The Spread of Immunotherapies Within the Healthcare Community

By Vera Viner

For decades, the most common treatments against cancer have been chemotherapy, radiation, and surgery. At times, cancer patients may be adequately treated with these procedures and may recover from the disease. Nonetheless, these common regimens often leave cancer survivors with debilitating side effects and many take months or even years to recover from the chemotherapy and radiation.

Luckily, immunotherapy is making headway in the medical sector and many patients are seeing the benefits of a different form of treatment based on the patients’ own immunity. MedCity News reported on one story where Coris Shepard, a lung cancer patient, found that his tumors actually grew after undergoing chemotherapy and radiation procedures.

At this point, Shepard agreed to participate in a clinical trial to test a new drug that would use his own body’s immune system to combat the cancer. After four months of this treatment, an MRI showed that some of his tumors had shrunk while others were completely gone!

“I was absolutely elated,” Shepard told MedCity News. “I’m more hopeful now because nothing else I had tried had actually worked.”

Mount Sinai Comprehensive Cancer Center in Florida is one of the only places in the nation that administers this treatment. Right now, researchers are using this drug to study lung, kidney, and colon cancers as well as melanoma.

The researchers found that cancer cells use two proteins found on the cells and tissues of our immune system “to make themselves invisible.” The tumor cells are able to shield themselves from our body’s immune system in this way.

The pertinent results show that tumors have been shrinking from this new treatment. The medical oncologists working on this research, however, warn that the experiment is at its earliest stages of the clinical trial and future trials may not go as hoped.

“There are many steps involved in this process and we’re just beginning to discover them,” Dr. Jose Lutzky, oncologist at Mount Sinai, told the source. “While we are seeing significant tumor shrinkage, we’re trying to find the right dose. We also know that the blockage offered by the cancer cells is going to vary from tumor to tumor.”

Immunotherapy drugs are making headway in the cancer community and this form of treatment may be the next big thing to curing cancer and saving the lives of hundreds of thousands of patients. Provenge is the first cancer immunotherapy that was approved for use in 2010 to treat prostate cancer. Yervoy is another immunotherapy that was approved two years ago for treating metastatic melanoma.

With immunotherapy, no longer would the sick need to undergo intensive chemotherapy or radiation treatments that leave them with harsh side effects. The National Cancer Institute write on their website that chemotherapy side effects include anemia, bleeding, infection, memory changes, nausea/vomiting, nerve changes, pain, swelling, skin and nail changes, and more. Treatments that can keep patients from undergoing these difficult challenges would be the hope that the healthcare community has been searching for.

Major Breakthrough for the Breast Cancer Community: Gene that Propagates Metastasis Discovered

By Vera Viner

One of the scariest things that a cancer patient may hear from their doctor is: “Your cancer has metastasized.” Fighting for your life is hard enough, but knowing that cancer cells have infected other parts of your body … that is more than enough to break anyone’s spirit. However, the devotion of scientists and medical professionals to saving lives may have brought us a breakthrough that could put a stop to breast cancer metastasis altogether.

Science Daily reported that researchers from the Robert Wood Johnson Medical School in New Jersey discovered a gene that, if limited, could reduce breast cancer metastasis and the risk of death. Their findings were published in the journal Cancer Research. Such research could lead the medical field to develop specific treatments for patients in order to cut the risk of metastasis.

“Our research has shown that HGMA2 [the gene that enables metastasis] plays a part in regulating the spread of cancer and could be considered a driver of the process,” Dr. Kiran Chada, principal investigator of the study and professor of biochemistry and molecular biology at Rutgers, told the news source. “Further studies could result in the development of therapeutic treatments for patients with breast cancer which could prevent HGMA2′s function, reduce the spread of cancer and extend a patient’s life.”

According to the study, only a few cancer cells are able to metastasize and these are located at the edges of the tumor in a place called the “invasive front.” In the laboratory, normal, healthy cells did not express the HGMA2 gene. When these cells were converted to express the gene, they became metastatic.

Interestingly enough, mice studied in the lab that were unable to express the HGMA2 gene had a significantly lower incidence of breast cancer. Additionally, most of the breast cancer cells that express HGMA2 in human tissue were located at the invasive front.

This research is revolutionary for the breast cancer community. If the medical sector could create a treatment that limits or silences the actions of the HGMA2 gene, women around the world may have a much lower likelihood of breast cancer metastasis. This breakthrough could lead us to saving the lives of mothers, daughters, sisters, and friends.

