Junkfood Science: February 2008

February 29, 2008

Google Health update — A new Google World

Thursday, the CEO of Google, Inc. spoke publicly for the first time about what they’ve been designing and building with Google’s new Health project. For those who understand doublespeak and what’s been going on, it was as Dr. John Crippen, a physician in the
UK, wrote: “Google is really frightening. [Unlike the NHS centralized data collection effort] they will get it right from the beginning.”

This is not about our health or convenience. This is a vast private-government partnership to create the world’s largest ever database of genetic, medical and personal lifestyle information, that can and will be used against us.

The Google Health team has been at the 2008 conference of the Healthcare Information and Management Systems Society in Orlando this week, where Google CEO, Eric Schmidt, gave the closing address. He described the enormous database of citizen medical and lifestyle information they are working to gather and store on Google. As reported by Healthcare IT News editorial director Jack Beaudoin, Schmidt said that populating the electronic medical records with enough data to be useful is Google’s biggest initial hurdle because re-keying information (typing it all in) isn’t efficient. So instead, “Google has been aggressively developing partnerships with major employers, health plans and current electronic medical record vendors in order to,” as Schmidt said: “suck up the data they have in their proprietary systems. With the user’s permission, we would take it all and put it in one place.”

[What wasn’t revealed, is that they don’t really need permission to suck up personal information from third party databases, compiled when untold numbers of Americans voluntarily turned it over through commercial health risk assessments, online personal health records and wellness programs through employers or private wellness companies. Participation in those offered through insurers or healthcare providers was also tacit permission for them to use it on your behalf and share it with management vendors, thanks to carefully worded privacy statements and HIPAA regulations. The major healthplans have also already built vast databases merging personal health records with laboratory results, pharmacy records, medical claims and medical records.

It has been sadly easy to convince the public to support these health and wellness initiatives and volunteer private information about their lifestyles, diets and mental and physical health. Even those who understand “correlations don’t equal causation” have come to believe in ‘health risk factors’ and signed onto health risk assessments and “wellness programs.” The lure of the promise that some ‘healthy’ diet or lifestyle, and having ideal health indices — the solutions sold by these third-party stakeholders — can prevent us from getting sick or developing chronic diseases of aging is compelling.]

According to Google Vice President of Search and User Products, Marissa Mayer: “We’re assembling a directory of third-party services that interoperate with Google Health. Right now, this means you’ll be able to automatically import information such as your doctors’ records, your prescription history, and your test results into Google Health... you will be able to interact with services and tools easily ... and start using new wellness tools.”

[In addition to stakeholder partnerships, they are eliciting the cooperation of consumers to voluntarily share their personal health and private lifestyle information. Google is getting you to help them build their database and give permission to pull in data from third parties that have records on you, such as your laboratory results and prescription records, clinic and hospital records, etc. Google has set up partnerships with hospitals, labs, clinics and pharmacies to make self-populating the data into Google Health just a matter of clicking on “upload your records.” Note that you will not be able to keep out select data or change any of it coming from these sources. So, if you don’t want it to be known that you’re on highly active antiretroviral therapy for HIV or antipsychotics, smoke, don’t eat all of your vegies, or drink alcohol, you’re out of luck.]

Today, Google Health announced its partnership with Quest Diagnostics, Inc. With just a click, all of its records can now also be transferred to Google Health. According to Quest’s website, it is the nation’s leading provider of diagnostic testing, information and services to health plans and employers. Quest has partnerships with “pharmaceutical, biotechnology and information technology companies” and provides support to expedite the efforts of these partners. “Quest Diagnostics Employer Solutions provides the most comprehensive pre- and post-employment screening services and health management solutions available.” Its employer wellness program, Blueprint for Wellness, is a health risk assessment and health education service purchased by employers.

Each year, Quest Diagnostics performs personal health testing on more than 150 million people and does more than $660 million in genetic tests. As its “About Us” page says:

With $5.5 billion in annual revenues, Quest Diagnostics offers the broadest access to clinical testing services through its national network of 30-plus regional laboratories, approximately 150 rapid response laboratories and over 2,000 patient service centers. Quest Diagnostics is the leading provider of specialty testing, including gene-based testing, and is the leader in routine medical testing, drugs of abuse testing, and a leader in anatomic pathology testing.... Quest Diagnostics is also the leading provider of risk assessment services to the life insurance industry.

Google Vice President of Search and User Products, Marissa Mayer, emphasized convenience, writing on Google’s blog: “Google Health aims to solve an urgent need that dovetails with our overall mission of organizing patient information and making it accessible and useful. Through our health offering, our users will be empowered to collect, store, and manage their own medical records online.” Portability is an added advantage for snowbirds, she said, as they would have easy access to their health data anywhere they are. “Previously, this would have required carrying paper records back and forth.”

[This ignores the fact, that those with computer access to use Google can easily keep their own information on their own personal key drives and already don’t need to carry paper records. The word “empowered” is more accurately described as convincing people to turn over their records online to Google. Do most consumers believe themselves incapable of managing their bodies and health, and in need of Google to organize and make sense of it? And “For whom is Google making people’s personal health information ‘accessible and useful’”? We can already get copies of our medical records ourselves by simply asking for them.]

“Google Inc. won’t sell ads to support a new Internet service that stores personal medical information,” said Schmidt. “Google intends to profit by increasing traffic to its search site” and “third parties can build direct-to-consumer services” like medication tables or reminders.

[Every analyst has said that ads are inevitable, as advertisers will pay exorbitant amounts to be able to target people with known health issues or needs, such as prescriptions. For now, though, Google doesn’t need to sell ads. Lucrative deals will come through stakeholder partnerships. Information makes effective and convincing marketing: medical and health ‘education’— especially information that’s ‘personalized’ for you about how to manage your health problems, reminders to get your screening tests and fill your prescriptions, make sure you’re following your prescribed diet and taking your medications, and other interactive “wellness tools” to monitor your behavior and help you to their health management. But the really big profit potential for Google’s stakeholders will come from your personal information.]

True to its word, Google Health is accruing partnerships with companies eager to participate in the project and cash in. Yesterday, it announced another new third-party partner: HealthGrades. The company’s CEO, Kerry Hicks, said in a press statement that more Americans use Google to begin their searches and his company’s “goal is to guide Americans to better healthcare...so that they can choose the best possible doctor and hospital.” HealthGrades is a service used by many of the nation’s largest employers and healthplans. It rates healthcare providers based, most notably, on their compliance with performance measures (P4P). Consumers are told they are quality ratings.

HealthGrades has a database on 700,000 doctors, nearly every practicing doctor in the country, as well as hospitals, nursing home and home-health agency.

[This partnership will enable HealthGrades to reach vastly more consumers and steer them to providers complying with government and insurer-mandated guidelines... and away from those who don’t. Doctors’ livelihoods and professional reputations are increasingly depending on their following performance measures, whether they are best for their patients or evidence-based; or else, they will have no patients referred to them. But according to Dr. Richard L. Reece, M.D., while insurers and government officials and health system executives are pushing with great vigor the idea that performance measures are about quality, medical professionals resist because clinical outcomes and cost savings have proven negative, modest or not worth the expense. Nor can clinical care being provided to individual patients be judged by third parties.]

As Beaudoin reported, Schmidt said Google Health has no “monetization path” at this time.... but “didn't rule out future possibilities, such as using depersonalized data for research and clinical studies.”

[A very important plan to let slip, given Google’s investment partners. Read on.]

Associated Press reported that Schmidt reassured the public about the security of their private health information, saying: “Google Health would be at least as secure as current systems.”

[That is not a reassuring euphemism, given Google’s history of protecting the security of its data. It’s also not reassuring, given the regularity of reports of lost, missing or stolen electronic medical data. Just today, a health insurance company in California reported that the personal information, including social security numbers, on 103,000 doctors had been accidentally posted on the internet. Most critical to realize is that Google is not a health care provider, payer or entity bound by HIPAA or federal privacy regulations and no matter what it promises now, it can change its mind and do whatever it wants with personal health information.]

Pam Dixon, executive director of the nonprofit World Privacy Forum, explained that once your private information is outside federal privacy protections, as limited as those are, you have no protection at all: “Your physician has taken a Hippocratic Oath, and they are bound to have your best interests in mind. A publicly traded company is supposed to have shareholders in mind first,” she told AP.

Dixon said even the issue of consenting online to the release of information is muddy. “I think we've all consented to things online we haven't meant to simply by failing to check or uncheck a box.”

