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March 2008
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Why are toxic drugs the continual focus of conventional cancer therapy despite the fact that so little progress has been made in treating advanced and metastatic solid cancers in the last 50 years?

In this edition of CancerWire we focus on the conventional paradigm - how the cancer industry approaches the treatment of cancer. We begin with a fascinating article about the esteemed physician and researcher Dr. Andrew Ivy and what happened to him after he discovered a potential cure for cancer from an unlikely source - the blood of horses. We will also look at current alternative and complementary clinical trials for cancer and highlight the few that address survival. And finally, we review the approval of the expensive new drug Avastin for breast cancer despite the fact that it did not improve survival in the patients tested.


Disclaimer - Please Read: None of the information in CancerWire is a substitute for professional medical advice, examination, diagnosis or treatment and you should always seek the advice of your physician or other qualified health professional before starting any new treatment or making any changes to an existing treatment. No information contained in Cancer Monthly or CancerWire including the information below, should be used to diagnose, treat, cure or prevent any disease without the supervision of a medical doctor.

Paradigm - A Way of Looking at Cancer
 
nurse with drugs


A paradigm is defined as a thought pattern in any scientific discipline or a way of looking at the world. In the context of conventional medicine and cancer there is a very well defined paradigm. It can be described as:

Cancer is caused by personal choices, genetics and acts of God. Scientists around the country are making important discoveries that are getting us closer to a cure every day, but more money and research is needed. When it comes, a cure for cancer will come from a large pharmaceutical company. Only a deeply researched expensive drug can cure cancer. Anyone who is serious about alternative or nutrition-based therapies is ill advised, a multi-level marketer, or a quack. Alternative therapies are ineffective, unproven or disproven and a waste of money.

Of course, there are cancer survivors who feel they owe their lives to various alternative therapies and would beg to differ with the conventional paradigm. And there are also innovative and open-minded physicians that believe that there is more to cancer treatment than the latest FDA approved drug. Nonetheless, this paradigm has been with us for decades and continues to dictate to a large degree what is available to cancer patients and how drugs are approved. In this edition of CancerWire we examine the paradigm from three aspects: historical, research, and regulatory.


Professor Andrew C. Ivy, M.D.
 
Esteemed Physician and the Cancer-Krebiozen Saga
Dr. Andrew Ivy


Most people have never heard the name of Dr. Andrew Ivy. He was a highly respected doctor who received an enormous number of accolades over his distinguished career. Yet, in the 1950's he became involved in a cancer treatment called "krebiozen" and within a short time his reputation was challenged. Was Dr. Ivy onto something or was he unfairly criticized? Here are some more details:

Professor Andrew C. Ivy, M.D. enjoyed an impeccable reputation as a researcher, scientist and physician. (1) He taught thousands of medical students, had been involved in over 1,300 medical studies, and had discovered several of the body's hormones.(2) He was President of the American Gastroenterological Association in 1940. In 1946, he was appointed as the sole Medical Scientific Consultant to the U.S. Military Tribunal No. 1 at Nuremberg to serve as "an expert witness on scientific and ethical subjects."(3) After the war, Ivy became the vice-president of the University of Illinois where he ran that university's large medical school.(4) He was also named Executive Director of the National Advisory Cancer Council and a director of the American Cancer Society.(5) Dr. Ivy also received many honors including: five honorary Doctor of Science degrees, one honorary Doctor of Law degree, the Distinguished Alumni Award of the University of Chicago, and The Certificate of Merit from the President of the United States. Dr. Ivy's name can be found in most standard medical dictionaries.(6)

For over twenty years, Ivy taught his medical students that rare spontaneous remissions of cancer found in the medical literature indicated the existence of some chemical substance produced in the body which acts as a defender against this disease.(7)

In 1949, Ivy began testing a cancer treatment called krebiozen.(8) Invented by Dr. Stevan Durovic, (9) krebiozen was made from a hormone that horses generated when they had been exposed to a fungus (Actinomyces bovis) that caused a cancer-like disease called "lumpy jaw."(10) The results of the therapy were very encouraging. Reportedly, the first terminal cancer patients found their tumors disintegrating after being administered the experimental drug.(11) In 1954, Dr. Ivy collated, analyzed and evaluated the various reports from physicians who had used krebiozen on terminal cancer patients. A summary of this medical report indicated, "In 111 of 226 externally measurable cases, or in about 50% of these cases, the tumors decreased in size."(12)

Rather than represent the start of a new direction in treating cancer, these observations were rejected by the medical establishment. In rapid succession after his involvement with krebiozen, Dr. Ivy was suspended from membership in the Chicago Medical Society, removed from the vice presidency of the University of Illinois, and had his resignation accepted by the National Advisory Cancer Council and the American Cancer Society. In addition, his work with krebiozen was assailed as inaccurate and unscientific. Apparently his methods which had been good enough to earn him a worldwide reputation were suddenly wrong.