Estrogen Positive Breast Cancer Patients May Have Another Option

Written By Representatives from The Breast Health and Healing Foundation

Estrogen positive breast cancer plagues the majority of women who have been diagnosed with this disease. As much as 70 percent of breast cancer patients are diagnosed with this type of cancer. Estrogen positive breast cancer often recurs in women within 15 years of remission and may lead to fatality. However, the Science Daily reported that new research from Australia could lead the way in effectively treating these tumors with chemotherapy drugs.

Oncology experts from Sydney's Garvan Institute of Medical Research were able to determine through epigenetics that the BCL-2 gene is silenced in resistant tumors. The findings are published in the journal Molecular Cancer Therapeutics.

The researchers showed that this could be detected in the blood with the use of a diagnostic marker. The study of epigenetics involves determining how biochemical changes affect cellular DNA. The published research shows that DNA methylation causes the BCL-2 gene to be silenced in estrogen-resistant tumors.

"The main purpose of the BCL-2 gene is to keep cells alive, so when the gene is silenced, cells become more vulnerable to chemotherapy," Dr. Andrew Stone of the Garvan Institute told the news source. "The next step will be to test our findings in clinical studies. We propose that if the BCL-2 gene is silenced, patients with estrogen receptor positive breast cancer would benefit from combination therapy. In other words, tamoxifen could be used in combination with a chemotherapy drug, to kill off vulnerable tumour cells."

Because the chemotherapy drugs needed for this experiment - such as tamoxifen - are already in practice, this study could be applied clinically very quickly, said Stone. According to The Herald Sun, the research points toward combination therapy in which both tamoxifen and chemotherapy are used to treat women with estrogen positive breast cancer. This treatment may be able to stop tumor growth in much earlier stages, which is definitely a hopeful, positive discovery for estrogen positive breast cancer patients.

Sources

http://www.sciencedaily.com/releases/2013/07/130722123122.htm

http://www.heraldsun.com.au/lifestyle/health-fitness/blood-test-breakthrough-gives-new-hope-to-breast-cancer-sufferers/story-fni0dgux-1226683995837

How a Vaccine May Change the Entire Breast Cancer Culture

By Vera Viner

A few months ago, a famous Actress – Angelina Jolie – made headlines and brought media attention toward breast cancer, mastectomies, and BRCA1/BRCA2 mutations. However, this woman is not the only who has had to choose whether to remove a body part or undergo a strict screening regime. Thousands of women across the United States undergo mastectomies and lumpectomies every year. In fact, approximately 40,000 American women perish from this disease every single year.

However, there may be a way to stop women from having to go through these tough decisions and difficult treatments. Dr. Vincent Tuohy and his team from the Cleveland Clinic are working on starting clinical trials for the first preventive breast cancer vaccine. This vaccine was able to keep 100% of mice prone to developing breast cancer from contracting the condition.

“There’s a certain tragic component to all of this,” Dr. Vincent Tuohy spoke toKnow More TV, mentioning Jolie’s mastectomy. “Angelina did something defensively because she is in a situation where her only option is surgery—so she dealt with it now by removing her breasts … In other cases, we wait until the breast cancer is discovered, and then we proactively attack the tumor with all sorts of offense, including surgery, radiation, and chemotherapy.”

Tuohy has spent the last 11 years developing the preventive vaccine and has targeted both mice in the lab as well as human breast tumors. The vaccine is positioned to identify a particular protein – alpha lactalbumin – found in both lactating breast cells and cancerous breast cells. If the preventive method is found both safe and effective, it would only be administered to women who are past their childbearing years.

However, there has been some resistance for funding the breast cancer vaccine toward clinical trials. The medical community has not been fully ready to accept immunology research as a standard way for curing cancer.

“We need to promote more of the innovative research such as the type Dr. Tuohy is doing,” Dr.  Carol Fabian, a medical breast oncologist, told the source. “I think part of the resistance may be because he’s an immunologist rather than someone with a track record in cancer research. But really, we need to be looking at other alternatives and I think he’s onto something.”

The whole breast cancer industry may be another obstacle in the way. For instance, the Komen Foundation turned down funding the vaccine on THREE separate occasions. With the amount of money to be made for diagnosing and treating breast cancer, it may be difficult to push through a potential cure for the condition as a whole.

“Breast cancer is a huge and varied industry and one that is highly profitable and may not necessarily be inclined to sacrifice itself on the altar of prevention,” said Dr. Kathleen Ruddy of the Breast Health and Healing Foundation. “Of the estimated $50 billion devoted to breast cancer (diagnosis, treatment, support, philanthropy, and research) less than two percent is spent either on understanding the causes of the disease or working toward primary prevention of the disease.”

