PUBLIC CITIZEN HEALTH RESEARCH GROUP

SIDNEY M. WOLFE, M.D., EDITOR September 2006 N VOL. 22, NO.9 The Changing Dynamics of C-Sections in the United States: Cesarean Delivery on Maternal Request Part 2

Last month in Health Letter, we over time, the focus was on cesareans usually constrained by physician prac- described recent trends in cesarean on maternal request. Over the course tices and preferences, and the informa- sections in the United States. Here, we of two days, however, it became tion women receive. The National summarize the major findings of an evident that the data are spotty, many Center for Health Statistics uses the NIH conference on the topic. This arti- studies are not amenable to compar- term “cesarean with no medical indica- cle is the second in a two-part series. isons, and there are no easy algorithms tion,” thereby focusing on the apparent or decision trees to provide reliable lack of a health rationale rather than on ast March, the National Institute guidance to patients and physicians. the women’s choice; others use “no of Child Health and Human Although The Washington Post’s report medical risk cesarean” for the same LDevelopment (NICHD) and the reason. But the acronym CDMR on the conference was headlined “NIH Office of Medical Applications of panel finds no extra risk in cesarean (cesarean delivery on maternal Research convened a panel of experts section,” the discussions reflected a request) has already entered the and held a State-of-the-Science more complicated reality. medical literature, and the conference’s Conference on “Cesarean Delivery on The idea of “maternal request” is title and the ensuing report may give Maternal Request” to into the actually misleading. Despite a few additional legitimacy to this nomencla- following questions: high profile celebrities who have said ture. Although the final report states they want to deliver by cesarean that CDMR “is not readily identifiable in 1. What is the trend and incidence of section, there is limited evidence that any existing studies or U.S. national cesarean delivery over time in the women actually request a particular databases, either currently or historical- United States and other countries? type of delivery. Instead, their choice is continued on page 2 2. What are the short-term (under one year) and long-term benefits and C O N T E N T S harms to mother and baby associat- ed with cesarean by request versus Patients Without Borders, Part 2 attempted vaginal delivery? Health Letter takes a second look at medical tourism...... 3 3. What factors influence benefits The “Utimate Prize” for Big and harms? smuggling in China opens the doors to 4. What future research directions need a massive Chinese market...... 5 to be considered to get evidence for making appropriate decisions Recalls regarding cesarean on request or July 19, 2006 – August 21, 2006 attempted vaginal delivery? This month, Synthroid tablets and coffemakers are on the list...... 6

Although the initial question Outrage of the Month Fairness creams in South Asia — a case of disease mongering?...... 12 referred to overall c-section trends

VISIT HEALTH RESEARCH GROUP’S WEB SITE AT WWW.CITIZEN.ORG/HRG/ C-SECTIONS, from page 1 ture found only three instances in babies delivered prior to 39 or 40 ly,” and that there is “little confidence which there was at least moderate weeks of gestation. As a result, one of in the validity of estimates” suggesting evidence of maternal and neonatal only two practice guidelines included that CDMRs represent four to 18 outcomes favoring one modality over in the report’s conclusions state that percent of all c-sections, the report the other. There was a lower frequen- “cesarean delivery upon maternal assumes that a growing proportion of cy of postpartum hemorrhage with request should not be performed prior c-sections are driven by medical need. planned cesarean delivery than with to 39 weeks of gestation or without The only survey to directly gauge the planned vaginal delivery or unplanned verification of lung maturity, because incidence of CDMR was sponsored by cesarean delivery. But two other of the significant danger of neonatal Childbirth Connections and conducted respiratory complications.” by Harris Interactive. This study, which There is a reluctance to adopt interviewed women who gave birth in any “ideal rate” of cesarean deliv- 2005, found that less than 0.4 percent ery as a goal. The conference panel (1/252) of the respondents who had a There is limited evidence rejected that option, which the World primary cesarean initiated a planned Health Organization and other organ- cesarean without medical reason. Two that women actually izations have espoused. In the other women with a primary c-section absence of benchmarks, women and said that the procedure was scheduled request a particular type practitioners will therefore lack a ahead of time without medical reason of delivery. Instead, their legitimate yardstick to assess the and initiated by a health professional. labor practices of particular physi- The medical literature, though choice is usually cians and hospitals. This may eventu- growing, does not provide much ally be reflected in the nation’s guidance for practitioners. In constrained by physician Healthy People objectives when they preparation for the conference, are revised. NICHD commissioned a literature practices and The data may very well become review comparing cesarean delivery more muddled over time. Despite on maternal request with planned preferences, and by the calls for more targeted, better- vaginal delivery. The review found designed studies and more funding that the existing studies lack consis- information women for research, it is unlikely that any tent definitions of routes of delivery clear guidance will come from this and are therefore difficult to compare. receive. source. The gold standard for In addition, most focus on the actual medical evidence — the randomized route of delivery rather than on what clinical study — presents a number was planned. Not surprisingly, the of difficulties. First, it would probably final conference report concludes that outcomes — maternal length of hospi- be unethical to randomize women to “there is insufficient evidence to eval- tal stay and neonatal respiratory a planned cesarean delivery versus a uate fully the benefits and risks of morbidity — favored planned vaginal planned vaginal birth, nor would cesarean delivery on maternal request delivery over c-section. Evidence many women be willing to consent as compared to planned vaginal deliv- concerning the association of neonatal to such randomization. In addition, ery, and more research is needed.” respiratory morbidity with c-section is the study would have to be very large In fact, those reviewing the litera- particularly strong and consistent for continued on page 3

