Health Letter

SIDNEY M. WOLFE, M.D., EDITOR MAY 2011 – VOL. 27, N o. 5

HEALTH LETTER LOOKS BACK Losing Weight Safely and Effectively The following is a partially updated is 25-29.9, and an obese BMI is 30 or TableHeight 1. Normal, OverweightOver- and Normal Obese version of a March/April 1986 Health Obese(feet, inches) Weight Ranges (inweight pounds)* more. Table 1 provides the approximate Letter article. 4'6" 77-103 104-124 >124 weight ranges (measured in pounds) for 4'7" 80-107 108-128 >128 normal weight, overweight and obese ew aspects of self-image have so weight for a particular height. 4'8" 83-111 112-133 >133 Ftotally captured the American imagination as persistently as that of 4'9" 86-114 115-138 >138 What is wrong with being weight. In a complete turnabout from 4'10" 89-118 119-143 >143 obese? 4'11" 92-123 124-148 >148 the “old-fashioned” view of plumpness People who are obese have a as a sign of prosperity and health, 5'0" 95-127 128-153 >153 significantly increased chance of getting Americans now rush to spend money 5'1" 98-131 132-158 >158 the diseases discussed below: on any book, service or product — 5'2" 101-135 136-163 >163 • Hypertension (high blood however far-fetched, ineffective or even 5'3" 105-140 141-169 >169 pressure). There seems to be an dangerous it may be — that promises to 5'4" 108-144 145-174 >174 get rid of an extra pound or two. One overlap between (especially recent report even stated that about 80 5'5" 111-149 150-179 >179 obesity that develops late in life and percent of fourth-grade girls are ! 5'6" 115-154 155-185 >185 that involves the upper half of the With sales in excess of $240 million 5'7" 118-158 159-191 >191 body) and high blood pressure. • Diabetes (non-insulin dependent). in 1983, over-the-counter pills such 5'8" 122-163 164-196 >196 as Acutrim, Control, Dexatrim and As with hypertension, there is 5'9" 125-168 169-202 >202 Dietac are among the leaders in over- an overlap between diabetes and the-counter drug sales. Combine this 5'10" 129-173 174-208 >208 obesity. Ninety percent of non- figure with sales of hundreds of other 5'11" 133-178 179-214 >214 insulin dependent diabetics, the type who become diabetic as diet products and diet books that flood 6'0" 137-183 184-220 >220 adults, are obese. In many cases, the market each year, and the American 6'1" 140-188 189-227 >227 preoccupation with slimness jumps into losing weight, or even starting a 6'2" 144-193 194-233 >233 sharp focus. (See the end of this article weight-loss program (before the for a history of dangerous, now-banned 6'3" 148-199 200-239 >239 pounds come off), can improve the diet drugs and a discussion about the 6'4" 152-204 205-246 >246 diabetic’s blood sugar levels. Diet is a better approach than diabetes future of such drugs.) *Updated from 1986 article But while a constant barrage of medication in most non-insulin movies, television programs and thickness; height, weight and waist dependent diabetics. advertisements presents a slim body measurements; and body water-content see WEIGHT, page 2 as the ideal, experts have calculation, but these techniques are become increasingly doubtful about usually used only in research. the correlation between fashion-model, Today, determining whether In This Issue extra-thin looks and good health. someone has a normal weight, is In a strict sense, the determination of overweight or is obese is determined Fourteen Years of Deceptive Television Drug Advertising...... 7 whether someone is overweight or obese by calculating a person’s body mass RECALLS...... 8 is based on the amount of total body index (BMI). BMI is calculated using a weight that is fat. This can be measured person’s weight and height. A normal OUTRAGE!...... 12 in a variety of ways, including skinfold BMI is 18.5-24.9, an overweight BMI

