Affordable Care Act to Cover Breast Cancer Risk Reduction Drugs

On the heels of a new recommendation from the United States Preventive Services Task Force (USPSTF), and in line with the Affordable Care Act’s coverage of prevention services, the federal government has announced that beginning in September most health insurance plans will be required to provide breast cancer risk reduction medications free of charge to high-risk women.

 Two drugs, tamoxifen and Evista (raloxifene), are offered for breast cancer risk reduction, also known as chemoprevention. These medications can reduce the risk of invasive breast cancer by about 40 to 50 percent—but not without potential side effects. Both drugs increase the risk of blood clots, and tamoxifen increases the risk of uterine cancer.

The USPSTF recommendation, published in the Nov. 19, 2013, Annals of Internal Medicine, advises doctors to discuss chemoprevention with high-risk patients for whom the drugs’ potential benefits outweigh their risks.

Currently, only a small number of high-risk women choose chemoprevention. A study published in the February 2010 Cancer Epidemiology, Biomarkers & Prevention by Erika Waters, a psychologist at the School of Medicine at Washington University in St. Louis, and her colleagues found that close to 121,000 U.S. women who had not had breast cancer were taking tamoxifen in 2000 for risk reduction. By 2005, the number had dropped to about 51,000. Yet based on data from the National Health Interview Survey, Waters found that 10 million U.S. women would have been classified as eligible for tamoxifen in 2000—and for 2.4 million of these women, the benefits of the drug would have outweighed the risks.

The USPSTF recommendation has the potential to increase the number of high-risk women who choose to take tamoxifen, says Waters, “but maybe not in the way people expect. I think what the recommendations will do is alert clinicians and primary care physicians to the availability of the drugs, which [might then] make them more likely to offer the treatment to a high-risk woman.”For women considering whether to take these drugs, she says, the USPSTF recommendation is likely to have some weight, but “it will be only one of many factors women consider.” Similarly, she says, while the ACA coverage may help low-income women who have already decided to take tamoxifen or Evista, “just because it is free is not going to change someone’s mind if they are worried about the side effects.”

Waters also stresses the need to put the benefit of chemoprevention in perspective. “Tamoxifen can reduce risk of developing invasive breast cancer by 50 percent, and it is estimated that about one-third of postmenopausal women would be eligible to take it,” she says. “But … physical activity, not gaining weight, and losing weight if overweight can also reduce breast cancer risk up to 50 percent.” There are other ways to reduce breast cancer risk beyond taking medication, Waters says, and it’s important for health care providers to tell women about these options so that they can take them into consideration when thinking about their treatment decisions.

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Cancer Risk Reduction and the ACA

Under the Affordable Care Act, most health care plans will cover preventive services without requiring a copay or coinsurance, even if you have not met your annual deductible. This includes cancer prevention and screening services such as:

• Alcohol misuse screening and counseling
• Breast cancer chemoprevention counseling and treatment for high-risk women
• Breast cancer genetic counseling for high-risk women
• Cervical cancer screening
• Colorectal cancer screening
• Human papillomavirus (HPV) vaccination
• Mammography
• Obesity screening and counseling
• Tobacco use screening and cessation interventions

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Investigating a Novel Combination of Treatments for MS Patients

Frequently utilized MS treatments are prescribed with the goal of disease stabilization. However, they may share a common deficiency: lack of effectiveness in addressing many of the symptoms associated with the disease. Additionally they may lead to a troubling array of side effects which in themselves can negatively impact quality of life.

Newer treatments are now being investigated that seek to address many of the most debilitating symptoms related to MS. Since these novel therapies do not involve long-term treatment with pharmacological agents, they present a possible option for MS patients who are either unable to tolerate the side-effects of MS medications or who are unsatisfied with the results of their current therapies.

Dr. Michael Arata of Autonomic Specialists in Newport Beach, California has been investigating a therapeutic approach that targets many of the more troublesome symptoms suffered by MS patients, particularly those related to autonomic dysfunction (including brain fog, fatigue, headaches upon awakening, bladder and bowel problems, and inability to thermoregulate). This endovascular therapy, called Transvascular Autonomic Modulation (TVAM), has been shown to improve symptoms in a majority of patients, according to research published in Acta Phlebologica.

More recently, Dr. Arata has been investigating a surgical treatment involving the use of adult mesenchymal stem cells in conjunction with the Cell Surgical Network. This treatment involves mesenchymal stem cells in a stromal vascular fraction (SVF) that is produced from the patient’s own fat cells (extracted via a mini-liposuction procedure).

Mesenchymal stem cells and growth factors contained in SVF are known to have strong anti-inflammatory properties. Mesenchymal stem cells also have the capacity to remain dormant until they reach an area of injured or damaged tissue.

Now Dr. Arata is investigating an approach for patients with MS that includes both TVAM therapy and the SVF/mesenchymal stem cell treatment in a single outpatient visit.

It is possible that including both mesenchymal stem cell therapy and the TVAM procedure may lead to an enhanced effect. Therapeutic synergy might be achieved through both the anti-inflammatory effects of the SVF and the reparative capabilities of mesenchymal stem cells along with enhanced autonomic function seen in patients following TVAM.

