By Bill Scott

After reading recent media reports such as The Seattle Times series, “Methadone and the politics of pain,” I’ve been saddened to learn of the overwhelming number of Washington residents living in chronic pain and/or addicted to painkillers. Also, the near universal frustration of both patients and providers for solutions is alarming.

I’m sure that all caring persons agree that no one should ever be left in agonizing pain, but is increasing dependence on painkillers the only answer?

For instance, why is this largely an American problem? With less than 5% of the world’s population, Americans consume 80% of painkillers sold. A recent comment on the Times website noted, “I just worked in Cuba. There (are) NO narcotics except for a couple of doses after major surgery. Tylenol is over the counter and ibuprofen by prescription. Somehow they manage and they have a lot less pain. Consider that paradox? They have no pain medicines and have less pain?”

According to recent news reports, I’ve been encouraged to hear that some patients are managing to get off painkillers, including Cynthia Toussaint. From an ABC NEWS report last June, she “was confined to her bed, writhing in pain from muscle spasms, unable to walk or to live a meaningful life.”

Yet, ten years later, after turning to a variety of integrative medicine treatments, she resumed her singing career. Toussaint noted, “There’s a whole range of under-appreciated non-traditional treatment options that are low-cost, effective and with no side effects.”

A recent article in The St. Petersburg Times explains how addiction to prescription painkillers nearly killed ex-NFL star Randy Grimes. Yet, at a point that Grimes describes as “a spiritual moment,” he began to regain control of his life, found renewed purpose and now works to help others to overcome the same addiction. Throughout my entire life, I’ve taken a spiritual approach to my own health and have experienced consistent, positive results.

It’s also encouraging to read reports on therapeutic approaches that focus on thought and the mind in reducing pain. Studies at Stanford, Duke and Wake Forrest Universities have proven many mind-body approaches to be effective in clinical trials.

One reason alternative therapies are not more commonly used by the public appears to be the lack of insurance coverage. According to The Seattle Times, Rep. Jim Moeller believes it is “unfortunate” that Medicaid covers narcotic painkillers but not alternative treatments.

However, there are signs this may be changing. From a recent press release, starting in July of 2012 the 13,000 employees of Maricopa County, Arizona will soon have the option of an integrative approach “that embodies the philosophy and practice of healing oriented medicine, addressing mind, body and spirit.”

Specialists who work with patients dealing with pain have told me they support expanding health coverage to include alternative therapies that are less obtrusive and generally more affordable.

On Dec. 16, the Obama administration surprised many by declaring that each state will now be allowed to have greater freedom in what their respective health exchanges will include.

This may be a unique opportunity to include alternative treatments, especially the treatments that already qualify as medical expense deductions for federal income tax purposes. Including alternative therapies in health insurance will make them more accessible to patients who may be struggling to find better ways to manage their pain.

This article first appeared on Blogcritics.

A retired architect, Bill Scott writes about spirituality and health for Blogcritics.org and also serves as the Christian Science Committee on Publication for Washington State.

Anyone who has ever been on a diet—and there are many of us—knows that there are sensible ways to lose weight. These include balanced diets, exercising and realistic goals.

And then there are reckless ways to shed pounds—fads and diet aids that promise rapid weight loss, but often recommend potentially dangerous practices.

These include HCG weight-loss products marketed over-the-counter (OTC) that are identified as “homeopathic” and direct users to follow a severely restrictive diet.

The Food and Drug Administration (FDA) is advising consumers to steer clear of these “homeopathic” human chorionic gonadotropin (HCG) weight-loss products.  They are sold in the form of oral drops, pellets and sprays and can be found online and in some retail stores.

FDA and the Federal Trade Commission (FTC) have issued seven letters to companies warning them that they are selling illegal homeopathic HCG weight-loss drugs that have not been approved by FDA, and that make unsupported claims.

(For the list of manufacturers, distributors and products—and more information about FDA’s concerns about HCG—visit www.fda.gov/hcgdiet.)

HCG Makes Big Claims

HCG is a hormone that is produced by the human placenta during pregnancy.

Products that claim to contain HCG are typically marketed in connection with a very low calorie diet, usually one that limits calories to 500 per day.

Many of these popular HCG products claim to “reset your metabolism,” change “abnormal eating patterns,” and shave 20-30 pounds in 30-40 days.

“These products are marketed with incredible claims and people think that if they’re losing weight, HCG must be working,” says Elizabeth Miller, acting director of FDA’s Division of Non-Prescription Drugs and Health Fraud. “But the data simply does not support this; any loss is from severe calorie restriction. Not from the HCG.”

