Say Good-bye to Acomplia...for now

We all remember last December when every story in the media was selling the wonders of the “Miracle Drug,” Acomplia. Meanwhile, Junkfood Science readers got the real scoop on the evidence from the clinical trials.

Since then, things haven’t looked good for the FDA approving Accomplia for sale in the U.S. The FDA first put it on the slow track for approval due to concerns over its efficacy and safety, and then an FDA advisory panel failed to recommend it for approval.

Today, Sanofi announced that it was withdrawing its FDA application for Acomplia. They haven’t given up on their efforts to sell it in the U.S., however. By withdrawing their application, they avoid outright rejection of the drug by the FDA and can modify their application and come back and try again, claiming it’s a treatment for something else, such as diabetes. The company spokespersons haven’t said how they will get around the side effects. The European Medicines Agency is currently reviewing those and is expected to announce its conclusions in a few weeks.

It remains to be seen what this will mean for the other pharmaceutical companies with their own brand names of cannabinoid-2 receptor antagonists — Merck’s Taranabant and Pfizer’s CP 945598.

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Figure Flaws — Did this diet really work?

News services around the world have reported of a “Family-based weight program effective for children and teens.” Not surprisingly, the stories were all taken from the Yale University press release, announcing that its weight management program had been shown to be a success. But had it really?

The study said to prove the benefits of their weight program was just published in the Journal of the American Medical Association. It’s typical of the strengths and foibles found in diet studies.

These “figure flaws” will astound you. So let’s start from the top.

Study design and interventions

The news correctly reported that this was a randomized clinical trial of 209 fat children. But that’s where accuracy in the news ended.

The study participants were recruited from healthy fat (above the 95th percentile on CDC growth curves) children enrolled at the Yale Pediatric Obesity Clinic, seeking to lose weight. The children had to have an involved parent or caregiver, speak English, and have no health problems, physical or psychological. There was no true control group of similarly healthy fat children outside the clinical setting, without interventions.

The children, average age of 12, were randomized, with two-thirds to receive intensive weight management and the rest to get standard clinical weight management, with the promise of being enrolled in their Bright Bodies program after the study. Standard clinical intervention consisted of diet and exercise counseling by a registered dietician — which included the usual diet instructions to decrease juice and sweetened drinks, switch to low-fat milk and foods, read labels, bring healthy lunches to school, decrease sedentary activities, and get regular exercise — and physical, psychological counseling by a social worker.

The intensive intervention group was secondarily randomized into a structured diet plan group and a group undergoing Yale’s proprietary Bright Bodies program. However, 83% of the kids dropped out of the diet plan group during the first 6 months and the researchers had to abandon that arm of the study.

Bright Bodies is a program created ten years ago by dietician, Mary Savoye-Desanti. It uses a curriculum called Smart Moves™ which includes intensive nutrition classes to teach young people and their parents and caregivers, how to make “better food choices” with low-fat foods and portion control. Behavioral modification classes teach children to “become more aware of overeating triggers” and how to control urges to eat; and parents are taught to role model healthy behavioral change. And finally, “children are encouraged to exercise 30 to 40 minutes five times per week,” with high-intensity cardiovascular workouts supervised by exercise physiologists. According to Salon writer, Amy Benfer, this week, Bright Bodies doesn’t hesitate to confront really fat kids about their eating and exercise habits, believing being overweight is a health issue and requires aggressive intervention. As Ms Savoye said in response to those concerned about making kids feel bad about themselves by calling attention to the fact they’re fat, she believes that being overweight was worse for their self-esteem.

For the first six months of this study, the kids attended exercise sessions twice a week (100 hours per week) and were instructed to exercise at home three additional times a week; they and their families attended Smart Moves nutritional/behavioral sessions once a week; and the kids had weekly weigh-ins. During the final six months, they attended weekly exercise and nutrition/behavioral modification classes and biweekly weigh-ins.

So what happened?

Only 28 kids from the standard clinical weight management stayed in the program for the full year — meaning 60% dropped out.

Only 56 kids in the Bright Bodies intervention group were still in the study at the end of the year — meaning 53% dropped out.

So, this study ended up having data on only 84 of the original 209 participants — 40% of what they started out with! It would seem a lot easier to show favorable results, when one eliminates 60% of the unfavorable ones, wouldn’t it?

But the researchers included all of the original kids from both intervention groups in their analysis. How’d they do that?

The magic of computer modeling. Here’s how they described it:

Multiple imputation with data augmentation under the multivariate normal model using PROC MI from SAS was performed to impute missing outcome data. The details of this process are described by Allison. The imputation was conducted on continuous missing data with log transformations applied for normality where necessary.

Did you get that? :)

Dr. Joseph Schafer, associate professor at Department of Statistics and The Methodology Center at Pennsylvania State University, explained multiple imputation:

Imputation, the practice of ‘filling in’ missing data with plausible values, is an attractive approach to analyzing incomplete data. It apparently solves the missing-data problem at the beginning of the analysis. However, a naive or unprincipled imputation method may create more problems than it solves, distorting estimates, standard errors and hypothesis tests, as documented by Little and Rubin and others.

In Rubin's method for ‘repeated imputation’ inference, each of the simulated complete datasets is analyzed by standard methods, and the results are combined to produce estimates and confidence intervals that incorporate missing-data uncertainty. Rubin addresses potential uses of MI primarily for large public-use data files from sample surveys and censuses. With the advent of new computational methods and software for creating MI's, however, the technique has become increasingly attractive for researchers in the biomedical, behavioral, and social sciences whose investigations are hindered by missing data.

If this sounds to you like it’s a fancy way of saying they filled in the blanks with guesses, you’re not the only one.

The researchers said they also made assumptions that the missing data were at random and not due to anything observable in the study. Dr. Paul D. Allison, of the University of Pennsylvania and author of Missing Data, referenced in this study, however, cautioned that even when using the conditions described by Rubin: “The problem is that it’s easy to violate these conditions in practice. There are often strong reasons to suspect that the data are not missing at random. Unfortunately, not much can be done about this.” [To fill in missing data in their computer modeling, other diet researchers have carried forward the last known weight lost among drop-outs, assuming no regain.]

Concerning the significant percentage of missing data in this study, David L. Cassell, a mathematical statistician and Senior computing specialist for the EPA, and co-director of Design Pathways in Corvallis, OR, is considered an expert on the computer database model, SAS. He recommends caution to researchers when using the PROC MI: “I also have seen it misused. Are you missing just a few percent of the observations? Okay, then MI should work well for you. Are you missing 30% of the data points? If so, then nothing is going to solve all your problems, not even PROC MI. So be forewarned...”

The findings

Despite all of this, few would view the findings of this study as convincing evidence of effectiveness.

