PUBLIC CITIZEN HEALTH RESEARCH GROUP

SIDNEY M. WOLFE, M.D., EDITOR JULY 2001 + VOL. 17, NO. 7 Hormone Therapy: Doubts Grow

7be following is reprinted from USA accompanying the JAMA paper. "If it's many women with misinformation 10DAY, june 13, 2000 Copyright© for hot flashes, it's clear it works. If it's about how they can hope to benefit 2001, USA 10DAYReprinted with Per­ for the prevention of anything (else), from taking it," says Cynthia Pearson of mission. It was written by Rita Rubin. it's not clear yet." the National Women's Health Network, Rita Rubin~ excellent overview of It's not difficult to find Web sites or a non-profit group in Washington. the increasing evidence ofserious risks even articles in scientific journals tout­ "There's something deep that explains of hormone replacement therapy and ing HRT's beneficial effects on the the irrational behavior around this, and the increasing doubts about the ben­ heart and brain. But those notions stem I don't know what it is." efits deseroes to be read by all women from the inconsistent findings of stud­ In the North American Menopause using or considering the use of these ies that involved women who chose to Society's most recent survey of women drugs. Although there is some evidence go on HRT. Skeptics question whether ages 45 to 65, conducted in 1998, 34 ofpreventing osteoporotic fractures in other characteristics of those women, percent of respondents said they were women who begin use before age 60, and not HRT itself, might deserve the on HRT. Premarin, the leading brand of the need to continue use for the rest of credit. estrogen, remains one of the most their lives-or lose the benefit shorlly Apparently, though, the latest re­ widely prescribed drugs in the world. thereafter-places them at even greater search about HRT's effects has not It is sold alone or combined with risk for breast cancer. trickled down to many doctors who another hormone in Prempro and care for postmenopausal women, nor, Premphase. Worldwide annual sales ormone replacement therapy as a result, to the women themselves. total nearly $2 billion, and Premarin in has been promoted for every­ "The problem, from our perspec­ all its forms last year became one of the H thing from protecting against tive, is it's still being offered to too 10 U.S. prescription drugs most heavily heart attacks to staving off Alzheimer's. But evidence is accumulating that <: () N T E N T S women should not count on it for more than relief of menopause symptoms Drug Companies' Antics Can Really Make You Sick such as hot flashes. A nationally syndicated columnist weighs in on the issue of "pharrnas" Even osteoporosis prevention, the and the ways they make a profit...... 4 main reason women older than 60 who are no longer having menopausal symp­ Product Recalls toms are prescribed hormone replace­ May 12-June 11, 2001 ment therapy (HRT), is seriously Children's Mylanta, glue guns and swings are on our list this month .... 5 questioned in today's journal of the Why Doesn't tbe Government Know About These Doctors? American Medical Association UAMAJ. Because the Drug Enforcement Administration didn't report them to the At the same time that HRT's benefits National Practitioner Data Bank and the National Practitioner Bank didn't are becoming murkier, the potential aggressively ask for them ...... 00 ...... 00 .... 00 ...... 8 risks of long-term therapy-mainly an increased risk of breast and ovarian Outrage of tbe Month "Operation Cure.All" Wages New Battle in Ongoing War Against cancer and blood clots-are becoming Internet Health Fraud more worrisome. The FDA and the FTC are going after fraudulent and dangerous products "Why take it?" asks Steven on the Internet. Find out why they haven't gone far enough...... 12 Cummings, co-author of an editorial