Editor...... Sidney M.Wolfe, MD The Health Research Group was co-founded in 1971 by Ralph Nader and Sidney Wolfe in Managing Editor...... Kate Resnevic Washington, D.C. to fight for the public’s Contributor ...... Annette Ramírez de health, and to give consumers more control Arellano, DrPH over decisions that affect their health. Proofreader...... Shiloh Stark Copyright © Health Letter, 2006 Published Monthly by Material in the Health Letter may not be Production Mgr...... Kristy I. Jackson Public Citizen Health Research Group re-printed without permission from the Editor. All rights reserved. ISSN 0882-598X Send letters and requests to HEALTH LETTER, President...... Joan Claybrook Editor, 1600 20th St., NW, Washington, D.C., 20009. Annual subscription price is $18.00 (12 is- sues). Mail subscriptions and address changes to Health Letter, Circulation Department, 1600 20th St., NW, Washington, D.C., 20009. Our Web site address is www.citizen.org/hrg.

2 N September 2006 Patients without Borders: The Emergence of Medical Tourism Part 2 In the July issue of Health Letter, involved. Here, we will present some surprising that hospitals seeking to Public Citizen wrote about the rapid- of the trade-offs the U.S. consumer is attract foreign patients have taken ly emerging phenomenon of medical making when opting for medical pains to provide the amenities that tourism. The article described a kind tourism, and some of the issues that ensure patient approval. Many have of “patients without borders” whereby should inform this decision. therefore invested an inordinate more and more Americans are travel- amount of resources to create posh ing beyond national boundaries to How good is the care? facilities combining high-technology receive medical care. Here, Public For Americans going abroad, the medicine with resort attractions. Citizen expands on this topic. This possibility of trading off quality care In addition, some hospitals designed article is the second in a two-part for affordability may be of vital impor- for a foreign clientele have adopted series. tance. And the choice consumers face Western standards of care, and sought between “suffering with a health prob- and obtained accreditation from the growing number of U.S. lem or facing significant damage to international arm of the Joint patients are turning to other their finances” may not be easy. Commission for the Accreditation of Acountries for surgical and The short answer to the question Healthcare Organizations. They also other care. The lure of “first-class concerning quality is: it depends. As capitalize on the fact that some of their services at third-world prices,” as with health services in the United physicians were trained in the West. tantalizingly portrayed in the elec- States, the quality of the product can And, because they are in the hospitali- tronic and other media, is attracting vary widely, and patients are often ty business, they tend to have a high those who want to combine their not in a position to judge what they staff-to-patient ratio and stress gracious care with a vacation, are seeking are getting. In the absence of stan- care. alternative therapies, or are simply dards, the obvious trappings of care enticed by the lower prices of most — physical facilities, size and cleanli- What does this mean for the U.S. procedures. In the previous article, ness of rooms, availability of staff, consumer? we provided a summary of some of physician attentiveness — often take American medical consumers who the international and local implica- precedence over medical skill and are able to travel see the expanding tions of the trends for the countries accountability. It is therefore not global market as another option enabling them to get care at afford- able prices. Because pay scales are C-SECTIONS, from page 2 in birth outcomes between women lower and service volumes higher in in order to pick up rare but serious having a c-section and those having a number of developing countries, complications affecting the woman vaginal births. This may in turn their medical “products” may be and her child. Finally, the study increase the tendency to opt for a significantly cheaper. In some cases, population would have to be cesarean, running the risk of having surgical procedures may cost a fifth followed up on for a number of years the trend become self-sustaining. and even a tenth of what they would in order to detect effects on subse- As a “snapshot in time” of the state of cost in the United States. With few or quent deliveries and other long-term knowledge on cesarean delivery, the no restrictions concerning length of sequelae. This would increase the presentations and final statement of the stay, patients may appreciate relief likelihood of women being lost to NIH conference therefore reflect an from drive-by surgeries and difficult follow-up, make the study very cost- uneasy state of “clinical equipoise” in convalescences at home. And the ly, and run the risk of introducing which there is genuine uncertainty promise of “peaceful relaxation in additional threats to validity, includ- about what to recommend. Most of the complete anonymity” may appeal to ing history and maturation. conclusions of the conference address those who want to avoid prying eyes If the current trend goes the current lack of data rather than the and uncomfortable questions. For the unchecked and the rate of cesarean need for clinical direction. Women who more adventurous, the possibility of delivery increases, more low-risk are contemplating childbirth are there- exploring another culture and envi- women will undergo surgical deliv- fore advised to discuss the risks and ronment may be seen as a bonus. ery and the outcomes for this will be benefits of vaginal and surgical delivery Moreover, the Internet has greatly more favorable. As a result, the statis- with their physicians, remembering that eased the process of getting informa- tics are likely to show decreasing chance fights on the side of the tion about far-flung hospitals, bridg- risks, and hence less of a difference prudent. I continued on page 4

