PUBLIC CITIZEN HEALTH RESEARCH GROUP

SIDNEY M. WOLFE, M.D., EDITOR August 2003 +VOL. 19, N0.8

Profitably Inventing New Diseases

ecent article in Medical and change its name to "halitosis," Developing a new condition to Marketing and Media (May thereby creating "awareness - and build recognition for an unmet Al 003), aimed at the marketing anxiety - around a serious-sound­ market need." departments of the pharmaceutical ing medical condition." Halitosis, in industry, provides an extraordinary ads, was made responsible for prob­ An example of the second sugges­ view of this industry of which the lems ranging from lack of career tion is Pfizer's marketing strategy that public, unfortunately, remains advancement to divorce, and within turned Viagra into an acronym for unaware. Vince Parry, the "Chief six years, sales increased from erectile dysfunction. Branding Officer" for a company $100,000 to $4 million. Drug companies are now masters of called "InChord," tells his pharma­ Today, healthcare marketers are suggestion number three - develop­ ceutical company readers - and much more imaginative: they take ing a new condition - spectacularly potential clients - how to increase their pharmaceutical product and so in the field of mental health. Parry sales by combining the "creation" of add in "external thought leaders advises, "No therapeutic category is a disease with a drug to treat it. [usually physicians who vouch for more accepting of condition branding There is no dispute that the phar­ the drug's worthiness], support than the field of anxiety and depres­ maceutical industry, first and fore­ groups and consumers." Parry lists sion." The manual used to describe most, is an industry needing and three principal strategies that can be mental disorders, the Diagnostic and seeking ways to increase profits for used to create a new condition: Statistical Manual of Mental Disorders its shareholders and that larger prof­ (DSM), is compiled by the American its require a continuing increase in "Elevating the importance of an Psychiatric Association, an organiza­ sales, a feat orchestrated by market­ existing condition tion heavily funded by the pharma­ ing departments. But in the past, Redefining an existing condi­ ceutical industry. simply letting the public know the tion to reduce a stigma continued on page 3 uses for a drug too often failed to generate the robust growth in sales CONTENTS desired. The solution, as described by Parry, is something called "condi­ Secret No More tion branding" in which a company Medicare investigation results now fair game ...... 2 defines a new condition (along with its worry-provoking symptoms) to Bad Medicine convince physicians and patients Why Bush's malpractice policy will only help insurers ...... 3 that they must treat the condition and use one particular drug. Product Recalls From sunscreen to extension cords: watch out! ...... 6 Parry begins with an early exam­ ple: Warner-Lambert's desire to Do Not Use Finasteride For Preventing Prostate Cancer expand its market for Listerine, Study shows benefits may not outweigh risks ...... 9 which in the 1920s had multiple uses but lacked sales growth. Warner­ Outrage of the Month Lambert's strategy was to take a Taxol: How the NIH gave away the store ...... n ..... 12 harmless concept, unpleasant breath,

VISIT HEALTH RESEARCH GROUP'S WEB SITE AT WWW.CITIZEN .ORG/HRG/ Secret No More: Medicare Investigation Results Now Fair Game