One leading breast cancer blog mentioned that the major topic of discussion at the annual American Society of Clinical Oncology, held from May 31 to June 3, was on cancer vaccines and other immunotherapy drugs. These areas seem to be most promising and are leading the way in treatment and prevention of cancer.

“We believe that this vaccine will someday be used to prevent breast cancer in adult women in the same way that vaccines have prevented many childhood diseases,” said Dr. Tuohy.

Using the Immune System to Save Lives

Written By Representatives from The Breast Health and Healing Foundation

Immunotherapies for treating cancer have brought forward the biggest breakthroughs in medical research in many years. Many scientists and doctors have focused on this innovative area when treating patients and developing better ways to save lives.

Researchers from the United Kingdom told the United Press International (UPI) that, for many years, cancer has been treated through surgery, chemotherapy, or radiation, which is often thought of as slicing, poisoning, or burning by some healthcare professionals.

"Immunotherapy is radically different," Bent Jakobsen, the chief scientific officer of Immunocore, told The Independent. "It doesn't do away with the other cancer treatments by any means, but it adds something to the arsenal that has one unique feature - it may have the potency to actually cure cancer."

The organization Immunocore has developed a new therapy that instigates T-cells to seek and stop invasive pathogens. The treatment focuses on cellular immunity. Instead of working with antibodies, this company targets T-cells specifically.

The immunotherapy works by using small protein molecules to specifically adhere to cancer cells on one end and to T-cells on the other side. The other great potential of this therapy is the ability to engineer the molecules to stick to any type of cancer.

"You can find any type of cell and any kind of target. This means the approach can in theory be used against any cancer, whether it is tumors of the prostate, breast, liver, or the pancreas," Jakobsen said.

News Medical reported that the study of the immune response to cancer has also been an important area of study for the Cambridge, Massachusetts-based David H. Koch Institute. The clinical research and pharmaceutical industries have taken notice of promising results of early-stage clinical data from several cancer immunotherapies.

On June 14, 2013, the Koch Institute held a symposium titled “Cancer Immunology and Immunotherapy.” More than 1,000 leading researchers and specialists met to discuss the impact of immunotherapy on their field and how to address the immune response with growing tumors.

At this point in time, the U.S. Food and Drug Administration (FDA) has approved two cancer immunotherapies, one for treating advanced melanoma and the second for treating prostate cancer. Additionally, the company Activaris has received FDA approval granting their cancer immunotherapy AV0113 orphan drug status for treating malignant glioma, an aggressive type of brain cancer. Along with these developments, ongoing research may bring more immune-based treatments for stomach, lung, and kidney cancers in the coming years. A major point that attendants of the symposium focused on was how to improve the function of T-cells, which compose the stronger part of the immune system and destroy tumors. Groundbreaking work with cancer vaccines are making headlines across the medical industry.

While many researchers use mouse models to show the capabilities of their immunotherapies, one scientist - Michael Graner, PhD, a CU Cancer Center investigator - used his very own dog to save its life through immuno-based treatment, according to the source Science 2.0.

The animal had lung cancer at age 12, specifically advanced bronchoalveolar adenocarcinoma. The prognosis was grim - Graner’s dog had only one month left to live. Instead of chemotherapy treatment, it was decided to attempt immunotherapy to save the dog’s life.

A 10-gram sample of the tumor enriched with a high amount of heat-shock proteins  in chaperone-rich cell lysate (which show T-cells what to target) was made into a vaccine and administered to the animal. The dog was able to beat its prognosis and survive an additional year due to this immunotherapy.

Graner has submitted a proposal to the FDA to allow him to perform human clinical trials. He hopes to use this vaccine to treat patients who have brain cancer.

"It's one thing to treat mice in these fake systems and another to treat a naturally arising tumor that had a poor prognosis," Graner told the source, explaining how his animal model is different from others. "Star's [his dog] success may make it much easier for the FDA to approve similar treatment with human glioblastoma."

All of these stories show that immunotherapy has become an innovative and strong area of research that may save the lives of countless cancer patients in decades to come.

References

http://www.pmlive.com/pharma_news/fda_grants_orphan_status_to_activartis_brain_cancer_immunotherapy_487070

http://www.science20.com/news_articles/cancer_researcher_saves_his_dog_immunotherapy_now_seeks_clinical_trial_humans-115655

http://www.news-medical.net/news/20130709/Cancer-immunotherapies-promise-to-be-a-new-tool-in-fight-against-cancer.aspx

http://www.upi.com/Science_News/Technology/2013/07/14/A-cure-for-cancer-may-be-a-step-closer/UPI-42471373778934/

Plant-based Diet Offers Solution for Preventing Cancer

By Vera Viner

The mission of the Breast Health and Healing Foundation is to discover the specific causes of breast cancer and to use that knowledge to prevent the disease. As such, one of the main ways to prevent this disease is to focus on one’s diet and consume cancer-fighting foods throughout one’s day.

