Junkfood Science: May 2008

May 31, 2008

Loophole Part Two: The canary in the mine?

Part One here.

Should failings in the integrity of science and evidence-based clinical guidelines matter, regardless of the popularity of their proposals? Or, do we look the other way because we don’t want to appear to be endorsing politically incorrect unhealthy behaviors? Do the ends ever justify the means if it’s at the expense of science or lives?

How would you feel upon learning that an expert panel that had written clinical care guidelines issued by the Department of Health and Human Services had been commissioned and funded by a group which held the bulk of shares in the pharmaceutical companies whose products it had recommended as mandatory first-line treatment for all patients with this condition, and that the chairman and most of the hand-selected members of this expert panel had extensive financial interests with those same companies?

Do you feel it’s okay for clinical guidelines to be written by those who stand to benefit from their own recommendations? Or, do you feel that such financial connections should at least be disclosed?

How would you feel to further learn that the research and efficacy of the drug advised by this panel had been called into question by other medical professionals, had been linked to more adverse events than any other drug, and that the FDA had even issued public health advisories because of severe adverse effects with the drug? Would you still feel that you could trust the objectivity of these experts and their interpretation of the evidence? As a healthcare professional, would you want to be in the position of having to follow those clinical guidelines?

As has been repeatedly said by those behind the war on obesity, it would be tackled just like smoking by convincing the public that it is such a threat to society and so repulsive that the tiniest exposure is dangerous and intolerable. (We’ve moved from the era of Fred Astair to now hearing statements that even a brief whiff of second-hand smoke causes permanent heart disease. The soundest science is probably in between, given that the fundamental principle of toxicology is ‘the dose makes the poison.’) As the Washington Post wrote last week in the article, “Like smoking, like obesity,” the strategies used in the campaign against smoking could serve as a blueprint for anti-obesity initiatives.

Of course, no medical professional would recommend most people take up smoking for their health. That’s not what this situation is about. Smoking has come to be seen so negatively, though, that surprisingly little attention or concern has been given to conflicts of interest behind the clinical care guidelines for tobacco use issued by the HHS, even as it appears people are being hurt. Regardless of what you may personally believe about smoking, improper science and conflicts of interest, and a system that encourages and allows such breaches, should concern all of us... as we could be next.


Pharmaceutical treatments

Last November 20, 2007, the Food and Drug Administration had issued an Early Communication, warning the public and healthcare professionals that it was investigating serious adverse events from the drug, Chantix (varenicline), a drug made by Pfizer and marketed to help smokers quit. The FDA said it had received reports of “changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior” among users and had asked Pfizer to “elevate the prominence of this safety information to the warnings and precautions section of the Chantix prescribing information, or labeling.” [No specific mention of FDA issued warnings was found on the Chantix website.]

On February 1st, the FDA issued a formal Public Health Advisory and a Medwatch alert, warning consumers and healthcare professionals about safety concerns with this drug, which it updated on May 16th. By the end of the following week, the Federal Motor Carrier Safety Administrations had banned commercial driving licenses for anyone on Chantix and the Los Angeles Times published an investigative story on Chantix linked to dozens of highway traffic accidents. It profiled perfectly healthy people suddenly having seizures, losing consciousness and running their cars off the road (including a young man with his girlfriend and baby who found themselves in a murky river); and reported thousands of serious reactions involving Chantix had been reported to the FDA, including suicides.

In fact, according to a full report issued to the FDA from the Institute for Safe Medication Practices, which describes the adverse reactions in detail, this smoking cessation drug is associated with more serious adverse event reports than any other drug. “In the 4th quarter of 2007, varenicline accounted for 988 serious injuries in the U.S. reported to the FDA, more than any other individual drug in this time period. By comparison the FDA received a median of 5 reports of serious injury” apiece for other drugs. In the U.S., 78 deaths were reported “in which varenicline was the principal suspect drug,” the report also found. While this doesn’t prove causality, this large number of cases in real-life settings warrant immediate safety concerns and it recommended doctors and patients exercise caution. [For those unfamiliar with the ISMP, since 1975, it’s been the country’s only nonprofit organization devoted solely to medication error prevention and safe medication use, and is funded only by charitable donations.]

As doctors who’ve examined the research have cautioned, the safety profile for Chantix is incomplete as it’s a relatively new drug with only short-term trial evidence. While it appears somewhat better than other cessation interventions, “it appears to have more risk,” according to Dr. Sidney Wolfe, M.D., with Public Citizen. “That part of the risk-benefit equation is missing, and it’s changing rapidly,” he told Associated Press. As AP reported:

Lois Biener, a researcher of tobacco use and control efforts at the University of Massachusetts in Boston, said most people who quit do so without smoking-cessation drugs. There's little evidence that these drugs are superior in the long run to quitting without help, and while a few studies have shown some benefit, it's “way less than what is claimed” by medication advocates, Biener said.

Since September 2007, the Public Citizen has been warning the public not to use Chantix. The May 2008 issue of the British Drug and Therapeutics Bulletin also reported concerns about the psychiatric complications with Chantix, saying that the “marketing claims of a ‘favourable safety and tolerability profile’ are questionable.”

Suzanne Danforth, writing in SeaCoastOnline, described the controversy surrounding this drug and the various theories being advanced how it could be responsible for so many systemic reactions, from suicidal impulses to heart attacks and diabetes. As she explained, there are no “nicotine receptors” in your brain. So, this drug is believed to block all of your pleasure receptors, and those resulting warm fuzzy chemicals that allow our sense of contentment and pleasure, “whether it comes from kissing your kid or smelling a flower or smoking tobacco.”

“[W]hy wouldn't the world turn gray and dispiriting? But how to account for aggression, psychosis, heart attacks, diabetes?” Perhaps, she said, brain chemistry is more complicated and there’s a delicate balance that influences everything in our body and our interactions with the world. For now, the science isn’t known and “we’ll just have to use our common sense.”


New HHS clinical care guidelines

Yet, despite even the FDA communications and numerous medical concerns raised in the medical community since last year, the HHS just issued the new smoking cessation Clinical Practice Guidelines, “Treating Tobacco Use and Dependence, 2008 Update” ... which specifically recommends Chantix.

According to the guidelines, the use of medications should be encouraged for all patients (except where medically contraindicated, such as pregnant women) attempting to quit smoking. The “seven first-line medications” include: Bupropion SR, Nicotine gum, Nicotine inhaler, Nicotine lozenge, Nicotine nasal spray, Nicotine patch, and Varenicline (Chantix). Chantix is given its highest recommendation, an “A=Strength of Evidence.”

This update differs from the original 1996 and the 2002 versions of these clinical guidelines, specifically in highlighting and emphasizing more medications as being effective (including both controversial over-the-counter and this prescription drug). According to this update, pharmacological tobacco dependency treatments, especially when combined with counseling, are “both clinically effective and highly cost-effective.”

The guidelines also note that in 1997, only 25% of managed care health plans covered tobacco dependence treatment, but 90% offered coverage by 2003, adding weight to the impact of these guidelines. This provides extra incentives for recommending covered treatments.

Anytime we encounter research or guidelines that appear to depart from the strength of the scientific evidence, we turn to those financial disclosures to better understand what might have influenced the conclusions. In Appendix A of the 2008 clinical guidelines (page 223), the financial disclosure section specifically notes that all of the panelists were required to complete exhaustive disclosures in accordance with those ORI policy regulations. It reveals that 9 of the 24 members on this expert panel have received pharmaceutical moneys, most of which stand to benefit from the clinical guideline recommendations. The chair of the panel, Michael Fiore, M.D., is listed as having no financial interests, but, as has been reported, such as Kevin Hilliker’s article in the Wall Street Journal, Dr. Fiore oversees an academic center that is funded in part by drug companies that make smoking cessation products and “he personally has received tens of thousands of dollars in speaking and consulting fees from those companies.”

