Better than a soap opera

For those who’ve been following blogger, Kathleen Seidel’s case with the anti-vaccination lawyer who tried to intimidate her silence: As we last left things, the U.S. District Court for the District of New Hampshire had granted her motion to quash the subpoena against her. Magistrate Judge James R. Muirhead had ordered the attorney to give the court cause for why he should not be sanctioned. He filed his response this week and you won’t believe his comeback. It’s priceless.

It’s not fair and must be some big conspiracy network (with “co-conspirators”), he says (in essence), because she’s just a girrrrl. A "mother and housewife" can’t possible be smart enough to able to research the internet and medical journals, and write such well-researched pieces. She couldn’t just be a concerned mother of an autistic child, somebody had to be helping her, he says, and she must be “either an agent of the defendant or of industry.” Therefore, he wanted to find out who she was working for or with. Yes, she must be an industry shill. LOL! How many of us have heard that before?

Any lady who dares believe that she, too, is capable of doing science, just has to read Kathleen’s full account, titled “Welcome to my conspiracy.” Only she can do it justice. Too funny for words.

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

Government of the people in action

The Citizens' Council on Health Care demonstrated today what the power of people can accomplish. Twila Brase, RN, who led efforts to stop the State of Minnesota from taking DNA from every newborn to store in its genomic biobank without parental consent, just announced success. Today, Governor Pawlenty vetoed the DNA bill (SF 3138).

As he wrote in his letter to the Senate, while newborn screening helps about 140 babies a year be diagnosed early to allow for medical intervention that may have prevented their deaths or disability, this bill would have exempted the State Department of Health from requiring informed consent to store and use the personally identifiable genetic information for nonscreening purposes. He found the government storing and using genetic information for other purposes concerning. “I believe written informed consent should be obtained for the long-term storage or use of the blood samples for nonscreening research,” he wrote.

Ms Brase issued a press release today thanking the legislators who voted no on the bill and helped to work for its veto. She also encourages everyone who called, emailed or sent in petitions to the Governor to thank him with the same fervency that they asked him to veto the bill, believing that the health department will likely try again next session.

Governor Pawlenty:
Telephone: (651) 296-3391
Toll Free: (800) 657-3717
E-mail: tim.pawlenty@state.mn.us

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

Confusion about supplement disclaimers

With the news seeming to bring regular reports of dietary supplements being recalled for problems, contaminants or not containing what the label says, or for making unsubstantiated disease claims, many consumers appear to be attributing it to a failure of the FDA to protect them. It’s not exactly the FDA’s fault, in the way you might think.

A recent study in the Journal of Community Health by Johns Hopkins University may help to explain the source of some of the confusion. The researchers, led by Dr. Bimal H. Ashar, M.D., FACP, Assistant Professor of Medicine at Johns Hopkins University School of Medicine, randomly surveyed 300 patients in three primary care practices in the Baltimore area. The adults all had internet access and some exposure to online advertising. The researchers asked questions to assess the public’s understanding of the regulation of supplements.

More than half of the adults didn’t realize that supplements aren’t approved by the government and nearly two-thirds didn’t realize that dietary supplement advertisement claims weren’t validated by the FTC or any government agency. In fact, a full 10% were certain that the FDA approved dietary supplements, meaning they were safe, with another 42% unsure. These beliefs could make them more vulnerable to being taken advantage of or harmed.

A helpful point to understand is that supplements are not regulated like other foods or medical products. The Dietary Supplement Health and Education Act (DSHEA) of 1994 was passed, on the grounds it would empower consumers to make their own choices and in response to consumers who believed supplements provided health benefits. As the FDA explains, with the passage of DSHEA, ingredients in supplements no longer have to be approved by the government, and supplements don’t have to be registered with the FDA or undergo safety evaluations before they can be sold, “as is required of other new food ingredients or for new uses of old food ingredients.” With this legislation, the government also doesn’t validate a manufacturer’s claims or test supplements to verify their purity, strength or that they contain what the label says.

With the passage of DSHEA, supplement manufacturers are allowed to say their products provide nutritional support, effect the body’s function or structure, or support general well-being. DSHEA also expanded the meaning of dietary supplement beyond essential nutrients (such as vitamins and minerals for deficiencies) to include other substances and nutraceuticals (including ginseng, garlic, fish oils, psyllium, enzymes, glandulars, etc.). The Nutrition Labeling and Education Act of 1990 added herbs or similar nutritional substances to the term “dietary supplement.”

With dietary supplements no longer considered “drugs” under DSHEA, the FDA’s role in regulating them dramatically changed. The FDA legally cannot act to take a fraudulent product off the market until it proves a supplement is unsafe. The FDA has been given the burden of proof and must prove a product is unsafe and poses “a significant and unreasonable risk” before it can act... and then, only after a product is already being sold. Even ingredients that are useless but harmless are protected.

As Dr. Stephen Barrett, M.D., explains:

Because manufacturers are not required to submit safety information before marketing "dietary supplements," the FDA must rely on adverse event reports, product sampling, information in the scientific literature, and other sources of evidence of danger. Since the FDA is unable to monitor and regulate thousands of individual products, the public is virtually unprotected against supplements and herbs that are unsafe.

According to FDA Commissioner Jane E. Henney, M.D., they’ve found even ingredients like prescription drugs or illicit drugs being sold as dietary supplements. As we’ve seen repeatedly, the moment a company receives a FDA warning letter, though, they can just set up shop somewhere else or give their products a new name; or just ignore the letters altogether, as the fines are typically only a fraction of the money they’re making. So, trying to chase after fraudulent products is intrinsically ineffective.

It’s up to consumers to educate and protect themselves with all medicines. Supplement companies, however, haven’t had to report adverse reactions to the FDA and few doctors file reports, which makes getting information even more difficult. With the recent passage of the Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462), manufacturers of supplements sold in the United States are now supposed to report to the FDA all serious adverse events (deaths, life-threatening condition, hospitalization, disability, congenital anomaly or birth defect, or requires surgical or medical intervention) due to their supplements.

The Office of Dietary Supplements at the FDA keeps a listing of FDA warnings and advisories for consumers, as well as a link for consumers to report adverse reactions here. And if you think you’ve suffered a harmful effect from a supplement, you and your doctor are encouraged by the FDA to report it to them at 1-800-FDA-1088. The FTC has Operation Red Flag [click on image to enlarge], which provides information for people on how to avoid false claims that might hurt them or defraud them of their money here and keeps a list of companies that have been cited for fraudulent weight loss claims here.

The FDA and FTC work together — with the FDA overseeing the product, label and product literature, and the FTC overseeing the marketing and advertising. Both say they determine if claims are truthful and not misleading to the public, based on whether the company can substantiate their claims with “competent and reliable scientific evidence.” According to Vickey Lutwak at the FDA Office of Nutritional Products, Labeling, and Dietary Supplements, they look at the manufacturers’ evidence to ensure that each study is actually related to the claim (a surprising number of studies on reference lists aren’t); each study is a valid test (looking at bias and if it’s a “fair test”) and uses reliable design and analysis; the study methodologies are reliable to support the claim (i.e. tests on humans versus test tubes; clinical trials versus observational correlations or testimonials); if the claim is meaningful and biologically plausible; and the overall strength of the body of evidence.

These are the same valuable techniques important for us to use to protect ourselves with any health product. No government agency will ever be infallible.

What’s the story with a “disease” claim?

You've seen the disclaimer on supplement claims that says: "This statement has not been evaluated by the FDA. This product is ot intended ot diagnose, treat, cure or prevent any diease." But, as the Johns Hopkins' researchers found, this doesn't make the regulations clear to significant numbers of consumers.

