Junkfood Science: March 2008

March 31, 2008

Good behavior

Health and wellness seem to have become the national obsession. That’s not because we’re so horribly unhealthy, but because there is tremendous profit, along with power and control, that can be waged over a population when people can be convinced to believe that health is a matter of personal responsibility and good behavior ... that chronic diseases can be prevented by living a “healthy” lifestyle and eating “healthy” … that those who are healthy have idealized characteristics (health indice measures as seen in 20-year old white people of privilege), and everyone else — ageing, minority, fat, disadvantaged or sick — are seen as ill-behaved, ignorant and indulgent masses burdening the rest of society. Health and fitness becomes a duty to society and the common good, and those who aren’t become enemies of the state and are viewed as diseased and inferior, and in need of oversight and management.

Large numbers of Americans, who have forgotten history, have been convinced, not realizing what’s really behind it all...

Dr. Westby Fisher, M.D., FACC does. Yesterday, he discussed a troubling and specious health initiative organized by a group of vested interests. He translated their claims and prescriptions, in a post describing what’s coming, which began: “First, blame the patient.... Of course, do not CALL it ‘the patient,’ instead, work to ‘fight chronic disease.’”

The organization calls itself the Partnership to Fight Chronic Disease and is chaired by Dr. Richard Carmona, the former U.S. surgeon general. It was actually launched on May 15, 2007 and, according to its press release, is the largest partnership working to make chronic diseases, and health and wellness, the key health issues for 2008. It includes more than 50 organizations vested in health care, insurance, business and labor, most of whom will be familiar to JFS readers. It claims “chronic diseases [people] are creating a national health crisis...[and] are the single greatest threat to our nation's health and to our health care system.” According to its website:

The Implications for the Nation

As America's population grows and, as the aggregate profile of its citizens ages, Americans' behavioral choices, the availability and access to good health care and health information, and the resulting incidence of chronic disease will all have a substantially important bearing upon the national economy, the nationwide employment base, mortality trends, and other demographic factors.

The Future. Should the incidence of chronic diseases expand along with the rapid rate of growth in the country's population, especially among ethnic and low-income communities, an impending national health care crisis could confront future generations. Mortality rates could rise, average life spans contract, medical costs skyrocket... severely impacting every aspect of society – from the nation's overall health care infrastructure to the national economy.

The Good News. Experts tell us that good nutrition, regular physical activity and exercise, better health care awareness, and improved health maintenance and disease prevention routines should reduce or alleviate the potential for serious chronic illness within the population as a whole, along with associated costs.

Good lifestyle behaviors can help ensure that the health of the nation's population overall improves over time, that health care costs will stabilize, and that the current strains upon our health care system will be significantly reduced.

Changing the way the nation approaches chronic disease prevention and management will require the participation of the multiple groups that have a stake in, and an influence on, Americans' health – including our nation's policymakers and business leaders.

The policy initiatives of these special interests include petitioning the next president that “the vast majority of the death and disability caused by chronic disease is preventable or could be alleviated through better management of disease – if only our nation took the right steps.”

The “right steps” they envision are taking us to a Medizinischepolizei. More on that coming up.


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Gastric bandwagon

Over recent years, television and medical stories reporting on the wonders of lap band surgeries seem to be everywhere. That’s no accident, nor are they actual medical news stories. As today's Wall Street Journal reveals, we’ve been witnessing the largest, slickest marketing ever seen for an elective surgery. It’s being led by two industry giants, medical-device makers and venture capitalists, along with surgeons eager to cash in on the next big thing in commercial medicine.

The WSJ article, “Competitive Squeeze: Industry giants push obesity surgery,” portrays the fierce competition that has pitted Johnson & Johnson, Inc. against Allergan, Inc. JFS readers will probably see a very different story here than readers of medical device publications.

Allergan, Inc., best known for its antiwrinkle drug Botox, acquired Inamed for its portfolio of cosmetic medical devices in 2006. But, said Allergan’s chief executive officer, “we quickly realized the real jewel was Lap-Band.” In November 2006, it began advertising the Lap-Band directly to consumers on television, even though that’s an unusual tactic for a surgical device, according to the WSJ.

The campaign was an immediate success: Within a week, visits to Allergan's Lap-Band Web site had increased nearly fivefold. Sales of Lap-Band and other obesity-intervention devices soared 50% last year to $270 million, making them Allergan's fastest-growing product line.

J&J’s Ethicon Endo-Surgery makes surgical devices and recently got FDA approval to sell its gastric band. J&J’s Ethicon Endo-Surgery has created its own slick website to lure customers by showing them what they can look like in a new wardrobe, let them shop for new clothes, as well as have their progress followed. J&J has also been working on doctors, bringing them in for “weekend training sessions to teach them how to implant the device.” With its “small army of specialized salespeople selling other bariatric surgery supplies and instruments,” J&J is expected to grab a chunk of the market almost immediately, said the WSJ.

Fighting back, Allergan rolled out a new multimillion dollar campaign this month, featuring television spots targeting female watchers of daytime soaps. Allergan also recently signed a co-marketing pact with Covidien, J&J’s largest competitor in the bariatric field, said the WSJ. Covidien’s sales force will be used to scout out general surgeons to interest them in getting into “the banding business.”

The WSJ article itself reads like marketing copy in parts as it uncritically depicts the studies showing the benefits and minimal risks for lap bands. But it reveals what’s been driving the spin on the research that we’ve been hearing: “There's no question that advertising and the commercialization of the band is what's driving it," said Dr. J.K. Champion, an Atlanta bariatric surgeon. Doctors who once dismissed gastric bands as a gimmick, said the WSJ, are now jumping on the “gastric bandwagon.”

Around the country, the television ads bombarding the public aren’t just coming from the makers of the bands, but from growing numbers of for-profit banding centers that are backed by venture capitalists. The reason they’re advertising so vigorously is because “unlike the band makers, physicians and clinics can make advertising claims that aren't subject to the strict rules imposed by the Food and Drug Administration.” They can also use testimonies, like one ad featuring a woman saying: “I’m going to be around much longer for my family.”

According to the director of Cleveland Clinic's bariatric center, people who’ve heard about the bands through advertisements come in regularly. He told the WSJ that the ads exert a powerful influence. “You don't see commercials for gastric bypass,” he said.

True Results clinics in Texas says it has performed more than 11,000 surgeries since 2001. “We basically took the Lasik playbook and ran it for banding,” said founder Peter Gottlieb, referring to the popular eyesight-correction surgery. Band Surgery Centers Inc., in Los Angeles, Las Vegas and Orange, Calif., has a billboard and is running commercials on the "Dr. Phil" and "Oprah Winfrey" television shows.

These new bariatric centers and chains sprouting up around the country are spending “liberally on marketing to lure cash-paying customers,” according to the WSJ. “Banding typically costs $17,000, versus $25,000 for gastric-bypass surgery, though surgeons sometimes charge much more,” it said. Growing numbers of doctors are signing on for this entrepreneural opportunity. “Unlike gastric bypass, gastric banding is a relatively simple procedure, making it easy for surgeons to pick up,” in a weekend. “Now, scores of surgeons across the country are touting weight-loss surgery at free seminars.”

To capture the most patients, these giants have been working hard on changing the minds of insurers’, many of whom “are still reluctant to cover the procedures” due to the unknown efficacy of the procedure. Allergan has employed 100 people devoted to working on insurers and are beginning to see their efforts pay off, said the WSJ:

The federal agency that oversees the Medicare program instituted coverage for bariatric surgery in early 2006. That was followed by a favorable assessment on gastric banding last year from the BlueCross BlueShield Association, whose member health plans look to it for guidance. In September, the federal Tricare program, which provides coverage for 9.2 million active and retired U.S. military personnel, as well as their families, said it would cover gastric banding, retroactive to February 2007.