VISIT HEAI.TII RESEARCH GROUP'S WEll SITE AT WWW .CITIZEN .ORG / HRG / marketed to consumers. more than a decade increases the risk creases the risk of blood clots in the Many of these women hope HRT of breast cancer. legs and lungs, he notes. Perhaps, will prevent osteoporosis. But in "My thought is to stop taking it," Rossouw says, estrogen also increases today's JAMA, an analysis of 22 HRT says Thomas, who lives in Ocean View, the likelihood of blood clots in the trials by a pair of British researchers Delaware. "I'm really gathering infor­ coronary arteries of certain women. found a reduction in bone fracture mation at this point to figure out if More than 27,000 women ages 50 to risk only in women who started treat­ that's what I'm supposed to do." 79 are participating in the Women's ment before age 60. Health Initiative, one of the largest . In their accompanying editorial, Self-fulfllllng Prophecy prevention studies ever conducted in Cummings and Deborah Grady, both Intuitively, it makes sense that HRT the USA. Only about 10 percent had from the University of California-San would work wonders. Osteoporosis, been diagnosed with heart disease Francisco, question whether HRT even heart attacks and Alzheimer's disease before enrolling, Rossouw says. The prevents fractures in women who start become more common as women age. women will be followed for up to 11 taking it before 60, because the studies And with ovaries intact, younger years, and final results won't be re­ in the analysis weren't designed to women's bodies produce far more leased until late 2005 or early 2006. look at osteoporosis. estrogen than older women's. What's In April2000, though, the Women's They write that the JAMA study more, estrogen appears to lower LDL, Health Initiative alerted participants to "highlights the fact that evidence about the "bad" cholesterol, while raising an unexpected finding by the study's the efficacy of postmenopausal estro­ HDL, the "good" cholesterol. data and safety monitoring board. Ev­ gen for prevention of osteoporotic frac­ Early research supported the notion ery six months, this independent group tures is weak." that women benefited from taking of experts reviews information col­ Jacques Rossouw, acting director of supplemental estrogen once their bod­ lected from the participating centers to the huge Women's Health Initiative, ies' own supplies diminished. In those make sure the study is safe. which is studying whether HRT pro­ so-called "observational studies," After most of the women had been tects against heart disease, concurs. "If women who chose to go on HRT were in the trial for two years, the board one of my women friends asks me indeed less likely to suffer heart attacks noticed an increased heart attack and 'what should I do for osteoporosis?' I than their peers who decided not to. stroke risk in those on HRT compared don't advise estrogen," he says. All along, though, skeptics have to those on placebo. The board recom­ Instead, Rossouw says, he would wondered whether HRT's apparent mended that the researchers inform recommend non-hormonal drugs such advantage was really a self-fulfilling participants of the finding but continue as alendronate, sold as Fosamax, which prophecy. Women who opt to go on the study. he calls "effective and very safe alterna­ HRT tend to be better educated and "There's going to be more from the tives" to HRT. more health-conscious, both factors Women's Health Initiative, and it's not Maureen Thomas, 62, has been on that could reduce their heart disease good," Cummings says. He declined to HRT for 11 years. She started taking it risk. Maybe it was the HRT users' elaborate on the nature of the findings for relief of symptoms and, like mil­ lifestyle and not the HRT itself that because they are not yet ready to be lions of women, stayed on it for protec­ made the difference. made public. tion against osteoporosis and heart The only way to know for sure In 1998, the Heart and Estrogen/ disease. A self-described "wellness buff' would be to conduct studies in which Progestin Replacement Study, or HERS, who thinks nothing of biking 50 miles a coin toss would determine which reported a finding similar to that of the at a time, Thomas on one hand regards women went on HRT and which re­ Women's Health Initiative's monitor­ HRT as a kind of fountain of youth. "I ceived a placebo. Such randomized ing board. HERS involved 2,763 post­ keep track of the gals I went to school clinical trials are considered the gold menopausal women with established with," she says. "The ones who are on standard of scientific research. heart disease. They were randomly the hormones have a younger essence, To the surprise of many, four ran­ assigned to take HRT or placebo pills. which I can't exactly explain." domized clinical trials over the last few After the first year, the HERS found But Thomas, an avid reader of health years found that HRT actually increased a 50 percent increase in the risk of newsletters published by medical women's risk of heart attacks and suffering a non-fatal heart attack or schools, has been hearing that HRT strokes during the first year or two, dying of heart disease in the HRT might not really help her heart. And Rossouw says. group compared with the placebo she's concerned about the findings of "At least hi tlie· shornerm," he-says, gr0\.1p-:By the end offour years; though, a study out in March that suggest long­ "the benefit has not been there for the number of such cases in each term HRT raises women's risk of ova­ heart disease." group had evened out. rian cancer. Rossouw says he suspects that the In light of such findings, the Na­ That follows earlier reports from the early increased risk is because of tional Cholesterol Education Program Nurses Health Study, which has been estrogen's effect on blood clotting. It last month dropped a previous recom­ following more than 100,000 female was only five years ago that scientists mendation that postmenopausal nurses for years, that using HRT for recognized estrogen replacement in- women go on HRT to lower their

2 • july 2001 cholesterol. Instead, the government program advised such women to try HRT Benefits: Fact or Fiction cholesterol-lowering drugs called Conventional Wisdom New Research statins, such as Zocor or Lipitor. Despite HERS and the Women's Cardlovasc:uJar DJsease Health Initiative, the proportion of U.S. Since the 1970s, more than 30 studies Recent trials that randomly assigned women who believe that estrogen re­ reported that women who chose to women to HRT or a placebo found placement can prevent or reduce the take estrogen after menopause had an increased risk of heart attack or risk of heart disease actually increased fewer incidents of heart disease than stroke in the first year or two in the from 47 percent in 1997 to 54 percent women who decided not to. women on HRT. in 2001, according to survey results reported May 15 in the journal Circula­ Alzheimer's Disease tion. That's the very time frame in Estrogen appears to be necessary for A review of29 studies concluded that which evidence emerged that HRT has optimal brain function so scientists HRT might have a positive effect on no beneficial effect on the heart, at have theorized that HRT might help certain aspects of mental performance least in the short term. protect against dementia or at least a that should be investigated further. "I think that the results, even of a big decline in mental performance. The review also found a decreased trial like HERS, take a long time to risk of dementia in HRT users but wend their way out to the public," says added that the research had signifi­ American Heart Association president cant design flaws. Rose Marie Robertson of Vanderbilt University in Nashville. "They take a Osteoporosis substantial time to wend their way out Besides relief of hot flashes, the only Some scientists now say that non­ to all physicians." other approved use ofHRT is preven­ hormonal drugs are safer and more Unfortunately, Robertson says, the tion of osteoporosis, the bone-thin­ effective in preventing bone frac­ emphasis on HRT as a way of protect­ ning disease that becomes more tures. ing against heart disease distracted common with age. women and physicians from tried-and­ true methods. Like exercise. Like quit­ tively little research even into how best and Sterility, conclude that women ting smoking. Like losing weight. to prescribe estrogen. "We had wide­ could cut the standard estrogen dose in spread use of estrogen before there half and still relieve hot flashes. In Gynecologists Hostlle was very good knowledge about what addition, the lower doses minimized "I talk to gynecologists, trying to lay kind of information you need to get as vaginal bleeding, the main reason out the pros and cons (of HRT), and I far as clinical science is concerned," women go off HRT. often get quite a hostile reception for says Robert Recker, an osteoporosis Wyeth's findings might not mean being skeptical," Rossouw says. researcher at the Creighton University much to the one-third of women on The cover story in the new spring School of Medicine in Omaha. HRT who take another form of estro­ issue of Managing Menopause, pub­ Early trials were conducted in young gen, such as estradiol. Information lished for patients twice a year by the women who had experienced a sud­ about equivalent doses stems from American College of Obstetricians and den, dramatic drop in estrogen after research that involved weighing the Gynecologists, focuses on heart dis­ having their ovaries removed. They uteri of mice given varying doses of ease prevention. The article lists all the could tolerate fairly high daily doses of different estrogens. Ifthe uteri weighed steps recommended by Robertson and estrogen, so for years, doctors pre­ the same, researchers assumed that the her colleagues, then cites HRT, sug­ scribed 1.25 milligrams or even 2.5 doses were equivalent. gesting that some OB-GYNs are reluc­ milligrams of Premarin. "Is .5 of estradiol really equivalent tant to abandon the idea that estrogen The dose wasn't cut to .625 milli­ to .625 ofPremarin?" Recker asks. ''That's protects the heart. grams until a journal article in 1975 more in the category of folklore." "There still are a lot of people who linked estrogen replacement to cancer Meanwhile, postmenopausal women lecture on the subject who continue to of the endometrium, the uterine lining. such as Carol Dennis, 56, a government say estrogens protect against heart dis­ About five years later, doctors began lawyer from Arlington, Virginia., con­ ease," says Isaac Schiff, Managing prescribing estrogen with progestin, tinue to struggle over whether HRT Menopause editor and head of obstet­ another hormone that minimizes makes sense. rics and gynecology at Boston's Massa­ estrogen's effect on the endometrium. "I don't have a clue as to what to chusetts General Hospital. "I personally It wasn't until the late 1990s that do," says Dennis, who has gone on and have never told my patients to take Wyeth-Ayerst, maker of Premarin, be­ off HRT several times since her 48th estrogens to prevent heart disease." gan testing lower doses of estrogen birthday. "I just don't think there's Despite decades of use-or, per­ and progestin. Two reports from that been the research done to figure out haps, because of it-there's been rela- study, in the current issue of Fertility what's best for women."