Public Citizen’s Health Research Group N Health Letter N 3 MEDICAL TOURISM, from page 3 2. Insurance coverage may be and consultation. ing distances and making the exotic spotty. While is it mostly the unin- deceptively familiar. Some businesses sured who seek health services 4. Problems of communication specialize in orchestrating both the outside the United States, some may arise. Many medical errors travel and medical arrangements, insured individuals may also opt to are the result of poor communica- easing the process by providing undergo elective surgery abroad. tion. Misunderstandings and gaps Destination Program Managers In the latter case, it is important for in information often occur when a (DPM) to help the patient navigate consumers to verify beforehand provider speaking medical jargon the new system upon arrival in the that they will be covered or reim- is face-to-face with a nervous new setting. “All you really need is an bursed for expenses incurred patient. Adding linguistic, cultural, air ticket!” pledges one enterprising abroad. Each insurance plan has and class barriers to the mix company. specific requirements governing further complicates the situation. Nevertheless, there are a number coverage. Aetna, for example, Additionally, religious and gender of factors to which the potential covers routine care outside the nuances and taboos may increase consumer should be alert. While U.S., but only for certain benefici- the probability of missed cues or seemingly ancillary to medical care, aries: those not in closed-panel misconstrued messages. they can greatly influence, if not HMOs. In most cases, insurers determine, the efficacy of treatment exclude cosmetic and other elec- 5. An adequate support network and the success of the experience. tive surgery. In addition, even will most likely be missing. Most when care is covered by insur- patients require help during conva- 1. Travel may be contraindicated. ance, there may be other hurdles lescence. In the event of a prolonged Unless the patient is getting an to coverage. For example, pre- recovery, the patient/tourist may feel elective procedure (which may certification may be required. In stranded with limited help. There is very well be unneeded and risky), addition, some insurers cover no “mustering the troops” when the he or she may have a condition complicated transplant procedures patient is alone or has a single that is exacerbated by airplane only if these are performed in companion. There are occasions travel. A 10-hour plane trip can be specific medical centers that meet when the familiar is comforting and stressful, and being strapped in a established quality standards and broader resources may be needed. seat confined to a small space, other criteria for care. As incen- Illness can be isolating, and a foreign with limited mobility, for a long tives for patients to choose these environment can only make a diffi- time may trigger deep-vein throm- “centers of excellence,” some cult situation more onerous. bosis (DVT), more commonly insurers may offer travel and lodg- called “coach class syndrome.” ing reimbursement. Patients 6. “Alternative” treatments may This rare but possibly lethal condi- should read the small print and get not be the right alternative. tion is a risk of long-distance trav- information in writing before Some countries attract patients el. The combination of immobility, making a final decision concerning seeking treatments that are dehydration, and seat pressure on where to get care. routinely performed elsewhere but veins at or below the knees are not approved in the United increase the risk of blot clot forma- 3. Continuity of care can be States (e.g., robot-assisted joint tion and hence of a pulmonary compromised. In-hospital service replacement). Whatever the defi- embolism. Undiagnosed in 80 represents a small part of the ciencies of the current U.S. regula- percent of cases, DVT is neverthe- continuum of care. Longitudinal tory systems, they are designed to less associated with a wide range responsibility for a patient’s care limit procedures to those that meet of risk factors, including varicose fosters accountability and reciproc- standards of safety and efficacy. veins, pregnancy, recent surgery, ity on the part of both patients and More likely than not, there are autoimmune disorders, Type A providers. Even if the patient valid reasons for not approving blood, cancer/chemotherapy, clot- remains in the country following certain therapies. ting disorder, congestive heart fail- treatment, long-term follow-up ure, elevated cholesterol, inflam- may be difficult. While proximity 7. “Natural” does not mean “safe.” matory bowel disease, and is neither necessary nor sufficient Most toxic substances are found in elevated platelet counts. As a for continuity of care, it certainly nature; that does not make them result, many potential medical facilitates it. Patients traveling for a any less dangerous. Patients equat- travelers may be unwittingly plac- procedure should take their ing “natural” with “harmless” run ing themselves at risk and possibly medical records, including test the risk of taking products that worsening the condition for which results and x-rays. In addition, may have intrinsic adverse effects they are seeking care in the first they should inform their providers or cause bad reactions when taken place. at home of their plans in order to with other drugs and medications. ensure easy access to medical data continued on page 5