Allergan is also working to expand Lap-Band applications to younger and lighter patients. It is sponsoring human tests in teens between the ages of 14 and 17 as well as adults who aren't as heavy as most bariatric surgery candidates.

If you’ve been wondering how the actual research on lap bands could differ so much from everything you’ve been hearing, it might be that salesmen often see the facts differently than scientists.


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March 30, 2008

ENHANCE trial published today

To coordinate with a special session at today’s American College of Cardiology meeting in Chicago, the official results of the ENHANCE trial were simultaneously published at 1 pm in a special edition of the New England Journal of Medicine. There were no surprises.

The authors, led by John J.P. Kastelein, M.D., Ph.D., at the Department of Vascular Medicine, Academic Medical Center, in Amsterdam, the Netherlands, concluded that the combined therapy of ezetimibe and simvastatin (Vytorin) did not result in a significant difference in changes in intima–media thickness (ultrasound measurement of the thickness of the walls of the carotid arteries, believed to reflect the amount of coronary artery disease), as compared with simvastatin alone, despite decreases in levels of LDL cholesterol and C-reactive protein:

Nor were there any clinically meaningful treatment-related changes in the patients’ vital signs or heart function, and adverse events between the groups were similar (34.2% and 29.5%, respectively). Reducing LDL-cholesterols is one of the cornerstones in current preventive treatments in cardiovascular disease, the authors noted. So, the reasons for the failure to observe clinical improvement after two years of this treatment, despite reductions in LDL-cholesterol, remains unknown. Treating surrogate measures, health indices, as we're continually learning, is not the same thing as addressing actual clinical health and outcomes.

The New England Journal of Medicine also published two editorials on this study, both discouraging use of Vytorin by physicians, as well as a paper led by pharmacist, Cynthia A. Jackevicius, Pharm.D., M.Sc. from the University Health Network. Dr. Jackevicius and colleagues compared the prescribing practices in the United States and Canada from 2002 through 2006 and found that by 2006, prescriptions for Vytorin drugs had grown to four times higher in the U.S. than in Canada, where direct consumer advertising is banned. “In 2007, more than $200 million was spent on direct-to-consumer advertising [by Merck and Schering Plough] for Vytorin alone, which probably had an effect on U.S. sales,” they wrote. Those sales have “eclipsed $5 billion.” While the meds increased overall healthcare costs, they wrote, the effect on clinical outcomes is uncertain.

Since JFS has covered the ENHANCE trial extensively, there’s no need to rehash it, but the discussions among cardiologists might be of interest. Dr. Richard Fogoros, M.D., former instructor of clinical cardiology at the University of Pittsburgh, said that patients currently taking Vytorin or Zetia shouldn't just stop their prescription medications without consulting their doctors, but “ought to discuss with their doctors whether the drugs were begun appropriately, in light of what now has been officially reported.”

Matthew Herper at Forbes has just written a comprehensive article based on more than a dozen cardiologists who reviewed the completed study for them. Among the doctors’ comments were:

Harlan Krumholtz, of Yale University, a member of an expert panel that discussed the drugs at the ACC meeting: "The burden of proof is on the companies to prove Zetia and Vytorin are safe and effective. They have not done that yet."

"The willingness of U.S. physicians to so rapidly adopt an unproven therapy is worrisome," says Paul Ridker, a cardiologist at the Brigham and Woman's Hospital in Boston. "The questions patients with high cholesterol should ask their physicians is simple: Will the drug you are giving me lower my risk of heart attack or stroke? If not, why are you prescribing it?"

The [arterial thicknesses] difference is so small as to be unimportant, says John Kastelein, the University of the Netherlands doctor who led the trial. "This is a zero trial," he says.

William Boden of the University of Buffalo says the idea that the arteries were thin does not explain away worries about Zetia's effectiveness against heart attack-causing atherosclerosis. "There's not a hint of things moving in the right direction," says Boden.

The full discussions in the Forbes article, “Vytorin Backlash,” are found here.


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March 29, 2008

They were persuaded

In other pharmaceutical news this week, the evidence review committee for NICE (the National Institute for Health and Clinical Excellence) issued a final appraisal determination on the diet drug Acomplia (rimonabant) that surprised the world. It reversed its December draft technology appraisal recommending against the diet drug.

Yesterday, NICE recommended the diet drug become part of UK’s nationalized health coverage and clinical guidelines, going against not only its own earlier decision, but expert reviews and rulings by regulatory agencies from the United States to Europe. While this appraisal determination is not its final formal decision, that’s expected to be released soon.

In its just-released guidance report, Final Appraisal Determination, NICE recommends Acomplia, writing:

Rimonabant, within its licensed indications, is recommended as an adjunct to diet and exercise for adults who are obese or overweight and who have had an inadequate response to, are intolerant of or are contraindicated to orlistat and sibutramine. Rimonabant treatment should be continued beyond 6 months only if the person has lost at least 5% of their initial body weight since starting rimonabant treatment...

The Committee was persuaded to reverse it earlier decision in response to information presented to it by the manufacturer, Sanofi-Aventis, and the testimonies of representatives from various stakeholders, listed at the end of its report.*** NICE said: “The Committee heard from consultees, clinical specialists and patient experts that rimonabant was an important innovation and offered an additional line of treatment.”

Its earlier ruling had concurred with the European Medicines Agency and the Food and Drug Administration Advisory Committee, whose experts were concerned about the drug’s safety and efficacy. The FDA Advisory Committee recently recommended against approval after growing reports of adverse psychiatric reactions. A recent German panel also decided against coverage in that country. Similarly, the earlier NICE draft had not recommended the drug be approved in the UK and had called for more information on its efficacy and safety, as well as its cost effectiveness.

Yet, nowhere in the 28-page report was NICE presented with any new clinical or financial evidence that might support its reversal. In fact, each conclusion it reached, by its own acknowledgement, was the opposite of the data. As the NICE evidence reviewer group wrote:

The manufacturer’s evaluation of the effectiveness of rimonabant focused primarily on the results of four randomised controlled trials. The RCTs showed that rimonabant, as an adjunct to diet and exercise, was associated with a statistically significant greater weight loss than placebo with diet and exercise at 1 and 2 years… After rimonabant treatment was stopped at 1 year, there was a gradual increase in weight until there was no statistically significant difference from placebo at 2 years….

[An extensive review of those clinical trials and the lack of evidence for effectiveness, and the safety issues, is here.]

The NICE committee went on to say it was persuaded that rimonabant, with diet and exercise, was more effective in achieving weight loss than diet and exercise alone, and that “participation in lifestyle and diet and exercise programmes was essential in order to achieve long-term weight loss.” The committee admitted that the evidence from clinical trials showed weight loss was not maintained and that short term weight loss may not have long-term benefits. Yet, the committee was persuaded to approve the drug, saying that “the impact of rimonabant on weight loss and biochemical markers for cardiovascular risk, including those relating to diabetes, was likely to be sustained in the long term.”

The committee specifically discussed the adverse effects of Acomplia, especially related to psychiatric symptoms, and the safety concerns of clinical specialists with the FDA and European Medicines Agency. NICE said these issues were a “significant concern,” but agreed with the representatives who spoke to its committee that screening and monitoring for psychiatric illness and depression could be accomplished through a short questionnaire and tools to identifying pre-existing depression.