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Copyright ~ by Molly Ivins who writes best friend, her mother-in-law and many from using generics to treat the disease. for Creators Syndicate. more. I know the gratitude caused by The lawsuit was a public relations surviving cancer. I just didn't expect to disaster, necessitating more pharma­ e're all used to eco-pom by see it exploited by Big Pharmas to porn here lest anyone get the idea that now-those beautiful tele­ counter all the rotten publicity-they've­ the pharmas are-greedy beyond human W vision ads featuring some been getting for their greedy, blood­ comprehension and perfectly willing natural jewel, during which an an­ sucking, murderous behavior all over nouncer with a deep voice tells us how the globe. much Exxon or some other gross pol­ John LeCarre, the British master of luter is doing to keep our precious the spy novel, based his latest work on Abbott agreed to Earth green. the pharmas' role in Africa and recently We always get a get a lot of this wrote in 'The Nation': "Big Pharma in pay Zenith as much greenwashing after oil spills or when­ the United States has persuaded the ever Congress contemplates regulating State Department to threaten poor coun­ as $2 million a anything. tries' governments with trade sanctions But just as we are learning to cope in order to prevent them from making month not to with eco-porn (any ad involving both their own cheap forms of the patented, wildlife and an oil company is to be life-saving drugs that could ease the produce its generic. hooted and jeered immediately), sud­ agony of 35 million men, women and denly they unleash a flood of pharma­ children in the Third World who are porn on us. O'm embarrassed to say HIV positive. In pharma jargon, these that I didn't know the new politically patent-free, copycat drugs are called trendy way to refer to the big drug generic. Big Pharma likes to trash them, to let millions of Africans die. insisting they are unsafe and carelessly Here's one of their many tricks. In administered. Practice shows that they 1984, Congress passed the Drug Price are neither. They simply save the same Competition Act, intended to promote lives that Big Pharma could save, but at competition between brand and ge­ How come they a fraction of the cost." neric companies and to promote the We all know the drug companies' generics. In July 2000, Tbe New York spend twice as famous excuse that they have to make Times chronicled how well it was work­ huge profits on a drug in order to ing: In 1998, Zenith Goldline Pharma­ much on finance research and development of ceuticals sued Abbott Labs overwhether more. There's quite a bit of pharma­ Zenith could sell a generic version of marketing as they porn on this very subject. LeCarre re­ Hytrin, Abbott's $500 million-a-year sponds, "Then kindly tell me, please, drug for high blood pressure. do on research and how come they spend twice as much According to Zenith's lawyer," Abbott on marketing as they do on research makes a million dollars a day for every development? and development?" day it keeps us off the market." After Because it pays, of course. Spend­ opening arguments in the case, the ing on drugs in this country is up by a lawyers all strolled off to lunch at the whopping 19 percent-so far out of Hay-Adams in Washington, and the companies is 'pharmas.' I've been call­ line with the rest of the cost increases case was there settled. ing them big drug companies-but the in the economy as to be obscene. The Times wrote: "Abbott agreed to advantage of being in Texas is that no Furthermore, a new study by the Na­ pay Zenith as much as $2 million a one ever expects you to be up on this tional Institute for Health Care Man­ month not to produce its generic, up to stuff.) agement Foundation says the $20.8 a maximum of $42 million. The next As a cancer survivor, I am particu­ billion in increased spending "was at­ day, Abbott agreed to pay another larly susceptible to the wonderful ad in tributable, in large measure, to the rival, Geneva Pharmaceuticals, even which a woman recovering from breast rising volume of prescriptions for top­ more: $4.5 million a month up to $101 cancer tries to express her gratitude to selling drugs." million over the life of the contract." the drug companies that saved her life. Big Pharma's record on AIDS in Think how instructive it would be if I know she feels the same gratitude Africa is so appalling that in April it NBC ever put a story like that on "The to the doctors, the nurses, the order­ finally dropped its own lawsuit against Fleecing of Ameri01." lies, the health insurance company, her South Africa to prevent the country

4 • July 2001 Product Recalls May 12-]une 11,2001

D R lJ 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 and 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.

