Posts Tagged ‘Screening’

How Good are Colonoscopies?

Posted by medconsumers on January 1, 2009

Colonoscopy’s Benefit Found to be Overestimated

Regular visitors know that this Web site has never championed cancer screening tests. They are inevitably oversold to the public—benefits hyped, risks downplayed. Now colonoscopy has been exposed as a less than sure-fire lifesaving procedure. When colonoscopy screening first took off about nine years ago, people were often told by their doctors, “No one would die of colorectal cancer if every adult over age 50 had a colonoscopy.”

This inflated promise, based on no direct evidence, was downsized in time to: 90% of all colorectal cancers will be prevented. Now a new study, published this month in Annals of Internal Medicine, indicates that the true statistic may be nearer to 60%. It found that colonoscopy often misses polyps in the right, or ascending, colon where many colorectal cancers develop.

Why did it take so long to find this out and to be honest with the public? It’s not as if colonoscopy had ever been proven 90% effective or that disappointing information about colorectal cancer screening hasn’t been around for years. A 2000 San Francisco meeting of colorectal cancer researchers from all over the world is a case in point. Screening continually came up at this three-day conference as the most important way to reduce deaths. At the end of the conference, Dr. Wendy Atkin, a researcher from the UK, went up to the microphone to warn that there are only three randomized, controlled colon cancer screening trials worldwide, and all three showed screening is not lifesaving. True, a 30%reduction in colorectal cancer deaths was shown in the screened people, but this was offset by an equivalent increase in heart-related deaths.

As one of a handful of consumer advocates invited to attend this conference, I found her statement to be astounding and expected it to generate a heated discussion. Instead the waters folded over, and talk went on to other topics. I asked Dr. Atkin, as she was rushing to a taxi, whether researchers knew why people screened for colorectal cancer showed an increase in heart-related fatalities. She said they had no idea.

The first (and possibly only) doctor to share this disturbing bit of information with the public is H. Gilbert Welch, MD, professor at Dartmouth Medical School and author of the excellent 2004 book entitled, “Should I be Tested for Cancer? Maybe not and here’s why” (University of California Press). The three screening trials* involved the fecal occult blood test (FOBT). The participants received a colonoscopy only after the FOBT indicated the possibility of cancer. (Colonoscopy was not a screening procedure in the pre-1990s era when these studies were planned.) As for the question of why screening would cause an increase in cardiac deaths, Dr. Welch could only make a few guesses because no researchers have come up with, or perhaps ever looked for, a plausible explanation.

Dr. Welch’s book is not a rant against cancer screening tests. He takes a hard look at the supporting research and advocates realistic expectations. “Some believe that anyone who dies of cancer and wasn’t screened would have been saved had they had a test. But that’s not true. Sometimes cancers appear in the interval between screening tests. These interval cancers are growing rapidly and are more deadly than cancers detected by screening. Other times cancers are found by screening but people still die from the disease. Clearly, screening helps only in certain cases.” Dr. Welch also takes on the prevailing assumption—among doctors and consumers alike—that screening is a risk-free endeavor.

The new study that found colonoscopy misses many polyps did not randomly assign participants to have a colonoscopy or not. We’ll have to wait for that type of trial to see whether colonoscopy actually saves lives or whether colonoscopy screening merely trades one cause of death for another. Instead the new study drew information from the insurance claims for people living in the Canadian province of Ontario. It matched each of the 10,292 people who died of colon cancer with five people of the same age, sex and socioeconomic status who did not have colon cancer or any type of bowel disease.

The research team led by Nancy N. Baxter, MD, University of Toronto, checked how many had had colonoscopies and whether doctors had removed polyps. During the 1996 to 2001 study period, the colorectal cancer death rate was 7% among those who had ever had a colonoscopy and 9.8% among those who never had one. The decline in colon cancer deaths was “strongly associated” with the left side of the colon. And most of the missed cancers were located in the right (ascending) colon. Dr. Baxter and colleagues speculate that some of the colonoscopies might have been inadequately performed. About 30% were done by family doctors.

Doctor’s Skill Unknowable
This study comes on the heels of another one published last spring showing that many polyps are missed during colonoscopies that are performed too quickly. Unfortunately, people have no way of determining the skill of the doctor who will perform the colonoscopy. The American Cancer Society and the Centers for Disease Control and Prevention are reportedly working on developing quality standards for physicians to measure their performance and make improvements. The discussion about how to know whether you have a skilled colonoscopist who does many of these procedures is ongoing.

The renewed attention to colon cancer screening accuracy reminds me of an encounter with another researcher, this time at a 2004 conference. I recognized his name as a leading colorectal cancer researcher who has co-authored many important studies and is a strong proponent of screening. I asked him privately what we should make of that increase in heart-related deaths among people screened for colon cancer, half expecting him to deny any such finding. Instead, his response was surprisingly candid. “I guess we all have to die of something.”

