These are the times that try men’s souls. Thomas Paine
Let me begin with this: I believe truth has a pure heart, untainted by vanity, in need of nothing more than peace and quiet.
One of my breast cancer patients came to see me last Thursday. She is in her late 30′s, a very upbeat, attractive black woman who works for the Post Office. I treated her for triple-negative breast cancer about 18 months ago. She had lumpectomy, radiation therapy, and chemotherapy. Though her tumor presented as a lump in the left breast and not as an abnormality on her mammogram, it was relatively small and easily excised. The patient had only two lymph nodes involved with tumor, a fairly typical finding in young women with breast cancer whose tumors tend to metastasize to the lymph nodes even before their cancer has been fully diagnosed and treated. Good news at the time: there was no evidence that her cancer had spread to other parts of her body. She kept a strongly positive attitude every step of the way, and her hair (lost during chemotherapy) grew back quickly and well. As she was before her diagnosis, she is now an abundantly attractive and vibrant woman.
But she has triple-negative breast cancer, a very aggressive form of the disease. Because she has triple-negative breast cancer (i.e., her tumor does not express estrogen, progesterone, or Her2 receptors), she is not a candidate for any further, targeted therapy such as tamoxifen or Herceptin. She’s been feeling just fine, she told me when I saw her three days ago. According to my records, she felt so fine that she skipped her last regular appointment which is routinely scheduled every three months during the first two years following treatment. As per my routine, I sent her a reminder letter; but she didn’t respond to it. I kept a copy of it in her chart. Then three days ago she showed up in my office, as pleasant and as upbeat as ever. She was mighty glad that the Post Office was no longer an official department of the United States government, for she needs to work and she needs a regular paycheck just like the rest of working America.
But my patient was not exactly “just fine” as it turns out. Indeed, she had a new problem to discuss: she had felt a lump on the left side of her neck (the same side as her breast cancer) and another just above her left collar bone. She discovered them both about a week ago, she said. Other than that she was fine, she said. She had no pain. She hadn’t lost any weight. She looked terrific and was as happy as could be – except she was a little worried about these two new lumps that suddenly appeared out of the clear blue sky.
Her cancer has returned. This was no surprise to me, albeit a shock to her. All women with triple-negative breast cancer have a high risk for tumor recurrence and death, but especially young black women. Unfortunately, there’s very little I or anyone can to do get rid of her killer cancer now. Sure, we can blast her with more (and more toxic) chemotherapy. No doubt, her medical oncologist will offer her exactly that. And, I suspect, she will agree to give chemo another chance. More surgery would be a waste of time, for removing the lumps will not add a day to her life but only two more scars to her body. Radiation therapy, if offered, might shrink the lumps, but not by very much.
I’m afraid that when I get the results of the scans I ordered next week, I will find evidence that her breast cancer has spread to other organs in her body. There is no race that can keep up with what she now has; in fact, there is no race that could have caught up with the dreadful disease she was diagnosed with two years ago.
As a black woman, my patient already had a higher risk for breast cancer than white women her age. As a black woman, she already had a worse prognosis compared to white women with her exact tumor and extent of disease. As a black woman, my patient already had a higher risk for triple-negative breast cancer. And like all women with triple-negative breast cancer whose cancer has recurred, she has a dismal prognosis. This lovely, vibrant woman has but a short time to finish up her life. I can’t say just how long she has to live, but it’s not long. What remains of her life will not be pleasant, though I will do my best to keep her spirits high and relieve any suffering she may have to endure. But despite my best efforts, and despite every advantage modern medicine has to offer, she’s likely to get worse by the month, then worse by the day, and then worse by the hour.
But there is a glimmer of hope, though it won’t come in time for her. In laboratory studies, the preventive breast cancer vaccine developed at the Cleveland Clinic in May 2010 looks especially promising against just this kind of breast cancer – triple-negative, the kind that is more common in black women than in white, the kind most commonly found in women who carry a BRCA mutation.
The Cleveland Clinic’s preventive vaccine, which sat on the shelf for more than three years before it was funded by venture capitalists who were willing to bet big money that it might work and who hope that one day they’ll make more money than God, may be just the thing for women with triple-negative breast cancer, and women with a BRCA mutation. The Cleveland Clinic now has the money it needs to apply to the FDA for approval of Phase I clinical trials to see if its vaccine is safe and effective for use in women. Generally, the application process to FDA and completion of the Phase I trials takes approximately five years.
