Herceptin vs Deception

[tousled1]

Has anyone heard of or have any info on the Moss Reports? I found the following site http://www.cancerdecisions.com/ and ordered the report "Herceptin vs Deception" ($9.95) a 20 page PDF report. According to the report the benefits of herceptin are greatly questioned.

[heblaj01]

Kate,

I read the full text of the essay by Ralph Moss titled "Herceptin..Deceptin".
He does not deny that Herceptin is a good drug . He complains that some of the glorious comments made after the release of trial results in 2005 were exagerated mainly because they only considered the relative risk reduction of recurrence, not the absolute reduction & did not dwell on overall survival.
He criticizes the validity of combining the statistical data of 2 trials .
He also seem to imply that the most optimistic commentators were biased because one way or another they were compensated financially by the manufacturer of the drug for their services as medical advisors or trial supervisors.

However, one must recognize, based in large part on what is reported on this web site, that Herceptin is the first low toxicity drug to effectively treat one of the agressive form of breast cancer, providing in many cases medium to long term regression or stabilization of the disease.
The QOL afforded by Herceptin compared to previously used chemo & the prolonged survival which increases the probability of getting a newer treatment (such as Lapatinib) cannot be ignored.

[R.B.]

Heblaj01.

I have not seen the Moss report but your summary does seem a fair.

I previously posted the trials. If you look at the authors and declarations at the end it is a fact that many of them had connections with the companies direct or indirect. A totally independent assessment must surely be preferable even if the only difference is perceptual.

I saw a report in the UK that the companies were funding and actively approaching? women that were seeking access to the drug, and that it was reported that this was part of their marketing strategy as they are not allowed to advertise. Difficult questions.

Human nature being what it is, observation of human behaviour in the corporate environment, and the vast potential profits for new treatments must be kept in mind in considering the hyperboli soup that accompanies some new drugs, in order to come to a fair assessment of the facts.

More figures and breakdowns would have been useful too.

However the fact the drug has been adopted by so many health authorities says a great deal, and the information available suggests as Heblaj01 put it

"However, one must recognize, based in large part on what is reported on this web site, that Herceptin is the first low toxicity drug to effectively treat one of the agressive form of breast cancer, providing in many cases medium to long term regression or stabilization of the disease.
The QOL afforded by Herceptin compared to previously used chemo & the prolonged survival which increases the probability of getting a newer treatment (such as Lapatinib) cannot be ignored."

RB

[AlaskaAngel]

Ralph Moss's views are controversial, but to me it is remarkable that anything as minimally successful and as toxic as treatment for breast cancer has been hasn't had even more probing criticism. When I was diagnosed one of the first 3 books I bought was his book "Questioning Chemotherapy", not because avoiding chemo was an "easy way out", but because oncologists were unable to say which patients would respond to chemotherapy -- and that was reason enough to try to find someone who at least was openly discussing its value.

Based on what we know so far, I agree with Helbaj01 and RB. But I still have to throw a bit of skepticism about traztuzumab due to the fact that so many "invisible" HER2-positive bc patients were not allowed to participate in the USA study at all (those who were node-negative and under 2 cm) and whose recurrence may be only delayed/long-term and who are thus an open question. After all, we do know that most breast cancer is being caught much earlier now, so that too could make that particular group of patients quite large. I would think that excluding this group allowed the traztuzumab results to be more spectacular.

AlaskaAngel

[karenann]

AA,

What about the Hera trial?

Karen

[tousled1]

If anyone wants to access the full report that I purchased please go to www.cancerdecisions.com/mossreports/25PDF/002/report.pdf (http://www.cancerdecisions.com/mossreports/25PDF/002/report.pdf)

userid: sKathlee8
password: hyuqkfb7

userid and password are case sensitive

You will probably have to cut and past the URL

[RhondaH]

http://her2support.org/vbulletin/showthread.php?t=22275&highlight=ralph+moss

Rhonda

[Christine MH-UK]

This report came out last autumn, at a time when it had not yet been shown that herceptin improved overall survival at all.

