PUBLIC CITIZEN HEALTH RESEARCH GROUP
The Pharmaceutical Industry To Whom Is It Accountable?
be following editorial is ans and Canadians for the same drug. who play out their prescriptions for as reprinted from the New Prices also vary widely within the United long as possible by taking reduced doses, T England Journal of Medicine States, where-perversely-they are or who share drugs with their spouses, with theirpermission from theirjune highest for those in greatest need and or who simply do without, choosing 22, 2000 issue. Copyright © 2000 least able to pay. Medicare redpients food and heat over drugs. Massachusetts Medical Society. All with no supplementary insurance pay The media have recently highlighted rights reseroed. It was written by the on average twice as much for the 10 another inequity in drug access--the former Editor-In-Chief of the publi most commonly prescribed drugs as do inability of people in the underdevel cation Marcia Angell, M.D. favored customers, such as large HMOs oped world to obtain the drugs they and the Veterans Affairs System. For desperately need. Some underdevel The pharmaceutical industry is under example, a month's supply of Zocor oped countries, overwhelmed by the mounting scrutiny because of rapidly (simvastatin) was reported last year to human immunodefidency virus (HIV) increasing expenditures for drugs in the be priced at $103.87 for Medicare redpi epidemic and unable to afford brand United States. Drug expenditures are ents, as compared with $42.95 for fa name antiretroviral agents, have sought now the fastest growing component of vored customers. Chronically ill, older exceptions to patent protections, so that health care costs, increasing at the rate of Americans may thus be hit with annual they can manufacture or import generic about 15 percent per year. They account drug costs of many thousands of dol drugs. The pharmaceutical industry, with for about 8 percent of health care spend lars--sums they simply cannot pay. There the support of the U.S. government, has ing, and at their current rate of increase, are frequent stories of older Americans fought these efforts. The industry has they will soon surpass spending for physidans' services and, for many health <: () N T E N T S maintenance organizations (HMOs), the costs of hospitalization. The increase is Hundreds ofThousands ofWorkers at Risk from Hexavalent due both to a greater use of drugs and to Chromium, Study Obtained Through FOIA Shows higher prices for individual drugs. Pa Health Research Group released this important information with tients feel drug costs keenly, because Erin Brokovitch at a press conference last month ...... 4 they pay much of them out of pocket. Product Recalls june 8-]uly 12,2000 Many private insurers tightly limit drug Aerosals and Bicycle Helmets are on our list this month...... 5 coverage, and Medicare does not cover outpatient drugs at all. Report Estimates Air Lead Levels From Some Candle Wicks at The President and members of Con Up to 36 Times EPA Standards gress on both sides of the aisle are Health Research Group repeats demands to ban these dangerous considering adding some sort of drug products ...... 8 benefit to Medicare. Discussions of this The Risks of Tranquility issue have drawn attention not only to Find out how to protect yourself from dangerous tranquilizers ...... 9 the acceleration in drug expenditures, but also to the apparent capridousness Outrage Of The Month: Erroneous and Misleading Reports In MedJa About Prescription Drugs of drug pridng and other practices of the A medical journal study shows TV newspapers are not necessarily phannaceutical industry. Americans regu a good source of information on drugs ...... 12 larly pay up to twice as much as Europe-
VISIT HEALTH RESEARCH GROlJP'S WEB SITE AT WWW.CITIZEN.ORG/HRG/ also been notably uninterested in devel the introduction of many new drugs that only later, when the research shows oping drugs to treat tropical diseases have changed the face of medicine and practical promise, that the drug compa that afflict millions of people with low improved the lives of millions. (Whether nies become involved. The industry also purchasing power. A recent story in the they have resulted in net savings from enjoys great tax advantages. Not only New York Times described the reluc averted hospitalizations is far less clear.) are its research and development costs tance of manufacturers to maintain pro But much of the case for the pharmaceu deductible, but so are its massive mar duction of drugs to treat trypanosomiasis tical industry is exaggerated or mislead keting expenses. The average tax rate of in Africa. According to a spokesman for ing, and some of it is simply false. Let's major U.S. industries from 1993 to 1996 one of the drug companies, "The indus look at the argument more closely. was 27.3 percent of revenues. During try has never been philanthropic. It has How risky is the pharmaceutical busi the same period the pharmaceutical always produced products with an aim ness? For a small company pinning industry was reportedly taxed at a rate of to getting a return on investment." everything on a few products, it may be only 16.2 percent. Most important, the How do the drug companies respond immensely risky. But that is not the case drug companies enjoy 17-year govern to these aitidsrns? First, they point out that for the large drug companies that domi ment-granted monopolies on their new the American pharmaceutical industry has, nate the market. True, their research and . drugs-that is, patent protection. Once over the past two decades, produced development costs are high, as com a drug is patented, no one else.may sell remarkably effective drugs-drugs that pared with those of other industries. The it, and the drug company is free to notonlyextendlifeandimproveitsquality, top 10 drug companies are reported to charge whatever the traffic will bear. but also save money by holding chronic spend on average about 20 percent of Is it correct that the U.S. pharmaceutical diseases at bay and averting hospitaliza their revenues on research and develop industry is highly innovative? Only partly. tions. High prices, according to this view, ment. (Many critics charge that market Some recently launched drugs do indeed simply reflect high value. As for the fact that ing and promotional costs are fill important, previously unmet medical Americans pay more for the same drugs misleadingly included in this figure.) But needs. But it is hard to escape the conclu than people in other countries, the industry the pharmaceutical giants have so many sion that many other new drugs add little maintains that it needs to make up for the drugs in the pipeline at any given time to the therapeutic armamentarium except depressed prices in countries that impose that they can count on being able to expense and confusion Consider the wel price controls. Similarly, it is argued that bring a certain number of drugs to ter of very similar drugs to lower choles differential pricing within the United States market regularly. terol levels. Developing genuinely is justified by the need to offset the steep It is instructive to compare the research innovative drugs is difficult and chancy. It discounts demanded by high-volume pur and development costs of the large drug is easier to make "me-too" drugs or minor chasers ofdrugs . Supporters say that some companies with their profits. The top 10 variants of established products. To be one needs to pay prices high enough to drug companies are reported to have profitable, the variation need only be attract the investment necessary to sustain profits averaging about 30 percent of rev sufficient to serure a new patent, and the the industry's extraordinary research and enues---Q stunning margin. Over the past rest is marketing. Critics believe drug com development costs. They frequently re few years, the pharmaceutical industry as panies are doing far too much of that sort mind cities that for every drug brought to a whole has been by far the most profitable of thing. They also charge that many market, there are innumerable false starts industry in the United States. According to industry-sponsored