After 6 months of intense interventions in the Bright Bodies program, the kids had lost an average of 5.7 pounds, but during the second half of the year were rebounding, as is seen with all weight loss interventions. By the one year mark they were already nearly a pound above where they started. Conveniently, the study stopped there.

The single most important point to recognize about this weight loss study, like virtually all such studies promoting a certain diet or weight loss plan, is that it’s too short-term to credibly demonstrate effectiveness. Neither a sustained weight loss has been shown, nor have any of the temporary changes in health risk indices been shown to be equivalent to actual health outcomes. The children in this study were 12 years old at the beginning of the study and this is a period of especially rapid growth and development. Was yo-yo dieting of any benefit to their health?

As we’ve learned, the scientific evidence and obesity experts, including those with the National Institutes of Health and the Federal Trade Commission’s scientific expert committee, have concluded that no weight loss program can be evaluated until it demonstrates weight loss for at least five years because virtually all weight is regained within five years. That’s the rule, not the exception. Short-term diet studies under five years in length are little more than dieting stunts.

It is reasonable to ask why, if this program has been in existence for ten years, has there been no research to demonstrate its long-term effectiveness? These same researchers published a smaller, and nearly identical short-term study more than two years ago — how are those 25 children today? Instead of following children for years to see how their program has affected long-term health, they conducted another short-term study. Nor, has there been any study done to see if there’s been any long-term harmful effects on these children, such as self-esteem, eating disorders, academic performance or to their health from dieting and the invariable yo-yoing.

Ms Savoye-Desanti also admitted in the press release that the “expense incurred in operating such a program [as Bright Bodies Smart Moves] is substantial.” Future studies will be done on cost-benefit analysis, she promised.

The take home message is not found in this study or specific program, but in the realization that it is by no means unique for weight loss studies. You won’t find any long-term study of any weight loss intervention — even those programs and diets that have been around decades — that’s proven it to be safe and effective for weight loss or to improve actual clinical health and longevity — because there aren’t any.

© 2007 Sandy Szwarc

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Be careful what we wish for

Sometimes, what sounds logical isn’t logical at all when we carry it forward. Worse, no matter how good it sounds at first blush, when it’s actually put into action, it might not really be what we ever wanted at all!

In this entertaining think piece, Mike Feehan takes off the masquerade and cuts to the chase at where we’re really heading with all of these efforts to make sure we're healthy and fit, have perfect children, and the highest life expectancy in the world. ....

Why isn’t health care compulsory?

I say it’s time for Congress to face up to Americans’ needs, and make health care compulsory. I’m not talking about health insurance. I’m talking about health care....

Once this concept is understood, it's clear what must be done. First, all health care professionals become employees of the Federal Government, paid a living wage from public funds. Second, hospitals, clinics, labs and other facilities are nationalized and their staffs also become employees of the Federal Government. Fair compensation is paid to the former owners just as for the condemnation of any other private property for public use. Third, the Federal health care professionals examine any person who wants health care, and issue health care orders to anyone who is determined to actually need health care. Fourth, it is illegal to seek or receive health care from anyone except a Federal health care professional....

The Federal Health Tribunals are empowered to impose heavy fines upon individuals who shirk their civic duty to follow health care orders, including refusal to alter lifestyle when so ordered (e.g., exercise, stop smoking, lose weight). The Tribunals also have authority to order health shirkers confined until treated.... The Tribunals also have the power to order a provider who refuses to deliver care that is ordered by a regional Federal Health professional, to perform unpaid community service within the Tribunal’s region....

Entire article is here.

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Why isn't there a cure?

Dr. Steven Novella, a neurologist at Yale University School of Medicine and Associate Editor of the Scientific Review of Alternative Medicine, has a thoughtful article at NeuroLogica on why, with all of the money going towards research, have we not yet found a cure for cancer. He looks at the most common misconceptions about cancer and addresses theories that there is no incentive to find a cure. This information can help people from getting taken in by someone claiming to have a miracle cure or treatment.

He concludes his long article by saying:

The overall reality is that the standard of scientific medicine is not a monolithic entity, controlled by any one institution, agency, or industry. It is a complex and dynamic set of many forces and interests. It is ultimately driven by science, which is a transparent and public process, and prevents any big brother type of control (this is partly why it is so important that healthcare be based upon science).

Cancer is a very difficult type of disease to treat, and the public has a very distorted view of the nature of cancer and of medical scientific progress in general. This has lead to unrealistic expectations of progress in curing cancer, which then in turn leads to thoughts that cancer research is somehow not working.

I find the same to be true in medicine in general – the public thinks of scientific progress in terms of dramatic “breakthroughs.” Media hype feeds this misconception. The reality is that medical scientific progress is largely a series of very small steps, with a cumulative effect of slow steady improvement in treatments. We have not cured Alzheimer’s disease, ALS, Multiple Sclerosis Parkinson’s disease, and many other diseases as well. But treatments are slowly improving. Slow steady progress does not make good headlines, however, so the myth of miracle medical breakthroughs will likely continue to be promoted by the media.

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

Information firewall?

He who controls access to information controls “the truth.”

Two extraordinary developments have occurred this week that could make it difficult for those who use the internet regularly — and that’s most of us — to learn anything but what certain interests want us to know. Equally disturbing, is the information they’re gathering on us.

This week brought news that Google was racing “to accumulate the most comprehensive database of individual information” on users. As the Financial Times reported, these efforts are being made to enable industry to target us with personalized advertisements and suggest products and services based on the personal information it gathers on us. Its proposed $3.1 billion takeover of DoubleClick sparked concerns it will lead to an erosion of online privacy. But that could be the least of our worries....

We’ve already examined that much of the health “news” we get on television, radio and in print is little more than the latest form of canned, scripted advertising from various interests. We’ve learned to view documentaries with an equally critical eye, as most of them are also just carefully-crafted marketing pieces. [Readers here are way ahead of the pack when it comes to that.]

But many of us believe the internet is different. When we research for news and information online, we believe that the hits we get are genuine and objective reflections of the relevance to our search terms. We would be wrong.

Search engines have inordinate abilities to censor information by simply making it invisible to searches. It is not uncommon for key documents and papers that don’t support government initiatives or special interest agendas to be buried and take extraordinary effort to hunt down, or to disappear from the internet altogether, something anyone who’s been researching for any length of time quickly discovers. [It explains why us “technological dinosaurs” save things on private hard drives and paper files.]

But it appears that finding objective information about our health, drugs or treatments could soon be a thing of the past. Google has just announced that it has created a “Google Health Advisory Council.” In its media announcement, it said:

We want to help users make more empowered and informed healthcare decisions, and have been steadily developing our ability to make our search results more medically relevant and more helpful to users.

