Posts Tagged ‘Heart’

Overtreated—Why too much medicine is making us sicker and poorer

Posted by medconsumers on March 1, 2008

New Book: Overtreated by Shannon Brownlee (NY: Bloomsbury, 2007)

In a nutshell, overtreatment is unnecessary treatment. It’s treatment that has no positive impact on health or longevity, and in many cases, causes harm. It’s the coronary-artery opening procedures given yearly to more than one million Americans for whom drug therapy has been proven to be the better choice. It’s the long-term drug regimens recommended to people at low-risk for hip fracture, heart attack or stroke. It’s the PSA blood test for finding prostate cancer at its earliest stage, despite the fact that studies have yet to prove immediate treatment is better than no treatment at all. Just to name a few.

About one-third of the medicine we receive is unnecessary, according to “Overtreated” by journalist Shannon Brownlee. “We spend between one fifth and one third of our health care dollars, between $500 and $700 billion, on care that does nothing to improve our health.” Central to this excellent book is the work of John Wennberg, MD, whose pioneering research spans four decades.

Wennberg was the first to detect wide geographic variations in medical care, first within his home state of Vermont and later in the country at large. Wennberg recalls that he embarked on this research project in the late 1960s with a notion shared by many doctors of that era: The most serious problem in American health care was that many citizens were not getting enough of it. Still, it was startling to find, for example, that in Middlebury, VT, 7% of children under the age of 16 had their tonsils removed, and in Stowe, VT, 70% of children had the operation. Similar variations were shown for other procedures like hysterectomy, hernia operations and hospitalizations for heart attacks.

Extensive interviews of 4,000 people living in this most homogeneous of states ruled out the obvious explanations like patient demand and the possibility that people were sicker in some areas of Vermont. The high rates of surgery were, in fact, driven by doctors not patients. Findings like these ultimately led Wennberg to conclude, “Medicine had wrapped itself in the mantle of science, yet much of what doctors were doing was based more on hunches than good research.” Wennberg’s work drew hostile reactions from fellow physicians, and medical journals turned down publication of his findings. When they were finally published in Science magazine in 1973, they drew no attention. More medical care was still considered to be better care.

Cost Becomes an Issue

In time Medicare provided Wennberg, who had moved on to Dartmouth Medical School, with a treasure trove of patient records to learn not only about regional variations in care for everyone over age 65 but also the cost of treatment. Cost had become a major issue for Medicare by 1995 due to the huge 6000% increase in spending over the 30 years following its launch. With Dartmouth colleagues, Wennberg spent the next three years combing through the Medicare data. One example of what they found: Medicare spent an average of $8,414 for an enrollee living in Miami compared with $3,341 for an enrollee in Minneapolis.

The price of major treatments, as it turns out, played an insignificant role in explaining the differences. The cost of a hip replacement, for example, was only slightly more in Miami than in Minneapolis. Another obvious possibility—elderly people are sicker in some areas of the country than in others—also accounted for only a small difference in cost.

Findings like these began to get national media attention, but the Dartmouth researchers still had to determine whether more care means better care. In 2000 Wennberg’s colleague Elliott Fisher, MD, conducted another study that showed Medicare recipients living in high-cost regions were no healthier and no less disabled than those in regions that got less medical care. The big shocker, however, was this: More care sometimes led to more deaths.

Ultimately, Fisher showed that the people in high-spending regions were not getting more major surgery. Rather they were getting more tests, drugs and procedures that were likely to be done even when it didn’t make sense in frail elderly people with a short life expectancy. An excess of specialists was a major part of the problem. “Patients with heart attack, hip fracture or colon cancer got more care—but not better care—in hospitals where there were more specialists,” concluded Fisher.

Eventually Fisher determined that the 2-6% increase in deaths among Medicare recipients living in high-cost regions was due to the fact that they spent more time in the hospital. Patients are exposed to all the risks that include hospital-borne infections, medical errors and the complications and side effects that come with any treatment.

The results of the Wennberg and Fisher studies have been known for years and have long been available to all in the Dartmouth Atlas of Health Care (www.dartmouthatlas.org). The author of the new book “Overtreated,” Shannon Brownlee, a senior fellow at the New America Foundation, provides a public service by calling attention to this important research which is even more relevant today when the newest costliest imaging, cardiac and other high-tech procedures receive almost instant uncritical acceptance.

Brownlee brings us up to speed on the few surgical procedures and drugs that are well studied and proven to be of value…but to a much smaller proportion of current recipients. One outstanding example is the coronary-artery-opening procedure called angioplasty, which, by the way, was shown to have wide regional variations by West coast researchers building on the Dartmouth researchers’ work.

Each year two million Americans receive an angioplasty, but studies show that only 800,000 of them who are in the midst of a heart attack are likely to benefit. The majority have other cardiac-related conditions like stable angina or shortness of breath, which can be more safely and effectively treated with the same drugs that will be given after an angioplasty. In a 2006 federally funded trial, the rate of death and heart attack was lower in those treated with multiple-drug therapy alone than in those given angioplasty plus multiple-drug therapy. Angioplasty with a stent costs insurers $10-15,000.

While angioplasty is an example of doctors ignoring scientific evidence that clearly shows who should get this treatment and who should not, there is no definitive information one way or another about the vast majority of tests and treatments. The Institute of Medicine estimates that only 4% are backed up by strong scientific evidence, more than half have very weak evidence or none.

Malpractice fears cause doctors to order more tests, but to Brownlee the more powerful reason doctors and hospitals overtreat is they are paid more for doing more. She calls for an overhaul of malpractice laws because they fail to punish and weed out incompetent doctors and to compensate patients for injuries that result from medical errors.

Brownlee takes consumers to task for contributing to overtreatment by making irrational demands for drugs advertised on TV or over-the-top diagnostic tests like an MRI for a sprained ankle. She calls for more independent sources of information like the federal Agency for Healthcare Policy and Research so that consumers can be better informed. Studies show that when they are given high-quality decision aids describing the benefits, risks and unknowns about treatment options, many will make an informed decision not to be treated.

The last chapter called “Less is More” presents solutions that will go a long way toward fixing our dysfunctional system. The ideal medical care system Brownlee envisions is one that rewards doctors for using evidence to improve quality; keeps specialist care to a minimum; coordinates care in ways that will reduce errors and overtreatment—among other ideas. Pie in the sky? Brownlee says that several U.S. health care systems have already implemented these ideas—Kaiser Permanente, Veterans Health Administration (VHA), Group Health of Puget Sound and the Mayo Clinic where doctors are on salary.

The VHA is especially interesting because it managed to turn around a failed medical care delivery system in less than a decade. The VHA decentralized its health care; put doctors on salary; makes sure every veteran has a primary care doctor at a local VHA clinic; rewards hospitals that hit performance measures set by Washington; negotiates discounts for drugs; and computerizes patient records to reduce medical errors and repeat testing. In 2003 The New England Journal of Medicine published a study that compared veterans’ health facilities with traditional Medicare. The quality of the care delivered at VHA health facilities proved to be significantly better on nearly all 11 performance measures.

Yet-another kudo for the VHA came from the independent National Committee for Quality Assurance which ranks health-care plans according to 17 performance measures, such as prescribing beta blockers for patients after a heart attack. By every measure, the VHA system outperformed the highest rated non-VHA hospitals, including those widely perceived to be the best in the country.

If the VHA can do it….

Maryann Napoli, Center for Medical Consumers©March 2008

Posted in Book Reviews, surgery | Tagged: Book Reviews, Drugs, excessive treatment, Heart, overtreatment, PSA | Comments Off

Failed Vytorin Study Raises Questions About Cholesterol

Posted by medconsumers on February 1, 2008

A firestorm of bad publicity erupted over cholesterol drugs last month when an expensive combination drug proved to be no better than an older drug alone. This finding was suppressed for 20 months by Merck and Schering-Plough, the two companies that make Vytorin, which is a one-pill combination of Zetia and Zocor. Their two-year trial failed to prove that Vytorin is better than Zocor alone for slowing plaque accumulation; instead atherosclerosis worsened in those taking Vytorin.

But the study results were not revealed until the two drug companies were pressured into doing so by an article in The New York Times and a Congressional inquiry. Worldwide, about one million prescriptions for Vytorin and Zetia are written each week, and they generated about $5 billion in sales last year. Zocor can be purchased under its generic name simvastatin for less than $6 for a month’s supply; whereas an equivalent amount of Vytorin costs about $100. It was obviously in the two companies’ interest to withhold the negative results for as long as they could get away with it.

When Vytorin came on the market two years ago, it was impossible not to be cynical about its purpose. Merck’s patent for Zocor was running out, and its blockbuster status would soon be diminished with generic competition. The company joined forces with Schering-Plough, maker of Zetia, and sought FDA approval for Vytorin. Their FDA-required trials showed a 17% greater reduction in LDL, the so-called bad cholesterol, than Zocor alone.