Maryann Napoli, Center for Medical Consumers©

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*Dr. Welch described the only one of the three trials to be conducted in the U.S.: the Minnesota Cancer Control Study—published in 1993 in the New England Journal of Medicine .

Posted in Cancer, Screening | Tagged: Cancer, colonoscopy, fecal occult blood test, FOBT, FOBT vs colonoscopy, Screening | Comments Off

Having A Medical Test?

Posted by medconsumers on September 1, 2008

Ask Questions and Don’t Forget to Get the Results

Numerous mistakes are made all along the way once the primary care doctor orders a test, according to a new survey of eight family medicine practices. The wrong test is ordered; the test is incorrectly administered; incomplete results are conveyed to the doctor; and the results are not reported to the patient. These are a few of the errors reported in this survey that allowed 243 doctors and their staff to report their experiences anonymously.

The research team, led by J. Hickner of the University of Chicago Pritzker School of Medicine, set out to learn the most common testing errors and how often they harm patients There was no attempt to determine the total incidence of testing errors.

The findings were published in the journal Quality and Safety in Health Care. Either not ordering a test or ordering the wrong test accounted for nearly 13% of the errors reported in the survey. In about 18% of the reported errors, the correct test was ordered but not administered properly. The most common type of error (25%) involved delays in getting results from the lab, especially in practices that use a high number of different labs and in practices that have poor follow-up systems.

Patients were unharmed by 54% of errors, but 18% did result in harm. Worse, “harm status” was unknown for 28%. “Minority patients were more likely than white, non-Hispanic patients to suffer adverse consequences or harm,” wrote Hickner and colleagues.

Bottom Line:

Always ask what the test is for and its estimated rate of accuracy. Don’t assume that “no news is good news.” Always call for an explanation of your test results. Better yet, request a copy for your files.

Maryann Napoli, Center for Medical Consumers ©
September 2008

Posted in Screening | Tagged: medical errors, Screening | Comments Off

MRI Scans and Mastectomies

Posted by medconsumers on September 1, 2008

Preoperative MRI Linked to Increase in Mastectomies at Mayo Clinic

Magnetic resonance imaging, or MRI, made news last spring at a meeting of cancer doctors when a Mayo Clinic oncologist reported that the use of this diagnostic technology appears to increase the number of women who are choosing mastectomy over breast-conserving surgery. The finding is based on a study of early-stage breast cancer patients treated at the Mayo Clinic in Rochester, MN.
The rate of mastectomy in the U.S. had been declining steadily since the mid-1980s when a landmark national trial proved it to be no more lifesaving than breast-conserving surgery. For example, 36% of the women treated at the Mayo Clinic had a mastectomy in 2002, down from 45% in 1997.

Matthew Goetz, MD, the medical oncologist who presented these findings at the meeting of the American Society of Clinical Oncologist, called attention to the change that began to occur once preoperative MRI was introduced. The rate of women given this imaging procedure preoperatively went from 11% to 22% between 2003 and 2006. During the same period, the mastectomy rate rose from 30% to 43%.

MRI is sometimes recommended in addition to a mammogram, especially for women with dense breasts and/or a genetic predisposition to breast cancer. The newer technology has several advantages over mammography, such as no radiation exposure, no compression of the breast, and a sharper imaging that identifies more abnormalities. The downsides of MRI include high cost and sharp imaging that causes a high rate of false alarms (19% in first year and 9% in the second, according to one study).

The Mayo Clinic findings do not prove that MRI directly caused the increase in the number of women choosing mastectomy. Nor were women or doctors asked about their decision-making process. Referring to MRI’s ability to find tiny lesions that may or may not be cancer, Dr. Goetz said, “What we don’t know from this study is whether the higher rate of mastectomy observed in our patients undergoing MRI leads to greater anxiety for the patient and physician, thus leading patients and physicians to choose mastectomy over lumpectomy.”

In a recent issue of the Journal of the National Cancer Institute, Dr. Goetz elaborated on this theme, “I wonder whether patients reach a threshold where they are unwilling to deal with the uncertainty of future imaging and biopsies,” he said. “They are tired of a physician saying, ‘We’re not sure, follow up in six months with a repeat test,’ and so those patients may say, ‘Thank you very much, but let’s just proceed with a mastectomy.’”

For More Information About MRI and Other Cancer Tests:

Go to www.cancer.gov, the Web site of the U.S. National Cancer Institute (type: MRI in the search box at the top of home page).