Screening out “irrelevant” and “unhelpful” information? That sounds like a euphemism for censorship. Look at every name on their new prestigious advisory panel and the interests they represent. Most will be familiar to Junkfood Science readers, as we've examined the soundness of their consumer information — RAND Corp., the Cleveland Clinic, the AMA, Robert Wood Johnson Foundation, AARP, Kaiser Foundation Health Plan, Inc., California HealthCare Foundation, and others.

Despite all of the flaws and utter garbage on the net, it’s still been the primary way for most people to break through the media groupthink to learn other viewpoints and sounder information. This development could be the beginnings of the world's biggest internet information firewall.

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

The costs of efforts to whip kids into shape

Public health officials widely believe that children are little adults. If kids aren’t engaging in 60 to 90 minutes of sustained adult-style exercise every day, they are deemed insufficiently active and labeled unhealthy couch potatoes.

Today’s medical news brings more research showing the toll that efforts to “shape up” today’s children are having on them. Kids “as young as four are being treated in increasing numbers for injuries caused by excessive physical exertion,” reports the Independent. It is to the Independent’s credit that it reported on these studies because most media has ignored them. Roger Dobson writes:

Exercise takes toll on child athletes

Contrary to a growing perception that young people are increasingly becoming sedentary couch potatoes fixated by the internet and video games, new research from Europe and the US reveals that the past 20 years have seen a rise in the number of children seeking medical help for chronic injuries caused by long-term overexercise.

“There has been an overall increase in both acute and overuse injuries in young athletes over the past 20 to 30 years....” says a study from the University of Utah School of Medicine and Northwestern University, reported in Pediatric Emergency Medicine....

Cases cited [in the European Journal of Radiology] include thigh muscle strain in a four-year-old boy with a history of intense running; stress fracture in a five-year-old gymnast; an eight-year-old footballer with indications of cruciate ligament damage. In the US, there are now an estimated 2.6 million emergency department visits annually for sports-related injuries in patients aged five to 24 years.

Gone are the days of just letting kids play. Today, in the effort to address “childhood obesity,” the focus is on structured exercise and organized sports — despite the advice of experts on children’s physiology who caution that children are not naturally active in the same way as adults. Their growing and developing bodies can be harmed by adult types and durations of exercise. As recently examined in Little League-itis and a review of school PE initiatives, efforts to engage children in sports and structured exercise are having adverse effects which are not popular to acknowledge in the frenzy to get young people to burn more calories.

The Utah researchers mentioned by the Independent published their study in Clinical Pediatric Emergency Medicine and cautioned that “because of the effects of growth on the musculoskeletal system, [children] are at risk for injuries to the growth plate, apophysis, and joint surface as well.” Another article in that same issue from Dr. Cynthia R. LaBella M.D., at Northwestern University's Feinberg School of Medicine, and the Institute for Sports Medicine, both in Chicago, IL described the growing numbers of sports-related injuries to the lower extremies being seen in emergency rooms, which include contusions, muscle strains, fractures, ankle and knee sprains, and patellar dislocations.

The European Journal of Radiology has had several medical reports about the increase of exercise-related injuries seen in children and teens. Researchers from Italy described spinal injuries. While they said “most acute injuries are minor and self healing,” they also cautioned that “severe and catastrophic events are possible.” Researchers from Greece described injuries unique in childhood and teenage years “due to the inherent weakness of the growing skeleton at specific sites, mainly the cartilaginous parts.” They focused on the radiological findings and best imaging approaches to helping doctors diagnose injuries in skeletally undeveloped bodies.

Growing numbers of pediatricians are worried about young athletes who are taking activity to an extreme. Their concerns are drowned out in the media by claims of an childhood obesity epidemic.

In this month’s issue of Pediatrics, Dr. Joen Brenner, a sports medicine pediatrician at Children's Hospital of The King’s Daughters in Norfolk, VA, and doctors from across the country with the Council on Sports Medicine and Fitness, reported: “As more children are becoming involved in organized and recreational athletics, the incidence of overuse injuries is increasing. Many children are participating in sports year-round and sometimes on multiple teams simultaneously.” They went on to describe how that this overtraining “can lead to burnout, which may have a detrimental effect on the child participating in sports as a lifelong healthy activity.” They found that it wasn’t just community and school officials who were overly obsessed with pressuring kids to compete, but that parents were part of the problem. They supported recent recommendations made by an American Academy of Pediatrics sports medicine council urging moderation.

Despite repeated admonitions and growing evidence in the medical literature that today’s anti-obesity initiatives to get kids fit aren’t benign, thing’s are not likely to change. One reason: there’s no money to be made selling a program of just letting kids play.

And even that’s not possible today. Even play is being regulated and structured by adults — down to determinations of what makes appropriate clothes for schoolchildren so as to be “suitable for active play.” One of the editors at Spiked-online recently had something to say about that!

A new British study of the way girls play at school recommends schools to encourage or even compel children to wear clothes ‘suitable for active play’, like sweatshirts, trousers and trainers. It also recommends football, apparently played almost exclusively by boys, be banned from sections of the playground to encourage girls to stay active for longer and help tackle obesity. With today’s obsession with body size, reflected in the ever-growing panic about Britain’s ‘obesity epidemic’ ...it is hardly surprising if some young people have a problem with body image. Normal, healthy children are being infected with an unhealthy obsession about the way they look....

[T]hrough the gaze of academic researchers and bullying- and obesity-obsessed adults, plain obstinacy (like refusing to take part in physical education lessons or move around during breaks), power negotiations (who’s in and who’s out), and other behaviour that’s just part of growing up and socialising in schools, are pathologised and seen as alarming signs that the ‘obesity epidemic’ is growing and must be stopped by any means necessary.

No matter what it costs our children.

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Looking before we leap

Healthcare news from England has been copious this past week but, oddly, virtually none of it has made its way onto our news despite its relevance for us. Instead, our media seems to be presenting us with a single portrait of nationalized healthcare in England — an idyllic one, where no one is ever denied care or ever waits, everything is free, there is plenty of money and no shortages, and everyone is healthier than us because the healthcare is better. Anytime we hear only one story, it’s time to do some investigating.

As healthcare professionals, many of us know many intelligent and caring doctors and nurses in the UK whom we tremendously respect and correspond with regularly, and there’s a generous exchange of medical research and ideas. We all recognize the value of information. It can help us ensure our patients get the best care possible. Without questioning things, digging deep for the facts, and exploring all sides we can’t hope to reach sound conclusions.

The same goes for considering whether to abandon our entire healthcare system for one like the UK’s. There are very different realities coming from healthcare professionals working in the UK, as well as from the British media, than we're hearing. Let’s look at a few of those stories for ourselves.

