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Posts Tagged ‘Cancer’

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Overtreatment of thyroid cancer

Posted by medconsumers on June 11, 2010

Thyroid cancer incidence has tripled since the 1970s. Most of the increase is attributed to the introduction of diagnostic ultrasound and fine-needle aspiration biopsies. Use of these two procedures escalated once ultrasound machines, initially found only at hospitals, became increasingly available in doctors’ offices. Autopsy studies show cancer is present in the thyroids of most people who died from other causes. Consequently, some researchers suspect that diagnosing thyroid cancer at the earliest stage is causing much more harm than good.

This suspicion was confirmed in a new study that found people with papillary thyroid cancer (the most common type) have an excellent prognosis whether or not they are treated within the first year of diagnosis. And they have an excellent prognosis whether part or all of the thyroid gland is surgically removed. Those who receive the latter treatment must go on thyroid replacement therapy for the rest of their lives.

These conclusions are based on 20-year data collected from 17 cancer registries maintained by the U.S. National Cancer Institute. Of particular interest were the people diagnosed with papillary thyroid cancer that had not progressed beyond the thyroid gland. More than 35,600 thyroid cancer patients, diagnosed between 1973 and 2005, fit this description. The researchers specifically wanted to know what happened to the people whose tumors were not treated for a year or more after diagnosis.

Here’s the bottom line: At six years, less than half a percent of those treated within a year of diagnosis had died. The death rate of the people who did not receive immediate treatment was also low (1.2%). As for those followed for 20 years: 99% of immediate-treatment group and 97% of the no-immediate treatment group were alive at 20 years. In other words, early diagnosis and immediate treatment accounted for a 2% difference.

This study was conducted by Louise Davies, MD, and H. Gilbert Welch, MD, of the Dartmouth Institute for Health Policy and Clinical Practice, and published last month in Archives of Otolaryngology, Head and Neck Surgery. It’s a sequel to their 2006 landmark study that identified ultrasound and fine-needle biopsies as the major reasons for the increase in thyroid cancer incidence. The new study was funded in part by a Research Enhancement Award from the U.S. Department of Veterans Affairs.

Davies and Welch caution doctors that the “outcomes” of patients treated for papillary thyroid cancer “are extremely favorable,” but the risks of treatment must also be taken into account. “Survival is so good that it is appropriate to consider whether the risks of complications outweigh the benefits of treatment during discussions about when and how to treat the disease. The risk of permanent hypoparathyroidism and significant damage to laryngeal function have been reported to range from 3% to 5%…”

In the editorial that accompanied this study, a counter argument was offered by Erich M. Sturgis, MD, and Steven I. Sherman, MD, of the M.D. Anderson Cancer Center, Houston. They agreed that a “wait and see” approach may be appropriate for many patients, particularly those with additional, more serious medical conditions. On the other hand, a person with a large tumor and a history of radiation exposure should be treated immediately. Furthermore, Sturgis and Sherman say that they see many patients with recurrent thyroid cancer “after an inadequate initial evaluation and/or treatment.”

And as for that 2% difference in the 20-year survival rate between the patients who were treated immediately and those who were not. Sturgis and Sherman extrapolate that 2% to the estimated 35,000 Americans diagnosed yearly with papillary thyroid cancer. It might be a tiny statistic, they say, but it represents about 500 to 700 people who will die of papillary thyroid cancer. “Certainly, most of these hypothetical 500 to 700 people would have wished their physicians had offered them the treatment that had ‘statistically’ better survival (i.e., surgery).”

Still, the editorialists do not dismiss the overtreatment concerns of Davies and Welch. Like the tiny tumors detected in the prostate, they state that occult papillary thyroid cancers “might even represent the normal aging process of the thyroid gland.” Davies and Welch are quoted approvingly:

“Because so many of these cancers would likely never have caused symptoms during life, epidemiologists have labeled the phenomenon, ‘overdiagnosis.’ Overdiagnosis is a cause for concern because it makes it hard to identify which patients need treatment…Further studies will be needed to determine if a more cautious diagnostic approach—perhaps simply providing follow-up for symptomatic thyroid nodules—is worthwhile. In addition, papillary cancers smaller than 1 cm could be classified as a normal finding.”

For more information
Read this 2006 article about Davies and Welch initial paper on the rise in thyroid cancer incidence. See the suggestions from Dr. Davies about finding a second opinion, including a second opinion about undergoing an ultrasound of the thyroid in the first place. (Click here for “Cancers that do not kill”)

The thyroid cancer incidence has been rising for three decades, and most Americans are treated immediately. Yet there’s no change in U.S. thyroid cancer death rate, which has always been very low. Click here for the National Cancer Institute’s take on this point.