This article was written by Several months after he requested an purpose of overseeing Medicare serv­ Amanda Frost, the Public Citizen investigation, the government sent ices. QIOs are groups of independent attorney who successfully litigated Mr. Shipp a letter informing him that doctors charged with the responsibili­ this case. the investigation had been complet­ ty of ensuring that doctors provide ed, but that he would not be Medicare patients with adequate care. he government is not allowed informed of the results because the Anyone on Medicare, or their repre­ to keep secret the results of its doctors he had complained about sentative (such as a family member), T investigations into complaints had refused to allow him to obtain may file a complaint with their local by Medicare beneficiaries, the United that information. QIO about the medical care received States Court of Appeals for the D.C. In its lawsuit, Public Citizen through Medicare. The QIO is Circuit ruled on June 20, 2003. The argued that the government's policy required by federal law to investigate decision handed a victory to Public violated the Peer Review all complaints and - as a result of the Citizen in its lawsuit against the Organization Act because it did not recent legal victory in the D.C. Circuit Department of Health and Human provide a meaningful response for - to provide the results of those Services (HHS), in which Public Medicare beneficiaries who investigations to the complaining Citizen challenged HHS' policy of complain about the quality of party. keeping secret the results of its medical services they received. The A directory of the names and tele­ investigations into complaints by D.C. Circuit, affirming the district phone numbers for QIOs all over Medicare beneficiaries when the court, agreed with Public Citizen on the country is located at doctor under investigation refused to all counts, and ordered HHS to begin www.cms.hhs.gov/qio/default.asp. consent to disclosure. As a result of disclosing the results of its investiga­ Information about Medicare benefits that policy, Public Citizen members, tions to any Medicare beneficiary, or more generally can be found at along with many other Medicare representative of a beneficiary, who www.cms.hhs.gov/medicare. If you beneficiaries and their families, have complains about the quality of have questions or concerns about the been denied access to the results of Medicare services. quality of Medicare services that you investigations into their complaints Public Citizen hopes the litigation or a close relative have received, you about sub-standard medical care. will help raise public awareness should write your local QIO and ask The case arose from Public Citizen about the rights of Medicare benefici­ them to investigate. If you have ques­ member David Shipp's request that aries to challenge the quality of tions about the process of filing a the government review whether his medical care provided under complaint with a QIO or obtaining the wife received appropriate care while Medicare. Few Medicare beneficiaries results of a QIO investigation, you being treated for cancer. Mr. Shipp's realize that the government has should write to Amanda Frost, Public wife, Doris Shipp, had been diag­ established Quality Improvement Citizen, 1600 20th Street, NW nosed with cancer in December Organizations (QIOs, formerly called Washington, D.C. 20009. 1998, and she died six months later. Peer Review Organizations) for the

THE PUBLIC CITIZI!N JIEAl.TH R.ESI!ARC}l GROUP Edltor ...... Sidney M. Wolfe, MD The Health Research Group was co-founded Managing Edltor ...... Lynn Miller in 1971 by Ralph Nader and Sidney Wolfe in Hutltl1l~ttcr Washington, D.C. to fight for the public's Staff Researchers...... health, and to give consumers more control Peter Lurie, MD, MPH over decisions that affect their health. Larry Saslch, PharmD, MPH Copyright © Health Letter, 2003 Elizabeth Barbehenn, PhD Published Monthly by Material in the Health Letter may not be Amanda Frost, ]D Public Citizen Health Research Group re-printed without permission from the Editor. Send letters and requests to HEALTH LETTER, Information Specialist..... john Paul Fawcett All rights reserved. ISSN 0882-598X Editor, 1600 20th St., NW, Washington, D.C., Production Mgr...... Kristy Ljackson 20009. Annual subscription price is $18.00 (12 is­ sues). Mail subscriptions and address changes Presldent ...... joan Claybrook to Health Letter, Circulation Department, 1600 20th St., NW, Washington, D.C., 20009. Founder ...... Ralph Nader Our Web site address is www.citizen.org/hrg.

2 +August 2003 Bad Medicine Why Bush's Malpractice Policy Will Only Help Insurers

The following article by Sasha cases. Karl Rove must be thrilled. reimbursements declining and Polakow-Suransky is reprinted from For an administration determined to malpractice premiums rising, trial The American Prospect val. 14 no. 7, deplete the coffers of Democratic lawyers are the physicians' new july 3, 2003. trial-lawyer donors - and damage target. presidential hopeful Sen. John President Bush's AMA-backed or the third time in as many Edwards CD-N.C.) in the process - proposal to cap pain and suffering decades, doctors across the malpractice reform is a godsend. damages at $250,000 will satisfy the Fcountry are protesting rising It is also a powerful wedge issue AMA's desire to shield doctors from medical malpractice insurance with the potential to alienate doctors liability while curtailing maimed premiums. The American Medical from Democrats after their recent patients' rights to sue. But in the end Association (AMA) is promoting its collaboration on the Patients' Bill of it is more likely to line the pockets of longstanding goal of medical liability Rights. Just one year ago, the AMA insurance companies than reduce reform in the shape of a $250,000 and trial lawyers were working rates for doctors. cap on "pain and suffering" (noneco­ together to pass legislation allowing Depending on whose statistics nomic) damages in malpractice patients to sue HMOs. But with continued on page 4

