Ralph Moss' report on Herceptin

[energystar]

Has anyone read this? I'd like to know what you think.

[al from Canada]

where is it? Love to read it,

Al

[RhondaH]

http://www.cancerdecisions.com/121805_page.html

Rhonda Hoffman

[CherylS]

Who the heck is Ralph Moss. Sorry for my ignorance.

i bought and downloaded the report. Funny how things happen, just today I cried and cried while talking to my husband and trying to explain to him why I did'nt want the herceptin. I am stage 4 with liver and lymph mets. just starting on herceptin alone the past few weeks. but after doing research and reading clinical trials and studies, i came up with the same conclusion Dr. moss did. that herceptin is alot of hype. it benifits a small, very small percentage of people in my boat. and increases time to death by a few months. a few months isnt anything. for me, i would rather face my fears . its a very personal decision. for some herceptin may be a good thing. but if you really read the study, not dr. moss's report, you will see for yourself that its the chemo thats keeping the cancer at bay, not the herceptin. I choose not to stay on chemo the rest of my days. i would rather just enjoy the remaining time i have. not strapped to the oncology chair every week of my life. if it worked i would run there. i read this forum every day. don't you find it strange that everyone progresses? that is what spurred me on to research herceptin in the first place. some have been on chemo numerous times, progressing while on the herceptin. i thought it was as clear as the nose on my face. its not a miracle drug. it works for a few. and God bless you, but for me, i would rather be given the facts, not the media hype of a drug , so i can make an informed decision about the rest of my days. thanks for listening, i needed to unload.

[Lolly]

I'm glad you feel you can share your feelings with us here, but I'm sorry you don't have more faith in the very real benefit you could receive from Herceptin. But as you say, it's a personal choice.

I personally think there is a very real and measurable benefit for many of us from the addition of Herceptin to our chemo regimens. For myself, the increase in time can be measured in years, not months. I was diagnosed Stage IIIB in Sept. 99, and recurred less than 6 months later when I then went on Herceptin/Navelbine. After 6 months of tx I had over 2 years of disease free time, during which time my daughter was married and settled in her first home, and my son bought his first home with our help, events I am sure I would not have been around to witness without the addition of Herceptin to my treatments. I base this belief on watching no less than four friends with breast cancer die during this period of time. Their diagnosis was similar to mine, their stage of disease actually earlier, their treatments similar and in fact two of them had the added advantage of having hormone positive disease which expanded their options. The ONLY difference between their situations and mine is that I am able to receive Herceptin to help keep the cancer contained. I am not under any illusions that this is a cure, that I will one day wake up and be disease free, but I do feel hopeful that Herceptin IN COMBINATION with chemo and other newer therapies in development will help this to be a manageable, chronic disease. I know many people who live with diabetes, COPD, heart disease, etc. and they don't mind taking doing whatever they need to do to live with their condition. I believe cancer can be managed the same way. I may eventually die of cancer BUT in the meantime I plan to live WITH cancer for as long as possible. I owe this to my loving family and friends, to my doctors and nurses who celebrate every victory with me, and most of all to myself.

<3 Lolly

[sherri]

Hi Lolly,
I read all your posts and enjoy your wise attitude; nobody could say it better than you did.

[Becky]

You said it all Lolly. Its exactly how I feel too. Herceptin is no magic bullet alone (perhaps for some) but it is a powerful weapon in the arsenal to fight Her2 disease. It also adds quality of life and adds to the lifeline so that when another weapon is invented or approved, we are still here to benefit from that because of Herceptin being here.


Best regards

Becky

[Lyn]

Hi there, like LOLLY I was diagnosed in 1998 and given 2-3 years at best with a very agressive fast moving cancer with no clear margin. I call my disease cancerbeties, I have been having continual treatment non stop but not for agressesive cancer, biopsies say similar but not the same as the original, my onc says it is a miracle I am still alive, I say no it is called hercerptin.. While I can still get through to the tomorrows there is the chance that there will be an answer. I have also parted with friends who compared to me were curable but not so. It is a personal choice and while I do have times where I just want to throw it all in, what stops me is how will my family manage without me, I know everyone says they will survive, but at what cost. I have a 16 year old daughter who I want to see get married, a 22 year old son who cannot read or write yet has a very well paid job, and tells me that he loves me and will never leave home, no he is not mentally impaired he just likes his cars and family life and an older son while in a relationship with an adorable 4 year old red head stepdaughter, I would like to see him have children of his own. This year for the first time I have bought Xmas decorations after Xmas that were on sale for next year , my daughter's response was lets hope you are still here, not the statement I expected from her but she knows what pain I have been in this last year with my fractured shoulders, nothing to do with the cancer but from accidents. You are not on your own, a lot of us have the same thoughts as you but something happens and we snap out of it until next time. We all pray for each other on this site and respect each others decisions, we all do care.

Love & Hugs Lyn

[Joe]

Mr. Moss has a Phd in classical literature and is an advocate of complementary therapy.

