Please find another professional opinion on the Dateline show about Alternative Cancer Treatments. This show has created quite a ripple effect.
Sincerely,
Suzanne Somers
As someone who has followed alternative medicine research and policy for almost two decades, I watched with great interest the Dateline show discussing the book Knockout and two of the medical doctors who offer alternative approaches to treating cancer, Stanislaw Burzynski, MD and Nicholas Gonzalez, MD. I first met these two doctors as well as Andrew Weil, MD and Barrie Cassileth, PhD when serving in the National Institutes of Health’s (NIH) Office of Alternative Medicine around 1993 where I served in an administrative capacity including as the Committee Management Officer for the original Alternative Medicine Program Advisory Committee (AMPAC), Dr. Cassileth, whose degree is in medical sociology[1] served. From the NIH I was invited to lead the health oversight activity of the House Committee on Government Reform in 1998 where I had the opportunity to further review the work of both these doctors.
Freedom of Speech in Medicine
In the first minutes of the segment I was shocked to hear Dr. Cassileth make two statements which are in my opinion were un-American and un-scientific. She stated that Suzanne Somers is not qualified to talk about cancer therapies and then went on to state that personal stories and anecdotal information have no value. Ms. Somers enjoys the same rights to freedom of speech that Dr. Cassileth does, as do all Americans. Ms. Somers is obviously of above average intellect and she has proven time and again that she delves deep into the facts and is not closed minded. The mistletoe therapy that she opted to use instead of chemotherapy had been researched in Europe, clinical trials published in the 1980s, and as would be uncovered in Congressional hearings was ignored by the US National Cancer Institute. How many women in the United States were not given the same option to use mistletoe therapy because the institutional bias against alternative or non mainstream therapies prevented US cancer centers from studying it and offering it? As a sociologist, Dr. Cassileth holds no specialized training that gives her greater insights into the Burzynski or Gonzalez protocols than Ms. Somers. What Dr. Cassileth does hold is an extreme prejudice against most alternative therapies. A cursory review of the Memorial Sloan Kettering Integrative Cancer Therapy Website Frequently Asked Questions on Herbs, Botanicals and Other Products finds not a single positive statement about their potential benefit.[2]
The statement that anecdotes have no value is nonsense. Through medical history, the perspectives of patients have played an essential role in understanding diseases including cancer. It is a cornerstone of the scientific process as much as observation of a doctor. If there is no value in personal testimonials then why do all of the major cancer centers have patients in their commercials and on their websites and promotional materials? Someone facing a cancer diagnosis for themselves or a loved one needs to hear first hand from others who have walked the cancer path. There is great value in anecdote.
Hold Conventional Cancer Centers to the Same Standard
During the course of the interview Dr. Snyderman asked Dr. Burzynski how many patients he had cured. He stated that over the 42 years he has been in practice, and of the 14,000 or so patients he has seen that he has cured hundreds. Dr. Snyderman found this to be an unacceptable and unscientific answer. She called for transparency as if Dr. Burzynski was hiding something.
Putting that call for transparency to the test I went to the websites of Sloan Kettering in New York (close to Dr. Gonzalez) and MD Anderson in Texas (close to Dr. Burzynski). I made a request online to learn about these two centers’ cure rates. No one at Sloan Kettering responded. A few days later I received the following response from an MD Anderson staffer:
Dear Ms. Clay, Thank you for contacting askMDAnderson.
Unfortunately, at this time, there is no one "cure" for cancer. The word"cure" is not a word you hear often with cancer. This is because canceralways has the potential to recur, so technically the term "cure" would bemisleading. When dealing with cancer, the term "remission" is morecommonly used. According to the National Cancer Institute (NCI),remission is, "a decrease in or disappearance of signs and symptoms ofcancer. In partial remission, some, but not all, signs and symptoms ofcancer have disappeared. In complete remission, all signs and symptoms ofcancer have disappeared, although cancer still may be in the body."
Unfortunately, our resources do not contain statistical informationregarding success rates for each type of cancer and/or treatment used ineach case. Many times our patients come here previously treated by anotherfacility, so the statistics would not be an accurate review of MDAnderson's care. However; I can tell you that MD Anderson's overall 5-yearsurvival rate is above the national average.
I wish I had more information for you. If you have any other questions,please feel free to contact us again.
Kind regards,
Chelsea Lee
Health Information Specialist, askMDAnderson
Public Education Office1-877-MDA-6789
My follow up question asking for clarification that MD Anderson does not release any statistics on survival rates went unanswered.