We don’t have 5 years. I have a patient right now with triple-negative breast cancer who I think may not even have 5 more months. Everywhere you look there are patients with breast cancer who don’t have 5 weeks, 5 hours, and in some cases not even 5 minutes – for one woman dies of breast cancer somewhere in the world every single minute.
(Go to the home page of my website where you will see my iconic Cancer Counter, the clock ticking off the new cases of breast cancer diagnosed here and around the world, as well as the poor women dying of this dreadful disease. http://www.breasthealthandhealing.org)
The Cleveland Clinic’s preventive breast cancer vaccine – aka, the Pink Vaccine (as I named it three years ago when first I learned of it) – sat on the shelf for three years while most of the rest of the world sighed and looked the other way. The Pink Vaccine sat ignored while, the following year, Fran Visco of the National Breast Cancer Coalition (an organization to which I once naively belonged) created its Artemis Project, which is nothing more than a blatant, not even thinly veiled attempt to steal the seething swampy show around Washington, D.C. in favor of Visco’s promise to one day create a preventive vaccine of her own, in the hope that the world would follow her and not him, Professor Vincent Tuohy of the Cleveland Clinic, the man who actually has developed the world’s first preventive breast cancer vaccine. To be clear, Tuohy’s vaccine is safe and effective in animals; it remains to be tested in clinical trials to see if it’s safe and effective for use in women.
All the world’s a stage. Like Desdemona, Iago (I mean Visco) feels Tuohy’s vaccine must die as payment for an ego thwarted. Enter Breast Health & Healing Foundation and Champions of the Pink Vaccine: we don’t want Tuohy’s vaccine to perish tragically like Desdemona, slaughtered on the whim of a disgruntled captain.
The Pink Vaccine sat on the shelf at the Cleveland Clinic for three years while 3.9 million women around the world were diagnosed with breast cancer. It sat around for three years while another 1.5 million women around the world died of breast cancer. The Pink Vaccine sat and collected dust for three years while traditional funding sources (Komen, Avon, NBCC, etc.) collectively snubbed it, and while Congress, well-aware of its existence (especially breast cancer survivor, Representative Wasserman who was deeply and thoroughly briefed about this vaccine) dithered in its own incomprehensible way.
The vaccine sat. And sat. And sat. Like a pretty young girl who’s been given an evil and undeserved bad rap, the Pink Vaccine sat on the sidelines like a wallflower. It sat while others danced, while Congress fiddled, while Komen raced, while Visco puffed, and while women around the world burned.
The vaccine sat forlorn, looking like it might grow old and useless in its sedentary spot in the middle of a fractious country. But then capitalists appeared like the calvary, arriving to ask if they might dance with the pretty girl sitting all alone in the corner, the girl who most agreed was, yes, pretty, but otherwise worthless. Venture capitalists came to dance with the pretty, lonely girl. And they brought with them an army of lawyers – lawyers that moved through Ohio like Grant went through Richmond.
Briefcases were opened. Pencils were sharpened. Cell phones were muted. Faxes hummed. Who wants what? Who gets what? Who pays for what? Who gains what? What’s my cut? Every argument, every conceivable point of contention, and every possible eventuality was considered, considered again, and considered yet again. Forests died, and women died while all the papers were shuffled into their proper slots.
Finally, the documents were signed. Money – big money, the kind of money people like us only dream of – was wired from Bank A to Bank B and beyond. The term, Pink Vaccine, which I had invented and used for more than three years, was lifted intact, with not even a nod or a call in my direction, and placed squarely on the Cleveland Clinic’s web address. Cold comfort, that. Once all the dollar bills had fallen into their new featherbeds, a press release was issued. It was the equivalent of a birth announcement sent out by the very proud parents: the father, Professor Vincent Tuohy; the mother, The Cleveland Clinic; and the godparents … well, like the Corleone’s, they wish to remain anonymous.
At last, the new baby’s home became a new company created by the venture capitalists and the Cleveland Clinic, Shield Biotech. It’s where the Pink Vaccine now lives and will likely to grow up. We all hope it will be walking soon, in the direction of Silver Spring, Maryland, the headquarters of the Food and Drug Administration where it must go to receive permission – a blessing, really – to begin Phase I clinical trials to see if the vaccine is safe and effective for use in women.
