Category Archives: news-you-can-use

Heart Disease and Breast Cancer

Diana Zuckerman PhD and Danielle Shapiro, MD, MPH, Cancer Prevention and Treatment Fund

In a first-of-its-kind scientific statement, the American Heart Association reminds women that heart disease is the #1 killer of women and that frequently used breast cancer treatments can increase a woman’s chances of developing heart disease.  These treatments include radiation, hormone therapy, chemotherapy, and targeted therapy.

Facts that will Help you Decide your Treatment Options

Fact:  Heart disease affects almost 50 million U.S. women, and 1 in 3 deaths in women in the U.S. are due to heart disease. Breast cancer affects about 3.3 million U.S. women, and 1 in 32 deaths in women are due to breast cancer.  That means that women are about 10 times more likely to die of heart disease than to die of breast cancer.

 Fact: Women with a history of breast cancer are more likely to die from heart disease than women without a history of breast cancer.  That is because some health habits cause both heart disease and breast cancer, and because some breast cancer treatments can also increase your chances of dying of heart disease.

Fact: There are many things you can do to decrease your risks of developing both breast cancer and heart disease:  not smoking, eating a healthy diet, losing weight (if you are overweight or obese) and being physically active

Which Breast Cancer Treatments Harm the Heart?

Radiation therapy:

Radiation therapy is often recommended for women who have a lumpectomy, so it is important to know that it can cause inflammation that can damage heart muscles and blood vessels. Studies on animals show that it can also cause clots to form in the coronary arteries. The risks are higher for radiation that is directed at the left side of the chest. The effects are not immediate, but radiation can increase the chances of heart disease at any time between 5-30 years after radiation therapy.

Hormonal therapy:

Tamoxifen is a hormone therapy that is often prescribed for breast cancers that are sensitive to the hormone estrogen. Studies show that tamoxifen lowers bad cholesterol, but there is no evidence this decreased their chances of developing heart disease or dying from it. Perhaps that is because tamoxifen also increases the chances of forming blood clots, which can be dangerous if they are in the lungs, heart, or brain.

Aromatase inhibitors are a type of hormone therapy that is often prescribed for postmenopausal women with breast cancers that are sensitive to the hormone estrogen. Aromatase inhibitors increased the chances of developing heart disease by less than 1%, but the risks may be higher (about 7%) in women who already have heart disease. The U.S. Food and Drug Administration issued a warning about this for one aromatase inhibitor, anastrazole (brand name arimidex).

Chemotherapy:

Doxorubicin, a type of anthracycline-based chemotherapy, can have harmful effects on the heart, which can be permanent and irreversible. Doxorubicin can damage heart cells and cause inflammation that can weaken the heart muscles, which can lead to heart failure. Heart failure means the heart isn’t pumping well, which can cause the body to become swollen and the lungs to fill with fluid.  This can cause you to feel short of breath, tired, or weak.

5-Fluorouracil (5-FU), is a type of antimetabolite chemotherapy used for metastatic breast cancer and other cancers. Some women who take 5-FU develop chest pain caused by a blood clot or tightening in the blood vessels that feed the heart (coronary arteries). In very rare cases, the heart does not get enough blood, which can cause a heart attack.

Targeted Drugs:

Trastuzumab or pertuzumab are targeted drugs that work against breast cancer cells that make the protein HER2. These medications can cause heart failure that is reversible. Because of the risks, women should only take these medications for 1 year.  Women who are over age 50 with diagnosed heart disease, high blood pressure, reduced heart function, or prior use of doxorubicin are most likely to be harmed by this drug.

Prevention

Studies show that there are things you can change to help prevent breast cancer and heart disease.

  1. Stop smoking
  • For heart health – Smoking increases the chances of having a heart attack or stroke.
  • For breast health – Women who start smoking at a younger age, and smoke for many years, are more likely to develop breast cancer. Smoking causes about 4 in 1000 breast cancers. Quitting decreases the chances of developing breast cancer, but it may take about 20 years to see the full benefits. To read more, click here.
  1. Maintain a healthy weight
  • For heart health – Being overweight or obese (a BMI of 25 or above) increases the chances of developing heart disease.
  • For breast health – Every extra 10 pounds over “normal” weight (BMI below 25) increases the chance of developing breast cancer by about 10%.
  1. Be physically active
  • For heart health – Sitting, watching TV, lying in bed, or driving for 10 hours or more a day while you are awake instead of 5 hours or less per day increases the chances of developing heart disease by about 18%. The AHA recommends exercising for 30 minutes or more a day 5 days each week.
  • For breast health – Those same sedentary activities for 12 hours or more a day compared to 5.5 hours or less increase the chance of developing breast cancer by about 80%. To prevent breast cancer, exercise for 30 minutes or more a day 5 days each week.
  1. Eat a healthy diet
  • For heart health – Eating a diet rich in fresh vegetables, Fresh fruit, fish, poultry, and whole grains reduces your chance of dying from heart disease by about 28% compared to eating a typical U.S. diet with many fast foods, red meats/processed meats, and packaged or processed foods.
  • For breast health – The typical U.S. diet is associated with a greater chance of developing breast cancer, but the clearest evidence is for eating at least 15 oz of red meat or processed meat each week compared to less than 9 oz. of red meat or processed meat.

Heart Health for Breast Cancer Patients and Survivors

High blood pressure, diabetes and high cholesterol increase the chances of having a heart attack or dying from one. The AHA recommends controlling blood pressure, blood sugar, and blood cholesterol with diet, exercise, and medications when needed. Exercise is good for the heart and it also fights off cancer. Studies show that exercising 30 minutes a day for 5 days out of the week decrease the chances of breast cancer returning and from dying from breast cancer.

