$26 Million Settlement Moves Forward Over Hair Loss From Wen Cleansing Conditioner

A federal judge in Los Angeles gave preliminary approval to a $26.25 million settlement for a class-action lawsuit against Wen by Chaz Dean and distributor Guthy-Renker.

The more than 200 members of the lawsuit say that the brand’s cleansing conditioner led to hair loss, scalp irritation, and balding. If approved by a U.S. district judge, the suit would pay $25 to anyone who bought a bottle of the cleansing conditioner (total capped at $5 million) and up to $20,000 to people who experienced adverse reactions; that figure includes reimbursement for treatment as well as injury awards.

Attorney Amy Davis told CBS Los Angeles: “From what we understand about the product and how it causes hair loss is it contains virtually no cleanser. It’s like using lotion to wash your hair. So instead of removing the product when you rinse it off, it just becomes impacted in your hair follicle.” Wen disputes this claim and said in a statement that the product is safe.

“We continue to provide our hundreds of thousands of customers with the Wen by Chaz Dean products that they know and love. Since the process of litigation is time consuming and costly, we made a business decision to pursue a settlement and put this behind us so that we can focus on delivering quality products.”

In July, the U.S. Food and Drug Administration issued a safety alert for the cleansing conditioner after it received 127 complaints of “hair loss, hair breakage, balding, itching, and rash” associated with the product. The FDA is also investigating thousands of complaints made directly to Chaz Dean, Inc. and Guthy-Renker.

Cold cap can combat hair loss from chemo for breast cancer

A cooling cap that prevents hair loss during chemotherapy has come through its clinical trials and can make a huge difference to the quality of life of patients, Dr. Paula Klein, medical director, Breast Cancer Clinical Trials, Mount Sinai Health System in New York told NY1.

One such happy patient was Donna Tookes, a patient who was treated with the cap during her breast cancer therapy and had been resigned to hair loss. She told the station, “I accepted it.” In fact, she did not have to. Thanks to her participation in a trial of the Dignicap from Dignitana headed by Klein, she didn't lose any hair at all. The cap “literally freezes the scalp so that it shuts down blood vessels,” Klein told NY1. “Less chemotherapy is delivered to the scalp.”

The cap Klein used pumps coolant through it. The patient's hair is wet and this keeps the temperature of scalp and hair near freezing during therapy. This constricts the blood vessels in the region, and thus reduces the amount of anti-cancer drugs that reach hair follicles. The scalp-cooling technique has been in use for years in Europe, but is only now gaining FDA approval and greater use in the U.S. There had been fears that sparing the scalp from treatment might allow cancer to spread to that area. But clinical evidence from Europe has now suggested that this is not the case.

“In Europe they do not show a significant increase in scalp metastases,” said Klein. The cooling system which chills the hair and scalp to just above freezing during therapy received the agency's okay for a multicenter clinical trial in 2015. “Some of today’s most powerful, lifesaving chemotherapy treatments still cause complete hair loss, a side effect that many women consider to be emotionally devastating,” Dr. Hope S. Rugo, principal investigator for the study and Director of Breast Oncology and Clinical Trials Education at the UCSF Helen Diller Family Comprehensive Cancer Center noted in a 2015 statement about the trials.

In the Mt. Sinai trials about seven out of 10 early-stage breast cancer patients kept at least half their hair without any negative events linked to the cooling cap. The FDA approval is, for the present, limited to early-stage breast cancer, but Klein stated that she thinks it will eventually find more widespread use. “I am extremely excited to finally be able to offer patients scalp cooling during chemotherapy, which allows them to retain normalcy and privacy in their lives,” she stressed.

For patients, the loss of hair is among the most important chemo side effects, according to a 2008 article published in the journal Psycho-Oncology by Julie Lemieux, Elizabeth Maunsell and Louise Provencher. They found that “chemotherapy-induced hair loss is considered to be the most important side effect of chemotherapy, frequently ranking among the first three for breast cancer patients, and can lead to refusal of chemotherapy. Secondly, it is described by breast cancer women as causing distress and as being traumatizing. Thirdly, there might be an impact on body image, although not all studies reported this association.”