NEW DISEASES, from page 1 Sarafem. Lilly was a beneficiary and established a public relations As a result of carving out more of DSM-IV with its newly created outfit ,"Heartburn Across America," all and more subcategories, DSM has "premenstrual dysphoric disorder" of which succeeded in driving sales to increased dramatically in size from (PMDD). Unknown to many, except $2 billion at the peak of its popularity. 106 categories (in 1952) to 357 (in to industry insiders, was the fact that 1994). Parry states that, "Not surpris­ Lilly's drug to treat PMDD, Sarafem, Parry lists questions to help indus­ ingly, many of these newly coined was identical to Prozac. However, try determine whether "branding is conditions were brought to light since Prozac connoted mental disor­ right for your product." He through direct funding by pharma­ der, Lilly changed the brand name concludes, "If you feel that your ceutical companies, in research, in (to Sarafem) and pill color (to laven­ product could benefit from condition publicity or both." der) and in their ads, built public branding . . . remember the basic awareness, "recasting diagnosis to lessons learned over time: evaluate Xanax. One example of such a conform to the new criteria." all the strategic options for what suits newly created mental health need your product best, develop nomen­ was Xanax for panic disorder, a Zantac. In the digestive disease clature, ... and build consensus condition first appearing in the third area, Zantac (made by [convince the medical professionals] edition (DSM-III) in 1980. To create GlaxoSmithKline; GSK) was originally early on." this need, the manufacturer, Upjohn, used to treat ulcers, a limited market. What is never mentioned is that funded research, publications, and By converting Zantac into a treatment many drugs that people are induced speaking tours. They also funded an for a disease, gastroesophageal reflux to take as a result of this pressure are unrestricted three-day "thought disease (GERD), GSK opened up a not only not needed but may cause leader conference at NIMH [National large market for a condition that could adverse reactions that result in extra Institutes of Mental Health]," a U.S. be treated chronically. GSK ads aimed doctor's visits or even hospitaliza­ government agency. As a result, to frighten the public with the poten­ tions and deaths. The public needs NIMH published a consensus on tial for serious long-term conse­ to become aware of the subterfuges diagnostic criteria for panic disorder quences if GERD were left untreated. employed by the pharmaceutical and Upjohn was able to get the first According to Parry, GSK went even industry - to use Parry's phrase, "a drug for this disorder approved from further, creating the Glaxo Institute for better brand of illness" - and keep the Food and Drug Administration. Digestive Health for "education and these clearly in mind in order to Parry notes that since DSM-III first awareness." The institute sponsored avoid being misled and potentially recognized the syndrome of panic research awards, involved powerful harmed. disorder, its incidence has increased third-party advocates such as the 1000-fold. American College of Gastroenterology,