I definitely belief the stories about the drugs company approaching women in the UK. I believe that there was even a ham-fisted attempt by somebody connected with Roche, posing as a medical student of all things, to mobilise patients through a chatroom in which I participate. Of course, there was more to it than that. Alot of women, including myself, were involved in a real grassroots campaign to get the government to move faster on herceptin, since even women with her2+ inflammatory breast cancer weren't getting it. The government body that recommends treatments was originally expected to approve herceptin in February 2008, which seemed to slow. So, there was some real grassroots but there some 'astroturf' out there as well. And there was alot of hype in the UK, partly due to the more sensationalist newspaper's casting things in black and white, such as making it seem like women were 'condemned to death' without herceptin.

In the end, however, the UK's National Institute of Clinical Excellent recently recommend herceptin and they are pretty strict about what they will accept. They are so strict that they recently failed to recommend taxotere, even though it seems to be highly cost effective, simply because Sanofi-Aventis hadn't sought a license for the most relevant chemo combination. The NICE document only looked at herceptin after chemo and did raise questions, such as whether the benefits of herceptin would really last a lifetime or maybe only buy five extra years. It only looked at herceptin after chemo:

http://www.nice.org.uk/page.aspx?o=328476

The real question about herceptin now isn't whether it works to increase overall survival, but whether the current treatment is perhaps much longer and more expensive than it needs to be. There have been some excellent results from smaller trials using just herceptin + taxane (with or without platinum salt) followed by anthracycline (FEC or AC) and these shorter treatments seem to have alot less cardiotoxicity.

[tousled1]

Rhonda,

Thanks for the link to the previous discussion on the Moss Report. I'm a relatively new member and still trying to get educated.

[RhondaH]

we ALL were new once too:) Have a great day! Take care and God bless.

Rhonda

[heblaj01]

An other point made by Ralph Moss in his essay is concerning the potential under reporting of heart side effects when the population of patients using Herceptin is extended beyond the limits of the criteria for admission to the clinical trials.
The accepted women were relatively young & without cardiovascular problems.
This may not be the result of a devious design to show improved outcomes.If the women had been admited with debilitaing heart preconditions the observed side effects of Herceptin could have been "messed up" by confounding factors.

However,as the use of Herceptin is extended to either older or heart weakened women the rate of ocurrence of heart side effects is likely to rise.

[AlaskaAngel]

Hi Karenann,

When I post, I feel I am "every woman" because there is so much I do not know, and I know there are plenty more who read here who are like me. So thank you for your patience and understanding with my somewhat simple views.

I find it confusing that the medical system in the U.S.A. has separated out what I see from the posts here to be a reasonably significant group of people who clearly do have HER2 positive bc but who, HERA or no, remain officially irrelevant in regard to any recommendation for treatment with traztuzumab.

If those like me who fall in this group should ignore the silence about this by ASCO and look to HERA for a better answer, what is wrong with the wizards of oncology in the U.S.A. who are responsible for exploring and offering the best possible outcome for those in the U.S.A. like me?

Do you know if off-label drugs that seem appropriate based on HERA results are broadly and routinely paid for by the drug company or medicare for the growing numbers with HER2 bc in the USA who are economically at risk?

AlaskaAngel

[StephN]

I know that there is followup for adjuvent Herceptin trial participants and am hoping those of you in these trials can shed some light on how this is going, your plan, how you are kept track of, etc.

These results for the 4 -5 year out group will give us a better picture of how these trials worked in the longer term.

There are also better and more precise screening tests to determine the best patients for Herceptin as well as other chemos and targeted therapies. All of this will change data as cancer targets are better pinpointed through ongoing research.

Mr. Moss will either stand or fall on his own sword when there is future data released.

As for ME, I still know that as Stage IV, without Herceptin I would not be writing these words. Having come through the chemos for my secondaries, and maintained on Herceptin during FOUR years, there is NO DOUBT which drug is working.