Exclusive Patents on the BRCA Genes: Adding Burden to an Already Overburdened Cancer Community March 2, 2012Posted by patoconnor in cancer, gynecological cancer, ovarian cancer, tubal cancer, Uncategorized, uterine cancer, vaginal cancer.
Tags: BRAC2, BRCA1, cancer, gene, genetics, patents, patient care
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By Sue Friedman, Executive Director, Facing Our Risk of Cancer Empowered (FORCE)
As part of the ACLU’s Taking Back Our Genes campaign , guest blogger Sue Friedman, the Executive Director of FORCE, describes the adverse impact the exclusive patents on BRCA1 and BRCA2 have on the cancer community.
It is our position that the awarding of exclusive patents for the BRCA1 and BRCA2 genes to Myriad Genetics has adversely affected access to care and research specific to hereditary breast and ovarian cancer, adding additional burden to our already overburdened hereditary cancer community. For that reason, we support the litigation challenging the BRCA gene patents and filed an amicus brief with the U.S. Supreme Court with other patient advocacy groups.
In our 13 years of advocating for and serving the hereditary cancer community, we have seen firsthand the adverse effects of exclusive gene patenting.
Exclusive licensing of BRCA testing stifles research, including:
Research on PARP inhibitors, targeted therapy for BRCA-associated cancer: We believe that the BRCA gene patent has had a profound impact by delaying and slowing the development of targeted cancer therapies for people with BRCA mutations. PARP inhibitors are a class of drugs that were developed based on scientists’ knowledge of how hereditary cancers develop in people with BRCA mutations. The drugs showed activity and early studies were promising in several types of hereditary cancers including breast, ovarian, and prostate. PARP inhibitor research has been ongoing since 2005, and today, seven years later, the drugs have yet to gain FDA approval. After meeting with the FDA, we were told that for targeted therapies that benefit a distinct population (such as people with a BRCA mutation) to receive FDA approval, they require that any companion laboratory test identifying a target population must be FDA approved as well. BRACAnalysis — Myriad’s test for BRCA mutations is not FDA-approved. Myriad is a CLIA-approved laboratory; they were never required to receive FDA approval in order to market their test, and it doesn’t appear that they have plans to seek FDA approval. Because Myriad holds the patent on the gene, no other lab can develop an FDA-approved test to identify BRCA mutation carriers.
Research that helps determine which BRCA genetic changes are deleterious and which are not: BIC (Breast Information Core) is a large international consortium organized by the National Human Genome Research Institute (NHGRI), which is part of the National Institutes of Health. BIC’s goal is to provide critical research to determine gene changes that may be cancer-causing versus those which aren’t. Around 2004, Myriad stopped contributing data to the BIC database. About 7 percent of BRCA tests return with an inconclusive result and data from BIC is used to help better classify these variants to determine if they are cancer-causing. According to a 2010 article in the Genomics Law Report, Myriad quietly stopped contributing data to BIC in favor of building its own database to retain a competitive advantage over other gene testing companies once their patent runs out.
Exclusive licensing negatively impacts BRCA test interpretation: Myriad’s decision to no longer contribute to the BIC database has impeded the interpretation of a type of inconclusive test result known as a Variant of Uncertain Significance (VUS). Once the patent does expire, the fact that Myriad no longer contributes mutation information to the BIC consortium will limit other laboratories’ ability to interpret certain test results. A 2011 article from the New York Times suggested that withholding this data may provide a competitive benefit to Myriad over other laboratories after their patent expires. But it comes at the cost of critical information that could help provide information to families that have inconclusive genetic test results right now.
The excessive cost of testing limits access and negatively affects clinical care: There is now evidence-based information demonstrating that identifying those who have the highest risk for breast and ovarian cancer can lower breast, ovarian, and all-cause mortality through genetic testing and surgical prevention. The cost of prevention, both in dollars and human lives, is less than the cost of treating cancer once it is diagnosed. Yet, people are being denied access to critical health information due to the excessive cost of BRCA testing. Financial assistance for BRCA testing is limited, especially for people who have any type of health insurance. With patent exclusivity and a monopoly on the test, Myriad has increased the cost of their test even as the cost of genetic technology and gene sequencing has gone down. The full-sequencing BRCA testing costs about $3,500, making it cost-prohibitive for many people. Further, Myriad charges an additional $750 for expanded testing known as BART to look for mutations known as large rearrangements in some people who test negative with full BRCA sequencing.