Making this 17% reduction in LDL look like an amazing achievement was not much of a stretch. Merck and the makers of other statin drugs like Lipitor and Pravachol had already paved the way. Their respective marketing machines had long ago misled most of us (doctors included) into thinking that cholesterol reductions equal heart attack reductions. One consistently overlooked fact about statins: They are far better at lowering cholesterol than preventing heart attacks or strokes. And those small reductions in heart attacks and strokes shown in clinical trials are largely confined to high-risk middle-aged men and those with heart disease or diabetes. Vytorin, on the other hand, has not been proven to reduce heart attacks or strokes in anyone.

LDL Reduction Irrelevant

Though doctors tend to focus their statin-taking patients on the size of their LDL reductions, heart disease researchers have long ago noted that this is likely irrelevant. Statin trials often show that the size of the cholesterol reductions are not consistent with reductions in heart attacks. Such observations led researchers to suspect that the ability of statins to reduce heart attacks and strokes has less to do with cholesterol reduction and more to do with other biological effects like plaque stability and anti-inflammatory effects. Another important but overlooked observation: “Elevated LDL identify less than one half of individuals who will die from coronary heart disease” (Rosenson et al. Antithrombotic Properties of Statins, JAMA, May 27, 1998).

The fall-out from the Vytorin debacle continues to reverberate. At this writing, Merck and Schering-Plough are running full-page ads daily in the Times and Wall Street Journal, warning people not to be confused by a single study and to continue taking Vytorin. The advice was backed by the American Heart Association, which appeared to be an independent source until The Times reported that the AHA receives nearly $2 million a year from Merck/Schering-Plough Pharmaceuticals.

One of the unintended consequences of two drug companies withholding their negative trial results is that it led some in the media, notably Alex Berenson, an investigative reporter for the Times, to look back at another important failed cholesterol drug trial and question the very foundation of heart disease prevention. In his heretically titled article “Cholesterol as a Danger Has Skeptics,” Berenson cites Pfizer’s trial of its much-anticipated drug torcetrapib that raised HDL, the good cholesterol, and lowered LDL. The trial had to be stopped in 2006 because the drug caused heart attacks and strokes. (Sound familiar? Postmenopausal hormones were widely prescribed because they were so good at improving cholesterol levels but they also increased the risk of heart attack, stroke and blood clots.) “Torcetrapib’s failure shows that lowering cholesterol does not prove a drug will benefit patients,” said a skeptical Walter Reed cardiologist quoted in Berenson’s article.

Many researchers, physicians and scientists around the world have long questioned the import of high cholesterol for anyone other than middle-aged men. In fact there is an International Network of Cholesterol Skeptics (disclosure: we belong), but the skeptics have been marginalized over the years. Now some mainstream media like Business Week and the cardiology Web site, TheHeart.org are willing to give them voice.

Could the house of cards be falling? Would the house of cards be allowed to fall when a worldwide $40 billion-a-year industry is at stake?

For More Information

The International Network of Cholesterol Skeptics www.thincs.org

Business Week magazine (www.businessweek.com) click into past issues, January 17, 2008 Lipitor cover story: “Do Cholesterol Drugs do any Good?”

TheHeart.org from Web MD www.theheart.org, see video blog of Eric J. Topol, MD, who questions the import of LDL reduction in “Temple of the LDL Cholesterol.”

Maryann Napoli, Center for Medical Consumers ©
February 2008

Posted in Conflict of Interest, Heart | Tagged: cholesterol, Drugs, Heart, marketing, overtreatment, pharmaceutical industry, side effects, statins | Comments Off

Gary Taubes Challenges Conventional Wisdom on Diet, Weight Control and Disease

Posted by medconsumers on January 1, 2008

Good Calories, Bad Calories – Challenging the Conventional Wisdom on Diet, Weight Control, and Disease by Gary Taubes

If your doctor has ever told you to go on a low-fat diet, read this book. For 50 years the public has been told that dietary fat and excess calories are the cause of obesity, heart disease and other chronic illnesses. Journalist Gary Taubes, a correspondent for Science magazine, has spent years tracking down the scientific underpinnings for both assertions and found little to support them.

In “Good Calories, Bad Calories,” Taubes shows how the low-fat recommendation has steered Americans to higher consumption of refined carbohydrates, especially processed foods, sugar and white flour. It is the quantity and poor quality of the carbohydrates consumed today, he says, that are making us sick and overweight.

Initially, the low-fat guidelines were aimed solely at people who had suffered heart attacks. By the 1980s, the entire nation was advised to keep their cholesterol down and that meant a major reduction in saturated fats, which was, and still is, recommended to prevent heart disease. Taubes writes, “Though women were clearly meant to adhere to the low-fat guidelines, they had not been included in any of the clinical trials. The evidence suggested that high cholesterol in women is not associated with more heart disease, as it might be in men, with the possible exception of women under fifty, in whom heart disease is exceedingly rare.”

Taubes first presented his case against the low-fat diet in a 2001 Science magazine article entitled, “The Soft Science of Dietary Fat,” and one year later, in a New York Times Magazine article entitled, “What if it’s all been a Big Fat Lie?” With 115 pages of references and bibliography, his new book, “Good Calories, Bad Calories,” is clearly aimed at research scientists and physicians.

The book documents a big change that occurred in U.S. dietary recommendations. For well over a century, carbohydrates (white bread, potatoes, noodles, beer, etc.) were widely believed to be fattening. That conventional wisdom was displaced by the dietary fat/heart disease hypothesis promoted by two influential people of the 1950s.

One is Dr. Paul Dudley White, President Dwight D. Eisenhower’s cardiologist, who asserted that America’s heart disease epidemic began after World War II when the country started to eat more fat and red meat and less cereal and grains. The other is Ancel Keys, a University of Minnesota physiologist, who compared the diets of seven countries and found that those with high-fat intake also had a high rate of heart disease. He was also the first to promote the familiar message that dietary fat makes us fat.

Taubes found that the facts do not support the claims of these two early proponents of the low-fat diet. The American diet was high in fat and red meat prior to World War II, according to government food surveys. Drawing on the Bureau of Census records, Taubes argues that heart disease was not all that rare in the first half of the 20th century when better diagnostic technology became available (primarily the electrocardiogram).

By the 1950s, premature deaths from infectious disease and nutritional deficiencies were mostly eliminated, thereby moving heart disease up the list of common causes of death. And lastly, changes in classification of heart-disease deaths in 1965 account for the increase that began that year.

As for Keys’s study, the seven countries were selectively chosen to support his high-saturated fat/heart disease hypothesis. Had he randomly chosen France and Switzerland, for example, rather than Japan and Finland, Keys would likely have seen no heart-damaging effect from a diet high in saturated fat. (And Taubes wryly observes, there might be no such thing as the “French paradox,” referring to the country’s storied high intake of saturated fat and comparatively low rate of heart disease.) This criticism was leveled at Keys’s work when it was first published. Still the American Heart Association eventually approved his low-saturated fat hypothesis as if it were backed by strong evidence and word went out to the public at large when Keys made the cover of Time magazine in 1961.

The fat-restriction recommendation has been kept alive in the last three decades by a small, select group of obesity researchers with university affiliations. The most striking fact about the evolution of the low-fat diet consensus, says Taubes, is that it has been tested in only two trials—on a few hundred middle-aged men who had already suffered a heart attack. Results of these trials were contradictory. The diets tested thereafter were cholesterol-lowering diets that replaced saturated fats with unsaturated fats.

Big Test Fails

By the 1970s, the National Heart, Lung, and Blood Institute decided it was time to test the low-fat, low-cholesterol diet hypothesis with a large, expensive trial. The MRFIT, or the Multiple Risk Factor Intervention Trial, randomly assigned 12,000 men either to a treatment group or a control group. All were healthy middle-aged American men with cholesterol so high (over 290 mg/ml) they were thought to be at imminent risk of heart attack.

The men assigned to the treatment group were counseled to quit smoking, take drugs to lower high blood pressure and eat a low-fat, low-cholesterol diet. They were told to substitute margarine for butter; eat no more than two eggs a week, drink skim milk; and avoid red meat, cakes, puddings, and pastries. The men assigned to the control group were left to their own devices about eating and seeking medical care. All were followed for seven years.

When MRFIT was published in 1982, the disappointing results were summarized nicely in one Wall Street Journal headline, “Heart Attacks: A Test Collapses.” Though slightly more deaths occurred in the treatment group, Taubes shows how heart disease researchers did not let go of the dietary fat/heart disease hypothesis, even when proven wrong. In a subsequent large U.S. trial, all the participants were instructed to go on a cholesterol-lowering diet because it was considered unethical not to. Cholesterol-lowering drugs became the distinguishing feature of the treatment groups in subsequent trials.