According to Dr. Fiore’s testimony on May 9, 2005 in the Department of Justice tobacco lawsuit: “GlaxoSmithKline gave a grant to the University of Wisconsin that established a chair for the treatment of tobacco dependence. That donation by GlaxoSmithKline was to the University. Named chairs at the University of Wisconsin provide the person who sits in that chair to access to the revenue generated from the investment on the initial grant. So in this instance, I have access to up to $50,000 per year to support my University approved and sanctioned educational, research, and policy activities.” He also stated: “Over the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year.”

The 18-member panel that developed the earlier 2000 guidelines had also been headed by Dr. Fiore. “He and at least eight others on it had ties to the makers of stop-smoking nicotine,” wrote Hilliker. However, looking at the actual financial disclosure statements in the earlier 2000 guidelines, I count 13 with extensive pharmaceutical connections, including those reported by the chair. [See below*.]

For those unfamiliar with smoking cessation products, here’s a quick overview. GlaxoSmithKline is one of the world’s largest over-the-counter product companies and distributes the leading smoking cessation products: Nicoderm CQ, a nicotine patch; Nicorette gum; and Commit, the only approved nicotine lozenge. Pfizer is the manufacturer of Nicotrol, a nicotine patch, as well as Chantix. Johnson & Johnson’s family of companies includes the ALZA Corporation which developed NicoDerm CQ and Clear NicoDerm CQ nicotine patches; McNeil Consumer Healthcare which manufactures the Nicotrol nicotine patch, licenses sales of Nicoderm nicotine patches and Nicorette gum, and markets the Nicotrol inhaler; and McNeil Pharmaceuticals which markets Nicotrol nasal spray. J&J’s nicotine products, alone, bring in $500 million a year for the company. In June 2006, J&J bought Pfizer's Consumer Healthcare business for $16.6 billion dollars, which includes the entire Nicorette line of smoking cessation products. [Readers may remember that, as of 2006, RWJF held 55,983,308 shares of J&J common stock, valued at $33.4 billion dollars.]

Dr. Michael Siegel, M.D., a professor at Boston University School of Public Health who specializes in preventive medicine and public health, and whose research focus has been on smoking and the health effects of second hand smoke, wrote of these conflicts:

While there is room for debate about issues such as whether Chantix should still be prescribed for smoking cessation and about whether a pharmaceutical-based or a cold turkey-based approach would be more effective for smoking cessation on a population level, what I don't think there is room for debate about is whether decisions about these issues should be made for the nation by experts who have severe financial conflicts of interests with Big Pharma.

While having experts writing clinical care guidelines who also have connections with the very drug companies whose products they are recommending is disturbing, regardless of the health issue, if we stop here, we miss even more serious issues raised in this incident: that greater potential influences come from nonprofits.

RWJF isn’t just the largest funder of anti-obesity programs and legislation efforts, but anti-tobacco, too. Yet, being a foundation, it’s not only exempt from taxes, it doesn’t have to file disclosure reports required of other lobbying organizations. Going down the list of members on the 2008 expert panel that developed the tobacco clinical guidelines, finds 15 members with extensive ties and funding from RWJF, including a number serving on a variety of RWJF programs such as Prescribe for Health (advances behavioral counseling interventions for tobacco cessation and obesity), Addressing Tobacco in Managed Care (working to get smoking cessation products and interventions covered by healthplans), Smoke-free Families, and its Smoking Cessation Leadership Center.

To get an idea of the significance of these ties, Susan Curry, for example, is director of smoking cessation programs at the University of Illinois in Chicago which has received active grants from RWJF of $2,996,867 in 2005-2008 and $1,240.783 for 2007-2009. Her university program was also awarded an $8 million, 4-year grant from RWJF in 2003 for a smoking cessation program. She’s also served on the Board of the American Legacy Foundation (a lead agency for the 2008 guidelines) which received a $720,000 grant from RWJF for smoking cessation programs.

According to the University of Wisconsin’s website, Dr. Fiore founded and has served as director of the University of Wisconsin Center for Tobacco Research and Intervention (UW-CTRI) since it was established in 1992. He is also co-director of the RWJF national program, Addressing Tobacco in Managed care. In 2003, RWJF awarded UW-CTRI, with Fiore as project director, $300,000 to translate tobacco dependence research into policy. Another $400,000 was granted in 2005 to evaluate a national quit line. RWJF granted another $400,000 from 2005 through July 2008 to build a network to fund tobacco-related research. In September, 2007, RWJF granted $99,316 to increase Medicaid recipient demand for tobacco dependence treatment. And in December 2007, Dr. Fiore and UW-CTRI was granted $100,000 to update, test and disseminate the 2008 tobacco clinical guideline.

Yet, he and the other panelists didn’t see this money as a conflict and didn’t recuse themselves from serving on the clinical guidelines panel. But, there are not required to even disclose these financial interests.

What you may have realized is that not only these latest clinical guidelines, but the 1996 and 2000 versions, were co-sponsored by RWJF, as is described on its website and the Executive Summary of the guidelines themselves. RWJF also funded numerous grants to disseminate the guidelines, established and funds the Addressing Tobacco in Managed Care program, and assembled the expert panel members developing the clinical guidelines. “Seventeen of the 18 panel members who developed the original Guideline reconvened to produce the update,” said RWJF. “The final version was sent to RWJF” before being “submitted to the US Public Health Service” for publication. Also, the “University of Wisconsin Comprehensive Cancer Center paid the project director's salary [Dr. Fiore] during part of the project.”

We are so quick to condemn ties to pharmaceutical companies, but when even stronger financial connections and potential influences come through a foundation or nonprofit professional organization tied to a pharmaceutical company, those go unquestioned. This leaves open any pharmaceutical company or special interest to be able to buy influence and weaken the integrity of science and medicine simply by setting up a nonprofit or working through one. You may not think that this example has influenced the public messaging about the deadliness of cigarettes or that this applies to you. But it does. It illustrates that the groundwork has been laid to make it possible for stakeholders to influence clinical practice guidelines for obesity and other preventive health measures, as well as the public policies that follow.

If you feel that financial disclosures are important for helping to preserve the integrity of science and evidence-based medicine and public health policies, then financial disclosure statements should include all moneys, including those from nonprofits.


© 2008 Sandy Szwarc


* Clinical Practice Guideline Treating Tobacco Use and Dependence
U.S. Department of Health and Human Services, Public Health Service
June 2000

Appendix C: Financial Disclosures for Panel Members, Consultants, and Senior Project Staff

Panel Members

Michael C. Fiore has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil, Elan Pharmaceutical, and Glaxo Wellcome.

William C. Bailey has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Glaxo Wellcome, SmithKline Beecham, Schering-Plough, 3M Pharmaceuticals, Pfizer, and Sepracor.

Stuart J. Cohen has not served as a consultant for, given lectures sponsored by, or conducted research sponsored by any pharmaceutical company.

Sally Faith Dorfman has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by various pharmaceutical companies.

Michael G. Goldstein, in addition to being an employee of the Bayer Corporation, has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Glaxo Wellcome, McNeil, Ciba-Geigy, SmithKline Beecham, Boehringer Ingelheim, Sano Corporation, Dupont Pharmaceuticals, and Eli Lilly.

