actions were taken to investigate areas of concern, to bring in independent reviewers, and to take action where necessary.”

But HCA declined to show that it had ever notified patients, who might have been entitled to compensation from the hospital for any harm. And some of the doctors accused in the reviews of performing unnecessary procedures still practice at HCA hospitals.

How “significant” can its actions have been?

The Times reviewed hospital communications and concluded that rather than asking whether patients had been harmed or whether regulators needed to be contacted, hospital officials asked for information on how the physicians’ activities affected the hospitals’ bottom line.

Maybe that’s because HCA is less concerned about doing no harm than in recouping expenses for its chronic bad behavior. In 2000, HCA settled one in a series of huge Medicare fraud cases with the Justice Department that tallied $1.7 billion in fines and repayments, mostly concerning charges of overbilling.

Only two years after that fraud settlement, HCA started uncovering the “questions regarding the medical necessity of some of the procedures” that remain problematic.

Today, the surgeon who inserted a cardiac stent after the whistle-blowing nurse (and others) had seen no blockages in the images of the patient’s artery continues to practice at the same HCA hospital. This, despite the fact that an outside heart specialist found problems with 13 of the 17 cases the surgeon performed, including unwarranted cardiac catheterizations and patients who were needlessly subjected to multiple procedures.

To learn more about options for treating coronary problems, visit the website of the Informed Medical Decisions Foundation.

Warfarin, the generic name for the most widely prescribed oral anticoagulant (blood thinner) in America, is used to prevent thrombosis (blood clots) and thromboembolism (blood clots that migrate throughout the body). People diagnosed with atrial fibrillation (rapid or irregular heartbeat), narrowed coronary arteries, who have had valve or stent replacement surgery or have a history of blood clots in the legs or lungs, often are prescribed warfarin, or its most common brand name, Coumadin.

The blood thinner can be a lifesaver for people at risk of stroke or heart attack caused by blood clots. (To learn more about maintaining heart health, see our newsletter, “A Healthy Heart: Unlocking the Key to Long Life.”)

But according to the Harvard Medical School heart health newsletter, these patients must ensure that they’re not posing additional risks by taking warfarin with certain antibiotics and antifungal drugs, which enhance warfarin’s blood-thinning effect, and possibly prompt internal bleeding.

The amount of warfarin in the bloodstream is measured by clotting time, and is expressed by the international normalized ratio, or INR. The higher the INR, the longer it takes blood to clot. In warfarin patients, medical practitioners look for a ratio of 2 to 3, although individual numbers might vary. Antibiotics affect these levels. Somebody who’s stable at 2.5 and takes an antibiotic can measure 5. If that level is sustained, it can cause gastrointestinal bleeding; a bump on the head, as the newsletter notes, can prompt bleeding in the brain.

Because antibiotics affect people differently, warfarin patients must be evaluated carefully and monitored regularly as soon as they begin a long-term antibiotic regimen. (With a short-term prescription, such as that used for two or three days in advance of dental work, an increase in INR isn’t necessarily worrisome, as the antibiotic clears the system quickly.)

Potential problems must be monitored particularly with broad-spectrum antibiotics, including erythromycin, penicillin and ciprofloxacin. Sometimes their doses must be lowered to accommodate warfarin patients.

In addition to pills, topical antibiotics—those delivered via ointment, cream or suppository—also are absorbed into the bloodstream and interfere with warfarin. Antifungal cream is a prime example. It’s often prescribed to women with vaginal yeast infections.

Like all drugs, warfarin taken alone carries potential side effects and risks. A recent story in Forbes noted that last year, warfarin was the second most prevalent drug in FDA safety reports “and has been high on the FDA list for many years.” It was the subject of 1,106 serious adverse events, including 72 deaths.

Although doctors generally discuss the risks of antibiotics with their warfarin patients, there’s plenty of opportunity for an adverse event if:

• a patient doesn’t understand the potential significance of the drug-drug interaction;


• a patient forgets the drug information;


• a doctor prescribing the antibiotic is different from the doctor prescribing the warfarin, and communication between the two falters;


• a patient doesn’t comply with INR testing;


• the drug-interaction alert function in the doctor’s computerized medical records is inoperative and/or the medications it lists is out of date;


• a patient uses different pharmacies for filling the warfarin and antibiotic prescriptions, so the pharmacists aren’t aware that a warning should be issued;


• a patient gets an antibiotic sample or handwritten prescription, bypassing a computer system alert.