Sunday, the Observer reported that efforts to cut costs were leaving increasing numbers of their most vulnerable citizens being neglected and suffering:

We have discovered that an insidious kind of rationing is happening in England and Wales, more covert - and in some senses more cruel - than the kind we read about when an expensive cancer drug is not prescribed by the NHS. It is a rationing that involves not giving baths to frail elderly people who are unable to clean themselves, cutting back on the daily visits from care staff, closing day centres, not visiting homes to ensure they have the right medication. No dramatic headlines perhaps, but home care is a lifeline for thousands of old people.

Nearly 160,000 households occupied by pensioners have stopped receiving the care they need from social services in the past decade - a tide of neglect that will have long-term consequences for the whole country. As local authorities' budgets have come under pressure, the eligibility criteria that an older person has to meet to receive free care have been made so restrictive that in many areas only someone who is dangerously ill will be given support....

A few weeks ago, the Telegraph reported that “Cancer survival rates worst in western Europe.” These were the findings of the European Society for Medical Oncology (ESMO) Guidelines Working Group, published in the Annals of Oncology:

British cancer patients are substantially more likely to die of the disease than those in other western European countries because of poor access to the latest drugs, according to an authoritative report to be published today....While more than half of patients in France, Spain, Germany and Italy have access to new treatments provided since 1985, the proportion in the UK is four out of 10....They found that the proportions of female cancer patients surviving five years beyond diagnosis in France, Spain, Germany, Italy were 71 percent, 64 percent, 63 percent and 63 percent respectively. In the UK it was 53 percent.

This confirmed the report of the Commonwealth Fund's International Working Group on Quality Indicators which found cancer survival rates were lowest in the UK and patients had the longest waits for elective surgery. “Roughly 40 percent of cancer patients never get to see an oncology specialist. Delays in receiving treatment are often so long that nearly 20 percent of colon cancer cases considered treatable when first diagnosed are incurable by the time treatment is finally offered,” Michael Tanner of the Cato Institute wrote in the Detoit News. And say what we might about pharmaceutical companies, they save lives, too. “U.S. companies have developed half of all the major new medicines introduced worldwide during the past 20 years,” said Tanner. “In fact, Americans played a key role in 80 percent of the most important medical advances of the past 30 years.”

Medical News Today reported that the number of women having abortions since 2005 has risen to the highest levels ever. According to Anne Weyman, chief executive for the Family Planning Association:

[This] isn’t surprising given that contraceptive services are in crisis and at their lowest point for many years. Services are being cut and clinics are closing up and down the country. In England, the average amount spent on each woman's contraception is about eleven pounds. Some Primary Care Trusts have admitted they spend just 18 pence. This is unbelievable and wouldn't be tolerated if it happened in another part of healthcare. Women get blamed for irresponsible behaviour - when the real cause is Primary Care Trusts neglecting their duty to provide comprehensive contraceptive services....

Yesterday, the Telegraph reported on a new Healthcare Commission report finding that a stunning one in four NHS hospital systems had failed to comply with basic hygiene standards:

A Healthcare Commission report shows 99 of 394 healthcare trusts admitted to failing to have adequate infection control, safely decontaminate reusable medical equipment or keep their facilities clean....The proportion failing to meet the required standards on ensuring reusable medical devices are properly decontaminated was 14.3 per cent, up from 12.6 per cent in 2005-06. Katherine Murphy, of the Patients' Association, said: “We are killing more people with C. difficile than on our roads. The death toll with MRSA is equivalent to two train crashes every week.These are avoidable infections. Every week there is a different priority for the Government. Infection control has never been given a high priority."

Anna Walker, the chief executive of the Healthcare Commission, said she believed the drop in the three hygiene-related standards was because trusts were monitoring the issue more rigorously than before. She said: “There is greater clarity about what is required of trusts and, secondly, they know the spotlight is on this issue and they are looking at it more thoroughly. From the point of view of patients that is a good thing."

Today, the Scottish News reported on new patient waiting time goals:

Health secretary Nicola Sturgeon has pledged to bring in a new waiting times target for patients as part of an NHS action plan....would include a target of patients being treated within 18 weeks of being referred to more specialist care by their GP. Currently patients wait up to 18 weeks from seeing a consultant for treatment. But they can still wait up to 26 weeks for a specialist appointment after being referred by their GP, although this is to be reduced to a maximum of 18 weeks at the end of this year.

On Monday, the Guardian reported on a new study just released by the British Medical Association finding that the public was as unhappy with the NHS reforms over the past ten years, as was the medical profession. Apparently, some of the controversy is on the issue of charging for services due to limited resources, something the BMA opposes, but consumers are finding preferable to long waits and limited services.

[O]nly 34% of the public thought a decade of reform had made the NHS any better, while 42% thought there had been no improvement. Against this background of apparent public discontent, doctors will today mount a full-scale attack on NHS reforms, accusing the government of “contemptuous disregard" for the views of the profession and of introducing changes “that are not fit for purpose and are damaging to medicine and healthcare in the UK."

The survey results run counter to most of those commissioned by the government and the official watchdog, the Healthcare Commission, which have traditionally found most patients are happy with their doctors and the treatment they receive on the NHS. Vivienne Nathanson, head of science and ethics at the BMA, said the survey “reflects a big difference of opinion between the government, patients and doctors".

The findings of the survey of around 1,000 members of the public in England, questioned on the street, generally reinforced the views of doctors - but there was divergence on the issue of charges in the NHS. The BMA is adamantly opposed to any charges, but 53% of the public thought there was a case for a small charge for some services where resources are limited.

The Times reported last month that annual spending on the NHS has increased to $184 billion (in U.S. dollars) and “health outcomes have improved, although not as dramatically as the injection of funds would suggest.” But it accompanied news of rationing of services and cost containment measures, as well as problems with red tape and higher taxes.

While we envision a government-run healthcare system that’s more streamlined, with less bureaucracy and waste, a BBC News story illustrated the skyrocketing growth of the National Health Service bureaucracy: [doctors and nurses are the bottom two lines; managers and consultants are at the top]

It’s hard for Americans to get a complete picture of what things are like. The perspectives of medical professionals working in the British healthcare system can help. It also helps to understand the history of their system. Dr. Satyajit Bhattacharya, a doctor working in the NHS, wrote an overview ten years ago in the Indian Journal of Medical Ethics. While the NHS set out with goals to “provide an adequate and comprehensive healthcare system, available to all citizens, funded from taxation, and free at the point of delivery,” the cash supply versus demand had reached crisis proportions by 1987, he reported. He outlined the multiple reforms which ensued, as well as their effects on the:

· medical infrastructure (Hospital systems are now independent trusts and many in the red, resulting in “cutting down on what they perceive as non-essential services,” he wrote. “Closure of wards and in some instances casualty departments has led to increasing demands on the existing beds and facilities, with longer waiting times for patients.”)

