Junkfood Science: August 2007

August 29, 2007


The latest issue of Health Freedom Watch, published by the Institute for Health Freedom, has a “this couldn’t happen in America” story.

The IHF reported that “the Minnesota Department of Health has been collecting and storing blood and DNA material on newborn babies without their parents’ consent.” The Citizens’ Council on Health Care (CCHC), a health-policy organization based in Minnesota, discovered that the health department has been illegally collecting DNA material for ten years and has DNA on at least 670,000 babies which it is giving away for genetic research.

Twila Brase, president of CCHC, said this violates the state’s newborn screening and genetic privacy laws. The CCHC has been working to get the health department to comply with state law and, so far, the Governor has failed to act.

Just a few weeks ago the news from the UK reported a similar story. Government law enforcement agencies in England and Wales want expanded powers to collect DNA material on citizens, creating a huge genetic databank. As the Daily Mail reported:

Speeding drivers face DNA swabs under new Big Brother powers

Drivers stopped for speeding - or even for failing to wear a seatbelt - could soon be placed on the 'Big Brother' DNA database for life. The most trivial offences, [sic] such as dropping litter, would also lead to samples being taken under sweeping new powers which police are demanding. The samples would stay on the database, alongside those of murderers and rapists, even if the people involved were later cleared of any wrongdoing....

[Police - backed by the Crown Prosecution Service] argue that, just because a person initially commits a low-level misdemeanour such as dog fouling, it does not mean they will not progress to the gravest crimes. A chance to take their DNA - making any future crime far easier to solve - would be missed without new powers. Police also want to take samples - usually a mouth swab - at the scene of the "crime." ...There are already four million samples on the database - including those of a million suspects who turned out to be innocent...

The Times revealed more facts about those 4 million DNA samples already held by the government, reporting:

There are almost four million samples on the database, including more than 100 of children aged under 10, even though they have not attained the age of criminal responsibility. A further 883,888 records of children aged between 10 and 17, and 46 records of people aged over 90, are held on the database, which cost more than £300 million. Baroness Scotland of Asthal, QC, the Attorney-General, admitted when she was a Home Office minister that three quarters of the young black male population would soon be on the DNA database.

The Human Genetics Commission, the Government’s independent DNA watchdog, yesterday announced the first public inquiry into the database. Baroness Kennedy of The Shaws, QC, chairwoman of the commission, said: “The police in England and Wales have powers, unrivalled internationally, to take a DNA sample from any arrested individual, without their consent. We want to hear the public’s views on whether storing the DNA profiles of victims and suspects who are later not charged or acquitted is justified by the need to fight crime.”

Lady Kennedy added: “The database has a preponderance of young men, with a third of black males currently on it. And anyone on it is there for life.

The public comments and debate are well worth reading. History is about to repeat itself, some warn. Benjamin Franklin’s famous quote was cited several times: “Any society that would give up a little liberty to gain a little security will deserve neither and lose both.” And some American commentators were unaware that it’s the new world order, not an issue exclusive to the UK.

While national security or science for the common good might sound like noble reasons for governments to gather genetic material of its citizens, that’s not what this is really about. And the potential for abuse and financial and political gain go far beyond anything George Orwell even envisioned. [Hopefully, everyone has read the classic novel, 1984, published in 1949 where Orwell describes the world under Big Brother. This historic book is available free here.]

The Council for Responsible Genetics, based in Cambridge, Massachusetts, hosts a website called Gene Watch with a collection of thought-provoking articles on abuses of our genetic material, such as genetic discrimination. It’s already happening:

Genetic Testing, Discrimination, And Privacy

The concept of “genetic discrimination” only recently entered our vocabulary. But the problem is well documented. In as many as five hundred cases, individuals and family members have been barred from employment or lost their health and life insurance based on an apparent or perceived genetic abnormality. Many of those who have suffered discrimination are clinically healthy and exhibit none of the symptoms of a genetic disorder. Often, genetic tests deliver uncertain probabilities rather than clear-cut predictions of disease. Even in the most definitive genetic conditions, which are few in number, there remains a wide variability in the timing of onset and severity of clinical symptoms. Employers have access to medical/genetic information, which may be used to discriminate against their employees. One recent example is the discrimination faced by workers in the Burlington Northern Santa Fe Railroad Company, which the Equal Employment Commission last year revealed to be conducting genetic tests on its employees without their informed consent, as a means of counteracting workers compensation claims for job-related stress injuries.

Beneath the issue lies an endless number of personal stories. A woman diagnosed with hereditary hemochromatosis, a condition that causes excessive iron storage, but the symptoms of which are preventable through medication, loses her health insurance despite clear medical evidence that she is healthy. A middle-aged man applying for a government job is denied employment after medical and genetic tests reveal that he is an unaffected carrier ....

The current patchwork of federal laws, including the Americans with Disabilities Act and the Health Insurance Portability and Accountability Act, hardly scratch the surface of the problem.... In all cases, state and federal laws have primarily addressed the unlawful use of genetic data, sidestepping the question of whether employers and insurance companies should have access to genetic information in the first place.

The most effective way to prevent the misuse of genetic information is to keep it confidential and securely out of the reach of outsiders. The right of privacy is recognized in common law and the Fourth and Fifth Amendments of the Constitution....

As one of the public commentators at the Times insightfully noted: “They want your DNA because of all the information it reveals about you. As the human genome is decoded, government, employers, insurance salespersons, banks, and everybody else will be able to read what diseases you are genetically predisposed to and make decisions affecting you without your control. Government et. al. will have this increased power over you, but you will not have any more power over your government. In fact, it is just one more means of rendering you helpless and vulnerable to the whims of bureaucrats who have their own interests in mind, not yours. Eventually all people will be monitored and controlled from cradle to grave - the journey of which is adjustable by those with enough power.”

This is so much bigger than public health and safety.

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August 28, 2007

Grand Rounds - the latest edition

The latest edition of Medical Grand Rounds is up at Improbable Optimism, with the top thirty medical articles on the blog (with extras in a second cut). It’s an unusually enlightened edition.

This week's theme is Narrative Medicine, pioneered by Rita Charon, an internist and professor at Columbia's College of Physicians and Surgeons. Narrative medicine isn’t some new age medical modality. It trains doctors and other caregivers to listen to their patients so that they can give better care.

Junkfood Science readers may find Mary's posts especially helpful. Mary, a psychiatric social worker, shared her anxieties about going to the doctor, even though her doctor is a “fat friendly” one. [That’s a term for doctors who understand weight issues and treat patients’ medical conditions without weight bias. They’re unlike the ones who tell every fat person to “just lose weight.”]

Mary found herself suffering the same symptoms her mother had at her age. Back then, her mother’s doctor had dismissed her and told her that her lung problems were simply because she was fat. Even though Mary knew her severe symptoms had nothing to do with being fat, the thought of going to the doctor still brought fears of humiliation and shame. There’s a happy ending, though, in a later post when her doctor came through for her. He proved to be the fat friendly doctor she always knew him to be and took care of her symptoms. She was amazed when "he said things no doctor has ever said before as far as I can tell from personal experience, media and the fatosphere: ‘Weight is only a very minor risk factor for heart disease.’"