The Bottom Line

Heart disease is a major cause of deaths in women, and remains a number one cause of death in breast cancer survivors. Women who are at a higher risk of heart disease should talk with their doctors about the risks and benefits of commonly used cancer treatments.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References:

Laxmi S. Mehta. et al. Cardiovascular Disease and Breast Cancer: Where These Entities Intersect: A Scientific Statement From the American Heart Association. Circulation. 2018, originally published February 1, 2018. https://doi.org/10.1161/CIR.0000000000000556

Jones ME. et al. Smoking and risk of breast cancer in the Generations Study cohort. Breast Cancer Research. 2017;19:118. https://doi.org/10.1186/s13058-017-0908-4

 

Alcohol and Cancer

Danielle Shapiro, MD, MPH, Cancer Prevention and Treatment Fund

The link between and alcohol and cancer may surprise you. A 2017 statement by the American Society of Clinical Oncology (ASCO) reports that drinking alcohol increases the risk of cancer of the mouth and throat, vocal cords, esophagus, liver, breast, and colon. The risks are greatest in those with heavy and long-term alcohol use. Even so, moderate drinking can add up over a lifetime, which could be harmful.[1]

What is Moderate Drinking? Heavy Drinking?

According to the National institute of Alcohol Abuse and Alcoholism (NIAAA), “moderate” drinking is 1 drink per day for women and 2 drinks per day for men, but not all “drinks” are equal. A drink is defined as approximately 14g of alcohol, which equals: 1.5 ounces of distilled spirits (e.g., vodka, gin, tequila, etc), 5 ounces of wine, 12 ounces of beer, and 8 ounces of malt liquor.[1,2] (Click here to see the CDC’s fact sheet.)

Heavy drinking is defined as 8 or more drinks per week OR 3 or more drinks per day for women and 15 or more drinks per week OR 4 or more drink per day for men. Most adults who engage in high-risk drinking started as teens.[1] (Click here to see our article on teen drinking.)

Drinking Amount and Cancer Risk

According to the International Agency for Research on Cancer (IARC), a branch of the World Health Organization (WHO), alcohol is a “group 1 carcinogen.” That means it can cause cancer in humans. Group 1 carcinogens include cigarette smoke, UV solar radiation, radon, and asbestos, for example.[3] Alcohol is known to cause six types of cancer, including cancer of the mouth and throat, vocal cords, esophagus (squamous cell), liver, female breast, and colon/rectum. Alcohol may also be tied to cancer of the pancreas, stomach, and lung, but more research is needed to find out for certain.[4] (Click here to see the National Cancer Institute’s Fact Sheet.)

Some of these cancers, such as mouth and throat cancer, are rare (about 1% lifetime risk), while colon cancer and breast cancer are much more common. [7] Depending on the amount a person drinks, he or she can increase the risk for even rare cancers. For example, moderate drinkers can almost double their lifetime risk of mouth and throat cancer to almost 2%, while heavy drinkers have a 500% increased risk of having mouth or throat cancer, from 1% to 5%.

Scientists believe that when alcohol comes into direct contact with tissue through drinking and swallowing, it causes more damage. For example, in the heaviest drinkers, alcohol raises the lifetime risk of esophagus cancer from about 0.5% to about 2.5%.[1,7]

Women need to be more cautious when drinking any amount of alcohol. The World Cancer Research Fund estimates that for every additional average drink per day, breast cancer risk goes up by 5% pre-menopause and up by 9% after menopause. Alcohol affects the amounts of certain sex hormones circulating in the body. For women who have had hormone receptor-positive breast cancer, 7 or more weekly drinks increased the chances of having a new cancer diagnosed in the other breast from about 5% to about 10%.[1]

How Alcohol Causes Cancer

Scientists believe that alcohol causes cancer in several ways:[1, 4]

  • Alcohol (ethanol) is broken down into a toxic substance called acetaldehyde. Acetaldehyde is directly toxic to the body’s cells.
  • Alcohol causes damage to cells through a process called free-radical oxidation.
  • Alcohol causes the body to absorb less folate (an important B vitamin) and other nutrients (antioxidant vitamins A, C, and E), which naturally repair damage and fight off cancers.
  • Alcohol increases the body’s level of estrogen (a sex hormone associated with breast cancer).

Does Quitting Change Your Chances of Developing Cancer or Cancer Recurrence?

Yes, drinking less alcohol on a regular basis reduces cancer risk, even in people who were already diagnosed with cancer. Research has shown that heavy or moderate drinkers who substantially reduce their alcohol consumption will slowly reduce their risk of developing mouth, throat, vocal cord, and esophagus cancer, but it would take 20 years of abstention to reduce the chances of developing those cancers to the lower chances of someone who never drank so frequently.  It is not clear whether reducing or giving up drinking after years of moderate or heavy drinking will have much impact for other alcohol-related cancers.[1]

In those who survived an esophagus cancer, drinkers tripled their risk for a new primary cancer diagnosis. On average, the risk of a new cancer diagnosis after esophagus cancer is removed is 8 % to 27%, and continuing heavy drinking will triple that risk.[5]

Among all cancer survivors, heavy drinking caused an 8% increased risk in dying and a 17% increased risk of cancer recurrence. Patients with cancer who abuse alcohol do worse because alcohol causes poorer nutrition, a suppressed immune system, and a weaker heart.[1]

