This week’s Natural News lead with an eye-pop ping headline that asked readers to think about CHEMO differently. I have to admit, I have been thinking about Chemo differently for several years. When Suzanne Summers announced that she was treating her breast cancer “naturally”– the media fire storm could not have been greater if the woman had clubbed baby seals to death while naked on live TV. Her announcement didn’t phase me as much as the medical establishment’s reaction to her statement concerning, what to me was, a personal choice. I’m of the ‘Cher-school of thought’ when it comes to boobs. “They are mine, and if I want to and am willing, and have the ability to pay for it, I can move them to my back if I want to.”  The move to the state decreed ‘Doctatorship’ is troubling. Should the medical profession have the right to dictate, backed up by the court system, a treatment for an individual, be that individual a child or an adult? Personally, I’m still thinking about the whole process of  “Public Health Decrees vs Personal Choice” In the mean time read what the writers at Natural News have to say about this new Research on Adverse Drug Events and Reports (RADAR) pharmacovigilance program at Northwestern University Feinberg School of Medicine has to say. Inconvenient Women, read all sides of an issue before making a medical decision.

(NaturalNews) Chemotherapy drugs used in standard cancer treatments are associated with a huge list of side effects, from hair loss and nausea to nerve pain, sexual problems and mouth sores. Now a new study from the Research on Adverse Drug Events and Reports (RADAR) pharmacovigilance program at Northwestern University Feinberg School of Medicine has identified another side effect caused by a commonly used chemotherapy drug — death.

A startling number of women have died from a severe allergic reaction after being injected with Cremophor-based paclitaxel, a solvent-administered taxane chemotherapy. What makes this extra tragic is that the researchers found some of the dead women had already been treated for early stage breast cancer and could well have been cured — if the chemo prescribed to prevent a theoretical recurrence of cancer in the future had not killed them.

The report, presented at the 45th Annual Meeting of the American Society of Clinical Oncology held recently in Orlando, Florida, found there were 287 unique cases of hypersensitivity reactions submitted to the FDA’s Adverse Event Report System between 1997 and 2007 in patients who received the solvent-laced chemo drug. Of these, an alarming 38 percent, 109, died. Because adverse event reports usually only document from one to 10 percent of the actual incidence of serious side effects, the number of hypersensitivity reactions as well as deaths is probably much greater.

The severe allergic reactions are believed to be caused by the chemical solvent used to dissolve some chemo drugs before they can be injected into the blood stream. Two of the women who died from an allergic reaction had early-stage breast cancer, which had already been surgically removed. They were being subjected to the Cremophor-containing paclitaxel to supposedly keep the cancer from returning.

Although both of these patients were given additional drugs before the chemotherapy to reduce the risk of hypersensitivity reactions, they still died. In fact, RADAR researchers found that 22 percent of all the deaths from the chemo drug occurred in patients who had been pre-treated with medications to prevent hypersensitivity reactions. Another 15 percent of these chemo patients experienced life-threatening respiratory arrest.

“The deaths of women with early-stage breast cancer are particularly disturbing because without the adverse reaction, they could have likely had 40 years of life ahead of them,” study leader Charles Bennett, M.D., RADAR program coordinator and a professor of hematology/oncology at Northwestern’s Feinberg School, stated in a media release.

“Patients receiving Cremophor-based paclitaxel should be given medications to prevent hypersensitivity reactions, but what is sobering, as the study has shown and as the black-box warning indicates, women suffer anaphylaxis despite receiving steroid premedication,” he added. “Physicians may also want to consider exploring other alternative chemotherapy options that do not include Cremophor.”

Cremophor-containing paclitaxel has been associated with a wide range of hypersensitivity reactions, ranging from mild skin irritations to cardiac collapse. “The results of our review suggest that physicians should be vigilant in monitoring the safety of their patients undergoing chemotherapy treatment,” said Dr. Bennett, who also is the A.C. Buehler Professor in Economics and Aging at the Feinberg School and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

For more information:
http://www.cancer.gov/cancertopics/…
http://www.oncolink.com/treatment/a…

©2012 An Inconvenient Woman. All Rights Reserved.

June 3, 2009 (Orlando) — The hormone replacement therapy taken by millions of women to relieve hot flashes and other  symptoms of menopause may raise the risk of dying from lung cancer, researchers say.