While researchers continued to explore the idea that restricting dietary fat reduces the risk of premature death in population studies, some found that the opposite was true. The 1985 Honolulu Heart Program, for example, found that high-fat diets are significantly associated with a lower risk of total mortality, cancer mortality and stroke mortality. Questionnaires filed periodically by participants of another study called the Nurses Health Study showed that the less fat consumed, the more likely they would get breast cancer.

Finally, in 2001, the Cochrane Collaboration sought to answer the low-fat diet question once and for all when it published a systematic review of the world’s best quality trials that had randomly assigned healthy adults to go on a “reduced or modified dietary fat” diet or continue eating as usual. The 27 trials that met the predetermined high-quality criteria had a combined total of about 10,000 participants. The trials lasted an average of three years. The Cochrane reviewers found that the low-fat or cholesterol-lowering diets had no effect on longevity and “no significant effect on cardiovascular events.”

The topic of weight control takes up about half the book. Though weight loss has long been promoted as the additional advantage of going on a low-fat diet, studies failed to prove this purported benefit as well. A 2002 Cochrane review of all relevant clinical trials (28 in all) concluded, “Low-fat diets induced no more weight loss than calorie-restricted diets, and in both cases the weight loss achieved was so small as to be clinically insignificant.” Conversely, Taubes cites trials showing that the high-fat diet, most notably the Atkins diet, results in more weight loss.

Total immersion in the last two centuries’ worth of research has convinced Taubes that dietary fat, including saturated fat, is not a cause of obesity, heart disease or any other chronic disease of civilization. Instead: “Through their direct effect on insulin and blood sugar, refined carbohydrates, starches and sugars are the dietary causes of heart disease and diabetes. They are the most likely dietary causes of cancer, Alzheimer’s disease and other chronic disease of civilization.” And contrary to conventional wisdom, obesity is not a disorder of overeating. Rather it is a disorder of fat accumulation due to too much insulin. (See related interview below.) What’s more, Taubes concludes that exercise is highly overrated as a means of weight control.

Taubes found enough evidence to warrant a clinical trial that tests his carbohydrates-make-you-fat-and-sick hypothesis. But he has no faith in the carbohydrate-restricted diet trials planned by the U.S. National Institutes of Health and the Dr. Robert C. Atkins Foundation because they will include only obese or overweight participants and are designed to test only weight loss.

What Taubes would like instead is a trial with healthy lean and normal-weight participants followed long enough to see whether an excess of refined carbohydrates will make them fat and develop chronic diseases. Another suggested trial would include a spectrum of participants—lean to obese—including many who have metabolic syndrome and/or type 2 diabetes.

Trials like these are not likely to take place—at least not in the near future—because a carbohydrate-restricted diet is by definition a fat-rich diet, and the medical community has been telling the public for the last half century that such a diet is dangerous. In the meantime, read this book and make up your own mind about which hypothesis has the most merit.

Maryann Napoli, Center for Medical Consumers © January 2008

Posted in Book Reviews, Diet & Exercise, Heart | Tagged: Book Reviews, diet, Heart, low-fat, obesity | Comments Off

Heart News 2007

Posted by medconsumers on December 31, 2007

The heart-related news has lately been a roller coaster of good, bad, and maybe not so bad. One popular prescription cholesterol-lowering statin drug might soon be sold over the counter. Defibrillators of the kind implanted years ago in Vice President Dick Cheney were in the news last month when studies showed they are more likely to be given to white men. But this needn’t be seen as yet-another example of women and minorities deprived of appropriate heart care. A new study showed that men with implanted defibrillators had a higher death rate than women with exactly the same heart condition who were not given implanted defibrillators.

And remember those drug-coated stents that scared heart patients over a year ago when it was announced that they increased the risk of potentially fatal blood clots long after they were inserted to prop open a constricted artery? Well, drug-coated stents made headlines again last month suggesting that they may not be so dangerous after all.

What do we make of all this?

For starters, an over-the-counter cholesterol-lowering drug might be a good idea for certain people. Not simply as a money-saver, but as a means of getting good-quality written drug information to the user. With a few exceptions, prescription drugs do not automatically come with FDA-approved printed information, though it comes tucked into the packaging of virtually all drugs sold over the counter.

We might be grasping at straws here, but mandated consumer drug information produced with FDA oversight is far better than the current situation. Then warnings like this about Lipitor—“tell your doctor if you have more than two drinks a day”—might actually reach the people who take the drug.

The prescription drug under consideration for over-the-counter status is Mevacor. That it is a statin drug and therefore a member of the top-selling drug class worldwide—$35 billion in annual sales—makes the switch all the more interesting. (Other statins are Lipitor, Crestor, Lescol, Pravachol, and Zocor.) Merck, the company that makes Mevacor, has recently applied to the FDA for permission to sell the drug over the counter. And an advisory committee of experts will decide the issue this month. (In 2005, an FDA Advisory Committee rejected a similar application for Mevacor.)

Two statin drugs Pravachol and Zocor are already available generically, which means that their patents have run out and now any company can produce these drugs under their generic names at a far lower cost than any brand-name statin. For example, Zocor, prescribed generically as simvastatin, costs from 75 cents to $1 a day at most retail drug stores and 10 cents a day, if purchased at a discount pharmacy like Costco’s. Lipitor, on the other hand, can cost $2.50 to $4 a day. From the FDA point of view, generic versions are equivalent to branded drugs because they must go through a process of proving that to the agency.

Many drug plans are encouraging members who take an expensive statin to switch to one of the generic versions with financial incentives like lower co-payments. And if Mevacor gets FDA approval for over-the-counter sale, statin users will have yet another low-cost alternative with the added feature of eliminating some doctor visit charges.

All this is cutting into the huge profits long enjoyed by Pfizer, the company that makes Lipitor, which is the most prescribed drug in the world. Naturally, the company wants to make as much money as possible before Lipitor loses its patent in March 2010. Consequently, Pfizer has escalated its long-running ad campaign featuring Dr. Robert Jarvik, inventor of the Jarvik artificial heart, who has been hugely successful in convincing many doctors and consumers that Lipitor is superior to other statins.

Currently, some of the Jarvik/Lipitor ads, say, “There’s a common misconception that all cholesterol-lowering medications are the same.” And more specifically, “In clinical studies LIPITOR lowered bad cholesterol significantly more than generic Zocor and Pravachol.”

Both points refer to a 2004 clinical trial that found people with heart disease showed a reduced degree of atherosclerosis progression if they were on high-dose Lipitor (80 mg) for 18 months, compared with those on a moderate dose of Pravachol (40 mg). There was also a greater reduction in LDL, or “bad” cholesterol, shown in the heart patients who took the high-dose Lipitor.

Three things to keep in mind about this trial, known by its acronym REVERSAL: Its participants all had heart disease (the overwhelming majority of U.S. statin-takers do not); REVERSAL was not designed to see whether Lipitor or Pravachol prevented heart attacks or strokes. And lastly, it compared a high-dose of Lipitor with a moderate-dose of Pravachol, leaving open the possibility that Pravachol at 80 mg might be just as good. Still, REVERSAL provides the basis for the Pfizer claim that Lipitor is not only better than other statins but it should also be prescribed in high doses for people with heart disease.

As for the most crucial goals of statin therapy: all statins, with the exception of Crestor, have been shown in clinical trials that predate REVERSAL to reduce the risk of heart attack and stroke in people who already have heart disease.

Healthy But High Risk

As for people without heart disease, the proven benefit of statins is largely confined to high-risk men between 30 and 69 years. The magnitude of this benefit, however, is not impressive—1.5% fewer of those taking a statin will suffer a non-fatal heart attack. But one analysis of all statin primary prevention trials showed that this 1.5% benefit was canceled out by an equivalent risk of experiencing a serious reaction to the statin.

The promotional activities of statin manufacturers have successfully focused most doctors and the general public on the excellent cholesterol-lowering effects of these drugs. But no head-to-head comparison study of all six statins has answered the most important-to-consumers questions: Which drug is best at preventing a heart attack or stroke? How large is the benefit?

There is a Jarvik/Lipitor print ad that answers the how-large-is-the-benefit question for high-risk people without heart disease. “In patients with multiple risk factors for heart disease, Lipitor reduces risk of heart attack by 36%* if you have risk factors such as family history, high blood pressure, age, low HDL (‘good’ cholesterol) or smoking.” In smaller print, the same ad has this explanation of “reduces risk” under the asterisk: “That means in a large clinical study, 3% of patients taking a sugar pill or placebo had a heart attack compared to 2% of patients taking Lipitor.” This ad is a rarity because it explains the 36% reduced risk. Take Lipitor for years and your risk of having a heart attack drops from 3% to 2%.

