HER2+

Lago, I'm sorry you weren't able to find the citation that Herceptin was tested in double blind placebo controlled trials. This is how rumors get started. People think they read something somewhere and it turns out not to be true. Thanks for trying anyway.

Also, thank you for the book suggestion. But I don't get breast cancer study information from journalists. I only use citations from the medical literature so I'll pass on the suggested read by Bozell.

Good luck to you!

Two trials of Herceptin were HERA and BCIRG 006. For more info you will have to look them up because I am link challanged. They both had Herceptin and control groups. It is interesting to read them.

Here is an article which summarizes the benefit of Herceptin, citing the various studies.

Adjuvant Trastuzumab: A Milestone in the Treatment of HER-2-Positive Early Breast Cancer 

Abstract

Up to one fourth of women diagnosed with early breast cancer (EBC) have tumors that are human epidermal growth factor receptor 2 (HER-2) positive. This is associated with a high risk of relapse and death from meta-static disease. Trastuzumab, a monoclonal antibody directed against the extracellular domain of HER-2, improves survival and quality of life in women with HER-2-positive metastatic breast cancer receiving chemotherapy. Four major adjuvant trials-Herceptin® Adjuvant (HERA), National Surgical Adjuvant Breast and Bowel Project (NSABP) B-31, North Central Cancer Treatment Group (NCCTG) N9831, and Breast Cancer International Research Group (BCIRG) 006-including between them >13,000 women with HER-2-positive EBC, have investigated different adjuvant treatment approaches with trastuzumab. These trials have shown that trastuzumab reduces the 3-year risk of recurrence by about half in this population. The benefit was similar across the trials despite differences in patient populations, chemotherapy regimens, and sequencing of treatment. At a 2-year follow-up, interim results from the combined analysis of the NSABP B-31 and NCCTG N9831 trials showed a one third lower mortality for trastuzumab, and there was a trend toward an overall survival benefit in the HERA and BCIRG trials. A small Finnish trial, FinHer, investigating another regimen of trastuzumab, has also shown similarly positive results. Further follow-up of the major adjuvant trials will clarify the survival benefit for women receiving trastuzumab, as well as the optimal treatment duration (1 or 2 years). Notably, cardiac events in the trastuzumab-containing arms of these trials have remained within acceptable levels, with a slightly higher (0.6%-3.3%) incidence of congestive heart failure that mostly responded to treatment. Further follow-up will provide information on long-term cardiac safety. Overall, results from clinical trials are sufficiently compelling to consider 1 year of adjuvant trastuzumab treatment for women with HER-2-positive EBC based on the risk:benefit ratio demonstrated in these studies.

I don't buy the stat that oncs wouldn't give their family chemo, either.  I haven't met a conventional doctor yet who would pass on chemo.  And yes, all drugs approved by the FDA are done with double blind studies.  

IMO, Dr. Ralph Moss is a highly qualified source on an Alternative Forum.  He is the protegé of none other than nobel prize in medicine laureate Albert Szent-Gyorgyi

His biography is available on the net. 

Dr. Moss also worked at the famous Sloan-Kettering cancer hosp.

I think he is well qualified.  Thanks, Maud.

tucker

Hi SpecialK,

I am posting this in its entirety. Ralph Moss got his PhD from Stanford. What he has to say about the drug industry and cancer is interesting and true. If you can prove otherwise - that Sloan did not suppress the info re: laetrile, please let me know.

WHY WE ARE LOSING THE WAR ON CANCER - PART I
by: Moss, Ralph, Ph.D.

Ralph Moss is the former assistant director of public affairs at Memorial Sloan-Kettering Cancer Center. He has spent fifteen years investigating the field of cancer research and is the editor of a quarterly newsletter, The Cancer Chronicles. He is the author of six books, including An Alternative Approach to Allergies, A Real Choice, a study of breast cancer patients, and Free Radical, a biography of Nobel Prize winner, Albert Szent-Gyorgyi, for which he was nominated for a Pulitzer Prize. He has written and produced several documentaries, including "The Cancer War" for PBS. Dr. Moss received his Ph.D. from Stanford University and currently teaches science writing at the New School for Social Research in New York City.

In 1974, I was hired as science writer and subsequently as assistant director of public affairs at Memorial Sloan-Kettering Cancer Center in New York. Sloan-Kettering is the world's largest private cancer center. At that time, we had 4,600 employees and dealt with tens of thousands of cancer patients from around the world. It really seemed like an ideal job for someone like myself who was interested in the cutting edge of science.

