PUBLIC CITIZEN HEALTH RESEARCH GROUP

SIDNEY M. WOLFE, M . D . , EDITOR SEPTEMBER 2001 + VOL. 17, NO . 9

Criminal Charges Should Be Filed Against Schering-Plough

1befollowing is a letter sent to Tommy Plough albuterol products which had for which the Schering-Plough albuterol Thompson, Secretary, Deparlment of occurred around the time of the two was listed as the "primary suspect" and Health and Human Services, on Au­ (9/ 99 and 3/ 00) recalls. Thus, this new in which there is a date of death. gust 9th, by Dr. Sidney Wolfe urging information, along with other findings During the last two quarters of 2000, criminal prosecution of Scbering­ discussed below, significantly adds to the last period for which we have been Plougb based on their leaving danger­ the compelling case for criminal pros­ able to obtain data, there have been no ous asthma inhalers on the market ecution of Schering-Plough. subsequent deaths reported to have knowing they bad caused at least one As can be seen on the chart on the occurred in users of these products. death. following page, there were no deaths For an additional seven deaths in people reported to the FDA to have occurred using these asthma inhalers, there was n March 1st of this year [see in users of Proventil or Warrick's no exact date of death given and the the April 2001 issue of Health albuterol (generic version also manu­ cases were reported to the company 0 Letten, I wrote to you, urging factured by Schering-Plough) during between March 30th and August 9, that you "launch an investigation into the first three quarters of 1998. How­ 2000. criminal charges against Schering­ ever, starting with a death that oc­ This pattern of deaths, with none Plough based on the possibility that the curred in the fourth quarter of 1998 and occurring before or after the interval company knowingly shipped millions continuing through the second quarter during which the defective albuterol of the 59 million units of albuterol­ of 2000, there were a total of 17 deaths inhalers were shipped for use, is known containing asthma drug eventually re­ called, between the time the company became aware of the seriously flawed CONTENTS manufacturing processes and the time the March 2000 recall was finally ac­ Direct-to-Consumer (DTC) Ads: illegal, Unethical or Both complished." The company had ex­ Find out how accurate these ads are and what the FDA is doing--or not plained that the basis for the recall was doing-about it...... 3 "the remote possibility that an aerosol container may not contain active drug." Below the Beltway The failure to be able to treat and A Washington Post columnist takes a humorous look at food supplement advertising ...... 5 stop an acute asthmatic attack, because there i's no asthma drug in the inhaler Product Recalls upon which the patient relies, is obvi­ July 12-August 18, 2001 ously a life-threatening situation. We Benadryl, insulin pumps and bicycle parts are on our list this month . .. 6 therefore subsequently have analyzed adverse reaction report data obtained Outrage of the Month Crouching Government, Hidden Snake Oil from the Food and Drug Administra­ Yet another dietary supplement is making outlandish claims and the FDA tion (FDA) and found that there was a can't do much to stop them ...... 12 pattern of deaths in users of Schering-

VISIT HEALTH RESEARCH GROUP'S WEB SITE AT WWW.CITIZEN.ORG/HRG/ as a point source epidemic and strongly implicates these products as causes of Schering-Piough Albuteroi/Proventil the deaths. Asthma Inhaler Deaths• Of the 17 patients with known dates of death, 10 of them were using, or Reported to the FDA listed by Date of Death (defective inhalers-some with no drug-recalled 9/9/99 and 3/29/00) attempting to use, inhalers from the lots which were eventually recalled, 5 5 including two from the lot recalled in ..... September 1999 and eight from the lots Q) t: I 4 recalled in March 2000 according to the ~4 FDA documents. For the other seven 0' ..... Q) patients, lot numbers were not listed in 0... the FDA data we received. In informa­ ~3 ·;:: tion also included with the FDA ad­ ..... :J u verse reaction reports, for 5 of the 17 u patients who died, there were com­ 02 ments indicating that the patients had ...r::...."' ~ not gotten relief from their asthmatic Q) attacks from the Schering-Plough in­ 0 1 halers. The remarks included those of a 21-year-old, shortly before his death, I 0 0 o•t l f;J~I--1 lll9! 0 0 who "complained on several occasions 0 that his albuterol inhaler did not seem ,01 02 03 04, ,01 02 03 04, p1 02 03 04, to treat his asthma attacks as usual." A 1998 1999 1999 10-year-old boy who had an asthmatic • FDA adverse event reports with death dates, compiled by PubUc Citizen Health Research Group attack "reached for his inhaler and obtained no relief" and died shortly ate attention." inhalers from a lot eventually recalled thereafter. Both of these people were However, at least one death case in March 2000, died in September 1999 using inhalers from the recalled lots. Of was known to the company on Janu­ and the company was notified on those who died whose ages were ary 4, 2000, prior to the second (March January 4, 2000. Unfortunately, it was known, six were under the age of 30 29, 2000) recall and this death may almost three months after Schering­ including three who were less than 20 well have helped to precipitate the Plough learned about her death that (10, 12, and 16). the March 29th recall was belatedly Although many of these deaths oc­ undertaken. During these first three curred before the first recall and most If you were using either an months of2000, while Schering-Plough of the rest before the second recall, was aware of her death but did not most were not reported to the com­ albuterol, Proventil, or recall the inhalers, another five deaths pany, according to the company's data, Warrick inhaler and had a occurred in people using inhalers that until after the second recall. One likely were recalled on March 29, 2000. explanation is that it is counterintuitive problem with its Aside from delaying the second re­ for patients, their families, or physi­ effectiveness, please email us call almost three months after learning cians to believe that an asthma inhaler of a death in a woman using the could be so shoddily manufactured as at hrgl @citizen.org eventually-recalled product, Schering­ to fail to contain the asthma drug. so we can send you some Plough was reckless in not recalling all Therefore, until the widespread pub­ of the eventually recalled lots at the licity following the second recall, the questions to answer time they recalled the one lot, 9-BBS- link between the deaths and the defec­ concerning the situation. 525, in September 1999. According to tive inhalers was probably not sus­ the company's press release of Sep­ pected by many people. It was, in fact, tember 9, 1999, announcing that first after the second recall, on March 29, February to April2000 outside audit by recall of 190,000 asthma inhalers, it 2000, that Schering-Plough advised that the AAC Consulting Group, during was precipitated after "one patient re­ "Proventil and Warrick brand albuterol which the March 29th recall of 59 turned an inhaler that did not contain patients using a canister without active million units of albuterol aerosol inhal­ drug substance." It is of great impor­ drug will not obtain their usual relief ers was finally done. tance that when the massive, 59 million from asthma symptoms." The com­ According to FDA documents, a unit recall of March 29, 2000 was finally pany press release stated that "an in­ woman of unknown age who had a ordered, lots which, according to their haler that does not contain active drug previous history of "well-controlled lot number and expiration dates, were is a serious matter that merits immedi- asthma" who was using one of the continued on page 3