In a press conference following the keynote address yesterday, Schmidt said Google was willing and interested in working with regional health information networks and health information exchanges. “Their goals are our goals," he said. “[F]rom our perspective, the more, the merrier.” Google Health could serve as the repository for patient data that partners within a network or exchange could access, he said.

[Google is clearly laying the groundwork to share your health information with its third party partners.]

According to Google Vice President of Search and User Products, Marissa Mayer: “We won’t sell or share your data without your explicit permission. Our privacy policy and practices have been developed in thoughtful collaboration with experts from the Google Health Advisory Council.”

[First, as we know, they can change their minds about their privacy statement and you may never know or be able to do anything about it. But, Google has let its third party corporate and government stakeholders, via its Advisory Council, write their own policies and practices. This is not at all inspiring to those familiar with the government agencies and organizations on Google’s Health Advisory Council, all actively promoting electronic health records and anxious to share and use them. Electronic records are absolutely fundamental for their new national managed healthcare delivery system these very same public-private partnerships have been working for years to build.]

Google’s team

One member of Google’s Health Advisory Council hasn’t been discussed and may not be familiar to JFS readers — FasterCures. An introduction may help better understand Google’s interests.

FasterCures calls itself an “action tank” towards “aggressive efforts” to identify and implement global solutions to deadly diseases. It was created “under the auspices of the Milken Institute,” whose chairman, Michael Milken, is also on the Board of Directors of Faster Cures. The two organizations share similar member partners.

Milken Institute is a Santa Monica think tank that released a report this past October, “Unhealthy America: The Economic Burden of Chronic Disease.” It claimed that chronic health conditions cost the country more than $1 trillion a year and could reach $6 trillion by 2050 if people don’t change their lifestyles. They arrived at this figure with considerable creativity, counting every health indice separately and including calculations for lost or reduced productivity. “Curbing obesity alone by close to 15 million cases could translate to a savings of $60 billion by 2023 and improve the country's productivity by $254 billion,” the report said.

Last April, Milken hosted a global conference called “Shaping the Future,” where Hala Moddelmog, of Susan G. Komen for the Cure, claimed that “60 percent to 70 percent of all chronic diseases are preventable through behavioral changes.” Ross DeVol of Milken Institute asserted that cancer, heart disease, stroke and diabetes are all highly preventable. The conference speakers lamented the lack of a “single massive campaign targeting obesity.” The solution, advanced by WebMD, was to expand use of the internet in preventive health initiatives and to adopt electronic medical records to improve efficiency and “increase quality of life.” The Milken conference also supported raising the intensity of the war on obesity; changing patent laws so that prevention drugs can be tested; and encouraging the sharing of data for research.

FasterCures drafted an “Acceleration Agenda” to achieve change in key areas. Its report, “Think Research: Using Electronic Medical Records to Bridge Patient Care and Research,” forms the foundation of its agenda to push for the adoption and implementation of electronic medical records (EMRs).* It also reveals that what they are actually interested in is building a genetic database:

The creation and development of databases and database technologies — that is, methods for storing, retrieving, sharing, and analyzing clinical and biomedical data — is the next essential step in the Human Genome Project.

EMR systems could speed data acquisition and searching, allow mass computing and sampling, and provide the research community access to a broader and more diverse patient population. As physicians record new actions, outcomes, and demographics in EMRs, researchers will have access to more in-depth and clean data.

Among the key potential benefits of EMRs that it highlighted was the enhanced monitoring of the population to “detect patterns of health and illness” and speed the identification of potential targets for participants for clinical trials. Among the innovators it spotlighted was Mayo Clinic’s “growing bank of genomics data,” which links to its tissue and serum repositories, surgical index, and pathology records. Potentially, it could be linked with other systems, the report said. And “one unified, crossreferencing system” would allow “immediate access to millions of records.” Another database the report featured was the Partners HealthCare Research Patient Data Registry, a data repository of information on two million Massachusetts General Hospital and Brigham and Women’s Hospital patients accumulated since the 1980s. “The RPDR stores 500 million diagnoses, medications, procedures, reports and laboratory values with demographic and encounter information.” It can be accessed to elicit correlations and trends between population characteristics and genetic information with various conditions.

Last April, FasterCures announced the launch of its BioBankCentral — “a web-based portal dedicated to advancing the use of human biological materials.” According to its press release, “BioBank Central will assist researchers who require biological materials for their studies, encourage the donation of tissue and blood by patients, and inform the public about the critical role of biobanks (or biorepositories) in enabling modern biomedical research...With an Internet search engine, you can find the answers to all sorts of things in less than a second.” It promises to accelerate the process for researchers who want tissue, blood or DNA for research. FasterCures said:

Human biospecimens can provide a bridge between emerging molecular information and clinical information...Specifically, human biospecimens can be used to identify and validate drug targets; identify disease mechanisms; develop screening tests for “biomarkers” associated with certain sub-types of a disease; group patients based on their genetic characteristics...

Google’s genome project

Google’s interests in creating a vast genetic database go far beyond this member of its Advisory Council. As Google VP, Marissa Mayer said: “We have some genetic partners where we’ve already been making investments.” Who might those partners be?

Last May, Google invested $3.9 million in 23andMe, Inc., a genetic start-up company working on proprietary web-based software to make use of genetic information and DNA analysis technologies. Its co-founder and member of the Board of Directors is Anne Wojcicki — wife of Google’s co-founder and President of Google technology, who also owns 35% of Google’s Class B common stock.

Google collaborated with Genentech, whose CEO Arthur Levinson also sits on Google’s Board of Directors, and other venture capital firms to the total tune of at least $10 millon in investments in 23andMe. As 23andMe investor and board member, Esther Dyson said on Charlie Rose, they want you to turn over not just your medical records and lifestyle information, but your personal genetic information, too, and entrust it all with Google. She dismissed privacy concerns, saying “Like it or not, it’s gonna happen.”

On 23andMe’s website, it encourages the public to send in a saliva sample using its home-kit and, through its interactive web tools, it promises to tell you about yourself. Just today, Quackwatch posted the testimonies given to the U.S. Senate when it examined the science behind home DNA tests. An investigation by members of the U.S. Government Accountability Office included submitting DNA samples to four websites offering genetic testing. “Experts who reviewed the test reports concluded that they made predictions that were medically unproven, ambiguous, and provided no meaningful information for consumers.” But the ultimate goals for 23andMe go far beyond amusement.

John Lauerman said in Bloomberg this morning that Google has also backed George Church, a Harvard geneticist, with an unspecified donation in his quest on the “largest human genome sequencing project in the world.” Google spokesman, Andrew Pederson, said they began supporting Church last year. As Bloomberg reports:

By matching genetic data from each person with his or her health history, Church would build a database that would link DNA variations and disease ... Church also said he'll explore other human traits under genetic control. Participants will give facial and body measurements, tell researchers what time they get up in the morning, and detail other behaviors, he said....

By pairing medical histories with genetic data on the Web, Church is also confronting ethical boundaries. It's possible that subjects' identities can be deduced from their health information, scientists said. “He's explicitly going after medical histories, and there's very mixed feelings about this,” said Kevin McKernan, one of the developers of Applied Biosystems' SOLiD sequencer. “I think it's helpful and needed. We need to understand some of these issues that could scare everyone out of the field.”

“The convergence of biotechnology, the web, and big business is, in fact, quite alarming,” said Jesse Reynolds, MS, Project Director on Biotechnology in the Public Interest at the Center for Genetics and Society, a nonprofit information and public affairs organization based in Oakland, California. “This data will be a goldmine, but only the corporations will get a cut,” he said. Only genetic companies will benefit from patents and drugs, for example, while the public will lose their genetic privacy.

The ethics of these renewed efforts to link behaviors and physical characteristics with genetic information, and the potential abuses of this information, are frightening. Of greatest concern is what can happen when personal genetic information is divulged. 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, leaving you without any recourse and vulnerable to the whims of corporations that have their own interests in mind, not yours. It is doubtful businesses will acknowledge how little is actually known about the implications of genes. How many companies will admit that a gene may be merely a tendency to develop a disease. What happens when the results are inaccurate?

Should you trust Google?

According to advocates of Google Health, Americans can trust Google to keep their personal information about their bodies, health, lifestyles and even their genes private. Schmidt promises “Google Health would be at least as secure as current systems.”

How many people know that Google has the worst privacy practices, and record for privacy protection, of the world’s top internet-based companies? Google was found by an international, independent investigation, to not just be a “substantial threat” to privacy, but the only company evaluated to actually be “hostile to privacy.”