New findings from the landmark Women’s Health Initiative study show that women with non-small cell lung cancer are 59% more likely to die from the disease if they take combined estrogen and progestin.

The risk was particularly high for smokers: There was one avoidable death from non-small cell lung cancer for every 100 women who both smoked and took hormone therapy over eight years, the study showed.

Non-small cell lung cancer is the most common type of lung cancer and the leading cause of cancer death in women.

In light of the findings, “women almost certainly should not be using combined hormone therapy and tobacco at the same time,” says study head Rowan Chlebowski, MD, of the Harbor-UCLA Medical Center.

Combined hormone treatment did not increase the odds of developing lung cancer, the study showed.

Hormone Therapy Linked to Host of Problems

The findings represent the latest in “a series of problems that work against widespread use of combined hormone therapy,” Chlebowski says.

He’s referring to the fact that previous analyses from the Women’s Health Initiative showed that long-term use (at least five years) of hormone replacement therapy combining estrogen and progestin raises women’s risk of heart disease, stroke, blood clots, and breast cancer.

In the WHI, more than 161,000 women were randomly assigned to take combined hormone therapy or a placebo. The trial was stopped prematurely in 2002, when it became apparent that the risks of combined hormone treatment outweighed the benefits.

Although fewer women are opting for the combination in light of those findings, about 25 million prescriptions are still written every year in the U.S., Chlebowski says.

Hormone Therapy and Lung Cancer

Since the WHI was stopped, researchers have observed a significant increase in both fatal and nonfatal cancers among women who took the hormones, Chlebowski tells WebMD.

The new analysis used data from the WHI to try to answer the question of whether the increase could be explained by the influence of combined hormone therapy on lung cancer, he says.

The researchers looked at lung cancer cases and deaths for the 5 1/2 years that the women took either hormones or placebo and for nearly  2 1/2 years afterward.

Among the findings, presented at the annual meeting of the American Society of Clinical Oncology:

• There were 67 deaths from non-small cell lung cancer among the 8,052 hormone users vs. 39 among the 7,678 women who took the placebo, a significant difference.
• After a diagnosis of non-small cell lung cancer, hormone users lived a median of 9.4 months, compared with 16.1 months for women taking placebo.
• Among smokers, 3.4% of those who took hormones died from non-small cell lung cancer, compared with 2.3% of those who took placebo.
• Among never-smokers, 0.2% of hormone users died from non-small cell lung cancer, compared with 0.1% of those on placebo.
• There was no link between hormone therapy and risk of developing or dying from small-cell lung cancer.

Bruce Johnson, MD, of the Dana-Farber Cancer Institute in Boston, tells WebMD that the new study was better designed and thus “likely more accurate” than previous studies that showed no link between lung cancer and hormone therapy.

Hormone Therapy: What Should Women Do?

Smokers should definitely quit the habit if they are taking or considering taking combined hormone treatment, Chlebowski says.

Also, talk to your doctor about other options for relieving hot flashes and symptoms of menopause, he says.

If hormone treatment is needed, heed the FDA’s advice to take estrogen and progestin at the lowest doses for the shortest duration to reach treatment goals, doctors say.

©2012 An Inconvenient Woman. All Rights Reserved.

Consumers can only  hope. Of course if  MERCK corporate lawyers figure out that such an open source platform may lead to a clear chain of custody of the type of information they would rather not have readily available during a trial environment, we will see who prevails, the scientist or the lawyers

Reported by Kevin Davies

March 3, 2009 | SAN FRANCISCO – Merck scientists and executives Stephen Friend and Eric Schadt unveiled their plans for Sage, an open-access platform for sharing and disseminating complex data representing disease biology, in a major announcement at CHI’s Molecular Medicine Tri-Conference last week.*

In a joint presentation, Friend, Merck senior vice president and former oncology chief, and Schadt, an outstanding researcher based at Merck’s Seattle subsidiary Rosetta Inpharmatics, reviewed the successes and outstanding challenges that prompted them, with Merck’s blessing (in the form of money and resources) to entertain a bold new approach to improving the expense, time and productivity of drug development.