His income is solely derived by writing and selling medical reports although he has no formal medical training. I question many of his conclusions.

Regards
Joe

[karenann]

If I have to have Her2 cancer, now is the time. I am grateful to be able to take Herceptin. Thank you, Lolly and Lyn for your insite.

Karen

[Lolly]

FYI, a review of one of Mr. Moss' books has been cited in "QuackWatch".

http://www.quackwatch.org/04Consumer...iews/moss.html

[StephN]

... I was about to ask that VERY question!

How could he come to such conclusions after supposedly attending the SAME conference as I in San Antonio and hearing and seeing the same studies and research!!

As one who OWES MY LIFE to Herceptin, I cannot recommend that anyone who is HER-2 positive NOT try the drug to see if it will do for them what it has done for me and so many others that I know. I am NOT cured, but have had no evidence of systemic disease (after raging mets 4 years ago) in almost 3.5 years.

If you value your life and your family and friends, at least give this drug a chance. If you can get your mets under complete control there is a good chance that you can have a good quality of life for many years. We don't know everything - but are helping to write the book, for goodness sake!

[tammymarie1971]

Oh my where to start.....I'm not even sure what to say or how to say it...Sure there was alot of media hype about herceptin..and good thing even though some of it may have been "hyped" up the fact remains that it has helped a great deal of women!!!! without the horrendous side effects of lots of other treatments. Sure it doesn't work for everyone by itself..but from what I understand even if you progress while on it and it seems not to have "worked" it has done something to slow all the her2 receptors at least somewhat. Maybe I'm wrong but hasn't it been said that the longer you're on it by itself or in combination that it is keeping the her2 from exploding out of control, thus changing a very fast growing cancer into one that is more slower growing? It is not a cure but it has certainly paved the way for the cure..as now new biologicals are being tested and proven very frequently..Also lots of women when having chemo added to herceptin acheive stable disease which can then be maintained for long periods of time. I think Ralph Moss has some very good points on some things, but I do believe he is one sided..I have been to his website many times in the past, but I'm not sure I trust him to be fully non-biased in regards to anything in the cancer industry. I realize that it can seem somewhat daunting to think of being on treatment for the rest of one's life, but I do believe that we just have to find the right combo and not necessarily(sp?) the same one for all, but a great deal of us!! I don't know if all of this has made sense as I have so many thoughts swirling at the same time, but if I had a friend or sister or anyone that I cared anything about and they were her2 pos I would strongly urge them to at the very least to try herceptin.!!!!!
Tammy

[Christine MH-UK]

OK, I'm a cheapskate. Instead of spending the money, I have tried to figure out what it probably said and rebut it because I can tell everyone is getting upset. Did I get it right?

" The crucial difference between 'relative risk' and 'absolute risk' and how that difference has been used to exaggerate the importance of the Herceptin findings." Doesn't this just mean that herceptin reducing recurrence by 50% only means that recurrence is halved, not that somebody with a 50% chance of it coming back without herceptin gets a guaranteed cure with it (50%+50% being 100%), which we already know. Still, somebody with a 50% of disease free survival would surely welcome improving that to a 75% chance of disease free survival.

" The difference between disease-free survival and overall survival and why a focus on 'disease-free survival' can obscure the weak performance of a treatment." I guess he means that improved disease free survival doesn't prove that the drug isn't just delaying the onset of the secondary disease and improving overall survival. This is a major question, but the problem here, of course is that herceptin for secondary patients has greatly improved survival after recurrence, so any difference takes a while to show up. This point is legitimate, though.

"What did these studies really show about overall survival, and in particular what is surprisingly revealed in one of the charts on survival?" I think he means here that there is a chart that shows that patients who recur when receiving early herceptin live no longer than those who never received it in the first place. Which isn't that surprising, since those patients clearly have a herceptin resistant cancer. Maybe he also means that herceptin doesn't do a thing against CNS and brain mets (and don't we all know that one?). Still, there are all those patients who don't recur.

"What life-threatening complication is seen so often that it reduces the actual benefit of Herceptin to almost nothing?" He must be talking about cardiotoxicity here, but this varies between the trials from none (HERA, FinHer) to very low (HCT) to very high (the ones using adriamycin). Risks and benefits would also really depend on a particular patient's relative risks of heart disease versus death from cancer.

"Which other standard drugs—already received by a majority of breast cancer patients—increase the potentially fatal adverse effects of Herceptin?" Anthracyclines, which is why Slamon recommended HCT in his SABCS talk. Interestingly, if you look at the charts from that talk, the main culprit in cardiotoxicity is the conventional treatment, since cardiotoxicity shows up in the AC->taxotere control arm as well. HCT produced 30% fewer recurrences than AC->taxotere with much LOWER cardiotoxicity.

"Why patients over 50 years of age are harmed more and benefited less by Herceptin? Why patients in community clinics are unlikely to benefit as much as those in clinical trials?" Older patients are more likely to suffer heart problems. Benefitted less, though? I am not sure that you can say this. The only data are from HERA and it had relatively few patients over 60, which makes it difficult to judge the relative benefit, since the trial wasn't set up for this. I would guess that the monitoring in community clinics may not be as good as those on trials.