NICE, which also assesses the cost-effectiveness of treatments in the UK’s National Health Service, found the manufacturer “significantly underestimated the real costs to the NHS” in its costs estimates, “particularly relating to the long-term effect on cardiovascular disease and diabetes and the costs and quality of life associated with treatment-related depression.” The NICE reviewers felt that the mere 1.5 minutes of doctors’ time the manufacturer assumed would be all that would be needed to monitor patients for psychiatric effects, for example, was unrealistic. Despite these admissions, the NICE committee was persuaded to approve the drug centered on the cost effectiveness model submitted by the drug manufacturer which was based on health risk indices costed out over a lifetime. As the NICE report said:

The manufacturer’s submission included an economic evaluation of rimonabant based on a Markov model. The model evaluated the following treatment comparisons: lifetime treatment with rimonabant plus diet and exercise versus lifetime diet and exercise alone …versus lifetime orlistat plus diet and exercise …versus 1 year of treatment with sibutramine plus diet and exercise.

The [NICE reviewers] considered the economic model structure to be appropriate for the decision problem. In addition, [they] considered the general approach employed by the manufacturer (in the absence of long-term event data) of translating changes in intermediate risk factors to changes in event rates was appropriate for the purpose of estimating lifetime cost effectiveness.

So, unresolved adverse reactions; no proven, sustained clinical benefits for patients; and costs for the public that are likely to surpass all estimates, and NICE was persuaded to reverse its earlier determination to now recommend Acomplia for the treatment of 'overweight' and 'obesity'.

Would you have been persuaded, or do you think other factors may have influenced the NICE decision?

News has reported that not only are representatives of Sanofi-Aventis delighted, but the director of the National Obesity Forum called it excellent news.


*** The sources of evidence (click images to see full-size) that were presented to the NICE committee:



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When science and sales get mixed up

There’s an old adage in business and politics that when you need to release troubling news, issue the press release late on a Friday afternoon when it’s certain to get the least notice and be forgotten by Monday morning’s news. A remarkable and disturbing announcement was issued late yesterday that deserves to make the news and receive the attention of the scientific and medical community.


Background

JFS readers have been following the riveting pharmaceutical clinical trial melodrama that’s been playing over at Merck/Schering-Plough Pharmaceuticals. As you’ll remember, first, there were repeated delays in issuing the results of their long-awaited clinical trial, ENHANCE, which had been completed in April 2006. ENHANCE was designed to determine if Vytorin [Zetia (ezetimibe) combined with Zocor (simvastatin)] worked better than generic Zocor alone. Then, the company announced that, based on the advice of a secret panel it had convened, they were going to change the primary endpoints and only release part of their findings.

This raised a firestorm among medical ethicists and doctors. It was bad enough that the trial was using surrogate endpoints, and not actual clinical outcomes, as its primary endpoints; that the drug company sponsors controlled the raw study data and its interpretation, and not the primary investigators; and that the trial hadn’t been registered on the government website, clinicaltrials.gov, where all clinical trials are supposed to be listed before they begin and their designs clearly defined — but changing the primary endpoints after a trial is completed is not how sound science is conducted, as it’s easy to move the goal posts to match the results and claim positive findings. The repeated delays in learning the results of this trial were also affecting millions of patients who were being prescribed the combination, even though Zetia had never been shown to be effective in improving outcomes and had been approved by the FDA on the basis it could lower LDL-cholesterol by 15-20%. But Zocor’s patent expired and by adding it to Zetia, the drug manufacturer could create a “new” drug, Vytorin, that could be patented and save Zocor from generic death for the company. ENHANCE would help doctors know if this new combination was more effective than generic Zocor.

Then, in a surprising move, the ENHANCE results were announced showing there were no benefits in the primary endpoints seen among patients receiving Vytorin over generic Zocor, even among the study population of people at the highest risks and believed the choice group to demonstrate a benefit. This launched quite a tumult of marketing spins, controversies and conflicting information, and lost among it all was that this was about the integrity of the scientific process that could provide the soundest evidence upon which to base medical decisions for patients and doctors.

The pharmaceutical companies assured everyone that its new trial IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial) would provide the conclusive evidence needed on the drug’s effectiveness, as it was designed to give definitive answers as to if the drug showed actual clinical benefits. The trial was due to be completed in January 2011.

While the IMPROVE-IT trial could be used to claim effectiveness if the results were favorable, it was actually designed to not give doctors any real answers. Even the ethics of this trial have been questioned by Dr. Scott K. Aberegg, M.D., M.P.H, Assistant Professor of Medicine at Ohio State University in Columbus, Ohio. IMPROVE-IT was designed to compare half doses of Zocor and Zetia to half doses of Zocor alone, so there will be no way for doctors to know if Zetia is better to Zocor at full dose, or if its addition to full dose Zocor offers any additional benefit, he said. Using full doses would be too risky for the company, he said because it might show no incremental value over full-dose Zocor and “this trial was designed primarily for the purpose of maintaining patent protection for Zocor in the combination pill.”


NEWS

A press release about the IMPROVE-IT trial was quietly issued late yesterday afternoon from Brigham and Women’s Hospital, not the pharmaceutical companies. For those concerned with the integrity of scientific research and clinical trials, this news was disturbing. It is a novel and effective way to delay releasing the results of this trial for an undefined period of time.

The researchers announced that they are changing the study protocol in order to nearly double the number of study participants to 18,000, reportedly to ensure the study is large enough to have the statistical power to measure the clinical effects. We are to believe that the original study was not correctly designed to measure effects.

The decision was made, according to the press release, “based on ongoing evaluation of blinded, aggregate” findings and a “further review of the statistical assumptions surrounding the relationship between LDL-cholesterol lowering and the expected reduction in clinical events.” Making the highly unusual move of changing a study in the middle of a trial makes you wonder if the data they were seeing wasn’t favorable.

This is not the first time that the investigators effectively created a delay by changing the trial design in the middle of the trial, either. It amended the trial in September 2007 to increase the targeted number of events to meet its primary endpoints from the original 2,955 to 5,250 and the study enrollment size from the original 10,000 to 12,500 people.

To help readers understand what this means, this trial is designed as an “event-driven” trial. So, its completion date depends on when the targeted number of primary endpoints events are reached and the last person enrolled will have been followed for a minimum of 2 ½ years. In other words, because of how its primary endpoint is defined, now, at least 5,250 people will have to die from “any cardiovascular events, non-fatal coronary events (such as heart attack), and non-fatal strokes” and everyone else enrolled in the trial has been followed for at least 2 ½ years.

They estimate that could take until 2012, but they couldn’t give an exact date when the trial will end. How much do you want to bet that won’t be until the Vytorin patent has expired and Merck and Schering have enjoyed $5 billion in annual sales? All the while, millions of people will be prescribed Vytorin or Zetia by their doctors, believing they’ll prevent heart attacks and strokes and help them live longer. With no evidence at all.


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March 28, 2008

Bald vitamins

The FDA issued a consumer warning today advising people not to purchase or consume the “Total Body” dietary supplement formulas. Severe adverse reactions have been reported among people consuming flavors tropical orange, peach nectar and orange/tangerine, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.

The Florida Department of Health recently reported to the FDA that 23 people had had serious reactions seven to 10 days after consuming them and the FDA has learned of similar reports in Tennessee. FDA laboratories are analyzing samples to identify the cause of the reactions, and suspects excessive amounts of selenium, which causes similar reactions. Selenium, a trace mineral, is needed only in trace amounts.

Total Body Essential Nutrition markets its supplements as powerful combinations of vitamins, minerals, amino acids, essential fatty acids and antioxidants that are claimed to be necessary to maintain energy and optimal health because of today’s “depleted soils” that leave our foods and American diet “nutritionally bankrupt.” Its formula also includes grape extract which it claims is superior to all other antioxidants, 50 times more powerful than vitamin E and 20 times superior to vitamin C, to protect from free radicals that lead to aging, impaired immune system and chronic diseases.


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Computer Gaming: Your waist doesn’t really go to your head

[This story is being bumped ahead of the scheduled piece….]