The benefits of analyzing complex bionetworks are very good, said Schadt, but “more expensive than any one company can afford.” The vision of Sage was “to create open access, integrative bionetworks, evolved by contributor scientists, to accelerate the elimination of human disease.” An all-star advisory team includes Nobelist Leland Hartwell, Sir David Lane (A*STAR Singapore), Navigenics co-founder Dietrich Stephan, Merck research chief Peter Kim, Yale’s Rick Lifton, and John Wilbanks (Science Commons).

“We need massive amounts of information appropriately integrated to build models that are predictive,” said Schadt. “Scientists across the globe involved in different areas of research need to be actively engaged in accessing these networks and contributing information back.”

The transition from a linear to a network mindset would require the generation of coherent datasets, the development of predictive models to design novel therapeutic approaches, and the leveraging of social networks and other means to foster a contributor network. “Watching the trends of public data access, we anticipate a transition of disease biology into the precompetitive space,” said Schadt. Friend added, “The concept of making disease biology a pre-competitive space is… something that we feel in the long run has an opportunity [to succeed].”

Schadt said Merck’s leadership had recognized an opportunity where donating some of its data into the public domain, forming an open access platform that will emerge from an incubator phase, would provide a potentially significant long-term understanding of disease biology.

As for why scientists should include their own data, Friend said, “picture chemistry, picture physics. The people who were originally trying to mix compounds didn’t get very far until they found molecular structures… This is the analogy for what’s going to happen in biology.” New representations of disease allow for data to be shared and layered.

The hardest part in making Sage successful may not be the technology, Friend concluded. “It’s either going to be … our institutions … that have a certain culture about what we do with data. Or it’s going to be the clinicians,” who aren’t used to presenting clinical data using defined standards.

Decade of Discovery

Over the past decade, Friend said Merck has introduced numerous bold technologies that have been successful to a degree. Widescale RNA expression profiling in tumors (in conjunction with the Netherlands Cancer Institute) led directly to the development of Mammaprint and Oncotype diagnostic tests for breast cancer metastases. But such measurements are confounded by multiple variables, making it impossible to infer causality.

Merck also championed whole-genome RNA interference (RNAi) screening. “Often we use it to choose what drug should be combined with what standard of care, and what patient is likely to respond to what therapy,” said Friend, such as identifying gene networks that influence the activity of cisplatin. But heterogeneity of samples made it almost impossible to put the results into context. “It’s like looking at a single frame in “Slumdog Millionaire” and going, Ah, that’s what that movie was about,” he said.

A third initiative, beginning around 2002, was to merge databases of clinical information and genetic information. Merck forged collaborations with European and Chinese cancer institutes, as well as the Moffitt Cancer Center, which enables Merck researchers to direct patient selection in clinical trials based on molecular signatures in the database. But Friend said that the volume of disease data amounted to “a clinical/genomic Tower of Babel” problem.

More recently, Merck has been riding the success of Schadt’s team in Seattle, which has taken major steps to harness the explosion of data and analyze biological networks to predict the physiological state of the system. “Drug companies were betting the farm on seeing things correlated with disease and beautiful patterns of expression and then developing drugs, without having any real idea of the casual nature of those patterns,” said Schadt. The key was to leverage DNA information and environmental effects. “To be competitive in the future and to impact human health, we must become masters of information,” Schadt said, displaying a picture of Aria, the all-seeing master computer from the film Eagle Eye.

Ed’S NOTE: Eric Schadt will keynote the 2009 Bio-IT World Expo on Tuesday, April 28.

*CHI’s Molecular Medicine Tri-Conference. San Francisco, February 23-26, 2009.

©2012 An Inconvenient Woman. All Rights Reserved.

but only if you get a good night’s sleep

After my last week’s rant about focusing efforts to PREVENT cancer as well as CURING cancer, I was please to review a research study that did just that! The study examined the link between exercise and cancer risk, paying special attention to whether or not getting adequate sleep further affected a women’s cancer risk.

The U.S. Centers for Disease Control and Prevention calls sleep loss a growing and as yet an under-recognized public health problem, saying Americans are getting less and less slumber. The CDC said the percentage of adults reporting sleeping six hours, or fewer, a night increased from 1985 to 2006. In previous studies reported in “The Inconvenient Women”, the rates of “short duration sleep” are even higher in the female population.

A resent National Cancer Institute study, presented at the American Association for Cancer Research’s Seventh Annual International Conference on Frontiers in Cancer Prevention Research, reported that physically active women, who slept less than seven hours nightly, had a 47 percent higher risk of cancer than those who got more sleep.

