The Cleveland Clinic announced today that it has secured the necessary funds to move the preventive breast cancer vaccine developed by Professor Vincent Tuohy in 2010 forward into a Phase I clinical trial to see if it’s safe for use in women.
As an early supporter of this, the world’s first preventive breast cancer vaccine, I am thrilled that the money that has been denied by traditional funding sources to Professor Tuohy for the last three years has finally materialized. A scripture reading taken from Psalms – part of my church service this past Sunday – seems appropriate: ”Thou shalt make me hear of joy and gladness: that the bones which thou has broken may rejoice.” And they do.
Tuohy’s vaccine, which took ten years to develop and two years of vetting before his data were published in Nature Medicine (May 2010), is completely safe and 100% effective in preventing breast cancer in three animal models. The vaccine, which targets an unique protein made in the majority of breast tumors, alpha lactalbumin, is especially powerful against the deadliest form of breast cancer, triple-negative breast cancer. Triple-negative breast cancer also happens to be the most common tumor found in women who carry a BRCA mutation. Thus, while Tuohy’s vaccine holds great promise for all women, it is especially promising for women with BRCA mutations and those with triple-negative tumors.
But we must not get ahead of ourselves in rejoicing, for the next step is to test Tuohy’s vaccine in a small group of healthy volunteers to make sure it is safe for use in women. Such a clinical trial is called a Phase I study, and it must – and will be – rigorously conducted and reviewed. As happy as we are that the funds required for such a study are now at hand, we must be sober about what lies ahead, for it is a most difficult process to seek permission from the FDA to conduct a Phase I study. The Cleveland Clinic is ready for the ordeal, and we must be too.
The vaccine must be proved safe. If it’s not safe, it will be abandoned and rightly so. But, optimistically, we can say that the vaccine is completely safe in three animal models and, thus, it is reasonable to move forward to see if it’s safe for use in women.
At this juncture there is a cautionary tale to share: it is the story of the early years of the AIDS epidemic when promising new treatments for patients with HIV languished at the FDA. It took a vigorous shaking of the cages at the FDA to move HIV drugs more quickly through the approval process. The result of this grassroots movement, known as “Act Up”, was the creation of a “fast track” through the FDA to accelerate drug approval so that patients who desperately needed new treatments could get them as quickly as possible.
Tuohy’s vaccine, aka the “Pink Vaccine”, should be fast-tracked too. There are approximately 3 million women now living with breast cancer in the United States, another ~250,000 new cases will be diagnosed by the end of year, with a total of 1.5 million new cases and 500,000 deaths predicted worldwide. To put a finer point on this staggering data, a woman is diagnosed with breast cancer somewhere in the world every 20 seconds; another one dies every minute. I can’t think of a better reason to fast track Tuohy’s vaccine than the argument made by this awful arithmetic.
Please help us fast-track the application for a Phase I study of Tuohy’s vaccine through the FDA so that the study can begin as soon as possible. Millions of lives, millions of breasts, and billions of dollars are at stake in answering the question, Is Tuohy’s vaccine safe for use in women?
“Act Up” taught us to speak up, so speak up and let your Congressmen know that you want Tuohy’s vaccine fast-tracked through the FDA.
Fast-track the Pink Vaccine and “let slip the dogs of war” to prevent this disease.
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