PUBLIC CITIZEN HEALTH RESEARCH GROUP
SIDNEY M. WOLFE, M. D., EDITOR APRIL 2001 + VOL. 17, NO . 4 Latin America: the Answer to Drug Companies' Problems?
t never seems to end. Once again, While the researchers in the HIV foreign investigators registered with U.S. researchers are proposing a studies were generally government the FDA grew over five-fold in the I study in developing countries in scientists or academics who were ap decade of the 1990s. which poor people would receive pla parently committed to helping resi The latest scandal involves a biotech cebos instead of proven, lifesaving dents of the developing world, the new startup company in Doylestown, PA therapies. And this time, the U.S. gov wave of unethical research involves called Discovery Laboratories, which, ernment, in the form of the Food and the for-profit pharmaceutical industry in collaboration with Johnson & Drug Administration (FDA), is playing whose motives are far less clear. Seiz Johnson, manufactures an experimen a leading role. ing upon some of the same justifica tal drug called Surfaxin for the treat In April 1997, Public Citizen blew tions put forth by the HIV researchers ment of the often-fatal Respiratory the whistle on a set of 15 research ("they wouldn't have been treated any Distress Syndrome (RDS) in premature studies involving HIV -positive preg way"), drug companies are now invad infants. The drug belongs to a class nant women in which some of the ing the Third World with intent to called surfactants, which are naturally women were not given AZT, a drug conduct research that would be clearly occurring compounds that help the that had been shown to reduce dra unethical in the U.S. The number of continued on page 2 matically the transmission of HIV from mother to infant (Health Letter Vol. 14, No. 5). Instead of AZT, thousands of c: () N T E N T S women were given inactive drugs called placebos. Our criticism of those studies Election 2000 Commentators on ethical grounds unleashed an inter Read what Dr. Sidney Wolfe feels about the Ia~ five years at the FDA ...... 2 national storm that has yet to abate; in fact, the storm has just struck a new Product Recalls front. February 12-March 12, 2001 The HIV trials resulted in an attempt Aspirin, knee support straps and candles are on our list this month ..... 3 by the research industry to greatly weaken the World Medical Association's One Drug Company-Scherlng-Plough-Faces Massive Recalls The only thing that was wrong with these asthma inhalers was the active (WMA) Declaration of Helsinki (Health ingredient got left out...... 7 Letter, Vol. 15, No.5). However, at its annual meeting in Edinburgh, Scotland High Drug Prices For Research or Profit? in October 2000, the WMA settled Most Health Letter readers already know the answer to this question . .. 8 upon the following language: "The benefits, risks, burdens and effective Is This Doc Deadly? His Practice Hasn't Been Perfect See what one doctor had to do before he was stopped from ness of a new method should be tested practicing...... 9 against those of the best current pro phylactic, diagnostic, and therapeutic Outrage of the Month methods." The WMA also explicitly CASHCOW-Here a Moo, There a Moo rejected the notion that researchers can This outrage just "dropped in" to our email system courtesy of the New provide inferior care in poorer coun England]ournal ofMedicine ...... 12 tries.
\'ISIT IIL\LTII H.ESE.\HCII GH.OlTP'S WEB SITE AT WWW.CITIZEN.OH.G/IIRG/ Election 2000 Commentators
The following article was written the standards for approval. provisions concerning presaiption drugs by Health Letter editor, Dr. Sidney Third, the August 1997 relaxing ofFDA were largely crafted by the pharmaceuti Wolfe and appeared in the publica requirements for 1V ads of presaiption cal industry, has made the FDA legally tion Medical Marketing and Media, a drugs has created a windfall for the most more friendly in a variety of ways to the journal directed at the pharmaceuti industry. cal industry. What has been good news for the pharmaceutical industry, however, is not he election of a Republican The FDA's good news for patients. The FDA's perfor President, after eight years of a mance during the past four or five years T Democrat leading the country, performance is worse than at any time in the past 30 might seem to be good news for the years, worse than under Presidents Nixon, pharmaceutical industry. However, the during the past Ford, Carter, Reagan or Bush the first. last several years of the Clinton regime Since it is hard to imagine how the FDA's have brought little but praise from the four or five years drug safety record can get worse, I am industry, which currently gives the [Food optimistic enough to hope that it will and Drug Administration] FDA the high is worse than at actually improve, prompted in part by the est marks I have witnessed in the 29+ extraordinary spate of drug safety with years I have monitored the pharmaceuti any time in the drawals in the past several years. The cal industry and the FDA. There are Congress will be no more constructive in several reasons for this, including the past 30 years its FDA oversight than it has been but relative silence and lack of aiticism of the there may be some effort to modify the industry in the media, especially 1V, by patient-endangering Dietary Supplement the current Commissioner, Dr. Jane Health and Education Act which has Henneyandherpredecessor,ActingCom heavily advertised products whose sales aippled the FDA's ability to regulate missioner Dr. Michael Friedman. have rocketed up with this massive, fre herbs and food supplements. Negotiated In addition, the 92 new drugs ap quently misleading 1V exposure. prices or price controls on presaiption proved in 1996 and 1997 are the largest Fourth, the passage and signing by drugs, at least for Medicare beneficiaries, number ever approved in a two-year President Clinton into law of the 1997 will be forced onto the table as part of the period, clearly the result of a lowering of FoodandDrugModemizationAct, whose consideration of a Medicare drug benefit.