HCG is approved by FDA as a prescription drug for the treatment of female infertility, and other medical conditions. It is not approved for weight loss.

In fact, the prescription drug label notes there “is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or ‘normal’ distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets.”

HCG is not approved for OTC sale for any purpose.

A Potentially Dangerous Diet

Living on 500 calories a day is not only unhealthy—it’s hazardous, according to FDA experts. Consumers on such restrictive diets are at increased risk for side effects that include gallstone formation, an imbalance of the electrolytes that keep the body’s muscles and nerves functioning properly, and an irregular heartbeat.

Shirley Blakely, a nutritionist at FDA’s Center for Food Safety and Applied Nutrition, echoes concerns about such restrictive diets. They can be dangerous, she says, and potentially fatal.

Very low calorie diets are sometimes prescribed by health care professionals for people who are moderately to extremely obese as part of medical treatment to lessen health conditions caused by obesity, like high blood pressure.

But even then, strict—and constant—medical supervision is needed to ensure that side effects are not life threatening, says Blakely.

Without medical oversight, consumers on very low calorie diets may not be getting enough vitamins, minerals and—most critically—protein.

“In general, the reference (average) calorie level is 2,000,” says Blakely. “If you want to lose weight, reduce your daily intake by 500 calories. Over the course of a week, that equals 3500 calories, which is the loss of a pound. Gradual weight loss is the way to do it.

Story Started Decades Ago

Miller explains that HCG was first promoted for weight loss in the 1950s. “It faded in the 1970s, especially when it became apparent that there was a lack of evidence to support the use of HCG for weight loss,” she says.

The diet has become popular again and FDA and FTC are taking action on illegal HCG products. “You cannot sell products claiming to contain HCG as an OTC drug product. It’s illegal,” says Brad Pace, team leader and regulatory counsel at FDA’s Health Fraud and Consumer Outreach Branch. “If these companies don’t heed our warnings, they could face enforcement actions, legal penalties or criminal prosecution.”

Elisabeth Walther, a pharmacist at FDA, explains that the agency does not evaluate homeopathic drug products for safety or effectiveness, and is not aware of any scientific evidence that supports homeopathy as effective.

However, those that meet certain conditions set by FDA can be marketed. A reference document called the Homeopathic Pharmacopoeia of the United States lists active ingredients that may be legally included in homeopathic drug products.

“HCG is not on this list and therefore cannot be legally sold as a homeopathic medication for any purpose,” Walther says.

FDA advises consumers who have purchased homeopathic HCG for weight loss to stop using it, throw it out, and stop following the dieting instructions. Harmful effects should be reported online to FDA’s MedWatch program or by phone at 800-FDA-1088 (800-332-1088) and to the consumer’s health care professional.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Dec. 6, 2011

The science of public health was still in its infancy in the 19th and early 20th centuries when early incarnations of the modern Food and Drug Administration (FDA) tried to protect consumers from “snake oil salesmen” and other shifty characters who swindled the sick and gullible.

Red Flags for Fraud:

When you see claims like these: think scam.

• CURE ALL! For unrelated diseases
• QUICK FIX! Within days
• ANCIENT REMEDY! Or a secret formula
• REVOLUTIONARY! Or new science
• AMAZING RESULTS! Difficult to verify
• MY TUMOR SHRUNK! Unproven testimonials
• ACT NOW! Limited availability
• LOSE WEIGHT! No diet or exercise
• MONEY-BACK GUARANTEE!

Visit FDA’s Health Fraud Scams Website!

Back then the agency was known as the Division, and later the Bureau of Chemistry. Its agents pursued the traveling con men who sold tonics and elixirs—such as “miracle oil” supposedly made from snakes—with promises to cure whatever ails you. Labels did not list ingredients and unsuspecting buyers only found out through bitter experience that they were at best ineffective and at worse deadly.

FDA is still on the case—more than a century later.

The agency has created a new Internet resource to help consumers recognize and protect themselves from the 21st century versions of these bogus health products.

FDA’s Health Fraud Scams website (www.fda.gov/healthfraud) pulls together videos and articles on how to avoid fraudulent schemes, and offers information about products that have been seized, recalled or are the subject of warnings from the agency.

The site also provides links to government resources on health fraud involving FDA-regulated products, such as drugs, dietary supplements, tobacco products, alternative medicines, medical devices, and cosmetics.

Gary Coody, R.Ph., national health fraud coordinator at FDA, calls the site “one-stop shopping” for people who want to learn how to recognize and avoid health fraud scams. Anyone can search the site to see if FDA has taken an action against a product or company. However, just because a product is not listed does not mean that it is legally marketed or safe to use.

