Posts Tagged ‘interviews’

Alternatives to Open Breast Biopsies

Posted by medconsumers on February 1, 2009

Excessive Use of Open Breast Biopsies: An Interview

Too many U.S. women are having the more drastic, more expensive open biopsy once a mammogram detects an abnormality, according to a new study conducted at one academic medical center. This is diagnostic overkill given the facts that 80% of all such breast abnormalities eventually prove to be benign and that minimally invasive needle biopsy techniques have been available for years.

Overuse of the open biopsy means that women’s health is unnecessarily compromised because the procedure can have serious complications. The development of scar tissue, for example, may inhibit the diagnosis of a future breast cancer. Incredibly, 1.6 million breast biopsies are performed yearly in the U.S. If this study is representative of the rest of the country, nearly 40% are open biopsies.

“Where’s the Outrage?” asked surgeon Melvin J. Silverstein, MD. In the editorial that accompanied the new study, he reminded readers that the women’s movement of the mid-1970s eventually put an end to the drastic one-step diagnosis/treatment procedure. Up to that era, women with a breast lump had to sign a consent form before going under anesthesia, allowing their surgeons to determine malignancy on the basis of a quick frozen biopsy and to do an immediate radical mastectomy when results showed cancer. (Years later, the frozen-section biopsy was acknowledged to be unreliable.)

Now there’s another pressing need for advocacy, says Dr. Silverstein, Director of the Breast Program at Hoag Memorial Hospital Presbyterian, Newport Beach, California, and professor of surgery at the Keck School of Medicine, University of Southern California. He is interviewed by Maryann Napoli, Center for Medical Consumers.

MN: A shockingly high 40% of the breast biopsies done at one Manhattan teaching hospital were open (excisional) biopsies, according to the new study, conducted by Emily M. Clarke-Pearson, MD, and colleagues at Beth Israel Medical Center and Columbia University Medical Center (January 2009, Journal of the American College of Surgeons). How can a woman tell whether she truly requires an open biopsy?

MJS: She needs to know that well over 90% of all breast abnormalities can be biopsied with a needle. Very few people need an open biopsy. For example, if the abnormality is in an extremely difficult place, such as right on the chest wall, a needle biopsy may not be possible. Another possibility is that the patient may not be able to lie on her abdomen thereby making stereotactic biopsy nearly impossible. More and more, needle biopsies are being done with ultrasound guidance and they’re much easier.

MN: You were appalled to learn that so many women in this study with palpable or mammography-detected abnormalities were going straight to the operating room for diagnostic open surgical breast biopsy. What is the typical scenario?

MJS: If the radiologist has control of the patient and the radiologist is an interventionalist—that is, one who knows how to put needles in, then he or she will do a needle biopsy*. But the radiologists often do not control the patients in the U.S. The patients “belong” to the referring doctor. Many breast centers won’t do a mammogram without a doctor’s prescription. In general, a patient goes to a radiologist with a doctor’s prescription that says “bilateral mammography”. If an abnormality is found, the radiologist typically calls the referring doctor, and most of the time, he or she will say, “go ahead and do the biopsy.” But often that referring doctor is a surgeon, and he or she will do an open surgical biopsy because they do not know how to do a needle biopsy.

MN: Breast biopsies are so lucrative., I assume there’s a turf war between the radiologists and the surgeons.

MJS: Yes, when the needle biopsy came along in the early 1990s, the radiologists captured the market, and the surgeons didn’t care. But as time went on, the surgeons said, “I used to do 280 biopsies a year, but now I’m not doing any because the radiologists do them all. I’d better learn.” So the American Society of Breast Surgeons formed, mainly to teach surgeons how to do ultrasound-guided biopsies and stereotactic biopsies. Now there are probably 3,000-4,000 surgeons in U.S. who are competent to do needle biopsies, but there also [another] 30,000 surgeons who do open breast biopsies because they don’t know how to do needle biopsies. It comes down to this: If I don’t know how to do a needle biopsy, then I either have to send the patient to someone who does or do an open biopsy myself.

MN: And the cost differences?

MJS: I used to do 225 open biopsies a year for diagnosis and now I do only two or three a year. An open biopsy in New York City is probably $2,000 to $3,000 [just the surgeon’s fee]. If I lived there, I would have given up $600,000 in billing fees**. So you can understand the motivation. A lot of surgeons now know how to do needle biopsies and those who know how will do it. Open biopsy costs rise to $5,000 to $7,000 once you include the operating room fee and the anesthesia, which can be either local or general. A needle biopsy in New York City is about $2,000. In a smaller city, it will probably be between $1,000 and $1,500.

MN: There are plenty of downsides to the open biopsy besides the expense.

MJS: I’m a professor of surgery. I get a lot of referred patients and half have already had open surgical biopsies. Many times the incision was done in wrong place, and it compromises what I’m going to do, or the margins are not done well because the biopsy was done simply as a diagnostic procedure, not as a therapeutic procedure.. On the other hand, when I get a patient who has had a needle biopsy, nothing has been compromised. Studies have shown that in competent hands, the needle biopsy is just as accurate as the open biopsy.

MN: And many inconveniences are avoided.

MJS: Yes, when a woman has a needle biopsy, she is in and out in one or two hours. She doesn’t need someone to drive her home; she can go to work; she can lift things. When she has an open biopsy, the wound has to heal. She has to be careful of what she does for a few days or a week.

MN: You seemed to be counting on consumer advocacy to change doctors’ practices.

MJS: Yes, the study was done at Beth Israel Hospital, an academic medical center where the work should be top of the line and it’s in New York City, which has some of the most demanding consumers of medicine in the world. And yet nearly 40% were getting open biopsies [in 2007]—that’s outrageous. Once women all over America know about this, that number will drop precipitously.

MN: Your editorial and the study are circulating on the Internet among breast cancer advocates.

MJS: Remember about 10 or 15 years ago, there was a new procedure called sentinel node biopsy. Instead of doing a full axillary node dissection [removal of 20 or so nodes near the armpit], the surgeon could remove only one or two lymph nodes. And surgeons said, “We don’t know if it works.” And you know what happened? Women heard about it and they demanded it. And if the surgeon didn’t offer it, she came down the street to me. The surgeons were losing their patients so they learned how to do it. Now everyone does it.

*Dr. Silverstein said that the term needle biopsy refers to several different minimally invasive techniques including core biopsy, vacuum-assisted biopsy, ultrasound-assisted biopsy (most common and easiest to perform) and the MRI-assisted biopsy (most difficult and least common).

** Billing fee is different from what the physician actually receives. According to one New York City breast surgeon, Medicare and many insurance companies will reimburse only 20% of the billing fee.

Maryann Napoli, Center for Medical Consumers© February 2009

More on Breast Biopsy
One co-author of the breast biopsy study is Susan K. Boolbol, MD, Chief, Appel-Venet Comprehensive Breast Service and Director, Breast Surgery Fellowship, Beth Israel Medical Center, New York City. In a telephone interview Dr. Boolbol was asked whether her study is representative of care in the rest of the country.

SKB: Yes, I do think so. First, keep in mind that the overwhelming majority of breast abnormalities are benign and the introduction of new needle biopsy techniques means that women do not have to go the operating room for diagnosis any more.

MN: But your study was done at one teaching hospital. Do we know how women are treated in the real world?

SKB: When you look at our study, you will see that we have three separate sets of physicians. First, the academic breast surgeons like me; second, the breast surgeons in private practice who don’t work for the hospital, but perform surgery there; and third, the general surgeons who do all types of surgery, including breast surgery.

MN: It does provide a window into what’s going on in the real world. During the seven-month study period, the academic breast surgeons did only 10% of their breast biopsies as open biopsies; compared with the breast surgeons in private practice (35%) and general surgeons (37%).

SKB: Another study showed that the majority of women with breast cancer in New York State are not operated on by breast surgeons. That could be true of the rest of the country. Educating women is the whole issue raised by our study. [If told they should have an open biopsy] they need to ask the question: Is there another way to do the biopsy? Women should know that the operating room is for treatment, not diagnosis.

Note: Read this 2010 update on this topic: “Breast biopsy: one type is much safer.”

Maryann Napoli, Center for Medical Consumers©

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Safe Drug Use: An Interview

Posted by medconsumers on November 1, 2008

Prescription Drug Use: New Podcast Dispels Many Myths

One of the many information sources used in preparing our articles is Therapeutics Initiative, which publishes a free online newsletter. This project was established in 1994 by the Department of Pharmacology and Therapeutics in cooperation with the Department of Family Practice at the University of British Columbia, Vancouver. According to this Web site, its purpose is “to provide physicians and pharmacists with up to date, evidence-based, practical information on rational drug therapy. The Initiative is an independent organization, which is at arms length from government, pharmaceutical industry and other vested interest groups.”