Ellen R. Gritz has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Bristol Myers Squibb, SmithKline Beecham, and Glaxo Wellcome.

Richard B. Heyman has not served as a consultant for, given lectures sponsored by, or conducted research sponsored by any pharmaceutical company.

Carlos Roberto Jaén has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Glaxo Wellcome Pharmaceuticals.

Thomas E. Kottke has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by McNeil Consumer Healthcare.

Harry A. Lando has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Glaxo Wellcome and SmithKline Beecham.

Robert Mecklenburg has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by SmithKline Beecham and GlaxoWellcome.

Patricia Dolan Mullen has not served as a consultant for, given lectures sponsored by, or has conducted research sponsored by any pharmaceutical companies.

Louise M. Nett has not served as a consultant for, given lectures sponsored by, or conducted research sponsored by any pharmaceutical company.

Lawrence Robinson has not served as a consultant for, given lectures sponsored by, or conducted research sponsored by any pharmaceutical company.

Maxine L. Stitzer has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by McNeil and SmithKline Beecham.

Anthony C. Tommasello has not served as a consultant for, given lectures sponsored by, or conducted research sponsored by any pharmaceutical company.

Louise Villejo has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ortho Biotech.

Mary Ellen Wewers has not served as a consultant for, given lectures sponsored by, or conducted research sponsored by any pharmaceutical company.


Consultants

Timothy Baker has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Elan Pharmaceutical, SmithKline Beecham, Glaxo Wellcome, and Lederle.

Victor Hasselblad has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by CorTheraputics, Skinceuticals, Merck, Novartis, AstraZeneca, AstraCharnwood, The Medicines, Pfizer, Daiichi, Hoffman-LaRoche, RhonePolenc Rorer, Alexion, SmithKline Beecham, Dade, Quad-C, and Centocor Lilly.

Marc Manley has not served as a consultant for, given lectures sponsored by, or conducted research sponsored by any pharmaceutical company.

David L. Schriger has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Pfizer Corporation and the MedAmerica Corporation.

David W. Wetter has not served as a consultant for, given lectures sponsored by, or conducted research sponsored by any pharmaceutical company.


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May 30, 2008

Loophole Part One: Who is writing clinical care guidelines and public health policies?

While financial disclosures don’t guarantee that research or conclusions of researchers are sound, they are invaluable in helping to alert us to potential biases that might have influenced the findings. Their role in helping to promote the integrity of medical research, as well as deter and detect misconduct, is so important that the Office of Research Integrity at the U.S. Department of Health and Services has made financial disclosures mandatory for all institutions receiving public funds. Most medical journals and expert committees setting clinical care guidelines also follow these financial disclosure regulations.

But there’s a major loophole in these financial statement requirements that you’ll want to understand because it can explain why we too often read research conclusions that depart radically from sound science, but are written by authors declaring no conflicts of interest... when a closer look can find that the most significant financial interests didn’t have to be reported.

Before describing how this discovery came about, the changes that have taken place in the agencies creating clinical care guidelines and health policies that have opened the door to greater abuses of this loophole, and recent examples of why this matters, let’s skip to the ending first.


Office of Research Integrity defines financial disclosures

In March of 1989, the U.S. Public Health Services created the Office of Scientific Integrity at the office of the National Institutes of Health director’s office and the Office of Scientific Integrity Review at the Assistant Secretary for Health’s office. These two offices were combined in 1992 into the Office of Research Integrity (ORI) at the HHS. This office oversees allegations of research misconduct at some 4,000 institutions that receive government agency funds for research. Since 2000, this office has also worked to educate and train investigators in the responsible conduct of research and to prevent misconduct in research and research review programs. It is also the source of disclosure regulations.

Federal regulation 42cfr50 specifically applies to financial interests and disclosure statements. Investigators are required to report ‘significant financial interests’. What that means, as with everything, is a matter of how it’s defined. These definitions have also been adopted by most professional publications and organizations. While reading this ORI policy definition, pay particular note to the financial interests excluded from required disclosures: According to the ORI financial disclosure policy:

Significant Financial Interest means anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights).

The term does not include:

(1) Salary, royalties, or other remuneration from the applicant institution;

(2) Any ownership interests in the institution, if the institution is an applicant under the SBIR Program;

(3) Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;

(4) Income from service on advisory committees or review panels for public or nonprofit entities;

(5) An equity interest that when aggregated for the Investigator and the Investigator's spouse and dependent children, meets both of the following tests: Does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a five percent ownership interest in any single entity; or

(6) Salary, royalties or other payments that when aggregated for the Investigator and the Investigator's spouse and dependent children over the next twelve months, are not expected to exceed $10,000.

In other words, money from nonprofit foundations and professional organizations don’t have to be reported. Nor do salaries, grant funding or other financial benefits that come to researchers through their institutions or university programs. This is the first crucial point.


Changing role of USPSTF and clinical guidelines

The next key point is that changes have taken place at the U.S. Preventive Services Task Force and the Agency for Healthcare Research and Quality. Since its creation in 1984 by the HHS, the USPSTF has been seen as the leading source for objective, systematic reviews of medical research and advice to medical professionals on the evidence for various preventive healthcare measures. Its reviews of the evidence have also become integral to public health policies and initiatives, performance measures and public funding advanced by AHRQ, an arm of the HHS and National Institutes of Health.

The very first USPSTF panel consisted of 20 nonfederal experts, including 14 doctors, a dentist, nurse, researcher, educator, economist and sociologist. In other words, they had broad expertise in research methodology and medicine to allow them to address a range of topics “and to lessen the potential for conflicts of interest in any given issue,” according to a historical review of the USPSTF and the evolving role of preventive health, written by Steven H. Woolf, M.D., MPH. and David Atkins, M.D., MPH.

The USPSTF’s first Guide to Clinical Preventive Services was published in 1989 and evaluated 169 screening and preventive interventions. This first guide helped to establish the credibility of the USPSTF and support for evidence-based medical reviews. But its strict approach drew heated criticism from certain groups which ardently advocated services which the USPSTF found unsupportable. Its neutral position when evidence was lacking drew complaints for eschewing the opinions of experts as a basis for making its recommendations, said Woolf and Atkins.

When the USPSTF reconvened in 1990 to write its 1996 guide, this time its work was marked by stronger ties with both federal and nongovernmental partners, including various professional societies and foundations, said Woolf and Atkins. By the time of this second edition, the medical environment had also changed dramatically, and managed care was the dominant force for the delivery and paying of healthcare. In this cost-containment focus of managed care, its recommendations would have a greater impact and importance to purchasers, health plans and policy makers, they said. The USPSTF guide would be used by these interests to defend their health maintenance programs and benefits packages. Its recommendations also became part of HEDIS (Health Plan Employer Data and Information Set) “quality measures” (performance measures) developed by the National Committee on Quality Assurance for evaluating health plans.

“At the same time, specialty societies and professional organizations that had reorganized and invested in the early 1990s to establish their own practice guideline programs soon found their efforts eclipsed by guidelines developed by commercial vendors and sold to health plans and hospital systems with the promise of lower health care costs and lengths of stay.”

