In vino veritas — Part One

Within days of each other, two major news stories from Europe have reported sensational claims about alcohol and cancer. It appears no one has bothered to go directly to the studies behind the news and read them. Or, perhaps, media and governmental health ministries, don’t understand them or realize that not all studies are created equal. Just because something calls itself a study doesn’t mean it actually studied anything, was designed to soundly test an hypothesis, or that it actually found what is being claimed.

The first news story came from the French National Cancer Institute (INCA). It claimed that a single glass of wine or alcoholic drink a day doubles one’s risk of getting cancer. A single glass! “Small daily doses of alcohol are the most harmful,” the president of INCA told French consumers, adding: “There is no amount [of wine], however small, which is good for you.” With the INCA report, the French Ministry of Health published guidelines advising the public that “the consumption of alcohol, especially wine, is discouraged.”

The French government’s latest pronouncement suggesting that French citizens should stop drinking wine altogether has been met with considerable derision, as you can well imagine!

It’s not only oenophiles who argue the healthful benefits of wine, of course. Even the American Heart Association’s evidential reviews found that the body of evidence supports lower overall mortality associated with alcohol consumption. And, any science-minded, intelligent person knows that when someone is making a scary claim that there is “no safe exposure” and that any amount at all is dangerous just because extreme exposures may be unhealthful has fallen from sound reason. Such efforts to terrify people violate the most fundamental laws of science and biological plausibility: the dose makes the medicine or the poison.

INCA said in the press this week that “alcohol is now the second most avoidable cause of death after tobacco.” It was quick to add that the French’s love of red meat, fatty charcuterie and salt was also bad for them. So much for the French paradox, it would seem.

Not.

Going to the source

It turns out that the source of this news story, not surprisingly, was a “Communiqué de presse 17 février 2009” — a press release issued on February 17 by INCA. In French, it explained that at the request of the government, the National Nutrition and Health program was launched in 2001 to focus on food and physical activity among the population. Coordinating with a variety of food, preventive health and cancer stakeholders, in 2003, it had released a publication — Food, Nutrition and Cancer: truths, assumptions and misconceptions — summarizing the purported relationships between cancers and diet, obesity and lifestyle.

This week’s press release announced the re-release of this report. We’ll look at it in a moment. But before this latest report…

In November 2007, INCA had also published a report specifically on alcohol and cancer, titled “Alcool et risques de cancer: état des lieux des données scientifiques et recommandations de santé publique.” It reported that alcohol increases the risk of cancers in men and women, based on epidemiological studies it claimed provided a “convincing level of evidence.” It also asserted that the “scientific literature shows that the risk of cancer increases linearly with dose provided by ethanol alcohol beverages without a threshold effect. In other words,” it said, “even moderate alcohol consumption increases the risk of cancer.” In its recommendations, this report said that regular consumption of alcohol should be avoided because the increased risk is significant even with moderate drinking.

Few people, and certainly not public health policy officials, it appears, had bothered to read the report, let alone go directly to any of the studies referenced as providing evidence in support of its assertions. This report’s findings had been based on eight case-controlled (observational) studies, which it claimed had found outstanding increases in relative risks for cancer associated with alcohol, and five meta-analyses.

Reading the actual research. To give you an example of what this report considered “convincing” evidence to back its claims, we’ll look at the largest case-controlled study it referenced. This study, published in the International Journal of Cancer in 1999, had been designed and coordinated by the International Agency for Research on Cancer (IARC) in Lyon, France and led by cancer epidemiologists in Barcelona, Spain. It included five observational studies on a total of 830 esophageal cancer patients seen between 1986 and 1992 in South American hospitals in Argentina, Brazil, Paraguay and two in Uruguay. The cancer patients selected for this study were in their mid-60s, more than half had 3 or less years of schooling, 82.7 percent had smoked and most (78.4 percent) had drunk alcohol.

Already, you can see that these patients are not typical of citizens in most developed countries, nor were these patients well “matched” with the 1,779 controls. Not being randomized studies, the control groups chosen for comparison had higher education levels, were slightly younger and consisted of considerably fewer people who smoked or drank alcohol (40 percent fewer had ever had any alcohol, for example). As is readily apparent, there are immeasurable ways (confounding factors) the cancer patients probably differed from the control groups. Yet, in looking for correlations between cancer and drinking and smoking, the authors didn’t consider ANY other confounding factors.

Despite this allocation bias, the Spanish authors still found no correlation between the amounts of pure ethanol or years of drinking and esophageal cancer in women, only in the amount of alcohol consumed among the men. But rather than recognize that other factors may be at work here, alcohol was considered the culprit. To illustrate how uncredible and capricious the link attributable to alcohol itself and the men’s esophageal cancer, there was no correlation among the men between esophageal cancer and the number of years the men had been drinking alcohol. And men who waited until age 66 or older to quit drinking had no higher risk for cancer but those who stopped drinking between ages 48-65 doubled their relative risk. As we see daily — with studies finding something good for us one day and bad for us the next day — epidemiological studies can find all sorts of meaningless, contradictory and nonsensical correlations.

Compiling the five groups, the authors found untenable relative risks between esophageal cancer and any of those who had ever drank alcohol — which, of course, described nearly everyone in their study group. The relative risks (95 percent CL) were 1.3–3.3 in women and 2.7-4.9 in men. Given the weaknesses in the study design (clearly failing as a “fair test”), these correlations were untenable. And, in the actual published study, even the original Spanish authors had concluded: “Our data show that light-to-moderate drinking (i.e., 1 to 3 drinks per day) without smoking does not substantially increase the risk of esophageal cancer.”

This isn’t meant to frighten you about what government public health officials consider convincing evidence to make the exact opposite conclusions, but you really do deserve to know what the evidence really shows, not what they claim it shows.

So, this week, the new edition of the nutrition and cancer report from INCA was released, saying it was written to provide healthcare professionals with “updated, documented and recognized” scientific research linking alcohol, diet (namely salt, red meat and sausages) and weight to elevated risks for several cancers. It called for the need for health professionals to support interventions to get everyone to diet, exercise and stop drinking.

You won’t believe what the new, updated science was that necessitated a new edition of this booklet.

As INCA explained, since its first edition in 2003, the Expert Report of the World Cancer Research Fund and the American Institute for Cancer Research had been published in November 2007. In establishing the evidence of the relationship between diet and cancer, INCA said, the 2007 WCRF/AICR report had been based on 7,000 original scientific articles, systematic reviews and hundreds of meta-analysis conducted by nine international centers, and then subjected to an independent evaluation by 21 international experts. In light of its findings, INCA said it was necessary to publish an update of its own report, which was indistinguishable from the WCRF/AICR Expert Report.

In other words, this is another adaptation of the WCRF/AICR Expert Report, mentioned in a thousand news stories earlier this week! Yes, the same 2-year old report that had not only failed to provide what most scientists would consider convincing evidence (in fact, its authors had created their own unique method of claiming to prove causation from correlations), but its conclusions were repeatedly the opposite of the evidence. The original JFS examination [here] found that none of the 17 cancers examined in the WCRF/AICR Expert Report had found credible associations with foods (sugars or sugary drinks, fats, meats, fruits, vegetables, legumes, vitamins, alcohol or processed foods), nor was there a credible association between all cancers and obesity or BMI.

In this INCA report, the authors said that alcoholic beverages have recently been classified as a human carcinogen by the International Center Cancer Research.(!) Based on “relations considered convincing” in the meta-analysis of epidemiological studies in the WCRF/AICR report, the authors estimated an increased relative risk of cancer per glass of alcohol consumed each day of 168 percent for oral cancers of the mouth, pharynx and larynx, and of 28 percent for esophageal cancer (Table 1).