It might seem logical that it would be illegal for any company to make any claims for products affecting our body or health that aren’t true, and many medical professionals wish for that, too. But that’s not how DSHEA works, either. Dietary supplements can claim pretty much anything and stay under the radar unless they specifically make a “drug” claim. (The Food, Drug and Cosmetic Act defines a “drug” as anything intended for the “diagnosis, cure, mitigation, treatment or prevention of a disease...”)

Only then, can the FDA take action to protect the public and stop products from making unsubstantiated claims. That’s why those FDA warning letters so thoroughly review disease claims.

The DSHEA has been a topic of increasing controversy, with two huge financial interests wrangling. The huge supplement industry objects to any changes in this legislation that might make supplements, like other drug, have to conduct clinical trials and demonstrate their supplements are safe and effective before they can be approved for marketings. The drug industry wants supplements that claim health effects to be regulated like other drugs. With U.S. consumers spending more than $322 million just on supplements for weight loss in 2005, according to the Obesity Society, it has been most active in working to change DSHEA for weight loss supplements that compete directly with GlaxoSmithKline’s over-the-counter Alli (low-dose Xenical, a fat blocker, and the first FDA-approved over-the-counter prescription diet pill, with anticipated annual sales of $1.5 to $3.9 billion).

Regardless of the source, taking a critical eye to any advertising claims for pills and potions, and giving careful consideration of the evidence of demonstrated benefits and harms, using the fair test method, can help keep us all safer.

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

War on childhood obesity is showing its desperation

How do we respond to those scaring children, becoming increasingly more hysterical and outrageous, in ways that might hurt them? If it was someone in your living room or your child’s school saying such stuff to your child, you would intervene to protect your child and other children.

What if it came from medical professionals behind a national political agenda and written by science journalists in the newspaper of our nation’s capital? As much as one might find it easier to play it safe, politically and professionally, and let it pass without saying anything, one can’t. History has shown us the costs of silence and complicity. It wouldn’t be right not to speak out.

The Washington Post began a week-long series on Saturday, seemingly to create panic over childhood obesity. It is so over-the-top, even Google News appears to have largely ignored it, and surprisingly few other publications across the country have picked up its syndicated series. Perhaps, to their credit, editors recognize that it is nothing more than a string of anecdotes, unsubstantiated claims and off the wall predictions — rather than credible science, evidence or balance. In fact, its sensationalized rhetoric is so wildly out of control, it betrays a desperation in trying to convince us all of the need to be freaked out.

Brief review with counter perspectives and a few missing pieces

The Washington Post series has used as its sole source of information the leaders in creating a childhood obesity crisis and behind the claims that have been repeated so often they’ve become gospel in the war on obesity, key among them Robert Wood Johnson Foundation (RWJF) and the Obesity Society.* Science writer, Rob Stein, was a panelist at last month’s RWJF “Active Living Research Annual Conference” that was themed around integrating RWJF ‘research’ into public policies. Stein’s panel gave the media perspective and talked about “what makes a good story.” While there is no transcript of his talk, might sensationalized wordsmithing been recommended for creating a story to bring people around to RWJF’s policies?

He and Susan Levine’s article accuses children of being afflicted with toxic fat that is destructive to their well-being and puts every major organ at risk with probably irreversible damage. The carefully chosen language manipulates emotions and elicits fears, rather than impartially and calmly presenting accurate scientific evidence as one might expect from science journalists. Fat children is a catastrophe that threatens to shorten the lives of an entire generation, they write. “The future health and productivity of an entire generation — and a nation — could be in jeopardy.”

Their series opens with a feature video from Risa Lavizzo-Mourey, M.D., president of RWJF, who had announced last year that RWJF was committing $500 million over the next five years with their goal to build “the missing sense of national urgency about childhood obesity.” Readers will remember that her claims were so extreme at that press conference, she actually said children were fat because they ate too much bad foods and were inactive and, by her math, this “energy gap” would mean the average teen would gain as much as 1,042.85 pounds over the next ten years. She had also admitted, by the way, there was no evidence in support for any of their far-reaching policy recommendations. She is quoted in the Washington Post as claiming: “Many of these kids may never escape the corrosive health, psychosocial and economic costs of their obesity.” In her video, she says that we have millions of kids whose future paints "a pretty bleak picture."

The Post’s article also reported claims of a “huge burden of disease” these children will bring to the population, by William Dietz, M.D., Ph.D., of the Centers for Disease Control and Prevention. He had partnered with Kaiser Permanente “to develop a national broad-based approach to the public health crisis of obesity,” and their “roadmap for advocacy and action” meeting was jointly sponsored by RWJF, CDC, American Association of Health Plans, Health Partners, and the National Business Group on Health. JFS readers may most remember when he organized that Expert Committee on Childhood Obesity which developed the new clinical guidelines for the management of child and teen fat children recently released by the AMA, CDC and HHS. Those guidelines received considerable negative feedback from readers and parents.

Then there’s our U.S. Surgeon General Steven Galson, M.D., MPH, who is quoted in the Post as claiming that child obesity is nothing less than “a national catastrophe.” JFS readers remember that his first news-making initiative against childhood obesity when he took office was to declare that Santa Claus is too fat to be a good role model for children and his second was his nationwide campaign, “Healthy Youth for a Healthy Future.” This campaign was born in the Childhood Overweight and Obesity Prevention Council he established, made up of stakeholders in the government’s healthy eating and physical activity programs. He is currently making his way around the country, talking to schools, politicians and even joining Lavizzo-Mourey and Dietz at CME programs for healthcare providers.

The Washington Post also quoted claims from Melinda S. Sothern, Ph.D., CEP, who they identified only as being from the Louisiana State University Health Sciences Center in New Orleans. What wasn’t disclosed, is that she is director of the pediatric obesity section and directs the Prevention of Childhood Obesity Laboratory at the LSU Pennington Biomedical Research Center in Baton Rouge. (Information on its founding, funding sources and research here and here). She is also a member of the Obesity Society, leading its 2007 scientific meeting in New Orleans on initiatives to prevent childhood obesity, and she served on that same Expert Panel on Childhood Obesity. In the Washington Post article, Professor Sothern said obesity exerts a cruel price that “robs children of their childhood...the natural enjoyment of being a kid — being able to play outside, run. If they have high blood pressure, they have a constant risk of stroke.” (Different perspectives and medical information on blood pressures in fat children here and here.)

Another unidentified member of both the Obesity Society and that Expert Panel, Jeffrey B. Schwimmer, M.D., a pediatric gastroenterologist at the University of California at San Diego, said in the article that “obese children are victimized and bullied” and treated differently by other children and teachers. But the Post authors didn’t follow through with this information or examine the role of anti-obesity scaremongering in fostering such harmful discrimination of fat children.

The claims, rather than the science, continued to come fast and furious, all of which have already been addressed here. One made by the Post authors warrants a special note. They blamed the epidemic of fat children for higher hospital costs and for potentially adding “billions of dollars to the U.S. healthcare bill.” (This myth turns out to be hype, too, as explained here and here.)

Finally, the Washington Post authors saved the most outrageous claims for the end, quoting from David S. Ludwig, M.D., Ph.D., identified only as an obesity expert at Children's Hospital in Boston. JFS readers will probably remember him as the originator of that illogical claim that “a single 12-ounce soft drink with sugar per day raises a child’s risk of obesity by 60 percent” — which, when the actual research was examined, was found not to be true at all. But the myth that soda pop causes childhood obesity was born and lives on. He made news last year telling kids at his pediatric weight loss program, Optimal Weight for Life Program, that fake foods are bad and make them fat and diseased. He is also recognized for making equally absurd claims in medical publications that a fat child will have a heart attack before age 30 and that childhood obesity is “a massive tsunami headed for the United States.” The Washington Post also failed to disclose that he’s with the Obesity Society and also served on that Expert Panel on Childhood Obesity.