The FDA never approved krebiozen.(13) At least two lawsuits (one brought by a patient and one brought by another physician) attempted to make this drug accessible, but failed. In both cases the courts decided that the FDA was in the best position to determine whether krebiozen should be accessible or not.

At the time the United States government was outlawing krebiozen, it was widely accepted amongst orthodox medicine that human beings possessed no specific resistance to cancer in their blood. Hence, the notions that a substance from the blood of horses could arrest or cure cancer in people sounded like quackery to government scientists.

Today, Drs. Ivy's insights may be better appreciated. In the last 20 years, mainstream science may have caught up with the insights of this physician. According to a leading medical treatise, "Animal studies have conclusively shown that the immune system can recognize and eliminate malignant tumors in vivo."(14) In recent years, billions of dollars have been invested in isolating and synthesizing interleukin, interferon, and other cytokines-all natural immune-related substances which can kill or arrest cancer and that are found in the blood of mammals including horses and man.

End Notes

1) For partial biographical material please see: The American Physiological Society, 17th APS President (1939-1941), Andrew C. Ivy, (1893-1978), at http://www.the- aps.org/about/pres/introaci.htm
2) HERBERT BAILEY, A MATTER OF LIFE OR DEATH 28-29 (1958).
3) ALEXANDER MITSCHERLICH & FRED MIELKE, DOCTORS OF INFAMY, THE STORY OF THE NAZI MEDICAL CRIMES IX (1949). "[T]he [U.S.] Secretary of War asked the Board of Trustees of the American Medical Association [AMA] to nominate a medical scientist to serve as a consultant to the Nuremberg trial of Nazi physicians." From the tens of thousands of AMA physicians, this organization chose Dr. Ivy.
4) BAILEY, supra note 2, at 28-29.
5) Id. at 30.
6) DORLAND'S ILLUSTRATED MEDICAL DICTIONARY 1611 (25th ed. 1974). Ivy invented a test he used to measure platelet and capillary function. Id.
7) BAILEY, supra note 2, at 31.
8) The word "Krebiozen" was compounded from Greek terms meaning "that which regulates growth." BAILEY, supra note 2, at 38-39.
9) Durovic was a Yugoslav refugee who had been living in Buenos Aires. Id. at 10. He had worked at the Pasteur Institute in Paris prior to WWII. BAILEY, supra note 2, at 16.
10) Id. at 22.
11) Id. at 39-43.
12) HERBERT BAILEY, KREBIOZEN-KEY TO CANCER? 300 (1955).
13) Tutoki v. Celebrezze, 375 F.2d 105, 107 (7th Cir. 1967).
14) HARRISON'S PRINCIPLES OF INTERNAL MEDICINE 535 (Anthony S. Fauci, et al. eds., 14th ed. 1998).


Clinical Trials and Alternative Treatments
 
Small Number of Clinical Trials Focus on Alternative Approaches
fruits and vegetables


The conventional paradigm that a viable treatment for cancer will come from a toxic synthesized drug and not an alternative non-toxic remedy is reflected in how our research dollars are spent. For example, there are thousands of cancer clinical trials. Many of these are funded or partially funded by our tax dollars through the National Cancer Institute (NCI). Others are funded wholly by pharmaceutical companies, foundations, and medical centers. Cancer Monthly recently performed a cursory analysis to determine which and how many clinical trials are focused on alternative or complementary therapies. The results were disappointing, but not surprising.

According to the NCI database there are currently 7,080 active clinical trials for cancer. A review of these trials found nearly half were focused on chemotherapy and over two thousand looked at cutting edge biological therapies like anti-angiogenesis approaches such as Veglin. Many of these biological therapies apply our latest understanding of genetics and the biological basis of cancer and no doubt reflect a quantum leap from the indiscriminate toxicity of chemotherapy. Nonetheless, only 123 trials were "complementary or alternative" - treatments focused on naturally occurring agents.

These 123 represent only 1.7% of the total and included trials of various foods, herbs and modalities such as: soy, ginger, Valerian, Curcumin, acupuncture, Reiki, meditation, garlic, Green tea, and Tai Chi. At first glance, this is encouraging. A more thorough analysis, however, revealed that the overwhelming majority of these trials examined questions that did not focus on whether these approaches alone improved survivability from cancer.

The breakdown revealed:



Most of these categories are self explanatory with the possible exception of Dr. Stanislaw Burzynski's antineoplastons. These 24 trials are "alternative or complementary" in the sense that this is an original modality not taught in U.S. medical schools and not generally available in U.S. hospitals. The constituents of antineoplastons include natural components and sodium phenylbutyrate, arguably a drug. Dr. Burzynski has had some success especially with aggressive brain cancers and his clinical trials focus on survival as one of the primary outcome measures.

