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Posts Tagged ‘overtreatment’

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Overtreatment of thyroid cancer

Posted by medconsumers on June 11, 2010

Thyroid cancer incidence has tripled since the 1970s. Most of the increase is attributed to the introduction of diagnostic ultrasound and fine-needle aspiration biopsies. Use of these two procedures escalated once ultrasound machines, initially found only at hospitals, became increasingly available in doctors’ offices. Autopsy studies show cancer is present in the thyroids of most people who died from other causes. Consequently, some researchers suspect that diagnosing thyroid cancer at the earliest stage is causing much more harm than good.

This suspicion was confirmed in a new study that found people with papillary thyroid cancer (the most common type) have an excellent prognosis whether or not they are treated within the first year of diagnosis. And they have an excellent prognosis whether part or all of the thyroid gland is surgically removed. Those who receive the latter treatment must go on thyroid replacement therapy for the rest of their lives.

These conclusions are based on 20-year data collected from 17 cancer registries maintained by the U.S. National Cancer Institute. Of particular interest were the people diagnosed with papillary thyroid cancer that had not progressed beyond the thyroid gland. More than 35,600 thyroid cancer patients, diagnosed between 1973 and 2005, fit this description. The researchers specifically wanted to know what happened to the people whose tumors were not treated for a year or more after diagnosis.

Here’s the bottom line: At six years, less than half a percent of those treated within a year of diagnosis had died. The death rate of the people who did not receive immediate treatment was also low (1.2%). As for those followed for 20 years: 99% of immediate-treatment group and 97% of the no-immediate treatment group were alive at 20 years. In other words, early diagnosis and immediate treatment accounted for a 2% difference.

This study was conducted by Louise Davies, MD, and H. Gilbert Welch, MD, of the Dartmouth Institute for Health Policy and Clinical Practice, and published last month in Archives of Otolaryngology, Head and Neck Surgery. It’s a sequel to their 2006 landmark study that identified ultrasound and fine-needle biopsies as the major reasons for the increase in thyroid cancer incidence. The new study was funded in part by a Research Enhancement Award from the U.S. Department of Veterans Affairs.

Davies and Welch caution doctors that the “outcomes” of patients treated for papillary thyroid cancer “are extremely favorable,” but the risks of treatment must also be taken into account. “Survival is so good that it is appropriate to consider whether the risks of complications outweigh the benefits of treatment during discussions about when and how to treat the disease. The risk of permanent hypoparathyroidism and significant damage to laryngeal function have been reported to range from 3% to 5%…”

In the editorial that accompanied this study, a counter argument was offered by Erich M. Sturgis, MD, and Steven I. Sherman, MD, of the M.D. Anderson Cancer Center, Houston. They agreed that a “wait and see” approach may be appropriate for many patients, particularly those with additional, more serious medical conditions. On the other hand, a person with a large tumor and a history of radiation exposure should be treated immediately. Furthermore, Sturgis and Sherman say that they see many patients with recurrent thyroid cancer “after an inadequate initial evaluation and/or treatment.”

And as for that 2% difference in the 20-year survival rate between the patients who were treated immediately and those who were not. Sturgis and Sherman extrapolate that 2% to the estimated 35,000 Americans diagnosed yearly with papillary thyroid cancer. It might be a tiny statistic, they say, but it represents about 500 to 700 people who will die of papillary thyroid cancer. “Certainly, most of these hypothetical 500 to 700 people would have wished their physicians had offered them the treatment that had ‘statistically’ better survival (i.e., surgery).”

Still, the editorialists do not dismiss the overtreatment concerns of Davies and Welch. Like the tiny tumors detected in the prostate, they state that occult papillary thyroid cancers “might even represent the normal aging process of the thyroid gland.” Davies and Welch are quoted approvingly:

“Because so many of these cancers would likely never have caused symptoms during life, epidemiologists have labeled the phenomenon, ‘overdiagnosis.’ Overdiagnosis is a cause for concern because it makes it hard to identify which patients need treatment…Further studies will be needed to determine if a more cautious diagnostic approach—perhaps simply providing follow-up for symptomatic thyroid nodules—is worthwhile. In addition, papillary cancers smaller than 1 cm could be classified as a normal finding.”