Last Spring, two professors affiliated with this program began podcasting on the Therapeutics Initiative Web site (www.ti.ubc.ca). One of them, James McCormack, Pharm.D, who is with UBC’s Faculty of Pharmaceutical Sciences, is interviewed by Maryann Napoli, Center for Medical Consumers.

MN: Your podcasts are unique. There is no show that I know of in the mainstream U.S. media that draws upon the evidence the way you do to dispel myths about drug treatment. You are addressing primary care physicians, but there is much to be learned by anyone who takes drugs.

JM: Thank you. My co-host, Dr. Mike Allan, who is a great family doc at the University of Alberta, Edmonton, and I have been doing these podcasts primarily because they are fun to do and hopefully the information is useful to the listeners.

MN: I’m going to touch on different subjects to give my readers an idea of the range of topics you address in your shows. I’ll start with dose. Whether you’re talking about drugs for high blood pressure or antibiotics for sinusitis or strep throat, you make the point that drug doses are often set arbitrarily and the high-end doses are usually too high for most people. Is there general advice you can give here?

JM: If the condition [for which you will be taking the drug] will kill you tomorrow, take a big dose just in case. If the condition is not life-threatening or urgent, then there is absolutely no reason to start with the dose that is typically recommended. Typically, those are the doses that have been shown to work in most people.

MN: Because there’s a range of responses.

JM: Yes. It has been established that the initially recommended doses, especially for new drugs are, on average, too high for many people. When you look at the dose-response curve from trials, you see that many people respond to lower doses, but there is absolutely no way you can predict in advance who will respond to what dose. If there’s no hurry, and given that many conditions get better on their own, start with a small dose. Typically, ¼ of the recommended dose is where to start.

MN: Now for the duration of drug treatment. In one show, you said something that sounded like heresy because the public is told to complete the 10- or 14-day antibiotics regimen or something horrible will happen. Yet you said that for respiratory infections like sinusitis, bronchitis, and even community-acquired pneumonia [as opposed to hospital-acquired pneumonia], people can stop taking their antibiotics when they feel better and have no fever for three days. Typically that would be a 5-day course for many people, but you also said it depends on how quickly they respond.

JM: Three-day courses of antibiotics have been shown in studies to be effective for bladder infections and there is even a study of 3-day treatment for pneumonia. For almost all upper respiratory tract infections the most you need is five days. The key is if you are not improving after 2-3 days, you need to be reassessed by the prescribing physician. Interestingly, there was no evidence to support that 10- to 14-day recommendation in the first place. However, there are a few infections that require taking antibiotics for a longer time—bone infections, prostate infections, cardiac infections, but for most non-life-threatening infections, shorter [until you have felt better for 3 days] is usually just as good.

MN: You often joke that “we [health care practitioners] don’t know what we’re doing.” You said it recently in one of your shows about upper respiratory illnesses. Why is it that doctors don’t know the correct dose or type of antibiotic to use for these common conditions?

JM: It ‘s not so much we don’t know what we are doing, but we don’t always have studies that look at the answers to the important day-to-day clinical questions. I want to know what is the best drug and how long must it be taken. Many of the antibiotics in use today came on the market way before we did lots of trials. Unfortunately, the research done by drug companies often doesn’t answer the questions we need to know the answers to. We do what we were taught and don’t question whether it’s the best way to do something. How can I predict whether you would need 10 or 5 days of an antibiotic?

MN: People on anti-hypertension drugs might be surprised to learn from your show that drugs reduce the risk of heart attack, cardiac death, stroke by only 1-2% over five years. You said that there is uncertainty about whether this is due to the mechanism of the drugs or the lowered blood pressure.

JM: We don’t know exactly, but we’re pretty convinced that some of the effect is from blood pressure lowering. But there are a number of studies that show drugs that equally lower blood pressure do not produce equal reductions in the rates of heart disease. For instance, atenolol* is a highly prescribed drug that lowers blood pressure. However in clinical trials lasting 5 years, the people taking atenolol had the same number of heart attacks or strokes as those taking a placebo. That tells you something else is going on. Either blood pressure reduction is not the major reason for that 1-2% benefit from anti-hypertensive drugs, or any potential benefit from atenolol’s blood pressure lowering effect was offset by the inherent toxicity of atenolol. Even though we don’t know exactly what is going on, we do know that patients who take atenolol for 5 years are not reducing their chance of heart disease, which is the only reason to take drugs for high blood pressure.

MN: Given your general advice about starting with a low drug dose and the lack of certainty that anti-hypertensives work by lowering blood pressure or some other mechanism, why is dose a guide here?

JM: Because the major reason to start with a low dose is to reduce side effects and the second is to reduce cost. You’re right, it’s a catch-22 situation here. The drugs are given to lower blood pressure. We know very well that lower doses typically produce most of the blood-pressure lowering effects and increasing doses rarely adds much more benefit. We also know from studies that even if you did nothing, many patients’ blood pressure would go down over time.

MN: Blood pressure goes down without drugs?

JM: We know from any anti-hypertensive trials about 50% of the people on placebo will have normal blood pressure within a year. So take low doses, see the doctor periodically to have blood pressure measured and every year or so, in conjunction with your physician, start slowly cutting back on your medications to see if you still need them. Don’t lose sleep over your blood pressure. It’s inappropriate to scare people by telling them it is a silent killer. Blood pressure of, say, 160/100 increases your risk of cardiovascular disease by 2-3 % over 5 years compared to someone who has a blood pressure of say 140/85. That’s what you need to know.

MN: Why give anti-hypertensive drugs if untreated blood pressure goes down in so many people?

JM: The 1-2% reduction in cardiovascular disease over five years we mentioned earlier. Hopefully, there will be more over a lifetime. Many people see this as an important difference [over a placebo—that is, no treatment]. However, and most importantly, if these drugs cause any side effects you are on the wrong drug.

MN: I liked something you said about osteoporosis: “If you’re not prepared to take one of the bone drugs like Fosamax or raloxifene, then don’t have a bone density test. That makes so much sense, but I doubt many women have had this explained.

JM: It’s in the Physician’s Guide to Prevention and Treatment of Osteoporosis. National Osteoporosis Foundation; 2000. “Utilizing any procedure to measure bone density is not indicated unless the results will influence the patient’s treatment decision,” which is in agreement with the U.S. Preventive Service Task Force recommendations for postmenopausal women.

MN: In describing studies, you often show how small the benefit of drug treatment can be, demonstrating that most people with self-limiting conditions get better in time without treatment. For example, you cite a Cochrane Review of the best trials involving the use of steroid intra-nasal spray for sinusitis, which made 73% feel better, compared with 66% of those on placebo.

JM: People don’t know the questions they should ask about drugs. Most important is: What will happen if I do nothing? What’s my ballpark chance of death, heart attack, stroke, fracture, symptoms etc) over, say, the next 5-10 years if I don’t take drugs. Then get the doctor to give a rough idea of how much the drugs will reduce that chance. Then get a ballpark estimate about your chance of having severe side effects.

Based on that information, you decide whether or not to take the drug and whatever decision you make, your doctor should support that decision.

*Atenolol has been sold under brand names like Tenoretic, Tenormin and Apo-Atenolol for nearly 35 years. A 2004 analysis of four randomized trials, published in the British journal Lancet, challenged atenolol’s safety and efficacy.

Maryann Napoli, Center for Medical Consumers ©

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On Exposure to Light at Night

Posted by medconsumers on September 1, 2008

On Exposure to Light at Night, Cancer…and Rethinking Normal Sleep

There is no scientific consensus about the cause of breast cancer, according to Richard G. Stevens, PhD, Professor and Cancer Epidemiologist at the University of Connecticut Health Center, Farmington. That’s as true today as it was in 1987 when Dr. Stevens began to publish a new theory about exposure to electric light at night and how it may trigger disruptions in the body’s circadian rhythm—that is, the cyclical changes that recur regularly over a 24-hour period.

These disruptions, in turn, can cause hormonal disturbances implicated in the development of breast cancer. Central to this theory is melatonin, a hormone that helps regulate the sleeping/waking cycles. Melatonin is primarily produced by the pineal gland at night and is suppressed by exposure to light.
Since his theory was first proposed, Dr. Stevens has co-authored studies showing an increased risk of breast cancer among women who work the graveyard shift. And he has co-authored another study showing a decreased risk among women who sleep nine hours or more each night. He also challenges the prevailing medical wisdom about normal sleep in the following interview conducted by Maryann Napoli, Center for Medical Consumers.

MN: In just 20 years, you went from proposing what might have seemed like a crackpot idea at the time to having it validated by the International Agency for Research on Cancer, based in Lyon, France. In 2007, that agency, which is part of the World Health Organization, declared shift work to be a “probable human carcinogen.” What made you initially suspect the link between breast cancer and exposure to electric lighting at night?