According to the Post article, Ludwig now compares the childhood obesity crisis to global warming. “We don't have all the data yet, but by the time all the data comes in it's going to be too late,” he was quoted as saying. “You don't want to see the water rising on the Potomac before deciding global warming is a problem.”

After all of that piling on of a single viewpoint from people affiliated with one group of vested interests, the science writers then balanced it with factual information from medical, nutrition, child development, obesity and eating disorder professionals, and scientists, presenting other viewpoints, right? Readers also learned the potential harms resulting from these anti-obesity messages and of the proposed interventions, right?

Wrong and wrong.

[I am edited myself here, but regular JFS readers will understand exactly what merits saying.]

The most heartbreaking aspects of this series are the children, who’ve been indoctrinated by these scares. In today’s video, a boy said he believes that fat is like a “spread of the plague or something” and that he would have a heart attack and die unless he keeps his weight under control, exercises and eats right. He is concerned about his cholesterol because if it gets high it “blocks blood flow and you’ll die.” He is only 12 years old.

While it seems there will always be people who will readily believe whatever they’re told to think, and whatever slick marketing shows them on television; for growing numbers of thinking Americans, the claims about childhood obesity are becoming so unsound and exaggerated, they are seeing it for what it is: groupthink.

Propaganda.

© 2008 Sandy Szwarc. All rights reserved.

* The Obesity Society was formerly called the North American Association for the Study of Obesity. The American Obesity Association also merged with it on Sept. 5, 2006. Attorney Morgan Downey had been Executive Director/Chief Executive Officer of the AOA for a decade and since June 2006 has been Executive Vice President of the Obesity Society. “Recognition of obesity as a disease is a central goal of the AOA, founded in 1995,” according to its mission statement. This lobbying organization led the change of IRS rules (IRS Ruling 202-19), announced on April 2, 2002, which were reworded to say: "Obesity is medically accepted to be a disease in its own right," and enabled weight loss treatments to be claimed as a medical deduction. AOA was part of HHS Secretary Tommy Thompson’s obesity roundtable in 2003 and lobbied the FDA that “obesity is the most prevalent, fatal and chronic disease of the 21st Century.” It was instrumental in the FDA revising its guidelines for reviewing and approving weight loss prescription drugs to expedite their release. It lauded Secretary Thompson’s famous 2004 launch of the HHS campaign against obesity called “Healthy Lifestyles and Disease Prevention,” and increasing NIH annual funding for obesity research to more than $400 million. The AOA also successfully lobbied to have weight loss interventions covered by Medicare (and hence, by most insurers) and hailed HHS Secretary Thompson when he eliminated the Medicare policy that had said obesity is not a disease. The AOA-Obesity Society has been actively lobbying for coverage of bariatric surgeries, for the promotion of “healthy” foods and taxation of fattening foods. Since 2006, the Obesity Society has been a member of the National Committee for Quality Assurance (NCQA) Advisory Committee, which sets the clinical care guidelines healthcare providers must follow, and in recent months, the NCQA obliged by issuing two new guidelines calling for BMI assessment for all children and adults and mandatory reporting of counseling for nutrition and physical activity. “It will mean that thousands of patients in managed care plans, Medicare and Medicaid will have their BMI measured and tracked and that weight will become a topic for physician-patient interaction,” said Morgan Downey. [Click on image to enlarge.]

Much of the information we hear about obesity, healthy eating and weight control is driven by these dominant interests, yet it is also why we rarely hear contrary information. Few scientists or medical professionals dare speak out against them without risking their careers and reputations. We were poignantly reminded of this in February when the prestigious upcoming President of the Obesity Society himself, David Allison, Ph.D., made the mistake of saying that mandating calorie counts on restaurant menus wasn’t sound. He quickly found himself castigated and run out the door and replaced by Gary Foster, Ph.D., who authored that School Nutrition Policy study of the government’s healthy eating and physical activity guidelines. In a surreal irony, one of the largest special interest lobbies in the country came down on one of its own for having conflicts of interest by consulting for companies. As Dr. Roy Poses, M.D., of Health Care Renewal noted: “[D]id the Obesity Society cast out a leader because he was aligned with commercial interests opposed to the commercial interests that provide most of the society's support? That is, was he cast out not because he had conflicts of interest, but because he did not have the same conflicts of interest as the society?”

If this happens to one of its own biggest names, you can imagine how few little guys will risk their livelihoods to say anything against the groupthink.

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

Our country on drugs

One of the world’s largest pharmacy benefit managers announced more success of its drug benefit management this week. More than half of all insured Americans, children and adults, are now on prescription medications for chronic diseases — and 20% are on three or more drugs. Nearly half of all young women in their 20s and 30s are now chronically taking prescription drugs, as are nearly one in three children.

While the media has been quick to conclude this is evidence we’re more chronically diseased and unhealthy than ever, that is not what this reveals at all. Prescriptions are not a measure of health, but of marketing...

Medco Health Solutions, Inc. offers health risk assessments and pharmacy benefit management for major insurance companies, corporations, unions, health maintenance organizations, federal employees and those with Medicare* Part D. It states it is now "the nation's leading pharmacy benefit manager based on 2007 total net revenues of more than $44 billion." Its sales had first reached $1.4 billion in 2002 — meaning, it's had over a 3,143% increase in revenue in just 5 years.

According to Medco’s press release, for the first time in history, the majority of Americans have now been placed on prescription drugs for chronic conditions. People under insurance company managed care, more specifically. The greatest jump in prescription drug sales since 2001 of any group is among young women. Nearly half of all young women in their 20s, 30s and up to age 44 are taking prescription pills, with most on antidepressants — nearly one in five young women in our country is now taking antidepressants. One in three young men of similar ages are also being prescribed drugs, mostly for blood pressure and cholesterol — cholesterol drug sales among young men soared more than 80% over the past 7 years. Prescriptions for cholesterol drugs being given to women in their 40s to early 60s have doubled over those same 7 years. Nearly one out of every three children and teens is taking a drug, most for allergies/asthma, attention deficit hyperactivity disorder (ADHD) and antidepressants. And seniors are the most drugged of all, with about a quarter being given 5 or more chronic prescription drugs (28% women 22% men).

We are largely witnessing the successful marketing of “health risk factors,” that people have been misled to believe must be treated and perfectly controlled to prevent chronic diseases of aging and premature death; or to believe that the indices, themselves, are lifestyle diseases.

We are largely witnessing the success of being surrounded by nonstop scares about disease and the pervasive preoccupation with health and “wellness.” Even little kids before they’re barely old enough to read are being taught to worry about their weight, fitness, health indices and getting adult diseases of aging. It’s sad to see so many normal, healthy people, needlessly anxious and scared. Younger patients in particular are becoming ‘health obsessed', said Dr. Michael Fitzpatrick, author of The Tyranny of Health— doctors and the regulation of lifestyle.

We are largely witnessing the success of managed care by insurers and pharmacy benefit managers. PBMs are a missing piece to the puzzle as to why insurance companies, government agencies and employers are so intent on getting us to participate in wellness programs, undergo prolific health screenings and lab tests, and complete health risk assessments. Why “health risk factors” — health indices such as BMI, cholesterol, blood pressure and blood sugars — are being medicalized. And why performance measures for our healthcare providers are tying their pay to their conformity.