For more information
Read this 2006 article about Davies and Welch initial paper on the rise in thyroid cancer incidence. See the suggestions from Dr. Davies about finding a second opinion, including a second opinion about undergoing an ultrasound of the thyroid in the first place. (Click here for “Cancers that do not kill”)

The thyroid cancer incidence has been rising for three decades, and most Americans are treated immediately. Yet there’s no change in U.S. thyroid cancer death rate, which has always been very low. Click here for the National Cancer Institute’s take on this point.

Maryann Napoli, Center for Medical Consumers©

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Treatment for Early Prostate Cancer

Posted by medconsumers on March 1, 2009

Not Better Than “Wait & See” Approach

A common treatment given to men with early-stage prostate cancer—one that has significant harms—was found to be no more effective in extending life than the “wait-and-see” approach. The study, published last summer in the Journal of the American Medical Association, highlights the fact that doctors have been using this treatment for decades without proof of benefit. Its finding became the centerpiece for an unusual article in a recent issue of the Journal of the National Cancer Institute that candidly discussed the many reasons for overuse, chief among them are the financial incentives that encourage treatment…but more on that later.

The treatment in question is called androgen deprivation therapy (ADT), aka drugs that shut off the male hormones known to promote tumor growth. It is given to men whose cancer is confined to the prostate and received no other treatment, such as surgical removal of the prostate. The 2008 study that showed ADT does not increase survival was conducted by Grace L. Lu-Yao, MPH, PhD, University of Medicine and Dentistry of New Jersey, and colleagues who drew their information from Medicare claims.

The men in this study were diagnosed with localized prostate cancer in 1992-2002. They were age 66 years and older at the time of diagnosis with a median age of 77 years. Survival results favored the untreated. During the ten year follow-up period, those given ADT had a lower prostate-cancer survival rate (80%) than those not given ADT (82.6%).

Wide variations were seen in the treatment duration—half of the ADT-treated stayed on the drugs more than 30 months. Such long-term use has been associated with 10% to 50% increases in the risks of fracture, diabetes, coronary artery disease, heart attack and sudden cardiac death, according to Dr. Lu-Yao and colleagues. Hot flashes and swollen breasts are some of the common adverse effects.

This is not the first study to show ADT for early-stage disease did not prolong life, though its use steadily increased over the last 20 years. In a telephone interview Peter C. Albertsen, MD, a co-author of the ADT study, acknowledged a trial that randomly assigned men to ADT or no treatment would be ideal. But that type of trial would have taken too long, he continued, “So we did the best we could by going to the Medicare claims data.”

Dr. Albertsen, who is a professor and chief of urology at University of Connecticut, Farmington, went on to explain, “It was thought that early use of ADT would offer a longevity benefit, but our analysis is convincing that early use of hormone therapy doesn’t make sense. In fact it makes much more sense to wait for the patients to develop symptoms before they are offered this treatment.”

That conclusion also calls into question the current practice of giving the PSA (prostate-specific antigen) blood test to symptom-free men, as part of a routine physical exam, though the test has yet to be proven life-saving. And many experts suspect that it causes far more harm than good, particularly in elderly men, because it leads to unnecessary drastic treatments [e.g., prostatectomy] for cancers that would never produce symptoms or become lethal. Furthermore, there is no accurate way to distinguish the cancers that will progress from those that will remain dormant for a lifetime. These concerns led to new recommendations from the U.S. Preventive Services Task Force.

Last summer, the USPSTF announced that men over the age of 75 years should no longer be screened for prostate cancer and men younger than 75 years should know “the benefits of screening for prostate cancer are uncertain and the balance of benefits and harms cannot be determined.” With this recommendation, the USPSTF parts company with many other medical organizations like the American Urological Association that recommend PSA testing for all men after the age of 50 years.

With the new USPSTF recommendation in mind, Dr. Albertsen was asked whether it is reasonable to see his study’s findings as an example of the harm that results from the aggressive promotion of the PSA test over the last 20 years. “Yes it is,” responded Dr. Albertsen, after a moment’s hesitation, “because you can only have early, localized cancer [diagnosed] if you are screened—otherwise you’d have a tumor that causes symptoms and that’s not what we’re talking about here.” (See Just Say No to PSA Test article.)

There are other forces driving the overuse of ADT, according to James Talcott, MD, director of the Center for Outcomes Research at Massachusetts General Hospital Cancer Center. In a telephone interview, Dr. Talcott, who was not involved in the ADT study, said, “Two drugs [used in ADT]—Lupron and Zoladex—have been aggressively promoted by their makers—Tap Pharmaceuticals and AstraZeneca.” Both companies used illegal kickbacks to encourage and reward urologists who were high prescribers of these expensive drugs, although a less expensive drug is widely available.