Privacy International, a nonprofit human rights research and campaign organization founded in 1990 with members in 40 countries, just conducted a six-month investigation into the privacy practices of 23 top internet companies (Amazon, AOL, Apple, BBC, Bebo, eBay, Facebook, Friendster, Google, Hi5, Last.fm, LinkedIn, LiveJournal, Microsoft, Myspace, Orkut, Reunion.com, Skype, Wikipedia, Windows Live Space, Xanga, Yahoo! and YouTube).

Privacy International has been concerned about internet privacy, especially with the increasing disclosure of personal information by consumers to web-based companies that capture and process data to a significant extent and new technologies that permit the collection of increasingly detailed information. Their legal experts poured over company privacy statements and “became alarmed.” In fact, they said:

“We as specialists in this field, cannot fully understand the full range of surveillance practices of some companies [which] leaves us greatly concerned about the ability of consumers to make informed decisions in the marketplace.”

The investigation they initiated included consultations with experts around the world. They evaluated:

· the backgrounds of corporations’ leadership and self-regulatory mechanisms

· the types of information sites collects, with and without consent; the collection of unnecessary information; whether companies collect and mine other information, such as viewing habits and references; if they collect and track users’ movements through their IP addresses and profile people’s habits and interests

· the storage of personal information after it’s no longer needed

· openness and transparency of privacy policies, which often disclose little about a company’s true practices. “Some companies also cover up or refuse to engage publicly about privacy concerns,” they said. “[M]any of the privacy policies seem to have been written with the same goal: to say very little but in as complex a way as possible.”

· how companies respond when privacy problems occur, their responsiveness and sincerity; if they allow access to customers to use or correct their personal information

· ethical compass of each company and how it has dealt with ethical challenges such as warrants from law enforcement agencies

· customers’ control over their own information, if customers are allowed to delete their accounts and control who has access to their personal information

· the creation of profiles on customers based on resources customers access and read

· privacy enhancing and protective technologies invested in and adopted by companies to protect people

· companies that “use blunt instruments to collect personal information without consent” were highlighted, as were those that used technologies to delve deeper into personal profiles. “While many companies use cookies (in a variety of ways) a number of companies go well beyond this practice into using 'web beacons' or 'pixel tags' to even identify whether users are reading their emails.”

Google ranked dead last. In its interim report, made available this past September, Privacy International wrote:

[T]hroughout our research we have found numerous deficiencies and hostilities in Google's approach to privacy that go well beyond those of other organizations. While a number of companies share some of these negative elements, none comes close to achieving status as an endemic threat to privacy. This is in part due to the diversity and specificity of Google's product range and the ability of the company to share extracted data between these tools, and in part it is due to Google's market dominance and the sheer size of its user base. Google's status in the ranking is also due to its aggressive use of invasive or potentially invasive technologies and techniques....

Google's increasing ability to deep-drill into the minutiae of a user's life and lifestyle choices must in our view be coupled with well defined and mature user controls and an equally mature privacy outlook. Neither of these elements has been demonstrated. Rather, we have witnessed an attitude to privacy within Google that at its most blatant is hostile, and at its most benign is ambivalent.

This material [on the merger between Google and Doubleclick], submitted by the Electronic Privacy Information Center (EPIC) and coupled with a submission to the FTC from the New York State Consumer Protection Board, provided additional weight for our assessment that Google has created the most onerous privacy environment on the Internet. The Board expressed concern that these profiles expose consumers to the risk of disclosure of their data to third-parties, as well as public disclosure as evidence in litigation or through data breaches. The EPIC submission set out a detailed analysis of Google's existing data practices, most of which fell well short of the standard that consumers might expect. During the course of our research the Article 29 Working Group of European privacy regulators also expressed concern at the scale of Google's activities.

Privacy International reported that Google “does not believe it collects sensitive information” needing protection and it readily shares information ‘with consent’ to its business partners. Their summary list of specific privacy failures and Google’s “track history of ignoring privacy concerns” is alarming. Among the concerns Privacy International found in its investigation:

· Google retains a large quantity of information about users, often for an unstated or indefinite length of time, without clear limitation on subsequent use or disclosure, and without an opportunity to delete or withdraw personal data even if the user wishes to terminate the service.

· Google maintains records of all search strings and the associated IP-addresses and time stamps for at least 18 to 24 months and doesn’t allow an expungement option.

· Google has access to additional personal information, including hobbies, employment, address, and phone number, contained within user profiles in Orkut. Google often maintains these records even after a user has deleted his profile or removed information.

· Google collects all search results entered through Google Toolbar and identifies all users with a unique cookie that allows Google to track the user's web movement; yet the company does not disclose how long the information is retained, nor does it offer users a data expungement option.

· Google fails to follow generally accepted privacy practices such as the OECD Privacy Guidelines and elements of EU data protection law. As detailed in the EPIC complaint, Google also fails to adopted additional privacy provisions for specific Google services.

· Google logs search queries in a manner that makes them personally identifiable but fails to provide users with the ability to edit or otherwise expunge records of their previous searches.

· Google fails to give users access to log information generated through their interaction with Google Maps, Google Video, Google Talk, Google Reader, Blogger and other services.

Which would you find more credible: privacy assurances from Google Health or the evidence of Google’s actual past performance in protecting peoples’ privacy?

Before you click “upload” to give your private health information to Google, or any third party online, pause to consider if you want the entire world to know it; if you really need a giant corporation with government and financial interests to monitor your body, behaviors and genome, and manage your health, and what they might really want or need with your information.

Google Health can only be described as Orwellian — amassing a vast database of your most private information, including what you eat, your lifestyle, where you live and work, your finances, your shopping habits and interests, your health records and your genetic material — all under the control of a giant corporation with powerful government-industry partners.

In 1949, when George Orwell first published his book, 1984, he described a society where the government watched every movement of its citizens to control them. “Big Brother has become a common term for ubiquitous or overreaching authority, and Newspeak is a word we apply to the dehumanizing babble of bureaucracies and computer programs, wrote Walter Cronkite in the forward for the 1984 reprint of the book. 1984 was a warning, wrote Cronkite:

[A] warning about the future of human freedom in a world where political organization and technology can manufacture power in dimensions that would stunned the imaginations of earlier ages.... It was a novelistic essay on power, how it is acquired and maintained, how those who seek it or seek to keep it tend to sacrifice anything and everything in its name.

1984 is an anguished lament and a warning that vibrates powerfully when we may not be strong enough nor wise enough nor moral enough to cope with the kind of power we have learned to amass....

And we hear echoes of that warning chord in the constant demand for greater security and comfort, for less risk in our societies. We recognize, however dimly, that greater efficiency, ease, and security may come at a substantial price in freedom, that “law and order" can be a doublethink version of oppression, that individual liberties surrendered for whatever good reason are freedoms lost.

© 2008 Sandy Szwarc

* Readers who’ve not been following the agenda to create electronic medical records and health information will find Appendix F startling — ten pages (small type) listing the vast network of interlinking organizations, all with interests in electronic records:

A. Standards and Standards-Setting Organizations
B. Federal Government Health Information Technology Agencies and Initiatives
C. Large Private-Sector Electronic Medical Record Systems
D. Organizations Involved in Health Information Technology
E. Resources for Choosing an Electronic Medical Record
F. Journals, News and Information Sources, and Trade Publications
G. Information on State Initiatives
H. Personal Health Record Organizations and Initiatives
I. Open Source Groups and Initiatives
J. Security and Privacy
K. Information on Databases and SQL
L. Clinical Research Databases and Related Sites
M. Online Forums, Listservs, and Discussion Boards
N. Health Information Technical Glossaries
O. Others

Click here for complete article (and single page version).
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February 27, 2008

Miracle thigh cream — new medical findings!

“Thinner thighs in just weeks!... Lose inches and pounds with our magical weight reducing cream! ... Clinically proven to remove fat! ... Miracle cellulite disappearing cream!”

Our email inboxes are filled with spam promising miracle ways to lose fat and have thinner, more youthful figures. Most of us delete it unread or use spam filters to automatically throw it in the trash. Yesterday, medical professionals found in their inboxes a message for a fat-reducing cream, but a lot of people, seeing it came from a medical journal, probably read it. Some may have even believed it.