There was also tremendous promotion and commercial advertising among consumers for “healthy lifestyles” which had helped to create an interest among the public “in low-fat diets, exercise and weight management,” they explained. These intense preventive health campaigns had also led to new screening technologies and tests promoted heavily by celebrities and national organizations. “Health plans, in turn, recognized that including comprehensive health promotion and disease prevention was a valuable marketing tool for attracting patients.” Preventive health was becoming big business and a fiercely competitive market. In response to this need, the USPSTF was also tasked to create a Guide to Community Preventive Services, targeting communities and healthcare systems, rather than individual patients, with funding from RWJF to the American College of Preventive Medicine to promote the USPSTF strategies.

“By 1996, the enthusiasm for clinical practice guidelines and for evidence-based medicine had been tempered by a realization of their attendant practical and political challenges,” they wrote. Cost considerations took equal importance to quality care. Financial and political interests were also leading to re-examinations of the role of the USPSTF, as well as that of the Agency for Health Care Policy and Research (renamed AHRQ in 1999) in its role of developing guidelines and policies based on the USPSTF recommendations.

As experience with evidence-based guidelines grew, their shortfalls and limitations were becoming better recognized, including unintended harm, according to Woolf and Atkins.

By the time the third USPSTF was convened in 1998 to update the recommendations of the second Task Force, the Task Force members were selected differently, and were now chosen from nominations by national and specialty organizations.

The role of the AHRQ in developing guidelines changed the most. Congress redirected the AHRQ to not sponsor the development of guidelines, but to support the production of information to be used by outside partners, such as professional societies, who could in turn interpret it and develop guidelines and policies. The AHRQ established a network of 12 practice centers at universities and private organizations to produce reviews for the USPSTF and provide it with reports summarizing the evidence for specific preventive care interventions. These outside technical reports would then serve as the basis for brief summaries and recommendations from the USPSTF.

In other words, while clinical practice recommendations still officially come from the USPSTF and the Department of Health and Human Services, they are actually developed and written by outside centers. We can feel the growing influence of politics and stakeholder interests.

There are now “close relationships” between these academic centers, federal health agencies and professional organizations, which regularly attend Task Force meetings and provide draft review documents, explained Woolf and Atkins. This helps to ensure that “consensus is achieved when the position is supported by evidence.”

For the scientists reading, you’ve no doubt realized that this is now a different USPSTF than you’ve come to know. Consensus among private-public stakeholders is not the work of science. Consensus embodies compromise, after negotiations among various interests, rather conclusions based solely on the most rigorous, objective evidence. Dr. Michael Crichton, M.D., explained it best in his famous 2003 speech at the California Institute of Technology:

I regard consensus science as an extremely pernicious development that ought to be stopped cold in its tracks... Whenever you hear the consensus of scientists agrees on something or other, reach for your wallet, because you're being had. Let's be clear: the work of science has nothing whatever to do with consensus. Consensus is the business of politics... In science consensus is irrelevant. What is relevant is reproducible results...

There is no such thing as consensus science. If it's consensus, it isn't science. If it's science, it isn't consensus. Period.

The AHRQ also established the National Guideline Clearinghouse in 1998, in partnership with the American Medical Association and the American Association of Health Plans (now called America’s Health Insurance Plans, the trade and lobbying organization for health insurance companies). The National Guideline Clearinghouse provides public internet access to help distribute hundreds of clinical practice guidelines, not just those from the USPSTF. It includes clinical guidelines produced under the auspices of medical associations, professional societies, public or private organizations, government agencies, or healthcare organizations or insurance plans. Healthcare professionals must now closely evaluate the source for each of these dissimilar guidelines, even though they are found through the AHRQ.

The Woolf-Atkins paper made its most critical revelations when it described the “final frontier of preventive medicine.” It was referring to implementing the USPSTF clinical recommendations. As the authors wrote:

Practice guidelines are relatively weak tools for changing clinical practice... To effect change, guidelines must be coupled with strategies to improve their acceptance and feasibility. Such strategies include enlisting the support of local opinion leaders, using reminder systems for clinicians and patients, adopting standing orders, and audit and feedback of information to clinicians about their compliance with recommended practice. In the case of preventive services guidelines, implementation needs to go beyond traditional dissemination and promotion efforts to... ensure the delivery of recommended preventive care.

As they explained, factors other than scientific evidence shape public health policies. State legislatures, for example, have mandated screenings that the USPSTF hasn’t recommended. So, they said, a number of efforts have been put into place to “increase the impact of future USPSTF reports.” As they added:

The USPSTF convened representatives from the various audiences for the Guide — clinicians, consumer, and policymakers from health plans, national organizations and Congressional staff — about how to modify the content and format of its products to address their needs. With funding from the Robert Wood Johnson Foundation, the USPSTF and Community Guide Task Force [its Guide to Community Preventive Services was also funded by RWJF] conducted an audience analysis to further explore implementation needs...

National efforts such as the USPSTF face inherent limitations in trying to influence practice in individual physicians'offices. To be successful, approaches for implementing prevention have to be tailored to the local level and deal with the specific barriers at a given site, typically requiring the redesign of systems of care. Such a systems approach to prevention has had notable success in established staff-model health maintenance organizations, by addressing organization of care, emphasizing a philosophy of prevention, and altering the training and incentives for clinicians. Staff-model plans also benefit from integrated information systems that can track the use of needed services and generate automatic reminders aimed at patients and clinicians, some of the most consistently successful interventions. Information systems remain a major challenge for individual clinicians' offices, however, as well as for looser affiliations of practices in network-model managed care and independent practice associations, where data on patient visits, referrals and test results are not always centralized.

The door has been opened for special interests to fund and influence university and outside technical reviews to benefit their interests. The focus is no longer solely on providing healthcare professionals with careful reviews of the evidence. Compliance with those clinical guidelines is being made increasingly obligatory through performance measures and surveillance of electronic medical records. The sources of such funding and potential conflicts of interest, however, don’t have to be disclosed by the researchers when it comes to them through salaries or grants to their various universities and institutions. And they don’t have to disclose funding from nonprofit groups.

Finally, Woolf and Atkins described the inevitable tensions that result when translating the USPSTF recommendations to care provided by doctors in a variety of settings and situations. While one approach might be for the USPSTF to merely describe the quality of supporting evidence for specific situations and leave it up to healthcare professionals to apply appropriately, they said, feedback from stakeholders had clearly indicated they want the USPSTF to state explicit recommendations, that can be enforced.

For preventive care interventions without sufficiently robust evidence for the USPSTF to make evaluate and make conclusions about the benefits versus harms, some want the USPSTF to avoid making recommendations and leave it to clinicians to review the trade-offs with their patients. But, these authors suggested, “the USPSTF has a duty to proffer what that advice [to patients] should be.” Remembering that these guidelines are increasingly being used by healthplans and government agencies no longer as guides, but as mandates for healthcare providers, doctors may find this statement particularly troubling.

Which leads to their final insights. “The Partnership for Prevention convened a panel to develop methods for prioritizing services,” they wrote. It ranked the preventive interventions recommended in 1996 by the second USPSTF. The findings of the Partnership for Prevention, written with Robert Wood Johnson Foundation, Merck & Co., the AHRQ, Health Partners Research Foundation, American College of Preventive Medicine, CDC, etc. were published in the American Journal of Preventive Medicine and were developed to provide a basis for future priority-setting among policy makers to improve the execution of preventive guidelines.


This month has tied all of this together in what seems an almost surreal turn of events. While the ethics of public health has been in the news recently, some of the hardest questions and their answers aren’t at all popular to examine.

Part Two here, looks at a recent example that tests all of us.