Maryann Napoli, Center for Medical Consumers©

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Prostate cancer treatment misused

Posted by medconsumers on December 14, 2009

Androgen deprivation therapy (ADT) is prescribed inappropriately for many men in the early stages of prostate cancer and is associated with an increased risk of cardiovascular disease and diabetes. This was shown in a new study of over 37,000 men treated at the early stages of prostate cancer in the Veterans Healthcare Administration between 2001 and 2005. Published in a recent issue of the Journal of the National Cancer Institute, the study raises questions about informed consent and how much information men are given about ADT beforehand. There is no proof that it can prolong life or help men with low-risk, early-stage disease, yet ADT can cause severe adverse effects because it is drug-induced castration.

The research team led by Nancy L. Keating, MD, Brigham and Women’s Hospital, Boston, found that the high risks of diabetes (25%) and cardiovascular disease (20%) were associated with the gonadotropin-releasing hormone (GnRH) agonists. The drugs, sold under the brand names of Lupron and Zoladex, are injected by a physician or implanted under the skin every few months. No increased risk of diabetes and cardiovascular disease was associated with oral anti-androgen drugs like Euflex and Casodex, which are usuallly given in conjunction with GnRH agonists or, rarely, by themselves.

The increased use of ADT was linked to widespread screening with the PSA (prostate-specific antigen) blood test in a hard-hitting editorial that accompanied the VA study. The author, Peter C. Albertsen, MD, Department of Surgery, University of Connecticut Health Center, Farmington, states that the VA study offers a rare glimpse into the extent of ADT usage. He went on to note that PSA screening has dramatically changed the type of patient newly diagnosed with prostate cancer. “Before the advent of PSA screening, physicians used ADT to relieve symptoms of advanced prostate cancer. Now we use ADT primarily to treat patients with a rising level of PSA.” And most tellingly, Dr. Petersen writes, “We do not know whether these treatments [ADT] have prolonged survival, but [this study] confirms that this approach has the potential for substantial unintended side effects.”

Hot flashes, weakness, fatigue, cognitive impairment, and depression are the “substantial unintended side effects” of ADT, aka chemical castration. The VA study is not the first to link ADT to an increased risk of diabetes and cardiovascular disease, but it shines a light on unproven uses of this drastic therapy. The study shows that ADT is often given as the primary treatment for men with local and regional prostate cancer who have no symptoms of the disease, as well as symptomless men whose post-treatment PSA test show rising levels. The increased use of ADT can be chalked up to the fact that the PSA screening test was introduced in the late 1980s. This is well before the benefit of finding prostate cancer before symptoms appear was proven to reduce a man’s chances of dying from prostate cancer. See results of two recent clinical trials that explored this important question.

Dr. Keating, the lead author of the VA study, was asked to identify the men with prostate cancer for whom the proven benefits of ADT outweigh its considerable risks. “There are proven benefits to ADT for men with symptomatic metastatic prostate cancer in terms of controlling the spread of the disease which causes symptoms such as bone pain and fractures,” answered Dr. Keating in an e-mail, “and [there is] also a survival benefit to ADT when used as adjuvant [additional] therapy for men with high-grade disease, which is localized disease with high-risk features that make it more likely to return after primary treatment [with surgery or radiation therapy].”

And for whom is ADT most likely to be questionable? “The concern is that many men are treated with ADT for indications where there have never been studies showing benefit (e.g., as a primary treatment of prostate cancer and as a preventive against recurrence in those whose PSA levels rise after primary treatment). In these settings, the risks may outweigh any benefits,” answered Dr. Keating. “I think this has become a popular treatment because patients and doctors like the idea of doing something to treat the cancer. But the problem is, it has never been studied, and may have substantial adverse effects.”

So has the PSA screening test saved at least some lives? Apparently not, according to editorialist Dr. Petersen, who compared the current prostate cancer death rate with that of the era when men were not diagnosed with prostate cancer until they noticed symptoms. “Before the widespread use of PSA screening, an American man had an 8.7% lifetime risk of being diagnosed with prostate cancer and 2.5% risk of dying from this disease. By 2005, the lifetime risk of being diagnosed had increased to 17%, whereas the lifetime risk of dying from prostate cancer remained virtually unchanged.”

