Prioritizing Prevention With A Breast Cancer Vaccine: Understanding The Steps Involved

The world’s first preventive breast cancer vaccine was developed at the Cleveland Clinic in 2010.  The vaccine is 100% safe and effective in three animal models, as published in Nature Medicine, May 2010.

The next steps toward bringing this vaccine from the bench to the bedside involve a series of clinical trials to test if the vaccine is safe and effective for use in women.  A brief explanation of these clinical trials is important so that women can follow along as we move from milestone to milestone on the way to “Omega” – the Pure Cure via prevention of breast cancer.

A Phase 0 study is a laboratory investigation in which a researcher designs and develops a vaccine and then tests it in animals.  The Cleveland Clinic’s preventive breast cancer vaccine was developed by Professor Vincent Tuohy, an immunologist, and tested in three animals models where it was shown to be completely safe and effective in preventing breast cancer.

A Phase I study is a clinical trial that tests the vaccine in humans.  This is typically a small trial that involves 20-100 healthy volunteers.  The objective of a Phase I trial is to prove that the vaccine is safe for use in humans.  If the vaccine is not safe, no further studies can be done.

A Phase II study is conducted to see if the vaccine actually works; that is, is it effective?  Does it prevent breast cancer in women as it does in mice?  A Phase II study typically involves 100-300 healthy volunteers.

A Phase III study is conducted once a vaccine is proven safe (via a Phase I study) and effective (via a Phase II study) to show that it is effective when tested in a larger, more diverse population.  Typically, a Phase III study involves 1000-2000 volunteers.

If a vaccine is proven to be safe and effective through Phase 0-III clinical studies, it can be made available to the general public.  Such was the case when Merck released the world’s first preventive cervical cancer vaccine, Guardisil.

A Phase IV study is conducted after the vaccine is released for use in the general population.  The objective of a Phase IV study is to see if there are any problems with the vaccine not identified during the initial clinical trials.

The world’s first preventive breast cancer vaccine has successfully completed a Phase 0 study:  it is 100% safe and effective in preventing breast cancer in three animal models.  It is especially useful against triple-negative breast cancer, the most aggressive form of the disease that afflicts the majority of women who carry a BRCA mutation.

The next step, as outlined above, is to test the Cleveland Clinic’s vaccine in a Phase I study to see if it’s safe for use in women.  This study will involve less than 100 women and will take approximately two years to complete, including obtaining permission from the FDA to undertake the trial.

To learn more about the Cleveland Clinic’s preventive breast cancer vaccine please use this link:  http://my.clevelandclinic.org/giving/where-to-give/tuohy_vaccine.aspx

A Primer On The Pink Vaccine

 

The world’s first preventive breast cancer vaccine was developed by Professor Vincent Tuohy, an immunologist at the Cleveland Clinic, in 2010.  Tuohy tested his vaccine over a period of ten years, finding that it was safe and 100%effective in preventing breast cancer in three animal models.  After vetting Tuohy’s data for more than two years, a panel of experts on the editorial review board of Nature Medicine verified and validated his results and then published his paper in May 2010.  While it’s true that not everything that works in mice works in humans, it can be said with equal conviction that everything that now works in humans first worked in mice.

Tuohy’s vaccine targets a protein called alpha lactalbumin (ALA) that is made by the majority of breast cancer cells, especially those that are triple-negative (i.e., lack estrogen, progesterone, and Her2 receptors).  Of note, triple-negative breast cancers are the most common tumors found in women who carry a BRCA mutation.  Because ALA is normally made only in women who are breastfeeding, and since the majority of breast cancer patients are diagnosed with their disease after menopause, Tuohy’s vaccine holds great promise as primary prevention of breast cancer, the most common malignancy in every country around the world.

The next step in furtherance of Tuohy’s vaccine is to conduct a clinical trial in a small group of healthy volunteers to see if the vaccine is safe.  Such a study would likely involve 40-100 women and would take a very short time to complete.  This is called a Phase I study and requires both funding and permission from the FDA before it can begin.  If Tuohy’s vaccine proves safe at the conclusion of a Phase I study, it can then be tested in a Phase II study to assess its effectiveness in preventing breast cancer.  Again, women who carry a BRCA mutation would be ideal candidates for a Phase II study, as they have the highest risk and rates of breast cancer and, thus, an effective preventive breast cancer vaccine would quickly prove its worth in such a cohort of high-risk women.