“Together, these two companies had to pay over a billion dollars to the federal government in fines for kickbacks to urologists [in 2001],” said Dr. Talcott. (The kickbacks included free TVs, VCRs and seminars at resorts.) “Drugs like Lupron and Zoladex—that are given by injection or infusion—are where all the money is made,” he continued, doctors can bill for them which is not the case for drugs given orally. “A great majority of men are treated by a urologist and moved on to an oncologist only after they don’t respond to Lupron or Zoladex.”

Part of the ADT overuse problem is not the physicians’ fault, stressed Dr. Talcott. “It’s also the payment mechanism. Doctors are paid to do something like give an injection, but talking to patients is a money loser.” Dr. Albertsen made a similar point, saying it’s easier to give a drug than to explain the seemingly counterintuitive option of leaving cancer untreated.

Men are bombarded with the message that early detection is best, observed Dr. Talcott, and yes many cancers are found, but “men are at least tenfold more likely to be harmed than helped by treatment of early-stage symptomless cancer.”

Maryann Napoli, Center for Medical Consumers© March 2009

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Hospitals Compared

Posted by medconsumers on June 1, 2008

Consumer Reports Provides Comparisons of Aggressive vs. Conservative Hospital Care

The “more is better” approach to American health care has been challenged consistently over the last 15 years by research compiled by two Dartmouth Medical School physicians. As reported in previous issues of HealthFacts, these researchers have studied the care given to Medicare patients in the last two years of life and shown that more tests, more procedures, more specialist care, more days in the hospital do not lead to a longer life or a better quality of life.

Now Consumer Reports has put the Dartmouth findings in a consumer-friendly format that will help Americans determine whether a hospital in their part of the country is likely to deliver aggressive or conservative care. Nearly 3,000 hospitals across the U.S. are included and will be available in the July 2008 issue of Consumer Reports and is freely accessible on the magazine’s Web site. It relies on data from the Medicare claims records of over 4.7 million elderly people treated from 2001 through 2005 for severe illnesses like cancer, congestive heart failure, lung diseases, dementia and coronary heart disease.

The brains behind this research are John E Wennberg, MD, and Elliott S. Fisher, MD, at the Dartmouth Medical School, who have regularly published findings in medical journals as part of a 30-year study of U.S. health care. Entitled the Dartmouth Atlas of Health Care 2008, this research project has also made its findings freely available at its own Web site (www.dartmouthatlas.org).

Contrary to what many Americans believe, aggressive care and consulting many specialists do not improve outcomes or lead to more patient satisfaction. In fact, altogether they slightly increase mortality. The Dartmouth researchers demonstrated years ago that more care often results in more procedures that are painful and unnecessary; more days in the hospital raises the chances of suffering a medication error or getting a fatal hospital-borne infection; and more specialist care leads to uncoordinated care. (Get a good primary care doctor is one of the take-home messages of the Dartmouth researchers.)

At a time when hospitals typically advertise their new high-tech equipment and friendly staff members, Consumer Reports provides an easy way for the public to see just how aggressive their care will be compared to other hospitals in their cities. (Next, we need to know the infection rate of all U.S. hospitals.) It raises a larger question for everyone to consider: Since overly aggressive care is not limited to the elderly, how can people of any age protect themselves when they become hospital patients?

Things aren’t likely to change until consumers make their wishes known and raise questions. Consumer Reports provides many excellent suggestions: Is this treatment likely to extend my life, and if so, for how long? How do its side effects and risks compare with the symptoms and risks of my disease itself? What will happen if I do not have the treatment? Will this test change the way you treat the disease? If not, what is the benefit of doing it? Is this test likely to lead to follow-up tests, biopsies, or other diagnostic procedures? How will this benefit my health?

The Consumer Reports Web site illustrates why New York University Langone Medical Center in Manhattan is #1 in the country in terms of delivering the most aggressive (and expensive) care. The Medicare cost per person in the last two years of life at this hospital was $105,067. This is compared with $44,090 at the country’s #1 hospital in terms of the most conservative care —Scott & White Memorial Hospital in Temple, Texas. (Both are chosen from a subcategory of 93 U.S. hospitals called “integrated medical centers”—that is, hospitals affiliated with medical schools.)