The three additional clinical trials that focused on improving survival included:

1. Sun's Soup in lung cancer - this trial compares the survival of patients with stage IIIB or IV non-small cell lung cancer receiving selected vegetables (Sun's soup dietary supplement vs placebo). Sun's soup consists of 19 vegetable and herbs in a highly concentrated form. According to information on this trial, "These vegetables and herbs were selected based on their anti-cancer and immune-enhancing activities." (Trial # NCT00246727)

2. Green tea in leukemia - this phase I/II study of green tea extract (Polyphenon E) focuses on patients with previously untreated stage 0-II chronic lymphocytic leukemia (Trial # NCT00262743)

3. Fruits and vegetables for head & neck cancer - this randomized phase II trial is studying how well fruit and vegetable extracts work in preventing the recurrence of stage I, stage II, stage III, stage IVA, or stage IVB head and neck cancer. (Trial # NCT00064298)

Therefore if one includes Dr. Burzynski's antineoplaston studies, a total of 27 clinical trials out of 7,080, less than half of one percent are focused on alternative and complementary therapies as a stand alone treatment to assess survival. If one considers the Burzynski trials as a separate category, then only 3 of 7,080 or .04% are focused on this question.

These numbers speak volumes. Alternative therapies represent a small minority of cancer clinical trials and only a smaller number of these are focused on whether they are viable treatments. While there were 3,198 chemotherapy trials, a treatment that has been experimented with for over fifty years, less than 30 trials were focused on natural approaches. This analysis suggests what many observers have been reporting for some time that alternative therapies - stand alone natural cancer treatments have been co-opted into the conventional paradigm. They are no longer seen as potentially powerful treatments in their own right, but rather "add-ons" to ameliorate the side effects or improve the quality of life for patients who receive the toxic conventional treatments.


FDA Approves Cancer Drug Despite No Increase in Survival
 
woman upset


Taking the conventional paradigm to its logical eextreme we get the recent FDA approval of Avastin for breast cancer. The FDA actually approved an expensive and toxic cancer drug that does not improve the survival of the patients who take it.

You have seen the headlines - "Genentech Shares Jump on FDA Avastin Nod," "Genentech shares soar after FDA action," "Genentech rockets on FDA approval for Avastin." After the FDA approved Avastin for breast cancer, the stock for the biotech company Genentech jumped over 10%. According to some analysts this approval may add over $500 million in sales. Other estimates are over one billion dollars in three years.

A review of the transcript of the FDA's own Oncologic Drugs Advisory Committee suggests a number of unsettling aspects, including:

· Survival - The drug did not increase overall survival in the breast cancer patients tested.

· Toxicity - More patients died toxic deaths who received Avastin in combination with paclitaxel than those who received paclitaxel alone. In addition there were more life threatening adverse events (side effects) in those breast cancer patients who received Avastin.

· Problems With the Clinical Trial that Led to Approval - There were a number of issues with the clinical trial highlighted by the FDA including lack of data, the subjective nature of the findings, missing information, and protocol violations.

· Committee Voted "No" on Approval - The FDA's own Oncologic Drugs Advisory Committee voted not to approve Avastin for breast cancer 5-4. Inexplicably, FDA bureaucrats overturned the decision of its own Advisory Committee.


Challenging Paradigms
 
right way wrong way


Paradigms by themselves are not bad. But a false paradigm especially in the context of a life threatening disease like cancer, can be exceedingly dangerous. Nonetheless, even when paradigms are demonstrated to be false again and again, the status quo may not change.

For example, in the mid 1800's, after much observation and analysis, the Austro-Hungarian physician Semmelweis concluded that more women were dying when attended on the physician and medical student ward, versus those attended by midwives.

According to the website " RationalWiki" "Semmelwies developed several hypotheses to test, among them that doctors and medical students some how passed "particles" of disease to patients. Semmelweis noted that doctors and medical students would perform autopsies, then go to the ward to deliver babies, one after the other. Midwives did not. He posited that particles of illness were making mothers ill, and that washing hands might prevent illness. He tested this by instituting a strict regimen of hand washing with a chlorine-lime solution before examining mothers or delivering babies. The death rate from sepsis quickly fell to the level seen in the midwife deliveries. The hypothesis was successfully tested elsewhere, as mentioned above, but communication was poor. The hypothesis had been tested and made correct predictions. It was immediately and resoundingly rejected."

It would take decades before doctors would wash their hands before delivering a baby.

So where does that leave the conventional cancer paradigm? Simply put, if we wait for the status quo to change we shall be waiting a very long time. For patients and families who do not have years or decades to wait, you must become your own advocate. There are forward thinking open-minded physicians who can help you.


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