It is also worth noting that Tuohy’s vaccine, because it targets cells that produce ALA – the majority of breast cancers, especially those that are triple-negative – also holds some therapeutic potential for use in preventing breast cancer recurrence.  But before the vaccine can be moved from the bench to the bedside, the first and most important step must be completed:  we must answer the question, Is Tuohy’s vaccine safe?  That question can only be answered in the course of a Phase I study.  And since so much depends on getting this question answered – millions of lives, millions of breasts, billions of dollars – it’s worth getting the answer as soon as possible.

New Genetic Test Predicts Breast Cancer Recurrence within 10 Years

By Vera Viner

When a woman becomes diagnosed with breast cancer, she may have the fear of death surrounding her for years or even decades. Even when breast cancer is cured, the fear of recurrence strikes a chord in many women. Breast cancer survivors may have overcome the initial diagnosis and treatment, but there are still countless women who have their cancer return.

However, science research has once again brought us good news. A new test has been developed to see which women may have their cancer come back within a 10-year period, according to CBS News.

“We have validated a unique ‘fingerprint’ in the primary tumor of breast cancer patients that can help identify a high or low risk of cancer recurrence,” Dr. Paul Goss, director of the Breast Cancer Research Program at Massachusetts General Hospital Cancer Center, said in a release.

The researchers focused on three ways that are currently being used to anticipate recurrence risk in women with estrogen receptor-positive breast cancers. The three methods include the breast cancer index (BCI), the Oncotype Dx Recurrence Score, and a genetic test used to study the ICH4 gene, which is linked to the disease.

The tests were used to study 665 patients. The researchers compared the test results with the patients’ histories to see if breast cancer recurred within five years and after ten years. Only the BCI method was able to accurately predict the recurrence risk within 10 years. All of the methods, however, were able to distinguish the risk within five years time. The test was able to show that 60 percent of the patients were at very low risk of recurrence while 40 percent were at a significant long-term risk.

“Since the BCI identifies two distinct risk groups, it may provide a much-needed tool in determining those patients who need extended hormonal therapy and those who may be spared its well-known adverse side effects,” study leader Dr. Dennis Sgroi, a cancer researcher and pathologist at MGH, told the news source.

Understanding How Early Pregnancy Protects Against Breast Cancer

Women who deliver a baby before the age of 20 have a 50% reduction in their lifetime risk for breast cancer.

But what causes this dramatically effective benefit of an early pregnancy?  At least two mechanisms appear to be involved, though, surely, more discoveries will be made to explain the protective benefit of early pregnancy on future breast cancer risk.  The first mechanism involves a protein, alpha fetoprotein, and the second involves breast stem cells.

Alpha fetoprotein (AFP) is made by the liver and the yolk sac of the growing fetus.  The high levels of estrogen made by the placenta over the course of a full-term pregnancy stimulate increased production of AFP.   Scientists have discovered that AFP inhibits the growth of breast cancer cells in culture and delays the growth of breast tumors by 30-50% studies of live animals..

Breast stem cells are the longest living cells of the breast.  Many scientists believe that breast stem cells are the primary source of all breast malignancies.  Breast stem cells are able to accumulate more mutations over the lifetime of the patient and, as a result, are the most susceptible to malignant transformation.  Pregnancy changes both the total number of breast stem cells – reducing them by half – and the genes expressed by the stem cells that remain behind after a full-term pregnancy.  One of the genes altered by pregnancy is Wnt 4, a gene that has been found to be particularly important in breast cancer formation.  Pregnancy reduces the amount of Wnt 4 made by cells in the breast.  Early pregnancy thus protects against breast cancer by reducing the total number of breast stem cells and reducing the expression of a particularly notorious breast cancer gene, Wnt 4.

The beneficial effect of an early pregnancy on lowering the incidence of breast cancer is dramatic:  a 50% reduction in lifetime risk is seen in women who deliver a child before the age of 20.  Several factors appear to be involved, including increased production of AFP, decreased expression of Wnt 4, and a 50% reduction in the total number breast stem cells.