Maryann Napoli, Center for Medical Consumers(c)

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New Pap test guidelines

Posted by medconsumers on November 21, 2009

It’s about time. That was my first thought yesterday when I read that the American College of Obstetricians and Gynecologists had changed its screening guidelines for cervical cancer. ACOG made it clear that reducing harm is the main reason for raising the starting age for Pap tests to 21 and widening the intervals between tests. The harm is the multiple, often painful, biopsies that become necessary once abnormalities are found on the cervix. Most of these abnormalities will go away on their own, but the damage to the cervix can lead to problems when women get pregnant. Two examples are an inability to carry a baby full term and an increased risk of needing a caesarean.

What infuriates me is information about Pap-related harm was available decades ago. Yes decades. It was 1980 when I first read about the Pap test as a contributing factor to the high rate of hysterectomy in the U.S. Many women in that era went directly from an abnormal Pap test to the operating room for a total hysterectomy, even though some researchers knew that many of the so-called precancers found on the cervix regress spontaneously. This was noted in a review of all studies about cancer screening tests, which was commissioned by the American Cancer Society in the late 1970s and conducted by David Eddy, MD. This review was published in the July/August 1980 issue CA–a Cancer Journal for Clinicians, the ACS’s own journal. Why, you might ask, did the ACS continue to unequivocally promote Pap testing? Why not warn women so they can make an informed decision about accepting this test?

Fast forward about ten years, when I read about a study conducted in Sweden, showing that precancers of the cervix regressed spontaneously in nine out of ten women who were left untreated. A study like this had to be done in another country because U.S. gynecologists were quicker to do a hysterectomy than their counterparts in Europe. This study was published in the Journal of the National Cancer Institute, which at the time was the federal government’s official medical journal.

Here’s another sobering thought: 15 million Pap tests are done annually in the U.S. to detect cervical cancer in women who have had a hysterectomy. The absurdity (and danger) of trying to detect cervical cancer in women who do not have a cervix hit home about 20 years ago in a call to our office. The woman on the line sounded extremely emotional. And for good reason. She had been given a Pap test that indicated precancer even though she had no cervix. The reason her doctor gave for doing a Pap test anyway was evidence-free, but fairly common: “we’ll check you for vaginal cancer.” Her life was turned upside down for two weeks while her doctor sent her for multiple invasive, painful tests to search for an extremely rare cancer. She was relieved but furious to learn that the Pap test has no proven value in detecting vaginal cancer and therefore no proof that finding it early (i.e., before symptoms develop) would alter the course of the disease.

The Pap test is the first of the cancer screening tests, introduced in the early 1960s without benefit of a clinical trial to prove it was a good idea. Pap test results did not even become standardized until 1988. Up to then, one pathologist’s precancer was another pathologist’s benign abnormality.

I doubt many women have had the pros and cons of the Pap test explained to them by their doctors. Nor are they told how rare cervical cancer is. We have been led to believe that Pap testing is the reason cervical cancer is rare, but in fact the cervical cancer death rate was going down a good decade before the Pap test was given to a significant portion of the female population (see my 2007 article on the topic). And here’s the National Cancer Institute’s cautions about the Pap test that have been on its Web site for several years. I think women deserve an apology from the ACS and ACOG. It’s unethical to give a screening test without explaining both the harm and benefit.

Maryann Napoli, Center for Medical Consumers©

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Reduce your risk of breast cancer: Avoid mammograms

Posted by medconsumers on July 14, 2009

Want to know the best way to cut your chances of developing breast cancer? Stop having screening mammograms. Sure, the researchers who recently published a five-country study in the British Medical Journal would never express their findings in this manner. But read their results and decide for yourself. And keep in mind, many breast cancers detected by mammography will not become deadly or even produce symptoms if left untreated. Now it is known, one in three breast cancers fit that description.

Two Danish researchers conducted a systematic review of the breast cancer incidence in the seven years before a mammography screening program was introduced and the seven years after the screening program had been in full swing. The women in this review began having mammograms at the age of 50 years in the United Kingdom, Manitoba, Canada, New South Wales, Australia, Sweden and parts of Norway. The researchers were looking specifically at the number of women diagnosed with breast cancer after mass screening began. Although they expected a lower breast cancer incidence among the women as they grew older, this was not the case.

Here is what the researchers concluded, based on women who began screening at age 50 years. For every 2,000 women who undergo regular mammography screening over the next ten years, one will avoid a breast cancer death; 10 women will be diagnosed with a non-lethal breast cancer and treated unnecessarily; 10 to 15 women will be told they have breast cancer earlier than they would otherwise have been told, though this will have no affect on their prognosis (i.e., whether a woman’s breast cancer is found on a mammogram at age 55 or she finds it herself at age 65, her destiny is unchanged); and 100 to 500 women will have at least one “false alarm” that in about half the cases leads to a biopsy.