The average patient treated at NYU hospital in the last two years of life spent 54 days in the hospital, 12 days in the ICU, had 34 primary-care visits and 97 specialist visits. The average patient at the Hospital in Temple, Texas spent 16 days in the hospital, four days in the ICU, had 23 primary-care visits and 18 specialist visits. Yet, as Consumer Reports notes, “The Centers for Medicare and Medicaid Services rates care at Scott & White to be at least as good as that at NYU.”

The New York Times reported that the list of New York City hospitals at the Consumer Reports Web site shows a clear division in terms of aggressive care between the private and the public hospitals. As a group, the private hospitals were in the 94th percentile of aggressive care compared with the public hospitals in the 69th percentile. Although the latter is still above the national average, the difference cries out for explanation. The most obvious would be that poor people get inferior (i.e., less) care.

Dr. Eric Manheimer, who is the medical director at Bellevue (a public hospital) and on the faculty at NYU medical school, offered a unique perspective to The New York Times of someone who works for both the public and private systems. “The care at public hospitals was less aggressive because most of their doctors—he estimated 75-85%–were salaried physicians with little financial incentive to order tests or other interventions. At private hospitals, he said, supply can creates its own demand. There is often an abundance of beds and an endless list of specialists who can be called.”

Maryann Napoli, Center for Medical Consumers ©
June 2008

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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

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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 with 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

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Screening for Prostate Cancer: The More They Test, The More They Find

Posted by medconsumers on November 1, 2007

It’s a controversy that has been roiling among research physicians for two decades: Does the prostate-specific antigen, or PSA, blood test for prostate cancer cause more harm than good? Does the early detection of prostate cancer—that is, before symptoms appear—actually save lives? These questions still haven’t been answered, though many physicians automatically test their middle-aged and elderly male patients as if they have.

A new study conducted in Europe was initiated to see whether PSA screening symptom-free men every two years has any advantage over screening at four-year intervals. The short answer is no, but this study, published in the September 5 issue of the Journal of the National Cancer Institute, suggests that the PSA test is more likely to find non-life threatening cancers without reducing the number of advanced and potentially lethal cancers.

Monique J. Roobol, PhD, and colleagues at medical centers in Holland and Sweden based their findings on data from a large trial called the European Randomized Study of Screening for Prostate Cancer. Initiated in 1993, this trial will answer the question of whether early detection of prostate cancer reduces mortality from this disease.

The reason that this trial and its American equivalent, the Prostate, Lung, Colorectal and Ovarian Cancer trial ongoing since 1992, will take so long to provide answers is the fact that most prostate cancers found on the basis of PSA screening are either non-progressive or so slow-growing that they will never become life threatening or symptomatic. A minority of the prostate cancers diagnosed during the course of this trial will be the deadly aggressive version, and it is unclear whether early detection and prompt treatment of these fast-growing cancers will result in prolonged lives. About 17% of U.S. men contract prostate cancer and 3% of them will die of the disease.

Context Needed

Any discussion of the new study about screening intervals requires some background information on prostate cancer itself. Pathologists have long known that many of the cancers that show up in the prostate will never become lethal had they remained undetected for a lifetime. Autopsy studies of men who died in accidents show that the older they are, the more likely they will have cancer in the prostate.

That’s why the measure of a screening test’s value is not how many cancers it can find; instead it is a reduction in prostate cancer deaths. But that’s not all. Harm must also be taken into account. The detection of prostate cancers that would never progress or become lethal clearly results in a high rate of biopsies and unnecessary treatment. The latter—irradiation or surgical removal of the prostate—is associated with an increased risk of urinary incontinence, bowel dysfunction and impotence.

The diagnosis of new cases of prostate cancer increased substantially in all countries after PSA screening was introduced. In the U.S., for example, PSA screening began in the late 1980s. But contrary to expectations, the prostate cancer death rate has decreased only modestly. And it is not known whether the drop in prostate cancer mortality is due to early detection or improvements in treatment, or both. Such uncertainties can be resolved by a long-term clinical trial that randomly assigns men to be screened (with a PSA test and a digital rectal examination) or not. This describes the European and the American ongoing trials.

“Interval Cancers” Studied

The new study by Roobol and colleagues takes on yet-another unanswered question about prostate cancer screening: What is the appropriate interval for screening? In the U.S. trial, men are usually screened annually.