The Top 8 Foods to Consume for Breast Cancer Prevention

By Vera Viner

We all know that staying at a healthy weight is a major part of reducing our risk of breast cancer. Along with exercise, this means that we must incorporate a healthy diet in our daily lives. What type of foods should we eat to keep ourselves at low risk of breast cancer? Below is a list of the top 8 foods that prevent breast cancer.

1) Berries. Two of the most nutritious types of berries you should have in your refrigerator include blueberries and red raspberries. According to the websiteHealwithfood.org, clinical studies have found that raspberries may help prevent breast cancer possibly because of its high levels of ellagic acid, an anti-carcinogen. This chemical has even caused apoptosis (cell death) in cancerous cells. Fox News reported that blueberries are full of antioxidants and are able to reduce the risk of diabetes and lower cholesterol levels.

2) Broccoli. This super-food has plenty of antioxidants and other compound that fight carcinogenic toxins and reduce DNA mutation as well as malignancy. Additionally, broccoli can bring about apoptosis of breast cancer cells and stops the spread of breast cancer throughout the rest of the body. Broccoli has plenty of vitamins A, B6, and K along with folic acid, calcium, and potassium. This vegetable also has powerful chemicals that prevent cancer. In general, broccoli should be part of every woman’s diet for keeping their breasts healthy.

3) Walnuts. These nuts should be consumed in moderation due to a high calorie-count, but they offer significant health benefits and may prevent breast cancer. Walnuts are high in omega-3 fatty acids, phytosterols, and antioxidants, which are all known to prevent breast cancer and other health problems. Make sure to eat some walnuts as a snack or add them to your salad for lunch!

4) Salmon. Because salmon is full of omega-3 fatty acids, it is a food rich in cancer-fighting properties. Research has shown that omega-3 fatty acids can actually stop the growth of breast cancer cells. Studies show that this compound can also prevent inflammation, diabetes, and Alzheimer’s disease as well as strengthening your cardiovascular system. Salmon also has a particular antioxidant that gives it its pink color. Make sure to eat salmon about twice a week to avoid too much exposure to mercury and certain toxins. A moderate diet of salmon could go a long way to improving your health and preventing breast cancer.

5) Brussels sprouts. This particular vegetable has various benefits for your health and it includes the substance indole-3-carbinol (I3C), which can detox harmful chemicals like carcinogens. Additionally, Brussels sprouts have been shown to block the overproduction of some hormones that are associated with a higher risk for breast cancer.

6) Turmeric and other spices. Turmeric is the spice that provides a yellow hue to curries and other Asian dishes. This spice has been used to prevent various diseases in traditional Asian medicine, according to Health With Food. Turmeric has a wide range of anti-cancer properties and even contains a compound that can identify cancer cells and induce self-destruction of the tumors. Additionally, this spice is full of antioxidants and may even reduce the risk of Alzheimer’s disease. Some other spices with health benefits include cinnamon and ginger. Cinnamon can lower cholesterol levels and stabilize blood sugar. Ginger reduces inflammation and strengthens digestive health.

7) Kale. There are few foods that have as many anti-cancer benefits as kale. This amazing vegetable has more beta-carotene than even broccoli. Research has shown that pre-menopausal women who consume a diet rich in beta-carotene (2 servings per day) reduce their risk of breast cancer by 17 percent! In addition, kale is rich in vitamins, phytonutrients, and antioxidants.

8) Green tea. This particular tea can do so much for your physical health. Not only does it promote weight-loss, but there is evidence that it can prevent several types of cancers. One property of green tea is catechins, which are highly protective against DNA damage. In addition, green tea can stop the actions of urokinase, an enzyme that causes metastasis in breast cancer patients.

By filling your kitchen with these cancer-preventive foods, you will be much healthier and have a very low risk of breast cancer. Please pass this on to your friends and family members. Let’s get the word out about breast cancer prevention!

Uniquely Female: Understanding Alpha-Lactalbumin In Health And Disease

Alpha-lactalbumin (ALA) is a protein.  A protein is made of amino acids.  Amino acids are like Legos – building blocks that are used to make proteins.  (Forgive me, I want to make this very simple, in consideration of those readers who barely made it through high school biology and hated every minute of it.  I love you and I want and need for you to understand this stuff.)