This review was conducted by Karsten Juhl Jorgensen and Peter C. Gotzsche, MD, of the Nordic Cochrane Centre in Copenhagen. Both have written extensively on the topic of overdiagnosis, which they define as “the detection of cancers that will not cause death or symptoms.” There is no foolproof way to determine which mammography-detected cancers do not progress from those that will. Virtually all are treated as if they will.

The lead author, Dr. Jorgensen, was asked by e-mail whether it is reasonable for a woman to decide not to have screening mammograms as a means of reducing her chance of having breast cancer. “In the light of our estimates of overdiagnosis, I would say that we now have to consider mammography screening as a major risk factor for getting a breast cancer diagnosis. And a preventable one, too,” he responded. “Of course, the breast cancers overdiagnosed through screening differ from the symptomatic ones by being non-lethal, but the individual woman cannot know this and the remaining consequences are the same (the surgery, radiotherapy and psychological stress).”

This is not the first time mammography screening was shown to cause more harm than good. Overdiagnosis and overtreatment were first identified in a 2000 systematic review of all seven trials worldwide that had randomly assigned women to receive mammograms or not. That review, which originally appeared in the British journal Lancet, has been updated as a Cochrane review.

Safest course of action? Seek medical attention at the first sign of a breast symptom.

Maryann Napoli, Center for Medical Consumers(c)

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Posted in Cancer, Screening, surgery | Tagged: , , , , , , | 1 Comment »

Anemia drugs hasten death in some cancer patients

Posted by medconsumers on July 13, 2009

For seven years Johnson & Johnson ran deceptive ads on prime time TV and in magazines with this recurring theme: A cancer patient cannot continue working because of debilitating fatigue due to chemotherapy. The ads told people in similar circumstances to ask their doctors about Procrit, which always quickly put an end to the fatigue. There is no published evidence to support the cure-for-fatigue claim, according to a 2007 press briefing at the FDA. Eventually, the agency required warning labels for Procrit, Aranesp, and Epogen —- all drugs widely prescribed to treat anemia in cancer patients. Warning label refers to the black box warning that appears in the 20 or so pages of information that comes with the drug (sometimes). The warnings for Procrit, Aranesp, and Epogen now list a higher incidence of potentially fatal blood clots, heart damage and increased tumor growth.

Now they can add “decreased survival” to the list. This week, the Cochrane Collaboration, the independent, international organization that evaluates research, published a meta-analysis of the information generated by the care of nearly 14,000 cancer patients entitled, “Anti-anemia drugs shorten survival for some cancer patients.” This meta-analysis is co-authored by Maryann Napoli, Center for Medical Consumers. For background on how their drugs came on the market and how financial incentives encouraged oncologists to overprescribe them, see her testimony on this topic before the FDA’s Oncologic Drug Advisory Committee in 2007 and one year later in 2008.

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Bladder Cancer: No adequate research to guide treatment decisions

Posted by medconsumers on May 1, 2009

“Bladder cancer is among the most prevalent and expensive cancers to treat in the U.S.” This is the opening line of a new study that looked at how early-stage bladder cancer is treated. It showed that treatment is all over the lot—from mild and minimally invasive to extreme and mutilating—because no head-to-head comparison study has ever been conducted to identify which is best.

The new study, based on information from Medicare claims, shows that the people treated least aggressively survived just as long as those treated aggressively Moreover, the initial high-intensity treatments failed to prevent the need for more interventions in later years. These findings were published recently in the JNCI (Journal of the National Cancer Institute) by Brent K. Hollenbeck, MD, and colleagues at the University of Michigan.

Details about the first two years of care given to over 20,000 people, diagnosed with early-stage bladder cancer from 1992 through 2002, were taken from the Surveillance, Epidemiology, and End Results-Medicare database. Early-stage bladder cancer is defined as a cancer that has not spread to the muscle of the bladder wall.

“What our study highlights is that physicians who practice aggressively in terms of surveillance [followup procedures like cystoscopy] also practice aggressively in terms of the major interventions [e.g., chemotherapy, removal of all or part of the bladder etc.]. That’s their practice pattern,” said the lead author, Dr. Hollenbeck in a telephone interview. The “more is better” paradigm is pervasive among patients as well as physicians, he added, and it is encouraged by our medical care system that pays physicians for doing more.