Editor-in-Chief of Medscape Journal of Medicine**, Dr. George D. Lundberg, M.D., described ‘exciting’ new findings that spot-reducing creams might actually work to make fat go away. He wrote in his Medical Minutes:

I'm Dr. George Lundberg. So many people struggle with body fat, generalized and localized. How wonderful it would be if a person could rub on a topical cream and make the fat go away. Three researchers at Louisiana State University recently published in the journal Diabetes, Obesity & Metabolism, a randomized, placebo-controlled clinical trial that asked this question. If 50 adult men and women with body mass indices over 27 kg/m were on a prescribed 1200-calorie balanced diet and a walking program, would the addition of the application of 0.5% aminophylline cream to the waist twice a day change BMI and waist circumference? After 12 weeks, the answer was yes, 11 cm less in the cream group and 5 cm less in the control group — a significant difference. BMI decreased in both groups; waist-to-hip ratios declined; women lost more; aminophylline blood levels were undetectable. Small sample size, but an exciting result, worthy of further study. [emphasis added]

Even when incredible claims, that sound too good to be true, come in the form of a study, our own spam detectors always need to be on. Are you curious what we weren’t told about this miracle fat-reducing cream or wondering: “How’d they do that?”

Figure flaws

This study was not a government registered clinical trial and does not appear on clinicaltrials.gov. The study was led by Mary K. Caruso, MS, a research assistant who reported it as part of her master’s thesis under co-author Dr. Frank Greenway, M.D., at the Pennington Biomedical Research Center in Baton Rouge, Louisiana. Pennington was established by Claude Bouchard, Ph.D., outgoing president of the International Association for the Study of Obesity. This study was published in the May, 2007 issue of the peer-reviewed journal Diabetes and Obesity Metabolism.

The flaws in this study are too numerous to count. Fifty “overweight” adults (21-65 years of age) were enrolled in this study. All were told to follow a 1,200-calorie a day diet and “encouraged to follow a walking program.” Twenty women and 5 men were randomly assigned to the treatment group and were given aminophylline 0.5% cream to rub (15 cc) onto their waists twice a day throughout the 12-week study.

Dr. Lundberg incorrectly reported this randomized study as being a placebo-controlled, clinical trial. It was neither placebo-controlled nor double-blind. Those getting the treatment were not blinded and knew they had the cream that was supposed to melt fat. The researchers knew it, too. The researchers saw the treatment group every 2 weeks, encouraged them to follow their diets, continue their walking program and to apply the cream twice daily; took their vital signs, inspected their waists and asked them about any side effects. Each month, the intervention group also had blood drawn to measure for theophylline levels.

There was no placebo cream given to the control group. There was no follow-up to encourage them to follow their diets and exercise. The control group knew they were merely the controls.

At the beginning and end of the study, BMIs, waist and hip circumferences were measured. The evaluators knew which participants had gotten the cream and which hadn’t, yet the study didn’t control for how the measurements were taken: with clothes/shoes, on exhalation or inhalation, sucking in their tummy or relaxing, the position of the subject (sitting, standing, slouched, etc.), after a 12-hour fast or meal, or how many measurements were taken. The study didn’t control for age of the participants; or if the subjects had been weight stable or been dieting prior to the study, to control for stable metabolisms. The study didn’t control for the type (aerobic, weight lifting, etc.) or amount of exercise done, or measure lean muscle mass. In fact, the researchers made no note of how anyone in the study actually followed their diets or how much and what type of exercise they’d actually done. Most importantly, given it was purportedly evaluating fat reduction, the study made no measurements of body fat composition.

BMIs in the treatment group went from an average of 28.2 to 26.1 during the study; compared to the control group that went from an average BMI of 28.5 to 26.2. The control group actually lost a bit more weight. Both waist and hip measurements reduced during the dramatic weight loss. The changes in the waist-to-hip ratios between the treatment and intervention groups at the end of the study, however, actually differed by only 0.04cm — an imperceptible and easily manipulated difference [see above paragraph].

And, finally, 12 weeks isn’t even close to the 5 years that the FTC determined in its 2003 crack down on fraudulent weight loss claims, “Deception in Weight-Loss Advertising,” is necessary before credible claims can be made about the merits of any weight loss intervention.

Caruso and colleagues concluded that this trial demonstrates it is possible to cause “cosmetic redistribution of body fat” and spot reduction of fat wherever their cream is applied. “Thus, one can extend the principle of local fat reduction with aminophylline cream to both genders and to a body area different from the thigh,” they wrote. The theory proposed for how a topical cream might work was essentially that, just as aminophylline gets the heart pumping when it’s inhaled by asthmatics, the cream drinks through the skin and jump-starts the metabolism to burn off underlying fat. They found, however, no systemic effects of their cream and aminophylline levels were undetectable in all of the blood tests they conducted during the study.

How does this study add to the body of evidence on reducing creams? There is no body of evidence supporting fat-reducing creams in the medical literature. The only study they cited for the effectiveness of aminophylline cream was a paper published in a 1995 issue of Obesity Research by co-author Dr. Greenway and Dr. George Bray, director of the Pennington Biomedical Research Center. That paper had briefly summarized a trial of 2% aminophylline thigh cream in 12 women which had concluded “topical fat reduction for women’s thighs can be achieved without diet or exercise.”

The rest of the story

There were no disclosure statements in this published paper, led by Caruso. In this case, such disclosures are noteworthy. Dr. Greenway first developed this aminophylline cream in the 1980s with Dr. Bray at Pennington. And Dr. Greenway holds the patents for anti-cellulite, fat spot reducing creams, applied for in 1985-1986.

They published their first thigh cream study in an obscure journal, Clinical Therapeutics, in 1987. Twenty-eight fat women had been placed on a strict low-calorie diet and 5 different creams or injections were tested. Five of the women had been given the aminophylline cream. The authors reported that thigh measurements were less after 4 weeks among all of the treatment groups. The study received little notice.

The Los Angeles Business Journal reported on April 4, 1994, that Drs. Greenway and Bray had been trying, unsuccessfully, for years to find potential financial backers in their spot-reducing cream. They sold licensing rights to Dr. Bruce Frome, a colleague at Harbor UCLA Medical Center, in 1992 who also tried to find backers. As reported by Robin Berger for the LA Business Journal, major drug companies “felt that it was too frivolous for them.” She went on to report:

Realizing that the product’s selling point was really cosmetic, the three physicians decided to shift gears — focusing on cellulite elimination instead of girth reduction. Greenway and Bray then began working on developing a product to smooth out dimpled thighs, which requires less aminophylline than their earlier girth-reduction product.

In early 1993, Frome licensed multilevel marketing distribution rights to the new creamy cosmetic to Orange-based D&F Industries. But the big breakthrough for the thigh cream and its proponents came last October at a conference sponsored by the North American Association for the Study of Obesity.

In October, 1993, at the NAASO meeting they presented their study [the one mentioned in the 1995 issue of Obesity Research above] of 12 women. They reported that only 8 women had completed the study and that the thigh cream resulted in as much as 1.5 cm lost around their thighs. This got media attention. Associated Press headlined with “Researchers describe cream that shrinks thighs” and USA Today reported news of the new “miracle thigh cream.” This publicity enabled them to find a retail distributor, Nutri/System weight loss center, to buy the license to sell their cream.

It would became best known as a cellulite cream and magical solution for “cottage-cheese” thighs. Remember when advertisements for these miracle creams seemed to be everywhere? The surge in popularity of thigh creams also caught the attention of the FDA, which began investigating the safety of these creams, FDA spokesman Mike Schaeffer told the LA Business Journal.

But no other researchers have been able to credibly replicate the findings of Dr. Greenway and Bray.

Dr. Leroy Young, M.D., of Washington University in St. Louis (and chairman of the nonsurgical procedures committee of the American Society of Aesthetic Plastic Surgery) conducted a study on fat-melting creams and found that 16 out of 17 women showed no improvements in their thighs after two months. As was reported by The Mercury News on March 22, 1995, “happiness, at least in the form of thin thighs, might not come in a jar [at $30 each].”

Dr. Judith S. Stern, S.M., Sc.D., professor in the departments of Nutrition and Internal Medicine, Division of Clinical Nutrition and Metabolism, at the University of California, Davis, said at the 2003 FTC workshop on fraudulent weight loss advertising that their researchers’ efforts to replicate the research were unsuccessful.

Doctors at the Department of Plastic Surgery, Bradford Royal Infirmary, West Yorkshire, England, conducted a randomized, placebo-controlled, double-blind clinical trial of aminophylline cellulite thigh cream and another popular cream, endermologie, in 69 women. The researchers assessed the results after 12 weeks by clinical examination, photographic assessment by the surgeon, body mass index, thigh girth at two points, and thigh fat depth measurement by ultrasound. No statistical difference existed in measurements between legs for any of the treatment groups. The researchers reported their results in a 1999 issue of Plastic and Reconstructive Surgery and concluded that these thigh creams are not effective and don’t improve the appearance of cellulite.