Having a plant-based diet is a major step toward remaining cancer-free. In addition, there are specific vitamins or supplements one can take to prevent different types of cancer. According to the Huffington Post, this includes vitamin D, curcumin found in curry-containing foods, vitamin B, and selenium.

Vitamin D can be obtained by going on daily walks and being out in the sun. Sunscreen is necessary for avoiding skin cancer, but getting some sunlight and vitamin D goes a long way to protecting against breast, ovarian, pancreatic, renal, and colon cancer.

In order to get enough selenium in one’s diet, it is necessary consume seafood, nuts, whole grains, meats, and poultry. Some other cancer-fighting foods include garlic, green tea, and carrots for their beta carotene components.

The Science Daily reported today that a diet rich in walnuts was able to block prostate tumors from growing in mice. Researchers from the School of Medicine at The University of Texas Health Science Center San Antonio injected human prostate cancer cells into mice with a compromised immune system. After four weeks, the scientists split the mice into two groups – one on a walnut-rich diet and one control group.

A total of 44 percent of the mice in the control group had their tumors grow and develop while only 18 percent of the mice on the walnut diet developed prostate cancer. Additionally, previous studies have shown that a walnut-based diet could also slow down the growth of breast tumors.

“We found the results to be stunning because there were so few tumors in animals consuming the walnuts and these tumors grew much more slowly than in the other animals,” Study author Russel Reiter, Ph.D., professor of cellular and structural biology at the Health Science Center, told the news source. “We were absolutely surprised by how highly effective the walnut diet was in terms of inhibition of human prostate cancer.”

Along with these diet tips, research from the University of California, Los Angeles shows that a low-fat diet may lower mortality risk in breast cancer patients by as much as 66 percent, according to the News Fix. By following a healthy, plant-based diet filled with vitamins, fruits, nuts, and vegetables and avoiding sugary, fatty foods, it is possible to prevent a number of different cancers and become heart-healthy.

Being a Woman is the Biggest Risk for Contracting Breast Cancer

By Vera Viner

Breast cancer is one of the most common types of cancers in this country. According to statistics from the American Cancer Society, more than 232,000 women are diagnosed with this disease every year in the United States alone. Approximately, 40,000 Americans die each year from this dreadful disease. The only cancer more common is prostate cancer, but the mortality rate for this medical condition is approximately 10,000 patients less than that of breast cancer.

A major reason that breast cancer is so common is due to the biological processes of the breast throughout a woman’s life. After all, the biggest risk for contracting breast cancer is to be born a woman. Dr. Marisa Weiss, a practicing oncologist with 25 years experience, wrote for the Huffington Post about why the breast is more susceptible to tumors than other organs in the body.

The development of the breast gland takes much longer than other organs within the human body, which means that every time bits of DNA are introduced into newly formed breast cells, genetic mutations can form and disrupt the common development of this gland.

Evolution has also played a role in how hormones affect the breast. Feeding offspring is a huge boost for the survival of the human species, evolutionarily speaking. This is why estrogen is able to impact estrogen receptors to tell breast cells to start growing – whether it is during puberty or pregnancy. All of this shows exactly why Hormone Replacement Therapy is dangerous for women – such hormones may tell women’s glands to start growing during menopause, possibly creating a dangerous, cancerous environment.

In today’s modern world, evolutionary processes have led women to become more susceptible to breast cancer. Because estrogen receptors are able to interact with substances that are similar to estrogen in shape, smell, or taste, women’s breasts are more vulnerable to contracting cancer from various chemicals, plastics, pollution, and sugars/junk foods. Bisphenols found in plastics, prescription drugs in the form of birth control pills or HRT, flame retardants, and other chemicals all pose danger to human survival.

While our bodies have not evolved quickly enough to counter the effects we have put upon ourselves in the modern world, it is up to women everywhere to protect each other from these dangerous chemicals. Breast cancer prevention is of the utmost importance and we need to avoid bisphenols, Hormone Replacement Therapy, birth control pills, cigarettes, additives or sugars, and excessive alcohol. In addition, we must maintain a healthy plant-based diet, exercise regularly, and remain at a healthy weight. While our own biological processes and evolutionary strategies may push us closer to contracting breast cancer, there are various steps we need to take to prevent this disease.