2 +September 2001 Direct-to-Consumer (DTC)Ads: Illegal, Unethical or Both

The following testimony was given had safer, more effective drugs been in DDMAC staff to monitor such adver­ by Dr. Sidney M. Wolfe in front of the prescribed. tising and it comes none too soon. Senate Commerce Committee Subcom­ The more than 500 prescription drug Even this may well not be adequate. mittee on Consumer Affairs bearing advertisements that have been found As seen in the table on the next on july 24, 2001. by the Food and Drug Administration page, there has been a sharp and (FDA) to violate federal laws and regu­ steady decrease during the last three ecause of the strong First Amend­ lations from 1997 through the present years in the number of FDA warning ment in the U.S constitution, include approximately 90 DTC ads. letters and notices of violation of FDA B there is no way that DTC pre­ These numbers would be significantly laws and regulations to drug compa­ scription drug advertising could ever larger if FDA's DDMAC (Division of nies concerning prescription drug ad­ be banned in this country. Having said Drug Marketing Advertising and Com­ vertising. From a peak of 84 such that, however, there is an urgent need munication) had more staff to investi­ enforcement actions during the first six for more fine-tuned, better-staffed and gate the rapidly expanding area ofDTC months of 1998, the number has fallen much tougher government regulation drug promotion. Such advertising has steadily to 36 FDA actions during the of its content. There is little doubt that more than tripled in dollar volume last six months of 2000 and an esti­ false and misleading advertising to from $791 million in 1996 to $2.5 mated 38 actions during the first six patients and physicians can result in billion in 2000. But the number of FDA months of 2001. prescriptions being written for drugs staff assigned to reviewing and inves­ For the last year (mid-2000 through that are more dangerous and/or less tigating all of prescription drug adver­ mid-2001) the total number ofDDMAC effective than perceived by either the tising, during the same interval, has advertising enforcement actions-74- doctor or the patient. This can then only increased from 11 in 1996 to 14 at was less than one-half (47 percent) of lead to a subsequent toll of deaths and present. I have been informed that the 158 enforcement actions taken three injuries that would not have occurred there is, or will shortly be, an increase years ago (mid-1997 through mid-1998). There is no evidence of an advertising/ pharmaceutical industry epiphany, re­ SCHERING-PLOUGH,from page 2 albuterol inhalers, at Schering-Plough's sulting in fewer illegal advertisements manufactured both before and after New Jersey plant, repeatedly docu­ for prescription drugs. Therefore, the the 9-BBS-525 lot were ultimately re­ mented in FDA inspections, FDA warn­ only plausible explanation for this dan­ called. Thus, Schering-Plough made a ing letters to the company and in the gewus decrease is that the police financially conservative but public company's private audit by AAC Con­ force-DDMAC-has not been strong health reckless decision in September sulting Group, during which the March enough in numbers of investigators 1999 that, despite a long history of 2000 recall finally occurred. Now, there along with a lack of adequate pro­ systemic problems involving the manu­ is additional evidence that the com­ enforcement leadership from the top facture of albuterol inhalers, only the pany not only failed to recall millions officials in the FDA. That this latter lot from which the patient was unable of defective asthma inhalers for three explanation, inadequate enforcement, to relieve his/her asthma attack would months after learning on January 4, is correct will be seen when the FDA, be recalled. At the time of the second 2000 of a death in a woman using one with the urging and support of your (March 2000) recall, the company be­ of these inhalers, but that there were committee, begins to increase the num­ latedly admitted that "the [March] recall many deaths in people which would ber of actions taken against these vio­ relates to an aerosol manufacturing have been avoided if there been an lative ads. Until then, Americans-both problem that had been previously iden­ earlier, September 1999 recall of the 59 physicians and patients-will be tified in October 1999." Although all million units. harmed by prescribing decisions about lots of the massive March 2000 recall Based on this new information con­ which drugs to use based on all-too­ were said to have been manufactured cerning the deaths, there is even more frequently false and misleading infor­ before September 30, 1999, it is likely, reason for criminally prosecuting mation from advertisements which are if not certain, that the company shipped Schering-Plough for introducing these much less likely to be stopped because many of these lots into channels of defective products into the market­ of poorer enforcement by the FDA. commerce after that date. place and failing to recall them much In addition to more staff, there is a In our initial letter, the request for a earlier. If you have any questions about dire need for DTC-specific regulations criminal investigation was based on this serious problem, please call and I since, other than the late 1990s guid­ the long standing pattern of danger­ will meet with those involved. ance concerning1V advertising-which ously sloppy manufacturing, including continued on page 4