A press release went out on Tuesday to enable the media, in lockstep, to announce the results of a new study on the embargoed date — before it was published or even available to medical professionals who had paid subscriptions to the journal — ensuring the media release spin would pre-empt any professional critique. Accordingly, at least 638 (and counting) news stories have been breathlessly reporting that “big bellies increase risk for dementia.”

This was our first clue that what we’ve been hearing is marketing, not science. They are not remotely the same thing.

If it seems like a lot of studies linking fat to dementia have been in the news over recent years, you would be right. But repeated media stories do not mean there’s a growing body of evidence, or any new research. Reports of the same studies, on the same patients, and by the same researchers, are frequently published in multiple journals, each time often generating a press release and media coverage. Repetition can give us an illusion of something being real.

And the more fanatical the rhetoric — such as the lead researcher quoted in the Wall Street Journal yesterday calling tummies “toxic fat” — the more it seems to reinforce the need for us to feel worried and anxious… and the more we know that our emotions are being played. That’s a marketing tactic, too. Not impartial science.

Wordsmithing can also lead us to think that this study had shown large waistlines to be the cause for dementia. In actuality, through the magic of computer modeling, a correlation was found. Computer models have this dandy ability to cull through data and endlessly find all sorts of meaningless correlations. Especially when the data is tenuous to begin with.

The headlines should have said: “After eliminating 3/4ths of the records, a single waist measurement taken nearly 40 years earlier was linked in a computer model to mental impairment checked off on electronic billing records.” That would have been recognized as another meaningless correlation and not generated the sensational media stories.

When study results are so overstated and employ such intense marketing techniques, it pays to take a look closer with a critical eye.


How soon we forget

Three years ago, the very same story hit the news, reporting: “Study links middle-age obesity to dementia.” Media around the world reported that this new study provided “the most convincing research so far” that being fat raised one’s risk for dementia. It was held up as another reason to be concerned about the “obesity crisis” and the need for action. “For God's sake, we better get cracking," said Philip James, the head of the obesity lobbying group, International Obesity Task Force.

That 2005 study was actually the first to suggest a link between fat and dementia and its authors are the main source for this continued fear. The 2005 study was done on the very same study population, using the same techniques and led by the same researchers, as the study released this week online, ahead of the print edition of the journal Neurology.

As readers may remember, the 2005 study also used science by press release and was not only reported in at least two different medical journals, it was released to the media before being published in the British Medical Journal.

When medical professionals finally had access to the actual study, however, they found that it hadn’t been able to find a single tenable correlation between dementia and BMI (body mass index) or body fat as measured by skinfold thickness (subscapular and tricep). By then, the media had moved on to the next news story and the public never heard these facts.

In the study, the authors said they were unable to come up with a biologically plausible explanation for how fatness might make anyone senile, either. They said they had exhausted all of the possible explanations among the fat dementia patients they could come up with — and found no link with cardiovascular disease, diabetes, “metabolic syndrome,” inflammatory markers, etc. Few consumers heard that, either.

Despite finding no link to obesity or body fat, for this new paper, the authors reanalyzed the data using new permutations, looking for a link between waist size and dementia. Examining the 2005 and 2008 studies together, comparing and contrasting, provides a valuable opportunity to see for ourselves the machinations in data dredges and enable us decide for ourselves how much “weight” these types of studies deserve.


Authors

Both studies were led by Rachel A. Whitmer, Ph.D., an epidemiologist with Kaiser Permanente Northern California. Kaiser Permanente is one of the largest health-maintenance organizations in the country and since 2002 has taken a leading role, partnered with the Robert Wood Johnson Foundation, CDC, American Association of Health Plans, Health Partners, and the National Business Group, to develop the national anti-obesity agenda, including clinical guidelines for doctors and education for children and healthcare professionals.


Study design

These studies were both retrospective. This is significant because it is the weakest type of observational study design. The authors culled through data they specifically chose to consider that had been gathered on a group of people, one time nearly 40 years earlier, searching retrospectively (backwards in time) for correlations among those with and without dementia recorded on their charts today.

“With few exceptions, retrospective study designs are inferior to prospective study designs,” said Dean R Hess, Ph.D., RRT FAARC, at Massachusetts General Hospital, and Harvard Medical School in Boston, Massachusetts. As he explained in “Retrospective Studies and Chart Reviews,” published in a 2004 issue of Respiratory Care, this study design should never be used when a prospective design can be done.

Retrospectives are rife with disadvantages that cloud their results, said Dr. Hess, such as “garbage in—garbage out” as they rely on the accuracy of records not generated for the purpose of the study; they are subject to bias and the actual important data and confounders may not be considered or available; there is no randomization and no blinding; and you cannot establish cause and effect. The “results are, at best, hypothesis-generating,” he emphasized.

Each of his points are evident in these studies.


Study population

These studies both used the identical database and exact same criteria to identify the people to include in their analyses — but the numbers and demographics of those included were very different, with no explanation given for the discrepancies.

The studies stated they included the records of members of the Kaiser Permanente Medical Care Programme of Northern California who participated in Multiphasic Health Checkups (MHC) in San Francisco and Oakland, California, between 1964 and 1973. Both of these papers used people aged 40-45 during those years and who were still members of Kaiser Permanente in 1994. These studies used the information recorded at the first checkup. As part of the MHC, comprehensive physical exams were conducted by healthcare professionals, which included blood tests for cholesterol and glucose, vital signs, physical measurements (height, weight, skinfold thicknesses, waist circumferences, etc.), demographic and medical history information.

The 2005 paper reported that 25,290 Kaiser members met this criteria. According to this paper, of the original cohort, 13,014 people were lost in follow-up (including 2,598 who died and 10,407 who were no longer members by 1994). The 2005 paper conducted its analysis on 10,276 people.

The 2008 paper said there were only “8,664 continuous members” who met the very same criteria, and they excluded 2,081 more for missing data. This paper conducted its analysis on 6,583 members.

So, the 2008 analysis was done on a mere 26% of the original cohort, but nowhere did this paper disclose that fact or that there were actually 25,290 people in the original cohort and most had been excluded. Nor did it provide any explanation why their figures for continuous members differed from 2005. Nor do we know how the people they chose to exclude differed (physically, demographically, or medically) from those they used.

Neither paper presented the medical, demographic and physical characteristics of members they lost in follow-up or excluded, compared with those that they used. We might be tempted to trust there were no differences, except, that doesn’t appear to be the case. While detailed information on the study participants wasn’t provided, what is available even shows notable differences between the 2005 and 2008 papers. For example, only 19.5% had less than a high school education in the 2005 paper, compared to 38.3% in the 2008 study. In the 2005 paper, 10% of the people were obese in mid-life, but only 7% were obese among the people used in the 2008 paper.

No explanation is given for how they managed, using the same criteria, to create an incarnation of members for this 2008 study that differed so much from the earlier one.


Dementia cases

How dementia was identified may surprise you. The cases of dementia were not determined by actual clinical examinations or confirmed by medical evaluations. The authors used electronic billing records and noted when the ICD code for “dementia” was checked off. The codes they tallied included the code for any “memory impairment.” These codes are taken from the International Classification of Diseases, an enormous, complicated and continually changing system which assigns a number to every disease and medical procedure, and currently has about 12,000 codes. The medical literature is filled with documentations of their inaccuracies in reflecting actual patient disease rates. Over recent years, healthcare providers are being encouraged to check these codes in order to receive reimbursements.