· medical practice (Medical practice has been compromised, he wrote, exampling discontinuation of elective surgeries, expensive drugs, and even hospitals refusing to admit any patients over age 75.)

· research (“Research funding is one of the first casualties of healthcare penny- pinching,” he wrote. “This was predicted, and has already begun to happen.”)

· morale (Efforts to downsize the workforce as a means of economizing has “led to job losses, increasing workloads and a severe crisis in morale and a growing sense of insecurity.”)

He concluded: “A demoralized workforce of health workers and a disgruntled population who view their NHS in a poor light cannot be reassured by the utterances of a paternalistic government, or by the sight of growing numbers of managers grappling with unbalanceable budgets.”

An article entitled “Low Morale in the British National Health Service” in a 1999 issue of the Journal of Public Health Policy verified the morale problems. How are things today?

For that, we can go to nurses who always know the inside scoop. :)

Nurses for Reform is an organization of nurses in Britain and Europe that’s devoted itself to helping improve the healthcare systems there. In their mission statement, they say they believe in telling the truth and that only by putting patients and consumers’ interests first will healthcare improve. In 1948, the British government had promised them that the NHS would provide all medical, dental and nursing care and it would be free for everyone. Yet, after sixty years of attempting to make socialized medicine work, they said, the NHS is in a perilous state.

Helen Evans, the director of Nurses for Reform, wrote an impassioned article this week for Americans, imploring us to actually investigate Britain’s experience with state-sponsored medical care before we head down the road they’ve already traveled. She wrote:

[F]or free hospital care, Britons pay an awfully high price. Just ask the nearly 1 million British patients on waiting lists for treatment. Or the 200,000 Britons currently waiting merely to get on NHS waiting lists....Across Britain, patients wait years for routine — or even emergency — treatments. And many die while waiting. Indeed, the NHS cancels around 100,000 operations because of shortages each year....

After admittance to state hospitals, more than 10 percent of patients contract infections and illnesses that they did not have prior to arrival. And according to the Malnutrition Advisory Group, up to 60 percent of NHS patients are undernourished during inpatient stays.

Consequently, many Britons have turned to outside practitioners for treatment, and the private health-care market has boomed. Today, more than 6.5 million people have private medical insurance, 6 million have cash plans, 8 million pay out-of-pocket for a range of complimentary therapies, and 250,000 self-fund each year for private surgery. Millions more opt for private dentistry, ophthalmics and long-term care.

Meanwhile, despite the state's continued claims that it can deliver quality health care to all, government ministers are increasingly willing to quietly outsource health care to the private sector. In other words, instead of directly providing health care through the NHS, the British government is shifting to simply paying the bills....But even with these efforts, the British government has found it hard to cover its expensive obligations. So in addition to waiting lists, substandard care and increased outsourcing, the government has adopted outright rationing to control costs.

Many Americans don’t realize that among efforts to contain costs, they have a government-appointed body which decides which drugs, procedures and treatments are available to the public. “Charged with controlling costs and watching the bottom line, these bureaucrats are expected to save money — not lives,” she said. This system has barred the purchase of the breast cancer drug, Herceptin, and Alzheimer’s medications such as Aricept, she exampled.

Thanks to the medical blogging world, nurses and doctors are also helping to give us a more rounded picture than we get in our news. The Dr. Rant team is a group of NHS doctors who regularly blog abouttheir system. For doctors and nurses wanting an inside view of what it’s like to work in British system, this blog is a must read.

A consistent theme of shortages, cost cutting measures and rationing, along with people who care, quickly emerges from the UK. For our sakes, they’re hoping that we’ll hear what they’re trying to tell us.

© 2007 Sandy Szwarc

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When evidence-based clinical guidelines aren’t

There’s been a lot of talk lately that our health might be more ideally managed by the government. Some trust the government to know what’s best for us. While it might be a comforting thought to believe an omnipotent entity will take care of everything on our behalf, how many of us have investigated for ourselves the reality of that?

Today’s news from England provides a glimpse. New clinical guidelines under the national healthcare system will direct doctors to identify people whose health risk numbers fall outside ideal ranges, and track them down for blood testing and prescribed medications.

This morning, the Telegraph announced that new government guidelines for cholesterol management for the primary and secondary prevention of cardiovascular disease had just been drafted. According to the Telegraph, they would mandate:

GPs...to draw up a “systematic strategy" to identify which patients on their books are most at risk of developing heart disease. These patients will then be called to their local clinic or health centre for blood tests to measure their cholesterol levels, the guidance from the National Institute for Health and Clinical Excellence (NICE) will say. People who are found to have a 20 percent or greater chance of developing cardiovascular disease over the next decade will be prescribed statins to try to reduce their cholesterol.

These go further than the national screening programs already in place for breast and cervical cancer, for example. The article said:

[T]he NICE plans for heart disease will ask GPs to use information they already have on patients — including whether they smoke, their weight and family history — to identify those most at risk of developing heart problems. It would then be up to GPs to arrange for these patients to have their cholesterol measured to see if they should be prescribed statins. Sources stressed that there was no age limit on who would be covered by the guidelines...

“Cardiovascular risk assessment: the modification of blood lipids for the primary and secondary prevention of cardiovascular disease”

This NICE guideline states it is “based on the best available evidence.” Far from being evidence-based, however, determinations of those at risk for cardiovascular disease, and hence, to be prescribed statins, are to be made using the Framingham risk score. In actuality, as we’ve seen, those popular heart disease risk factors don’t predict disease or premature death for most people, nor is the evidence in support of statins for the primary prevention of cardiovascular disease nearly as conclusive as popularly believed. The evidence for cholesterol and statin guidelines for children and adolescents is even more lacking.

Yet, for the primary prevention of cardiovascular disease, for instance, the guidelines call for identifying patients through electronic medical records which will calculate their risks using their BMI, age, gender, smoking status, blood pressure and cholesterol test results. All those with a Framingham risk score of 20% are recommended for statins.

This new NICE guideline will result in an estimated 14 million people in the UK being put on statins and about 28 million new consultations with GPs, equivalent to the entire workload of 14,000 GPs, according to Dr. Malcolm Kendrick, author of the Great Cholesterol Con. As he told the Daily Mail: “This programme is a complete waste of time. The cost will be about £3billion [nearly $6 billion in U.S. dollars] a year, for very little benefit.”

The guideline also includes “healthy” lifestyle modifications for the primary prevention of heart disease — nearly identical to those just reviewed and issued by the American Heart Association here. They include a low-fat diet, with saturated fats 10% or less, dietary cholesterol less than 300 mg/day, five daily servings of produce, and two weekly servings of fish. Stop smoking. And the guideline states that people who are overweight or obese should “achieve and maintain a healthy weight in line with the NICE guideline ‘Obesity: the prevention, identification, assessment and management of overweight and obesity in adults and children.’”

