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Type 2 diabetes drugs: risks w/o benefit

Posted by medconsumers on December 14, 2009

Yet another study, this one conducted in the U.K, has shown that the oral drugs typically prescribed for people with type 2 diabetes are killing some of them; and many more have suffered heart attacks and congestive heart failure while on the drugs. Ironically, these are the very conditions that the drugs are intended to prevent. The British Medical Journal recently published findings from a 15-year database of more than 91,000 people with type 2 diabetes. The drugs they were taking—Avandia, Actos, Glucophage, and Amaryl—will be familiar to Americans. This is the eleventh published study to acknowledge the fact that oral hypoglycemic drugs are associated with an increased risk of serious harms. This one shows that some are riskier than others.

For those of you who are on one of these drugs, I provide access to the new study and leave it to your doctor to explain. I want to move on to the larger issue of why doctors continue to prescribe these dangerous drugs and how they got on the market in the first place. That last point is more easily addressed. Drugs most often receive FDA approval on the basis of what researchers call surrogate endpoints, for example, blood sugar levels are controlled, blood pressure or cholesterol is lowered, etc. The studies are usually too short in duration to prove what matters most to the people taking the drugs—i.e., they cut the chances of heart attack, stroke, etc.

I put the question of why doctors continue to prescribe these drugs in the face of so much proven danger to Nortin M. Hadler, MD, whom I consider the informed-skeptic-in-chief on this topic. Dr. Hadler is a professor of medicine and microbiology/immunology at the University of North Carolina, Chapel Hill. He is the author of two books, each with excellent sections devoted to type 2 diabetes (see below). Of course, the place to start questioning Dr. Hadler is the very definition of type 2 diabetes, which has been expanded over the years to include more and more people.

Dr. Hadler had a ready answer, “I don’t think America realizes how much input industry has on the medical organizations and their thought leaders who are involved in writing these definitions and treatment guidelines. Several of these entities are so heavily underwritten as to be almost wholly owned subsidiaries of the pharmaceutical industry. Professional meetings have much more the tone and the feel of the marketplace than they do of the academy. And all of this happened in the last 20 years.

“There are several pharmaceutical industry-supported medical groups that compete to establish standards of care for type 2 diabetes and related conditions. Some endocrinologists believe that type 2 diabetes, obesity, high blood pressure, and high cholesterol—all cluster together because they are parts of a single metabolic syndrome, which responds poorly to the treatment of its components. Others argue strenuously for the treatment of one or the other components [of metabolic syndrome]. Rather than choosing meaningful effectiveness as their battle cry, they are more interested in turf wars. The cardiologists are averse to this metabolic syndrome notion and want to pull out cholesterol and maybe hypertension as the most important risk factors to treat. The Endocrine Society and the American Diabetes Association finally got together and came out with their definition of type 2 diabetes and guidelines for lowering blood sugar.

“All of this is driven by the belief that if we normalize cholesterol or blood sugar we will improve longevity and decrease the incidence of blindness, kidney failure, stroke, heart attacks and leg ulcers. The thought leaders are so convinced of their belief that they focus on treating the blood sugar and to question whether they are treating the patient seems unnecessary. Their shortsighted efforts are rewarded with renown by the pharmaceutical industry. Almost all the thought leaders are heavily involved in drug trials where they are paid for studying the drugs. And almost all are vying for a place on the committees that set treatment guidelines.

“We now have three randomized controlled trials of oral hypoglycemic drugs in the treatment of type 2 diabetes and based on these three, we doctors cannot offer any meaningful assurance whatsoever that taking these drugs will decrease the likelihood of having a stroke, death before your time, amputation, renal failure, blindness. Anybody who tells you otherwise is exercising firm beliefs in the face of the evidence. They are wont to argue that oral hypoglycemics might have proven effective if we had done a bigger and/or longer trial. Such an argument is on the thinnest of ice. The available trials are impressive for their duration (measured in over a decade for two of the trials) and their size. Little of importance, if anything, has been missed.

“Maybe it’s time to address the other aspect of the metabolic syndrome that is too long and too often ignored. Most people who fall into the metabolic cluster are facing serious socioeconomic challenges in our society for which type 2 diabetes is one surrogate measure and for which pharmaceuticals are irrelevant.”

When I asked Dr. Hadler about metformin, the oldest and some doctors believe the safest diabetes 2 drug, he was unmoved by the British study that showed it to be effective at reducing the risk of heart attack, stroke, etc. “When you look carefully at that study, you will see the finding [of effectiveness] was not statistically significant [which means it could be due to chance].” As someone who has done an in-depth assessment of this landmark study, called the United Kingdom Prospective Diabetes Study, Dr. Hadler states, “…we doctors cannot offer any meaningful assurance whatsoever that taking these drugs will decrease the likelihood of having a stroke, death before your time, amputation, renal failure, blindness.”

Dr. Hadler is the author of The Last Well person. How to stay well despite the health-care system and Worried Sick. A prescription for health in an overtreated America, each has a strong section on type 2 diabetes. He appears frequently on National Public Radio.

For More Information:
Type 2 diabetes is largely due to lack of exercise and poor eating habits. See our 2008 interview with Dr. Steve Blair on the importance doing at least one-half hour of brisk walking five or more times a week. And to learn how to eat well and lower your risk of type 2 diabetes and other chronic conditions, read Michael Pollen’s new book entitled, “Food Rules.”

If you would like to know more about how the pharmaceutical industry brings the thought leaders around to its way of thinking, read Our Daily Meds by former New York Times business reporter Melody Petersen.

