Caution Overtreatment Breast And Prostate Cancer

Cancer Caution Overtreatment

Too often it is a family member of a cancer patient who will turn to us at the Foundation when they observe that their loved one is becoming weakened and fragile. Often they fear the patient can withstand no more treatment.

Weekly we hear heartbreaking stories like, “Radiation has my husband so fatigued he had to crawl to the bathroom.” Or, “We just cannot go through the horror of another round of chemotherapy.” The sad fact is we spend a great deal of time and effort helping cancer patients deal with overtreatment.

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• I became vividly aware of overtreatment in the early 1990s. A young California mother by the name of Nelene Fox turned to us for guidance. She had advanced invasive ductal carcinoma and asked if we could help her raise the $250,000 needed for a bone marrow transplant. Her insurance provider, Health Net, refused to cover the procedure because they considered it unproven and experimental.
• Those were brutal days in cancer treatment. Oncologists boldly proclaimed that high-dose chemotherapy followed by bone marrow transplant offered the cure for advanced breast cancer.
• And medical journalists, especially the major weekly news magazines, blindly fanned the flames of this optimism. Many in the cancer community proclaimed high-dose chemo and bone marrow transplants to be the Holy Grail.
• The procedure was exceedingly dangerous. I retain a newspaper clipping of one doctor describing the process: “We bring the patient to death’s door through an intensive pre-transplant regimen of chemotherapy and radiation.
• Our treatment involves a four-drug regimen and is 35 to 40 percent more intensive than the regimens used in the recently reported studies. We administer our regimen in a highly specialized transplant unit, not in the outpatient setting.

Although the treatment itself is associated with a 21-percent mortality rate, the payoff may be a higher proportion of women surviving and being cancer-free.” Brutal by any standards.

• While trying to persuade Health Net to pay, Nelene Fox raised the funds to have the procedure. But eight months later she died. Her brother, Mark Hiepler, an attorney, brought suit against his sister’s insurance company.
• In what was considered a landmark case, he won. The jury awarded the Fox family $89 million. The case is considered a watershed moment in that thereafter most health insurance companies began approving high-dose chemotherapy with bone marrow transplant for advanced breast cancer.
• This era spawned a desperate flurry of activities that attempted to position this procedure as the quintessential answer to cancer. With the financial help of the nation’s biggest pharmaceutical companies, transplant doctors testified before Congress and appeared before the media.
• Advocacy groups like the Susan G. Komen Breast Cancer Foundation, now called Susan G. Komen for the Cure, lobbied both federal authorities and state legislatures to mandate insurance coverage for the procedure. Hospitals from coast to coast proudly rushed to equip their facilities with bone marrow transplant units, encouraging their physicians to learn the procedure. Transplanting cancer patients was a good business.
• At that time, the Cancer Recovery Foundation was based in Southern California, where we ran the largest cancer support group in the nation. We always built our message around less-toxic and least-invasive prevention and treatment options. But in the early 1990s, our message was drowned out.
• For nearly five years, the number one request from patients and their family members was information on high-dose chemo and bone marrow transplants.
• New drugs were introduced that made it possible to harvest marrow cells from blood rather than having to extract it from a woman’s hip. And soon it was possible to administer high-dose ( chemo and transplant on an outpatient basis.
• All systems were ‘ “go” to make high-dose chemotherapy and bone marrow transplants the new standard of care. Its efficacy was accepted as an i article of faith.
• We were located near the University of California-Irvine Medical Center. Their oncologists were only too happy to accommodate our organization’s requests for presentations.
• And the transplanters were considered the ultimate authorities. Soon their lectures were filled to capacity.
• The presentations went beyond metastatic breast cancer to suggest transplants had application in women with early-stage breast cancer—making for a larger market.
• It was not long thereafter that we received a report on the first application of the procedure in ovarian cancer, even though there was no evidence to support this use.

High-dose chemotherapy followed by bone marrow transplant was the emerging model for all cancers.