Lately, Pfizer has been trying to stem the exodus to generic statins by touting a new study that purportedly shows more heart attacks or strokes in people who switched from Lipitor to simvastatin, compared with those who stayed on Lipitor. There’s little reason to take this study too seriously.

First of all, Pfizer funded the study, and drug company-funded studies are notorious for coming up with conclusions that favor their products. Second, it was presented on a poster at a recent European cardiology conference, and has yet to be published or fully peer reviewed. (The New York Times, however, recently reported that this study has been accepted by the British Journal of Cardiology and will soon be published.) Lastly, the study is based on an analysis of medical records of British heart patients who did or did not switch from Lipitor to the generic version of Zocor (simvastatin). The study’s design is not regarded as high quality; in fact the authors describe its limitations this way: “This is an observational database study, and as such has recognizable limitations; therefore the findings should be regarded as hypothesis-generating.”

NB: There’s a consensus among cardiologists that statins are generally safe and are extensively studied. Perhaps they are, but three of the five major primary prevention randomized trials have not released all of their statistics on serious adverse reactions, according to James Wright, MD, and John Abramson, MD, who co-authored a commentary early this year in The Lancet, entitled “Are Lipid-Lowering Guidelines Evidence-Based?” The full story about the safety of statin drugs is unknown.

NEWS ABOUT DEFIBRILLATORS

An unexpected finding showed up when a team of Duke University researchers tracked elderly people with heart failure who did and did not have defibrillators implanted to prevent sudden death. Those who had a defibrillator implanted lived no longer than those who did not. That was the contrary-to-expectations finding 180 days after implantation.

But when these heart patients were followed longer, the results were worse for the men. Their mortality rate in the year after implantation was higher than that of women without defibrillators, though all had similar heart problems. To take into account the fact that women live longer than men, Leslie H. Curtis, PhD, and colleagues at Duke University School of Medicine, confined their study to men and women under the age of 75 years.

Their new findings come at a time when implantable defibrillators are, once again, in the news for having serious defects that have caused a few deaths. These devices monitor the patient’s heart rhythm and deliver an electric shock once dangerously erratic rhythms are detected.

The Duke researchers analyzed a national 5% sample of the Medicare claims filed for more than 35,000 people from 1991 through 2005. All had been diagnosed with heart attack and either heart failure or cardiomyopathy. Men were three times more likely than women to have the device implanted. Of those with heart disease but no prior cardiac arrest or tachycardia (rapid heartbeat), defibrillators were implanted in 32 per 1,000 men and about 9 per 1,000 women.

The gap between man and women didn’t close for the most seriously ill patients—those with prior cardiac arrest or tachycardia. For this group, the implanted defibrillator rate was 102 per 1,000 men and 38 per 1,000 women.

A related study, published in the same October 3 issue of the Journal of the American Medical Association, found that black men and women were also less likely to have a defibrillator implanted than white men.

“The bad news may not be for women and minorities, but for white men who are undergoing a procedure that for primary prevention does not extend their lives,” wrote Rita F. Redberg, MD, in an editorial that accompanied the two studies.

NEWS ABOUT DRUG-COATED STENTS

The bad news about this topic originally came from the World Congress of Cardiology in September 2006. Presented at this international conference were clinical trials that found a slightly increased risk of death and a higher rate of potentially fatal blood clots in people who had drug-coated stents implanted during a coronary-artery-opening procedure called angioplasty. The trials compared them with other heart patients whose constricted coronary arteries were propped open with stents not coated with a drug.

The higher risks among those given drug-coated stents did not show up until four years of follow-up. These complications were confirmed in two separate analyses of the combined results of company-sponsored trials by Boston Scientific, maker of the Taxus stent, or Johnson & Johnson, maker of the Cypher stent. The medicine coating these stents is intended to keep the constricted arteries from closing up again.

Last month the national media reported good news about drug-coated stents from the annual meeting of the American Heart Association in Orlando, Florida. Two-year follow-up results from a new, yet-to-be-published clinical trial showed that drug-coated stents are no more risky than bare-metal stents. Some media reports left the impression that the issue of stent safety had been resolved with this trial. “Heart Stent Gets a Reprieve From Doctors” was the over-the-top New York Times headline.

Keep in mind that the new trial announced at the heart meeting lasted only two years and the blood clots in the above-mentioned company-sponsored trials did not show up until four years. More details will be available when the new trial is published in Circulation, the journal of the American Heart Association, according to a “Late-Breaking News Release” from the heart meeting.

The meeting organizers managed to focus the media on stents rather than the more critical issue—overuse of artery-opening procedures. Many of the one million or so Americans who undergo angioplasty each year (with or without stents) can be treated just as successfully with drug therapy. It is generally the same multiple drug therapy advised for everyone who undergoes angioplasty. This was proven in a government-sponsored study called the Occluded Artery Trial, or OAT, published last year in The New England Journal of Medicine. A follow-up analysis of the OAT results was presented at the American Heart Association meeting. Yet no mainstream media reported the new OAT analysis, according to Health News Review, a medical media watchdog group led by journalist Gary Schwitzer.

All 2,166 OAT participants had a totally blocked major coronary artery and were 3 to 38 days away from suffering a heart attack. All were randomly assigned to receive an artery-opening procedure plus drug therapy or drug therapy alone. The multiple-drug therapy included daily aspirin, beta-blockers, ACE inhibitors and cholesterol-lowering drugs.

After four years, the OAT participants in the angioplasty/drugs group had the same rate of survival, second heart attack, and heart failure as the group given drug therapy alone. When the 469 American OAT participants were singled out (this was an international trial), the angioplasty-treated heart patients generated costs that were $10,000 higher than the drug-treated people. After three years, the cost difference had dropped to $7,000.

In an editorial that accompanied the OAT findings last year in The New England Journal of Medicine, L. David Hillis, MD, and Richard A. Lange, MD, wrote, “The open-artery hypothesis, although not previously validated in a prospective, randomized study, has nonetheless been embraced by many practicing physicians.” Translation: Heart surgeons have been opening constricted coronary arteries for years on the unproven premise that this will save lives and reduce the risk of a future heart attack. The OAT results failed to validate that hypothesis.

Opening a blocked artery during or right after a heart attack has been proven beneficial, but the OAT results showed no benefit to the common practice of performing angioplasty well after the patient had been stabilized—3 to 38 days after suffering a heart attack.

Maryann Napoli, Center for Medical Consumers ©
2007

Posted in Chronic Conditions, Heart | Tagged: Drugs, Heart, pharmaceutical industry, Screening, side effects, statins | Comments Off

Antibiotics Prior to Dental Procedures: Big Change in Recommendations

Posted by medconsumers on July 1, 2007

For over a half century, millions of Americans with common heart valve problems, such as mitral-value prolapse, were told to start taking preventive antibiotics prior to undergoing routine dental procedures. To ignore this standard recommendation is to risk a potentially life-threatening case of bacterial endocarditis triggered by the dental procedure. Or so went a widely held belief that has been revised recently by the American Heart Association.

The AHA now restricts its preventive antibiotics advice to a much smaller group of people—those with serious heart conditions. The new guidelines were published recently in the journal, Circulation, where the AHA acknowledged its longstanding policy was based on expert opinion rather than evidence.

The AHA appointed a writing group comprised of people selected for their expertise in the prevention and treatment of endocarditis. After reviewing all relevant studies, the AHA writing group concluded that the odds of suffering a serious adverse reaction to the antibiotics are higher for most people with heart conditions than their odds of getting endocarditis due to a dental procedure. In other words, endocarditis is a rare possibility. This is similar to the conclusion of a 2004 review of all relevant studies on this topic conducted by the Cochrane Collaboration.

Central to the now-outdated AHA recommendations was the concern that even the most routine of dental procedures, such as tooth scaling, could let loose bacteria into the bloodstream. Theoretically, the bacteria would lodge on abnormal heart valves or other damaged heart tissue and cause endocarditis, an infection of the heart’s inner lining (endocardium) Ironically, the AHA guideline writers said that the chances of developing endocarditis from the more mundane everyday activities, such as tooth brushing, flossing, and use of toothpicks, are higher than getting it during a dental procedure.

On another ironic note, the AHA writing group found that studies involving the antibiotics typically prescribed before dental procedures—penicillin or amoxicillin—failed to prove that either drug is effective in reducing the release of bacteria into the bloodstream. (The studies had compared drug-treated people with untreated people who underwent the same dental procedures.) Also, there is no evidence to show that amoxicillin, the antibiotic of choice since 1990, can reduce the risk of or prevent endocarditis.