"Why did doctors stop this clinical trial early, before the full effects of Herceptin and other treatments had a chance to fully play themselves out?" This one I don't know. I know that HERA had planned to announce in San Antonio and had to declare early because of the US trials had decided to announce early. Maybe the scientists wanted to be first and get all the glory.
What does Moss suggest?

"What are some of the other drawbacks of Herceptin? Why does this 'targeted' drug, touted as a nontoxic miracle, routinely cause serious adverse effects in over 40 percent of patients?" OK, finally one that has me stumped and I have read just about everything on side effects.

"Which of the researchers currently promoting Herceptin as a cure for breast cancer are financially entangled with the manufacturers of this drug?" It depends on what you mean by 'entangled.' All of the trials, except I believe Finher, received some funding from Roche or Genentech. According to the Finher listing on an oncology website, it only received Finnish money and funding from Sanofi-Aventis. Like the Roche and Genentech funded trials, it indicates that herceptin does work against breast cancer and, indeed, that it may work so well that much less of it is needed.

"Which famous medical journal has also criticized the hyping of Herceptin?" The Lancet editorial, which I posted in the articles of interest section. The main valid criticism is that putting the results of the two US trials together raises questions about whether overall survival has been improved. The Finher trial, which had no financial stake, is nonetheless pretty close to achieving statistically significant overall survival and will help to resolve this issue I hope.

Personally I think that the worst one can say is that the only big trial with no heart problems reduced recurrence over AC->taxotere alone by a statistically significant 30%, that improved overall survival has not been decisively demonstrated, and that the big trials probably used excessive amounts of herceptin.

Okay, how did I do? Did I guess right?

[Joan]

More comments on Herceptin can be found at www.healthyskepticism.org.

Joan

[Marlys]

How sad that someone who makes his living writing could have this much say in something he knows little about. I believe that our guest is entitled to her choices but I am grateful for what is available for me to choose to participate in in order to prolong my life. For a lot of us at this site our disease is not progressing and if and when mine does I hope some other drug is being developed with as much promise as this one!

here are few of the statistics cited in the paper:

1. the u.s national cancer institute states that in patients previously treated with cytotoxic chemo whose tumors overexpress her/2, administration of herceptin as a single agent resulted in a 21 percent response rate, the median duration of their response was 9.1 months, while the median duration of survival was 13 months. since this was a phase 2, single arm trial we do not know how these patients would have fared with a different anticancer treatment, or no treatment at all. why are there no studies about how women live, survive, progress without treatment???

2.for women with advanced breast cancer with her/2 herceptin, on an average , extended their lives by about 5 months, compared to chemo alone.however their was serious heart damage in 1/4 of the patients in the study. 27%

3.when we get to overall survival (piccart-gerhart study) there were 37 deaths overall in the observation group(2.2) percent as opposed to 29 deaths (1.7) percent in the herceptin group. not really any significance at all

4. concerning the graph. it show a graph from the piccart-gebhart study showing the percentage of patients surviving with either hercptin or observation alone(i.e no further cancer treatment)the two lines on the graph
a solid one showing survival with herceptin and a dotted one showing survival with no herceptin- are virtually indistinuishable.

5.conflict of intrest......Dr. hortobagyi, a breast specialist at m.d.anderson, houston, wrote an accompanying editorial in the new england journal of medicine. he is one of the best known figures in contemporary oncology. yet he qoutes this about herceptin........"the strenth of evidenceis so overwhelming at this point that it would be almost immpossible to withhold this drug"Herceptin should be made the standard."
well what is disturbing is that dr hortobagyi, serves as a paid consultant to gentech, and has recieved monetary honoraria from Pharmacia and astraZeneca. That makes me skeptical was someone has their fingers in the pot.
6. the rest is about cardiotoxic side effects. and i know we all agree that that is an issue.

i just want to clarify that my position is concerning taking herceptin as a stand alone treatment. which is the decsion i am faced with. my muga was only 58% before i had any chemo, i.e. ac/t and herceptin and i haven't had a second one yet. im just wondering how many times you women who are 3 and 4 year survivors have been through chemo? 2 times, 3, 4? more? i am curious.i just dont want to be someone driven by desperation and fear. i want to use the good sense god gave me and not listen to every pharmacutical company and dr that stands to benifit from a standarized treastment with their drug. the trial was to short. and nobody know the true picture of herceptin. based on what i read here i am not impressed with the handful of people who praise the name of herceptin as the"cure". last week in the submitted articals forum, some newbie wrote"looking for survivors", well when i read the post there wer only a couple out of 450 members and how many visitors to this site who could site an instance of survival. i am trying to be realistic, the numbers just are not there without including years and years of chemo therapy treatments. i can understand saying you've survived with chemo, but i really dont see through study and numbers how you can attribute your success to 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