To support these brazen interventions, the NICE guideline (draft here) states that there’s an epidemic of cardiovascular disease that has been “socially generated” by people eating diets high in fat and salt, being sedentary and smoking. Yet in the very next sentence they admit that death rates have halved since the 1970s and 1980s!

NHS practice guidelines

This is just one of a multitude of “evidence-based” clinical practice guidelines that have been developed by NICE to be followed by doctors in the British National Health Services (NHS). Their national contracts call for them to follow NICE best practices and these are increasingly viewed in a regulatory light rather than advice. The NICE guidelines cover a vast array of conditions and can be viewed here.

It’s all in the name of wellness and keeping people healthy, which sounds well and good except for the fact that “health” is defined by the government. Their definition of health, and beliefs of how to achieve it, however, don’t enjoy especially sound evidence and may not be what you or your doctor believe appropriate for you, either. But under a national healthcare system, you can’t change healthcare systems.

Like here, many NICE preventive health measures are largely based upon maintaining idealized health risk indices — from BMI, blood pressure, blood sugars, bone densities, to cholesterol — which are believed to prevent chronic diseases of aging and premature death. Except, these indices have been shown to be largely genetic and related to aging, and not significantly malleable with “healthful” lifestyles. The ideal health indices have also been redefined over the years, despite considerable controversy about the soundness of the evidence behind those changes, so that most adults now fall outside of ideal ranges. The end result is a fair amount of compulsory interventions and medications.

Many of the NICE preventive health guidelines are strikingly similar to the employer-insurer wellness and weight management programs and pay-for-performance measures being proposed by insurers here in the United States.

The NHS has been incentizing compliance by rewarding doctors since 2004 with bonuses for complying with these quality measures and by the greater number of healthy patients they have. The NHS is making it irresistibly lucrative for GPs — compliance with all of the new clinical measures equates to 50% of their total compensation. According to the Information Centre for Health and Social Care, salaries rose by 30% during 2004-2005 when contracts were radically changed to begin to reward those performing more screenings and services, and improving patient outcomes. The average GP salary is now about $215,000 (in U.S. dollars), with those attached to pharmacies averaging even more. But salary figures from the Association of Independent Specialist Medical Accountants suggest some are earning up to $500,000 (U.S. dollars). The Quality and Outcomes Framework provides 1050 points for doctors who meet all of the clinical targets and each point is worth an additional 120 pounds pay ($239 in U.S. dollars).

No one has mentioned, however, how these incentives bode for people who are sick, who don’t agree to undergo tests and take medications, and whose health indices are outside ideal ranges — i.e. are older, fat, genetically predisposed, or among minority and discriminated groups.

While the guidelines say that patients may choose to not go along with the NICE guidelines and may refuse the interventions, just imagine how popular that will make you with your doctor!

“Obesity: prevention, identification, assessment and management of overweight and obesity in adults and children”

What may be of special interest to readers here are the NICE guidelines for obesity that were issued last December. They define what GPs should do to assess people’s weight status, help people lose weight, and make sure they and their children stay at a “healthy weight.” These wide-ranging recommendations aren’t just for the NHS, but also state what actions must be taken by local authorities, employers, town planners, communities, childcare providers and schools to stop the epidemic of obesity claimed to be threatening the health of the country. There is also a guideline for patients.

The clinical practice guidelines open by saying: “The recommendations are based on the best available evidence of effectiveness, including cost effectiveness. The prevention and management of obesity should be a priority for all, because of the considerable health benefits of maintaining a healthy weight — as defined as a BMI of 18.5-24.9 — and the health risks associated with overweight and obesity.” [There’s no need to explain the fallacies for readers here.]

These guidelines were developed by a long list of NHS staff, local authorities and other public bodies in the Guidance Development Group, chaired by Professor James McEwen of the University of Glasgow and chair of PharmacyHealthLink. It worked along with about 250 stakeholder organizations which included the major pharmaceutical companies, Atkins Nutritional, Inc., various obesity and bariatric trade associations, International Obesity Taskforce of the International Association for the Study of Obesity, Slim-Fast Foods Ltd, Weight Watchers UK, etc. Like here, it’s naive to believe that government public health guidelines are immune from powerful marketing and political influences.

These obesity guidelines bear a striking resemblance to those recently proposed by the AMA, HHS and CDC here. The clinical management includes the assessments of patient’s BMI and lifestyles; referral of overweight children and adults to specialists; weight loss programs that encourage healthy low-fat, low-calorie diets and exercise and expect weight loss of 1-2 pounds a week; counseling for behavioral changes; obese adults who have reached a plateau in weight loss may be put on very low calorie diets of less than 1,000 kcal/day for 3 months; clinical tests for both children and adults to identify comorbidities (cholesterol, blood pressure, insulin and glucose, liver and endocrine function, etc.); drugs should be considered for those failing to reach their target weight (orlistat or sibutramine are also recommended for children 12 years and older with comorbidities) and may be used indefinitely to maintain weight loss after consultation with providers; and bariatric surgery is recommended for adults with BMIs of 40 or more, or 35 with healthrisks “who have failed to achieve or maintain adequate, clinically beneficial weight loss for at least 6 months” and should be the “first-line option for adults with a BMI of 50 or more” who can undergo surgery. Families are expected to eat regular meals together without television, including breakfast, encourage active play and discourage sedentary activities in children.

Public health officials in the UK have been doing their part in promoting their government’s health program with various lifestyle initiatives, too. We’ve already heard about their recent bans against advertising of such “unhealthy” foods as milk and eggs. Spiked-online recently discussed the NHS’s alcohol strategy to discourage even responsible drinking at home.

Monday, the media reported on new research by Lloydspharmacy finding that nearly 2,1000 GPs and 54,600 nurses still haven’t quit smoking and the smoking ban across England is due to go into effect in just two weeks. It found there were about 13 million smokers in the UK who will be affected by these new smoking bans.

Last week, a new white paper was released to reform its National Health Services. At the heart was “a new public health act and efforts to fight obesity.” Financial Times reported:

People would be asked to take more responsibility for their lifestyle with a focus on tackling drugs and obesity and cutting tobacco and alcohol consumption. The report will propose “a new partnership with the professions” that gives staff a bigger say in decision-making and addresses “failures of employment practice.”

The BBC describes in more detail the heightened coercion the public may feel from government-paid healthcare providers to comply with government’s healthy lifestyles:

More emphasis should be put on tackling public health issues like obesity, drugs, smoking and alcohol, says a Conservative health policy review. It proposes measures to strengthen the Chief Medical Officer's office, with a separate budget for public health - and all government departments involved. It also seeks to cut NHS red tape and proposes more powers for patients....The policy review group says people should take individual “responsibility" for their health, with the government informing people of potential dangers of their lifestyle choices... They should also help establish a set of “outcome measurements" to show how individual trusts and hospitals are performing. A “health watch" body should be set up to monitor local health services on behalf of local communities.

