PUBLIC CITIZEN HEALTH RESEARCH GROUP

SIDNEY M. WOLFE, M.D., EDITOR FEBRUARY 2002 + VOL. 18, NO. 2 The Destruction of Medicine by Market Forces: Teaching Acquiescence or Resistance and Change?

1be following article by Dr. Sidney Health Services and Medical profit managed care companies, Wolfe is reprintedfrom Academic Medi­ Education squeezing doctors and patients into cine, Vol. 77, No. 1, january 2002. Among developed countries, the shorter visits and less care, in too many United States is unique in having a instances simply to pay CEOs and edical schools have too often substantial proportion of health ser­ stockholders more. The managed care taught- actively, or passively vices delivered by for-profit businesses. industry has driven teaching hospitals M by example-acquiescence Research has documented that the into an entrepreneurial response that to the increasing trends toward medi­ quality of care is worse in for-profit undermines the critical missions of cine as a business rather than teaching HMOs, kidney dialysis centers, nursing teaching as well as professionalism resistance to those trends in a manner homes, and hospitals than in nonprofits, and service. consistent with medicine as a profes­ just as Flexner documented poor qual­ Resistance to these dangerous di­ sion. A rapidly growing amount of ity education in for-profit medical rections is needed to diminish the research has documented the deleteri­ schools. We are also the only country incursions of for-profit medical care. ous effects of this business model on in the world in which the predominant Research and teaching concerning the doctors and/or patients. But except in mode of health care delivery is for- poorer quality of for-profit care would rare instances, medical curricula for students or residents neither include C () N T E N T S in-depth discussions of such research nor map out strategies for resisting and reversing these dangerous trends, in­ Good Busin.ess Suggestions ...... ••..•..•...... •.•••.•••.••••...... •..•..•. 4 cluding encouraging more research in these areas. As we approach the 100th Product Recalls December 6, 2001-:January 10, 2002 Allergy medications, wheelchairs and candles are on our list anniversary of the 1910 Flexner Re­ this month ...... 4 port, which revolutionized and ratio­ nalized medical education, we must Health Research Group Asks New Mexico to heed his admonition to apply the sci­ Sanction Doctor •....•...... ~········································ s entific method to all dimensions of medicine, including elucidating evi­ New Study Shows Low Income Min.orlty Seniors Restrict dence for the destruction of medicine Use of Prescription Dn~gs •••....•.•.••••••••••••...•...•.••.•...... •.....•. 9 and medical education by market forces. Ironically, the revolution in medical What Ails the Mass. Board of Medicin.e? .•...... •..... 10 education occasioned by that report included the evidence-based elimina­ FDA Action on Red Cross Long Overdue...... 11 tion of a large number of poor quality Canadians Begin Recall of Dangerous Drug Supplement medical schools being run on a for­ Ephedra. ..••••..•...•.•...••••••••••••••••••••••••••.•.•.•...... •...•.•...... •.... 11 profit basis. The new model that evolved emphasized a non-commercial ethic of The AMA Does It Again ••••••••••••••••.•••••.•..••.•...... •.•...... •..... 12 professionalism and service, but this model is now in jeopardy.