For more health-related news, visit our website at www.citizen.org/hrg WEIGHT from page 1 lose weight will also help you reduce factors that may lead to other diseases. • Coronary artery disease (blockage of blood vessels that supply the What influences body PUBLIC CITIZEN heart; the blockage causes heart weight? attacks). Several factors influence your weight: Health Letter • Heart disease. Recent research has shown that being overweight alone May 2011 • Vol. 27, No. 5 • Food intake. The more you eat, makes the heart work harder and the more fuel you have for your leads to a thickening of the heart body. Extra fuel that is not used Editor muscle, which can increase the in daily activities is stored for use Sidney M. Wolfe, M.D. risk of dangerous heart rhythms another day in the form of fat. or sudden death. This change is If that day never comes, the fat Managing Editor separate from the heart effects of remains. Cynthia Williams high blood pressure and coronary • Food’s energy content is heart disease and can be reversed measured in units of heat called Contributors by weight loss. Together, obesity, calories. Despite the claims of Sidney M. Wolfe, M.D. high blood pressure and coronary many popular fad diets, the body Michael A. Carome, M.D. artery disease are a very hazardous does not really distinguish between combination. different kinds of calories as far as Graphic Designer • Hypercholesterolemia (high weight accumulation is concerned. Erin Hyland levels of a fatlike substance called • Activity. The more active you are, cholesterol in the blood) and the more fuel you burn. That fuel hyperlipidemia (high levels of fat Public Citizen President may consist of recently eaten food in the blood). Robert Weissman or previously stored fat. • Stroke (the blockage of blood • Size and body type. The heavier vessels that supply the brain). The Health Research Group was co- you are, the more food you need • Osteoarthritis (the most common founded in 1971 by Ralph Nader and just to maintain your weight. In arthritis, considered “wear and addition, more fuel is required to Sidney Wolfe in Washington, D.C., tear” arthritis). Strain on joints maintain muscle mass and bone to fight for the public’s health and bearing body weight, such as the than to maintain fatty tissue. As give consumers more control over hips and knees, causes and worsens a result, large-boned, muscular decisions that affect their health. this joint destruction. Excessive people need to eat more just to body weight increases this strain. maintain their weight than do Annual subscription rate is • Pulmonary disease (breathing small-boned plump people. $18.00 (12 issues). difficulties). Obesity is associated • Metabolism. This is the process with various respiratory problems, by which food and stored fat are Material in the Health Letter may not including sleep apnea. converted into energy. People with be reprinted without permission from • Other diseases, including higher metabolic rates burn food the Editor. Send requests, subscrip- hormone imbalances, gall bladder and fat at a higher rate than do tion and address changes to: disease, and kidney disease. those with low metabolic rates. Obesity also causes increased risks Health Letter to pregnant women and male or Genetics 1600 20th St., NW, female surgical patients, since A new study shows that the tendency Washington, D.C. 20009 it results in a higher probability to become fat can be transmitted of medical complications. In genetically as well. Regardless of addition, physical examination of Copyright © Health Letter, 2011 environment, children of obese parents very obese patients by doctors can Published monthly by Public Citizen’s were more likely to become obese adults; be made very difficult. Health Research Group this happened even when the children All rights reserved. ISSN 0882-598X were adopted into separate homes. But Some of the conditions mentioned even if your parents are overweight, above may result not from obesity itself, you should not be overly discouraged but from the kind of diet or sedentary by this information. Instead, efforts lifestyle that leads to obesity. A sensible diet and activity plan that will help you see WEIGHT, page 3