LATIN AMERICA, from page 1 pared to a known effective drug (with countries use surfactants, so the plan is lungs to inflate. When given to prema out a placebo group) as evidence of to conduct the experiment in those ture infants, mortality is reduced by 34 efficacy, FDA officials have been trying hospitals that don't-the race to the percent. There are four approved sur to persuade them to require placebo ethical bottom. factants on the U.S. market, selling at controls more often. The FDA is currently considering $1,100---$2,400 per course of treat But, as the FDA readily admits, whether to endorse this trial design, an ment. "Conduct of a placebo-controlled sur endorsement the company craves if it Discovery Laboratories is eager to factant trial for premature infants with is to gain access to the lucrative U.S. market its drug in the U.S. because 40 RDS is considered unethical in the market. The issue was raised at an percent of world-wide pharmaceutical USA." Indeed, the company is plan internal FDA meeting in late January sales occur in North America. But the ning a study in Europe in which its with the all-too-revealing title: "Use of company seeks to include a placebo drug is compared to an already ap placebo-controls in life threatening arm in the study. One reason for this is proved surfactant, without a placebo diseases: is the developing world the that it is easier for the company to group. answer?" demonstrate that its product is better This is where the developing world Public Citizen is concerned that this than nothing than to show that it is on comes in. The company has planned a is just the beginning of a new trend in a par with known effective drugs. placebo-controlled trial in Mexico, which the poverty of developing coun The company must also be well Bolivia, Peru and Ecuador, ensuring tries is used by drug companies and aware that the FDA has a long-standing that at least a dozen infants in the potentially the FDA to justify the provi love affair with inappropriate placebo placebo arm will die unnecessarily. sion of substandard medical care to controlled trials. Because European And these wouldn't be just any Latin their research subjects. The line in the regulators are more likely to accept American infants; the company and the sand must be drawn now. studies in which the new drug is com- FDA admit that some hospitals in these
2 • April 2001 Product Recalls February 12-Marcb 12,2001
I) R 11 c; s & I) 1 E T A R Y s 1 T P P L E ~~ 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. lbe 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. lbe FDA web site is wwwfda.gov.
Lot #; (!utmfity 111111 Di~trilmtiou: .llttm~J'adllrer
Advll Suspension (Children's), brand of ibuprofen, grape flavored, Lot No. 99231; 8,640 bottles distributed nationwide; Whitehall Robins 100 mg/5 ml, packaged in 4 ounce plastic bottle, 36 bottles/case; Heallhcare, Richmond, Virginia Class Ill; Some of the product may be subpotent
Anso Comfort Capsules, Extract of Hainanensis Merr Leaf, 200 mg, Lot OH0041 EXP 9/03 and Lot 9422 EXP 7/02; At least 6,420 bottles 60 capsules per bottle; Class II; Product contains the undeclared distributed nationwide, and in China and Canada; Numeridian, Inc., prescription drug chlordiazepoxide Arcadia, California
Aspirin Tablets (adult low strength) enteric coated, 81 mg, 120 unit Codes0032636,0032637,0032856,0032858,0033126,0033127, bottles; Class Ill; Superpotency 0033129,0033203,0033204,0033459,0043676,0043691 and 0066784; 109,716 bottles distributed nationwide; Time-Cap, Inc., Farmington, New York. Recalled by Leiner Health Products, Inc., Carson, California
Cytomelllothyronlne Sodium Tablets, 25 MCG, bottles of 100; Lot No. 549D16, EXP 05/01; 23,748 bottles distributed nationwide; Class II; Subpotency Schering Canada,lhc., Pointe-Claire, Quebec H9R 1B4, Canada. Recalled by Jones Pharma, Inc., St. Louis, Missouri
Ollantln Capsules, KAPSEALS (Extended Phenytoin Sodium Lot No. 10039F EXP 2/01 , Lot No. 00299F EXP 8/01 ; 44,496 bottles Capsules) 1OOmg, 100 and 1OOO.units bottles; Class Ill; Dissolution distributed nationwide. 18 bottles sent to South Africa and Thailand; failure Warner Lambert (Parke-Davis), Fajardo, Puerto Rico. Recalled by PFIZER Inc., New York, New York
Hydrocortisone and Acetic Acid OTIC Solution, 1%/2%,10 mL Lot No. 22900 EXP 05/01, 22725 and 22761 EXP 02/01; 66,581 bottles bottle; Class Ill; Degradants out of specification results during stability distributed nationwide; Morton Grove Pharmaceuticals, Inc., Morton testing Grove, Illinois
Hydrocortisone and Acetic Acid OTIC Solution, 1%/2%,10 mL Lot No. 22864 EXP 05/01; 66,581 bottles distributed nationwide; bottle; Class II; Subpotency-Hydrocortisone Morton Grove Pharmaceuticals, Inc., Morton Grove, Illinois
lsosorblde Dlnltrata Tablets, 10 mg, bottles of 270 tablets; Class Lot No. 12040012 EXP 12/28/01; 3, 700 bottles distributed in South II; Tablet mix-up Carolina, Virginia, and Kansas; Repacker: Veteran's Administration Centralized Mail Order Pharmacy, Lancaster, Texas
Public Citizen's Health Research Group + Heallb I.ener + 3 J) R l ' (; S ,'\: D I E T A R Y S { I P P L E ,\l E !\; T S CIJII/ .
