The high price of co-payments impacts medication compliance


Yesterday, I told you that 40% of women aren't being screened regularly for mammograms. Today, we look at how many more women aren't filling their proven life-extending prescriptions. At least this time, we know why.

A higher prescription co-payment, especially among older women, is associated with both early discontinuation and incomplete use of adjuvant aromatase inhibitor therapy, a life-saving therapy for women with hormone-sensitive, early-stage breast cancer. Dawn L. Hershman, MD, associate professor of medicine and epidemiology and co-director of the Breast Cancer Program at the Herbert Irving Comprehensive Cancer Center at Columbia University, told us that previous research has identified several factors affecting compliance, such as age, severity of side effects and belief that the medication is useful. This time, Hershman and her colleagues looked at the impact of prescription co-payments on hormone therapy use. Working with the Medco Research Institute, the investigators used anonymous patient information to target women older than 50 years who were prescribed aromatase inhibitors for early-stage breast cancer. "We looked at two different factors: women who discontinued use altogether or had no subsequent refills and those that did not refill their prescription on time or did not take the medication at least 80 percent of the time," said Hershman.

Results showed that of the 8,110 women aged 50 to 65 years, 21.1 percent stopped taking the medication, and of those who properly continued with their regimen, 10.3 percent didn't take the medication as directed over the two-year period.

In the older population of 65 years and up, almost 25 percent stopped taking the medication, and of those who continued, 8.9 percent were non-adherent. Co-payments were categorized as less than $30, between $30 and $89.99, and $90 or more. The 90-day co-payments ranged from $0 to $893.49.

In the 65 and older group, women were more likely to discontinue medication use if they fell in the co-payment categories above $30. However, it was not until the co-payment reached $90 that the 64 and younger age group was more likely to discontinue use or not take it as prescribed. Additionally, the study results showed that women whose prescriptions came from a primary care doctor or women who were prescribed many other medications were also more likely to stop taking the medications or not take them as prescribed.

I am an awful "pill taker." In fact, I have to put my vitamins next to the daily arthritis medication I give my dog so I'll remember to take it. I am the poster child for the millions of us who take "medication vacations." For me, it's not so much about cost as it is about placing the care of others before myself--a bad habit I am trying to break. Cost, however, is a huge issue for many of us who are all too familiar with the mounting costs associated with aging. I've seen my own parents struggle with high co-pays and, in their opinion, the limited rate of return with regard to my dad's Alzheimer's medications.

What an awful choice to have to make.


33rd Annual San Antonio Breast Cancer Symposium kicks off


What if I told you that losing your hair during chemotherapy may not be inevitable or that sometimes making irrational decisions can be beneficial? Or how about this...did you know that even cancer cells get stressed? Would I have your attention? These fascinating topics will be explored over the next few days at the 33rd annual San Antonio Breast Cancer Symposium, along with presentations on the latest research and treatment in breast cancer.

What began in 1978, when a group of 141 physicians and surgeons from a five-state area got together to discuss ways to reduce the death rate caused by breast cancer in San Antonio and surrounding counties, has turned into an international conference attended by physicians, researchers and advocates from over 90 countries. The overall objective of SABCS, however, remains the same. Its mission is to produce a unique and comprehensive scientific meeting that encompasses the full spectrum of breast cancer research, facilitating the rapid translation of new knowledge into better care for breast cancer patients.

For the next few days, the CURE team will be bringing you updates from this very important gathering of international thought leaders. Not only will we deliver the latest and greatest scientific news surrounding breast cancer, but will also be talking to survivors and advocates about their passionate causes. We'll be blogging, tweeting, writing and filming daily so be sure to follow us!


Patient Protection & Affordable Care Act (PPACA) shouldn't limit its focus to insurance carriers


Yesterday I was opening a stack of mail that had accumulated in my inbox when I came across a hefty-sized letter from a CURE reader. We get heart-wrenching letters from readers on occasion so I cleared my desk, pulled the tissues close to me and opened it.