2 ✦ May 2011 WEIGHT from page 2 One recent report even stated that about to achieve a sound weight control 80 percent of fourth-grade girls are dieting! program, including lifestyle changes as discussed later in this article, need to start earlier and require more work in diet and exercise habits, not just to supermarkets and bookstores. Here are “obesity prone” individuals. lose weight fast (only to gain it back). a few suggestions that may help: A much less common cause of Aiming for minor or gradual alterations changes in metabolic rate is hormonal in diet is a more realistic approach to • Make some sensible substitutions, disturbance, such as increased or long-term weight loss than switching to using more low-calorie foods in decreased rates of thyroid activity. a radically different diet. your daily diet. For example, if Obviously, of all the factors A pound of fat represents an estimated you eat a lot of meat, substitute influencing weight that were listed 3,500 calories. In other words, in chicken, fish or seafood for beef, above, food intake and physical activity order to lose one pound, you must use lamb or pork. The former have less are the two over which you have the (through physical activity) 3,500 more fat and, generally, fewer calories. most direct control. A sensible weight calories than you eat. Eat more vegetables and less reduction program should therefore A reasonable, fairly ambitious meat. (bean curd), one of a begin with those two elements. program is to make a calorie adjustment variety of vegetable protein sources of 3,500 calories per week. This program becoming more widely available, Principles of weight loss will average about one pound lost each has even fewer calories and is a good The guiding principle of weight loss week, assuming that your weight is now source of protein. Other simple is simple: If more calories are eaten than constant with your current diet and substitutions can include low-fat burned, weight is gained; if fewer calories activity. cottage cheese rather than other are eaten than burned, weight is lost. In a long-term program like cheeses; nonfat skim milk rather Unfortunately, as most who have this one, weight loss may be more than whole milk; fresh fruit (more tried to diet can tell you, losing weight pronounced in the early weeks of this filling) rather than fruit juice; fresh is not an easy task. Dieting must be a reducing program, as it is in any weight vegetables rather than sweet, salty long-term process involving permanent reduction program. During this initial or fried snacks; and fresh fruit changes in eating habits and physical period there is significant water loss rather than sweet desserts. activity. as well as other body adjustments. • Eliminate invisible calories Any program that results in, or After the initial drop in weight, your (calories that do not add to the promises to result in, short-term weight weight may level off (sometimes for a taste, quality or appearance of loss without any dietary or lifestyle few weeks) before dropping again. This food) by trying new methods of changes will typically fail after the quick pattern of plateaus followed by drops in food preparation. Several excellent success: Pounds rapidly lost are rapidly weight continues through a weight-loss cookbooks now on the market gained back! program. will help you prepare flavorful The fact that millions of people A caloric adjustment of 3,500 calories with far less fat and sugar. hop from the Last Chance Diet to the per week requires a net change of 500 Trimming visible fat from meat, to the Beverly Hills Diet calories each day. We recommend that removing skin (a major source of to the Cambridge Diet reveals that you reduce 400 calories of this through fat) from poultry prior to cooking sustained weight loss rarely occurs with a decrease in dietary intake and 100 (or eating), cooking food in any such diets. calories in increased activity each day. bouillon or broth instead of butter Diet pills are similarly ineffective. or oil, and using lemon juice or They may help short-term weight Diet: how to eat 400 fewer bouillon instead of butter or oil loss, but they play no role in long- calories per day for basting or seasoning fish and term weight loss. In addition, they are Any effective weight control program vegetables will eliminate calories dangerous. involves changes in diet. We suggest that you will scarcely miss. that you design a reduction in calories • Learn to be calorie-wise when A reasonable plan: how to that you can live with for good, not just dining out. Ask the waiter or safely lose a pound a week for the short term. waitress to remove the tray of rolls Setting a calorie adjustment that will To reduce your daily diet by 400 or bread from the table and, if result in permanent weight loss and calories, review the foods you eat to see possible, to bring some fresh celery allow you to integrate these changes what you can eliminate. You may find or carrots. Enjoy a glass of club into your life is a considerable challenge. a “calorie counter” book helpful; they soda with a wedge of lime instead The goal is to develop new, healthier are inexpensive and available in many see WEIGHT, page 4 Public Citizen’s Health Research Group ✦ Health Letter ✦ 3 WEIGHT from page 3 In order to succeed, dieting must be a long-term of a drink before dinner — alcohol process involving permanent changes in eating habits is a major source of non-nutritional calories. Substitute a squeeze of and physical activity. lemon wedge for that heavy salad dressing and avoid fried foods. were nutritionally adequate. Starting a serious exercise program • Arrange for low-calorie meals. If Basically, it is best to maintain a after years of relative inactivity can be your meals are prepared in a school balanced diet, which provides adequate a strain on your body, especially your dormitory, company cafeteria or protein, and minerals. A diet heart. If vigorous exercise has not been similar kind of institutional setting for weight loss should also include high a part of your regular activities for some where you are not in control of food fiber foods. Many high fiber foods, time, we recommend that you start preparation, consult the director whole grain vegetables and beans are slowly with walking rather than another of food services. Sometimes he or also higher in complex carbohydrates, more strenuous form of exercise. she will be able to help you work a better source of energy than simple You should seek medical advice out a low-calorie plan using sugars such as sugar, honey or molasses). before starting an exercise program if the available food or, depending Many of the problems associated with any of the following are true: You 1) are on the size and resources of the the most recent fad diets — including over 45 and have not had a check-up kitchen or food source, help you liquid protein diets, the Doctor’s Quick by a physician in the last year, especially to obtain specially prepared meals. Weight Loss Diet, Dr. Atkins’ Diet if you have been fairly inactive; 2) have Most major airlines will serve low- Revolution and the Beverly Hills Diet, heart disease or high blood pressure, or calorie meals if you request them a — stem from inadequate allowance are under the care of a physician for any day before your trip. of vitamins or protein. In a moderate, other chronic disease; 3) have a family • Keep a record of what you eat more sensible, weight-loss program, history of heart attacks; or 4) experience and when you eat, even checking you will benefit most from avoiding any chest pain, dizziness or shortness out portion sizes with a small items containing large quantities of fats, of breath with or without physical scale. This will help you to learn oils and sugar. exertion. what you should avoid in order to There are a number of books of We recommend that you use (burn) acquire and maintain your desirable varying quality published on nutrition. at least an additional 100 calories every weight. Jane Brody’s Nutrition Book is an up- day. One hundred calories is roughly • Learn to recognize and handle to-date, sensible guide that we can equivalent to one of the following: 20 stress without responding by recommend as a source for further minutes of brisk walking (about one overeating. Frequently, people information. mile), 12 minutes of bicycle riding, with weight problems use food as a nine minutes of swimming, or five way of coping with stress. Anxiety, minutes of fast running. You should anger, sadness and even boredom Exercise: 100 calories more exercise hard enough to make yourself are feelings that at times can be per day breathe faster. Any kind of new exercise attributed to stressful situations. As anyone who has tried it knows, should be preceded and followed by People sometimes handle these losing weight and keeping it off by several minutes of stretching exercises, uncomfortable emotions by seeking dieting alone is very difficult. especially at the ankles and hips. comfort in food, and consequently, As an example, a woman of 120 Depending on your physical they overeat. Then, after eating too pounds with a sedentary job (burning condition, you may find that you are much food, or the wrong kind of about 1,800 calories per day) would able to increase this amount of exercise, food, people frequently feel guilty have to cut calories by 28 percent to lose and hence improve upon your weight or disappointment with themselves, one pound per week through dieting control program. Keep in mind that which results in still more stress. alone. To lose weight, she would have to this increased activity should become cut her meals back to Spartan portions permanent daily activity. Proper nutrition and dieting (which maintain minimally adequate Keep a log of your exercise. This During a weight control program, it nutrition), with little or no leeway can serve not only to keep you faithful is especially important to provide the for fattening “treats.” If, however, she to your new program, but also to body with proper nutrition. A program walked at a brisk pace for 20 minutes encourage progress. With exercise, that involves only a slight change (such as to and from her job) each many people feel an increased sense of from past habits, as described in this morning and evening, she would only energy and a decreased desire for food. article, should not result in nutritional have to cut back calories by 17 percent deficiencies, as long as those past habits to lose the same amount. see WEIGHT, page 5