Public Citizen's Health Research Group + Health Letter + 3 BAD MEDICINE, from page 3 commissioner, tracked premiums in Scranton, Pa., has seen his total you use, the median jury award for and insurance industry investment malpractice insurance payments malpractice ranges from $125,000 to returns over the last 30 years. He double in the last few years to $1 million. The Physician Insurers found that each of the three malprac­ approximately $150,000. Meanwhile, Association of America reports that tice insurance "crises" directly coin­ other area neurosurgeons have claim payments of more than $1 cided with declining insurance stopped practicing or retired early, million have increased from less than investment returns. and one recently moved to Maryland. 2 percent in 1990 to almost 8 percent Insurance competition in the "I am unable to recruit anyone to in 2001, driving the median up from 1990s, followed by steep drops in come to this town," says Halla. As a $150,000 to more than $300,000. interest rates, drove premiums up result, he finds himself on call for Contrary to insurance industry sharply. As The Wall Street journal three different area hospitals on any claims, however, overall medical exhaustively documented in 2002, given night, and he is sometimes the malpractice payouts have not malpractice insurers launched a price only surgeon willing to perform risky increased substantially. During war in the 1990s after major compa­ operations that trauma centers will market downturns, insurers set aside nies realized they had set aside too no longer undertake. "Once some of vast reserves to pay anticipated much capital in loss reserves. As large us retire, this state is going to have a claims, counting these reserves as insurers such as St. Paul Companies. tremendous problem in terms of "incurred losses" - even while these released reserves, medical malprac­ providing health care to its citizens," funds accrue investment income. But tice suddenly appeared immensely says Halla. excluding these set-asides, actual profitable and multiple new compa­ The Bush plan is modeled after insurance company payouts nies entered the market, aggressively California's 1975 Medical Injury increased only 15 percent from 1998 undercutting the larger companies Compensation Reform Act (MICRA). to 2001, according to Americans for and one another. The result was a From 1976 to 2000, according to the Insurance Reform (AIR) - far less bargain for doctors and a brewing AMA, California malpractice premi­ than premium increases in most storm for insurers. As claims piled ums remained stable, rising 167 states. up, the low rates no longer proved percent compared with a 505 percent Medical malpractice law is a lucra­ adequate to cover costs. The largest increase nationwide. However, tive industry, as many a phone book insurer, St. Paul, left the market. To California premiums increased cover will attest. But contrary to the add to the mess, falling interest rates dramatically in the years immediately administration's line, increasing jury meant declining yields on bonds. To following MICRA. They did not stabi­ awards are not single-handedly driv­ stay afloat, insurers had to raise rates. lize until 1988, three years after the ing premiums through the roof. "When interest yields decrease, rates California Supreme Court upheld Rather, a steep decline in insurers' must increase," Jim Hurley, a medical MICRA and the same year that projected investment income is malpractice expert at the actuary firm California voters passed Proposition largely responsible for rising rates. Tillinghast-Towers Perrin, told the 103, forcing publicly traded insur­ Medical malpractice insurers do not Senate Committee on Appropriations ance companies to reduce rates by invest heavily in stocks; in fact, in March. 20 percent. Both reforms likely approximately 80 percent to 90 While general practitioners have played a role in stabilizing percent of their investments are in not been particularly hard hit by California's insurance rates. the bond market, and bond income rising premiums, neurosurgeons, But critics of caps insist that pain has been declining. Moreover, insur­ obstetricians and other high-risk and suffering damages are necessary ance companies are technically specialists have seen rates soar. to deter careless medical practice and barred from recovering past losses According to the trade journal compensate for injuries such as by raising premiums, an argument Medical Liability Monitor, annual blindness, disfigurement and the loss the , AMA parrots to dismiss claims premiums for obstetrician/gynecolo­ of sex function, which cannot be that insurance companies are at fault. gists in Las Vegas increased from quantified in economic terms. But insurance companies do regular­ $79,000 in 2001 to nearly $108,000 in Limiting these awards, they argue, ly raise rates based on projected 2002, while those in Miami saw will do nothing to reduce costs to investment losses. For medical premiums skyrocket from $159,000 doctors and will only trample malpractice insurers, investment to more than $210,000. In states such patients' rights. Linda McDougal, the income represents a far greater share as Pennsylvania, Nevada and Florida, Minnesota woman whose breasts of profits than in other lines of doctors have retired early, left the were mistakenly removed after she coverage due to the long lag (up to state or stopped delivering babies to was incorrectly diagnosed with 10 years) between premium contain their insurance costs. While cancer because her files were mixed payments and claim payouts. And the overall number of doctors in up with another patient's, suffered when investment income evaporates, these states is actually rising, certain few quantifiable economic losses. it hits hard. AIR's]. Robert Hunter, an specialties are feeling the pressure. She had health insurance, and her actuary and former Texas insurance Dr. Shripathi Halla, a neurosurgeon employer covered medical bills and