Under the chapter, “Number Crunching,” Grand Rounds featured the recent “rigorous challenge to popular interpretations of data about bariatric surgery” from Junkfood Science.

Med Journal Watch was also alarmed by the misuse of statistics in this clinical trial. His post about the art of lying with statistics explained how the Swedish researchers were able to create a 30% reduction in mortality out of 1.3%. “Thirty percent...sounds impressive if we are not aware that this figure comes out of a statistical microscope....”

Among the other articles, see if you can find where “Sanity is madness put to good use.”

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August 27, 2007

Just because you’re paranoid, doesn’t mean they’re not out to get you. :)

One reader wrote in with a terrific comment, explaining why he doesn’t use his real name on those grocery store discount cards. He said he's just waiting for the insurance folks to figure out a way to access our food purchase records to make sure we’re “eating healthy.”

“I’m sure co-pays, deductibles and premiums will be adjusted accordingly. And most people will think it’s okay, as long as its ‘for the children,’” he wrote.

He was a lot closer to reality than he realized....

The News & Observer recently reported on a new tracking system that the government, drug and insurance industries are sure to pee their pants over:

Wireless tracking system would monitor patients

Confidant Inc. of Durham has partnered with packaging company MeadWestvac to a develop a wireless tracking system that can monitor when patients take their medications. The partnership, which will target drug and health-care companies, hopes to start selling next year.... “If we can also capture information about patients' prescription adherence, we'll have an even fuller set of data for health-care providers to deliver quality care," said Thomas E. Wall, vice president of business development and marketing. Patients who deviate from their medication treatment programs risk ....

MeadWestvaco Health & Beauty Packaging will craft electronically equipped packages for drugs and medical-devices that transmit data within those systems. Care providers, for example, will be able to monitor the blood-sugar level and insulin intake of a diabetes patient, Wall said. Unlike traditional pill bottles, packages would have to be designed with the capability to count off specific units of drugs as they are dispensed.

The system begins with a mobile phone that is programmed to capture data from home medical devices or prescription drug packages. It uses Bluetooth short-range wireless technology to transfer the data. The phone then automatically transmits the information to a server where it is cross-checked with patients' medical histories and treatment programs....

[Wall] said the system would also work as a behavior modifier, detecting when patients lapse on their prescribed regimens and issuing reminders.

[If you’re puzzled as to why health insurers are so interested in making us take our medicines, stay tuned.]

Thanks so much PB! :-)

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August 26, 2007

An advertising opportunity

Do you fill out those product registration cards? You know, the ones that ask all about your lifestyle, hobbies, the car you drive, products you shop for, favorite brands, age, marital status, salary, if you own or rent, etc. Many of us think we have to fill them out to validate a warranty and receive important product updates. Or, perhaps, we’re lured by the promise of special promotions, free products and discount coupons.

The same precautions about sharing our personal information on product registration and warranty cards apply to our health information.

The collecting of personal information for product registration is deceptive, said Chris Hoofnagle, deputy counsel with the Electronic Privacy Information Center in Washington, D.C. to Bankrate. “Product warranty cards are information collected under the pretense of a benefit where the information goes straight to marketers. The purpose of a product warranty card is not to protect you, it’s to collect marketing information.”

While they may appear harmless, the information is put into a database of consumer portfolios and sold to marketers, giving a vast array of people access to your personal information and putting your privacy and safety in jeopardy. “The people who don't send them back are in the know. The ones who do send them back are the biggest and best targets for marketing,” said Bob Blumash, creator of Illinois-based Private Citizen.

As careful as consumers may be about revealing personal information to product companies, few take the same care when it comes to volunteering private health information to third parties who aren’t their doctors or healthcare providers. Yet, online health risk assessments, offered by growing numbers of employers and insurance companies, ask for even more personal information about lifestyle habits, medical histories, and health. The information is compiled into electronic medical databases and used to identify people to be targeted for health tests, monitoring, education and health care management.

Many are promoted as online medical records to make it easier for consumers to put all of their records and health information in one place for ready access wherever they are. In return, besides free tote bags or discounts on their insurance, participants are given targeted health information to guide them to healthful behaviors. Growing concerns are being raised about these electronic databases, including how personal information is being shared, sold and used, especially as the marketing interests behind them are becoming better recognized.

Recently, Google has entered into the arena of online health care, raising a new set of concerns. It began with a new health information project to control information to what “trusted health community contributors” believe is relevant for you. As Adam Bosworth, Vice President of Google, explained last fall:

We have already launched some improvements to web search that help patients more easily find the health information they are looking for... If you click on “treatment," your search results are refined and reordered so that sites that have been labeled as being about treatment by trusted health community contributors are boosted in the rankings. Note that how trusted a contributor is — and thus how much they affect your search results — is dependent both on Google's algorithms and on who the user decides they trust...

Recently, we learned who makes up the “Google Health Advisory Council” and you’ve no doubt already noticed its influence when you’ve tried to research controversial health topics and news. Few medical professionals would deny the importance of patients learning about their disease and medications — from objective sources. That’s not this.

Mr. Bosworth went on to say:

This is just the beginning of what our industry can do... Health information should be easier to access and organize, especially in ways that make it as simple as possible to find the information that is most relevant to a specific patient's needs.

With Microsoft, they’re developing their own online health records “to enable people to make smarter choices about their health habits and medical care,” as the New York Times reported. Concerning Microsoft’s role in this new project, the newspaper added:

This year, Microsoft bought a start-up, Medstory, whose search software is tailored for health information, and last year bought a company that makes software for retrieving and displaying patient information in hospitals. Microsoft software is already used in hospitals, clinical laboratories and doctors’ offices, and as [Steve Shihadeh, general manager of Microsoft’s health solutions group] noted, the three most popular health record systems in doctors’ offices are built with Microsoft software and programming tools.

Microsoft will not disclose its product plans, but according to people working with the company the consumer effort will include online offerings as well as software to find, retrieve and store personal health information... Mr. Shihadeh declined to discuss specifics, but said, “We’re building a broad consumer health platform, and we view this challenge as far bigger than a personal health record, which is just scratching the surface.”

You’ve probably caught the recent blog buzz about Google Health’s online health record initiative, called Google Weaver. It is not an online medical record, it’s another health risk assessment with even broader marketing potential. It asks consumers to voluntarily share the very same personal information about their health and lifestyle habits as those online health risk assessments being offered by insurance companies and employers. There are pages asking family history, health history, lab test results, etc.

Take a look at this sample page entitled “Age, sex, height...” It asks for personal details, such as your birthday, gender, ethnicity, weight, smoking habits and if you drink alcohol:

Why does Google need this information and what can they do with it? Google already can track you via your IP address and direct you to sites and offers you personalized advertising for products and services based on your established preferences. But a database with detailed information about your health and lifestyle behaviors would be even more valuable for commercial interests.

Once people fill in the online health assessment, Google Weaver will offer custom “Health Guides.” Quoting from the Google Weaver prototype, Blogoscoped said:

Get the most out of Google Health — If your medical providers or pharmacy offer secure downloading of medical records, you can find and add your records to a profile. You can also browse for websites that connect securely to Google Health and provide services for managing your health care... When you add some information to your profile, Google Health will search trusted medical sources and create a health guide targeted for you. ... Google Health will check for relevant updates to your guide whenever you add new information to the profile.