Lot#; {!lllllltitl' 111111 JJi.,trifmtiou: .lltllll(/ilcl/lrer
Levslnex (Hyoscyamine Sulfate 0.375 mg), 100 (extended Codes: OE02119 EXP 1/02, OH03126 EXP 4/02, OH03170 EXP 5/02; release)Timecaps Capsules per bottle; Class Ill; Product packaged with 1,409 bottles distributed nationwide and Puerto Rico; Schwarz Pharrna, incorrect Insert, providing incorrect description of capsules Inc., Seymour, Indiana. Recalled by RightPak, Inc., Madison, Wiscon sin
Medl-Tussln OM Cough Suppressant/EXpectorant, Lots: 9HD0020 mfr. date 8/5/99 EXP 8/02, 9GD0132 mfr. date 7/15/99 (Dextromethorphan HBr, 10 mg/Guaifenesin, 100 mg), in 8 fl. oz. EXP 7/02, OGD0326 mfr. date 8/3/00 EXP 5/03, 9GD0369 mfr. date bottles; Class Ill; Tussin OM product mislabeled as Tussin CF on the 8/1/99 EXP 7/02, 9HD0021 mfr. date 8/5,6/99 EXP 8/02, OGD0379 bottles mfr. date 8/1/00 EXP 5/03; 91 ,800 units distributed nationwide; Perrigo, Allegan, Michigan
Oxygen; liquid, in Cryogenic Horne Units; Class Ill; Use of improper Lot and serial numbers: 120400-7 C065A86, 120400-6 S021185, oxygen analyzer for identity testing 12040Q-7 C034K08, 12040Q-6 S027185; 4 units distributed In Ohio; Kern Medical Inc. doing business as Dasco Home Medical Equipment Company, Alliance, Ohio
Pancrellpasa Capsules; Class II; Dissolution failure Lot 40629 EXP 12/00; 3,125 bottles distributed nationwide; Mutual Pharmaceutical Company, Inc., Philadelphia, Pennsylvania
PremarllltE Tablets (conjugated estrogens tablets), 1.25rng in Lot 00344 EXP 08/03, 01065 EXP 02/04, 00430 EXP 10/03; 6,518 1,000 count bottles and 2.5mg in 100 count bottles; Class Ill; bottles distributed nationwide; Ayerst Laboratories, Div. of Wyeth Manufacturer's dissolution failure Ayers! Pharmaceuticals, Inc., Rouses Point, New York and Wyeth Pharmaceuticals Co., Guayarna, Puerto Rico. Recalled by McKesson HBOC, Memphis, Tennessee
Tram adol HCL Tablets, 50 mg, bottles of 240 tablets; Class II; Lot No. 112000TM94 EXP 11/28/01; 200 bottles distributed in South Tablet mix-up: Tartrate 50 mg with tramadol Carolina, Virginia, and Kansas; Repacker: Veteran's Administration Centralized Mail Order Pharmacy, Lancaster, Texas
JVI E D I C A L D E V I C E S
Device recalls are classified in a manner similar to drugs, Class I, II or Ill, 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, caii1-80Q-FDA-1 088. The FDA web site is http.//WWW.fda.gov.
Lot #; (!111111tity ami IJiMrifmtiou: .llaut({ilctltrer
Support Straps: Neoprene Knee Support with Ova Pad, Perforated All codes for products manufactured from 9/30/98 through 12/4/00; Knee Splint, 3" Elastic Ankle Wrap, Universal Pelvic Traction Belt, 402,742 distributed nationwide and internationally; DeRoyallndustries, Universal Abdominal Binder 9", Universal Rib Belt 6", Rib Belt, Clavicle Inc., Powell, Tennessee Strap II, Clavicle Strap- Self Adjusting, Tennis Elbow Strap, Universal Ambidextrous Wristlet; Class II; Undeclared natural rubber in the products
4 • .Aprll200 1 C 0 N S lT M E R P R 0 D ll C T S
Contact the Consumer Product Safety Commission (CPSC) for specific instructions or return the item to the place of purchase for a refund. For additional information from the Consumer Product Safety Commission, call their hotline at 1-800-638-2772. The CPSC web site is http://www.cpsc.gov.