The first day I arrived, my boss gave me a very strange assignment. I was to track down information on one of the scientists at the center who it turned out was painting white mice with black splotches with a magic marker and claiming that he was actually transplanting black skin onto the white mice. This work had been so highly acclaimed that it made the front cover of Time magazine. However one of the lab technicians had become suspicious and when he rubbed the black skin with a little alcohol, lo and behold it disappeared. It had been applied with magic marker. The person who did this was punished by being given $40,000, and he has been practicing dermatology in the south since then. I thought this was a strange way to be introduced to a job at a place that's like the Harvard or the McGill of cancer science.

LAETRILE

The next thing they gave me to do, practically the same afternoon, was to answer a stack of correspondence which my predecessor had not gotten around to answering. There were 100 to 150 letters to be answered. The center got loads of mail from all kinds of people who were concerned about cancer, and most of those letters were about a substance called laetrile. Laetrile is a derivative of apricot kernels, and it contains, embedded into the molecular structure, cyanide. The theory of the laetrile proponents was that the cyanide somehow broke off and killed the cancer cells, but normal people were unaffected by it. Well, I had watched 20-20, so I knew that laetrile was quackery, and we were giving out a press release at that time which said that we were investigating laetrile and had no evidence that it was effective.

About two months later when I was still a rookie at the job, I visited the Walker Laboratories, Sloan-Kettering's animal research facility, to interview an elderly scientist by the name of Kanematsu Sugiura. By the way, this story is told in full detail in my book, The Cancer Industry. Dr. Sugiura was a wonderful character to interview. He was almost 80 at that point and he had been in cancer research since 1912. So he had 62 years of experience in the field and he had risen to a full member of the Institute. At the end of the interview, I asked him what he was doing at the present time. He was officially retired and did not have to come in, yet I knew he was coming in to work every morning at 8:00 and going home at 5:00. He told me he was working on amygdalin. It took me a minute to realize that amygdalin was another name for laetrile. I was very perplexed and asked him what there was to work on if it doesn't work. He said, "Oh, but it does." He took down one of his notebooks. He kept meticulous notes on all of his animal experiments going back to the 1920's and 1930's. He showed me that the tumours in the mice who were administered laetrile stopped growing; whereas the tumours in the control mice continued to grow and the mice died. I said, "Well, that's amazing!", not because these were the greatest results anyone had ever seen, but because I was sending out a press release saying we had not gotten any results at all with this substance. Dr. Sugiura said, "Well, that's nothing. The really important result is the prevention of metastases, the spread of cancer, which is what cancer patients die from nine times out of ten." Cancer spreads from some organ like the breast to a vital organ like the liver or brain or kidneys, and you die from the effect of that secondary growth, the metastasis. In laetrile treated mice, only 20% showed metastases in the microscopic examination after death. In the ordinary untreated or saline-control animals, 80% had metastases. So you can see that is quite a significant difference right there, between 20% having spread and 80% having spread. That was astounding to me. There were no drugs, and as far as I know, there are no drugs that control the spread of cancer in animals or in humans. It's one of the holy grails of cancer research to find a drug like that. Here it was - here was a drug that did that!

I could not believe what I was hearing and asked him why the officials at the center were so against this substance. He said, "Maybe the doctors are making too much money in the cancer field". Now, this statement from a man in his 80's who had spent 62 years in the cancer field astounded me, and it began a whole train of events in my life. I began by questioning successively higher officials at the center, starting with my boss who was director of public affairs, up to the top, to the president of the center. I asked each of them what was going on - why weren't we releasing the truth about laetrile? I got evasive replies to put it mildly. One of the most interesting replies came from the vice-resident for research at Sloan-Kettering. He showed me the American Cancer Society's book on unproven methods of cancer management, the quack list, and told me that this is where they get their ideas. He was an exceptionally honest man, but would obviously not come out in public and say that.