“What makes bladder cancer so expensive to treat is that about 80% of patients have the chronic form and our study indicates that intensive management of early-stage bladder cancer is common but potentially unnecessary,” said Dr. Hollenbeck who is the Director of the Division of Oncology, Department of Urology at the University of Michigan.

For example, the main diagnostic and surveillance technique is cystoscopy, which involves the insertion of a thin tube into the bladder. It is used to remove cancerous cells from the bladder, check for recurrence, and as a means of infusing chemotherapy directly into the bladder. Cystoscopy carries a small risk of urinary tract infection and can find abnormalities that require further intensive investigations that ultimately prove to be benign, explained Dr. Hollenbeck, citing two reasons why doctors would not want to overuse this procedure.

When asked how a newly diagnosed patient can identify overly aggressive surveillance and treatment, Dr. Hollenbeck offered this advice. “The real issue of this disease is figuring out whether the cancer is a pussy cat or a tiger. For the majority, you will know very early on—in about three months—whether it’s a pussy cat,” said Dr. Hollenbeck, referring to the chronic, slow-growing form of bladder cancer (80% of all).

The physician will know this after surgically removing the tumor and in some cases, going back and removing cells in the section of the bladder where the tumor had been, Dr. Hollenbeck explained. The idea is to make sure that the cancer did not invade the muscle of the bladder wall. “Then, the three-month evaluation with cystoscopy, will more than likely let you will know whether you’re dealing with a pussy cat, and if so, the physician doesn’t have to be nearly as aggressive from then on. Surveillance should gradually be spaced out thereafter. The optimal intervals are unclear. We are trying to get a better handle on this as part of our ongoing effort.”

Maryann Napoli, Center for Medical Consumers© May 2009

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Very Hot Tea Linked to Esophageal Cancer

Posted by medconsumers on April 1, 2009

People who drink very hot tea increase their chance of developing cancer of the esophagus, the muscular tube through which food passes from the throat to the stomach. This is the finding of a new study conducted in one province of northern Iran where people are known to drink large amounts of very hot tea because the water supply is unsafe. It is not the black tea they are drinking but its temperature that accounts for their high incidence of esophageal cancer.

The take-home message from this study: Wait four minutes or more before drinking any freshly boiled beverage.

In a recent issue of the BMJ (British Medical Journal), the lead author of this study, Resa Malekzadeh, Tehran University, and colleagues explained that their finding goes well beyond one region of one middle-eastern country. Worldwide, there are wide variations in the incidence of esophageal cancer, which suggests to cancer researchers that the disease is preventable.

Heavy alcohol and tobacco use are long known to be factors in the development of esophageal cancer and this explains why men are more likely to get esophageal cancer than women. But alcohol and tobacco are not implicated in non-Western countries with very high rates of the disease and where women are as likely as men to be diagnosed with esophageal cancer.

This made one province in northern Iran the perfect place to study another strongly suspected risk factor—drinking very hot beverages. The province has a higher rate of esophageal cancer than the rest of Iran, no gender differences in incidence, and a high intake of extremely hot tea. The investigators asked about the tea drinking habits of 300 people who were diagnosed with esophageal cancer and a control group of 571 people from the same province who were cancer-free.

To test the definitions of lukewarm, hot, and very hot, the researchers spent time measuring the actual temperature of the tea consumed by nearly 50,000 residents of the province.

The people who said that they drank their tea within two minutes after the water was boiled were five times more likely to have esophageal cancer than the people who waited four minutes or more to drink their tea.

The investigators could only guess at the reasons why. They suspect that chronic heat injury to the lining of the esophagus could cause the development of cancer. More research, they advise, should be directed to this subject.

In the editorial that accompanied this study, Australian researcher David C. Whiteman wrote that it provides “persuasive evidence” against the practice of drinking very hot tea. Whiteman also pointed out that others knew this long ago, citing the advice of Victorian cookbook writer, “Mrs Beeton, who prescribes a five to 10 minute interval between making and pouring tea, by which time the tea will be sufficiently flavorsome and unlikely to cause thermal injury.”

The first rapid response to this study (an electronic letter to the editor) came from someone in Argentina who wrote: “In Latin countries the majority of people drink black coffee, just as hot and potentially just as dangerous in terms of cancer risk. In Argentina, of course, traditionally as well as coffee, they drink maté [an herbal beverage], which is never drunk with milk and is frequently scaldingly hot.”