VISIT IIEAI.TII H.ESEARCII GROUP'S WEB SITE A1' WWW.CITIZEN.ORG/HRG/ add to the atmosphere and strength of cal trials, corporate sponsors have been influences has been articulated by the resistance. able to dictate the terms of participa­ eminent medical historian and ethicist, But there are two concomitant and tion in the trial---terms that are not David Rothman: "Medical training similarly unique aspects of this market­ always in the best interests of aca­ should not include acquiring a sense of driven system, now caused and con­ demic investigators, the study partici­ entitlement to the largesse of drug trolled by private insurance companies pants, or the advancement of science companies .... Medical schools should ... with an increasing amount of for-profit generally." prohibit all gifts from drug companies care. First is the failure to provide But the publication step is at the to students .... Teaching hospitals should health care as a right to all citizens, end of the research process, and much proscribe drug company sponsorship leaving one seventh of our population, damage can be done by then, espe­ of lunches, conferences, and travel for about 40 million people, without health cially because many of the most alarm­ residents." insurance. Second is the failure of our ing findings of drug-company-spon­ An extensive collection of refer­ government to provide low cost medi­ sored research are not published. Medi­ ences and slides of published articles cal education to all who are qualified to cal schools should prohibit equity in­ refuting the notion that there can be, in enter medical school because of the terest in drug companies by academic the context of the relationship be­ lack of an overall national policy to pay researchers who are doing clinical tri­ tween drug companies and physicians, for medical education. als. The broader issue is that drug a truly free lunch, is available on the Medical schools should end the gen­ companies should fund clinical trials Internet and is frequently updated. eral silence on the absolute necessity but have no control over their design Bob Goodman, of Columbia Univer­ for a single payer, government-financed and implementation, the interpreta­ sity College of Physicians and Sur­ health insurance plan by teaching stu­ tion of data, or publication. More than geons, the founder of the No Free dents its unique advantages. In addi­ merely a change in journal publication Lunch web site, www. nofreeluncb.org, tion, a coalition of medical students policy is needed for this to occur, and is currently developing, with several and faculty should be leading a na­ medical schools need to be at the colleagues, a curriculum for use with tional effort for government subsidy of forefront of advocating such a change. medical students and residents to re­ a much larger part of medical educa­ There has been an increase in deals view this evidence and teach resis­ tion so that socioeconomic-class-based between medical schools and pharma­ tance to the "free lunch" concept. discrimination does not continue to ceutical or medical device manufactur­ Other educational efforts to counter pose barriers for many to attend medi­ ers to develop products under exclusive drug industry influences on prescrib­ cal school and so that medical teaching arrangements that will generate in­ ing practices could include teaching institutions and their faculties are on come for the medical schools and students and residents a process for the firmer financial footing, less depen­ faculty members. The formation of evaluation of newly emerging or older dent on commercial ventures. Another small companies involving faculty to prescription drugs that utilizes publicly important advantage of a single gov­ develop products is, at the least, a available information from the FDA ernment payer for all medical setvices drain on teaching and other non­ web site, wwwfda.gov, or other infor­ would be to overcome the perpetual commercializable research efforts. mation available from the FDA through private health insurance industry's re­ There is good evidence that money the Freedom of Information Act. sistance to such a subsidy. from drug companies or contacts with The Center for Drug Evaluation and them can influence faculty decisions Research (COER) Freedom oflnforma­ The Pharmaceutical Industry and regarding hospital formulary additions. tion web page is located at Medical Schools There is also widespread drug com­ wwwfda.gov/cder/foilindex.btm. The Another important area in which pany funding of hospital rounds, and link can then be made to New Drug medical educators need to be offering contact with drug reps is allowed in Approval Packages. These documents much more resistance involves the many academic medical teaching cen­ are the reviews by FDA scientists of the pharmaceutical industry. Medical jour­ ters. Attendance at free drug-company­ data submitted by a manufacturer to nal articles that distort the actual results sponsored dinners, sports events, and support the approval of a new drug of clinical trials concerning drugs or thinly disguised marketing efforts la­ and include reviews of clinical trials. A other medical products, ghost-written beled as research are often viewed as direct link can be made to the new­ articles, delayed articles and publica­ an acceptable norm. Contrary to a drug approval packages at tion bias as a result of industry pressure recent statement by former AMA Presi­ wwwfda.gov/cder/foilnda/index.htm. have led to guidelines endorsed by dent Alan Nelson, MD, that "Ongoing FDA scientific reviews are also avail­ editors of 13leading international medi­ interaction and strong communication able for drugs not yet approved that go cal journals. The cause was succinctly between physicians and [the pharma­ before public advisory committees. stated in the prologue to the guide­ ceutical] industry is vital for good pa­ These reviews are known as briefing lines. "As CROs (contract research or­ tient care," many of the best physicians information. In general, briefing infor­ ganizations) and academic medical have little if any contact with this mation is not as complete as approval centers compete head to head for the industry. packages and focuses mainly on effi­ opportunity to enroll patients in clini- The need for resistance to these cacy and safety. Briefing information is

2 +December 2001 organized by the year and by the name (http://dev.citizen.org/documents/ www.citizen.org/hrg/activistcourses. of the advisory committee undertaking ACFDC.PDF). There is a need for medi­ Over the 30 years since the Health the review. This information can be cal schools to advocate government Research Group was begun, 20 medi­ accessed at wwwfda.gov/ohrms/ price controls or negotiated prices as cal students and 11 residents in pre­ docketslac/acmenu.btm. It will also be the only way prescription drug ben­ ventive medicine have done rotations necessary to know the date of the efits--for Medicare or for everyone­ with us, lasting from two months to a advisory committee meeting. would be affordable. Medical school year. In addition, we have collaborated This site also allows a link to the ties with drug companies are probably with 35 post-residency physicians since transcripts of advisory committee meet­ another deterrent to advocacy for these 1996 on research-based activism ings, which are organized in the same price controls. projects. Many of the projects they manner as the briefing information. worked on have resulted in bans or Reports made to the FDA's adverse Medical School Courses In warnings on prescription drugs and drug reaction reporting system Research-based Activism restrictions in the amounts of danger­ (MedWatch) can be purchased from In many ways, the public is more ous chemicals workers are exposed to. the U.S. Department of Commerce's educated about the evils and dangers The results of some of these projects National Technical Information Ser­ of market medicine than is the medical have been published, and our web vice (NTIS) on CD ROM. Data are profession. In order for a joint effort of site, www.citizen.org/hrg, includes the available back to 1969. The NTIS's web doctors, working with patients, to suc­ full details of many of the most recent site is located at www. ntis.gov! A direct ceed in supplanting the current mar­ efforts at research-based change. link to descriptions of this information ket-based system and restoring is http://neptunefedworld.gov/cgi-binl professionalism to medicine and to the Conclusion waisgate. doctor patient relationship, there needs As long as the predominant vision These sources often provide data to be a radical shift in medical educa­ of medical educators is acquiescence concerning safety and efficacy unfa­ tion to include such information. to market forces instead of resistance vorable to the drug's approval, data We in the Public Citizen Health and constructive change, market medi­ that are often never published or are Research Group have been involved in cine will thrive, to the detriment of published in ways that distort the re­ helping to start several medical school doctors and patients alike, and medi­ sults. courses in research-based activism that cine, as a profession, will suffer, along Medical schools are mainly silent on provide students with examples of with the simultaneous erosion of the the need for drug company price con­ evidence about such problems with doctor patient relationship. trols or negotiated prices, having bought our health care system. In some courses, Flexner taught evidence-based-re­ into the misleading arguments that students are taught to design protocols sistance and change. The lesson of the unless Americans pay about twice as or even execute research projects that elimination offor-profit medical schools much for pharmaceuticals as do citi­ would add information and presum­ must not be lost, and a concerted effort zens of other developed countries, the ably help to cause changes in these by medical educators and our students industry-the most profitable among areas. Information about one of the and residents as well as patients to major American industries--will not first such courses, at Case Western eliminate all for-profit health services have enough money to do important Reserve University School of Medicine, and to reduce medical school depen­ research and develop new pharmaceu­ is available on a web site that is being dence on commercial activities must ticals. A recent report by Public Citizen's expanded to include information be undertaken. Congress Watch casts serious doubt on about other such courses at Johns the validity of these industry claims Hopkins, NYU, and other schools,