4 +August 2003 lost wages. But "she will have to go "[Doctors] are not economists. They premiums. through life mutilated for no reason," don't think in terms of how a busi­ Ironically, Bush boasted about just says Carlton Carl of the Association of ness makes up for a loss of profits. such a policy during the 2000 Trial Lawyers of America. George They have been at loggerheads with campaign, when he proudly credited Annas of the Boston University the trial lawyers for so long that it's a Texas law with saving consumers School of Public Health contends that always a knee-jerk reaction." billions of dollars. But these days the doctors in general are far too worried Moreover, she observes, many White House won't give its blessing about being sued. lawsuits arise due to the lack of a to any such reform. Enticed by the "Most doctors don't get sued," says social safety net. "As long as we have prospect of passing widespread tort Annas, referring to a 1990 Harvard a system based on avoiding sick reform, Rove and Senate Majority study showing that only one in eight people and not taking care of them, Leader Bill Prist (R-Tenn.) have other malpractice victims ever takes his or you leave sick and injured people things in mind. In early April, a far­ her case to court. "Compare that to with very little alternative other than reaching bill cracking down on class patients who worry about being to sue and to get some care that action lawsuits was approved by the killed; it's not even in the same way," says Angell. Senate Committee on the Judiciary, league." Remarkably enough, insurance bringing it to the floor even before Far more effective than an arbitrary companies don't even promise that a malpractice reform. cap on damages would be a more cap on lawsuits will solve the prob­ AMA President-elect Dr. Donald systematic effort to weed out bad lem. In 2002, the American Insurance Palmisano concedes that other reme­ doctors and prevent malpractice in Association noted, "The insurance dies are available. In Massachusetts, the first place. Dr. Sidney Wolfe, industry never promised that tort Indiana and Louisiana, malpractice director of Public Citizen's Health reform would achieve specific premi­ lawsuits undergo a pre-screening Research Group, says, "You should um savings." And American Tort process, substantially reducing the protect patients with doctor discipline number of questionable lawsuits and protect good doctors with low without restricting the rights of premiums." Public Citizen ranks state patients to sue. Other top AMA offi­ medical boards according to their cials admit that the caps for which records of disciplining negligent Far more effective than they are lobbying hard may not even doctors. "Five percent of the doctors bring premiums down. "Dropping account for 50 percent of the an arbitrary cap on premiums would be great, but stabi­ malpractice payouts," he says. "The lizing is what we want," says an AMA primary failing is at disciplining damages would be a spokeswoman. But stabilizing rates doctors. A lot could be remedied by at levels that are already driving taking bad doctors out of practice." more systematic effort neurosurgeons and obstetricians out Meanwhile, CEO Richard Anderson of business is no solution. While a and President Manuel Puebla of the to weed out bad cap on pain and suffering damages Doctors' Company, a so-called physi­ may result in marginal savings for cian-owned mutual, each earn doctors and prevent general practitioners, there is no approximately $2 million per year. evidence that it would provide relief Wolfe declares that doctors are "being malpractice in the first to those who perform the riskiest used as a human shield by the procedures. If the AMA succeeds in malpractice insurance companies" place. passing a $250,000 cap without a who want tort reform to protect only provision forcing insurance compa­ themselves. After all, in many states nies to pass their savings on to where caps have been enacted, insur­ doctors, rates may well continue to ance premiums have continued to Reform Association President climb, in which case growing rise. Nevada, Missouri and Ohio all Sherman Joyce told Liability Week in numbers of obstetricians will stop have some form of cap, but all three 1999, "We wouldn't tell you or delivering babies, more neurosur­ figure prominently on the AMA's anyone that the reason to pass tort geons will retire early or shy away "crisis states" map. Instead of turning reform would be to reduce insurance from risky procedures, and more their backs on the real causes, Wolfe rates." If doctors are genuinely mutilated patients will be denied says, doctors "should be marching for concerned about reducing the cost of compensation. discipline reform and insurance malpractice premiums and not simply And in the end, Karl Rove and his reform." shielding themselves from liability, it buddies in the insurance industry Dr. Marcia Angell, former editor of would only be logical to demand that will be laughing all the way to the The New England journal ofMedicine for every dollar an insurance compa­ bank. and now a professor at Harvard ny saves as a result of tort reform, Medical School, is not surprised. doctors should save a dollar on their

Public Citizen's Health Research Group + Health Letter + 5 Product Recalls june 12, 2003 -july 14, 2003

~is chart includes recalls from the Food and Drug Administration (FDA) Enforcement Report for drugs, dietary 1 supplements and medical devices, and Consumer Product Safety Commission (CPSC) recalls of consumer products. DRUGS AND DIETARY SUPPLEMENTS

The recalls noted here reflect actions taken by a firm to remove a product from the market. Recalls may be conduct­ ed 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 probability that the use of or exposure to the product will cause serious adverse health conse­ quences 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.

Name f!{ Drug or SujJjJII'IIII'IIt: Class f!{ Rem /I: Pro!JII'm Lot #: Quaufi~l' aud Distri!Juliou: Malll!{acturt>r Cholestyramine for Oral Suspension, USP Powder, 4 grams Lot no. 1A32512 Exp. Date 2/29/2004; 2,011 ctns/60 packets cholestyramine resin, per packet, 60 single dose packets, Apothecon; ea.distributed nationwide; Bristol-Myers Squibb Company, New Class Ill; Superpotent (6 month stability) Brunswick, NJ

Coppertone_ Bug & Sun Sunscreen with Insect Repellent, Numerous lots; 902,519 units distributed nationwide; Schering-Piough (N, N-diethyl-m-toluamide 9.5% and other isomers 0.5%), SPF 30, Health Care Products/DBA Bain de Soleil, Co., Cleveland, TN Kid's Formula, 4 FL OZ (118mL) and 8 FL OZ (237mL) bottles; Class Ill; Incorrect inactive ingredient; product contains Benzophenone-4 rather than Benzophenone-3 and product contains undeclared preser­ vative