This is especially problematic for a difficult diagnosis like dementia. Dementia is a deterioration in brain function and cognitive skills that comes with aging. Today, it’s known to have many different manifestations and causes, including brain abnormalities, vascular problems and infections. Dementia doubles in prevalence every 5 years after age 60, so that by 85 years old, 30 to 50% of seniors are affected. Diagnosing dementia is extremely imprecise, according to the Merck Manual of Geriatrics, and requires a very thorough physical evaluation to differentiate it from benign age-related memory loss. It also needs to be differentiated from a lot of treatable conditions that mimic dementia among elderly, such as the effects of illness; prescription medications; hypothyroidism; vitamin B12 deficiency; depression and isolation; and poor oxygenation due to lung, heart or circulation problems. A busy practitioner might understandably check-off the ICD code for memory impairment to ensure receiving compensation for the extra time spent with a confused, elderly patient, without having done a full work-up for an accurate diagnosis of true dementia, as these authors assume.

The 2005 study reported that among the 10,276 people seen between 1964-1973 and who were still plan members in 1994, 713 cases of dementia (about 7 percent) were identified between January 1994 and April 3, 2004, at an average age of 74.5 years. About 77 cases/year were identified during these follow-up years.

The 2008 study reported that among the 6,583 members in their analysis, there were 1,049 cases of dementia between January 1994 and June 16, 2006. They provided no explanation as to why in the two additional follow-up years, the annual rate of dementia rose by more than 112%, considerably beyond what would be expected.


Findings

In 2005, the researchers created three models for each measure of fatness (BMI and skinfold thicknesses), looking for a correlation to dementia. Their computer models were unable to find any tenable associations — above random change or a computer modeling error for these types of studies. Underweight was associated with a 24% higher odds ratio with dementia; “overweight” with a 35% risk, and “obese” a 74% risk.

Not only were these correlations untenable, but fatness was not what distinguished those with dementia. Increased risks for dementia were found in elderly women of all weight categories, but not in the men — although the men were fatter than the women! The relative risks for dementia associated with the greatest obesity in men was 0.84 to 1.20 — hugging either side of 1 and within random chance— a null finding. They tried to explain this by blaming it on not having the power to statistically detect an effect: “There were fewer obese and overweight men, thus the power to detect an effect was reduced.” But there were more obese and overweight men (2,741) than women (1,960).

This 2008 data dredge found the most variability in risks for dementia among the ‘normal’ weight people (odds ratios 0.94 to 3.81) compared with heavier people, negating a link to weight itself, but to other factors, such as genetic predispositions. Individual body shapes, including where fat accumulates, are also genetically determined, admitted lead author Dr. Whitmer. Yet, genetic or familial predispositions were not considered.

According to the authors in both papers, “those with a grade-school education were significantly more likely to be diagnosed with dementia,” suggesting a role for socioeconomic factors in memory function among elderly. They admitted, for example, that no information on dieting, nutrition, or actual cognitive function had been collected on the study participants at any time. Undernutrition and underweight has repeatedly been shown in other studies to have a key role in mental decline among elderly. Nor did they examine the use or overuse of certain prescription medications, even though it is one of the most common reasons for cognitive problems among elderly.

Once again, the association between fatness and dementia appears spurious. Even if the data used had been sound and a link to obesity tenable, countless confounding factors were not included or considered that could be the actual contributing causative factors, especially since they included all memory impairments in their term for dementia. Elderly women, for example, are more likely than men to have things known to exacerbate mental decline with advanced aging, increasing their risks of being misdiagnosed as having dementia in this study: be widowed, live alone with less social and mentally-stimulating interactions, live on lower fixed incomes and to have been smokers; and to have spent years “watching their figures,” undereating and restricting their food choices, and to have nutritional shortfalls.

Correlations are not causations. Correlations reported in epidemiological studies, as Dr. Hess noted, can only suggest a hypothesis for a role that then needs to be tested in clinical intervention trials and replicated. Here, there are no other studies. As the Kaiser Permanente author and colleagues wrote in 2005: “To date, this is the first study to determine the contribution of mid-life adiposity... on risk of dementia.”

And that study showed no link between BMI or obesity and dementia. With no link, weight loss makes no sense, especially since there is no known way to safely lose weight and keep it off. This new study is being cited as “another good reason to drop a few pounds” with no connection at all.

Even more nonsensical, this study is being used to recommend people “get rid of” their bellies. But everyone knows, spot reducing is a weight loss myth, too.


© 2008 Sandy Szwarc. All rights reserved.


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March 26, 2008

Bits and pieces

[Apologies for the light posts this week. Computer problems and loss of long-time main computer — one cannot reason with a machine. :)

Thank you for your patience. Hope to be up and running soon, until then, here are few news bites of possible interest:]

Extreme fitness for kids

A fitness program in Russia makes children work out in their underpants and then run outside in the snow — barefoot and in their undies — and be poured with ice water, to kick them in the butt to get thin and fit. Mothers are seriously disturbed by the program and calling it child abuse disguised as fitness.

More unsettling, they reported that a Massachusetts pediatrician shown the video actually commended the program, saying it had “all the right ingredients even if somewhat atypical by U.S. expectations. In a U.S. world where we don't have enough fitness in our schools and childhood obesity is at an all-time high, I have to applaud this school for thinking outside the box.” Story here.


Mandatory high-intensity bootcamp fitness before school to fix fat children

The Mercury reports that the trainer for the Biggest Loser (television show), has introduced a program to put Australian school children through high-intensity bookcamp-style workouts before each school day to help fix the problem of 'obesity'. The children would be put through drills and obstacle courses under the direction of local trainers for 30 minutes before class. It would be great, she said, kids love it. Girls couldn’t wear dresses to school, though, as they need to be in fitness gear, she added. She said “fat adults were passing bad habits on to children, breeding whole families that were 'obese'.” Story here.


Can your spit identify you as having a mental disorder?

A flurry of private startup companies are already rushing to exploit human genome research and sell genetic tests claiming to identify people at risk for health problems. AOL reports that more than one thousand at-home gene tests have come into the market in recent years, claiming to help diagnose serious diseases and prescribe phony personalized diets or treatments. Medical ethicists and medical professionals have been speaking out against these tests because the evidence for them is thin to none, even though they’re being sold as tools for consumers when making medical decisions. Most disturbing, they take advantage of people by preying on their deepest fears and anxieties.

A controversial new company claims that it can identify those at risk for mental health problems and manic-depression (bipolar disorder). A psychiatric geneticist from the University of California, San Diego, began selling home tests over the internet in December for $399, after reporting that he’d discovered several gene mutations linked to the diagnosis. He projects sales of about $12 million in the next five years.

The company, Psynomics, claims it will test for two mutations that have been associated with bipolar disorder and also says it can identify which patients will respond to serotonin-based psychiatric drugs. The trouble is, even the creator admits that these genetic links are far from complete and his discovery is just the starting point at understanding the links to such diagnoses. But there’s more to it than that. This test been not shown to be valid or reliable for making a diagnosis. According to Science, the genetic variation used in the test was “associated” with bipolar — but it was found in only 3% of people with bipolar and found in 1% of those without it. Clinical Psychology blog wrote in “Genetic testing for bipolar: Are you kidding me?” that he “fears marketing may yet again trump science.”

Science hasn’t begun to identify the genes involved in or that might be predictive of any mental health problems, not is there any legitimate scientific basis on which to claim that it’s a genetic disorder. Mental health professionals and advocates are concerned about these being used for genetic profiling discrimination and mislabeling people.

Other psychiatric genetic home-tests are due out soon, claiming to predict who will get schizophrenia and depression.

The FTC has issued a fact sheet for consumers entitled, "At-Home Genetic Tests: A Healthy Dose of Skepticism May Be the Best Prescription." As it says:

Be wary of claims about the benefits these products supposedly offer. Some companies claim that at-home genetic tests can measure the risk of developing a particular disease, like heart disease, diabetes, cancer, or Alzheimer’s. But the FDA and CDC say they aren’t aware of any valid studies that prove these tests give accurate results. Some companies also may claim that a person can protect against serious disease by choosing special foods and nutritional supplements....The FDA and CDC say they know of no valid scientific studies showing that genetic tests can be used safely or effectively to recommend nutritional choices. Be skeptical of claims that the tests can assess a person’s ability to withstand certain environmental exposures...

