Credit: Wikipedia - Creative Commons License

By Carolyn M. Clancy, M.D.

January 3, 2012

Whether it’s music, lifestyles, or a refuse-to-age outlook, Baby Boomers think of themselves as trailblazers.

Now, that generation born between 1946 and 1964 can claim credit for another “first”—a dramatic increase in knee replacement surgeries.

Women and men between the ages of 45 and 64 were more than twice as likely to have had knee replacement surgery in 2009 than in 1997, recent data from the Agency for Healthcare Research and Quality (AHRQ) show. The rates among women were even higher.

Knee replacement surgery is most common in people whose knees have been damaged by osteoarthritis (OA), rheumatoid arthritis, or injury.

Due to their age and fondness for sports, Baby Boomers fit neatly into each category.

The percentage of people who have osteoarthritis, the most common type of arthritis, grows with age. About 27 million Americans have this condition, and, after age 45, it is more common in women. Osteoarthritis occurs when the cartilage that coats the end of each bone breaks down. This can cause the bones to rub against each other, causing pain and stiffness.

Knee pain may also be caused by rheumatoid arthritis, a less common form of arthritis that occurs when the membrane surrounding the joint becomes inflamed. Over time, inflammation damages cartilage, resulting in pain and stiffness. Rheumatoid arthritis affects about 1.3 million people—more women than men. It often begins in middle age, but can occur in children and young adults.

Arthritis after a serious knee injury or repeated stress is another reason for knee replacement surgery. Pain caused by ligament tears or bone fractures caused by sports injuries, for example, may be managed non-surgically for years. Over time, however, pain and limited knee function causes some patients to consider knee replacement surgery.

If you have knee pain from one of these causes, you’ve probably heard about treatments that are intended to relieve pain and even postpone the need for surgery. Some, but not all, of these options work, a review of 86 research reports funded by AHRQ has found.

What has been shown to work?

• Exercise. Becoming more active—whether through walking, swimming, or water aerobics—can reduce pain and make movement easier. Physical therapy may also help, so ask your doctor if you would benefit.

• Maintain a healthy weight. A 10 percent weight loss combined with a moderate exercise program reduced knee pain in patients with knee osteoarthritis by 50 percent, a recent study  by Wake Forest University researchers has found.

• Pain medicines. Medicines can relieve osteoarthritis pain, AHRQ’s research review concluded. Your doctor or nurse may prescribe an over-the-counter or prescription medicine. Learn more about choosing pain medications for osteoarthritis in this guide developed by AHRQ.

What has been shown not to work?

• Glucosamine and chondroitin. Some people take nutritional supplements to help build new cartilage. Studies have found that people who take these supplements report less pain, but people who don’t take the supplements report the same result.

• Joint lubrication shots. This treatment is a gel-like substance given by a shot into the knee. Studies have found that most people who get the shots do not improve very much.

• Arthroscopic knee surgery. In this procedure, a flexible tool is inserted into the knee, which is used to rinse the joint. It can be helpful for other types of knee problems, but not for knee osteoarthritis.

If conservative treatments don’t provide relief from pain, it may be time to consider knee replacement surgery. The good news is that this procedure has been shown to give a better quality of life that makes it worth the cost, a Government-funded study has found.

The benefits of this procedure are even better if the surgery is done at a hospital that does a large number of knee replacement procedures.

Before you have surgery, prepare yourself for the best possible outcome by asking questions of your surgeon. You will feel more in control of your health if you have a good idea of what to expect before, during, and after surgery.

I’m Dr. Carolyn Clancy, and that’s my advice on how to navigate the health care system.

Resources

Agency for Healthcare Research and Quality
Healthcare Cost and Utilization Project

Statistics on Hospital-Based Care in the U.S., 2009
http://www.hcup-us.ahrq.gov/reports/factsandfigures/2009/TOC_2009.jsp

Effective Health Care Program

Osteoarthritis of the Knee: A Guide for Adults
http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=132

Choosing Pain Medicine for Osteoarthritis
http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageAction=displayProduct&productID=4

Having Surgery? What You Need to Know
http://www.ahrq.gov/consumer/surgery/surgery.htm

National Institute of Arthritis and Musculoskeletal and Skin Disease

Handout on Health: Osteoarthritis
http://www.niams.nih.gov/Health_Info/Osteoarthritis/default.asp

Handout on Health: Rheumatoid Arthritis
http://www.niams.nih.gov/Health_Info/Rheumatic_Disease/default.asp

Total Knee Replacement Found Cost-Effective for End-Stage Knee OA
http://www.niams.nih.gov/News_and_Events/Spotlight_on_Research/2009/knee_OA_replacement.asp

American College of Rheumatology

Weight Loss Best Medicine for People with Knee Osteoarthritis
http://www.rheumatology.org/about/newsroom/2011/2011_ASM_21_weightloss.asp

Current as of January 2012

Internet Citation:

Baby Boomers Trigger Major Increase in Knee Replacement Surgeries. Navigating the Health Care System: Advice Columns from Dr. Carolyn Clancy, January 3, 2012. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/consumer/cc/cc010312.htm

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 the United States, traditional Western medicine is the dominant form of care. But in Seattle many people favor alternative approaches. What do different approaches to wellness have to offer? How can western and alternative practitioners and institutions work together to achieve the best result for patients?