The new AHA guidelines now confine preventive antibiotics to people at the very highest risk for endocarditis, including those who have had the disease, and those with a prosthetic heart valve, congenital heart disease, hypertrophic cardiomyopathy or cardiac valvulopathy (after heart transplant). A single antibiotic dose before the dental procedure is sufficient for people in these circumstances.

Mitral Valve Prolapse

People with mitral valve prolapse (MVP), estimated to be about 18% of the population, are now freed from the need to take preventive antibiotics. The AHA writing group noted that the incidence of endocarditis is extremely low in the entire population of people with MVP. Moreover, the disease does not have the same deadly consequences in people with MVP as it does for those with the above-mentioned highest risks.

Bottom Line: A 50-year-old health policy without much supporting evidence has been revised. For most people with heart valve problems, antibiotics before a dental procedure pose more of a threat to health than the rare possibility of developing endocarditis. Furthermore, there is no evidence to show that antibiotics can reduce the risk of endocarditis. The American Dental Association endorsed the new guidelines.

Maryann Napoli, Center for Medical Consumers ©
July 2007

Posted in Drugs, Heart | Tagged: antibiotics, antibiotics dental, antibiotics prior dental procedures, dental procedures, Drugs, endocarditis, endocarditis dental procedures, Heart, prevention | Comments Off

Low-Dose Aspirin for Heart Protection: How Low Should a Safe Dose Be?

Posted by medconsumers on June 1, 2007

Daily aspirin protects the heart, but the dose at which this can be safely accomplished has never been established. It has long been known that the risks of aspirin—gastrointestinal or brain hemorrhage—cannot be completely eliminated even at the lowest possible doses. An international team of researchers recently determined that daily doses of aspirin as low as 30 mg are adequate for achieving the anti-clotting goal; whereas doses higher than 75 to 81 mg merely increase the risk of adverse reactions without providing any additional advantage.

The research team led by Charles L. Campbell, MD, University of Kentucky, based its conclusions on a review of 11 studies comparing people on different low doses of aspirin after a major stroke, a minor stroke (transient ischemic attack), a heart attack or a recent artery-opening procedure. It was published last month in the Journal of the American Medical Association.

The 11 studies had a combined total of about 47,000 participants (one-third were women) who were followed up to four years. The aspirin doses given in these studies, ranged from 30 mg/daily to 650 mg/ twice daily. Though millions of Americans take low-dose aspirin to prevent cardiovascular problems from occurring in the first place, no studies in this review included participants without heart disease.

Dr. Campbell, the lead author of the review was asked by e-mail how low a dose should be taken by people without heart disease, who were not addressed in this review. “The lowest dose I have seen evaluated in the primary prevention setting was 100 mg every-other-day in the Women’s Health Study,” he responded, referring to a 2005 trial that found, even at that low dose the women on aspirin had a higher rate of gastrointestinal bleeding than the women on placebos.

“I typically use 81 mg of uncoated aspirin for primary prevention in either men or women, but would not object to using lower doses among women.” (Enteric-coated products were questioned by Dr. Campbell and colleagues because they are not absorbed as well as plain aspirin.)

“I suspect the patients I recommend primary prevention for are of higher risk than the majority of women in the Women’s Health Study (more than 40% of whom had NO traditional risk factors for coronary disease),” wrote Dr. Campbell in an e-mail. “My patients are more like the over-65 population in the Women’s Health Study where low-dose aspirin was associated with a reduction in MI [heart attack]. I typically avoid alternate day dosing to keep things simple and compliance high, but don’t have a philosophical objection to that approach either.”

Aspirin is a non-steroidal anti-inflammatory drug. Though gastrointestinal bleeding is usually attributed to other drugs in this class like ibuprofen and naproxen, this adverse reaction was most often caused by aspirin in one study that looked at 18,820 hospitalized patients. Of the 1225 patients admitted as a result of adverse drug reactions, low-dose aspirin was identified as one of the most common causes, with 18% of hospitalizations and 61% of the fatal cases associated with low-dose aspirin.

Bottom line:

The conclusion of this review contradicts the typical dosage recommendation in the U.S.—between 81 mg and 325 mg. A baby aspirin (81 mg) a day is a sufficient dose for protection for people with heart disease. People without heart disease were not represented in this review, but the lead author suggests 81 mg uncoated aspirin daily, though a lower dose could be appropriate for women. No primary prevention trial has had participants taking an aspirin dose lower than 100 mg every other day.

Maryann Napoli, Center for Medical Consumers ©
June 2007

Posted in Drugs, Heart | Tagged: dental procedures, Drugs, Heart, prevention | Comments Off

Drug-eluting Stent

Posted by medconsumers on October 1, 2006

A Failed Solution to an Iatrogenic Problem

The long-term safety of drug-releasing stents implanted during angioplasty has been called into question. These tiny wire-mesh tubes emitting low doses of a powerful drug are now the predominant means of propping open a constricted coronary artery in the U.S and many other countries. Called drug-eluting stents by their makers, they show a slightly increased mortality and a higher rate of serious adverse events in longer follow-ups of trials in which participants were implanted with either a drug-eluting or an uncoated stent.

This was announced at the World Congress of Cardiology 2006 held last month in Barcelona, Spain and reported worldwide by UPI and other wire services. The findings have huge implications for the estimated 800,000 Americans who have had a drug-eluting stent implanted and for the multi-billion dollar business that artery-opening has become.

At the Barcelona meeting cardiologist Salim Yusuf, MD, McMaster University, Hamilton, Ontario, gave “a thundering indictment” of artery-opening procedures, according to the cardiology Web site, www.theHeart.org. “The whole field of angioplasty has been led astray by a preoccupation with restenosis [re-narrowing of the artery after angioplasty], for which study after study has shown no prognostic value. We’re chasing problems that are iatrogenic that naturally would not exist in people. We’ve had a perverse financial incentive on the practice of cardiology. It is time to stop and reevaluate.” (That angioplasty* and bypass surgery are not very effective in preventing future heart attacks was explored in the April 2006 HealthFacts “Dramatic Rise in Cardiac Procedures, But No Drop in Heart Attack Rate.)

Dr. Yusuf’s point was lost in the ensuing media coverage of the serious adverse events that showed up in the longer follow-ups—two to four years—of people given drug-eluting stents in clinical trials that compared them with people given uncoated stents. All were company-sponsored trials by Boston Scientific (Taxus stent) or Johnson & Johnson (Cypher stent).

Two separate analyses of the combined results of these trials were described at the Barcelona meeting by Edoardo Camenzind, MD, University Hospital in Geneva, and Alain J. Nordmann, MD, University Hospital, Basel, Switzerland. “What we saw in the long term was more deaths and MIs [heart attacks] in the groups with the first-generation drug-eluting stents,” said Dr. Carmenzind.

Dr. Nordmann’s analysis showed that the people implanted with a drug-eluting stent did better at one year, but there was “a trend toward increased mortality” with drug-eluting stents at up to four years of follow-up. People implanted with a Cypher stent fared worse than those with a Taxus stent in this analysis. They had a higher rate of non-cardiac mortality and serious adverse events than the people with a Taxus stent. Within two days of the Barcelona meeting, Boston Scientific and Johnson & Johnson each released results of one trial claiming safety for its stent and advantages over the uncoated stent. This hasty release of data was, no doubt, intended to counter the negative press from Barcelona.

Shortly thereafter, Boston Scientific did an about-face. The company announced by way of The Wall Street Journal that its Taxus stent does in fact show a slightly higher rate of “late stent thrombosis [potentially fatal blood clots].” The announcement was based on the company’s own reanalysis of its trials. Stent thrombosis should not come as news to Johnson & Johnson because the FDA sent a warning letter to doctors about it months after the Cypher stent was approved in 2003. The following year, Boston Scientific had to recall 99,200 stent systems because of a defect that made it hard, in some cases, to deflate the balloon used to implant the stent. The defect was linked to three deaths and 47 serious injuries.

Stents were introduced after studies showed that about 40% of the coronary arteries close up again (restenosis) in the 6-12 months after angioplasty. This procedure involves the threading of a catheter to the constricted section of a coronary artery and then inflating a balloon at the tip of the catheter to compress the plaque or fatty deposits against the lining of the artery. The introduction of stents, mounted on the balloon catheter, was the intended solution to restenosis. Once the balloon is inflated, the stent expands and is pressed permanently into the inner wall of the constricted portion of the artery.

But physicians found that tissue growth around the stent caused restenosis. Drug-eluting stents were developed to prevent this problem. The Taxus stent emits paclitaxel, an anti-cancer drug that has anti-inflammatory effects. The Cypher stent emits sirolimus, an immunosuppressive drug. These stents reduce but do not eliminate the possibility of restenosis. Once implanted, people go on anti-clotting drugs (aspirin, Plavix) for the rest of their lives.