RGS: I’ve been interested in breast cancer for a very long time. It’s a mystery why it is so common in industrialized countries and why it becomes common as countries become industrialized. Up until the mid-1980s, we [researchers] thought it had to be due to the Western diet that is high in fat, but the really good, big cohort studies of diet that followed hundreds of thousands of women for 10-30 years – all came up negative. There is no relationship between fat consumption in adulthood and the risk of breast cancer.

MN: So you began thinking of other possible causes.

RGS: Yes, I was lying in bed awake in the middle of the night with the light from the street lamp coming into my room—and I’m not suggesting that streetlights alone are the problem. [It was so bright] I could almost read in my bedroom, and I thought this is something that has changed since society has become industrialized. I wondered if that had anything to do with cancer. Then I found out about what light can do and the hormones and the melatonin connection. Then I started publishing on the topic.

MN: You took off from the idea that we humans have evolved over the course of three billion years, but we have dramatically changed the environment only in the last 130 years with the introduction of electricity. How did you start to prove your theory?

RGS: The way we gather evidence is to make predictions. For example, if shift workers get lots of light at night and their circadian rhythms are disrupted, then, according to the theory, they should be at higher risk of breast cancer. Another prediction was that blind women would be at a lower risk [because their melatonin is not suppressed by exposure to light]. Another is the association between long sleep duration and a lower risk of breast cancer.

MN: You co-authored a study of shift workers that was published in the Journal of the National Cancer Institute in 2001. It showed an increased risk of breast cancer among women who worked long hours and many years in the graveyard shift, compared with those who didn’t do shift work. But it was only a modest increase in risk, wasn’t it?

RGS: That’s correct. But keep in mind that the comparison group, though it was comprised of women who didn’t do shift work, was getting plenty of the usual exposure to electric light at night. The strongest evidence is for the shift workers, but we don’t have a lock on it yet. There are also the four or five studies of breast cancer in blind women, and they all reported a lower risk of breast cancer as predicted. There are three good studies of sleep duration, two of which found that women who sleep a long time have a lower risk of breast cancer. So you get the idea—it looks as though the more time you spend in darkness, the lower the risk of breast cancer, although there is no scientific consensus on this. We need more studies consistent with those we have if we are to get to that point.

MN: What other ill effects might be associated with circadian disruption?

RGS: Three studies about prostate cancer were published in the last few years. Two showed that shift-working men were at a higher risk of prostate cancer. And another, just published in the British Journal of Cancer, was about sleep duration—the longer the sleep, the lower the risk of prostate cancer.

MN: What about interrupted sleep? People who wake up in the middle of the night will read or watch TV. Or they turn on the light briefly just to go to the bathroom.

RGS: There is evidence that those vanity lights in the bathroom [with light bulbs all around the mirror] are bright enough to start lowering the melatonin almost immediately.

MN: Is it OK to keep a night light in the bathroom?

RGS: We don’t know yet whether this is relevant to breast cancer, but just in terms of circadian health, the best thing to install in the bathroom is a night light with a red bulb.

MN: Why red?

RGS: The wavelength with the maximum ability to affect melatonin is blue. Red is much less efficient. You need a lot of red light to affect melatonin. So a dim red bulb will almost surely have no effect on your melatonin.

MN: My husband has a very bright digital alarm clock on his side of the bed. It’s irritating to me when he’s not in the bed to block the light.

RGS: What color is it?

MN: Green.

RGS: Throw it away and get a red one. We don’t know whether that green light is bright enough [to cause a problem], but if it irritates you, throw it away.

MN: So the point is to keep the bedroom as dark as possible.

RGS: You don’t have to be asleep for melatonin rhythm to be fine, but you do have to be in the dark.

MN: So, if you can’t sleep, you’re better off just staying in bed in the dark, perhaps listening to your radio or iPod?

RGS: I don’t think there are experts on this anymore. What we have been told by the sleep doctors for some time now is that you’re supposed to be getting eight straight hours of sleep. And if you wake up in the middle of the night, you should leave the bedroom and read or watch television. But that view runs counter to our evolution and is being seriously questioned by many sleep researchers.

MN: Why?

RGS: We have evolved in 12 hours of dark—a biphasic sleep—a first sleep and a second sleep. There’s an historian who points out that there are many references to the first sleep and the second sleep in medieval literature, in Shakespeare and in Chaucer. What it means is that it was normal—up to the invention of electricity—to go to sleep fairly close after the sunset, sleep for a few hours and then wake up and be awake for maybe an hour or two in the dark. (See Recommended Reading).

MN: But isn’t this is a form of insomnia?

RGS: There is a growing group of sleep researchers who are challenging that idea. I think it’s fine to be awake in the middle of the night. Enjoy the period of quiet wakefulness. But if you do get up and turn on the lights, you are suppressing melatonin, you are disrupting circadian rhythms and that, to me, may be increasing your risk of breast cancer and perhaps other maladies.

MN: What about taking melatonin supplements?

RGS: People often say to me, “Melatonin is good for you because it fights cancer, so I’m going to take a melatonin tablet every day.” I would certainly not do that. It has become clear with experiments in people taking melatonin tablets in the evening that this will actually change circadian rhythm and that can’t be good.

MN: So in summary: If you have insomnia, you shouldn’t take melatonin supplements or get up to watch TV or read. You should just lie there in your bedroom that is as dark as possible. How do you think that advice will go over with the millions of pill-popping insomniacs out there?

RGS: Change your attitude. That period of quiet wakefulness in the middle of the night is a time to wander peacefully in your mind and spirit.

Recommended Reading:

“Acknowledging Preindustrial Pattern of Sleep May Revolutionize Approach to Sleep Dysfunction” by Walter A. Brown, MD, May 26, 2006, Applied Neurology. This article is accessible at www.psychiatrictimes.com/display/article/10168/56881

Maryann Napoli, Center for Medical Consumers ©
September 2008

Posted in Alternative Medicine, Cancer, Women's Health | Tagged: Alternative Medicine, breast cancer, interviews, light and breast cancer, shift work and cancer | 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

You Can Be Fat and Fit

Posted by medconsumers on April 1, 2008

Walk More—That’s all you have to do

For cardiovascular and other health benefits like increased longevity, you need only exercise moderately for 30 minutes at least five days a week. That has been the recommendation for nearly 15 years, and it has decades of high-quality research to back it up. In an attempt to refine things further, a team of researchers asked the questions: Can this exercise recommendation be cut back further and still produce health benefits? Will 45 minutes five days of the week provide even more?

The study designed to answer these questions drew participants from the most sedentary segment of the U.S. population—postmenopausal women. Published last year in the Journal of the American Medical Association, this study continues to produce surprise findings as researchers are still analyzing the mountains of data it has generated.

A co-author of this and many other landmark studies is exercise scientist Steven N. Blair, PED, professor in the Department of Exercise Science at the University of South Carolina. One of the world’s leading researchers on the health benefits of exercise, Dr. Blair is interviewed by Maryann Napoli.

MN: Is it fair to summarize your research as providing proof that people can be fat and fit and that they can achieve cardiovascular fitness with only a moderate degree and amount of activity?

SNB: Scientists try to stay away from using the word “proof”, but we have provided pretty compelling evidence that you can be fat and fit—just as you can be thin and unfit. And that fitness provides important protection from many chronic diseases and premature mortality even in people who are obese.

MN: And it need not be vigorous exercise.

SNB: To attain what we’ve labeled “moderate fitness”—that is, if one follows the recommendation of 30 minutes of moderate intensity activity, such as walking on five or more days a week, you will develop a level of fitness that is protective.

MN: Must it be done in 30 consecutive minutes?

SNB: You can do it in separate segments—in bouts of at least ten minutes or more. The evidence for that has accumulated since we first made that recommendation back in the mid-1990s. It’s clear that whether you do 30 minutes of walking in three ten-minute bouts or two 15-minute bouts or all at once, the physiologic benefits are identical.

MN: That would also cut down on injuries.

SNB: It’s clear from our studies—and those of others—that as the amount and the intensity of the exercise goes up, the risk of injury does as well. The injury rate associated with moderate-intensity activity is incredibly low.

MN: How fast should people walk?

SNB: Walk purposefully as if you were going to a meeting—about 3 miles per hour, or 20 minutes a mile—but that will vary a bit depending on a person’s age, fitness, and health status. Some will need to walk a bit slower, especially when starting a program, and more fit individuals may walk at a faster rate.

MN: Why is it that those cardiac risk calculators that doctors use to determine an individual’s chance of having a heart attack in the next ten years do not include a question about physical activity? I’m referring to “risk assessment tools” like the one from the National Heart, Lung and Blood Institute that ask questions about blood pressure, cholesterol, etc. to identify who should be on drug therapy.

SNB: That calculator is largely based on the Framingham Heart Study [initiated 60 years ago], and they have never incorporated fitness. I tell physicians if you use the Framingham risk score to characterize your patients’ risk, you’re not finished with the job, unless you also have a measure of fitness or at very least, take a careful physical activity history.