.\ IIIII<' 1!/ Protlud: Pru!Jfem Lot #; {!111111/ily 1111tl /Jistributio11: .1111111~/ilclun•J'
Bicycle Forks; Forks on these bicycles can break apatt, causing Mongoose S-20 and MGX S-10 (orange) and Roadmaster Ridge Rider riders to lose control and fall (red). Forks are black: 40,000 sold nationwide from June 1998 through June 2000; By Us International Co. Ltd., Taiwan and Brunswick Corporation, Vernon Hills, Illinois (877) 211-3525 www.mongoose.com
Barbie 1M Sunglasses: Frames can break, allowing the petroleum Pink tinted eyeglasses with floating glitter in the temples and distillate and floating glitter to leak out, which could be harmful to "BarbieTM" and "Mattel(r)" on the left side of the earpiece: 70,000 sold children's eyes and skin and fatal if ingested nationwide in Target, Walgreen's and Brad lee's from June 1999 through August 2000; IMT Accessories, New York, New York (800) 868-7870
Bleach: Bottles were mislabeled, containing ammonia. If mixed with UPC Code of 11166 20961, found on the back of the label; 500 bottles bleach or acid, irritating or toxic gases could be produced sold throughout Pennsylvania, New York, New Jersey, Maryland, and Northern Virginia from January through February 2001: SuperValu Eastern Region, Richmond, Virginia (866) 376-1257
Candles: Candles can burn with a high flame, posing a fire and burn Sold in glass containers, a label on the bottom reads, "Nature's hazard to consumers Preserves• "Horne Fragrance Filled" or "Spring Hydrangea·, "Trim wick to 1/4" before each lighting,• "The White Barn Candle Co." and/or "Bath &Body Works": 2.8 million sold nationwide at Bath &Body Works and The White Barn Candle Co. stores from June 1999 through January 2001: Xanadu Candle Co., Guatemala City, Guatemala (800) 395-1001
Commercial Cleaners: Some of the bottles can leak through the cap Zep Acidic Toilet Bowl Cleaner: Calcium Lime & Rust Stain Remover when turned on their side, allowing contents to come into contact with Grout Cleaner & Whitener: and Driveway, Concrete & Masonry Cleaner: consumers which can cause irritation and burns to the skin and eyes 1.4 million bottles sold nationwide at Home Depot stores from January 1998 through February 2001: National Service Industries Inc. (NSI), Atlanta, Georgia (888) 805-HELP www.zepcommercial.com e-mail to [email protected]
Cribs (Recall to repair): Bracket hooks that are used to position the "Little Folks" cribs, made in 1998, 1999 and 2000. "Simmons• and the height of the mattress can break, causing the mattress to collapse two-digit year of manufacture are written on a label affixed to the crib's headboard; 68,600 sold nationwide from January 1998 through December 2000; Simmons Juvenile Products, New London, Wisconsin (800) 421-2951 www.simmonsjp.com
Cross-training Shoes: Thin metal strip on the outside of the heel Jordan Trunner LX model number 136040 and Jordan Trunner 2000 can protrude from the shoe and form asharp edge that can cut model number 136050; 225,000 pairs sold nationwide from May 2000 consumers - February 2001: NIKE USA Inc., Beaverton, Oregon (800) 344-6453 www.nikebiz.com
Educational Games: Metal weights found in the games contain lead, Classification Activity Kits and Opposites Take-Home Pack; 13,000 presenting a poisoning hazard to children sold to teachers and schools nationwide between January 1992 and January 2001: Lakeshore Learning Materials, Carson, California (800) 421-5354
Public Citizen's Health Research Group + Health utter + 5 C 0 N S l T M E R P R 0 0 ll C T S co11f.
.\'t11ue f~{ Pmtluct: Pm/1/em Lot#: f}llllllfifl' 1111tl J)isfl'ilmtiou: .1111111(/itcturer
Halrdryers; Hairdryers have undersized wiring, are not equipped with Pebco and Dubl Duck brands Black Jet 1200, Black Jet 1700, and ground fault circuit interrupters, and have loose electrical connections Pebco 1500 models; 22,500 sold at beauty salons and hair care stores that pose an electrocution and fire hazard nationwide March 1999 through December 2000; Pebco Inc., Congers, New York (888) 391-Q900
Happy Meal Toys; Antenna can break off, posing a choking hazard to ·scooter Bug" with "Fisher Price" on the top of the toy; 234,000 young children distributed with Happy Meals at McDonalds throughout the U.S. and Canada from November 2000 through February 2001; McDonald's Corp., Oakbrook, Illinois www.mcdonalds.com.
Highchairs; Chair's legs can come out, causing the chair to fall to the Model number contains "3170," "36051" or "74001" within it. First six ground numbers in the serial number indicate the date of manufacture. Recalled chairs were manufactured from January 1, 1995 through December 8, 1997 (010195 through 120897); 860,000 sold nationwide from January 1995 through June 1998; Graco Children's Products Inc., Elverson, Pennsylvania (800) 617-7447 www.gracobaby.com
Kids Meal Toys; Metal pins with plastic caps that attach the paddle Rattling, Paddling Riverboat-red plastic with captain figure; 400,000 wheel to the riverboat toy can come out and pose a choking hazard to distributed nationwide in Burger King Kid's Meals during January and young children February 2001; Burger King Corp., Miami, Florida, and Alcone Marketing Group, Irvine, California (800) 661-9173 www.burgerking.com
Lighters; Lighters can leak butane when ignited, causing an excessive 10 1/2 inches long, packaged in cardboard display sleeve under brand burst of flame, presenting a risk of fire and burn injuries name "DIY"; 180,000 sold nationwide at Joann Stores, Family Dollar Stores, Bill Dollar Stores, and Hancock Fabrics from December 1998 to December 1999; Double L Inc., Charlotte, North Carolina (800) 253- 1399
Nlghtllghts; Electrical connections are loose, made from flammable Different colored shades and designs, including some molded in the plastic and the power switch does not work, posing shock and fire form of religious figures; 459,000 sold at discount stores nationwide hazards from March 1999 through August 2000; Dura Kleen (USA) Inc., Brooklyn, New York. Call CPSC hot line for more information (800) 638-2772