To my surprise, it wasn't a letter at all. A single page from our Summer 2010 issue was included with a highlighted sentence regarding upcoming legislative changes intended to give cancer patients improved access to affordable care. The reader highlighted a sentence that said, "The Patient Protection and Affordable Care Act will limit the ability of insurance companies to charge higher premiums based on health status." The article went on to say that eventually it will be illegal for insurance companies to charge higher premiums based on a person's medical history. The envelope also contained stacks of claim detail statements indicating that the reader was responsible for thousands of dollars worth of medical bills because the hospital and the insurance carrier disagreed on the value of the services rendered.

A letter from her employer was also enclosed. It stated that the hospital system where she was receiving care was no longer going to be covered by her insurance carrier because "it was charging up to three times the market price compared to other area hospitals." At the top of that page the reader scribbled, "I have metastasized cancer."

At that point, I realized that the tissues I had pulled close were unnecessary. I wasn't sad--I was mad as hell. How incredibly frustrating! So, this poor patient with metastatic cancer is going to have to find a new healthcare team at an entirely different facility because it was determined, well into her treatment I might add, that the cost of care was too high. Was this a case of price gauging by the hospital or a way for the insurance company to control costs? Who knows? All I know is that this poor reader is stuck in the middle of what is all too common a bureaucratic mess.


Triple negative breast cancer drug one step closer to approval


On Friday, sanofi-aventis announced that the FDA has granted fast track approval to their investigational PARP1 inhibitor, BSI-201, and that accruals for their phase 3 clinical trial is on schedule and meeting expectations on patient accrual and trial site coverage in the United States. Investigators have enrolled 214 of their target number of 420 patients.

The "fast rack" process is designed to expedite the review of drugs being developed for serious diseases with the potential to address an unmet medical need.

BSI-201 entered a phase 3 clinical trial in the United States in July 2009 and is being evaluated in combination with chemotherapy in patients with metastatice triple-negative breast cancer (mTNBC), a condition defined by tumors lacking expression of estrogen, progesterone receptors and without overexpression of HER2. BSI-201 is a novel investigational targeted therapy that inhibits poly (ADP-ribose) polymerase (PARP1), an enzyme involved in DNA damage repair.

The decision to commence with the phase 3 study in July was based on the encouraging phase 2 study results presented at ASCO on May 31, 2009. In the phase 2 clinical trial, women with mTNBC were randomly assigned to receive gemcitabine and carboplatin (GC) in combination with the investigational agent BSI-201 or GC alone. Updated phase 2 data including overall survival were presented on Friday at a poster session during the San Antonio Breast Cancer Symposium.

The addition of BSI-201 to GC improved median overall survival from 7.7 months to 12.2 months. BSI-201 did not add to the frequency or severity of adverse events associated with chemotherapy. This is not a final analysis of the phase 2 data, but an updated analysis of overall survival. Median survival hasn't yet been reached in the BSI-201 arm, therefore the data cut-off period for the phase 2 trial was from September to November.

"The updated analysis from the phase 2 program, including data on overall survival, are consistent with the positive results presented earlier this year at ASCO," declared Marc Cluzel, executive vice president, R&D, sanofi-aventis. "We are very encouraged by the fast recruitment of patients in phase 3 trial. We hope the findings will lead to emerging strategy that may help women with metastatic triple negative breast cancer."


Endocrine therapy passion gives three researchers rock star status


This afternoon I attended a general session at SABCS where Susan G. Komen for the Cure awarded the Brinker Awards for Scientific Distinction to three researchers for their work in endocrine therapy. Huh? Ok, first, let me give you a definition of what endocrine therapy is. According the the National Cancer Institute, endocrine therapy is:

Treatment that adds, blocks, or removes hormones. For certain conditions (such as diabetes or menopause), hormones are given to adjust low hormone levels. To slow or stop the growth of certain cancers (such as prostate and breast cancer), synthetic hormones or other drugs may be given to block the body's natural hormones. Sometimes surgery is needed to remove the gland that makes a certain hormone. Also called hormonal therapy, hormone therapy, and hormone treatment.