Public Citizen's Health Research Group + Health Letter + 3 DIRECT TO CONSUMER ADS, frompage3 Deceased FDA Enforcement of Prescription is a guidance not a regulation-there Drug Advertising are no regulations specifically written 1997 through mid-2001 for DTC advertising. The FDA has been using the regulations promulgated af­ 100 ter the 1962 Kefauver-Harris Amend­ * ..s:::."' ments to the Food, Drug and Cosmetic ....c: 0 Act that were clearly intended for pre­ ~ 80 scription drug advertising directed at X v; health professionals such as doctors .... Cl) and pharmacists. We have been urging c.. 60 ....c: the agency since the mid-1980s to Cl) propose and finalize such consumer E Cl) specific DTC regulations that would ~ 40 ..9 make it easier to evaluate the ads in the c: LU context of patient, not health profes­ -c sional, comprehension. Beyond more < 20 < staff and DTC-specific regulations, there 0 is a need for much more enforcement LL.. power. At present, the FDA is limited to 0 1-6/97 7-12/97 1-6/96 7-12/98 1-6/99 7-12/99 1-6/00 7-12/00 1-6/01•• a Notice of Violation or Warning Letter to companies found to violate the law • FDA notice of violation/warning letters by date of letter or regulations. Theoretically, in the •• Extrapolated from data through mid-June face of multiple warnings to the same company, criminal prosecution is a • In one study, researchers found that thors concluded that the ads provided possible tool. This latter power has consumers rated the safety and appeal only a minimal amount of educational only been used a handful of times in of drugs described with an incomplete information. the past 35 years. To our knowledge, risk statement significantly more posi­ criminal prosecution has never been tively than those whose risks were • One study asked patients what they used in the context ofDTC advertising, described more completely. (This has would do if a doctor refused to pre­ despite, for example, a series of 11 significant implications since so many scribe a drug that the patient wanted as illegal ads for Claritin (8 DTC), 14 DTC ads understate the safety of drugs.) a result of a DTC ad. One-fourth of illegal ads for Flonase/Flovent (8 DTC). patients said they would seek a pre­ (Flonase and Flovent are the same • Another study found that consumer scription elsewhere and 15 percent drug in two versions, one used for beliefs that there was prior scrutiny of said they would consider terminating allergy, the other for asthma). There DTC ads by the FDA and that they were their relationship with their physician. have also been five illegal ads for held to higher standards than other ads The patients with these attitudes were Celebrex (1 DTC). were generally wrong. A substantial ones who had a more favorable evalu­ The ability to assess drug compa­ proportion. believed that only the saf­ ation of DTC advertising and who nies large civil monetary penalties for est and most effective drugs could be possessed more faith in the current advertising violations might actually advertised DTC and that the FDA re­ government regulation of DTC drug serve as a deterrent for companies who quired prior review of ads. DTC ads ads. now just stop the violative ad, when led one-fifth of people to request a requested by the FDA, then create and prescription. In summary, FDA resources and massively disseminate a new one shortly specific regulatory authority to moni­ thereafter. The FDA currently lacks the • A study on the educational content tor the accuracy of drug safety and authority to impose any civil penalties of DTC ads found that while many ads effectiveness portrayed in DTC ads are for drug advertising or, in fact, for any provided information about the name dangerously inadequate and many other illegal drug industry activity con­ and symptoms of the disease for which patients' perceptions of the ads and cerning prescription drugs. It is long the drug was being promoted, few their subsequent response to the "in­ overdue that the Congress give the educated the patients about the suc­ formation" therein is similarly danger­ FDA this authority. cess rate of the drug, how long you had ous. The present situation concerning A search of the peer-reviewed, pub­ to use the drug, alternative treatments DTC advertising is unacceptable and it lished medical studies concerning DTC including behavioral changes which is our hope that your committee will advertising yields findings that, for the could improve their health, or miscon­ initiate actions to remedy these serious most part, are also quite worrisome: ceptions about the disease. The au- problems.