clinical trials are de drugs that never make it Prices reflect the a recent issue of Fortune, in 1999 the signed more to find small advantages that development costs of not just a particular pharmaceutical industry realized on aver can be highlighted in promotional cam drug, but all the potential drugs that enter age an 18.6 percent return on revenues. paigns than to fmd clinically meaningful the pipeline. Commercial banking was second, at 15.8 effects. In sum, the industry contends that it percent, and other industries ranged from The industry has certainly been inge leads the world in innovative drug de 0.5 to 12.1 percent An industry whose nious in finding ways to extend patents velopment because it functions in a free profits outstrip not only those of every on its best-selling drugs. For example, a market where returns can be commen other industry in the United States, but recent Wall Street journal article de surate with the very great risks. Yes, often its own research and development scribes a complicated business deal be drug coverage should be extended to costs, simply cannot be considered very tween Merck and Schering-Plough for everyone, but not at the cost of price risky. the marketing of two new drug combi controls or other government interfer What about the picture of the drug nations, one to lower serum lipid levels ence that would stifle innovation. (That industry as an exemplar of the free and the other to relieve allergies. Each is why the industry opposes a Medicare market? That image is very far from the combination will pair one company's drug benefit unless it is administered truth. On the contrary, the pharmaceu "blockbuster'' drug, whose patent as a through the private sector.) tical industry enjoys extraordinary gov single product will soon expire, with a The case for the pharmaceutical in ernment protections and subsidies. Much drug with supplementary action owned dustry sounds reasonable, but is it valid? of the early basic research that may lead by the other company. The combination Some of it undoubtedly is. There is no to drug development is funded by the drugs will have new patents, and their question that the past 20 years have seen National Institutes of Health. It is usually profits will be shared by both compa-
2 +August 2000 nies. This may be good business, but the bringing them to market. lbis is clearly accordingly have more influence. The medical soundness of fixed drug combi a job for the private sector. But, in my panel should consist of distinguished nations as opposed to flexible combina view, an industry so important to the experts with no stake in the pharmaceu tions of separate drugs is debatable. public health and so heavily subsidized tical industry. Although its recommen The marketing budgets of the drug and protected by the government has dations would not be binding, they industry are enormous-much larger social responsibilities that should not be would stimulate and inform a public than the research and development so totally overshadowed by its drive for debate that would lead to reforms. costs--although exact figures are diffi profits. There needs to be a better bal Among the most important questions cult to come by, in part because market ance between the interests of the share belonging on the panel's agenda should ing and administrative expenses are holders and those of the public. be whether some form of price controls often folded together and in part be This is not the place to propose detailed is desirable, and if so, how it might be cause some of the research and devel reforms that might right the balance. My implemented. lbis is an exceedingly opment budget is for marketing research. purpose here is primarily to desaibe the difficult question that will require careful According to its annual report, Pfizer problems. Butl would like to suggest a few study and analysis, but in my opinion, spent 39.2 percent of its revenues on steps that could be taken. some method of constraining prices will marketing and administration in 1999; Congress should modify its enabling probably be needed. Just as public utili Pharmacia & Upjohn is reported to have legislation to permit the Food and Drug ties are not permitted to charge whatever spent about the same. The industry Administration to require some pre the traffic will bear, neither should drug depicts these huge expenditures as serv marketing trials to compare new drugs companies. It is hard take seriously the ing an educational function. It contends inevitable industry argument that price that doctors and the public learn about controls would stifle innovation and new and useful drugs in this way. Unfor frighten investors when profit margins tunately, many doctors do indeed rely are so great and so much revenue is on drug company representatives and The spent on marketing. · promotional materials to learn about The panelmightalsoconsiderwhether new and useful drugs, and much of the pharmaceutical some small fraction of the industry's public learns from direct-to-consumer revenues should be set aside for social advertising. But to rely on the drug industry is purposes. I believe it should. Such funds companies for unbiased evaluations of might be used to subsidize HIV treat their products makes about as much ment in sub-Saharan Africa or the pur sense as relying on beer companies to extraordinarily chase of drugs by the needy. The recent teach us about alcoholism. The conflict decision by five drug companies to cut of interest is obvious. The fact is that privileged. the price of HIV drugs in Africa was a marketing is meant to sell drugs, and the good but small start. There have been less important the drug, the more mar other generous actions by drug compa keting it takes to sell it. Important new nies, notably Merck's 1987 decision to drugs do not need much promotion. with the best available drugs, not with donate millions of doses of ivermectin to Me-too drugs do. placebos, and to make its approval treat onchocerdasis and lymphatic ftlari How about the claim that the Ameri contingent on the results of those trials. asis in underdeveloped countries. These can pharmaceutical industry is the world's In some cases, the new drug should be are examples that the rest of the industry engine for drug innovation? The United compared with both the best available might do well to emulate in an organized States accounts for 36 percent of global treatment and a placebo. Requiring way. Drug companies should also allow pharmaceutical research and develop manufacturers to demonstrate that a exceptions to patent restrictions that ment. Europe accounts for 37 percent, new drug is substantially better than currently prevent underdeveloped coun and Japan for 19 percent. The U.S. anything available would help to stem tries from manufacturing generic drugs fraction is certainly large, but not greatly the rising tide of me-too drugs. lbird for humanitarian purposes or importing disproportionate to the country's popu party payers might also link coverage to drugs from the countries where they can lation. Innovative products come from the quality and outcome of trials, as be obtained most cheaply. the pharmaceutical industries of many suggested by Ray et al. The pharmaceutical industry is extraor countries, including those that regulate To consider other reforms, I believe dinarily privileged. It benefits enormously drug prices, and most large companies we need an independent national advi from publicly funded research, govern have global markets. sory panel to study the pharmaceutical ment-granted patents, and large tax breaks, The pharmaceutical industry deserves industry's practices thoroughly and then and it reaps lavish profits. For these rea recognition for the many truly extraordi make recommendations. There have sons, and because it makes products ofvital nary drugs it has developed. Further been such panels in the past, but the importance to the public health, it should more, it is hard to imagine any other magnitude of the problems is greater be accountable not only to its shareholders, system for developing new drugs and now and a prominent panel would but also to sodety at large.