Equal Opportunity Fraud

Consumers spend a fortune on products that “are either worthless or may cause harm,” says Coody. “Consumers can buy very dangerous products on the Internet and in stores that can cause serious injury or death.”

The waste of money is bad enough but using one of these unproven treatments can delay getting a potentially life-saving diagnosis and medication that works, he says.

The schemes can take many forms. “Some products billed as “all natural” in fact have prescription drugs and other chemicals not listed on the label that could be dangerous,” Coody says. The most common categories of these tainted products include weight loss, sexual performance, and bodybuilding.

 “The snake oil salesman is still alive,”

Other products claim to be a cure-all for such serious chronic diseases as cancer, arthritis, diabetes, Alzheimer’s disease and multiple sclerosis. Seniors are particularly vulnerable to this kind of deception but consumers of all ages are taken in by fraudulent products, says Coody, adding, “Everyone is vulnerable.”

With every new health threat, phony products appear overnight, Coody says. For example, after the Japan nuclear incident in March, 2011, he says the market was flooded with products that falsely claimed to offer protection from harmful radiation.

“The snake oil salesman is still alive,” says Coody.

Back to FDA’s Roots

Rampant health fraud was a significant reason for the passage of the 1906 Food and Drugs Act, says FDA historian John P. Swann, Ph.D.

“So-called ‘patent’ medicines, with their outrageous claims and unlabeled, often harmful ingredients had been a mainstay of the American medical landscape throughout the 19th century (and before),” he says.

“Examples abound, from alleged rapid cures for serious diseases like cancer, tuberculosis and syphilis, to remedies with harmful and dangerous ingredients, such as addiction cures that included the unlabeled ingredient that was the source of the addiction,” says Swann. “There were also soothing syrups for colicky and teething babes that included alcohol and opiates.”

The 1906 law prohibited the marketing of adulterated and misbranded drugs, and required labeling of a few ingredients, including alcohol, opium, morphine, heroin, and cocaine.

More than 30 years later, the 1938 Federal Food, Drug and Cosmetic Act gave FDA (named the Food and Drug Administration in 1931) new power to regulate medical devices.

The agency was then able to act against the “countless gadgets that could deflect the attention of consumers from seeking established therapies,” Swann says.

The Difference Today

Health fraud is more pervasive today, says Coody, because “the Internet has opened up the world market to people from their personal computers.” If you’re tempted to purchase any unproven or little known treatment, especially if it’s sold on the Internet, check with your doctor or health care professional first, he advises.

But shady products are also peddled by TV infomercials, radio, direct mail, word-of-mouth marketing and ads in newspapers and magazines.

“There are many ways that consumers are getting these messages,” says Coody, and they should view these ads with a healthy dose of skepticism.”

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

November 9, 2011

In a smaller, earlier trial, lead author Dr. Karen Sherman, Ph.D. and colleagues found that yoga was slightly more effective than a program of aerobic, strengthening, and stretching exercises, so they decided to do a larger trial in which patients with back pain were randomly assigned to participate in a yoga program, a stretching program or to self-care.

The yoga and stretching programs consisted of 12 weekly, 75 minute classes at Group Health facilities. In addition, participants were asked to practice for 20 minutes a day on non-class days.

To supplement class instruction, the participants received handouts and instructional yoga CDs or stretching DVDs.

The yoga program included seven simple postures adopted from a style of yoga called viniyoga. Each class included breathing exercises, 45-50 minutes of yoga, and ended with a session of “guided deep relaxation,” the researchers write.

The self-care group received The Back Pain Helpbook, which provides information about the causes of back pain, advice on exercising, lifestyle modifications and the management of flare ups.

At the end of 12 weeks, back-related symptoms and function had improved in all three groups, but those in the stretching and yoga programs saw significantly more improvement than those in the self-care group.

“We expected back pain to ease more with yoga than with stretching, so our findings surprised us,” said Dr. Sherman.

“The most straightforward interpretation of our findings would be that yoga’s benefits on back function and symptoms were largely physical, due to the stretching and strengthening of muscles,” Dr. Sherman said.

Dr. Sherman speculated that because the stretching classes included more stretching than many programs and because the stretches were held for a relatively long time, the stretching classes may have “been a bit more like yoga than a more typical exercise program would be.”

“Our results suggest that both yoga and stretching can be good, safe options for people who are willing to try physical activity to relieve their moderate low back pain,” Dr. Sherman said. “But it’s important for the classes to be therapeutically oriented, geared for beginners, and taught by instructors who can modify postures for participants’ individual physical limitations.”