Maryann Napoli, Center for Medical Consumers© April 2009

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How Good are Colonoscopies?

Posted by medconsumers on January 1, 2009

Colonoscopy’s Benefit Found to be Overestimated

Regular visitors know that this Web site has never championed cancer screening tests. They are inevitably oversold to the public—benefits hyped, risks downplayed. Now colonoscopy has been exposed as a less than sure-fire lifesaving procedure. When colonoscopy screening first took off about nine years ago, people were often told by their doctors, “No one would die of colorectal cancer if every adult over age 50 had a colonoscopy.”

This inflated promise, based on no direct evidence, was downsized in time to: 90% of all colorectal cancers will be prevented. Now a new study, published this month in Annals of Internal Medicine, shows that the true statistic is nearer to 60%. It found that colonoscopy often misses polyps in the right, or ascending, colon where many colorectal cancers develop.

Why did it take so long to find this out and to be honest with the public? It’s not as if colonoscopy had ever been proven 90% effective or that disappointing information about colorectal cancer screening hasn’t been around for years. A 2000 San Francisco meeting of colorectal cancer researchers from all over the world is a case in point. Screening continually came up at this three-day conference as the most important way to reduce deaths. At the end of the conference, Dr. Wendy Atkin, a researcher from the UK, went up to the microphone to warn that there are only three randomized, controlled colon cancer screening trials worldwide, and all three showed screening is not lifesaving. True, a 30%reduction in colorectal cancer deaths was shown in the screened people, but this was offset by an equivalent increase in heart-related deaths.

As one of a handful of consumer advocates invited to attend this conference, I found her statement to be astounding and expected it to generate a heated discussion. Instead the waters folded over, and talk went on to other topics. I asked Dr. Atkin, as she was rushing to a taxi, whether researchers knew why people screened for colorectal cancer showed an increase in heart-related fatalities. She said they had no idea.

The first (and possibly only) doctor to share this disturbing bit of information with the public is H. Gilbert Welch, MD, professor at Dartmouth Medical School and author of the excellent 2004 book entitled, “Should I be Tested for Cancer? Maybe not and here’s why” (University of California Press). The three screening trials* involved the fecal occult blood test (FOBT). The participants received a colonoscopy only after the FOBT indicated the possibility of cancer. (Colonoscopy was not a screening procedure in the pre-1990s era when these studies were planned.) As for the question of why screening would cause an increase in cardiac deaths, Dr. Welch could only make a few guesses because no researchers have come up with, or perhaps ever looked for, a plausible explanation.

Dr. Welch’s book is not a rant against cancer screening tests. He takes a hard look at the supporting research and advocates realistic expectations. “Some believe that anyone who dies of cancer and wasn’t screened would have been saved had they had a test. But that’s not true. Sometimes cancers appear in the interval between screening tests. These interval cancers are growing rapidly and are more deadly than cancers detected by screening. Other times cancers are found by screening but people still die from the disease. Clearly, screening helps only in certain cases.” Dr. Welch also takes on the prevailing assumption—among doctors and consumers alike—that screening is a risk-free endeavor.

The new study that found colonoscopy misses many polyps did not randomly assign participants to have a colonoscopy or not. We’ll have to wait for that type of trial to see whether colonoscopy actually saves lives or whether colonoscopy screening merely trades one cause of death for another. Instead the new study drew information from the insurance claims for people living in the Canadian province of Ontario. It matched each of the 10,292 people who died of colon cancer with five people of the same age, sex and socioeconomic status who did not have colon cancer or any type of bowel disease.

The research team led by Nancy N. Baxter, MD, University of Toronto, checked how many had had colonoscopies and whether doctors had removed polyps. During the 1996 to 2001 study period, the colorectal cancer death rate was 7% among those who had ever had a colonoscopy and 9.8% among those who never had one. The decline in colon cancer deaths was “strongly associated” with the left side of the colon. And most of the missed cancers were located in the right (ascending) colon. Dr. Baxter and colleagues speculate that some of the colonoscopies might have been inadequately performed. About 30% were done by family doctors.

Doctor’s Skill Unknowable
This study comes on the heels of another one published last spring showing that many polyps are missed during colonoscopies that are performed too quickly. Unfortunately, people have no way of determining the skill of the doctor who will perform the colonoscopy. The American Cancer Society and the Centers for Disease Control and Prevention are reportedly working on developing quality standards for physicians to measure their performance and make improvements. The discussion about how to know whether you have a skilled colonoscopist who does many of these procedures is ongoing.

