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Women kept in the dark about the facts about mammography
Dr. John Briffa, 20 February 2009
Mammography is a widely advocated and popular intervention designed to pick up breast cancers earlier than they would otherwise be, and therefore allow less invasive and more effective treatment. However, as I pointed out in a blog back in 2007, some researchers believe that the benefits of mammography are somewhat overblown, and that the potential downsides are at the same time downplayed or not mentioned at all. A major problem with mammography is that it may detect cancers that would not go on to trouble women during their lifespan. This can obviously subject women to unnecessary stress and anxiety, not to mention unnecessary treatment in the form of, say, surgery, radiotherapy and chemotherapy.
The debate about the relative benefits and harms of mammography has reared up again in the UK because of the publication of a letter in the Times newpaper which can you read here. In it, 23 interested parties cite evidence that is published by the researcher Peter Gøtzsche and his colleagues from the independent Nordic Cochrane Centre in 2006 [1]. This review of the available literature concluded that: “for every 2000 women invited for screening throughout 10 years, one will have her life prolonged. In addition, 10 healthy women, who would not have been diagnosed if there had not been screening, will be diagnosed as breast cancer patients and will be treated unnecessarily. It is thus not clear whether screening does more good than harm.”
The letter in the Times appears timed to coincide with the print publication of an article by Peter Gøtzsche and colleagues in this week’s British Medical Journal [2]. The article outlines some of the apparent deficiencies and omissions in the information given to UK women regarding breast screening. The article refers to the UK Department of Health (DoH) leaflet entitled ‘Breast Screening; the Facts’. The authors of the article make the point that the title of the leaflet suggests the information can be trusted. But can it?
The authors of the BMJ piece make the point that the DoH leaves no doubt that screening is good for women, and quote excerpts from the leaflet which include: “Why do I need breast screening?”, “If changes are found at an early stage, there is a good chance of a successful recovery,”. The leaflet also claims that breast screen saves “an estimated 1400 lives each year in this country” and “reduces the risk of the women who attend dying from breast cancer.”
However, according to the authors, the leaflet has many deficiencies which mean that women cannot make informed decisions about whether they attend breast screening or not.
For instance, no mention is made of the major harm of screening—that is, unnecessary treatment of harmless lesions that would not have been identified without screening. It is in violation of guidelines and laws for informed consent not to mention this common harm, especially when screening is aimed at healthy people. The new guidelines from the General Medical Council state: “You must tell patients if an investigation or treatment might result in a serious adverse outcome, even if the likelihood is very small.” The likelihood of being overdiagnosed after mammography is not very small; it is ten times larger than the likehood [sic] of avoiding death from breast cancer.
The leaflet notes that about one in every 20 women screened will be recalled for more tests because of ‘false positive’ results (results that suggest a problem when, in reality, there is none). But, as Gøtzsche and colleagues point out, the more screenings a woman has, the more likely she is to end up with a false positive result. They cite evidence that shows that after 10 screens, risk of false positive diagnosis was 50 per cent in one piece of research and 20 per cent in another. The authors add: “We now know that the psychosocial strain of a false alarm can be severe and may continue after women are declared free from cancer.”
Basically, mammography can lead to women have unnecessary treatment including radiotherapy. Gøtzsche and colleagues point this out, and also explore some of the risks associated with this. They note that the leaflet tells women that the dose of radiation from mammography is very small, but does not tell women of the risks associated with healthy women having radiotherapy. They cite evidence that radiotherapy suggesting that radiotherapy may double the risk of death from heart disease and lung cancer. The authors that that “Technological improvements may have diminished these harms to some extent, but they are still important.”
The authors also tell us that the leaflet summary implies that screening leads to fewer mastectomies. In fact, research shows that screening leads to 20 per cent more mastectomies being performed.
Also, we are told that the leaflet expresses no reservations about screening older women, “only a scare that the breast cancer risk increases with age, although it has not been shown that screening these women decreases their risk of dying from breast cancer. Furthermore, the problem with overdiagnosis becomes more pronounced, and the likehood of gaining any benefit smaller, due to competing risks of death.”
And, finally, the authors point out that it has not been proven that screening saves lives. While it may reduce the risk of breast cancer mortality (by about 15 per cent), studies show that breast screening does not decrease total cancer mortality. As the authors point out “This indicates that the benefit of screening is likely to be smaller than generally perceived.”
The authors then conclude: “We believe that if policy makers had had the knowledge we now have when they decided to introduce screening about 20 years ago, when nobody had published data on overdiagnosis or on the imbalance between numbers of prevented deaths from breast cancer and numbers of false positive screening results and the psychosocial consequences of the false alarms, we probably would not have had mammography screening.”