You can learn more about FORCE’s advocacy here.
And if you agree that human genes should not be patented, please join us in Taking Back Our Genes.
Understanding the Lymph System October 28, 2009Posted by patoconnor in cancer, gynecological cancer, ovarian cancer, tubal cancer, uterine cancer, vaginal cancer.
Tags: cancer, functions, immunity anatomy, lymph channels, lymph fluid, lymph nodes, lymph system, lymph vessels, lymphatic system, lymphedema
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Understanding the Lymph System
I thought it would be helpful for readers to understand the lymph system, the anatomy, what it does, and how it helps with immunity.
Listed below are information pages that should be quite helpful and each page has many additional links for more a more in depth study.
Lymphedema For the Newly Diagnosed November 25, 2008Posted by patoconnor in cancer, gynecological cancer, ovarian cancer, uterine cancer, vaginal cancer.
Tags: acceptance, cancer, coping, emotions, leg swelling, lymphedema, new diagnosis, patient education, treatment compliance
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The immediate time period after being diagnosed with lymphedema can be a confusing and frightening time. In one sense, there may be relief…finally there is a name to this awful “thing” that has attacked your body. But there is also a bewildering amount of emotions, fear…questions of what do I do now and where do I turn to begin dealing with this condition.
I wanted to share a few ideas that hopefully can make this period a little smoother and help give a bit of direction.
You may go through a time when you try to say to yourself that this swelling will just go away by itself or that you don’t really have to do anything about it and that it may not matter much anyway.
But as hard as this is to say, the reality is that if you have lymphedema, it just isn’t going to go away by itself. It isn’t a medical condition that you can just ignore and hope for the best. While there is no present cure, there is treatment available that can help manage it and help you get back on track with your life.
It is so very important to understand this and to get into a treatment program as soon as you can.
Point to Ponder: Acceptance doesn’t mean surrender or giving up to lymphedema.
As you may have already experienced, there is a great deal of ignorance in the medical profession about lymphedema. Sometimes, it takes years for a diagnosis and after even that is achieved, most doctors really don’t know what to do next.
That is why it is critical that we as lymphedema patients take the initiative and proactively educate ourselves on every aspect on the condition. You will want to find out what lymphedema is, what it does, what to expect from it, how to have the correct treatment and perhaps most important, how to have a full and meaningful life even with it.
You will also want to educate yourself so you will not fooled by or damaged by all the very bad misinformation out there regarding lymphedema and the lymph system. I’ve noticed that in the last couple years, the lymph system bas become a buzzword in the cyberworld and there a all too many uneducated and badly informed people trying to sell pills, potions and promises of quick cures. Unfortunately, often these supposed cures cause more damage and can even dangerous to your life.
The good thing is that there are many excellent websites that you can go to and find solid, credible, life giving information. In addition to Lymphedema People, there is The Lymphatic Research Foundation, theNational Lymphedema Network, Circle of Hope Lymphedema Foundation, Lymphovenous Canada, Lymphoedema Association of Australia and UKLymph to mention only a few.
Point to ponder: Knowledge is Empowerment. Remember the life you save, may be your own.
Once you have finally gotten that diagnosis, it is equally important that you get referral to a trained and certified (Lymphedema Association of North America standards) lymphedema therapist.
Lymphedema therapist are among our best friends and they actually do more on a day to day basis to help us then doctors actually do.
But, sadly as so many therapist will tell you, the number one reason their patients don’t get better or even experience a worsening of their lymphedema is the failure of the patient to be compliant with the proscribed treatment program.
We all understand the fatigue, the pain and the depression that can come with lymphedema. But, my friend, the truth is, is that it is up to you to work with your therapist – as a team to insured you get the most out of your treatment.
Point to ponder: It is your life and your responsibility to do all that you can to help yourself.
After that diagnosis you will go through a period of intense emotional conflict. You may swing from anger, feel bitter that this has happened to you and start feeling sorry for yourself.