So, that’s all very good news, wouldn’t you agree? Common sense – if only in the shape of dollars and cents – prevails at last, even if it’s a common sense brought forth by those whose only goal is to make a fortune. (BTW, this doesn’t include Professor Tuohy, who would have been more than happy to have received grant money from any one of the various traditional funding sources for breast cancer research and gotten on with his work three years ago.)
So, here’s my worry in the face of all this good news about funding for the Pink Vaccine, and it’s not just another interior blogologue from a contrary mind: the same forces that prevailed against the vaccine three years ago – ignorance, politics, vanity and power – have not only not gone away, I fear (in the manner of someone familiar with Shakespeare and history) that these opposing forces are preparing to sail a thousand ships to thwart the vaccine’s success at the FDA now that they have clearly failed to smother it by suffocation of funds. To wit:
Fran Visco of the National Breast Cancer Coalition has just recently recruited immunologists to her Artemtis Project to see if a new crew might be able to race ahead of Tuohy’s vaccine on their way to creating a similar vaccine, one based on specific cancer proteins rather than their previously conceived deep dive troll for DNA sequences to use as vaccine targets. Visco’s vainglorious attempt to end breast cancer with a preventive vaccine by 2020 would be noble if it were not so obvious an attempt to say, “Look at me!” As an aside, I couldn’t agree more with Visco’s website concession to the presumed outcomes of the Artemis Project, “We’ve already failed.” I expect she and NBCC and her new crew of immunologists will continue to fail if what they want to do is come in first. For the sake of women everywhere, I hope I am wrong and that the Artemis Project is able to produce a vaccine that safely and effectively prevents all breast cancer by their drop-dead date of 2020. I’m not opposed to success; I’m not opposed to competition; I’m not opposed to the idea that “many hands make light work.” But I am skeptical that Visco’s crew can create a safe and effective preventive breast cancer vaccine in seven years, for it took Tuohy a dozen years to perfect and test his. Nevertheless, let the record show, I am fully prepared to be pleasantly surprised if Visco’s team manages to prove me wrong. But let’s be clear, Visco’s crew have nothing to show us at the present time, and Shield Biotech does. Sheild Biotech has Tuohy’s Pink Vaccine that has been proven completely safe and 100% effective in preventing breast cancer in three animal models. It’s on its way to the FDA as I write this bulletin, but I’m worried what about what might happen to it when it gets near the seething swamp crawling with the Coalition in and around Washington, D.C.
Competion, even the furious and fretful competition thrown up by the ever vituperative Visco, is not what concerns me now. What has me worried is the congealing mass of stakeholders in our profit-driven, treatment-oriented breast cancer industrial complex – a business that is 3 times as big as the NFL, twice as big as tobacco, and represents the biggest threat in terms of female malingnancy in every country around the world. This industry, these people, these corporations that are the fiercest, bloodiest, and most ruthless ‘people’ (according the the rule of law) on the planet have no intention whatsoever of falling on their individual or collective swords to end a disease that makes them so much money. They busy themselves calculating their share of the pie, pay slick marketeers a king’s ransom to sell a sweet, pink massage to the public while women perish for want of a potentially life-saving treatment or, better, a preventive vaccine.
At this moment while I write this bulletin, I feel like Thomas Jefferson, John Adams, and Thomas Paine hunched across their desks on the eve of revolution. Instead of quill and ink and parchment, I have Mac, and screen, and Internet to hand. But I, as they, feel a looming, imminent danger if we don’t get together and do something now before it’s too late. But what, you ask, are we to do?
Download my FREE app, Lobby Me Pink. Use it to contact your Congressman and Senators: tell them you want the Pink Vaccine moved expeditiously through the FDA’s Fast-Track application process. Ask them to declare their position with regard to Fast-Tracking the Pink Vaccine. Make them take a stand, for you are about to take yours.
Take a stand.
Turn your smart phone (iPhone, Blackberry, or Android) into a voting booth.
Make history. Help us Fast-Track the Pink Vaccine.
We don’t have 5 years.
I have at least one patient who probably doesn’t even have another 5 months. Every minute we waste, another woman dies.
Come on, people, common sense says, Take a stand and Fast-Track the Pink Vaccine.