Remember, relative risks are the tool of agendas

These relative risks sound enormous and scary to lay people who don’t understand that these correlations are derived from epidemiological studies and aren’t even tenable — more than random chance, statistical error and due to confounding factors. [Tenable risks were explained here.]

But let’s pretend the relative risks these computer modelings found are real. They would translate to clinically meaningless actual (absolute) increased incidences.

According to the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) Program, the foremost source for cancer statistics in the United States, age-adjusted incidence rates of all oral cancers combined among the U.S. population is 0.0108 percent, with a mortality of 0.0026 - 0.004 percent (and has shown a steady drop among all population demographics since 1975). So, the 168 percent increased relative risk associated with drinking a glass of alcohol every day would theoretically raise actual risks of getting an oral cancer by 0.016 percent and dying of it by 0.004 percent.

According to SEER, overall age-adjusted incidence rates of esophageal cancer in the United States is 0.004 percent — virtually identical since 1985. So, a 28 percent increase in relative risk associated with drinking a glass of alcohol every day would theoretically raise the actual incidence by 0.001 percent.

And if, as the WCRF/AICR new policy report released earlier this week claimed, “healthy” eating, weight loss and exercise could really lower the percentage of esophageal cancers by 69 percent (another untenable statistic from epidemiological correlations), that would equate to a reduction in actual risk of 0.002 percent.

These are all clinically meaningless values.

But reporting actual risks don’t have nearly the same scare value as relative risks, do they?

Based on alcohol consumption in France, the INCA report tallied all of the untenable relative risks for all of the cancers (science doesn’t really work that way, untenable numbers don’t become more credible by adding them up) to estimate that 10.8 percent of cancers in men and 4.5 percent of cancers in women were caused by alcohol. While alcohol consumption has been declining in France since the 1960s, the INCA report stated, the French still have among the highest alcohol consumptions in the world — sixth in the world and fourth largest in Europe, according to the World Health Organization.

The public health message was that the French are drinking too much wine and it’s bad for them — but did anyone bother to see if there is even any correlation between the amount of wine the French drink compared to other countries and cancer mortality rates? It turns out, based on World Health Statistics 2008 and World Statistics of per capita wine consumption by country**, there is no association at all. Without even a link, wine can’t possibly have a relevant causal role for population health.

The world’s highest cancer mortality rates, for example, are in Bolivia (256/100,000), with an average life expectancy of 66 years — yet it has about the lowest wine consumption (0.28 liter/year). Grenada’s cancer mortality rate is also high at 199/100,000, and its people have a life expectancy of only 68 years; yet they drink only 2.28 liters wine per year per person. [By comparison, most European and developed countries, including the U.S., share similar life expectancies of 78-82 years.] Contrast that with Switzerland’s low cancer mortality rate of 116/100,000 to its higher consumption level of nearly 40 liters of wine each year per person. Italians and Americans have the same rates of cancer mortality (134/100,000) — which are about the world averages — yet very different wine consumptions, with Italians drinking 48.16 liters of wine apiece each year compared to the mere 8.69 liters in the United States. The French and British have similar cancer mortality rates, at 142 and 143/100,000, yet wildly divergent wine consumptions, too. Individuals in the UK drink only 18.97 liters/year of wine compared to 55.85 liters among the French.

In other words, no one can credibly blame the wine!

Next, we’ll look at the other study in the news this week, telling women that if they don’t want to get cancer, they may not want to drink anything…

© 2009 Sandy Szwarc

** Vatican City, by the way, has the world’s highest wine consumption per capita, at 62.02 liters per year.

Click here for complete article (and single page version).

Evidence-based health policies don’t necessarily mean credible evidence

If we believe a thousand news stories that appeared in lockstep today, a new study just released by the World Cancer Research Fund and the American Institute for Cancer Research found that “cancer is mostly preventable with clean living.”

The new policy report “is based on an exhaustive review of nearly 7,000 scientific studies” and said to have found that bad diets, obesity and sedentary lifestyles cause one out of three cancers.

“It's a very compelling case,” Shiriki Kumanyika, Ph.D., MPH at the University of Pennsylvania in Philadelphia and a member of an expert panel that oversaw the report, told the media. “I definitely feel confident,” that the scientific evidence strongly supports that poor diet, obesity and lack of exercise cause at least one out of three cancers. “Cancer is not inevitable,” she said. “When it comes to cancer prevention,” she said, the evidence shows that what’s important are nonprocessed foods higher in water and lower in calories. After its earlier 2007 Expert Report identified the healthy choices to prevent cancer, this new report “takes the next step,” said Kumanyika.

According to the press release, Policy and Action for Cancer Prevention is a “landmark policy report” providing “comprehensive, evidence-based recommendations for all levels of society.” It calls for sweeping global changes in public health policies and for governments to use all measures at their disposal to advance healthy behavior and diets based on fruits, vegetables and whole grains and low in fats, sugars, salt, meats and dairy. Its recommendations include nonprofits, the United Nations, governments, industry, media, schools, workplaces and healthcare settings.

“On a global level every year, there are millions of cancer cases that could have been prevented and this is why we need to act now before the situation gets even worse,” lead author, Michael Marmot, said. “Promoting public health is not just the responsibilities of governments and health departments,” said the AICR report, “but is shared by all sections of society.”

How many public health officials, deciding what’s best for all of us, will bother to go to the original scientific studies behind these far-reaching recommendations — and how many will just take the word of “experts?”

An actual examination of those “7,000 scientific studies” in the 517-page Expert Report found that not one of its key recommendations had been supported in clinical studies. In fact, the Report not only failed to provide what most scientists would consider convincing evidence, its conclusions were repeatedly the opposite of the evidence. The lengthy JFS examination [here] found that none of the 17 cancers examined in the WCRF/AICR Expert Report had found credible associations with foods (sugars or sugary drinks, fats, meats, fruits, vegetables, legumes, vitamins, alcohol or processed foods) or BMI.

“Evidence-based” is another example of doublespeak that doesn’t always mean what it seems.

Click here for complete article (and single page version).

Another look at the science of wellness

Whether they call themselves health or lifestyle coaches or wellness practitioners, the person at the other end of the telephone of the wellness program offered by your employer or healthplan could be anyone. Wellness is not a recognized or licensed medical discipline.

This past week, the New York Business Strategies Examiner interviewed a wellness practitioner of therapeutic touch, reconnection healing and clinical aromatherapy. The story offered a helpful caution about wellness. This practitioner had recently moved from her corporate position to launch a company selling wearable aromatherapy that the inventor called “the first accessory-ceutical on the market.” Wicks are dipped in essential healing oils and worn as jewelry. For her, aromatherapy has been “the sweet smell of success.”

She offers seven blends of oils in her “life-enhancing jewelry” collection. One blend is said to provide emotional well-being and a deep sense of peace; another to think clearly, stay alert and energized; one is for joy, romance and inspiration; another to protect yourself from airborne micro-organism that cause disease; one for confidence, courage and self-esteem; Endoflex is said to balance your hormones from PMS to menopause and increase vitality; and the final blend promises to do “all that you desire with abundance.”

Her website, aromawear.com, says: “We have proof of the benefits of aromatherapy, the art and science of utilizing naturally extracted aromatic essences from plants to induce relaxation, increase energy, and restore lost balance to mind, body and soul.’” No proof was provided, however. Instead, visitors read that “since ancient time, special objects and plants were believed to possess magical powers and jewelry filled with herbs and their essences were worn for protection from disease and to promote mental and spiritual well-being.”