Not so in Europe. Some medical centers participating in the European trial screen participants every four years, and others screen every two years. This difference in intervals provided the opportunity for Roobol and colleagues to see whether one has any advantage over the other. Of particular interest was the number of prostate cancers detected in men between screening tests. These are what researchers call “interval cancers.” And they are worrisome because they are likely to be the potentially fatal, advanced cancers. A reduction in their detection would be a good sign that screening might eventually reduce the number of prostate cancer deaths.

Roobol and colleagues found that, after 10 years, more cancers were diagnosed in the men (12%) screened at the shorter (two-year) intervals than in the men (8%) screened at longer (four-year) intervals. Contrary to expectations, the number of potentially life-threatening prostate cancers was the same in both groups. The downside of too frequent screening is overdiagnosis, i.e., the increased detection of cancers that do not progress, resulting in more unnecessary biopsies and treatments.

Asked by e-mail for the bottom line message from her study, Dr. Roobol wrote, “Screening should not be done at fixed intervals but through a more personal approach. Men with very low PSA levels (<1.0 ng/ml) can, depending on their age, be screened at much longer intervals. Screening every year for me looks [like] too much for the majority of men in the age group 55 or higher.”

E. David Crawford, MD, University of Colorado Health Sciences Center, author of the editorial that accompanied this study, had this observation: “Although many of us believe that early detection is saving lives, definitive evidence is lacking.”

This uncertainty is reflected in the treatment options listed for all stages of prostate cancer on the National Cancer Institute Web site (www.cancer.gov). Whether prostate cancer is diagnosed at stage I (early) or stage IV (advanced)—no treatment is as reasonable a choice as having the prostate surgically removed or irradiated.

That raises the obvious question: Why test symptomless men when—once cancer is found—no treatment is a valid option? We still don’t know whether the man whose cancer was detected after symptoms appeared is any worse off than the symptom-less man whose cancer was detected with a screening PSA test.

More Needle Biopsies, More Prostate Cancers Detected

“Despite the considerable attention given to the prostate-specific antigen (PSA) as a screening test for prostate cancer, it is needle biopsy—and the PSA test result—that actually establishes the diagnosis of prostate cancer.”

With that as background, H. Gilbert Welch and colleagues at Dartmouth and other Medical Centers studied Medicare claims to determine the proportion of men, aged 65 years and older, who have prostate cancer after a needle biopsy (removal of prostatic tissue by inserting a thin needle through the rectum and into several sections of the prostate). Their study was published in the September 19 issue of the Journal of the National Cancer Institute

The researchers found: Over 10,000 needle biopsies were performed in 1993 through 2001 in 8,273 men, age 65 and older. The overall proportion of needle biopsies found to contain cancer was 32%, and it increased with age—35% for men in their late 70s and 41% for men over age 80.

The risk of finding prostate cancer increased with repeat biopsies in those initially found to be cancer-free, with 50% of the men diagnosed with prostate cancer after two biopsies, 62% after three biopsies and 68% after four biopsies.

The odds of finding cancer go up not only with the age of the man undergoing a needle biopsy but also the number of tissue samples taken. Over the years, the needle biopsy has become more and more aggressive. Initially, needle biopsies consisted of jabs for prostate tissue in six different sites. Now many urologists advocate 12 or more and some even advocate “saturation biopsy,” which involves 32 to 38 jabs, say Welch and colleagues, “the more biopsies taken, the more cancer is found.” The incidence of biopsy-induced infection was not recorded in this study.

Maryann Napoli, Center for Medical Consumers ©
November 2007

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Restless Legs Syndrome: Two Heavily Promoted Drugs

Posted by medconsumers on September 1, 2007

Very likely you never heard of restless leg syndrome (RLS) before 2003. That’s when Glaxo-SmithKline launched a media campaign to promote awareness of this condition that the company described as “underdiagnosed.” Not incidentally, two years later Glaxo’s drug Requip received FDA approval for the treatment of RLS. The drug was already on the market as a treatment for Parkinson’s disease.

Within a year of its RLS approval, Requip was on track to post sales of $500 million, making it one of the fastest-growing drugs in Glaxo’s portfolio, according to the Wall Street Journal. Predictably, another company Boehringer Ingelheim got in on the action with its Parkinson’s drug, Mirapex.