This Web site is also a good source of information about all cancers and their respective ltreatment options by stage. There is a patient’s version for each cancer, which is billed as “less technical,” but it only describes the treatments options. To find out how good the supporting scientific evidence is for these treatment options, go to the “health professional” version. You can click into the abstracts of the clinical trials that produced the supporting evidence. The health professional version also ranks the quality or strength of the evidence. Or, call 1(800) 4-CANCER.

Maryann Napoli, Center for Medical Consumers ©
September 2008

Posted in Cancer, Scans and X-rays, Screening, surgery, Women's Health | Tagged: breast cancer, mammography, scans, Screening | Comments Off

How to Select a Mammography Facility

Posted by medconsumers on July 1, 2008

Can women do anything to improve their chances of receiving an accurate interpretation of a screening mammogram? A new study found that there are several important characteristics to look for when selecting a mammography facility. The finding is based on a survey of 44 U.S. mammography facilities published last month in the Journal of the National Cancer Institute.
To learn how women can act on the results of this study, Maryann Napoli, Center for Medical Consumers, interviewed one of its co-authors, Joann G. Elmore, MD, Professor of Medicine, Adjunct Professor of Epidemiology, University of Washington School of Medicine, Seattle.

MN: Doesn’t the physician usually choose the mammography facility?

JGE: Most often women see their primary doctors and that doctor will refer them to a mammography facility that is linked with the primary care office.

MN: So women don’t actually do the choosing?

JGE: Mammography screening is a unique medical test in that women can refer themselves. There are mobile vans going around the country, stopping at work sites. I don’t know the actual number of women who self refer, but I suspect many women are actively involved in choosing mammography facilities.

MN: You have co-authored dozens of mammography-related studies. I recall being shocked by your first one, published in The New England Journal of Medicine in 1994. You found that experienced board-certified radiologists interpreting the same images often come to different conclusions about the presence or absence of breast cancer.

JGE: For many years I’ve been trying to figure out why there is so much variability in the interpretation of mammograms. Then we went on to identify characteristics of the patients that put them at risk of having an inaccurate exam. Some characteristics you cannot change like having dense breasts, and some you can change. For example, menstruating women can make sure not to schedule a mammogram around the time of their periods when the breasts swell and become tender. A few studies show accuracy is lower at this time.

MN: And now you’ve taken on the characteristics of the mammography facilities in your latest study.

JGE: Yes, I have been working in this area for 15-20 years, but I had never really asked the question: Does it matter which facility women choose? We found that facilities that have breast imaging specialists on their staff had a higher degree of accuracy.

MN: Don’t all facilities have breast imaging specialists interpreting the mammograms?

JGE: No, in some facilities mammograms are interpreted by general radiologists who do not have specialty training in breast imaging. And these radiologists interpret the minimum number [of mammograms] required for accreditation, but they may also interpret chest x-rays, MRI scans, ultrasounds, etc. Mammography may be a small part of their clinical workload.

MN: So women should ask this question of the facilities on the phone, prior to making an appointment: Do you have a breast imaging specialist on the staff? I know this is an awful question but do you really think women will get an honest answer from facilities that have only general radiologists reading their mammograms?

JGE: Well yes, if women ask the question this way: Do you have a radiologist that spends more than 50% of the time working in breast imaging? That’s pretty clear-cut. That’s how we define a breast imaging specialist in our study.

MN: What else did you find that women should ask about the facility?

JGE: They should ask whether the facility conducts audit reviews two or more times a year. Our study found higher accuracy among the facilities that review their audit data with the radiologist on a regular basis. This finding makes sense to me because the radiologists are learning from the prior history and probably improving the quality of their interpretations.

MN: Audit reviews are a form of quality control. The facility should compare the mammogram interpretations with the results of the breast biopsies in order to regularly test the accuracy of the radiologists’ decisions.

JGE: If you read the fine print of the Mammography Quality Standards Act, you’ll see that the facilities don’t have to show the audit results to the individual radiologists.

MN: That’s disturbing. Why collect audit information if the facility doesn’t show it to the radiologist?

JEG: Yes, as a physician, I believe that we have the opportunity to improve when we get feedback.

MN: That changes the second question women should ask when choosing a facility. It should be: Does your facility do audit reviews at least twice a year, and is the radiologist routinely given the results of these reviews?

JEG: Yes.

MN: You did not find volume to be important to accuracy. One would think that the more images a radiologist reads, the more likely he or she will make accurate interpretations.

JGE: Many studies have evaluated whether high volume is associated with performance, and there’s an assumption that really high volume by the radiologist is good because it means that the radiologist has a lot of experience. But like all areas of life, it’s more difficult than that. It’s possible that the facility could have high volume, but the facility might not be collecting and reviewing the audits and therefore not following up on those many thousands of patients whose mammograms have been interpreted.

MN: What’s the definition of high-volume?

