Clinton Global Initiative, Commitment To Action – Alpha & Omega: Breast Cancer Virus, Preventive Vaccine

By Dr. Kathleen T. Ruddy

If we can prevent breast cancer, we ought to try to do so diligently.

Scientists agree, at least 30% of breast cancer is preventable using known and proven risk reduction strategies.  Given this bedrock, we ought to build a fortress of prevention around women at risk – that is, all of us!  Based on this simple arithmetic, I suggest we spend 30% of all breast cancer research dollars working on primary prevention of breast cancer.  At the present time, and as best I can calculate (for these data are not easily retrievable via a Google search), less than 2% of all money spent on breast cancer research focuses on primary prevention.  So we have a long way to go down a road less traveled, don’t we?

Perhaps with the advent of the preventive breast cancer vaccine developed at the Cleveland Clinic in 2010, now funded to begin Phase I studies to see if it is safe for use in women, we can cure at least part of the frantic race for a cure with primary prevention of the disease.  And while I have been, and continue to be a strong proponent of testing this vaccine in clinical trials as soon as possible, I think a cautionary note is in order.  To wit:  the preventive breast cancer vaccine is 100% effective in preventing breast cancer in animals.  It also appears to be completely safe in animals.  But sober scientists and experienced public healthcare leaders like myself know well that not everything that works in mice works in women.  As the Director of the National Institutes of Health, Dr. Francis Collins, said to me in a round table discussion I attended yesterday at the annual meeting of the Clinton Global Initiative, “We’ve cured cancer in mice a thousand times.”  Yes, I know, we’ve been over this rainbow more than once.  Nobel laureates and a heaven of other scientists have been deeply frustrated bringing promising results from the lab to patients in their beds, only to be driven back on a current of discouragement like Nick Carroway in the final scene of the “Great Gatsby”.

So it is with sober eye yet hopeful heart that I support moving the Cleveland Clinic’s preventive breast cancer vaccine into clinical trials via the FDA’s Fast-Track approval process, first instituted during the early years of the AIDS epidemic when treatment for HIV was non-existent.  The FDA’s fast-track process now allows promising new discoveries that address diseases for which therapy is absent or marginal to be brought forward and tested quickly.  Because the Cleveland Clinic’s preventive breast cancer vaccine appears to be especially effective against triple-negative breast cancer, the most aggressive form of the disease for which there is at present no available targeted therapy, it is expected that the FDA will give permission to fast-track the Phase I clinical trials of the vaccine.   Fast-tracking the Cleveland Clinic’s preventive breast cancer vaccine is the “Omega” in my Clinton Global Initiative (CGI) Commitment To Action.  This CGI Commitment To Action is a requirement of every CGI member, a commitment that involves actually doing something, not just talking about something.  President Clinton is not about raising awareness, but about raising the bar and getting people and problems over it.

So what is the “Alpha” in my CGI Commitment To Action?  It is to answer the question, Does a virus cause breast cancer in women?

At this point, scientists are 75% certain that a virus found in mice and adapted for human transmission is responsible for 40-75% of breast cancer.  Scientific data regarding these two viruses (mouse mammary tumor virus, MMTV, and human mammary tumor virus, HMTV) have been accumulating and converging for more than 100 years.  But not one person I spoke to at the annual meeting of the Clinton Global Initiative in New York City this past week had ever heard of them.  And worse, less than $100,000 per year is given to support this research.  It is my goal to change this sad arithmetic and increase funding for research on the possible viral cause of human breast cancer.  Ignorance on this subject is no longer an option.  Everyone who heard me agreed.  Even Dr. Collins, with whom I discussed the history of this research at length, agreed to look into it when he returned to Bethesda and discover what the National Cancer Institute’s (NCI) position was with regard to this research.  When I told him the NCI was not spending a dime supporting research on the human mammary tumor virus, he looked a bit surprised and assured me he would take it up with Dr. Harold Varmus, Director of the National Cancer Institute, winner of the Nobel Prize, and former tumor virus hunter.

My CGI Commitment To Action, “Alpha & Omega:  Breast Cancer Virus, Preventive Vaccine”, is the culmination of five years of work as a healthcare leader, 24 years of work as a surgeon, and 61 years of work as a woman.  I hope, and fully expect, that my CGI Commitment To Action will galvanize the public and achieve for this research the kind of global attention it deserves.

I am deeply grateful to President Clinton for creating the Clinton Global Initiative, and to Secretary Clinton who, I imagine, helped envision it; and to both of these visionaries for giving me the opportunity to work with them and the most amazing people I have ever met or hope to meet.