Health insurance shirks its duty to women with breast cancer complications

Karen Chavez

When I wear sleeveless tops, there isn’t a day when I’m not asked about my lymphedema garments. These are a full-length sleeve and a fingerless glove on my left arm. “Do you golf?” “Are you a bowler?” “What’s wrong with your arm?” and even, “Cool sleeve, where did you get it?” Um, the Asheville Orthopedic Appliance Co.

I wear the garments, not as a fashion statement, not to bowl, but to control the non-stop pain and swelling in my left arm and hand, known as lymphedema. Over the past three years of wearing the garments, I now use the questions as a teaching moment. Lymphedema is a chronic disease that results in a backup of lymph fluid (which carries away the waste from the blood stream). It occurs when the lymphatic system is damaged, said Emily Jones, an occupational therapist at CarePartners. In my case, the damage was caused by breast cancer surgery and the removal of lymph nodes from under my arm. There is no cure for lymphedema.

Once you have it, you have it forever. An estimated 3 million-5 million people Americans suffer from lymphedema. Two out of five breast cancer patients will develop lymphedema within five years of surgery. With lymphedema, I cannot type. I wouldn’t be able to write this story, which is my livelihood. But there is treatment. The two most effective are manual lymphatic drainage, performed by a physical therapist specializing in lymphedema, and compression garments. The garments require a doctor’s prescription and are custom made. They are about $328 for one sleeve and one glove. I need two at a time, $656 – one to wear while the other is being washed. (They are tight to the skin, get sweaty and dirty and need to be changed daily, kind of like underwear). I need new pairs twice a year because they stretch out, get damaged and then are no longer effective. That’s about $1,312 a year. It is cost prohibitive. My former health insurance paid for them.

My new insurance company – Blue Cross Blue Shield of Texas – does not cover compression garments. When I told the BCBS customer service person that I have breast cancer and cannot function without them and can’t afford them, on top of my ever-growing mountain of breast cancer-related debt, she said “those are the rules.’’ Well, North Carolina has its own rules. Actually, it has a law. Passed by the General Assembly in 2009, HB 535 states that every health benefit plan in the state must provide coverage for the diagnosis, evaluation, and treatment of lymphedema, including benefits for equipment, supplies, complex decongestive therapy, and gradient compression garments. North Carolina and Virginia and the only two states in the country with such laws. Bravo.

I told the BCBS rep about that and that the N.C. law should cover me. She said it did not, since the company is based in Texas. Sound barbaric? Heather Ferguson thought so. A mom of two from Charlotte, one of her sons was born with primary lymphedema in both legs. He was prescribed his first compression garment at age 7 months. Ferguson’s insurance denied it. Not a woman to be messed with, Ferguson reached out to her state representative, Tricia Cotham, D-Mecklenburg. Cotham helped Ferguson with the appeal, which only gave her one year of payment. Now 10, he needs to wear the knee-high socks every day. He will need them for life. Ferguson continued to work with state representatives until the lymphedema law passed.

She formed the Lymphedema Advocacy Group. Now she has taken her cause to Congress. Introduced in 2010, the Lymphedema Treatment Act would amend a section of the Social Security act to provide for Medicare coverage for lymphedema compression items. That would extend to all states, even Texas. The bill has 249 House co-sponsors, including Rep. Mark Meadows, R-Jackson, and 28 senators, including Thom Tillis. Sen. Richard Burr has not signed on. “It already has a large amount of bipartisan support,” Ferguson told me. “It’s a win-win for everyone. It improves patient care and quality of life, and provides a net saving to Medicare. We’re paying for so many things that can be prevented if we manage the disease from the start.” Even with my sleeve and glove, I often have to raise my arm to further control the swelling. Then people ask, “Do you have a question?” Yes. Why won’t my health insurance pay for my lymphedema sleeves?

No Cure Yet for Breast Cancer, but 3 Big Advances in 2016

In the U.S., one in eight women will be diagnosed with breast cancer in her lifetime. I became one of those eight women a decade ago and endured the go-to treatment at the time for breast cancer -- chemotherapy, surgery, radiation, with ensuing hair loss and constant nausea. But there's great news for all women. That toxic regimen may be headed out the door, because breast cancer treatment is rapidly moving to a more personalized and targeted paradigm that could save millions of lives and drastically change the quality of life of patients. Here are three dramatic advances that are leading to more effective treatments, as well as brand new ways to think about what causes the deadly disease. 