JGE: There have been a few studies, but many of them have contradictory results. In the U.S., radiologists must do a minimum 480 mammograms per year, as required by law.

MN: That doesn’t sound like much.

JGE: In Europe, the minimum in some countries is 5,000 cases a year. But the question is: Are some countries doing better because they have higher volume? The published studies have contradictory results. There’s an ongoing study funded by the American Cancer Society and the National Cancer Institute. It will be helpful to see if they can clarify this at all.
MN: What are you working on now? What are the other major unanswered questions about mammography that should get research attention?

JGE: I’m continuing my research efforts aimed at improving the quality of breast cancer screening and detection. I am investigating the efficacy of new technology, such as digital mammography and computer-aided detection, and how we can improve our communication related to mammography.

MN: Mammography screening has been aggressively promoted to women ever since the early 1970s. It’s interesting to see how long it takes to get some basic questions answered. You are to be congratulated for being in the forefront of mammography screening research and for continuing to ask the research questions that will lead to more improvements. See Mammography Leaflet from the Nordic Cochrane Centre.

Maryann Napoli Center for Medical Consumers ©
July 2008

Posted in Cancer, Screening, Women's Health | Tagged: breast cancer, interviews, mammography, Screening | 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

Screening for Stroke, Peripheral Artery Disease and Abdominal Aortic Aneurysm

Posted by medconsumers on June 1, 2007

Perhaps you got a mailing from Life Line, or noticed its mobile clinic at your synagogue, church or workplace. Life Line is in the business of selling vascular screening, primarily tests for stroke, peripheral artery disease and abdominal aortic aneurysm. The prices are low—$45 each test—because most insurance companies and Medicare will not pay for the tests (with one exception).

Life Line has a presence in nearly all states, and according to its Web site, has already screened 4,715,306 people. Often the company sets up shop at local hospitals, but its promotional literature offers this qualification, “We are in no way trying to replace the services provided by these local hospitals. Rather, we want to work in conjunction with them to identify asymptomatic individuals with significant disease.”

It’s unlikely that local hospitals would see Life Line as encroaching on their turf. On the contrary, screening symptomless people creates customers who can be funneled right to the hospital, where more tests and, often, surgery can be done.

Screening by definition involves testing people without symptoms. “Don’t wait for a medical problem” is Life Line’s seductive sales pitch. Screening sometimes can extend life or result in less drastic surgery than would be necessary had the disease been discovered after symptoms appeared. However, all screening tests have their risks that are rarely mentioned to the public. They find abnormalities that may be better off left undetected. In the case of abdominal aortic aneurysm—not all will rupture and, in certain circumstances, an operation on one that is symptomless can be riskier than leaving it alone.

Mass screening for vascular disease is a relatively new idea. Before plunking down your money, the question to be answered is this: Have any studies proven that detecting and treating this symptomless problem will either prolong my life or improve its quality?

An objective source of screening information is the U.S. Preventive Services Task Force, which appoints an independent panel of experts to review all relevant studies and issue screening guidelines for doctors and consumers based on the findings.

The USPSTF has taken an in-depth look at the three screening tests promoted by Life Line and advises against ultrasound screening for peripheral artery disease (hardening of arteries in the leg), ultrasound screening of the carotid artery in the neck (purportedly to prevent strok) and abdominal aortic aneurysm (AAA) in women. In all cases the potential harm of false-alarm test results and unnecessary surgery outweigh any life-prolonging benefit.

The one exception is AAA screening for men between the ages of 65 and 75 years who have ever smoked—the only people who will benefit and the only ones to receive Medicare reimbursement.

An aneurysm is the widening of a small section of an artery that can burst once the vessel wall becomes weakened. An AAA occurs near the aorta, the main artery from the heart that passes through the abdomen. The condition is frequently symptomless, but a rupture is life-threatening and requires immediate surgery.

The decision to screen symptomless people for any disease should be based on its prevalence and the likelihood of successful treatment. Elderly men are six times more likely to have an AAA than elderly women. Most AAA deaths occur in men over 65; whereas most AAA deaths in women occur when they are older than 80. Men are more likely to survive AAA surgery (probably because they are younger at the time of aneurysm repair).

The USPSTF and, more recently, the Cochrane Collaboration conducted separate reviews of all relevant studies and came to similar conclusions in favor of AAA ultrasound screening for men, age 65 to 75 years (who have ever smoked), which will reduce AAA-mortality. (The potential benefit to men who have never smoked is too small to be worthwhile.) An aneurysm larger than 5.5 cm requires surgery because it has a higher risk of rupture than smaller aneurysms, which can be followed with ultrasound.