ALA is a protein that is uniquely female:  men don’t make it.  Ever.  And women only make ALA under one circumstance – when they are breastfeeding.

ALA begins to be made by the cells that line the ducts of the breast during the third trimester of pregnancy.  Sounds sensible, right?  This is the time when the breasts are ramping up for milk production.

If a women delivers a baby and then breastfeeds her infant, the cells that line the ducts of the breast continue to make ALA.  They will do so as long as she continues to breastfeed.

A woman who does not breastfeed her infant after she delivers her baby will no longer make ALA.  We say that ALA is “retired” because it is is no longer needed and is, therefore, no longer made.

Oh, BTW, what does ALA do?  What function does it serve?  ALA increases the amount of glucose entering the cells that line the ducts of the breast so that they have the EXTRA FUEL they need to make milk.  Also, ALA regulates the amount of water contained in breast milk.  This what ALA does and why it is only made by women who are either getting ready to, or actually are breastfeeding.

To summarize:  ALA is made only by women, and only if they are either getting ready to breastfeed (third trimester of pregnancy) or actually are breastfeeding.

Men don’t make ALA ever.  Sorry, guys; you just don’t need it and wouldn’t know what to do with if it we gave it to you.

This is the nature of the universe of ALA when all is proceeding according to plan.

But cancer is another whole universe, isn’t it?  (Shall we say, hell?  I think so.)

Breast cancer cells, which in approximately 85% of cases arise from the normal cells that line the ducts of the breast, also make ALA! You see, cancer cells are crazy.  They go wild – genetically and behaviorally – and they start spitting out all kinds of proteins, including ALA.

And, as I say, the majority of breast cancer cells – crazy lunatics that they are – also make ALA.

So, let’s say someone – oh, like, Professor Vincent Tuohy of the Cleveland Clinic – makes a vaccine against ALA and then primes the immune system by virtue of this vaccine so that whenever the immune system “sees” a cell that is “expressing” (i.e., making) ALA, it DESTROYS IT LIKE A HEAT-SEEKING MISSILE.  Any breast cancer cell – like the majority of tumor cells found in women with breast cancer – that makes ALA would be, metaphorically speaking, VAPORIZED.

Tuohy’s vaccine – the world’s first preventive breast cancer vaccine (sorry, Fran Visco of the impressive National Breast Cancer Coalition on Capitol Hill, he beat you and your, well, well-intentioned Artemis Project congregation to the punch by, oh, about 12 years) – does just that:  IT VAPORIZES ALL BREAST CANCER CELLS THAT EXPRESS ALA.  Tuohy’s vaccine targets ALA.  Any cell expressing ALA is annihilated by the Seal Team Six immune system primed by Tuohy’s vaccine.

Get it?  Simple.  Divine.  Like truth, beauty, love, and joy, Tuohy’s vaccine works every time.

Tuohy’s vaccine is 100% effective in preventing breast cancer in three animal models.

Tuohy’s vaccine is completely safe.

Tuohy’s vaccine was thoroughly vetted by a panel of scientific experts on the editorial advisory board of Nature Medicine before the paper that announced his discovery and reported the results of his experiments was published in May 2010.  So, ladies, this is no joke/hoax/too-good-to-be-true baloney.  It’s a proven thing.

Tuohy’s vaccine is ready for clinical testing in women to see if it is safe (i.e., a Phase I study).

That’s what you need to know about alpha-lactalbumin and Tuohy’s vaccine.

Well, actually, there’s more you need to know, more we all need to know:  When will Tuohy’s vaccine receive the funding it needs (~6 million) to begin the Phase I study to see if it’s safe for use in women?  I mean, come on, people.  When?

God knows.  And I, for one, trust in God to make that answer clear to us very soon.  So, stay tuned.

