Ralph Moss quotes
Ralph Moss
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In fact, randomized clinical trials with appropriate controls are rarely performed in conventional oncology before or after the approval of a new drug. When studies are reported as positive that is usually in comparisons with other agents, or it is a measurements of surrogate markers rather than of increased survival.
If you want to change it you change the law that establishes the need for double blind clinical studies in drugs. You eliminate the efficacy clause from the Harris amendment to the food and drug act, which Harris himself didn't even want. This was imposed by the FDA and the drug industry. This upped the ante and made a regulatory barrier. Now instead of it taking 1 million dollars to establish the safety of a drug, you now need 300 million dollars. So none of the small inventors, or the people with good ideas can ever hope to possibly hope to get their drugs approved. They put you in administrative limbo where the best you ever hope to get is this backburner simmering kind of thing, and I know of a number of good scientists who have got IND's (Investigative New Drug Applications) to test drugs, but when you try to market the drug they will put you out of business, and Dr Burzynski is the prime example. Brilliant scientist, wonderful results in cancer, validated by the NCI, and yet he is on the verge of federal indictment. Interview of Dr Ralph Moss, Ph.D. (see)
For the past 25 years, most of the laboratory research into metastatic breast cancer has been based on a single breast tumor cell line known as MDA-MB-435. At least 650 papers have been published on studies involving this cell line. Yet it has been revealed that this supposed breast cancer cell line may in fact not be composed of breast cancer cells at all. Instead, it appears that the cells are derived from melanoma. For 25 years, therefore, breast cancer research using this cell line - and it is one of the most widely used - has been based on an incorrect model. Melanoma-derived tumor cells are not biologically equivalent to breast cancer cells; they have different molecular and genetic characteristics. STARTLING REVELATION ABOUT BREAST CANCER RESEARCHDrugs may be reported to increase survival but upon closer examination this
turns out to be an increase in "relapse-free survival," or "time to recurrence,"
and not an actual increase in median overall survival. Yet, I would argue that
only an increase in overall survival conveys a true benefit to the patient. A
patient who has an increased relapse-free period, but no increase in actual life
time, is not actually benefited by treatment, except in a psychological sense.
Real benefit in terms of overall survival is rarely demonstrated by chemotherapy
for the solid tumors of adults.
This is what I call the "Grand
Illusion of Chemotherapy." It is the idea that the shrinkage of tumors, or
improvement in tumor markers, or increased relapse-free survival, necessarily
correlate with actual benefit to patients. Surveys have shown, and common sense
tells us as well, that the two outcomes that cancer patients seek from
chemotherapy are (1) an improvement in quality of life, and (2) an increase in
their actual survival. Tumor shrinkages are not a high priority {CA Cancer J
Clin 2000;50:123-32}.
Medical oncologists, by contrast,
tend to concentrate on the shrinkage of tumors. Such shrinkages are called
"responses." The FDA defines a complete response as a complete disappearance of
all clinical and X-ray signs of cancer for one month or more. A partial response
refers to a 50 percent or greater decrease in measurable tumour size for one
month or more. In the past, the FDA also required some proof of life
prolongation. But this stringent requirement led to very few drug approvals.
From the 1940s to the mid-1990s, in fact, only about three dozen drugs had been
approved by the FDA, less than one per year. The FDA's reluctance to approve
drugs based on shrinkages angered the pharmaceutical industry, as well as some
oncologists and patient activists. So, in the mid-1990s the government relaxed
these requirements and since then FDA has approved many new drugs. Our task is
to see if these new approvals have actually resulted in improved treatments.
[2000] The Grand Illusion of
Chemotherapy by Ralph W. Moss, Ph.D.
Advertisements for Arimidex (anastrozole) show a woman's hand holding a star-like tablet. It urges doctors to "put survival in the palm of her hand" and claims "56.1 percent survival" for patients treated with this drug. This figure clearly implies that more than half the women who take Arimidex are significantly benefited, if not saved from their breast cancer. However, this 56.1 percent represents two-year survival figures in studies comparing Arimidex to an older drug, Megace. In fact--as the advertisement itself notes in the fine print-women treated with Arimidex have a median time to death of 26.7 months compared to 22.5 months for patients treated with Megace. Thus, the actual difference between the two groups is 4.2 months, a difference that the study itself notes is not statistically significant {Cancer 1998;83:1142-1152}. [2000] The Grand Illusion of Chemotherapy by Ralph W. Moss, Ph.D.
Taxotere is a semi-synthetic derivative
of the Pacific Yew tree, similar to Taxol. In non-randomized clinical trials in
breast cancer, there was indeed a very high rate of responses. While only
2 out of 37 patients had complete responses, another 18 (49 percent) had partial
responses. The median time to progression was 26 weeks, while with the older
drug Adriamycin it was 21 weeks. Thus, at best, there was a gain of five
weeks. The median survival time (which, as I have said, is the key indicator
of benefit) was 15 months with Taxotere compared to 14 months with Adriamycin,
a gain of one month. But 87 percent of patients had fluid retention or
other serious side effects with Taxotere {J Clin Oncol 1999;17:2341-54}. One
must question what the quality of life is during that extra month.
