This book has 612 pages organized into 24 chapters. It was published in 2006. The full title is of the book is, Money Driven Medicine – Tests and Treatments That Don’t Work. Readers will be surprised to know that among those dubious treatments discussed include unnecessary Caesareans, cholesterol lowering pills, high blood pressure treatment, invasive cardiology treatment, blood thinners for clots, antidepressant medications, etc., and etc. In Chapter 16, the author discussed chemotherapy – the subject of this review.
The author of the book is Dr. David K. Cundiff, M.D. He wrote: “Shortly after President Nixon signed the “Cancer Act” in 1972, I decided to become a medical oncologist … I was a third year medical student at the University of California, San Diego … I felt that many of my cancer patients were neglected. After internship and residency in internal medicine at the University of Pittsburgh Hospitals, I took a fellowship in medical oncology at the Cancer Control Agency of British Columbia in Vancouver, BC. I returned to San Diego in 1977 for another fellowship combining further medical oncology training with hematology …. I became an Assistant Professor in medical oncology at the Harbor-UCLA Medical Center in Los Angeles.”
Dr. Cundiff later left oncology and became a hospice doctor. He wrote, “It helped me to be able to critically analyze claims about the effectiveness of cancer treatment based on clinical research trials. I can now better spot the numerous potential biases in chemotherapy trials.”
Dr. Cundiff shared some of his experiences. Below are statements quoted directly from his book (pages 217 to 243). All these words are his. I took the liberty to present them in point by point form. I hope this makes the delivery of his messages, one shot at a time, more precise.
Chemo for the sake of doing something heroic or a way to earn more money?
- I would not recommend chemotherapy if I did not think that the benefits outweighed the risks. I was so out of step with the other practicing medical oncologists that it became clear that I could not make a living with such a conservative treatment philosophy.
- Medical oncologists are paid almost nothing for talking with patients and their families. Their income depends entirely on the number of chemotherapy treatments that they order and how much they charge for each treatment. Unlike other specialists, the government allows them to also profit by selling chemotherapy drugs to their patients.
On chemotherapy clinical trial
- While about 60% of all newly diagnosed cancers are in people over 65, they make up only 36% of patients in drug studies. Many chemotherapy drug trials do not accept patients over age 70. This bias is troubling because younger patients tend to respond and tolerate side effects better than older patients.
- Older patients that do volunteer for drug trials may be healthier than older patients that do not volunteer or who are not recommended for research studies by their oncologists.
- Evidence-basis of cancer chemotherapy, is much less established than in other areas of medicine.
- Randomized trials with untreated control groups are hard to do. (My comment: how can you say for sure that chemo is better? Perhaps without chemo patients are better off?).
- Clinical responses are divided into complete response (absence of all measureable tumor and freedom from tumor symptoms lasting at least three months); and partial response (reduction in size of the volume of all tumor masses by at least 50% lasting at least three months). Most chemotherapy clinical trials report the response rate (complete and partial) as the main endpoint.
- Shrinking tumors may not mean that patients live longer or have a better quality of life. (My comment: They are not talking about cure at all, only response! Patients hope or expect to find a cure!).
- The unresponsive tumors have response rates of less than 50%. For patients with these unresponsive tumors, claims of increased survival become statistical exercises of researchers financed by drug companies, with nebulous parameters of measurement wide open to wishful thinking and biases. (My comment: They will manipulate and massage the data to get what they want. Ever heard of this saying – Lies, damned lies and statistics?)
- Clinical endpoints that matter to patients – survival and quality of life – often lose out to the endpoint that is important to medical oncologists, drug companies and cancer researchers – tumor shrinkage.
- Researchers, paid by drug companies, may harbor biases in favor of new experimental treatments when reporting the results of clinical trials.
- Patients, clinging to any thread of hope for a cure, hear what they want to hear from the oncologist. If their medical oncologist does not offer them chemotherapy, they may shop for another oncologist.
- Survival of people with identical malignancies varies widely due to factors that are not always well understood and often have nothing to do with chemotherapy given by medical oncologists.