What You Can Do to Lower Cancer Risk for You and Your Family

  1. . If you drink alcohol, limit drinks to an average of 1 a day for women and 2 a day for men.
  2. Recognize heavy drinking in a loved one, because the more a person drinks, the greater his or her chances of developing cancer. The “CAGE” questionnaire can help spot heavy drinking. Has the person tried to Cut back? Has the person been Annoyed when asked about drinking? Has the person felt bad or Guilty? Has the person needed a drink first thing in the morning (Eye opener)? Each “yes” counts as 1 point. A score of 2 or more suggests problem drinking.[6]
  3. Talk with your doctor about your risk. Doctors can refer or offer counseling and treatment services to patients with risky drinking habits.
  4. Seek help early. Problem drinking can’t be wished away. There are many resources to access information and help. The Substance Abuse and Mental Health Services Administration (SAMHSA), which is part of the U.S. Department of Health and Human Services (HHS) has a toll free hot-line and website. Call 1-800-662-HELP (4357) or visit https://findtreatment.samhsa.gov/  today.
  5. Practice healthy habits. Eating a diet rich in cancer-fighting nutrients (i.e., fruits and vegetables), exercising, maintaining a healthy weight, reducing stress, and getting restful sleep can all help to lower cancer risk. Don’t smoke, and quit if you do. Drinking and smoking increases cancer risk more than either one alone.

The Bottom Line

To prevent cancer, try to limit your drinking by sticking to a maximum average of 1 a day if you’re a woman and 2 a day if you’re a man.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

Footnotes:

  1. LoConte, NK. et al. Alcohol and Cancer: A Statement of the American Society of Clinical Oncology. Journal of Clinical Oncology. published online before print November 7, 2017. DOI: 10.1200/JCO.2017.76.1155. Available online: http://ascopubs.org/doi/full/10.1200/JCO.2017.76.1155
  2. Centers for Disease Control and Prevention. Alcohol and Public Health. Fact Sheets- Moderate Drinking. Accessed November 16, 2017. Available online: https://www.cdc.gov/alcohol/fact-sheets/moderate-drinking.htm

 

Can Aspirin Prevent Cancer and Cancer Deaths?

Nyedra W. Booker, PharmD, Tracy Rupp, PharmD, MPH, RD, Laura Gottschalk, PhD, and Danielle Shapiro, MD, MPH, Cancer Prevention and Treatment Fund

Doctors have prescribed aspirin to prevent heart attacks and stroke for many years. There is now good evidence that regular aspirin use can also prevent cancer. Experts already recommend an aspirin a day to prevent colon cancer, but aspirin may also “play a strong role in reducing death from cancer.”[1]  

Recommending Aspirin for Cancer Prevention

The U.S. Preventative Service Task Force (USPSTF), an independent group of medical experts, recommend  that people between the ages of 50 and 59 should take 81 mg of aspirin daily (which is the typical dosage of “baby” or low-dose aspirin) to prevent colon cancer. Since colon cancer develops slowly overtime, aspirin should be taken for at least 10 years.[2]

Daily aspirin is not for everyone between 50 and 59, however. For example, if you have an increased risk of bleeding because of other medication you are taking or because of a history of stomach or intestinal ulcers, kidney disease, or severe liver disease, the risks of taking aspirin daily may outweigh the benefits. 

The benefits of aspirin in preventing death from cancer are based in part on a 2016 study published in the prestigious Journal of the American Medical Association (JAMA), which looked at the rate of cancer in two large long-term studies.  The Nurse’s Health Study and the Health Professionals Follow-up study included almost 48,000 men and more than 88,000 women.[3] The study found that people who took aspirin regularly had a slightly lower risk for overall cancer and a 19% lower risk for colon cancer. These benefits were seen after just five years of use and are statistically significant, which means they are almost definitely due to the aspirin and not to other factors.

The new study results were presented at a national cancer conference in April 2017 and go beyond the results published in 2016.[1] Women in the studies who took aspirin regularly had a 7% lower chance of dying of any cause than women who did not take regular aspirin. Men who took aspirin regularly had an 11% lower chance of dying of any cause than men who did not take regular aspirin. Dying from cancer was 7% lower in women and 15% lower in men who regularly took aspirin. Women who regularly took aspirin had an 11% lower risk of dying from breast cancer. Men who regularly took aspirin had a 23% lower risk of dying from prostate cancer.  

Aspirin can have many benefits, but since it also has risks more studies are needed to examine who is most likely to benefit and who is most likely to be harmed. The study was observational, which means that it evaluated the health of people in the “real world,” rather than a randomized clinical trial.  Since it is not possible to know as much about all the health habits and other possible influences of the thousands of people in these huge studies as is possible in a clinical trial, the conclusions are considered less certain.

What You Need to do Before Starting Aspirin Therapy

Remember that aspirin is a drug, and it has risks even at low doses. You should talk about whether taking a daily aspirin is a good idea with your doctor, so that you can discuss:

  • Your medical history and all the medicines you are currently using, whether they are prescription or over-the-counter
  • Any allergies or sensitivities you may have to aspirin
  • Any vitamins or dietary supplements you are currently taking

Aspirin should not be taken with certain other over-the-counter pain medications such as ibuprofen (Motrin and Advil) and naproxen (Aleve) because they can increase the risk of internal bleeding. These medications are called NSAIDS.  Aspiring should also not be taken daily by those who regularly use herbs and nutritional supplements.  Vitamin E, fish oil (omega-3 fatty acids) and what’s known as the “four Gs”– garlic, ginger, gingko, and ginseng– can all increase your risk for bleeding when taken with aspirin and other blood thinners.[4]

If taking aspirin is not a safe option for you, there are other ways to reduce your chance of developing heart disease and cancer, without any side effects!  They include quitting smoking, eating a diet rich in fruits and vegetables, and getting up from your chair or couch regularly rather than sitting for hours without moving around. Walking or other exercising for at least 20-30 minutes each day is also helpful. However, for people at highest risk of heart disease or cancer, aspirin could truly be a lifesaver.