Maryann Napoli, Center for Medical Consumers(c)

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Posted in Chronic Conditions, Conflict of Interest, Drugs, Heart | Tagged: , , , , , , , , , , , , , | 2 Comments »

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)

Posted in Cancer, Men's Health, Screening, surgery | Tagged: , , , , , , , , , , , | Comments Off on Prostate cancer treatment misused

Swine flu hysteria

Posted by medconsumers on December 4, 2009

So far the H1N1 virus, or swine flu, has been extremely contagious but mild to moderate in severity. About 9,820 Americans have died from swine flu since it emerged in April, according to the Centers for Disease Control and Prevention. The CDC and the World Health Organization estimate that the swine flu may have already peaked in the U.S. But some experts point out that the flu season usually starts in December, therefore another peak would be expected in early 2010. By these estimates, I figure that the 2009-2010 flu season is still not likely to become the pandemic it was heralded to be. Think of it this way, even if the second peak doubles the number of deaths, the total would be lower than the CDC-estimated number of deaths (36,000) in any given flu season. As observed in our September 2009 article, the H1N1 virus appears to be just another seasonal flu, see “Why the Swine Flu is Not a Major Threat.”

The media kicked off the season with the usual fear-mongering that focused on the deaths or near-deaths of healthy young people. 60 Minutes provided the prime example of flu reporting at its worst. It focused on one healthy teenager who became desperately ill with the swine flu, which landed him in the intensive care unit. A news show of this caliber would be expected to let us know who is most likely to die (this teenager did not) and how many deaths occur in those hospitalized with swine flu. In other words, provide a context for this one case.

It wasn’t like a context was unavailable. A “window” on what was to come appeared in the October 2009 Online First version of The New England Journal of Medicine. In the early phase of the swine flu “pandemic,” a research team reviewed the medical records of 272 people hospitalized in the U.S. between April and June 2009. All had tested positive for swine flu. Here’s the finding that 60 Minutes might have included in its reporting, 7% of the people in this study died and nearly half were children. Almost three-fourths of all who died had at least one underlying medical condition, primarily asthma; diabetes; heart, lung, and neurologic diseases; and pregnancy. 60 Minutes might have compared these findings to what happens in a normal flu season when 90% of the deaths occur in people over the age of 65, mostly in those with serious underlying medical conditions.

To its credit, 60 Minutes started the story this way: “99% of people with H1N1 virus, it’s just the flu…a few miserable days at home.” Funny, I didn’t remember hearing this until I saw the show over again on the 60 Minutes Web site while writing this article. Unfortunately, the camera focus on a young man struggling for his life with terrified parents at his side totally overwhelmed the fact that this might be the fate of 1% of the people who contract the H1N1 virus and a tiny fraction of 1% of the entire U.S. population. The tragic deaths of healthy young people would be rarer yet. As of December 10, the CDC estimates that there were 1,100 deaths in children under the age of 18, two-thirds of them had an underlying medical condtion, mainly asthma, cerebral palsy and muscular dystrophy.

Sometimes I get the feeling that the media is doing the CDC’s bidding by encouraging panic so we’ll all rush off and line up for the swine flu vaccine. After all, the federal government paid for these vaccines and would not want to see them go to waste, nor would the CDC want the public to lose faith in vaccines. Maybe this was all a trial run in the event of a real pandemic. Many who lined up for the vaccine were elderly people, usually the priority group, now told to get to the proverbial back of the line.

As time went on, we learned that everyone born before 1957 has natural immunity so they don’t need the vaccine. This is a startling public health about-face. Haven’t we always been told that vaccines are equal to or better than natural immunity—that is, getting the flu naturally? “It is a false assumption that the vaccine provides similar immunity to the natural infection. We have evidence that the natural infection provides long-term immunity for more than 50 years. We don’t know how long the vaccine-induced immunity lasts, but estimates are two to three years at best,” explained researcher, Jim Wright, MD, in response to an e-mail inquiry.

Dr. Wright, based at the University of British Columbia, co-authored a recent letter to the editor of the British Medical Journal in which he called attention to the need for a randomized trial to determine whether vaccines are actually effective for both the H1N1 virus and the seasonal flu. Some of us in the U.S. would like to know why the seasonal flu death rate has remained unchanged in the last 20 years, despite the fact that there was a steady increase in the number of people vaccinated during that time. Even the CDC is tacitly admitting the lack of progress with its 36,000 annual flu deaths statistic that hasn’t changed in years.

There are plans to form a panel of experts from outside the government to watch for any rare or unexpected side effects in the millions of Americans who were vaccinated in the last three months. But that’s not all I want verified. I’d like to know whether we were getting an honest assessment of the threat level of the swine flu. And was it worth spending the billion dollars that the U.S. government put into the production of these vaccines, or are there better ways to spend the taxpayers’ health dollars? Most of all, I want to know whether the H1N1 vaccines were effective in preventing death and hospitalization, especially in young people. When I directed these concerns to the CDC, a spokesman told me no decision has been made to study these issues.

For more information
Read this about the World Health Organization and the investigation of the gross conflict of interest of its expert on the H1N1 virus. And this on the home front: “Advisers on vaccines often have conflicts, report says.”

Maryann Napoli, Center for Medical Consumers©

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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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Mammogram uproar

Posted by medconsumers on November 18, 2009

Ten years ago I opened my driver’s license renewal notice and out dropped a pink slip reminding me to have an annual mammogram. While it was touching to know that the New York State Department of Motor Vehicles cared about my breast health, I saw the pink slip as yet another example of over-the-top mammography promotion. (My husband has yet to receive any health instructions from the DMV.) When a test’s lifesaving benefit has been oversold to the public for over three decades—and the harms downplayed—any cutback in recommendations will be met with a firestorm of anger.

That’s exactly what happened yesterday when a highly respected organization recently broke ranks with others that issue screening guidelines and advised women at average risk for breast cancer to begin having regular mammograms at age 50, not age 40. The U.S. Preventive Services Task Force also changed two longstanding recommendations: women age 50 to 74 should have a mammogram every two years rather than annually (cuts down on the biopsies without altering the number of lives saved), and doctors should stop teaching women how to do breast self-examination (no benefit, more biopsies). Shock, horror, and condemnations followed the announcement in the media on Monday. Not a surprising reaction considering the advice to the public preceded the science.