“Seek and ye shall find” is the principle of screenings to identify more for lifestyle and medical interventions, and prescriptions. Most health indices have been redefined with ideals set so low, that most normal healthy adults as they age, or by genetics, now find themselves “needing” treatment. Health indices are not malleable by “healthy lifestyles,” however, only prescriptions will get them down to those increasingly stringent “ideal” ranges. All toll, the quality measures in the new performance program with 74 clinical measures recently launched by the Centers for Medicare & Medicaid Services, for example, would encourage doctors to prescribe some 15 different prescriptions for adults over age 50 in order to meet the requisite health indices. How many people know if all of these pills have really been shown to improve health and longevity, or sufficiently enough that they might personally choose to accept the potential risks that go along with them?

For its health insurance provider clients, Medco Health Solutions, Inc. not only manages the prescriptions, but their health to make sure members “live life well.” It has online health risk assessments and “a tool to track and manage daily health activities,” health and wellness information specific to their conditions and to inform them of their medication needs, information on healthy lifestyles said to improve members’ health score, disease management and health alerts and reminders for screening tests and prescriptions, and medication management. Its “integrated data and predictive modeling identifies potential health risk factors” by compiling health risk assessments, lab results and pharmacy claims, then comparing their health indices against clinical rules, and then alerting healthcare providers and monitoring their performance in accordance with the health plan directives.

As was covered last fall, today’s pharmacy benefit managers (PBMs) don’t just fill prescriptions as they once did, they’ve become managed care companies. Ethical concerns come to bear when those who control the access and costs of prescription medications are also in control of our medical records, the health information we get, and the medical care we receive. According to FTC hearings on PBMs, they mandate tight management of health risk indices based on their guidelines and steer doctors to write prescriptions for drugs that they make the greatest money on through manufacturer rebates and through point spreads on each prescription between what’s billed the insurance provider and paid to the pharmacy.

The more prescriptions filled, the greater their profits.

Consumers’ compliance has been elicited by convincing them that health is under their personal control, and that obesity and chronic diseases of aging are lifestyle diseases that can be prevented by “healthy” diets and lifestyles. Their cooperation has been elicited by convincing them that “health risk factors” need regular monitoring and medications in order to prevent dire health consequences. Dr. Fitzpatrick has seen the number of healthy young people in their 20s wanting physicals and screening tests soar over recent years, “but they need nothing of the sort,” he said. Most of this preventive screening is unnecessary. “They should be enjoying themselves, not testing their cholesterol,” he said. “These companies are feeding off people's anxieties and making a vast income from something of dubious value.”

Few consumers really understand that risk factors are not actual risks for diseases, but correlations. [See The greatest myth of health risk factors.] The public rarely hears that even the biggest popularly believed risk factors don’t predict who will succumb to chronic diseases or premature death. As Dr. Prediman K. Shah, M.D., director of cardiology at Cedars-Sinai Medical Center explained: “Our traditional risk factors [BMI, blood “cholesterol,” blood sugar, blood pressure, and lifestyle factors] are very weak overall predictors of future risk.”

Virtually all heart disease occurs in those without risk factors and the clinical evidence for managing risk factors such as cholesterol levels to prevent heart disease have been “overemphasized and overmarketed,” said Dr. Donald L. Vine, M.D., a cardiologist and professor at the University of Kansas School of Medicine in Wichita, who reviewed the evidence in American Family Physician.

The public rarely hears how controversial among medical professionals the micromanagement of health indices in these moderate ranges are, as well as the evidence behind such guidelines for primary prevention. The public rarely hears how minimally cholesterol-lowering drugs increase lifespans in men, for instance, as explained Dr. Malcolm Kendrick, Medical Director of Adelphi Lifelong Learning, Cheshire, UK, and long-time cholesterol researcher. Let alone do women know that statins are absolutely pointless for them, as he said, while putting them at risk for serious side effects. Few consumers realize that cholesterol screening for young people is even more controversial and, not only have normal values not even been established and associated with cardiovascular health, but the long term safety of cholesterol-lowering drugs is unknown. Neither the American Academy of Family Physicians or the U.S. Preventive Services Task Force recommends screening for hyperlipidemia in children or teens.

As was reported here, the latest Health US 2007 report issued by the U.S. Health and Human Services Department, found that antidepressants make up the largest percentages of drugs prescribed for Americans — 35.5% of all prescriptions. Prescriptions for antidepressants have dramatically increased, more than tripling among adults just between 1988-94 and 1999-2002. Usage among women is twice that of men and rose from 3.3% to 10.6%; with nearly half (47.7%) of every prescription written for a woman in 2004-2005 was for an antidepressant. Have we all really become this unable to cope or is this another sign of our fear-driven culture?

Yet consumers may also not realize how vehemently the efficacy of antidepressants has been debated within the medical community for years. When all of the clinical trial data submitted to the FDA for licensing of the six most widely-prescribed antidepressants approved by the FDA between 1987 and 1999 for adults was examined (the only analysis to include both published and unpublished randomized, placebo-controlled clinical trials), the authors found virtually no difference in the improvement in depression scores [Hamilton Rating Scale of Depression, the 65-point scale used to evaluate severity of depression] among patients with moderate depression taking the drug versus a placebo. Effects only reached statistical significance (yet still smaller than is considered clinically meaningful), among patients with severe depression. The controversial paper was originally published in 2002 and more recently in the open public access journal, Public Library of Science Medicine. Dr. Irving Kirsch, Ph.D., of the Department of Psychology at the University of Hullin the UK and colleagues argued that with marginal clinical benefit for vast numbers of people being put on these drugs, the potential risks associated with the drugs become so much more important to weigh.

The concerns are similar to those being discussed in the medical community for other drugs, such as for weight loss and cholesterol-lowering: that adverse effects could needlessly be putting the health of millions of people at risk, in return for minimal or no benefits. For example, antidepressants, specifically various SSRIs, have been shown to be associated with increased risks for hyperglycemia and diabetes, weight gain and the metabolic syndrome, as researchers at the Einar Martens' Research Group for Biological Psychiatry, Center for Medical Genetics and Molecular Medicine in Norway reported. Dr. Gerard Ahern, Ph.D., assistant professor of Pharmacology at Georgetown, led a study in a 2006 issue of the journal Blood, suggesting that SSRIs could also play a role in auto-immune disorders or immunity. According to Dr. Daniel Hall-Flavin, M.D., Mayo Clinic psychiatrist, “weight gain is a reported side effect of nearly all antidepressant medications currently available.” Antidepressants have been reported in obesity research for over a decade as producing weight gain, unrelated to diet or activity changes, an adverse effect not widely reported. The evidence and risks for children are even more controversial and worthy of a separate future article.

Few consumers realize the enormity of the financial interests behind today's health promotion and preventive health. They don’t hear about the evidence that even intensive disease management programs through third-parties for serious conditions, which would seem intuitively beneficial, haven’t demonstrated improved health outcomes or lowered healthcare costs, let alone most preventive health and “wellness” programs with even less efficacy. Unlike the classic public health programs, such as immunizations, that have been wonderfully effective in preventing actual disease and saving lives, the diseases we die from today are the result of aging, genetics and the luck of the draw and can’t be eradicated like polio or prevented by controlling risk factors. We’ve examined the lack of evidence behind those who want us to believe that by eating “healthy” and having optimal nutrition and wellness, we can prevent chronic diseases and aging (and all be slim, too). The nonprofit Canadian Health Services Research Foundation based in Ottawa, also examined the evidence surrounding the adage “An ounce of prevention buys a pound of cure” and concluded that “the evidence is simply not there” to support the cost-savings argument for most health promotion and disease prevention measures, even the most popularly claimed initiative, physical activity. “The health and cost benefits of these programs remain largely anecdotal.” The fact is, we can spend our entire lives religiously eating some special "healthy" way (however that may be defined) and following some ideal lifestyle, and it won't prevent us from growing old or getting cancer, heart disease or some other chronic disease.