The Bottom Line

Regular aspirin use may prevent deaths from many causes including cancer, heart attacks, and strokes.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

Footnotes:

  1. American Association for Cancer Research News Release. Regular Aspirin Use in Associated with Lower Cancer Mortality. April 3, 2017. Available online: http://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1036#.Wib80kqnGM9
  2. USPSTF. Final Update Summary: Aspirin Use to Prevent Cardiovascular Disease and Colorectal Cancer: Preventive Medication. April 2016. Available online: https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/aspirin-to-prevent-cardiovascular-disease-and-cancer
  3. Cao Y, et al. Population-wide Impact of Long-term Use of Aspirin and the Risk for Cancer. JAMA Oncol. Published online March 03, 2016. DOI: 10.1001/jamaoncol.2015.6396
  4. U.S. National Library of Medicine. MedlinePlus: Drugs, Supplements, and Herbal Information. Accessed December 2017. https://medlineplus.gov/druginfo/herb_All.html

Libertarians Score Big Victory In ‘Right-To-Try’ Drug Bill

Sarah Karlin-Smith, Politico: August 3, 2017

The Senate unanimously approved a bill Thursday that would allow people facing life-threatening diseases access to unapproved experimental drugs, providing a victory for libertarian advocates who see government regulators thwarting patients’ rights.

The bill, S. 204 (115), passed swiftly and easily in a Senate bitterly divided over health care. The powerful pharmaceutical lobby, which had quietly opposed an earlier version, kept an unusually low profile. The industry has been focused on fighting off any efforts to go after drug pricing, which President Donald Trump has said he would tackle. […]

The legislation would allow patients with serious diseases — anything from a late-stage cancer to multiple sclerosis — to request access to experimental drugs directly from drug companies without having to go through the FDA, which has its own compassionate use program that approves 99 percent of requests.

But the right-to-try bill doesn’t require drugmakers to make the experimental treatments available. In the 37 states that have similar laws on the books, Goldwater can point to only one doctor who says he has utilized a state right-to-try law for a patient — and that medicine was being made available to certain patients by the FDA anyway.

That’s led some critics to call it “right-to-ask” — and it may give desperately ill people false hopes. […]

And if the experimental drugs do become widely used outside the standard clinical trial system, it could undermine some of the rigorous science needed to know whether medicines are safe and effective. Many drugs that start the clinical trial process flop. Some are harmful.

“You have a situation where patients think they want to take a risk and don’t necessarily understand what risk they are taking,” said Diana Zuckerman, president of the National Center for Health Research, which lobbied against the bill.

And while the revised bill would require annual reports on whether the drugs used by these patients helped — or potentially harmed — them, patient safety experts are concerned it may not be enough. […]

 

Read the original article here.

A Shocking Diagnosis: Breast Implants “Gave Me Cancer”

Denise Grady, The New York Times: May 14, 2017

Raylene Hollrah was 33, with a young daughter, when she learned she had breast cancer. She made a difficult decision, one she hoped would save her life: She had her breasts removed, underwent grueling chemotherapy and then had reconstructive surgery.

In 2013, six years after her first diagnosis, cancer struck again — not breast cancer, but a rare malignancy of the immune system — caused by the implants used to rebuild her chest.

“My whole world came crumbling down again,” said Ms. Hollrah, now 43, who owns an insurance agency in Hermann, Mo. “I had spent the past six years going to the oncologist every three months trying to keep cancer away, and here was something I had put in my body to try to help me feel more like a woman, and it gave me cancer. I thought, ‘I’m not going to see my kids grow up.’”

Her disease — breast implant-associated anaplastic large-cell lymphoma — is a mysterious cancer that has affected a tiny proportion of the more than 10 million women worldwide who have received implants. Nearly all the cases have been linked to implants with a textured or slightly roughened surface, rather than a smooth covering. Texturing may cause inflammation that leads to cancer. If detected early, the lymphoma is often curable.

The Food and Drug Administration first reported a link between implants and the disease in 2011, and information was added to the products’ labeling. But the added warnings are deeply embedded in a dense list of complications, and no implants have been recalled. The F.D.A. advises women only “to follow their doctor’s recommended actions for monitoring their breast implants,” a spokeswoman said in an email this month.

 Until recently, many doctors had never heard of the disease, and little was known about the women who suddenly received the shocking diagnosis of cancer brought on by implants.

An F.D.A. update in March that linked nine deaths to the implants has helped raise awareness. The agency had received 359 reports of implant-associated lymphoma from around the world, although the actual tally of cases is unknown because the F.D.A.’s monitoring system relies on voluntary reports from doctors or patients. The number is expected to rise as more doctors and pathologists recognize the connection between the implants and the disease.

Women who have had the lymphoma say that the attention is long overdue, that too few women have been informed of the risk and that those with symptoms often face delays and mistakes in diagnosis, and difficulties in receiving proper care. Some have become severely ill.

Implants have become increasingly popular. From 2000 to 2016, the number of breast augmentations in the United States rose 37 percent, and reconstructions after mastectomy rose 39 percent. Annually, nearly 400,000 women in the United States get breast implants, about 300,000 for cosmetic enlargement and about 100,000 for reconstruction after cancer, according to the American Society of Plastic Surgeons. Allergan and Mentor are the major manufacturers. Worldwide, an estimated 1.4 million women got implants in 2015.

As late as 2015, only about 30 percent of plastic surgeons were routinely discussing the cancer with patients, according to Dr. Mark W. Clemens II, a plastic surgeon and an expert on the disease at the University of Texas MD Anderson Cancer Center in Houston.