Pharmacology professors at the University of Kentucky, Lexington, reviewed the evidence for aminophylline thigh creams for cellulite and found the two reports by Dr. Greenway and Bray. The professors reported in the 1999 Annals of Pharmacotherapy that no studies to date have demonstrated safety and efficacy and these creams are “a dream cream.”

At the FTC 2003 workshops, held as part of its efforts to curb false and deceptive advertising of weight loss products, a scientific panel of researchers, academicians, medical professionals and industry experts examined the scientific evidence to date. They evaluated weight loss creams, nonprescription drugs, dietary supplements, wraps or patches and found claims that they can cause permanent weight loss to be “not scientifically feasible.” Claims that anything worn on the body or rubbed into the skin can help users lose weight — “Thigh Cream drops pounds and inches from your thighs” — would also constitute an unapproved drug in violation of the FDA, they said. The FTC stated that since 1990, it has challenged numerous products in this category, including acupressure devices, skin patches, slimming insoles, body wraps, and creams, charging that “efficacy claims for these products were not supported by reliable scientific evidence.”

The FTC also examined spot-reducing products. The weight loss experts noted that it is biologically impossible to lose fat preferentially from a single fat store, such as the thighs or buttocks. Their expert committee spent time specifically discussing research on aminophylline cream. They found that the only studies in the literature are extremely small and lasting only 4-6 weeks, with methodological shortcomings as well as inconsistent and “extremely small” effects. Based on the evidence and analyses to date, the FTC found weight loss creams were “not scientifically feasible at this time.”

The FDA has issued Warning Letters to companies selling anti-cellulite and weight reducing creams and making drug-like claims. In its January 22, 2004 letter to University Medical Products USA, Inc., in Irvine, California, the FDA objected to the claims that anti-cellulite thigh creams reduced thigh circumference, stimulated the release of stored fat or were clinically proven. It also found claims that weight reducing creams break down unwanted fat, stimulate metabolism and help lose inches and pounds. “Because these drugs are not generally recognized as safe and effective when used as labeled,” said the FDA, they cannot be legally marketed in this country.

Is it spam advertising or a study published in a medical journal? Sometimes, it’s both. :)

© 2008 Sandy Szwarc

** Medscape, which delivers health information and free continuing education credits to doctors and nurses, is one of the online publications owned and operated by WebMD Health Network. WebMD reports it now reaches 44.8 million visitors each month. It supplies much of the online health information reaching consumers and found on employer and insurer health risk assessments, and preventive health and wellness programs. WebMD also has a Weight Loss Clinic and its obesity reference material is offered in collaboration with The Cleveland Clinic.

WebMD announced just last Thursday that its 2007 revenue was $332.0 million compared to $248.8 million a year ago, an increase of 33%.

We've seen another example that it is impossible to judge the reliability and soundness of information by the size, prestige or popularity of a website. Comparing actual study results with the information WebMD provides gives daily opportunities for critical thinking.

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They didn’t want the surgery, but believed it was their only chance to live

So rarely does mainstream media attempt to report another view of the war on obesity, that when it does, it deserves notice. The Herald Sun obtained figures from Medicare on lap band surgeries done in Victoria and found that hundreds of people are putting their lives at risk. The popularity of the surgeries have soared — increasing 400% just since the year 2000, they report, with nearly 2,300 Victorians having lap bands last year. Each year, 500 people are left suffering painful complications.

As reporters Grant McArthur and Fay Burstin write:

Danger worries surface in fight against obesity

... Medicare figures reveal almost one in 10 patients who had lap-band surgery last year needed to have the gastric band repaired, revised or replaced. A further 374 had weight-loss surgery reversed, including lap-band surgery and stomach stapling, for reasons including misplacement of the band or other adverse effects. The procedure has become such a risk that insurance companies are refusing to insure doctors who perform it unless they pay a $50,000 excess.

A 38-year-old woman from country Victoria told the Herald Sun she almost died of complications from her surgery in December. The mother of three, who weighs 150kg, spent 11 days in intensive care with a perforated stomach, lost her spleen and had three operations to repair the damage.... “I am a positive person, but I was very angry. But I have to get over that because at least I am still alive. “I came close to dying and I don't think it is as easy as everyone says. “You do realise that there are going to be complications, but I think it is glossed over by how much weight you can lose, not what can go terribly, terribly wrong."

It is widely perceived, and widely marketed, that lap bands are completely safe, reversible and result in few complications. The reality, which sadly most patients like this young mother only come to realize after their surgeries, is that the complications far exceed what most people believe. Even the clinical trials for FDA approval of the band, conducted under ideal situations, encountered high rates of complications. In just the first 3 years post-op, Lap Band reported 89% had one or more adverse events, ranging from mild, moderate, to severe. The most common were:

· vomiting (experienced by over half)

· gastroesophageal reflux (regurgitation)

· band slippage/pouch dilatation and stoma obstruction (stomach-band outlet blockage)

· esophageal dilatation or dysmotility (the long-term effects of dysfunctioning esophagus are currently unknown)

· constipation, diarrhea

· dysphagia (difficulty swallowing)

As Lap Band reported, in their study, 25% of the patients had their bands removed during their 3-year follow-up, most after adverse events. Another one in ten needed a second surgery to fix a problem.

The Mayo Clinic reported in 2000 that 20% to 25% of gastric bypass patients develop life-threatening complications. While many consumers believe the newer, less invasive laparoscopic bypasses and lap-band procedures (which tighten a constrictive band around the stomach to make it smaller) are safer, they merely have their own “unique set of complications,” according to surgeons Shanu N. Kothari, M.D., and Harvey J. Sugerman, M.D. writing in Healthy Weight Journal. Ulcerations and the bands can erode into the stomach, which is usually are why they are not reversible or removable.

While the lap band FDA trials were looking primarily at surgical complications, nutritional complications are proving serious, such as the neurological disorder and brain damage from Wernicke’s encephalopathy. Nutritonal deficiencies have been widely reported — not surprisingly, not only because of the vomiting that afflicts every other patient (51%), but because gastric acid and pepsin and a period of time in the stomach are needed for many vitamins and nutrients to be released from foods or supplements, and intrinsic factor is needed for intestinal absorption of nutrients.

Long-term complications are increasingly worrisome, 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 had second operations, almost always to have their bands removed or converted to bypasses. The reasons were esophagitis, band erosion, pouch dilatation, leakage from the balloon, and esophageal dilatation. As surgeon and author of the study, Dr. Westling Gustavsson, M.D., at the University Hospital in Uppsala, Sweden, wrote: “Our prediction is that laparoscopic adjustable gastric banding will not stand the test of time.”

As the Herald Sun reported today, the number of medical claims resulting from lap bands far exceed those for other surgeries:

Paul Nisselle, general manager of risk assessment at Avant medical insurers, said...the number of claims “is disproportionately high for the volume of the surgery being performed, even allowing for the fact that you are starting with a risky patient pool... I am talking about situations where there has been a complication as a result of the surgery, not the patient.”

...Weight management expert Dr Rick Kausman said the number of patients coming to see him with lap-band surgery problems had doubled in the past two years.

The incessant scares about the unhealthiness of being fat has proven profitable for the weight loss and bariatric industries. It has left most fat people believing their life is endangered and they must lose weight at all costs. The sentence in the Herald Sun that deserves special note was this one:

Dr. Samantha Thomas, a medical sociologist at Monash University's Centre for Ethics in Medicine and Society found 90 percent of obese people didn't want the surgery and saw it as very much a last resort.

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February 26, 2008

National Eating Disorder Awareness Week

This week is commemorated to raising awareness of eating disorders. Most college campuses are hosting programs for education, outreach, support and intervention. Even well meaning programs can perpetuate myths about eating disorders and dysfunctional eating or, worse, reinforce among participants worries over their bodies, food, and exercise that encourages disordered eating and dieting behaviors.

A few recent articles have tried to correct common misunderstandings.

As examined last year in “The hidden faces of eating disorders,” those suffering from eating disorders don't always fit the image seen in media. The Ottawa Sun writes of the increase in serious eating disorders being diagnosed in young boys, age 12 and younger:

More boys with eating disorders

...boys make up 10% of adolescents with eating disorders. But [Dr. Mark Norris] said a recent national study found that among children 12 and younger, boys make up 20% of youngsters with eating disorders. In North America, about five out of every 100 teens suffer from an eating disorder. Norris said boys and girls show the same anxieties and stresses that lead them to restrict what and when they eat. A complex combination of genes and personality are at play, said Norris, adding kids who are anxious and perfectionists are more at risk....