4 N September 2006 The “Ultimate Prize” for Big Tobacco: Opening the Chinese Cigarette Market by Cigarette Smuggling

The following article was written by percent), and 3.8 percent of Chinese smoking statistics is like trying to think Thomas E. Novotny, a Professor in women, are smokers, giving a total of about the limits of space”. Residence at the Department of 350 million smokers in China, with China has been a member of the Epidemiology and Biostatistics at the more on the way. Young Chinese World Trade Organization since 2001, University of California, San Francisco, women are likely to be an important and this membership may reduce in California. It originally appeared in target group for growth for Big barriers to market entry through the Public Library of Science (PLoS), a Tobacco. lowered tariffs on imports by transna- , web-accessible journal on science According to a 1998 survey, among tional tobacco companies (TTCs). and medicine (www.plos.org). Chinese adolescents aged 11–20 years, Thus, it is important to understand almost half (47.8 percent) of the boys how these markets will be entered by The Prize and 12.8 percent of the girls surveyed the TTCs, as market entry also means China has long been identified as were experimenting with tobacco. globalizing the imagery, advertising, the most important international ciga- This survey would surely warm the and health effects of smoking. Market rette market, now and in the future cold heart of any multinational tobac- entry into China also means that with — O’Sullivan and Chapman called co company executive. Robert greatly increased numbers of smok- China the “ultimate prize” among the Fletcher, regional public affairs manag- ers, the burden of non-communicable world’s emerging tobacco markets. er for the tobacco company Rothman, diseases attributable to smoking will Almost two-thirds of Chinese men (63 said that “thinking about Chinese continued on page 9

MEDICAL TOURISM, from page 4 and water, noise, and sanitary condi- natory prices that would not be Moreover, even some seemingly tions outside the premises may affect acceptable in the United States. For innocuous products may be the salubriousness of the environ- example, one company in the health combined with other ingredients ment. Similarly, a blood transfusion travel business advises potential that are potentially toxic. One can be either a life-saver or a major clients that the charge for a particular study of Ayurvedic medications threat, depending on how the blood surgical procedure may be 30 published in 2004 found that, of 70 supply is screened and managed. percent more than the regular rate if over-the-counter remedies, 14 (20 There are a number of blood-borne the patient is HIV positive. percent) contained mercury, lead, diseases, and many countries lack or arsenic at levels that could be adequate means for their surveil- 11. There may be no legal harmful. lance and prevention. According to a recourse if needed. In the event World Health Organization study, 11 of an adverse effect, resorting to a 8. Travel ‘frills’ can eclipse medical percent to 21 percent of cities legal process may be difficult or care. Patients are well-advised to surveyed had inadequate screening simply not available. Some coun- separate their medical requirements of blood donations for the infectious tries have malpractice laws that from other aspects of the health trav- agents associated with malaria, HIV, limit damage awards, thereby el “package.” If you want cosmetic and hepatitis. protecting physicians and hospitals surgery and are convinced that from litigation. Argentina is the best place for you, 10. The “rules of the game” may be your decision should not be contin- quite different. The Centers for Summing up gent on whether or not the package Disease Control warns that systems U.S. consumers may be well advised includes the services of “a personal outside the United States may oper- to separate their medical needs from assistant who will help direct you to ate differently from those in the U.S. their vacations. The lower cost of care ...Señor Tango, one of the hottest and are not subject to the same rules abroad, however important a motivator, tango halls in Buenos Aires.” and regulations. Procedures regard- has to be weighed against other intan- ing informed consent, advanced gibles that can make the difference 9. Environmental conditions may directives, and guardianship, for between success and failure in health not be equal to those of more example, may not be in place. outcomes. I developed countries. Even if the Similarly, hospitals and other health hospital is impeccable, quality of air care facilities may maintain discrimi-

Public Citizen’s Health Research Group N Health Letter N 5 Product Recalls July 19, 2006 — August 21, 2006 his chart includes recalls from the Food and Drug Administration (FDA) Enforcement Report for drugs and dietary Tsupplements, and Consumer Product Safety Commission (CPSC) recalls of consumer products.

DRUGS AND DIETARY SUPPLEMENTS

The recalls noted here reflect actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by FDA request or by FDA order under statutory authority. If you have any of the drugs noted here, label them “Do Not Use” and put them in a secure place until you can return them to the place of purchase for a full refund. You can also contact the manufacturer. If you want to report an adverse drug reaction to the FDA, call (800) FDA-1088. The FDA Web site is www.fda.gov. Visit www.recalls.gov for information about FDA recalls and recalls issued by other government agencies.

CLASS I — Recalls and Field Corrections Indicates a problem that may cause serious injury or death

Name of Drug or Supplement; Problem; Recall Information

Tacrolimus Bulk Powder; Subpotent. Lots TA1210 pack letters (Batch 20051129), & VB0031 pack letter A-B (Batch 20051129), A-F (Batch 031002); Lots UD1060 pack letter A (Batch 20050323), Spectrum Laboratory Products Inc. UF0298 pack letter A-B (Batch 20050323), UL0964 pack letter A

CLASS II — Recalls and Field Corrections Indicates a problem that may cause temporary or reversible health effects; unlikely to cause serious injury or death

Name of Drug or Supplement; Problem; Recall Information

Comfort Shield Personal Cleansing Perineal Care Fexofenadine Hydrochloride, 60 mg tablets; Packaging mixup- Washcloths, Dimethicone 3%; Microbial contamination; The outer packaging is labeled as Fexofenadine Hydrochloride 60 mg Burkholderia cepacia. Reorder #7503 - Lot 1999; reorder #7503-M - tablets, but the unit dose blister strips inside the box may contain and Lots 1702 and 1995; reorder #7403 - Lots 1301, 1312, 1457, 1651 be labeled Hydralazine Hydrochloride, 100 mg. tablets. Lot and 1677; reorder #7408 - Lot 1848; reorder #7905 - Lot 1766; K43240R30, exp. date 12/12/2006, Lot K43240R25, exp. date reorder #7524 - Lots 2070 and 2086, Sage Products, Inc. 12/12/2006, Heartland Repack Services LLC.