You can use the health guide, Google writes, to learn about drug interactions, treatments, tests and preventive measures.

The health information you access from Google could be selected for you, even down to your internet searches — information you use in making healthcare decisions. Commercial interests who’ve purchased access to your online health data could guide you, through ads and content, to their products and services, and help you make the “right” healthcare decisions.

There is a very significant way online health records, like Google, differ from the medical records kept by healthcare providers and hospitals: They are not bound by any medical privacy laws.

“Even though the federal HIPAA law does not protect privacy ... it's important to understand that Google wouldn't have to comply with it,” said Twila Brase, RN, president of Citizens' Council on Health Care. Google is not a covered entity, she explained. “In fact, Google could share the data broadly. They could sell it to anyone, including insurers and government. They could use it anyway they wished. They could even create medical profiles on users.”

“The real danger here is not the loss of privacy, although that certainly is a problem,” she said. “The real danger is potential loss of personal control over medical decisions.”

“Personal control and patient privacy are not found in online electronic medical records... Health plans, hospitals, government, employers and the data industry will have ready computer access to comprehensive medical records on anyone,” Ms Brase said. The potential for abuse, such as using the information to deny medical treatment, insurance coverage or benefits, employment, or to financially penalyze those not complying with government or insurer treatment protocols, is very real.

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August 25, 2007

Was this really proof that bariatric surgeries save lives?

Not a single medical professional, scientist or journalist has dared take a critical eye to this study. That fact alone is the best evidence yet of the power of financial interests and bias. What is most disturbing, and should be for everyone who cares about research being used to learn the truth rather than sell us on something, is that this is about life and death.

Media outlets — professional and consumer — all came out with nearly identical stories and interpretations of this study on the same day — having, of course, received the same embargoed press releases providing the script. Great marketing, but it would have benefitted their readers, viewers and patients if one of them had done their jobs. Starting with reading the study.

Instead, we heard: “‘Weight loss’ surgery extends lifespan.”

According to the Pennington Biomedical Research Center press release:

Lars Sjöström, M.D., Ph.D., and Claude Bouchard, Ph.D., of the Pennington Biomedical Research Center, were members of an international research team that tracked more than 4,000 obese individuals for upwards of ten years. About half of the individuals underwent bariatric surgery (the general term for various forms of weight loss surgery), the other half received conventional treatments....Those results are published in the August 23rd issue of The New England Journal of Medicine and, according to the researchers, is the first major report to confirm that weight loss of this magnitude decreases mortality. To the contrary, according to the researchers, some studies had reported in the past that weight loss was associated with increased mortality....

Led by Lars Sjöström, professor at the University of Gothenburg Medical Center and an adjunct and visiting professor at the Pennington Biomedical Research Center, the researchers examined 4,047 obese subjects in a long-term study called the Swedish Obese Subjects (SOS) study. 2,010 underwent bariatric surgery in one of three forms: gastric bypass, vertical-banded gastroplasty or banding while 2,037 subjects received conventional weight loss treatments. The researchers then tracked the weight, behavior and health indicators of the subjects for an average of 11 years.

The average 11-year weight loss of the non-surgery group was less than 2-percent, while the average weight loss among the three surgical groups ranged from 14 to 25-percent. During the study, researchers recorded 129 deaths in the non-surgery group and 101 in the surgery group, most commonly caused by myocardial infarction and cancer. This result indicates a 23-percent reduction in total mortality within the surgical groups.

“We count these results as a milestone in our understanding of the benefits of bariatric surgery for obesity,” Bouchard said. “We are confident in the results and believe this will lead to an acceptance that bariatric surgery is a viable, life-saving option for severely obese patients.”

The glowing, one-sided coverage by the Washington Post was typical of the news around the world. It quoted:

· An editorial by Dr. George Bray, also of the Pennington Center, saying: “The question as to whether intentional weight loss improves life span has been answered. The answer appears to be a resounding yes.”

· Dr. David Flum, of the Department of Surgery, University of Washington, Seattle, and lead author of the largest report on actual mortality rates of bariatric surgeries done in the United States, saying: “This is very exciting...This is huge.”

· Dr. Louis Aronne, director of the Comprehensive Weight Control Center in New York City and co-chair of GlaxoSmithKline’s Reality Council, adding: “Now we have proof. These papers represent a milestone.”

· Kelvin Higa, president of the American Society for Metabolic and Bariatric Surgery, calling it another landmark study.

Missing throughout the media were viewpoints and analyses from professionals without financial interests.

Even this study entitled, “Effects of Bariatric Surgery on Mortality in Swedish Obese Subjects,” was funded by grants from Hoffmann–La Roche, AstraZeneca, Cederroth, and the Swedish Medical Research Council. [See below for the financial disclosures of the authors.]

Medical professionals who’ve followed the inordinate complication rates, the long-term health and nutritional problems, and excessive death rates documented by all objective sources, as well as those who’ve personally watched as fat friends and family die, have good reason to examine this study more closely.

As Junkfood Science regulars know, study designs can be manipulated in countless ways to help lead to whatever conclusions the authors or sponsors set out to "prove." Ideally, such problems are less widespread in clinical trials since people have risked their lives for science, but, sadly, that is not always the case. The tactics, however, can be hard to see and take an especially discerning eye. This study offers a valuable example of things to consider whenever you come across a study that claims to have found something that no other careful study has been able to find. As even the study authors admitted, “our observations are at variance with most other observational studies regarding weight loss.”

Since a comprehensive examination is beyond what most readers have time to read, we’ll look at just a few of the more obvious flaws in this paper. Even this simplified look will show that the actual facts presented in this study are quite different from what we’ve been hearing in the media. So, let’s dig in.

Years of follow-up

We’ll begin with one of the most common misconceptions: years of follow-up. Since this study was examining the long-term effects of bariatric surgery on mortality, it’s understandable you might think that the average 10.9 years of follow-up reported meant the patients were followed for 10.9 years after having surgery. Here is the first example of not reading the study. The follow-up period — which actually ranged from 4 to 18 years — began from the “matching date.” That was the date that the study recruitment campaign ended and the surgical candidates were chosen and matched with controls. This was about 1 1/2 years before the surgeries were actually performed. So, we’re down to just over an average 9 years of post-surgical follow-up.

While the authors spent pages describing weight loss year-by-year through 15 years (which we’ll see in a moment is useless data), when it came to reporting mortality, they lumped all of the causes of deaths together. There were holes in the data reported. They provided no detailed breakdown information on how the people died over the years. The greatest number of deaths occurred after ten years and the number of deaths rose most significantly the further out from surgery the patients were. Yet most of the available mortality data and patients in this study were newer post-ops still in the first 5-8 year honeymoon period, ameliorating the overall mortality rates and the worsening long-term outlooks. There were fewer older surgical patients in this study — only 760 patients were 12 years post-op, only 422 were 14 years out, and only 169 were 16 years out.

Types of surgeries

Not all bariatric surgeries are the same or have the same rates of complications and deaths. The SOS study began in 1987 and the patients underwent three types of surgeries. Most (68%) had vertical banded gastroplasty (VBG). Another 18% had banding and only 13% had gastric bypass. This is significant for several reasons.