Please understand, this is totally normal and yes, you do have a right to experience those feelings. Actually, if you didn’t, I would really be concerned for you.
But the key is not to stop with either of those emotions. They are to me, the triple malignancies of the spirit. They have destroyed more lives throughout history then all the medical conditions combined.
Work your way through them…keep pressing forward knowing that this terrible time of emotional struggle ends.
The following is something I do each morning and it really has made a difference in my life.
Point to Ponder: Every morning, before you start your day, ask God to help you be a source of joy, hope and encouragement to another person
When you are first diagnosed, it is easy to be overwhelmed. You feel like your whole life is over with and you will never be able to do anything you love doing again.
Please, believe me when I say, that is simply not true. Lymphedema isn’t about giving up and quitting life, it is about adaptation. You may need to change how you do things, figure out new and less strenuous ways of working and in recreation. But it doesn’t eman to have to stop everything you are used to enjoying.
Besides, if that were true, why even be alive??
If you do find there may be one particular activity you can not do anymore, find another to replace it with.
It is impossible for me to spend all day (lol..even a couple hours) working in my garden. But, I am able to sit at a computer and reach out to help others with lymphedema.
There just are too many wonderful activities, hobbies and interests to pursue to crawl into a cave and hide.
Point to Ponder: If one dream is taken away, God will send another, even more special to replace it.
In conclusion, yes, it can be devestating to be diagnosed with and stricken by lymphedema. But, I honestly do believe, it ultimately comes down to how we choose to handle it. Do we choose to surrender or do we choose to have a meaningful and joyous life despite lymphedema.
LIFE IS A CELEBRATION OF THAT WHICH WE CAN DO, NOT A REQUIEM FOR THAT WE CAN NOT DO.
Leg Swelling (Lymphedema) in a Patient With Gynecologic Cancer November 14, 2008Posted by patoconnor in cancer, gynecological cancer, ovarian cancer, tubal cancer, uterine cancer, vaginal cancer.
Tags: cancer, cancer of the vulva, cernival cancer, chemotherapy, endometrial cancer, Fallopian Tube Cancer, gynecologic cancer, immune system, leg lymphedema, leg swelling, lymph nodes, lymph vessels, lymphatic system, ovarian cancer, quality of life, radiation, uterine cancer, vaginal cancer
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Leg Swelling (Lymphedema) in a Patient With Gynecologic Cancer
Lower-Extremity Lymphedema in a Patient With Gynecologic Cancer
Kathleen Appollo, RN, BSN, OCN
Oncology Nursing Forum – Vol 34, No. 5, 2006
H.F. is a 56-year-old woman who presented to the gynecologic oncology department at a major comprehensive cancer center after an endometrial biopsy revealed an International Federation of Gynecology and Obstetrics grade III serous carcinoma of the endometri- um. In addition to relevant endometrial cancer statistics, she received information about choices for treatment. The standard surgical treatment at the cancer center consists of a total abdominal hysterectomy with bilateral salpingo-oophorectomy, pelvic lymph node dissection, and para-aortic lymph node sampling. The acute and chronic side effects of surgery were discussed, including develop- ment of lower-extremity lymphedema. H.F. was informed that the lymphedema could occur anytime after surgery and she would need to monitor for lymphedema development for the rest of her life.
After preoperative testing, H.F. had an uneventful surgical procedure and routine postoperative course. The ﬁnal pathology showed high-grade stage IIIC papillary serous carcinoma deeply invading the endometrium, with spread to a left para-aortic lymph node. As result, her oncologist recommended both radiation and chemotherapy.
H.F. completed all therapy and was scheduled to return every three months for evaluation. She was cautioned to maintain skin integrity by applying moisturizers and sunscreen as needed and to avoid sources of trauma, injury, infection, and constriction to the lower extremities. In addition, she was encouraged to maintain her weight with a healthy diet and she was advised to return to the lymphedema specialist for lymphedema control.
She understands that she must be diligent in her care to maintain control. H.F. knows that she should be joyous that she is free from cancer but often wonders about the sacriﬁces that she has made in the quality of her per- sonal life. She did not feel the need to seek professional psychiatric help but did join a support group. Although the members of the group all have cancer, none has lymphedema.
