Dr. Tuohy Vaccine....Have you Heard?

I think that mice and humans do not translate.

I wish with all my heart his vaccine would be "the one" and he get a shot at trials...win-win, but many things that worked 100% in mice failed in humans.

CBS news had a story on the great woman scientist who developed meds for HIV, other vaccines, and began a drug that worked 100% in mice for Alzheimer's.  Ironically, she was dx with AZ at 64.  Her drug has failed in humans to date, but she is taking the vaccine.  Her comment was she feels it is slowing the disease, but not curing/treating it.

This is why they have trials in humans...to see if what pans out in mice or in vitro works in vivo-human.

I agree with wallycat.  Mice are not humans.  Neither are rats.  What works in mice and rats in a lab under extremely controlled conditions will not, necessarily, translate the same way with humans.  That's why all medical research must be regulated by an outside institution with no interest in the outcome.  Sometimes research, simply, isn't conclusive enough or is faulty.  Sometimes, clinical trials prove that something that works in the lab will work on humans, but - most of the time - they don't.  We, only, read about the success stories.  And I know because I used to work for a pharmaceutical research company.  Far more research- and drug compounds failed during outside scrutiny or clinical trials than succeeded.

If the United States Federal Government and a nationally-recognised breast cancer coalition have raised concerns about the efficacy- or the safety of the vaccine in a lab setting, I would suggest that those concerns are likely valid and need to be addressed before the vaccine is ready for clinical trial.  No one wants the vaccine to hurt more people than it helps or provide false hope.  That would be cruel. 

Sorry. 

Dr. Slamon did hit every road block imaginable.  But he persisted, tightened his research, and addressed all the concerns raised by outside regulatory bodies.  Moreover, he became an excellent advocate for patient welfare in the face of big pharmaceutical interests.  And, as a result, Herceptin made it to market and helped a lot of people.

If - and I stress "if" - this vaccine is all that the doctor is hyping it up to be, he would do well to emulate Dr. Slamon.  Persist.  Tighten the research.  Address the concerns.  Ensure that the vaccine will perform as expected and be very sure that it's safe and effective.  Go over the results; again and again, and again.  Ensure that the results can be duplicated by someone else.  Cutting corners- and trying to circumvent regulatory agencies is not a good way to start.

If the vaccine is really that promising?  It will make it to clinical trial.  And so it should. 

What are the objections of these groups to funding further research?

I don't know much about this vaccine.   The original paper was impressive.   And cleveland clinic is one of the best.

I remember a news article that says Dr Tuohy applied for a big government grant, and failed due to some "technical issue".   If it's a minor technical issue, I'm sure the vaccine will get more funding soon.   Hope he will persist and get this to clinical trial.

SelenaWolf and Wallycat have also the good point that mouse trial is very different from human trials.   That's why good animal model of a disease is worth the weight in gold, no worth tons and tons in gold.   Which unfortunately we do not have for cancer, we just don't have good enough animal models.

I don't know about Komen.  I'm surprised they'd only give 1 grant to the very best research project.   Given their trade-marked claim of "for the cure", I'd imagine they'd give at least 50% for research projects on the frontiers of MBC care.  And there never was never will be "the best" research projects for the cure, because we need multi-pronged attack on different subsets of breast cancer.  Wait, maybe I'm wrong.   They actually spend a lot less than that.   Woops.   They should consider change their spending priorities.

Oh well.   Personally, when looking at a clinical trial, the first question I ask is:  will this help MBC patients?   If Dr Tuohy's vaccine is designed for curing MBC patients, then I'll be very excited.

Cool. I'll look for the full paper by Dr Tuohy then. Is there a link?

I only found a letter by Dr Tuohy rebutting other researchers' opinions:

http://breast-cancer-research.com/content/12/6/405

http://breast-cancer-research.com/content/12/4/310 

Sounds like this vaccine in mouse models don't do much about established BC (maybe slow the BC for a short while), much less MBC.       

Preventive vaccines are expensive to test in humans.   You need to make sure it's absolutely safe and effective in the LONG LONG term (think decades) for MANY MANY patients.   Therapeutic vaccine for MBC is much less expensive to test in humans and you don't need as many patients in your clinical trials.   So even though I think it's a good idea, I hope Dr Tuohy will persist and tweak it or change the approach to tackle MBC instead.

Patient advocacy is wonderful for helping early stage research to go into clinical trials. On the other hand, peer-reviews are also absolutely necessary to guarantee sound science.  

Can't remember the grant that was lost but it wasnt the FDA.

The same thing happened with herceptin in terms of lack of funding. Sadly this happens, and it takes great effort to get around the blocks. Thank god herceptin finally got through, or I wouldn't be alive.

As others have pointed out, Dr. Tuohy is not the first doctor or scientist to find a treatment that stops cancer in mice.  As many before him have discovered, that doesn't mean that the treatment will work on humans.

Dr. Tuohy is also not the only doctor or scientist working on a breast cancer vaccine.

"Breast cancer has perhaps seen more vaccine development activity than any other kind of cancer. Neuvax, a vaccine developed by Galena Biopharma to prevent recurrence, is in phase 3 clinical trials and there are many more candidates in the early stage pipeline from pharma giants like GSK to startups like Immunophotonics. Oral vaccines are being studied as well by researchers at Mercer University and Swiss-German biotech company VAXIMM AG, which enrolled the first clinical trial of its oral therapeutic cancer vaccine last fall." http://medcitynews.com/2013/01/oral-vaccine-to-prevent-breast-cancer-recurrence-delivers-promising-results-in-early-study/

It appears to me that Dr. Tuohy's vaccine has the most prominence in the media because Dr. Tuohy and a couple of his supporters are the best at promotion.  When I Google “breast cancer vaccine”,  I get dozens and dozens of articles about Dr. Tuohy and his vaccine but it turns out that they all source from the same few people. So this makes me wonder why Dr. Tuohy’s vaccine doesn’t have more support within the medical and research communities, and if there is something about it that we haven’t heard.  It seems to me that it’s been stalled at the same place for years now…. and while I understand that major funding and approvals are required for a human trial, I would think that there would be more that could be done, without much cost, to continue to show that the vaccine has promise. If there are reasons why he's been refused funding by some of these major organizations, what is he doing to address those reasons/concerns? 

All that's not to say that his vaccine might not be the wonder drug we are all looking for or that testing shouldn't continue.  But I have to admit that knowing that he's from as prestigious an organization as the Cleveland Clinic and yet he hasn't been able to get funding from any of the big funders, and knowing that the NBCC decided not to work with him but instead have chosen to go down their own path for a vaccine, I can't help but feel that we aren't getting the whole story here.