Reading all of this leaves us with a better understanding of the challenges faced daily by those who may choose to enjoy a lifestyle different from one their government approves of or who have bodies that don’t fit the mold, and for healthcare providers who work to provide the quality care best for their patients. Most of all, it reminds us of the value of looking beyond what sounds good to what might actually be good.

© 2007 Sandy Szwarc

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Seeing more than a child’s size

A mother’s sweet reminder that children come in all shapes and sizes, and that they all deserve a spot in our world and hearts. This special story of Aaron begins:

The view from down here

Here’s Aaron’s view from down there, up at his dad who is about twice as tall as he is.

Aaron has officially hit the 3 foot mark. People with Down syndrome are often termed short in stature. One of the first things people notice about Aaron is that he’s a little guy. I’m forever answering the question - how old is he - with the answer - he’s four...and he’s a little guy - because of the disbelief on people’s faces. Many 2 year olds are taller than he is.

Have you noticed that our society likes to comment on the size of kids? It starts with birth - how much does the baby weigh? How long is he?....

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The spitball diet?

Did you hear that a new magical weight loss “bio-granule” has been licking obesity in the United States? That’s certainly news to us!

But sadly, this phony weight loss gimmick was sold across the UK and took thousands of people there for about $250,000 (U.S. dollars). The British press reported that a U.S. company has finally agreed to stop marketing the pill — which sounds like a spitball. Here’s the news:

US company promises end to slimming ads

...[M]ore than 120,000 UK households received mailings promoting the weight loss qualities of the SlimBall. The company behind the mailings – Kirkwood Advertising – described the device as a “surgery free gastric balloon” and the “No.1 weight loss treatment that's beating obesity in the USA.”

Consumers were told that a “bio-granule” taken 15 minutes before a meal would swell the stomach by up to fifty times its original size and suppressed users' appetites, ensuring safe and fast weight loss. More than 4,000 people in the UK placed orders for the treatments.... The Office of Fair Trading (OFT) asked Kirkwood Advertising to back up the claims but the company failed to provide any proper evidence. Instead it said it would stop sending the mailings to UK consumers.

There is nothing in the medical literature to support such a bio-granule.

The closest thing is a recent story in Wired Magazine a few weeks ago describing two Italians testing a new diet pill made of a cellulose compound of hydrogel that’s about the size of a spit wad. When taken with a LOT of water, they claim it will grow to the size of a tennis ball and could make people feel fuller and less likely to overeat.

Wired reported that the inventors had “been working with a team to develop super-absorbent materials for Swedish paper-product company Sca and wondered whether a hydrogel could produce an effect similar to gastric banding — without the surgery.”

Like a paper spitball.

What exactly happens to this tennis ball after it expands in one’s stomach hasn’t been revealed. But Wired did note that “in a market glutted with miracle cures and trendy diets, some folks don't gel with th[is] concept.”

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

Please be careful out there!

The U.S. Food and Drug Administration recently announced that manufacturers of dietary supplements, vitamins, herbals will now have to test their products and ensure that they contain what is claimed on the label and that the ingredients are pure. This announcement probably came as a surprise to many consumers who mistakenly believed that supplements had been being regulated.

The FDA’s recent action was sparked after years of finding supplements adulterated with ingredients such as prescription drugs; to contain lead and other heavy metals, pesticides, glass, bacteria or other contaminants; or not even contain the vitamins or herbals listed on the label at all.

It is imperative for consumers to understand, however, that this new ruling doesn’t address if the supplements are safe and effective for the conditions they claim to remedy. Unlike many countries, such as Germany, supplements here aren’t regulated like drugs. By calling it a dietary supplement, companies don’t have to provide any evidence that their claims are true before they can sell them. Why?

The reason is a law called the Dietary Supplement Health and Education Act. As the FDA explains:

In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements.

Under DSHEA.... dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products. Also, manufacturers do not need to register themselves nor their dietary supplement products with FDA before producing or selling them... the manufacturer is responsible for establishing its own manufacturing practice guidelines to ensure that the dietary supplements it produces are safe and contain the ingredients listed on the label.

According to Dr. Timothy N. Gorski, M.D., F.A.C.O.G., of the University of North Texas Health Science Center and Board Member of the National Council Against Health Fraud:

[T]he 1994 DSHEA legislation, however well-intended it may have been at the time, is a principal contributor to the problem of fraud in the dietary supplement industry. This assessment has also been made by others, including former FDA Commissioner David Kessler and the editors of The New England Journal of Medicine.

Yet, DSHEA severely limits the FDA’s ability to regulate these products, explained Dr. Stephen Barrett, M.D. in a history of dietary supplement regulations. According to the FDA Center for Food Safety & Applied Nutrition:

The FDA cannot take action against supplements that are worthless or merely suspected of being harmful, as it can — and has — in the case of both prescription and over-the-counter medications. ... the FDA has been unable to remove even dangerous supplements from the marketplace, not even ephedrine products which have injured thousands of people. When enforcement actions are taken, the FDA has no authority to inflict financial penalties, so that perpetrators of fraud bear no net financial cost from their predations. There is not even a requirement that the FDA be notified about the sale of a “dietary supplement" or of the identity and whereabouts of its manufacturer and promoters.

Essentially, the FDA can issue Warning Letters when it finds marketing claims that violate the Federal Food Drug and Cosmetic Act, which bans unapproved claims for products that are intended for curing, mitigating, treating, or preventing of diseases. But, in the vast majority of cases, the supplement companies are making so much money, they simply ignore these letters and continue selling the products, despite the lack of support for their health claims. Unless consumers sift through the FDA product warning letters, they are none the wiser.

When cited for one false health claim, supplement companies will also frequently continue to sell the products using a different claim, and the FDA can hardly keep up with them all. For instance, the FDA concluded in a scientific review and ruling on January 27, 2004 that: “there is no credible evidence to support qualified health claims for green tea consumption and a reduced risk of gastric, lung, colon/rectal, esophageal, pancreatic, ovarian, and combined cancers.” Yet green tea products abound among dietary supplements making endless other claims.