Both the USPSTF and the Cochrane review based their conclusions on the same four studies, which provided the best evidence about AAA screening. They had a combined total of 127,891 men and 9,342 women. (Only one trial included women.) The studies randomly assigned people over age 65 to receive an invitation to be screened or continue “usual care”. Significantly, the men who received AAA screening had more AAA operations, but not one of the four studies provided information regarding surgical complications or quality of life.

Bottom Line:

Life Line is exactly the type of business that would emerge from a profit-driven medical care system. It preys on people’s fear of death and counts on the prevailing overly optimistic belief that early detection is always beneficial. The company’s justifications for testing are based primarily on the high prevalence of a particular condition and its symptomless early stages. There is no evidence to show that the benefits of screening for stroke or peripheral artery disease outweigh the risks.

As for AAA screening, it could be summed up this way: We have to die of something. Four studies showed that it lowered the AAA-related death rate for the elderly male smokers but they didn’t live any longer than their non-screened counterparts. The rate of death from all causes was exactly the same in both groups 3 to 5 years after screening. Here’s another way of explaining this finding: By the time a male smoker reaches advanced age, he is more likely to die of heart disease or cancer than an AAA.

More Information:

USPSTF recommendations at www.ahrq.gov/clinic/uspstfix.htm#recommendations
Ever wonder why the public has an overly optimistic view of screening? Read: “Unhealthy Advocacy: Journalists and Health Screening Tests” by Gary Schwitzer at www.poynter.org/column.asp?id=101&aid=123044

Maryann Napoli, Center for Medical Consumers ©
June 2007

Posted in Screening | Tagged: Screening, stroke | Comments Off

A Critical Evaluation of the Pap Test and Its Role in Reducing Cervical Cancer Deaths

Posted by medconsumers on March 1, 2007

Widespread use of the Pap test has successfully reduced cervical cancer incidence and mortality. This bit of medical wisdom has largely gone unchallenged with one noteworthy exception in 1978, when Anne-Marie Foltz and Jennifer L. Kelsey co-authored “The Annual Pap Test: A Dubious Policy Success” in the Milbank Memorial Fund Quarterly. This critique is worth recalling today, now that the Pap test is an integral part of the discussion surrounding the merits of the new HPV vaccine. Many consumer advocates who are against mass HPV vaccinations see Pap testing as the safer alternative.

Would that things could be that simple.

The Pap test’s role in the much-heralded “dramatic” decline in the cervical cancer death rate is overstated, according to Foltz and Kelsey, because the rate began to drop well before the Pap test became widely used. Moreover, they report that estimates of the effect of hysterectomy on this decline vary from 10% to 25%. (Hysterectomy involves the removal of the cervix which is the neck of the uterus.)Foltz and Kelsey estimated that one in five American women are without a uterus. After their paper was published, the U.S. hysterectomy rate eventually rose to one in three women. At very least, this would explain why the incidence of cervical cancer has declined in the last 50 years.

Whatever the reasons, the decline in cervical cancer deaths can hardly be described as dramatic. In 1968, there were 7,108 cervical cancer deaths in the U.S. (by 1973, nearly 50% of women reported having had one Pap test during the previous year). In 1976, there were 5,525 deaths. [In 2006, it was 3,700 deaths. For the role of the Pap test in half these deaths in 2006, see below.]

Cervical cancer is not a major cause of death in the U.S. or other Western countries, wrote Foltz and Kelsey, who pointed out that screening people for a disease of low prevalence flies in the face of the medical research standards set by leading thinkers of the time. “The lower the prevalence, the less likely it is that a positive test will correctly identify a woman who really has cancer. This means that many women with positive test results but without disease will be referred unnecessarily for further diagnostic tests and treatment, with concomitant costs and worry,” explained Foltz and Kelsey, respectively, of the Graduate School of Public Administration, New York University; and the Department of Epidemiology and Public Health, Yale School of Medicine.

Wrong Women are Getting Pap Test
Making a point that is relevant today in the promotion of Gardasil, a 1976 editorial in The New England Journal of Medicine raised the issue of whether the wrong women were being screened, “since it was the middle-class low-risk women who were coming in for Pap tests, while the low-income high-risk women were not being seen in clinics.”

If low-risk women are the major customers for the Pap test, their odds of false alarm test results will be unacceptably high, but that was never a major concern to the promoters of cervical cancer screening, chief among them, the American Cancer Society. “The accuracy and reliability of the Pap test have not been established despite its use for over 30 years,” wrote Foltz and Kelsey in 1978.

In other words, no clinical trial has ever been conducted to determine the value of the Pap test because its promotion predated the introduction of the “gold standard” of medical research. Had a large trial randomly assigned women to a Pap test or no Pap test, its efficacy and harms would have been established. And the harms are many, especially in the early days of the Pap screening, according to Foltz and Kelsey. The primary purpose of the Pap test was to detect cancer or tiny lesions that may be pre-cancerous. But by 1978, it was known that these so-called “early,” pre-cancers, carcinoma in situ detected so frequently on a Pap test do not always progress to become deadly, if left untreated.