4 +September 2001 Below the Beltway

The following column is reprinted control of the Food and Drug Admin­ ally, call me. He talks exactly like he from the Washington Post of Sunday, istration, permitting all sorts of thinly does in the ad-fast, and energetic. No, july 29, 2001 with their permission supported claims. he is not a medical doctor, he said, but and was written by Gene Weingarten . I called the Focus Factor 800 num­ so what? "Are you saying you think you ber. The salesman, Tom, kept trying to need to be a doctor to be an expert on f you're l! ke me, you suffer the get me to pay $149.99 for a special nutrition?" occasional absent-minded moment: introductory three-month supply, and Well, urn, yeah. I misplaCing your keys, losing y ur I kept saying I wanted to talk to Dr. Dr. Smith disagreed. Brain starva­ train of thought, arriving at work with­ Smith personally. Exasperated, Tom tion is real, he said: "The brain is the out pants, etc. That is why I snapped to finally said, "If you were gonna buy a most nutritionally sensitive organ in attention the instant I heard the ad on Chrysler, would you call up and ask to the body." the radio for a food supplement called talk to Lee Iacocca?" and hung up on It certainly does seem to be suscep­ Focus Factor: me. tible to manipulation. So then I decided to research Dr. Kyl Later that day I heard the radio ad It's one of the top complaints that Smith via Mary Lou . Mary Lou is a again-it seems to run every 12 sec­ doctors hearfrom their patients today. Washington Post librarian. Washing­ onds or so on WTOP, Washington's all­ The symptoms include fatigue, poor ton Post librarians-! don't mean to news-and-brain-mush station. So I memory and trouble concentrating. alarm you, personally--can find out called Matt Mills, WTOP's general sales It's called Brain Starvation/ everything about you, such as your manager. What did Mills, profession­ birth date, your professional affilia­ ally, think of the ad? At last, a diagnosis. I wasn't old, I tions, your address and the price you "I am not going to give any opinion," was hungry! Could this be? After I got paid for your home. (Too much, in he said, "that might be adversarial or to work I telephoned my doctor, but your case. She checked.) challenging to an advertiser." when the receptionist answered-true The most intriguing thing I learned This led to the obvious question: If fact-I forgot why I had called. Fortu­ from Mary Lou was that Dr. Smith I paid in cash money, would WTOP run nately, this ad is everywhere, and I appears to be "Dr." Smith more or less an ad for a pill that guaranteed endless soon heard it again on my way home. in the sense that Dr. Seuss was "Dr." sex with strangers? Or offered a car that Focus Factor's creator, Dr. Kyl Smith, Seuss. Kyl Smith lives in Texas, but he could go 7,000 mph? Matt said he could explains in his ad that modern food­ is not licensed to practice medicine not discuss these things because they processing practices leach nutrients there. He appears to be a chiropractor. would involve "internal station proce­ from our foods: This can turn an other­ I tried to phone Dr. Smith to ask him dures." wise healthy brain into mush! about this, but for two days he didn't I was going to write a scathing This was more serious than I thought. answer the messages I left on his indictment about WTOP but then had To hell with my doctor, a mere GP . machine. I did reach his father-in-law a better idea. Kyl Smith might not be a I telephoned Washington's most (Mary Lou does good work), who medical doctor, but he is no dope. He's renowned nutritionist, C. Wayne informed me that the best way to reach making money to pay for those ads, Calloway, and demanded to know why Kyl was to buy his product, look at the and I am guessing it's coming from medical science had not warned us of label, and then contact the company people who hear his ads and buy Focus this national scourge. He listened to and ask for an appointment to speak Factor. So instead of embarrassing Matt, the text of the ad, and laughed. "It's with Kyl. When I said it would be easier I am going to become his client. ludicrous," he said. The body takes for me to reach, say, the vice president Coming soon on WTOP: care of the brain first, he said, before of the United States, Dr. Smith's father­ any other organ: So, as a medical in-law replied huffily that Kyl is a busy Do you sufferfrom extreme gullibil­ diagnosis, "brain starvation" can be man. Reporters, he said, have to learn ity? I have [a} product that can help adequately summarized by its initials. to go through publicists "the way you restore your natural body defenses Dr. Wayne blamed this sort of ad on do with movie stars." against hype. Fora mere $149.99, . .. Congress, which in 1994 passed a law Even movie stars eventually get in­ exempting food supplements from terviewed, and Dr. Smith did, eventu-

Public Citizen's Health Research Group + Health Letter + 5 Product Recalls july 12-August 18,2001

his chart includes recalls from the Food and Drug Administration (FDA) Enforcement Report for drugs, dietary Tsupplements and medical devices, and Consumer Product Safety Commission (CPSC) recalls of consumer products. DRUGS & DIETARY SUPPLEMENTS

The recalls noted here reflect actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. 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 Recalls

Name of Drug or Suppleme11t; Clt1ss o.f Recal~· Problem Lot #; Qua11tity all(/ Distrilmtio11: Mmmjttctm·e1·

Deltasone Tablets 10 mg. [prednisone tablets] in 500 tablet Lot 29DRB EXP 9/04; 6,792 bottles distributed nationwide; bottles, Rx; Tablet mix-up, bottles labeled to contain 10 mg tablets Pharmacia Corporation, Kalamazoo, Michigan. Recall conducted may contain 5 mg tablets through National Notification Center, Indianapolis, Indiana

Sci-Fit Tri·Cuts Dietary Supplement Capsules sold in 90 and All codes of the product on the market; 10,453 bottles distributed 180 count bottles, contains 1000 meg of tiratricol (also known as nationwide; Synergy Nutritional industries, Inc., (also known as Trent triiodothyroacetic acid or TRIAC), an active thyroid hormone (100 mg Pharmaceuticals), Fort Walton Beach, Florida. Recalled by ATF of Tricol) and is sold 12 bottles per case; Product's label recom­ Fitness Products Inc., Oakmont, Pennsylvania mends to not exceed three capsules daily. This dose is in excess of the usual replacement dose of thyroid hormone and therefore would cause hyperthyroidism. Particularly in patients with underlying cardiac disease, this poses a significant health risk because of immediate, life-threatening consequences such as heart attack, stroke, heart failure and arrhythmia

Name of Drug or Suppteme11t; Class of ReCti I~· ProfJiem Lot #; Quantity aud Di.~tribution; Mmmjt1cturer

AndroGel Testosterone Gel1 %, 5 gram unit doses aluminum foil Lot 00207, EXP 5/02; 1,512 cartons distributed in Illinois, North packets, 30 packets per carton; Class II; Subpotency Dakota, Florida, Pennsylvania, Indiana, Tennessee, Arizona, New York, Massachusetts, New Jersey, Kentucky; Laboratories Besins lscovesco, Montrouge, France. Recalled by Unimed Pharmaceuticals, Inc., Deerfield, Illinois

Aspirin Tablets (extra strength enteric-coated), 500 mg in 60 tablet Equate Lot number 0044685 EXP 3/01, Bi-Mart Lot number 8E01222 bottles, packaged under labels: Equate (Walmart), Bi-Mart (Eugene, EXP 3/01, Western Family Lot number: 8E01222 EXP 3/01; 15,192 OR) and Western Family (Portland, OR); Class Ill; Dissolution test bottles distributed in Arkansas and Oregon; INK International, failed Hauppauge, NY. Recalled by Leiner Health Products, Carson, California

6 +September 2001 D R lJ <~ S 8.: D I E T A R Y S lJ P P L E M E N T S cont.