I was really in a quandary, because as time went by, the official position on laetrile became increasingly negative until, contradicting all established facts, in the summer of 1975, the other vice-president of the center told an interviewer from Medical World News: "We have found laetrile negative in all the animal systems we have tested." Now, this was patently untrue. We had tested it in three animal systems. It had been positive in all three animal systems, mainly in the prevention of metastases, and in the improved health and improved well-being of the mice. The mice who got laetrile had shiny coats. It acted like a vitamin just like its proponents said it did. My options at that point were very few. I could have just quit and gone off quietly. But what about all the people who had cancer who were calling every day, and the 500,000 people who are dying every year of cancer in the U.S. alone? So I kept on pursuing the truth of this matter, and it kept on getting worse and worse. Ultimately, I called a press conference to issue a counter report to the Sloan-Kettering report on laetrile. The result of course was that I was fired for "failing to carry out my most basic job responsibilities"

So my most basic job responsibilities, I guess, was to lie on behalf of Memorial Sloan-Kettering. I couldn't do that and I didn't do that. I had no connection at the time with any alternative cancer therapies. I didn't particularly like the laetrile movement. I didn't think laetrile was the greatest thing since sliced bread. I wasn't at all convinced that there were alternative treatments for cancer. I pretty much felt that surgery, radiation and chemotherapy were the way to go. But I knew that they were lying and that's about all I knew. I was suddenly out of a job. So my wife went out and got a job and has been working ever since while I do this investigation, trying to figure out what's going on in the cancer world. The political sphere of the cancer industry interests me very much.

POWER BEHIND SLOAN-KETTERING

Memorial Sloan-Kettering is a private non-profit organization. It became apparent to me in the four years I worked there that it was the board of trustees who ran the outfit. Even though they were not doctors, even though they were not involved in the day to day running of the place, the ultimate decisions always went to the board. The structure of the board was really amazing when you looked at it closely using power structure research. Two things stood out very clearly. First of all the board was just packed with people who had a vested interest in the most environmentally polluting industries in North America. Let me give you some examples of the present day board of trustees: the director of Olin Chemical, the president of Exxon, the chairman of the board of RJR Nabisco, makers of RGR Reynold's tobacco, the director of Philip Morris, the chairman of the board of Texaco, the director of Algoma Steel, the chairman of the board of General Motors, the director of Bethlehem Steel. Laurance Rockefeller, who is chairman of the board of Sloan-Kettering, is a director of Philip Morris and owns big chunks of Exxon, Mobil, Standard Oil of Indiana, Standard Oil of California and so forth. These substances that they are manufacturing all revolve around the automobile and its exhausts, petroleum and its byproducts. There is and there has been for some time ample evidence that the products of combustion and of petrochemicals are known carcinogens. They cause cancer. Why would these people want to be on the board of a cancer center? It seemed obvious to me. There is no research at Sloan-Kettering into environmental causes of cancer. You can read through the 1987/88 annual report and you won't find one research project into any environmental cause. No research into diet, no research into chemical causes, nothing-except the pharmaceutical approach to cancer.

They are looking for a cure for cancer, but they're not looking for anything that's going to upset the apple cart, that's not going to make money for somebody, big money for somebody. The second discovery I made was the strong ties of Sloan-Kettering to the drug industry. The largest producer of cancer chemotherapy, toxic anti-cancer drugs, is Bristol-Myers-Squibb. They have about 40 to 50% of the entire market. The chairman of the board of Bristol-Myers-Squibb is the vice-chairman of Sloan-Kettering Institute. The president of Bristol-Myers-Squibb is on the board of Sloan-Kettering Institute. A director of Bristol-Myers-Squibb is the other vice-chairman of Sloan-Kettering Institute. The chancellor of Memorial Sloan-Kettering is a former director of Squibb. The center itself owns millions of dollars of stock in Bristol-Myers-Squibb as it does in many of the other companies that produce the drugs used for cancer. They receive hundreds of thousands of dollars in gifts from the drug industry. There is no way you can look at this thing without seeing the unity of interests of the manufacturers of these drugs with the so-called objective, academic research into cancer and the direction of the war on cancer in general. Well, there may be nothing wrong with that if they were indeed finding cures for cancer. The problem is that with that power and with the agendas of the drug companies comes a very great narrowing of the research that is done, as it does also with many other diseases.