4 ✦ May 2011 WEIGHT from page 4 The basic, primitive human drive to eat Weight control in children is so fundamental to our survival and is so enmeshed in and adolescents our overall body function that any of the drugs Moderately overweight young people, that “work” to lose weight are certain to affect otherwise in good health, are usually able to safely increase the calories other parts of the body. expended by exercising more. This can be very effective when combined with a program of restrained dieting that is very pulmonary hypertension (high also possessed some amphetamine- careful not to sacrifice any nutritional blood pressure in the lungs, much like properties. Meridia was needs. Drastic weight-control programs more difficult to treat than the approved in 1997 despite the in children and adolescents may cause common systemic hypertension conclusion by the FDA reviewer a variety of health problems (including and more likely to result in death) and an FDA advisory committee slowing growth and development) and were reported in people using that the risks outweighed the are not recommended. Very obese dexfenfluramine or fenfluramine. benefits. Both risks, high blood children and adolescents should seek Then a researcher at the Mayo pressure and increased heart rate, professional assistance. Clinic discovered that the drug threaten increased heart attacks and Some adolescents, overly concerned also causes serious damage to heart strokes. Public Citizen originally about weight and appearance, may be valves, and the drug was banned in asked the FDA to ban the drug in tempted to use over-the-counter diet 1997. 2002, but the petition was denied aids. As with adults, these products • PPA (phenylpropanolamine). in 2005. should not be used, as they can be This over-the-counter diet drug, Late in 2009, a large European dangerous. most popularly sold as Dexatrim, study involving 10,000 overweight had been on the market since 1960 people — 5,000 randomized to History of unsafe diet drugs when, in the late 1990s, because of sibutramine, 5,000 given a placebo The road to safe and effective diet a suspicion that it caused strokes in — was finished. This was the only drugs is littered with a rapidly increasing younger women, its manufacturer long-term study ever done to test number of banned products, both over- sponsored an epidemiological study the safety of a diet drug. Although the-counter and prescription, which to look into the claim. The study people using sibutramine lost more were approved based on relatively clearly confirmed the increased risk weight than those getting a placebo, short-term weight loss but without any of hemorrhagic (bleeding) strokes there was a statistically significant evidence of long-term safety. in people — mainly women — increase in both heart attacks and In the past 14 years alone, four such using the drug, and it was removed strokes in the sibutramine group. drugs have been removed from the from the market in 2000. Public Citizen again asked the market in the United States when it • Ephedra. This “natural,” also FDA to ban the drug. Europe became unequivocally clear that serious available over-the-counter dietary immediately banned the drug injuries and deaths caused by these supplement was widely promoted when the results of the study were drugs vastly outweighed the meager, for weight reduction. Since it is also made public, but in the United transitory benefits of weight loss. in the same family as amphetamines, States, the FDA delayed for almost In chronological order, they begin it increased heart rate and blood a year, taking no such action until with Fen-Phen and, as of now, end with pressure. As it became more and October 2010. Meridia (sibutramine). more popular in the late 1990s and early 2000s, many cases of sudden Before fenfluramine and • Fen-Phen. This combination of death — including in healthy after Meridia? two separate drugs, fenfluramine soldiers — began being reported to Fenfluramine was not the first, nor and phentermine, a relatively old the Food and Drug Administration will Meridia be the last, diet drug to be amphetamine-like drug, became (FDA). Public Citizen petitioned banned after injuring or killing large quite popular in the early 1990s the FDA to ban ephedra in the fall numbers of people. In the 1940s and and even more popular following of 2001, and after congressional 1950s, both amphetamine and thyroid the approval of dexfenfluramine hearings and many additional cases medications were used for weight (a version of fenfluramine, of heart attacks and strokes, the loss. They both had risks — psychosis brand name Redux) in 1996. FDA banned ephedra in 2004. Several hundred cases of primary • Meridia (sibutramine). This drug see WEIGHT, page 6

Public Citizen’s Health Research Group ✦ Health Letter ✦ 5 WEIGHT from page 5 drugs that “work” to lose weight are Learn to recognize and certain to affect other parts of the body. and addiction for amphetamine and handle stress without As soon as this magic-bullet notion is dangerous hyperthyroidism for thyroid responding by overeating. more thoroughly discredited, the rush medications — that greatly outweighed for magic ways to lose weight (with their benefits, and their use for weight the risks inevitably outweighing the loss was eventually stopped. Williams, of the University of Bristol, benefits) will be seen as the dangerous Public Citizen recently — in April appeared in the British Medical Journal folly that it is. 2011 — asked the FDA, for the second on the larger topic of losing weight by The same can be said for the time (first in 2006), to ban the diet using drugs. The key point made is seemingly infinite number of magic, drug orlistat. Its prescription version is quoted below: but usually unsustainable or unhealthy, called Xenical; over-the-counter, it is diets in diet books that keep surfacing “The fate of sibutramine reminds sold as Alli. The most recent evidence, and, in most cases, keep being forgotten us how little antiobesity drugs have which we obtained from FDA adverse before too long. had to offer—at best, a reduction reaction files, concerned 47 cases of As discussed earlier in the article, of a few per cent in the total burden acute pancreatitis and 73 cases of kidney there is a relatively slow, but effective, of excess weight carried until stones. This is in addition to FDA’s route to lose a pound a week. It death. With energy homoeostasis safely admission in 2010 that the drug causes involves eating 400 fewer calories a so deeply enmeshed in physiology, hepatitis. As in the examples above, the day and exercising enough to burn 100 it has always seemed unlikely that loss of weight was not very impressive more calories a day. Some may prefer a magic bullet could ever switch and was clearly overshadowed by the a different combination — say, eating off food intake without hitting increasing number of serious adverse 300 fewer calories and burning 200 something vital.” reactions in patients. more. We hope that those of you who In other words, Professor Williams is want to lose weight will try this instead The future of diet drugs saying that the basic, primitive human of the seemingly limitless parade of diet In February 2010, immediately after drive to eat is so fundamental to our drugs that do more harm than good. ✦ Europe banned the use of Meridia, a survival and is so enmeshed in our very wise editorial by Professor Gareth overall body function that any of the