So both prescribing doctors and their warfarin patients both must take responsibility for managing drug use.

It has been 10 years since the U.S. Preventive Services Task Force (USPSTF) raised a red flag of concern for women who take hormone replacement therapy (HRT). A systematic review of scientific research published on the subject since 2002, the task force concluded last week, confirms the initial call for caution.

HRT is most often prescribed to alleviate the symptoms of menopause, including hot flashes, vaginal dryness, sleep disturbances and mood swings. Although HRT might be appropriate for people in this situation, the task force said that the risks for most women taking HRT for the long term still outweigh any benefits it confers in preventing chronic conditions.

As reported widely, including on MedPage Today, the hormones at issue—estrogen and progestin—do help prevent bone fractures, used alone and together. But they increase the risk of stroke, thromboembolisms (blood clots that dislodge and move through the circulation system), gallbladder disease and urinary incontinence.

The review of HRT was published on the Annals of Internal Medicine.

Most women prescribed HRT are given estrogen plus progestin because unalloyed estrogen increases the risk of uterine cancer, so plain estrogen is generally prescribed only for women who have had a hysterectomy. The new study indicates that the estrogen/progestin compound also increases risk for breast cancer and dementia. Estrogen alone decreases the risk for breast cancer.

In 2002, the USPSTF recommended against routine, long-term HRT use, and in 2005 recommended against long-term us of estrogen alone. The recommendations did not address short-term use of HRT to relieve menopause symptoms.

The new review of nearly a decade’s worth of clinical studies evaluated HRT’s effect on cardiovascular disease, cognitive decline, osteoporosis (thinning of the bones) and cancer.

Use of estrogen alone showed significant decreases in invasive breast cancer and mortality. Use of estrogen/progestin showed significant decreases in diabetes. Bone fractures were reduced significantly with both hormone regimens in some studies but not others.

But the harms significantly increased by one or both hormone replacement regimens were:

• invasive breast cancer (estrogen plus progestin);


• stroke (both);


• deep vein thrombosis (DVT/blood clot—both);


• pulmonary embolism (blood clot in the lung—estrogen plus progestin);


• breast cancer mortality (estrogen plus progestin);


• lung cancer mortality (estrogen plus progestin);


• gallbladder disease (both);


• probable dementia (estrogen plus progestin);


• urinary incontinence (both).

The number of women who would be expected to suffer harm, the study concluded, was far greater than those who would benefit from either regimen. With estrogen alone, there would be eight fewer invasive breast cancers, 56 fewer fractures and two fewer breast cancer deaths, but 11 more strokes, seven more DVT episodes, 33 more gallbladder disease cases and 1,271 cases of urinary incontinence per 10,000 person-years (the product of the number of years times the number of people in a population who have been affected by a certain condition; that is, years of treatment with a given drug).

The corresponding numbers for estrogen plus progestin, according to the study, were just as unfavorable.

There might be benefits worthy of HRT (and different harms) for certain people with certain conditions, for which the study was inconclusive. Such different results could occur because of differences in age, type of hormone therapy, natural versus premature menopause or other medical conditions.

But the bottom line for most women is that hormone replacement therapy generally should be used only for short-term relief of menopausal symptoms. Individuals should discuss its suitability for other concerns only in the context of a complete medical history and an understanding of the risks.

For some people with heart rhythm abnormalities, an implantable cardiac defibrillator (ICD) can be a lifesaver. The small, electronic device is surgically implanted inside the chest to prevent cardiac arrest from hearts that beat abnormally fast (“tachycardia”). An ICD monitors the heart rhythm, and if it senses tachycardia, it delivers an electrical shock to restore the rhythm to normal.

The devices, which are a couple of inches in size, include cable-enclosed wires, or leads, that connect to the heart. As we recently reported, such defibrillators represented nearly 1 in 3 recalled medical products from 2005 through 2009, and a 2006 study linked defibrillator failure to more than 300 deaths over a 10-year period.

A story in The New York Times earlier this month focused on one manufacturer of ICDs with an unacceptable number of adverse events. The Riata wires in devices made by St. Jude Medical have a tendency to work their way out of the cable coating, causing the device to fire wildly. That’s life threatening to anyone who hosts such a device.