Even so, H.F. has found that sharing difﬁculties with others has helped her to cope, and she feels good when she has helped another deal with a difﬁcult issue. Although she has not returned to her former music activities, she has found that helping others in the support group has given her the same satisfaction that she felt when her music brought happiness to others.
Lymphatic System and Lymphedema
Lymph is extracellular fluid composed of water, fats, proteins, bacteria, and waste products. The lymphatic system is an inter connected network of organs, lymph vessels, and lymph nodes that transports lymph from body tissues to the bloodstream, helping to maintain body ﬂuid balance. It also is a major component of the body’s immune system.
The superficial lymphatic capillaries are made up of endothelial cells that overlap but do not form a continuous connection. Each cell is anchored to surrounding tissue by ﬁlaments that pull on the cells in response to changes in tissue pressure. As the cell is pulled by the ﬁlament, ﬂuid drains into the vessel. Pressure changes occur during muscle contraction, respiration, and arterial pulsation and when the skin is stretched. Lymph ﬂows into progressively larger deep vessels that have one-way valves to ensure that the ﬂuid moves away from tissues in a slow, steady, low-pressure system. Afferent vessels carry lymph into lymph nodes, where the lymph is ﬁltered of cellular waste products, pathogens, and cancer cells and where lymphocytes are added.
Efferent vessels carry lymph out of the lymph nodes to return to circulation. Lymph drains from the lower limbs into the lumbar lymphatic trunk, joining the intestinal lymphatic trunk and cisterna chyli to form the thoracic duct that empties lymph into the left subclavian vein (Casely-Smith & Casely-Smith, 1997; Mortimer, 1998).
Lymphedema occurs when lymph remains in the tissues because the lymphatic system is unable to transport interstitial ﬁltrate (Foldi, 1998; International Society of Lymphology, 2003). Primary lymphedema is a result of an absence of or abnormalities in lymphatic tissue. Secondary lymphedema, which is the focus of this discussion, results when the ﬂow of lymph is interrupted because of malignancies, surgery, infection, trauma, or postradiation ﬁbrosis and the lymph remains in the tissue.
Incidence and Risk Factors
Although much has been written about upper-extremity lymphedema after breast surgery, information about lower-extremity lymphedema is lacking. The literature varies widely about the number of patients affected. In one study, the incidence of lymphedema in patients after a hysterectomy with lymph node removal was 20% (Ryan, Stainton, Slaytor, et al., 2003). Another study reported a 3.4% incidence rate in patients following endometrial staging surgery, including hysterectomy, bilateral salpingo-oophorectomy, and lymph node dissection (Abu-Rustum et al., 2006). A retrospective series of staging surgery for endometrial cancer followed by radiation therapy reported an incidence of 4.6% (Nunns, Williamson, Swaney, & Davy 2000).
H.F. was at risk to develop lymphedema after her surgery for endometrial cancer because of the disruption of lymphatics and lymph nodes during staging surgery. She was at additional risk because of the postoperative radiation. Other risk factors are believed to include injury, trauma, heat changes, infection to the extremity, and weight gain and decreased mobility (Brewer, Hahn, Rohrbach, Bell, & Baddour, 2000; Mortimer, 1998).
Although research is lacking to support many recommendations for the prevention of lymphedema (Ridner, 2002), education regarding measures that are believed to reduce risk include protecting the skin from trauma and infection. Those measures were discussed with H.F. postoperatively and at each ofﬁce visit. The plan is based on the concept that any action or condition that predisposes a patient to or increases swelling may disrupt the ﬁne balance of drainage after surgery (Mortimer, 1998). In addition, open skin may lead to infection, which can occur more easily in stagnant, protein-rich lymph ﬂuid, a perfect medium for bacteria growth (Brewer et al., 2000). Because deep vein thrombosis and cancer recurrence can cause swelling, they were ruled out before H.F. was referred for complex decongestive therapy. Her treatment began with manual lymphatic drainage, a gentle massage that starts proximally to encourage the flow of lymph from the distal extremity. More lymph is encouraged to move into the normally functioning lymphatics (Cheville et al., 2003; Foldi, 1998; Lerner, 1998).