James McClain, Ph.D., MPH, cancer prevention fellow at the National Cancer Institute and lead author of the study, said it is unclear exactly how getting too little sleep may make one more susceptible to cancer, but getting adequate sleep has been long associated with maintaining good health. “We think it’s quite interesting and intriguing. It’s kind of a first look into this. It isn’t something that has been widely studied,”, said McClain.

“Greater participation in physical activity has consistently been associated with reduced risk of cancer incidence at several sites, including breast and colon cancers,” said James McClain, and “Short duration sleep appears to have opposing effects of physical activity on several key hormonal and metabolic parameters, which is why we looked at how it affected the exercise/cancer risk relationship.”

The Maryland-based study involving 5,968 women, aged 18 years or older with no previous cancer diagnosis, confirmed previous findings that people who engage in regular physical activity are less likely to develop cancer. The women completed an initial survey in 1998 and were then tracked through the Washington County Cancer Registry and Maryland State Cancer Registry. McClain and colleagues followed the women for almost 10 years to determine the association between physical activity energy expenditure, sleep duration and incidence of overall breast and colon cancers.

First incidence of cancer occurred among 604 women, 186 of which were breast cancer cases. According to McClain, sleep duration altered the association between physical activity and cancer risk among this population. In terms of the amount of physical exercise the women got per week, researchers found that sleep appeared to play an important role in cancer risk.

Even though the exact mechanism of how exercise reduces cancer risk isn’t known, researchers believe that physical activity’s effects on factors including hormone levels, immune function, and body weight may play an important role.

“Short duration sleep” increases all levels of health risk

Sleep experts say chronic sleep loss is associated with obesity, diabetes, high blood pressure, stroke, cardiovascular disease, depression, cigarette smoking and excessive drinking.

Source Document:

McClain J. #B145. Presented at: AACR Seventh Annual International Conference on Frontiers in Cancer Prevention Research; Nov. 16-18, 2008; Washington.

©2012 An Inconvenient Woman. All Rights Reserved.

A friend sent me this image yesterday, with the message, “From her cute lips to God’s ear.”

I smiled and sent the e-mail on to my writing partner, Leslie. But last night, as I fell asleep, I thought about the e-mail’s real message.

I asked myself, “Why do we keep looking for “Cures” in our various “wars against (name of disease here)?”

Of course we want to heal and save our moms, grandmothers, sisters and daughters from Breast Cancer, but what are we doing as a society to PREVENT Breast Cancer in the first place?

I realize that we have learned much of what to avoid, and what to embrace to remain Cancer free from the all of the past and current Cancer research. I am grateful for that research and to those who contributed ‘time, talent and treasure’ to vanquish a disease that has taken so many of our beloveds.

Maybe I’m just ready to think about the issue differently…ready to switch the problem around 180 and look at the situation as an opportunity for change. What if we women were able to refocus our intention from being ‘at war’ with a deadly enemy, to being ‘in harmony’ with our body and our planet?

Just maybe, by living in peaceful accord with our feminine cycle, and all the other natural cycles of Mother Earth, our bodies would find the balance to heal. Perhaps living in synchronicity with nature would prevent illness? I don’t know, but living in alignment with your natural cycle can’t hurt, and being at war with Mother Nature has proven to be a failed strategy.

I vote for a peaceful, gentle approach to appreciating the wonder of the female cycle and just maybe we could reach that state of balance before our little lady “Grows Boobs”.

Think of just one thing you can do for your self to live within your feminine cycle.

Just one, it is a start.

Live gently on this earth and treat your body with love and understanding.

Be as kind to your self as you are to others.

Love yourself and appreciate the miracle of your body, mind and spirit. Laugh, feel your inner joy, if only for a moment, it is a start.

I would love to credit the creative team who developed this thought-provoking image, but the e-mail did not include a credit line. If some one knows, please let me know so I can thank them for their creativity in my Blog.

My best hope for the little girl in the photo that she grows up with healthy boobs, a vibrantly healthy body and the spirit to be an Inconvenient Woman.

©2012 An Inconvenient Woman. All Rights Reserved.

Please take the time to visit the Sister Study web site.