1111! PUBLIC CmzEN HEALTH RES !!ARCH CROUP IJdUor ...... Sidney M. Wolfe The Health Research Group was co-founded In 1971 by Ralph Nader and Sidney Wolfe in Maru~gtng lidttor ...... PbyUts McCarthy 1-lutltlll_...cttcr Washington, D.C. to fight for the public's Staff Researchers...... Larry Sastcb health, and to give consumers more control Amer Ardati, Bentta Marcus Adler over decisions that affect their health. Information Spectaltst ..... jobn Paul Fawcett Copyright C Health Letter, 2002 Material In the Health Letter may not be re­ Contributing Writer Published Monthly by printed without permission from the Editor. Public Citizen Health Research Group and lidttor ...... WtUtam Htnes Send letters and requests to HEALTH LETI'ER, All rights reserved. ISSN 0882-598X Editor, 1600 20th St., NW, Washington, D.C., Production Mgr...... Krlsty l jackson 20009. Proofreader ...... Bentta Marcus Adhw Annual subscription price Is $18.00 (12 is­ sues). Mall subscriptions and address changes Preskknt ...... joan Claybrook Founder ...... Ralpb Nader to Health Letter, Circulation Department, 16oo 20th St., NW, Washington, D.C., 20009. Our Web site address Is www.dtizleo.org/hr

Public Citizen's Health Research Group + Health Letter + 3 Good Business Suggestions

nee again, some radical ideas drugs, used by a small fraction of the advertising "promotes high-priced new from an unexpected busi­ population, "but by cholesterol-lower­ drugs with marginal [if any] improve­ 0 ness source: With the title, ing heart medications, psychiatric medi­ ments over cheaper generic versions. How to Control Drng Costs, Simply, an cations, and painkillers used by tens of The FDA should crack down harder on editorial in the December lOth, 2001 millions of people. Exercise and a misleading ads." issue of Business Week tackled this good diet can help reduce heart dis­ Although we agree with all of the serious problem with keen analyses ease, diabetes, anxiety and some pain." above, we would add that there needs and an interesting, if not completely "Get Tough" introduces their accu­ to be government-negotiated prices or right, list of what needs to be done. rate accusation that the drug industry is price controls, as currently exist in Under the banner of "Get Smart," "gaming the patent system to stymie every other industrialized country in Business Week points out that "for competition." Under current law, the the world. For now, this would benefit every dollar the country spends on Food and Drug Administration is com­ Medicare recipients for whom a drug drugs, it wastes another dollar fixing pelled to "freeze generic versions of benefit is unlikely without such con­ medical problems caused by those drugs for 30 months if a drug company trols, which now benefit those in the same drugs. Doctors and hospitals are complains that the generic infringes on military and Veterans' Administration prescribing the wrong drugs to many its patent. Two and a half years is a programs that purchase pharmaceuti­ and too many drugs to others." ridiculous wait; it should be shortened cals at deep discounts. But otherwise, The editorial goes on to say that the to three months." not bad, Business Week. extraordinary rise in drug spending is "Get Honest" attacks drug advertis­ not primarily due to cancer and AIDS ing by stating that 1V pharmaceutical Product Recalls December 6, 2001-]anuary 10,2002

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

D R l T (; S & 1) I E T A R ) ' S l l P P L E ~~ E N T S

The recalls noted here reflect actions taken by a finn to remove a product from the market. Recalls may be conducted on a finn'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

Sa nil! t~f' I>ru.~ or .~11/JjJlemeut; Cia.\,\ of' Recall: Pmhlem Lot #; (jlltllttity ill/(/ /)j,\lrilmtiou; Jltlllt!/itclurer T3 Pro· Thyroid Technology, 90 capsules, tiratricol, 1000 meg; All codes are recalled; 8,253 bottles distributed in Texas; Golden Unapproved new drug Desert Manufacturing, Phoenix, Arizona. Recalled by Global Enterprises, College Station, Texas

BIOPHARM T·Culs Capsules, trycan 100 mgs (pharmaceutical Lot #2276 EXP 6/03; 400 units distributed in California, Virginia, grade tiratricol), 90 count bottles; Unapproved new drug West Virginia, New Mexico, Indiana, South Carolina, Washington, North Carolina, Louisiana and Canada; Golden Desert Manufacturing, Phoenix, Arizona. Recalled by ATF Fitness Products, Inc., Oakmont, Pennsylvania continued on page 5

4 +December 2001 Class I Recalls conttnued Lot #;Quantity aiUI Dist1·ilmtiou: Jlmll({tldllret·

Prostatln Formula 1103, 500 mg capsules, 30 &90 capsule All lots and codes; 5/30 capsule and 2/90 capsule bottles distributed bottles; Product contains aristolochic acid, a potent carcinogen and in Arizona, Kentucky, Pennsylvania and the Philippines; Sheng nephrotoxin Chang Pharmaceutical Co Ltd., Taipei Hsein, Taiwan. Recalled by Herbal Doctor Remedies, Monterey Park, California