Aromatherapy — a homeopathic energy modality

Aromatherapy was first coined by the French chemist, Rene Maurice Gattefosse, in 1928. By the mid-1990s, aromatherapy had become a more than $100 million industry just in the United States. According to the National Association for Holistic Aromatherapy — a grassroots organization founded in Boulder, Colorado, with a nurse one of the co-founders — aromatherapy is a holistic energy medicine that acts as both a preventative and active treatment during acute and chronic stages of illness. The oils are said to “enhance the individual’s innate healing process [and] assist the body’s natural ability to balance, regulate, heal and maintain itself.”

All pleasing aromas — like any lovely fragrance worn as a perfume, bathed in or enjoyed with a massage; or even home-baked bread and cookies fresh from the oven — are enjoyable. The potential dangers with aromatherapy, like all alternative modalities, come when they are marketed as having medical and health benefits that exceed the science or biological plausibility. People can potentially be put at risk by turning away from proven, effective treatments or by being hurt financially, costing them when they’re most vulnerable.

Aromatherapy has been purported to be effective for everything from infections, asthma, depression, fibromyalgia to cancers. An illustration of the health claims being attributed to aromas is found in an article published in Aromatherapy Journal, the journal of the National Association for Holistic Aromatherapy. Author Linda Chudzik wrote of her personal path to enlightenment that began with nutritional and chiropractic healing after her own breast cancer and led her to energy healing and “balancing her electrical energy field …to obtain optimal balance of the body, mind and spirit.”

At the 4^th Wholistic Aromatherapy Conference, she wrote, naturopath and homeopathic practitioner, Bruce Berkowsky, taught that cancer is the result of “cancer miasm” and that aromatherapy’s essential oils can effectively “penetrate the layering of superficial symptoms in a case and gain access to the germinal, central disturbance of the dynamic plane from which those symptoms emanate.” Another aromatherapy concept developed by Rudolh Steiner, she said, “teaches that plants produce fragrance as a means of absorbing ‘the soul’ of the sun, which contains the essence of spirit.”

Cancer and other disease miasms, she explained, is a homeopathic concept from Samuel Hahnemann, its founder. It believes people are predisposed to disease passed down from generation to generation by bioenergy, not genetics and heredity. People with a cancer miasm are believed to have certain mental personality and emotional traits that predispose them to cancer — everything from fear of disease, love of animals and dancing, oversensitivity, sentimentality, to a desire for chocolate. [The “cancer personality myth” was covered here.]

Anyway, Chudzik continues through a convoluted string of energy beliefs, such as that malignancy is an expression of disorganized astral bodies and spiritual forces and abnormalities in our auric fields. She finally described the purported ability of essential oils to combine energetic modalities of natural healing and homeopathy to treat cancer miasm and a wide range of cancers. Aromatherapy, she says “may be the major breakthrough against cancer that mankind is so desperately searching for.”

Aromatherapy and other fragrance products are considered cosmetics by the FDA and cosmetic marketing claims “for cleansing, beautifying, promoting attractiveness or altering the appearance” don’t need FDA approval. But, according to the FDA, anyone who tries to market a scent by suggesting it is effective as an aid in quitting smoking, sleeping, or to treat or prevent any other condition or disease, or otherwise affect the body's structure or function, would be subject to regulatory action because such claims would come under FDA drug regulations.

Can odors really heal?

Dr. Edzard Ernst, M.D., Ph.D., chair of the Department of Complementary Medicine at the University of Exeter, has unwaveringly examined the clinical evidence for alternative modalities. Working with Brian Cooke, also at the Dept of Complementary Medicine., they did a systematic review of the published research on aromatherapy to learn if there were any clinical indications to recommend its use. Their findings were published in the British Journal of General Practice.

Their review found six studies — in none were the findings ever independently replicated — and all but one suggested benefits of aromatherapy merely for anxiety and general well-being. The effects, however, “were modest and could all have been attributed to flaws in the study design,” the authors said.

All of these studies were conducted by nurses, using aromatic oils with massage, and all suffered from methodological flaws, said Drs. Cooke and Ernst. Only one study was a randomized, double-blind study and it found no measurable benefit. “None of these studies offers a clearly stated hypothesis at the outset, and the general tone of the reports is one of documenting, assessing or evaluating (rather than testing) the ‘established’ effects of aromatherapy by using questionnaires administered before and after an intervention,” the authors concluded. As they described:

There was a prior assumption that the patients in these studies suffered from a degree of anxiety or distress that warranted intervention. Some of these patients were sedated, but there is no suggestion that they were candidates for conventional anxiolytic therapy. The patients were not seeking relief from a symptom and then being offered entry into a randomised controlled therapeutic trial of an established treatment for that symptom. They were not recruited into the studies because they were complaining of anxiety, but because the investigators believed that they were potential subjects with a level of anxiety or other symptoms that would respond satisfactorily to aromatherapy massage. This may of course be true, but the scientific rigour of this approach in effectiveness research is questionable.

There is no credible science to support the health claims surrounding aromatherapy. “Aromatherapy is pleasant and relatively safe compared with many other ways of spending an hour or so and £20 to £45,” said the authors. But the evidence is sufficiently flawed and has not shown aromatherapy to be cost-effective in health care settings and the overall evidence is insufficient to advocate its use, they concluded, adding:

There is no published literature that provides a sound rationale for the use of aromatherapy massage as a medical intervention. In the absence of hard efficacy data for lasting and relevant health effects, it is probably best considered as a pleasant diversion for those who can afford it and are prepared to pay for it.

There is no accreditation or licensure for wellness practitioners, meaning the person offering lifestyle coaching on the telephone or via the internet could be anyone. And their advice warrants the same caution as that from any unfamiliar person. Yet, even clinically-trained medical professionals and nurses are promoting aromatherapy at hospitals as part of wellness programs, and selling aromatherapy products on the side. With that, how can we trust that the life-and-death medical care we’re being given in the hospital is really grounded in good science and not based on how much money can be made on the side?

Click here for complete article (and single page version).

New research few American women heard about breast cancer screening

Nearly two dozen medical professionals in the UK took bold action this past week. They joined together to speak out and confront the National Health Services and call for patients to be given the full facts about preventive health screening. Public health recommendations and information women receive about breast cancer screening is not only unsupported and one-sided, they said, but denying women their right to give informed consent before submitting to a medical procedure that has been shown to harm ten times more women than it may help.

The bottom line, none of the information women receive about breast cancer screening “comes close to telling the truth,” they wrote in The Times. As a result, they said, women are being manipulated to undergo mammography.

The National Health Services Screening Programme tells women that mammography saves lives and is responsible for dramatic declines in breast cancer mortality since it began twenty years ago. That claim is disputable, they said, and equally explained to improvements in treatment.

Missing is balance. Women don’t hear about the risks. Nor do they hear about the evidence showing that up to half of all breast cancers, and their precursor lesions, found by screening would not likely to have ever done any harm to women in their lifespans if they’d been left alone, they reported.

Yet, if found at screening, they potentially label the woman as a cancer patient: she may then be subjected to the unnecessary traumas of surgery, radiotherapy and perhaps chemotherapy, as well as suffer the potential for serious social and psychological problems. The stigma may continue to the next generation as her daughters can face higher health-insurance premiums when their mother’s overdiagnosis is misinterpreted as high risk. We believe that women should be clearly informed of these harms in order to make their own choice about whether to attend for screening.

Times Health Editor interviewed a few of the medical professionals who signed the letter. Michael Baum, Emeritus Professor of Surgery at University College London, said there is no evidence that breast cancer screening was bringing significant benefits. Even with screening and early detection, the numbers of invasive breast cancers being detected hasn’t been dropping, he pointed out. The claims that screening prevents invasive breast cancer simply don’t add up. It is “outrageous that the full facts are not being set out so women could make informed decisions,” he said, and that women are being inappropriately pushed into aggressive treatments.