The recommendation to start mammography screening at age 40 was premature to begin with, dating back to the early 1970s. Incredibly, it was based on one clinical trial conducted in the 1960s that found a 30% reduction in breast cancer deaths in the women over age 50 but no benefit for women in their forties. That clinical trial, known as the Health Insurance Plan of Greater New York study, had followed the participants for three to five years. Not unreasonably, public health officials at the time thought that the younger women in this study would eventually show a reduction in breast cancer mortality with longer followup. They didn’t bother to wait and the aggressive promotion of mammography took off after President Nixon declared the “war on cancer.” Thus began a nationwide campaign, sponsored by the American Cancer Society and the National Cancer Institute, urging women over the age of 35 to seek yearly mammograms complete with the overly optimistic message that early detection will save their lives.

Radiation exposure was the only acknowledged harm in this era, and it was usually dismissed as unimportant in comparison to the benefit of finding breast cancer early. By the 1980s, mammographic techniques had improved and the radiation exposure greatly reduced. A modest reduction in breast cancer deaths in younger women was found in some, but not all, clinical trials done in other countries. The largest trial intended to answer the question of mammography’s value to women in their forties found no lifesaving benefit. Basing its estimate on the trials that did find a benefit, the U.S Preventive Services Task Force concluded that one in every 1,900 women who undergo an annual mammography over a ten-year period will avoid a breast cancer death.

In 2001 the Lancet published the first evidence indicating that mammography screening leads to overtreatment without reducing mortality. The authors, both researchers at the Nordic Cochrane Centre, did an in-depth assessment of the data generated by all the randomized mammography screening trials. To this day the Cochrane researchers continue to reassess the research (read a 2009 update of their findings). What they have found is entirely counterintuitive and not confined to women in the forties. Mammograms can detect tiny cancers, but not all of them would become deadly or even produce symptoms if left untreated. Yet virtually all are treated aggressively because no test can accurately sort out the potentially lethal cancers from those that do not progress. Overdiagnosis and overtreatment are the terms for this problem, which was quantified in a study published recently in the British Medical Journal, showing that one in three cancers found on a mammogram would not become life-threatening. This should have been the major reason for the change in recommendations, but the media coverage frequently presented mammography’s major harm as the anxiety from false alarms and breast biopsies. As for the other major harm—radiation exposure—the USPSTF cites this estimate, “annual mammography of 100,000 women for 10 consecutive years would result in up to 8 radiation-induced breast cancer deaths.”

The USPSTF based its revised recommendations on the findings of a panel of experts made up of research physicians and most crucially, biostatisticians who quantified some of the harms as well as the benefit. Their task was to assess the evidence generated by the world’s gold standard trials, as well as observational studies. While we all hope that our physicians are familiar with the evidence supporting their advice, the sad reality is that many are not. Most simply follow the advice of organizations like the American Cancer Society and the American College of Obstetricians and Gynecologists. What’s more, it’s as hard for them to change their thinking as it is for us. Here’s just one example. From the professional advice given my daughter and her friends, I know that the long-discredited American Cancer Society recommendation for women to have a baseline mammogram in their late thirties continues to live on. (The ACS quietly withdrew this recommendation in 1992, but it takes time for the word to get out.)

Other sources of information:
If you want to make an informed decision about mammography, go directly to the scientific evidence instead of your doctor. Here’s a timeline for the key studies and previous failed attempts to raise the starting age for mammography which was published recently in the New York Times. This is a “summary of the evidence” from the randomized trials and observational or population studies (i.e., mammography done in the real world), which formed the basis for the USPSTF’s revised recommendations. And this is the National Cancer Institute’s summary of pretty much the same clinical trials (note that the first trial that justified the advice to start mammography at age 40 is described as being of “poor quality”), as well as population studies. The NCI summary is difficult to read, but this sentence from the summary is easy to understand, “Screening for breast cancer does not affect overall mortality, and the absolute benefit for breast cancer mortality appears to be small.” This applies to women who start mammgraphy at age 50 as well as those who started at 40.

Using the same data, researchers at the Nordic Cochrane Centre have produced a more understandable summary for women that is available on the Web (see link within this article). To increase your chances of having a mammography performed skillfully, read How to Select a Mammography Facility . And to reduce your chances of an inaccurate diagnosis, read “When to get a 2nd pathology opinion.”

Maryann Napoli, Center for Medical Consumers(c)

Two days after the USPSTF issued its recommendations, HHS Secretary Kathleen Sebelius issued a statement distancing the Obama Administration from the new guidelines. In short, she told women to ignore them and claimed disingenuously that more research is needed. This is very disappointing to those of us who had high hopes that health care reform would mean that medical treatment and screening decisions, as well as cost-cutting measures, would be evidence-based. Once again, mammography’s evidence is clouded by politics. This time around, however, the politics make sense. No doubt, Secretary Sebelius did not want to derail the current health care reform efforts.

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Walk-in clinics good choice for minor ills

Posted by medconsumers on September 29, 2009

Big chain stores like Wal-Mart and CVS have opened on-site medical clinics for customers seeking care for minor problems like sore throats. Though these retail clinics have been targets of disapproval from medical organizations, a Rand Corp. study showed that the quality of the care they provide is comparable to and less expensive than the care provided at physician offices and urgent care centers. The study was led by Ateev Mehrotra, MD, University of Pittsburgh, and published this month in Annals of Internal Medicine.

Store-based walk-in clinics have become popular for a variety of reasons. No appointments are required; they are open seven days a week and some evenings; less time is usually spent in the waiting room; and an increasing number of Americans do not have a primary care physician. Many of these clinics are manned by nurse practitioners or physician assistants, which raises the possibility of inferior care in the minds of some people, primarily physicians. The most high-profile criticism, however, came from the AMA, which saw a potential conflict of interest in retail clinics where health workers may be overprescribing drugs sold in their stores. (It’s hard to keep a straight face about this complaint from the AMA, not known to have the same concerns about surgeons recommending surgery.)

The Rand Corp. study is based on information from the claims made by 2,100 enrollees in a large Minnesota health plan that has allowed its enrollees to use retail clinics for the last five years. Dr. Mehrotra and colleagues looked at the claims made for three common illnesses—sore throat, urinary tract infection and ear infection. The claims for these three illnesses treated at retail clinics were compared with claims for the same illnesses treated at physician offices, urgent care centers, and emergency rooms (ERs).