Whether in muffins, rolls, or loaves, wheat bread is found in most households. But few consumers may appreciate the substance that helps the dough rise, keeps the bread from falling apart, makes it chewy, and adds to its flavor.

That substance is gluten. Breads, cakes, cereals, pastas, and many other foods are made with wheat or added wheat gluten to improve their baking quality and texture.

Technically, gluten represents specific proteins that occur naturally in wheat. However, the term “gluten” is commonly used to refer to certain proteins that occur naturally not only in wheat, but also in rye, barley, and crossbreeds of these grains and that can harm people who have celiac disease. The only treatment for this disorder is a life-long gluten-free diet.

Eating gluten doesn’t bother most consumers, but some people with celiac disease have health-threatening reactions, says Stefano Luccioli, M.D., a Food and Drug Administration (FDA) allergist and immunologist. They need to know whether a food contains gluten.

FDA has been working to define “gluten-free” to:

• eliminate uncertainty about how food producers may label their products.
• assure consumers who must avoid gluten that foods labeled “gluten-free” meet a clear standard established and enforced by FDA.

FDA’s actions on Aug. 2 bring the agency one step closer to a standard definition of “gluten-free.” On this date:

• FDA reopens the public comment period on its proposed gluten-free labeling rule published on Jan. 23, 2007.
• FDA makes available, and seeks comments on, a report on the health effects of gluten in people with celiac disease. The report includes a safety assessment on levels of gluten sensitivity in people with the disease.

Celiac Disease

According to the National Institutes of Health, celiac disease affects as many as 1 percent of the U.S. population.

The disease occurs when the body’s natural defense system reacts to gluten by attacking the lining of the small intestine. Without a healthy intestinal lining, the body cannot absorb the nutrients it needs.

Delayed growth and nutrient deficiencies can result and may lead to conditions such as anemia and osteoporosis. Other serious health problems may include diabetes, autoimmune diseases, and intestinal cancers.

“Some people don’t get immediate symptoms, but when they do, they are typically gastrointestinal-related, such as abdominal pain, bloating, and diarrhea,” says Luccioli. “In infants, there may be a lot of vomiting, and they don’t grow and thrive.”

And some people do not have any symptoms at all, adds Luccioli, but still may have intestinal damage and risk for long-term complications.

It is important for individuals with celiac disease, who may vary in their sensitivity to gluten, to discuss their dietary needs with their health care professional.

Grocery shopping is challenging for people with this disease, says Andrea Levario, J.D., executive director of the American Celiac Disease Alliance. “When they find a product labeled ‘gluten-free,’ they don’t necessarily know what that means because today there is no federal standard for the use of this term.”

Having a federal definition of “gluten-free” is critically important, says Levario. “If we have one national standard, the individual will know that all products labeled ‘gluten-free’ will have no more than a minimal amount of gluten.”

Is Gluten-Free for Me?

“Eating gluten-free is not meant to be a diet craze,” says Rhonda Kane, a registered dietitian and consumer safety officer at FDA. “It’s a medical necessity for those who have celiac disease.”

“There are no nutritional advantages for a person not sensitive to gluten to be on a gluten-free diet,” she adds. “Those who are not sensitive to gluten have more flexibility and can choose from a greater variety of foods to achieve a balanced diet.”

Gluten-free is not synonymous with low fat, low sugar, or low sodium. For people who must be on a gluten-free diet, Kane says it’s important to check the ingredients list and Nutrition Facts information on food labels to find the most nutritious options.

How Is FDA Proposing to Define ‘Gluten-Free’?

In 2007, FDA proposed to allow manufacturers to label a food “gluten-free” if the food does not contain anyof the following:

1. an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains
2. an ingredient derived from these grains and that has not been processed to remove gluten
3. an ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten
4. 20 ppm or more gluten

In the notice reopening the comment period, FDA states that it continues to believe the proposed definition of “gluten-free” is the correct one.

FDA’s notice also describes current analytical methods that can reliably and consistently detect gluten at levels of 20 ppm or more in a variety of foods.

The agency is interested in hearing from the public and industry. The public comment period on the proposed rule will officially open after noon on Aug. 3, 2011, and will remain open for 60 days. To submit comments electronically, go to www.regulations.gov and

1. choose “Submit a Comment” from the top task bar
2. enter the docket number FDA-2005-N-0404 in the “Keyword” space
3. select “Search”

After FDA reviews and considers the comments, the agency will issue a final rule that defines “gluten-free” for labeling food products, including dietary supplements.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Aug. 2, 2011

Consumer Updates on Nutrition and Healthy Diets