“It is time we had a complete rethink, but anyone who dares challenge the sacred cow of screening has a terrible time,” Dr. Baum said.

Margaret McCartney, a GP in Glasgow and another signatory, told The Times that the pros and cons of screening were not being relayed to her patients. Women come to her for surgery after a screening recall, she said, with great anxiety and no idea of the fallibilities of the system through which they were being processed.

The doctors’ letter has been widely reported in the UK, but mainstream media here in the United States has taken little notice.

Breast Screening analysis

The study behind their letter, published in the current issue of the British Medical Journal, has also received virtually no media attention here, but every woman deserves to have this information.

This study examined the data of nearly 2 million breast cancer screenings and found that of 2,000 women screened regularly for ten years, one will benefit and avoid dying from breast cancer, but ten healthy women will have needlessly undergone mastectomies, radiation and sometimes chemotherapy, and another 200 will have endured a false alarm and follow-up tests and biopsies.

This examination of breast cancer screening was led by Dr. Peter C. Gøtzsche, director of the Nordic Cochrane Centre in Copenhagen, Denmark. Three years ago, they’d published a review of information on mammography breast cancer screening that women were receiving in six countries with publicly funded screening programs. They found that none of the literature had even mentioned the major harm of screening: overdiagnosis and subsequent unnecessary treatment of healthy women. About a third of the literature even told women that screening leads to less invasive surgery or simpler surgery, when “it actually results in 30% more surgery, 20% more mastectomies and more use of radiotherapy,” they wrote.

The evidence — well-recognized among medical professionals and in the medical literature — is so startlingly different from what American women have been hearing, it’s almost hard to believe. In an in-depth article during Breast Cancer Awareness month, JFS examined breast cancer screening, including the evidence in the medical literature, the actual U.S. statistics, Cochrane Collaborative’s Systemic Review of mammograms and the conclusions of the U.S. Preventive Services Task Force. [This story is here, if you missed it.] The breast cancer screening information that American women receive from health insurance plans and hear from the media is exactly as Dr. Gøtzsche and colleagues described. The information is universally one-sided — women never hear the evidence or balancing information about the downsides. And they’re never told that not having a mammogram can even be a reasoned option.

Blue Cross Blue Shields, for example, tells women that deaths from breast cancer have declined in recent years, due in large part to more women getting regular mammograms, raised awareness and improved treatment options. Mammograms are the best way to detect breast cancer early, it says. Women are told “There is no good excuse!” for them not to get mammograms. It recommends annual mammograms beginning at age 40 and monthly self exams beginning at age 19.

CIGNA HealthCare claims that mammograms have reduced death rates by 25 to 55% among women aged 50 and older. Women who don’t get mammograms get a “house call” from the health plan reminding them they need to get a mammogram, as part of its Breast Cancer Awareness Month Pink Ribbon Campaign. “Mammograms are the best screening tool we have to detect breast cancer in its earliest stages, when it is the most treatable,” said CIGNA HealthCare national quality medical director. “Early detection is not only a lifesaver, but it may also allow women to have more control over their treatment options,” he said.

Kaiser Permanente similarly calls women beginning on their 40^th birthday, notifying them that it’s time for their mammogram. Kaiser Permanente President for the Hawaiian region, claims that more than 90% of women found to have early stage breast cancer will be “cured” and that detecting and treating lumps in early stages greatly improves the odds of survival and eliminates the need for more costly and invasive treatments. She called for policy leaders to increase insurance coverage for preventive care and patient education to promote annual screenings.

The information women are given in the UK’s authoritative booklet, Breast Screening: the Facts, said Dr. Gøtzsche and colleagues, “is inadequate as a basis for informed consent” and fails to provide women with the information they “need to make a rational decision.” The doctors used this government publication as it was representative of the information women around the world are being given — and not given — and to point out the medically unethical practices behind this preventive screening education:

No mention is made of the major harm of screening — that is, unnecessary treatment of harmless lesions that would not have been identified without screening. This harm is well known and acknowledged, even among screening enthusiasts. It is in violation of guidelines and laws for informed consent not to mention this common harm, especially when screening is aimed at healthy people.

Medical ethical guidelines hold that patients should be told if an investigation or treatment could result in serious harm, even if the likelihood is very small. But “the likelihood of being overdiagnosed after mammography is not very small,” they said, “it is ten times larger than the likelihood of avoiding death from breast cancer.”

Another harm is false positive diagnoses. The leaflet downplays the serious numbers of women who will be told they have cancer, when they don’t. The doctors point out that patient literature tells women that about one in every 20 women screened will be recalled for more tests, but doesn’t explain that this rate applies to only one round of screening. “The rate of false positive diagnosis after ten screenings was 50% in the United States and 20% in Norway.”

About half of all American women who get annual mammograms for ten years will be wrongly told they have cancer. Half. This is not harmless, nor insignificant. “We now know that the psychosocial strain of a false alarm can be severe and may continue after women are declared free from cancer,”the Nordic Cochrane Centre authors explained.

A third harm is caused by radiotherapy of overdiagnosed women. The NHS literature states that a mammogram “involves a tiny dose of radiation, so the risk to your health is very small.” But, as the doctors pointed out, the rate of overdiagnosis was 30% in randomised trials of screening and 50% in observational studies. They concluded that it was misleading to reassure women they would only be exposed to tiny doses of radiation when significant numbers of healthy women will be put at risk with much larger doses in radiotherapy.

“The summary implies that screening leads to fewer mastectomies,” they wrote. “This is incorrect.” Most women would be stunned to learn that the evidence shows that “screening led to 20% more mastectomies in randomised trials” and that observational studies have confirmed that the number of mastectomies increases when screening is introduced. “These initial increases are not compensated for by reduced rates among older women who are no longer screened,” the doctors found.

The literature makes no mention of carcinoma in situ, their research found, even though it “constitutes about 20% of the diagnoses made at screening in the UK.” Fewer than half of the cases progress to invasive cancer, they said, yet 30% are treated with mastectomy.

Women are also told in screening literature that breast cancer risk increases with age. However, screening in these women has not been shown to reduce their risk of dying from breast cancer, the doctors said. Yet, there are no reservations in the literature about screening older women. In fact, among older women, the problem of overdiagnosis becomes more significant and “their likelihood of gaining any benefit smaller, due to competing risks of death.”

Most stunning, their study found:

Finally, it has not been proved that screening saves lives. There is an inevitable bias in assessment of cause of death that can be particularly difficult when women have more than one cancer. Trials show that breast screening does not decrease total cancer mortality. The relative risk was 1.02 (95% confidence interval 0.95 to 1.10) in the two most reliable trials and 0.99 in the others, and there is no reliable evidence that screening decreases total mortality, although half a million women participated in the screening trials. This indicates that the benefit of screening is likely to be smaller than generally perceived.

The evidence and the balance of harm is so notable, the authors said, that “had policy makers had the knowledge we now have when they decided to introduce screening about 20 years ago …we probably would not have had mammography.”

The authors said this “one-sided propaganda about breast screening is a global phenomenon” that has resulted in women coming away with gross misconceptions about the benefits of breast cancer screening and their risks for breast cancer.

A survey of American and European women found that 68% believed screening reduced their risk of contracting breast cancer, 62% that screening at least halved mortality, and 75% that 10 years of screening saved 10 of 1000 participants (an overestimate of 20 times). Another study showed that only 8% were aware that participation can harm healthy women and that 15% believed their lifetime risk of contracting the disease was more than 50% (an overestimate of five times).