• I sat on the community advisory board of the hospital’s cancer center. Prior to one meeting, there was an animated discussion that transplants could be used for advanced prostate cancer.
• Finally the center’s director, Dr. Frank Meyskens, Jr., quietly pointed out that advanced prostate cancer rarely responds to chemotherapy,- I pay, no matter how high the dose.
• It wasn’t until 1999 at an American Society of Clinical Oncology (ASCO) meeting that researchers presented four studies that showed women did no better with the high-dose chemotherapy W and bone marrow transplant treatment than those who received only low-dose chemotherapy. P from that point forward, the procedure was discredited and today is largely abandoned.

More Is Not Better

The beliefs behind the more-treatment mindset die hard. And clinging to that worldview is why so much unnecessary care is delivered by doctors and hospitals. In the world of cancer, it is widely agreed that surgery is the most effective treatment, contributing more to halting the progression of the disease than the other treatment modalities combined. Yet beyond surgery, there is little certainty about which drugs or which procedures actually work best.

• Our culture seeks cures. Most people in developed societies believe fervently in the doctrine that modern medicine cures. Cureit’s almost a statement of faith, pervasive on every continent.
• And most cancer patients look to its high priests, the oncologists, as their saviors. We seldom question the ongoing march of science. In fact, we expect it, taking scientific progress as a given. Both patients and healthcare professionals are deeply in need of believing that medicine cures and is safe.
• This is exacerbated by the “Hammer Syndrome,” something I first explored over twenty years ago. The syndrome looks like this: If you are a surgeon, every answer looks like surgery.
• If you are a radiation oncologist, all your answers point toward radiation. And if you are a medical oncologist, every answer involves drugs. Essentially, if you are trained in a narrow subspecialty, that’s what you see as the answer. If you re a hammer, the whole world looks like a nail and you go around looking for nails to pound.
• But there is much more to this overtreatment warning. Most oncologists lack the specialized training needed to independently interpret the evidence that is available to them.
• This leads even well-intentioned physicians to treat out of an understandable altruistic and humanitarian motive to help, even when they may not know what is the best thing to do based on actual outcomes.
• Medical oncologists are famous for statements like, “We will never know if this drug can help you unless we do just one more round.” There is a vast array of evidence to point out the last round is often the fatal round.
• And it is widely believed that thousands of patients die each year not from cancer but from cancer treatment. It’s called treatment-related mortality, or fatal adverse events (FAEs) and is typically discussed only in quiet whispers within the confines of doctors’ lounges in America’s hospitals.

In a series of 2010-2011 articles, the prestigious Journal of the American Medical Association again brought to the attention of the physician community the seriousness of FAEs.

• The editors included a detailed focus on the new drug Avastin. Originally thought to be helpful in marginally prolonging life in patients with colorectal cancer, non-small cell lung cancer, and kidney cancer, the drug was now being touted and tested for the lucrative breast cancer market.
• But in November of 2011, the FDA, the agency in the United States responsible for the approval of pharmaceutical drugs, revoked the use of Avastin for breast cancer. The drug was linked to severe high blood pressure, internal bleeding, hemorrhaging, heart attack, heart failure, and death.
• Despite vocal protests by dozens of breast cancer groups and patients who claimed Avastin “saved their lives,” the FDA withdrew approval because the drug, at best, prolonged life but also led to unacceptably high rates of FAEs.
• It is interesting to note that in the United States, many health insurance companies refuse to pay for all or part of the costs of Avastin because of the low ratio of benefits to cost.
• In countries with national health systems, such as the UK and Canada, the healthcare systems restricted their use for the same reasons. The drug’s manufacturer, Genentech, which charged up to $100,000 per year per patient, stood by its claims that the cost of Avastin was justified and the drug was effective.
• In the mid-1990s, my wife and I personally walked through a cancer experience with Denise, a close family friend. After the oncologist delivered Denise’s diagnosis and reviewed the recommended treatment protocol, the kindly, soft-spoken, and well-meaning oncologist pulled me aside and said, “Your friend is in for a rough time. We can give her a year, maybe a little more.”
• Denise and her family had blind faith in medicine and wanted to know all the “newest” treatment options. The answer was some early-stage clinical trials. I tried to explain the dangers of early-stage clinical trials, as well as the limits of chemotherapy, to our friends. But Denise’s answer was always, “Let’s try.” At the end of her battle, the kindly doctor said, “We need to try this new drug. It’s a shot in the dark. But we’ll never know unless we try.”
• She never made it out of the hospital alive. Her mother shared Denise’s medical records with me, including the autopsy report. There we found the words “death not due to disease progression,” which is medical code for overtreatment. Denise was another victim.
• In America, the fear of malpractice drives what is euphemistically called “defensive medicine.” This is the practice of diagnostic and therapeutic procedures conducted primarily as a safeguard against possible malpractice liability, not as a means to improve a patient’s health.