Name of Drug or SllpfJ[emlm f: Class of Recal~· Problem Lot #; Q11t111tity a11d Distributio11: Mamifacturer

Benadryl Fastmelt Products; Class II; Mislabeled, Phenylalanine Children's Benadryl Allergy & Cold FASTMELT Tablets, cherry amount is 4.6 mg per tablet/capsule but labeled to contain 1.2 mg flavored, Benadryl Allergy Kapseals or Ultratab Tablets packaged in a 48 count box and including a free, 10-count tablet sample of Benadryl Allergy & Sinus FASTMELT, Benadryl Allergy & Sinus FASTMELT, box of 20 tablets; All lots and all configurations; 88,403 cases (24 units/ case), 2,382,429 professional samples and 36,780 displays distributed nationwide; Shaklee Technica, Norman, Oklahoma. Recalled by Warner Lambert Consumer Group, Pfizer Inc.

Cortisporin TC, topical antibiotic/steroid, 1OmL; Class II; Subpo­ 23,316 units distributed nationwide; Warner-Lambert Co, Rochester, tency Michigan. Recalled by King Pharmaceuticals, Bristol, Tennessee

Eco Dent Ultimate Natural Dally Rinse, Tangy Orange-Clove; Lots 9431, 0002, 0376; 14,209 bottles distributed nationwide, and in Class II; Bacteria contamination-Pseudomonas alcaligenes & Canada and Australia; Truett Laboratories, Inc., Azusa, California baleurica

Levothyroxine Sodium Tablets 25 meg., 50 meg., 75 meg in Numerous lots; 119,249 bottles distributed nationwide; Vintage bottles of 100's and 1000's, some packaged under QT, VPI and URL Pharmaceuticals, Inc., Charlotte, North Carolina labels; Class II; Stability, May not maintain potency through the expiration date

Oxycodone HCL/Acetaminophen 5/500 mg, 100 capsule bottles Lot 126060A and 126060B; 9,425 bottles distributed nationwide; packaged under the Vintage and Qualitest labels; Class II; Dissolution Vintage Pharmaceuticals, Inc., Charlotte, North Carolina failure (Acetaminophen)

Q Tuss Tablets in bottles of 100's and SOD's, packaged under the Numerous lots; 110,538 bottles distributed nationwide; Vintage Zenith Goldline, URL, QT, VPI and URL labels; Class II; Super-Potency Pharmaceuticals, Charlotte, North Carolina (Scopolamine)

Vlra-A [Vidarabine Ophthalmic Ointment]3% sterile ophthalmic Lot Nos.5550-1 and 53D0-1; 39,338 units distributed nationwide; ointment, 3.5 gm tubes, Rx; Class II; Stability Failure (9 month assay) Warner Lambert Co., Rochester, Michigan. Recalled by King Pharma­ ceuticals, Inc., Bristol, Tennessee

MEDICAL DEVICES

Device recalls are classified in a manner similar to drugs, Class I, II or III, depending on the seriousness of the risk presented by leaving the device on the market. Contact the company for more information. You can also call the FDA's Device Recall and Notification Office at (301) 443-4190. To report a problem with a medical device, call1-800-FDA-1088. The FDA web site is http://wwwfda.gov.

Name (if De1•ice; Class (if Reetlll,· Problem Lot #; Qlltmtity a11d Distrilmtio11; Mamifacturer

Focus Dailies Spherical Contact Lenses; Class Ill; Primary label Lot No. 1096004; 10/15 packs shipped to Arizona, Florida, Massachu­ indicates Focus Dailies Spherical, while secondary label indicates setts, Missouri, New Mexico, North Carolina, Pennsylvania; Ciba Focus Dailies Progressive Vision Corp., Duluth, Georgia

H-TRDNplusV100 Insulin Infusion Pump; Class II; Labeling 30,000 distributed nationwide; Disetronic Medical Systems, St. Paul, claims insulin pump is waterproof but some pumps malfunctioned Minnesota when exposed to water

Public Citizen's Health Research Group + Health Letter + 7 C 0 N S U M E R P R 0 D lJ 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.

Name (if Product; Problem Lot #; Q11a11tity a11d Distributio11; Mmmfacturer Apple AC Adapter; Adapters could overheat, posing a fire hazard Sold with prior generation PowerBook G3s; 570,000 sold worldwide from May 1998 through March 2000; Apple, Cupertino, California (866) 277-2096 www.apple.com/adapterexchange

Baby Walkers; Walkers will fit through a standard doorway and are Model ST -1 08ST; 600 sold in California, Arizona and Texas from not designed to stop at the edge of a step January 1998 through July 2001; Sun Tome Trading Corp., Los Angeles, California (888) SUNTOME

Bassinets; Children and adults can be injured when their fingers are Model numbers 79338, 79334 or 79336. Sold under names Sit & pinched or cut between parts of the folding mechanism Soothe Portable Bassinet, Soothing Sounds Bassinet and Soothing Sounds Portable Bassinet; 569,000 sold nationwide from November 1997 through March 2001 ; Fisher-Price, East Aurora, New York (800) 285-0324 www.fisher-price.com

Bicycles; Front fork steering tube can break, causing the rider to lose Long-wheelbase recumbent models RANS Stratus, Stratus XL, Gliss, control of the bicycle Tailwind, Wave, Response and Nimbus; 4,000 sold at specialty bike shops from June 1993 through July 2001 ; RANS Inc., Hays , Kansas (877) 990-7267 www.rans.com/recall or www.ransbikes.com/recall