Protect your privacy. At-home test companies may post patient test results online. If the website is not secure, your information may be seen by others.... [N]o at-home genetic tests have been reviewed by the FDA, and the FDA has not evaluated the accuracy of their claims.


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Paranyms

"Every age has its dominant caste. This is the age of the zealot," writes Dr. John Brignell, Ph.D., of Number Watch. In an article that will invite controversy and discussion, he explains how and why Orwell’s vision of the future has become our reality. Interestingly, he mentions the use of paranyms to create an obesity crisis, just as we’ve been looking at words like “overeat,” “maintain,” “fit” and obesity “paradox.” As he writes:

In the world of the zealot, which is now our world, there are no simple problems. Everything is a crisis, epidemic, disaster or catastrophe. There is always the need for urgent action, which usually means taxation, authoritarian control and further loss of liberty….

The obesity crisis. Fat is the new age is deemed unaesthetic. There have been times when a different view prevailed: it is all a matter of fashion, but now fat has to be condemned without trial. The overweening state, by dint of the efforts of the zealots, demands the right to determine the shape of its clients.

Zealotry is rich in paranyms. A paranym is a word used as an evasion, often in a sense that is opposite to its actual meaning: liberate for conquer, liberal for authoritarian etc. Zealots like to change the vocabulary in this way and paradox is one of their victims. Time and time again reality diverges from the dogma, so there has come to be, for example, the obesity paradox. Never mind though, for one of the first principles of zealotry is to ignore any contrary evidence. Another of their favourite techniques is to exploit the end-point fallacy. In Britain, for example, they almost invariably choose the fifties as a point of reference, a time when British women had suffered more than a decade of starvation. In America obesity rates have not changed for seven years, but are still routinely portrayed as a growing crisis. Over and over again the obesity scam is exposed, but the campaigners simply ignore the contrary evidence and march on.

There’s been a lot of talk among bloggers about how we could have possibly reached the point where so many people believe things about obesity, diets and our world that aren’t true. Dr. Brignell notes it was foreseen by Orwell. The control of language is the key to political power, as Orwell wrote: “Don’t you see that the whole aim of Newspeak is to narrow the range of thought? In the end we shall make thoughtcrime literally impossible, because there will be no words in which to express it.”

Also, “it would be difficult to overstate the effect that the decline in standards of statistical practice have had on science in general and medicine in particular,” Dr. Brignell writes. “Examples abound, the valuable drug Vioxx was withdrawn on the basis of a statistical absurdity, while the multibillion dollar statins industry flourishes on, to say the least, dubious grounds. The whole drugs industry is a lottery for unprecedented prizes (and losses). Junk epidemiology can produce results to order by statistical insouciance and manipulation. The establishment is able to purchase the ‘evidence’ it requires.”

Along with control over language, the abuse of science and statistics to create whatever evidence the establishment cares to purchase, he writes, are fallacies of logic. He describes some of the factors needed to create what he calls a campaign of zealotry, which begins by creating a myth and ignoring all evidence countering the myth, encouraging an authoritative government, damaging science and its methods, collusion by the established media, and “promotion of limits and constraints that are simply invented without reason.”

When the media is complicit, all that is reported and repeated is the newspeak, the myth, making it inconceivable to think anything different. And all the more important for people to think.

His full article, “March of the zealots” is here.


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March 25, 2008

Do you know how your genetic information could be used? You may be surprised!

Despite the seeming lax attitudes of some towards protecting our genetic data and the information obtained from genetic screening, that’s not what the public wants. Two new reports this week on the use of genetic information from human genome research describe ethical and social concerns that you may never have considered.

A March 2007 survey by Johns Hopkins Genetics and Public Policy Center found that 86% of Americans trust their doctor with their genetic information, but they do not trust health insurers or employers not to misuse the information (whether by disclosing it or discriminating against them). Some genetic researchers fear that these concerns could potentially harm patients who might benefit from genetic testing or might restrict participation in research and hinder advances in medical and scientific knowledge.

The American College of Physicians released a policy paper yesterday on genetic discrimination, with some insightful information for healthcare professionals and consumers. The American College of Physicians described some of the misconceptions surroundings beliefs that HIPAA (Health Insurance Portability and Accountability Act of 1996) protects the privacy of genetic information.:

It is often thought that HIPAA regulations provide sufficient federal protection against genetic discrimination; however, that is not the case. HIPAA regulations do not prohibit use of genetic information as a basis for charging a covered group larger premiums for health insurance if one member of that group tests positive for a genetic disorder; limit the collection of genetic information by insurers; prohibit insurers from requiring an individual to undergo a genetic test; limit the disclosure of genetic information by insurers; or prohibit the use of genetic information for underwriting in the individual market.

A May 2005 report commissioned by the Department of Health and Human Services’ Secretary’s Advisory Committee on Genetics, Health and Society found that current federal statutes and constitutional protections — including HIPAA, the Americans with Disabilities Act, Title VI of the Civil Rights Act, and the Right to Privacy and Fourth Amendment protections — that address genetic information in employment and health insurance are “incomplete in both the scope and depth of [their] protections.” Current federal protections against discrimination in health insurance do not cover individual insurance policies. Additionally, an insurer of a group may request, require, or otherwise obtain an individual’s genetic information as a condition of coverage and may charge all members of the group higher premiums based on the genetic information obtained.

A review of state genetic nondiscrimination laws found great inconsistencyes in the protections from state to state. As of May 2007, 35 states had enacted laws prohibiting genetic discrimination in employment and 47 had laws prohibiting it in health insurance. But:

Currently there is no body of case law that protects an individual from genetic discrimination at the federal or state levels. Further, although insurance companies have portability protections across states, these protections do not transfer for the insured. As such, if an individual moves from one state that provides protection against genetic discrimination in health insurance to another state without such protections, he/she is no longer protected, even if the individual remains with the same insurance company. In the states that protect against genetic discrimination, self-insured companies are generally exempt from those protections under the Employee Retirement Income Security Act of 1074 (ERISA); however, they are subject to federal regulations.

The Genetic Information Nondiscrimination Act (S.358/H.R.493) (GINA) would prohibit health insurers from using genetic information to set eligibility, premium, and/or contribution standards; prohibit insurers from requesting or requiring a genetic test; prohibit employers from using genetic information in making employment decisions, such as hiring, firing, and promoting; and prohibit employers from requesting, requiring, or purchasing about an employee or an employee’s family member. On April 25, 2007, the House of Representatives finally passed GINA by a vote of 420-3. As of March 5, 2008, it had yet to be voted on in the Senate. President Bush has indicated his willingness to sign GINA if Congress finally passes it.

The ACP issued its positions on the role of doctors in genetic testing and counseling, and on what it believes are needed in federal protections. (See the ACP legislative Positions below**.) The ACP wants GINA to become law and so does the Personalized Medicine Coalition (made up of research Universities and hospitals, lab testing companies, patient advocacy groups and government partners). So, why hasn’t it passed?

According to GenomeWeb, the insurance industry lobbying group, American Health Insurance Plans, doesn’t want this law:

Speaking on AHIP’s behalf to a US House committee a year ago, William Corwin, the medical director of clinical policy at Harvard Pilgrim Health Care, said the law could get in the way of “appropriate health care decision-making.” Corwin said the bill “could limit consumer access to life-saving treatments” because it would keep insurance companies from “requesting or requiring” an individual or a family member to undergo a genetic test, and that AHIP would prefer insurance companies to retain this right.