Extra Strength Super Troche DM, 15 mg Benzocaine and 10 mg Cilostazol, 100 mg tablets; Packaging mixup; The outer package is Dextromethorphan HBr; Drug Facts label on back of the bottle does not labeled as Cilostazol, 100 mg tablets, but the unit dose strips inside list Dextromethorphan HBr as an active ingredient and lacks the warn- the outer packaging may contain and be labeled as Benztropine ing not to use the product if taking a monoamine oxidase inhibitor. Lot Mesylate, 0.5 mg tablets. Lot K43243R30, exp. date 12/132006, Lot 06039A1, exp. date 07/2008, Weeks & Leo Co., Inc. K43242R25, exp. date12/13/2006, Heartland Repack Services LLC.

FDG F-18 Fluorodeoxyglucose Injection, 20 mCi/mL; Flumazenil Injection, 1 mg/10 mL (0.1 mg/mL); Mispackaging: Pharmaceutical for injection was out of specification for endotoxin Some of the boxes of Flumazenil Injection may contain vials of levels. Lot 140718061, exp. date 7/18/2006, Cardinal Health Inc. Levothyroxine Sodium for Injection. Lot 200324, exp. date 04/2007, Abraxis Pharmaceutical Products.

Hydralazine Hydrochloride, 100 mg tablets; Packaging mix-up- The outer packaging is labeled as Hydralazine Hydrochloride, 100 mg tablets, but the unit dose blister strips inside the outer packaging may contain and be labeled as Benztropine Mesylate, 0.5 mg tablets. Lot K43263R30, exp. date12/13/2006, Lot K43263R25, exp. date 12/13/2006, Heartland Repack Services LLC.

6 N September 2006 DRUGS AND DIETARY SUPPLEMENTS cont.

CLASS II — Recalls and Field Corrections cont’d. Name of Drug or Supplement; Problem; Recall Information

Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 125 mcg Triphasil, Packages of 3 Dial Packs; Presence of Foreign Substance; (0.125 mg), 137 mcg (0.137 mg), 200 mcg (0.2 mg); Subpotent. Lot phenol. Lots: A36954, A36955, A63687, A67660, A67664, A67671, C04T1921A / 04T14200 / 04T14210; Lot C05T0441A / 05T1130 / A67680, A86544, A88644, A92651, A93846, A97336, A97337, 05T1140, Lot C05T0111A2 (05T7060), Lot C05T0471A / 05T2250 / B15552, B22428, B24181, B31843, B32893, B40792, and B47404, 05T2260; Lot C05T0221A4 / 05T7140, Lot C05T0701A3 / 05T2960, Wyeth Pharmaceuticals. Lot C05T0711A / 05T3010; Lot C05T0131A2 (05T7330), Lot C05T0801A2 (05T11190), Lot C05T0721A / 05T3070 / 05T3080 / 05T3090, Lot 05T3051A, Lot 05T3061A, Lot 05T3101A, Lot 05T3111A, Lot 05T3201A, Mova Pharmaceutical Corp.

Lorazepam Tablets, 2 mg; Lorazepam 1 mg tablets packaged and Zosyn for Injection (Piperacillin and Tazobactam for Injection), 2.25 distributed as Lorazepam 2 mg tablets. Lot 452E0622, exp. date gram, 3.375 gram, 4.5 gram; Lack of Assurance of Sterility; possible 4/30/2007, Sandoz, Inc. damage to the breakaway cap. Multiple lots, Wyeth Pharmaceuticals.

Synthroid Tablets, (levothyroxine sodium tablets, USP, 25 mcg (0.025 mg), 200 mcg (0.2 mg), 100 tablet; Failed Impurity Specification. Lot 0000354304 exp. date 09/2006, Lot 0000354314 exp. date 09/2006, Abbott Laboratories.

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 information from the Consumer Product Safety Commission, call their hotline at (800) 638-2772. The CPSC web site is www.cpsc.gov. Visit www.recalls.gov for information about FDA recalls and recalls issued by other government agencies.

Name of Product; Problem; Manufacturer and Contact Information

All-Terrain Vehicles. The mounting brackets used to secure the Children’s Lamp. The Hampton Bay® Transitional Collection Fire left-front suspension arm to the Suzuki 2006 Model Year Eiger ATV’s Truck and Bulldozer Accent Lamp with Night Lights have a red toy fire frame may not have been welded completely and could break off truck or yellow toy bulldozer base that sits on a 6-inch wide by 9.75- during riding. If this occurs the rider could lose control of the ATV and inch long hand-painted wood base. SKU No. 167-367 is printed on the crash, posing a risk of serious injury or death. American Suzuki Motor bottom of the base of the fire truck lamp and SKU No. 167-939 is Corp., (800) 444-5077 or www.suzukicycles.com. printed on the bottom of the bulldozer lamp. The fire truck and bulldozer have glass windows. The overall assembled dimensions are about 12 inches wide by 20.5 high. “Made in China” is printed on the bottom of the lamps. Hampton Bay® is printed on the box only. Emess Design Group LLC, (800) 678-2579 or www.emessdesign.com.