Bicycles (Children's): Frame can break during use causing the rider 2001 Hemi Pro 12-inch boys red and 2001 Hemi Fastgirl12-inch girls to lose control of the bicycle pink; 3,500 sold by specialized dealers nationwide from July 2000 through May 2001 ; Specialized Bicycles, Inc., Morgan Hill, California (800) 214-1468

Bicycles (Children's); Frames can break during use, causing the Models: Cool Taz, Sweet Tweety, Mudslinger, Secret Treasures, rider to lose control of the bicycle Rugrats, Best Friends, Space Racer, Fairy Magic, MX1200, High Gear, and MX 1800; 38,800 sold nationwide from October 1999 through March 2001; Acetrike Bicycle Co., Taiwan (888) 366-3828

Bicycle Handlebars and "Bar Ends," Handlebars can crack and "PAZZAZ" ATB-98 and "PAZZAZ," 125 handlebars (sold from June break, causing the rider to lose control of the bicycle 2000 through May 2001) and 199 pairs of bar ends (sold from July 2000 through May 2001) at Supergo stores in California and Arizona and nationwide through mail order; Supergo Corp., Santa Monica, California (800) 326-2453 www.supergo.com

Bicycle Hydraulic Disc Brakes; Brakes could fail, causing the rider 2001 Gustav M with silver brake levers, also sold with Cannondale MT to lose control of the bicycle 4000 tandem bicycles; 360 sold nationwide from September 2000 through May 2001; Magura USA, Olney, Illinois (800) 448-3876

Bicycle Suspension Forks; Forks can break, causing the rider to "Carbon Lefty" on 2001 models Cannondale F4000 SL, Jekyll 4000 SL, lose control of the bicycle Raven 4000 SL; 367 sold at Cannondale dealers from December 2000 through June 2001; Cannondale Corp., Bethel, Connecticut (800) BIKE USA

Cabinet and Drawer Spring Latches; If latch breaks, a small Made of white plastic with a spring which holds the latch closed. spring could be released. Young children could choke on the small "SAFETY 1st" is written on the top of the latches; 1.7 million packages spring or gain access to a cabinet or drawer where dangerous items are sold nationwide from January 1993 through December 1999; Safety 1st, stored Canton, Massachusetts (800) 366-1282 www.safety1st.com

8 +September 2001 C 0 N S U M E R P R 0 D U C T S cont.

Name (if Procluct; ProiJlem Lot#; Qua11tity tiiUI Distributio11; Mmwjacturer

Coffeemakers: An electrical connection can overheat and ignite the Automatic drip Model398 with black or white exterior, Model405 with filter basket support, presenting a risk of fire and burn hazard wood-grain: 218,000 sold nationwide from January 1996 through April 2000; Krups North America, Closter, New Jersey (800) 810-8687

Contact Adhesive: Adhesive contains toluene, which presents a fire Tube is marked, "Super Contact Adhesive," UPC code is 7-31015- and poisoning hazard and packaging does not have required caution­ 04471- 9; 90,000 sold at Discount and "Dollar" stores nationwide from ary labeling January 2000 through January 2001: Kale Imports, Carson, California (866) 251-0982

Educational Kits: Red and gold paint contains lead "Let's Start™ Numbers" and "Optical Illusions Lab," 160,000 sold nationwide from February 1999 through May 2001: Advantage Publishers Group, San Diego, California (866)748-3731 www.advantagebooksonline.com

Electric Wrenches: Power cords can release from handle, posing Model9070-20 serial numbers 229A401010001 through injury or electrocution hazard 229A401250722, model 9071-20 serial numbers 239A401 010001 through 239A401250404 and model 9075-20 serial numbers 230A401 010001 through 230A4012601 04; 6,000 sold nationwide from March through July 2001: Milwaukee Electric Tool Corp., Brookfield, Wisconsin (866) 473-2288 www.mil-electric-tool.com

Furnaces: Substantial risk of fire Seven manufacturers with numerous models; 30,000 sold in California from January 1983 through December 1992; For complete details, read the recall notice on the CPSC web site, or call their hot line at (800) 638-2772. You can also call the furnace hotline at (877) 347-6456 or visit the recall web site at www.furnaceinspect.com

Hand Trucks; Rims can separate under intense pressure and strike P-Handle: 32,000 sold at Sears stores nationwide from February the user or bystanders through May 2001: UnionTools, Inc., Columbus, Ohio (888) 808-6657 www.uniontools.com

High Chairs: When seat is reclined, chairs have space between the "Prima Pappa," "Roller," and "Martinelli Pappa and Nanna;" 325,000 armrest and backrest in which a child's head or arm can become sold nationwide from June 1996 through October 1999; Peg Perego entrapped, posing a risk of suffocation or injury USA Inc., Ft. Wayne, Indiana (877) 737-3464 www.perego.com

Infant Seat Pads; Pad has two shoulder straps that create a v­ Baby Sitter brand seat pad designed to restrain a child on a chair in a shaped opening around the head and neck, presenting a strangulation sitting position: 16,000 sold nationwide from October 1998 through hazard May 2001: Basic Comfort Inc., Denver, Colorado (800) 456-8687 www.basiccomfort.com

Jordan Trunner Cross-Training Shoes: Shoes have a thin metal Models Trunner, Trunner Mid, Trunner Bubble, and Trunner 2000; strip on the outside of the heel that can protrude from the shoe and 425,000 sold nationwide from July 1999 through July 2001: NIKE USA form a sharp edge that can cut consumers Inc., Beaverton, Oregon (800) 344-6453 www.nikebiz.com

Kids Meal Toys; Toys can break causing small parts to be released, "Hourglass Space Sprout" and "Look for Me Bumblebee," 2.6 million which poses a choking or aspiration hazard to young children distributed nationwide from January through July 2001 in Kids Meals at Burger King; Burger King Corporation, Miami, Florida and Alcone Marketing Group, Irvine, California (800) 661-9173 www.burgerking.com

Public Citizen's Health Research Group + Health Letter + 9 C 0 N S U M E R P R 0 D U C T S cont.