Yet the public doesn’t get all sides of these issues. They aren’t given all of the available evidence and allowed to freely make choices for their own bodies, with their own doctor free to advise them. This raises concerns about the increasingly coercive nature of care managed through a third party with its own interests.

Consumers are subjected to the most intrusive and paternalistic monitoring of their personal lifestyles by third party “wellness coaches” and case managers through insurance company and PBM-originated programs, as covered here. Their participation and compliance with meeting indices set by the PBMs and insurers, and even their doctors’ compliance with the performance measures, are being monitored and incentivized.

So, yes, most Americans are now on prescription drugs.

But, no, this is not evidence that we’ve all suddenly become so unhealthy. And, with obesity rates among young people and adults unchanged since 1999-2000, according to the CDC National Center for Health Statisitics, this spike in drugs isn’t because we’ve all suddenly become fat, either.

© 2008 Sandy Szwarc

Click on images of Medco literature to enlarge.

*Federal prosecutors charged the company with attempting to defraud Medicare and Medicaid, paying kickbacks to insurers in exchange for their business, seeking kickbacks from drug companies to promote their prescriptions, and switching prescriptions without physicians consents and not filling others and destroying patient prescriptions. It settled in October, 2006, agreeing to pay the government $137.5 million and an additional $9.5 million in civil charges.

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

Another cruel breast cancer scare falls flat

There was a press release about a new study... sent out to media before the study was published in the medical journal... more than 500 media outlets reported on the study on the same day and all saying the same thing... Stop me if you’ve heard this before.

This week, people around the world were told about a new study of 65,000 women said to have found another threat for girls and young women who fail to exercise regularly: a higher risk for breast cancer, “which kills 40,000 American women every year.” From the press release, media reported that parents should get their daughters off the couch because women ages 12-35 who exercise regularly can cut their risk for breast cancer by 23%. This study was said to be one more reason to require girls to take PE to stay in shape, said a Mercury News editorial.

Science isn’t marketed through public relations firms, nor does it try to manipulate or scare you. If the media’s lockstep coverage, verbatim from a single press release, wasn’t enough of a clue that this was marketing and “science by press release,” then your next clue was the size of the study. No, the bigger the study doesn’t necessarily mean the findings are more important. In fact, it rarely does. The bigger the number of people studied, the less likely it is to have been an actual clinical trial, the only kind of study that can test a hypothesis and credibly suggest a cause or effective intervention. That’s because good clinical trials are expensive to conduct, while those done in a computer, using numbers and data rather than people and verified clinical evidence, aren’t.

Since we know all studies are not created equal, let’s look at this one. Was it a randomized clinical trial that followed tens of thousands of women from age 12 and found that vigorous daily exercise resulted in fewer cases of breast cancer? No. The study, published in the Journal of the National Cancer Institute, was authored by researchers at Brigham and Women’s Hospital and Harvard Medical School in Boston, which houses the largest and longest-running Rorschach test of epidemiology: The Nurses Health Study. This is a huge quarry of questionnaires gathered since 1976 from more than 120,000 nurses and has been used by its researchers to pick out characteristics in unlimited combinations to find all sorts of correlations and conclude just about anything they set out to find. Well over 500 such computer studies have been published from this database and many of the correlations reported even contradict each other.

Definitions

Study population. For this paper, they first culled down the original 116,608 self-reported questionnaires on lifestyle factors in the Nurses Health Study II cohort (began in 1989). They took only those questionnaires turned in since 1997 among women age 33-51 who had also answered questions about their current exercise levels, as well as retrospectively estimated their activity decades earlier as young girls. This left them with data on 64,777 women. This is our Trojan Number reported in the news.

Cancers. For this paper, they only considered invasive premenopausal breast cancers that had been reported as occurring between 1997 and 2004, for which they also had physical activity data. They further eliminated all in-situ and unconfirmed cases (another 189 cases), leaving 550 cases for their analysis. There were too few (129) cases of invasive postmenopausal breast cancers to include in their analysis. So, this study was actually only looking at 550 cases of premenopausal breast cancer.

Physical activity. For this paper, they defined physical activity only as leisure-time activity and used the average hours per week at each age the women reported and recalled having done, in each of three specific activity categories: strenuous (running, aerobics, lap swimming), moderate (hiking, power walking, bicycling and yard work) and walking to and from school or work. Not only is leisure-time activity a marker for things like socioeconomic status, but retrospective recall data is the weakest type of data to use in research. Beyond the fact that few people can accurately remember what they were doing decades earlier, it suffers from recall bias. For instance, if you believe that your fatness is caused by being too sedentary, you are more likely to believe you must have been too inactive and to report it thusly. The further back the recall data, the less reliable it is. The authors then took this self-reported data and estimated a metabolic equivalent (MET) value based on the intensity, and labeled the activity by METs per hour per week. They then assigned MET values of 7.0, 4.5 and 3.0 to strenuous, moderate and walking categories, respectively.

Despite claims that young women are sloths, all of the women had been active during their teen years and 20s and activity declined in their mid-30s. The women who engaged in the most leisure-time activity were also slightly more likely to not have babies, be taller, use oral contraceptives and to smoke. Their weights and diets and menstrual cycles didn’t significantly differ from the less active women, however.

Computer model. They tossed all of this into their handy dandy computer and tried every possible permutation of activity at each age, and at various cut-offs of age groups, and at every type of activity and intensity, trying to derive correlations between activity and premenopausal breast cancer.

Findings

None of the relative risks were tenable and beyond random chance or statistical error for this type of study. This study was unable to find any credible relationship between exercise and premenopausal breast cancer. All of the relative risks hugged null (RR=1).

We could stop right there, but, if we want to split hairs, there are a few observations that can help reinforce the lack of a credible correlation. Looking at their adjusted relative risks (which adjusted for age, contraceptive use, history of benign breast disease, mother or sister with breast cancer, parity, alcohol, and height — but not socioeconomic status, smoking, dieting history, etc.), there was no consistent dose-relationship. In other words, more exercise didn’t mean lower risks for premenopausal breast cancer.

Among the women engaging in strenuous-type activities, for example, those doing 3 hours a week had lower risks than those doing 4 or more hours; among the walkers, those walking a mere 1 hour a week had lower risks than those doing up to 2.5 hours a week.

This same quirk was seen in most of the different age groups. Among women 23-34 years of age, those doing the lowest levels of activity (<15 MET-h/week) had lower risks than all of the higher activity counts but one. Among women 35 years of age and older, those doing the most exercise had the same risks as those doing the least.

Only when they created an age group of 12-22 years, was any kind of linear correlation produced, although none of the relative risks were tenable and all hugged null. But the women who reported that as teens they’d done the highest levels of exercise (calculated as 72 MET-h/wk) had a mere 7% difference in relative risks from the women who as girls had done about half that (36-47.9 MET-h/wk) — but the difference in actual numbers of cases was only 0.13% versus 0.15%, respectively, not a credible correlation, let alone clinically meaningful. Especially given the questionable quality of the data going back decades.

Nevertheless, the authors said in their conclusion:

In conclusion, these results suggest that consistent physical activity during a woman’s lifetime is associated with decreased breast cancer risk. Unlike many risk factors for breast cancer, physical activity is an exposure that can be modified ed. This association, if found to be causal, has public health implications for prevention.

And if you just read the Abstract, it appeared to suggest even stronger findings, concluding:

High levels of physical activity during ages 12 – 22 years contributed most strongly to the association. Leisure-time physical activity was associated with a reduced risk for premenopausal breast cancer in this cohort. Premenopausal women regularly engaging in high amounts of physical activity during both adolescence and adulthood may derive the most benefit.

