CURRENT TOPICS
An editorial published last summer in the New England Journal of Medicine (NEJM) raised questions concerning the effectiveness of Gardasil, Merck’s cervical cancer vaccine, and called for a more cautious approach toward public policy decisions on Gardasil vaccination.
The NEJM editorial accompanied the publication of a study in the same issue confirming that the effectiveness of the vaccine was greatest when it was administered to girls and young women who had not previously been exposed to any of the four major types of human papillomavirus (HPV) that are associated with cervical cancer. Among this highly selected population, Gardasil was 98 percent effective in preventing infection with these four strains of HPV. However, the vaccine's effectiveness fell dramatically - to only 17 percent - when it was administered to girls and women in the broader population who had previously been exposed to HPV, and who already had very early signs of cervical pre-malignant change.
Not only is the vaccine considerably less effective in the general population than the publicity blitz at the time of Gardasil’s launch had suggested, it may also be less safe than originally assumed. According to documents obtained from the Food and Drug Administration under the Freedom of Information Act, more than 1,600 adverse reactions to the vaccine have already been documented by the FDA's Vaccine Adverse Event Reporting System (VAERS), including three deaths which were related to blood clotting (thrombosis). Among 42 women who were vaccinated with Gardasil while pregnant, 18 experienced reportable adverse events ranging from miscarriage to fetal abnormalities. Concern and caution over this vaccine is therefore amply justified.
Our Current Topics report On Guard - Gardasil is a full-length discussion of the vaccine and the deeply flawed clinical trials that led to its approval. You can order a copy of this report by clicking or going to:
http://cancerdecisions.com/030407.html
Other reports in our Current Topics series include:
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 200 individual reports - The Moss Reports - on different cancer diagnoses.
These reports examine both the standard treatment options that are likely to be offered for a particular cancer diagnosis, and the possible alternative and complementary approaches to that disease. Also included is 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.
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).
PHONE CONSULTATIONS
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 such a pleasure to speak with. It was as if I was talking with an old friend. I always felt that I had his full attention as he patiently addressed each of my concerns and questions - something we don't often get from the experts. There is a vast sea of cancer information out there, oftentimes confusing and conflicting, which makes it hard for the lay person to process. Dr. Moss sifted and separated the information, making it so much easier for me to understand what my true needs might be. He validated many of my healthcare decisions, without advocating or pushing me in any particular direction. The word that comes to mind is "honor." I felt deeply honored by Dr. Moss. Cancer is not a linear path. I never know from day-to-day how I will feel or what new issues (oftentimes frightening) will be in front of me. The fact that I can email him at anytime should new questions arise is deeply appreciated." - L.V.
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.
A NEW BOOK TAKES AIM AT THE COST OF U.S. HEALTH CARE - PART II
Increasingly sophisticated tests and imaging techniques have largely supplanted the traditional process of diagnosis, and have, in effect, become the new physical exam. "Testing," says Brownlee, "has replaced thinking on the doctor's part and feeling cared for on the patient's. What's lost in the process…is the personal relationship, the trusting interaction that once formed the basis for healing. But when the patient views the doctor as a tool of the insurer, and the doctor views the patient increasingly through the narrow lens of a computer screen, it's difficult for either to see the other as a partner in the process of healing."
Every year in the US, we undergo millions of tests - MRIs, CTs, PET scans, blood tests - that frequently lead doctors to diagnose conditions that, if left alone, might never have developed into overt, detectable disease. A very high proportion of the normal, well population harbors what are known in the medical profession as ‘incidentalomas' - lesions of little or no clinical significance that are only detected as a result of a test or scan for another condition entirely. But because theoretically any such lesion might - just might - progress, further investigations are almost always recommended. These further investigations - biopsies, excisions, tests - not only represent an enormous financial burden on our health care system but may also lead, in their own right, to illness, complications and even death - all in the service of preventing or "curing" what are essentially pseudo-diseases.
Elective and ostensibly preventive procedures are not without risk. Any surgical intervention, especially one requiring anesthesia, carries an intrinsic risk. Hospitalization itself is associated with it an increased risk of serious and sometimes fatal hospital-acquired (‘nosocomial') infection. One estimate cited by Brownlee puts the number of deaths directly attributable to unnecessary care at 30,000 Americans per year.