During this part of the interview Dr. Cassileth scoffed at the idea that tumor reduction was a legitimate measure of treatment response. The public was not informed that this is exactly the measure that most chemotherapy and radiation research uses to determine success. In fact, when conducting a Congressional investigation I would learn that many cancer researchers report successful outcomes for their drugs and radiation with a partial reduction of tumor size, even if all of the patients died. Furthermore, when the Committee was looking into why the government refused to allow little Thomas Navarro access to the Burzynski clinical trial we were initially told the chemotherapy and radiation treatments were 75 percent effective. As time went on that number was increased until doctors were telling us that the treatment was 90+ percent effective, so therefore Thomas should be treated with chemotherapy and radiation. I even contacted a number of researchers who published research papers and asked if they could put me in touch with some of their survivors. Everyone told me that was impossible because they were no longer in touch with the patients in their studies. So, truly they had no way of knowing if the treatment was a success if they had not followed the patient for more than the 2-3 years of the study.
In the two years we worked on that issue and in the 8 years since I never had the parent of a medulloblastoma patient or an adult medulloblastoma patient who went through chemotherapy or radiation contact me to say they were cured or in remission.
I believe that Dr. Snyderman and Dateline should investigate Sloan Kettering, MD Anderson and other major cancer treatment centers, who receive millions in government grants, insurance reimbursement and payments from private citizens. Ask them the same questions they asked Dr. Gonzalez and Dr. Burzynski. Demand transparency from these centers. They will find that cancer patients who receive chemotherapy and radiation also pay out of pocket (or their insurance company pays) even during clinical trials. They will find that no cancer center in the country likely will provide the actual complete outcomes data. By this I mean, Sloan Kettering is not going to tell you how many patients over the last 10 years, much less the last 42 years they have treated, and of those, how many were cured, or even how many lived 2, 5, 10 or 15 years.
The Dateline interview purported that Dr. Burzynski had never published in peer reviewed journals, and that antineoplaston research had never been replicated by another researchers. Neither statement is accurate. A search of antineoplastons on PUBMED finds Dr. Burzynski and numerous researchers have published both positive and negative outcomes on antineoplastons.
Mud Baths versus Coffee Enemas
It is a sad day indeed when a famous individual speaks negatively about a protocol that he has never thoroughly studied. Dr. Andrew Weil, who famously appeared on the cover of a major magazine a decade ago covered in mud, disparaged Dr. Gonzalez’s protocol, calling the coffee enema something out of the hippie generation. Dr. Weil, who in his early writings discussed how easy it was as a Harvard Medical Student to obtain marijuana from the government for ‘research purposes’ and who has also promoted mud baths for their purported health benefits; has never visited Dr. Gonzalez’s clinic or reviewed at length his protocol and the basis for it misspoke about the history of coffee enemas. Enemas have been a part of medical practice since the Ancient Greeks and Egyptians. The use of coffee in enemas goes back to 1917 and appeared in the Merck Manual until 1972. We now know that coffee has strong antioxidants and several of the components play a key role in detoxification. While I have the utmost of respect for the Integrative Medicine Training program that Dr. Weil established, this is not the first, and will not likely be the last time Dr. Weil gets the facts incorrect during interviews.
Ignoring the Real Story – the Pancreatic Cancer Clinical Trial and What Went Wrong
Back in my NIH days, Dr. Gonzalez presented a Best Case Series to the National Cancer Institute (NCI). This is a program the NCI created to learn about innovative cancer therapies and to stimulate future research. Dr. Gonzalez agreed to participate in an NIH funded clinical trial comparing his protocol to the standard of care in pancreatic cancer. A ten year fiasco would result in millions spent and no valid scientific outcomes due to the mishandling of this trial by the principal investigator at Columbia University (the NIH required an academic researcher to lead the trial because they did not have confidence that an alternative medicine physician could lead the study.) Dr. Chabot at Columbia agreed to run the study. It would later be learned that he had not disclosed his clear bias to the chemotherapy regimen, since he had been a part of the development of this regimen.
After the study began, the principal investigator cut Dr. Gonzalez and his colleague Dr. Isaacs out of the screening process, instead requiring they take every patient he sent them. Dr. Chabot often sent patients who did not meet the study criteria for a number of reasons including (1) they could not eat and swallow the required pills, and (2) some had no support system at home. It would be learned during the trial that Dr .Chabot was not matching the two arms equally. Instead, there was a disproportionate number of patients with stage III and stage IV cancers in the Gonzalez arms when the Chabot arm had more patients that were stage II and stage III.