Though RLS invites the usual suspicions that this is yet another illness made up by drug companies intent on expanding their markets, it appears to be real. For some people it can be disabling enough to interfere with sleep on a regular basis. But it is also likely, thanks to Glaxo’s ongoing promotional campaign with its ads aimed at doctors and the general public, that RLS is now overdiagnosed. And many people may be taking a serious drug indefinitely for a minor annoyance that could be treated non-pharmacologically or not at all.

How do you know you have it? These four criteria must be met for a diagnosis of RLS:

  • An urge to move the legs due to an unpleasant feeling in the legs;
  • Onset or worsening of symptoms when at rest or not moving around frequently;
  • Partial or complete relief by movement (e.g., walking) for as long as the movement continues;
  • Symptoms that occur primarily at night and that can interfere with sleep or rest.

Several things to keep in mind if you are taking Requip or Mirapex:

  • According to company-sponsored trials, about 70% of the people on Mirapex or Requip reported a reduction in symptoms; so did more than 50% of those on placebo.
  • These FDA required pre-approval trials lasted only 3 to 36 weeks; therefore the safety and effectiveness of taking a RLS drug longer is unknown.
  • The precise mechanism of action of Requip and Mirapex as a treatment for RLS is unknown, according to company-generated label information.
  • Because the FDA-required pre-approval studies have a relatively small number of participants and are short-term, information about a drug’s serious adverse effects usually comes out years after it comes on the market (if at all). Here is what is known to date: Both drugs can cause some people to fall asleep during everyday activities like driving, eating or talking to someone.

Have all non-pharmacological alternatives been explored?

  • Try doing without any drug that can precipitate RLS, such as antihistamines, caffeine, alcohol, nicotine, as well as numerous prescription drugs, including antidepressants, anti-nausea, neuroleptics (e.g., antipsychotic drugs, major tranquilizers).
  • Engage in moderate exercise, for example, a brief walk before bedtime. Avoid unusual and excessive exercise, which may precipitate RLS.

Maryann Napoli, Center for Medical Consumers ©
September 2007

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Statins and Mediterranean Diet

Posted by medconsumers on February 1, 2007

One might reasonably expect the U.S. government’s cholesterol-treatment guidelines to be firmly based on scientific evidence. Certainly, that was the claim of the National Cholesterol Education Program when it issued an updated report in 2004. What alarmed some researchers and consumer advocates at the time was the expansion of statin use to include people who do not have heart disease but are supposedly at “moderately elevated risk” for developing it.

The updated guidelines would put an additional 23 million Americans on statins for the rest of their lives. A cloud of doubt hung over the entire issue once it became known that the majority of physicians who established the guidelines had financial ties to companies that make statin drugs.

Statins, the top-selling class of drugs in history, are cholesterol-lowering drugs that include atorvastatin (Lipitor), lovastatin (Mevacor), pravastatin (Pravachol), fluvastatin (Lescol), simvastatin (Zocor) and rosuvastatin (Crestor). Their benefit to people with heart disease is proven, but there is a controversy regarding the use of these drugs by everyone else. Three-quarters of all Americans now on long-term statin therapy do not have heart disease.

In a recent issue of the medical journal, Lancet, John Abramson, MD, Harvard Medical School, and James Wright, MD, University of British Columbia, Vancouver, co-authored a commentary entitled, “Are Lipid-Lowering Guidelines Evidence-Based?” They conducted an analysis of all the major trials in which participants were randomly assigned to take either a statin or a placebo. The seven trials that included adults between 30 and 80 years old who already have heart disease clearly showed that statins lower the risk of a cardiac death as well as a death from any cause.

However, their analysis of the other trials that included healthy but high-risk people without heart disease showed that statins should not be prescribed to women of any age who do not have heart disease or diabetes, or to men older than 69 years who do not have heart disease or diabetes because no benefit was shown for them.

There is a modest benefit for men aged 30-69 years who are at high risk of developing heart disease. Out of 50 high-risk men taking a statin every day for five years, only one avoids a “cardiac event” —that is, a heart attack or heart-related death. Put another way, out of every 50 men who stay on statins for five years, 49 risk an adverse drug reaction for no benefit. “In our experience,” wrote Drs. Abramson and Wright, “many men presented with this evidence do not choose to take a statin, especially when informed of the potential benefits of lifestyle modification on cardiovascular risk and overall benefit health.”