Public Citizen's Health Research Group + Health Letter + 3 Hundreds ofThousands ofWorkers at Risk from Hexavalent Chromium, Study Obtained Through FOIA Shows Erin Brockovich and Public Citizen to Criticize OSHA Inaction
ublic Citizen release. d a study groundwater contaminated with The current promise is to issue a pro in July that demonstrates more hexavalent chromium was featured in posed regulation by June 2001. The P clearly than any prior research the recent movie titled "Erin chromium industry has insisted that no that hexavalent chromium is a potent Brockovich," in which Ms. Brockovich regulation take place until the present cause of lung cancer. Lung cancer rates was played by Julia Roberts. study was published. among plant workers exposed to the "How long must the suffering con The study, to be published in the chemical in their workplaces were al tinue?" Brockovich said. "I have per August issue of the American journal most double what would have been sonally seen the suffering of ofIndustria/Medicine, included 2,357 expected among otherwise simHar in chromium-exposed people. For men who began working at a chro dividuals, according to the study, which OSHA to permit the ongoing poison mate production plant in Baltimore, was obtained through the Freedom of ing of American workers is a dis MD, between 1945 and 1974. Unlike Information Act. The study was funded grace." previous studies, it was able to adjust by the U.S. Environmental Protection Added Edward Masry, principal part for smoking status and had detailed Agency (EPA) through a cooperative ner at Masry & Vititoe, the firm that chromium exposure data. It also had agreement with Johns Hopkins Uni seven times as many workers, five versity School of Hygiene and Public times as much follow-up data and Health. twice as many deaths as the previous "The case is closed. Hexavalent chro leading study. mium is a potent carcinogen. The only . .. hexavalent Workers in the study were divided remaining question is why it has taken into four groups, or quartiles. Workers the Occupational Safety and Health chromium is a in the third-highest exposure quartile Administration (OSHA) so long to ad had a risk of death from lung cancer 1.6 equately regulate it," said Dr. Peter potent cause of times higher than would have been Lurie, deputy director of Public Citizen's expected for otherwise similar indi Health Research Group. lung cancer viduals; this quartile included the per "The results of this study were first missible exposure limit for which the presented publicly five years ago, yet OCAWand Public Citizen petitioned in the EPA and Johns Hopkins permitted 1993. Workers in the fourth quartile the results to remain unpublished even were 2.2 times more likely to die from as hundreds of workers unnecessarily filed a class action lawsuit seeking lung cancer than would have been contracted and died from lung cancer," compensation for the chromium-ex expected; this quartile included the Lurie said. "This is public health irre posed residents, "This new study makes current OSHA permissible exposure sponsibility on a grand scale." OSHA's failure to adequately regulate limit. The increased risk of lung cancer In a 1993 petition and a 1997 law chromium in the workplace all the persisted even after controlling for suit, Public Citizen and the Oil, Chemi more reckless." other variables such as smoking and calandAtomicWorkersUnion(OCAW, Hexavalent chromium is used in the race. now the Paper, Allied-Industrial, Chemi production of metal alloys such as "In seven and a half years in office, cal and Energy Workers International stainless steel, chrome plating and pig the Clinton administration has failed to Union, or PACE) argued that OSHA's ments. Hundreds of thousands of U.S. issue a single proposed regulation for permissible exposure limit for workers are exposed to hexavalent an occupational chemical," said Dr. hexavalent chromium should be low chromium, particularly those in the Sidney M. Wolfe, director of Public ered from the present 100 micrograms pigment and plating industries, and in Citizen's Health Research Group. "This per cubic meter (ug!m3) to 0.5 ug!m3• chromium production plants. is the poorest record for chemical At the press conference, Public Citi Since Public Citizen and the OCAW health standards of any administration zen was joined on the phone by Erin filed its petition in 1993, OSHA has since the Occupational Safety and Brockovich, director of research at made a series of unkept promises about Health Act went into effect in 1971." Masry & Vititoe, whose struggle to when it would regulate hexavalent compensate residents exposed to chromium, starting with March 1995.
4 +August 2000 Product Recalls june 8-]uly 12, 2000
D R ( i G S & D I E T A R Y S lT P P L E M E N T S
his chart includes recalls from the Food and Drug Administration (FDA) Enforcement Report for drugs, dietary Tsupplements and Consumer Product Safety Commission (CPSC) recalls of consumer products.
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. A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death. Class II recalls may cause temporary or medically reversible adverse health consequences. A Class III situation is not likely to cause adverse health effects. 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 wwwfda.gov.