The prescription drug costs were the same at retail clinics, physician offices, and urgent care centers. The exception was the ER where the average prescription costs were higher and the quality of care was significantly lower than in the other three settings. The overall cost of the visit to a walk-in retail clinic was $110, compared to $166 for physician offices, $156 for urgent care centers, and $570 for the ERs.

A related study published in the same issue of Annals of Internal Medicine explored the general question of whether these clinics provide access to care for “underserved populations.” Using data from the U.S. Census and 2008 Health Resources and Services Administration, the study found that retail clinics are currently located in more advantaged neighborhoods and concluded that this makes the clinics inaccessible to those most in need.

Both studies were funded by California HealthCare Foundation.

Maryann Napoli, Center for Medical Consumers©

Posted in Children's Health, Chronic Conditions, Drugs, Women's Health | Tagged: , , , , , , , | 1 Comment »

How good is Tamiflu?

Posted by medconsumers on September 28, 2009

The antiviral drugs Tamiflu (generic name: oseltamivir) and Relenza (zanamivir) are getting renewed attention now that the flu season is upon us. Both are in the same drug class called neuraminidase inhibitors. Because Tamiflu dominates the market for antivirals, it is named throughout this article but the findings are generally applicable to both drugs.

The benefit once you get the flu:
Roche Laboratories had to conduct two trials to get FDA approval for this indication. The studies showed that Tamiflu, reduced the duration of the seasonal flu by a little more than one day…but only when taken within 40 hours of the onset of flu symptoms. This benefit, however, is limited to those with influenza A or B. The two trials had a combined total of 1,355 people who were randomly assigned to take 75 mg Tamiflu or a placebo, twice daily for five days. At the start of the trials, all participants were proven to be infected with influenza A. In time, more studies were published and all were reviewed for a recent issue of Lancet Infectious Diseases. This review found Tamiflu shortened the duration of influenza by 13 hours for healthy people and by 18 hours for high-risk people. Tamiflu costs between $5 and $10 a pill, depending on where it is purchased.

Problems with the above: When flu symptoms develop, you are not likely to know whether you have influenza A or B; nor will there be much time for laboratory confirmation. (The test is highly inaccurate anyway.) Chances are high that you don’t have influenza A or B because both are relatively rare, representing less than 10% of the 200 or so circulating viruses. What’s more, the symptoms are indistinguishable from the other 90% of circulating viruses that cause what is known as influenza-like illness. H1N1, or swine flu, is an influenza A virus, which is why this drug is allowed to be marketed for seasonal as well as H1N1 influenza. (The yearly seasonal vaccines are also aimed solely at influenza A and B viruses.)

Benefit when trying to prevent the flu:
In the Roche-sponsored trials for this purpose, healthy unvaccinated adults, aged 13 to 65 years, took 75 mg Tamiflu once daily for 42 days during an outbreak of influenza in their community. 5% of the people taking a placebo got the flu, compared with 1% of those taking Tamiflu. In healthy children, aged 1 to 12 years, taking 30 mg or 60 mg (depending on the child’s weight) Tamiflu once daily for ten days, 17% of those taking the placebo got the flu, compared with 3% of those taking Tamiflu. As for Tamiflu’s ability to reduce complications, see Postscript below.

Resistance: “Emergence of drug-resistant influenza viruses after treatment has been reported, particularly in children in Japan, where the dosing schedule is different [i.e., more aggressive] from that used throughout the rest of the world,” according to a report in the February 15, 2009 issue of Clinical Infectious Diseases. The authors of this report also found that resistance to Tamiflu is more likely to occur in H1N1 influenza A [swine flu] than in other influenza A or influenza B viruses.

Revised CDC recommendations:
On September 22, 2009, the CDC updated its recommendations to physicians, stating that Tamiflu should be reserved for high risk populations like pregnant women and babies. “Most healthy persons who develop an illness consistent with influenza, or persons who appear to be recovering from influenza, do not need antiviral medications for treatment or prophylaxis.” In other words, now that antivirals have shown some resistance, not to mention marginal effectiveness, the CDC says these drugs should be reserved for people at high risk for flu-related complications.

History: Tamiflu was approved by the FDA in 1999 for the treatment of influenza A and B. About four years ago when the avian flu was the threat, several governments, including that of the U.S., started stockpiling Tamiflu. In the U.S. government’s case, the stockpiling was for the military. Just since the emergence of swine flu in Mexico last spring, J.P. Morgan, the investment bank, estimated that governments have placed new orders for antiviral drugs of $3billion, despite the fact that this flu season looks like it will be relatively mild. Initially, Roche was required by the FDA to state in the drug’s label that Tamiflu’s efficacy in the treatment of influenza in people with chronic cardiac disease and/or respiratory disease had not been established. This disclaimer appears again in the updated 2008 FDA-approved label for Tamiflu because Roche still has not tested its drug for this high-risk population that needs it the most. [The drug label is the package insert that comes with medications and reprinted in the Physicians’ Desk Reference. The label is written by the drug company and then negotiated and approved by the FDA.]

Unanswered questions:
Why haven’t the government-customers for Tamiflu leaned on Roche to prove its drug is effective in treating people with chronic cardiac disease and/or respiratory disease? What incentive does a company have to develop a better drug when it can make a billion dollars selling a barely effective drug like Tamiflu to the U.S. government each year?

Risks: Years after Tamiflu went on the market, reports surfaced that Tamiflu-treated people with influenza had experienced delirium and abnormal behavior, leading to injury and even death. Most of the cases occurred in children and in Japan where this drug was used excessively. Influenza itself (without Tamiflu) can be associated with a variety of neurologic and behavioral symptoms such as hallucinations, delirium, and abnormal behavior. In 2008, the FDA and Roche revised the label for Tamiflu accordingly. Nausea is a common side effect of Tamiflu.

Other antiviral drugs to avoid:
In 2005 the Lancet published a study showing that influenza A viruses had developed resistance to Symmetrel and Flumadine and other antiviral drugs in a class called amantadine. These drugs were widely prescribed before 2005.

