Arthritis Supplements Don't Work

Researchers are patting themselves on the back for finally proving that the popular arthritis supplements glucosamine and chondroitin don't work. Too bad physicians don't have much else that eases pain without causing serious side effects.

The latest analysis is from the British journal BMJ (online, Sept. 16, 2010). Investigators reviewed 10 studies that covered 3,800 subjects. They concluded, "Compared with placebo, glucosamine, chondroitin, and their combination do not reduce joint pain or have an impact on narrowing of joint space."

This comes on the heels of a Norwegian study that investigated the benefits of glucosamine for lower back pain due to spinal osteoarthritis (Journal of the American Medical Association, July 7, 2010). Six months of glucosamine was no more helpful than placebo in that study either.

Many health professionals get a certain amount of pleasure from studies that show an alternative therapy is ineffective. They may feel vindicated when a pill that was not FDA-approved turns out to be no more helpful than an inactive placebo.

Even FDA-approved treatments for osteoarthritis are not above question, however. Doctors have prescribed nonsteroidal anti-inflammatory drugs (NSAIDs) for decades. The assumption is that they are effective for joint pain and relatively benign. The data on many of these drugs are not as convincing as many health professionals assume.

For one thing, there are surprisingly few long-term trials of NSAIDs. That's a disappointment for drugs that may be taken for months or years. A meta-analysis of 23 studies involving more than 10,000 patients concluded, "NSAIDs can reduce short-term pain in osteoarthritis of the knee slightly better than placebo, but the current analysis does not support prolonged use of NSAIDs for this condition. As serious adverse effects are associated with oral NSAIDs, only limited use can be recommended" (BMJ, Dec. 4, 2004).

There is growing recognition that NSAIDs such as ibuprofen, naproxen and diclofenac carry substantial risk, including digestive distress such as heartburn, nausea or even life-threatening bleeding ulcers. Other NSAID complications may include elevated blood pressure, irregular heart rhythms, dizziness, fluid retention, ringing in the ears, kidney and liver damage.

A recent report from Denmark suggests that high doses of ibuprofen and diclofenac are associated with an increased risk of heart attacks and other cardiovascular problems (Expert Opinion on Drug Safety, online, June 23, 2010).

With such questionable benefits and serious side effects, it is not surprising that people are looking for alternatives. That's why home remedies are so popular. They are generally affordable and far less risky. Readers of this column report that fruit juices such as cherry, grape, pineapple or pomegranate can be helpful. Spices like cayenne, turmeric and ginger may also give relief.

For those who like such approaches, we offer our book, Favorite Home Remedies, at www.peoplespharmacy.com. None are likely to be studied in double-blind trials, but they're also unlikely to cause the kinds of complications associated with NSAIDs.

Death by Rubber Duck

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Many of the products we use every day, from non-stick frying pans to plastic toys like rubber ducks, expose us to chemicals. How safe are they? Phthalates and BPA are endocrine disruptors. Do we get enough in day-to-day life to make a difference?

Two Canadian environmentalists decided to find out. They ran the experiment on themselves, and what they discovered is disconcerting.

Guests: Rick Smith, PhD, is executive director of Environmental Defense. He's one of Canada's leading environmentalists and has a doctorate in biology from the University of Guelph.

Bruce Lourie started one of Canada's largest environmental consultancies. He is president of the Ivey Foundation.

Their book is Slow Death by Rubber Duck: The Secret Danger of Everyday Things. The

Does Funding Influence Study Outcomes?

Political reporters know they need to follow the money to get the story. It turns out that doctors and medical reporters should, too. Investigators analyzed the outcomes of more than 500 drug trials. Studies funded by the federal government showed benefit about half the time. Those sponsored by the pharmaceutical industry demonstrated a positive response to the drug 85 percent of the time. Studies supported by drug company money were published less often than government funded trials. The investigators speculate that bias can be introduced in subtle ways including the design of the study, the selection of subjects, and the analysis of data.

[Annals of Internal Medicine, August 3, 2010]

Healthy Heart Boosts Brain

Exercise has been shown to be good for the heart and also the brain. Now researchers may have come up with a possible explanation. They measured something called cardiac index, which is a marker for how much blood the heart pumps relative to body size. People with a lower cardiac index score also had demonstrable brain shrinkage. Roughly 1500 people were studied. The relationship was seen even for people in their thirties with no obvious heart disease. The investigators were quick to point out that smaller brain volume was not necessarily linked to cognitive decline, but it is associated with aging. They hypothesize that the pumping power of the heart could influence the amount of blood, oxygen and nutrients that get to brain cells.