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Brethalre(r) Inhalation Aerosol (Terbutaline sulfate,) 7.5 mL, Lot Numbers: 1971259, 2971259 and 4971259, 3971259 EXP 11/99; Complete Unit. Rx inhaler for relief of bronchospasm; Class II; 72,078 units distributed nationwide; 3M Pharmaceuticals, Northridge, Aerodynamic particle size failure (stability) California. Recalled by Novartis Pharmaceuticals Corporation, Suffern, New York
Glyburlde Tablets (micronized), 1.5 mg, and 3 mg 100 tablets, Rx Lot Numbers: 1140588 EXP 10/00,1140598 EXP 10/00,1140608 as an adjunct to diet to lower blood glucose in patients with non EXP 10/00, 116884A EXP 4/01, 114061 D EXP 4/01, 114062D EXP 4/ insulin dependent diabetes mellitus (type II); Class Ill; Impurity failure 01, 114063D EXP 4/01, 1145178 EXP 5/01, and 116893A EXP 12/01; (12 month stability testing) 1,386 units distributed nationwide; Novopharm, Ltd., Toronto, Canada. Recalled by Teva Pharmaceuticals USA, Sellersville, Pennsylvania
Goldllne brand Acetaminophen Suppositories, USP, OTC Lot #AL 606 EXP 9/20/02; 49,392 suppositories distributed in indicated for the temporary relief of fever, ache, pains, and headaches, Kentucky; Clay-Park Labs, Inc. (CPL), Bronx, New York 120 rng and 650 mg; Class II; Misbrandinq--Some 650 mg (correctly labeled) suppositories were packaged into cartons labeled as 120 mg.
Herbal Dietary Supplements: a) Zhen Oi, Herbal Extract Capsules, All lot codes; Undetermined quantity distributed nationwide and 500 mg capsules, in 60-unit bottles; b) Diabetes Angel Pearl Hypogly internationally; Tongyi Tang Pharmaceuticals Company, Harbin, China. cemic Capsules, 0.5 grams per capsule, in 60-unit bottles; c) Diabetes Recalled by Sino American Health Products, Inc., Torrance, California Angel Hypoglycemic Capsules, 0.5 grams per capsule, in 60- unit bottles; Class I; Misbranded-All three products contain undeclared prescription ingredient glyburide
lmltrex(r) (sumatrlptan succinate) Rx tablets, 25 mg, in 9- Lot Numbers OZP0151 and OZP0152; Approximately 37,710 units tablet units; Class Ill; Misbrandinq--81ister text incorrectly declares distributed nationwide; Glaxo Wellcome, Zebulon, North Carolina product strength at 50 mg (outer carton is correctly labeled 25 mg)
Nasacort AQ (Triamcinolone Acetonlde) Nasal Spray, Rx 120 metered actuations-all lots with EXP DATE 03/00 through 11/01 indicated for treatment of nasal symptoms of seasonal and perennial and 30 metered actuations-all lots with EXP DATE 03/00 through 01/ allergic rhinitis; Class Ill; Stability: (Super-potency) potential for 02; 11,870,820 units were distributed nationwide and internationally; patients to receive a higher dose than labeled of triamcinolone Rhone Poulenc Rorer Puerto Rico, Inc., Manati, Puerto Rico. Recalled acetonide by Aventis Pharmaceuticals Products, Inc., Collegeville, Pennsylvania
Public Citizen's Health Research Group + Health Letter + 5 D H l l (I S ..'\: D I E T A H Y S {I P P L E .\1 E N T S coni.
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a) UriTAB(tm) Caplets (Phenazopyridine HCL 95 mg), 30 caplet box, a) Lot #J15460; b) Lot #J15466; c) Lot #J16148; d) Lot #J15548; 856 OTC, for urinary pain relief; b) PremeTAB(tm) Tablets (Acetaminophen cases distributed nationwide; Formulex Canada, Inc., Quebec, Canada. 500 mg, Pamabrom 25rng, Pyrilamine Maleate 15 mg) 15 tablet units, Recalled by Olus Laboratories, Farmindale, New York OTC , for use in premenstrual discomfort; c) PrevenTAC{tm) Caplets (Aspirin 81 mg), 30 caplets, OTC, to help in the prevention of heart disease and heart attacks; d) SomaTAC(bn) Caplets (Diphenhydramine Hydrochloride 50 mg), 15 caplets, OTC, helps relieve occasional sleeplessness due to stress, anxiety, restlessness, and irritability; Class II; Products are unapproved new drugs
Vasotec Tablets (Enalapril Maleate), 5 mg in 1,000 and 10,000 Lot Numbers: K0634 EXP 12/01 and K0635 EXP 12/01 ; 149 units tablet bottles, Rx indicated for treatment of hypertension and symptom distributed in Florida, Nevada, New Mexico, Texas, Arizona, South atic congestive heart failure usually in combination with diuretics and Dakota, Illinois; Merck Manufacturing Division, Division of Merck & digitalis; Class Ill; Dissolution (low) failure Company, Inc., Caguas, Puerto Rico
C 0 N S ll ;\I E R P H 0 D ll C T S
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 1-800-638-2772. The CPSC web site is http://www.cpsc.gov
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Bicycle Helmets; Helmets fail impact testing. Riders wearing these Pink with silver glitter, size Small; 9,000 sold at Toys RUs nationwide helmets are not adequately protected from falls, and could suffer severe from October 1999 through Apri12000; Cycle Express Inc., New York, head injuries or death New York (877)714-6117
Bicycle Helmets; Helmets fail impact testing. Riders wearing these L.A. Cruisin' various models; 70,000 sold at Krnart and Rose's stores helmets are not adequately protected from falls, and could suffer severe nationwide from April1999 through March 2000; Rand International, head injuries or death Farmingdale, New York (800) 338-7677
Bicycle Trailers, used to transport young children; The wheel can Burley-Bravo TM; 2,200 sold nationwide from November 1999 through separate from these trailers during use, and result in crashes and June 2000; Burley Design Cooperative, Eugene, Oregon (800) 311- injuries to children riding inside and also can cause the riders to crash 5294 and suffer injuries
Children's Rocking Chairs; Rear legs of the chair can separate from Chairs are 23" long, 13" wide and 16.5" high; 48,000 sold nationwide the rocke~s base causing it to collapse at Target stores from November 1999 through March 2000; Jetrnax International Ltd., Stamford, Connecticut (800) 880..0714
Hedge Trimmers and Augers; Fuel tank vents on these products Trimmer models THT-2100, 2120. 2510, 2520. 2540 and Auger model can leak, posing a fire hazard TLA-340; 7,500 hedge trimmers and 1.400 augers sold nationwide from September 1998 through September 1999; Tanaka America, Auburn, Georgia (888) 401-3885
Light Boxes; Light boxes have loose wires and lack adequate Models LB 100, LB 101, LB 102, LB 11 0; 30,000 sold nationwide from grounding, presenting fire, electrocution and shock hazards to June 1997 through April 2000; Apollo Presentation Products, consumers Ronkonkoma, New York (800) 352-6853
Pacifiers; Because the latex is aging faster than normal, the nipple Classic Patterns Cherubs & Soft Comfort; 1.8 million sold nationwide can detach from the shield, presenting a choking hazard to babies before June 2000; Playtex Products Inc., Westport, Connecticut (800) 522-8230
6 +August 2000 C 0 N S l l \1 E R P R 0 D lT C T S co11t.