He added that there may be many “unforeseen advances” that could create circumstances where insurance companies would “need to request genetic tests to determine whether customized therapies or treatments are warranted.” Corwin also said GINA would stop health insurers from using genetic testing to identify “patients who may benefit from specific types of screening or disease management services.”

Insurer-mandated testing and “disease management” identified by genetic markers, or denial of care based on the results of genetic tests — these are not likely the “benefits” of genetic profiling welcomed by consumers.


Ethics of genome research

Released today by the Public Library of Science, was a consensus statement (available free online) of recommendations of ethics for whole-genome research, led by Timothy Caulfield at the Health Law Institute, University of Alberta, Edmonton, Alberta, Canada.

“As technology continues to advance, whole-genome research activities seem likely to intensify and expand, necessitating carefully considered consensus guidelines for ethical research practice,” they wrote. So, they convened an interdisciplinary consensus workshop to develop “ethically rigorous and practical guidance for investigators and research ethics boards.” In addition to discussing the obligations to obtain consent and report results, the right of people to withdraw, and a risk/benefi analysis, this paper also explained why such guidelines are necessary, when it described the potential abuses and misuses of your genetic material.

What are the possible risks? If you’ve never thought about it, their scenarios are unsettling. As they explain, sequencing of entire genomes will enable unprecedented amounts of detailed genetic information to be produced by researchers.:

As a result, all known genetic predispositions will be available and, depending on the data sharing policy, accessible to a wide range of researchers and, possibly, the public at large—this, at a time when we are still seeking to understand the social, clinical, and personal implications of genetic information. These uncertainties can create unique ethical challenges…

Imagine you are watching the news and learn about a study linking race to IQ, which you find offensive. You later learn that they used your DNA for this study. You donated your DNA five years ago for use in a genetic association study of cancer and heart disease. At the time, you were told that other researchers might want to use your DNA for other types of research. You want to withdraw your consent, but it is too late. Your genetic information has been analyzed by many researchers and is now integrated in databanks throughout the world.

Imagine that you are sitting home, minding your own business, and the police show up at your door with a search warrant. They are looking for the suspect from a crime scene… some DNA that was left at the crime scene matched a sample from a publicly accessible scientific database that contained DNA from one of your brothers….

Years later, you develop a heritable form of cancer and learn that the research team must have known you were genetically predisposed to the disease. To complicate matters further, you have a large number of siblings, none of whom want to know about their genetic predispositions. This information is now available to all.

Imagine you... are trying to find private health insurance… As part of the enrollment process, the company accesses a [publicly accessible database and] finds out that you are at increased risk of early-onset Alzheimer disease and are highly susceptible to cancer from the chemicals encountered in your recycling process. They also find that you are at greatly increased risk of colon cancer, which alerts you to now take early screening and preventive measures…

The implications and potential social risks associated with sequencing the human genome are unknown, they write. “While most of the data will have limited immediate clinical significance, the massive volume of the data triggers challenges to protecting privacy and respecting autonomy.”

The involvement of commercial interests and potential commercialization of the results bring troubling ethical aspects that suggest greater potential abuses than clinical benefits.


** ACP legislative Positions

Position 1: Insurance providers should be prohibited from using an individual’s genetic information to deny or limit health coverage or establish eligibility, enrollment, or premium contribution requirements.

Position 2: Insurance providers should be prohibited from establishing differential premiums based on an individual’s genetic information or request for genetic screening.

Position 3: Employers should be prohibited from using an individual’s genetic information in employment decisions, such as hiring, promoting, or terminating an employee or establishing the terms, conditions, and benefits of employment.

Position 4: Insurers and employers should be prohibited from requiring individuals and families to undergo genetic testing.

Position 5: Insurers and employers should be prohibited from collecting and/or disclosing an individual’s or a family’s genetic information. Written and informed consent should be required for each disclosure of genetic information and should include to whom the disclosure is made.

Position 6: Congress should establish comprehensive and uniform federal protection against genetic discrimination that closes the gaps in protection due to varying state laws. Federal protection should also cover ERISA health plans.


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Potential for bias?

Might the objectivity of the information on the obesity “epidemic” sweeping the world be tainted in green?

Obesity market set for explosive growth, says report

The market for obesity treatments will grow five-fold by 2016, according to research firm Decision Resources. The category, worth an estimated $478 million in 2006, will grow to $2.7 billion by 2016 in the US, UK, France, Germany, Italy, Spain, and Japan, the firm projected. Growth will be most rapid in the US, where sales will increase from $222 million in 2006 to nearly $2 billion in 2016….

The sticky wicket, as this report notes, is that most of the pharmaceuticals being developed to take advantage of this growth market, “lack blockbuster potential because they are either associated with safety concerns or are available only in inconvenient injectible formulations.”


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March 24, 2008

Parents threatened by the State for “allowing” their children to have puppy fat

Despite the fact that there is no “alarming” crisis of fat babies or a childhood obesity epidemic in Scotland, Scottish authorities and special interest groups will not rest until they’ve threatened and terrified parents into starving their naturally larger babies and children into slimness. The latest news from Scotland is leaving readers around the world horrified. Mark Smith at the Mirror reports:

Parents told to put their six obese children on a diet or face having them taken into care

A couple have been given three months to get three of their six overweight kids slimmer - or have ALL of them taken into care…. And social workers have threatened that unless the tough weight loss ultimatum is met through diet and the children taking football and dance lessons, they will seize them and their three siblings to safeguard their welfare….

"This is every family's worst nightmare and I feel we're being victimised. I can't stop crying at the thought I could lose my beautiful children for ever." … [The mother] insisted they ate healthily and merely had puppy fat. She said: "I don't even own a deep-fat fryer. All my food is home-cooked and the kids are not fed junk food at all. But social workers keep making an issue about their weight."

She fears the girl, 11, may develop an eating disorder as she now shuns proper meals, while her oldest son has temper tantrums. The Dundee family came to the attention of social services when they asked for help in caring for the kids, including the girl, three, who has developmental problems….

Arguing that “it is right” to do was Tam Fry, Chairman of the Child Growth Foundation, who cited incorrect claims and threatened other parents:

In 99 per cent of cases, obesity is so avoidable. Letting a child get so fat is a form of abuse as there's a possibility they could die before their parents. It's important they are taken out of their homes and put under 24-hour surveillance from doctors and nurses… if your kid is obese, do something. Apart from the name-calling they will suffer, do you want a death on your hands?

The director of a children’s weight loss clinic encouraged compassion towards families, incorrectly accusing parents of not being able to help themselves and that “they just need to be taught how to do things right.” She blamed the “abundance of junk food, kids' TV shows and computers that contribute to today's unhealthy diets and sedentary lifestyles.”

The Scotsman reports that another couple there is facing the same fate over their child. These developments have “already forced some as young as 13 to seek NHS weight-loss surgery,” according to the paper.

Families destroyed and children’s lives shattered forever. Abuses of power based on lies, prejudices, and corruption. Are there riots in the streets there?


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One little magic word

A single word can lead us to believe something that isn’t real. Nothing illustrates this better than a study in the current issue of the Journal of the American Medical Association. According to the press releases and media stories, this study showed that losing weight and keeping it off is possible.

Weight loss can be maintained and sustained, this study reported, when dieters have long-term support and regular contact from a professional health counselor. Said to be the largest weight loss maintenance study to date, the Weight Loss Maintenance Trial (MAINTENANCE) found that the services offered by the study’s authors — obesity disease case management and health coaching through online wellness programs — are the “key to successful, long-term weight management.” The authors said: “In conclusion, the majority of individuals who successfully completed an initial 6-month behavioral weight loss program maintained weight below their entry level after 30 additional months.”

Maintain.