Flashback: Correlations are not causations

The correlations found in this study weren’t tenable at all. But even if they’d been huge, they’d still have been just correlations. Remember, correlations derived from data dredges and looking at characteristics among groups of people (epidemiology), no matter how strong or intuitively correct they might seem, cannot provide evidence of a cause, and most certainly not for any treatment we should act on.

Most observational, epidemiological studies are actually overturned and found to be bogus when their hypotheses are tested in randomized, controlled clinical trials. Growing numbers of research experts are so concerned that epidemiological studies are so often wrong, they say they’re next to worthless. As Dr. Stan Young, a statistician at the National Institute of Statistical Sciences in Research Triangle Park, N.C., said: “We spend a lot of money and we could make claims just as valid as a random number generator.”

We all need to be regularly reminded of why this happens. The more correlations you look for in a lump of data, said Dr. Young, the more likely you’ll be able to pull out something statistically significant — just by chance, luck, nothing more. It’s the classic parlor trick of cold reading and getting an audience to believe you can read their minds or are able to communicate with their dead relatives. Ask dozens of questions and eventually you’re bound to come up with something positive.

But our minds also trick us. Few of us realize that coincidences, even huge ones, are not that unusual. Nor do they usually mean anything. Our understanding of probabilities and statistics isn’t so great, though, and we’re easily taken in by coincidences. Instinctively, we want to believe that there must be a reason for all links, rather than the truth being that they’re just random chance.

We also don't understand the laws of dealing with numbers, especially big ones. The law of truly large numbers means that when enough data or people are involved (as in epidemiological studies), "unusual" occurrences become highly usual.

Epidemiology can dredge up all sorts of correlations and it’s inordinately successful at making us worried sick about our health. Nowadays, epidemiology is primarily being misused to link diets and lifestyle behaviors to cancer, diseases, obesity, and death; then twist them around into causation, and make us believe that our health is a matter of personal responsibility. As Dr. Paul R. Marantz of Albert Einstein College of Medicine, New York, wrote in the American Journal of Public Health: “The misleading message that an individual will prevent a particular disease by altering a particular behavior or exposure (and its converse, than an individual will develop a particular disease if such behavior is not changed) has unfortunately been widely conveyed.”

The sad fact of the matter is that beliefs and fears surrounding risk factors defy the fundamental laws of human biology, and bodies that are naturally robust and impervious to small changes in the external world, as Dr. James LeFanu, M.D., wrote in “The Fall of Medicine.” How else could the human species have survived to this point? But epidemiological scares have undermined our confidence in our bodies and have left so many perfectly normal people feeling weak and vulnerable, at risk of falling ill at the slightest exposure, he said. They’ve affected our very concept of what it means to be healthy. Rather than realize that most of us are healthy most of the time and only occasionally get sick and then get better again; it’s become widely believed that healthy young people need regular medical attention and constant diligence to stay healthy.

One perceptive blogger wrote a great comeback about this week’s study, that I’ll refer you to because it was such fun. The scientist author of Big Liberty wrote about our cultural programming of sloth and fat = cancer:

You know what also equal cancer risk? Being tall. Yup, says so right here. They found that the risk of experiencing breast cancer increased by 7% with each 5cm increase in height for post-menopausal women, with a marginally increased risk among pre-menopausal women...

But wait, there’s more from this fun little article: “Paradoxically, however, being obese appears to have a protective effect in women before the menopause.” Since they’re scared of stating this stat (scared of losing their grant money, that is), we don’t know how *much* of a protective effect being obese before menopause has. It’s not good marketing to use comparative statistics on the non-lucrative stats, you know... So it seems like there isn’t some magical prescription to make sure you don’t get cancer...

How does this week’s study fit with what’s been shown to date?

If you hadn’t tossed this study for the bird cage upon reading the headlines — recalling that recent news story trying to scare women that having a single drink a day could give them breast cancer — you might be curious about how its findings fit into the scheme of things.

First of all, despite the scary death claims in the news, tens of thousands of young women are not dying of premenopausal breast cancer each year. Breast cancers, like most cancers, are most related to advancing age. Age is the single greatest risk factor for post-menopausal breast cancer and breast cancer deaths, occurring 34-fold more often among women over age 50 (with most over age 65).

According to the American Cancer Society’s Breast Cancer Facts and Figures, 2005-2006, breast cancer death rates are also dropping and have decreased 2.2% every year since 1990. There is no evidence to support a sudden need for new public health interventions or for panic. Nor is there any evidence that young women need to fear that by not following a certain lifestyle, they could get breast cancer.

In a 2005 issue of the Nurses Health Study Annual Newsletter, Walter Willett, MD, MPH, the principal investigator of the Nurses Health Study II, which is the cohort used for this week’s study, had a very different report on what the Nurses Health Study data had shown: “Being physically active doesn’t seem to offer women much protection against premenopausal breast cancer — and being lean actually seems to increase risk,” he wrote.

His message on the exact same data calmly defused worries that premenopausal breast cancer is a woman’s fault. We’ll give him the last word:

Despite most efforts [to identify a cause or risk factor], premenopausal breast cancer remains something of a mystery, and women understandably feel frustrated when they’ve ‘done everything right’ and still develop this disease. Clearly, the usual advice to exercise and eat well is not enough to prevent breast cancer.

© 2008 Sandy Szwarc

* The principle investigator of the first Nurses Study is Dr. Graham A. Colditz, who originated the “economic costs of obesity” claim, saying obesity cost $39.3 billion in 1986, and has continued to be the lead proponent of this claim. The numbers have grown, as have claims of and death counts attributed to an obesity epidemic. Most “costs of obesity” figures are extremely flawed elaborate creations of computer models.

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

Quote of the day: “We need a more fluid concept of evidence”

I’ve waited to write more more about the roots of unscience in medical schools and universities, to include what I knew would be a priceless synopsis of his trip to the United States. Professor David Colquhoun of the Dept of Pharmacology at University College in London, recently spoke at the Integrative Medicine at Yale. As covered in-depth here, medical professionals in the UK are actively working to advocate for the safety and welfare of patients and the integrity of science in medicine by exposing quackery.

As readers will remember, Yale joined nearly 40 other top medical schools around the U.S. opening integrative medicine programs and bringing alternative modalities to their medical training and practices. Much of the funding and support for spreading these programs comes from the $250 million a year in federal grants through the NCCAM and National Cancer Institute. (There’s a reason so much flawed research and ideas surround cancer.) Another major source is through private billionaire backers who began the Bravewell Collaborative for Integrative Medicine in 2001, with the goal of integrating alternative modalities into mainstream medicine.

Bravewell was founded by John Mack, the Wall Street tycoon, and is run by his wife. Based in Minneapolis, in just its first 5 years, it had raised $21 million from backers, all of whom had to agree to support Bravewell in every course of action. It has established the Consortium for Academic Health Centers for Integrative Medicine with nearly 40 medical schools now, all readily abandoning science to teach “other ways of knowing” in return for countless millions of dollars. Forbes wrote about one of the those centers, Duke Center for Integrative Medicine, when it opened the fall of 2006 after being financed with a $10 million donation from the C.J. Mack Foundation. As Robert Lenzner reported for Forbes:

The Macks, along with other Bravewell members, also raised money for the PBS special this year, "The New Medicine," which featured the use of hypnosis and guided imagery as techniques to reduce pain and help ill people lead active lives. The special won the Freddie Award for Health and Science Media in the area of health and wellness.