The renewed attention to colon cancer screening reminds me of an encounter with another researcher, this time at a 2004 conference. I recognized his name as a leading colorectal cancer researcher who has co-authored many important studies and is a strong proponent of screening. I asked him privately what we should make of that increase in heart-related deaths among people screened for colon cancer, half expecting him to deny any such finding. Instead, his response was surprisingly candid. “I guess we all have to die of something.”

Maryann Napoli, Center for Medical Consumers©

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*Dr. Welch described the only one of the three trials to be conducted in the U.S.: the Minnesota Cancer Control Study—published in 1993 in the New England Journal of Medicine .

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Vitamins: Research Shows No Benefit and Some Risks

Posted by medconsumers on December 1, 2008

Vitamins Don’t Work: Research Continues to Find No Benefit and Some Risks

Looking for ways to save money? Stop taking vitamins. The scientific case against them has been building over the last few years, starting with the report from the 2006 U.S. National Institutes of Health State-of-the Science Conference on Multivitamins/Mineral Supplements. The next year, a Cochrane review of all antioxidant trials caused an uproar because it found no preventive benefit to taking these supplements and a slight increase in mortality. And just in the last month alone, one new trial found no cancer preventive benefit to taking B vitamins; and another trial found no cardiovascular preventive effects for vitamins C and E. Both were published in the Journal of the American Medical Association.

B Vitamins
The B vitamins trial was led by Shumin M. Zhang, MD, and colleagues at Brigham and Women’s Hospital in Boston and Harvard Medical School. The impetus for this trial, explained the researchers, was the prevailing idea that folate, vitamin B6 and vitamin B12 might play an important role in cancer prevention. Yet the researchers also noted that information from earlier trials of folic acid alone or in combination with B vitamins have produced mixed results, and one trial “even raised concerns about deleterious effects.” What’s more, women were underrepresented in these trials.

Zhang and colleagues recruited 5,442 female health professionals, aged 42 years or older with cardiovascular disease or three or more risk factors for heart disease. All were randomly assigned to take a placebo or a daily supplement that combined 2.5 mg of folic acid, 50 mg of vitamin B6 and 1 mg of vitamin B12.

After seven years, the women taking the combination supplement had the same rate of cancer as those taking a placebo. This trial was funded by a grant from the U.S. National Institutes of Health.

Vitamins E and C
The other new trial found that vitamins E and C did not prevent cardiovascular disease in healthy men, aged 50 and older. The Physicians’ Health Study II involved 14,641 male physicians, 5% of whom had cardiovascular disease at the start of the trial. The men were randomly assigned to take 400 IU of vitamin E every other day and 500 mg of vitamin C daily or a placebo.

After a mean follow-up of eight years, the supplements had not reduced the risk for heart attack, stroke, death, heart failure, angina or the need for a coronary artery-opening procedure. Worse, vitamin E was associated with an increased risk for hemorrhagic stroke, or bleeding in brain (39 hemorrhagic strokes in the men taking vitamin E, compared with 23 in those taking a placebo). The negative results shown for vitamin E confirm those from earlier studies that involved men and women with preexisting cardiovascular disease.

This trial was led by Howard D. Sesso, ScD, Harvard School of Public Health, and funded by grants from the National Institutes of Health, the BASF Corporation, Wyeth Pharmaceuticals, and DSM Nutritional Products Inc (formerly Roche Vitamins).

Earlier Vitamin Research:
These two new trials are but a small part of the research that has found vitamins do not prevent illness or prolong life. Far more extensive is the following government report about multivitamins and the Cochrane review of antioxidant trials mentioned at the beginning of this article.

The report from the 2006 NIH State of the Science Conference on Multivitamins/Minerals for the Prevention of Chronic Conditions. A panel of experts was charged with the task of reviewing all placebo-controlled trials designed to see whether multivitamins and/or minerals can prevent cancer; age-related sensory loss; and cardiovascular, endocrine, neurologic, musculoskeletal, gastroenterologic, renal and pulmonary diseases. This is the report’s conclusion:

In systematically evaluating the effectiveness and safety of multivitamins and/or minerals in relation to chronic disease prevention, we found few rigorous studies on which to base clear conclusions and recommendations. Most of the studies we examined do not provide strong evidence for beneficial health-related effects of supplements taken singly, in pairs, or in combinations of 3 or more.

Within some studies or subgroups of the study populations, there is encouraging evidence of health benefits, such as increased bone mineral density and decreased fractures in postmenopausal women who use calcium and vitamin D supplements. However, several other studies also provide disturbing evidence of risk, such as increased lung cancer risk with beta-carotene use among smokers.”