Postscript, added December 8, 2009
The British Medical Journal announced the publication of an updated review of all studies related to Tamiflu effectiveness, concluding, “There is no clear evidence that the antiviral drug most commonly used against influenza – oseltamivir (Tamiflu) – prevents complications like pneumonia in healthy people [who who become ill with influenza]. …Yet such claims have been a key factor in decisions to stockpile these drugs as part of global pandemic preparedness plans.” The review is described as part of a joint investigation by the Cochrane Collaboration, the British Medical Journal, and [BBC] Channel 4 News.

And this addendum December 7, 2010: See this new website for an excellent explanation of the benefits and risks of Tamiflu.

Maryann Napoli,Center for Medical Consumers(c)

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Statins: Low chance of Benefit

Posted by medconsumers on July 1, 2006

Statin-Treatment Guidelines: 198 to 1 odds that the drug won’t help

Would you go on long-term statin drug therapy if you knew that the odds are one in 23,000 that the drug will save you from a cardiac death? How about one in 198? And are you prepared to stay on that drug for the rest of your life, though the full story on the drug’s harms is yet to be known? That is what the experts who put together the U.S. and Canadian statin-treatment guidelines expect of the public, according to an analysis published last month in the British Medical Journal.

So much of medical decision-making boils down to probabilities. What is my chance of having a heart attack? And how will this drug reduce the risk? Cholesterol drug ads, for example, proclaim a 25% reduction in heart attack. But that means nothing unless you know your personal odds of a heart attack. Always ask: 25% of what?

If, for example, you are a healthy middle-aged woman with high cholesterol but a tiny chance of having a heart attack in the next five years, then the drug offers a 25% reduction in those already miniscule odds. But, if you are a middle-aged male smoker who has already had a heart attack, then the 25% reduction offers a large benefit.

Researchers who study drug trials have another way of determining odds called number needed to treat. They frame the research question this way: How many people must take this drug every day for five years to save one person from a cardiac death? That formula is the basis of the new analysis of international guidelines for prescribing the cholesterol-lowering statin drugs that include Lipitor, Mevacor, Zocor, Pravachol, Crestor, and Lescol. It highlights some major deficiencies in the information intended to guide physician prescribing practices. And in turn, deficiencies in the information consumers need to make informed decisions.

The statin-treatment guidelines from five countries—Australia, Canada, New Zealand, the U.K., the U.S.—and several European medical societies were assessed by a team of Canadian researchers led by Douglas G. Manuel, MD, of the Institute for Clinical Evaluative Sciences in Toronto. The number needed to treat was determined by applying each set of guidelines to the same population of 6,760 Canadian men and women, aged 20 to 74 years.

The “winners” are the Australian and British guidelines because they are the most effective in potentially avoiding the most deaths. However, the New Zealand guidelines were deemed the most efficient because they potentially avoided almost as many deaths while recommending statin drugs to the fewest people. Based on the New Zealand guidelines, the number needed to treat is 108, or for every cardiac death prevented, 108 people must take statins for five years. (By comparison, the number needed to treat is 198 and 154, for the U.S. and Canada, respectively.)

What is most troubling about the results of this new analysis is not just that the U.S. and Canadian guidelines identify a larger pool of people as candidates for statin therapy in order to prevent one cardiac death. But it is also the fact that the crucial topic of drug-related harm was ignored by those who established the guidelines. “Treatment guidelines don’t discuss harms. I don’t know why,” said Douglas G. Manuel, MD, the lead author of the analysis, in a telephone interview.

“Harms are idiosyncratic, meaning everyone has more or less the same chance of harm. I say that with lots of caveats,” explained Dr. Manuel, a scientist and primary care physician. “But this is not so where it concerns benefits. If a person is at high risk because he has had a heart attack, then the benefit [of statin therapy] will be large. But as a person’s risk of heart disease gets lower, then I am more uncomfortable [about prescribing statins].”

The harm question was put to David Atkins, MD, medical officer at the U.S. Agency for Healthcare Research and Quality, the lead federal agency charged with improving the quality, safety, efficiency, and effectiveness of health care for all Americans. “Many guidelines about drugs skirt around the issue of harms,” he said in a telephone interview. “With anti-hypertension drugs, for example, side effects include sexual dysfunction and dry mouth, but they affect a small number of people—2-5%.” They are not addressed, Dr. Atkins explained, because it “complicates the message too much.” What’s more, he said, “Doctors tend to regard the issue of side effects as trivial in light of a heart attack.”

All of the statin-treatment guidelines are purportedly evidence based, meaning they are drawn from the same published results from clinical trials in which participants have been randomly assigned to take a statin or a placebo and followed for about five years. However, a healthy skepticism is in order where it concerns women without heart disease. A 2003 government report, Diagnosis and Treatment of Coronary Heart Disease in Women: Systematic Reviews of Evidence on Selected Topics, concluded, “There is insufficient evidence to determine whether lipid lowering [i.e., with drugs, diet or other lifestyle changes] reduces risk for any clinical outcome [e.g., heart attack, stroke].” The main reasons for the “insufficient evidence” are: women are underrepresented in statin trials and most of the trials pool the results of men and women together.

Informed decision-making about statin therapy is hampered further by another problem with medicine’s gold standard evidence—the randomized clinical trial, according to Dr. Manuel. “My expectation to get good information about harms from a randomized clinical trial is somewhat low because we are missing key parts of the information about adverse events from drugs in general, not just statins. What we need is better postmarketing surveillance,” he said, referring to mandatory reporting of adverse drug reactions after a new drug goes on the market. (Currently, reporting is voluntary and captures less than 10% of all serious adverse drug reactions.)

The FDA-required clinical trials conducted prior to approval usually have a few thousand participants at best. Only when hundreds of thousands of people begin taking a drug for years do the rare or uncommon serious adverse reactions come to light. Cardiologists are often quoted in the media saying that statins are safer than aspirin, but they are likely unaware that drug trials frequently fail to report all serious adverse reactions. (To see how common it is for drug companies to withhold information about adverse reactions suffered by clinical trial participants, see “Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.”)