This study involved a mix of procedures that's not remotely reflective of the surgeries performed today, especially in the United States. Among 16,155 bariatric procedures performed in the United States from 1997 to 2002, for example, 81% were gastric bypasses, 8.9% were VBGs, and 2.1% were bandings.

The shorter followup periods (4+ years) in the SOS study are more likely to reflect contemporary procedures, but not provide long-term data. The SOS study gives no breakdown of mortalities based on types of surgery, however, to enable anyone to find figures that are relevant for patients today.

As Dr. Michel M. Murr, MD, FACS, Director of Bariatric Surgery at Tampa General Hospital in Florida, and colleagues reported in the January issue of Bariatric Times, VBG was the operation of choice during the 1980s. It has fallen out of favor, however, because of its ineffectiveness for long-term weight loss and its significantly higher incidences of long-term complications, leading up to 36% of patients seeking revisional surgery. According to all surgical research to date, secondary operations have higher mortalities and morbidities compared to initial surgeries.

As the clinical trials for FDA approval of lap bands reported, banding patients also suffer high rates of complications (89%). Long-term complications are especially severe, and one of the U.S. centers that have been performing bands the longest recently reported 41% of patients have second surgeries to remove them because of intolerable side effects and another third were currently wanting second surgeries to have their bands removed or get gastric bypass because the bands had resulted in inadequate weight loss. One of the first long-term studies on bandings reported that 7 years post-op, 58% of patients had been reoperated on to have their bands removed or converted to bypasses.

The SOS researchers reported that 31% of their banding patients, 21% of the VBG and 17% of their gastric bypass patients had had reoperations or conversion surgeries because of poor results. (These don’t include those due to post-op complications, they said. Yet, the only additional information on reoperations provided was that 26 patients had immediate post-op complications serious enough to necessitate reoperations.) While this study was reporting on bariatric surgery-related mortalities, there were no surgical-related deaths listed among the “Causes of death.” A footnote reveals there were five deaths within the first 90 days after the study initiation among the surgical patients. “Three of these fatalities were due to gastrointestinal leakage detected too late. One death was caused by a technical mistake during a laparoscopic operation and one by postoperative myocardial infarction,” according to Anna Ryden, Ph.D. and Jarl S. Torgerson, M.D., Ph.D. in an SOS report published in Surgery for Obesity and Related Diseases last fall.

Nor do the SOS researchers offer any explanations for why their mortality figures about 9 years after surgery (5%) are similar to real-life ones seen among American bariatric patients after just the first year. The study by Dr. Flum published in the October 2005 issue of JAMA, for example, reported that for bariatric surgery patients of the same average age as the SOS study patients (47 years), the one-year mortality rates were 4.1% overall (7.7% for men and 3.1% for women).

Lost in follow-up

As we’ve talked about this before, it warrants only a brief reminder. Extraordinarily high “lost in followup” (attrition) rates are common in bariatric and diet studies, meaning that most studies typically have data on fewer than half the original patients. This makes it much easier to report favorable outcomes, as a higher proportion of those who drop out of weight loss studies are those not having good results. But using data on only a small fraction of the original population makes any claims that an intervention is responsible for changes in health indices or weight loss uncredible.

At year ten, the SOS researchers had data on only 31.8% (641) of the original surgical group!

Even with these enormous gaps in the data, the SOS study reported a uniform trajectory of weight regain among all of the remaining surgical patients from years 1 through 8, which continued steadily upward for the banding patients through year 15. They also found no significant correlation between the degree of weight loss and later mortality. “The low cumulative mortality in our study hindered the detection of modest differences.”

But when reporting mortality figures, the authors used social security numbers to cross-check their database against the Swedish Population and Address Register to locate those who had died. They said they found vital statistics on all but three of the original study participants as of November 1, 2005. Does this make their mortality claims any more relevant? Of course not.

Did you catch the leap of logic? The researchers have no idea what’s been happening for nearly a decade to more than two-thirds of the patients they’d operated on ten years earlier. Yet people are ready to believe that the surgery is responsible for purported improved mortalities.

That would be like attributing your beautiful smile to a cleaning a dentist had done ten years ago, ignoring the countless other interventions (dental procedures, sealants, fluoride treatments, antibiotics, etc.) done in the meantime. [Or, perhaps you have rotting teeth ten years later. Lots of other things might explain those, too.]


The biggest problem with this study not only sets it apart from gold standard clinical trials, but calls into question every one of its conclusions. Incredibly, even the authors pointed out this problem, yet the media, medical and scientific communities have completely overlooked it.

Randomization, where study participants are randomly selected and grouped by chance, is the most important way to help ensure that intervention and control groups are comparable (even in ways researchers may not have considered) and that the participants haven’t been hand-chosen to manipulate the findings towards a predetermined conclusion. Randomization prevents stacking the deck, so to speak. While randomization isn’t always ethically possible in human studies, when there has been no randomization, a study needs to be examined with an especially critical eye. Without randomization, findings are less likely to be defensible.

The selection of intervention and control groups can be maneuvered in unimaginable and subtle ways, but the cumulative results can virtually guarantee researchers their findings will satisfy their sponsor.

The SOS study began with a massive recruitment campaign that ran 13.4 years (September 1987 to January 2001), in which application forms were sent out to 11,453 people. It was initially a registry and longitudinal intervention study, with a population study added later. The obese people for the registry study had extensive health examinations performed at 480 collaborating primary healthcare centers in 19 Swedish counties. “Obese subjects were characterized in great detail with respect to medical history, metabolic aberrations, adipose tissue distribution, food habits, and psychological, socioeconomic, and genetic variables,” explained Drs. Ryden and Torgerson. Finally, 2,010 individuals had been carefully selected for the surgical arm and invited to participate based on “detailed inclusion and exclusion criteria.” And 2,037 people were matched using a computer algorithm that took 18 variables into account...

SES. What factor plays one of the most important roles in health outcomes and healthcare that is always controlled for in the most careful medical research? Socioeconomic class/status. The researchers had this information on all of the applicants, yet SES was the most obviously missing variable in their study and one they specifically chose not to control for. That does not mean it wasn’t part of their selection process.

They also chose to not control for other factors, such as genetics/family history, dieting behaviors or physical activity. The SOS study also made no mention of race or ethnicity. All are well-known factors that can affect health and mortality outcomes.

AGE. What is the single strongest predictor of mortality? Age, of course. Even the authors revealed that in both of their computer models of hazard ratios for overall mortality, age was the strongest predictor.

Yet, the people selected to be in the control group for this study were older than the surgical group, by about 1.5 years. As the authors said, this significant difference “would benefit survival in the surgery group.” As expected, mortality among the older participants (over age 47.8) in the control group was higher.

An interesting note regarding age was found in the supplemental data. A greater percentage of younger patients (under 47.8 years) died in the surgical group than the control group. The younger adults had a 50% greater chance of dying having surgery than if they hadn’t had it. The study authors provided no explanation.

PRE-EXISTING CONDITIONS. The authors stated: “Overall mortality was higher in subjects who had had cardiovascular events (myocardial infarctions [heart attacks] or stroke) before baseline [surgery] than in subjects without such events.”