In cancer, fear of litigation is often behind a long list of diagnostic scans, genetic tests, specialty surgeries, and treatment recommendations involving radiation and chemotherapy, even when the cancer has been diagnosed at the very earliest stages.

• Overtreatment may also be a result of the prevailing local medical practices. This phenomenon rests with the fact that the same types and stages of cancer are treated in very different ways in different geographic regions. Even when excellent outcomes evidence exists, treatment choices can and do vary dramatically from place to place.
• This is clearly the case in early-stage breast cancer. Studies show that mastectomy and lumpectomy achieve similar long-term survival. But doctors differ sharply in their attitudes toward these treatments.
• John E. Wennberg, M.D., Ph.D., pointed out in the Dartmouth Atlas of Health Care studies that there are regions in the United States in which virtually no women covered by Medicare underwent lumpectomy, while in another, nearly half did.
• Why such massive disparity? Clearly, it was not the science, as the studies show similar outcomes. Based on the science you could expect something closer to 50 percent mastectomies and 50 percent lumpectomies.
• But many treatment decisions are based on nothing more than the attitude of, “That’s the way we treat here.” As an informed cancer patient, it is critical that you understand whether local customs, rather than the best medicine, may be driving your treatment recommendations. Check the Dartmouth Atlas, www.dartmouthatlas.org, to be sure.
• Such extreme variations arise because patients commonly and willingly delegate decision-making to their physicians. Decision delegation is most often given under the assumption that the doctor knows best.
• Behind it is a belief that physicians can always understand a patient’s values and thus recommend what is the most appropriate treatment for each person. But often, very often, local custom rather than outcomes-based evidence drives these treatment recommendations. Studies show that when patients are fully informed about their options, they often choose very differently from their physicians.
• Beyond all these very understandable reasons, I have come to believe that the most powerful reason American doctors and hospitals overtest and overtreat is that most of them are paid for how much care they deliver rather than how well they take care of their patients. Western medicine, especially as practiced in the United States, is largely reimbursed on a piece-rate basis.
• It’s like the man on the old-fashioned assembly line; the more widgets he made, the more he was paid. This one factor alone has led to a massive overtreatment of many illnesses, including cancer, and especially breast and prostate cancers.
• I understand this next statement is harsh—but absolutely true. To better understand much of cancer treatment,/0//W the money. Hospitals, doctors, medical equipment manufacturers, pharmaceutical companies, and all the organizations that derive their revenue from cancer diagnosis and treatment have a bias.
• They have a deeply vested interest in the more-treatment-is-better- treatment paradigm. Pharmaceutical companies do not want medical oncologists to prescribe less chemotherapy. Manufacturers of radiology equipment do not promote the use of less radiation. And the companies that manufacture surgical gloves do not want fewer surgeries. It goes on and on and on.

Overtreating Breast Cancer and Prostate Cancer

If you have been diagnosed with either breast or prostate cancer, be especially careful of overtreatment. These are the two most overdiagnosed and overtreated cancers.

• There is a raging debate around the question of whether early-stage breast abnormalities, called ductal carcinoma in situ (DCIS), are actually cancer. These micro-calcifications come and go. With the newest digital mammography, DCIS can be tracked from their very earliest appearance.
• Most disappear on their own. Some do not. Most are benign. A very small percentage are malignant. The problem lies in the fact that current technology has no way of tracking whether they are cancerous unless a needle or tissue biopsy is performed. Current thinking and practice is to treat all DCIS as a possible malignancy. With that mindset comes overtreatment and all the attendant complications.
• The same experience is at work with prostate cancer. A blood test called the prostate-specific antigen (PSA) measures a protein that is secreted by the prostate gland. High levels of this protein are often associated with the presence of prostate cancer and other prostate problems.
• However, the PSA test is so imprecise that the U.S. Preventive Services Task Force declared,

“Prostate-specific antigen-based screening results in small or no reduction in prostate cancer-specific mortality and is associated with harms related to subsequent evaluation and treatments, some of which may be unnecessary.”