* * *

susieq,

I realize that. It wasn't about the time interval, but about who Dr. Moss is. He has current newsletters about cancer. As I said previously, I suggest you read "Herceptin or Deception?" by Dr. Moss. I always like to read what the person has to say before I criticize them, you know? He believes in CAM, and I see nothing wrong with that.

tucker

More info about chemo pros (?) and cons: 

One of the current remedies offered by conventional medicine when dealing with cancer is chemotherapy. Let it be said once and for all: chemotherapy does not have any positive effect on cancer. There is no scientific evidence that supports such fact. It shrinks tumors, but it doesn't initiate the healing that needs to take place to reverse cancer and to stay cancer free. What's more, its side effects are well documented - effects that worsen the patient's condition instead of improving it. (http://www.naturalnews.com/024536_cancer_women_breast.html)


Learn more: http://www.naturalnews.com/035063_vitamin_D_cancer_facts.html#ixzz1pA08f0yZ

tucker

And yet.....there are women with her2+ who have not had herceptin. And they are still alive. Who does the graphs? An unbiased source?

tucker

I'm going to settle this discussion..once and for all.

Read Eric Topol, MD's new book The Creative Destruction of Medicine!  Below is an interview with him regarding his new book that is in the current ASCO journal:

According to nationally regarded cardiologist and geneticist Eric Topol, MD, Chief Academic Officer of Scripps Health, the next frontier of the digital revolution can create exponentially better health care. Dr. Topol, who is also Director of the Scripps Translational Science Institute and Professor of Genomics, The Scripps Research Institute, recently shared his thoughts with The ASCO Post on an unprecedented transformation in medicine, as described in his recently published book, The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care (see book review). Here he discusses issues of value and cost in health care, the problems inherent in mass screening efforts, "individualized" vs "personalized" medicine, and how future innovations may be introduced to our health-care system.

Radical Innovation

Congratulations on your new book. It's quite a provocative title; what was the inspiration?

The title simply captures the extraordinary opportunity we have to vastly improve the way we think about and practice medicine. The term "creative destruction" denotes a transformation that accompanies radical innovation. But this transformation is not likely to emanate from the medical community, the traditional way innovation jumps forward. In the current era of social networking, the transformation will likely come from a convergence of technology and consumerism, especially in the cancer space, which offers the most near-term opportunity for positive change.

As one example, when we have a tumor biopsy or tissue sample, it solely gets put in formalin, then fixed in paraffin, which is completely unacceptable. We need frozen tissue so we can rapidly conduct exome or whole-genome sequencing and use it to customize the right care for the individual's driver mutations of a particular cancer. We have this technology; however, we have a challenge getting surgeons, pathologists-basically the whole oncology community-to switch to frozen samples. Of course, this is just one of many "rules" that need to be broken in the oncology sector.

Value and Cost

The health-care debate seems to get mired in issues of value and cost. How can we make systemic improvements given our limited resources?

One of the steadfast rules is that when you introduce new technology into health care, it is invariably coupled with increased costs. But we have an opportunity to turn that model around by being able to track physiologic metrics, genomic sequences, and advanced imaging modalities. By making medicine more precise, these advances can markedly reduce costs while improving care. The convergence of digital technology and consumerism will provide real, actionable data attached to specific health needs, which will in turn drive costs down by eliminating the waste involved in population-based medicine.

Screening and Individualized Medicine

Many in the oncology community believe that if we could replicate the mass screening efforts that are routine in breast and prostate cancer for application in other cancers, it would have a large impact on cancer mortality. What are your thoughts on screening?

The problem is that we don't recognize the primacy and uniqueness of each individual. To date, the judgments we make and things we do in medicine-the old rules, whether it's screening or therapy-are related to large populations, not individuals. Previously, we didn't have the digital tools to do otherwise. But now we're at this exciting inflection point, where we are able to zoom in on individual patient characteristics.

I never use the popular term personalized medicine, which to me denotes a concierge-style model. Instead, individualized medicine can define a patient biologically, physiologically, and anatomically, aggregating into what I call homo digitus-in effect, digitizing a human being for all the essential characteristics that make that person tick.

That approach will lead to far better outcomes going forward. For instance, we won't have to have all women undergo routine mammograms after age 40 or 50, because a substantial proportion of women have no risk of developing breast cancer. We will ultimately identify that no-risk or extremely low-risk population, thus eliminating false-positives, biopsies, and the associated anxiety and attendant costs. In this case, mass screening disregards individual variability and promotes unnecessary medical procedures.

Further, once we have a diagnosis, with few exceptions we don't screen that person to see what drug will work; we give the same drug to all people with that diagnosis. In diabetes, everybody gets metformin even though metformin doesn't have any beneficial effect in 25% of those patients. However, in today's medical mindset, we don't take the patient off metformin; we simply add another drug, without screening to see if the drug is going to work. There are almost 400 million diabetics worldwide, so it's a huge issue of wasteful medical resources. Again, that's just one example of many.