Bottom Line: Though constricted coronary arteries are not the cause of future heart attacks (as outlined in April 2006 HealthFacts), a lucrative industry has built up around opening them. Because restenosis is common after angioplasty, drug-eluting stents were approved by the FDA in 2003 to reduce the risk. Approval was based on company-sponsored trials that lasted 6-24 months and an agreement that participants will continue to be followed to five years. The companies did not have to prove that their stents were better than drugs in reducing heart attacks. Instead, they merely had to prove drug-eluting stents are better than uncoated stents in avoiding restenosis. Longer follow-up data from these trials formed the basis of two new analyses that found potentially fatal blood clots are not as rare as previously thought. These analyses, however, remain to be confirmed as they have not yet been published.

In his role as discussant at the Barcelona meeting, Dr. Yusuf, the Canadian cardiologist who delivered the thundering indictment of his profession, summarized the situation: “With about six million of these procedures done [worldwide], isn’t it a terrible indictment of our system that we don’t know the safety of these things?”

What to do:

If you have had a stent (or other type of medical device) implanted, get the name of the manufacturer, the type of stent, and model number. Keep this information in your personal records in case a defect is reported in the future.
If you had a drug-eluting stent implanted, consult your cardiologist about the need for anti-clotting drugs and the danger of stopping them. Last year the FDA issued a warning that it had received an unspecified number of reports of heart attack, stent thrombosis, and death that occurred in people “who received a drug-eluting stent and then stopped taking their antiplatelet [anti-clotting] medication prematurely.” Some were told by their practitioners to stop the medication prior to undergoing a surgical or dental procedure, others stopped on their own.
Web casts from the September 2-5 Barcelona meeting can be accessed at the World Congress of Cardiology www.worldcardio2006.org.

*Angioplasty is lifesaving for those who receive the procedure while in the midst of a heart attack.

Maryann Napoli, Center for Medical Consumers ©
October 2006

Posted in Heart, heart surgery | Tagged: angioplasty, cardiac stent harm, Heart, ineffective at preventing heart attacks, restenosis, stent harm, stents, surgery | Comments Off

Drug-emitting stents a failed solution to an iatrogenic problem

Posted by medconsumers on September 1, 2006

The long-term safety of drug-releasing stents implanted during angioplasty has been called into question. These tiny wire-mesh tubes emitting low doses of a powerful drug are now the predominant means of propping open a constricted coronary artery in the U.S and many other countries. Called drug-eluting stents by their makers, they show a slightly increased mortality and a higher rate of serious adverse events in longer follow-ups of trials in which participants were implanted with either a drug-eluting or an uncoated stent.

At the Barcelona meeting cardiologist Salim Yusuf, MD, McMaster University, Hamilton, Ontario, gave “a thundering indictment” of artery-opening procedures, according to the cardiology Web site, www.theHeart.org. “The whole field of angioplasty has been led astray by a preoccupation with restenosis [re-narrowing of the artery after angioplasty], for which study after study has shown no prognostic value. We’re chasing problems that are iatrogenic that naturally would not exist in people. We’ve had a perverse financial incentive on the practice of cardiology. It is time to stop and reevaluate.” (That angioplasty * and bypass surgery are not very effective in preventing future heart attacks was explored in the April 2006 “Dramatic Rise in Cardiac Procedures, But No Drop in Heart Attack Rate.”)

Dr. Yusuf’s point was lost in the ensuing media coverage of the serious adverse events that showed up in the longer follow-ups–two to four years–of people given drug-eluting stents in clinical trials that compared them with people given uncoated stents. All were company-sponsored trials by Boston Scientific (Taxus stent) or Johnson & Johnson (Cypher stent).

Bottom Line: Though constricted coronary arteries are not the cause of future heart attacks (as outlined in April 2006 HealthFacts), a lucrative industry has built up around opening them. Because restenosis is common after angioplasty, drug-eluting stents were approved by the FDA in 2003 to reduce the risk. Approval was based on company-sponsored trials that lasted 6-24 months and an agreement that participants will continue to be followed to five years. The companies did not have to prove that their stents were better than drugs in reducing heart attacks. Instead, they merely had to prove drug-eluting stents are better than uncoated stents in avoiding restenosis. Longer follow-up data from these trials formed the basis of two new analyses that found potentially fatal blood clots are not as rare as previously thought. These analyses, however, remain to be confirmed as they have not yet been published.

Maryann Napoli, Center for Medical Consumers© October 2006

Posted in Drugs, Heart, surgery | Tagged: Drugs, Heart, heart surgery, surgery | Comments Off

Angioplasty: No Effect on Future Heart Attack

Posted by medconsumers on April 1, 2006

Dramatic Rise in Cardiac Procedures, But Heart Attack Rate Stays Constant

Over the last 10 to 15 years there has been a dramatic increase in cardiac procedures in the U.S. and Canada. Coronary artery bypass surgery and artery-opening procedures are intended to restore blood flow to the heart in order to prevent heart attacks. One might reasonably expect each country’s rate of heart attack to show an equally dramatic decline. But the heart attack rate stayed relatively constant in both countries. The findings came from two studies, one in the U.S. and one in Canada, published in the January 24 issue of the journal Circulation. They appear to validate the longstanding, but widely ignored, research indicating that today’s cardiac surgeons are still operating on an outmoded understanding of heart disease.

Each country’s study drew on claims data from its publicly funded Medicare program to determine the cardiac procedure rate. Medicare in the U.S. primarily covers people age 65 and over, while Medicare in Canada covers everyone, though the study looked solely at adults in Ontario. At the start of the study period, Canada’s rate of cardiac procedures was lower than that of the U.S., but both countries showed similar massive increases. The researchers determined the heart attack rate by looking at the claims submitted by people hospitalized for a heart attack during a 15-year period in the U.S. study and a 10-year period in the Canadian study.

“There are a couple of different messages for consumers in our study,” said F. Lee Lucas, PhD, Center for Outcomes Research and Evaluation, Maine Medical Center, the lead author of the American study. “The increased rates [of bypass surgery and artery-opening procedures] over time likely mean that doctors are quicker to intervene for milder and milder symptoms, particularly in white men,” she noted in a telephone interview. Dr. Lucas explained that the data collected in her study did not allow conclusions to be drawn regarding the percentage that might have been unnecessary.

David Waters, MD, who was not involved in either study, was less reticent about their implications. “We can assume that that these procedures are not influencing the heart attack rate, and some may be unnecessary,” he said in a telephone interview. Dr. Waters is chief of cardiology at San Francisco General Hospital and professor of medicine at University of California, San Francisco.

The two studies also indicate that an outmoded understanding of heart disease still dominates the way it is treated. According to the so-called new view of heart disease, a major constriction in the coronary artery is not where a future heart attack will occur. “There’s lots of data to show that opening a narrowed artery will not reduce your chances of having a heart attack,” said Dr. Waters, citing the one exception. “If, however, a person is having a heart attack, and that person has an artery-opening procedure while having the heart attack, there is good evidence that this will reduce the risk of dying of that heart attack.” In other words, the procedure will have no effect on future heart attacks.

The old model for the development of a heart attack is based on heart disease as a plumbing problem. The metaphor, which is still served up to the public to explain heart attacks, goes like this: A coronary artery slowly becomes narrowed with plaque in much the same way a pipe becomes corroded with rust and other gunk. In time, the artery becomes so constricted that blood flow to the heart is eventually shut off with a blood clot.

New Mechanism for a Heart Attack

The new understanding of heart disease is far more complex and is based on the observation that the vast majority of heart attacks do not occur in the portion of the artery that is most obstructed. Instead, most heart attacks occur where plaque breaks off and a clot forms over the area that can abruptly stop blood flow to the heart. In this scenario, the plaque is soft, symptomless, and would not be seen as an obstruction to blood flow. Heart disease is an inflammatory process by which the coronary arteries are subjected to a constant cycle of irritation, injury, healing and reinjury that makes the plaque likely to rupture. The solutions are the standard prevention advice: stop smoking, and take drugs to reduce clotting, inflammation, blood pressure and cholesterol.

If the new view of heart disease has been around for more than a dozen years, why hasn’t this changed the way it is treated? Do heart surgeons know about it? “The interventional cardiologists know about it, but they ignore it,” answered cardiologist Thomas Graboys, MD, in a telephone interview. “A new breed of over-trained cardiologists has now flooded into the community,” said Dr. Graboys, professor of medicine at Harvard Medical School and president of the Lown Foundation. It is no longer the large urban-based academic medical centers that come overstocked with interventional cardiologists. They have now come to the community hospital near you. And there is a strong financial incentive for them to look for constricted arteries and open them. “Economics drive the train,” said Dr. Graboys. “The starting salary of an interventional cardiologist is $300,000-400,000 a year, and for one that has been in practice three years, it is $500,000 to $600,000.”