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Sky Dancers® Flying Dolls; The hard plastic Sky Dancers® Many styles; 8.9 million sold nationwide from November 1994 through launching dolls can fly rapidly in unpredictable directions, and can hit June 2000; Galoob® Toys Inc., San Francisco, California (877) 598- and injure both children and adults 5599 www.galoob.com/skydancer
Shingling Hatchets; Heads on these tools can detach when in use, 13" long with "ACE" etched on tool head; 22,000 sold at Ace Hardware striking the user or a bystander and causing serious injury Stores nationwide from March 1994 through April 2000; Ace Hardware Corp., Oak Brook, Illinois (877) 223-4391
Spinning Ride Toys; Center column can break, causing a child to Music & Lights Kidaround Spinner; 103,000 sold nationwide from July suddenly fall backward or be hit in the face by the broken column 1999 through May 2000; Today's Kids, Dallas, Texas (800) 916-TOYS
Teething Rings; When bent, these teething rings can fit into an Yellow, rabbit-shaped; 475,000 sold nationwide attached to bottles of infant's mouth and trigger a gagging reflex which poses a risk of Baby Anbesol from May 1999 through June 2000; Whitehall-Robins choking and aspiration Healthcare, Madison, New Jersey (800) 525-2607 www3.young-america.com
Toy Baby Phone; Phones have a ball-shaped antenna which can Soft Songs Baby Phone 39100; 34,000 sold nationwide at Wal-mart detach, presenting a choking hazard to young children from January through May 2000; Vtech Industries LLC, Wheeling, Illinois (800) 521-2010
Toy Cars; Tires can detach from wheels of these cars, posing a Nascar Pull 'N Go Hot Wheels cars that were packed inside some choking hazard for young children Kellogg's cereal boxes; 837,000 sold nationwide from March through June 2000; Kellogg Company, Battle Creek, Michigan (800) 962-0037
Tot Wheels® Entertalnere Infant Walkers; Walkers can Entertainer Activity Center; 31 ,000 sold nationwide from September collapse unexpectedly during use and injure infants 1999 through February 2000; Graco Children's Products Inc., Elverson, Pennsylvania (800) 345-4109 www.gracobaby.com
VInyl Window Blinds; These blinds contain lead exceeding White miniblinds and wood grain roll-up blinds; 87,000 sold at Ace government guidelines, and do not have required labeling warning they Hardware and other hardware stores nationwide from August 1999 through contain lead May 2000; Ace Hardware Corp., Oak Brook, Illinois (877) 223-4391
Public Citizen's Health Research Group + Health Lener + 7 Report Estimates Air Lead Levels From Some Candle Wicks At Up to 36 Times EPA Standard Lead Experts join Public Citizen's Demand for Banning Candle Wicks Containing Lead
he july 12th issue of the journal using lead in candle wicks after a 1973 States. There is no defense for the of the American Medical Public Citizen petition to ban them, but persistence of this product. The indus T Association(JAMA) has just pub the industry resumed using lead in the try has proven unable to police itself." lished a Public Citizen study indicating late 1970s. that burning lead-wicked candles can "This study underscores the CPSC's • Dr. Howard Hu, associate profes result in air lead levels in homes that irresponsibility and the need for imme sor of occupational health at the are 10.1 to 36 times the U.S. Environ diate regulatory action, not more dilly Harvard School of Public Health: "I mental Protection Agency's (EPA) stan dallying and caving in to industry," said am writing in strong support of Pub dard of 1.5 micrograms per cubic meter. Peter Lurie, deputy director of Public lic Citizen's petition... to immediately At these levels, children inhaling lead Citizen's Health Research Group. ban and recall all candles with lead from candles on a consistent basis Since Public Citizen filed its recent containing wicks .... ! hope you will could readily reach blood levels asso petition, it has been supported by a act expeditiously on Public Citizen's ciated with behavioral and neurologi number of prominent experts in lead findings." cal problems. toxicity, who filed the following com Drs. Howard L. Sobel, Peter Lurie ments with the CPSC: • Dr. Barry Castleman, environmental and Sidney M. Wolfe, all of Public consultant: "I am writing to agree with Citizen's Health Research Group, ex • Russell Train, administrator of the Public Citizen that there is no justifica amined 285 types of candles from EPA during the Nixon administration: tion for the U.S. government permit stores in the Baltimore-Washington ''The 1974 voluntary agreement has not ting ANY fraction of lead to be present area. Thirty percent contained metal proved effective. I strongly urge an in candles .... There is simply no reason wicks, and 10 percent of those con immediate ban and recall. The 25 years why the government should sanction tained lead. The measured lead con since 1974 would seem to be ample time the use of lead in any amount." tent of the wicks was converted into air for the industry to take effective action." lead levels using calculus and was In addition, in a letter to Public compared to the EPA standard. • Dr. Philip J. Landrigan, director of Citizen, Dr. Herbert Needleman, pro On February 24, Public Citizen peti the Center for Children's Health and fessor of psychiatry and pediatrics at tioned the Consumer Product Safety the Environment, Mount Sinai School the University of Pittsburgh Medical Commission (CPSC) to immediately of Medicine, and a senior advisor on Center, wrote, "It is now established ban and recall the millions of candles children's environmental health to the that small amounts of lead can be brain with lead wicks. Since then, more than EPA: "I am writing now to urge [CPSC] damaging, and that infants and chil a million candles with lead wicks have to take strong and immediate action to dren have increased sensitivity to this been sold in the United States. In 1974, ban all manufacture and import of poison. The only sane step is to penna- the industry voluntarily agreed to stop leaded candle wicks in the United continued on page 9