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6 ✦ May 2011 Fourteen Years of Deceptive Television Drug Advertising

The following article, by Martha Rosenberg, originally appeared on OpEdNews.com. It has been reprinted with permission.

an anyone remember life before CAsk Your Doctor ads on TV? All you knew about prescription drugs were creepy ads, with a lot of fine print, in a Journal of the American Medical Association at the doctor’s office. Even if you knew the name of a drug, you’d never ask your doctor for it because that would be self-diagnosing and cheeky for a patient. Flash forward to the late 1990s when direct-to-consumer (DTC) drug advertising, drug Web sites and online drug sales came on board, and self-diagnosing and demanding pills became medicine-as-usual for many doctors and patients. The DTC/Web perfect storm didn’t just sell drugs like Claritin, Prozac and the Purple Pill. It sold the diseases to I thought I was fine. (Illustration by Martha Rosenberg) go with them, like seasonal allergies, gastroesophageal reflux disease and risk disclosures — brain bleeds, for the drugs out of their pockets and depression. It sold risk of diseases — sudden death, difficulty breathing, you told them to add a drug that costs like heart events, for which you’d take stomach bleeding, liver failure, almost $500 a month because the first a statin like Lipitor; osteoporosis, for kidney failure, muscle breakdown, one isn’t working, they would say the which you’d take a bone drug like fainting, hallucinations — perversely only thing “treatment resistant” is your Boniva; and asthma attacks, for which sold the drugs more, either because ad sales pitch — go find another sucker. you’d use a second asthma drug like frequency itself sells or because people But if third-party payers get stuck with Advair. Of course, by the very definition like the identity in having a disease, the bill, no one seems to mind pharma’s of prevention, you didn’t know if the like chemically experimenting on “Double (and Triple) Its Money” plan drugs were working but you weren’t themselves or like taking a dare. — or even notices it. paying out of pocket anyway so what Soon anxiety graduated to In fact psychiatric drug cocktails the hay. depression, which graduated to bipolar of eight, 10 and 12 drugs are now Thanks to DTC advertising, people disorder. Children got schizophrenia common medical practice for started taking seizure drugs like and depression like adults and adults “treatment resistant” depression and Topamax and Lyrica for everyday got ADHD like kids. And it didn’t stop post-traumatic stress disorder (often pain or headaches and antipsychotics there. If the depression you or your kid paid by government entitlement health — hello? — for everyday blues or had didn’t go away — maybe because plans), even though the drugs have mood problems. They started taking it wasn’t depression in the first place never been tested when taken together monoclonal antibodies — made from but a thing called “life” — you needed — unless you count the patients taking genetically engineered hamster cells, to add a drug like Abilify or Seroquel them now! like Humira, which invite cancer, on to the original drug(s) because your Pharma also adds an urgency pitch to superinfections and TB — when they depression was “treatment resistant.” the sell in case you think you can wait didn’t have to. And FDA-mandated Of course if people were paying see ADVERTISING, page 11

Public Citizen’s Health Research Group ✦ Health Letter ✦ 7 Product Recalls April 15, 2011 – May 11, 2011 This chart includes recalls from the Food and Drug Administration (FDA) Enforcement Report for drugs and dietary supplements, and Consumer Product Safety Commission (CPSC) recalls of consumer products. DRUGS AND DIETARY SUPPLEMENTS Recalls and Field Corrections: Drugs – Class 1 Indicates a problem that may cause serious injury or death

Clomed Capsules , 50 mg proprietary blend, Nifedipine Extended-Release Tablets, USP, 60 mg, 100-count unit 60 capsules/bottle. Volume of product in commerce: 20,000 bottles. dose box (10 blister cards of 10-unit dose tablets), Rx only. Volume Marketed without an approved NDA/ANDA. Lot#: All lot codes. Watson of product in commerce: 1,153 cartons (each containing 100 tablets Industries Inc. in blister packs). Does not meet sustained-release specifications: Above specification dissolution results at four hours were found during nine-month stability testing. Lot#: 0809T01A, expiration date 06/2010. Biovail International Corp.

Recalls and Field Corrections: Drugs – Class 11 Indicates a problem that may cause temporary or reversible health effects; unlikely to cause serious injury or death

Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only. Volume Gemfibrozil Tablets, USP, 600 mg, 60-count bottle, Rx only. Volume of product in commerce: 5,568 bottles. CGMP Deviations: Firm’s of product in commerce: 17,667 units. CGMP Deviations: Firm’s laboratory investigations were not performed in accordance with strict laboratory investigations were not performed in accordance with strict adherence to the “FDA Guidance for Industry.” Lot #: 04C118, expira- adherence to the “FDA Guidance for Industry – Investigating Out-of- tion date 7/12. Teva Pharmaceutical Industries. Specification Test Results for Pharmaceutical Production.” Lot #: 01G495. Teva Pharmaceutical Industries.