Dr. Waters also sees money as the driving force. “If you have chest pain and the cardiologist you see does coronary angiography (see sidebar below) and that pays for his kids to go to college; well, are you are more likely to wind up with that procedure?” He advises, “Get a second opinion from a cardiologist who is not in the same building, the same group, or the same hospital as the first opinion cardiologist.” Dr. Waters also suggests that people give careful thought to the type of cardiologist chosen for a second opinion. There are, he explained, regular cardiologists who prescribe drugs; interventional cardiologists who do cardiac catheterizations, artery-opening procedures and stenting; and cardiovascular surgeons who perform coronary bypass surgery. The received opinion will likely mirror the doctor’s area of expertise.

The number of people undergoing artery-opening procedures continues to rise not only because they are huge money-makers but they are also very effective at relieving the severe chest pain of angina, which is a common symptom of heart disease. They are virtually useless, however, in stopping the progress of the disease itself. “The public is looking for a magic bullet,” observed Dr. Graboys, who offered this advice to people who are not in an acute situation. “Go to a non-hospital-based doctor in the community. A well-trained internist can take care of the lion’s share of people with coronary heart disease. The vast majority of people do well on medication—cholesterol-lowering drugs, antihypertensives, low-dose aspirin.”

Still, clogged arteries cannot be good. Won’t they eventually close off? “The body performs its own bypass,” explained Dr. Graboys, describing what is often seen during cardiac catheterizations. “The body forms new blood vessels around the constricted area, thus restoring blood flow.”

Dr. Graboys knows whereof he speaks; he is a cardiologist at the Lown Cardiovascular Center in Brookline, Massachusetts, a second opinion consultation center affiliated with Brigham and Women’s Hospital. For over two decades, the Center has helped many people avoid unnecessary surgery. Long before others made this connection, Dr. Graboys began to see the stress test and cardiac catheterization—two diagnostic procedures—as somewhat akin to a conveyer belt that funnels people to an artery-opening procedure or bypass surgery. A constricted artery is discovered, often several (not at all unusual in anyone over age 55), and the person goes on to what doctors call “a cascade of interventions”. In fact, the odds are so high that a cardiac catheterization will set people on to this course of events that Dr. Graboys advises a second opinion before agreeing to it.

A second opinion is all the more important given that Dr. Lucas, the lead author of the American study, said her data suggest that the threshold for deciding who is a candidate for an artery-opening procedure has been lowered over time. “Rates of bypass surgery have leveled off. This is due to the fact that bypass surgery is clearly the more invasive procedure requiring prolonged anesthesia and use of a heart/lung machine, etc., but with artery-opening procedures you’ve got the person in the cath lab, and you’ve got that catheter in there already; it’s tempting to go ahead and do the procedure, so the threshold for performing the procedure might be lower than it would be for bypass surgery,” Dr. Lucas explained. “Many people who have had it done firmly believe that it saved their lives, but the benefit of most procedures is [solely] control of symptoms.”

What does all this mean to the average older person who suspects that one day he or she might wind up in an emergency room with chest pains? To Dr. Waters, the people who show up in the emergency room with severe chest pain are the ones most likely to require an artery-opening procedure. “The person I worry about is the person who goes to the doctor with a vague symptom and finds himself with a doctor who is not skilled at distinguishing the important symptoms of a heart disease from other symptoms.”

Asked for an example of a vague symptom that an unskilled physician might mistakenly identify as heart-related: “I was recently playing catch with my dog and now have shoulder pain,” he responded, suggesting that this could be enough to start the cascade of interventions. It is, in fact, common for symptom-free people to be told to have a stress test and this alone can start the cascade.

The cascade may be worth it, if all these cardiac procedures were lifesaving, but so far proof is lacking. “There is no evidence to show that artery-opening procedures will prolong life,” said Dr. Graboys, citing the exception of a person in the midst of a heart attack. “Although these procedures are good at alleviating the heart-related chest pain called angina, so too are drugs and lifestyle changes.” Dr. Graboys continued, “Data show that people with angina can be treated successfully with medicines and lifestyle changes like stress reduction, regular exercise, smoking cessation, and treatment of risk factors like high cholesterol and high blood pressure.”

For more information on different types of angioplasty, see below.

The U.S. study led by F.L. Lucas, PhD, was supported in part by a grant from the National Institute of Aging. The Canadian study led by David A. Alter, MD, PhD, was supported in part by a grant by the Heart and Stroke Foundation of Canada.

Cardiac Procedures Explained

Cardiac catheterization is a general term for a group of procedures involving a thin tube (catheter) inserted into a blood vessel in the groin or arm. The catheter is threaded up to the coronary arteries andpositioned either in the chambers of the heart or at the arteries supplying the heart. Once the catheter is in place, the doctor can inject a special dye or fluid that is visible by x-ray. This produces motion x-ray pictures called an angiogram, which are used to diagnosed the health of the coronary arteries. Other names for cardiac catheterization are coronary angiography and coronary arteriography.

This diagnostic technique becomes therapeutic once the doctor decides to widen a constricted artery in another procedure called angioplasty. This can be done in several ways. The plaque can be pressed against the walls of a constricted artery with an inflated balloon at the tip of the catheter. In the currently most popular version of angioplasty, tiny wire cages called stents are used to destroy the obstruction and keep the constricted artery open. In the new study by Dr. Lucas and colleagues, artery-opening procedures were grouped under the name of percutaneous coronary interventions.

Posted in Heart, heart surgery, surgery | Tagged: angioplasty, cardiac catheterization, Heart, overtreatment, surgery | Comments Off

Women’s Health Advice Falls Short

Posted by medconsumers on March 1, 2006

Prevention Advice to Women Doesn’t Hold Up

This is not the first time we’re seen medical dogma upended. Remember breast self-examination? It was proven to have no life-saving benefit and an increased risk of unnecessary breast biopsies. Now it is calcium supplements and a low-fat diet that will not save your life.

February 2006 was a banner month for disproving medical dogma. First, the public learned that the low-fat diet does not prevent heart disease. The next week, another study found that calcium does not protect against fractures or colon cancer. And in between, yet another study provided the surprising news that estrogen might lower the risk of heart disease in some women. (This last one actually reconstituted a previously disproved medical belief. For over ten years, women had been told that estrogen will save them from heart disease, but a major clinical trial was stopped early several years ago when it found that this hormone caused heart-related problems.) In each case, the findings were strongly contested.

Women’s Health Initiative

All these newsworthy announcements came from the same landmark clinical trial called the Women’s Health Initiative (WHI), an $18 million government-funded project, which involves thousands of healthy women over age 50. It is designed to test the prevailing health advice about how to prevent the chief causes of death and disability in older women.

Medical research is constantly evolving and we should expect health advice to change as more studies are published. But how is it that so many recommendations based on uncertain evidence can become orthodoxy? Recall how women were made to feel negligent by their doctors for not doing breast self-exams. A similar guilt was laid on those who refused to take postmenopausal hormones or were doubtful about high-dose calcium.

Surrogate Endpoints

Physician acceptance of the preventive measures was nearly universal, though they were based on a less reliable type of study called population, or observational studies. In this type of study, for example, the women who chose to take estrogen (as opposed to being randomly assigned to take it in a clinical trial) tended to have lower rates of heart disease. A closer look at these less reliable studies showed that women in the higher income brackets were more likely to take estrogen, and a high income is known to be associated with better health and a longer life.

Often, health recommendations are based on what researchers call surrogate endpoints—plus a heavy dose of assumptions. Estrogen lowers cholesterol in women; therefore it must save them from heart disease. Calcium improves bone density; therefore it must cut the risk of hip fracture. Long-term trials that follow participants until they have a heart attack or a hip fracture are expensive and take many years to produce answers, which is why so much health advice is based on surrogate endpoints.

The WHI is a massive research effort that involves multiple clinical trials. As researchers continue to sift through the data generated by the WHI, they will be publishing results for years to come. What follows is a summary of the evidence (or gaps in the research) that led the WHI to study the low-fat diet, high-dose calcium, and estrogen in younger women; the doubts that long surrounded each preventive measure; and the questions that remain unanswered.

LOW-FAT DIET AND HEART DISEASE

The supporting evidence:

No long-term trial had ever been conducted to support the idea that a low-fat diet (below 20% of total calories) reduces the risk of heart attack in healthy older people. While the WHI was still underway, a 2001 Cochrane review on this topic was published in the British medical journal, BMJ. Lee Hooper, PhD, and colleagues assessed all clinical trials in which healthy older men and women had been randomly assigned to continue on their normal diet or go on a low-fat or a reduced-fat diet.

This review exposed the difficulty in finding definitive answers as heart disease takes years to develop and few of the trials lasted more than six months. Results were predictably unimpressive: There was no reduction in heart attacks or cardiac deaths, but the few trials that lasted two years hinted at a lower risk of heart disease.