[Circulation, online, August 2, 2010]

Can Resveratrol Reverse Inflammation?

A dietary supplement that is gaining in popularity has new evidence to support its potential benefits. Resveratrol is a compound found in many plants, but peanut and grape skins are particularly rich in this antioxidant. In a small placebo-controlled study, 40 mg of resveratrol daily for six weeks significantly reduced the levels of several markers for inflammation. A number of chronic diseases have been linked to inflammation, including diabetes and heart disease. It is still too early to conclude that resveratrol could prevent these conditions, but the evidence is tantalizing.

[Journal of Clinical Endocrinology & Metabolism, online June 9, 2010]

Health Hazards from Dietary Supplements

Some ingredients in dietary supplements may pose health hazards. That's the conclusion of a review by Consumer Reports working in collaboration with the Natural Medicines Comprehensive Database. The so-called "dirty dozen" include herbs and minerals. For example, bitter orange has replaced a banned herb called ephedra in many natural weight loss and energy supplements. But bitter orange may itself be associated with heart rhythm problems, heart attacks and strokes, the same sorts of cardiovascular problems that got ephedra banned. Another perennial problem is the herb comfrey, which is popular for a range of problems such as cough, joint pain and excessive menstrual flow. But comfrey can damage the liver when taken internally. Some of the other herbs to be wary of include coltsfoot, lobelia and yohimbe.

[Consumer Reports, September, 2010]

Nitrates and Bladder Cancer

Common ingredients in processed meat like salami, bologna, hot dogs and ham may increase the risk of bladder cancer. Nitrates and nitrites are frequently used to preserve lunch meats and hot dogs. They also add the familiar pink color and add to the flavor of such foods. But researchers have raised concerns about the safety of such compounds for decades. A joint National Institutes of Health-AARP study of more than 300,000 older Americans lasted seven years. The investigators found that those people who consumed the most dietary nitrite in processed red meat were 30 percent more likely to be diagnosed with bladder cancer than those who ate the least. Beef, chicken and turkey were not linked to a higher risk of bladder cancer.

[Cancer, published online Aug 2, 2010]

Will SAMe Combat Depression?

A dietary supplement called SAMe, also known as S-Adenosyl Methionine, may be helpful against resistant depression. SAMe is available without prescription and has long been used to relieve arthritis pain and ease depressive symptoms, but there has been little research. The most recent study recruited people with major depression who had not gotten better on standard antidepressant medications. They were randomly assigned to add either SAMe or placebo to their existing drug regimen. After six weeks, measures of depression showed that more of the subjects taking SAMe had improved. No serious side effects were detected. The researchers call for larger, longer studies to confirm their preliminary findings.

[American Journal of Psychiatry, published online July 1, 2010]

Acetaminophen Use and Asthma

Acetaminophen is one of the most popular pain relievers in the pharmacy. It is considered very safe, especially for babies and children. A new study suggests, however, that acetaminophen may be contributing to wheezing and asthma in children and adolescents. This epidemiological research is not the first to link acetaminophen use to a greater risk of asthma. Perhaps this latest research will encourage pediatricians and parents to be more cautious in using this common painkiller and fever reducer.

[American Journal of Respiratory and Critical Care Medicine, online August 13, 2010]

New Morning-After Pill Approved

The FDA has just approved a new contraceptive. This so-called morning-after pill called Ella is effective for five days after intercourse. Unlike Plan B, the first emergency contraceptive marketed in the U. S., Ella does not contain hormones. Instead, it prevents pregnancy by blocking the effects of progesterone. Ella will be available only by prescription. Side effects may include abdominal pain, headache, fatigue, menstrual discomfort, nausea or dizziness. It has been used in Europe for more than a year.

Calcium Supplements Fail to Protect Pregnant Women from Bone Loss

Calcium supplements did not protect pregnant women from bone loss. This new study comes on the heels of a controversial analysis showing that calcium pills increased the risk of heart attacks among older people. Although the evidence that calcium supplementation strengthens bones is modest, tens of millions of women have been popping down calcium in the belief that it would protect them against osteoporosis without negative consequences. The recent analysis in the journal BMJ suggests that assumption may not be valid.