Yes, “These are the times that try men’s souls.” It seems they always have been.
NOTE: The following press release issued by the Cleveland Clinic on September 17, 2013 announcing the creation of Shield Biotech, the corporate vehicle for advancing clinical trials for the preventive breast cancer vaccine, included the “Pink Vaccine” as part of the web address for seeking ‘further information’. Lots to learn in reading through it:
PRESS RELEASE
Contact:
Joe Milicia, 216.312.0591, milicij2@ccf.org Laura Ambro, 216.470.7961, ambrol@ccf.org
CLEVELAND CLINIC INNOVATIONS CREATES SPIN-OFF COMPANY TO DEVELOP A VACCINE FOR PREVENTING BREAST CANCERShield Biotech will Seek FDA Permission to Determine Whether Vaccination Can Prevent the Development and Recurrence of Breast Cancer
Tuesday, Sept. 17, 2013, Cleveland: Cleveland Clinic Innovations has created a spin-off company to develop a preventive breast cancer vaccine based on research from Cleveland Clinic’s Lerner Research Institute.
The new company, Shield Biotech, will complete preclinical development and seek permission from the FDA to test the vaccine as an investigational new drug in proof-of- concept, first-in-human clinical trials. The trials are expected to start within two years and will take about three years to complete.
“The mission of Shield Biotech will be to translate the scientific research on a breast cancer vaccine, led by Vincent Tuohy, Ph.D., at Cleveland Clinic, into a viable preventive alternative for the patients who may benefit,” said Thomas Graham, MD, Cleveland Clinic’s Chief Innovation Officer. “We believe that the vaccine has the potential to stop the more lethal forms of breast cancer, as well as inhibiting the recurrence of triple-negative breast cancer in women after they have recovered from their initial disease.”
Initially, Shield Biotech will extend the development to the clinical stage in which the vaccine will be tested in two Phase I clinical trials as part of the process to obtain FDA approval. These trials are designed to establish the safety of the vaccine in women and to characterize and optimize the immune response.
Researchers at Cleveland Clinic’s Lerner Research Institute found that a single vaccination could prevent breast tumors from occurring in mice genetically bred to
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9500 Euclid Ave. / JJN4-01 Cleveland, OH 44195 Phone: 216.444.0141 Fax: 216.445.3040 clevelandclinic.org/newsroomdevelop breast cancer, while also inhibiting the growth of already existing breast tumors. The research was originally published in Nature Medicine in 2010.
Tuohy, the principal investigator on the original vaccine study, and an immunologist in Cleveland Clinic’s Lerner Research Institute, will be Shield Biotech’s chief science officer.
“We have proposed that breast cancer may be effectively controlled by providing healthy cancer-free women with pre-emptive immunity against emerging breast tumors,” said Tuohy. “We propose to provide women with an immune defense or shield that will protect them from developing breast cancer. Our data show that safe and effective immune protection against this disease can be induced by vaccinating against proteins that are no longer expressed in aging breast tissues but are significantly overexpressed in triple-negative breast cancer, the most aggressive and lethal form of this disease. We hope to provide women with a safe, effective and relatively benign alternative to invasive prophylactic mastectomy.”
Triple-negative breast cancer has a higher recurrence rate than other forms of breast cancer and is insensitive to current forms of adjuvant therapy. It’s the predominant form of breast cancer that occurs, for example, in women with BRCA1 mutations.
G. Thomas Budd, M.D., of Cleveland Clinic’s Taussig Cancer Institute, will be on the company’s scientific advisory board charged with the design and execution of the clinical trial protocol.
The first (Phase Ia) trial will involve women with triple-negative breast cancer who have recovered from current standard of care involving chemotherapy, radiation therapy, and/or surgery. This trial will determine the dose and frequency of vaccination needed to provide an optimum immune response. The second (Phase Ib) trial will involve healthy cancer-free women at high risk for developing breast cancer who have decided to undergo voluntary bilateral mastectomy to lower their risk. This trial will focus on the safety of the vaccine by examining the removed breast tissue for any potential changes.
“We expect these clinical trials to lead to more advanced trials designed to determine the effectiveness of the vaccine in treating triple-negative breast cancer, as well as its potential for immunoprevention,” said Dr. Budd.
For more information, visit http://www.clevelandclinic.org/pinkvaccine
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