Statin trials are a case in point. James Wright, MD, and colleagues at the University of British Columbia conducted a 2003 review of all five statin primary prevention trials and found that the serious adverse events* went unreported in three of these published trials. When Dr. Wright was asked for an update, he explained by e-mail that the serious adverse events were collected in all 12 major statin trials. However, ten of these trials have failed to report these important results (i.e., make them publicly available). Worse, the authors of these trials refused the UBC reviewers’ repeated requests for the harms data.

Treatment guidelines may be aimed at physicians, but the brunt of their deficiencies will be borne by the people who unquestioningly follow their doctors’ recommendations, especially those who are at low risk of developing heart disease. Understanding the probabilities that relate to the drug as well as your own personal risk is crucial to informed decision-making.

If your doctor says that statin therapy will reduce your odds of having a heart attack by 25% but cannot answer the question—25% of what?—here is how to do it yourself. Go to the National Heart, Lung and Blood Institute Web site for the less than perfect 10-year risk calculator. If, for example, you have a 2% chance of having a heart attack in the next ten years (two out of 100 people with exactly your risks), then the 25% reduction from statin therapy will bring your odds down to 1.5%. Predictably, the quiz, or anything else on this Web site, won’t help you understand the odds of harm or benefit from statin drugs. It is easy to see why pharmaceutical companies like to convey benefit in terms of a 25% reduction in their ads without explaining what that means or how it relates to a person’s baseline risk of having a heart attack. It is much harder to understand why information gathered and disseminated by a government agency funded with taxpayers’ money would not be more forthcoming.

Bottom Line: The new analysis of international guidelines shows a wide variation in the number needed to treat, though all are based on the same clinical trials. Harms are not addressed, possibly because there is a consensus among cardiologists that statins are safe and that serious side effects are rare. But there is also a consensus among people who study the FDA’s postmarketing surveillance system that less than 10% of all serious adverse drug reactions are reported to the agency. Inefficient guideline like those from Canada and the U.S. will send many people to statin therapy who have only a low risk for heart disease. Using the Canadian guidelines, Dr. Manuel and colleagues estimated that at least 23,000 low-risk people would have to take statins for five years to prevent one death from heart disease.

* Defined as “any untoward medical occurrence that results in death, is life-threatening, requires hospitalizations, requires prolongation of hospitalization, or results in persistent or significant disability.”

Maryann Napoli, Center for Medical Consumers ©

Controversy over U.S. Cholesterol-Treatment Guidelines

On July 12, 2004, the U.S. National Cholesterol Education Program updated its statin-treatment guidelines, greatly expanding the pool of candidates for statin drugs. They include men and women without heart disease but who have a moderately high risk of developing it, plus low-density lipoprotein (LDL) levels between 100 and 129 mg/dL; and those with heart disease and LDL levels between 70 and 100 mg/dL. The new recommendations are applied to men and women regardless of age. Overnight, millions more Americans became eligible for life-long statin therapy.

Within days of the announcement, two reporters at Newsday revealed that eight of the nine physicians on the committee that established the new guidelines had strong financial ties to companies that make statin drugs.

Two months later an open letter went to the media and the heads of the National Institutes of Health (NIH) and its division, the National Cholesterol Education Program, calling for the creation of an independent review panel free of conflicts of interest to conduct another review of all the new data from the five studies that led to the updated recommendations. The letter was written by Merrill Goozner of the Center for Science in the Public Interest and signed by 36 physicians, researchers, scientists, and politicians.

The letter charged that the expanded guidelines do not reflect the evidence. Among the objections: the evidence does not support the broad use of statins in women (including those at “moderately high risk”) and people over 70 without heart disease. And there is conflicting evidence about the value of statins to people with diabetes. Additionally, the letter asked whether the lower levels of LDL are justified by the scientific evidence.

A point-by-point response came in a letter from Barbara Alving, MD, NIH acting director, which is also available on the NCEP Web site. A new panel will be formed when results of the ongoing trials are available and the guidelines require another update, wrote Dr.Alving, and future guidelines will be posted in draft form on the National Heart, Lung, and Blood Institute Web site, along with “financial disclosure information.”

Maryann Napoli, Center for Medical Consumers ©

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Cholesterol Skeptics: Conference Report

Posted by medconsumers on June 1, 2003

Cholesterol Skeptics and the Bad News about Statins

The cholesterol skeptics were there. So were the physicians who challenge the safety and necessity of cholesterol-lowering drugs. And then there were the lipid researchers whose findings totally contradict the prevailing dietary advice to the public: Avoid saturated fats, limit cholesterol, and use more polyunsaturated oils. Their presentations were met with enthusiastic approval at a conference held last spring in Arlington, Virginia. But then again, the attendees were not the usual people who show up at a conference billed as “Heart Disease in the 21st Century: Beyond the Lipid Hypothesis.” They were practicing physicians, biochemists, farmers, greenmarket activists, researchers, cooks, parents of young children, and people who have been told their cholesterol is too high. The general message was: Fats are extremely important to good health…the right kinds of fat, that is.

Cholesterol was the dominant topic of the two-day event, as well as the subject of the opening lecture provocatively entitled, “High Cholesterol Protects Against Disease.” Uffe Ravnskov, MD, PhD, a Danish physician who has published many critical papers about the purported association between cholesterol and cardiovascular disease, led off with a slide showing the results of all the major clinical trials that attempted to prove that lowering cholesterol in healthy but high-risk people would reduce their death rate from heart disease. “The reduced rates of cardiovascular mortality were small for men and non-existent for women,” said Dr. Ravnskov, who is the author of The Cholesterol Myths, a paperback that refutes the theory that cholesterol in our food and in our blood causes heart disease.

These cholesterol trials also looked at total mortality, that is, the deaths from all causes, and found little difference between the study participants who tried to lower their cholesterol and those who did not. In other words, some clinical trials showed that the heart disease death rates were, in fact, lower among men who had reduced their cholesterol levels. But this benefit was offset by a higher rate of deaths from other causes.

Given these unimpressive research results, why is high cholesterol so firmly imbedded in our consciousness as a sure-fire sign of a future heart attack? Dr. Ravnskov said that it all started with the landmark Framingham Heart Study, which began following healthy people in the early 1950s to see who had a heart attack and what distinguished them from the people who did not. High cholesterol was one risk factor–but it was only one of more than 240 others. “They [public health officials, cardiologists, etc.] have confused a statistical association with causation,” he observed. “It’s as if they saw a house burning and determined that the bigger the fire, the more fireman are present, and then concluded that firemen cause burning houses.”