- Consequently, by treating enough cancer patients with drugs, chemotherapy advocates can always find some patients with unusually long survivals.
- To approve new drug … the FDA does not require evidence that the drug prolongs life or improves the quality of life. Dr. Robert Temple, FDA Director of Medical Policy describes this policy that favors drug company profit over patients and the public as follows: “… our accelerated approval rule allows us to rely on a reasonable surrogate, a surrogate end point reasonably likely predict clinical benefit.” Dr. Temple said, surrogate endpoints (My comment: Tumor shrinkage for example does not have to be shown to correspond with clinical endpoints like living longer and feeling better).
- Pharmaceutical companies used endpoints other than survival as the basis for 73% of all cancer drug approvals between 1990 and 2002. Consequently, just one cancer medicine in five has ever proved that it extends patients’ lives. For drug companies and health care providers that are “money driven,” this very vulnerable patient population is ripe for exploitation.
Dr. David Cundiff provided a brief review of the present practice of chemotherapy and the effectiveness of the drugs used.
Chemotherapy for Advanced Non-small Cell Lung Cancer (NSCLC)
- Unfortunately, we do not have chemotherapy that significantly increases survival chances for non-small cell lung cancer (NSCLC) patients (about 75% of those with lung cancer).
- In my days as a medical oncologist, I never liked to recommend chemotherapy to people with NSCLC because of poor results and distressing side effects. The fact that there is no evidence-basis to support chemotherapy for NSCLC hasn’t stopped drug companies and the FDA from encouraging its use.
- Cisplatin (Platinol) has been the acknowledged standard of practice in NSCLC … the average survival with cis platinum chemotherapy added to radiation therapy was 7 months versus 4 months with radiation alone. However, lung cancer patients not receiving chemotherapy probably have more quality time since they do not have to endure the potential toxicities of cis platinum.
- Vinorelbine (Navelbine). In 1994, the FDA approved Navelbine on a 6 to 4 vote … to treat advanced NSCLC. What evidence supports this FDA decision? In the first trial, they compared patients receiving vinorelbine given alone with patients receiving the combination of cisplatin with Navelbine. The combination of the two drugs gave a much higher response rate (43% versus 16%) and considerably more side effects. However, the average survival was virtually equal (32 versus 33 weeks). Quality of life comparisons were not reported. Since untreated control groups were not included … these results do not show that either one of these drugs improves survival or benefits patients.
- Etoposide. Despite the lack of evidence showing efficacy, etoposide and cisplatin became the acknowledged combination as the standard for treatment of NSCLC in the mid 1990s. One well-designed Italian trial … survival in the drug treatment group averaged 8.5 months versus 5 months without chemotherapy.
- Taxol, Gemzar and Taxotere. In 1998, the FDA added Taxol to the list of “safe and effective” drugs for NSCLC. Shortly after …. Gemzar … and Taxotere …. Became FDA approved for NSCLC in combination with cisplatin … Non-inferiority trials served as the evidence basis. These are not medical breakthrough medications ….. (they) used the same kind of purposefully mangled science, poorly designed studies and skillful lobbying to win FDA acceptance. (My comment: Non-inferiority means the effect of a new treatment is not worse than that of an active control by more than a specified margin).
- Iressa. Of all the undeserved FDA approvals of chemotherapy drugs for NSCLC, the most irresponsible was the approval of Iressa for patients. The FDA approval of (Iressa) based on a 11 to 3 vote … based on one uncontrolled trial in which 10% of 216 patients receiving the drug had 50% or more shrinkage of tumors lasting for one or more months …. Researchers did not show increased survival or quality of life in these patients. People may die faster with (Iressa) for all we know. (Iressa) should be withdrawn from the market. (My comment: Yes, Iressa was later withdrawn after many deaths in Japan. Currently, it is being replaced by a sister drug called Tarceva).
Colon cancer chemotherapy
- In my training and practice as a medical oncologist in the late 1970s and early 1980s, I treated few colon cancer patients with chemotherapy. I did not believe that benefits exceeded risks.