Event Horizon: Engineering T-Cells To Cure Cancer

By Dr. Kathleen T. Ruddy

Emily Whitehead was six years old.  She was also dying of leukemia.  There was nothing else doctors could do for her, so her parents took over:  they found a doctor who was doing chapter-one research on experimental therapy using T-cells, sentinels of the immune system whose job is akin to Seal Team 6 – identify the target, find it, and destroy it.

Emily was dying, hopeless dying, at an age when children ordinarily lose a few teeth, not their life.  Emily’s parents found Dr. Carl June, who had lost his own young wife to ovarian cancer and had been left to raise a 9-year daughter in the wake of his grief-stricken misery, so he knew what was at stake:  everything.

June is a researcher stalking an entirely new way to attack cancer.  He planned to take some of Emily’s T-cells, engineer them to attack her cancer cells, inject them back into her bloodstream, and see if they could conquer the leukemia that had eluded everyone else.

Emily’s parents agreed.  I’m sure I would have too.

The engineered T cells worked; in fact, they worked too well.  In the process of annihilating all traces of Emily’s leukemia, the engineered T-cells produced a chemical by-product (interleukin-6) that nearly killed the poor child.  Emily ended up on a respirator in a pediatric Intensive Care Unit, with her family gathered at her beeping bedside in anguished expectation of her death.  (I can assure you, there is no horror more exquisite than that visited upon the parents of a dying child.)

But then June remembered that when his daughter developed rheumatoid arthritis following the death of her mother, the child had been given an anti-inflammatory drug that inhibits interleukin-6.  He suggested that Emily’s doctors try it on her.  Why not?

It worked.

Emily is now in complete remission.  At eight years old, she’s the image of what a child her age should be – pig-tailed, cute, and ready to play.

And June and others are ready to work, as hard as possible to push this Sisyphean cart, brimming with engineered T cells, over the summit and into the Valley of Cure.

Can T-cells be engineered to Seal-Team-6 solid tumors like breast cancer?  We’ll see.  Novartis has taken the field like defending Super Bowl champions busting through the gates of the Superdome in search of another gaudy, diamond ring.  Their competitors can’t wait to take them on.  The big boys, and a ban of smaller bros, are lining up, itching for a fight, with benches of patent attorneys and greedy capitalists on the sidelines talking into microphones behind cupped hands.  There’s a fortune to be made, sports fans!

Meantime, the once skeptical National Cancer Institute, which turned down early grant requests for this research, is now as born again as a fallen Baptist at a summer revival, quoting from the T-cell bible as if it were received wisdom delivered into their receiving hands.  Stand back, game on everywhere!

Mark my word, even if Komen has fallen off its track – another trained derailed by politics, ignorance, and vanity – the race is now back on and revved up.  If this is the final leg of the race in the race for a cure, the runners are sprinting and the dust is flying.

But a word of caution, for heartbreak hill is straight ahead.  Inevitably, progress runs a circuit, like a mill horse:  success is followed by failure, is followed by learning, is followed by success, is followed by failure, and more learning, and this goes on until the finally sun sets on the problem.  So don’t become over-heated in expectation that we’re close.  Rather, allow yourself to become intelligently engaged and reasonably excited about the tremendous potential of this work, for engineering T-cells as special ops in the fight against cancer is progress worth knowing, understanding, sharing, and supporting.  While the Pure Cure is prevention – my special mission – there are, nevertheless, millions of women with breast cancer in need of a cure.

Stay tuned, this may be the big one.

Updated Guidelines Released for Women at High Risk of Breast Cancer

By Vera Viner

The genetic link behind breast cancer has been highly cited in the news lately. First, Angelina Jolie’s high risk of breast cancer and decision to undergo a mastectomy brought forth the major issues surrounding BRCA1 and BRCA2 gene mutations. Shortly after, the Supreme Court passed down a ruling that prevents Myriad Genetics from being able to patent the rights to BRCA gene testing.

Recently, more new information has come out regarding women at high risk of breast cancer. Nursing Times reported that the National Institute of Health and Care Excellence released updated guidelines for this sect of women. Females at high risk are recommended to take tamoxifen or raloxifene to reduce their likelihood of contracting breast cancer.

The guidelines explained that taking these measures could prevent the disease in more than 480,000 women over 35 years of age. The two drugs, tamoxifen and raloxifene, are selective estrogen receptor modulators, which means they block estrogen from affecting breast tissues and cells.