According to Foltz and Kelsey, this was acknowledged by pathologists, but it took time for the word to get out to the surgeons (i.e., gynecologists). The unnecessary hysterectomies, oophorectomies (surgical removal of the ovaries), and biopsies for “cancers” that would have spontaneously regressed went uncounted. The focus was entirely on the decline in cervical cancer deaths.

Today, a hysterectomy following a Pap test-discovered pre-cancerous lesion or a carcinoma in situ (Latin for cancer in place) is no longer as common. But then again, who’s counting? What were cancers or precancers in another era have long since been renamed as LSIL (see the quote below) or ASCUS, which stands for atypical squamous cells of uncertain significance. The latter nicely describes the unknowns that continue to surround most of what is currently detected on a Pap test.

Today, other harms are acknowledged to result from mass Pap screening. The following quote is from the National Cancer Institute’s Web site www.cancer.gov. “Based on solid evidence, regular screening with the Pap test leads to additional diagnostic procedures (e.g., colposcopy) and treatment for low-grade squamous intraepithelial lesions (LSIL), with uncertain long-term consequences on fertility and pregnancy. These harms are greatest for younger women, who have a higher prevalence of LSIL, lesions that often regress without treatment.”

Half of the 9,710 U.S. women who develop cervical cancer have not had a Pap test. The other half of all cervical cancers occur in women who have had one. Imperfect testing is estimated to be responsible for 30% of all cervical cancers in women who have had Pap test and improper follow-up of abnormal test results for another 10%. Even under the best screening circumstances, an incidence rate of two to three per 100,000 women can be expected. Some risk factors for not having a Pap test are lack of insurance, poverty, geographic isolation, and lack of provider.

From the American Cancer Society Guidelines for Human Papilloma Virus (HPV) Use to Prevent Cervical Cancer and Its Precursors reported in CA: A Journal for Clinicians, January 23, 2007.

CDC: HPV Prevalent, But Not Cancer-Causing Types

Could it be a coincidence? Just as the media was losing interest in Gardasil, the Centers for Disease Control and Prevention (federal promoters of all vaccines) published a study in the Journal of the American Medical Association entitled, “Prevalence of HPV Infection Among Females in the U.S.” (Why no study of prevalence in males?)

The short of it is this: HPV is much more common than previously thought. In fact the prevalence is highest among those aged 20 to 24 years. The overall prevalence is 26.8%, but the overall prevalence of the high-risk HPV types was only 2.6%. Though this study also noted previous research showing that “approximately 90% of infections clear within two years,” the new findings have already begun to play out in the media as: HPV is prevalent, get your Gardasil shots.

Posted in Cancer, Screening, vaccines, Women's Health | Tagged: Cancer, pap test challenged, pap test risks, Screening, Women's Health | Comments Off

Support for FDA Regulation of “Home Brew” Diagnostic Tests

Posted by medconsumers on February 8, 2007

Support for FDA Regulation of “Home Brew” Diagnostic Tests

On February 8, 2007, the FDA held a meeting to discuss the agency’s plan to regulate certain diagnostic laboratory tests for cancer and many other diseases. The central question of the day was: Should the FDA have regulatory power over “home brew” tests, which are multi-gene profiles? These tests will be used to diagnose cancer, determine the most effective treatment, as well as seeing who is at high risk of getting the disease. Traditionally, the FDA has not regulated tests, such as these, that are not done in one central lab. However, the agency has recently designated these tests, called in vitro diagnostic multivariate index assays, as devices. This opens the door to regulation.

At the public comment portion of the meeting breast cancer advocate, Helen Schiff, presented her position on behalf of the Center for Medical Consumers. Her testimony follows:

My name is Helen Schiff. I am a breast cancer survivor and a member of SHARE a breast and ovarian cancer organization in New York City. I am also a patient consultant for the FDA.

The potential for complex biomarkers known as IVDMIAs (In vitro diagnostic multivariate index assays) to change the face of breast cancer treatment is tremendous. For too long we have been plagued with a one size fits all approach to treatment. Even though many women are cured with surgery they have to suffer through radiation, chemotherapy, and 5 years of hormonal treatment because there is no way to know with certainty what treatment a woman really needs, IF ANY. While this treatment strategy has had a small impact onbreast cancer mortality, it has meant that many women have been exposed needlessly to the lethal and life altering effects of all these modalities. Just to name some of the worst ones: leukemia, cardiomyopathy, endometrial cancer, stroke, pulmonary embolism, infertility, lymphedema, “chemobrain,” and loss of libido.