The purpose of health education is to provide information to enable women to make informed choices about what is best for them, they said, “not to recruit” them. In order to help women around the world have more balanced, objective information, the authors tested various versions of breast cancer screening information to find one that didn’t steer women to make a particular decision, but presented the facts to best help them decide for themselves. You can down load a copy of the breast cancer screening booklet that resulted from these efforts, here.

The vast majority of women around the world have never heard what the medical evidence supports. In fact, it’s so opposite to what we continually hear, that it can even sound incredible.

Yet, this is just one cancer screening test.

Think of the far greater interests advocating other preventive health interventions, such as surrounding obesity, heart disease, cancer, health indices and “healthy” eating. This study serves as a valuable example and reminder that, all too often, health information is more marketing and disease mongering than we may realize.

Click here for complete article (and single page version).

Pudge Police coming

As we’ve known was coming, employers and state governments providing health insurance to employees are increasingly requiring American workers to undergo regular metabo check and evaluations of their diets and lifestyles, and to participate in corporate “wellness” programs… or else.

The Atlanta Journal-Constitution reports this week that city employees of Kennesaw, Georgia who are fat, smoke or have been “identified by the company’s wellness consultant as being at high risk of health complications” are looking at their health insurance premiums doubling under a plan scheduled for a vote on Monday. The city’s health insurance program is underwritten by LifeWell, a managed care company focused on ‘wellness’ coaching and disease management, as part of the growing field of “lifestyle medicine.” It incorrectly tells its corporate clients: “The majority of chronic illnesses are lifestyle related and can therefore be diagnosed early and prevented.”

According to the news, twice a year, employees are already required to undergo a screening to determine their risk factors, said Miranda Jones, assistant to Kennesaw’s city manager. Those employees who refuse to participate in their wellness program, said the mayor, should be hit with higher premiums. “It’s just a good incentive to help…owners of the plan to save money,” he said.

Not reported is that the evidence shows such plans don’t save money or lower costs for employers, but are most designed to make money, with the core profits being the weight programs and the drugs to treat health indices. Lifewell’s four key partners are, accordingly, pharmacy benefit managers. As with all such wellness programs, the risk factors most targeted are weight, cholesterol, and other metabo indices which have proven to be poor predictors of future health or those at higher risk of premature death. Nor are they measures of, or appreciably amenable to, ‘healthy’ diet or lifestyle interventions. They are primarily reflections of aging, along with genetics and class. JFS has examined at length the medical evidence behind the most popularized beliefs, such as type 2 diabetes, cancers and heart disease, blood pressure or obesity, said to be caused by bad foods, diets or lifestyles; or able to be prevented by ‘healthy’ diets and lifestyles.

Nevertheless, the premium charges were recommended as “an incentive,” said the city manager. “The noncompliance comes from if you are determined to be a ‘high risk’ employee [and] make no effort to do anything about it.” She explained that “a report on an at-risk employees participation in the wellness program will be provided the benefits committee which then can determine the surcharge non-compliant employees must pay.”

Other Georgia cities, according to the newspaper, are moving to Kennesaw’s model.

States and city governments across the nation are currently looking at compulsory diets, weight loss and lifestyle management for workers. WIS-TV in Columbia, South Carolina reports that its Senate has made state employees’ weights a legislative issue. A subcommittee is looking at legislation to penalize state workers $300 a year if they’re fat. Family members on the state employee’s health insurance plan will also have to pay the fee if they’re fat. “Among the questions, would there be "pudge police" and how do you determine who is fat and who is just a little fluffy?”, the news reported.

Senator Greg Ryberg told WSPA that the penalty will be based on employees' BMI — weight and height. Clearly a believer of the populace myths of fat people and obesity stereotypes, he said: “It is actually trying to stimulate people to think that what they put them in their mouth is causing them an unhealthy lifestyle and in many cases the back injury and knee injuries that people incur are a direct result of decisions they make at the dinner table.”

According to the news, the State Employees' Insurance Board in Alabama approved a plan last week to charge state workers if they don’t comply with health screenings. Even if workers have the evaluations, should their blood pressure, cholesterol, glucose or obesity numbers be marked unacceptable, they’ll have a year to see a doctor, enroll in a wellness program, or “take steps on their own to improve their health”— a euphemism for lose weight and take prescription drugs to get their numbers to the new normal levels. If their health indices aren’t in line by January 2011, the employees “must start paying.”

Yesterday, the Charlotte Observer reported that lawmakers in North Carolina are similarly targeting state employees who are fat or smoke. “Legislative leaders introduced a bill Thursday that seeks to keep the State Health Plan solvent by reducing some benefits and raising premiums,” the paper said. With aging members, younger people are not part of the plan. Subsidies for basic eye exams are being cut, copays raised 8-fold, deductibles increased $300 to $600 and basic premiums increased nearly 8% per year. The plan also has a new pharmacy initiative to encourage more cholesterol lowering drugs because “many members who should be taking the drugs aren’t.”

Smokers and fat people would be “forced into the coverage option that carries the highest deductibles and co-payments.” Fat people would have until July 1, 2011 to become an acceptable weight, and smokers to quit, in order to stay on the regular plan, according to the bill. The only exceptions to those who fail to “fit the standard” would be ‘overweight’ people who can prove they have a medical reason for their size.

A smoker would be hit with a $2,000 penalty and any employee who weights 35% or more than is considered “fit” — a 5’10” man weighing 135-175 pounds or a 5’4” woman weighing 112-146 pounds — will incur a $2,360 penalty. Apparently, politicians believe that humans, regardless of their age and genetics, should all have the same body type, height and weight. There would be no exceptions for smokers, said the paper, and special sanctions for those who lie about smoking are being suggested.

Not one politician or journalist has made any attempt to examine the scientific evidence behind employer wellness programs, and diet and lifestyle interventions to learn there is no evidence that they are effective in reducing costs, improving clinical outcomes, or even for long-term weight loss. Nor are employees being allowed a chance to give an informed consent. They aren’t told that half a century of evidence on weight loss by the National Institutes of Health and recent evidential reviews have concluded that most studies and the strongest evidence show weight loss interventions can actually increase risks of premature deaths, heart disease, stroke, type 2 diabetes and cancers — by as much as several hundred percent — as well as put them at risk for a vast range of adverse events.

If you’re fat, older, picked the “wrong” parents, or don’t want to eat and live how politicians have determined best, you are noncompliant and they want you to pay.

Click here for complete article (and single page version).

Behind closed doors

How many Americans knew that since last fall, key stakeholders in the health insurance industry and lobbyists for a wide range of interests in managed care have been secretly meeting with Democratic staff of Senator Edward Kennedy, working to develop the terms for legislating universal health insurance? As the New York Times reports, the talks taking place behind closed doors are unusual. Staff aides said that anyone who revealed the details of the group’s plans outside the secret meetings have been threatened with expulsion.

Reporter Robert Pear writes:

The ideas discussed include a proposal to penalize people who fail to comply with the “individual obligation” to have insurance. “There seems to be a sense of the room that some form of tax penalty is an effective means to enforce such an obligation, though only on those for whom affordable coverage is available,” said the memorandum, prepared by David C. Bowen, a neurobiologist who is director of the health staff at the Senate Committee on Health, Education, Labor and Pensions.

Clearly, they aren’t planning to allow Americans the freedom to choose to self-insure or to buy an inexpensive major-medical type of policy. Lobbyists said that with the government subsidizing insurance premiums, it would set minimum Federal standards for benefits and Congress would define the minimum coverage that everyone would be required to purchase.

