Ralph Moss' report on Herceptin

[Christine MH-UK]

Hi Guest,

I am very concerned that this whole things has just gotten too divisive and am deeply troubled that one patient with secondary breast cancer may have decided to give up herceptin, which definitely has been proven to lengthen survival in patients with secondaries. Personally, I must say that I believe in herceptin not just because of the scientific studies but because I know somebody whose mother was given six months to live with liver mets and she is still doing well three years later. Is she cured? No, but without herceptin she would have been long since dead.

It's not that surprising that there are no studies of how women would do without treatment, since such a trial would be highly unethical. There are women who reject conventional treatment, but they are probably atypical in many ways.

Yes, there is a cardiotoxicity problem, but the 1/4 figure applies to one particular treatment, anthracycline, cyclophosphamide and trastuzumab. The figure for paclitaxel and trastuzumab was half that.

Maybe Hortobagyi has conflicts of interests, but what about the Finnish doctors who don't seem to have gotten anything from Roche/Genentech except criticism, partly because they showed that with herceptin a little goes a long way? I asked my oncologist if he had any conflicts of interest when he recommended herceptin (I had to, since the Sanofi-Aventis saleswoman was present and I don't want them thinking that we are a bunch of pushovers on drugs) and he looked very shocked and hurt and said no, that that would be unethical. I must apologise next time.

So, yes, herceptin has been hyped, but the big question with it isn't whether it is effective against primary breast cancer, but the most effective use for it. And, of course, nobody who really knows about herceptin would use the word cure, in part because on every trial somebody's cancer has come back.

Supported by F. Hoffmann–La Roche (Roche), Basel, Switzerland.

Dr. Piccart-Gebhart reports having received consulting fees from GlaxoSmithKline and, on behalf of the Breast International Group [BIG], an unrestricted educational grant from Roche; Dr. Leyland-Jones, consulting fees from Genentech and Roche and lecture fees and grant support from Roche; Dr. Goldhirsch, consulting fees from GlaxoSmithKline; Dr. Untch, consulting fees from Roche and GlaxoSmithKline and lecture fees from Roche and
This is an abstract from the HERA trial. Link below.

I simply do not have sufficient expertise to enter into the debate.

I would make some very general observations.

It looks mot and more that whilst BC is a broadly categorisable disease because it is at least in part genetically based it is also an "individual" disease with each person having the potential to form their own subtly different variant.

It is a mutli stranded disease.

Statistics show that many of the drugs produced do have effect, the question is for whom.

Finally the drugs and medical industry is a multi billion one, there are a lot of shareholders , patients and marketing men out there. The whole process involves humans. Humans when ever and where ever exhibit the same strenghts and weakness, the same desiire for position, acknowledgement, belonging and incredible power of acheivment..... We regularly see the results of our failings - the admissions as to stem cell research in Korea the latest, and the benifits - the web. Embracing new possibilities with a degree of vigilance and healthy cynicsm would seem to be a sensible stand point.

Below is an abstract of declarations of interest contained in the text of the Hera trail, and below the authors listed on the front page of the same.



http://content.nejm.org/cgi/content/...urcetype=HWCIT

ABSTRACT

AstraZeneca; Dr. Smith, consulting and lecture fees from Roche; Dr. Gianni, consulting fees from Genentech and Roche and lecture fees and grant support from Roche; Dr. Baselga, consulting fees from Roche; Dr. Bell, consulting and lecture fees from Roche and AstraZeneca and grant support from AstraZeneca; Dr. Jackisch, lecture fees from Roche; Dr. Cameron, consulting fees, lecture fees, and grant support from Roche; Dr. Dowsett, consulting fees, lecture fees, and grant support from Roche; Dr. Steger, consulting fees and lecture fees from AstraZeneca and Roche and lecture fees from Merck; Dr. Andersson, lecture fees from GlaxoSmithKline and Roche; Dr. Láng, consulting fees, lecture fees, and grant support from Roche; Dr. Nitz, lecture fees from Chugai and grant support from Roche; Dr. Thomssen, consulting fees from Roche and AstraZeneca and lecture fees from Roche; Dr. Suter, consulting fees and grant support from Roche; Dr. Rüschoff, fees for serving on the advisory board to Roche and for central diagnostic services from Roche. Dr. Süto"is an employee of Roche and holds equity in the company. Ms. Greatorex and Ms. Ward are employees of Roche.


Martine J. Piccart-Gebhart, M.D., Ph.D., Marion Procter, M.Sci., Brian Leyland-Jones, M.D., Ph.D., Aron Goldhirsch, M.D., Michael Untch, M.D., Ian Smith, M.D., Luca Gianni, M.D., Jose Baselga, M.D., Richard Bell, M.D., Christian Jackisch, M.D., David Cameron, M.D., Mitch Dowsett, Ph.D., Carlos H. Barrios, M.D., Günther Steger, M.D., Chiun-Shen Huang, M.D., Ph.D., M.P.H., Michael Andersson, M.D., Dr.Med.Sci., Moshe Inbar, M.D., Mikhail Lichinitser, M.D., István Láng, M.D., Ulrike Nitz, M.D., Hiroji Iwata, M.D., Christoph Thomssen, M.D., Caroline Lohrisch, M.D., Thomas M. Suter, M.D., Josef Rüschoff, M.D., Tamás Süto, M.D., Ph.D., Victoria Greatorex, M.Sc., Carol Ward, M.Sc., Carolyn Straehle, Ph.D., Eleanor McFadden, M.A., M. Stella Dolci, Richard D. Gelber, Ph.D., for the Herceptin Adjuvant (HERA) Trial Study Team

[AlaskaAngel]

I see this as a very, very healthy discussion, as long as it does not turn into a personal attack on anyone. This the right place for discussions pro and con by adults about cancer.

Like Christine, I know some individuals who personally are likely to have benefitted from traztuzumab. From the little bit posted about Mr. Moss I don't interpret Mr. Moss's conclusions to be saying that no one benefits from traztuzumab but quite the opposite. It appears he says that some do. I would think that those people we personally know are probably some of those he indicates that do benefit.

When I was first diagnosed, one of the first 3 books I bought about cancer included Mr. Moss's book Questioning Chemotherapy. I'm not paid by anybody to study about it and I don't buy into whatever happens to be current. We would still all be having radical mastectomies and we wouldn't have sentinel node biopsies if we aren't willing to seriously look at those who question the status quo.

It makes perfect sense to me for Mr. Moss to state that most breast cancer patients are not HER2 positive, and of the remaining patients who are HER2 positive, there are those who are HER2+ or HER2++, with HER2++ being somewhere between uncertain to unlikely to benefit from traztuzumab. Is this not true?

But for me a very real question about traztuzumab has to be raised because the clinical trials fail to include or represent those who were diagnosed in the group I am in. I have to say this because, as we all know, more and more breast cancer patients are being diagnosed in the early stages -- and not in the later stages used for the clinical trials. I believe the group not included is a very large group, since it also includes all those diagnosed with breast cancer in the past who have not yet recurred and who, know it or not, happen to be HER2-positive.

So I too have an open mind about the question of traztuzumab. Thank you all for the interesting responses to Energystar's honest and personal comments.

[DeborahNC]

I went to a BC support group run by Duke last night and was the only one of 10 women who was Her2 positive; they had no idea what I was talking about. I felt like we Her2 positives were underrepresented there.

I asked my onc about the studies showing 50-52% decrease in recurrence on Herceptin and she said that "we know Herceptin works for +++'s, it's the + and ++'s that are in question." So, as a +++ woman I'm feeling rather fortunate to have Herceptin in my arsenal.