MN: Why do you think the public continues to be told that excess weight will cause premature death and heart attacks? Three years ago, researchers at the Centers for Disease Control and Prevention (CDC) published a study that showed people who are overweight or even obese do not have shortened life spans. Decreased mortality was shown only at either end of the spectrum—the morbidly obese and the very thin.

SNB: Some people are dedicated to a concept that being overweight is hazardous to your health and they have an unwillingness to look at the actual data. When you look at the work of Katherine Flegal who headed that CDC study, you will see that she found that overweight is not the hazard for mortality as it has been made out to be, and it may even be protective. She used the best available data, such as that from the National Health and Nutrition Examination Surveys, which are broadly representative of the U.S. population. Yet there are people who have been vehement in their unrelenting criticism of Katherine and her work.

MN: Your work is focused on cardiovascular benefits, but weight loss motivates most people to exercise. I want to talk about a weight-related finding from your latest study that included 464 postmenopausal women who were sedentary, overweight or obese but basically healthy when they were randomly assigned to one of three exercise groups or the control group. This finding surprised me: After six months, “There were no differences in weight or body fat percent across the groups at follow-up but waist circumference was significantly smaller in all three exercise groups compared with the control [no exercise] group.”

SNB: That finding was not a surprise to anyone who works in this area. My colleague Bob Ross from Queen’s University in Kingston, Ontario has done more work on exercise and visceral adiposity than just about anyone. Bob said, “If you get people exercising, the visceral fat is going to go.” What we saw [in our study] was no difference in weight change across those four groups, yet all three exercising groups lost waist circumference, presumably visceral fat, compared with the control group.

MN: It should be pointed out here that one important aspect of your study is the fact that the women in the exercise groups performed their exercise routines under observation in the laboratory, thus bypassing the unreliable self-reporting that so often characterizes physical-activity studies. Your study measured what researchers call “dose response,” i.e., whether any health benefits were gained or lost by going lower or higher then the standard recommendation of 30 minutes five days a week of moderate exercise. Any other surprises?

SNB: I was a little surprised that the high-dose exercise group [225 minutes of exercise a week] did not lose more weight because they were doing three times the amount of exercise per week as the low-dose exercise group [72 minutes a week].

MN: What are you working on now?

SNB: We continue to analyze data from our study. When we looked at weights that were measured weekly in all the women, there are some fascinating findings there that I cannot talk about because we have not yet published our findings. It’s based on the notion promoted by the U.S. dietary guidelines 2005, which state, in order to prevent weight gain or promote weight loss, 60 minutes of activity a day is needed. Others have been trumpeting similar ideas. Well, if that’s the case, then the women in our high-dose exercise group should have lost a good bit more weight than the women in the lowest exercise group. We didn’t see that.

MN: Any idea why?

SNB: I’m not sure we’re ever going to know, but it is an area of research that cries out for more study—to try to understand where exercise fits in relation to weight management.

MN: The exercising study participants may not have lost weight, but regular testing of their cardiovascular/respiratory fitness during the study showed that they improved according to the amount of exercise they were assigned to perform.

SNB: Yes. As you see from our study there was a strong positive dose-response relationship for VO2 peak across the control and the three doses of exercise. Even the women in the lowest exercise group significantly improved their cardiovascular/respiratory symptoms and they only did 72 minutes of moderate intensive exercise a week. I’m coming to the conclusion that doing anything is better than nothing. I should be standing up right now while I’m talking with you.

MN: The blood pressure reductions in all three exercise groups were pitifully small.

SNB: Yes, I had expected exercise to show a dose-response gradient for blood pressure.

MN: You mean that you had expected the women doing the highest amount of exercise to have larger reductions in blood pressure.

SNB: Yes, the women were mildly hypertensive at the start of the study but all the exercise groups lowered their blood pressure only a few millimeters of mercury.

MN: There are still many proponents of vigorous-intensity exercise out there. I read that you used to be one of them until your own studies showed the health benefits of moderate-intensity exercise. I also read that you continue to enjoy running. Do you think that one day researchers will find that there are more health benefits to be gained with an intensive exercise routine?

SNB: Perhaps there might be some additional health benefits shown for vigorous exercise, but I frankly think the jury is still out on that one. I’m willing to go out on a limb here and say that doing something is better than doing nothing.

Maryann Napoli, Center for Medical Consumers ©

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Posted in Alternative Medicine, Diet & Exercise, Heart | Tagged: Alternative Medicine, Diet & Exercise, fat and fit, Heart, interviews, minimal exercise, prevention | Comments Off

Hospital-Acquired Infection…and What To Do About It

Posted by medconsumers on February 1, 2008

What kills more than five times as many Americans as AIDS? Betsy McCaughey, PhD, chairman and founder of the Committee to Reduce Infection Deaths (RID) wants you to know that it is hospital infections, specifically a bacterium called methicillin-resistant Staphylococcus aureus. MRSA infections are far more difficult to treat than ordinary Staph infections because they are resistant to most types of antibiotics.

Dr. McCaughey, former lieutenant governor of New York State, has made it her mission to get hospitals and especially the Centers for Disease Control and Prevention (CDC) to make prevention a high priority. In a recent Wall Street Journal op-ed article, she notes, “These infections are caused largely by unclean hands, inadequately cleaned equipment, and contaminated clothing that allow bacteria to spread from patient to patient. At one time, hospitals routinely tested surfaces for bacteria, but in 1970, the CDC and the American Hospital Association advised them to stop, saying testing was unnecessary. Astoundingly, the CDC still adheres to that position despite a 32-fold increase in MRSA infections.”

Dr. McCaughey is interviewed by Maryann Napoli, Center for Medical Consumers.

MN: The statistic that you use—100,000 deaths due to hospital infections annually in the U.S.—comes from the CDC, doesn’t it?

BM: The CDC is only one source. Their more recent statistic is: One out of every 10 to 20 people contracts an infection [while in the hospital]. The CDC puts the number of deaths at 99,000, but other sources say that is a severe undercount. So I usually say, “At least 100,000 deaths.” In fact it’s probably quite a bit more.

MN: What is your basis for saying that?

BM: Last October the Journal of the American Medical Association published a study about the extent of the MSRA infections in U.S. hospitals that nearly doubled what the CDC had been estimating. The reason is the methodology used. Instead of relying on what hospitals report or tell patients’ families, these new data are based on laboratory results which cannot be diminished or modified.

MN: Explain that.

BM: When the hospitals send all their tests to the labs, the laboratories simply count, “How many MSRA infections do we have here?” This was the first nationwide study using this methodology on the extent of MSRA—85% of which occurred in hospitals. The CDC realized that the extent of MSRA infections is far larger than what hospitals had been reporting. And if that’s true for MSRA infections, then it’s likely true for other types of bacteria. So the previous CDC guesstimates need to be reevaluated, based on this October 17 study in JAMA. It revealed the truth gap in the previous methodology.

MN: Denmark, Finland and the Netherlands reduced their soaring rates of MRSA infections to near eradication with multiple preventive measures (see “15 steps” at Dr. McCaughey’s Web Site). You are very critical of the CDC for not encouraging similar actions.

BM: For 25 years, the CDC has tracked the rapid rise in drug-resistant infections. They have consistently understated the extent and cost of the problem. And they have done too little to prevent it.

MN: How do you explain the CDC inaction?

BM: I can only imagine, but having been in government, I know that often agencies that are created to oversee an industry become co-opted by the industry. They spend so much time with hospital administrators rather than with grieving families and ill patients that they begin to share the hospitals’ concerns about the difficulties of changing procedures, the difficulties of more effective cleaning.

MN: You’ve been known to take cleaning matters into your own hands when friends or relatives are hospitalized.

BM: I’ve often gone into the hospital to visit a patient with a bag of cleaning supplies, including gloves, and cleaned the bed rails, the over-the-bed table, the TV monitor. I do it myself, knowing that otherwise it would not be clean.

MN: What do you use?

BM: Something like Windex [ammonia] because it has to stay on the surface for three minutes to kill the germs. It’s not a quick spray and wipe; it’s a drench and wait. Spray it on, wait three minutes to kill the germs and then wipe it off. The only one that Windex won’t kill is Clostridium difficile [bacterium that attacks the colon]—there you need something with bleach in it generally.

MN: We’ve been told that, when hospitalized, we should tell the hospital staff to wash their hands before touching us, but that’s difficult when you’re the one in the bed.

BM: Generally it’s the families [that should do it] because patients are usually too sick, too scared, too old, or in too much pain to act on their own behalf. Families should not be worried about being too aggressive when their loved one’s life is at stake.

For more information:

See 15 steps you can take to reduce your risk of a hospital-acquired infection at the Web site of Dr. McCaughey’s Committee to Reduce Hospital Infection Deaths (www.hospitalinfection.org).