“St. Jude officials have acknowledged that reports show that at least 20 patients have died in such episodes,” The Times reported, “but say that such incidents are not unique to the Riata and that the rate of the fatal episodes is comparable to that of other devices.”

As The Times noted, last year researchers reported that among patients tested, wires protruded out of 15 in 100 St. Jude leads. As doctors and the medical device industry grapple with the scope of the problem, worry only intensifies because the wires are dangerous to remove, and potentially dangerous to leave implanted.

Three highly visible lead episodes in the last seven years, according to The Times, have raised questions about the FDA’s scrutiny of heart devices. St. Jude’s primary competitors—Guidant/Boston Scientific and Medtronic—have also experienced patient injury or death with their flawed products.

Despite pronouncements by St. Jude executives that it has warned doctors about problems with its leads, medical experts say the company was slow to inform doctors of the 128,000 patients with its device. Giving credence to that claim is the fact that the adverse events associated with St. Jude’s leads were not discovered by its own monitoring system, but by outside researchers

St. Jude took both the Riata and the Riata ST models off the market in late 2010. It continues to sell the Durata, which features extra insulation to keep the wires confined.

The medical journal Heart Rhythm published the article by Dr. Robert Hauser of the Minneapolis Heart Institute Foundation about deaths associated with the Riata lead. St. Jude objected, claiming that it contained several errors, and has called for a retraction.

Company executives said Medtronic was just as culpable, if not more, than St. Jude because it also produced flawed products and intimated that Durata also carried risks of failure. They said Riata looked worse than competitors only because St. Jude had been more complete in filing reports to the FDA than Medtronic.

As Global Data, a research and analysis concern, described it, “The gloves are off and the fight has begun. St. Jude … must defend its honor against a report … [that] compared 71 deaths associated with St. Jude’s Riata and 62 associated with Medtronic’s Quattro Secure, a competing product. Of the Riata deaths, 22 out of 71 were identified as resulting from lead failure as compared to 5 out 62 Quattro Secure deaths. The study suggests that unlike the Medtronic leads, the St. Jude Riata lead deaths were caused by electrical malfunction at high voltages. This differs from the previous conclusion that externalized cables (lead wires coming out of their insulation) were the culprit.”

Merrell Goozner, writing on GoozNews, offered additional perspective on the subject last week. When St. Jude Medical accused Hauser of undercounting the deaths associated with rival devices, he wondered why the phrase “falling out among thieves” came to mind.

“St. Jude and Medtronic are not thieves, of course,” he wrote. “They merely take advantage of a flawed Food and Drug Administration process for approving new devices, where updated devices can enter the market without extensive clinical trial testing because they are only minor variations from earlier technology. When the ‘minor’ variation turns out to be flawed electronic leads that cause the device to repeatedly misfire, leading to the equivalent of a mule kicking the nonpatient in the chest, … then perhaps we have a problem with our regulatory system.”

Goozner, who noted that Hauser also has written about the regulatory mess in the New England Journal of Medicine, examined who supports the Minneapolis Heart Institute. Medtronic, he wrote, has given more than $1 million to the organization and St. Jude/ Boston Scientific have given as much as $999,999. The trial lawyers who sued Medtronic also gave more than $1 million.

“So here I think we have finally found the solution to the vexing conflict-of-interest problem,” Goozner concluded. “Rather than banning people with conflicts of interest from writing editorials and commentaries in leading medical journals (which, if properly reported, might have caused NEJM editors to pause before letting Dr. Hauser write his piece), editors should simply insist that they take money from everyone. It clearly hasn’t dissuaded Dr. Hauser from doing yeomanlike work on behalf of the public health and safety, for which he is to be congratulated.”

This corporate spitting match ignores the overarching concern: What if you’re an ICD patient?

St. Jude says it’s conducting a study of patients with the Riata lead, and will advise doctors how to manage such patients. That’s nice, but it’s not enough.

A story late last week in the Wall Street Journal said that the FDA, pushed by doctors to strengthen safety reporting requirements for medical devices, is planning to introduce a safety-monitoring program whose purpose is to remove faulty devices from the market quickly. Supposedly, the plan assigns each medical device a unique number to enable tracking its malfunctions.