“I’d like to think that since then we’ve made progress on that,” Dr. Clemens said.

Late last year, an alliance of cancer centers, the National Comprehensive Cancer Network, issued treatment guidelines. Experts agree that the essential first step is to remove the implant and the entire capsule of scar tissue around it. Otherwise, the disease is likely to recur, and the prognosis to worsen.

Not all women have been able to get the recommended treatment. Kimra Rogers, 50, a nursing assistant in Caldwell, Idaho, learned last May that she had lymphoma, from textured implants she had for more than 10 years. But instead of removing the implants and capsules immediately, her doctor prescribed six rounds of chemotherapy and 25 rounds of radiation. A year later, she still has the implants.

“Unfortunately, my doctor didn’t know the first line of defense,” Ms. Rogers said.

She learned about the importance of having the implants removed only from other women in a Facebook group for those with the disease.

Her health insurer, Blue Cross Blue Shield of Montana, covered the chemotherapy and radiation but has refused to pay for removal of the implants, and told her that her appeal rights were “exhausted.” In a statement sent to The New York Times, a spokesman said, “Cosmetic breast implants are a contract exclusion, as are any services related to complications of the cosmetic breast implants, including implant removal and reconstruction.”

Physicians dispute that reasoning, saying the surgery is needed to treat cancer. Her lawyer, Graham Newman, from Columbia, S.C., said he was planning a lawsuit against the implant makers, and had about 20 other clients with breast-implant lymphoma from Australia, Canada, England and the United States.

Ms. Rogers has been unable to work for a year. If she has to pay to have the implants removed, it will mean taking out a $12,000 loan.

“But it’s worth my life,” she said.

Insurers generally cover implants after a mastectomy, but not for cosmetic enlargement, which costs $7,500 or more. Repeat operations for complications are also common, and usually cost more than the original surgery.

Diagnosis and Treatment

Most of the cancers have developed from two to 28 years after implant surgery, with a median of eight. A vast majority occurred with textured implants.

Most implants in the United States are smooth. But for some, including those with teardrop shapes that would look odd if they rotated, texturing is preferable, because tissue can grow into the rough surface and help anchor the implant.

Researchers estimate that in Europe and the United States, one in 30,000 women with textured implants will develop the disease. But in Australia the estimate is higher: one in 10,000 to one in 1,000. No one knows why there is such a discrepancy.

What’s inside the implant — silicone or saline — seems to make no difference: Case numbers have been similar for the two types. The reason for the implants — cosmetic breast enlargement or reconstruction after a mastectomy — makes no difference, either.

Symptoms of the lymphoma usually include painful swelling and fluid buildup around the implant. Sometimes there are lumps in the breast or armpit.

To make a diagnosis, doctors drain fluid from the breast and test it for a substance called CD30, which indicates lymphoma.

The disease is usually treatable and not often fatal. Removing the implant and the entire capsule of scar tissue around it often eliminates the lymphoma. But if the cancer has spread, women need chemotherapy and sometimes radiation.

“In the cases where we have seen bad outcomes, it was usually because they were not treated or there was a major delay in treatment, on the level of years,” Dr. Clemens said. Doctors at MD Anderson have treated 38 cases and have a laboratory dedicated to studying the disease.

About 85 percent of cases can be cured with surgery alone, he said. But he added that in the past, before doctors understood how well surgery worked, many women were given chemotherapy that they probably did not need.

Case reports on the F.D.A. website vary from sketchy to somewhat detailed and rarely include long-term follow-up. Some describe initial diagnoses that were apparently mistaken, including infection and other types of cancer. In some cases, symptoms lasted or recurred for years before the right diagnosis was made.

What exactly causes the disease is not known. One theory is that bacteria may cling to textured implants and form a coating called a biofilm that stirs up the immune system and causes persistent inflammation, which may eventually lead to lymphoma. The idea is medically plausible, because other types of lymphoma stem from certain chronic infections. Professional societies for plastic surgeons recommend special techniques to avoid contamination in the operating room when implants are inserted.

“It could also just be the immune system response to some component of the texturing,” Dr. Clemens said. The rough surface may be irritating or abrasive. Allergan implants seem to be associated with more cases than other types, possibly because they are more deeply textured and have more surface area for bacteria to stick to, he said. Allergan uses a “lost-salt” method that involves rolling an implant in salt to create texture and then washing the salt away. Other makers use a sponge to imprint texturing onto the implant surface.

Allergan is studying bacterial biofilms, and immune and inflammatory responses to breast implants, a spokesman said in an email. He said the company took the disease seriously and was working with professional societies to distribute educational materials about it.

Another possible cause is that some women have a genetic trait that somehow, in the presence of implants, predisposes them to lymphoma. Dr. Clemens said researchers were genetically sequencing 50 patients to look for mutations that might contribute to the disease.

Dr. Clemens was a paid consultant for Allergan from 2013 to 2015, but not for breast implants, and no longer consults for any company, he said.

A spokeswoman for Mentor said the company was monitoring reports about the lymphoma, and stood behind the safety of its implants.

[…]

Read the full article here.

What If Ryan Gets His Wish and Trumpcare Becomes Law

Shannon Firth, Washington Correspondent, MedPage Today: March 14, 2017

WASHINGTON — The Republican’s repeal and replace bill, American Health Care Act, cleared two congressional committees and the Congressional Budget Office released its scoring report, Speaker of the House Paul Ryan (R-Wisc) says passing the GOP plan is a make or break issue Congress.

So it is time to ask the pundits: what will happen if this bill becomes law?

MedPage Today asked policy experts on both sides of the great healthcare divide to answer that question and this is what they told us.