*****

What follows is an interview with the lead author of this analysis, John Abramson, MD, who is also the author of the 2004 book entitled, “Overdosed America” and serves as an expert consultant to plaintiffs’ attorneys in litigation involving the drug industry including Pfizer and Lipitor. He is interviewed by Maryann Napoli.

MN: Whenever I write about statins, I get calls from readers that indicate many are misled about their level of risk. Typical is the healthy woman over the age of 65 pressured to take statins by her doctor who says that she is at high risk for a heart attack solely because of age and high cholesterol.

JA: 1) The evidence shows that the higher her cholesterol, the longer she will live; 2) no trial shows that statin therapy will benefit her; 3) people over 65 who exercise routinely, eat a Mediterranean-style diet, don’t smoke, drink moderately, will have a 60% lower rate of death than the people who don’t do these things.

MN: That one trial with people over 70, called PROSPER (PROspective Study of Pravastatin in Elderly at Risk), is often misrepresented.

JA: This trial clearly showed the limited benefit of statins in the elderly. For those who already have cardiovascular disease, taking a statin reduces the risk of heart attack or cardiac death. But it also showed that people in this age range who are at increased risk of, but do not have, cardiovascular disease do not benefit from taking a statin. Importantly, the study also found that at four years, there was one extra new cancer for every 70 people taking a statin. No reduced risk of stroke and no benefit for people without cardiovascular disease and an increased risk of cancer, yet millions of elderly Americans without heart disease or diabetes are taking these drugs because they and their doctors are misled into believing that clinical trials have shown that statins are beneficial.

MN: And people who have had a heart attack?

JA: Statins are definitely helpful for people who have already had a heart attack. Still, the Lyon Diet Heart Study shows how much more effective a healthy diet is in reducing the risk of heart attack for these folks. The participants were randomly assigned to receive counseling about a Mediterranean-style diet (see end of article) or a standard post-heart attack diet. Those who went on the Mediterranean-style diet developed 72% less heart disease than those in the control group. There was also a 56% lower death rate and 61% less cancer than the people in the control group. Simply eating a Mediterranean-style diet is nearly three times more effective at preventing recurrent heart disease and death in post-heart attack patients than is taking a statin. Even more surprising, those on the Mediterranean-style diet did not have lower cholesterol than those eating the standard post-heart attack diet. So when your doctor tells you to get your cholesterol down…keep that in mind.

MN: Lifestyle changes aren’t given much attention.

JA: The vast majority of communication about heart disease is influenced by the drug companies. They focus on cholesterol, rather than diet, exercise, and not smoking because their primary responsibility is to maximize the financial return to their investors, and that’s where the money is. All but one of the major statin trials was funded by a company that makes statins.

MN: That should make us all wary—studies show that the majority of drug company-funded studies produce results favorable to their product.

JA: The ALLHAT [Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial] was the only one of the 14 major statin trials included in the most recent review [published in the Lancet in October 2005] not funded by a drug company. It included a good mix of people: men and women with and without heart disease and/or diabetes. Half of the participants were randomly assigned to be treated with a statin and half to go to their regular doctor and do whatever he or she thought was right. By the end of the study, 26% of the people assigned to “usual care” had been put on a statin by their doctors and 77% of those in the statin group were still taking the statin (the others discontinued because of side effects, other medical conditions, etc.). But the results showed that there was no less heart disease or death in the group with three times as many people taking statins.

MN: These results seem to be widely misperceived.

JA: One of the reasons is a misleading editorial that accompanied the publication of ALLHAT in the Journal of the American Medical Association. It stated: “Physicians might be tempted to conclude that this large study demonstrates that statins do not work; however, it is well known that they do.” That’s not quite what I think of as evidence-based medicine. The editorialist actually had the chutzpah to suggest that statins may be less effective when they are prescribed by primary care physicians, as they were in the ALLHAT, than by cardiologists. At the time of the editorial, the writer had financial relationships with at least seven drug companies. He is now employed by Merck, which makes Zocor.

MN: All but two of the statin trials failed to report their serious adverse events, defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization, requires prolongation of hospitalization, or results in significant disability.

JA: The statin trials that report only the drug’s effects on heart disease are not presenting what we all really need to know. The most important question is: What is the overall effect of taking the drug? In other words, if a statin decreases the risk of heart disease but does not reduce the overall risk of serious illness or death unrelated to heart disease, is it worth taking? And the difficulty of answering this question ought to lead people to wonder if there are alternative ways to reduce the risk of heart disease.