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May 29, 2008

In memory — Rubens with a smile

Her art brought smiles. It depicted a joyfulness of life with its unpretentious, endearing portrayals of real people enjoying everyday things. She was known for the vibrant, fun-loving fat women that cavorted across her paintings. In an era where it’s uncommon to find positive, nonjudgmental images of rounded, unselfconscious people, her artwork captured people’s hearts.

Artist Beryl Cook died today at the age of 81. As the Guardian wrote, she achieved fame for her fun, cartoon-like portrayals of generously proportioned ordinary people and chronicled everyday life with a sympathetic eye. As Alastair Sooke wrote in the Telegraph, her paintings were vilified by art critics as being too sunny to sustain scrutiny. But their popularity with real people was in the exuberance and wit that animated her figures.

You can feel the outpouring of love and the joy her art brought people by the comments made at The Times. “A ray of sunshine in a stuffy self concentrating world, thanks for the humour and laughs and your original view of the world made millions smile,” one wrote.

According to the Sun, she said: "I’m only motivated by people enjoying themselves." The Sun has a video of several wonderful paintings. You’ll find more on her website here that will brighten your day and make you wish for many more.


Hat tip to Mariellen.


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May 28, 2008

The epidemic that wasn’t?

The ‘epidemic of childhood obesity’ is increasingly harder to keep spinning. Each time another report with actual stats and positive health information is issued — facts that shatter any notion of a crisis — it must be buried or spun to try and convince us of a catastrophe.

The latest statistics on childhood overweight from the National Center for Health Statistics at the Centers for Disease Control and Prevention were just published in the Journal of the American Medical Association. They show that since the childhood growth charts were redesigned nearly a decade ago, there have been no statistically significant change in the percentages of young people at or above the 95th percentile (labeled as “overweight” and some are now calling “obese”).

This is significant because prior to 1999, the definition of “overweight” and how it was measured changed, as did surveillance. Even the NHANES surveys were redesigned several times. That makes it especially challenging for the public to readily see what’s happened and exactly how much children have grown. [See Creating an Epidemic.] The last statistical change that helped to accentuate public perceptions of an epidemic was when new child growth charts were issued in 2000, using BMIs rather than heights and weights (instantly placing nearly two-thirds of children in higher percentiles, despite no increase in their actual weights). An epidemic of obesity was declared by Health and Human Services Secretary Tommy Thompson on March 9, 2004, launching an aggressive government campaign and massive funding to address a purported crisis. This was followed in 2005 by the Surgeon General Richard Carmona making the epidemic of childhood obesity a national priority and anti-obesity initiatives went into high gear. Claims of an epidemic of childhood obesity continued even while repeated reports were being issued by the National Center for Health Statistics continuing to show no actual increase in children’s sizes since 1999.

This new report adds the latest data through 2005-2006. The figures are based on the National Health and Nutrition Examination Surveys, which the CDC has gathered from a representative sampling of Americans since the 1960s and are considered the most reliable statistics available. Their findings state:

No statistically significant change in high BMI for age was found between 2003-2004 and 2005-2006. Although the estimate of BMI for age at or above the 95th percentile of the CDC growth charts decreased from 17.1% to 15.5% for children and adolescents aged 2 through 19 years, the change was not statistically significant.

Analyses of the trends in high BMI for age showed no statistically significant trend over the 4 time periods (1999-2000, 2001-2002, 2003-2004, and 2005-2006) for either boys or girls. Results were similar for non-Hispanic white, non-Hispanic black, and Mexican American boys and girls. Trends were not statistically significant for any racial/ethnic group... No statistically significant trend in high BMI for age was found over the time periods 1999-2000, 2001-2002, 2003- 2004, and 2005-2006... Even at the highest BMI for age level no change in prevalence was found between 2003-2004 and 2005-2006, either overall or by racial/ethnic group.

So, the most recent figures show 15.5% of children fall at or above the 95th percentile on the BMI growth charts, labeling them “overweight” (or “obese” depending on the source) — with no real change in nearly a decade.

The authors, Cynthia L. Ogden, Ph.D.; Margaret D. Carroll, MSPH; Katherine M. Flegal, Ph.D.; made a specific point of describing the new CDC growth charts created in 2000 based on BMI for ages that were constructed using population samples of U.S. children in the 1960s, 1970s and 1980s. The arbitrarily selected percentiles, they said, were smoothed out but there was too sparse of data to accurately estimate children below 3rd or above 97th percentiles. Any “extrapolations beyond this range should be done with caution,” they concluded. This is a poignant caution as the bariatric industry attempts to define a new 99th percentile of the largest children to target for bariatric surgeries and lead us to believe their numbers are soaring.

The spin in the media attempting to downplay this report and preserve alarm about an epidemic of childhood obesity has exhibited near desperation as obesity interests frantically scream louder of a crisis. As this JAMA issue was released, Newsweek reported Dean Ornish, M.D. describing the “obesity epidemic spreading like cancer, metastasizing across the country... as though an alien force.” He suggested this latest figure might be just a statistical artifact and went on to describe the leadership of the Robert Wood Johnson Foundation in calling for a needed “social movement like none other” to change every aspect of our societal environment to reverse the epidemic of childhood obesity.

Most media has incorrectly reported this study as this being the first time in 25 years that skyrocketing childhood obesity rates have stabilized. The leveling off between 2003-4 and 2005-6 offers the first glimmer of hope, we’ve heard. Media has been similarly quick to report that it’s too soon for optimism or to tell if it’s real. The Associated Press graph appeared to show increases right up to this latest report:

Last night’s health segment on NBC Nightly News with Brian Williams illustrated how vigorously this study’s findings are being downplayed. NBC’s chief science correspondent, Dr. Robert Bazell, said that, as we know from so many reports, the percentage of obese children in this country climbed steadily. Starting in 2006 it is beginning to level off, he reported. “No one is declaring victory,” he said. “This is still a big public health emergency.” It’s possible that all of those public health messages are having an effect, he told viewers, and it’s time to redouble our efforts. Viewers were shown this image of skyrocketing childhood obesity rates:

But, there have been no soaring rates of childhood obesity. Viewers were hoodwinked. Here is what the CDC actually illustrated in JAMA for childhood "obesity" rates among boys and girls since 1999:

A very different picture of an “epidemic,” isn’t it?

It’s easy to be fooled by graphs and illustrations, as was brilliantly described by Darrell Huff in the classic book on statistical reasoning, How to Lie with Statistics. In the chapter, “Gee-Whiz Graphs,” he illustrated how the very same statistics can be graphed to mislead people and appear to give any impression desired.

The past 24-hours, we’ve also heard some suggest that this plateau might be the result of successful anti-obesity programs to limit junk food and increase physical activity in schools. Perhaps things are working, the New York Times reported. We are to believe that childhood obesity programs — all of which have proven to be resounding failures in reducing childhood overweight — are actually successes.

The New York Times cited the Shape Up Somerville program in Massachusetts and the country’s most massive childhood obesity program in Arkansas as examples of successful programs being copied around the country. Never mind that, despite spending millions of dollars, neither actually demonstarted any positive changes in the children’s BMIs or health. We also have to forget that these programs were begun well after childhood obesity rates were already known to be flat.

The New York Times noted what’s probably the truest reason for concern about these latest CDC findings: “One worry is that as obesity rates stabilize, financing for childhood health efforts will wane.” While childhood “obesity” rates haven’t increased since 1999, CDC funding, alone, for "healthy" eating and physical activity programs to combat the nonevidenced epidemic has grown by more than 2,000%.