The greater the amount of medical care a patient is exposed to, the greater the likelihood of medical error. A 1999 report by the Institute of Medicine, titled To Err Is Human, put the number of Americans killed each year by medical error at 98,000, with tens of thousands more directly harmed or killed by prescribing errors and avoidable drug interactions.
If all unnecessary and elective procedures we undergo each year led to increased longevity and health, perhaps they would be worth the expense. However, the evidence overwhelmingly suggests that opposite is the case. Many of the interventions that are fueling the current explosion in overtreatment have never been shown, in rigorous scientific studies, to confer significant benefit. There is no evidence, for example, that surgery for back pain is an effective way to manage this condition. Some people may benefit from it, but many are left in far worse shape following surgery than they were beforehand. Or take the procedure known as carotid endarterectomy, which is designed to prevent stroke by improving blood flow to the brain. In a small but significant number of cases this procedure actually causes stroke to occur in a patient who had previously been completely asymptomatic.
The first half of Brownlee's book focuses heavily on the consequences of the medical profession's increasing infatuation with imaging technology, and its undiminished enthusiasm for elective interventions that often carry serious risks. But she then turns her attention to another, and altogether more insidious, source of overtreatment - the deliberate use of "disease-mongering" by the drug industry in order to create lucrative new markets.
The drug industry spends billions of dollars each year ($29.9 billion in 2005) on advertising, one result of which is the creation of a vast new class of "worried well" patients who will put pressure on their physicians to prescribe specific brand-name drugs, often for medically inconsequential conditions that do not represent a real threat to health.
Brownlee became interested in the largely hidden and unexplored issue of overtreatment when, in 1999, as a staff medical writer at US News & World Report, she began researching high dose chemotherapy and bone marrow transplantation - a drastic treatment for breast cancer that was then causing immense excitement in the media and medical profession. More than 40,000 women underwent this procedure, and more than 9,000 died as a direct result of it, before properly designed clinical trials showed unequivocally that high dose chemotherapy and bone marrow transplantation was no better than standard treatment.
"As I dug more deeply into the history of high dose chemotherapy," Brownlee writes, "I learned that medicine was often driven more by money than by science, and that many of the "cures" that we in the press wrote about over the years didn't pan out when - and if - they were actually put to a test. I also began to wonder about the connections between the lack of good science behind a lot of medicine and our health care system. Why was American health care so much more expensive per capita than health care in other industrialized countries, and getting pricier by the year? And why were our health statistics so much worse?"
In Overtreated, Shannon Brownlee offers both a compelling investigation of the economic forces that drive unnecessary care, and a rational prescription for what can - and must -be urgently done about it. It is highly encouraging that this book has been enthusiastically received by various prominent members of the medical profession. In a glowing review of the book, Marcia Angell, MD, former editor-in-chief of the New England Journal of Medicine, has written: "This book could save your life. In gripping detail, Brownlee explains how well-insured Americans get much more high-tech medical care - CT scans, angiograms, and the like - than they need, enriching the hospitals and doctors who provide it, but driving up the overall costs of health care and often endangering patients' lives. Brownlee clearly shows in this important book that overtreatment, like under-treatment, is very bad medicine."
Brownlee, Shannon. Overtreated: Why Too Much Medicine Is Making Us Sicker And Poorer. Available from: Amazon.com at:
http://www.amazon.com/gp/redirect.html?ie=UTF8&location=http%3A%2F%2Fwww.amazon.com%2FOvertreated-
Medicine-Making-Sicker-Poorer%2Fdp%2F1582345805%3Fie%3DUTF8%26s%3Dbooks%26qid%3D119937
3314%26sr%3D8-1&tag=cancerdecisio-20&linkCode=ur2&camp=1789&creative=9325
--Ralph W. Moss, Ph.D.
References:
Anderson GF, Hussey PF, Frogner BK, et al. Health spending in the United States and the rest of the industrialized world. Health Affairs 2005;24(4):903-914
Foundation for Taxpayer and Consumer Rights (FTCR):
http://www.consumerwatchdog.org/malpractice
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