Class I Recall

\a me '!I'JJru,r.: or .\ufJfJlt•lllellt; Class '!1' Recall; Pro{Jfem Lot#; Quantity ami JJi.\trilmtiou; Jllllll!{adurer NEO CONCEPT Aller Relief Capsules In 30 and 90 count Lot #003480 EXP 3/03, Lot #006480 EXP 6/03, Lot #003480 EXP bottles; Product contains arlstolochic acid, a potent carcinogen and 3/03, Lot #006480 EXP 6/03; 1,665 bottles distributed nationwide; nephrotoxin BMK International, Inc., Wellesley, Massachusetts

Lot#; Q111mtit\' fllltl /Jislrilmlion; Mmll!fitrlm·er

Anti-Microbial Hand Soap, packed in 800 ml bags (active Numerous codes; 6,899 cases distributed in Illinois; Steiner Company, ingredient is parachlorometaxylenol); Class Ill; Product contains C.l. Inc., Holland, Ohio Acid Yellow #36, which is an unapproved dye

Armour Thyroid, 2 Grain (120 mg), levothyroxine (T 4) and Lot 30012, EXP 12/01; 553 tablet strip boxes distributed nationwide; liothyronine (T3), 100 tablets, individually blister-sealed tablets, RX Forest Pharmaceuticals, Inc., Cincinnati, Ohio indicated as a replacement or supplemental therapy in patients with hypothyroidism; Class Ill; The incorrect NDC number is printed on the blister cards

Children's Mylanta Upset Stomach Relief (Calcium Carbonate Code: DCF 033 EXP 2/02, DCF 060 EXP 3/02, DEF 044 and DEF 134 Antacid), 5 oz liquid bottles; Class II; Failure to perform microbiologi­ EXP 4/02, DEF 047 EXP 5/02, DHF 023 EXP 6/02, DJF 066, DJF 118 cal testing as per USP antimicrobial effectiveness test method and DJF 123 EXP 7/02, DPF 042 EXP 10/02, DSF 032 and EAF 011 EXP 12/02, EBF 049 and EBF 071 EXP 1/03; 770,000 bottles distrib­ uted nationwide and in Puerto Rico; Johnson &Johnson Merck Consumer Pharmaceuticals Company, Fort Washington, Pennsylvania

Clmetldlne Tablets, 800 mg., bottles of 100 tablets; Class Ill; Failed Lot 90570A and Lot 00197A; 2,013 bottles distributed nationwide; the 12 month test station dissolution test at room temperature TorPharm, A Division of Apotex, Etobiocoke, Ontario, Canada conditions

( Crlnone 4% and 8% (progesterone gel); Class Ill; Failure to Lot Numbers: C00103 EXP 02/02, C00104 EXP 03/02, C00107 EXP meet the specifications for viscosity 04/02, C001 09 EXP 06/02, C00113 and C00114 EXP 08/02, C00115 and C00116 EXP 09/02, C0118 and C00119 EXP 10/02, C00122 EXP 11/03; 118,296 units distributed nationwide; Fleet Laboratories, Watford, England

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\111111' t!f' Dl'll)!. m· .'illfJfJlewt•ut: Cfms 1!/' Recaff: Pm(Jfem Lot #: (j111111fily 111111 Dislrifmtiou; .1111111~/ttd/11'1'1'

Eagle Brand Medicated 011, 0.8 fl. oz. (24ml) glass bottles; Class All lot codes; 288,000 bottles distributed nationwide; Anhing Corpora­ II; Superpotency: methyl salicylate tion, Los Angeles, California

Flnast -Acna Wash, acne treatment with salicylic acid, containing - - Lot OH01 B.- ~P 08/02; 2,592 containers -distributed in New ¥ark; - 23.0% salicylic acid, packaged in 6-fl. oz. containers, 12 per case, Qualis, Inc. Des Moines, Iowa OTC; Class Ill; Component defect: Stainless steel spring within pump assembly is discoloring

Frash-n-Ciaan Hand Washing and Sanitizing Compound, 1 Case codes 050697,090397,082698,0824991, and 1116991; 768 gallon containers (active ingredient Didecyldimethylammonium cases distributed in Ohio; Steiner Company, Inc. Holland, Ohio Chloride); Class Ill; Product contains C.l. Acid Blue #80, which is an unapproved dye

Genaton Antacid 12 fl. oz. bottle; Class II; Product odor and Goldline brand, lots 01011 and 01 012; 12,899 bottles distributed discoloration nationwide; RIJ Pharmaceutical Corp., Middletown, New York

Geneva Tratlnoln Gal, 0.025%; Class Ill; Viscosity failure (3 month Batch I PM IP and PM IP-1, EXP 11 /02; 28,188 bottles distributed stability station) nationwide; OPT Laboratories, San Antonio, Texas. Recalled by Spear Pharmaceuticals, Titusville, Florida

Haart-Trax Tablets; Class Ill; Product distributed without an All lots of safety pack boxes (250 Packets of 2) and unit boxes of 8X2 approved new drug application for the cardiovascular related uses packets; 617 boxes distributed nationwide; Otis Clapp &Son, Inc., represented in the labeling and because it bears no dosage direction Canton, Massachusetts for use in pain and fever relief

Methocarbamol Tablets, skeletal muscle relaxant, 750 mg, 100 Lot 73013340, EXP 11/01; 7,065 bottles distributed nationwide; count, Rx; Class II; Product may contain metal fragments Watson Laboratories, Corona, California

Parphenazlna Tablets, 2 mg., 4 mg., 8 mg., 16 mg. tablets; Class Lots OB224, OJ900, 1A680, OC382, OJ891, 05474, 18909, OA067, II; Discoloration of tablets prior to expiry OP287, 08119, OS399; 12,557 distributed nationwide; Zenith Goldline Pharmaceuticals, Northvale, New Jersey. Recalled by UDL Laboratories, Inc., Rockford, Illinois