Among teens, boys who are athletic develop more eating disorders than non-athletic types.... Physicians are getting better at spotting the symptoms of eating disorders in boys, said Norris. A decade ago, a teenage boy with a low heartbeat would more likely turn up at a cardiology clinic than at an eating disorder clinic....

The most heart-stopping and disturbing piece about eating disorders — one that calls out to be read in full [link in headline] by every healthcare professional — is the personal story of a young woman whose bulimia was so severe she landed in the emergency room. Her story poignantly illustrates that eating disorders are weight blind, nor are they stereotypical mental problems and attention-getting growing-up acts. At First, Do No Harm, a site where people share their experiences with the healthcare profession, she writes:

Binging? Purging? Vomiting blood? Try dieting…

Two years ago, I landed myself in the ER at around 2 AM. I’d been puking my guts up multiple times per day, every day, for months ...[and found] the toilet was filled with blood. The doc in the ER was compassionate and thorough, if somewhat clueless about eating disorders... the doc apprised my internist’s office of my situation and released me. Three hours later (approximately one of which was spent sleeping) I made my way into my new doc’s office. I explained that recently I had lost about a bunch of weight starving and puking nonstop and that now I was restricting much less but still bingeing and throwing up constantly; I told her that I’d had an active eating disorder for about four-five years and I filled in the details of the previous night’s ER episode. She asked about my highest and lowest weights—despite several times losing dramatic amounts of weight quickly and unhealthily, I’ve never been “thin,” and when I told her my highest weight, she said it was “great” that I’d lost the weight ...

Then she put me on the scale. I told her I didn’t want to know my weight, and that she at least respected, but then I got off and she said to me, “well, you’re overweight, but I’m sure you knew that... She goes on to tell me that what she wants to do is put me on a modified Weight Watchers plan and have me come back in a month and weigh me again. (... I am so sick with an eating disorder I am barfing up blood and she’s talking about a DIET?!)

I tell her that I’m really not interested as I’m already working with a nutritionist. She then asks me, in a hostile tone, what exactly I want from her; I’m at a loss for words since I figure it’s pretty self-evident that, um, she’s a doctor and I want her to…monitor my health? ... she then asks why I have an eating disorder—“were you raped or abused or something, or is this just kind of a going-off-to-college/growing up thing?”

She did not do a physical exam other than weight and blood pressure; she did not discuss the ER incident. She did not bring up the possibility that, given that I was puking blood, more tests might be necessary... I’m not sure what level of insensitivity or stupidity you have to reach to actually think that the most important thing you can tell a 21 year old with an eating disorder is that she should lose weight...

The medical community needs a serious wake-up call: not only can there be health at a range of sizes, there can also be illness at a range of sizes. WEIGHT IS JUST A NUMBER!!!

Not only are many eating disorder symptoms being recognized as the physiological and psychological bodily response to weight loss and dieting, dieting can appear indistinguishable from the “healthy” eating and exercise tips being encouraged in our culture today. It is not normal eating, it is dieting and dysfunctional eating, and has even led to a growing form of eating disorders coined by Dr. Steven Bratman, M.D., medical director of Prima Health, as orthorexia nervosa.

There are a number of college eating disorder prevention and treatment programs being conducted this week teaching similar “healthy behaviors,” such as eating “right,” exercising and building self esteem by healthy habits. One Eating Disorder Week initiative for children calls itself “grow your kids slim,” claims that childhood obesity is disordered eating of epic proportions, and offers similar healthy tips for parents. The author believes these are healthy eating and exercise, and different from “unhealthy dieting.” Harriet Brown, author and mother of a recovering teen, received some scary literature from eating disorder professionals that she shared with her readers as an illustration of “what’s wrong with the way we think about food and eating these days:”

Now this is scary

... First off, the newsletter came with a title that suggests that its goal is to empower parents to help heal eating disorders.... But then — now remember this is all going out under the aegis of eating disorders — there's a list of “10 Healthy Eating Tips for Your Child." And here's where things get ugly.

“1. Encourage your child to drink water. Lots of it. Drinking water is essential to losing weight as it keeps the metabolism healthy and functional. Plus, lots of kids feel the urge to eat when, in fact, they are not experiencing hunger, but thirst. Are you aware that drinking soda pop leeches the calcium from your child’s bones? Water is undoubtedly the better way to go!”

Note the assumption here: That “healthy eating" involves losing weight. For a child... Plus, drinking lots and lots of water to feel full is a classic eating disorder strategy. I thought we were trying to heal eating disorders here, not cause them.... Again, this is a strategy designed to fool the child into feeling like s/he has actually eaten something with calories in it. A big no-no....

Instead of “healthy eating” and worrying about the health and appearance of bodies and food, it is “normal eating” that's been forgotten. As incredible as it may sound, a lot of young people don’t know what it means to eat normally and not continually focus on, and fear, what they eat. The closest definition of normal eating was published in 1991 in Radiance Magazine:

Normal eating is being able to eat when you are hungry and continue eating until you are satisfied. It is being able to choose food you like and eat it and truly get enough of it — not just stop eating because you think you should. Normal eating is being able to use some moderate constraint in your food selection to get the right food, but not being so restrictive that you miss out on pleasurable foods. Normal eating is giving yourself permission to eat sometimes because you are happy, sad or bored, or just because it feels good. Normal eating is three meals a day, most of the time, but it can also be choosing to munch along. It is leaving some cookies on the plate because you know you can have some again tomorrow, or it is eating more now because they taste so wonderful when they are fresh. Normal eating is overeating at times: feeling stuffed and uncomfortable. It is also undereating at times and wishing you had more. Normal eating is trusting your body to make up for your mistakes in eating. Normal eating takes up some of your time and attention, but keeps its place as only one important area of your life. In short, normal eating is flexible. It varies in response to your emotions, your schedule, your hunger, and your proximity to food. — Ellyn Satter, R.D., A.C.S.W.

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February 25, 2008

"Prevention" programs that promise to save healthcare costs

In his latest article, Dr. Westby G. Fisher, MD, FACC carries the torch for health care that is evidence-based and remembers first, to do no harm. Public health initiatives that talk about preventing diseases may sound convincing, but might most really be little more than political rhetoric, backed by huge monies from companies needing to “get the word out” about their wonder drugs and scanners? We’d all like to believe we can prevent diseases and aging, but it just isn’t so. He calls upon us to stop and ask if these massive preventive health programs actually waste money that could doom our healthcare system.

His article begins:

When It Comes to Prevention: First, Do No Harm

...[D]o "prevention" programs really reduce costs to our health care system? Can people with cancer or heart disease or pneumonia or multiple sclerosis “prevent” their disease? Can people “prevent” getting older? Can all accidents be “prevented?” How about arthritis or diabetes? Can we prevent their onset? Can government force people to eat less or stop smoking? Would we want this? Or in the case of the much ballyhooed genetic testing – can people really “prevent” a genetic disease from developing? As a doctor, I’d love to prevent all disease that afflicts man, but I know this is impossible....

But new “prevention” initiatives are underway by healthcare insurers who “reward” (bribe?) their policy members with financial incentives to participate in weight reduction classes and to stop smoking. We are told this will keep costs down. But the overall benefit to reducing costs to our healthcare system has not been clearly demonstrated. On the contrary...

What is clear is that programs and tests to perform “prevention” are consuming huge health care dollars – from advertising, marketing, frequent doctor visits, early CT scans, carotid ultrasounds, lipid monitoring, mammography, colonoscopy, genetic testing – all of these are expensive (and becoming more so). Just diagnosing something earlier – does that save healthcare costs or increase them overall? Early diagnosis might prevent later complications of disease, to be sure. But it might also increase the contact with the healthcare system and extend expensive treatments. Early diagnosis also provides a convenient means for insurers to deny a patient coverage if they change jobs. This might save the insurers costs, but the patient? ....

Follow link in title for full article.

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Super reds and super foods — Will more antioxidant flavonoid foods make us healthier?

Have you caught the red craze yet? Every weekend, local radio stations run hours of shows describing the miraculous health benefits of concentrated essences of nature’s most colorful fruits and vegetables. Super berries, red cherry concentrates, super reds, and super berry blends — there are countless products to choose from. Before the first “commercial” break — it’s unclear how you can have a commercial during a show that is a “paid commercial advertisement” but, perhaps they’re hoping you’ll forget it’s not a real show and that they’ve aired the same segment every weekend for the past year — you’re certain to be convinced that you if you’re not consuming vast amounts of flavonoids in your diet every day, then you’re not eating right and not doing everything you need to stay healthy.