• Ycr’s current thinking anti-practice is to consider a PSA level of 4 ng/mL as a possible malignancy. In actuality, current medical technology has no way of determining if the prostate is malignant unless a needle or tissue biopsy is performed, once again leading to unnecessary treatments.
• My suggestion with suspicions of both early-stage breast cancer and early-stage prostate cancer is “active surveillance.” for suspected breast cancer, this means three clinical breast exams followed by a mammogram over six months and a subsequent comparison of the results.
• For suspected prostate cancer, this means three PSA tests over six months and a subsequent comparison of those results. Provided there are no other symptoms, the six-month time frame is not too long to wait if treatment is needed. Six months is also an adequate time frame to compare tests and determine if there is a natural regression in the initially suspicious results.
• As you set foot on the cancer journey, be very aware. Overdiagnosis and overtreatment arc hidden parts of the system. You arc not looking for more medicine, you are seeking the best medicine. The two are not the same. This book will guide you in that quest.

Chemotherapy Be Skeptical

In nearly three decades of experience in this field, nowhere in the world of cancer is there more overtreatment than with chemotherapy. At Cancer Recovery Foundation, we receive more calls and e-mails involving the subject of chemotherapy than all other inquiries combined.

• First, I wish to make it clear to all who read this that I am not a fan of chemotherapy. I am very cautious, even skeptical, about this treatment modality. I want you to know of my belief—some have called it a blind bias—and then ask you to balance it with your own research and convictions regarding your cancer treatment choices.
• Make no mistake: Chemotherapy is exceedingly dangerous, even when administered by the most experienced oncologists. It is a chemical, a cytotoxin, a poison. Simply put, the goal of chemotherapy is to harm cancer cells by poisoning them in order to disrupt their ability to grow and multiply. Sometimes, in some cases of cancer, it works.
• However, in this process your host defense system is poisoned, typically compromised, and, at high doses, often irreparably damaged. Further, tumors that initially respond to treatment frequently develop a resistance to these toxic drugs. And while a tumor may respond a second time, the response is often at a much lower level of effectiveness.
• Worse, with longer-term treatment, the body is typically weakened to a point where less-invasive alternatives have little chance to effectively rebuild immune function, extend life, or yield quality-of-life gains.

I initially raised my concerns about chemotherapy in the first edition of this book. Since that time I have been relentless on the overuse of this treatment modality. Sadly, little has changed in the twenty years since that first warning.

This treatment modality remains overused. It also underperforms. And all the while tens of thousands of patients are left with life-altering permanent disabilities.

• Let me be clear. I want to state where chemotherapy has a place. Science shows chemotherapy to be efficacious in producing long-term remission in most cases of Hodgkin’s disease, acute lymphocytic leukemia, and testicular cancer.
• Chemotherapy is also shown to be effective in a handful of relatively rare, mainly childhood cancers including Burkitt’s lymphoma, lymphosarcoma, and choriocarcinoma. Used with surgery and/or radiation therapy, chemotherapy also plays a role in the successful treatment of Wilms’ tumor, Ewing’s sarcoma, rhabdomyosarcoma, and retinoblastoma.
• In addition, research shows chemotherapy to be effective in extending life by several months in many cases of ovarian cancer and small-cell lung cancer. However, chemotherapy does not produce a cure.
• Sadly, “adjuvant” (additional) chemotherapy has become the standard of care for many cancers. This is sad because the evidence is simply not conclusive. Breast cancer is a perfect example.
• At best, there may be a very small statistical advantage, at most a 2 to 4 percent point gain, in survival rates for those women who receive chemotherapy. This small gain must be weighed against the very real potential for collateral damage caused by the same treatment.