From the Pro Repeal and Replace Camp:

Douglas Holtz-Eakin, PhD, president of the American Action Forum touted the bill because it allows people to make their own choice. He predicts that eliminating the individual mandate will mean 5 million fewer uninsured in 2018.

“The bill basically says we respect your decision to not purchase insurance. There’s a public policy decision about how much we respect people’s decisions and clearly we know where the bill comes down on that,” he said. […]

And Now the Loyal Opposition:

Under the Affordable Care Act, the reason everyone pays for all of the various benefits was because doing so lowered costs, explained, Diana Zuckerman, PhD of the National Center for Health Research.

In the same way that car insurance lowers the cost of having an accident when everyone buys it, under this philosophy healthcare also protects everyone who buys it, Zuckerman said.

“Under [the AHCA] it’s a different view. It’s not that view of ‘We’re all in this together,’ and if we all share the cost, we’ll all get good insurance. Instead the view of this plan is every person for themselves. Everybody should get what seems best for them, even though that could result in 24 million not getting any insurance.” […]

Read the full article here.

Trump’s FDA Nominee Spurs Concerns About Drug Approvals, Off-Label Promotion

Bronwyn Mixter, Bloomberg BNA: March 14, 2017

President Donald Trump’s pick to head the FDA is spurring concerns about drug approvals and off-label promotion.

Trump March 10 nominated Scott Gottlieb to be the commissioner of the Food and Drug Administration. The nomination was widely praised by drug and device industry groups, but a consumer group and other stakeholders told Bloomberg BNA they are concerned that Gottlieb, who is a resident fellow at the American Enterprise Institute and previously worked at the agency as a deputy commissioner, has advocated for quicker drug approvals with less evidence and wants to loosen restrictions on off-label promotion of drugs and medical devices. Critics of the nomination also are concerned that Gottlieb is too closely tied to industry. […]

Gottlieb “is someone who is entangled in an incredible, unprecedented web of ties to industry spanning his professional career,” Public Citizen’s Carome told Bloomberg BNA.

Carome said Gottlieb has been both a venture capitalist and sat on the boards of several drug companies. Gottlieb also “accepted large amounts of money for the period 2012 to 2015, at least $400,000, in speaking fees and consulting fees from several companies and we think it’s just impossible for him to really fully disengage from those ties to industry,” Carome said.

“Like many of President Trump’s other nominees, Scott Gottlieb has extensive financial ties to the industries he’d be in charge of regulating and has shown more interest in reducing regulations rather than enforcing them,” Diana Zuckerman, president of the National Center for Health Research, told Bloomberg BNA in an email.

Zuckerman said “when FDA focuses too heavily on easing the burdens on industry, that shifts the burden to patients, consumers, and physicians” and “none of us can make informed decisions about medical treatments, diagnostics, or prevention strategies when the FDA doesn’t require clear scientific evidence and isn’t transparent about its decisions.”

“If he becomes Commissioner, I hope Dr. Gottlieb will enforce the law and focus on fulfilling the FDA’s essential public health mission,” Zuckerman said. “I expect that industry will strongly support Dr. Gottlieb’s nomination but divesting could potentially be complicated and therefore could delay his confirmation.” […]

Read the full article here.

Less Radical Surgery Is a Healthier Choice for Women with Breast Cancer

Brandel France de Bravo, MPH and Diana Zuckerman, PhD, Cancer Prevention & Treatment Fund

Experts have long advised that lumpectomy patients live as long as mastectomy patients.  But the latest research, based on hundreds of thousands of women, indicates that women with DCIS or early-stage breast cancer are more likely to live longer, healthier lives if they choose less radical surgery.

Four studies indicate that lumpectomy patients live longer.

In a study of almost half a million women with breast cancer in one breast, Harvard cancer surgeon Dr Mehra Golshan  reported in 2016 that those undergoing double mastectomies did not live longer than women undergoing a mastectomy in only one breast.[1] On average, women who underwent a lumpectomy instead of mastectomy lived longer than women undergoing either a single or double mastectomy for cancer in only one breast.

Similarly, a study of more than 37,000 women, also published in 2016, women with early-stage breast cancer who underwent lumpectomy with radiation were more likely to be alive 10 years later, compared to women who underwent mastectomies.[2] They were also less likely to have died of breast cancer or of other causes.  This was true even when age and factors that could influence survival were taken into account.

Dr. Shelly Hwang and her colleagues found similar results in a 2013 study of more than 112,000 California women who had lumpectomies to remove their early-stage breast cancer were more likely to be alive and free of breast cancer 5 years after surgery than women who had mastectomies.[3] The women had been diagnosed between 1990 and 2004 with either Stage 1 or 2 breast cancer. All of them had either a lumpectomy with radiation or a mastectomy. After surgery, their health was monitored for an average of 9 years (the women were all studied for 5-14 years). The women who had a lumpectomy and radiation tended to live longer than the women who had mastectomies, when controlling for age at diagnosis, race, income, education levels, tumor grade or the number of lymph nodes with cancer. Lumpectomy with radiation was especially effective for women who were 50 years and older with hormone-receptor positive tumors: they were 19% less likely to die of any cause during the study than women just like them who had mastectomies. Perhaps more surprising, they were 13% less likely to die of breast cancer than women just like them who had mastectomies.

In a study published in 2014, Dr Allison Kurian and her colleagues at Stanford studied 189,734 California patients diagnosed from 1998 to 2011 with early-stage breast cancer in one breast, ranging from Stage 0 (DCIS) to Stage 3.[4The study showed that the percentage of women having both breasts when only one breast had cancer (called bilateral mastectomies) increased dramatically, but there was no advantage to that more radical approach.  Instead, the women who underwent lumpectomies (removing only the cancer, not the entire breast) lived longer and were more likely to be alive 10 years after diagnosis compared to women undergoing a mastectomy.  Women who had both breasts surgically removed did not live longer than those undergoing a mastectomy on one breast.