The Sister Study is the only long-term study of women aged 35-74 whose sister had breast cancer.  It is a national study to learn how environment and genes affect the chances of getting breast cancer.  A total of 50,000 women will join the effort to find the causes of breast cancer

WHO CAN JOIN THE SISTER STUDY?

You may be eligible to join the Sister Study if —

• Your sister, related to you by blood, had breast cancer.
• You are between the ages of 35 and 74.
• You have never had breast cancer yourself.
• You are a woman living in the U.S. or Puerto Rico.

SISTERS ARE STILL NEEDED!

As we approach our goal of enrolling 50,000 diverse sisters, we want to make sure that groups not yet as well represented among participants have an opportunity to join. Unfortunately, this means turning away some women who are already very well represented in the study group. Caucasian women ages 35-64 with more than a high school degree will no longer be able to enroll, but can help the Sister Study in other ways.  This group is now very well represented among our current participants

We still need women from the following groups to enroll in the Sister Study:

• African Americans, Latinas, Asians and Pacific Islanders, and Native Americans between ages 35-74
• Caucasian women between the ages of 65-74 or with a high school degree or les

CAN YOU JOIN NOW?

If you need help determining whether you can join at this time, please call our toll free number 1-877-4SISTER or CLICK HERE to answer the screening questions at the Sister Study web site.

You can be a part of this landmark research effort to find the causes of breast cancer.

Join the Sister Study for your daughters, nieces,

granddaughters, and future generations!

Visit the Sister Study Homepage

©2012 An Inconvenient Woman. All Rights Reserved.

Cook with Indian spices. These aromatic seasonings do more than add flavor and clear your sinuses: Hundreds of studies suggest curcumin— the ingredient in turmeric that turns curries yellow—can kill cancer cells by inhibiting the enzymes that cause inflammation in the body. For an easy way to use turmeric, click here.

Drink plenty of green tea. An antioxidant found in green tea shields cells from premature aging and greatly decreases the advancement of breast cancer in mice. Worried about getting too much caffeine from the recommended 5 cups? Click here for a DIY decaf tip.

Eat more Mexican food. Scientists find that following a traditional Mexican diet (which is rich in beans, soups, cheeses, and tomato-based sauces—and low in processed foods) may help shield you from breast cancer. Click here for the recipe for a healthy black bean dip.

Avoid bad fats. Women with higher levels of trans-fatty acids in their systems have almost twice the risk of getting breast cancer. Common trans fat-filled foods include processed cakes, cookies, chips, and fast food. But can you trust brands that advertise “0 grams of trans fat”? Click here to find out.

Curious about your natural treatment options? Adding complementary therapies to your breast cancer treatment plan can both improve your prognosis and help you feel better. When it comes to breast cancer, conventional therapies such as surgery, chemotherapy, and radiation may be unavoidable, but the holistic strategies listed here offer healing benefits.

©2012 An Inconvenient Woman. All Rights Reserved.

But 55-percent of all strokes and 60-percent of stroke deaths occur in women.

About 100,000 women die annually of stroke, 40,000 more than the number of men who die from it. The fact that risk goes up with age and women live longer account for a large portion of that difference.

Strokes can affect younger women as well, including after childbirth when the blood is more likely to clot — probably an evolutionary adaptation so new mothers don’t bleed to death, says Dr. David Sherman, chief of neurology at the University of Texas Health Science Center.

And for women who have migraine headaches — about 18 percent of women do — and those who smoke and take oral contraceptives, there is more risk of stroke.

Twice as many women die from stroke every year than from breast cancer

That is why I’ve posted the following Harvard Medical report. LEARN the early warning signs of stroke. Inconvenient Women know their bodies and are proactive about their health. For more information go to ‘Stoke Facts In America‘