VItal Nutrients Joint Ease Capsules 60 and 120 count and All lots; 692 bottles distributed nationwide; VITAL Nutrients, Verified Quality Brand Joint Comfort Complex Capsules 60 Middletown, Connecticut and 120 count; Products contain aristolochlc acid, a potent carcino­ gen and nephrotoxin

\'mue of'IJru:,:, or SujljJ/emeut: Cla.,s f~{Remll: ProiJiem Lot #;Quantity anti IJistrilmtiou: Jlmuifacturer

CortlsjJorln Ointment (neomycin and polymyxin Bsulfates, Lot MK1 0/8899, EXP 12/04; 38,481 units distributed nationwide; King bactracin zinc, and hydrocortisone ointment), Rx, 1/2-ounce tube; Pharmaceuticals, Inc., Bristol, Tennessee Class II; Subpotent for Polymycin BSulfate component (Stability 28- month test point)

Equate Allergy Medication Decongestant Caplets, 24 caplet Lots 1GB0825, 1GB1041, 1GB1042; 45,504 24-caplet cartons blister cartons; Class II; Misbranding. Directions for use may lead to a distributed nationwide; Recalled by Leiner Health Products, Inc., doubling of the dosage Carson, California

Pangestyme Capsules (Ethex brand); Class II; Subpotency Numerous lots; 46,256 bottles distributed nationwide; KV Pharmaceuti­ (Stability) cal Co., St. Louis, Missouri. Recalled by ETHEX Corporation, St. Louis, Missouri

Rescrlptor 200 mg tablets (delavirdine mesylate tablets), bottles of Lot 17DSJ EXP 11/01; 1,949 bottles distributed nationwide; Pharmacal 180 tablets; Class II; Lowered therapeutic effectiveness & UpJohn Barceloneta, Puerto Rico. Recalled by Pfizer Inc., New York, New York

,\II 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 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.

Lot#; Quauti~l' aiUI Di.~trilmtiou: Jllllll({tlcfurer

Sterile Dressings, labeled in part: "SURGIPAD" Combine Dressing Code 2144, Lot Numbers 2001 071 01, 2001 07 2 01, 2001 07 3 01, DRESSING 8 in x 7.5 in.; Class II; Seal integrity-possibly non-sterile 2001 081 01,2001 08 2 01 , 2001 08 3 01; 751 ,680 distributed device nationwide; Johnson & Johnson Medical, Div. of Ethicon, Inc., Sherman, Texas

Wheelchairs, powered; Class II; While in operating mode, an Quickie brand Model P-222, Serial Range: P22-8516 to P22-9181; 652 unanticipated stop can occur distributed nationwide and worldwide; Sunrise Medical, Fresno, California

Wheelchairs, powered; Class II; The dual-post clamping armrest Quickie brand G-424, S-525, S-626, V-521, Model I Serial Number receiver can collapse from the wheelchair Range: G-424 G42-601 0 to G42-12531 S-525 S52-1 0060 to S52- 17155 S-626 S62-5801 to S62-11281 V-521 V52-10786 to V52- 12221; 12,322 distributed nationwide and worldwide; Sunrise Medical Quickie Designs, Inc., Fresno, California

Public Citizen's Health Research Group + Health Letter + 5 C () N S lT ;\'l E R P R () l) lT <: 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.

.Yame l!f'Procluct; Problem Lot#; Quantify aucl Distribution: Jlt/111!/ilcflll'el· AII-Tenaln Vehicles (ATVs); Pressure switch in braking system 13 different models of manual and automatic transmissions; 15,500 leaks fluid, which can cause brakes to fail sold nationwide from July through December 2001; Arctic Cat Inc., Thief River Falls, Minnesota (800) 279-9419 www.artic-cat.com

Candles; Glitter on the candles can ignite, posing a fire hazard Candela Glitter Candles, 3 and 6 inch high pillars coated with glitter; 50,500 sold at Walgreens stores nationwide from August through December 2001; Walgreen Co., Deerfield, Illinois (866) 241-0105 www.walgreens.com

Candles; Candles can collapse, causing the flame to spread Pine Tree shape; 12,000 sold at Dillard's stores nationwide from October through December 2001. 620 sold at Neiman Marcus stores nationwide and Bergdorf Goodman stores in New York from early Fall through December 21, 2001; Dillard's, Inc., Little Rock, Arkansas (800) 235-9660 www.dillards.com. The Neiman Marcus Group Inc., Dallas, Texas (800) 634-6267

Christmas Lights; Wires can be easily pulled out of the plugs and Rice lights, 22-feet long with 8 lighting effects; 7,500 strings sold at light sockets, posing electrocution and electric shock hazards specialty garden stores nationwide from June through December 2001; Flora-Lite Co., Clearwater, Florida (800) 411-7381

Christmas Lights; Lights have undersized wire and could present Marked "Rice Light," 21-feet long with 140 mini bulbs; 100,000 strings electric shock or fire hazards sold nationwide from June 1998 through November 2001; NBG International Inc., Houston, Texas (877) 532-8949 email to [email protected]

Christmas Lights; Lights have undersized wiring and lack over­ Miniature multi-color lights, 100 per string; 9,000 sold at discount and current protection, posing electrocution, electric shock and fire hazards dollar stores in New York and New Jersey from October 2000 through November 2001; Winstar International Inc., Brooklyn, New York (718) 768-5172

Climbing Sticks and Tree Steps; Buckles can fail, posing a risk of Gorilla Ultralite Climbing Sticks, model number 3163, serial numbers serious injury to hunters 040501, 050501, and 060801. Strap-on Tree Steps, model numbers 3152 and 3153, serial number 2899; 25,000 sold nationwide from February 1999 through September 2001; Game Tracker Inc., Flushing, Michigan (800) 241-4833 www.thegametracker.com