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Dr. Arata responds personally to Facebook comments between the hours of 3:30-5pm PST on Thursdays and throughout the week as his schedule permits.

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Diabetes Drug Metformin May Lower Glaucoma Risk

The diabetes drug metformin was linked to a lower risk of developing the eye condition glaucoma in a new study.People who took the most metformin during the 10-year study period had a 25 percent reduced risk of glaucoma compared with people not taking the drug, researchers found.

“Glaucoma is a leading cause of blindness worldwide and classic open-angle glaucoma develops in late middle age or late age. So we hypothesized that a drug that mimics caloric restriction, such as metformin, might reduce the risk of glaucoma,” said lead researcher Julia Richards, a professor of ophthalmology and visual sciences at the University of Michigan in Ann Arbor.

Exactly how metformin might reduce the risk of glaucoma isn’t known, the researchers said. And, while this study found an association between metformin use and lower glaucoma risk, it wasn’t designed to prove a cause-and-effect relationship.Dr. Mark Fromer, an ophthalmologist at Lenox Hill Hospital in New York City, explained that glaucoma is caused by too much fluid in the eye, when fluid doesn’t drain adequately, or when the blood vessels in the optic nerve are damaged. “Somehow metformin is affecting one of those conditions,” he said.Fromer pointed out that although the results of this study are impressive, using metformin to prevent or treat glaucoma in non-diabetic patients is problematic. Metformin could drop blood sugar too low in people without diabetes, he said.

“People without diabetes should not be taking metformin,” he said. “If not monitored carefully by a doctor, it can have significant consequences,” said Fromer, who was not involved with the study.Richards, however, said that it might be possible to use metformin as a treatment for glaucoma even in people without diabetes.“But since this study was done in a diabetic population, the conclusions are currently limited to this population,” she said. “Further work, such as a clinical trial, would be needed to tell if this could be extended to non-diabetic populations or used to prevent progression of glaucoma in those who already have the disease,” Richards said.The study was published online May 28 inJAMA Ophthalmology.

For the study, Richards and colleagues collected 10 years of data on more than 150,000 people with diabetes. All were 40 or older at the start of the study. The investigators found that 4 percent of the participants developed glaucoma.The researchers said that people taking the highest amount of metformin (more than 1,110 grams in two years) had a 25 percent reduced risk of developing glaucoma compared with those not taking the drug.For every 1-gram increase in metformin taken, the risk was reduced by 0.16 percent. The researchers estimated that taking a standard dose of metformin (2 grams per day) for two years would reduce the risk for glaucoma by 21 percent.This risk reduction was seen even after accounting for lower blood sugar levels, the study authors said. Other diabetes drugs were not associated with reduced risk of glaucoma, they added.

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WHO draws lessons from Ebola to prepare roadmap for future epidemics

The World Health Organization (WHO) has concluded a meeting on Ebola R&D to look at lessons learned from the outbreak and develop a roadmap for future epidemics. Dr. Marie-Paule Kieny, WHO assistant director-general for health systems and innovation, said the Geneva meeting aimed to “come up with a new framework for R&D for diseases with epidemic potential and other health threats, so that next time we can be better prepared, faster and more effective.” Kieny said, “If something like Ebola ever happens again, the world needs to be ready with a blueprint for an R&D preparedness plan with clear rules, platforms for information sharing, established processes to expedite development and clinical trials—to activate coordinated action and limit the damage.” The meeting in Geneva, Switzerland, took place as an independent panel of experts tasked to assess the UN global health agency’s response to the Ebola outbreak in West Africa concluded in a report that “at present, WHO does not have the operational capacity or culture to deliver a full emergency public health response” and urged investments by its member states to make it fit for purpose. “Ebola is not the only epidemic-prone disease for which there are no medicines, vaccines or diagnostics. Nor is this the first time the world has been caught unprepared in the face of an epidemic,” said Kieny. “With more frequent travel, globalized trade and greater interconnectedness between countries, disease outbreaks that once used to be localized and quickly extinguished now have a much greater chance of spreading more widely. Therefore, we as a global community need to be prepared for such a possibility in the future.” To date, the Ebola outbreak in West Africa has affected more than 26,000 people and left some 11,000 dead. Dr. Margaret Chan, WHO director-general, said the Ebola R&D effort has mobilized people, institutions and resources in ways never before seen in an “otherwise horrific human calamity” and noted that the world was “likely very close to having a vaccine that can protect against Ebola.” Kieny said that thanks to “this joining of forces from all corners of the world and different sectors accelerating all actions, we now have commercial diagnostics to detect Ebola, and at least two possibly effective vaccines. These results would normally have taken five to 10 years. All this was done in less than 10 months. Even as Ebola wanes and some of the R&D efforts may not reach the goals aspired, the pioneering work done so far can be leveraged to put in place standards and best practices to improve expedited data and results sharing.”

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Pfizer launches $3M grants program to further breast cancer research

Pfizer has launched a competitive, peer-reviewed grants program to support clinical research projects investigating Ibrance (palbociclib) in advanced breast cancer.