Bravewell is aiming its proselytizing guns at university medical centers, attempting to promote the construction of integrative health facilities. It funded the development of the curricula on the topic for medical schools and trains 30 doctors a year in integrative medicine at a cost of $30,000 per doctor, using the works of Andrew Weil, a best-selling author and guru in the wellness field. And it gives a biannual $100,000 prize to recipients of its Bravewell Leadership Award, given to doctor who have made a big impact within the field.

Bravewell has also recently set up its own BraveNet (Bravewell Integrative Medicine Research Network) with 8 of those university integrative medical centers, to increase knowledge about alternative modalities and their “evidence-base.”

One of the most revealing parts of professor Colquhoun’s talk was his coverage of the recent Integrative Medicine Scientific Symposium at Yale [JFS background here; YouTube video here] where Dr. David Katz, the founder and direct of the integrative program, spoke. Do listen to professor Colquhuon’s tape of Dr. Katz’ talk as he describes randomized clinical trials of vitamins for fibromyalgia, homeopathy for ADHD, coenzyme-Q10 and carbetalol for heart disease, phytoestrogens, yoga, acupuncture, and others that all found no demonstration of clinical efficacy using the most credible clinical evidence. We know the evidence on antioxidants also shows them to be ineffective, said Dr. Katz, but “we need to think more fluidly about evidence.” He repeated this idea several times. As Colquhoun reports today:

Pretty remarkable uh? Dr Katz goes through several different trials, all of which come out negative. And what is his conclusion? You guessed. His conclusion is not that the treatments don’t work but that we need a “more fluid concept of evidence” ...

This is not science. It isn’t even common sense. It is a retreat to the dark ages of medicine when a physician felt free to guess the answer. In fact it’s worse. In the old days there was no evidence to assess. Now there is a fair amount of evidence, but Dr Katz feels free to ignore it and guess anyway. He refers to teaching about evidence as ‘indoctrination’, a pretty graphic illustration of his deeply anti-scientific approach to knowledge. And he makes a joke about having diverted a $1m grant from CDC, for much needed systematic reviews, into something that fits his aims better. [“We knew it was silly, but on the other hand, a million dollars sounded really good,” said Dr. Katz.]

As Colquhoun explains with no holds barred spunk, the foundation of these alternative-integrative programs is nutritional quackery, nutrigenomics, antioxidants and flavonoids, diets and ‘healthy’ eating for preventive health and optimum wellness. These issues have been heavily covered here at JFS, but the unsoundness of so much of them is still difficult for many readers to grasp because feel-good modalities have become so incorporated into what people believe is legitimate health and medicine. They also include just enough interventions with a degree of efficacy (such as general massage and relaxation techniques to reduce anxiety and pain perception) to make all the mind-body vitalism-based modalities and their claims appear credible. It’s understandable for people to want to believe that by diligently following a certain lifestyle and eating ‘healthy’ they can prevent chronic diseases of aging, cancers, diabetes and heart disease. But disease, just like actual obesity, is not a measure of good behavior or eating some certain way.

In response to dietary quackery in preventive health, optimal wellness and longevity, experts funded by the National Institute on Aging emphatically stated: “Our language on this matter must be unambiguous: there are no lifestyle changes, surgical procedures, vitamins, antioxidants, hormones or techniques of genetic engineering available today that have been demonstrated to influence the processes of aging.”

But fostering these beliefs among consumers is an ingenious way to enact policies to control food and lifestyles and get people to believe it’s in their best interests. It also promotes blame and discrimination against those with health problems, as it being their own fault and costing everyone else. This melding of alternative beliefs into mainstream medicine is seeing rapid success. Some additional background information may be helpful in understanding why. Bravewell has also created powerful “strategic partnerships” to promote “preventive health and wellness” and alternative modalities as part of the national health agenda. Its partners seek to “change the way healthcare is delivered in this country.” You’ll recognize most of these influential organizations, such as the NIH, National Committee for Quality Assurance (NCQA), National Business Group on Health (behind employer and insurer “wellness” programs and insurance mandates) and Robert Wood Johnson Foundation.

As professor Colquhoun reports today, the main thing that’s brought medical schools and universities down to the level of promoting nonscience is “simply money.” But he ends on a positive note, saying that this can be stopped if people and healthcare professionals care enough to speak out. When Florida State University proposed setting up such a program, public pressure on legislators and the governor was able to stop the passage of a funding bill and shut the project down. “In the end, reason won,” he writes. Will healthcare professionals and consumers act to ensure Yale and the 39 other universities on the list follow their example? Will they speak out against these wellness programs being enacted by government agencies, insurers and employers? Or is the money too good?

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

A look at some of the companies behind your employer’s wellness program

You might be interested in the latest preventive health and wellness management companies marketing themselves directly to your employer. Delivered to employer in-boxes over recent weeks:

Targeting fat employees or those who call in sick

This first company tells employers it will improve their worker productivity and company profits by managing the health, disability and absenteeism of employees and teach them how to make healthier decisions.

On its “About us” webpage, it says it has identified trends that negatively affect employers: obesity, diabetes and heart disease, but that workplaces need to develop a prevention mindset. So, it pieced together the products of several vendors to enable it to compile health information and productivity data on all employees and provide them to employers. The “advantage” to employees, it says, is that they only have to share their private information once and then would have a nurse health coach to counsel them on healthy diets and lifestyles, who would work to preserve the company’s most important asset: the health and well-being of workers.

Through its partner (GatesMcDonald, an Ohio insurance claim management company), it will monitor unplanned absences, health risk assessments, and pharmacy and medical claims data to target employees for intervention. “Until now, no company had thought to use absence management this way,” it says. [Although it is nearly identical to another absenteeism and productivity management company covered here.]

Last year, it merged with the company founded by its Chief Medical Officer, INTERVENT, a health management company that does screenings, health risk assessments and lifestyle coaching. It also partnered with the American Heart Association (the CMO was also former chairman of the AHA Committee on exercise). This has allowed it to “build a culture of health with the association’s new ‘Fit Friendly’ certification,” it says. It also offers generic pharmacy management.

The company’s leadership team is also introduced, along with descriptions of their exemplary lifestyles: low-fat diets and eating healthy, one finds ways to keep moving all day, another does gym work-outs six times a week along with several sports, another rides his bike every day, another jogs daily, another is a mountain climber, one’s an exercise trainer, another does aerobic classes and weight training with a personal trainer, and a marathon runner says she also “eats a steady diet of fruits and vegetables.” How many are aged, disabled or disadvantaged?

Fat people appear especially unwelcome. A recent press release describes their vision of workplaces as a “solution to unhealthy lifestyle habits.” Citing a growing obesity epidemic, it claims fat people miss double the work as normal weight employees and cost employers additional billions of dollars in lost productivity, and that employers can put an end to this. It illustrates the bad habits of employees by saying a survey found that 72% of employees eat an “unhealthy snack” at least three times a week. “Leading a healthy lifestyle is crucial to long-term weight management,” it says. Among its products is an "obesity management program," based on getting fat people to make healthy behavior changes, with intensive health coaching sessions and action plans for eating and exercises. According to its website, “obesity is a killer” and can cut up to 20 years off a person’s life.

It changed its name in 2006 to Nationwide Better Health to reflect it’s new vision: "Leading the way to a healthier, more productive nation…one person at a time."

They are serious.

Biogenetic screenings

Another company promises employers it will connect them to the health of their employees and keep them informed. BioIQ offers biometric* screening tests that promise to screen employees for key health conditions, orders tests to monitor those conditions and offers a “complete communication continuum” to monitor employees.

“You send one introductory message [to the employee] and we handle the rest,” it tells employers. Employees will receive screening tests and online health assessments to identify risk factors and it will “set a baseline for improvement” and map their health metrics.