When will taxpayers call these special interests on their bluff and begin to hold them responsible for the massive amount of public moneys and resources they’ve spent in the name of a childhood obesity epidemic — money that could have gone a long way towards improving educational opportunities and healthcare for children and families? When will the public demand evidence-based public health policies? When will parents hold these obesity interests accountable for the harmful effects of their initiatives and the nonstop weight obsessions that have surrounded their children?


© 2008 Sandy Szwarc. All rights reserved.


Photo: Comedian John Park's Plate Spinning


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May 27, 2008

Public health — a different concept of medical ethics

Monday, while we were commemorating Memorial Day, the Health Law Institute at the University of Alberta, Canada, hosted a seminar titled: “Ethical Obesity Policy: Paternalism, Preference Change & the Good Life.” It illustrates the growing movement to eliminate the distinction between private and public health and redefine medical ethics. Governmental preventive health interventions are increasingly said to be ethically imperative for the collective good of society.

This seminar was given by professor Angus Dawson, a visiting professor from the Centre for Ethics at the University of Toronto. He is the founder of a revival of the field of “public health ethics” and the founder of a new international network and an academic journal by the same name.

Essentially, this philosophy argues that the obesity “epidemic” is such a threat to society and our quality of life, that to be moral and ethical, public health policies and preventive health must act in the name of the common good. Public interests are more important than those of individuals. The government must determine what is best for all, as individuals are incapable of protecting themselves. Society, most importantly, must act on behalf of children. Today’s public health has reached such crisis proportions, the viewpoint goes, that coercive policies that strip away individual freedoms and leave people no choice but to comply with “healthy behaviors” are now justified.

As Dr. Arya M. Sharma, M.D., head of the Canadian Obesity Network, wrote on his blog today: “Dawson's basic thesis was that when it comes to preventing obesity simply providing information does not work, some form or ‘paternalism’ (not to use the term coercion) will be required to help people change behaviours.” That’s because simply providing information on how people should behave to slim down hasn’t worked. People have no choice in today’s environment but to make bad decisions and eat “unhealthy” and drive their cars, according to this philosophy, making it necessary to take collective action for societal changes. Those societal changes are based on the myth that obesity and diversity of body size is a matter of diet and exercise.

“Getting the majority to change their behaviour is unlikely to happen without some form of paternalism, which raises the ethical dilemma of how much individual ‘freedom’ society as a whole is willing to sacrifice for the common good,” wrote Dr. Sharma.

Professor Dawson’s talk was a repeat of the one he gave at the International Society of Behavioral Nutrition and Physical Activity annual conference held this past weekend in Alberta and sponsored by the Canadian Obesity Network. According to the symposium abstract, its focus was aimed at addressing obesity by intervening in lifestyles and changing people’s behaviors — eating and physical activity. As professor Dawson argued:

[G]iven the nature of obesity, we need to employ the resources of public health ethics, rather than medical ethics, to formulate a relevant and coherent ethical framework for policy. Contemporary discussions assume that autonomy is the key ethical principle in policy formation: as a result they focus on the provision of neutral information to consumers with the intention of increasing the likelihood of individuals making informed choices about their lifestyles. However,... if we are serious about tackling obesity this approach will fail, as it, wrongly, assumes... that we ought to respect an individual's existing preferences... an alternative policy (given the relevant facts about the nature and causes of obesity) is proposed. This alternative argues that ethical obesity policy ought to focus on collective interventions, brought about through changes to regulations and features of the environment... individuals will not be able to opt out. The objection that this is unethical because it is paternalistic and imposes a certain view of the good life is rejected.

Conclusions: Obesity policy should prioritise seeking to change people's existing preferences and norms (or influencing the creation of new ones) not the promotion of autonomy.

The take home message from the Thursday session at this international symposium is that allowing individual freedoms and lifestyle choices is unethical and no longer “morally neutral,” given the “severity of the problem.”

This surely scares the willies out of everyone who remembers history.

Your body belongs to the nation! Your body belongs to the Führer!
You have the duty to be healthy! Food is not a private matter!
(German National Socialist slogan, 1937 - 1944)


Dr. James Gault comments at MDredux.


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New Mexico is being irradiated by WiFi?

Once again, the City Different has made news by becoming a source of amusement for the rest of the country. Sadly, this news illustrates the power of our fears when they aren’t balanced by science. As was first reported by KOB-TV, a group of people in Santa Fe, New Mexico, is trying to get the capital city to ban WiFi from public buildings. They claim they are allergic to electromagnetic fields and suffer an array of physical problems when exposed to wireless technology — symptoms that range from headaches to chest pain, “depending on where their weak spots are.” They say that WiFi in public places discriminates against those with their sensitivity and violates the Americans with Disabilities Act.

The story has been picked up by national media from Fox News, USA Today and publications around the country, laughing at the group and the video broadcast. While it may have made entertaining news, it unkindly exploits the handful of people suffering from these misapprehensions. Most lacking has been news of the science to help prevent reinforcing such beliefs and escalating fears among others.

Those who believe they have electromagnetic sensitivities (ES) and other environmental illnesses experience very real symptoms which tragically illustrate how fears and the power of our beliefs can hurt people. Their fears are driven by a string of misunderstandings of what is happening to them.

This local group, calling itself WhyFry?, has a website and last summer set up its own Yahoo discussion group, with 16 members. Their website shows a picture of a microwaved rat brain and they believe that WiFi can fry their brains like a microwave. It’s a fact, their website says, “wifi uses the same frequency as a microwave oven.” They are organizing to stop what they call microwave pollution, saying WiFi is microwaving the entire planet! Wifi, of course, is not microwaving your brain. While the wavelengths are similar to a 2.4 GHz wifi, the wattage is very different. Microwaves put out 800-3,200 Watts, while a wifi base station uses only 0.1 Watts. You are exposed to far more radiation than that from sunshine.

Yet, they are outraged that cell phone towers are now “disguised.” In Santa Fe, they write, “we have a tree cell phone tower, a lamp post cell tower, a church steeple cell tower, water tower cell towers, a smokestack cell tower and cell towers attached to the sides of buildings looking like pipes. Do you know where they all are, or how to protect yourself from them?” Some people are able to shield themselves using the beekeeper headgear like the women featured in the London news last year, according to the group. But, they argue, this fabric is expensive and isn’t completely effective. And the special suits worn by microwave workers in Europe cost thousands of dollars, meaning it’s unfair to subject them to having to resort to that in order to go to public buildings.

The website is filled with a string of scary science-sounding claims and says that “many prominent scientists” in Europe are questioning WiFi’s safety. They believe that WiFi affects their “essential life force” and can harm brains and nervous systems, hearts and even damage DNA. Their spokesperson was shown on the news measuring radiation levels in his house and attributes the symptoms he experiences to the WiFi emanating from his neighbor’s house.

What television viewers, and visitors to their website, haven’t been told is that there is no biological plausability to their fears. Even the famous expert panel established by Sir William Stewart in 1999 to examine the science, found that the balance of evidence shows no adverse health effects from WiFi. The national guidelines set by the National Radiological Protection Board on the maximum levels of exposure to radiation emitted from mobile phones, base stations and other sources are based on a comprehensive review of the scientific literature.

As John W. Farley, Ph.D., physics professor at the University of Nevada, Las Vegas, explained in an article describing the science surrounding fears about radiation coming from electrical power lines, there is no plausible mechanism to link such exposure to cancers and “the verdict from large-scale scientific studies has been conclusively negative, and scientific and medical societies have issued official statements that power lines are not a significant health risk,” he wrote. In short, there is nothing to worry about. In fact, ”power lines produce electric fields inside the human body that are much smaller than the electric fields that normally exist in the body.”