TH£ f'UBUC CrrtZI!N HEALTil RI!SBARCH CROUP Editor ...... Sidney M. Wolfe The Health Research Group was co-founded Managing Editor ...... Pbyllts McCartby l-lutltl1 Letter In 1971 by Ralph Nader and Sidney Wolfe in Washington, D.C. to fight for the public's Staff Researchers...... Peter Lurie health, and to give consumers more control Larry Sastcb over decisions that affect their health. Howard L Sobel Copyright C Health Letter, 2000 Material in the Health Letter may not be re Published Monthly by Benita Marcus Adler printed without permission from the Editor. Public Citizen Health Research Group Send leners and requests to HEAL1H LE1TER, Infonnatton Specialist ... jennifer L Howard All rights reserved. ISSN 0882-598X Editor, 1600 20th St., NW, Washington, D.C., Contributing Editor ...... Wtlltam Hines 20009. Production Mgr...... Krlsty l jackson Annual subscription price is $18.00 (12 Is Circulation Mgr...... Garland Auton sues). Mail subscriptions and address changes to Health Letter, Circulation Department, 16oo Proofreader ...... Ragin jennings 20th St., NW, Washington, D.C., 20009. Our Web site address is www.cldzen.org/hrg.
8 +August 2000 The Risks of Tranquility
he following article was printed 1.5 million Americans have taken one or For example, Drs. jose Catalan and in Health Letter's first year of more of these medications long enough Dennis H. Gath-both of the Oxford T publication and is rerun here. to be in serious danger of addiction. University Department of Psychiatry Unfortunately, these drugs are still just how long is long enough is not ran an interesting experiment. In the around, still dangerous, and still over entirely clear. What is known, however, experiment half of a group of patients used. is that benzodiazepine addiction sends with minor affective (mood) disorders ••• thousands of people to hospital emer such as anxiety, depression and insom For years, librium, (which preceded gency rooms each year and that it is nia, were randomly assigned treatment Valium), and its sister drugs--Ativan, because they have become hooked on with benzodiazepines. The rest of the Centrax, Dalmane, Paxipam, Restoril, benzodiazepines that at least 4,000 patients with the same complaints were Serax, Tranxene andXanax-have been Americans annually enter addiction treat chosen by lot to get brief counseling the most prescribed drugs in the United ment centers for the first time. instead. Although the counseling took States. Although many of these are no The manufacturers of these drugs no more of the doctors' time or the longer as popular as they once were, stoutly maintain that the chances of patients' than the benzodiazepine Americans continue to consume mil addiction are minimal if they are used at therapy, the rate of improvement in the lions of tablets of these drugs and a the recommended dosages and for no two groups-both at one month and at newer one called Haldon every day. In longer than specilled by the informa seven months after treatment-was the 1984, for example, Americans filled 78 tional leaflets (known as package in same. million prescriptions for these drugs. serts) the companies provide to Similarly, another study looked at The peak use of these addicting benzo physicians. However, sdentiflc studies what happened when patients going to diazepine tranquilizers and sleeping pills suggest otherwise. With the passage of the offices of a surgeon, an internist or was in 1975 when 91.4 million prescrip time, there has been growing evidence an obstetridan-gynecologistwere treated tions were filled for these drugs. As the that benzodiazepine dependency can for anxiety with either Valium, one of public and the medical profession belat occur even if the manufacturers' instruc two other benzodiazepine tranquilizers edly learned about the addictive proper tions are followed to the letter and that, or a placebo (dummy pill). ties and other dangers of these drugs, indeed, some patients get hooked on Weekly evaluations were made both the sales fell, "bottoming out" in 1982 even low doses of benzodiazepines in by the patients themselves and by pro but now beginning to rise slowly. Too as little as three or four weeks. fessional evaluators with neither the little recognized is that because all these One might suppose, as some benzo patients nor the evaluators knowing at drugs belong to the same closely-knit diazepine manufacturers have claimed, the time who was getting which type of chemical family, the benzodiazepines, that it is chiefly the "abuse-prone" medication. At the end of a month, it they can be dangerous to your health. people who have long-standing emo turned out that all four treatments tional or psychological problems who including treatment with the dummy valhun, xaoax And Their Cousins are at greatest risk here. Again, it doesn't pills-were equally effective. Are Addk:ting seem to work out that way. Anyone Said another way, it was not whether Some benzodiazepines are promoted who takes a benzodiazepine at the high or not the patients had taken a benzodi as tranquilizers; others (like Dalmane, end of the recommended dose range or azepine that made them feel better, but Restoril and Halcion) as sleep aids. For anyone who takes it for a month or more the opportunity the study had given whatever purpose they are advertised, at any dose can get hooked. That being them to talk with someone about their they can be both psychologically and the case, Health Research Group is anxiety that gave them relief. physically addictive and it is all too easy strongly in favor of using benzodiaz Nonetheless, there are some doc to get hooked on them. According to the epines very sparingly, if at all. And tors-and good ones-who sometimes Food and Drug Administration, in fact, Health Research Group is not alone. continued on page 10