The updated 2008 Cochrane review: “Antioxidant supplements for prevention of mortality in healthy participants and patients with various diseases.” The 68 placebo-controlled trials included in this review attempted to answer these questions: Can antioxidants prevent disease in healthy people? Can they prevent recurrences in people with cancer, heart disease or other illnesses?

This is the Cochrane review’s conclusion:

We found no evidence to support antioxidant supplements for primary or secondary prevention. Vitamin A, beta-carotene, and vitamin E may increase mortality. Future randomized trials could evaluate the potential effects of vitamin C and selenium for primary and secondary prevention. Such trials should be closely monitored for potential harmful effects. Antioxidant supplements need to be considered medicinal products and should undergo sufficient evaluation before marketing.

Funding Questioned: When this Cochrane Review was first published in 2007, we reported its findings and addressed one of the strongest criticisms leveled against it. Many suspected that the review was funded by the pharmaceutical industry to counteract public enthusiasm for vitamins. In our 2007 article on this topic, one of the review’s co-authors was asked about the funding: Christian Gluud, MD, of the Cochrane Hepato-Biliary Group, Rigshospitalet, Copenhagen University Hospital, responded, “The sole sponsor of this review is the Copenhagen University Trial Unit, a publicly funded, not-for-profit clinical research center, and about 90% of the trials in this review were funded by companies that make vitamins.”

Maryann Napoli, Center for Medical Consumers©

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Anemia Drugs For Cancer Patients

Posted by medconsumers on March 13, 2008

Testimony Submitted to FDA Oncologic Drugs Advisory Committee Meeting
March 13, 2008

Maryann Napoli, Associate Director, Center for Medical Consumers

As a consumer advocate who attended the May ODAC meeting, I came away wondering why these drugs remain on the market. They cause some patients to die sooner. They have many other risks that are severe and well documented, and any quality-of-life benefit has yet to be proven. The FDA approved the first ESA because it reduced the percentage of patients transfused. But the agency has since acknowledged that the infectious disease risks of a blood transfusion are far lower now than they were in 1993.

No doubt there are many cancer patients who see these drugs as an instant cure for chemotherapy-induced fatigue or as the means of allowing chemotherapy to continue. The former indication was fostered by Johnson & Johnson’s fraudulent ad campaign for Procrit, which continued for seven years in the mainstream TV and print media. I urge ODAC to discuss the misconceptions imparted by these ads and to consider recommending that the FDA require J&J to run a corrective ad campaign.

The ability of a cancer patient to make a truly informed decision with the help of her oncologist is seriously compromised by J&J’s and Amgen’s reprehensible practice of offering rebates—that is, kickbacks—to oncologists. Patients are always encouraged to discuss their treatment decisions with their doctors. Yet it’s hard for patients to believe oncologists’ recommendations are unbiased when they are “reaping millions” from the prescription of anemia drugs, as The N.Y. Times reported last May. (1) Companies that give kickbacks and other financial incentives intended to manipulate oncologists into using the most expensive drugs are poisoning the doctor/patient relationship.

Where can people turn for unbiased information? It should be the FDA, but it’s not clear to me that black box warnings are the way to go. The changes in the product labeling in 2004 did not change clinical practice. (2) And what do we know about the effects of black box warnings on the ones who need them the most—the cancer patients? The cancer patient should be given scientifically accurate, written information about ESA well before she needs it. The time to weigh the risks and benefits is not when she’s awaiting her next chemo treatment and just learned that her hemoglobin is too low for the next round.

Patients cannot make truly informed decisions unless they are given quantitative information to help them decide whether ESA is appropriate. They need to know, for example, the chances of…1) needing a transfusion; 2) suffering harm by foregoing a transfusion, 3) experiencing a serious adverse effect from the transfusion itself, and 4) having a severe adverse effect from the ESA. Patients need to know the magnitude of each of these four risks. Telling them that ESA will reduce their risk of having a blood transfusion is simply too vague. It gives them no way to compare this purported benefit with the other risks of taking ESA. If the FDA will not remove these drugs from the market, it must find the best ways to get clearly written, accurate quantitative ESA information to cancer patients.

(1) Berenson A, Pollack A. “Doctors Reap Millions for Anemia Drugs.” N.Y. Times, May 9, 2007

(2) Blau AC. “Erythropoietin in Cancer: Presumption of Innocence?” Stem Cells 2007; 25;2094-2097; originally published online Apr 26, 2007.

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