Outdoor Solar Lights; Beveled lens on the solar light can act as a Endura ·contempra" solar light with a beveled lens ring around the magnifying glass. Nearby combustible materials can catch on fire middle; 79,000 sold nationwide and through mail order catalogs from February 1998 through December 2000; Brinkmann Corporation, Dallas, Texas (800) 675-5301
Propane Cylinders; Cylinders could be overfilled, which can cause 20-pound cylinders are white, and at the time of purchase, had a red, them to release flammable propane gas unexpectedly, posing risk of white and blue shrink-wrapped sleeve around them with the names fires and explosions "AmeriGas," "Prefilled Propane Xchange" and "PPX(r)" on them; 1,600 sold in Ohio; AmeriGas Propane L.P., Valley Forge, Pennsylvania (888) 428-9779 www.amerigas.com
Toy Brooms; Paint on handles contains high lead levels, presenting a Ti-dee Helper brooms, 37" long with yellow wooden handle; 2,200 sold lead poisoning hazard from Apri12000 through February 2001; EMSCO Inc., Girard, Pennsyl vania (800) 458-0839 www.emscogroup.com
continued on page 7
6 +Aprll2001 One Drug Company -Schering-Plough Faces Massive Recalls
Thefollowing artic/eincludesexcetpts told the auditors that "aerosol products practice (GMP) regulations during their of a letter Public Citizen's Health Re are a major money maker for the com production. search Group sent to new Health and pany''. But, the auditors concluded, "sig The current quality control prob Human Services Secretary Tommy nificant manufacturing problems have lems found in that manufacturing Tbompson on 3/1/01 regarding huge re been experienced with this product class, plant during the recent FDA inspec calls that hadto bedonebythis company, which is indicative of insufficient techni tion are so serious that there has been all of which have been reported in our cal expertise and managerial oversight. ... " a "temporary interruption of some Product Safety Alerts inprevious issues of In addition, we have obtained the production lines" and it will not be the Health Letter. summary of a very recent 31-day FDA allowed by the FDA to gain approval inspection of the same plant completed or start shipping its new allergy drug, uring the past 15 months, 59 January 19th of this year in which FDA Clarinex, a metabolite of the active million asthma inhalers manu inspectors found a persistence of many ingredient in its top-selling Claritin, D factured by Schering-Plough for of the same kinds of problems with the which it had previously planned to treating acute attacks of asthma had to be quality of manufacturing uncovered one ship very soon. During that inspec recalled because of dangerously sloppy year ago during the private audit of tion, FDA investigators found that manufacturingprocedureswhichresulted Schering. The FDA investigators con "There was no assurance that the in many units failing to contain the active cluded that "The process validation for manufacturing process, parameters, ingredient, albuterol (brand name many products fails to support claims equipment or protocols ... conducted Proventil). We have obtained a confiden that manufacturing processes were ca at multiple sites for the production of tial external audit by the AAC Consulting pable of consistently producing prod Clarinex (Desloratidine tablets, 5 mg) Group of Rockville, Maryland, contracted ucts with the same quality, purity and are equivalent or capable of produc for by Schering-Plough, conducted at safety." ing product of the same quality." No Schering-Plough's manufacturing facility We urge you to launch an investiga other new Schering-Plough products at Kenilworth NJ, where these life-sus tion into criminal charges against will be approved until these serious tainingproducts were manufactured.lhis Schering-Plough based on the possibil manufacturing problems are resolved. audit took place from February 28, 2000 ity that the company knowingly shipped It is clear that there are an extraordi to April 14, 2000. The auditors were millions of the 59 million units of nary variety of serious problems at the extremely critical of the general attitude albuterol-containing asthma drug even Schering-Plough manufacturing plant ofmanagement personnel who described tually recalled between the time the in Kenilworth, New Jersey which to them "an imbalance between quality company became aware of the seri threaten the safety of drugs already and production, leaning considerably ously flawed manufacturing processes shipped out of the facility and bespeak toward production". They also found and the time the recall was fmally the need for extreme caution in allow serious specific problems with the qual accomplished. We also urge that you ing any further products to be shipped ity control of the production of the investigate the company for continuing from that plant. We expect a prompt asthma inhalers such as the fact that "An to ship other prescription drug prod response to this request. in-process assay for the active ingredient ucts while fully aware of the serious in Proventil is not performed." Managers violations of FDA good manufacturing
C 0 N S lT M E R P R 0 D ll C T S cmlt.
Stlllle ofProtluct: Pm/Jlem Lot#; Quautify ami Distributiou; .Umu!facturer
Toy drums; Mallet sold with the toy drum has spheres on each end Little Lessons Music Makers soft drum, shaped like stuffed green crab that can pose a choking hazard with multicolored stuffed feet and blue stuffed claws; 5,800 sold nationwide from May 2000 through February 2001; Eden LLC, New York, New York (800) 658-8373
Water Heaters; Heaters can produce dangerous levels of carbon AquaStar natural gas model number AQ38B NG; 320 sold nationwide from monoxide in the exhaust gas, which can cause serious injuries and March 1997 to January 2001; Controlled Energy Corporation (CEC), death Waitsfield, Vermont (800) 642-3111 httpitwww.controlledenergy.com
Public Citizen's Health Research Group + Healtb utter + 7 High Drug Prices For Research or Profit?