As we’ve seen, health insurance as mandated by states across the country is no longer actual insurance to cover potentially catastrophic events — it's managed care programs that compel people to get screening and preventive care, treatments and medications the state determines. Over the last 30 years, state and federal governments have also legislated more than 1,800 mandates, according to the Council for Affordable Health Insurance, which have raised the cost of policies for everyone by as much as 50%. Health insurance mandates are laws that require all policies to cover certain procedures, whether a member needs or wants them. “For almost every health care product or service, there is someone who wants insurance to cover it so that those who sell the products and services get more business,” says CAHI. Sadly, growing numbers of mandates are also for frivolous, fraudulent, marginally effective to completely ineffective, unproven to potentially dangerous things.

That’s what happens, it seems, when politicians and stakeholders decide what’s best for our health, rather than us and our own doctors.

Click here for complete article (and single page version).

Update: Stimulus Bill

As everyone knows, H.R. 1 was signed into law this past week. The full text of the final stimulus bill is available here. Readers might be interested to learn that the $1 billion “Prevention and Wellness Fund,” discussed here, did find its way back into the final version.

Margo Wootan, Director of Nutrition Policy and founder of NANA’s nutrition policy initiatives, sent out a CSPI Action Alert email thanking everyone who lobbied for these provisions. As she noted, the final Stimulus package also includes an additional $100 million for the National School Lunch Program. It has a provision giving priority in the distribution of the funds “to schools purchasing equipment for the purpose of offering more healthful foods and meals, in accordance with standards established by the Secretary.”

For months, mayors across the country have been scrambling, as we’ve all read in our local newspapers and heard on our television news, to garner as much of that free money for their projects as possible. The U.S. Conference of Mayors compiled a list of their stimulus projects and met with the Administration last week to present their formal requests. To see exactly how political leaders hope to spend our money, we can examine their list of projects, listed by state, here. Each of us can then decide for ourselves how many we think will stimulate economic development in our city and state.

Click here for complete article (and single page version).

Medical Homes and care coordination are tested

Older Americans who, understandably, have more chronic conditions of aging, are sadly also blamed for accounting for “disproportionately” large amounts of Medicare spending. It is sometimes thought that the increased services those suffering from chronic conditions require could be due to inadequate counseling on diet, medication, and self-care or not having ready access to medical care.

As the authors of a new study wrote, it’s often believed that patients “lack the knowledge and skills to understand how to manage their conditions or have barriers that prevent them from adhering to their doctor’s advice and prescriptions.” That’s been the thinking behind “coordination of care” and disease management programs provided by Medicare and other health plans (sometimes contracted out to commercial disease management vendors). In these programs, nurses provide patient education and monitoring (mostly telephonic) to improve adherence to medication, diet, exercise and self-care regimens.

Few trials of these interventions have successfully lowered hospitalizations for Medicare patients, however, the study authors noted. “To study whether care coordination improves the quality of care and reduces Medicare expenditures, the Balanced Budget Act of 1997 mandated that the Secretary of Health and Human Services conduct and evaluate care coordination programs in the Medicare fee-for-service setting.” Should, in this research, any of the components of these programs demonstrate effectiveness in reducing Medicare expenditures and improving quality of care for Medicare beneficiaries, under this legislation, they would be permanently implemented.

So, in 2002, the Centers for Medicare & Medicaid Services (CMS) competitively awarded grants to 15 health care programs to study care coordination. It also contracted with Mathematica Policy Research Inc. to conduct an independent evaluation of the findings. Their conclusions were reported in the current issue of the Journal of the American Medical Association.

This study has important implications, not only for how limited public healthcare resources are spent, but most importantly, the authors noted, this study would provide important answers to recent health policy interests in medical homes (managed care) as a way to improve care coordination, improve quality and reduce costs.

In this registered clinical trial [Id: NCT00627029], eligible Medicare patients at fifteen centers across the country were randomly assigned to participate in care coordination programs or a control group receiving usual care. These care coordination programs provided disease management for coronary artery disease, congestive heart failure, diabetes, COPD, cancer, stroke, depression and dementia.

This analysis, led by Deborah Peikes, Ph.D., and colleagues at Mathematica, used Medicare data from beneficiaries enrolled from April 2002 through June 2005, including claims through June 2006 to ensure follow-up data was available on all beneficiaries for at least one to four years. The study followed these patients for an average of 30 months. Only 14 of the programs completed the study, as one program proved nonviable and dropped out after 3 ½ years.

Findings

“None of the 15 programs generated net savings,” the authors found. “None of the programs reduced regular Medicare expenditures, even without the fees paid to the care coordination programs.” In fact, “for total Medicare expenditures including program fees, the treatment groups for 9 programs had 8% to 41% higher total expenditures than the control groups did, all statistically significant,” they said.

“These programs had favorable effects on none of the adherence measures and only a few of many quality of care indicators examined,” the authors concluded. Compared to the patients receiving usual care, slightly more of those participating in the care coordination program recalled “receiving education during the preceding 12 months on diet, exercise, and warning signs of disease exacerbation, and receiving educational materials.” But the results for the other process measures were not uniformly positive, they said, “with only a few scattered effects for self-reported influenza and pneumococcal vaccinations, mammography, and various routine tests.”

The quality of care indicators (reported in supplemental data) had asked the participants if they understood “how to follow a healthy diet [and] the proper way to exercise, and how often they “followed a healthful eating plan, exercised regularly, missed dose of medications [and] visited physicians with list of questions.” The trials also evaluated how the participants scored on surveys of health-related quality of life and satisfaction with health care; and compared hospitalizations and mortality data.

While all of the programs that followed lifestyle quality indicators reported their programs had increased the percentage of participants exercising regularly, and 8 out of ten reported more patients were taking their prescribed medications, it proved to have no effect on reducing hospitalizations.

This study found that even after years of disease management, the programs had no effect on overall hospitalizations. The diabetes management programs, however, did notably worse. They resulted in more hospitalizations for diabetes and microvascular complications compared to the control groups in 10 and 9 of the programs, respectively.

The only mortality data reported was from the diabetes managed care interventions. They reported higher death rates in the intervention group in 7 out of 14 programs and lower in the other 7 programs.

Conclusions

The authors concluded: “Our results suggest that care coordination, as practiced by the programs participating in the demonstration from 2002 to 2006, holds little promise of reducing total Medicare expenditures for beneficiaries with chronic illnesses.” Nevertheless, the two programs showing potential promise were given the option to continue for three more years, with continued interim evaluations.

This study’s findings were more favorable than the negative results of two other efforts by CMS to introduce care coordination or disease management into Medicare, the authors said. Still, “it is clear that even if savings could be achieved they would be modest, even for the most successful programs,” they said.

Rather than additional third-party managed care, patients do just as well, if not better, when cared for by their own doctors.

Click here for complete article (and single page version).

Government-oversight of healthcare — End of discussion?

As we all know, Congress passed the American Recovery and Reinvestment Act (H.R.1). Whether or not the enormity of this legislation, and what it means for the future of our healthcare, is understood probably depends on whether people have read the 1,434 pages of legislation and get the real meaning of words like quality, cost effective, harmonize, biosurveillance, public health, health disparities, genomics and preventive wellness.

There are seven versions of the legislation at various stages, including the final version the House approved, the Senate’s amended sections, and the most current print version for the public. There are widespread misunderstandings, rumors and healthy doses of doublespeak in the media about what the legislation says. The simplest solution is to go directly to the source.