- Dr. Charles Moertel’s uncontrolled colon cancer trial in 1960 had made national headlines. He reported an 85% complete and partial response rate in patients with advanced colon cancer who received chemotherapy drug 5-FU. This led to the FDA approving 5-FU for metastatic colo-rectal cancer in 1962. However, when other investigators reported their results in a few years, the response rate rates dropped to the 60% range. After further studies, the average response rates fell to the 40% range. Finally, about 20 years after his initial glowing report, Dr. Moertel wrote, “… lack of beneficial effect of 5-FU on survival.” The response rates around the country ranged from 12% to 20% and overall survival of chemotherapy patients was not proven better than for those not taking chemotherapy drugs.
- Leucovorin. In 1991, on a 5 to 4 vote, the FDA approved leucovorin in combination with 5-FU … trials showed only little if any effects on survival. The Mayo Clinic reported marginally significant survival data … and the results from … Canada … showed no statistically significant survival benefit. Mucositis (destruction of the gastrointestinal lining cells from the mouth to the anus) and diarrhea were both more severe with high dose leucovorin added.
- Irinotecan (Camptosar). While it may shrink tumors, there is no scientific evidence that irinotecan benefits people with colo-rectal cancer. Despite this lack of evidence, the FDA voted 9 to 0 to approve irinotecan.
- Xeloda. In 2001, the FDA approved (Xeloda) … for colorectal cancer. Again, no randomized trials with placebo treated or untreated control groups to show efficacy of (Xeloda) in prolonging or improving quality of life.
- Oxaliplatin (Eloxatin) obtained FDA approval in 2004 for colorectal cancer. This approval was based on randomized comparisons showing equivalence (non-inferiority) with other chemotherapy agents – no untreated or placebo control group was included.
- Avastin…. FDA approval (was) … based on one small trial comparing two strengths of (Avastin) added to 5-FU + leukovorin. Patients taking the higher does lived 16.1 months on average compared with 21.5 months for those taking half the higher dose. Those taking 5-FU + leukovorin alone averaged 13.8 months of survival. A subsequent trial comparing 5-FU +leukovorin + irinotecan with and without (Avastin) also showed about a 5 month survival advantage with (Avastin).
- Erbitux. In February 2004, the FDA approved (Erbitux) ….”although treatment with (Erbitux) has not been shown to extend patients’ lives, it was shown to shrink tumors in some patients and delay tumor growth, especially when used as a combination treatment.”
- From my days as a medical oncologist, I remember pancreatic cancer as the most refractory tumor to chemotherapy.
- Gemzar. The FDA approved (Gemzar) for advanced pancreatic cancer patients in 1996. This approval was based on a randomized comparison with 5-FU in which none of the 126 patients in either group had any significant tumor shrinkage. The FDA justified its approval on a new criterion that they called “clinical benefit,” defined as a reduction in pain or pain medication consumption, weight gain or improved functional status. This very subjective endpoint can easily lead to biased reporting by drug company funded investigators.
- Because of the so-called “blood brain barrier,” most drugs do not penetrate well from the blood stream into the brain tissue. With the exception of childhood neuroblastoma, brain cancers respond poorly to chemotherapy.
- For over 30 years, the standard chemotherapy drug for adult patients with the most common types of brain cancers (gliomas and astrocytomas) have been BCNU, CCNU and Matulane. These drugs cure no one, are not shown through scientific evidence to prolong survival and are not FDA-approved for brain cancer.
- In 1999, the FDA granted accelerated approval status to Temodar for treatment of adult patients with aggressive form of brain cancer. Only about 10% of brain cancer patients had tumor shrinkage in studies that had no untreated or placebo control groups. No meaningful assessment of survival or quality of life could be made.
- The direct cost of treating cancers in 2007 in the U.S. (physicians, drugs, hospitals, etc.) will be about US$89 billion. About $52 billion will be for chemotherapy drugs.