The following was written by Dr. percent of most pharma companies' which pharma companies pay phy Sidney Wolfe and appeared in the budgets are invariably devoted to sicians to encourage them to use publication Pharmaceutical Execu research and development. "[Pric~ and "study" certain drugs.It is likely, tive. control) issues are important, but if not certain, that some of that they will not stop the industry from counts as part of the R&D expendi ccording to data just released pursuing new drugs that are tures the industry uses to justify its by Bustness Week, U.S. phar needed." prices. A maceutical industry profits Third, although current industry Fourth, as discussed in a major for the year 2000 were $23.8 billion research efforts are producing some article in the Wall Street journal last l' and the profit margin of 16.4 per truly innovative products, there is a year, for reasons having little to do cent-net profits before extraordi large quota of me-too drugs that do with adequate research funding, nary items divided by sales-was not represent important therapeutic "The [industry's] production of the highest of any major American breakthroughs. Worse, several such breakthrough medicines ... has actu industry, roughly two-and-a-half ally declined since 1996." In that times greater than the 6.3 percent article, titled "Drug Firms, Stymied average profit margin for all U.S. in the Lab, Become Marketing Ma industries. Lilly, with a profit mar chines," reporter Gardiner Harris gin of 28.15 percent, is the leader, The [industry's] stated, "Drug makers' solutions to and Bristol-Myers Squibb follows at their lab woes-raising prices and 22.5 percent. Since the industry is productions of aggressively marketing-may make rolling in money, it is hard to sym good business sense for individual pathize with its whimpers about the breakthrough companies, but they are politically extent to which research will suffer perilous for the industry as a whole." when the United States joins the medicines ... has The major reason for the well rest of the developed world in con financed lobbying campaign against trolling prices as an essential part of actually pharmaceutical price controls in the a Medicare drug benefit. United States is not, as the rapidly There are several major argu declined since eroding story goes, that such long ments against the idea that price overdue and inevitable controls will controls inevitably lead to a dearth 1996. harm research because pipelines of innovative research for impor currently lack many important new tant new treatments. The first is that products. The real reason is the the industry's profit margin is so compelling desire to maintain the high that, even with controls similar bloated profits and profit margins to those in Europe, there will still products proved to be more dan shown in the 2000 data and for most be plenty of money for R&D. If, for gerous than older ones in the same of the last several decades. example, the profit margin were to therapeutic category and were In maintaining high prices and in fall to a "mere" 10 percent as a banned after injuring or killing large employing marketing machinery result of price controls-a larger numbers of people. The painkiller rather than developing important decrease than is likely-annual prof Duract (bromfenac) and the new drugs to make money, the its would still be $14.5 billion. appetite suppressant Redux industry is obeying the 1962 dictate Second, halting innovation is (dexfenfluramine) are but two re of Nobel Prize-winning economist \I anathema to the research-based cent examples. More emphasis on Milton Friedman, who said, "Few ( t pharmaceutical industry. According breakthrough therapies would both trends could so thoroughly under to Charles Versaggi, president of a improve the quality of pharmaceu mine our free society as the accep San Francisco-based marketing and tical research and decrease the of tance by corporate officials of a communications firm for the biotech ten confusing and dangerous clutter social responsibility other than to and medical industries, price con of me-too products. make as much money for their stock trols would not plug drug develop As the industry well knows, holders as possible." ment pipelines. "I don't think it postapproval market research often would have any impact at all," he masquerades as clinical research, in says, pointing out that more than 10
8 +Aprll2001 Is This Doc Deadly? His Practice Hasn't Been Perfect
1befollowing article is reprinted with of Fishtown and Kensington. This time, ter, Lauren Meehan, 18, died along permission of the Philadelphia Daily Paolino's alleged misconduct may have with her boyfriend's cousin in January News ©Philadelphia Newspapers, Inc., had deadly consequences. after taking OxyContin. All rights reseroed. Investigators say that a bottle of pills But despite his other woes, investiga found in the purse of an 18-year-old tors and others say there had been few t seemed there was almost nothing Fishtown woman who overdosed on significant complaints about Paolino's that could stop Bucks County OxyContin had been prescribed by medical practice before last summer. I family physician Dr. Richard Paolino Paolino. Sources said that the doctor's Paolino, 57, was well-known in from practicing medicine. Not a felony prescriptions were a "significant source" Bensalem and continued to see some conviction in 1988 for defrauding a of the drug in the neighborhood and regular patients even after his office local bank in a check-kiting scheme that several people recently arrested began filling up with young people, aimed at covering up his fmancial were carrying prescriptions from him. some glassy-eyed, who were paying problems. Paolino's long downward spiral raises cash to obtain prescriptions, drug agents Not filing for bankruptcy in the late the question: Should regulators have said. Investigators say the mustached, '80s after a failed real-estate deal had stepped in sooner to shut him down? beefy Paolino seemed to have a split him owing his creditors some $4 mil Annual surveys by the good-govern personality, coming off as a kind and lion-or a second bankruptcy filing ment group Public Citizen have consis caring doctor to some, but seemingly last year. tently shown that Pennsylvania ranks nasty and mean-talking to others. Not a 1991 sexual harassment judg near the bottom in its rate of disciplining Several who knew him wondered ment in