Targeted combo therapy completely obliterates signs of cancer

The biggest advance of 2016 in breast cancer has to be how a combination of targeted cancer drugs completely obliterated all signs of breast cancer in 11% of patients in only 11 days.

The UK-based study involved 257 women with particularly virulent type of breast cancer (HER2-positive), and combined two drugs from GlaxoSmithKline (NYSE:GSK) and Roche Holdings (NASDAQOTH:RHHBY). While 11% may not seem that impressive, for even one breast cancer tumor to be completely eradicated by a drug in less than two weeks is electrifying. Cancer tumors develop resistance to chemotherapy agents so rapidly, these drugs often have no impact on a tumor even after many months of treatment. Instead, tumors are removed surgically first. Chemotherapy comes afterwards -- to mop up stray cancer cells that might have spread elsewhere in the body.

In the past few years, a small minority of women have been having chemotherapy first. While that regimen sometimes shrinks the size of tumors, typically the order is reversed because the oncologist is more concerned about where the cancer could be going rather than the primary tumor. But Glaxo and Roche's drugs -- Herceptin and Tykerb -- are not infused chemotherapies, but simple oral pills. In addition, these drugs are highly targeted treatments, and attack cancer cells specifically. That's a huge plus because patients do not have to deal with the severe side effects of chemotherapy, which kills all rapidly dividing cells in the body like hair follicles and healthy bone marrow cells. Better yet, there is a large arsenal of these new therapies already on the market, including monoclonal antibodies like Herceptin and Tykerb, checkpoint products such as PD-1, and other treatments that unleash the power of the patient's immune system.

As was seen in the Glaxo/Roche drug trial, pairing these drugs together in a one-two punch is raising the success level of treatment and may eventually point the way to a cure.

93 genes causing breast cancer identified

This May, UK-based researchers at Cambridge Research Institute, unpacked the whole picture of what genetic events could be causing breast cancer. Thanks to their efforts, we should soon have a much better idea why the disease strikes certain individuals. Specifically, the scientists found 93 genes whose mutations convert a normal breast cell into a cancer cell. Professor Mike Straton, who led the study, said the list "would be handed over to the universities, the pharmaceuticals, the biotech companies to start developing new drugs."

It's hard to overstate how big this win is. The more we know about the genetics of cancer, the more we will know about what treatments will work for an individual women, paving the way to much higher survival rates.

Blood test could replace mammograms

Another huge breakthrough this year brought us much closer to a blood test for breast cancer. Specifically, researchers in France and Australiareported that a change in the isotopic proportions of carbon-13 and nitrogen-15 can reveal the presence of the disease. With this new way of detecting breast cancer, the project's lead researcher Professor Guillaume Tcherkez said we could have a simple blood test in a few years. That's terrific news for women, because mammograms, the best method currently available, are inaccurate 16% of the time. The resulting misdiagnosis includes highly stressful false positives, where the screening incorrectly shows breast cancer, and potentially fatal false negatives, where the mammogram fails to detect cancer. An innovative breast cancer blood test is already being developed in France, while here in the U.S. gene sequencing powerhouse Illumina (NASDAQ:ILMN) is working on all-in-one liquid cancer biopsy that can detect virtually any cancer. Illumina has said an early version of that test should be on the market in three years. If that goal is achieved, many forms of cancer will be found earlier, when it tends to be treatable, which should massively decrease the world's cancer mortality. 

How to take advantage of cancer breakthroughs

Anyone at risk of breast cancer -- which includes all women, and although much more rarely, all men -- strongly benefits from being informed about breast cancer breakthroughs. The disease strikes without warning, and with the flood of new treatments reaching the market, many doctors have never prescribed some of them and may be hesitant, or even uniformed, about their possible benefits. In fact, taking charge of your own health is the best way to beat this disease. That doesn't mean you should ignore your doctors' advice, but that you should diligently practice ways to prevent cancer such as eating a healthy diet and exercise, make sure you get necessary screenings, ask questions if you are diagnosed, and seek a second opinion if you are not satisfied with the answers.