So we welcome a new technology that has the potential to customize our treatments. To give us only what we need. To even tell us which chemotherapy, hormonal treatment, monoclonal antibodies, or small molecule will be optimal for our specific tumors. And we know that in the future IVDMIAs will also have the potential to find breast cancer earlier than is now possible and to do a better job than the Gail model at determining who is really at high risk for getting breast cancer.

Nevertheless, it is very important to be aware of the pitfalls that have plagued biomarker research over the years. In almost half a century of breast cancer biomarker research only TWO biomarkers have proved to be of clinical value: ER and Her2. The significance of what PR means is still disputed. We know for a fact that problems with assays have led to erroneous assessments, less than optimal treatment, and most importantly, premature loss of many lives. Unfortunately, recent studies indicate that there are still problems, for example, with accurate ER and Her2 assays. For example the cut point for ER positivity varies from 1 to 25% of cells with estrogen receptors. A recent study showed that 20% of Her2 tests were not accurate. As many have said, a treatment is only as good as its biomarker, and hence they too need to be rigorously regulated.

One of the most important recommendations of the National Breast Cancer Coalition’s Strategic Consensus Report on Breast Cancer Biomarkers is “to incorporate the best components of drug development to guide the development and validation of biomarker assays.” This new FDA Guidance for IVDMIAs is an important first step in that direction. It will assure that IVDMIAs are: 1) examined before they are marketed; 2) that their results are reproducible by an independent body; 3) that they are tested for accuracy; and 4) that they have clinical relevance. The writing of the IVDMIA label, as with new drugs, must be over seen by the FDA to ensure that there are no false claims and that the results of an INDMIA assays are understandable to both doctors and patients. It is clear to me that neither CLIA, the Federal Trade Commission, nor any other agency in HHS has the depth of the experience, the capabilities, or the resources to undertake such a job, nor do they have the regulatory power.

One need only look to the Ova Check experience to see why this kind of regulatory power is so important. Ova Check was developed as a blood test for the early detection of ovarian cancer in high risk women by Correlogic, a private company, in partnership with scientists from the FDA and the NCI. However, the FDA said that it would not allow Ova Check to be marketed until it published clinical evidence that it WORKED in patients. Keith Baggerly, a bioinformatics specialistat MD Anderson, when trying to replicate the study, found, among other problems, that test results were influenced by the order in which the assay was run. According to an article by David Ransohof in the Journal of the National Cancer Institute Ova Check had not been properly validated its finding in an independent data set and there was a possible problem with over-fitting and bias. Three years later, it has still not been approved to be marketed, confirming its problems were serious. If it were up to CLIA or the Federal Trade Commission, Ova Check would have been marketed-because they do not have the power to stop it. And we all know how hard it is to get something off the market once it is on. Not to mention the irreparable damage it would have done to women.

To me the arguments that FDA regulation of IVDMIAs will hinder development and commercialization, or that this new regulation is unfair, are non red herrings. Don’t we want to find out which IVDMIAs work and which ones don’t, regardless of when they were developed or by whom? If anything will hold up development in this field it will be the premature marketing of more Ova Checks. As we see this is not just a matter ofj “colorful characters” or fly by night companies as suggested in a recent GAO report. Reputable scientists can make honest mistakes.

As an advocate I think we need to introduce rigor and oversight into the biomarker field and I think the FDA Guidance on IVDMIAs is an important step in that regard. I certainly don’t follow the logic that when IVDMIAs are homebrews they should not be regulated by the FDA. My logic leads in the other direction. All biomarkers, including home brews, when used in the CLINIC should be regulated by the FDA. Otherwise we leave the successful commercialization of IVDMIAs to companies who write the best press release, do the most advertising or try and court advocacy groups.

Posted in Advocacy, Cancer | Tagged: Advocacy, Cancer, FDA, IVDMIAs, Screening | Comments Off

FDA Regulation of “Home Brew” Tests

Posted by medconsumers on February 8, 2007

Support for FDA Regulation of “Home Brew” Diagnostic Tests

At the public comment portion of the meeting breast cancer advocate, Helen Schiff, presented her position on behalf of the Center for Medical Consumers. Her testimony follows:

My name is Helen Schiff. I am a breast cancer survivor and a member of SHARE a breast and ovarian cancer organization in New York City. I am also a patient consultant for the FDA.

So we welcome a new technology that has the potential to customize our treatments. To give us only what we need. To even tell us which chemotherapy, hormonal treatment, monoclonal antibodies, or small molecule will be optimal for our specific tumors. And we know that in the future IVDMIAs will also have the potential tofind breast cancer earlier than is now possible and to do a better job than the Gail model at determining who is really at high risk for getting breast cancer.