Yet, the people selected for the control group had 25% higher rates of previous heart attacks and strokes, compared to the surgical group. They also had 6.5% higher rates of diabetes at the time of surgery. Not surprisingly, the mortality rates reported for the controls were higher than other general population studies for people of similar size and age.

Are you starting to see why randomization is so important?

With all of this, we might expect dramatically better mortality rates among their bariatric surgical patients as compared to their controls. The fact there wasn’t lends further question as to the value of bariatric surgery. The difference in actual mortality was a mere 1.3% between their surgical and control groups. In statistical reality, no difference. No better than chance!


There is another finding that wasn’t reported in the news but is valuable to note, especially given that bariatric interests are using this study to support bariatric surgeries for the “severely obese.” Those with BMIs ≥40.8 (where bariatric surgery is recommended) who had bariatric surgery had higher risks of dying than those of the same size who didn’t have surgery. Those with BMIs ≥40.8 who had bariatric surgery were 43% more likely to die over the follow-up years than those with the same BMIs in the control group. This is also what other studies to date have reported.

And also confirming other studies, more men died after bariatric surgeries than women. Men actually increased their risks of dying by having the surgery than if they didn’t.

I hope this was a valuable exercise in the importance of looking closely at studies and media claims. The study authors concluded that “bariatric surgery for severe obesity is associated with...decreased overall mortality.”

That is true as far as it goes, but as we’ve seen, it doesn’t begin to tell the full story.

© 2007 Sandy Szwarc

Financial disclosures of the authors of “Effects of Bariatric Surgery on Mortality in Swedish Obese Subjects:”

Dr. L. Sjöström reports receiving grants from Sanofi-Aventis and Ethicon and lecture and consulting fees from AstraZeneca, Biovitrum, Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Lenimen, Merck, Novo Nordisk, Hoffmann–La Roche, Pfizer, Sanofi-Aventis, and Servier, having an equity interest in Progenit, NMCT, and Lenimen, and serving on the board of directors for NMCT, PMCT, and Lenimen; Dr. C.D. Sjöström, receiving consulting and lecture fees from Sanofi-Aventis.

Dr. Lystig, being employed by AstraZeneca and having an equity interest in the same company and Amgen.

Dr. B. Carlsson, being employed by AstraZeneca and having an equity interest in the same company.

Dr. Jacobson, receiving research grants from Hoffmann–La Roche; Dr. Karlsson, receiving consulting fees from Pfizer.

Dr. L.M.S. Carlsson, receiving consulting fees from AstraZeneca and having an equity interest in Progenit and Sahltech.

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August 24, 2007

How real is the crisis of undiagnosed high blood pressure in children?

Worrisome news hit parents this week that more than a million children have high blood pressure that’s not being diagnosed by their pediatricians. Childhood obesity was blamed for growing numbers of children with elevated blood pressures. Before parents become alarmed that their pediatricians aren’t caring for their children properly, or that they need to put their kids on weight loss plans to prevent them from having organ damage, strokes and heart attacks, they’ll want to learn a few things about this study that the news hasn’t reported.

There are a few key questions to ask: How was blood pressure measured, how was “high” blood pressure defined and how was a “diagnosis” of high blood pressure determined?

First the news....

The Associated Press reported:

Many kids' high blood pressure undiagnosed

More than 1 million U.S. youngsters have undiagnosed high blood pressure, putting them at risk for developing organ damage down the road, a study suggests. Calculating elevated blood pressure in children is trickier than in adults, and many doctors may not bother evaluating kids' numbers because they assume that hypertension is an adult problem.

But the study shows that many children are affected, too, said lead author Dr. David Kaelber of Case Western Reserve University in Cleveland and Harvard Medical School. Roughly 2 million U.S. youngsters have been estimated to have high blood pressure; the study suggests that three-quarters of them have it but don't know it. The numbers are driven at least partly by rising rates of obesity, which is strongly linked with high blood pressure....

The researchers analyzed medical records for 14,187 healthy children aged 3 to 18 who had at least three checkups in northeast Ohio between June 1999 and last September... The researchers calculated that 507 study children had high blood pressure, or 3.6 percent, which is within estimates for the nationwide prevalence of high blood pressure in children. But only 131 of them, or 26 percent, had a documented high blood pressure diagnosis....

The Telegraph, like most television news, added fears about obesity:

The obesity epidemic is causing an increase in the number of children with high blood pressure, doctors have warned. New research has shown that the problems with obesity is causing conditions previously only seen in adults to be diagnosed in children....The team warned that doctors need to be more aware of the condition.

Listening to the news, most parents probably came away thinking that blood pressures have been rising in children and teens — when, in fact, there is no evidence that they have risen in decades (due to obesity or anything else). Many parents this week understandably thought that it must be important to watch their children’s blood pressures to protect them from heart disease and organ damage. Few heard that this is controversial in the medical community, nor did they hear of the uncertainties of blood pressure readings in growing children. Instead, parents heard frightening quotes like the one from Dr. Reginald Washington, a member of the American Academy of Pediatrics obesity task force, who said: “We can't wait until they've had a stroke to figure this is a problem.”

As has been extensively reviewed, there is no epidemic of heart attacks and strokes among kids, nor has any clinical research shown that kids’ blood pressure measurements identify those at risk of later developing heart disease or that treating their blood pressures decreases the incidence of cardiovascular disease in adulthood. The U.S. Preventive Services Task Force, after reviewing all available clinical evidence, recently concluded that the evidence is insufficient to recommend routine screening for high blood pressure in children and adolescents to reduce their risks for cardiovascular disease.

Despite the media’s focus on the dangers of high blood pressure in children, this new study did not find a single child who had been harmed by their blood pressures. It didn’t examine a single child at all.

This is another example of the need to look carefully at exactly what is being reported. I highlighted three phrases in the Associated Press story — medical records, calculated, documented — as clues. Let’s look at their meaning more carefully.

"Medical records"

The authors of this latest journal article culled through an electronic database of medical records on 14,187 children — not all children, just those in a Ohio health plan whose pediatricians’ offices had taken three blood pressure readings during well child visits and recorded them electronically. The blood pressures had been recorded during routine clinical care, using automated equipment. The significance of this bit of information will be recognized by Junkfood Science readers. [For those who missed it, blood pressure readings in children were covered extensively here.] Not only are 74% of blood pressures taken by clinical staff, especially using automated equipment, inaccurately high (by about 13.2 mmHg systolic and 9.6 mmHg diastolic), but larger children are most likely to have incorrect high readings. Offices routinely don’t control for appropriate cuff sizes, technique and equipment calibration, activity levels, excitement/anxiety, pain, asthma, or fevers in children when their check-in blood pressures are taken, for example.

The authors admitted: “We had no way to independently assess the accuracy of the blood pressure measurements in the electronic medical records or the degree to which the blood pressure procedures were followed.”


Then, to calculate the children they believed had high blood pressure, they arbitrarily labeled every child at or higher than the 95th percentile for age, sex and height as having “high” blood pressure. Children at or higher than an arbitrary 90th percentile cut-off were deemed to have “prehypertension.”

Of course, well-established facts are that blood pressures rapidly increase during growth and maturation and kids and teens are growing quickly and are varying stages of growth and development at any particular age and size. The idea that fat children whose blood pressure measurements naturally fall a few mmHgs over arbitrary limits for their age are in danger and in need of intervention to prevent heart disease is being popularized by vested interests, but unsupported by the evidence.