This is one group of reseachers’ view, and not everyone will share it. The figures regarding those that benefit and those who may come to harm have been disputed. However, there can be little doubt that many women are simply not being informed of the full facts about breast screening. So one figure I think we can be certain of is that chances of these women making a truly informed decision about mammography is zero. I’m not against mammography, but I am against women being kept in the dark about the true benefits and risks associated with this practice.
References:
1. Gøtzsche PC, Nielsen M. Screening for breast cancer with mammography. Cochrane Database of Systematic Reviews 2006, Issue 4. Art. No.: CD001877. DOI: 10.1002/14651858.CD001877.pub2.
2. Gøtzsche PC, et al. Breast screening: the facts—or maybe not. BMJ 2009;338:b86
FDA Warns of Potential of Serious Side Effects with Topical Numbing Agentsand
By Todd Neale, Staff Writer, MedPage Today, Published: January 16, 2009
ROCKVILLE, Md., Jan. 16 -- The FDA has issued a second warning about the potential dangers of using topical anesthetics for relieving pain from medical tests and conditions.
The latest advisory was prompted by a report last summer on the results of a randomized trial evaluating the use of lidocaine for the pain and discomfort of mammography. (See: Pre-Mammography Painkiller May Ease the Pinch)
The researchers found that women using lidocaine -- which was spread over the breasts and chest wall and covered with plastic wrap for a total absorption time of about 45 minutes -- reported significantly less discomfort than those using acetaminophen, ibuprofen, or placebo.
"Although no serious side effects were reported in this study," the FDA warning read, "it was not large enough to evaluate whether uncommon but serious reactions could occur with this use.
"FDA remains concerned about the potential for topical anesthetics to cause serious and life-threatening adverse effects when applied to a large area of skin or when the area of application is covered," the advisory read.
The agency said that some of the topical medication can pass into the blood stream upon application.
Under certain circumstances -- if a large area of skin is covered, the drug is applied to broken skin, or skin temperature increases -- the amount of medication entering the blood stream may be toxic, causing irregular heartbeat, seizures, breathing difficulties, coma, and death, the agency said.
This latest warning repeats the concerns of an advisory issued in February 2007 following the deaths of two women, ages 22 and 25, who applied topical anesthetics to their legs and covered them in plastic wrap to numb the anticipated pain of laser hair removal.
Both women had seizures, fell into a coma, and subsequently died because of the drugs' toxic effects.
The drugs involved were lidocaine and tetracaine.
The FDA advised physicians to determine whether a topical anesthetic would create the necessary pain relief when considering its use for any purpose and whether an alternate treatment would be as effective.
If a topical anesthetic is determined to be the best choice, the agency recommended using the lowest amounts possible, applying the medications as sparingly as possible, avoiding broken or irritated skin, and being aware that wrapping or applying heat to the areas treated with the medications can increase the risk of serious side effects.
Breast Imaging Premedication to Reduce Discomfort during Screening Mammography1
Colleen K. Lambertz, MSN, MBA, FNP, Christopher J. Johnson, MPH, Paul G. Montgomery, MD, and James R. Maxwell, MD
1 From the St Luke's Mountain States Tumor Institute (C.K.L., P.G.M.), 100 E Idaho St, Boise, ID 83712; Cancer Data Registry of Idaho, Boise, Idaho (C.J.J.); and St Luke's Regional Medical Center, Boise, Idaho (J.R.M.). Received August 27, 2007; revision requested November 1; final revision received November 29; accepted January 24, 2008; final revision accepted March 4. Supported by the Mountain States Tumor Medical Research Institute grant. Address correspondence to C.K.L. (e-mail: lambertc{at}slrmc.org).
Purpose: To test the hypothesis that premedication with acetaminophen, ibuprofen, and/or 4% lidocaine gel would decrease discomfort and improve satisfaction with screening mammography in women who expect a higher level of discomfort.
Materials and Methods: In this HIPAA-compliant, institutional review board–approved, prospective, double-blinded, placebo-controlled clinical trial, 418 women aged 32–89 years who expected substantial discomfort with screening mammography were randomly divided to receive premedication with acetaminophen, ibuprofen, and/or 4% lidocaine gel. Subjects provided informed written consent. The primary outcome was discomfort. Secondary outcomes were satisfaction and plans for future mammography on the basis of discomfort. Subjects completed structured questionnaires with visual analog scales to measure discomfort and satisfaction. A generalized linear mixed-models framework was used to assess the effect of medications on discomfort during mammography, and satisfaction with technologist and machine combinations was included as a random effect. The "plans for mammography next year" outcome was modeled by using a binary distribution and logit link function.