The latest challenge to calcium's benefits comes from the Gambia. Researchers randomly assigned women to take either 1500 mg of calcium carbonate or a placebo daily during pregnancy. The supplements were continued up to delivery. These women normally had low levels of calcium in their diets, so the scientists expected that the supplements would protect them from bone loss. Pregnancy puts extra demands on calcium stores to help build new bones in the baby. Contrary to expectation, however, the women who got extra calcium had lower bone mineral content than those on placebo. The investigators speculate that calcium pills disrupted normal adaptation to pregnancy and nursing.

[American Journal of Clinical Nutrition, Aug, 2010]

Unorthodox Cancer Treatments

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Research in rodents and test tubes has turned up many compounds that are active against cancer cells. But relatively few of these have been developed into cancer treatments. The established ways of treating cancer, such as chemotherapy and radiation, are often toxic and usually very expensive. Worse, they don't always work. What other therapies already available on drugstore shelves show promise for treating cancer? How can we utilize the body's own defense, the immune system, to fight cancer? This is the third in our three-part series on unconventional approaches to cancer.

Guests: Vikas Sukhatme, MD, PhD, oncology researcher and Professor of Medicine at Harvard University Medical School. He is co-founder of Global Cures.

Vidula Sukhatme, MA, MS, is co-founder and CEO of Global Cures. The photo is of Vidula Sukhatme.

Coley's Toxin, Cancer and Immunology Archive

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Dr. William Coley was a cancer surgeon at the turn of the 20th century. In an effort to improve the treatment he could offer his patients, he created a toxin that made them really sick. If they recovered from their fever, however, they were often cured of their sarcomas.

A century later, cancer researchers are taking a new look at Coley's toxin and how it might help us understand spontaneous remissions and the role of the immune system. In exploring this topic, we encounter an innovative immunologist who has developed a new paradigm for how the immune system works.

Guest: Uwe Hobohm, PhD, is a cell biologist and Professor of Bioinformatics at the University of Applied Sciences in Giessen, Germany. He has worked at the European Molecular Biology Laboratory in Heidelberg and at F. Hoffmann-La Roche in Basel. He is the author of Healing Heat: An Essay on Cancer Immune Defence.
http://bioinfo.tg.fh-giessen.de/pamp-cancer/

Polly Matzinger, PhD, is an ex-Playboy bunny turned scientist. At the National Institute of Allergy and Infectious Diseases, she is section head of the Ghost Lab, more formally known as the section on T cell tolerance and memory of the Laboratory of Cellular and Molecular Immunology. In her private life, she trains award-winning sheep dogs. The photo is of Polly and her dog Annie.

Improving Patient Safety

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Ten years ago, the Institute of Medicine shocked the medical establishment when it published To Err Is Human. The experts of the IOM estimated that nearly 100,000 Americans died of medical errors in hospitals every year. More studies of the problem have revealed that this may be only the tip of the iceberg.

Efforts to improve patient safety have had some effect. One doctor developed a checklist to reduce the risk of certain hospital-acquired infections. Find out about how he came up with the checklist and how his campaign to make hospitals safer is being waged.

Guest: Peter Pronovost, MD, PhD, is a professor at Johns Hopkins School of Medicine. He directs the Quality and Safety Research Group and serves as medical director for the Center for Innovation in Quality Care. Dr. Pronovost was named one of Time Magazine's 100 most influential people in 2008 and was the recipient of a MacArthur genius grant in 2009. Together with Eric Vohr, he has written Safe Patients, Smart Hospitals: How One Doctor's Checklist Can Help Change Healthcare from the Inside Out. He is also the author of a recent article in the Journal of the American Medical Association.

Dealing with Dizziness

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As many as 7 million people each year have dizziness or vertigo so severe it drives them to seek medical care. But although the symptom of dizziness is common, finding the cause and the proper treatment is complicated. We learn how balance disorders are best approached.

Guest: David M. Kaylie, MD, MS, is Associate Professor in the Division of Otolaryngology--Head and Neck Surgery at Duke University Medical Center.

Cancer and the Immune System

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Bonus Interview:
Dr. Jon Serody describes his work with cancer vaccines and how they may trigger the immune system to fight cancer.

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Bonus Interview:
Don MacAdam discusses Dr. Coley's success treating cancer. He describes his company's efforts to make Coley's fluid available.

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More than 100 years ago, a New York surgeon named William Coley developed an unusual cancer treatment that produced a high fever in his patients. Although the treatment was unconventional, it turned out to be successful surprisingly often. Should Coley's treatment be revived today? How else might we jump-start the immune system? Find out about the hope for vaccine treatments for cancer, as well as the status of Coley's fluid. This is the second in a three-part series on unconventional approaches to cancer.