Compared to women in other countries, women in the U.S. who are diagnosed with early-stage breast cancer are more likely to remove both breasts even if only one has cancer. It is not known why bilateral mastectomy provides no medical advantage, but a study of more than 4,000 cancer patients by Dr. Fahima Osman at the University of Toronto indicates that having a healthy breast removed in addition to the breast with cancer increases the chances of medical complications.[5] Removing the healthy breast (“contralateral breast”) doubled the chances of having wound complications in the first month after surgery: from about 3% for women who had only the breast with cancer removed to about 6% for women who also had the healthy breast removed. About 4% of women who had a single mastectomy experienced some kind of complication (not necessarily wound-related) in the 30 days after surgery, compared to 8% of women who had both breasts removed. The risk of cancer in that healthy breast was already less than 1% per year unless the woman has a BRCA gene or some other very high risk factor.[6] Hormone pills such as tamoxifen or aromatase inhibitors can further reduce that already low risk.

The Bottom Line: these enormous studies of women in the U.S. and other countries make it clear that women with DCIS or early-stage breast cancer should undergo surgery to remove only the DCIS lesion or cancer, not the entire breast.   The women who undergo lumpectomy with radiation usually live longer than those who undergo mastectomy or bilateral mastectomy.  In addition, mastectomy patients who have breast implants are more likely to kill themselves compared to mastectomy patients without implants. Unfortunately, the fear of breast cancer and desire to “get rid of the problem” has resulted in too many women undergoing mastectomies or bilateral mastectomies that threaten their lives.  Physicians and breast cancer advocacy groups need to make sure that patients understand why lumpectomy with radiation is a better idea.

For a free booklet on treatment options for DCIS, click here.  For a free booklet on treatment options for early-stage breast cancer, click here.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References 

  1. Wong, S., Freedman, R., Sagara, Y., Aydogan, F., Barry, W., & Golshan, M. Growing Use of Contralateral Prophylactic Mastectomy Despite no Improvement in Long-term Survival for Invasive Breast Cancer. Annals of Surgery. 2016 March; doi:10.1097/SLA.0000000000001698
  2. Marissa C. van Maaren, et al, “10 year survival after breast-conserving surgery plus radiotherapy compared with mastectomy in early breast cancer in the Netherlands: a population-based study”. Lancet Oncol. 2016 Aug; 17(8): 1158–1170. Published online 2016 Jun 22. doi: 10.1016/S1470-2045(16)30067-5
  3. Hwang ES, et al “Survival after lumpectomy and mastectomy for early stage invasive breast cancer: The effect of age and hormone receptor status” Cancer 2013 April 1; 119(7); DOI: 10.1002/cncr.27795.
  4. Kurian, Allison W., Daphne Y. Lichtensztajn, Theresa H. M. Keegan, David O. Nelson, Christina A. Clarke, and Scarlett L. Gomez. “Use of and Mortality After Bilateral Mastectomy Compared With Other Surgical Treatments for Breast Cancer in California, 1998-2011.” The Journal of the American Medical Association 2014; 312(9): 902-914. DOI:10.1001/jama.2014.10707
  5. Osman, Fahima, et al “Increased postoperative complications in bilateral mastectomy patients compared to unilateral mastectomy: an analysis of the NSQIP database.” 2013 Oct; 20(10): 3212–3217. Published online 2013 Jul 12. doi: 10.1245/s10434-013-3116-1
  6. National Cancer Institute. Breast Cancer Treatment (PDQ®). http://www.cancer.gov/cancertopics/pdq/treatment/breast/healthprofessional/page1

Prophylactic or optional mastectomies

Diana Zuckerman, PhD, and Brandel France de Bravo, MPH

Every year, thousands of women choose to undergo a mastectomy (surgery to remove the breast tissue) when lumpectomy (removal of only a small part of the breast) would be an equally effective option for them. Some women choose a bilateral mastectomy (removal of both breasts, also called a double mastectomy) when there is cancer in only one breast. Even women who do not have breast cancer may undergo mastectomies as a preventive measure because of their high risk of breast cancer, as was the situation with Angelina Jolie. If either one or two breasts without cancer are removed, the surgery is called a “prophylactic mastectomy.”

Helping patients make an informed decision about whether to have a mastectomy is an important aspect of the physician-patient relationship. Unfortunately, many patients are not able to get the information they need from their physicians. A patient who is seriously considering a mastectomy or bilateral mastectomy that is not medically necessary may be basing her decision more on fear than on information. They may benefit from unbiased information, counseling, or from a second opinion before making a final decision.

The purpose of this article is to provide information that patients and family members can use to help them discuss their options with their physicians.

Should I remove one breast or both?

 Women in the U.S. who are diagnosed with early-stage breast cancer sometimes remove both breasts even if only one has cancer.  However, new research indicates that having a healthy breast removed in addition to the breast with cancer increases the chances of medical complications.  Even though removing a healthy breast lowers the risk of getting cancer in that breast in the future, the risk of cancer in that healthy breast was already less than 1% per year unless the woman has a BRCA gene or some other very high risk factor.1 Hormone pills such as tamoxifen or aromatase inhibitors can further reduce that already low risk. In a study of more than 4,000 women, removing the healthy breast (“contralateral breast”) doubled the chances of having wound complications in the first month after surgery: from about 3% for women who had only the breast with cancer removed to about 6% for women who also had the healthy breast removed. About 4% of women who had a single mastectomy experienced some kind of complication (not necessarily wound-related) in the 30 days after surgery, compared to 8% of women who had both breasts removed. Dr. Fahima Osman of the University of Toronto presented these findings at the 2013 meeting of the American Society of Breast Surgeons.2

What if I have a breast cancer gene (BRCA1 and BRCA2)?