Results: Discomfort was significantly lower in the lidocaine gel group (P = .01). Satisfaction was significantly negatively correlated with discomfort (P < .001). Satisfaction and whether or not the subject had delayed her mammography because of fear of discomfort had significant effects on plans to undergo mammography next year (P < .001 for both). There were significant differences in discomfort between different combinations of technologists and machines.
Conclusion: Premedication with 4% lidocaine gel significantly reduced discomfort during screening mammography, and reduced discomfort may improve the likelihood of future mammographic screening and early detection of breast cancer.
(Radiology 2008;248:765-772.)© RSNA, 2008
Study: New way to spot breast cancer shows promise
By MARILYNN MARCHIONE, AP Medical Writer
Wed Sep 3, 2008
A radioactive tracer that "lights up" cancer hiding inside dense breasts showed promise in its first big test against mammograms, revealing more tumors and giving fewer false alarms, doctors reported Wednesday.
The experimental method — molecular breast imaging, or MBI — would not replace mammograms for women at average risk of the disease.
But it might become an additional tool for higher risk women with a lot of dense tissue that makes tumors hard to spot on mammograms, and it could be done at less cost than an MRI, or magnetic resonance imaging. About one-fourth of women 40 and older have dense breasts.
"MBI is a promising technology" that is already in advanced testing, said Carrie Hruska, a biomedical engineer at the Mayo Clinic in Rochester, Minn., which has been working on it for six years.
She gave results in a telephone news briefing Wednesday and will present them later this week at an American Society of Clinical Oncology conference in Washington, D.C.
Mammograms — a type of X-ray — are the chief way now to check for breast cancer. MBI uses radiation, too, but in a different way. Women are given an intravenous dose of a short-acting tracer that is absorbed more by abnormal cells than healthy ones. Special cameras collect the "glow" these cells give off, and doctors look at the picture to spot tumors.
Researchers tried both methods, on 940 women who had dense breasts and a high risk of cancer because of family history, bad genes or other reasons.
Thirteen tumors were found in 12 women — eight by MBI alone, one by mammography alone, two by both methods and two by neither. (The two missed cancers were found on subsequent annual mammograms, physical exams or other imaging tests.)
Looked at another way, MBI found 10 out of 13 tumors, missing three; mammograms detected three out of 13 tumors and missed 10. Using both methods, 11 out of 13 tumors would have been detected.
"These images are quite striking. You can see how the cancers would be hidden on the mammograms," Hruska said.
Mammograms gave false alarms — led doctors to conclude that cancer was present when it was not — in about 9 percent of patients, compared to only 7 percent for MBI. The MBI tests led to more biopsies than mammograms did, but they more often revealed cancer.
The Susan G. Komen for the Cure foundation and Bristol-Myers Squibb, which makes the imaging agent used in the study, paid for the work.
The next test will be to see how MBI stacks up against MRI. The federal government is paying for a new study Mayo is leading that compares the two in 120 high-risk women with dense breasts.
MRI is often used now for women with dense breasts, but it gives many false alarms that lead to unnecessary biopsies. Doctors hope MBI will prove more accurate and cost less — under $500 versus more than $1,000 for an MRI.
"We all know that mammography is, in and of itself, an imperfect tool, and we clearly need to do better in the future," said Dr. Eric Winer of the Dana-Farber Cancer Center in Boston, a spokesman for the oncology group. "It is fair to say that MRI will not solve all problems either."
One drawback of MBI: It uses about 8 to 10 times the radiation of mammograms, a dose that engineers like Hruska are trying to lower with newer technology. Other medical centers also are testing MBI.
"We're just beginning to see what this technology can do," she said.
___
On the Net:
Cancer conference: http://www.asco.org and http://www.cancer.net
Mayo Clinic: http://tinyurl.com/5rrwx3
Copyright © 2008 The Associated Press.
Thermography-------------------------
A new resource if you are in So. California -
IT'S HARD TO BELIEVE, BUT...
* Breast Cancer is the most common form of cancer among American women.
* Nearly 41,000 women die of Breast Cancer every year in the U.S. and and every year more and more young women are being diagnosed.
* Over 2,000 men are also affected by Breast Cancer.
* Out of some 800,000 biopsies that are done every year, over 180,000 women are diagnosed with breast cancer... the rest are benign lumps.