What a funny little word to describe their findings. Most people think that “maintain” means to keep in a steady condition for a period of time. Few would have chosen that word to describe this:


This is the typical picture of a rebounding weight trajectory seen in weight loss studies. There was no weight loss maintained for 30 months, as you might have come away believing, upon hearing the reports. Even more remarkable, perhaps, is that this rebound was seen even among a select study population.

The authors acknowledged that weight loss interventions offer only short-term results and that virtually everyone regains the lost weight, so much so that claims of weight loss maintenance are not credible unless they’ve been demonstrated least 5 years. Even the study sponsor, “the National Heart, Lung, and Blood Institute has recommended that truly long-term benefit be assessed over at least 5 years.” Yet, like all diet studies, this one was designed to conveniently end before the expected weight regains looked really bad and in time for weight loss success to be reported.

There were other findings in this study that demonstrate the reality of weight loss interventions and weight maintenance, which make it valuable to take a closer look.


Study design

Four clinical centers authored and conducted this trial: Duke University, Johns Hopkins University, Pennington Biomedical Research Center, and Kaiser Permanente. During Phase I of this study, people were hand selected to participate in a weight loss program. The authors specifically tried to enroll 40% men and 40% African-Americans. All of the participants were young adults, between the ages of 25-45, and taking medications for blood pressure or cholesterol, but without any history of cardiac events or other health problems.

For phase II, the maintenance part of the study, those participants who successfully lost at least 8.8 pounds after 6 months were than randomized into two different weight maintenance programs.

One group was assigned personal contact from a professional health coach or nurse case manager. It was the disease management program model, consistent with recommendations of the Medicare Medical Nutrition Therapy Amendment Act of 2001, and based on behavioral change management. The participants had monthly phone contacts and met personally with their case manager every four months for 45-60 minutes.

A second group was entered into a web-based program, where interactive features enabled them to set goals and action plans, graph their weights, food intake and activity, receive motivation and social support, and were sent email reminders and 2 weekly automated telephone calls. This is the design sold through online health and wellness programs.

A third control group was more or less left to their own devices. They were given printed lifestyle guidelines with diet and exercise recommendations and met briefly with a study interventionist at the 12-month assessment visit.

Food intake was assessed by food frequency questionnaires at the beginning of the study, at the end of Phase I, and at the 12-month and 30-month assessment visits. Physical activity was measured by accelerometers worn for at least 10 hours a day for 4 days, including 1 weekend day, and used to estimate total weekly minutes of moderate to vigorous physical activity. Actual weights and measurements were taken by trained staff members every 6 months during the study.


Results

Only 3 out of 5 people who participated in the weight loss program managed to successfully lose enough weight — a mere 8.8. pounds after 6 months — to go on to phase II of the study. So, 39% of the original study participants were dropped from the study before the maintenance part began and 3 died during the maintenance period. Among the remaining 1,029 participants, 36% were men, they had an average weight of 212 pounds, and nearly 2/3 were college-educated with household incomes ≥60,000.

At the end of Phase I, the dieters were engaging in an average of about 2 3/4 hours of vigorous-moderate intensity exercise per week (primarily brisk walking).

They were eating an average of only 1,596 kcal/day — nearly 1,000 calories fewer than the 2,510 kcal/day their bodies nutritionally required (based on their weights, BMI, genders, ages, and activity levels), according to the Adult Energy Needs recommended by Baylor College of Medicine (used by the 2005 Dietary Guidelines). Yet, they reported that this represented only about 325 kcal/day less than they had been eating before beginning this diet, indicating they had been restricting their intake and undereating for some time and likely had a recent history of dieting… diets that didn’t work. This would appear correct, as the only diet exclusion for this study was that the participants hadn’t lost more than 20 pounds in the past 3 months!

Here’s where it gets interesting.

There was no difference in the caloric intakes or the physical activities, or changes, among any of the groups throughout the 30-month ‘maintenance’ period. In other words, none of the expensive and intrusive interventions proved any more effective in encouraging behavioral changes than no interventions.

During the 30-month “maintenance” phase, the participants also actually continued to diet! Their caloric intakes rose only slightly (16 to 88 kcal/day) from their calorie restrictions during Phase I. At the end of the 30-month follow-up, the authors admitted the participants were still eating 231 to 326 calories per day less than they were at the start of the study — while they were all regaining weight. And remember, “changes in energy intake did not differ significantly between treatment groups.”

During the 30-month “maintenance” phase, their vigorous-moderate physical activity also dropped from their intense levels during Phase I, but only slightly. They continued to exercise 30 minutes/day, five days a week, gaining the health benefits attributed to physical activity. Some have suggested that activity might explain their regain, but it doesn’t. Their exercise times only dropped about 5 minutes a day during the maintenance period. Given their weights, ages and gender, this equates to a mere 161 calories a week. Nowhere near enough to compensate for the hundreds of calories less each day they were eating while continuing to diet trying to "maintain" a weight loss. This was not a blinded study and this select population appeared to be doing their best to comply with the study goals.

As we’ve seen in every weight loss study, weight regain is a biological reality for virtually everyone. Weight is not a matter of calories in-versus-calories out. Short term weight loss stunts are just that, temporary stunts. Sadly, unsuccessful dieters are typically blamed for “overeating” when they are not “overeating” as would be defined by any reasoned person, especially if nutritional health is our primary concern.

Examining the weight changes seen throughout the maintenance period, the authors reported there was “no significant differences between treatment groups.” In other words, none of the expensive and intrusive interventions proved any more effective in achieving long-term weight loss than no interventions. No mention was made of the adverse long-term health problems documented from repeated yo-yo dieting, losing and regaining weight.

Their comments and conclusions, however, were strikingly different from the study’s actual findings. They wrote:

The personal-contact intervention was effective across all subgroups… suggesting the potential for broad public health impact. Because most personal-contact intervention contacts consisted of monthly 10- to 15-minute telephone conversations, this is an efficient and practical mode of delivery.

[I]t is clear that preventing weight regain is extremely challenging. In fact, some observers have asserted that long-term success rates are so low that providing long-term behavioral weight loss treatments may ultimately be futile. However, our results suggest that clinically relevant weight loss maintenance is feasible. At the end of the study, more than 45% of those in the personal-contact intervention were still maintaining at least 4 kg of weight loss…

In conclusion, the majority of individuals who successfully completed an initial 6-month behavioral weight loss program maintained weight below their entry level after 30 additional months.

When you hear words like effective, success and maintain, remember that when it comes to obesity interests, just like results, definitions may vary.


© 2008 Sandy Szwarc

Disclosures. The authors report that the study was funded and sponsored by the National Heart, Lung, Blood Institute:

Some salary support for most individuals listed above was provided by the sponsor through the grants supporting this research, or, in the case of NHLBI project office, directly from the sponsor. Role of the Sponsor: The study sponsor participated in most aspects of the design and conduct of the trial and preparation of the manuscript.

The centers conducting this study offer weight management services, including case management and healthy lifestyle, wellness and fitness programs, with personalized behavioral and dietary education and support. For example, in addition to mainstream diets programs, such as Optifast meal replacement and Weight Watchers, Kaiser Permanente offers members personal health coaches and healthy lifestyle programs; and a full package of wellness products through its online service, Healthyroads. Through Healthyroads, people can access chiropractic care; acupuncture; massage therapy; fitness club memberships; herbs, vitamins and supplements; and health and fitness books and videos. Duke University offers a similar range of lifestyle and wellness programs, through its Duke Center for Living, Health & Fitness Center, Executive Health Programs and Lifestyle Retreats, Diet & Fitness Center, and Center for Integrative Medicine. Incorporated with clinical care, patients are encouraged to take control of their well-being through diet, exercise, positive lifestyle changes, and are offered complementary therapies, such as herbal medicine, acupuncture, massage, biofeedback, yoga, and mindfulness-based stress reduction. And Johns Hopkins Weight Management Center also offers a range of individualized programs.


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