The tables being promoted by the authors of this study are from the Fourth Report on the Diagnosis, Evaluation, and Treatment of High Blood Pressure in Children and Adolescents and are far more controversial and arbitrary than most parents, and clearly the media, realize. For example, there is a difference of one mmHg between the 90th and 95th percentile for systolic blood pressures among boys at every age. And the definitions for normal blood pressure, increases at each year of age by a mere one or two mmHg, leaving little room for error. The tiniest error in a blood pressure reading can tip a child into being misdiagnosed as “hypertensive” yet, as we’ve seen, blood pressure readings taken at most offices vary by considerably more than that.


The authors of this study defined the children who were “diagnosed” with hypertension as being that same as those checked off as “hypertensive” on ICD-9 codes. These codes (from the International Classification of Diseases, Ninth Revision) give a number to some 12,000 conditions and are used on billing claim forms by insurance companies for reimbursement purposes. Their inaccuracies in reflecting actual patient conditions is well documented. In today’s pay-for-performance, labeling a child as hypertensive also comes with a slew of mandated tests and interventions. The Fourth Report recommends extensive testing, lifestyle interventions (beginning with weight reduction), treatments and medications for children labeled as hypertensive.

The fact that a pediatrician doesn’t believe a growing child or teen whose blood pressure reading is a few points “high” on a standardized chart is diseased or benefitted by being labeled as “hypertensive” could be seen as sound medical judgment. As the U.S. Preventive Services Task Force latest review of the evidence noted, the evidence is most supportive of the merits of treating extremely high levels, not lesser numbers, and it found no evidence to support increasingly more aggressive blood pressure management goals.

Not putting “hypertensive” on a billing claim form is not the same thing as a pediatrician failing to recognize, treat or care for children with true high blood pressures. [See the recent review of hypertension in children for the medical issues doctors do watch for.]

The authors of this study said: “This low diagnosis rate could be accounted for by two primary factors: (1) lack of knowledge of normal blood pressure ranges and (2) lack of awareness of a patient's previous blood pressure readings...clinicians typically cannot remember normal blood pressures for the wide range of children observed in the typical primary care setting.” Besides being insulting to medical professionals, for whom blood pressure is a notable part of their medical training, pediatricians are quite capable of remembering normal values or how to look at a table if they “cannot remember.” Pediatricians who aren’t monitoring the blood pressures among healthy children aren’t doing so because they can’t be bothered, as the Associated Press suggested, but more likely because they have kept abreast of the medical research.

The authors concluded: “[I]n well-child care visits, clinicians should be focused on screening and prevention of diseases including hypertension.” They provided no new clinical evidence for this “should,” however, and it is inherent upon them provide it since, as the U.S. Preventive Services Task Force found, currently, the evidence is insufficient to recommend routine screening for high blood pressure in children and adolescents to reduce their risks for cardiovascular disease.

Nor is there any grounds for millions of parents to fear for their children or that pediatricians are putting their children in danger.

© 2007 Sandy Szwarc

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August 22, 2007

When is advocacy for you?

The Canadian Obesity Network believes 500,000 Canadians are in need of obesity treatment, specifically bariatric surgery. Years of lobbying the Ontario government to increase funding for bariatrics are paying off, in part because of a uniquely Canadian argument that CON was able to use.

A Ministry of Health press release has recently announced:

McGuinty Government Improving Access to Treatment for Severe Obesity

The McGuinty government is bolstering support for Ontarians who are fighting severe obesity by providing $700,000 to add more bariatric outpatient services at the Hamilton Health Sciences bariatric clinic, Health and Long-Term Care Minister George Smitherman announced today.... The growth of this program will improve patient accessibility for preliminary assessment, and ongoing treatment of the morbidly obese, in an outpatient clinic setting. It has been designed to provide an integrated range of services that will work in conjunction with the bariatric surgical Centre of Excellence ...

“This announcement is welcome news for Hamilton,” says Canadian Obesity Network Scientific Director and McMaster University Professor Dr. Arya M. Sharma. “Obesity is a complex and widespread disease that requires significant resources to address effectively, and I congratulate the Ministry on its decision to expand access to bariatric treatment for the many people in the region who will benefit from it.”...This is just the latest example of how, working together, Ontarians have achieved results in reducing obesity. Other initiatives include :

* Investing over $3.8 million for 225 additional bariatric surgeries and related capital expansions at Humber River Regional Hospital and creating Ontario’s first bariatric centre of excellence

* Launching EatRight Ontario telephone information service that provides healthy eating and nutrition advice to Ontarians....

* Launching a $10 million Healthy Eating and Active Living (HEAL) Action Plan designed to encourage all Ontarians especially youth to live a healthy, active lives.

As Dr. Sharma told the Edmonton Journal last week, “the Canadian Obesity Network (CON) has made great strides towards uniting Canada’s resources in the fight against obesity. This opportunity will allow us to expand its reach and open up new possibilities for our members.

For those unfamiliar with CON, it’s a coalition of weight loss, obesity and bariatric industry interests, government and policy makers, and universities. The lists of partners and supporters involve an extensive network of financial concerns. This partnership works to lobby for obesity treatment and public policies, according to its website:

The full weight of the obesity problem in Canada is only now coming into focus, and the news thus far is bleak. The crisis ...and its negative impact on our health, quality of life and economy is profound.... The Canadian Obesity Network (CON) facilitates effective partnerships that aim to remove the traditional barriers separating university research, private sector commercialization and the public use of research results. In an environment with ever-diminishing resources, economic factors play a key role in decisions about resource allocation, and so CON forges diverse partnerships designed to drive innovation forward and efficiently build Canada’s capacity to address the obesity dilemma.

CON’s influence over government spending and health policies also extends to the development of clinical practice guidelines for doctors, such as the “Canadian clinical practice guidelines on the management and prevention of obesity in adults and children” released this past April. It opens with warnings of the “alarming” problem of obesity, claiming it’s a pressing public health problem and that one in ten people die prematurely “directly attributable to overweight and obesity.” The epidemic of obesity in Canada, it says, costs Canadians $2 billion a year.

The clinical guidelines, themselves, are very similar to those recently released here in the U.S.: a focus on BMI and extensive and regular laboratory testing of fat people from the age of ten years; suggested screening for mood and psychiatric disorders and medications to be considered; a weight management program with diet and lifestyle interventions, and counseling by a clinical psychologist; prescriptions are suggested for those not able to maintain weight loss, including orlistat for adolescents; and bariatric surgery for BMIs ≥ 40 or ≥ 35 with health problems “when lifestyle intervention is inadequate to achieve healthy weight goals.”

Dr. Sharma, CON science director who was on the committee which developed the clinical guidelines, has repeatedly noted that “the track record for all commercial weight-loss programs in delivering lasting weight loss is pretty negligible, and there’s virtually no scientific evidence to back up the claim that many of the commercial weight-loss centres make.” Of course, the well-known failure of the usual lifestyle, diet and exercise interventions would lead to pharmaceutical and bariatric interventions.