Let’s hope that happens. In the meantime, if you have an ICD, find out if its among the ones detailed above; if so, your cardiologist should be able to address your concerns. If you’re not satisfied, seek a second opinion. Keep the FDA MedWatch program apprised of any problems you have. If you wish to research voluntary reports made to the Manufacturer and User Facility Device Experience (MAUDE) database consulted by the Heart Rhythm researchers, link here.

A class of drugs called statins lowers blood cholesterol levels by reducing the production of cholesterol by the liver. Lipid regulators, which are primarily statin drugs, are the most commonly prescribed medication in the U.S., according to a report by the IMS Institute for Healthcare Informatics.

Last month the FDA acknowledged that statins may play a role in elevated blood sugar, as well as memory and cognition problems. It determined that the increased risk of diabetes was sufficient to warrant a warning on statin labels.

Although cholesterol is essential to normal cellular function, it also contributes to the development of atherosclerosis, a condition in which cholesterol-containing plaques form within arteries. They can become blood clots and cause angina (chest pain) and heart attacks. If the clot occurs in the brain, the result is a stroke.

Statins are prescribed to prevent and treat atherosclerosis. The most common statin brands are Liptor, Lescol, Mevacor, Crestor, Socor and Pravacahol, among others. They can save lives, but, as always with prescription medicine, are not without risk.

Despite the additional warnings, according to a story by ABC News and MedPage Today, the FDA said it "continues to believe that the cardiovascular benefits of statins outweigh these small increased risks."

The agency backed away from an earlier recommendation that patients taking statins undergo routine liver function tests, but advised that their doctors order one before starting patients on statins. The FDA has determined that the risk of liver damage is rare, but unpredictable.

The diabetes warning is not surprising, given that one trial resulted in an increase of 27 percent in new onset of diabetes among patients taking statins. Those results were curious, because the study subjects were people without a history of cardiovascular disease—a so-called “healthy patient trial.”

At the time, the FDA approved the study drug (rosuvastatin) for prevention of cardiovascular problems, but the scientific community took note of its peripheral results.

Another study reported in the ABC/MedPage story, showed that hyperglycemia (elevated levels of blood sugar) occurred among patients taking atorvastatin, and analysis of 13 different statin trials yielded increased risk of diabetes in nearly 1 in 10 subjects.

The other concerns noted by the FDA were mostly the result of adverse event reports, which are made by patients, practitioners, pharmacists, etc., after a drug reaches the consumer market. The agency said they generally involved individuals older than 50 “who experienced notable, but ill-defined memory loss or impairment that was reversible upon discontinuation of statin therapy."

A few days after the diabetes/memory loss warning issued, the FDA said certain statins—atorvastatin (Lipitor), rosuvastatin (Crestor) and simvastatin (Zocor)—might prompt negative interactions in patients taking drugs to treat HIV/AIDS or hepatitis C. The agency issued a warning about those drugs, and reiterated its warning about combining lovastatin (Mevacor) with HIV and HCV drugs.

The potential problem here is kidney damage. If you take these drugs, consult your doctor immediately about lowering the dose or making other alterations.

Practitioners greeted the diabetes warning-label decision with mixed feelings. Although some expressed support for relaxing the liver function test, they were concerned that patients would be scared away from the statins they need to control their cholesterol.

"All drugs have side effects and rarely some patients will have an odd reaction to statins—cognitive effects are among those—and are usually mild and resolve with stopping the medication,” said Dr. Harlan Krumholz of Yale University.

Dr. Steven Nissen of the Cleveland Clinic said "these are reasonable and prudent recommendations. I am pleased that FDA did not overstate the diabetes and cognitive function risks. Both problems are uncommon and don't diminish the importance of statins in cardiovascular protection. For the vast majority of patients, the benefits far outweigh the risks."

If you take a statin drug, or are considering it, discuss potential side effects with your doctor. Ask him or her if you can try behavioral therapies—diet and exercise—first. We’re hardly alone in questioning whether statins are too often the go-to drug for practitioners. So if your doctor is unwilling to consider options, especially if you are not yet taking statins, it’s time to get a second opinion.

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.”

In case you're feeling the slightest twinge of sympathy for the tobacco makers, here's what Dr. Howard K. Koh, writing in the New England Journal of Medicine, says.

“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