Consumers Union (www.consumersunion.org/campaigns/stophospitalinfections/learn.html) for ways to take action and articles on the topic.

The Leapfrog Group (www.leapfroggroup.org) is aimed at reducing medical mistakes, including hospital infections. See whether the hospitals in your area have instituted 30 safe practices of which five are related to healthcare associated infections. The hospitals collect and submit their own data. The Leapfrog Group does not independently verify the data.

Maryann Napoli, Center for Medical Consumers ©
February 2008

Posted in hospital-acquired infection, hospitals | Tagged: CDC and hospital infections, hospital-acquired infection, hospital-borne infection, hospitals, infection, interviews | Comments Off

Is Back Surgery Worth It? An interview with the country’s leading back pain researcher

Posted by medconsumers on October 1, 2007

Last year, two landmark studies showed that 75% of people with the severe back and leg pain of a herniated disk got better without surgery by three months, but those who underwent surgery typically enjoyed faster relief. By two to four years, however, the study participants had the same level of pain relief whether or not they had surgery. Yet another trial published last May produced similar results at one year. It is noteworthy that these study results generally replicate those of a Norwegian trial published 30 years ago.

That the generous fees paid to surgeons might motivate them to overuse back surgery has always been a consideration for those concerned about the fact that the U.S. has the highest rate of spine surgery in the world. The financial stakes were raised even higher with the introduction of expensive screws and other hardware used in spinal fusion surgery.

The New York Times revealed in December 2006 that a single screw sells for $1,000, which is at least ten times the cost of making it. (Six screws are typically used in a spinal fusion operation.) There are about 30 start-up companies that have begun selling spinal devices, including screws, in the last few years, and many of these companies have back surgeons among their investors, according to The Times. Typically, this financial conflict of interest is not disclosed to their patients.

To learn how people with back pain can avoid unnecessary treatment, Maryann Napoli interviewed Richard A. Deyo, MD, who has co-authored many of the most important clinical trials about back pain treatment. Formerly a professor and co-director of the Center for Cost and Outcomes Research, University of Washington, Seattle, Dr. Deyo is now the Kaiser Professor of Evidence-Based Medicine at the Oregon Health and Science University, Portland.

MN: You wrote last May in a New England Journal of Medicine commentary that “Patients and primary care physicians now need a more sophisticated understanding of the diagnostic possibilities, treatment options, range of surgical techniques, and expected results.” How can people with back pain be expected to gain such a sophisticated understanding?

RD: It’s not easy. I don’t think people understand the expanding array of conditions that surgeons now intervene for and the somewhat differing results that are available from clinical trials.

MN: But how will they understand? There are so many good trials, but one would have to be a skilled Internet searcher to locate them and understanding them may be difficult. Can we start with a common scenario for unnecessary back surgery?

RD: It’s hard to come up with a simplistic cut-point, but a patient can ask him- or herself: Do I have back and leg pain, or do I have back pain alone? And if it’s back pain alone, the chances that surgery is going to be helpful are pretty small and may not be any better than a good rehab program. But surgery may be helpful if you have leg pain with sciatica due to a herniated disk, or if you have leg pain from degenerative stenosis or spondylolisthesis. Surgery speeds recovery, but patients are likely to improve—albeit more slowly—on their own. In the case of spinal stenosis, which is more common in older adults, surgery is moderately successful, and patients are less likely to improve on their own. For patients who just have worn out discs with back pain and no sciatica, it’s not clear whether surgery – usually a fusion operation—offers any advantage over rigorous rehabilitation.

MN: But doctors can look at the same scan and come up with different diagnoses.

RD: That’s true. There is an important variability in interpretation among even expert radiologists and musculoskeletal specialists reading the same x-rays, MRI or CT scans with important consequences. More important, you can see things on an MRI or CT scan that look just awful but may not be the cause of pain. And we know that because some of those awful looking things show up in many people who don’t have back pain.

MN: So how can one trust the diagnosis?

RD: What patients often don’t realize—and this is true of other conditions as well—is that imaging results alone do not mean a heck of a lot. What’s critical is their symptoms and the physical examination findings. So if those awful findings on the scan correspond with the leg symptoms and those leg symptoms correspond with neurologic deficits [e.g., weakness when lifting the foot], or at least, the symptoms are in the same distribution you’d expect from the scan—then it might be meaningful. So the imaging results, symptoms, physical exam and the medical history all have to line up.

MN: You wrote that back pain and disk degeneration are nearly universal with aging. Any advice specific to elderly people with back pain?

RD: For elderly people, the first thing to realize is that the range of things that can cause back pain is broader than it is in younger people. It’s important for a doctor to rule out other causes of the back pain like cancer, osteoporosis, compression fractures, or an aortic aneurysm. The second thing, unlike young people, herniated disks are fairly uncommon in older people, whereas spinal stenosis starts to become much more common. That’s a narrowing of the spinal canal which is the result of arthritic changes in the joints and the ligaments that surround the spinal cord. And if that’s causing leg pain as well as back pain, then surgery might be a consideration. The challenging thing for older patients is to balance the possible benefits of surgery with the risks of surgery.

MN: How can they do that?

RD: They can’t do it alone. But if you have a serious heart condition, for example, you might want to think twice about having a back operation, if the difficulty you’re having is tolerable. It’s rarely critical to have surgery. It’s one of those up-to-you decisions—how intolerable the pain is. In the case of spinal stenosis with leg pain, surgery is likely to bring the pain down a little, but it’s not likely to cure it altogether. Flat-out cures are unusual.

MN: Is there any type of decision aid—based on the studies—freely available to people who want to compare the risks of surgery with the benefits?

RD: Unfortunately, no, but it’s clear from the studies we and others have done that the risk of complications increases as you get older. Certainly for people over age 80, the risk of complications jumps up. As for people in their 60s and 70s, the risks are still relatively small—a 5-10% complication rate. Add to that a 1-2% risk of serious permanent complications [e.g., new neurologic deficit like foot weakness or failure of implanted plates and screws] and then there’s an additional few percent risk of MI [heart attack], pulmonary embolism and significant infection. It’s major surgery.

MN: Those ads for microinvasive surgery give the impression that it’s a minor procedure.

RD: I think you’re right. Most of the microsurgical procedures that are being proposed are simple diskectomy—that is a much more minor operation—usually done on younger people with herniated discs. In seniors, with spinal stenosis surgery, you’re often talking about multi-level laminectomy, a much more major procedure that can’t be done as a microprocedure.

MN: You have been outspoken in the media and in medical journals about the introduction of the expensive screws and other hardware used in spinal fusion surgery and how they have dramatically increased both the frequency and cost of fusion surgery.

RD: Spinal fusion surgery might be done for patients with spondylolisthesis and sometimes spinal stenosis. It’s important to realize that spinal fusion in addition to a laminectomy or diskectomy increases the invasiveness of the operation substantially and therefore its complications. Adding these screws to what otherwise would just be bone grafting increases the risks yet another notch. The best evidence suggests that the screws and the plates do result in better healing with the bone grafts and you’re more likely to have a solid fusion. [But] that’s true only by a few percents. So without the screws, the rate of solid fusion may be 85% and with the screws, it might be 90%. However, it’s not at all clear that that translates into a higher rate of pain relief or functional improvement, and so there is a trade-off between an increased risk of complications and the likelihood of a solid fusion.

MN: Any ideas about getting a second opinion from someone other than another surgeon?

RD: Seek out an expert in rehabilitation medicine—a physiatrist who would not only offer a more objective opinion about back surgery but would also have suggestions for rehabilitation.

MN: About 20 years ago, you co-authored a ground-breaking study that challenged the standard medical treatment of that time—bed rest for back pain. Other similar studies followed. What’s the final word on bed rest?

RD: There have been several randomized trials that were congruent with ours in suggesting no benefit from bed rest. This was also supported by a Cochrane review of all trials. If patients get some transient pain relief while they’re lying down, it may be useful to do that for a couple of days. But more than that is more counterproductive than beneficial.

MN: As I recall the take-home message of those studies is try to go about your normal everyday activities as best you can.

RD: Yes, it does seem counterintuitive, but patients are more likely to recover well if they try to remain active. Obviously, there are certain things you can’t do when you have a lot of pain, but the idea is to try to stay as active as you can. Do some walking— that sort of thing, which most people in pain can do.

Posted in Pain, surgery | Tagged: back pain, back surgery, interviews | Comments Off

Prehypertension—How Real Is This New “Disease”

Posted by medconsumers on August 1, 2003

The Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood pressure announced its latest guidelines last spring. People with blood pressures that were normal or high normal, as recently as three months ago, now have a condition called prehypertension. People in this new category have blood pressures of 120 to 139 millimeters of mercury systolic (top number) or 80 to 90 diastolic (bottom number), according to the National Heart, Lung, and Blood Institute which introduced the news at a May 14th press conference.