When this was revealed, at some point it appears that Dr. Chabot went back through the patients and reclassified their cancer stage. Among the many other irregularities in the study, was a failure on Dr. Chabot’s part to insure that every patient signed and turned in their informed consent documents before beginning in the trial. This is a violation of federal law, a point glossed over by the Dateline story. Throughout the study, it was Dr. Gonzalez who repeatedly brought to the attention of the NIH officials who were responsible for monitoring the study that there were irregularities. There is no real evidence that the NIH staff took his concerns seriously or did anything to insure the study was properly managed. What did happen however, was during one phase of the study, the NIH delayed payments for many months. Dr. Gonzalez paid for the supplements in the study for participants out of his own pocket until the NCI began paying for the study. Can you imagine the NCI not paying Sloan Kettering regularly for a chemotherapy trial and the doctors there paying for the chemotherapy drugs out of their own pockets? It would seem that the NCI wanted to trial to fall apart and used funding delays as an attempt to derail the study.
Sadly, many of the patients who were assigned to Dr. Gonzalez in this trial never fully participated, and yet they were counted in the study. If a patient does not receive the therapy, then how is that an accurate reflection of the protocol? Dr. Chabot was eventually reprimanded by the Federal Office of Human Research Protections (OHRP). His punishment was not a termination of his federal funding, or loss of medical license, or loss of his job, but rather a required retraining in human subject research process. He would go on to publish a paper without Dr. Gonzalez and fail to mention the OHRP finding. Had it been an alternative cancer doctor who violated federal law and ethical standards in research, he would have lost his license to practice, gone to jail, and the story would have been splashed across every major newspaper in the country, but when it is a conventional doctor at a major academic institution, it does not even make the news.
Dr. Gonzalez was able to compare the outcomes of all of the patients in the Columbia study and learned at the termination of the study as of 2006 that of the patients in the study who ardently followed his protocol, they had survived longer than any other patients in the study including those in the conventional arm. He presented these findings in a meeting to the new director of the National Center for Complementary and Alternative Medicine (NCCAM) more than a year ago. Sadly his follow up communications to Dr. Briggs has gone unanswered. Nor has she invited Dr. Gonzalez to brief the Advisory Committee of the NCCAM about the study and his experience. Several Committee members have expressed to me personally an interest in understanding what happened.
This study was the first head to head comparison of an alternative cancer therapy to the conventional, standard of care funded by the NIH. It was poorly managed, there was possible scientific misconduct and violations of federal law on the part of the principal investigator, and it is Dr. Gonzalez that Dateline wants to put under scrutiny. I have watched this unfold since I first met Dr. Gonzalez in the early 1990s, then on Capitol Hill, and for the last few years I have consulted with him on these matters. As a result I have had access to the thousands of pages of documents showing the failure of the NIH staff to act, the manipulation of patients and their cancer staging, and the evidence that the principal investigator did not live up to the standards required of clinical researchers in federally funded studies.
Integrity in Reporting
Cancer remains one of the scariest words in the English language. When a friend of mine last year was diagnosed with stage IV lung cancer and declined the chemotherapy and radiation offered because even with those treatments his oncologist said he had a year or less to live; I suggested he talk to Dr. Gonzalez. I know that Dr. Gonzalez like Dr. Burzynski will only take patients that have a good chance of benefit from the protocol. My friend visited and decided to become a patient. He had a strong support system at home and followed the protocol diligently. Today, more than a year later he is tumor free. More importantly, he is alive.
Sadly, this Dateline story was very slanted, at times factually inaccurate. Are Dateline and Dr. Snyderman up to the challenge of telling the whole story in cancer treatment outcomes? Will they share with the public the failure of every major cancer center in the country to be transparent?
Beth ClayDerwood, MDEmail: bclay@dc-strategy.com
[1] Medical sociology is a subfield of sociology which is concerned with the relationship between social factors and health, and with the application of sociological theory and research techniques to questions related to health and the health care system.
[2] The Center offers a host of complementary therapies such as Music and Dance Therapy, Yoga, Guided Imagery, Hypnosis, Relaxation Techniques. These are all very important complements to any cancer program, and are all more mainstream than alternative.
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