• Alex Cahana, MD, DAAPM, MEthics; Chief of the Division of Pain Medicine, University of Washington Medical Center

• Daniel C. Cherkin, PhD, Senior Investigator, Group Health Research Institute

• Jane Guiltinan, N.D., Dean of the School of Naturopathic Medicine, Bastyr University

• Sweetwater Nannauck; Research Assistant, Native People for Cancer Control Program; University of Washington Center for Clinical and Epidemiological Research

Moderator: Gretchen Sorensen, Principal, Sorensen Ideas

Where:

Rainier Square Atrium, 3rd floor conference room

When:

May 27, 11:30 a.m.-1:30 p.m.

Cost:

Buffet Luncheon: $20 CityClub members, $25 guests and co-presenters, $30 general public.

Coffee & Dessert: $12 CityClub members, $15 guests and co-presenters , $18 general public.

For more information:

• Call 206-682-7395.

• Or visit the CityClub event webpage.

What Are Dietary Supplements and How Are They Regulated?

Vitamins, herbs and other dietary supplements are sold as natural alternatives to pharmaceuticals and many people turn to them in an attempt to improve their health. Others seek supplements to lose weight or after hearing that they can help with serious medical conditions. These products are now used at least monthly by more than half of all Americans—and their production, marketing and sales have become a $23.7 billion industry, according to the Nutrition Business Journal.

98-year-old Bob Stewart, a retired podiatrist and senior Olympian, credits his use of supplements for his healthy aging. Writer Betsy McMillan, a mother of two now adult children, however, nearly suffered permanent liver damage due to a supplement that contained potentially fatal levels of niacin.

Unlike pharmaceuticals—which must be FDA-approved as safe and effective before they can be marketed—supplements are considered as foods by regulators and assumed to be safe until proven otherwise. Although pharmaceutical manufacturers face inspections to ensure that the right dose is in the right pill without dangerous contaminants, supplements do not undergo such intense government scrutiny.

Despite many reports of health problems, only one supplement has ever been pulled from the market: the stimulant ephedra, which was banned in 2004 following reports of deaths. With such little regulation and oversight, safe supplement use requires that consumers be cautious and savvy.

“Supplement is a broad term that includes vitamins, minerals, herbs and botanicals,” says Carol Haggans, a registered dietician and science and health communication consultant for the Office of Dietary Supplements of the National Institutes of Health. Herbs and botanicals are derived from plants, while other supplements may include animal sources. Vitamins are essential nutrients made up of organic compounds, while minerals is an imprecise term for certain chemical elements necessary to life, like calcium.

“They’re regulated under the umbrella of foods and are not intended to treat, diagnose, mitigate, cure or prevent disease. If something claims to do that, then it becomes a drug under FDA regulation,” Haggans says.

She adds, “The FDA has instituted ‘good manufacturing practices’ (GMP) that manufacturers must follow to ensure the identity and quality of supplements and they can take enforcement action if it’s unsafe or unfit for human consumption, but they do not routinely test products.” Once manufacturers implement these practices, they can display a seal on their packaging, noting their compliance.

But Dr. Bob Linden, a general practitioner and author who has used supplements but also has seen problems with them in patients, says he’s rarely seen the GMP seal in stores where he lives in Connecticut, despite the agency’s plan to complete most of the implementation by last year.

Looking for Safer Products

So how can consumers protect themselves and find high-quality products? Haggans says that several independent organizations test products and offer their seal of approval only to those that pass. “Those can give some assurance that the product is properly manufactured, contains the ingredients listed on the label and doesn’t contain harmful levels of contaminants,” she says. Consumer Reports Health also regularly reviews supplements but may require a subscription for full access to information. (See “Finding Safe Supplements” below.)

Finding Safe Supplements

Check out these sources of vitamin/supplement information before plunging in:

• These three organizations all keep regularly updated fact sheets on the most commonly used herbs, supplements and vitamins.
  • The Office of Dietary Supplements
  • National Center for Complementary and Alternative Medicine
  • Memorial Sloan-Kettering Cancer Center

• U.S. Pharmacopeia aims to help ensure the quality, safety and benefit of medicines and foods.
• Consumer Reports Healthregularly reviews supplements but may require a subscription for full access to information.
• NSF International, a non-profit NGO, also is involved in testing and certification efforts.
• ConsumerLab.com tests and reports on health and nutritional products.
• Natural Products Association participates in quality assurance programs for dietary supplements .