Cage Bell Instruments. If the bell inside the Cage Bell Musical Coffeemakers. The Bunn® home coffeemaker’s plastic pour-in bowl Instrument for Babies is damaged during manufacturing, the bell can and lid can melt or ignite due to an electrical failure, posing burn and be pulled out of the instrument, posing a choking hazard. Kindermusik fire hazards to consumers. Bunn-O-Matic Corp., (800) 385-2652 or International Inc., (800) 628-5687 or [email protected]. www.regcen.com/bunnrecall.

Children’s Cooking Sets. The glass pot lids can break, posing a Computer Batteries. Dell-branded lithium-ion batteries made with laceration hazard to children. Panline USA Inc., (800) 666-2539 or cells manufactured by Sony can overheat, posing a fire hazard to [email protected]. consumers. Dell Inc., (866) 342-0011 or www.dellbatteryprogram.com.

continued on page 8

Public Citizen’s Health Research Group N Health Letter N 7 CONSUMER PRODUCTS cont.

Name of Product; Problem; Manufacturer and Contact Information

Counterfeit Extension Cords. The 6-foot Power Xtension Folding Picnic Tables. The legs on the Folding Picnic Tables can counterfeit extension cords could have undersized wire and buckle or break during use, causing the table to collapse or fold substandard insulation, which can cause overheating, resulting in a unexpectedly. Atico International USA Inc., (877) 546-4835 or possible shock hazard. Greenbrier International Inc., (800) 876-8077 www.aticousa.com. or www.dollartree.com.

Dimming Ballasts. Tu-Wire® ballasts used with dimmable compact Fun Express Children’s Toys. The paint on the Fun Express fluorescent lights, if not properly grounded in accordance with the Bendable Dog and Cat Toys contains excessive levels of lead, which is National Electrical Code, can present a risk of electric shock to banned under federal law. Lead is toxic and if ingested by young persons who come in contact with the ballast or with a light fixture that children can cause adverse health effects. Fun Express Inc., a incorporates the ballast, such as when a consumer changes a subsidiary of Oriental Trading Company Inc., (800) 723-6155 or fluorescent lamp bulb. Lutron Electronics Co. Inc., (866) 793-4270 or www.funexpress.com. www.lutron.com.

Electric Hair Dryers. “Monica” and “Turbo 1200” Hand-Held Hair Gas Controls. Robertshaw FS Flame Switches and FM Automatic Dryers are not equipped with an immersion protection plug to prevent Safety Valves (installed in commercial cooking appliances) are electrocution if the hair dryer falls into water. Such electric shock designed to prevent gas from flowing when the pilot light is out. The protection devices are required by industry standards for all electric recalled controls can remain on after the pilot light is extinguished. If hand-held hair dryers. Style Tronics Inc., (888) 266-9272 or this happens, gas can continue to flow to the burner of the www.styletronic.net. appliance, which poses a risk of a gas explosion and fire. Robertshaw Controls Co., (800) 232-9389 or www.robertshaw.com.

Electric Lawnmowers. An electrical component in the Black & Glass Candleholders. The glue connecting the Clear Glass Decker and Craftsman Brand Cordless Electric Lawnmowers can Candleholders could fail causing the candleholder to fall apart. This overheat, posing a fire hazard. Black & Decker (U.S.) Inc., poses a fire and laceration hazard to consumers. Meijer, (866) 229-5570 or www.blackanddecker.com. (866) 280-8419 or www.Meijer.com.

ElectroPlasma Lamps. Arcing between an object and the removable Hooded Sweatshirts. A drawstring of Hide & Seek Hooded Sweatshirts cover of the Mars Lightning ElectroPlasma Lamps can pose a fire hazard. is threaded through the hood, posing a strangulation hazard to children. Spencer Gifts LLC, (800) 762-0419 or www.spencersonline.com. In February 1996, CPSC issued guidelines to help prevent children from strangling or getting entangled on the neck and waist by drawstrings in upper garments, such as jackets and sweatshirts. Quiksilver Inc., (877) 246-7257 or [email protected]. Engines. The plastic fuel tanks of Generac GTH410 and GTH220 Engines with Plastic Fuel Tanks can leak. If an ignition source is Lamps. The lamp’s electrical circuit board can spark and overheat due present, a fire or explosion can occur. Generac Power Systems Inc., to an electrical problem, posing a fire hazard to consumers. J.C. (800) 320-1143 or www.generac.com. Penney Corporation Inc., (888) 333-6063 or www.jcpenney.com.

Floor Stripper. 5-gallon sizes of “Zep Industrial Purple Cleaner & Light Fixtures. The reflector/trim pieces of Gotham 8-inch Degreaser,” and “Zep Heavy Duty Floor Stripper” can unexpectedly APR/APRH Down Lighting Fixtures may not be properly attached to crack and leak from the base, posing a risk to consumers due to the each other. The lower portion of the reflector/trim assembly could corrosive nature of these products. Acuity Specialty Products Group detach and fall from the ceiling striking consumers. Gotham Inc., a subsidiary of Acuity Brands Inc., (888) 591-5053 or Architectural Lighting division of Acuity Lighting Group Inc., www.zeprecall.com. (800) 315-4982 or www.gothamlighting.com.