Michael Alderman, MD, is a past president of the American Society of Hypertension. A professor of medicine and population health sciences at Albert Einstein School of Medicine, Bronx, New York, Dr. Alderman has co-authored many studies related to hypertension. He is interviewed about the new guidelines.

With the new guidelines, overnight, an estimated 50 million Americans become potential patients. Is it too cynical to think that drug industry influence is at work?

Dr. Alderman: There’s no doubt that there are elements of these new guidelines that the pharmaceutical industry will be gratified to read. As you note, the designation of prehypertension will raise the level of possibility that many among this new 50 million will be given drugs. Had the guidelines focused on global [overall] risk assessment, including people [with other risks for heart disease] then this new category would surely have made sense.

The recommended lifestyle changes, such as weight loss, exercise, and restriction of sodium and alcohol, are known to result in only small decreases in blood pressure. So everyone will eventually end up on drugs, right?

Dr. Alderman: That’s my concern. Despite these [long-standing] recommendations, Americans have been stretching at the middle. So why continue to recommend a strategy that appears to be unsuccessful? There’s an enormous amount of evidence that very intensive one-on-one intervention and counseling with a dietitian or a behaviorist can achieve modest effects, but it is 30% more expensive than taking diuretics. What’s more, lifestyle effects seem to attenuate over time. There is this notion that there’s a moral superiority to lifestyle interventions. Our goal is to save lives in the least intrusive and least expensive way possible.

What new evidence was produced to show that artery damage and an increased risk of heart disease begins at blood pressure in the 120 to 139 mm Hg /80 to 90 mm Hg range?

Dr. Alderman: For at least 20 years, there has been good evidence that the risk of cardiovascular events increases with increasing blood pressure. From a very low level there’s a continuous increase in the risk of heart disease. The question is, of course, where does the benefit from lowering blood pressure come. The Joint National Committee has arbitrarily picked a new level-instead of 140, now it’s 120. There’s no more evidence that that’s the place to go than there was before. Since I went to medical school, and I graduated in 1962, the continuous relationship of [blood] pressure to [cardiovascular] events has been known. The level at which we called people hypertensive is arbitrary, and that level has constantly been reduced since 1910. The effect of moving that level from 140 to 120 is to include 50 million Americans into something labeled prehypertension. That’s equal to the total number of people that we were calling hypertensives before. So now we have medicalized 100 million Americans instead of 50 million.

How do you determine when to be concerned about high blood pressure?

Dr. Alderman: I, and most modern-thinking doctors, believe that blood pressure is only one part of the determination of your global [overall] risk for cardiovascular disease. The concern is about risk for stroke and heart attack, and that is the sum total of many factors, including blood pressure. There are people with rather low blood pressure who are at a rather high risk for stroke and heart attack on the basis of their cholesterol, cigarette smoking, enlarged heart, kidney disease-a whole range of things that might increase the risk for a cardiovascular event.

Those people should have their blood pressure lowered-almost whatever their blood pressure is. There are studies to prove this because lowering blood pressure does lower their risk, even if the blood pressure is 125. If your risk is, let’s say, 50 chances out of a 100 that you’ll have a heart attack, and you can lower your risk by 25%—that’s a good buy. But if your blood pressure is 125 and you have nothing else, your risk is almost entirely a result of your age—then your additional risk is very small and not likely to be meaningfully reduced by lowering blood pressure. Wise doctors and patients will recognize that simply looking at the blood pressure level is no way to decide on the need for an intervention. It’s the total risk for cardiovascular events that matters.

What about the person who, other than age, has no other risk for heart disease, but his blood pressure is high, say 180 over 110?

Dr. Alderman: Then his risk, on the basis of his blood pressure, is high enough to justify drug treatment. What I’m worried about are those people between 120 and 139 who have now been accused of having prehypertension. There’s no evidence to show that people in that range, who have no other risk factors, will benefit [from drug treatment]. If they have other risk factors, that’s a different story. But that’s not what the new guidelines say.

According to the new guidelines, if you are prehypertensive, you should lower your blood pressure with lifestyle changes. That, as we have already discussed, is not very likely to work. So what will the patient say, “I’m a failure-doomed to whatever prehypertension dooms you to,” or “Do I take one of these drugs like low-dose diuretics that cost about a penny a day and have been proven to save lives?” Well, the new guidelines are silent on that important question which millions of Americans should be asking.

You said that treatment should start with diuretics. Is it a stepped approach that is recommended, starting with diuretics and if they don’t work, you move up to beta-blockers, and so forth?

Dr. Alderman: Yes, for most people, I think that’s right. However, there are specific situations, such as kidney disease characterized by leaking protein, where other drugs are useful, for example, the angiotensin-converting enzyme inhibitors* [e.g,, Capoten, Vasotec] and the A2 receptor blockers [e.g., Atacand, Avapro]. Clinical trials say that’s the best. But for the garden variety, uncomplicated hypertension-about 70% of all people with hypertension-starting with a diuretic is right. And there’s no evidence that there is anything better, though you have to worry a little bit about diabetes and loss of potassium with diuretics. Reasonable monitoring, however, should cover that risk.

*Each of the anti-hypertensive drug classes mentioned in this interview has numerous brand names for each medication. Only two are given as examples.

You have searched the scientific evidence related to sodium restriction and consistently found no cardiovascular benefit. If so, why do the guidelines continue to tell people with high blood pressure to cut back on the salt intake?

Dr. Alderman: The National Heart, Lung and Blood Institute has been heavily invested in sodium restriction for 30 years. It’s hard to change your views. Several things are becoming clear: When you lower sodium intake in some people, it lowers blood pressure. But for most people, it doesn’t. And in a few people, it actually raises blood pressure. There’s tremendous variation, and that’s understandable because we are all so different. For example, some of us work hard, sweat, exercise; and people who sweat a lot need a lot of salt to keep even. Others have genetic differences in the way they handle salt. There are seven individual single gene conditions in which salt and blood pressure are affected. In two of them, there are salt-losing situations-if you don’t eat enough salt, your blood pressure falls and you die. In five others, you eat salt and your blood pressure goes up. Thus, we are a diverse crowd with behavioral, genetic, and environmental differences in the way salt intake affects us.

Where does that leave us?

Dr. Alderman: Scientists have generally moved the discussion beyond the effect of salt on blood pressure. Everybody agrees that if you treat 100,000 people with a low-salt diet, you would probably lower the average blood pressure a millimeter or two of diastolic and three or four systolic. And everybody agrees that that benefit would be unevenly distributed throughout the population. But the question is: Is the price paid [harm caused] by lowering the salt to attain that blood pressure going to be greater than the benefit? The reason I ask that question is this: lowering salt to reduce blood pressure has other effects. It stimulates the renin angiotensin system and increases sympathetic nerve activity, which raises the pulse rate. Both of these things adversely affect the heart. And it decreases insulin sensitivity-that’s bad for you too.

So on the one hand, your blood pressure levels falls; on the other hand, you have all these other things. The effect on human health is the sum total of all those things. That’s why [doctors should] test interventions. And that’s why we demand clinical trials to make sure we’re not hurting people more than we help them. My guess is that, in view of the genetic, behavioral, and environmental heterogeneity of the population, it is not likely that one level of sodium intake will prove to be best for all Americans.

You have suggested that doctors tell people to restrict their salt intake but never test them again.

Dr. Alderman: They virtually never do. The government says it’s a good thing to do: put people with hypertension on a low-salt diet. [Hardly any] doctors tell them to collect their urine for 24 hours, which is a reasonable way to measure salt intake. It’s hard to tell how much salt you eat because most of it comes in bread, cake, etc. Only 10-15% of your salt comes out of a saltshaker.

I’d like to end by asking you what you think of this statement from the European Heart Journal in 2000, “No randomized clinical trial has ever demonstrated any reduction of the risk of either overall or cardiovascular death by reducing systolic blood pressure from thresholds to below 149 mmHg”?

Dr. Alderman: That’s correct. Although since then, I believe that the level has dropped to 140 mmHg. But it has been shown in high-risk patients that a small reduction in blood pressure, even at lower pressure can produce a real benefit. Half the people in the HOPE [Heart Outcomes Prevention Evaluation] trial didn’t have hypertension by our 140 mm or 120 mm definitions, yet they benefited from the addition of an ACE inhibitor [e.g., Altace, Capoten] which lowered blood pressure a few mmHg. Modern thinking, as shown in the recent publication of the European treatment guidelines, incorporates hypertension into a global risk. They get away from arbitrary definitions of high blood pressure and try to make a more comprehensive, patient-centered approach to treatment.

Note: For an update on this topic, read this 2009 interview with a research physician who found no benefit to using drugs to reduce blood pressure below 140 over 90.

