THE MEANING OF INFORMED CONSENT
Sophisticated medical imaging techniques such as CT scans have to a large extent replaced the traditional physical examination as the mainstay of diagnosis. In 2006, almost 60 million CT scans were performed in the US alone. Without any doubt, this kind of imaging has helped save countless lives. But there is another and more disquieting side to CT scanning that is seldom discussed. Like any imaging technique that uses ionizing radiation, CT is capable of causing cancer.
In an article in this week's British Medical Journal, entitled "CT Scanning: Too Much of a Good Thing, " Steven Birnbaum, a New Hampshire radiologist, expresses alarm over what he calls "the epidemic of exposure to diagnostic radiation," and warns that many doctors - including radiologists - have only very limited knowledge of the dosages involved in medical imaging. Worse, many seem to be unaware of the potential consequences of such exposure (Birnbaum 2007).
The National Academy of Sciences report on the biological effects of ionizing radiation (known as BEIR VII) offers perhaps the most thorough and definitive scientific analysis of the risks involved in diagnostic medical imaging. According to this report, previous estimates have seriously understated the risks involved. "Every exposure to radiation produces a corresponding increase in cancer risk," the report states. The report calculates that a spiral CT scan of the abdomen exposes a patient to a radiation dose of approximately 10 mSv, which carries with it a 1 in 1000 risk of developing cancer. The risk for women and children is a great deal higher; for children, such a scan would carry a 1 in 500 risk of developing cancer.
Why has the contribution of diagnostic imaging to the subsequent development of cancer been so trivialized by the radiology profession? One reason is that many of the estimates of potential harm from medical imaging have been drawn from old studies that predated the sophisticated technology available today. However, the BEIR VII study, published in 2005, focuses specifically on current diagnostic imaging, and its conclusions cannot be dismissed as pertaining only to older machinery and outdated techniques.
The principle of informed consent in medicine requires that patients should be given full explanations of potential risks as well as the potential benefits of any proposed intervention. Until now, it has not been customary for patients to be told that there is any appreciable risk inherent in medical imaging. But there is no longer any excuse for radiologists to be unaware of these risks, nor to refrain from disclosing them to patients.
The efforts of Dr. Birnbaum to educate his fellow radiologists are admirable. As he states so trenchantly in his British Medical Journal article: "It is time that medicine in all specialties became aware of the epidemic of exposure to diagnostic radiation and did something about it."
HERE AT THE MOSS REPORTS
Giving cancer patients the tools they need to understand medical procedures and choose treatments carefully is the motivating force behind everything we do here at the Moss Reports.
In the past 30 years I have written and published extensively on the subject of cancer and its treatment. I have compiled a comprehensive series of more than 240 individual reports on different cancer diagnoses, each of which examines both the standard treatment options and the possible alternative and complementary approaches for a particular cancer diagnosis. These reports also contain extensive dietary and nutritional information for those who are actively dealing with cancer as well as for those who are recovering from treatment and hoping to prevent recurrence.
Typical of the comments we receive from those who have purchased a Moss Report is the following:
"It was heartening to receive a well-researched unbiased opinion from Dr. Moss. I thank you for being a watchdog over the business of cancer with an objective outlook that is a very useful resource to many. I will recommend your report to anyone with a diagnosis of cancer. Thank you." - M. R.
If you would like to order a Moss Report for yourself or someone you love, you can do so easily and securely from our website, www.cancerdecisions.com, or by calling 1-800-980-1234 (814-238-3367 from outside the US).
To those who have already purchased a Moss Report I also offer phone consultations. A phone consultation can be enormously helpful in drawing up an effective treatment strategy and getting one's options clearly prioritized. A recent phone consultation client wrote:
"Dr Moss was most helpful in his thorough outline of treatment of my prostate cancer. Dr Moss covered the areas of diet, supplements and other treatment options in great detail. My naturopath and I came away with many new and positive ideas which we will be putting into practice immediately. Dr Moss was a breath of fresh air, able to sort fact from fiction in cancer treatment. My sincere thanks to him for his wonderful, independent advice and ongoing support." - A.S.