Canada’s clinical practice guidelines, according to its acknowledgements, were developed with “financial assistance provided in the form of arm’s length grants-in-aid” — (Was this odd phrase an attempt to lead people to believe there were no strings attached and that the sponsors had nothing to gain?) — “from Abbott Laboratories Ltd., AstraZeneca Canada Inc., GlaxoSmithKline Inc., Merck Frosst Canada Ltd., Pfizer Canada Inc., Hoffmann–La Roche Ltd., Johnson and Johnson Medical Products, sanofi-aventis Canada Inc. and Unilever Canada Inc.”

Similarly, the competing interests declared among the Obesity Canada Clinical Practice Guidelines Expert Panel members, themselves, who developed the guidelines include extensive ties with pharmaceutical interests.**

Yet pharmaceutical ties aren’t the only interests that deserve note. Dr. Sharma, for instance, is probably unfamiliar to most readers here, but he is known in Canada not only for having been instrumental in the creation of CON, but also as the Chair of Obesity Research and Management at McMaster University and Hamilton General Hospital in Ontario. He’s visibly worked for years to promote bariatric surgery and lobby for government funding for bariatric centers, established one of Canada’s first bariatric centers and was on the planning committee for the McMaster Bariatric Conferences, sponsored by Sanofi-Aventis, Johnson & Johnson, and Abbott pharmaceutical companies.

Soon after leaving Berlin, Germany, where he was a professor of nephrology, to join McMaster University as “an obesity professor” [his emphasis], he wrote a 2004 editorial in Obesity Surgery explaining his goals and describing obesity as a deadly malignancy:

Bariatric Medicine without Surgery is like Nephrology without Dialysis

[I]t took several years of working in nephrology before I fully accepted that, despite its often devastating impact on quality of life and its rather marginal impact on survival, hemodialysis is indeed a valuable and viable treatment option for patients otherwise faced with certain death...

My arrival in Ontario as the ‘obesity expert’ was heralded by the local media. Within weeks of my arrival, referrals for patients began coming in... All had significant histories of weight loss attempts, ranging from Weight Watchers and very low- calorie diets to rather questionable ‘medically supervised’ commercial weight loss programs. Many had also failed on pharmacotherapy. None had thus far been offered surgical treatment - the few who had tried to find surgeons in Canada soon discovered that there were only six surgeons performing obesity surgery in the province (population 9,000,000), none of whom were accepting referrals....

[F]rom all that I have read and seen so far, obesity surgery for morbid (or should we call it malignant?) obesity appears far more successful in terms of improving quality of life, resolving co-morbidities, and promoting physical, mental, and socioeconomic rehabilitation than either hemodialysis or renal transplantation for patients with end-stage renal failure...

Recognition of the important role of obesity surgery in the treatment of morbid obesity by internists and family physicians, and their commitment and dedication to the long-term medical management of patients who have undergone bariatric surgery, is long overdue. For my part, I will undertake all that is necessary to establish bariatric surgery as an important and much needed surgical program at our university medical center.

One of the arguments that he and other members of CON have used for years that’s resonated with the media has been to appeal to cost savings, saying that sending patients to the United States wastes money that should stay in Ontario. Because there are so few bariatric facilities in Canada, the government is spending millions of dollars to send Canadians to the United States for bariatric surgery, Dr. Sharma said. He has recommended these funds be kept in Canada and go to bariatric facilities and surgeons in Canada because that money could be used to do twice as many surgeries in Ontario.

Last month’s story from the news bureau at CTV, Canada's largest private broadcaster, is typical. CTV reported that Ontario, like most provinces, is unable to handle the requests for bariatric surgery, so patients come to the United States. They are paying $50,000 to $80,000 apiece for the surgeries, and sometimes over $100,000 — money that bariatric interests argue are better spent in Ontario. Dr. Mehran Anvari, a bariatric surgeon seeking government funding for his facility in Hamilton said: “We estimate $40 million to $50 million a year going to the U.S for obesity surgery... for that same money, we could meet the demand for bariatric surgery for the whole of Ontario.”

While some believed that the government’s announcement this past week meant more funds were being directed for improved care for fat people — going towards better access, larger blood pressure cuffs, wheelchairs and stretchers — Dr. Sharma pointed out, the need for these major investments was to gear up for the expected obesity epidemic and expanded bariatric treatments.

As health minister George Smitherman told reporters at this past week’s announcement, the funding will shorten wait lists and help to keep bariatric surgeries in Canada. He promised additional funding in the new future, saying: “In the next several years in Ontario, I would anticipate that these services will grow by something like six, eight or tenfold,” he stated. “We're at the beginning of a very, very dramatic expansion of services for obese individuals.”

Sadly, patient advocacy isn’t always what it seems, as was recently reviewed here. Governments and health officials are readily influenced by those with the money, power and interests to push the hardest to get what they want. That does not mean the same thing as being what may help the most people or be what is best for patients.

Aren’t supplies, equipment and diagnostics, such as open MRIs, to accommodate people of larger sizes needed at all healthcare facilities and not just bariatric surgery and weight loss centers?

While an additional ten million dollars was also allocated to tell people how to eat and live “healthy,” countless parents waiting more than 7 months to get needed surgeries and tests for their sick babies and children, for instance, might have preferred the government have devoted money towards expanding pediatric services, rather than bariatrics. There is nothing here in the U.S. like the website established for desperate Canadian parents to understand the wait times they can anticipate. Ontario’s Pediatric Surgical Wait Times and assistance for parents of sick children can be viewed here. It was heartbreaking to read about the scared young mother who had to be flown 300 miles out of the country, far from the support of family and friends, to deliver her premature quadruplets in the U.S. because there was no space or staff in a single neonatal intensive care unit (NICU) in all of Canada. [We share their joy, though, that the adorable babies are all healthy and send congratulations to the new parents!] As a 2002 issue of Pediatrics reported, there are only 0.72 such units/10,000 live births in Canada, compared to 1.21 units/10,000 live births in the U.S. There are also only 3.3 neonatologists/10,000 live births in Canada, compared to 6.1 here.

For Canadian patients awaiting surgery and treatment for cancers to heart disease, many provinces are posting their wait time information on the internet on Wait List Registries.

But CON successfully ensured that waiting times were shortened for bariatric surgery.

© 2007 Sandy Szwarc


Declared competing interests of the members of the Obesity Canada Clinical Practice Guidelines Expert Panel:

David Lau owns common shares in GlaxoSmithKline and Eli Lilly. He is a consultant to Abbott Laboratories, Ltd., AstraZeneca Canada Inc., Merck Frosst Canada Inc., Bristol-Myers Squibb Canada, Eli Lilly Canada Inc., Oryx Pharmaceuticals Inc., Pfizer Canada Inc., sanofi-aventis Canada Inc., Servier Canada Inc. and Solvay Pharma Inc.; and has received speaker fees from Abbott Laboratories, Ltd., AstraZeneca Canada Inc., GlaxoSmithKline, Merck Frosst Canada Inc., Merck/Schering, Eli Lilly Canada Inc., sanofi-aventis Canada Inc. and Novo Nordisk Canada Inc.; research grants from AstraZeneca Canada Inc., Bristol Myers Squibb, Dainippon Pharmaceuticals, GlaxoSmithKline, Pfizer Canada Inc., and sanofi-aventis Canada Inc.; and travel assistance to attend international meetings from Abbott Laboratories, Ltd., AstraZeneca Canada Inc. and sanofi-aventis Canada Inc.