* There is more than one type of breast cancer; you DO NOT need a lump to have breast cancer (IBC).
* Although rare, implants have been known to rupture during mammography.
* Women with dense breast tissue (usually younger women) is harder to detect breast cancers on mammograms.
* "...since mammographic screening was introduced in 1983, the incidence of ductal carcinoma in situ (DCIS), which represents 12% of all breast cancer cases, has increased by 328%, and 200% of this increase is due to the use of mammography. This increase is for all women: Since the inception of widespread mammographic screening, the increase for women under the age of 40 has gone up over 3000%."
* Once a tumor has grown to a sufficient size, detectable by either a mammogram or physicial examination, it has been growing for several years and achieved more than 25 doubles of the malignant cell colony.
* You have the right to investigate other safe screening methods, such as Thermography.
"no nation other than the United States routinely screens premenopausal women by mammography. In this context, it may be noted that the January 1997 National Institutes of Health Consensus Conference recommended against premenopausal screening (24), a decision that the NCI, but not the ACS, accepted (4). However, under pressure from Congress and the ACS, the NCI reversed its decision some three months later in favor of premenopausal screening. The U.S. overkill extends to the standard practice of taking two or more mammograms per breast annually in postmenopausal women. This contrasts with the more restrained European practice of a single view every two to three years (4)."
The researchers said their findings provide new insight on what is "arguably the major harm associated with mammographic screening, namely, the detection and treatment of cancers that would otherwise regress."
By Michael Kahn
LONDON (Reuters) - Researchers who tracked breast cancer rates in Norwegian women proposed the controversial notion on Monday that some tumors found with mammograms might otherwise naturally disappear on their own if left undetected.
But leading cancer experts expressed doubt about the findings and urged women to continue to get regular mammograms, saying this screening technique unquestionably saves lives by finding breast cancer early on when it is most treatable.
Dr. Per-Henrik Zahl of the Norwegian Institute of Public Health in Oslo and Norwegian and U.S. colleagues examined invasive breast cancer rates among nearly 120,000 women age 50 to 64 who had a mammogram -- an X-ray of the breast used to find evidence of cancer -- every two years over a six-year period.
They compared the number of breast cancers detected with another group of about 110,000 Norwegian women of the same age and similar backgrounds who were screened just once at the end of the six-year period.
The researchers said they expected to find no differences in breast cancer rates but instead found 22 percent more invasive breast tumors in the group who had mammograms every two years.
This raises the possibility that some cancers somehow disappear naturally, although there is no biological reason to explain how this might be, according to Zahl, whose findings were published in the Archives of Internal Medicine.
"We are the first ones to publish such a theory," Zahl said in a telephone interview. "What we say is many cancers must spontaneously disappear or regress because we cannot find them at later screenings. I have no biological explanation for this."
Mammography and breast self-examination for tumors are standard methods used for early detection of breast cancer, the leading cause of cancer deaths among women worldwide.
The American Cancer Society estimated that about 465,000 women die of breast cancer globally each year, and 1.3 million new cases are diagnosed.
"I think generally when we look at studies like this it is important to keep in mind there are some studies that change practice and others that make us think a little bit more, said Dr. Eric Winer, director of the Breast Oncology Center at Dana-Farber Cancer Institute in Boston.
"The idea that somehow these cancers go away entirely is, I would say, an intriguing hypothesis, but one we don't have a lot of evidence to support," said Winer, who was speaking on behalf of the American Society of Clinical Oncology.
In much of Europe women undergo mammograms every two years after age 50 except for in Britain where it is every three years, Zahl said. The American Cancer Society recommends that women get an annual mammogram beginning at age 40.
Bob Smith, director of cancer screening for the American Cancer Society, said Zahl's team misinterpreted the data, and expressed doubt about the idea that a significant number of breast tumors "spontaneously regress."
"I imagine there are still some people who believe the Earth is flat, but there are not very many of them," Smith said in a telephone interview. "It's not usual -- it happens every day that research is published that gets it wrong."
The researchers acknowledged many doctors might be skeptical of the idea but they cited 32 reported cases of a breast cancer regressing, a small number for such a common disease.
The researchers said their findings provide new insight on what is "arguably the major harm associated with mammographic screening, namely, the detection and treatment of cancers that would otherwise regress."
(additional reporting by Julie Steenhuysen; Editing by Will Dunham and Angus MacSwan)
© Thomson Reuters 2008 All rights reserved
http://www.reuters.com/article/scienceNews/idUSTRE4AO03H20081125
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