The sections that will potentially have the most significant impact on our healthcare are those referring to health information technology and the National Coordinator for Health Information Technology, the Agency for Healthcare Research and Quality (AHRQ) and Public Services Act, and the establishment of a Prevention and Wellness Fund.

Prevention and Wellness

A Prevention and Wellness Fund [pages 184+ in the House version], however, was struck out by the Senate in its version. Whether it’s off the table for good is yet to be determined. This Fund would be administered through the office of the Secretary of the Department of Health and Human Service Department, launched with a $3 billion outlay, to carry out provisions under the Public Health Services Act. A small portion of the fund was to go towards immunizations, but most: “Not less than $545,000,000, shall be used as an additional amount to carry out chronic disease, health promotion, and genomics programs, as jointly determined by the Secretary of Health and Human Services and the Director of the Centers for Disease Control and Prevention.” Included in this fund:

Not less than $335,000,000 shall be used as an additional amount to carry out domestic HIV/AIDS, viral hepatitis, sexually-transmitted diseases, and tuberculosis prevention programs, as jointly determined by the Secretary and the Director…

Provided further, That of the amount appropriated under this heading $500,000,000 shall be used to carry out evidence-based clinical and community-based prevention and wellness strategies and public health workforce development activities authorized by the Public Health Service Act, as determined by the Secretary, that deliver specific, measurable health outcomes that address chronic and infectious disease rates and health disparities, which shall include evidence-based interventions in obesity, diabetes, heart disease, cancer, tobacco cessation and smoking prevention, and oral health, and which may be used for the Healthy Communities program administered by the Centers for Disease Control and Prevention and other existing community-based programs administered by the Department of Health and Human Services.

The Secretary of the HHS will not only determine the programs funded under this provision, but “will directly or through contracts with public or private entities, provide for annual evaluations of programs carried out with funds provided under this heading in order to determine the quality and effectiveness of the programs” and make recommendations for future community prevention and wellness activities. Further:

The Secretary shall enter into a contract with the Institute of Medicine, for which no more than $1,500,000 shall be made available from funds provided in this paragraph, to produce and submit a report to the Congress and the Secretary by no later than 1 year after the date of enactment of this Act that includes recommendations on the national priorities for clinical and community-based prevention and wellness activities that will have a positive impact in preventing illness or reducing healthcare costs and that considers input from stakeholders.

Despite their popularity, there are no evidence-based “healthy community” prevention and wellness interventions that have been shown to be effective for reducing obesity or most chronic diseases of aging, or to offer benefits that outweigh the potentials for harm. Regular readers will note that the agendas in this Fund are the same as those of the stakeholders most sponsoring their review by the private organization, the Institute of Medicine. They are also the largest funders of the war on obesity and working to redefine public health — to manage lifestyles, rather than its traditional, proven role in communicable diseases.

Agency for Healthcare Research and Quality

Under this legislation [pages 806+ of current public print version], the AHRQ is to be expanded and receive increased funding of $700 million for comparative clinical effectiveness research — $400 million to the NIH Director — with an additional $400 million for comparative clinical effectiveness research to be allocated at the discretion of the Secretary of HHS:

[T]he funding appropriated in this paragraph shall be used to accelerate the development and dissemination of research assessing the comparative clinical effectiveness of health care treatments and strategies, including through efforts that: (1) conduct, support, or synthesize research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions and (2) encourage the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data: Provided further, That the Secretary shall enter into a contract with the Institute of Medicine, for which no more than $1,500,000 shall be made available from funds provided in this paragraph, to produce and submit a report to the Congress and the Secretary by not later than June 30, 2009 that includes recommendations on the national priorities for comparative clinical effectiveness research to be conducted or supported with the funds provided in this paragraph and that considers input from stakeholders Provided further, That the Secretary shall consider any recommendations of the Federal Coordinating Council for Comparative Clinical Effectiveness Research established by section 802 of this Act and any recommendations included in the Institute of Medicine report pursuant to the preceding provision designating activities to receive funds provided in this paragraph and may make grants and contracts with appropriate entities.

Section 802 (pages 826+) establishes this new Federal Coordinating Council “to coordinate the conduct or support of comparative clinical effectiveness and related health services research; and advise the President and Congress on strategies with respect to the infrastructure needs, appropriate organizational expenditures… to assure optimum coordination of comparative clinical effectiveness and related health services research conducted or supported by relevant Federal departments and agencies with the goal with the goal of reducing duplicative efforts and encouraging coordinated and complementary use of resources.”

The members of the Council will be political appointees from each of the federal agencies, “all of whom are senior Federal officers or employees with responsibility for health-related programs, appointed by the President [and] acting through the Secretary of HHS.”

Whether consumers and medical professionals feel the government or political appointees are the best entities to determine the medical efficacy of clinical care guidelines, should establish federalized electronic clinical registries and data networks for surveillance and data collection, or should contract with a private organization with strong ties to stakeholders to make recommendations for national priorities and what clinical research is funded and conducted — this would have been worthy of public discussion and input from the medical community.

Clearly, any clinical care this Council might deem suboptimum, ineffective or inconsistent with national priorities will die from lack of funding. And any healthcare professional whose practice fails to comply with its determination of clinically effective care will find him/herself not only uncompensated by third party payers, but vulnerable to claims of malpractice.

But how likely, in reality, will political appointees of Federal agencies with huge programs under their control be to shut down their own programs when they are shown to be clinically ineffective or for stakeholders to recommend discontinuing clinical guidelines that profit themselves?

● Does this mean that the CDC’s massive Division of Nutrition and Physical Activity will be closed, since its own NHANES data has shown that after fifteen years, its 5-A-Day program has been a complete bust and that its war on obesity focused on diet and exercise is similarly medically unsupported, even by AHRQ’s own evidential reviews?

● Will the National Center for Complementary and Alternative Medicine be shut down, since by its own definition and research, these modalities are not evidence-based?

● Will the 134 Pay-for-Performance clinical practice measures for physicians currently mandated by the Centers for Medicare and Medicaid Services be eliminated, since they are not being shown to improve actual clinical outcomes for patients or to reduce mortality or to save costs? Even the 2003 expert committee under the AHRQ found little benefit of many of the tests and clinical guidelines for the management of indices for a wide range of conditions (diabetes, cardiovascular disease, obesity, etc.) and suggested they only serve to increase the cost of healthcare and make money for pharmaceutical companies, while exposing many individual patients to unnecessary risks?

● As published this month (in upcoming post), Medicare’s major comparative clinical effectiveness research of 15 disease (“chronic condition”) management programs across the country found these programs did not reduce healthcare costs, hospitalizations or improve clinical outcomes or mortality. Will Medicare discontinue these costly care management programs as a result?

Or, is this not really about science and eliminating wasteful, ineffective and potentially harmful government programs and government-mandated clinical guidelines at all? Will this Council be most focused on finding support for programs behind the national agenda determined by the president and his HHS Secretary?

National Coordinator for Health Information Technology

For years, JFS has been warning of the plans being made for nationalized integrated Health IT, the research on its effects on patients' clinical outcomes, costs (both financial and to lives and medical errors), the public-private stakeholder interests behind this agenda, and privacy and multiple security concerns. As reviewed here, the National Coordinator for Health IT position was created in 2004. To date, it has focused efforts on mandating integrated electronic medical records for providers of care to Medicare and Medicaid beneficiaries.

This legislation expedites the adoption of nationalized electronic medical records with $3 billion in additional funding and empowers the Office of the National Coordinator to establish the technical standards, certify and regulate electronic medical records (EMRs) in accordance with the determinations of the Secretary of HHS and “towards a coordinated national goal.” It also “updates the Federal Health IT Strategic plan to include specific objectives.” These include mandating:

The electronic exchange and use of health information and the enterprise integration of such information. The utilization of an electronic health record for each person in the United States by 2014…

Strategies to enhance the use of health information technology in improving the quality of health care, reducing medical errors, reducing health disparities, improving public health, increasing prevention and coordination with community resources, and improving the continuity of care among health care settings.