Name of Product; Problem Lot #; Qmmtity ami Distributimt; Mmmfttcturer

0-Rlng Fire Sprinklers; Performance of sprinklers can degrade over Over 35 million manufactured from the mid-1 970s though 2000; For time. Sprinkler heads can corrode or minerals, salts and other more information, call the Notice Packet Request Line at contaminants in water can affect the rubber 0-ring seals which could (800) 871-3492 or access the program's web site at cause the sprinkler heads not to activate in a fire www.SprinklerReplacement.com; Central Sprinkler Company, an affiliate of Tyco Fire Products LP, Lansdale, Pennsylvania

Paint Ball Masks; Plastic facemask could crack around the ear cover Proteus Models 50085090201 and 50105090201; 4,000 sold when hit by a paint ball nationwide from March through May 2001; JT USA Inc. Chula Vista, California (800) 587-2246 www.jtusa.com

Percolators; If thermostat fails, the plastic housing of the percolator Atico's Kitchen Gourmet and Prinetti Electric 10 Cup Percolators; can overheat and melt while in use, posing a fire hazard 198,000 sold nationwide from January 1996 through January 2001; Atico International USA Inc., Fort Lauderdale, Florida (800) 645-3867

Portable Butane Stoves; Unit's safety fuel shut-off system could fail EXPRESS models B23000 or B23001; 3,500 marketed primarily to the to shut off when overheated, flame from the stove flares up, posing a boating industry, sold from March 2000 through April 2001; Kenyon fire hazard International Inc., Clinton, Connecticut (866) 585-7377 www.kenyonmarine.com

Stuffed Bears; Pieces can detach, presenting a choking hazard. The Small, medium and large sized bears with plastic eyes and noses; eyes also are a sharp point hazard 2,600 sold at stores in tourist areas throughout Arizona, California, Colorado, Montana, Nebraska, Oklahoma, and Texas from July 1997 through February 2001; Inca Imports, Denver, Colorado (800) 279-4040

Toy Feeding Sets; Nipple on the toy baby bottle included in these Set includes a baby bottle, plastic dish, strainer, spoon, juicer, and, in sets could come off, posing a serious choking hazard to small children some sets, afunnel; 100,000 sold nationwide from October 1995 through May 2001; Imperial Toy Corp., Los Angeles, California (800) 543-6551

Toy Kittens; Toys contain contaminated water that, if contacted, could 12 inches long, makes a purring noise when petted, six different styles, cause illness item number 16400; 238,000 sold nationwide from September 2000 through May 2001; DSI Toys, Inc., Houston, Texas (800) 628-8882 www.dsitoys.com

Velcro Wallets; Zipper pull contains lead, which can present a risk of 3.5 by 5 inches in various colors; 55,000 sold nationwide from August lead poisoning to young children 1998 through April2001; Raymond Geddes & Co. Inc., Baltimore, Maryland (800) 533-6273 www.raymondgeddes.com

Winch Kits (attached to All-Terrain Vehicles and used as a vehicle A2000, numerous part numbers; 50,000 sold nationwide from recovery tool); Electrical component of the winch kit, the solenoid, November 2000 through May 2001; Warn Industries Inc., Milwaukie, poses a fire hazard when used in this application, even when the Oregon (877) 277-0539 www.warn.com. The solenoid was manufac­ vehicle is parked and the winch is not in use tured by White-Rodgers.