Maryann Napoli, Center for Medical Consumers(c)

Posted in Drugs, Heart, hypertension | Tagged: 140 over 90, 140/90, Drugs, Heart, hypertension, interviews, prehypertension how real, prehypertension treatment | Comments Off

PSA Screening Test for Prostate Cancer

Posted by medconsumers on May 1, 2003

An Interview with Otis Brawley, MD

By Maryann Napoli

The prostate-specific antigen (PSA) screening test for early prostate cancer has been surrounded by controversy ever since it was introduced over 15 years ago. The test can indicate the presence of cancer, but many men have a form of prostate cancer that will remain dormant or is so slow-growing that it will never cause symptoms. Neither this test, nor any other can distinguish which prostate cancer will become lethal. Furthermore, there is no proof that the use of the PSA blood test to screen symptom-free men will spare anyone a prostate cancer death, yet it is associated with a considerable amount of unnecessary treatment with aftereffects that can be both severe and permanent. All of the treatments for early prostate cancer carry the risk of impotence and incontinence. In short, cancer researchers do not know whether PSA screening saves more lives than it ruins.

Otis W. Brawley, MD, is the brains behind the ongoing National Cancer Institute Prostate Cancer Prevention Trial, which is designed to answer questions about the effectiveness of screening and the causes of prostate cancer. After leaving the National Cancer Institute, Dr. Brawley became the Director of the Georgia Cancer Center and Professor of Medicine, Oncology, and Epidemiology at Emory University School of Medicine. He is interviewed about the ever-increasing use of PSA screening in the face of so much uncertainty about its value.

Napoli: Does the popularity of PSA screening concern you?

Dr. Brawley: First of all, I’m not against prostate cancer screening. I’m against telling people that it is well established; and that it works; and that it saves lives when the evidence that supports those statements simply does not exist. I’m a tremendous supporter of the real American Cancer Society (ACS) recommendation, which is: Within the physician-patient relationship, men should be offered PSA screening and should be informed of the potential risks, as well as the potential benefits and be allowed to make a choice.

Napoli: Do you think fully informing men about PSA screening happens very often?

Dr. Brawley: I think it rarely happens. Many doctors are uninformed, and that’s a big problem. My great concern is people being misled. I routinely follow the prostate cancer screening recommendations of 18 organizations in the U.S., Canada, and Western Europe. The two most pro-screening recommendations are those of the ACS and the American Urologic Association. Both of whom say it should be offered to men; men should be informed of the potential risks and the potential benefits; and they be allowed to make a choice. The ACS does not recommend that men of normal risk be offered mass screening. There’s a distinction between what is done within a doctor/patient relationship at a doctor’s office and mass screening.

Napoli: What is the difference?

Dr. Brawley: Mass screening takes place at a booth at a mall where screening is offered to anyone who comes by and wants screening. In the last few years, there has been screening on the floor of the Republican National Convention, health fairs at the mall, [TV] channel this or channel that will have a health fair with prostate cancer screening. Yet there is no organization that endorses mass screening because of the concern that you can’t have informed consent.

Napoli: If policy makers aren’t promoting the test, who is?

Dr. Brawley: The British Medical Journal recently published an article about how several of the leading prostate cancer survivor organizations [based in the U.S.] that do a lot of the pushing of screening are funded by the makers of the PSA screening kits. And, indeed, [these survivor organizations] do things that the Food and Drug Administration won’t let the manufacturers do—like make promises that there are only benefits from prostate cancer screening. Many of these prostate survivor organizations that I’m critical of—that take drug company money—offer mass screening.

Napoli: You were once quoted in The New York Times saying that 30-40% of men whose cancers appear to have been confined to the prostate at diagnosis will recur soon after treatment.

Dr. Brawley: Yes, this [brings up] one of the lies perpetrated about prostate cancer. If you look at the prostate cancer outcomes from a huge study conducted by the National Cancer Institute, close to 40% of men who undergo a radical prostatectomy will have a PSA relapse within two years. This means that they had disease that was outside of the prostate that was not obvious to the surgeon or the pathologist. It means that if the man lives long enough, metastatic disease will kill him.

Napoli: The public is always told that early detection is lifesaving. How true do you think that is for prostate cancer?

Dr. Brawley: If you have a group of men diagnosed as a result of PSA screening, 30-40% don’t need to know that they have prostate cancer because it’s meaningless in terms of risk to their health. And for somewhere between 30% and 40% of the men with prostate cancer, no matter what [treatment is given], the disease is not curable. And then maybe there are about 20% who actually benefit.

Napoli: And there’s no way to know which type of prostate cancer you have.

Dr. Brawley: That’s right.

Napoli: What about African American men, who as a group, are at a particularly high risk for prostate cancer? PSA testing is thought to be advisable for them at an earlier age.

Dr. Brawley: The proportion of black men in Rocky Feuer’s paper [for the Journal of the National Cancer Institute] who don’t need to know they have prostate cancer was over 40%, compared to 30% of white guys. The reason it’s higher for black men is that they have so many other competing causes of death. The other issue is this: It’s a principle of cancer screening that, unfortunately, many of the advocates of screening just don’t comprehend, and that is, the more aggressive cancers are less likely to benefit from screening. There are people out there who say we must screen black men because they have more aggressive prostate cancer. [These screening proponents] do not realize that they are saying, in effect, because prostate cancer screening is less likely to benefit black men, then we must screen black men.

Napoli: You recently published a medical journal article about informed consent and the PSA test.

Dr. Brawley: Yes, the problem I have is that people are not open and honest about all the controversies, and this extends to people being not open and honest about the treatments, once prostate cancer is diagnosed. Men tend to get railroaded toward radical prostatectomy or to external-beam radiation, or to seed implants.

Napoli: Since there’s no evidence that any one of these treatments is superior to another or superior to no treatment, for that matter, where do you suggest men go for unbiased information?

Dr. Brawley: First of all, I think we should tell men what is scientifically known and what is scientifically not known and what is believed and label them accordingly. [As for credible sources of information,] the National Cancer Institute’s PDQ treatment statements at www.cancer.gov are good [call 800/4-CANCER]. So is the ACS’s information. And by the way, we at Emory have figured out that if we screen 1,000 men at the North Lake Mall this coming Saturday, we could bill Medicare and insurance companies for $4.9 million in health care costs [for biopsies, tests, prostatectomies, etc]. But the real money comes later–from the medical care the wife will get in the next three years because Emory cares about her man, and from the money we get when he comes to Emory’s emergency room when he gets chest pain because we screened him three years ago.

Napoli: You’re saying that screening creates long-term customers. So, did Emory Healthcare decide to go ahead with the free PSA screening on Saturday?

Dr. Brawley: No, we don’t screen any more at Emory, once I became head of Cancer Control. It bothered me, though, that my P.R. and money people could tell me how much money we would make off screening, but nobody could tell me if we could save one life. As a matter of fact, we could have estimated how many men we would render impotent…but we didn’t. It’s a huge ethical issue.

(May 2003)

Posted in Cancer, Men's Health, Screening | Tagged: interviews, prostate cancer, PSA, Screening | Comments Off

Mammography: Should you have one?

Posted by medconsumers on October 1, 2002

Read This Before You Have A Mammogram
In 2001, yet another mammography controversy was triggered by two Danish researchers who, after an in-depth assessment of all mammography-screening clinical trials, found the test leads to more aggressive treatment; increases the detection of cancers that do not progress; and might not save lives. In this review, conducted by Ole Olsen and Peter Gotzsche of the Nordic Cochrane Centre, mammography-screened women showed a slight increase in heart-related deaths. The deaths are believed to be related to radiation therapy, a standard treatment for early breast cancer. (Read a 2009 update of this review.) Another controversy is brewing among researchers over the cause of the slight increase in breast cancer deaths among women in their forties shown in all mammography screening trials. This topic was addressed in two interviews conducted in 2002 by Maryann Napoli.

Mammography’s Risk to Younger Women

Last month, the Canadian National Breast Screening Study published follow-up results showing, once again, that mammography screening did not reduce the breast cancer death rate for women in their 40s (Annals of Internal Medicine, 9/3/02). The Study’s findings have challenged the prevailing belief that early breast cancer detection saves lives. Worse, they show that mammography screening leads many more women to be treated unnecessarily with mastectomy or radiation therapy. Though 40 more cases of non-palpable invasive breast cancer were detected in the mammography-screened women, their breast cancer death rate was no different from that of the women who did not get mammograms. Similarly, there were 42 more cases of ductal carcinoma in situ, a non-invasive cancer, detected in the mammography-screened women. This shows that mammography screening causes a significant number of younger women to suffer treatment-related harm without reducing their odds of dying of breast cancer.

Mammography proponents have criticized the Canadian Study ever since it first published results more than a decade ago. The Study now has 11 to 16 years worth of follow-up for women in their 40s. Its deputy director, Cornelia J. Baines, MD, was interviewed about the fact that—in the early years of this trial—there were more breast cancer deaths among women given mammograms. This was initially thought to be a statistical fluke when it first showed up. Now some researchers are having second thoughts.