Drug Safety Is a Growing Problem

Tylenol is one of the most familiar and trusted brand names in America. In fact, commercials for the popular pain reliever used to proclaim: "Trust Tylenol. The pain reliever hospitals use most."

Does Johnson & Johnson's McNeil Consumer Healthcare unit still deserve our trust? In the past several months, the manufacturer has issued recalls for a wide variety of over-the-counter products, including Children's Tylenol, Tylenol Arthritis Pain Caplets and Extra Strength Tylenol Rapid Release Gels.

The number and range of recalls the company has issued in the past year suggest serious problems with quality control. Affected brands included Benadryl, Motrin, Rolaids, Simply Sleep and St. Joseph Aspirin.

An unpleasant moldy odor prompted many customer complaints last year. Some people reported related symptoms of nausea, vomiting and diarrhea. The problem was eventually traced to fungicide used at a plant in Puerto Rico and an estimated 60 million bottles were recalled.

More recently the company has landed in hot water because of manufacturing deficiencies at its plant in Fort Washington, PA. A number of children's products (Motrin, Zyrtec, Tylenol and Benadryl) were recalled. Some of the products did not contain the correct amount of active ingredient, while others were contaminated. Overall, the plant did not demonstrate good manufacturing practices.

If Johnson & Johnson, one of the leaders of the pharmaceutical industry, could fall so far, what might we expect from other manufacturers? The news is not good.

According to The Gold Sheet, a pharmaceutical manufacturing periodical, 1,742 different drugs were recalled last year. That compares to 338 in 1999 (Wall Street Journal, June 11, 2010). Quality control problems seem to be on the rise.

One of the biggest changes within the pharmaceutical industry over the past decade has been the outsourcing of both raw materials and finished products. At one time, most medications sold in the U.S. were made here, start to finish.

According to FDA Commissioner Margaret Hamburg, MD, "Up to 40 percent of the drugs Americans take are imported, and up to 80 percent of the active pharmaceutical ingredients in those drugs come from foreign sources."

Both physicians and patients are often shocked to learn that the FDA does not monitor drugs for quality. The agency does not have the resources to inspect all the companies that make drugs for the American market.

Even more alarming, many drug companies themselves don't inspect the facilities producing their chemicals (Wall Street Journal, June 15, 2010). They are permitted to rely on paperwork that can easily be altered, although that rule may someday change.

Requiring on-site inspection would be a positive step. There are too many instances of falsified data from companies abroad. For example, the giant Indian generic manufacturer Ranbaxy has been accused of forging documents and fudging key information.

If the FDA has trouble ensuring the quality of a major brand like Tylenol made in the U.S., it's hardly any wonder it has challenges in China where many of today's generic drugs are manufactured. To report suspected problems, visit www.peoplespharmacy.com so we can pass complaints to the FDA.

How Safe Are Statins?

Statins are the most successful drugs in history. It's estimated that more than 20 million people take drugs like Crestor, Lipitor, lovastatin, pravastatin and simvastatin. Over the past decade, sales have reached hundreds of billions of dollars.

For people with heart disease, these medications lower cholesterol and save lives. But three fourths of the statin prescriptions in the U.S. are written for people who don't actually have heart disease. They just have elevated cholesterol levels, and their doctors are trying to prevent problems.

Is this a good idea? A recent issue of the Archives of Internal Medicine (June 28, 2010) throws doubt on the value of these drugs for people without heart disease. Investigators analyzed data from 11 clinical trials involving more than 65,000 people without heart disease. They did have elevated cholesterol and other risk factors. There was no evidence statins saved lives in these participants.

Yet questions remain about long-term benefits and risks. One comment at www.peoplespharmacy.comnotes: "I'm a neurologist who has seen countless cases of mild muscle weakness and several cases of profound weakness cured by stopping statins. There are a host of other statin side effects, including cognitive compromise and neuropathy, that go unaddressed."

The possible link between statins and ALS is controversial but unsettling. Here is one woman's story: "Two years ago, my cardiologist prescribed Zocor to treat moderately high cholesterol. Within a month, I had to take Vicodin for severe muscle pain; even small efforts like getting out of bed were extremely painful. I decided to stop taking Zocor, and the muscle pain decreased over time.

"My cardiologist strongly urged me to take another statin. Soon after starting Lipitor I noticed that I sometimes slurred a few words when I talked, and I 'ran out of air' after only a few words. I had to take short 'catch-up' breaths to finish sentences. I also choked on food and medications.