Posted in Cancer, Screening, Women's Health | Tagged: breast cancer, FDA, Screening | Comments Off

Only One in 2000 Women Benefit from Mammography

Posted by medconsumers on December 1, 2006

Over the 31 years of publishing our newsletter, we have reported frequently about the lack of honesty in the mammography-screening information directed at women. Whether it comes from the American Cancer Society or a family physician, the information tends to be heavy on the lifesaving benefits and light on potential harms.

Here’s something a woman is unlikely to hear: “For every 2000 women* who go for mammography screening throughout a ten-year period, one woman will have her life prolonged. BUT ten additional healthy women, who would not have received a breast cancer diagnosis had they avoided mammography screening, will be treated unnecessarily for a breast cancer that would never have become life-threatening. And more than 200 women will experience significant psychological distress for many months because of false-alarm findings on a mammogram.” click here for the source of this quote

This important information, so crucial to a woman’s informed decision-making, comes from a recent update of a 2001 Cochrane Review of the world’s major mammography screening clinical trials with a combined total of a half a million women. In all seven trials, which form the basis of the U.S. screening recommendations, women were randomly assigned to receive screening mammograms or not. These trials, conducted in North America and Europe, were published many years ago, but researchers continue to argue over their interpretation and conclusions.

* These statistics apply to women, aged 50-69 years. Odds of lifesaving benefit are even smaller for women in their forties.

Original Review in 2001
The 2001 Cochrane Review of these trials was co-authored by Peter Gotzsche, MD, of the Nordic Cochrane Centre in Copenhagen, as is the 2006 update published recently in the Cochrane Library. The original review triggered a prolonged debate in the American media in 2001-2002 after The Lancet published a summary of its results. The lifesaving benefit of mammography screening was shown to be far more modest than previously thought and the harms had been greatly underestimated.

The Cochrane Review also found that the mammography-screened women in the trials had more mastectomies, more lumpectomies, and many more cases of ductal carcinoma in situ (DCIS) than the women who were not screened. Although most cases of DCIS, a tiny non-invasive cancer within the milk duct, do not progress, they were—and in some parts of the country, still are—always treated with breast removal. Now radiation therapy is the more common treatment for DCIS.

In the two trials judged to be of the highest quality by the Cochrane reviewers, there were 30% more cancers in the mammography-screened groups than in the unscreened groups and 31% more mastectomies and lumpectomies. Yet surprisingly, in both of these trials, conducted in Canada and Malmo, Sweden, respectively, mammography screening did not reduce the rate of breast cancer deaths. The other five trials, judged to be of inferior quality by the Cochrane reviewers, did show a modest reduction in breast cancer deaths.

Old Trials, New Data
You might wonder why we are still learning new information from these seven trials, which were conducted between the 1960s and 1980s. The answer lies in the Cochrane reviewers’ thorough assessment of the enormous amount of data that was originally withheld and, in some cases, continues to be generated by these trials. The data, it should be noted, were requested by the Cochrane reviewers.

The long-term data provided by the Canadian trial are a case in point. Mammography’s ability to detect many more cases of DCIS has long been known. Not until this trial published 11- to 16-year follow-up results for women in their forties did it become evident that mammograms also detect non-palpable invasive breast cancers that do not progress. This means that some breast cancers can begin to invade the surrounding tissue, but go no further.

This was demonstrated by the Canadian trial results: There were 43 more invasive breast cancers and 42 more cases of DCIS in the women who underwent mammography screening, compared to those who did not. Yet 16 years later, the breast cancer death rate of both groups was exactly the same. (It is likely that there were just as many breast cancers of both types in the women not given mammograms, but these women benefited from being unaware of them.) Currently, doctors are not able to determine which cases of DCIS and invasive cancer will not progress to become life-threatening. All are treated as if they will be lethal.

Bottom Line: Mammography screening was introduced 35 years ago to reduce the rate of breast cancer deaths by finding and treating breast cancer before it can be felt by a woman or her doctor. even trials have produced contradictory results about the reduction in deaths. And some of these trials found that mammography can detect non-palpable breast cancers—both invasive and noninvasive—that do not progress. All are treated as if they will. For the first time, the benefit and harms have been quantified for women who want to make an informed decision. Based on the combined results of these trials, the Cochrane reviewers produced the one in 2000 women will have her life-prolonged estimate stated at the beginning of this article.

“Women, clinicians and policy makers should consider the trade-offs carefully when they decide whether or not to attend or support screening programs,” concludes the updated Cochrane Review, which was originally commissioned and funded in 1999 by the Danish Institute for Health Technology Assessment and the (Danish) National Board of Health.

Posted in Cancer, Screening, Women's Health | Tagged: breast cancer, mammography, Screening, side effects | Comments Off

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