Among a class of chemotherapy drugs called anthracyclines is one with the generic name Doxorubicin, better known under its most common brand name, Adriamycin, a product of Pfizer. In the back rooms of chemotherapy infusion bays, this drug is called “Red Devil” and even “Red Death.”

The single most common long-term problem, in 10 to 15 percent of patients so treated, is compromised heart function, even congestive heart failure. In addition, the side effects typically include hair loss, mouth ulcers, dark urine, night sweats, insomnia, distortion in fingernails and toenails, muscle weakness, and extreme fatigue.

• The list goes on to even more serious side effects like lowered white blood cell counts, lowered red blood cell counts, and lower platelet counts— all at a critical time when these natural immune system components need to be at maximum functioning levels. In other words, while “Red Devil” may marginally increase survival rates, it substantially increases the risk of other serious life-threatening health problems.
• For postmenopausal women with breast cancer, a statistically stronger case can be made for the hormone blocker raloxifene, now the preferred choice over tamoxifen. However, both these drugs have been linked to other health problems including blood clots, stroke, and increases in endometrial cancer, uterine cancer, and liver cancer.
• As previously noted, chemotherapy’s one other area of limited success is colon cancer. There is still no conclusive evidence of its effectiveness except after lymph node involvement.
• Even then, the gain in life expectancy is months, not years, and quality of life typically suffers. Sadly, once again, even though the clinical evidence is at best mixed, the current Western practice says to treat with chemotherapy in virtually all cases of colon cancer.
• After studying this carefully for over two decades, I believe oncologists who are trained in Western practices are administering chemotherapy to more patients, across a wider spectrum of malignant diseases, based on the hope it may show results.
• The cancer community has tended to extrapolate narrow successes and consider nearly all patients, especially those with metastatic or recurrent cancer, as candidates for chemotherapy. All this to the exclusion of high-level nutrition, moderate exercise, and mind/ body regimens.
• Once again, and despite my urgent warning, chemotherapy may have a role in your cancer treatment program, particularly if your diagnosis is one of the cancers that typically respond to the treatment.

But please do not blindly accept the recommendation to undergo chemotherapy. Conduct your own investigation. Understand exactly what can and what cannot be expected from any recommendation. Only then should you decide.

Stopping Chemotherapy A Call for a New Standard

Is there a time to stop chemotherapy? I believe there is. And I believe that time to be when there has been no demonstrated progress after three cycles of treatment. We recently assisted a woman whose mother was having extensive quality-of-life difficulties with her chemotherapy treatments. In their last conversation with the doctor, he suggested they consider stopping chemotherapy because it was no longer effective and was causing so many side effects.

• However, her mother said she wanted to continue because she wanted to “keep on fighting.” The woman asked, “How do we decide when to stop chemotherapy? And how do I talk to my mother?”
• Obviously, this was a very sensitive conversation to have. But when an oncologist acknowledges that cancer treatment is no longer achieving results, it is not only time, but past time, to discontinue that treatment. And an excellent rule of thumb is that if there is no progress following three cycles, it is time to stop.
• If you, or a loved one, are faced with this conundrum where treatment is not making a difference, ask key questions such as, “Is continuing treatment going to make a significant difference in stopping the progression of the cancer?” And,
• “If we discontinue treatment, can we expect the nausea, pain, and other discomforts to diminish?” If the doctor answers that treatment at this point will not make a significant difference in life expectancy but discontinuing it will improve quality of life, it is clearly time to stop.

Unfortunately, there is an exceedingly disturbing dark side to this issue. Thousands of oncologists urge as “best practice” the continuation of chemotherapy even when there is no response.