If you are curious whether you are at risk of breast cancer based on genetics, you should speak with your doctor who will decide whether you are a candidate for genetic testing. How does a physician assess whether you are a candidate? The factors include:

• A woman’s age
• The number of people in her family that developed ovarian or breast cancer
• The age these family members developed breast cancer
• The specific nature of her family history (such as who developed the disease)

If your family history includes a first-degree female or male relative that contracted breast cancer (or ovarian cancer) before the age of forty, it is recommended for you to receive genetic counseling. Additionally, women are advised to speak with a secondary care physician if they have a family history of cancer in both breasts, ovarian cancer, male breast cancer, Jewish ancestry, multiple cancers at a young age, or two or more relatives on the father’s side with breast cancer.

The guidelines also emphasized the need for women aged 40 and older to receive annual mammograms and women who are breast cancer survivors aged 30 years and older are also recommended to receive yearly mammograms.

Time Magazine reported on one study that assessed the number of mothers who told their children about their BRCA gene test results. Researchers from the Georgetown Lombardi Comprehensive Cancer Center followed 221 mothers and found that most chose to disclose their results with their offspring. Mothers tended to be more open with their eldest children. A total of 62 percent of mothers told their sons and daughters about their particular risk of breast cancer or ovarian cancer (whether high or low). Mothers with positive news, however, were more likely to share the results.

“Mothers who don’t discuss their results with their kids are relatively less satisfied and feel more conflicted,” Kenneth Tercyak, director of behavioral prevention research at Georgetown Lombardi and lead author of the study, told reporters.

Whether a woman is at high risk of breast cancer or has been diagnosed with the disease, the most important thing is to have a strong support system – family and friends that one can rely on can go a long way to reducing one’s worries and alleviate some of the stress related with any disease.

Supreme Court Declared BRCA Gene Patents No Longer Valid

By Vera Viner

It is distressing to think that one company – Myriad Genetics – held the patent rights to two genes that, if mutated, increased women’s risk of breast cancer. These patents forced all medical laboratories to pay for the right to perform a genetic analysis on the BRCA1 and BRCA2 genes. However, women around the nation recently celebrated a major decision by the U.S. Supreme Court that struck down the right of a corporation to hold patents to human genes.

USA Today reported that this decision would benefit the lives of breast cancer and ovarian cancer patients because health insurance companies would no longer be compromised when covering the costs of these genetic tests. Women who have been diagnosed with breast or ovarian cancer or are at high risk of these diseases would be able to get a second opinion or adequate information before performing any invasive procedures based on just one test.

“Myriad did not create anything,” Justice Clarence Thomas wrote in the final decision. “To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”

The court was unanimous on striking down the gene patent. This outcome will lead to lower costs and greater access for women in need of genetic testing. Instead of insurers and patients spending approximately $3,300 to have this genetic test, the costs will be slashed to less than $1,000.

The Supreme Court did, however, allow Myriad Genetics to have patent rights to cDNA, a synthetic type of DNA that is not naturally occurring. In the past, the Supreme Court ruled that forces of nature are not patent eligible and this decision may invalidate more than 40,000 patents related to genetic substances granted since 1984.

The court battle against Myriad Genetics has actually been going on since May of 2009 when the American Civil Liberties Union and the Public Patent Foundation filed a lawsuit in a New York Federal Court, according to Medscape News. Myriad began appealing the process once their patents were declared invalid. The case went as far as the Supreme Court and patenting of the BRCA genes was still found null and void.

“This ruling makes a huge and immediate difference for women with a known or suspected inherited risk of breast cancer,” Karuna Jaggar, executive director of Breast Cancer Action, told USA Today. “And it is a tremendous victory for all people everywhere. The Supreme Court has taken a significant stand to limit the rights of companies to own human genes by striking down Myriad’s monopoly.”

An editorial in the Boston Globe illuminated the essence of the Supreme Court ruling – nobody can own a product of nature. We are all a part of the natural world and our genes cannot be patented by companies.

“Maybe it takes a decision like this one to remember why it matters so much, in the end, to be just a ‘product of nature’ after all — imperfect, vulnerable, subject to all the vicissitudes and issues that are part and parcel of the natural world. Not everything, in the end, is man-made. At the same time, sometimes it takes human beings to uphold the right to be part of something bigger than we are, something we can’t own — and that can’t be controlled by patents,” The Globe reported.

Excellent Goal-Tending By The Supremes Against Myriad Genetics Blitz: No Patents On Human Genes!

By Dr. Kathleen T. Ruddy

They rarely all agree.  But when they do, you can be sure they’re right.