Pin-Rid Soft Gal Capsules, each capsule contains 180 mg Lot 5085H; 600 bottles distributed nationwide; Apothecary Products, pyrantel; Class Ill; All the bottles in recalled lot each contained 12 Inc., Burnsville, Minnesota instead of 24 capsules as labeled

Stool Softener Docusate Sodium (Discount Drug Mart Food Fair Lot J043, EXP 12/01; 1,440 bottles distributed in Ohio; PL Develop­ brand), 100 mg, 100 capsules (softgels) bottle (OTC); Class II; ments, Farmingdale, New York Mispackaging. Bottles of stimulant laxative plus stool softener (Casanthranol and Docusate Sodium ) were erroneously packaged into unit cartons labeled only as a stool softener (Docusate Sodium)

Trlmox 250 mg/5 mL-150 mL (Amoxicillin for Oral Suspension), Numerous codes with EXP 10/02; 831,267 bottles distributed Rx; Class II; Microbial contamination (mold) nationwide; Apothecon, A Bristol-Myers Squibb Company, Plainsboro, New Jersey

6 +JuJy2001 C () N S l T M E R P R () D l T 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 1-800-638-2n2. The CPSC web site is http://www.cpsc.gov.

.\'a me '!l Product: Pm/Jiem Lot#; Quauti~l' ttllll Di.~trifmtirm: Jlmll!/ilctm·e,·

Activity Rockers (Recall to replace toy bars); One of the toys, a clear Models #971 0-0 and #971 0-1 and lot #s 7000-10102 and 5000-6034; plastic ball can crack and break during use, exposing the small beads 4,100 sold nationwide from November 2000 through February 2001; inside, posing a choking hazard to young children COMBIInternational Corp., Carol Stream, Illinois (800) 992-6624 www.combi-intl.com

Bicycle Fortes; Forks can break during use causing rider to lose Giant-brand TRC Team and TCR 0, Year 00, Month: 8, 9, 10, or 11. control of the bicycle TCR 1, TCR 2 and OCR 1 Giant. beginning with "OH," "OJ," "OK" or "OL". Bicycles and Framesets, TCR 0 Giant Framesets; 2.400 sold nationwide from September 2000 through April 2001; Giant Bicycle, Inc., Newbury Park, California (800) 874-4268

Candles; Flame can ignite the silver paint coating on the candle Silver painted terracotta ceramic containers; 10,800 sold nationwide at container, presenting a fire hazard Schottenstein and Value City Stores from 10/00-12/00; Schottenstein and Value City Stores, Columbus, Ohio (888) 278-6370

Beech wood in variety of colors; 4,300 sold nationwide from August Changing Tables; Joints were not properly glued and can separate, 1998 through April2001; Child Craft Industries, Salem, Indiana presenting a fall hazard to babies (866) 423-3114 www.childcraftind.com

Glue Gun; Guns can overheat, presenting fire and burn hazards to Craftsman brand sold in Instant-On Bonder Kits; 33,000 sold nation­ consumers wide by Sears, Orchard Supply and OVC from October 2000 through March 2001; Return product to any Sears store or call Adhesive Technologies Inc. (800) 458-3486 •

Ovens; Door may not lock properly when in "self clean" mode, posing Thermador thermal/microwave model numbers CM301 UB, CM302UB, a fire risk CM301 UW, CM302UW, CM301 US, and CM302US with serial numbers 2003 through 201 0; 2,300 sold from May 2000 through May 2001; BSH Home Appliances Corp., Los Angeles, California (800) 735-4328

Push'n Pop Toys; Balloon tongues and the cylinders holding the Zapper toys-Tropical Fish and Rockin' Reptile; 6,500 sold nationwide tongues can detach, posing choking and aspiration hazards to young from August 1996 through March 2001; Raymond Geddes & Co. Inc., children Baltimore, Maryland (800) 533-6273 www.raymondgeddes.com

Swings (Recall to repair); Screws that hold the swing together can fall Star Cruiser and Rocket Rider swings sold with Hedstrom gym sets; out, causing the seat to fall to the ground 190,000 sold nationwide from September 2000 through April 2001; Hedstrom Corp., Bedford, Pennsylvania (800) 642-9193 www.hedstrom.com

Trimmers/Mowers; Trimmer heads, which control the cutting cords, Troy-Bitt models 52063 and 52064, and Garden Way 52067; 2,800 sold can split and detach, posing a serious injury risk nationwide from November 2000 through May 2001; Garden Way Inc., Troy, New York (800) 282-8965 www.troybilt.com

Vests (boys'); Elastic toggle cord on the end of the zipper pulls can URIT and Parisian Kids brands red nylon/blue fleece toddler sizes 2T- loosen and come off, posing achoking hazard 4T; 14,500 sold nationwide from July 2000 through January 2001; Saks Incorporated, Birmingham, Alabama. Return to any Saks store. Call CPSC hotline for more information.

Water Rocket Toys; Once propelled from launcher, can fly rapidly in Splash Blast with transparent blue plastic body; 108,000 sold nation­ unpredictable directions, posing injury risk wide from January through March 2001; Spin Master Toys, Ontario, Canada (800) 622-8339 www.spinmaster.com

Public Citizen's Health Research Group + Health Letter + 7 Why Doesn't the Government Know About These Doctors?