While survival rates have doubled over the past 20 years, a women still dies from breast cancer every 12 minutes in the United States. So never forget, this disease presents a serious threat to your life and no one cares about your life more than you do. But there's no reason to end on a somber note, because research is now showing how powerfully our own bodies can be mobilized to fight it. That's not only improving the odds for survival; it's also bringing us closer to the day when we can finally claim a cure.

Hello From the Other Side of Breast Cancer: 8 Tips From Survivors

According to the American Cancer Society, breast cancer rates among African American women are on the rise. This is a shift from previous data that showed that African American women got breast cancer less than white women, but due to many factors including later diagnosis, and more aggressive types they tended to have a higher mortality rate. The good news is that there are more black women who are surviving and thriving after the disease.

Here are a few tips from several survivors.

1. Don't blame yourself The notion of breast cancer prevention is complicated. A woman's overall risks can include family history, environmental factors, stress and diet. In fact, while race doesn't necessarily contribute to a black woman's chances of having cancer, research shows that it can contribute to the types and aggressiveness of the disease. Be vigilant about screening, so that you and your provider can take action in the earliest stages.

2. Don't let your hair get in the way of your life Many black women struggle with the idea of losing their hair during treatment. Janet Bennett, 67, was diagnosed in 2011. Bennett says her hair has never defined her, "so when I had to undergo chemotherapy and lose my hair and radiation, I didn't care." Bennett adds that she has opted to continue to shave her head, long after treatment.

3. Get a plan "When I heard the diagnosis, my mind went to scary images of images of women who had cancer, says Celeste Julian, a teacher who lives in Katy, Texas, outside of Houston. Julian, 61, was diagnosed in 2012. "I've always had fibrous breasts, starting in the eighth grade," she says. Julian had gone through several surgeries, to see if any of the growths were cancerous and they were always negative. " I had a mammogram this time and they found cancerous." While the diagnosis is scary, Julian says take time to do your homework and absorb the information. "It is important to take a little time to pause and process. "A lump, even if it is the size of a pea isn't going to turn into one the size of a sweet potato in a day, "Julian says. Cheryl Ward-Benjamin, 55, was 53 years old when she was diagnosed with inflammatory breast cancer, stage 3. She says, "There is a recommended treatment plan for Inflammatory Breast Cancer which is referred to as neoadjuvant treatment, which begins with chemotherapy to arrest the growth, then surgery, followed by radiation." Benjamin went through 16 rounds of chemo - the first four treatments were biweekly, followed by 12 treatments weekly. "I had a double mastectomy, with the second breast being elective and the other breast was a radical mastectomy. The final step was 40 rounds of chemotherapy Monday - Friday until completed," Ward Benjamin says. "I was determined that I was going to be an active participant, ask questions, and do some reading regarding what to expect."

4. Attitude makes all the difference "Attitude is everything," says Candice Bell, 60, who was diagnosed in 2005. "If you believe you will beat this thing, you will." Risë Ratney agrees. Ratney underwent a lumpectomy and 30 rounds of radiation, And because she, like many black women had estrogen receptive breast cancer, she also had a hysterectomy. "Take a minute to absorb the shock, be scared and feel sorry for yourself," she says. She believes in the mind body connection in getting through tough health challenges. "Once your treatment plan is established, you have to believe you can get through it," she says. But it isn't always easy. Julian says she was really challenged to stay positive after she had her first surgery to excise her tumor. "I ended up having a second surgery within 30 days of the first, because they didn't get it all out the first time. I went through depression, but that made it worse." Julian says that she learned to just stop and breathe to refocus in order to get her attitude back on track. Bennett says she focused on getting well versus the treatment. "Don't get so wrapped up in it. Put on your big girl panties and do what you need to do," she adds. She had a lumpectomy and an additional surgery to clean up the margins of her cancer before she underwent four months of chemotherapy and radiation. She was fortunate to be able to work a reduced schedule while she was undergoing treatment. She also says she did everything to keep it light. "Being around other people, enjoying my pets, and watching television and reading things that made me laugh helped."