To schedule an appointment for a phone consultation, please call 1-800-980-1234 (814-238-3367 from outside the US), or send an email to Jacquie@cancerdecisions.com.
We look forward to helping you.
CURRENT TOPICS
We continue to add new reports to our Current Topics series on important aspects of cancer treatment and prevention. These reports can be purchased for $9.95 each and downloaded directly from our Web site, www.cancerdecisions.com:
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CANCER DOCTORS ARE PAID TO PRESCRIBE DUBIOUS DRUGS
Procrit, Epogen and Aranesp - known collectively as epoetins or ESAs (erythropoiesis stimulating agents) - are among the world's best-selling drugs, with combined sales of $10 billion last year. In the US, they constitute the single biggest drug expense for Medicare and are given to about a million patients each year to treat the anemia that is caused by cancer chemotherapy or by kidney disease. Two of the world's largest drug companies, Amgen and Johnson & Johnson, have been paying hundreds of millions of dollars in incentive bonuses to doctors - including medical oncologists - who prescribe the anti-anemia drugs.
Procrit and Aranesp can be very effective in correcting the severe anemia that often accompanies cancer. Epogen is widely used in the treatment of patients with renal (kidney) failure, another situation in which anemia is extremely common. Epoetins have been heavily marketed to both physicians and patients on the basis of their ability to reduce the need for blood transfusions, give patients more energy and improve their quality of life. However, there is an emerging downside to the use of these drugs.
An increasing number of researchers have become concerned that the drugs may increase a patient's risk of heart attack and strokes. Furthermore, they do not improve the outcome of cancer treatment. In fact, there is growing evidence that they may actually shorten, rather than lengthen, survival. In the light of mounting concern over the dangers of these drugs, the US Food and Drug Administration (FDA) last month belatedly cautioned that epoetins may be unsafe at the commonly used dose levels, and insisted that a "black box" warning be added to the labels and prescribing information for Aranesp, Epogen and Procrit. In mid-May, an FDA advisory committee urged that additional restrictions be put on the use of drugs that treat anemia in cancer patients (Pollack 2007).
The FDA has been very slow to move on the question of epoetin safety. The first indication that the drugs might in fact be harmful came in 1996. A clinical trial sponsored by Amgen was set up to show that dialysis patients would benefit from having their hemoglobin raised to 14 g/dL, which is the level in a healthy person But the trial found instead that patients who were given epoetins to raise their hemoglobin to 14 g/dL suffered more deaths and heart attacks than a group treated with a hemoglobin goal of 10 g/dL. The trail was prematurely stopped. Dr. Anatole Besarab of the Henry Ford Hospital in Michigan, the lead author of that study, told the Times that Amgen and Johnson & Johnson had little incentive to conduct a definitive trial.
A full decade elapsed before FDA finally was spurred to act. On March 9th, 2007 it issued an advisory warning that "an increased number of deaths and of non-fatal heart attacks, strokes, heart failure, and blood clots [occurred] when ESAs were adjusted to maintain...hemoglobin more than 12 g/dL" (FDA 2007).
The FDA acknowledged that there is a higher chance of death and an increased rate of tumor growth when patients with advanced head and neck cancer who are receiving radiation therapy are given epoetins. Similarly, in patients undergoing chemotherapy for advanced breast cancer, epoetins such as Procrit, when given to push their hemoglobin levels above 12 g/dL, are associated with an increased rate of tumor progression. In addition, patients scheduled for major surgery who were given epoetin showed a higher rate of thromboembolism (blood clots).
FDA also says that when epoetins are given to anemic cancer patients who are not receiving chemotherapy, the need for blood transfusions is not reduced, and there is actually a higher chance of death. Similarly, patients with chronic renal failure have a higher chance of death and an increased risk of blood clots, strokes, heart failure, and heart attacks when epoetin is given to maintain hemoglobin levels of more than 12 g/dL.
Overall, the FDA has explicitly acknowledged that there is no evidence to indicate that epoetins such as Procrit, Epogen or Aranesp either improve patients' quality of life or extend their survival. Meanwhile, several studies suggest that the drugs actually shorten patients' lives when used at high doses.
To be concluded, with references, next week.

--Ralph W. Moss, Ph.D.
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