• As we previously discussed with treatment-related deaths and fatal adverse events, many treatments continue right until the patient dies. In the medical profession, this is called “flogging,” as in beating a dead horse.
• The root of this problem is the fee-for-service reimbursement system under which most of Western medicine operates. And in no place is it more disturbing than end-of-life care. I realize that the culture in America also drives the “more treatment” mindset.
• Millions of people believe so deeply in medicine that sometimes we like to believe death itself is optional. And so treatment is continued. But when a patient is so sick they can’t even raise their head off the pillow, another cycle of chemotherapy is absolutely not called for. I have witnessed just that too many times to count.
• I now issue a clarion call to the oncology community to stop condoning this unethical practice. If after three cycles of treatment, there is no progress, it is then time to stop. Thereafter, fully embrace the integrated cancer care options, especially nutrition, exercise, and the mind/body disciplines.
• Chemotherapy has a cumulative effect. It often takes longer and longer to recover from failed treatments. However provided the patient’s physical status has not deteriorated to incapacitation, integrated cancer care strategies may be able to help significantly.
• In fact, stopping chemotherapy treatment should be viewed not so much as “giving up” as it is “freeing one up” to embrace life and all the more natural alternatives that can lead to better days and more days.
• Just because one conventional treatment can no longer be expected to bring about a cure doesn’t mean there are no other options. And this is certainly not the time to give up hope.
• Science says, “Show me the data.” The data says, that beyond the previously mentioned cancers where chemotherapy is efficacious, there is no proof of chemotherapy’s effectiveness in the form of large-scale randomized clinical trials.

The unvarnished truth is that the widespread use of chemotherapy is not based on convincing scientific data. Even in those cancers where positive outcomes can be observed, current chemotherapy regimens alone fail to produce a cure, a longer life, or an improved quality of life. It is the multifaceted integrated cancer care approach emphasized throughout this book that is crucial to understand and implement.

Chemotherapy Fractionated Dose Treatment

Having stated my very real and urgent reservations, I need to add that chemotherapy may be right for you at some point in time. One important aspect of any treatment’s success is the belief both the doctor and the patient bring to the process.

• It’s understandable that many oncologists believe in chemotherapy based on tumor response, or “shrinkage.” Theoretically, it makes sense. If you can reduce the tumor burden, perhaps the body can rebuild immune function.
• From the patient’s viewpoint, it is also understandable. Since chemotherapy is widely accepted and supported by the medical community, since insurance will reimburse for its administration, and since billions of cancer research dollars are invested in investigating this treatment modality, it comes with a great deal of up-front cultural support. With all that evidence, it seems believable despite its mediocre outcomes. And based on that belief alone it may have a place.

If you do choose this therapy, I urge you to use extreme caution in approving high-dose chemotherapy.

• There are now dozens of studies on the use of high-dose chemotherapy across a broad spectrum of cancers.
• The results are universally disappointing! pointing. There simply are very few studies that show better outcomes with high-dose chemotherapy compared to those receiving lower doses. This data directly challenges earlier studies and | widely held assumptions among the cancer community’s research elite regarding increased survival rates with higher doses.
• Is there a middle ground you could choose? Fractionated dose chemotherapy, smaller doses infused over an extended period of time, is a good alternative. The toxic effects of the drugs are typically minimized because the lower doses do not create massive systemic toxicity.
• In fact, there exists an increasing body of evidence from Europe that low-dose chemotherapy appears to halt the growth of microscopic blood vessels that supply solid tumors. Other studies purport to show that fractionated dose chemotherapy may result in actually stimulating immune function.
• Although most conventionally trained Western oncologists dismiss this evidence, I predict variations of this homeopathic “less-is-more” approach will become more widely accepted.

Finally, if you choose to undergo chemotherapy or have already had chemotherapy, study carefully this book’s chapters on “Adopt This Nutritional Strategy During Treatment,”21, and “Determine Your Nutritional Supplement Program,” 25. Start strengthening and rebuilding your immune system immediately.

• When you analyze chemotherapy as a treatment for cancer, I beg you to understand the side effects, both short-term and long- | term, and compare them to actual proven results. Then make your choice.
• If chemotherapy is started and if you are debili- | tated, confined to bed, or unable to eat, you not only have every p right but you also have the responsibility to call a halt to treatment. Even in the face of threats and warnings from medical providers and family, continuing treatment or not is your personal decision.
• In the final analysis, the vast majority of chemotherapy-based cancer treatments do not of themselves cure. My general guidance: surgery, yes. Radiation, maybe. Chemotherapy, no—or at least be skeptical, very skeptical indeed.