Women with known mutations in the BRCA1 and BRCA2 genes have a lifetime risk of breast cancer ranging from 40% to 65% on average, compared to 12% for women in the general population. Women with BRCA1 or BRCA2 mutations often develop breast cancer before age 50 and have a high risk of bilateral breast cancer and ovarian cancer.3 Removing breasts with no sign of cancer is called a prophylactic (preventive) mastectomy. Prophylactic mastectomy and prophylactic oophorectomy (removal of the ovaries) have both been shown to greatly reduce – but not eliminate – the risk of breast cancer in BRCA mutation carriers.3  Among women with strong family histories of breast cancer, individuals of Ashkenazi Jewish descent have an 8 times greater frequency of carrying these mutations in BRCA1 or BRCA2 compared with other women.4

Lumpectomy with radiation therapy is just as effective for preventing same-breast tumor recurrence in breast cancer patients with BRCA mutations as it is for other women. Questions remain, however, about how other adjuvant treatments (such as chemotherapy) affect survival of women with these gene mutations.4

For women with the BRCA1 or BRCA2 genes, it is important to remember that the risk of breast cancer in the next 5 or 10 years is much lower than the lifetime risk of breast cancer. For example, the risk of breast cancer in her 20s is very low, even with BRCA1 (less than 3%) or BRCA2 (approximately 1%). For a 30-year old woman, the risk by age 39 is higher (10% for women with BRCA1 and 8% for BRCA2). For a 40-year-old woman, the risk by age 49 is 16% for women with BRCA1 and 13% for women with BRCA2.4 Although these 10-year risk levels are much higher than for most women, they are much lower than the life-time risk that is so frightening. It is also important to remember that cancer treatments and prevention strategies are improving, so the risks of cancer may decrease and the survival rates are improving.

Is there something I can do other than Prophylactic Mastectomies?

Prophylactic mastectomies can prevent breast cancer, but many women who undergo prophylactic mastectomies would never have developed breast cancer, even without the surgery.  To make an informed decision about whether to undergo a prophylactic mastectomy, women need a clear understanding of the risks and benefits as well as other strategies that also reduce risk.

Tamoxifen and raloxifene have both been shown to reduce the risk of breast cancer for women who have not had cancer but are at greater risk. These drugs can also reduce the risk of breast cancer for women with BRCA1 or BRCA2 mutations.

For women at high risk of breast cancer for any reason, routine screening starting at a young age can be an alternative to prophylactic mastectomy. Options include clinical breast exams, mammograms, ultrasounds, and MRIs. MRIs are much more accurate than mammograms for young women and women with dense breast tissue, and avoid the additional risks associated with radiation — risks that should be avoided by women who already are susceptible to breast cancer. A 2012 study of women with BRCA1/2 mutations who were under 30 years old showed that the increased radiation they were exposed to from early, frequent mammograms increased their risk of breast cancer. Women with the most radiation exposure had the highest risk of breast cancer, compared to other women with the same gene mutations.5 Those risks can be avoided by replacing early mammograms with MRIs instead. However, it is important to note that MRIs used for screening tend to result in overtreatment, including unnecessary biopsies and mastectomies.6

Research indicates that a low-fat diet, weight control, and exercise may reduce the risk of breast cancer for all women, including women at high risk and women who previously were treated for breast cancer.78

What do stakeholders think of FDA’s latest effort to get patients timelier access to devices?

By Michael Williamson, Bloomberg BNA

The FDA April 8 released two final guidance documents that will help provide timely patient access to high-quality, safe and effective medical devices for unmet medical needs, Jeffrey Shuren, the director of the agency’s Center for Devices and Radiological Health, said in a blog posting.

Reaction to the two documents is mixed – pitting industry against some patient advocates.

One guidance document describes the FDA’s Expedited Access Program (EAP), which should “speed qualifying devices to patients with life-threatening or irreversibly debilitating conditions” without compromising the agency’s high standards for safety and effectiveness, Shuren’s blog posting said. The other guidance document outlines the agency’s current policy on balancing premarket and postmarket data collection during FDA review of premarket approval (PMA) applications. In addition, the document addresses whether or not the circumstances when postmarket data collection is appropriate for PMAs meet the criteria for the EAP.

Two stakeholders seemed pleased with the EAP document. The Advanced Medical Technology Association (AdvaMed), “commends the agency for its efforts to explore supplementary review pathways to provide more timely patient access to new technologies for life-threatening or irreversibly debilitating diseases or conditions that addresses an unmet medical need,” Janet Trunzo, the association’s senior executive vice president for technology and regulatory affairs, told me in a April 9 e-mail.

In addition, Ben Moscovitch, officer with the medical device project of the Pew Charitable Trusts, a nonproft policy organization, told me April 9 many of the recommendations his group made on the draft version of the EAP document were included in the final document. For example, he told me that the EAP final guidance document reflects a Pew suggestion from 2014 that the FDA should require the initiation of postmarket trials and completion of those studies within a certain timeframe.

Not everyone is pleased with the guidance, however. The EAP final guidance “is part of a larger problem where the FDA is bowing to pressure from Congress to weaken safeguards that are intended to protect patients from unsafe medical products,” Diana Zuckerman, president of the National Center for Health Research, told me in an April 9 e-mail. She is also president of the Cancer Prevention and Treatment Fund.

See the original article here.