Taxotere has also been approved for
the treatment of non-small cell lung cancer. According to advertisements,
Taxotere is "the first single agent to show a significant one-year survival
benefitwith a predictable and manageable safety profile." However, when
scientists at M.D. Anderson Cancer Center compared both a high-dose and a
low-dose regimen to placebo, they conceded that "overall survival was not
significantly different between the three groups" {J Clin Oncol
2000;18:2354-62}. I find this study unusual in that it actually included a
placebo group-something that has been eliminated from most studies performed in
support of FDA approval. The failure of taxotere to impact positively on
survival is omitted from the company's four-and-a-half page advertisements
appearing in medical journals. There was also lung toxicity in 40 percent of
those who took Taxotere as well as many other side effects.
[2000] The Grand Illusion of Chemotherapy by
Ralph W. Moss, Ph.D.
"The great success stories of chemotherapy were always in relatively obscure types of cancer. Childhood leukemia constitutes less than two percent of all cancers and many of chemotherapy's other successes were in diseases so rare that many clinicians had never even seen a single case (Burkitt's lymphoma, choriocarcinoma, etc.)"—Ralph Moss
"Two to 4% of cancers respond to chemotherapy….The bottom line is for a few kinds of cancer chemo is a life extending procedure---Hodgkin's disease, Acute Lymphocytic Leukemia (ALL), Testicular cancer, and Choriocarcinoma."----Ralph Moss, Ph.D. 1995 Author of Questioning Chemotherapy.
"1.7% increase in terms of success rate a year, its nothing. By the time we get to the 24 century we might have effective treatments, Star Trek will be long gone by that time." Ralph Moss.
The fact that breast irradiation increases the risk of heart disease is not a new finding. Starting in the late 1960s, it became known that, after receiving adjuvant radiation to prevent breast cancer recurrence, more women than expected were dying of heart disease, sometimes decades after their initial surgery. It took brilliant medical detective work to prove that this apparently successful use of radiation therapy was also the cause of many cardiac deaths (Fajardo 2001). So many women were dying of the long-term adverse effects, in fact, that it more or less counterbalanced any survival benefit from the treatment itself."If you can shrink the tumour 50% or more for 28 days you have got the FDA's definition of an active drug. That is called a response rate, so you have a response..(but) when you look to see if there is any life prolongation from taking this treatment what you find is all kinds of hocus pocus and song and dance about the disease free survival, and this and that. In the end there is no proof that chemotherapy in the vast majority of cases actually extends life, and this is the GREAT LIE about chemotherapy, that somehow there is a correlation between shrinking a tumour and extending the life of the patient."---Ralph Moss
"A study was done which shows the majority of oncologists who refer patients for chemotherapy for lung cancer would not themselves take chemotherapy for lung cancer. And in fact if the chemotherapy involved cis-platen, something like 75% of them said they wouldn't take it. But what do these people do all day long? They're sending people for cis-platen."--Ralph Moss (www.ralphmoss.com
"The great success stories of chemotherapy were always in relatively obscure types of cancer. Childhood leukemia constitutes less than two percent of all cancers and many of chemotherapy's other successes were in diseases so rare that many clinicians had never even seen a single case (Burkitt's lymphoma, choriocarcinoma, etc.)"—Ralph Moss
"Kanematsu Sugiura…..took down lab books and showed me that in fact Laetrile is dramatically effective in stopping the spread of cancer. The animals were genetically programmed to get breast cancer and about 80 - 90% of them normally get spread of the cancer from the breast to the lungs which is a common route in humans, also for how people die of breast cancer, and instead when they gave the animals Laetrile by injection only 10-20% of them got lung metasteses. And these facts were verified by many people, including the pathology department."---Ralph Moss
"It amazes me how much of what passes for knowledge in cancer therapy turns out to be incomplete, inadequate, and anecdotal."---Ralph Moss, Ph.D.
"This (Coley’s toxins) is really an effective treatment and it an OUTRAGEOUS crime of the century that we at MSK were able to cure cancer a 100 years ago that they can't cure today."----Ralph Moss http://www.sumeria.net/canc/rmoss.html
"The fact is that all of the studies that have been supervised by the National Cancer Institute should now be re-examined by congressional committees to see wether or not there is real corruption in all of them."--Ralph Moss http://www.whale.to/c/moss.html
"I had a brain cancer specialist sit in my living room and tell me that he would never take radiation if he had a brain tumor. And I asked him, 'but, do you send people for radiation?' and he said, of course. 'I'd be drummed out of the hospital if I didn't."---Ralph Moss