Folding Chair Beds. Fingers can become caught in the folding Light-Up Backpacks. The Cool Blue Backpack’s battery pack can mechanism of the LYCKSELE Chair Bed and Sofa Bed, posing a overheat causing the battery case to melt, presenting a burn hazard if laceration and/or amputation hazard. IKEA Home Furnishings, touched. Lands’ End, (800) 200-6212. (888) 966-4532 or www.ikea-usa.com.

8 N September 2006 CONSUMER PRODUCTS cont.

Name of Product; Problem; Manufacturer and Contact Information

Lounge Pants. Quiksilver and Roxy Girl lounge pants fail to meet the Suunto Dive Computers. Suunto D9 and D6 Model Wristop Dive children’s sleepwear flammability standards, posing a risk of burn Computers could incorrectly track dive time, which could cause injury to children, due to the possible ignition of the garment. These incorrect calculation of decompression requirements. This could lead garments were not labeled or marketed as sleepwear, but because they to decompression sickness. Suunto Oy, (800) 543-9124 or are children’s loungewear, they must meet the children’s sleepwear [email protected]. flammability standards. Quiksilver Inc., (800) 576-4004 or [email protected].

Plastic Hardware Covers. The small cam lock of Homeroom Table Height Chairs and Bar Stools. The down shaft on the seat Bedroom Collection hardware covers on children’s furniture can be plate assembly of Frameworx Table Height Chairs and Bar Stools can easily removed, presenting a choking hazard to young children. Hold fracture, which can cause an occupant of the seat to fall. Brunswick Everything, (800) 840-2849. Bowling & Billiards Corp., (800) 937-2695.

Potted Candles. The packaging or holder of Toulon Potted Candles Utility Tractors. The seat bracket to which the seat belt of John can ignite, posing a fire hazard to consumers. Ballard Designs Inc., Deere 3000 Twenty Series and 4000 Twenty Series Open Station (800) 367-2810 or www.ballarddesigns.com. Compact Utility Tractors is attached could have been positioned incorrectly during the manufacturing process resulting in a poor weld. In a tractor roll over, the weight of the operator could cause the bracket to break off of the seat’s pivot plate. Deere & Co., of Moline, (800) 537-8233 or www.deere.com.

Scooters. The handlebars, wheels and wheel brakes of Firestreet Weed Trimmers. The blade of the Troy-Bilt 4-Cycle Gasoline String Scooters can break and detach, causing the rider to lose control, fall Trimmers that trims the excess string of these weed trimmers can and possibly suffer injuries. Triple Win Sports, (800) 440-0680 or detach from the plastic shield covering the trimmer head. The blade www.target.com. can be thrown outward, hitting the user or bystander, resulting in a laceration. MTD Southwest Inc., (888) 848-6038 or www.troybilt.com. Snowthrowers. The plastic fuel tank of Toro Snow Commander and CCR Single Stage Snowthrowers can crack and leak gasoline, posing a risk of fire and injury. The Toro Company, (800) 689-8671 or www.toro.com.

Speed Buckle Harnesses. The Speed Buckle Harnesses could be threaded incorrectly. If threaded incorrectly, the webbing will easily slip when loaded. Incorrectly threaded buckles can loosen, which could cause climbers to slip out of the harness and fall. Black Diamond Equipment Ltd., (801) 278-5533 or www.blackdiamondequipment.com/.

CIGARETTE SMUGGLING, from page 5 smuggling problem. Framework Convention on Tobacco explode, affecting China’s transitional Smuggling of into China is Control (FCTC), on October 11, 2005. healthcare system and its economic an especially critical issue in light of This treaty will have as one of its major stability. China’s desire both to open trade areas of focus the control of global ciga- through membership in the World rette smuggling. Although the United Smuggling as a Marketing Tool Trade Organization and to participate States has not ratified the FCTC, it may TTCs have used cigarette smug- more fully as a global partner in health. join in a protocol that addresses smug- gling as a market-opening tool With the 2002 SARS epidemic and the gling. At present, one-quarter of total throughout recent history (such as in potential avian flu pandemic serving as global cigarette exports are illegally Latin America and the former Soviet grim reminders of the need for interna- traded. This illegal trade is a big, multi- Union). Now, in an important new tional collaboration in health, China national problem, and multinational study published in PLoS Medicine, now participates more openly in other efforts are needed to control it; in addi- Lee and Collin document evidence health agreements. Specifically, China tion, there is still insufficient scholarly that (BAT) ratified the World Health Organization’s research on this problem. has exploited China’s large cigarette first ever global health treaty, the continued on page 10