"I told my cardiologist about these problems, but he seemed unconcerned. In a few months, my speech, choking and breathing had worsened considerably, and the cardiologist ordered a CT brain scan. It showed no signs of a stroke or other abnormalities. I was referred to a neurologist.

"The neurologist ordered an MRI of the brain and commented that I had 'extremely weak muscles.' (At this point, knowing that statins can cause muscle weakness, I quit taking Lipitor.) But he refused to answer any of my questions or tell me what was wrong.
"Another neurologist reviewed my tests (including the MRI), and ruled out a tumor or a stroke. He wants to test for ALS (Lou Gehrig's Disease), but I have not consented because weak muscles, speech and breathing problems are my only symptoms.

"None of my doctors will even consider the possibility that Lipitor caused my condition. It is documented that statins are tied to muscle weakness. Statins have also been associated with slurred speech and 'ALS-like symptoms.'"

In a postscript several months later, she reported: "I have been diagnosed with ALS. Do I blame statin drugs? Yes. Am I heart-broken? Yes. Am I scared? To death."

It is unclear whether statins trigger ALS, but we urgently need to learn about their long-term benefits and risks.

What Drives Patients Crazy?

Customer satisfaction is important if you want repeat sales. Many hotels are so interested in guest responses that they monitor social media such as Twitter, Facebook and blogs. If someone is dissatisfied, some hotels instantly apologize and upgrade the customer to a nicer room.

Car dealers frequently poll their customers about their experience. If service is lacking, the management tries to respond so the scores will improve.

Secret shoppers test service in many different retail outlets. Management is willing to spend good money to find out how well their customers are being served.

We wish that doctors were equally concerned about their patients' experience. We recently polled visitors to our Web site (www.peoplespharmacy.com) about their pet peeves. The computer played a role in a number of complaints such as this one: "I don't like it when my doctor spends the whole visit looking at his laptop screen while asking questions, and doesn't make eye contact."

Others complained that many physicians don't bother to review their history carefully before seeing them: "Someone comes into the exam room before the doctor and I have to tell them the personal details of why I am there. They write it down, but when the doctor finally comes in he doesn't even look at their notes. He just asks me all the same questions over again."

Another reader offered this: "Major irritant-1: Having to access the physician through too many other people (receptionist, nurse, physician assistant, etc.) This is like playing 'party line' at a child's birthday party: there's too much information lost or miscommunicated.

"Major irritant-2: Medical practices that do not provide the patient with copies of lab and test reports. Again, there are too many opportunities for mix-ups in communications."
Communication can be a sore point: "I hate it if the doctor doesn't listen when I tell him that statins make me sick."

Condescension is a pet peeve for many patients. Some find the front office staff is condescending; others pin it to the doctor herself. As one friend of ours put it, "I don't like being spoken to as if I were 12."

Wait times are a frequent source of irritation. One patient complained, "My biggest beef with the orthopedic office I go to is the l-o-n-g wait to be seen. Only after I voice my concern for the time is action taken."

Another added, "Something that really irks me is the way drug reps get top priority. They waltz in at any time and tie up office staff and the doctor giving their spiel and passing out samples and goodies. I've often been kept waiting while everyone socialized."

Sitting in a waiting room is one thing. At least there are magazines. Others dislike waiting in the exam room, "freezing in a flimsy gown because it's so cold."

Of course, running a medical office is complex. But one other repeated comment makes us think it could be done better: "My vet's office is more welcoming than my doctor's. At the vet, they know my name, my pets' names, recent problems, etc., because they actually are caring people!"

Doctors care, too. But if more of them thought about their practices from the customers' point of view, patients would have fewer complaints.

One reader reminds us all: "WE are the customers; we choose our doctors."

Delaying School Start Means More Alert Students

Teenagers are notoriously hard to rouse in the morning. Most schools are not very sympathetic to adolescent biorhythms, however. A new study from Rhode Island suggests that strict adherence to a traditional early-morning schedule is counterproductive. St. George's School, a boarding school, pushed class start times back half an hour during the spring 2009 semester. The head of the school had promised skeptical faculty that they would return to an 8 am start time if the experiment didn't pan out. But the results were dramatic.

Students were more likely to get to breakfast and less likely to fall asleep in class. Fewer were late to class, and most students reported being more motivated. The study was not long enough to judge changes in academic performance, but it does suggest that minor changes to make school schedules more teen friendly could have measurable benefits.

[Archives of Pediatrics and Adolescent Medicine, July, 2010]