Introducing Innovations

Considering that we have the tools to create "homo digitus" patients, how can we organize those tools to really make an impact on our vastly complicated system?

By self-organization-there are groups out there already taking the lead with online patient empowerment communities. The people in these communities trust their peers more than their doctors, for one reason, because their peers have like conditions that are discussed freely. We have already seen the profound impact of social networking in the health space, and it's just the tip of the iceberg. When people have their personal physiologic metrics and genomics on handheld devices, they'll band together, and you'll see a movement that will change medicine.

Does a digital landscape fit into the strictures imposed by our limited financial resources?

Innovations moving forward cannot induce added cost pressures on the system. That would be untenable. We have a dual challenge with technologic innovation; it must improve health outcomes and significantly reduce expenditures. With creative destruction, you destroy very expensive methods with marginal benefit. In the United States, we spend $350 billion per year for prescription dugs, and we know at least one-third of that is total waste, offering no benefit or, even worse, inducing serious side effects.

Pharmacogenomics is a perfect way to destroy the old wasteful model of prescribing drugs. It's very inexpensive to run genotypes, once we have basically cracked the code-knowing the specific variant allele(s)-for each drug.

We have inexpensive ways to drill down to the things that produce good outcomes. For instance, I'm a cardiologist and I don't have to send a significant proportion of patients to a facility to have a formal echocardiogram, because I have a handheld high-resolution device that's just as good as the hospital laboratory. Why do we send people to facilities for sleep studies that reimburse at $3,000 per night when the same study could be done in the person's home for less than $100 and get the same data?

Closing Thoughts

Any last thoughts you would like to share?

I would like to see a transformation in which the medical community engages in the health-care revolution that will ultimately be consumer driven. We have a remarkable digital infrastructure including social networking that complements new opportunities to change the course of medicine, such as advances in genomics, biosensors, and imaging. There will be a superconvergence of human data capture that will give us the ability to digitally define the essential characteristics of each individual, not heterogeneous populations. I hope that my colleagues in medicine will acknowledge and embrace this unique opportunity to reboot medicine. ■

Disclosure: Dr. Topol reported no potential conflicts of interest.

More for the non believers who question the 2.1 % figure often quoted :  THE study

The contribution of cytotoxic chemotherapy to 5-year survival in adult malignancies

RESULTS:

The overall contribution of curative and adjuvant cytotoxic chemotherapy to 5-year survival in adults was estimated to be 2.3% in Australia and 2.1% in the USA.

CONCLUSION:

As the 5-year relative survival rate for cancer in Australia is now over 60%, it is clear that cytotoxic chemotherapy only makes a minor contribution to cancer survival. To justify the continued funding and availability of drugs used in cytotoxic chemotherapy, a rigorous evaluation of the cost-effectiveness and impact on quality of life is urgently required.

http://www.ncbi.nlm.nih.gov/pubmed/15630849.1

On another note: 

"Not credible: a subversion of science by the pharmaceutical industry. Commentary on A global comparison regarding patient access to cancer drugs (Ann Oncol 2007; 18 Suppl 3: pp 1-75)

An industry seeking to purchase ‘independent' academic corroboration of an industry-funded study on drug access and cancer outcome, in order to support the launch of an industry-funded campaign in which wider use of the industry's products would be expected to figure highly, might expect to be viewed with some concern, if not by marketing executives, then at least by scientists. 

It is neither premature nor petulant to criticize a 75-page report that invents an incorrect method of estimating cancer survival in a single short sentence, gets the wrong answer, models the incorrect results with drug data for a period some 10 years after the patients were diagnosed, and then concludes that low national survival rates are due to poor access to cancer drugs and slow national drug licensing. 

The wider concern is that a drug industry-funded report based on incorrect science can still achieve wide and uncritical publicity, with the serious attendant risk of misleading oncologists, policy-makers, and the public."

http://annonc.oxfordjournals.org/content/18/9/1433.full

Susieq58,

You couldn't find a Herceptin chart measuring overall survival?

As we know lack of recurrence is not a measure of all cause survival. I'm sure you've looked into this. Thanks so much.

Hillck,

Overall survival statistics can be measured at any time. The scientists just check who is alive and who is dead from any cause at a given point.  There is usually a five year endpoint available. The National Breast Cancer Coalition gives a Project Lead course which covers this.