Employers will receive biometric data about the health of their employees and “a complete communications package for promoting the program and enforcing compliance.” Their package can also be incorporated with corporate wellness programs, disease management and health coaching. This company’s health management partners that are not named on its website.

On February 20^th, however, the company issued a press release announcing $2.5 million in financing from venture capital firm, Great Pacific Capital, run by the founder of Fastclick (which is said to install spyware onto computers and install itself onto computers “and does considerable harm to its security and privacy”). This managing partner now sits on the BioIQ board. The company’s spokesperson said it plans on expanding its biometric screening and wellness management to corporations and directly to consumers. In a March 6^th interview with the co-founder, president and CEO of the company, said their company was founded in 2005 and their screenings use “evidence based medical protocols.”

BioIQ is part of National Corporate Wellness, a collaborative of wellness, health risk assessment, diet and weight management, and alternative (CAM) companies, that includes Welcoa (Wellness Council of America), Real Living Nutrition Services (an online weight loss program), and Health Action (an integrative-alternative medicine wellness company offering circle of life wellness coaching and coach certifications). National Corporate Wellness president is Michael G. Framberger, author and creator of the Get Happy, Get Healthy, Be Wealthy system, and who certifies wellness agents.

Preventive health and “wellness,” and lifestyle medicine is the latest health field. It’s a lucrative $50 billion market rife with fringe but short on sound science or proven benefits for us.

* Background information on commercial genetic screening and profiling here and here, surveillance and reporting here, and how your biometric information can be used here and here. Another company pairing health risk assessments with biometric data, and the scientific and ethical issues, covered here.

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

The sneak attack

The President of the Citizens’ Council on Health Care, Twila Brase, RN, just issued an emergency notice that may be of interest to JFS readers who’ve been following the legislation in Minnesota [background here] to allow the State to take DNA from every newborn to store in its genomic biobank and share with genetic researchers without parental consent, or in adulthood without the person’s consent.

Here is what she reports:

The Sneak Attack

The "DNA Warehouse" bill passed the MN House and the MN Senate and is on its way to the Governor. The vote came out of the blue this afternoon. There wasn't a published version of the bill for the public. And the conference committee hearing hadn't even been published. The "big guns" showed up: the Commissioner of Health Dr. Sanne Magnan came to the State Capitol and seemed to spend most of her time trying to convince Republicans to vote for the bill. CCHC tried to talk to these legislators afterwards. There were 7-8 lobbyists from the Health Department, the March of Dimes, and others gathering around each legislator. On the House floor, Reps. Tom Emmer and Mark Olson said all the right things during the debate. They accurately said what the bill would do to current informed consent rights. Rep. Paul Thissen, the House author, even admitted that informed consent was being eliminated. Yet the bill passed.

The Senate passed the bill 51 - 12.

The House passed the bill 103 - 29.

She urges those concerned about Governor Pawlent’s decision, to contact him to veto SF 3138:

Telephone: (651) 296-3391 (if the phone is busy, call again. Try all night if necessary)

Toll Free: (800) 657-3717

Facsimile: (651) 296-2089

E-mail: tim.pawlenty@state.mn.us

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

When fears hurt: Measles are making a come-back

History may be one of the most important school subjects because forgetting its lessons can lead us to repeat the most costly and deadliest mistakes. Medical professionals reading the news over recent months can only watch in dismay as scares, soundly and repeatedly debunked by good science, have led parents around the world to not vaccinate their children. Before immunizations, about 500 children in the United States died each year of measles alone and others were left permanently disabled, while their parents could do nothing to prevent it. Vaccinations virtually eliminated such tragedies.

The latest issue of the CDC’s Morbidity and Mortality Weekly Report, says that measles had declined to fewer than 150 cases by 1997. “Before introduction of measles vaccination in 1963, approximately 3 to 4 million persons had measles annually in the United States; approximately 400-500 died, 48,000 were hospitalized, and 1,000 developed chronic disability from measles encephalitis,” the editors wrote.

Measles transmission had been declared eliminated in the U.S. in the year 2000, with a mere 62 cases a year during 2000 to 2007. However just between January and April 25^th of this year, already 64 cases have been reported. Measles is making a come-back.

All but one of the children with measles had been unvaccinated or had undocumented vaccinations. Eight out of ten of those cases had been contracted through people traveling abroad. Virtually all cases this year have occurred among children whose parents claimed vaccination exemptions for personal beliefs, according to the CDC.

It might be easy to think we don’t need vaccines anymore, but we forget that in other parts of the world outbreaks of polio, diphtheria, measles and whooping cough are still occurring. About 20 million cases of measles occur worldwide, killing about 242,000 children every year, according to the CDC. With more people traveling, it’s increasingly easy to import them along with our frequent-flyer miles. Dozens of measles cases are imported to the U.S. from abroad each year, threatening the health of unvaccinated children and others for whom the vaccine was not effective.

Dr. Lance Chilton, M.D., professor of pediatrics at the University of New Mexico and an Albuquerque pediatrician for 31 years said, “each time immunization rates have dropped in developed countries, such as England, Sweden, Japan and the U.S., they’ve had a rapid and dramatic increase in disease and deaths.”

In just the past three months, we’ve learned of 1,424 cases of measles and 126 deaths in Niger, most victims were children between one and three years old. The director primary health care, Dr. Mohammed Usman, said that the cases were from parents rejecting routine immunizations, with the highest mortality rates in Kontagora emirate, where parents have most rejected the vaccines.

In Tokyo where vaccination rates are low, 5,821 people, mostly young people, have come down with measles as of April 13^th this year. A major vaccination effort has been initiated on campuses.

Last weekend, seven cases of measles were diagnosed in Grand County of central Washington state, with eight others two weeks prior. All 15 of the children had been unvaccinated, according to public health officials.

In Switzerland, which has a vaccination rate of 78 percent, more than 2,500 measles cases have occurred since 2006, said pediatrician Dr. Henry de Give. In Israel, there have been 1,000 cases, he said.

In Tucson, Arizona, 20 confirmed cases of measles have been reported since February, with more than a dozen new cases now under investigation, including at several day cares.

Today, we learned of eights cases of measles just confirmed in Petersborough, Canada, with another two still being investigated, and a total of 36 cases in Ontario.

The number of measles cases in the UK increased more than 30% last year to the highest levels since records began in 1995. Most of the cases were in children under age 15, according to the Health Protection Agency, with most where vaccinations are low or picked up during travels.

The real source of this surge in measles outbreaks, said Dr. Scott Gottlieb, M.D., in the New York Post, are growing but groundless fears over the safety of vaccines, especially “flawed ideas about...the purported link to thimerosal.” But every expert review of the evidence has found “absolutely no causal link between autism rates and the amount of thimerosal children received.” Since 2001, he adds, “thimerosal has been removed from or reduced to trace amounts in all vaccines routinely recommended for children 6 and younger (with the exception of inactivated influenza vaccine).”

Because vaccines are given to millions of otherwise healthy children, he said, safety problems could have devastating consequences. That’s why, “vaccines are among the most closely scrutinized and carefully regulated health-care products on the market. But that reality, and reams of the scientific evidence, isn't enough to quell fears.”

The recent fears and evidence surrounding these fears were covered here.

An ER nurse recently wrote a heartbreaking account of a 9-month old baby who died despite all efforts to save him. His mother had chosen not to vaccinate him, she wrote, and had brought him in after her naturopath had failed. “Anyone who has ever watched a child die or become permanently disabled from a preventable illness supports vaccination,” she concluded. It and her readers’ comments, many nurses working in the front lines, are worth reading.

Making sound decisions about risks and what’s best for our children can be hard, especially when we get caught up in fears. As Dr. Chilton said, “nothing we do is ab