The awards went to Geoffrey L. Greene, PHD of the University of Chicago, Benita Katzenellenbogen, PHD, University of Illinois-Urbana Champaign, and Professor Ian Smith of the Royal Marsden Hospital of London. In a nutshell, their combined resarch revolves around understanding estrogen receptors and how we can provoke them respond to treatment.

I'm no scientist, and I promise to stick to "color commentary" from this point forward, but what I can tell you is these guys are heavy hitters. They have not only changed the way cancer is dianosed and treated, but also how outcomes can be predicted.

In a packed hall with hundreds of docs hanging on every word, each researcher told the audience about their work in endocrine therapy. Dr. Greene's research determined that receptors exist. Dr. Katzenellenbogen's reseach focused on how receptors respond to various hormones. Dr. Smith's research involved early clinical development of anti-cancer drugs based on this research.

One of the first questions doctors want to know when assessing treatment options for their patients is whether the tumor is ER positive or negative. The answer will determine which treatment pathway to follow. This reasearch will also help doctors determine which patients will (and won't) respond to chemotherapy. More on that tomorrow.

The cure to cancer is complicated, but tonight's award-winners have helped us better understand this deadly disease by finding ways to trick hormones into working with us instead of against us.


Cancer's silver lining... Free housecleaning!


If you know a woman currently undergoing chemotherapy, tell her that there is a cleaning service that provides FREE housecleaning once per month for four months while she's in treatment. All she has to do is sign up and have her doctor fax a note confirming the treatment. Cleaning for a Reason will have a participating maid service in her area arrange for the service. Click here to to learn more This organization serves the entire Country and has 547 partners to help take the tough work of housecleaning off of women in need. So spread the word and let them know that there are people out there that care-- and clean!


Federal task force says women need fewer mammograms. Sound reasoning or rationing?


Bewilderment. That's the only word I can use to describe how I felt upon reading an article in my daily newspaper this morning (Yes, I still read the daily paper). The story reported on an influential federal task force's recommendation that women have fewer mammograms. "We're not saying that women shouldn't get screened. Screening saves lives," said Diana Petitti, vice chairman of the U.S. Preventive Services Task Force. "But we are recommending against routine screening. There are important and serious negatives or harms that need to be considered carefully." The recommendations of this committee would set the standards for preventative health care services under health care reform and would be used to determine which tests would be covered by insurance plans. These guidelines are for the general population, not for those at high risk of breast cancer.

The 16-member committee recommended that most women in their 40s should not routinely get mammograms. Additionally, women 50 to 74 should get mammograms every other year until they turn 75, after which the risks and benefits are unknown. Women 75 and older should not get regular screening. The committee is also against teaching women to do regular self exams because "the value of breast exams by doctors is unknown and breast self exams are of no value."

Those who side with the task force's findings say that more testing, exams, and treatment are not always beneficial and may cause harm to patients. The article stated that in about 10 percent of cases, false positive results caused anxiety among patients and lead to unnecessary procedures such as disfiguring biopsies and in some cases, surgery, chemotherapy, and radiation.

Those on the opposing side said that this is a huge step in the wrong direction. Daniel Kopans, a radiology professor at Harvard Medical School said, "Tens of thousands of lives are being saved by mammography screening, and these idiots want to do away with it." Dr. Phil Evans, director of the Center for Breast Care at UT Southwestern Medical Center in Dallas predicted that conducting fewer mammograms would be a mistake. "Mammography is not a perfect test, but it's still the best test for finding breast cancer early," argued Evans.

The most ominous quote in the article came from Dr. Michael Grant, my breast surgeon at Baylor University Medical Center at Dallas. He said that the timing of this made him suspicious. "Ultimately, this may be how we provide rationale for rationing. They're not saying it isn't worth it -- just that the number of lives it saves is not counter balanced by the cost and trouble of doing it," said Grant. Roughly 39 million women in the U.S. have mammograms each year, costing the healthcare system more than $5 billion annually.

I think I need to dust off my old copy of George Orwell's, Animal Farm. This arguement is sounding vaguely familiar. "All animals are equal-- just some are more equal than others."