Specific plans for ensuring that populations with unique needs...are appropriately addressed in the technology design, as appropriate, which may include technology that automates enrollment and retention for eligible individuals.

Remember, words such as “quality” no longer mean what the public popularly believes them to mean. Despite the incorrect claims that EMRs won’t affect clinical care standards and that people can keep potentially damaging information private, as we’ve covered extensively, the critical aspect of nationalized, integrated electronic medical records means all information— from doctor and hospital records, diagnostic tests, lab results, prescription drug records, etc. — is automatically populated into the federal database and shared among a wide birth of interested parties, with no ability of consumers to opt-out or give their consent. Title XXX, Section 3000 Definitions (pages 900+) states:

The term ‘certified EHR technology’ means a qualified electronic health record and that is certified pursuant to section 3001(c)(5) as meeting standards adopted under section 3004 …The term ‘enterprise integration’ means the electronic linkage of health care providers, health plans, the government, and other interested parties, to enable the electronic exchange and use of health information among all the components in the health care infrastructure in accordance with applicable law, and such term includes related application protocols and other related standards.

The term ‘health care provider’ means a hospital, skilled nursing facility, nursing facility, home health entity, or other long-term care facility, health care clinic, community mental health center (as defined in section 913(b)), renal dialysis facility, blood center, ambulatory surgical center described in section 1833(i) of the Social Security Act, emergency medical services provider, Federally qualified health center, group practice (as defined in section 1877(h)(4) of the Social Security Act), a pharmacist, a pharmacy, a laboratory, a physician (as defined in section 1861(r) of the Social Security Act), a practitioner (as described in section 1842(b)(18)(C) of the Social Security Act), a provider operated by, or under contract with, the Indian Health Service or by an Indian tribe (as defined in the Indian Self-Determination and Education Assistance Act), tribal organization, or urban Indian organization (as defined in section 4 of the Indian Health Care Improvement Act), a rural health clinic, a covered entity under section 340B, and any other category of facility or clinician determined appropriate by the Secretary.

Electronic medical information is to be developed by the National Coordinator to allow the federal government to use and share the information “to reduce healthcare costs” (ration), monitor and ensure the ‘appropriateness’ of care delivered and ‘guide medical decisions’ made by individual care providers, to ensure compliance with its “quality” (performance) guidelines, and enable the government to identify people with chronic conditions for management (such as lab surveillance systems to identify those with treatable blood sugars, cholesterol levels and positive cultures for sexually transmitted diseases):

The National Coordinator shall perform the duties under subsection (c) in a manner consistent with the development of a nationwide health information technology infrastructure that allows for the electronic use and exchange of information and that… improves health care quality, reduces medical errors, and advances the delivery of patient-centered medical care; reduces health care costs resulting from inefficiency, medical errors, inappropriate care, duplicative care, and incomplete information; provides appropriate information to help guide medical decisions at the time and place of care;.. improves the coordination of care and information among hospitals, laboratories, physician offices, and other entities through an effective infrastructure for the secure and authorized exchange of health care information;… promotes early detection, prevention, and management of chronic diseases;… and improves efforts to reduce health disparities.

As pages 919+ note, the HIT policy committee will determine how to use EMRs to coordinate care among health care providers to improve the ‘quality of care’ by “improving population health, reducing chronic disease, and by advancing research and education [and] to ensure the comprehensive collection of patient demographic data, including, at a minimum, race, ethnicity, primary language, and gender information.” It has been tasked to also advise on the use of a “nationwide health information infrastructure” for the purposes of collecting data, public reporting, “biosurveillance and public health.”

Here, again, race and ethnicity as markers for biological weaknesses and disease risks, as well as undesirable lifestyles, and genetics has resurfaced as a disturbing line of public health policy under the guise of ‘health disparities’. A critically important discussion of science and history of race genetics was here. While reducing chronic disease in developed countries such as ours for improving population health may sound good to lay people, as we’ve examined at length, when the specifics are narrowed down, they fail to hold up to the science. These are euphemisms for lifestyle medicine and the unsupported beliefs that diet, lifestyle and pharmaceuticals are effective for the primary prevention of chronic diseases of aging — such as the big three: diabetes, cancer and heart disease — and obesity.

Despite claims that compliance with electronic medical records and the clinical performance measures it tracks aren’t compulsory, any healthcare provider who might ever want to provide care for any patient who is a beneficiary of federal health care coverage has no choice:

Each [Federal] agency shall require in contracts or agreements with health care providers, health plans, or health insurance issuers that as each provider, plan, or issuer implements, acquires, or upgrades health information technology systems, it shall utilize, where available, health information technology systems and products that meet standards and implementation specifications adopted under section 3004(b) of the Public Health Service Act.

This legislation [pages 1006+] not only enables the sharing of everyone’s private medical information with little privacy protections (as covered here at length, HIPAA offers little actual protection, either), it allows the sale of our protected health information to just about anyone who might want it. It even allows private health information to be sold for any purpose or in order to treat people as the Secretary of HHS might determine necessary and appropriate — not that which individuals and their doctors might choose or seek treatment for. Look closely at the exceptions under the Prohibition on the Sale of Protected Health Information:

Except as provided in paragraph (2), a covered entity or business associate shall not directly or indirectly receive remuneration in exchange for any protected health information of an individual unless the covered entity obtained from the individual, in accordance with section 164.508 of title 45, Code of Federal Regulations, a valid authorization ..

(2) EXCEPTIONS. —Paragraph (1) shall not apply in the following cases: (A) The purpose of the exchange is for research or public health activities… (B) The purpose of the exchange is for the treatment of the individual, subject to any regulation that the Secretary may promulgate… (C) The purpose of the exchange is the health care operation… (D) The purpose of the exchange is for remuneration that is provided by a covered entity to a business associate for activities involving the exchange of protected health information that the business associate undertakes on behalf of and at the specific request of the covered entity pursuant to a business associate agreement.. (E) The purpose of the exchange is to provide an individual with a copy of the individual’s protected health information… (F) The purpose of the exchange is otherwise determined by the Secretary in regulations to be similarly necessary and appropriate as the exceptions provided.

On page 1034, the legislation notes a point that’s also been covered here at length, but few consumers may yet realize: that vendors of personal health records and online personal health records are not “covered entities” under HIPAA and, therefore, not required to protect the privacy or access of people’s private health information at all.

The bottom line, electronic medical records have met resistance among medical professionals, who have been reticent to adopt them and who share a multitude of concerns both for patient safety and cost viability. The evidence continues to fail to support these systems as ready for prime time and even their proponents admit that they’re still experimental and being pioneered. Meanwhile, the potentials for abuse and misuse are mind boggling. It is one thing for an individual doctor’s practice or hospital to put their records into electronic form, or for a patient to voluntarily put their own records into an electronic form (such as on an inexpensive flash drive) for portability or convenience — it is a far different thing to make them part of a nationalized database under the dictates of the government and that are freely accessible and exchanged among a massive group of entities, with patients or doctors having no say about the matter.

But, of course, any public discussions were gagged as this massive healthcare legislation was inserted into an unrelated economic stimulus bill and rushed through Congress. That makes the government's motives behind nationalized, integrated Health IT feel more suspect among consumers. And, reading the legislation, perhaps, rightly so.

© 2009 Sandy Szwarc

Click here for complete article (and single page version).