Jan 18, 2011 06:04PM - edited Jan 18, 2011 07:26PM by otter
Tuohy was already awarded a 4-year, $1.3 million grant from the NIH (through the "American Recovery and Reinvestment Act") and the National Cancer Institute.
That award was publicized in 2009. I assume Tuohy wanted the NIH/NCI money to continue his research on mice. (I don't know that, because I haven't seen the project details listed anywhere.) Now he wants $16 million more, to start human trials with the vaccine. But, those will be "Phase I" toxicity studies, done in women with Stage IV breast cancer (as is often the case with the initial studies of a new cancer treatment or procedure).
Tuohy estimates that it will be at least 10 years before his vaccine is available for clinical use: "He estimates a target date of 2020 for the new vaccine, although time, funding, and FDA requirements are among the hurdles." http://www.lerner.ccf.org/news/2010/7/5.php and http://content.usatoday.com/communities/ondeadline/post/2010/06/cleveland-clinic-doctor-reports-a-possible-vaccine-to-prevent-breast-cancer/1
The approach he is using does have some critics, who point out that a great deal more safety testing is needed. (http://www.nature.com/scibx/journal/v3/n24/full/scibx.2010.721.html) Tuohy's strategy involves triggering an autoimmune response by injecting patients (or, at this point, mice) with α-lactalbumin, which is a normal protein found in lactating mammary tissue and in malignant breast tumors. The injected protein stimulates an inflammatory response, resulting in "breast inflammation and nipple irritation" in the immunized animals if they are lactating.
Tuohy concedes that "...the effects of the immune response to lactation would be a nuisance and discomfort” in women. So, he is proposing that the vaccine be used mainly in women over the age of 40, because they are less likely to become pregnant (and lactate) than younger women but are at greater risk of developing breast cancer.
He says, “The vaccine is really designed for a woman of any age who thinks she should have it, but the trade-off will always be an inability to breast-feed successfully.” ... "I have spoken to a lot of women about” having to trade breast-feeding for protection from potentially fatal breast cancers. Most women over 40 don't plan to have more children and said the trade-off was not an issue at all.”
It's interesting that all of the flurry of activity concerning Tuohy's research was triggered by press releases from his lab and from the Cleveland Clinic's Lerner Institute, where he works. And, all those press releases trace back to a single paper his lab published in 2010:
An autoimmune-mediated strategy for prophylactic breast cancer vaccination
Ritika Jaini, Pavani Kesaraju, Justin M Johnson, Cengiz Z Altuntas, Daniel Jane-wit, & Vincent K Tuohy. Nature Medicine 16, Pages 799–803 (2010)
Aside from that one paper, everything else he has published has dealt with autoimmune diseases. Maybe that's why he is having trouble obtaining funding for a clinical trial.
[Edited to take out reference to "solicitation for money."]