There is Nothing More Powerful Than The Pure Cure: Prevention

There is nothing more powerful than an idea whose time has come. Victor Hugo

Indeed.  I recall when, five years ago, I first went to the Susan G. Komen For The Cure Foundation in my neighborhood (Summit, New Jersey).  I told them about my discovery of the existence of a breast cancer virus, and I urged them to help support this research.  I also suggested that, in addition to their goal of finding a cure, they focus more attention on finding the causes of breast cancer and working for primary prevention of the disease.  I met with Komen’s staff on two occasions and they couldn’t have been nicer.  But despite my enthusiasm – some would say passion – they weren’t really interested in prevention, per se.  As I left the second meeting, they gave me a copy of an audit of their funding for the previous ten years and assured me they would get back in touch with me soon.  As you can imagine, I read their report with great interest.   That was when I discovered that only a small portion of their grants went to primary prevention of breast cancer.  Sadly, I noticed that this small portion had dwindled so much over the previous ten years that it was barely visible against the wedge of funding devoted to diagnosis and treatment.  When the Komen staff didn’t get back to me as they promised they would, I went elsewhere.

I went to my attorney, Jeffrey Pompeo.  It was April, 2008.  I was just finishing up the International Masters in Health Leadership at McGill University and I was looking for a way to apply my expertise as a breast cancer surgeon (I was trained at Memorial Sloan-Kettering Cancer Center) and my vision as a healthcare leader.  I told Jeff I wanted to steer my country’s ship more toward prevention of breast cancer, and that if Komen, the largest breast cancer foundation in the world, wasn’t interested in primary prevention of breast cancer, I intended to create one that was.  And, so, the Breast Health and Healing Foundation (501c3) was formed with the mission, “To discover the specific causes of breast cancer and to use that knowledge to prevent the disease.”

That done, I next approached the Avon Foundation in New York City.  I met with its director, Mark Hurlbert on two occasions.  Mark seemed to be genuinely interested in the idea of breast cancer prevention.  I was able to persuade him that primary prevention of breast cancer was an overlooked aspect of the “race for a cure”, and that the discovery of a mouse virus in human breast cancer specimens was worthy of support and further research.  He agreed.  He told me that the Avon Foundation intended to partner with Dr. Susan Love to create the Army of Women, and then he made an email introduction to Dr. Love on my behalf, explaining how passionate I was about finding the causes of breast cancer.  Dr. Love clearly agreed, for shortly thereafter, and upon the official launch of the Army of Women, Dr. Love appeared on “Good Morning America” talking about how we needed to find the causes of breast cancer and focus more on breast cancer prevention.  I was thrilled.  At last!  My message and my mission had been adopted by Dr. Love and the Avon Foundation and now the nation was hearing about something they’d not been told previously:  we can prevent a large portion of breast cancer and we should commit ourselves to doing so.  Ever since, Dr. Love has been a strong advocate for what I call the“Pure Cure”.  I’m glad she’s made prevention the focus of her message, and I’m pleased that she’s taken every opportunity on stage to market this gospel.  Like the apostle, Paul, Dr. Love is carrying this good news far and wide.  And we are all grateful for that.

Now, let me put forth another idea that I hope Dr. Love, Avon and, dare I say, Komen will support:  If we can prevent 30% of breast cancer using known and proven risk reduction strategies (e.g., don’t smoke, maintain ideal body weight, exercise moderately for 30 minutes four times a week, avoid hormone replacement therapy, and avoid oral contraceptives), then I believe we should spend that portion of our breast cancer research money attempting to do so.  I have blogged about this many times, and last October I shared this message with my fellow members on the Leadership Council of the Harvard School of Public Health.  I told the large group that had assembled in Cambridge for the annual meeting that after studying Komen’s funding pie chart (and others, including that of the federal government), I was convinced that we needed to portion out the grants differently – in such a way that prevention receives the money it needs and deserves.  When I shared this opinion with the Harvard crowd, one of the women running the program blew me a kiss.  I replied with a broad smile.

There is nothing more powerful than an idea whose time has come.  And the time has come to put the Pure Cure into action.  I say, Direct at least 30% of the money we spend on breast cancer research on primary prevention of the disease.  (And I don’t mean early diagnosis via mammogram screening:  I meanprevention.)  If we follow this policy, we will be taking care of all women – those who have breast cancer and those who do not.

Like the Pure Cure, re-slicing the research pie so breast cancer prevention gets its fair share is an idea whose time has come.  And I’ll know my idea has ‘arrived’ when I once again begin hearing echoes … when my words become action in the form of money moving in a different direction.

For more information about the human breast cancer virus and the scientists who are working on this exciting research, please take a look at this documentary film I produced in 2010.  It was nominated “Best Film of the Year” by Rethink Breast Cancer.