Yesterday, in an unanimous decision not seen in ages, the Supreme Court held, ‘You may not patent something made by God.’  Henceforth, there shall be no US patents issued on naturally occurring human genes.  Amen.

Opponents hammered all along, and continue their clamoring today, that patent protection of bits and pieces of human DNA insures innovation and progress.  It is a species argument spun from dank wool.  In the words of Thomas Jefferson, “invented where facts failed.”

I fully expect a joyful stampede of geeks driving venture capital wagons onto the opened field, wheels turning and hats flying such as has not been seen since the Oklahoma Rush.

The frontier is now open, and, as my dad likes to say, “There’s always room for somebody good.”

HIV Drug, Nelfinavir, Inhibits The Growth Of HER2+ Breast Cancer

By Dr. Kathleen T. Ruddy

Protease inhibitors are used to prevent progression to AIDS in patients infected with HIV.  A recent study conducted at the Johns Hopkins School of Medicine revealed that one of these protease inhibitors, nelfinavir, effectively inhibits the growth of HER2+ breast cancer cells, and also inhibits the growth HER2+ human breast tumors transplanted in mice.  Clinical trials using nelfinavir can now begin to see if it is similarly effective in treating women with HER2+ breast cancer.

What is HER2?

HER2 is a human epidermal growth factor receptor that increases the growth of breast cancer cells.

What percentage of women are diagnosed with HER2+ breast tumors?

Approximately 15-20% of women are diagnosed with HER2+ breast cancer.

How is HER2+ breast cancer different from other forms of breast cancer?

HER2+ tumors are highly aggressive and are associated with a higher risk of recurrence and death than tumors that express hormone receptors such as estrogen or progesterone.

What forms of treatment are effective for use in women with HER2+ breast tumors?

In addition to traditional forms of chemotherapy, targeted therapies with drugs like Herceptin can delay recurrence and increase survival for women with HER2+ breast cancer.

How did scientists at Johns Hopkins identify HER2+ tumors as potential targets for treatment with the HIV protease inhibitor drug, nelfinavir?

Dr. Joong Sup Shim discovered that nelfinavir inhibited the growth of HER2+ breast cancer cells and HER2+ human breast tumors transplanted in mice.  The results of his experiments were strongly positive, indicating a likely benefit of nelfinavir for use in women with HER2+ breast cancer.  Dr. Shim also discovered that nelfinavir was effective against HER2+ tumors that were resistant to Herceptin.

Will it be necessary to alter the dose of nelfinavir in human trials of women with HER2+ breast cancer compared to the dose used to treat patients with HIV?

No.  The same dose regimen used to treat patients with HIV can be used to test the efficacy of nelfinavir in women with HER2+ breast cancer.  Of note, nelfinavir has been extensively tested in humans and is associated with a low risk for dangerous side effects.

What can we conclude from Dr. Shim’s study of nelfinavir in HER2+ tumors?

Nelfinavir used in doses equivalent to those used to treat HIV in humans is effective in inhibiting the growth of HER2+ breast cancer cells and human breast cancer tumors transplanted in mice, and is ready for testing to see if it is similarly effective for use in treating women with HER2+ breast cancer.

REFERENCE

Joong Sup Shim, et al. “Selective Inhibition of HER2-Positive Breast Cancer Cells by the HIV Protease Inhibitor Nelfinavir”, J National Cancer Institute, October 5, 2012

Banging The Pots For Prevention

By Dr. Kathleen T. Ruddy

On May 31, in New York City, I attended a high-level meeting of members of the Clinton Global Initiative (CGI) gathered to consider how private-public partnerships can best tackle the worldwide challenges of non-communicable diseases (NCDs) like breast cancer, diabetes, and the ever-enlarging holocaust perpetrated by the tobacco industry.  Primary prevention of NCDs was our focus; our objective, to give prevention a Birth Of Venus moment.

Prevention, per se, has become the marketing darling at every healthcare event and forum. But truth be told,  few participants are truly interested in disease prevention.  The majority give it the nod, as they must, but quickly look the other way for they need disease to live in the way that, say, Dracula needs your blood.  No, prevention is more like the pretty girl in a flimsy dress – pursued not for the quality of her character but as the means of satisfying every suitor hoping to score.

After listening with interest to the varied opinions and cautionary tales put forth by my colleagues at CGI, I came to realize that we must have as our highest priority this first step:  to define and defend primary prevention of disease.  To wit: Primary prevention is what we do, or can do, to prevent disease from occurring in the first place.  This is not as simple as it looks, for there are many who have taken the definition of disease prevention and retooled it masterfully to further drive diagnosis and treatment of disease, and, thereby, thrive at our expense. Beware!