1be following is excerpted from a NPDB, has been a known source of • Anabolic steroids (used for body­ letter sent on june 6th by Dr. Sidney contention between the Department of building, etc.) were seized from the Wolfe to U.S. Attorney General john Health and Human Services (HHS) office of a California physician who Ashcroft. Division of Quality Assurance (DQA) pleaded guilty and was sentenced to which oversees the NPDB and the prison for receiving and distributing Dear Attorney General Ashcroft: justice Department's DEA for more steroids. than five years. It has resulted in the e have obtained informa­ deception of those who use the NPDB. • A California physician was found to tion documenting that the We obtained the public use file from have diverted in excess of 50,000 dos­ r W Drug Enforcement Admin­ the DQA (which deletes the names of age units of controlled substances in istration (DEA), a division of the De­ physidans) covering the period from 1992 and 1993. partment of]ustice, has failed to provide the inception of the data bank (Sep­ to the National Practitioner Data Bank tember 1, 1990) through the end of the • A Florida physician surrendered her (NPDB) reports on all U.S. physicians­ year 2000. We compared this to the controlled substance license because at least 2,592-who "voluntarily" sur­ DEA actions in our database, 20,125 of illegal exportation of Dexedrine rendered their federal (DEA) narcotic Questionable Doctors, excluding those (dextroamphetamine). prescribing licenses between Septem­ actions in our data which occurred ber 1, 1990 and the present. These prior to September 1, 1990, when the • A Kentucky physician admitted to physicians usually "volunteer" to do so NPDB became operative. having a sexual relationship with a only because of impending revoca­ The NPDB only contains data on patient in exchange for prescriptions. tion, after having been found to have 286 physicians against whom a total of violated the federal Controlled Sub­ 294 DEA actions were taken. All of The history of DEA's unwillingness stances Act or to have engaged in other these actions were license revocations. to disclose information about doctors unacceptable medical practices. As a There is not one report in the NPDB of who surrendered their narcotics licenses a physician who surrendered his or her dates back to 1992 when Public Citizen's DEA license from September 1, 1990 Health Research Group brought suit through December 31, 1999 although against the DEA arguing that the Free­ State medical boards, the Questionable Doctors database, dom of Information Act (FOIA) re­ published in August 2000, contains quired disclosure not only of license hospitals and HMOs, reports of 2,592 physicians who sur­ rendered their DEA licenses during the are not aware of the same interval. In addition to this seri­ ous DEA reporting deficiency, as of A Kentucky physician DEA's actions against May 15th of this year, the DEA had not submitted to the NPDB any reports for admitted to having a these 2,592 the year 2000, not even revocation ~ reports. sexual relationship physicians. Examples of offenses committed by physicians that led to their "voluntary" with a patient in surrender of their DEA license included in Questionable Doctors but not re­ exchange for result, those health entities making ported by the DEA to the NPDB in­ queries of the NPDB-state medical clude the following: prescriptions. bQards, hospitaJs and HMOs.-are not aware of the DEA's actions against • An Arizona physician was cnmi­ these 2,592 physicians. We urge you to nally convicted of obtaining Halcion immediately order the DEA to provide and Tylenol III (with codeine) by fraud. revocations (which are published in the NPDB with all the information on the Federal Register) but also of license these physicians so that this can be • A California physician was arrested surrenders. The DEA had contended added to the NPDB. The failure to for selling prescriptions in return for that it would not give us data on license report these physicians, as intended by large fees for office visits. surrenders because to do so would the laws and regulations governing the invade the personal privacy of physi-

8 • july 2001 cians who had surrendered their li­ The NPDB was not so fortunate as to ensure that health care entities will censes and would interfere with the we were but HHS's Division of Quality not resort to "plea bargains" in which a DEA's law enforcement efforts by lift­ Assurance did not seek to get the physician agrees to such a surrender in ing the cover on the voluntary DEA information from the DEA as aggres­ return for the health care entity's prom­ license surrender agreements. After we sively as we did. A House of Represen­ ise not to inform other health care filed suit, lawyers from the Justice tatives' report on the National Health entities about the circumstances of the Department decided that the DEA's Quality Assurance Act of 1986, which physician's surrender of privileges. position was indefensible as a matter provided for the initiation of the NPDB, While such agreements may serve the of law, and the case was settled in stateo;- -with re-specr--to- health- care immediate self-interests -- of -the two January 1993 with an agreement that entities, that "the purpose of requiring parties involved, they may jeopardize requires the DEA to provide us with reports even for circumstances in which the health and safety of future pa­ license surrender information. physicians surrender their privileges is tients .... " r 20,125 Questionable Doctors

To order Questionable Doctors by phone, please call1-877-747-1616. To order Questionable Doctors on line visit our web site at http://www.questionabledoctors.org. Although we cannot list the individual doctors names on the web site, there is statistical information for each state regarding the number of actions taken and the offenses for which they were taken. Clip this form and mail to: Public Citizen Publications, Dept. QD2000, 1600 20th Street NW, Washington, DC 20009. ·Please allow 6 to 8 weeks for delivery of publications.

The following editions are available:

Qty Item I Hem Price Total Qty Item I Hem Price Total FQON Quelllonable Do«ors4-vol. National EdHion $407.50 FQ114 Ka11111, Nebrallla, Norlll Dakota, Soutll Dakota $23.51 FQCD QulltiDfllble Drwftlll CD-ROM $807.50 FQ815 Oklahoma, Texn $23.111 2DDD Edition Queltlonable Doctors Rlflonal Edltloll FQ1111 Minnesota, Wisconsin $23.51 FQ001 Arbn111, Louisiana, Ml11l11lppl $23.51 FQ117 Mlchlga11, Olllo $23.51 r FQ011 Pennsylvania, West VIrginia $23.58 ,_, FQ002 Alaska, Idaho, Montana, Oregon, Washington, Wyoming $23.50 1'/1111 note: pr#cn Include lhlpplng 1nd hlndllng TOTAL FQ003 Arizona, Colorsdo, NIIVada, New Mexico, Utah $23.50 ' FQ004 California, HaWIII $23.50 o Payment enclosed (check or money order payable to "Public Citizen") FQ005 Connecticut, Maine, Massachusetts, 0 Charge to credit card !;] VISA D MasterCard D AMEX D Discover New Hampshire, Rhode Island, Vermont $23.50 Credit Card# ------Exp Date _____ FQOOII Delaware, New Jersey $23.58 Signature ______F0007 District of Columbia, Maryland, VIrginia $23.50 FQ008 Florida $23.50 Ordered By: FQ009 Alabama, Georgia $23.50 Name (Please Print) ------FQ010 Illinois, Indiana $23.50 Address ------FQ011 loWI, Ml110url $23.50 City ------Zip ______FQ012 New York $23.50 State ------­ F0013 Kentuclcy, North Carolina, Phone number:( __) ------South Carolina, Tennessee $23.50 HL0701

Public Citizen's Health Research Group + Health uuer + 9 Internal memos from the DQA and misconduct, or revoked ..... " As of now, revised HHS/DEA memorandum of correspondence between the DQA and almost four years later, this memoran­ understanding, then sitting at the DEA the DEA document the long-standing dum has never been signed by the for 1-1/2 years, was still "under review conflict over the submission of DEA DEA. by DEA's Office of Chief Counsel" and license surrender information to the For the last several years there have that "We will advise you when their NPDB. Some of this history is re­ been a series of broken promises by review is completed in the near fu­ viewed in a 1997 HHS Inspector Gen­ the DEA to provide this important ture." As of now, 2-1/2 years after this eral Report entitled Drug Enforcement promise and almost four years after the Administration Reporting to the Na­ memorandum of understanding was tional Practitioner Data Bank. The first sent by HHS to DEA, it remains report pointed out that between the DEA's promise to unsigned and DEA's promise to submit initiation of the data bank in Septem­ the information on the 2,592 physi­ ber 1990 and early 1996 "DEA has submit the cians who "voluntarily" surrendered reported a total of about 150 actions to their DEA narcotics licenses remains the Data Bank. However, according to information on the unfulfilled. DEA, it annually sanctions about three This is a matter of extreme urgency times the number of providers re­ 2,592 physicians since every day that goes by with the ported to the data bank." Referring to NPDB failing to include information the House report on the law cited who Itvoluntarily" about these 2,592 doctors is a day above, the Inspector General con­ when people making the thousands of cluded that, "Clearly, congressional surrendered their daily inquiries of the NPDB are being intent seems to warrant DEA reporting misled by the absence of information of 'voluntary withdrawals."' DBA narcotics concerning serious offenses by doctors The report recommended "that the such as detailed in the examples above. Drug Enforcement Administration and licenses remains The absence of such information about Data Bank officials work together to voluntary surrenders, as the House of include voluntary withdrawals as part unfulfilled. Representatives' report on the legisla­ of adverse action reporting to the Data tion establishing the NPDB clearly Bank." Included was a recommenda­ stated, "may jeopardize the health and tion to modify the 1988 Memorandum safety of future patients .... " of Understanding signed by HHS and information on voluntary surrenders I hope to hear from you promptly DEA concerning reporting require­ so that this information can be in­ about the long overdue resolution of ments to state, explicitly, that volun­ cluded in the Data Bank. A February 5, this issue and if there are further ques­ tary surrenders must be included. A 1998 memo of a phone conversation tions, please do not hesitate to call. draft of this new memorandum of between DEA'sJimSheehanand DQA's •••• understanding was sent by the DQA to Stan Levin stated that Sheehan had Later in the day the letter was sent, DEA in July 1997, including the state­ agreed "that DEA would submit the the DEA called the National Practitio­ ment that the DEA will report to the voluntary surrenders." ner Data Bank and assured them that NPDB all information on DEA regis­ The last written correspondence they would begin to receive the volun­ trants whose controlled substance reg­ from DEA to DQA concerning this tary license surrenders. istration "has been suspended, denied, issue was more than two years ago, We will eagerly await this tum in voluntarily withdrawn as the result of January 11, 1999. It stated that the events.

THE PUBLIC CrT'IZI!N HEALTH RI!SI!ARCH CROUP Bdttor ...... Sfdney M. Wolfe The Health Research Group was co-founded in 1971 by Ralph Nader and Sidney Wolfe in Managtng Bdttor ...... PbyUts McCartby Hutltl1 Letter Washington, D.C. to fight for the public's Staff Researcber ...... Bentta Marcus Adler health, and to give consumers more control Productton Mgr...... Krlsty 1 jackson over declsions that affect their health. Proofreader ...... Bentta Marcus Adler Copyright Cl Health Letter, 2001 Material In the Health Letter may not be re­ Published Monthly by printed without permission from the Editor. Public Citizen Health Research Group Send letters and requests to HEAL1H LE1TER, Presfdent ...... joan Claybrook All rights reserved. ISSN 0882-598X Editor, 1600 20th St., NW, Washington, D.C., Foutuler ...... Ralpb Nader 20009. Annual subscription price is $18.00 (12 is­ sues). Mall subscriptions and address changes to Health Letter, Circulation Department, 16oo 20th St., NW, Washington, D.C., 20009. Our Web site address is www.dtblcn.org/hrg