CANDLE WICKS,from page 8 Dr. Sidney M. Wolfe, director of Public tibilities of infants and children when nently ban lead-containing candles from Citizen's Health Research Group. "Vol setting standards and regulations. the market." untary bans do not work. This has been "It is the height of hypocrisy for the In the time since the Public Citizen proved once again by the CPSC's fail Clinton administration to, on the one petition was filed, New Zealand has ure to take appropriate regulatory ac hand, issue high-minded proclamations joined Australia in banning lead-con tion in this case." on child safety, while at the same time taining wicks. OnApril21, 1997, President Clinton allowing lead, a known and preventable "These countries are leading the signed an executive order requiring all hazard to their health, to continue to way in protecting their children from federal government agencies to ac poison them," Dr. Wolfe said. the well-known dangers of lead," said count for the unique biological suscep-
Public Citizen's Health Research Group + Health utter + 9 VALlUM, from page 9 your anxiety is your first priority and that the pills or that you're not at your best prescribe benzodiazepines to counter you in no way just want to let the unless you take them every day. muscle spasm, for the relief of anxiety or situation ride without re-evaluating it to help their patients through occasional soon and at regular intervals. • Needing to take more pills as time sleepless nights. If your doctor is one of In the meantime, you can facilitate goes on to get the same effect and taking them and you want to take Valium or the process by doing some evaluating higher doses than your doctor pre some other drug in this family, play it on your own. At the end of the first day scribed. smart by asking the physician to write and the end of every day you take any No Refill on the prescription and to order of these medicines, review for yourself • Being unable to quit. the pharmacist to give you no more than what you have done-by yourself or by 20 pills. talking with othe~o find out what is When you are physically dependent Both of these requests to your doc making you anxious so you can alter the on Valium, quitting suddenly can make tor are for your own protection. Twenty internal or external circumstances that you downright sick. You feel tense and pills of a benzodiazepine are typically are to blame. can't sleep, and you may go on to enough for about seven days of use; Keep a record of these evaluations. develop a full-blown withdrawal reac too short a period for there to be much And as soon and as often as possible, in tion--shakiness, headache, nausea, vom risk of addiction. And with the addition consultation with your doctor, try reduc iting, changes in sensation, and at times, of the No Refill stipulation, you will not ing the amount of benzodiazepine you hallucinations or seizures. When you have the opportunity to refill the pre are taking. resume taking Valium, the symptom scription several times without seeing But what if this advice comes too late usually go away within 24 hours. a doctor should you find yourself be and you suspect you may already be Withdrawal symptoms aroa very seri ginning to crave how the tablets make hooked on Valium or one of its close ous danger sign. If you aro physically you feel. relatives? How can you tell? addictedtobenzodiazepines,youshould Most importantly, however, urging Some of the warning signs of benzo taper offthese drugs gradually and un your doctor to put limitations on your diazepine addiction are: der a doctor'scaro. Do not attempt to quit prescription for benzodiazepines is a cold turkey or on your oum; it is always signal to him or her that coping with • Feeling that you can't cope without dangerous and can be fatal.
Other Hazards ofBenzodiazepines Worth mentioning, too, is that benzo Also avoid the use of benzodiaz As if it weren't bad enough that diazepines can cause profound confu epines in combination with three drugs benzodiazepines can be addictive, they sion, particularly in the elderly who may widely prescribed for Parkinson's dis also can have other adverse effects. then be falsely diagnosed as senile. ease. Benzodiazepines can make these Feeling drowsy, for example, is to be Many doctors recommend that these three drugs-U.rodopa, Levodopa and expected when taking these drugs and drugs not be prescribed for people over Sinemet-less effective. they also often take their toll on 65. At the least, older people should take Finally, although this is by no means memory, learning and attention span. only half the usual dose. And ifyou have an exhaustive list of the dangers of Moreover, some people, instead of narrow angle glaucoma or serious lung these drugs, some cautions for women being calmed by these medications, disease-chronic bronchitis, for ex of childbearing age. Ifyou are (or may become very hostile from using them ample-benzod.iazepines are notforyou, be) pregnant, taking benzodiazepines and fly into attacks of rage. whatever your age. may increase the risk of the child's Particularly important is that ben Other people who should not take having birth defects. Besides, use of zodiazepines interfere with muscu these drugs or, at least not without these drugs near delivery has been lar coordination, so that you should bringing it to the attention of their linked to the so-called floppy baby not drive or operate other powerful doctors, are those on a variety of syndrome. Infants with this syndrome machinery when under their influ other medications. These medica are weak, suck poorly and may have ence. And speaking of being under tions include: antidepressants, anti serious breathing problems. Continu the influence, benzodiazepines and histamines, barbiturates, narcotics, ous use of benzodiazepines in late alcohol are an especially danger psychiatric drugs, anticonvulsants pregnancy can cause infants to suffer ous mix. (epilepsy drugs), and non-benzodi from withdrawal symptoms as new These two "downers" potentiate azepine tranquilizers. borns. each other. Thus an overdose of ben Tagamet (cimetidine), a best-selling Valium and other benzodiazepines zodiazepines alone or in combination drug for ulcers and Antabuse for the also get into mothers milk. A nursing with alcohol, or, for that matter, barbi treatment of alcoholism should not be infant whose mother is taking any of turates and certain other drugs (see used in combination with any benzodi these drugs will be groggy and, over below) can be fatal. azepines except Ativan or Serax. time, may eat poorly and lose weight.