5. Be informed Be your own advocate and do your homework. "When I got my diagnosis I was so terrified that I could not research any options," says Ratney. "I wasn't given any other option so I just followed the plan outlined by my oncologist and surgeon." This is the case for many women, who hear the word "cancer" and have to make life or death decisions on how to treat it. And Ratney says if she had been given all the options she would have explored removing only the lead lymph nodes, versus removing several, that she says later caused chronic issues such as swelling and extreme stiffness.

6. Understand your health coverage Many women assume that they have "good" insurance through their jobs, without understanding what will actually be covered and what won't. Medical expenses that are not covered are a reason that people are forced to file bankruptcy. Bell had insurance through her job that covered most of her treatment and care, but had out of pocket medical expenses such as prescriptions — including one that was $1,500 and wasn't covered. Bell was able to go to her doctor for a less expensive option and got it. But Julian says that even though she had insurance, having the second surgery so soon created a pile of mounting medical expenses that she's still paying for.

7. Let people help you "Lean on the shoulders that are offered to you," says Ratney. She adds that it's important to find someone in your circle of friends and family to act as your healthcare advocate, willing to help you speak with the providers and think through any issues. "Team Benjamin" was formed very quickly after Ward-Benjamin's diagnosis and friends and family helped her piece together her options, providing resources and support. She agrees with Ratney about enlisting a health advocate. "I had particular family and friends who were always present for my sessions or key appointments to be my additional eyes and ears, or make sure I remained comfortable — physically and mentally."

8. Keep your eyes on the prize Bell, who lost her own mother to breast cancer several years before her own diagnosis, knows how precious life is. She retired from her job after over 30 years, and spends time traveling with family, including her two young granddaughters. And she is now getting trained to be a community health worker to help give back. Julian says that she too is focused family including her husband, and three children. "One is my fifteen year old daughter that I want to see graduate from high school." After she finished treatment Bennett went back to working full time. But there were mergers at her job when she got back. "I didn't need that kind of stress, so I left." She loves her life now because she says she is "able to do many of the things I hadn't been able to do before." Ward-Benjamin says that her perspective on what is truly important has changed her life and she now manages her stress and is more patient with people. "When I wake up in the morning it is a new day, with new opportunities and blessings," she says. "Each one of us has our own journey, symptoms, range of side effects - but we share a common strength which we are fighting to win."

NFL pink gear sales usually do not benefit any breast cancer-affiliated causes

For the eighth straight October, the National Football League has gone pink. Players wear pink gloves, cleats, hats and towels. Referees blow pink whistles. The league drops a pink ribbon beneath its shield on game-used footballs. All these displays are part of the league's partnership with the American Cancer Society to raise money and consciousness during breast cancer awareness month. On many high school athletic fields, players also are going pink, incorporating the colored gear into uniforms and sideline gear and apparel. Retailers have responded by pushing the pink gear front and center on store floor space and websites. But don't judge the purchase by its color: Aside from specifically licensed merchandise bearing the NFL pink ribbon shield logo, pink gear sales usually do not benefit any breast cancer-affiliated causes.

That means much of what is worn at the youth level is a fashion statement more than a philanthropic effort - whether athletes and their parents know it or not. Student-athletes and their families make most of these pink purchases on their own, coaches and parents said, usually in anticipation of a designated "pink-out" game. It's an informal but enthusiastic effort, they said, because student-athletes think they are being charitable. Players will purchase a pink towel or athletic tape ahead of a game, and if they cannot, teammates will help them improvise to present a unified look. "At the high school level, I don't think there's an awareness of it," said Bill Park, whose son plays football at a school in Fairfax County, Virginia. "It's certainly not at the forefront of what they talk about." While many apparel companies and retailers make donations that benefit cancer-fighting and awareness groups, such contributions are not tied directly to sales of the pink merchandise, a surprise to some athletes. Running back Joshua Breece of Stone Bridge High School wears a pink Nike camouflage sleeve and pink socks during October football games.

His Ashburn, Virginia, school held an in-school fundraiser for breast cancer research organizations the final week of September, and he and his teammates figured some of their purchases for their "pink out" game against West Springfield in West Springfield, Virginia, would go to a good cause. "I'm glad they do give some money," Breece said of manufacturers, "but I really thought it was a percentage that goes to it. That's what I was led to believe from other people." The NFL began its "Crucial Catch" program in October 2009 in partnership with the American Cancer Society. Used pink equipment is auctioned off after games, and the proceeds are donated.