The results of a 21-year study of actual cancer incidences associated with cell phone use were published in a 2006 issue of the Journal of the National Cancer Institute. The Danish researchers examined a large nationwide group of 420,095 people who subscribed to cell phones from 1982 to 1995 and followed their cancer incidences through 2002. They found “cellular telephone use was not associated with increased risk for brain tumors, acoustic neuromas, salivary gland tumors, eye tumors or leukemias.” In fact, while not statistically significant, nearly all of the incidences were lower among cell phone users. As they concluded:

We found no evidence for an association between tumor risk and cellular telephone use among either short-term or long-term users. Moreover, the narrow confidence intervals provide evidence that any large association of risk of cancer and cellular telephone use can be excluded.

The World Health Organization’s position is that “there is no scientific basis to link electromagnetic sensitivity symptoms to electromagnetic radiation exposure” and that electromagnetic sensitivity “is not a medical diagnosis.” Those said to suffer from environmental illnesses, such as electromagnetic sensitivity, most often follow a belief in chi, a vital energy force. But anyone can be taken in by fears that their food, water or air might be contaminated or cause them harm and experience very real symptoms that can even become debilitating. What’s at work is a very well recognized phenomenon known as the nocebo effect. It’s the flip side of the placebo effect and works much the same way. We can become convinced that exposure to even a minuscule amount of a chemical or contaminant can harm our health, just as a minuscule amount of a healing substance can heal - when neither can. The resulting symptoms can be extraordinary and far beyond anything we might ever imagine the power of suggestion could do to us. And when fears of a chemical, threat or exposure are shared among a group of people, the symptoms can spread.

Yes, studies have shown that the symptoms of electromagnetic sensitivity are real. This has been repeatedly shown using the “open provocation” technique with people who believe they suffer from health effects due to electromagnetic fields (EMF) from objects, such as cell phones or other wireless technology. When they know the signal is present (unblinded) and are openly exposed to such triggering devices, they report symptoms. But, when they are blinded and don’t know when the signal is present, they can’t tell and guess no better than chance. In other words, EMF itself is not the source for their symptoms, but the belief is the source. Our minds can convince us of amazing things.

Last year, researchers at the University of Essex in the UK, conducted a double blind study and measured subjective measures of well-being as well as physiological measures of heart rate, blood volume pulse and skin conductance. They found that EMF had no effect on the ES group or the control group when they didn’t know when they were being exposed.

A similar double-blind randomized study published in the British Medical Journal was conducted by doctors at King’s College London, Institute of Psychiatry in London, and led by G. James Rubin, Ph.D. They tested 60 people who reported being sensitive to cell phone signals and experienced headaches, and 60 control participants who didn’t report any such symptoms. The researchers exposed both groups to 900 MHz mobile phone signals, a non-pulsing carrier wave signal and a sham condition with no signal present. The number of ES participants who believed a signal was present during actual exposure (60%) was similar to those who believed one was present during sham exposure (63%). As the researchers explained:

The mean power of the signal in our active GSM condition was over 700 times stronger than that in the sham condition. Given this evidence of a dose-response relationship, it seems reasonable to assume that our active and sham conditions should have elicited very different levels of symptom severity, if GSM sensitivity does indeed have an organic basis.

In other words, if there actually was a biological basis for ES symptoms, then there would have been some indication of more symptoms when exposed to 700 times the exposure compared to none at all. As they concluded:

No evidence was found to indicate that people with self reported sensitivity to mobile phone signals are able to detect such signals or that they react to them with increased symptom severity... psychological factors may have an important role in causing this condition.

Professor Rubin later commented in the British Medical Journal that the body of evidence includes seven other similar blinded or double-blinded provocation studies and “the overall results of those experiments are the same as our own.” As he argued: “While it is possible that different methodological problems have affected each study, a more parsimonious explanation is that there is simply no effect there to be seen.”

In a 2005 issue of Psychosomatic Medicine, the King’s College researchers conducted a systematic review of blind and double-blind provocation studies of electromagnetic hypersensitivity to test if ES people responded with symptoms to the actual presence of EMF as compared to sham exposures with no actual EMF.

They explained that electromagnetic hypersensitivity is a relatively new phenomenon in which sufferers report a range of symptoms in the presence of weak EMF. However, these symptoms show no cohesive pattern and are typified by nonspecific, subjective symptoms such as sleep problems, headaches, fatigue and cognitive problems. Similarly, while there is a list of devices such as mobile phones, computer screens, cell phone base stations, fluorescent lights, overhead power lines and household appliances attributed to their symptoms, there is no consistency in the items sufferers report being sensitive to. Many report only 1 or 2 specific electrical items as being problematic, they wrote, yet the actual EMFs emitted by these devices vary considerably and encompass different frequency ranges. “In almost all cases, however, the intensity of the EMFs that seem to trigger ES symptoms is far below that known to cause physiological changes in animal models.”

Two earlier reviews of the evidence also examined blinded and provocation studies of ES, they described:

In 1997, a report for the European Commission described the results of 13 such experiments and concluded that, although “‘electromagnetic hypersensitive’ people do react in these provocation studies, ...these reactions have not been shown to be related to the fields.” More recently, a systematic review considered the results of 8 experimental studies published in peer-reviewed journals before coming to a similar conclusion.

Their review included only blind or double-blind studies among ES sufferers confirmed under open provocation. Among 31 such experiments involving 725 ES participants, they “could find no robust evidence to support the existence of a biophysical hypersensitivity to EMF.” They compassionately concluded that “complaints of ES may mask organic or psychiatric pathology, whereas others may benefit from a course of cognitive behavioral therapy.”

According to doctors Ronald E. Gots, M.D., Ph.D., and Stephen Barrett, M.D., the most harmful thing we can do is make accommodations that reinforce their fears and beliefs that they are unhealthy, as that will only worsen their symptoms, further isolate them from others and prevent them from receiving the help they might need.

In other words, we do not help people by spreading sensationalized and unsupportable scares or using the sufferings of troubled souls as entertainment. What will most help is to spread the science.


© 2008 Sandy Szwarc


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May 26, 2008

A day to remember

“...gather around their sacred remains and garland the passionless mounds above them with choicest flowers of springtime... let us in this solemn presence renew our pledges to aid and assist those whom they have left among us as sacred charges upon the Nation's gratitude, the soldier's and sailor's widow and orphan.” — General John Logan, General Order No. 11, May 5, 1868

In tribute to all who served with strength and honor, and lost their lives for our freedoms. All are heroes and have made our country proud.

May we never forget all those who've served and what they sacrificed for.


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May 24, 2008

Men are not mice — No link between fats eaten and risks for prostate cancer

Guys who are looking forward to enjoying a great barbecue this Memorial weekend may be interested in the results of what’s probably the world’s largest study looking to see if there is any link at all between dietary fat and risks for prostate cancer. If no link can be found at all, then, of course, it would rule out fat as a cause. So what did it find?

Good news, unlike the continual doom and gloom in the media. Every time we turn on the television or open a newspaper, it seems there’s another scary claim about the evils of fat. As each scare turns out to fall flat, those facts rarely seem to make headlining news. Major studies have demonstrated that being fat isn’t linked to prostate cancer, nor does losing weight lower risks. The news is just as reassuring about the fat they eat.