10 +August 2000 OUTRAGE,from page 12 and take alendronate for three years one vertebral fracture. This number is duce the incidence of hip fractures can reduce their risk of hip fracture 58, meaning that 57 women taking the (the most serious consequence of os from two percent to one percent, or a drug would receive no benefit from it teoporosis) by 50 percent. The CBS relative reduction in risk of 50 percent. and would only be exposed to its risks. reporter described the results as "al Alendronate can cause severe ulcer Overall, for all types of fractures most miraculous." None of the stories ation of the esophagus (the tube con- including vertebral, hip, and wrist, there cited the actual rates, or absolute risk, was no difference between alendronate of hip fractures in the alendronate and the placebo in protecting women treated patients (1 percent) and in the from fractures. When the FIT study group of women receiving an inactive researchers grouped the number of placebo or dummy drug (2 percent), News coverage fractures according to the women with an absolute difference of one percent. the highest and lowest bone mineral Only one network mentioned the gas of drugs can densities some unexpected results were trointestinal (GI) adverse effects of found for wrist and hip fractures. Ironi alendronate. None of the three stories include cally, the risk of wrist fracture was disclosed that the study investigator increased in women taking alendronate, being interviewed had received mor.- ~.y inadequate or though not by a statistically significant from alendronate's manufacture(, amount. The drug was of no benefit in Merck & Co. preventing hip fractures-the most Medical conferences, such as the incomplete devastating tyPe of fracture a woman one that spurred the alendronate hype can experience--in women with the in 19%, are prime sources of news, information highest bone mineral density. In and drug companies make an effort'to women with the lowest bone mineral attract journalists. Results of clinical densities, there were 11 women taking studies are often presented at medical alendronate who suffered hip frac meetings as summaries, or abstracts, necting the mouth to the stomach). tures, while there were only six frac before the results are published as full The FIT trial left unanswered the tures in women receiving the placebo. length journal articles that have been question of alendronate's effect in re This last finding requires more re peer reviewed. These study summa ducing the risk of all types of fractures, search before any conclusions can be ries do not contain enough detail about including hip fractures, in the largest drawn. how the study was conducted to deter group of postmenopausal women Drug companies exercise tremen mine if the results are valid or relevant. tnose who have not experienced a dous influence over the information In some medical disciplines, only about vertebral fracture. When this question they allow to see the light of day, and one-half of the study summaries pre was answered with publication of the what you see is the good news, while sented at meetings are ever published second part of the FIT trial in the the negative news goes unreported, as full-length, peer-reviewed journal December 23/30, 1998 journal of the unless there is a catastrophe. articles, yet too many health profes American Medical Association, inter sionals and some in the news media estingly these results went almost to What You Can Do accord study summaries the same tally unnoticed by the news media. Even if you are on a salt-free diet, weight as full-length articles that have We covered this study in the Febru take news reports about drug innova been through the peer and editorial ary 1999 issue of Wotst Pills, Best Pills tions (especially reports of the "break review processes. News. Over the four-year duration of through" kind) with a grain of salt. You The summary of the alendronate this part of the FIT study, alendronate cannot rely on media reports of studies clinical trial described above was pub did statistically reduce the risk ofwomen about new drugs presented at medical .•. lished as a full-length article in the developing one or more new vertebral meetings to gauge the therapeutic value British medical journal Tbe Lancet on fractures. In women taking the placebo of new drugs. Likewise, media reports December 7, 1996, six months after the 3.8 percent developed one or more of full-length medical journal articles 1V coverage. This study is known as vertebral fractures, while in those tak~ may be erroneous because of the the Fracture Intervention Trial, and ing alendronate 2.1 percent experi reporter's lack of full understanding of goes by the name FIT. enced a vertebral fracture. This is an the subject matter. The results of the FIT trial provided absolute risk difference of 1.7 percent evidence that women who have had at (3.8 percent minus 2.1 percent). We least one vertebral fracture (a type of also calculated the number of women fracture of bones comprising the spine that would need to be treated with that may go unnoticed by the woman) alendronate for four years to prevent
Public Citizen's Health Research Group + Health Letter + 11 OUTRAGE OF THE MONTH Erroneous and Misleading Reports In Media About Prescription Drugs
study published in the June 1, 207 reports came from 36 newspapers percent) cited at least one expert or 2000 New England journal of and four 1V networks. In total, 27 (13 study with a financial tie to a manufac A Medicine found lhat news percent) were on 1V, 53 (26 percent) in turer of the drug that the study's au coverage of drugs can include inad national newspapers like USA Today thors had learned about because the tie equate or incomplete information about and 1be Wall Street journal and 127 (61 had been disclosed in the scientific risks, benefits, and costs as well as the percent) in other newspapers. literature. These ties were disclosed in financial conflicts-of-interest between Of the 207 stories, 83 ( 40 percent) only 33 (39 percent) of the 85 news persons interviewed for stories and the did not report benefits quantitatively. media stories. drug companies sponsoring the re Of the 124 that did, 103 (83 percent) The authors of the study gave an search. reported relative benefits only, three (2 example to illustrate their findings. On The researchers analyzed coverage percent) the absolute benefits only. the evening of May 22, 1996, ABC, of three drugs: (1) the cholesterol-low and 18 (15 percent) both absolute and NBC, and CBS 1V news programs ering drug pravastatin (PRAVACHOL); relative benefits (the importance of carried stories about alendronate, pro (2) alendronate (FOSAMAX), a heavily reporting both relative and absolute VQ~ · ed by a medical conference at hyped drug for osteoporosis; and (3) benefit will be covered below). Only which the results of a randomized, aspirin for its use to prevent cardiovas 98 ( 47 percent) of the 207 stories controlled trial were presented. The cular disease. A sample of 180 newspa mentioned potential adverse drug re three network stories reported only the per stories, 60 for each drug, and 27 actions and only 63 (30 percent) men relative reduction in risk, saying that television reports that appeared between tioned costs. Of the 170 stories citing the new osteoporosis drug could re- 1994 and 1998 were examined. These an expert or a scientific study, 85 (50 continued on page 11
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12 +August 2000