Public Citizen’s Health Research Group N Health Letter N 9 CIGARETTE SMUGGLING, from page 9 exports and enforce customs regula- Getting Inside Information tions. There are three major reasons Lee and Collin used BAT docu- why it is crucial to stop tobacco ments from the Guildford Depository “Thinking about smuggling: (1) the profits from smug- in the United Kingdom. These docu- gling fuel TTCs’ efforts to buy politi- ments were made public as a result Chinese smoking cal influence and maintain economic of legal actions against the TTCs. The strength across non-tobacco sectors; terms of a legal settlement in statistics is like trying (2) smuggling leads to countries Minnesota, United States, stipulated losing tariff revenue from the legal that the public should be allowed, for to think about the trade of cigarettes; and, most impor- ten years, access to documents tantly, (3) the health of target groups produced during litigation against the limits of space”. such as young Chinese women will , via the creation of — Robert Fletcher, suffer immeasurably unless the FCTC two depositories, one in Minnesota is effective in reducing TTC market and one in Guildford. regional public affairs manager success. Document research is of specific for the tobacco company Rothman Much can be done to combat value in examining the smuggling smuggling as a tool of the TTCs, issue, since data on smuggling are not including implementing more aggres- easily found in other public sources. sive litigation to assure corporate The authors found suggestions of liability, pursuing anti-money-laun- large-scale smuggling of foreign ciga- show evidence of BAT’s efforts to build dering actions to remove the influ- rettes into China to circumvent barriers market presence in competition with ence of organized crime, improving to market access. By triangulating offi- other popular brands, using whatever it cigarette tracking systems, and strictly cial documents on legal imports subject takes to succeed in the new market, enforcing recordkeeping of ship- to tariffs, reported imports by all TTCs, including smuggling. ments and receipts by TTCs. There and BAT sales figures in China, they must be binding obligations to carry found significant discrepancies What Must Be Done out such anti-smuggling activities, between what was reported and what The FCTC came into force on enforced through a multinational was sold. The sales reported in internal February 27, 2005. The signatory protocol of the FCTC, not voluntary company documents made China one member states now have the best- compliance as proposed by the TTCs. of the larger profit centers for BAT ever opportunity to shut down the The world is a global marketplace, Industries, with 25 percent of profits pipeline of smuggled tobacco prod- and global problems such as cigarette coming from “transit” trade to China, a ucts and the associated illicit profits smuggling need global solutions as code word for smuggled cigarettes. for BAT and other TTCs through put forth in the FCTC. I Moreover, the Guildford documents multinational efforts to better track

OUTRAGE, from page 12 to halt the production of melanin and and audiovisual media. They create woman’s skin color on her marketabil- to bring out “natural” beauty. hype about their product. Many leading ity to marriage partners. Promoting a particular body image manufacturers have expanded their The craze for modern fairness or behavior pattern as the preferred range to include lotions, cold creams, creams has emerged in the last 50 one and then selling medicines or and soaps. years. International cosmetics giants products to help people attain the Most fairness creams are nonpre- were the initial manufacturers, but particular ideal may be regarded as scription products, and the medical these days Indian and South Asian disease mongering. Fairness cream profession may not be the main target companies are playing an important manufacturers have exploited the of marketing professionals. However, role in the skin bleaching and cosmet- preference for fair skin, portrayed it doctors as responsible and respected ic markets. Fairness creams have been as a necessary prerequisite for members of society have an impor- estimated to account for up to 40 success, and promoted the use of tant role to play in spreading aware- percent of the profits of the cosmetics their product to achieve the ideal. ness about this racial distortion of industry. Recently, a fairness cream has Controlled studies on the efficacy and body image. Fairness creams may been launched exclusively for men. safety of fairness creams are lacking. satisfy many of the criteria of disease Advertisements aim to produce a Disease mongering companies form mongering. The issues of freedom of hierarchy of values based on the alliances with doctors, consumer choice, economic impact (personal notion that “fairness” is an object of groups, and the media to promote sales and on the society), profits, social desire. Being fair has been represent- of their drugs. Fairness cream manufac- issues, and ideal body image should ed as an active process. Regular use turers sponsor beauty pageants and be seriously debated. I of fairness creams has been claimed carry out an advertising blitz in the print

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Public Citizen’s Health Research Group N Health Letter N 11 OUTRAGE OF THE MONTH Fairness Creams in South Asia — A Case of Disease Mongering?

The following article, written by three researchers, Ravi Shankar, Bishnu Rath Giri, and Subish Palaian, from Manipal College of Medical Fairness cream manufacturers have exploited the Sciences in Pokhara, Nepal, continues our discussion of disease mongering. It preference for fair skin, portrayed it as a necessary is reprinted from the Public Library of Science (PLoS), a free, web-accessable prerequisite for success, and promoted the use of journal on science and medicine (www.plos.org). their product to achieve the ideal.

e read with interest the article by Moynihan and WHenry on disease monger- been exploited by the manufacturers extraordinarily tall and breathtakingly ing. The authors argued that disease of “fairness creams.” “White” skin has a slim, have light honey-colored skin, mongering is the opportunistic colonial connotation of power and and peddle Western ideals of beauty. exploitation of a widespread anxiety superiority. The emergence of a South Asian culture has carried within about frailty and of faith in scientific “paler” global entertainment industry itself a capacity for female objectifica- advance and “innovation.” has served as a fillip to the marketing tion. Matrimonial columns and Web In South Asia there is a widespread of an international beauty ideal. sites reveal the influence of a young Beauty pageant winners in India are all

preference for “fair skin” and this has continued on page 10

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