- Chemotherapy for non-small cell lung cancer (NSCLC), metastatic colon cancer, pancreas cancer and brain cancer are but a few examples of FDA-approved drugs for which there is no convincing evidence of benefit.
- Inappropriate chemotherapy treatments cause incredible suffering. Most of the 550,000 Americans who die of cancer each year receive chemotherapy despite of the fact that only about 20% to 30% of them have tumors that respond well to drugs.
- Chemotherapy cures many children and some adults that would have otherwise died. However, for most people with advanced cancers of the lung, gastrointestinal tract, kidneys and brain, chemotherapy increases suffering and cost without significantly prolonging life.
- Cancer chemotherapy is lucrative for medical oncologists, hospitals, pharmaceutical companies and stock market investors.
- Patients and their families hope for miracles despite all odds. Many times their vulnerability leads them to accept treatments uncritically that are not in their best interests.
- Medical oncologists are paid well for giving chemotherapy and hardly at all for counseling and supporting their patients.
- The economic forces in the current medical marketplace work to patients’ disadvantage.
Let me stress again, the above 44 statements are words written by Dr. David Cundiff, a medical oncologist turned hospice doctor. Dr. Cundiff left oncology perhaps because he couldn’t “stomach” what he saw and practised. He has now joined the list of those brave souls who have enough conscience and guts to speak up. Einstein once said, The world is a dangerous place, not because of those who do evil. But because of those who look on and do nothing. I am sure, in the years to come, the world would say “thank you” to Dr. Cundiff for what he had said and done. Dr. Julian Whitaker, another medical doctor said this, I am convinced that the best protection against evil that lurks among us – and make no mistake that it lurks among us – is information. I believe Dr. Cundiff shared similar vision – to provide information to those who need it. It is for this reason that the front page of his book has this unique message, “Photocopy authorization policy: Authorization to print or otherwise reproduce items for internal or personal use, the internal or personal use of specific clients or for review is granted by David K. Cundiff, M.D., provided that the source is cited.”
Today, Dr. Cundiff is not alone in trying to call a spade a spade. In his book, The War on Cancer – an anatomy of failure, Dr. Guy Faguet – cancer researcher and medical doctor, wrote, “An objective analysis of cancer chemotherapy outcomes over the last three decades reveals that … the cell-killing paradigm has failed to achieve its objective …. a model based on flawed premises with unattainable goal, cytotoxic chemotherapy in its present form will neither eradicate cancer nor alleviate suffering” (pg.89).
Dr. Nicholas Gonzalez, a medical doctor from New York, USA (in Knock Out by Suzanne Sommers) put it more blatantly when he said, “It is hard for me to believe that an oncologist who has gone through four years of college, four years of medical school, three years of residency, and then three years of oncology post-residency training can’t connect the dots. You have to be an idiot not to be aware that for most of the cancers chemo isn’t doing anything. It’s in all the journals. It’s not like it’s a secret. The fact of the matter is that 95 percent of the patients who call my office have been brutalized by the orthodox system … my staff just sits there dumbfounded by their stories, story after story, over and over again. Everyday. Spend a one day in my office listening to the dozens of people who call in with these horror stories about the conventional therapies that were pushed on them with false hope, then you will see why we get upset when we are criticized as alternative guys offering false hope. These people come to me half-dead because they were promised that these treatments could work …”
I am aware that what is being presented here may not be palatable to some readers. Truths are always bitter. What is more, as Dr. Cundiff said, “Patients, clinging to any thread of hope for a cure, hear what they want to hear from the oncologist.” If they don’t hear what they want to hear, they go away disappointed!
History has shown that bearers of such truths are castigated and condemned – there is no exception, as we sometimes experienced in CA Care. The practitioners of alternative medicine are labeled as charlatans, quacks and snake oil peddlers. That is the way the world operates. Professionals on each side of the fence, throw mud at each other’s face and unfortunately leaving cancer patients with not much choice – having to choose between the devil and the deep blue sea. That is the reality of today.
So I say to all of you reading this, Try, if possible, not to get cancer! How? you may ask. That unfortunately again is another long and debatable subject.