These “superfoods,” part of the growing functional food movement, are said to contain plant chemicals, phytochemicals, called flavonoids. Purportedly, flavonoids have antioxidant and anti-inflammatory properties and can treat, prevent or cure practically anything that ails you — arthritis, gout, joint pain, heat disease, stroke, cancers, sleep problems, Alzheimers, Parkinson’s, cataracts, fibromyalgia, hypertension, diabetes, fatty liver, infections, aging, diminished cognitive function, varicose veins, headaches, hayfever, eczema, allergies, hemorrhoids, and, of course, obesity.

Not so fast.

What you probably haven’t heard is that the FDA issued a permanent injunction on Friday against cherry/berry companies making any health claims for their products. The companies, Brownwood Acres Foods Inc., Cherry Capital Services Inc. (doing business as Flavonoid Sciences) and top executives are prohibited from making or distributing any products (fruit products, juice concentrates, supplements or powders, glucosamine and fish oil capsules) claiming “to cure, treat, mitigate or prevent diseases.”

“The FDA will not tolerate unsubstantiated health claims that may mislead consumers,” said the associate commissioner for regulatory affairs in the FDA news release. “The FDA will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe, truthfully labeled products to consumers.”

Brownwood Acres Foods, Inc. company’s website now only says its products have “Powerful Antioxidants - to attack your body’s harmful free radicals...known to be highly beneficial for optimal health.”

Not only has the public heard little about this injunction, but fewer have heard that it occurred more than two years after the FDA issued its first warning letter, finding the company in violation of the Federal Food, Drug, and Cosmetic Act on October 17, 2005, for making unscientific and unproven medical claims. At that time, the company’s website said cherries have antioxidant power for “arthritis, gout, joint inflammation, cancer prevention, fibromyalgia syndrome and heart disease” and that “recent studies how the antioxidant compounds in cherries may be 10 times stronger than Aspirin or Ibuprofen in relieving arthritic pain.” Tart cherries contain perillyl alcohol which, they claimed, is “extremely powerful in reducing the incidences of all types of cancer...[and work] in the treatment of advanced carcinomas of the breast, prostate and ovary...[and] ellagic acid [in cherries] may be the most potent way to prevent cancer.” Wild blueberries were said to contain high levels of anthocyanins that may “help prevent heart disease and stroke, guard against Alzheimer's and other neurological diseases.” The website, according to the FDA, had included claims in the form of “testimonials,” such as being effective for joint pain and stiffness associated with osteoarthritis and other degenerative processes, fibromyalgia, rheumatoid arthritis and lupus, and urinary tract infections.

This company was one of 29 companies that received Warning Letters from the FDA on October 17, 2005, for making nearly identical claims on their websites and product labels. Of those, as of today, all have complied but five, which are blatantly thumbing their noses at the FDA and violating its ruling by continuing to make medical claims for their products and supplements. As of yet, no FDA injunctions have been issued on those companies.

Two companies took another tactic in response to the FDA warning letters. For medical claims, they now link their website visitors to the Cherry Marketing Institute website. This is a paid marketing company, funded by cherry growers and processors, with cooperative relationships with the American Heart Association, American Diabetic Association, American Dietetic Association, National Sleep Foundation, Arthritis Foundation, American Cancer Society, Mayo Clinic, and Cleveland Clinic. From this marketing group are found the most extreme claims, nearly verbatim to those that originally appeared on the FDA-cited websites. It also produces regular press releases for the media with claims for these super foods. This content has found its way into many of the papers and magazines consumers read. By going through these trade groups and health media companies, their spurious claims would appear untouchable by the FDA.

Friday, the same day the FDA issued its injunction, Natural News was reporting that fruits rich in these chemicals — including blackberries, blueberries, strawberries, raspberries, sour cherries, pomegranates and cranberries — held special anti-inflammatory properties and that with simple diet changes alone, the inflammatory processes in “heart disease, stroke, Alzheimer's, cancers, arthritis, gingivitis and other "itis" disorders” could be ended. “Anti-oxidant properties in some foods also help fight inflammation by protecting the body from free radicals,” the author wrote. “Quercetin is a flavonoid, and a very powerful one. It is found in red grapes, red and yellow onions, garlic, broccoli and apples.”

The current issue of AARP Magazine also gives members a list of “Superfoods... power-packed with nutrients that will help your body ward off infection.” Red and blue berries and tea made the list for their antioxidant flavonoids. Even WebMD includes berries and tea on its list of “superfoods everyone needs [to] help ward off heart disease, cancer, cholesterol, and more.”

Purity Products, Inc., whose radio spots have been especially prolific, says its super red formula berry blend “supercharge[s] your body with superior antioxidant protection [that] powerfully support heart and cardiovascular health, healthy joints, healthy immunity, health vision, healthy energy levels” And its phytonutrient rich berry blend “support[s] optimal liver, immune, neurological, cardiovascular and eye functions...”

The FDA cannot begin to keep up with the thousands of companies selling natural foods and supplements, claiming to offer some special healthful benefit. We have to understand a bit of science ourselves, or at least remember those basic adages: if something sounds too good to be true... and the dose makes the poison, just because a little of something might be beneficial doesn’t mean more is better.

What are flavonoids?

Flavonoids are polyphenolic compounds that are synthesized by plants. More than 4,000 different flavonoids have been identified and they are widespread in nature, many in fruits, vegetables and drinks made from them. They are among the numerous natural plant pesticides — array of chemicals plants produce to defend themselves against fungi, insects and other animal predators — that we eat everyday (1,500 mg/day/person).

Flavonoids are categorized by their chemical structure — flavonols, flavones, flavanones, isoflavones, chalcones, catechins, anthocyanidins — with most (but the last two) bound to sugar molecules which is the form most reach the small intestine to be digested. Quercetin is the most abundant dietary flavonol, according to Dr. Cristobal Miranda, Ph.D., Assistant Professor, Senior Research Department of Pharmaceutical Sciences and Dr. Donald R. Buhler, Ph.D., Professor, Department of Environmental and Molecular Toxicology, both with the Linus Pauling Institute at Oregon State University.

Perhaps not surprisingly given their function for plants, in a test tube (in vitro studies) flavonoids seem to have antiviral, anti-inflammatory, anti-tumor and antioxidant activities, which has sparked tremendous interest for their potential role in human health. To date, the only other evidence to suggest a possible role in human health has been epidemiology studies finding untenable associations. JFS readers are familiar with these studies that look for correlations and try to claim a causal link. Their main focus anymore seems to be to support marketing agendas and convince us that certain politically-correct foods are better than those some believe we’re not supposed to be eating.

Take the benefits of tea, for instance, which is on all of those “superfood” lists for its antioxidant flavonoids. Researchers have taken a group of people, compared those consuming tea and those not, based on food frequency questionnaires, and found that tea drinking is inversely related to heart disease mortality. Since tea contains flavonoids, that must be the “reason,” failing to consider a zillion confounders such as genetics, socioeconomic and stress factors.

Why did they pick tea? They could just as easily have chosen to look at beer, which Dr. Joe A. Vinson, Ph.D., from the University of Scranton in Pennsylvania, found contains flavonoids with higher antioxidant activity than green tea, red wine or grape juice. As Drs Miranda and Buhler pointed out in a recent Linus Pauling Institute article, the antioxidant activity of the flavonoids in hops and beer far exceeds that of red wine, tea or soy! Beer, however, doesn’t have the same feel good connotation associated with virtuous “healthy” eating. :)

Another epidemiological association gave birth to the current red food fad. In explaining the “French paradox,” it was assumed it must be the red wine — not the genetics among this more homogenous population — to explain lower heart disease. Since wine’s red color comes from grape skins which contain antioxidants like flavonoids and resveratrol, that was assumed to be the “cause” for the correlation. And the red myth was off and running. The science is controversial, though, as studies have since found that any alcoholic beverage appears to confer heart benefits. There’s probably not much of a market for an alcohol supplement or for medicinal brandy, either. It just doesn’t have the same “healthy” connotation.