Irene Hramiak is a consultant to GlaxoSmithKline Inc. and is on a National Advisory Board for Abbott Laboratories Ltd., Eli Lilly, Novo Nordisk, sanofi-aventis Canada Inc. and GlaxoSmithKline Inc. She has received honoraria for speaking engagements from Merck Frosst Canada Ltd., GlaxoSmithKline Inc. and Novo Nordisk and has received a travel grant from Novo Nordisk.

Arya Sharma is a consultant to Abbott Laboratories Ltd., Boehringer Ingelheim, Novartis, sanofi-aventis Canada Inc. and Merck Frosst Canada Ltd. He has received speaker fees from Abbott Laboratories Ltd., Boehringer Ingelheim, AstraZeneca Canada Inc., Novartis and Merck Frosst Canada Ltd. and travel assistance from Abbott Laboratories Ltd., Boehringer Ingelheim, Merck Frosst Canada Ltd., Novartis and sanofi-aventis Canada Inc.

Ehud Ur has received speaker fees from sanofi-aventis Canada Inc., Abbott Laboratories, Ltd., GlaxoSmithKline and Novo Nordisk; research grants from GlaxoSmithKline and Novo Nordisk; and travel assistance from sanofi-aventis Canada Inc., Abbott Laboratories, Ltd.

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August 19, 2007

Yes, they actually make this stuff up!

Tragically, parents were given another bogus scare today, as news warned that fat babies could die from SIDS. Before new parents panic, they’ll want to learn the source for this story. It wasn’t based on any research, but the most illogical contortions of the evidence, speculations and scaremongering.

The Australian Daily Telegraph reported:

SIDS risk for fat babies

FAT babies may be at higher risk of Sudden Infant Death Syndrome (SIDS) because their extra body weight suffocates them and restricts their ability to move, according to a top Australian pathologist. The warning, which comes as the weight of new mothers and babies rockets to record levels, is surprising, because until now it was believed that low-weight babies were most at risk.

Professor Roger Byard, a chief pathologist who specialises in SIDS at the University of Adelaide, reveals fears about the potentially-fatal effects of maternal obesity in the latest edition of the Journal of Paediatrics and Child Health.

Professor Byard’s name may be familiar to readers as he was quoted by Reuters earlier this month, saying that fat dead people in Australia were creating a safety hazard at mortuaries and “urgent action is required at the highest level to change unhealthy lifestyle habits by improving diet, increasing physical activity and making our environments supportive of these objectives.” This, or course, clashed with the latest NSW Health report that most Australians are eating the recommended servings of fruits and vegetables and exercising; and the findings of the Australian Bureau of Statistics that Australians are among the longest-living people in the world, even though they’re the fattest.

The source of today’s news stories turned out not to be a study, but a Letter to the Editor in the September issue of the Journal of Paediatrics and Child Health:

In many communities there have been recent increases in cases of maternal obesity with studies showing corresponding increases in numbers of obese infants....While an increase in obstructive sleep apnea has been shown to be associated with obesity in childhood, the situation in infants has not been fully explored.... Is it possible that markedly obese infants may be less able to move from the prone position, may have upper airway narrowing, and may have abnormal pulmonary function, particularly when prone?

Although previous studies have not shown a relationship between obesity and SIDS, with infants dying of SIDS often having low birth weights, perhaps it is opportune to examine the possibility that larger body masses could be an effect modifier or even a risk factor for sudden infant death by compromising movement and respiratory function.

Besides a lot of may bes and could bes, is there any evidence to support any of these scary speculations? Is there an epidemic of fat babies dying of SIDS? Are rates of SIDS even rising? No, no, and no.

SIDS is the tragic and unexpected death of a baby under one year of age for which no cause is ever found. Parents are left grieving and devastated, and often worry that they are to blame. Instead of using these heartbreaking and frightening deaths and the worries of new parents at one of the most vulnerable times of their lives to make insupportable conjectures, parents deserve the soundest facts available.

“References to SIDS exist throughout recorded history,” said Dr. Patrick L. Carolan, M.D., Medical Director of the Minnesota Sudden Infant Death Center, Children's Hospital and Clinics of Minnesota, and adjunct associate professor at the University of Minnesota Medical School. It is nothing new or the result of the “obesity epidemic.”

While the specific cause remains unknown, he explained, “population-based studies conducted in centers in Great Britain, Scandinavia, Australia, and New Zealand in the late 1980s and early 1990s... demonstrated that the risk of SIDS was highest for prone (ie, tummy-down) sleeping infants, intermediate for side-sleeping infants, and lowest for infants placed supine for sleep.” World-wide public health campaigns followed, advising parents to place infants on their backs to sleep, and the prevalence of SIDS dropped dramatically, said Dr. Carolan.

Here in the U.S., the National Institutes of Child Health and Human Development issued an advisory in 1992, which was followed by the federal "Back to Sleep" campaign launched in the Spring of 1994. Parents heeded the advice and the babies sleeping on their tummies went from 75% in 1992 to a mere 11% in 2002.

This proved to be a public health message that saved lives around the world. SIDS rates in the U.S., for example, fell by 58%! According to the National Vital Statistics Reports, National Center for Health Statistics at the Centers for Disease Control and Prevention, infant deaths from SIDS went from 1.30/1,000 live births in 1990 to an historic low of 0.55/1,000 live births in 2004.

If increasing numbers of fat babies were really a concern relative to SIDS, then we should see rising rates of SIDS, not the opposite!

In fact, for decades, researchers and SIDS monitoring programs have found no relationship between birth weight and SIDS. Weight gain after birth is also normal and no different among SIDS babies. A baby’s age is the biggest risk for SIDS, with two-thirds of deaths occurring in the first 4 months of life and 95% by 8 months. The babies are typically born full-term with no history of significant pregnancy-related complications, said Dr. Carolan. About 12-20% are born prematurely or low-birth rate. But SIDS babies are “thought to be feeding well and gaining weight normally,” he said. There’s usually no outward sign of any health concern, although about 70% had a minor viral infection the week preceding.

There is no evidence that fat babies are at higher risk of SIDS. Please mothers, don’t take your healthcare advice from the media or let the anti-fat hysteria frighten you into making decisions that might not be best for you or your baby.

To Reduce SIDS Risk

The NICHD offers this advice for parents, based on things that have been shown to help reduce the risk for SIDS:

·Always place babies on their backs to sleep — nap time and night time.

· Place your baby on a firm sleep surface, such as a safety-approved crib mattress covered with a fitted sheet. Avoid placing a newborn on a pillow, quilt, sheepskin, or other soft surface.

· Keep soft objects, toys, and loose bedding out of your baby’s sleep area and away from the face.

· Keep your baby from becoming overheated during sleep. Dress your baby in light sleepwear and keep the room at a temperature that is comfortable for you.

· Consider using a pacifier when placing your baby down to sleep, but don’t force the baby to take it if he/she spits it out.

[Note: These are general recommendations. If your baby has special needs, such as gastroesophageal reflux or any abnormalities of the head or neck, please talk to your baby's pediatrician.]

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