Chlorzoxazone Tablets, USP, 500 mg, 100 tablets, Rx only. Volume of product in commerce: 9,435 bottles. Adulterated: presence of Lansoprazole Delayed-Release Capsules, USP, 30 mg, 30-count foreign tablets: Isoniazid residue found in bottle of Chlorzoxazone bottle, Rx only. Volume of product in commerce: 74,521 bottles. tablets. Lot #: 314134, expiration date 12/2012. Barr Laboratories Inc. CGMP deviations. Firm’s laboratory investigations were not performed in accordance with strict adherence to the “FDA Guidance for Industry – Investigating Out-of-Specification Test Results for Pharmaceutical Diovan (valsartan), 160 mg, 7,000 tablets, NOVARTIS label, Rx only. Production.” Lot #: 44L007. Teva Pharmaceutical Industries. Volume of product in commerce: 278 bottles of 7,000 tablets. Adulter- ated: presence of foreign tablets; a bottle of Diovan 160 mg tablets was found to contain some tablets identified as Diovan HCT 320/12.5 Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 100 mg. Lot #: F0976, expiration date 12/2013. Novartis Pharmaceuticals tablets (10 x 10), NDC 51079-445-20 (packaged in blister packs, 10 Corp. tablets/card, 10 cards/package). Volume of product in commerce: 2,004 packages. Subpotent (single ingredient) drug: Pharmaceuti- cal did not meet assay specification. Lot #: OA432, expiration date Fexofenadine Hydrochloride Tablets, USP, 180 mg, 100-count 04/2011. Mylan Pharmaceuticals Inc. bottle, Rx only. Volume of product in commerce: 14,072 units. CGMP deviations. Firm’s laboratory investigations were not performed in accordance with strict adherence to the “FDA Guidance for Industry Metformin Hydrochloride Tablets, USP, 500 mg, 1,000-count bottle, – Investigating Out-of-Specification Test Results for Pharmaceutical Rx only. Volume of product in commerce: 6,494 bottles. Failed tablet Production.” Lot #: 26F109. Teva Pharmaceutical Industries. hardness: Some tablets may not meet friability specification. Lot #: 35201115A, expiration date 10/2011. Novopharm Ltd.

8 ✦ May 2011 DRUGS AND DIETARY SUPPLEMENTS (continued)

Nabumetone Tablets, USP, 750 mg, 100-count bottle, Rx only. Vol- Simvastatin Tablets, USP, 20 mg, 1,000-count bottle, RX only. ume of product in commerce: 8,085 bottles. CGMP deviations. Firm’s Volume of product in commerce: unknown. CGMP deviations. Firm’s laboratory investigations were not performed in accordance with strict laboratory investigations were not performed in accordance with strict adherence to the “FDA Guidance for Industry – Investigating Out-of- adherence to the “FDA Guidance for Industry – Investigating Out- Specification Test Results for Pharmaceutical Production.” of-Specification Test Results for Pharmaceutical Production.” Lot #: Lot #: 05N243. Teva Pharmaceutical Industries. 14S228, expiration date 06/2011. Teva Pharmaceutical Industries.

Pravastatin Sodium Tablets, USP, 1) 20 mg, a) 1,000-count bottle Simvastatin Tablets, USP, 80 mg, 1,000-count bottle, Rx only. and b) 90-count bottle; 2) 40 mg, 1,000-count bottle, NDC 0093-7202- Volume of product in commerce: unknown. CGMP deviations. Firm’s 10, Rx only. Volume of product in commerce: 12,552 units. CGMP laboratory investigations were not performed in accordance with strict Deviations: Firm’s laboratory investigations were not performed in adherence to the “FDA Guidance for Industry – Investigating Out-of- accordance with strict adherence to the “FDA Guidance for Industry Specification Test Results for Pharmaceutical Production.” – Investigating Out-of-Specification Test Results for Pharmaceuti- Lot #: 04S406, expiration date 05/2011. Teva Pharmaceutical cal Production.” Lot #s: 1) a) 04Y223, b) 04Y233; 2) 05Y219. Teva Industries. Pharmaceutical Industries.

Zolpidem Tartrate Tablets, 10 mg, 100-count bottle, Rx only. Volume Simvastatin Tablets, USP, 20 mg, 30-count bottle, Rx only. Volume of of product in commerce: 62,803 units. CGMP Deviations: Firm’s product in commerce: unknown. CGMP deviations. Firm’s laboratory laboratory investigations were not performed in accordance with strict investigations were not performed in accordance with strict adherence adherence to the “FDA Guidance for Industry – Investigating Out-of- to the “FDA Guidance for Industry – Investigating Out-of-Specification Specification Test Results for Pharmaceutical Production.” Test Results for Pharmaceutical Production.” Lot #: 23S031, expiration Lot #: 10Z005. Teva Pharmaceutical Industries. date 11/2012. Teva Pharmaceutical Industries.

CONSUMER PRODUCTS

Contact the Consumer Product Safety Commission (CPSC) for specific instructions or return the item to the place of purchase for a refund. For additional informa- tion from the CPSC, call its hotline at (800) 638-2772. The CPSC website is www.cpsc.gov. Visit www.recalls.gov for information about FDA recalls and recalls issued by other government agencies.

Name of Product; Problem; Recall Information

Beaded Curtains. The beaded curtains are prone to entanglement. Edge and HOG (Highly Optimized Gear) Buoyancy Control When an adult or child plays with or runs through the beaded curtains, Devices (BCD). The spring in the over pressure valve can corrode the risks of entanglement and strangulation are posed. Tween Brands and break, preventing the buoyancy control device from retaining air, Inc., d/b/a Justice, at (800) 934-4497 or www.shopjustice.com. posing a drowning hazard to consumers. WRK Enterprises d/b/a Edge Dive Gear, at (888) 370-3483 or www.edge-gear.com.