MN: Why do journals allow drug companies to publish only heart-related results of their trials?

JA: Medical journals are not fulfilling their responsibilities when they publish trial results and omit all serious adverse events and deaths from all causes.

MN: Any parting thoughts?

JA: People ask, “Why can’t I just take a pill, eat what I want and forget about going to the gym?” And I say to them: If the pill worked, that would be a good question, but there just isn’t any evidence from clinical trials showing that statins are beneficial for women or older men who don’t already have heart disease or diabetes. Healthy lifestyle changes are a more effective, less expensive, and safer way to reduce your risk of heart disease and improve your chances of staying healthy overall.

For information on the Mediterranean-style diet: go to www.americanheart.org and type into the search box: Lyon Diet Heart Study.

Maryann Napoli, Center for Medical Consumers ©

Posted in Alternative Medicine, Diet & Exercise, Drugs, Heart, Men's Health, Women's Health | Tagged: , , , , , , , , | Comments Off

Back surgery compared to non-surgical treatment

Posted by medconsumers on January 1, 2007

Back Surgery Compared to Non-Surgical Treatment

People with severe back pain due to a ruptured disk usually recover whether they have surgery or decide to wait it out, though an operation brings immediate pain relief. And contrary to what many people are told by their surgeons, avoiding surgery does not result in nerve damage. These findings are from a large clinical trial published in November in the Journal of the American Medical Association.

Many back surgeons criticized this trial before it began because they were convinced of disk surgery’s benefit. Some refused to refer their patients to a trial they saw as unethical because surgery would be withheld from some study participants, a necessary component to a study intended to randomly assign half to non-surgical treatment.

But the research team led by James N. Weinstein, DO, Dartmouth Medical School, had these justifications for going ahead: 1) ruptured disks are often seen on the CT or MRI scans of people without any back symptoms and these scans also show that untreated ruptured disks can regress in time; 2) the rate of disk surgery in some regions of the U.S. is 15 times higher than that of other regions and other Western countries, thus raising suspicion that many disk operations are unnecessary.

The clinical trial went forward despite surgeons’ objections, and 2,000 people were treated at one of 13 U.S. spine clinics. All had scan-confirmed disk herniation and the persistent back and leg pain of sciatica for at least six weeks. Some of the participants agreed to be assigned randomly to receive either back surgery or non-surgical therapy (physical therapy and counseling and anti-inflammatory painkillers). Other participants, however, wanted to choose their own treatment, and they formed the basis of a separate trial called an observational study.

The results did not identify one treatment as superior to the other because so many study participants “crossed-over.” Only 50% of the people assigned to undergo surgery actually had the operation, and 30% of those assigned to non-surgical therapies decided to have the operation.

A co-author of the observational study Richard A. Deyo, MD, Professor of Medicine and of Health Services, University of Washington, Seattle, was asked for the take-home message of both trials. “Most people got better, regardless of whether they had surgery. Surgery typically offered faster relief, but by two to four years, people are the same whether or not they had surgery,” he responded in a telephone interview. Surgery can be avoided, if the pain is tolerable and the patient is “risk averse,” he explained, referring to the small but definite risks of surgery, such as nerve injury, scarring, and anesthesia mishaps.

The risks of surgery, though small, are greater than any risk of the wait-and-see approach, he continued. “Many people have the impression they will become paralyzed or [suffer] permanent muscle weakness if they delay, but patients needn’t worry.”

Will the new findings reverse back surgeons’ opinions? “This study replicates a trial done in Norway 30 years ago with much the same results,” said Dr. Deyo, noting that many American back surgeons could be unaware of this trial. “It might bring some surgeons up to date,” he said, answering the question of whether the findings will reduce the country’s high number of herniated disk operations, estimated to be 300,000 yearly.

“But it’s spinal fusion surgery that is now the most controversial,” said Dr. Deyo, referring to another back surgery now done in excess. “It has exploded [in growth] over the last decade, and there is no evidence for it.” There are huge financial interests involved in terms of equipment, hospitals, and physicians, explained Dr. Deyo, and the circumstances for which the operation may be warranted, such as spondylolisthesis (vertebrae out of alignment), spinal fracture, and cancer metastasis to the spine—are all uncommon.

Maryann Napoli, Center for Medical Consumers ©
January 2007

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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.

Maryann Napoli, Center for Medical Consumers ©
April, 2006


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.

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