The multi-year program, which will award a total of up to $3 million in grants to investigators in the U.S., is an extension of Pfizer’s Advancing Science through Pfizer Investigator Research Exchange (ASPIRE) initiative. It is the first ASPIRE program to focus on breast cancer research.

Ibrance received accelerated approval by the FDA in February 2015 for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer as initial endocrine-based therapy for their metastatic disease.

“We believe the ASPIRE Breast Cancer Research Awards will contribute important information to our body of knowledge about the role Ibrance plays in the treatment and clinical management of advanced breast cancer, and will complement the robust clinical development program we have ongoing,” said Dr. Julia Perkins Smith, senior medical director, U.S. breast cancer lead, Pfizer Oncology. “Through these awards, we also look forward to supporting the mission of the ASPIRE program to further academic research and nurture the career development of emerging investigators in a disease area of high unmet medical need.”

Grantees will be selected through a competitive application process overseen by an independent review panel of breast cancer experts.

The review panel encourages investigators (with a special interest for emerging researchers at assistant professor level or equivalent) to submit applications for innovative research in several areas. Highlights of the research of interest include:

• Improving the medical knowledge of palbociclib in the treatment of advanced breast cancer
• Optimizing clinical management during palbociclib treatment that addresses or improves patient compliance and convenience and/or patient reported outcomes.

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SIMPLE MISTAKE MADE IN STUDY LEADS TO SEX BIAS BREAKTHROUGH IN MULTIPLE SCLEROSIS.

An innocent mistake made by a graduate student in a Northwestern Medicine lab (they accidentally used male mice instead of female mice during an experiment) has led scientists to an exciting breakthrough that offers new insight into why women are more likely than men to develop autoimmune diseases such as Multiple Sclerosis (MS).  The data finding focuses on a type of white blood cell, the innate lymphoid cell, that exhibits different immune activities in males versus females.

The team state that MS is a disease that affects the brain and spinal cord and is the result of a dysregulated immune response. Using a mouse model of MS in which only females get disease, this study showed that innate lymphoid cells are activated and protect male mice from the disease. Although female mice have these same cells, they remain inactive and do not protect them.  They go on to add that the research opens up new avenues for investigation into sex-determined disease susceptibility and could one day lead to better therapies for both men and women with MS and other autoimmune diseases.

Women are three to four times more likely than men to develop MS, and much of the current research focuses on this fact, states the researchers.   Now, thanks to a serendipitous moment in the laboratory, the team say they are investigating why males are protected from MS.  They hypothesize that understanding the mechanisms that limit disease in men can provide information that could be used in future therapy to block disease progression in women.

Like most laboratories that study the mouse model of MS, female mice are used in almost all of the  experiments.  Previous studies have shown that when the disease is induced in this strain of female mice, virtually 100 percent of them get very sick.  Male mice either got no disease or very little, so MS researchers typically use females in their studies.

A few years ago the team ran an experiment using two groups of female mice. One group was normal; the other had a genetic mutation in a growth factor receptor (c-kit) that prevented the development of a subset of immune cells.  Previous experiments from the team showed that female mice with the mutation didn’t get as sick as normal mice, and the researchers were looking into reasons why. However, instead of using females, the graduate student accidentally chose male littermates from each group.

The results of the previous study were striking; the male mice with the mutation got very, very sick.  Because this strain of male mice never get very sick, the researcher at first thought there was some sort of mistake and repeated the experiment.  The results were the same, the team realized that the mutation was behaving differently in males and females.   The team decided to investigate these findings further.

The current study shows that mice with the c-kit mutation lacked type 2 innate lymphoid cells. These cells are normally present in bone marrow, lymph nodes and the thymus of both males and females. The researchers think that in males these cells produce a protein that may help to protect from the disease by interfering with the damaging immune response.

The data findings show that when these cells are missing in the males with the mutation, that changes the whole immune response of the male animals and causes this lack of protection.  The researchers are now looking at what activates these cells preferentially in males and not in females. The next question is can the innate lymphoid cells in females be activated to decrease disease susceptibility.

The team note that this isn’t the first sex difference study in the field of MS research. In the 1990s, scientists found that testosterone was a protective hormone for women with MS, but long-term treatment of women with MS with testosterone is not a viable option because of undesirable side effects.

Type 2 innate lymphoid cells have been well studied in allergy, where they are thought to promote allergic inflammation, state the team. However, this is the first study to show that these cells exhibit sex differences in their activity and actually can protect in autoimmune disease. Early trials are underway with the researchers hoping to find clues to explain potential activators of these cells and whether those activators can be used in therapy.

The team surmise that the data findings could lead to a new approach to designing drug therapy that modulates instead of completely suppresses the immune system of MS patients, shifting the response to one that is not so damaging.

They conclude that the hope is to target these cells in a sex-specific way and provide a therapy with fewer side effects.  This early research may have implications for understanding other diseases such as lupus and rheumatoid arthritis, which also show a female bias.

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Source:  Northwestern University

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