Fans also can purchase pink licensed NFL gear, and the league's proceeds from those sales also go to the ACS. The league has raised almost $15 million, according to ACS chief development and marketing officer Sharon Byers. The "Crucial Catch" program and the society's "Making Strides" fundraising walks are the society's leading sources of revenue for breast cancer. And the attention garnered from the pink equipment showing up on TV every Sunday for a month is near impossible to value, she said. So is the impact of the awareness spread through other levels of football. Within a week of the NFL's first pink game in 2009, Anna Isaacson, the league's senior vice president of social responsibility, saw the look gaining traction. She was driving past a high school football game in Cleveland on a Friday night and saw the bleachers full of pink-clad fans.

Cheerleaders waved pink pom-poms on the sidelines. Players had colored their cleats in pink and wore pink tape. Isaacson pulled up to the school and started taking pictures. She said it's one of her proudest moments working for the NFL. Sporting goods manufacturers and retailers have filled the demand for pink gear, though the charitable benefits of such purchases vary.

 Dick's Sporting Goods promises free shipping for 18 categories of "Show Your Support" pink merchandise, but only one category - items bearing the NFL logo - are subject to donations per sale. Under Armour advertises a product line called "Power in Pink," which includes items bearing the pink ribbon used to signify breast cancer. Proceeds from those purchases fund a $10 million pledge to Johns Hopkins Hospital Kimmel Cancer Center in Baltimore to establish the UA Breast Health Innovation Center. Other manufacturers and retailers often make large contributions to cancer-fighting and awareness groups. Dick's, which reported $597 million in profits in the quarter ending in August, donated $50,000 this year to the National Breast Cancer Foundation.

But individual purchases do not benefit any particular charitable organization, and the lump sum gifts are not derived as a portion of sales. A representative of Dick's declined to explain how those donation decisions were made. Both companies in written statements said they were "proud" of their affiliation with breast cancer organizations. "If a company is putting out products that clearly consumers will think are supporting the breast cancer fight, they should make it very obvious that they have skin in the game in terms of the contribution they are making to that cause," said David Hessekiel, president of Cause Marketing Forum, a company that produces conferences and an online marketplace for business and charity executives.

The issue is transparency, Hessekiel said. Customers deserve to know when their money is going to a charity or a business, especially when merchandise is presented as if it's part of some larger effort. "This is where it gets difficult," he said. "You can't prosecute someone for making something pink. And nobody owns the pink ribbon." This year, the NFL has invited high schools, including Fairfax's W.T. Woodson, to sign up with "Crucial Catch" and borrow equipment such as goal post pads or pylons for pink-out games. And regardless of who's directly benefiting from the sales of pink socks, schools often organize fundraisers in conjunction with their "pink out" games. Plus, there's the "awareness" aspect of the campaign. "That's what's been really incredible to see," Isaacson said. "That the message could spread through youth football players who are encouraging their moms and grandmothers and the women in their lives to get screened."

And the colorful campaigns go beyond breast cancer awareness. At Briar Woods High in Ashburn, Virginia, players wore yellow socks and held fundraisers to raise money for a documentary film campaign about children battling cancer. They've also sported purple ribbon helmet decals and collected money for the Juvenile Diabetes Research Fund in memory of Coach Charlie Pierce's wife, who died of complications of diabetes.

Still, when fashion marketing gets conflated with charitable giving, consumers can be left feeling justifiably confused. "To the extent that it leads to a bump or moves the needle in terms of direct donations, that's great. It's all good on some level," said Charles Lindsey, a professor of marketing at the University at Buffalo. "But when you get down to the nitty-gritty and we're not just talking about indirect awareness and we talk about how much [money] passes through, it's like anything in society: We all can improve."

Experimental drugs restore hair loss

Experimental drugs regrew hair for patients with the second most common type of hair loss. Now scientists want to make them work for the first: plain old male-pattern baldness.


http://bit.ly/2ed7IYD