When studies failed to prove that lowering cholesterol made any lifesaving difference, researchers forged ahead with more multi-million dollar clinical trials. Not until the statin drugs (Lipitor, Mevacor, Zocor, Lescol, Crestor, Advicor) came along did cholesterol-lowering finally prove to be lifesaving to high-risk but healthy people. Whether this benefit might actually be due to the anti-inflammatory effects of statins has been the topic of controversy ever since.

As with several of the speakers who would follow him, Dr. Ravnskov is unimpressed with the reduction in heart disease mortality shown for the statin drugs “When you look at the CARE trial [Cholesterol And Recurrent Events], Pravachol did show a small benefit–after five years 5.7% had died from heart disease in the [untreated] control group, compared to only 4.6% in the treatment group, but [this benefit] was not dose related.” he said, referring to the expectation that the more a person lowers his or her* cholesterol, the less likely a heart-related death. Also, the people taking Pravachol had a few more deaths from other causes. Dr. Ravnskov managed to push the envelope further by making a case for high cholesterol as a protective against cancer. He showed slides listing published studies that found higher rates of infectious disease among hospitalized people with low cholesterol levels. Also, several studies found higher cancer rates in people with low cholesterol levels.

Women told to take statin drugs should be aware of this risk found in the CARE trial: There were 12 cases of breast cancer in the women taking Pravachol, compared with only one case in the untreated (control) group. Statin drug proponents dismissed this worrisome finding as a fluke, said Dr. Ravnskov, because the control group would be expected to have had more than one case of breast cancer.

“Anyone who questions cholesterol usually finds his funding cut off,” said Paul Rosch, MD, who started his talk with a reminder that half of all heart attacks occur in people with normal cholesterol levels. “Stress has more deleterious effects on the heart than cholesterol,” said Dr. Rosch, who is a clinical professor of medicine and psychiatry at New York Medical College and president of the American Institute of Stress. He put a different spin on the oft-quoted studies of immigrants with low rates of heart disease that change for the worse years after they emigrated to the U.S. The shift to a Western diet is usually identified as the culprit, but Dr. Rosch suggests that the stress of adapting to a new culture is harder on the heart. For example, a study of Japanese male immigrants found a lower rate of heart attack among those who consumed a Western diet but retained a Japanese lifestyle, compared to those who continued to eat only traditional Japanese foods but lived a Western lifestyle.

Statin Drugs & Memory Loss
Duane Graveline, MD, MPH, a retired family doctor and former NASA scientist/astronaut, recounted his own hair-raising experience taking the popular statin drug Lipitor for only six weeks. Soon after he went for a walk, Dr. Graveline was found wandering, confused, and reluctant to enter his own home because he didn’t recognize it or remember his wife’s name. Six hours later–after being examined by a neurologist and undergoing an MRI–he came to his senses. Transient global amnesia (TGA) was diagnosed. Neither he nor his physician suspected Lipitor, so Dr. Graveline was restarted on one-half the previous dose. Again, at six weeks, the TGA returned. This time, he regressed to his teen-age years with no memory for his time in college, medical school, or the recent past. “Many decades of my life were obliterated,” he said. “The diagnosis was TGA: cause unknown.”

To verify his growing suspicion that Lipitor might be the cause, Dr. Graveline wrote to Joe and Teresa Graedon, the husband and wife team that writes the syndicated column called The People’s Pharmacy, which specializes in warning the public about drug side effects. The Graedons asked for permission to print his letter in their column, and once it appeared, hundreds of people wrote in to say they, too, had experienced severe memory loss while on Lipitor. “Patients are reluctant to report amnesia, or they attribute the symptoms to old age or early Alzheimer’s,” explained Dr. Graveline. “And doctors are reluctant to see that the drug they prescribed was the cause.” Still, the official word on Lipitor is that memory loss is not a statin side effect. “Thousands of cases of memory dysfunction have been reported to the FDA’s Medwatch program,” he said, “but after two years, the agency still hasn’t acted. And most practicing physicians are unaware of the problem.” Lipitor is not the only statin linked to this side effect, observed Dr. Graveline.

A reporter pointed out that FDA-required trials do not report memory loss in people taking statins. An explanation was offered by Joel M. Kauffman, PhD, research professor of chemistry and biochemistry at the University of the Sciences in Philadelphia. “In drug trials, the pharmaceutical companies often divide similar adverse effects into six or seven different categories to keep the scarier side effects under 1%.” To illustrate his point, Dr. Kauffman said that amnesia could be divided into confusion, memory loss, senility, and cognitive impairment. There is general acknowledgment, however, that muscle pain, weakness, fatigue, peripheral neuropathy, and rhabdomyolysis, a potentially fatal muscle disease, are statin side effects, though they are thought to be rare.

With a little distance from his harrowing TGA experience, Dr. Graveline said that he began to question why he took Lipitor in the first place. “I had come to think of cholesterol as my personal enemy–my cholesterol levels had climbed [over the years] despite a fat-restricted diet, but no one mentions the proper function of cholesterol in the body,” he continued. “We doctors march to the low-fat, low-cholesterol band.” He soon learned that cholesterol plays a critical role in the maintenance and healthy functioning of cell activity in the body.

Coenzyme Q10
Several speakers expressed the opinion that the statin drugs’ ability to reduce cardiovascular mortality has nothing to do with cholesterol reduction, but instead can be attributed to their anti-inflammatory effects. (A viewpoint that has been appearing in medical journals over the last few years.) Furthermore, the physicians who addressed the conference were united in their concern that the statin drugs deplete the body of an important anti-oxidant with muscle wasting and heart failure as a result. Peter Langsjoen, MD, of Tyler, Texas, said that he left his invasive cardiology practice at the University of Texas Health Center to specialize in “congestive heart failure, primary and statin-induced diastolic dysfunction and other diseases of the heart muscle.” For over 20 years, he has been using coenzyme Q10 to treat a broad range of cardiovascular diseases. Q10, as he called it, can be purchased over the counter as a dietary supplement in health food stores and pharmacies.