Cribs; Cut-outs in the end panels may allow young children to get "Molly" and "Betsy" style wooden cribs in natural wood, antique green their heads entrapped. Cribs fail to meet CPSC's standards and white; 400 sold nationwide from May 2000 through September 2001; LaJobi Industries Inc., Edison, New Jersey (888) 266-2848 www. bonavita-cri bs.com

Dressers (children's), In-home repair; Dresser can tip over Model26224, production date 09-01 or older, light brown or off-white during use, posing a serious injury hazard with heart-shaped handles; 8,200 sold nationwide from July 1999 through November 2001; Sandberg Manufacturer Co., Los Angeles, California (800) 498-2979

Garden Tractors; Rear wheel can loosen and spin free on its axle, Model Cub Cadet 3184 44-inch cutting deck, 18 or 20 horsepower resulting in a loss of power to the wheel and brake, which poses the engine; 6,000 sold nationwide from October 1999 through November risk of injury 2001; Cub Cadet Corp., Cleveland, Ohio (888) 848-6038 www.cubcadet.com

6 +December 2001 C 0 N S ll ~~ E R P R 0 D l J C T S COJ 1t.

.Vaml' of Product; Problem Lot#; Quantity mul Distribution; Mttlll({ttcturer

Girls' Jackets and Vests; Zipper pull and metal ring on these Baby Cool and Kid Cool polyester fleece, pink or violet; 5,100 sold garments can detach, posing a choking hazard to young children nationwide from September through October 2001; Kid Cool LLC, New York, New York (800) 315-2376 www.sears.com lanterns; Lanterns can crack or catch fire due to excessive heat from Votive Snowman Holiday Porcelain Lanterns; 33,000 sold through LTO the tealight candles Commodities mail-order catalogs from September through November 2001; LTD Commodities Inc., Bannockburn, Illinois (866) 736-3654

Mini-bicycles; Front fork assembly can loosen or break Midget Racer, 31-inches long, 23-inches high; 28,000 sold in New Jersey, New York, Rhode Island, Minnesota and Massachusetts from October through November 2001; Kent International Inc., Parsippany, New Jersey (800) 451-5368

Outdoor Lighting Timers; Timers have reversed polarity in the Model HOT100; 50,000 sold at Menards stores nationwide from wiring, potentially allowing a current to flow through a consumer's October 2000 through October 2001; Homemaster Inc., Eatontown, body, posing a shock hazard New Jersey (800) 443-0224 www.home-master.net

Portable Generators; A small hole in the generator's fuel tank, where Porter-Cable model BSI550-W, date code 09-10-01; 600 sold it mounts to the frame, can leak fuel and pose a fire hazard nationwide from September through October 2001; DeVilbiss Air Power Co., Jackson, Tennessee (866) 422-4282 www.devap.com

Power Mowers; Stress cracks can develop in the mower's fuel tank, SilverPro and Gold Pro Series walk-behind, 21- inch mowers powered allowing gasoline to leak and posing a risk of fire and burn injuries by 2-cycle Duraforce engines; 90,000 sold nationwide from December 2000 through November 2001; Lawn-Boy Inc., Bloomington, Minne­ sota (800) 444-8676 www.lawnboy.com

Scuba Diving Devices; Overpressure valves can stick in the open Used with Buoyancy Control Systems, all overpressure valves with red position, posing a drowning hazard to divers pulls are included in recall; 3,500 sold nationwide from November 1997 through November 2001; Diving Unlimited International (DUI) Inc., San Diego, California (800) 325-8439 www.DUI-Online.com

Shower Doors; Hinges can fail, causing the shower door to fall Kohler Helios and Sterling Freestyle models made from January 1997 through September 2001; 41,000 sold nationwide from January 1997 through October 2001; Kohler Co., Kohler, Wisconsin (866) 782-6329 www.kohler.com/doorrecall

Spa Heaters; Heaters have an internal electrical connection that can No-Fault 6000 model spa heaters sold with Hot Spring and Tiger River overheat and ignite the heater and spa, posing a fire hazard spas; 142,000 sold nationwide from January 1997 through January 2001; TruHeat Corp., Allegan, Michigan (800) 858-2122

Toys; Tips on the links that snap together like a chain can break off, Pop Links model 883, variety of colors and shapes; 20,000 sold posing a choking hazard to young children nationwide from June through November 2001; Kids II Inc., Alpharetta, Georgia (877) 325-7056 www.kidsii.com

Toys; Button covers on the toy can come off, posing a choking hazard Round plastic baby toy with a face on the front, a red and blue to young children. "teethable ear" on each side; 8,800 sold nationwide from June through September 2001; Baby Buzz'r International, Sandy, Utah (866) 222-9289 www.babybuzzr.com

Public Citizen's Health Research Group + Health utter + 7 Health Research Group Asks New Mexico to Sanction Doctor