favor of four female staffers who bad doctors. In 1999, Public Citizen whether his recent downslide was re said that Paolino had routinely touched said, Pennsylvania ranked 36th. lated to the 1997 death after a brief their buttocks and waists, had tried to Indeed, Paolino's earlier misdeeds, illness of his wife, Elaine, a former feel their breasts while pirming on cor including the criminal conviction and Philadelphia teacher who later worked sages he had bought them, had pressed the sexual harassment judgment, led to in his practice. against them, and had made comments a slap on the wrist in 1993 from the "He was a nice guy," said Joy Silvi, like, "I bet you'd be great in bed." state agency that regulates doctors: a who lived on the same cul-de-sac of Last summer, the suburban doctor's reprimand and a $500 civil penalty. stately, $1 million-plus homes amid troubled existence spilled onto the Dr. Sidney Wolfe, director of Public the farm silos of central Bucks County streets of Philadelphia. Several phar Citizen's Health Research Group, said near Newtown. She said neighbors macists in Fishtown began seeing doz Paolino and doctors who commit simi were surprised in January when mov ens of prescriptions from the Bensalem lar offenses should be punished much ing trucks took away Paolino's posses physician, many for the powerful pain more severely than they are. sions-including his cars. killer OxyContin-typically given to "Someone like that should at least "It just didn't look right," Silvi said. cancer patients but increasingly popu get probation, an enforceable proba Indeed, attorney Diorio confirmed that lar on the street for a heroin like high. tion, if not something more serious," a bank had foreclosed on Paolino's But after the first pharmacist, Ron said Wolfe, whose organization re home and that the doctor had filed for Hyman, contacted federal drug agents, cently included Paolino in its book, Chapter 11 bankruptcy last summer, it still took months for the authorities "20, 125 Questionable Doctors." although he said the case was dis to move in on the doctor. They have Paolino, jailed in Bucks County on missed in January. t' r charged that he continued to write $8 million bail awaiting a hearing on It wasn't the first time Paolino had ( prescriptions for months even though April 10, has maintained his inno declared bankruptcy. In 1985, as Paolino his license to practice medicine was cence, telling reporters after his arrest was unsuccessfully seeking to convert a suspended last fall by state authorities that the reason he had written so many former school site in Warminster into a for failin~ to keep up his malpractice prescriptions was that his specialty was 250-unit senior citizen home, he and his insurance. pain management. wife reportedly owed creditors $4 million. In fact, authorities say that Paolino "He looks forward to defending In addition, prosecutors said Paolino wrote at least 1,200 prescriptions for himself at trial," said Joseph Diorio, had taken part in a check-kiting scheme OxyContin and the antidepressantXanax Paolino's business attorney. Paolino that was intended to inflate the value of during that time-most, allegedly, to has not hired a criminal lawyer. his bank account as he sought a mort patients who paid cash and were not "I think he's the slime of the earth," gage for the property and ultimately given physicals, some apparently to countered Theresa Meehan, the cost a bank in Bucks County $207,985. dealers who resold them on the streets Fishtown woman whose granddaugh- continued on page 10
Public Citizen's Health Research Group + Health Letter + 9 IS THIS DOCfOR DEADLY?, tients--some, she claimed, as young as seemed to drag on for months. At one frompage9 15-who were paying from $49 to $66 point he called in Channel10 news, but He was convicted in 1988 of theft by in cash and not undergoing medical the station held the stocy at the urging of deception and sentenced to from four exams. prosecutors seeking to build the case. to 23 months in jail. 1be Daily News Last summer, pharmacist Hyman According to prosecutors, one pa was unable to learn last night whether grew concerned when a man walked tient told an undercover investigator in he'd setved time. into his cluttered, 100-year-old phar Paolino's waiting room that, "He is Three years later, Paolino did not macy at Norris and Memphis streets in cool and knows what you're here for," offer a defense against the four former Fishtown with a prescription from while an informant told investigators female staffers who won a $254,000 Paolino for four 40-milligram tablets of Paolino handed him a prescription for sexual harassment judgment against OxyContin a day, or double the typical Vicodin and Xanax as a payment for him. daily dosage. doing office repairs. Public Citizen's Wolfe said state regu Hyman filled it after calling Paolino's In the meantime, OxyContin, selling lators needed to take sexual harass office, but shortly after an 18-year-old for as much as $20 to $40 a pill, was ment allegations more seriously, noting female holding a baby walked in with flooding the streets. Investigators be that "the record of recidivism is horren a similar prescription. lieve the drug may have played a role dous." "If she was carrying a baby, obvi in as many as 20 deaths in the Philadel Indeed, a woman who worked just ously she wasn't in pain" Hyman re phia area alone. last year at Paolino's office in a nonde called. This time he called Paolino In Fishtown, 18-year-old Eddie Bisch, script one-story medical park on directly, and the two had a heated who had been a friend of Lauren Hulmeville Road in Bensalem told in conversation. "He said that if I didn't Meehan, died in his sleep last month vestigators, according to court papers, fill it, he'd find someone else who after taking half an OxyContin pill and that she had quit in part "because of the would." drinking alcohol. sexual harassment." Hyman then called federal agents, Two weeks later, police showed up at But the documents say she also quit who eventually turned the case over to Paolino's office to arrest him for writing because of another problem: That the state attorney general's office and prescriptions without a license. They Paolino was prescribing powerful pain Bucks County prosecutors. He said he said they pried open the door to gain killers, especially OxyContin, to pa- became frustrated as the investigation access after he refused to let them in.