10 • july 2001 OUTRAGE,from page 12 Timothy Muris, Chairman of the FTC. by one foreign firm on automatic Commission has filed a complaint in As part of the coordinated Cure.All detention without physical exami­ federal district court against the sixth effort, the FDA is also highlighting a nation, which will prevent this de­ company. variety of initiatives it has taken in the vice from legally entering the United Among the many false and unsub­ past year to combat Internet health States. stantiated claims challenged in today's fraud. According to the FDA, "Many of cases were promises that: the Web sites targeted today are jeop­ Consumer Education ardizing the health and safety of con­ Because promoters of fraudulent • - People- €ould canGel-their- surgecy:,­ sumers with _outlandish_promises_and _ health__(;ar~p_mdu(:tLQfl~D- U.§..~ similar radiation or chemotherapy in favor false hope." claims and practices to lure consumers of herbal cures that cost hundreds of into buying their products, the FTC dollars; Colloidal Sllver advises consumers to be suspicious of: The FDA and FTC have identified • A device that delivered mild electric firms that marketed Colloidal Silver as • Claims that the product is "natural" current would kill the parasites that a cure, treatment, or prevention of or "non-toxic," suggesting it does cause such serious diseases as can­ serious diseases. As part of Cure.All, not have side effects. "Natural" or cer and Alzheimer's; and the FDA identified 48 Web sites that "non-toxic" does not necessarily made serious drug claims for Colloidal mean safe. Some "natural" supple­ • Those with HIV or AIDS could use Silver, as well as a number of other ments contain potent stimulants; St. John's Wort as a safe treatment products. The FDA sent these Web others, like St. John's Wort, can for the disease. In fact, the FTC sites Cyber Letters, untitled letters sent result in negative interactions with alleged, there is inadequate evidence via electronic mail, informing them medicines. to support the use of the herb to that their products were being prcr treat AIDS. Indeed, St.John's Wort is moted for conditions that may cause • Testimonials from people who claim known to interfere with proven HNI the products to be considered drugs amazing results. Testimonials often AIDS medications. and therefore may be in violation of the are undocumented and are not a Federal Food, Drug, and Cosmetic Act. substitute for scientific proof. Moreover, two cases challenge the As a direct result of these Cyber Letters, promotion of St. John's Wort as a safe 27 percent of the sites complied by • Claims that a product is a "scientific treatment for HIV/ AIDS, a claim that removing or changing the violative breakthrough," "miraculous cure," presented serious drug interaction risks. claims. "secret ingredient" or "ancient rem­ In February 2000, the FDA issued a edy." Public Health Advisory to alert health Rife Frequency Generators and care providers and consumers to the Zappers • Claims that the product is an effec­ results of an NIH study and other These are devices that purportedly tive cure for a wide range of ail­ reports in the medical literature indi­ send different amounts of electrical ments. cating that taking St. John's Wort may energy into the body to destroy para­ cause a loss of therapeutic effect for sites and/or shatter cells to cure serious • Claims that use impressive sounding any drug metabolized along the same diseases, such as cancer and AIDS. As medical terms. specified pathway, including HN medi­ part of "Operation Cure.All," the FDA cations, drugs to prevent transplant has taken several actions with respect • Claims that the product is available rejection, and oral contraceptives. The to these devices: from only one source, and payment Advisory is posted on FDA's web site at is required in advance. http://www.fda.gov I cder/drug/ advi­ • FDA issued warning letters to sev­ soryI stjwort.htrn. eral firms selling these devices in­ • Claims of a "money-back" guaran­ "Many herbal products and other forming them that they were in tee. supplements are promoted as natural violation of the Federal Food, Drug, and having no side effects. We want and Cosmetic Act; • Web sites that fail to list the consumers to understand that these company's name, physical address, products are pharmacologically active • FDA also issued several untitled phone number or other contact in­ and can be very potent, and that pa­ letters to firms questioning the legal­ formation. tients know to be careful not to mix ity of the marketing of these devices. medications without consulting their Most of these firms have either re­ To ensure the safe use of supple­ doctor, pharmacist, or health care prcr moved or modified their Web sites; ments and other health-related prod­ fessional. They need to be just as and ucts, consumers should let their health cautious about combining supplements care provider know if they are using with their medications," cautioned • FDA placed the Zapper promoted these products.

Public Citizen's Health Research Group + Health Letter + 11 OUTRAGE OF THE MONTH "Operation Cure.All"Wages New Battle in Ongoing War Against Internet Health Fraud

hilewearepleasedthatthe rected at doctors but an increasing •••• Federal Trade Commission proportion at patients, which have FfC, FDA and other law enforce­ W (FTC) and the Food and been found to violate FDA law and mentagenciesmovetostoplnternet Dntg Administration (FDA) are vig­ regulations, usually because they over­ scams for supplements and other orously going after fraudulent and state the benefits and understate the products that purport to cure can­ sometimes dangerous products such risks. Thanks to the pharmaceutical cer, mvI AIDS and countless other as the ones discussed in their an­ industry, the FDA has no authority to life-threatening diseases. FfC also nouncement below of their new pro­ assess civil monetarypenalties against warns of risks associated with some gram "Operation Cure.A/1", we have thesecompanies, evenwhen-asmany supplements, including drug interac­ several concerns about the breadth hav~they repeatedly violate the law tions. and depth of these efforts. and rnn a different misleading ad In the six FfC cases announced In addition to claims for products after the first has been found illegal. today, the companies were charged never proven to be safe and effective, Beyond the FDA~ inability to really with making false and unsubstantiated such as many dietary supplements and get serious with these prescription drug health and safety claims for a variety of herbals, we are equally concerned companies, neither the FDA nor the products advertised on the Internet. about false and misleading advertise­ FTC has anywhere near the adequate Five of the companies agreed to settle ments for prescription drngs. In the number ofstaff investigators necessary the charges and the proposed settle­ past four-and-one-half years there to tackle this epidemic of hucksterism ment agreements were announced to­ have been more than 500 advertise­ which peroades not only the internet day for public comment. The ments for prescription drngs, most di- but print and radio/television as well. continued on page 11

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