On November 2, 2001, Dr. Sidney Wolfe Since the Medical Officer of the ministering or supervising injection wrote the following letter to john Department of Corrections left New drugs .... prescribing or administering Romine, MD, President, of the New Mexico several months ago and be­ tranquilizers and other psychotropic Mexico State Board ofMedical Exam­ cause the company contracted by the agents and medications that are part of iners. state to provide prison health services the execution procedure .... monitoring ••• refused to be involved in the execution vital signs .... determining the point at have learned from several sources of Terry Clark, the Governor asked the which the individual has actually died .... " that Dr. Fred Pintz, the Chief Such participation unequivocally '! I Medical Officer of the State of New contravenes the Oath of Hippocrates Mexico, has flagrantly violated a prin­ as well as the AMA Code of Ethics. ciple implicit in the New Mexico Medi­ Unless these important codes are acted cal Practice Act by providing In 1992, the upon, adherence to them will be dan­ authorization for the acquisition and gerously low. The only way to accom­ provision of the drugs to be used by the American Medical plish this is to revoke the license of any New Mexico Department of Correc­ physician who so participates in any tions in the execution by lethal injec­ Association (AMA) way in the execution of a person. Dr. tion of Terry Clark, scheduled for next Pintz is the first such physician whose Tuesday, November 6th. Unless Dr. articulated a identity has come to my attention. Pintz is willing to immediately revoke Unless the New Mexico Board takes his order for providing these drugs and position immediate action to suspend and re­ ensure that the drugs are returned to voke his license if he refuses to reverse the pharmacy in the State Department condemning the the violent course of action which he of Health, I urge that there be an has facilitated, the Board will have emergency suspension of his license to participation of failed in its responsibility to uphold the practice medicine with the plan to legal and ethical principles under which permanently revoke it. physicians in state it must operate. In 1992, the American Medical Asso­ ••• ciation (AMA) articulated a position executions Epilogue: condemning the participation of physi­ The NM Board decided to call Dr. cians in state executions. A 1994 joint Pintz and warn him that unless he statement by the AMA, the American reversed his decision to participate in College of Physicians, the American Secretary of Health, Alex Valdez, to the lethal injection by facilitating the Nurses Association and the American facilitate the provision of the drugs for acquisition of the necessary drugs, the Public Health Association, Health Care the lethal injection. Valdez asked a Board might take an action against his Professional Participation in Capital stat~ pharmacist to obtain the drugs license. Dr. Pintz recanted and the Punishment: Statement from Profes­ but the pharmacist allegedly refused drugs which had been obtained with sional Societies Regarding Disciplin­ unless so ordered by a physician. Thus, his permission were returned. Unfortu­ ary Action, recommended that "state Dr. Pintz, the Chief Medical Officer of nately for the person on death row, the professional licensure and discipline New Mexico, was asked to facilitate the drugs were nevertheless obtained with­ boards treat participation in execu­ acquisition of the drugs so they could out the involvement of Dr. Pintz and tions as grounds for active disciplinary be provided to the Department of the execution was carried out. An im­ proceedings, including license revoca­ Corrections. portant precedent was set, however, tion." The New Mexico Medical Prac­ There have been 739 executions in wherein a state medical board has ~ tice Act has been interpreted to defer to the United States since 1976, including successfully threatened a doctor-lic­ the AMA's position on this issue, and 574 by lethal injection. In most, if not all ensee against participation in an ex­ thus, Dr. Pintz's participation in this cases, physicians have been involved in ecution because the board correctly planned execution clearly violates the one or more of the activities proscribed sees this as a violation of the state ethical and legal principles governing in the 1994 Joint Statement which in­ medical practice act as discussed in the the Board of Medical Examiners. clude: .... "Prescribing, preparing, ad- above letter by Dr. Wolfe.

8 +December 2001 New Study Shows Low Income Minority Seniors Restrict Use of Prescription Drugs

study of a large, nationally rep­ annual incomes under $10,000 and tor of Public Citizen's Health Research resentative sample of older 13.4 percent of those with out-of-pocket Group reacting to the study. "Our coun­ A Americans, published in the prescription drug costs of more than try fails to provide health insurance for December 4, 2001 issue of the journal $100 per month experienced medica­ about one-seventh of our population ofGenerallnternalMedicine, has found tion restriction due to cost. Looked at and fails to provide prescription drug that 43 percent of those people without from a different perspective, low-in­ · coverage for millions of Medicare-cov~ prescription drug coverage who are of come study participants lacking pre­ ered older Americans who cannot af­ •: minority ethnicity, have annual incomes scription drug insurance were about 15 ford to purchase drug coverage on of less than $10,000 and have out-of­ times more likely to limit their use of their own." pocket prescription drug costs of more prescription drugs than low-income The results of the study are consis­ than $100 per month reported restrict­ participants with full coverage. tent with a November 20, 2001 Harris ing their use of prescribed medicines. Thus, in the absence of a prescrip­ Poll of a random sample of 1,010 adult The study was conducted by re­ tion drug benefit, some of the country's Americans that found 39 percent of searchers from the University of Cali­ most vulnerable seniors are most likely people with annual incomes of less fornia, San Francisco, Department of to go without the medicines they may than $15,000 a year had not filled a Medicine, who collected information need to maintain their health. The prescription for medicine in the previ­ from a random sample of almost 5,000 study's authors note that previous stud­ ous 12 months. Americans, 70 or older, with and with­ ies have shown that "policies designed Dr. Michael Steinman, the lead au­ out drug coverage, who regularly used to limit medication use may have seri­ thor of the study, works in the Depart­ prescription medicines. Even one of ous consequences for patients' health, ment of Medicine, San Francisco three risk factors-ethnicity, income resulting in increased emergency de­ Veterans Affairs Medical Center and at and out-of-pocket drug costs of more partment visits, nursing home admis­ the University of California, San Fran­ than $100 a month-made it signifi­ sions, [and] use of emergency mental cisco. cantly more likely that people without health services." A copy of the Harris poll is available prescription drug coverage would be "These findings bring to the fore the at: bttp:llwww.barrisinteractive.com/ forced to restrict their use of medica­ idea that when you judge societies by news/newsletters!bealtbnewsl tions due to cost. how they treat their most vulnerable lD_HealtbCareNews2001 Vol1_iss32 .pdf In the study, 20.9 percent of minor­ members, the United States ranks very ity subjects, 15.6 percent of those with low," said Dr. Sidney M. Wolfe, direc-