		September 23, 2008

3 warning signs of stroke You know the signs of a stroke. Or do you? You’d probably recognize the classic symptoms, such as sudden weakness on one side of the body or blurred vision, but often the signs are much less obvious. A crushing headache may come on without warning. Your face may feel numb. You may have inexplicable trouble speaking or following what people say. How to tell when someone’s having a stroke Crooked smile. Have the person smile or show his or her teeth. If one side doesn’t move as well as the other or seems to droop, that could be sign of a stroke. Arm drift. Have the person close his or her eyes and hold his or her arms straight out in front for about 10 seconds. If one arm does not move, or one arm winds up drifting down more than the other, they may be having a stroke. Slurred speech. Have the person say, “You can’t teach an old dog new tricks,” or some other simple, familiar saying. If the person slurs the words, gets some words wrong, or is unable to speak, that could be sign of a stroke. Knowing all the warning signs of a stroke may one day save your life and well-being. That’s because the faster you recognize the symptoms, the sooner you can get medical help. And prompt treatment is the key to shielding your brain from a stroke’s damage and sparing you serious disabilities such as paralysis, speech impairment, and dementia. Every 45 seconds, someone in the United States has a stroke. Stroke is the third leading cause of death in the United States and other industrial countries, trailing only heart disease and cancer. In the United States, about 700,000 people have a stroke each year. If you have a stroke, the risk of dying from it increases with age: 88% of deaths from stroke are in people 65 and older. About two-thirds of people who have a stroke have some resulting disability and require rehabilitation. The odds of having a stroke more than double for each decade after age 55. Two-thirds of strokes involve people over 65. Men and women are about equally likely to have a stroke, but women have a greater risk of dying from one. Race is another risk factor. African-Americans, for example, are almost twice as likely to suffer a stroke as are whites. Although you can’t change your age or race, you can take steps to reduce other risk factors for stroke, especially ischemic stroke. The most common risk factors for both ischemic stroke and TIAs (transient ischemic attacks, or “mini strokes”) are high blood pressure (hypertension), diabetes, unhealthy cholesterol levels, and obesity. All of these factors affect the health of your blood vessels — increasing the risk not only of stroke, but also of heart disease. That’s why medications and other steps you take to reduce the risk of an ischemic stroke will also benefit your heart. Some types of hemorrhagic strokes are more likely to occur in people with chronic high blood pressure. But other types of hemorrhagic strokes seemingly strike out of the blue. Although abnormal blood vessel conditions such as an aneurysm (a bubble in the blood vessel wall that could rupture) or an arteriovenous malformation (an abnormal tangle of blood vessels) increase the risk, these conditions may only be discovered inadvertently while you are undergoing testing for something else or may not be discovered until a stroke occurs. Fortunately, medicine has made considerable strides in understanding how to treat and prevent strokes. Medical imaging devices now enable medical teams to begin to diagnose a stroke accurately within minutes. Large studies have clarified which medications and other treatments are best for which patients. For those who need rehabilitation, experimental techniques are showing promise in helping patients make better progress than was possible even just a few years ago.

FEATURED CONTENT: What is a stroke? How the brain works Subtypes and causes of stroke Diagnosing a stroke Treating ischemic stroke Treating hemorrhagic stroke Stroke rehabilitation Preventing stroke Reprinted from Stroke: Preventing and treating “brain attack” — A Special Health Report from Harvard Medical School, Copyright © 2008 by Harvard University. All rights reserved.

** Get your copy of Stroke: Preventing and treating “brain attack” Stroke: Preventing and treating “brain attack” provides up-to-the-minute information about stroke symptoms, diagnosis, stroke treatment, and rehabilitation. This report discusses stroke prevention and common signs of stroke. It also contains helpful illustrations, an extensive glossary, and an informative resource guide. Click here to read more or buy online. To order online, click one of the following links: Purchase printed version ($18.00) Purchase electronic download (PDF) ($18.00) Purchase print + electronic download (PDF) ($26.00) Or to order by mail, print and mail the order form below:

Harvard Medical School offers special reports on over 50 health topics. Visit our Web site at http://www.health.harvard.edu to find reports of interest to you and your family. Copyright 2008 by Harvard University.

©2012 An Inconvenient Woman. All Rights Reserved.

A mammogram is a safe, low-dose x-ray picture of the breast. It is currently the most effective method of detecting breast cancer in its earliest, most treatable stages.

Why should I have a mammogram?

A mammogram can find breast cancer that is too small to be seen or felt. If breast cancer is found early on a mammogram, it can be treated early when it is easiest to cure. In some cases, finding a breast lump early may mean that a patient can choose surgery to save her breast. Early detection also may mean that chemotherapy is unnecessary.

How is a mammogram done?