Bumble Bee and Lady Bug Infant Slipper Socks. The balls at the end of the bug’s antennae can detach, posing a choking hazard to Fixed-Side Cribs. The bottom rails on the crib sides can separate young children. Meijer Inc., at (800) 927-8699 or www.meijer.com. from the sides when the mattress is in the lowest position, causing the spindles to separate and the mattress to drop. This poses fall and en- trapment hazards for young children. Ducduc LLC, at (212) 226-1868

or www.ducducnyc.com. Danbar Knight Hawk Toy Helicopters. The battery housing under the helicopter canopy can overheat while charging, posing a fire hazard. UJ Trading, at (800) 536-2691 or www.UJToys.com. Girl’s Hooded Sweater with Drawstring. The hooded sweaters have drawstrings through the hood that can pose a strangulation or entrap- ment hazard to children. In February 1996, CPSC issued guidelines, Disney Princess Plastic Racing Trikes. The plastic castle display which were incorporated into an industry voluntary standard in 1997, and the princess figures protruding from the top of the handlebar pose to help prevent children from strangling or getting entangled on the a laceration hazard if a child falls on it. Kiddieland Toys Limited, at neck and waist drawstrings in upper garments, such as jackets and (800) 430-5307 or www.kiddieland.com.hk. sweatshirts. El Gringo Imports, at (877) 278-1434 or www.elgringoimports.com.

Public Citizen’s Health Research Group ✦ Health Letter ✦ 9 CONSUMER PRODUCTS (continued)

Kohler Courage Engines. A wire connector on the engine can Spot Satellite Communicator. The internal voltage regulator can become disconnected, causing the operator’s seat switch to fail. stop working, resulting in the inability to transmit messages and track- When this happens, the blades will not shut down, posing a laceration ing information in emergency situations. Spot LLC, at (866) 727-7733 hazard to consumers. Kohler Co., at (800) 451-2294 or or www.findmespot.com/replacement. www.kohlerengines.com.

Tea Lights. The candles have a clear, plastic cup that can melt or Light Bulbs. The light bulbs can overheat, posing a fire hazard to ignite, posing a fire and burn hazard to consumers. Pacific Trade consumers. Telstar Products, d/b/a Sprint International Inc., at (888) International Inc., at (800) 331-8339 or 828-1680 or www.telstarpro.com. www.chesapeakebaycandle.com.

Lights and Sounds Children’s Scooters. A child’s finger can get Toro Power Clear Snowblower and the Toro 20" Recycler Mower. caught in the hinge mechanism between the steering column and the The carburetors on both products develop fuel leaks and can ignite platform, posing a laceration hazard. Kiddieland Toys Limited, at (800) when exposed to an ignition source, posing a fire or burn hazard. The 430-5307 or www.kiddieland.com.hk. Toro Company, at (877) 738-4440 or www.toro.com.

Lithium-Ion Batteries Used with Magicshine Bicycle Lights. The Toy Story 3 Bowling Game. The red paint used on some bowling lithium-ion batteries can overheat, posing a fire hazard to consumers. pins has been measured to be in excess of the maximum allowable Shenzhen Minjun Electronic Co. Ltd., at level of 90 ppm, a violation of the federal lead paint standard. G.A. www.MagicshineBatteryRecall.com or [email protected]. Gertmenian and Sons LLC, at (888) 224-4181 or [email protected].

Marineland Stealth and Stealth Pro Aquarium Heaters. A wiring problem can cause the aquarium heaters to overheat or break during Wooden bunk beds. The wooden side rails that run from the normal use, damaging the aquarium and posing fire and laceration headboard to the footboard and hold the bunk bed’s mattress in place hazards to consumers. Overheating can cause the heater to shatter or can split and cause the bunk bed to collapse, posing a fall hazard to the aquarium glass to break. United Pet Group, at (800) 338-4896 or consumers. Dorel Asia SRL, at (800) 638-2772 or (301) 595-7054 www.marineland.com. (teletypewriter) or www.cpsc.gov/cpsclist.aspx.

Pacifier Clip.The clip can break apart, posing a choking hazard to Wooden Stool. The legs and seat of the stool can crack and break, young children. Sandbox Medical, LLC, at (800) 396-1550 or causing the consumer to fall. Heartland America, at (800) 398-8163 or www.gumdroppacifier.com. www.heartlandamerica.com/stoolrecall.

Photon Carabiners, Photon and Mach Express Quickdraws. The carabiner gate may open under a heavy load, posing a risk of serious injury or death if the climber falls. CAMP USA Inc., at (877) 421-2267 or www.camp-usa.com.

1 Ryobi /4 Sheet Sanders. Pieces of the fan can break off from the fan assembly and be ejected from the product, posing a laceration hazard to consumers. One World Technologies Inc., at (800) 597-9624 or www.ryobitools.com.

Sea Elite Systems Buoyancy Control Devices. The spring in the overpressure valve can corrode and break, preventing the buoyancy control device from retaining air and posing a drowning hazard to con- sumers. WRK Enterprises, at (888) 370-3483 or www.edge-gear.com.