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Public Citizen's Health Research Group + Health Letter + 9 What Ails the Mass. Board Of Medicine? 1befollowing arlicle isreprlntedfrom independence are often compromised process rather than on the medical the Boston Globe and was written by by political interference that goes be­ judgment of the board and its consult­ ArnoldS. Reiman, MD, professor emeri­ yond the legitimate claims of account­ ants, the state is in effect placing the tus in the Departments ofMedicine and ability. business interests of physicians ahead Social Medicine at Haroard Medical At least as great an impediment to of the welfare of patients. School andformer editor in chiefof the the board's effectiveness are the re­ Last but not least, the Massachusetts New England Journal of Medicine. strictions of its actions by lawyers and board, like state boards generally, has some ill-conceived provisions of the to contend with the suspicion and he front page of the Globe on law. Hospitals hire lawyers and admin­ timidity of most practicing physicians, January 1 had a story about the istrators to protect them from being who understandably are reluctant to T failure of the state's Board of sued. They call it "risk management." become involved in an investigation of Medicine to discipline an orthopedic When the focus is on patient safety a colleague's alleged misbehavior. The surgeon with a long history of malprac­ and prevention of medical mishaps, board is often frustrated by its failure to tice. Similar stories appear from time to "risk management" is fine, but too gain testimony from an accused time. Is the board as ineffectual in its often it simply becomes a legally man­ physician's colleagues and by the un­ disciplining of incompetent doctors as aged cover-up of the facts. Board in­ willingness of even its own expert these stories would have you believe? vestigations of alleged malpractice or witnesses to make judgments about And if the charge is even partly true, substandard care are often frustrated the competence of a physician. why is that? Having recently retired by the reluctance of hospitals to coop­ Practitioners who are whistle-blow­ after six years on the board, I can offer erate "on advice of counsel." ers have little to gain from what is often some answers. Such cover-up gains support from a a major investment of time and effort First, while not nearly as feckless as 1987 ruling of the state's Supreme while they risk the ostracism of col­ the news reports imply, the board is Judicial Court that the proceedings of leagues and possible countersuits by not providing the kind of protection hospital peer review committees are the accused. At the least they ought to against substandard practitioners that protected from disclosure. be protected against such legal repris­ the public has a right to expect. Massa­ Another legal obstruction to effec­ als. chusetts is not different from many tive disciplinary action is the widely Given all these difficulties, the Mas­ other states in this respect, but that held conception that medical licen­ sachusetts board does well to accom­ doesn't justify its poor performance. So sure, once granted, is the private prop­ plish what it has, but under present the answer to the first question is a erty of the licensee and therefore can constraints it cannot do a really good qualified yes. be limited or revoked only through a job of protecting the public interest. A There are too many substandard full legal process. Board hearings are good way to start improving things practitioners in this state who may conducted as if they were courtroom would be to give the board adequate never even be identified, let alone trials, with lawyers doing most or all of financial support and greater indepen­ reeducated or disciplined, including the talking for their physician clients. dence and authority. Most of all, it some who endanger their patients and Often, testimony submitted by both needs some relief from the paralyzing ought to be removed from practice. sides is evaluated in separate hearings notion that medical licensure is prima­ There are many explanations, the most by administrative magistrates. rily a property right that takes prece­ obvious and indisputable of which are Contested decisions are reviewed dence over public safety. the failure of state government to pro­ by the courts. ••• vide adequate financial support and its But a medical license is more a The problems with the Massachu­ habit of allowing cronyism and patron­ privilege than a property right. It is setts Medical Board, described by age to influence appointments, poli­ granted and renewed by the state only former Board member Dr. Arnold cies, and operations. after the applicant has satisfied re­ Reiman, apply to a large proportion of Almost all of the board's budget is quirements established by profession­ medical boards in the United States. In offset by medical licensure fees col­ als who, while acting under state our rankings of state medical boards, lected by the state, so the state makes authority, are following standards that based on the rate of serious disciplin­ essentially no contribution. The board can only be established and inter­ ary actions 1000 physicians, Massachu­ is left underfunded, understaffed, and preted by the profession. The applica­ setts has consistently been among the unable to meet all of its responsibili­ tion of legal procedures to medical poorest performing boards in the coun­ ties. The five physicians and two "pub­ disciplinary proceedings always de­ try. For serious disciplinary actions it lic" members on the board are lays and often stymies the process, and took in 2000, the state was 45th in the overworked and vastly underpaid (they it risks producing a result that is medi­ country and between 1991 and 2000 its get $35 for each day they work). In cally unsound. By making licensure a rank was never higher than 37th and addition, its professional quality and property right and relying on legal was as low as 48th.