You probably guessed that, just by knowing this study hadn’t made the news. Even its authors appeared to have expected different results. They opened by writing that, while biologically plausible mechanisms have been proposed for why fat might increase risk for prostate cancer, recent observational studies on people haven’t been able to demonstrate any credible association, including two large prospective studies. These findings have been downplayed and not widely reported, they said, with some proposing that the groups of people were too homogenous and their dietary fat intakes didn’t vary enough, or that different dietary assessment techniques have been used.

So, for this study, they set out to investigate the links between dietary fats from various animal products and risks for prostate cancer among men with a variety of dietary patterns and by grades and stages of their disease. They used the data from the prospective cancer study of 142,520 men from 19 clinical centers across 8 European countries (Denmark, Germany, Greece, Italy, the Netherlands, Spain, Sweden, and the United Kingdom). The men (average age 52) recruited for the European Prospective Investigation into Cancer and Nutrition study had been healthy and cancer free at the time of enrollment. The researchers used nearly all of the original cohort, only excluding those for whom there had been no dietary data completed or the reports exhibited dubious outlier extremes.

The men’s diet information was assessed in several ways and, while self-reported, the researchers took extreme care to design their dietary questionnaires to accurately measure the men’s fat intakes, using food-frequency questionnaires and diet histories, portion sizes and fat contents measured in foods in each country. To further validate the dietary intakes, they randomly selected a sample of 13,031 men among all EPIC centers, who completed carefully standardized 24-hour diet recall surveys. The men’s body mass index didn’t differ significantly by their fat intakes, although the men eating the most fats were slightly more likely to be married and significantly more likely to be smokers.

Cancers were identified through cancer registries available in 6 countries and they used a combination of self-reported and medical records and billing codes to confirm the other cases. For their further analyses, they also obtained the TNM stages and Gleason grades for most of the cancers through each medical center. The men were followed for an average of 8.7 years, during which time there were 2,727 cases of prostate cancer found.

The results were just published in the current issue of the American Journal of Clinical Nutrition. They found:

There were no statistically significant associations between intakes of total fat, the subtypes of fat, of the P:S ratio [polyunsaturated to saturated] and risk of prostate cancer. Compared with the lowest quintile [intake] of total fat intake, men categorized in the highest quintile had [a hazard ratio] for prostate cancer [that was lower] of 0.96 [95% CI: 0.84, 1.09]. Individuals categorized in the third quintile of total fat intake had a 15% lower risk of prostate cancer in comparison with individuals categorized in the lowest quintile... each 10% increase in energy [calories] from fat was associated with a 5% lower risk of prostate cancer, but this result was not statistically significant..

They found no tenable correlation between dietary fat and prostate cancer. This held after adjusting for weight, height, smoking, education, marital status and calorie intakes. All of the risks hugged null (ratios of 1/1 = 1). In fact, if you want to split hairs, higher total fats, saturated fats, monounsaturated fats, polyunsaturated fats and P:S ratios were all associated with (1-5%) lower overall risks for prostate cancer, although not significant. [Click on image to enlarge.]

They did a separate analysis based on sources of dietary fat and also found no statistical correlation between fats from red and processed meats, dairy products or fish and shellfish and the risks for prostate cancer. Interestingly, they also found no benefit among those with the highest intakes of what are popularly considered healthy fats, as in fish.

They did another analysis, excluding the first 4 years of follow-up to eliminate any possibility that the men had preexisting diseases, but it didn’t change their findings at all. Neither did their results change when they included or excluded the men’s calorie intakes.


Body of human evidence

To evaluate their findings with the body of evidence, they examined the most recent research, 7 studies with a total of 9,247 cases of prostate cancer. Those had also found no tenable link between dietary fat (total, saturated, polyunsaturated or monounsaturated) and prostate cancer risk. All of the risks hugged either side of null (RR=1). As they emphasized:

Thus, the totality of the evidence indicates that a higher intake of dietary fat is not a risk factor for prostate cancer.

All of the untenable associations found in their computer analysis, they noted, were likely due to chance. There is no biologically plausible mechanism to support a role for a high intake of fat in reducing the degree of cell differentiation association with high-grade [higher-severity] prostate cancer, they said.

These are similar to the findings of the Second Expert Report issued by the World Cancer Research Fund and American Institute for Cancer Research, examined here last year. Examining 2,471 international cancer-related dietary studies, it found no credible link between meats or processed meats, dairy products, vitamins, produce, alcohol, sugars, sodas and 17 different cancers, including prostate cancer.

The EPIC researchers concluded:

In conclusion, the results from this large prospective study showed that a high intake of dietary fat was not associated with an increased risk of prostate cancer. These findings add further evidence that the intake of dietary fat is not an important predictor of prostate cancer risk.


Men trump mice

The fear of fat appears so ingrained into our consciousnesses, that this study received no media attention the week it came out, while the media reported a study that had been published more than a month earlier... looking at prostate cancer in specially-bred transgenic mice. This study, by researchers at the University of California, Los Angeles, published in Cancer Research**, opened by writing: “Epidemiological studies suggest that environmental factors associated with Western lifestyle may promote the development of clinical prostate cancer,” specifically implicating dietary fat. So, this study sought to identify a mechanism for how lowering dietary fat in calorie-controlled diets could slow the development of prostate cancer.

The mice they used had been bred to develop neoplasia as early as 2-4 weeks and invasive adenocarcinomas between 6-9 months due to an overexpression of c-Myc in their mouse prostates. In other words, they’ve been bred so that anything and everything will give them cancer. At three weeks of age, 33 were given high-fat feeds of 42% fat from corn oil and 28 were put on a 12% corn oil feeds. They were killed at 7 months of age and 12 of the mice getting the low corn oil feed had invasive cancers compared to 23 of the high fat fed mice. Eleven mice. From this, the only diet-related conclusion that can be made is that transgenic mice don’t appear to do as well given high corn oil feeds.

Anything more is speculation and, in fact the discussion is filled with words such as possibly, suggest, may, could and believed. The authors were actually exploring various mechanisms and markers — Akt-mTOR pathway, androgen levels, IGFBP-1 levels — in cancer cell growth and such research is important for perhaps leading to a treatment for prostate cancer. But not in making dietary prescriptions on humans.

While most anything will give special research mice cancer, countless such scares suggested in animal studies haven’t played out when humans are examined. We’re ‘bred’ with resiliencies to a variety of exposures. So, while virtually everything gives mice cancer and in toxic enough doses can be harmful to us — even things essential to our survival like water, salt, sugars and fats — that doesn’t mean the ranges we eat cause us any harm at all. And, as the medical researchers across 8 countries [with no conflicts of interest declared] concluded this month, the totality of the evidence on humans shows that higher intakes of dietary fat is not a risk factor for prostate cancer.

Human studies trump mice every time.

For the sake of our sanity, with the sensationalized scares and whiplash that the media tries to give us — with dietary claims that contradict each other all in the same week — keep one simple fact in mind. Over the past fifty years, while we’re eating all of this supposedly “bad” food and Western diet, health and life expectancies in the U.S. have “dramatically improved,” according to former Health and Human Services Secretary Tommy Thompson. Cancer rates and deaths from cancer have continued to fall every year since the early 1990s, including nine of the top ten cancers commonly associated with “poor diets and sedentary behaviors.” Despite the negative media portrayals, cancers are primarily diseases of aging. And, as the HHS’s latest report on the health of the nation revealed, we’re healthier than ever and living longer, too.

Now, go out and enjoy your Memorial weekend barbecue!


© 2008 Sandy Szwarc


** This study notes: “The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked advertisement in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.”


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