For the record, mammograms do not prevent breast cancer any more than Pap smears prevent cervical cancer.  What prevents cervical cancer is a vaccine like Guardisil that targets the virus that causes cervical cancer, the human papilloma virus (HPV.)  As for breast cancer, known and proven risk-reduction strategies exist.  They include:  regular exercise (30 minutes of moderate exercise, like walking, four times a week), avoiding hormone replacement therapy, oral contraceptives, alcohol, and cigarettes; and maintaining ideal body weight.  The scientific data in support of these risk-reduction strategies are sound and convergent, despite those in a position to implement them who remain eerily silent.

As committed as we are to primary prevention of NCDs,  we’re banging our pots outside the walls of what looks like an impenetrable fortress.  The Race For A Cure and the profit-driven, privately-held healthcare system that runs it, has no more interest in the primary prevention of breast cancer than Caesar had in Brutus’s sword.  Look at what is funded under the category ‘breast cancer prevention’ and see for yourself:   it’s all about mammogram screening and early diagnosis; well and good if you’ve got the disease, but no use whatsoever if you want to prevent it.  Other NCDs fare no better.  Diagnosis and treatment are the mortar and bricks of the citadel that everywhere surrounds disease, as if defending it was the best way of defending us.  No, we’re going to need bigger pots, and we’re going to have to bang them more loudly if we wish to bring down the walls of this Jericho.

Mind the gap, for there exists a threatening gap that had been widened by theft of the accurate definition of prevention by slickly deployed marketers who intend to keep all races running, indefinitely.  Mind you, these are races whose irrational sustainability are bankrupting our healthcare system. There’s no way to provide universal healthcare unless we, its leaders, make primary prevention of disease our priority.  For this we must marshall the power of the english language more effectively. Prevention is prevention:  everything else is a path to or a form of treatment.

The halo effect of redirecting our efforts towards primary prevention of NCDs like breast cancer is that we could save a fortune.  More than a fortune.  Approximately $50 billion is spent every year on all things related to breast cancer: diagnosis, treatment, research, marketing, education, and philanthropy.  Using known and proven risk-reduction strategies, we could prevent at least 30% of breast cancer, now.  Back of the envelope, that’s $15 billion/year saved from our community chest.  A preventive vaccine, such as the one developed at the Cleveland Clinic in 2010, has the potential to shave off another $40 billion/year.  Do the math and what you come up with is Real Money.

One of the participants at the CGI meeting suggested we should learn from the tobacco industry’s mistakes; that is, how its missteps allowed policymakers to successfully ban smoking from public places, implement age restrictions on sales of tobacco to children, and require warnings to appear on packs of cigarettes. I think we might also want to spend some quality time studying its successes:   How, exactly, has an industry which unquestionably poisons everyone on the planet and provides nothing of value to any of us managed to stay in business for so long?  How has the tobacco industry played the system so adroitly that it survives victorious, and how can we do that too?  Surely, if tobacco can succeed with poison as its product, we can do it with prevention as ours.

Unfortunately, there is no authentic organizational voice for the primary prevention of disease other than the few raised yesterday at CGI.  The World Health Organization’s agreement to focus attention on NCDs is worthy, agreed; but the universal good will so radiantly on display is at risk of drowning in a sea of profit-driven diagnosis and treatment unless we plant the flag on the proper definition of primary prevention of disease and vigorously defend it against its foes.   Prepare for war, for they are legion.

Lack of research?  Lack of data?  Lack of evidence, you say?  Objections such as these are either diversionary tactics or blind spots.  Even a cursory review of the peer-reviewed literature on primary prevention of disease yields myriad ways to effectively drive down the incidence and prevalence of NCDs.  That is, if you want to.  And we want to.  Et tu?

One of the benefits of being a small shop like the Breast Health and Healing Foundation is that you’re more agile when you operate from the periphery.  Think for a moment, how fast does the center of the earth spin relative to an island sitting on the equator?  Right, the island moves very fast relative to the center, which hardly moves at all.  So, don’t look to the federal government or the World Health Organization or the United Nations or any of the industrially infiltrated philanthropies to take the lead on anything but talk as regards primary prevention of disease.  If we want disease prevention, then we must work from the periphery where the greatest flexibility exists and where the arc of change moves most rapidly.

Such a space now exists in the private-publc partnerships taking shape at the Clinton Global Initiative, and for that we’re very grateful.