10 +December 2001 FDA Action on Red Cross Long Overdue year ago, Public Citizen re­ blood supply cannot be overstated. harmed. That would be inexcusable, quested the U.S. Food and Drug The American public relies heavily on particularly given the fact that the gov­ A Administration (FDA) to ask the Red Cross blood supply, and pa­ ernment has known about the Red that the American Red Cross (ARC) be tients should know that when they Cross' violations for well over a de­ held in contempt of court because of receive blood, it will not be tainted. cade. Even the ARC's former president, longstanding, dangerous practices that Records indicate that the ARC has im­ Dr. Bernadine Healy, said in an August are jeopardizing the safety of the U.S. properly released blood products con­ 14, 2000, meeting that she found the blood supply. On December 13, 2001, taining cytomegalovirus, a virus that FDA's findings "alarming" and that the the FDA finally made that request. can cause blindness in newborns. Also, severity of the situation held the poten­ While we are pleased the govern­ FDA inspectors found that blood do­ tial for "grave impact" to patients, court ment took action, it is long overdue, nors had incorrect histories and that records show. and we urge the court to act swiftly. Red Cross staff failed to follow test kit We strongly support the efforts to Records indicate that the Red Cross has instructions for HN. hold the Red Cross in contempt of the not come into compliance with a 1993 Although the FDA insists the blood consent decree. Unfortunately, given consent decree or with U.S. laws and supply is safe, these findings cause the lengthy history of this case, the regulations concerning blood and blood grave concern. If proper procedures fines that would accompany a con­ products. are not followed, it is only a matter of tempt of court citation appear to be the The importance of having a safe time before someone is seriously only way the Red Cross will respond.

Canadians Begin Recall of Dangerous Drug Supplement Ephedra

n January 9, 2002, Canadian seizures, psychoses and deaths have ing Ephedra or ephedrine together regulatory authorities an­ been reported in association with the with another stimulant such as caffeine O nounced the initiation of a use of some products containing Ephe­ and other ingredients which might in­ voluntary recall of certain products dra or ephedrine. crease the effect of Ephedra or ephe­ containing the drug supplement Ephe­ This recall deals with the following drine in the body. dra and one of its pure chemical con­ types of Ephedra or ephedrine prod­ stituents, ephedrine. Ephedra and ucts: 3. Products with labeled or implied ephedrine are mostly found in dietary claims for appetite suppression, weight supplements promoted for weight loss 1. Products having a dose of more loss promotion, metabolic enhance­ and energy enhancement. If voluntary than 8 milligrams of ephedrine or with ment, increased exercise tolerance, compliance with the recall is not a label recommending more than 8 body-building effects, increased en­ achieved, the option for stronger regu­ ergy or wakefulness, or other stimulant latory action, including the seizure of effects. violative products, was left open. Public Citizen's Health Research You should not use This action by the Canadian authori­ Group has already filed a petition to ties is a rational regulatory policy to the Food and Drug Administration to Ephedra or protect their citizens from dangerous ban all ephedrine-containing dietary drug supplements. In this country, the supplements. You can access the peti­ ephedrine­ public must face alone the irrationality tion at www.citizen.org/publications/ of an unregulated market for drug release.cfm?ID=7053 or by writing to containing drugs supplements because of the Dietary us for a copy at Health Research Group, Supplement Health and Education Act 1600 20th Street, NW, Washington, DC enacted in 1994. 20009. The Canadian decision was reached milligrams per dose or 32 milligrams What You Can Do after a risk assessment concluded that per day and/or are labeled or implied You should not use Ephedra or these products pose a serious health for use exceeding seven days. ephedrine-containing drugs. They are risk. Adverse events including stroke, dangerous and without a legitimate heart attacks, heart rate irregularities, 2. All combination products contain- medical use.

Public Citizen's He2lth Research Group + Health Letter + 11 0 lJ T R A G E 0 F T H E M 0 N T H The AMA Does It Again he American Medical Associa­ To the extent that CHP A now repre­ pox who took aspirin. As a result of the tion (AMA) has added another sent<; the herbal/dietary supplement delay, hundreds more children died or T chapter to the seemingly end­ drug companies, and to the extent that sustained brain damage. less succession of extremely poor, dan­ a large proportion of these products We urge all physicians who still cling gerous choices for executive vice lack evidence of safety and efficacy, to their AMA membership--despite president of the organization. The an­ this appears to be another deadly em­ its embrace of the Sunbeam nouncement that the new AMA chief brace for the AMA. scandal (an uncritical proposed endorse­ executive, Dr. Michael Maves, is the Even in the realm of OTC drugs, ment of products under the leadership former president of Consumer CHP A funded and signed off on the of Dr. John Seward), the real estate Healthcare Products Association design of a Yale study on the decon­ scandal (under the leadership of Dr. (CHPA), the trade association repre­ gestant and weight reduction drug, James Sammons) and the recent pre­ senting the herbal, dietary supplement PPA (phenylpropanolamine). But when dictably poor leadership of Dr. E. Ratcliffe and over-the-counter drug (OTC) in­ the study showed a significant increase Anderson--to resign from this dying dustries (presumably with the approval in hemorrhagic strokes in people using organization, which once represented oftheAMA'sBoardofTrustees), threat­ products containing the drug, CHP A­ more than two-thirds of American doc­ ens to bring this troubled and dying under the leadership of Dr. Maves­ tors but soon will represent less than organization from the early part of the denounced the study. In the 1980s, the one-third. The hundreds of dollars of 21st century back to the 19th century. predecessor to CHPA, the Non-Pre­ patients' money, which goes to pay for In that earlier era, before medicines scription Drug Manufacturers Associa­ annual dues, could be better spent. had to be proven safe and effective tion, was instrumental in delaying the Subscriptions to excellent medical jour­ before being sold, patent medicines, addition of warning labels on aspirin nals such as thejournal oftheAmerican some of which were referred to as concerning the increased risk ofReye's Medical Association are available to snake oils, ruled the roost. Syndrome in children with flu or chicken non-members as well as members.

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12 +December 2001