When you have a mammogram, you stand in front of a special x-ray machine. The radiologic technologist lifts each breast and places it on a platform that holds the x-ray film. The breast is then gradually pressed against the platform by a specially designed, clear plastic plate. Some pressure is applied for a few seconds to make sure the x-rays show as much of the breast as possible. This pressure is not harmful to your breast. Studies show that most women do not find a mammogram exam painful for the short time needed to take the picture.

Should women be concerned about radiation dose during mammography?

No. The risk of harm from radiation is very small when compared to the benefits of early breast cancer detection. MQSA has established a maximum radiation dose limit that is considered to be safe. There have been such improvements in mammography that women receive 50 times less radiation than they received 20 years ago, with the risk of long-term effects being almost zero.

What is a screening mammogram?

A screening mammogram is a quick, easy way to detect breast cancer early when treatment is more effective and survival is high. It is a x-ray of the breast that doctors use to look for breast changes in women with no symptoms of breast cancer. Usually, two x-ray pictures are taken of each breast. A physician trained to read the mammograms examines them later. Screening for breast cancer is best achieved by including both mammography and a clinical breast examination in the screening process.

What is a diagnostic mammography exam?

A doctor uses a diagnostic mammogram to help learn the cause of a woman’s breast problems such as a breast mass, skin changes, or nipple discharge. Diagnostic mammography takes a little longer than screening mammography because more x-rays are taken. A qualified physician may check the mammograms while you wait.

Notification of Mammography Exam Results

How will a patient get the results of her mammogram?

Her mammography facility must provide her with a written report of the results of the exam. The results can be handed to her at the time of the exam, or mailed to her within 30 days after the exam. The report must be in words she can easily understand. Her doctor will be sent a copy of the more technical version of the exam results.

How will patients who do not have a doctor get their results?

Her mammography facility will provide her with the patient’s version of the results and a copy of the technical report within 30 days of the exam. If necessary, the facility personnel will refer her to a doctor.

What should a patient do if she does not receive her written results within 30 days?

If she does not receive her results within 30 days, she should call the mammography facility or her doctor, and ask for the results of the exam. This is very important. The results of most mammograms are “normal” – but the patient should not assume the mammogram is normal if she does not receive her results!

Are there special considerations for reporting results when they are “suspicious” or “highly suggestive of a malignancy”?

Yes. In these cases, the facility is expected to contact the patient as soon as possible. Although it is impossible to establish a precise time frame, it is expected that such communication could ordinarily be accomplished within five business days. Some facilities may discuss the results with the patient following the exam, or contact her by phone. Even if the results are given to the patient verbally, she should receive a written notification within 30 days.

©2012 An Inconvenient Woman. All Rights Reserved.

July 8, 2008

Media Inquiries:

Karen Riley, 301-827-6242

Consumer Inquiries:

888-INFO-FDA

FDA Approves New Genetic Test for Patients with Breast Cancer

The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab).

The SPOT-Light HER2 CISH kit is a test that measures the number of copies of the HER2 gene in tumor tissue. This gene regulates the growth of cancer cells.

A healthy breast cell has two copies of the HER2 gene, which sends a signal to cells, telling them when to grow, divide and make repairs. Patients with breast cancer may have more copies of this HER2 gene, prompting them to overproduce HER2 protein so that more signals are sent to breast cells. As a result, the cells grow and divide much too quickly.

“When used with other clinical information and laboratory tests, this test can provide health care professionals with additional insight on treatment decisions for patients with breast cancer,” said Daniel Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health.

The SPOT-Light test counts the number of HER2 genes in a small sample of removed tumor. The removed piece is stained with a chemical that causes any HER2 genes in the sample to change color. This color change can be visualized under a standard microscope, eliminating the need for the more expensive and complex fluorescent microscopes required to read assays already on the market. Unlike existing tests, the SPOT-Light allows labs to store the tissue for future reference.

Patients who over-produce HER2 protein are typically treated with the drug Herceptin, which targets HER2 protein production. This helps to stop the growth of HER2 cancer cells.

The FDA based its approval of the SPOT-Light test on a study using tumor samples from patients with breast cancer in the United States and Finland. These studies confirmed that the test was effective in determining how many HER2 genes were in these patients.

SPOT-Light is manufactured by Invitrogen Corp. of Carlsbad, Calif. Herceptin is manufactured by Genentech, of San Francisco, Calif.

©2012 An Inconvenient Woman. All Rights Reserved.