Finally, good news for triple negative breast cancer patients!


During ASCO's annual meeting this year, I was thrilled to learn that a new drug class is offering promise to patients with triple negative breast cancer. PARP inhibitors--experimental targeted therapy medicines, may make chemotherapy work better against aggressive forms of breast cancer (see Debu Tripathy's blog for the details). For years, I've been happy to see great advancements in the treatment of breast cancer, but have selfishly been concerned that no real progress was being made to better understand triple-negative cancers.

When I was diagnosed with breast cancer back in 1994, the term "triple-negative" breast cancer didn't exist. Diagnostic tests weren't as sophisticated as they are today. I did know that I was estrogen receptor-negative and that while my cancer was aggressive, it hadn't spread to my lymph nodes. I had surgery, chemotherapy, and radiation. Within six months my treatment was over, and I was told to get on with my life. Six months of treatment and I was done. So why were some of my friends, also estrogen receptor-negative, not so fortunate?

It was years later, during a routine check up with my oncologist that I asked him to review my pathology report to see if he thought that I might have fallen into the triple-negative camp. After close examination, he shrugged his shoulders and said that, most likely, I did. To be sure, they'd have to go down to the basement of Baylor, find my 12-year-old tumor, and run it through the gauntlet of diagnostic tests now available to determine such things. Eeek.

I've been cancer free for twelve years. I've lived with never really knowing what caused my cancer. I've lived with the fear that it might return--as we all do. I've lost friends with triple-negative breast cancer who ran out of treatment options far before they ran out of hope. For me, this new development honors their memory.


Mom and teen home, but debate rages on...


I'm sure many of you have been following the plight of Daniel Hauser, the 13-year-old Minnesota boy who scrambled to the Mexico border with his mom in order to avoid undergoing court ordered chemotherapy. For those of you who haven't, let me catch you up. In January Daniel was diagnosed with Hodgkin's Lymphoma-- what experts are calling "a highly curable disease". He had one round of chemotherapy before his parents told doctors that he wasn't going to have any further treatment. The first treatment resulted in a reduction of cancer, but because Daniel hasn't had another treatment since, his cancer has returned to pre-treatment levels. The doctors were very concerned. So concerned in fact, they turned the matter over to the courts. They said Daniel has a good chance of achieving a complete remission if he resumes treatment. They felt that Daniel's life was in jeopardy and that his parents weren't acting in his best interest. Knowing that the courts were likely to force Daniel into chemotherapy, he and his mom fled town. Well, they're home now, less than a week since their life on the run began. Daniel's parents have told the judge that they will abide by whatever ruling is made--even if that means undergoing more chemotherapy.

But why did the Hausers decide against such a proven treatment plan in the first place? Like most issues related to cancer, it's complicated. The family is Roman Catholic, but they belong to a group called the Nemenhah Band, which promotes a "Do no harm" philosophy. They believe in natural healing methods advocated by some American Indians as an alternative to traditional treatment. In fact, Daniel and his mother believe that the treatment for his cancer is what will end up killing him-- not the cancer itself. They were seeking "less toxic" options to treat his cancer.

That decision resulted in a heated national debate surrounding the government's right to intervene in cases such as this. According to a recent MSNBC poll in which participants were asked if parents should be allowed to refuse cancer treatments for their sick children, public opinion was split. Of the 77,276 people who responded as of May 28th, 55% said "Yes, families should be allowed to make their own decisions in every aspect of medical care", and 45% said "No, refusing care that could save someone's life is a form of medical neglect". Many who answered "yes" said that while they did believe that the parents were putting the child at risk, this is America and we have a little document called The Bill of Rights that protect people in cases such as this. Those who answered "no" said that this was just another form of child abuse and that refusing to render medical aid to a sick child is unjustifiable.

I was thinking about my own cancer treatment and wondered how I would feel if someone told me that I had no right to refuse a particular therapy. Granted, I was 35 when I was diagnosed--not 13. What do you think? I'm looking forward to your comments.