Massage was followed by padding of the extremity and application of short stretch compression bandages with gradual pressure changes distally to proximally. That type of bandaging helps the ﬂow of lymph to the nodal basins (Cheville et al.; International Society of Lymphology, 2003).
H.F. was taught the techniques so that she could continue maintenance therapy at home. She was encouraged to practice manual lymphatic drainage, use compression bandages at night, wear a ﬁtted compression garment, follow meticulous skin care guidelines, protect the leg from trauma and injury, and perform muscle-building exercises. H.F. also was taught to wear the compression garment especially during air travel because changes in atmospheric pressure may increase the pressure balance in the leg (National Lymphedema Network, 2005).
Quality of Life
Lymphedema may have a profound effect on the lives of cancer survivors (Kwan et al., 2002; Ryan, Stainton, Jaconelli, et al., 2003). H.F. described a heavy, achy feeling in her leg, which has been reported in patients with breast cancer before swelling occurred (Armer, Radina, Porock, & Culbertson, 2003). Pain assessment is crucial in helping patients to cope. An over-the-counter medication may sufﬁce, but some patients may need prescription-strength pain medication, making individual assessment critical.
H.F. stated that her pace was slower in her walks. In patients with breast cancer, fatigue often is a troublesome symptom affecting quality of life (Armer & Porock, 2002). Pacing activities or decreasing distances may help to maintain stamina. Pacing also may deter swelling that is associated with strenuous or long-distance exercise. The need for sleep medication should be evaluated because insomnia caused by leg discomfort or worry may contribute to fatigue.
Changes in wardrobe often are necessary when swelling occurs (Ryan, Stainton, Jaconelli, et al., 2003). Alteration in body image may result in changes to regular social activities and may lead to social isolation (Tobin, Lacey, Meyer, & Mortimer, 1993). Referrals to support groups or individual therapy sessions may be indicated depending on patient preference. H.F. found that she gained much by participating in a support group and thereby moved from one type of social interaction to another. Healthcare professionals must be sensitive to lifestyle changes as well as the ﬁnancial burden that may result from a forced change in wardrobe.
With increased survival after cancer treatment, the long-term sequelae caused by cancer treatment should be recognized and treated. Patients must be informed about the potential lifelong side effects of treatment. Although H.F. was informed about the possibility of lymphedema development, many patients have reported that they were not informed about this life-alterating condition until they developed symptoms (Beesley, Janda, Eakin, Obermair, & Battistutta, 2007; Ryan, Stainton, Jaconelli, et al., 2003). Continued research is needed to determine the best interventions to decrease the side effects of treatment and maximize quality of life.
Kathleen Appollo, RN, BSN, OCN can be reached at appollok @mskcc.org, with copy to editor at ONF Editor@ons.org.
Welcome to Ovarian Cancer Info November 11, 2008Posted by patoconnor in cancer, gynecological cancer, ovarian cancer.
Tags: cancer, chemotherapy, leg edema, leg swelling, lymph nodes, lymph system, lymphedema, ovarian cancer, polycystic ovarian syndrome, radiation
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Someone might ask, why would a man start a blog on ovarian cancer?
The answer really is quite simple. I had an aunt that past away from it. By the time it was detected, it was beyond treatment and had spread throughout her body. There was nothing that the doctors were able to do. Statistics indicate that ovarian cancer is now the fourth major cause of death from cancer for women. Clearly, not enough attention is being focused on this disease.
The females in my family also have a horrible ratio of ovarian problems including polycystic ovarian syndrome, my own lovely daughter included.
So it is a very relevant and important topic to me.
It is also important because of a complication that is becoming more and more prevelant among ovarian cancer survivors and that is called lymphedema. Lymphedema is a condition of leg swelling which results from lymph node removal, damage to the lymph system from radiation or from chemotherapy. I will have a complete page of information on this complication which will include how to recognize it, treatment and outcome.
I am a thirteen year survivor of a b-cell lymphoma and a fifty-six year hereditary lymphedema patient.
The information I want to provide involves symptoms, diagnoses, treatments, complications and I will include peer reviewed clinical studies relating to ovarian cancer.