10 + September 2001 OUTRAGE,from page 12 Biochoice "balances and supports the strung by a restrictive law that was of the world." immune system," but cannot claim that strongly supported by the so-called Intrigued, we investigated the Biochoice cures immunologic disease. nutraceutical industry. In the mean­ Biochoice web page where we found Perhaps the difference is obvious to time, the supplement trade has grown a link to an article in Alternative and the supplement manufacturer's lawyer from a $3.7 billion cottage industry in Complementary Therapies, the "official or federal regulators, but it is a point 1992 to a mighty $15.3 billion dragon in journal of the Society for Integrative likely to be glossed over by desperate 1999 that markets an unproven and Medicine," that explained the secret of AIDS patients looking for a cure. These largely unregulated product. The vic­ Biochoice. Biochoice's producers use minor distinctions are easily exploited tims are the vast majority of consumers "hyperimmune egg" technology, a pro­ by disingenuous marketing and slick who mistakenly believe that the law cess in which unsuspecting chickens advertising. protects them from these modern day are inoculated with bacteria, undoubt­ Biochoice is relatively benign com­ snake oil peddlers and prevents the edly the source for their company's pared to the hundreds of supplements sale of potentially lethal food supple­ logo: a muscle flexing chicken. The that actually contain pharmacologically ments. eggs, now enriched with protective active ingredients. Weight loss supple­ antibodies to the aforementioned ments containing ephedra and guarana What You Can Do agents, are then "spray dried and for­ produce effects similar to amphet­ • Call your congressperson and ask mulated into capsules of pure product amines and have been implicated in that he or she support the repeal of or a flavored vitamin-, mineral-, and adverse events ranging from psychosis DSHEA. Congressional Switchboard, nutrient-rich powder called Biochoice." and stroke to death. The active com­ (202) 225-3121. Not discussed, however, is the likeli­ pounds in St. John's Wort are able to • Call the FDA's Center of Food Safety hood that human digestive enzymes in change the way the liver processes and Applied Nutrition (CFSAN) and the gastrointestinal tract would destroy other drugs and can cause severe drug demand that Good Manufacturing Prac­ any active antibody that was spared by interactions with at least 15 medicines, tice regulations for the dietary supple­ the spray dry process. Could it be that including oral contraceptives, antide­ ment industry be released. Joseph Levitt, somewhere in this country thousands pressants, and immunosuppressants Director of CFSAN, (202) 205-4850. of chickens are being exposed to hu­ used to ward off rejection of trans­ • Carefully evaluate the contents of man pathogens for the sole purpose of planted organs. Already several kidney any dietary supplements that you might producing antibodies that may benefit transplant recipients have lost their purchase. Many of them contain phar­ no one other than DCV? All that chicken new kidneys due to the inhibitory macologically active compounds that power for naught! effect of St. John's Wort on the anti­ can result in injury and even death. Unfortunately, dietary supplement rejection drug cyclosporin. Every day • Remember that a balanced diet with producers are able to make such that passes without adequate regula­ adequate exercise is a proven and safe fantastical claims without adequate tion of dietary supplements places more way to maintain your health. supervision by the Food and Drug people at risk for lethal drug interac­ • Tell your doctor about any dietary Administration (FDA). The 1994 Di­ tions or direct toxicity from the supple­ supplements you are taking. etary Supplement Health Education ments themselves. • Report any adverse events due to Act (DSHEA) explicitly allows produc­ DSHEA has provided the makers of dietary supplements to the FDA at ers and distributors of dietary supple­ Biochoice and other unscrupulous di­ Food and Drug Administration, Office ments to make "structure and function" etary supplement manufacturers with of Emergency Operations, (301) 443- claims without FDA evaluation. This a shield against false claim liability. The 1240; http:!/www.fda .gov/medwatch / means that DCV can legally say that FDA has been made to crouch, ham- index.html

THE PUBliC CITIZEN I fEAt TH RESEARCH CROUP Editor ...... Sidney M. Wolfe The Health Research Group was co-founded in 1971 by Ralph Nader and Sidney Wolfe in Managing Editor ...... Phyllis McCarthy Health L£ttcr Washington, D.C. to fight for th e public's Staff Researchers...... Amer Ardati health, and to give consumers more control Benita Marcus Adler over decisions that affect their health. Contrlbuttng Editor ...... Willtam Hines Copyright © Health Letter, 2001 Material in the Health Letter may not be re­ Productton Mgr...... Krtsty l jackson Published Monthly by printed without permission from th e Editor. Public Citizen Health Research Group Proofreader ...... Benita Marcus Adler Send letters and requests to HEALTH LETTER, All rights reserved. ISSN 0882-598X Editor, 1600 20th St. , NW, Washington, D.C. , 20009. President ...... joan Claybrook Founder ...... Ralph Nader Annual subscription price is $18.00 (12 is­ sues). Mail subscriptions and address changes to Health Letter, Circulation Department, 1600 20th St., NW, Washington, D.C., 20009. Our Web site address is www.citizen.org/hrg

Public Citizen's Health Research Group + Health Letter + 11 OUTRAGE OF THE MONTH Crouching Government, Hidden Snake Oil

ecently, outside rhe Pub lic Banned!" by Mark Yarnell. Yarnell is a sides and the flip-side of Yarnell's Citizen offices in Dupont Circle, "presidential distributor" for Legacy For scheme was revealed. Side two of the Ra flu orescent yellow flyer ap­ Life, the marketing arm of Biochoice's tape, entitled "What Matters Most," peared heralding the arrival of an "Im­ producer, DCV Inc. makes it clear that what matters most, munity Breakthrough!! Biochoice". "I have taken control of my aging so to Yarnell at least, is the bottom line. This "clinically proven" product was that stroke, cancer, dementia, and dia­ Apparently Mr. Yarnell has been said to be "effective against viruses and pers are never part of my future; so that named "the greatest network marketer bacteria" and "directed against micro­ I can feel eighteen till the day I die," in the world" by Upline Magazine, a organisms of human concern." The expounds Yarnell in a tone reminis­ multi-level marketing industry publi­ claim that Biochoice would "greatly cent ofJimmy Swaggart (in fact Yarnell cation. This industry is based on the enhance autoimmune response" was was a minister prior to joining the premise that one can make large sums off-putting; which if true, Biochoice multi-level marketing industry-a of money by selling a product from would increase the severity of diseases polite term for pyramid scheme mar­ home and recruiting distributors who like lupus and rheumatoid arthritis, an keting). Yarnell then relates a heart­ will become a guaranteed revenue effect the producer presumably did not wrenching story of how his parents resource for the company. In this wish to claim. Nonetheless, we called died horrible, tortured deaths and how scheme, Yarnell benefits from the sale the number on the flyer to obtain more it "could have been prevented" had of Biochoice because a portion of all information about this product. Biochoice been on the market. "My sales through his distributor network is A few days later, a few samples of mom and dad are gone, are yours? Or kicked back to him. Graciously, this Biochoice Immune Support (french could you get them on Biochoice right pyramid scheme profiteer invites us to vanilla, strawberry and chocolate fla­ now?," asks Yarnell. Before we could become distributors of Biochoice so vored) arrived in the mail, along with avail ourselves of this life altering that we may join him "on the beaches a mysterious tape entitled "This Tape Is therapy the tape automatically changed continued on page 11

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12 + September 2001