While flavonoids have elicited tremendous interest for their potential antioxidant health benefits, the science turns out to be more complicated and a lot less conclusive. As researchers from the Vrije Universiteit Medical Center, Wageningen, Netherlands, found in a review of the possible mechanisms of action and potential health applications for flavonoids in the American Journal of Clinical Nutrition, most of the research on flavonoids has involved in vitro studies or occasional rodent studies, but the benefits are not being supported in clinical trials and studies on humans.

The antioxidant effects seen in test tubes may not have much effect inside the body and the science cannot draw definite conclusions about the usefulness of flavonoids in the diet, they found. Of special caution: “Data on the long-term consequences of chronic flavonoid ingestion are especially scarce.”

According to the Linus Pauling Institute:

Flavonoids are effective scavengers of free radicals in the test tube (in vitro). However, even with very high flavonoid intakes, plasma and intracellular flavonoid concentrations in humans are likely to be 100-1,000 times lower than concentrations of other antioxidants, such as ascorbate (vitamin C) or glutathione. Moreover, most circulating flavonoids are actually flavonoid metabolites, some of which have lower antioxidant activity than the parent flavonoid. For these reasons, the relative contribution of dietary flavonoids to plasma and tissue antioxidant function in vivo is likely to be very small or negligible.

Although various flavonoids have been found to inhibit the development of chemically-induced cancers in animal models of lung, oral, esophageal, stomach, colon, skin, prostate and mammary (breast) cancer, epidemiological studies do not provide convincing evidence that high intakes of dietary flavonoids are associated with substantial reductions in human cancer risk. Most prospective cohort studies that have assessed dietary flavonoid intake using food frequency questionnaires have not found flavonoid intake to be inversely associated with cancer risk. Two prospective cohort studies in Europe found no relationship between the risk of various cancers and dietary intakes of flavones and flavonols, catechins or tea ...

In other words, beliefs that flavonoids hold super curative powers in our diet greatly overstate the science.

There is no credible scientific evidence to believe any food or ingredient holds special powers to heal. People around the world have enjoyed a wide range of diets with no common relationship to lifespans or health. So, not surprisingly, every single primary prevention clinical trial of antioxidant supplementation or higher intakes of fruits and vegetables and “healthy eating” (for example here, here, here, here, here, here, here, here) has found no effect on heart disease, cancers or premature mortality. Not only can the science help us relax and return to the pleasures of the table, it can stop the blame and guilt imposed on those who get sick for having not eaten “healthy” or followed some chaste diet.

The sales pitches of super reds, which concentrate as many different flavonoid-rich fruits and vegetables possible, want us to believe that our diets are deficient, our health is bad and that we need far more nutrients than we get in our diets. This belief isn’t based on good science, either, wrote Dr. William T. Jarvis, Ph.D., while professor of public health and preventive medicine at the Loma Linda University School of Medicine, in a 1983 issue Annual Review of Nutrition. “Magical thinking about food,” particularly the idea that certain foods, vitamins or nutrients can prevent or cure illness and maintain youthfulness, has given foods pharmacological properties in pop culture, he said. Sadly, magical food beliefs have changed little over subsequent decades. Overstating the science, advertising, and even the overemphasis on nutrition education has promoted food faddism and health fears, he said, leaving consumers turning to healthy foods in an “attempt to obtain ‘supernutrition’ or to avoid ‘depleted’ foods."

Getting the small amounts of nutrients our bodies need actually isn’t hard to achieve by enjoying some variety of foods. Even the “emphasis on the ‘well-balanced diet’ also favors food faddism,” said Dr. Jarvis, who also founded the National Council Against Health Care Fraud. “A national study on health practices and beliefs conducted for the FDA found that 86% of the public believed ‘anyone who eats balanced meals can get enough vitamins in his regular food;’ yet the majority of the respondents still used or had used supplements because they didn’t think they ate ‘balanced’ meals. The words ‘well-balanced meal’ and ‘balanced diet’ apparently suggest that a healthful diet is a precarious achievement.” It’s not. The human species would never have survived to this point if we were that fragile.

Actual nutritional deficiencies are rare in populations where food is available. The most common cause of poor nutrition isn’t eating “bad’ foods, but eating too few calories, restricting our diets or eliminating foods, according to Dr. Sidney M. Wolfe, M.D., author of Worst Pills, Best Pills. Rates of heart disease and cancers have been dropping for well over half a century, and life expectancies have increased, despite the modernization of the food supply and no change in fruit and vegetable consumption. American health has improved, not deteriorated, and nutritional-deficiency diseases have been nearly eradicated.

There is no need to eat like food is medicine and that disease prevention is the sole reason for eating.

Too much of a good thing

But concerns with “healthy” eating and food fears can harm people, said Dr. Jarvis. And not just by costing more for special foods and supplements. Recommending the overuse and underuse or avoidance of certain nutrients has caused malnutrition and health problems. With anything, there can be too much or too little — water is essential for life but you can die from drinking too much. Flavonoids is another example of not just how our beliefs about foods often don’t make scientific sense, but why more isn't better.

To illustrate how illogical our fears about foods and chemicals can be, many people fear any detectible amount in food of any chemical that has ever been shown to cause cancer in rodent studies. No one would argue, though, that fruits, vegetables, nuts and teas can’t be part of a healthful diet. Yet, quercetin is one of the flavonoids that’s been tested and found to be carcinogenic in rodent studies (which use high exposures), according to Dr. Bruce N. Ames, Ph.D., renowned researcher on mutagenic and carcinogenic risks and professor in Biochemistry & Molecular Biology at the University of California, Berkeley and Dr. Lois Swirsky Gold, Ph.D., director of the Carcinogenic Potency Project at University of California, Berkeley. But like all chemicals, natural or synthetic, they caution, the low levels of chemicals our bodies are naturally exposed to every day are highly unlikely to be a risk for cancer. “Humans have many natural defenses that buffer against ordinary exposure to toxins and these are usually general, rather than tailored for each specific chemical.”

Researchers now understand that the antioxidant capacity of flavonoids is decreased when broken down by digestion; the body perceives them as foreign compounds and tries to excrete them rapidly. It also appears that it only takes small amounts to see healthful benefits, but more is not necessarily better. Just because certain foods are bursting with some nutrient that appears healthful does not mean that even more is very, very healthful.

The logic used by those promoting antioxidants for anti-aging also reflects a misunderstanding of how cells detect and repair the damage caused by free radicals and the important role that free radicals play in normal physiological processes (such as the immune response and cell communication), according to anti-aging experts. While free radicals promote beneficial oxidation, in excess they produce harmful oxidation that can cause cell damage, doctors Stephen Barrett, M.D., and Victor Herbert, M.D., J.D., M.A.C.P., F.R.S.M. have explained. Vitamins C and E and beta-carotene, for example, are mischaracterized as ‘antioxidants,’ when they are really redox agents (antioxidants in some instances and pro-oxidants in others, producing harmful free radicals). That may explain why antioxidant supplements or eating more fruits and vegetables high in antioxidants have not proven out to be beneficial in clinical trials on real people, and in some cases suggest harmful effects.

Dr. Martyn T. Smith, Ph.D., professor of toxicology at the University of California, Berkeley, has particularly cautioned about consuming high concentrations of flavonoids being sold as health food supplements. Writing in the journal, Free Radical Biology and Medicine, he and co-author Christine F. Skibolaa said that at low concentrations, flavonoids appear to acts as antioxidants and potentially have anti-cancer actions to block and inhibit cell division. But the amounts in some popular supplements they tested found levels 10 to 20 times what is recommended for the human body. “At high concentrations, certain flavonoids can act as pro-oxidants and become mutagenic, meaning that they could cause oxidative damage and cause DNA and chromosome damage,” they said. At these levels, flavonoids can also alter normal body functions, hormones, interfere with metabolism of drugs and interfere with the absorption of needed minerals.

Women of childbearing age who might become pregnant should be especially careful, they wrote, as flavonoids cross the placenta. The fact is, high levels of flavonoid consumption has never been tested and shown to be safe in humans, and the potential adverse effects may outweigh benefits. “Just because something comes from a natural source doesn't mean it can't hurt you,” Skibola said. “The dose makes the poison....unfortunately people tend to forget that.”

The FDA’s public announcements warn that companies claiming their foods and supplements act like drugs and can cure or treat various health conditions do not have scientific evidence behind them. Despite the Cherry Marketing Institute’s claim that “the higher the ORAC [Oxygen Radical Absorbance Capacity] score, the better a food is at helping our bodies fight diseases like cancer and heart disease,” there is no evidence that the more ORAC units we consume, the healthier we are.

We do not have to start counting ORAC units or anything else to eat well, live well and be well.

© 2008 Sandy Szwarc

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