~ 2.8,12.5 nuesttonahle 20,125 Questionable Doctors · ooctot•s t<.:.~ • nl1'1 t ; lPt'.l l'lt l ~' ' tii~• ' rr:..,-('l l :. To order flus~ Doctors by phone, please The following editions are available: call1-877-747-1616. · To order Quslltknrtlble Doctor& on line visit our Qty Item I Item Price Total ,:,..;::, web site at http-.//www.questlonabledoctors.org . . -...... FQON Qusstlonab/s Doctors 4-vol. National Edition $407.50 Although we cannot list the individual doctors names on the web site, there is statistical informa FQCD Questionable Doctors CD-ROM $607.50 -~ ·~ tion for each state regarding the number of actions 2000 Edition Questionable Doctors Roolonal Editions 1..• "'.,. ., taken and the offenses for which they were taken. FQ001 Arlcansas, Louisiana. Mississippi $23.50 FQ002 Alaska, Idaho, Montana, Oregon, Clip this form and mail to: Publk: CJtJzen Publk:adons, Washington, Wyoming DepL QD2000, 1600 20th Street NW, Washington, DC 20009. $23.50 FQ003 Arizona, Colorado, Nevada, New Mexico, Utah $23.50 Please allow 6 to 8 weeks for delivery of publications. F0004 California, Hawaii $23.50 FQ005 Connecticut, Maine, MassachuseHs, New Hampshire, Rhode Island, Vermont $23.50 o Payment enclosed (check or money order payable to "Public Citizen") Fll006 Delaware New Jers111_ $23.50 0 Charge to credit card 0 VISA 0 MasterCard 0 AMEX 0 Discover FQ007 District of Columbia, Maryland, Virginia $23.50 FQ008 Florida $23.50 Exp Date _____ Credit Card# ------FQ009 Alabama, Georola $23.50 Signature ______FQ010 Illinois, Indiana $23.50 FQ011 Iowa. Missouri $23.50 Ordered By: F0012 NawYork $23.50 Name (Please Print) ------FQ013 Kentucky, North Carolina, South Carolina, Tennessee $23.50 Address ______F0014 Kansas, Nebraska, North Dakota, South Dakota $23.50 Fll015 Oklahoma, Texas $23.50 City ------F0016 Minnesota, Wisconsin $23.50 State ------ ZIP ~---- FQ017 Michigan, Ohio $23.50 FQ018 Pennsylvania, West Vlrolnla $23.50 Phone number:(_) ------Pleaae note: prlt:Btl lnclude lhlpp/ng•nd handling TOTAL CODE ' -
10 +April2001 OUTRAGE,from page 12 __ ,for ed milk the jOUTTu.u has mo¥ tod by altering the cash and to o so I 'tself The From: CashCow@ YAHOO.COM f 1 . content o th e J''ouma researcher choice of Dr. Drazen, a harmaceu- To:
TilE PUBLIC CITIZI!N HEAL111 RESEARCH CROUP was co-founded Editor ...... Sidney'byllts McCarthy M. Wolfe The Health Research Grou~ Sidney Wolfe in Managing Editor ...... P. utltl1 Letter in 1971 by Ralph Nade~. a~t for the public's Washington, D.C. to lg mers more control d t0 give consu Peter Lurie health, an. that affect their health. Staff Researcbers ...... }j;;;,{;~ .. Marcus Adler over decisions not be re- Copyn'ght C!:> Health thlLetter, b 2001 lit ltb Letter may . Larry Saslcb Material in the ea . . n from the Ed1tor. Published Mon y yh Group . h t perm1ss!o TIER n spectaltst ... jenntji er L Howard . H lth Researc printed Wit ou HEALTH LE • Public CitiZen ead ISSN 0882-598X JnformaUo Wtlllam Hines All rights reserve · Send letters and reque~oWashington , D.C., Contributing Editor ...... ~rlsly l jackson Editor, 1600 20th St. , ' Production Mgr...... Adler 20009. ·s $ 8 00 (12 Is- . t' n pr1 ce 1 1 • Proofreader ...... Benita Marcus Annual subscnp IO d address changes U sues). Ma su b scriptions . lation an Department, 16oo to Health Letter, cu:cu D c. 20009. President...... joanRalpb Claybrook Nader Founder ...... 20th St., NW, Washmgton, · ~orglhrg. Our Web site address is www
Public Citizen's Health Research Grou p + Healtb Letter + 11 0 U T R A G E 0 F T H E M () N T H CASHCOW-Here a Moo, There a Moo
1befollowing letter was written by Health The scheme was in no way organized for excellence by sponsoring or Letter Editor, Dr. Sidney Wolfe and Drs. by the journal (it arose from "cobranding" profitable subsidiary ven David Himmelstein and Steffi [email protected]), and, not many tures, such as spin-off publications, of Woo/handler, Associate Professors at hours after its dissemination to the list dubious merit. As a result, and in order to Haroard Medical School, to Vi1(?inia T. seiVe by a journal employee, the new resolve the conflict, a distinguished editor, Latham, MD, President, Massachusetts editor, Dr. jeffrey Drazen, apologized for Dr. jerome Kassirer, was fired. His able Medical Society which publishes The this "administrative error" and promised successor, Dr. Marcia Angell, was pushed New England journal of Medidne on to prevent a recurrence. out of the journal after seiVing as the 1/24/01 regarding an email they re It is ironic, however, that this recent Interim Editor because of the hostile ceived. CASH COW mistake under the journal's environment created by the Society. As a new regime is so in tune with a more letter published in the journal protested: he week before last, those of us ominous, purposeful CASH COW mistake "The Massachusetts Medical Society's de on a Netv England journal of at the journal. During the past several cision to fire Kassirer because he refused T Medidne ema.U list serve, whlch years unprecedented conflict has roiled to squander the journal's reputation for nonnallyprovidesweeklyannouncements the relationship between the Massachu excellence confliTilS my cynicism about about the contents of the forthcoming setts Medical Society and its flagship medidne in the modem era: the only issue of the journal, received a surprising publication, 1be New Englandjournal of thing that matters is the bottom line." message entitled CASHCOW, see box on Medicine. Indeed, one member An acddent led to the journal's recent pg. 11. The message described a get-rich described the journal as the Medical emailbroodcastoftheCASHCOWscheme. quick publishing scheme, promising that Society's "cash cow." The conflict has But it is no acddent that the new editorial any partidpant could "earn $50,000 in the centered on the Society's desire to cash in regime installed by the Medical Society next 90 days by sending e-mail." on thejournal'swell-deseiVed reputation continued on page 11
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