Flaws in the WHI:

The most valid criticism of the WHI/diet trial centers on the fact that it made no distinctions in the types of fat, as in: olive oil is good; trans-fatty acids (partially hydrogenated vegetable oils) are bad. Participants were simply instructed to keep their total fat intake below 20%. Because the WHI was designed 15 years ago, it reflects the general thinking among nutrition scientists at the time, said nutrition scientist Sharon Akabas, PhD, in a telephone interview. “As recently as 12 to 15 years ago, you still had people [in the nutrition field] who thought trans-fatty acids were OK and omega-3 fatty acids were seen as fringe—olive oil and other monosaturated oils were thought to be neutral.”

The Mediterranean-type diet is favored by many nutritionists today and that is a glaring omission of the WHI, according to Dr. Akabas, who is associate director of education at the Institute of Human Nutrition, Columbia University in New York City. “If I could design the WHI now, I would have had a group whose fat intake was 40% of calories with a significant contribution from olive oil. The Mediterranean diet also puts more emphasis on omega-3 fatty acids; it is high in plant food; low in animal foods; has more whole food; and less processed foods,” she said, adding that there is more to healthful living than dietary choices. Referring to the numerous population studies that showed the Mediterranean diet to be one of the most healthful in the world, Dr. Akabas continued, “People eating the Mediterranean diet at the time of these studies were taking a nap in the afternoon, they didn’t snack all day; they were physically active. And they are on the diet by choice, as opposed to have it imposed on them during a study.”

Doubters Have Reason to Remain Doubtful:

Even the highly motivated women who volunteered for the WHI could not get their fat intake under 20% of calories. (Many critics of the WHI saw this as a sign that a low-fat diet is impossible for Americans.) The best the WHI participants could do was 24% in the first year and 29% in the subsequent years. Since that narrowed the difference between them and the other women who had been assigned to remain on their usual diet, the WHI results were seen by some critics as not proving anything one way or another about the value of the low-fat diet.

The most steadfast proponent of the low-fat diet is Dean Ornish, MD, president of Preventive Medicine Research Institute and clinical professor of medicine at the University of California, San Francisco. The author of several books about reversing heart disease, Dr. Ornish has also co-authored a study that showed regression of severe coronary atherosclerosis after only one year, without the use of cholesterol-lowering drugs. In addition to a low-fat vegetarian diet, the study participants took part in a program of comprehensive lifestyle changes that included smoking cessation, stress management training, and moderate exercise. As yet, Dr. Ornish has not published a clinical trial that proves his program results in lower rates of heart attack or cardiac death.

Other Potential Benefits to Low-Fat Diet

The WHI produced a hint that even small reductions in dietary fat might reduce the risk of developing breast cancer. There was a 9% reduced rate of breast cancer in the women who attempted a low-fat diet, but this was not regarded as statistically significant, though it came close. Dr. Jacques Rossouw, the project officer for the WHI has stated that this finding might have become statistically significant had the trial lasted longer.

CALCIUM AND HIP FRACTURES

Supporting Evidence:

The body needs calcium for strong teeth and bones. That’s a fact. A controversy, however, surrounds the question whether anyone (including children) has to get it from milk or other dairy foods. It was also unclear whether massive increases in calcium intake in middle age will make any difference in fracture reduction.

Many population or observational studies show an increase in calcium intake in middle age improves bone density, but others show that women with high intake of calcium from diet or supplements actually have higher rates of fractures. Until, the WHI published its results last month, no well-designed clinical trial followed women long enough to prove increased calcium intake in middle age will reduce the rate of hip fractures.

The WHI Findings:

The WHI/calcium plus vitamin D trial involved 36,282 women. The hip fracture rate in those taking calcium plus vitamin D was the same as that of the women taking inactive placebos. One benefit shown in the calcium/vitamin D3 group was a 1% increase in bone density at the hip. Another is a slightly lower risk of hip fracture in one subgroup—women over the age of 60 years at the start of the trial.

Only 70% of the women in the calcium/vitamin D group took their assigned supplements regularly. When the investigators looked solely at this group, they found that these women had 29% fewer hip fractures than those taking placebo. In other words, there were 10 compared to 14 hip fractures per 10,000 women each year.

Furthermore, the supplements did not prevent colon cancer as originally thought, but they slightly raised the risk of developing kidney stones. There were an additional five cases of kidney stones per 10,000 women per year among those on supplements.

Doubts That Remain:

Since the WHI was planned, researchers have begun to view the recommended dose of vitamin D3 (400 international units) as inadequate and the recommended dose of calcium (1200 milligrams) as excessive. The WHI chose to use a daily dose of 1,000 milligrams of calcium and 400 international units of vitamin D3 (cholecalciferol). Last year, an analysis of all clinical trials that looked at the relationship between fractures and vitamin D was published in the Journal of the American Medical Association. It concluded: “Oral vitamin D supplementation between 700 to 800 IU a day appears to reduce the risk of hip and any non-spinal fractures in ambulatory or institutionalized elderly persons. An oral vitamin D dose of 400 IU/day is not sufficient for fracture prevention.”

Doubters Proven Correct (so far):

The two high-profile doubters about the relevance of calcium intake to hip fracture are Walter Willett, MD, Harvard School of Public Health, and T. Colin Campbell, PhD, professor emeritus of nutritional biochemistry at Cornell, who have, respectively, conducted numerous studies on the topic. Both argue that there is too much focus on calcium and too little focus on exercise and vitamin D. Both cite the excessive protein intake in the American diet, primarily from meat as a probable cause of hip fracture (though this was not factored into the WHI).

For the last 25 years, Dr. Willett has been one of the principle investigators of the Nurses’ Health Study, which has spawned scores of nutrition and health related studies including one that found the highest rates of hip fracture among women with the highest calcium intake.

Dr. Campbell directed the Cornell-China-Oxford Project, the most comprehensive project on diet and disease ever conducted. He has observed: “Most of the world’s peoples do not consume cow’s milk, and yet most of the world does not experience the high rates of osteoporosis found in the West. In Asian countries, for example, where consumption of dairy foods is low (and where women tend to be thin and small-boned, universally accepted risk factors for osteoporosis), fracture rates are much lower than they are in the United States and in Scandinavian countries, where consumption of dairy products is considerably higher.”

ESTROGEN AND HEART DISEASE

New Evidence for Women Without a Uterus:

One component of the WHI was designed to test several assumptions about the health effects of hormone therapy by comparing it to a placebo. This trial made international headlines in 2002 because it had to be stopped early. There was a higher rate of heart disease, breast cancer, blood clots, and stroke among the participants who had been taking combination hormones, estrogen and progestin (the latter hormone is necessary only for women with an intact uterus due to estrogen’s ability to increase the risk of uterine cancer). Though the hormone combination was also associated with decreased risk of colon cancer and hip fracture, it is no longer universally recommended as a preventive measure because the risks clearly outweigh the benefits.

Another “arm” of the WHI/hormone study continued to follow the 10,739 participants who had undergone a hysterectomy. All had been randomly assigned to take daily doses of estrogen (0.625 milligrams) or a placebo. Their mean age at entry into the WHI was 63 years. In February 2003, this arm of the WHI was also stopped early due to a higher stroke rate among women on estrogen.

The WHI Findings:

A study that looked at the heart-related WHI findings for the hysterectomy group was published last month in the Archives of Internal Medicine. After about seven years, the rate of heart attack and cardiac death was exactly the same for both the estrogen and the placebo groups. But there was “a suggestion” of a lower heart disease risk only among the women who had started taking estrogen while in their fifties. There was no suggestion of benefit in women who were 60 years or older when they started taking estrogen. Stroke was not taken into account in this particular study.

Doubts that Remain:

Whenever researchers use the word suggestion to describe their results, as in “a suggestion of lower heart disease risk,” they are saying that the findings aren’t clearly established. Despite the breathless headlines that went out across the country heralding the results of this study (“Estrogen May Help Heart”), they could be due to chance, which is how the WHI Web site (see below) describes them. A co-author of this study, quoted frequently in the media, saw the lack of an increased risk of heart disease as reassuring to women who want to take hormones on a short-term basis to alleviate hot flashes.

For More Information:

The WHI is a 15-year project that includes 161,000 women. It is paid for by taxpayer money, and as such, the WHI has been entirely open—via its Web site (www.whi.org)—about its findings both good and bad. The WHI has two major components: a randomized clinical trial (RCT) and an observational study. The RCT section is divided into three additional components: hormones, dietary modification and calcium/vitamin D.

Posted in Alternative Medicine, Cancer, Heart, Women's Health | Tagged: Alternative Medicine, Heart, osteoporosis, prevention | Comments Off

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