MN: When you published your seven-year results, there were more breast cancer deaths (38) in the mammography-screened women, compared with those in the control group who had no mammograms (28). Were there any surprises now that you have 11-16 year results?

Dr. Baines: No, I knew by 1983 that more breast cancer deaths were occurring in the mammography-screened group rather than the control group. Of course, that’s not what we expected. When we started out, we were sure that we were going to show a major benefit. After all, the HIP Study [the first mammography trial conducted in the 1960s] had shown a benefit to women ages 50-69, and we assumed that the only reason a benefit wasn’t shown for younger women was that the mammography was archaic by today’s standards.

MN: When I interviewed you at the time you published the seven-year results, you said that the excess of ten breast cancer deaths was not statistically significant. I thought that meant it could be ignored.

Dr. Baines: You are quite right it’s not statistically significant, but what is disturbing is that this excess has happened in all screening trials in three different countries. 1985 was a landmark year for mammography screening trials. A Swedish study headed by Laszlo Tabar was published in The Lancet (4/13/85). When you read the abstract [summary] of that study, it says that women ages 40-74 showed a 31% reduction in breast cancer deaths. But if you look in the text of the article, you see that the number of deaths in the [small subset of] women in their 40s given mammograms was higher than in the control group. Similar results were observed in the Stockholm and HIP trials. The consistency of this trend demands further evaluation.

MN: Is anyone looking into it?

Dr. Baines: When we published our first results in 1992, it never entered my head that the people who have been promoting mammography would try to completely destroy the credibility of our study and ignore this phenomenon which had been clearly shown in Tabar’s study and which had also been shown in the HIP study. I started out saying that this needs investigating at the basic science level and believing that screening researchers would pay attention to these trends. Well, was I ever out to lunch. People, when they strongly believe in something, don’t waste time looking at evidence that challenges their beliefs. That’s just not human nature.

MN: Dr. Tabar is a recipient of an American Cancer Society award for his promotion of mammography screening and a teacher of Continuing Medical Education courses for American radiologists. He and the other mammography researchers might not want to look at the “why” behind the increase in breast cancer deaths, but haven’t some researchers begun to investigate a possible underlying biological mechanism for the deaths?

Dr. Baines: Yes, Michael Retsky, PhD, at Harvard Medical School, and Romano Demicheli and William Hrushesky. They studied the relapse patterns of 251 premenopausal women with node-positive breast cancer who had been treated only with surgery only and followed for 16-20 years. Retsky and colleagues found that the breast cancer mortality rates show two peaks: one occurs three years after diagnosis, the other at nine years, and after that, women seem to survive quite well. This, of course, corresponds with what we have been observing in mammography screening trials. Increasingly, researchers like Michael Retsky and Michael Baum speculate that something associated with the biopsy or surgery stimulates growth factors. In some women with micrometastases [undetectable spread of cancer outside the breast], these growth factors may stimulate the micrometastases, and the woman goes on to die. This is consistent with the suggestion made along time ago by Bernard Fisher [America's leading breast cancer researcher]—that micrometastases has already occurred in 90% of all breast cancers before clinical or radiological detection.

MN: Are you talking only about women in their 40s?

Dr. Baines: The finding was more prominent in younger women, but Tabar’s study showed a breast cancer mortality increase in older women as well.

SECOND INTERVIEW ABOUT MAMMOGRAPHY SCREENING

The following interview relates to the same topic. Michael Baum, MD, emeritus professor of surgery at University College in London, U.K., has been a breast cancer surgeon for 30 years. After leaving the Breast Screening Programme for the National Health Service in the southeast of England, Dr. Baum became an outspoken critic of mammography screening, particularly for women in their 40s.

In this interview, Dr. Baum is asked to comment on the new Canadian Study results. In doing so, he argues for a new paradigm for how and why breast cancer spreads. Dr. Baum champions the ideas of the famed Boston-based researcher Judah Folkman whose work is associated with angiogenesis. This is a natural process controlled by certain chemicals produced in the body, leads to the formation of new blood vessels. In adults, angiogenesis is involved in wound healing and menstruation. Angiogenesis can also have negative effects. Tumor growth is dependent on blood and oxygen supplied by these newly formed blood vessels, which also provide a means by which cancer cells can travel to distant organs and form new tumors.

MN: What do you make of the increase in breast cancer deaths shown in the women given mammograms in the early years of the Canadian Study?

Dr. Baum: I believe that it is a real phenomenon and not simply an artifact of this study. It appears in all the studies

MN: In all the studies, not just three?

Dr.Baum: Yes, to a lesser extent in all the other trials.

MN: There were more than twice as many cases of ductal carcinoma in situ [Latin for cancer in place] in the mammogram group. What do you make of that?

Dr. Baum: I’m very influenced by Judah Folkman’s work. He believes that in situ is probably not a good word, and we should call it latent cancer. These latent cancers, particularly in premenopausal women, are grossly overrepresented [in women given mammograms]–something like five times more, compared to what you would expect. That suggests if left to their own devices, these latent cancers might never trouble a woman. If you identify these latent cancers and biopsy them, you have traumatized the area. You immediately trigger the natural healing mechanisms, and natural healing mechanisms involve angiogenesis. So, effectively, the biopsy could be considered an angiogenic switch. You take a latent cancer that would never hurt a woman, biopsy it, turn on the angiogenic switch, and it ceases to be latent. A latent disease can become an aggressive disease.

MN: Is this true only for premenopausal breast cancer?

MB: You see this in other cancers. The most notorious is renal cell cancer. If you find a symptomless renal tumor by chance, and operate, [then] in no time the patient is riddled with metastasis. This happened to a dear friend of mine. I think that “angiogenic switch” might be an explanation. It’s really scary.

MN: Is that what you suspect is happening to some women with premenopausal breast cancer?

Dr. Baum: My explanation sounds a bit farfetched, but it is strongly supported by basic science that is coming out of the work on angiogenesis. There are profound cyclical changes going on in the premenopausal breast, and these changes can also be seen in a premenopausal cancer. So just by happenstance, you might get a surgical insult at a time in the menstrual cycle that favors the cancer cells. It’s all quite alarming.

MN: In the Canadian Study there were 71 cases of DCIS diagnosed in the women given mammograms, compared to 29 in the women not given mammograms.

MB: That tells you two things: 1) It emphasizes the quality of the study. If they were not detecting DCIS, then the screening zealots would say that the screening techniques in the Canadian Study were bad; 2) It demonstrates, yet again, that all screening programs will show an excess of cancers. And the excess is mostly DCIS. In women given a manual breast exam, only about 3% of cancers are DCIS; whereas in mammography-screened women, 20% of the cancers are DCIS.

MN: The breast cancer death rate was the same for both groups in the Canadian Study. Doesn’t that indicate that early detection is of no benefit to women with DCIS?

Dr.Baum: Yes, I think so. I don’t know if any lives are saved by screening, frankly. But the one argument about which I cannot be shaken is that women invited to screening should know these things. I was one of the people given the job of setting up a screening program in the 1987-88 in the U. K. Then it gradually dawned on me that this was state interference with public health, and it was coercion. I resigned in disgust from the National Screening Committee because they were intentionally deceiving women [about the harms]. They went on record saying, “We mustn’t let women know this because it might deter them from coming to screen.” So I decided to work outside the system to inform women about the truth of screening. I can see how some women, fully informed, would accept screening over the age of 50, but to promote mammography to women under the age of 50 is absolutely unethical.

MN: The American Cancer Society has been promoting mammography starting at age 40 for many years now.

Dr. Baum: Either the ACS is funded by the screening industry, or they’ve backed themselves into a corner and can’t admit they’ve been wrong all this time. The message is so seductive: “The secret to cancer is catching it early.” That’s rubbish. It’s so naive. The only thing that influences cancer mortality is better treatment, as far as I’m concerned. The word “early” has no meaning to a scientist. MN: Do you have an equivalent to the ACS in your country overselling the early detection message?

Dr. Baum: No, but we have “Black October,” which is what I call Breast Cancer Awareness Month, when lots of fine young women have these campaigns with catwalk models advising breast self- examination every month. And that gets across two false messages: 1) that self-examination is of any value; and 2) that the role model for breast cancer patients is a skinny girl of 23.

MN: Any parting thoughts about mammography research?

Dr. Baum: It ceases to be medical science now–it’s egos. A proper scientist should learn that you go through life being humiliated again and again. You have prepare yourself to admit you were wrong. That’s the very mechanism of science. Scientific truths are only temporary expressions of reality that serve us for the time being. There’s no such thing as scientific truth. It’s all an approximation to reality. A true scientist has to accept that his version of reality will be overturned in the fullness of time. If you can’t accept that, you’re not a scientist.

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

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