Dr. Langsjoen said that the research on the importance of Q10 ties in nicely with the underlying philosophy of this conference because increased levels of this “vitaminlike” substance can be found in traditional foods with high fat content like organ meats, seafood, and red meat. “I call Q10 vitaminlike because it has properties of a vitamin,” explained Dr. Langsjoen, “but since we synthesize it, as well as get it in our diet, it’s not truly a vitamin.” All statin drugs decrease both the blood levels and cellular concentrations of Q10, observed Dr. Langsjoen, the higher the dose, the greater the decrease in Q10. “As we get older, our Q10 levels fall, but we really don’t know why–could be the diet,” he said. “People who make it to 90 tend to have high Q10 levels, though. Most of the Q10 research has been focused on heart failure, said Dr. Langsjoen because the heart uses a huge amount of Q10. “It has been pretty well documented from biopsies that the severity of heart failure correlates with the people who have the lowest levels of Q10.”

What’s more, there is a serious gap in information regarding the role of statins in treating heart failure. “All the major statin trials excluded patients with class III and IV [advanced] heart failure, so we have no safety data in these patients with heart failure, though statins are prescribed to them with reckless abandon.” Dr. Langsjoen is not alone in this concern which was expressed over a year ago by Australian physicians who asked, “Statins and Chronic Heart Failure: do we need a large-scale outcome trial?” in the Journal of the American College of Cardiology.

Most medications destined to cause an adverse effect will do so early on, according to Dr. Langsjoen, who found this not to be the case with statins. “You don’t realize you’re in trouble until two or three years later, and it’s hard to relate it to a drug you started a few years ago.

Dietary Fats and Oils
The story of how statin drugs became a multi-billion-dollar industry may have started with the identification of cholesterol as the chief culprit in heart disease, but in time the public learned that the low-fat diet would prevent heart attacks in people without symptoms of heart disease–an idea that the sponsors of this conference believe has produced numerous health problems. Mary Enig, PhD, an expert in lipid chemistry, spoke of the misinformation perpetuated upon the public by the government-sponsored “pyramid diet,” which was introduced over 20 years ago and marked the beginning of the promotion of the low-fat diet. Along with the “use sparingly” advice, fats, oils, and sugar are at the very tip of the Food Guide Pyramid symbol that appears on food labels.

Dr. Enig believes that the rise of obesity is related to type of foods Americans have been encouraged to eat by the U.S. Department of Agriculture, the food industry, and consumer groups. “[People are eating] a diet high in grain and inappropriate fats, instead of the natural animal fats, such as lard, tallow, chicken fat, goose fat, and the natural vegetable fats, such as olive, palm, and coconut oils, that we used to have in our diets,” and contrary to the current “propaganda,” she explained that these fats and oils are essential components to a healthful diet. These so-called good fats provide the major fuel for the heart, kidneys, and skeletal muscles, said Dr. Enig, who said the inappropriate fats are the highly processed polyunsaturated fats, such as soybean, canola, and corn oils, which are promoted [ironically] as heart protective.

“Before the advent of modern vegetable oils, mankind consumed small accounts of fresh, undamaged polyunsaturated fatty acids found naturally as a component of his food,” according to Dr. Enig. “Consumption of polyunsaturated fatty acids is much higher today because vegetable oils are used widely as cooking oils and in salad dressings, baked goods, and snack foods. Polyunsaturated oils should never be heated–yet during the extraction process these oils are subjected to very high temperatures that encourage rancidity and the formation of many harmful breakdown products.” An example of the harmful breakdown product, she explained, is something called trans fatty acids, which are now generally recognized by mainstream medicine as harmful to the heart. Dr. Enig said that trans fatty acids do not appear on the nutrition labeling of food products, but they should. Trans fatty acids are abundant in partially hydrogenated vegetable oils, which are usually listed in the ingredients section of the food label, and are found in only small amounts in animal fats.

Dr. Enig is a leading spokesperson for the Weston A. Price Foundation, which sponsored this conference. The foundation is named for a dentist who, beginning in the 1930s, studied the dentition of healthy isolated people untouched by Western civilization. He found that they inevitably had great bone structure and beautiful straight teeth.
Primitive diets were nutrient dense, with four times the calcium and mineral and ten times the level of fat-soluble vitamins, compared to the modern American diet. Dr. Price continued to study these isolated people as Western foods were introduced. The white flour, sugar, devitalized oils, etc., gradually displaced the traditional foods, such as organ meats, fish eggs, and butter from pasture-fed cows. Changes in diet led to rampant tooth decay; narrowing of the face that brought on a susceptibility to sinus infections; narrowing of the pelvis that led to childbirth difficulties; and behavioral problems. Sally Fallon, president of the tax-exempt foundation, told the conference that its goal is to disseminate the research of this “nutrition pioneer. According to the information packet supplied to the conference attendees, the Weston A. Price Foundation takes no food industry funding.

For More Information:
-Lots of free information about the traditional foods championed by the Weston A. Price Foundation can be found on its Web site ( Tapes of this and past conferences can be purchased via this Web site. Those without Internet access can call (202) 333-HEAL to learn the cost of receiving printed material from the Foundation.

-Visit the International Network of Cholesterol Skeptics at Most of the conference speakers belong to this Network. The 51 members are listed along with their publications.

*A study of elderly French women living in a nursing home showed that those with the highest cholesterol levels lived the longest (The Lancet, 4/22/89). The death rate was more than five times higher for women with very low cholesterol. Several other studies have shown similar results. Ironically, Dr. Ravnskov noted that in his practice it was usually the elderly women who were most worried about their cholesterol levels.

Read our articles that have critiqued statin drugs over the years: “Statins don’t work for people without heart disease”, “Drugs to prevent stroke and heart attack,” “(Almost) Everything you need to know about statins,”Statins: Low Odds of benefit,” “Take a closer look at statin’s benefit,” and “Failed Vytorin study raises questions about cholesterol.”

Maryann Napoli, Center for Medical Consumers(C)

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