The National Council Against Health Fraud and the Quackwatch network worldwide have followed countless cases for years, which makes them very unpopular with the supplement industry and alternative modality practitioners, as you can imagine. Here is one example documented by Dr. Barrett at Quackwatch:

Joseph Mercola, D.O., who practices in Schaumburg, Illinois, also operates one of the Internet's largest and most popular health information sites. Mercola states that his site has over 50,000 pages and is visited by “millions of people each day" and his three-times-a-week electronic newsletter has over 850,000 subscribers. In 2004, Medical Economics reported that his practice employed 50 people and that he employed 15 people to run his newsletter, including three editors. Many of his articles make unsubstantiated claims and clash with those of leading medical and public health organizations. For example, he opposes immunization and fluoridation, claims that amalgam fillings are toxic, and makes many unsubstantiated recommendations for dietary supplements. Much of his support comes from chiropractors who promote his newsletter from their Web sites.

The FDA ordered Mercola and his Optimal Wellness Center to stop making illegal claims for products sold through his website in a warning letter issued on February 16, 2005, involving his virgin coconut oil, chlorella and “Living Fuel Rx,” and other products. You can read the FDA’s determination of the false or misleading claims here.

The FDA issued a second warning letter on September 21, 2006 after conducting an inspection of his facility and found numerous products being marketed in violation of the Federal Food, Drug, and Cosmetic Act, including chlorella, virgin coconut oil, vitamin K2, and “Cardio Essentials Nattokinase NSK-SD.” You can read the FDA’s letter and review of the false and misleading claims about these products here.

Are these products continuing to be sold? That answer was easy to find. Here, chlorella is listed on Mercola’s online store, with claims that: “chlorella is a nearly perfect nutritional food” that will detoxify the body of impurities, increase concentration, promote a healthy pH balance and freshen breath. On this product page, organic virgin coconut oil is still there, claiming to “help promote weight loss,” support immune system and thyroid function, and is “absorbed deep into the skin to strengthen underlying tissues and help to keep connective tissues strong and supple.”

Another of its online catalog pages lists CardioEssentials Nattokinase NSK-SD, which is said to contain a “powerful enzyme called nattokinase that has produced monumental success for maintaining vein health” and gives a list of other “many remarkable properties” for health beyond the circulatory system. The Vitamin K2 product page is here, calling this vitamin the “Pinnacle of Bone and Heart Health” and the supplement is said to contain menaquinone MK-7.

Mr. Scott J. MacIntire, district director at the FDA, wrote in their last warning letter to Mercola that it “is not intended to be an all-inclusive review of your website and products your firm markets” and reminded the company it was up to them to address all of their products. On the Mercola store are a host of dietary supplement products Mr. MacIntire was no doubt referring to, with such claims as:

Living Seas fücoTHIN — is the answer to jump-starting your weight control program (said to contain fucoxanthin, pomegranate seed oil and carotenoids)

Perfect Cleanse — to purify and remove toxins from the body and detoxify the liver (says it contains a proprietary blend of certified organic fibers to resists fermentation in the gut and the re-release of toxins back into the body)

Radical Fruits — an antioxidant compound to support the body’s defense system needed with “our increased level of stress, environmental pollutants, and fast food diets” (said to contain antioxidants; a proprietary “poten-zyme” to make nutrients more available to the body; and “fruit extracts with alkalizing minerals from hormone-free goat's milk to support your well-being”)

Himalayan Crystal Salt — “known as ‘white gold’ because it contains eons of stored sunlight”... to help you age gracefully, “balance the excess acidity from your cells, particularly your brain,” promote bone and sinus health, and more

Green Tea Extract — with anti-aging properties and ability to neutralize the effects of harmful fats; inhibit bacteria and viruses including HIV, hepatitis, and herpes; protect against oxidation in your brain and liver and promote healthy gums

Whey Healthier — an “immune boosting” protein drink claimed “to promote peak wellness by optimizing proper protein, fats, carbs, and micronutrients

Customers can also take an online “Metabolic Typing Test” that purports to customize nutrition based on your individual body type. Or purchase Ferrite Beans to “protect your brain from deadly cell phone radiation.”

Of course, this is just one dietary supplement marketer. There are countless others that have been cited by the FDA, such as the companies already mentioned selling shark cartilage products. When companies sell supplements that have been associated with especially serious health problems, the FDA will issue a Consumer Advisory, as it did on March 25, 2002 for kava. It cautioned the public that more than 25 reports of serious liver problems to the point of liver failure had been received around the world for kava-containing products. Yet, an investigation by Fox News on May 31, 2006 reported that kava products were still on the market and the FDA had since received nearly 100 reports of adverse reactions involving kava, including deaths.

The Federal Trade Commission (FTC) also gets involved when dietary supplement companies make unsubstantiated health claims in their advertising. In 1995, for instance, it settled with Nature's Bounty, Inc., and its subsidiaries, Puritan's Pride, Inc., and Vitamin World, Inc. for making deceptive claims about a number of its products which the company couldn’t substantiate. The FTC order “prohibits the respondents from making those claims that were challenged in the complaint as false, and requires them to have substantiation for specific health-related representations they make in advertising and promoting any product in the future.”

Testifying on March 9, 2006 before the House Committee on Government Reform, Lee Peeler, Deputy Director of the FTC’s Bureau of Consumer Protection, said:

The FTC has filed fourteen complaints in the past year against companies making allegedly unsubstantiated or false advertising claims for dietary supplements and other natural healthcare products, including oral sprays, creams, and patches. Also, in the past year, the Commission obtained orders against forty companies and forty-four individuals, which prohibited the unlawful practices and required the defendants to pay a total of $35.5 million in consumer redress, disgorgement, and civil penalties.

Products, such as shark cartilage, continue to be sold, but to help get around advertising restrictions, health claims may be presented indirectly through media stories.

The bottom line is that it really is up to consumers to protect themselves. Skepticism — i.e. critical thinking — isn’t a bad skill to have. Dr. Barrett wrote a helpful consumer guide a few years ago, entitled “The Herbal Minefield.”

The USDA Food and Nutrition Information Center has compiled a General Resource List For Consumers wanting to check out claims about dietary supplements.

And the FDA and FTC developed a Fact Sheet for consumers entitled “‘Miracle’ Health Claims: Add a Dose of Skepticism,” which offers tips on “how to spot false claims” and “avoiding unscrupulous dealers.” It cautions:

[C]onsumers may be spending billions of dollars a year on unproven, fraudulently marketed, often useless health-related products, devices and treatments. Why? Because health fraud trades on false hope....consumers who fall for fraudulent “cure-all" products don't find help or better health. Instead, they find themselves cheated out of their money, their time, and maybe even their health.

This information may soon become more important than ever for consumers in protecting themselves. A coalition of supplement companies calling itself the Dietary Supplement Education Alliance (DSEA) has just announced a new advertising campaign, with $750,000 to be spent on the initial phase. It’s set to launch in October and according to a press release: “This is the signature advertising program the industry needs to encourage consumers to take advantage of the benefits of dietary supplements.” You can read the media release here to learn about the companies and products involved.

© 2007 Sandy Szwarc

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