10 ✦ May 2011 ADVERTISING from page 7 Because of pharma-paid doctors, public relations firms, to take your or your child’s treatment industry-subsidized medical journals and Web sites resistant drug cocktail until symptoms worsen. like WebMD, pharma is able to create new diseases, And don’t think kids will outgrow “humanize” others by giving them nicknames and mood problems either, says pharma. elevate others to public health problems. That erratic behavior is no doubt early mental illness that will become worse if you don’t treat it in the bud. Even Nuvigil, what do you bet you’ll have While these “patients” — often flown mothers of one-year-olds with the sleep problems? by pharma to testify at FDA hearings sniffles are told serious asthma is just Because of pharma-paid doctors, — pretend they can’t get needed drugs around the corner if they don’t treat public relations firms, industry- like terminal cancer patients can, the their toddler now. subsidized medical journals and Web issue is seldom availability but money: Pharma is also having a field day sites like WebMD, pharma is able to either pharma wants a new use covered with sleep, because everyone is in the create new diseases (osteopenia, the by insurers or doesn’t want an older, demographic. In fact comedian Chris “risk” of osteoporosis; perimenopause cheaper drug substituted. Rock riffs about hearing a DTC ad and Low T), “humanize” others by The same patients appear on Web that asks, “Do you fall asleep at night giving them nicknames (ED, RA, RLS, site testimonials and phony grassroots and wake up in the morning?” and Hep C) and elevate others to public public service messages about the recognizing himself. “Yeah, I got that,” health problems like HPV/venereal epidemic of depression or childhood he says. warts. (It doesn’t hurt that Julie mental illness. How can you tell they’re Not falling asleep soon enough, Gerberding, M.D., and former Centers not real patients but pharma plants? of course, is the disease of insomnia, for Disease Control and Prevention The Web sites and PSAs look exactly which can have strains like “middle of head, resurfaced as head of Merck like direct-to-consumer ads.✦ the night” and “terminal” insomnia. vaccines after she left the government.) But it also sets you up for — what’s But more insidious sells are pharma- An earlier version of this report the pharma euphemism — wakefulness subsidized “patient groups,” which appeared on the online journal State of problems the next day. And once you’re lobby FDA and state agencies about Nature. using a wakefulness aid like Adderall or expensive drugs, often psychiatric.

OUTRAGE from page 12 independent, highly trained physician result, tens of thousands of patients readers. This led FDA reviewers will have either a false-positive test for each individual physician reader — to seriously doubt the validity and (told they have beta-amyloid deposits data that Avid Radiopharmaceuticals usefulness of florbetapir-PET scan for when they do not) or a false-negative (Avid), a wholly owned subsidiary of detecting beta-amyloid plaques in the test (told they don’t have beta-amyloid Eli Lilly Inc. and the company that brain. deposits when they do). This will lead makes florbetapir, had submitted to the Given the poor performance of the to unnecessary anxiety and treatment FDA on Sept. 17, 2010, four months test at the individual physician reader in some patients, false reassurance in before the JAMA article was published. level in a rigorously controlled setting, others and a waste of millions of health- FDA analyses of the individual the variability and unreliability will care dollars. ✦ physician reader data showed the only get worse when the test is widely substantial variation among the three distributed across the country. As a

Public Citizen’s Health Research Group ✦ Health Letter ✦ 11 NONPROFIT ORG U.S. POSTAGE PAID FREDERICK, MD Health Letter, Public Citizen Health Research Group PERMIT #999 1600 20th Street, N.W., Washington, D.C. 20009

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Printed on recycled paper. abnormalities foundinAlzheimer’s an experimentaldyetodetectbrain the effectivenessofbrainscansusing previous issueofthejournalwhotested criticized theauthorsofastudyin Association I it isapproved bythe Food andDrug rigorously conducted studiesbefore proven tobehighly accurateinlarge, for diagnosing thisdiseasemustbe effective treatments, any proposed test Alzheimer’s disease andthelackof it actuallyis. abnormalities wasmorereliable than that thistestforidentifying brain journal anditsreadersto believe information, the authors misled the actually do.Bywithholdingimportant such brainabnormalitieswhen they reassured thattheydonot have same token,otherscouldbe falsely when theyreallydonot,and bythe as havingsuchbrainabnormalities people could be incorrectly diagnosed fold: First,substantialnumbersof these unreliabletestswouldbetwo- Public Citizensaid. varies fromonephysician to another, to whichinterpretationofthesescans journal whendocumentingtheextent critically importantdatafromthe disease patients. The authors withheld Unreliable Alzheimer’sDiagnoses Outrage oftheMonth! Given what is knownabout The public health implications of Journal oftheAmericanMedical n aletterpublishedintheMay (JAMA),PublicCitizen

for theamountofbeta-amyloid seen and scoredeachflorbetapir-PET scan extensive training,independently read physicians, whohadundergone Importantly, threenuclear medicine plaques intheirbrainsduring autopsy. measurements of beta-amyloid compared thosescanresults to After theirdeaths,theresearchers diagnosed withAlzheimer’sdisease). subjects (only 17 of whom had been brain scansin35elderly,terminallyill researchers performedflorbetapir-PET visible onabrainPETscan. amyloid plaquesinthebrainandbe the injected dye would bindtobeta- scan. Theresearchersproposedthat positron emissiontomography(PET) using animagingprocedurecalleda plaques inthebrainsoflivingpeople 18, canbeusedtodetectbeta-amyloid radioactive dye, calledflorbetapir F whether injectionofanexperimental Public Citizen,researcherstested Administration formarketing. withheld critical dataonthescores on each florbetapir-PET scan. They for theamount ofbeta-amyloidseen score ofthethree physicianreaders researchers presented only the median in thesubject’sbrain. For thekeypartofstudy, In theJAMA study criticizedby In theirJAMA article,the see OUTRAGE, page 11 Health Letter