 

“I think people use them primarily because they think they’re natural [and from] plants,” Linden says. “They also think they’re safe because you don’t need a prescription.” He has taken supplements himself for arthritis. But he also had one patient who suffered liver damage after taking a supplement containing Chinese skullcap, which is known to be dangerous to the liver but is still on the market.

“They can’t label them as treating disease, on the bottle, they say it’s ‘promoting health,’” Linden says. “But people do take them specifically for [diseases], such as St. John’s wort for depression.”

Managing Interactions and Dosing

Like drugs, supplements can combine with other medications in unhealthy ways. “Dietary supplements can interact with both over-the-counter and prescription medication,” Haggans says. “That’s one reason we tell people to talk with their doctors about all the supplements that they’re taking.” For example, the anticoagulant medicine warfarin (Coumadin) can interact with gingko biloba and with garlic and cause bleeding. St. John’s wort, which is often used to treat depression, can weaken the effects of birth control pills and other medications. Vitamins C and E can also potentially interfere with chemotherapy used to treat cancer.

Doctors might not know about interactions between supplements and prescriptions and since supplement labels don’t list warnings, patients need to do their own research: look for guidance from the sites listed in the resource section and talk to a nutritionist or check with reliable sources at “health food” stores or reputable “wellness” centers. This is a situation where watching carefully for side effects is especially important and consumers are mostly on their own to be vigilant.

Some supplements can be monitored by testing blood levels. This can be expensive but it might also reduce problems related to potential toxicity or unusual individual reactions. Check with your doctor to see if blood tests might be suitable for you.

Researching Appropriate Supplements

The Office of Dietary Supplements, the National Center for Complementary and Alternative Medicine, and the Memorial Sloan-Kettering Cancer Center all keep regularly updated fact sheets on the most commonly used herbs, supplements and vitamins. (See panel.)

Beyond that, there are several important principles to keep in mind if you take supplements. First, “Natural is not always safe,” Haggans says. Both arsenic and poisonous mushrooms are completely natural but deadly to eat. Second, never rely on a single study or personal story to provide definitive evidence.

In contrast, review articles—particularly those done under the rigorous standards of the Cochrane Collaboration—can be a high quality source of evidence. “Review articles like Cochrane Reviews look at the totality of the evidence in different populations,” Haggans says, which is especially important since studies of nutrition often have conflicting results.

For example, beta-carotene was once thought to be a universal cancer fighter—but long-term studies found that smokers and other people at high risk for lung cancer who took it actually increased their risk of contracting the disease and their risk of early death from other causes.

Avoiding Overdose

The use of supplements—like much of American life—is highly susceptible to fashion. The “in” supplements of the 1980s and 90s like gingko biloba and ginseng were followed by an antioxidant fad for vitamins A, C and E in the 2000s. The 1994 study on beta-carotene and smoking and a 2005 finding that high-dose vitamin E may do harm took some steam out of those trends. Currently, omega-3 fatty acids and vitamin D are the headline makers. Overall, the supplement industry has grown dramatically, continuing to increase sales despite the recession.

Given this—and given the fact that some risky supplements like the Chinese skullcap that harmed Dr. Linden’s patient remain on the market—it’s important that people considering them “do their homework,” as Haggans puts it. “Go to a trusted source like your doctor for information.” At the least, your doctor can help you weigh the evidence.

Narrowing Your Choices

Linden suggests closely following directions on products’ bottles. He adds, “Stay away from supplements [advertised for] weight loss—you don’t know what you’re getting and it’s looking for trouble.” Some weight-loss supplements and some sold as sexual aids have been found to contain prescription medications that were illegally manufactured.

Stewart’s advice is to stick to supplements that are essentially unaltered whole foods, like flaxseed and vinegar. “The type of food we have now in grocery stores is terrible,” he says, echoing the complaints of nutrition experts about over-processed and chemical-laden foods.

Supplements can be helpful in some cases but they are less well regulated than drugs and have many of the same side effects, drug interactions and toxicities at high doses seen with pharmaceuticals. Consequently, they should be used with care and with guidance from a doctor.

Health Behavior News Service is part of the Center for Advancing Health

The Health Behavior News Service disseminates news stories on the latest findings from peer-reviewed research journals. HBNS covers both new studies and systematic reviews of studies on (1) the effects of behavior on health, (2) health disparities data and (3) patient engagement research. The goal of HBNS stories is to present the facts for readers to understand and use for themselves to make informed choices about health and health care.