Levsin Elixir (hyoscyamine sulfate elixir USP), 0.125 mg/mL, 473 Lot 20920; 393 bottles distributed nationwide; Schwarz Pharma mL (1 pint) syrup, Rx only; Class Ill; Mislabeled; front label incorrectly Manufacturing, Seymour, IN states the product strength as 0.125 mg/mL rather than correctly as 0.125 mg/5 mL

Lisinopril Tablets, 10 mg, 10 tablet bottles, Sample Not To Be Sold; Lot# 117955; 3,600 bottles distributed in California; Nucare Class Ill; Mislabeling; product label does not contain Rx only legend Pharmaceuticals, Inc., Orange, CA

Premarin Tablets (conjugated estrogens tablets, USP), 1.25 mg, Lots: #9000073B (1 OOs) and #9000073W (1 OOOs). Exp. Date on both 100 and 1000 tablet bottles, Rx only; Class Ill; Dissolution failure by lots is 07/04; 34.378 bottles distributed nationwide; National manufacturer (Wyeth) Pharmpak Services, Inc., Zanesville, OH

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

:Vaml' f!{ Det•ice: Class f!{ Rl'ca/1: Probll'm Lot #: Qtullllity aud Dislrilmliou: Mmll({actul'l'l'

LIFEPAK CR Plus Defibrillator; Class II; Defibrillation therapy may All serial numbers below 31058753; 7,095 units distributed nationwide be delayed or not delivered for persons needing defibrillation therapy and internationally; Medtronic Physio Control Corp., Redmond, WA

6 +August 2003 CONSUMER PRODUCTS

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 (800) 638-2772. The CPSC web site is www.cpsc.gov.

1\'ame of Product: Problem Lot #:Quantity ami Distl'ilmliou: Mmu({aclul'el'

Adjustable Beds; When exposed to severely cold temperatures and Includes all Sleep Number(r) Beds by Select Comfort sold from impact, such as may occur during shipping, the power cord insulation November 2002 through March 15, 2003 that were shipped through or on the electric air pump can crack, creating a short-circuit or exposing to cold weather locations; 90,000 sold nationwide from November live electrical wires and presenting a shock or electrocution hazard 2002 through March 15, 2003; Select Comfort Corporation; Minneapolis, MN; (800) 326-3541; email at questions@selectcom­ fort.com

ATVs; Kawasaki KFX700 "V-Force"; The throttle cable adjuster The Kawasaki KFX700 "V-Force"; 3,000 sold nationwide from March on the carburetor can loosen during operation, causing it to stick, 2003 through June 2003. Kawasaki Motors Corp., U.S.A.; Irvine, CA; which can cause the rider to lose control and possibly crash (866) 802-9381; www.kawasaki.com

"Egg Dippers" Easter Plush Toys. There have been two reports Four animal plush toys: white rabbit, green rabbit, purple bear and of children ingesting beads coming out of these plush toys yellow duck; each toy has a permanent label affixed which reads "The Boyd's Collection, Ltd ." 75,000 sold at department and specialty stores nationwide from February 2003 through April 2003; Small Small World, Englewood, NJ; (800) 377-3050

Electric Blankets; Blankets can overheat, posing a risk of burn SOIREE(r) (only those sold at Belk stores) and Soft n' Warm(r) (only injuries to consumers, especially when the blanket is folded or sold at K-mart), both of which were sold in king, queen, full and twin bunched sizes; 18,000 sold at K-mart and Belk stores nationwide from September 2002 through February 2003; Perfect Fit Industries, Charlotte, NC; (877) 882-9478

Extension Cords, Portable Lights, and Fluorescent Work 150,000, 180,000, and 54,000 respectively sold nationwide at traveling Lights. The extension cords and lights have undersized wiring , are sales shows, the company's two retail stores (in Huntington and not properly polarized, have inadequate grounding, faulty electrical Lafeyette, IN) and online at www.homier.com from January 2000 connections, and plastic handles that once ignited continue to burn through May 2003; Homier Distributing Co. Inc., Huntington, IN ; (800) and spread flames, posing a shock, electrocution and fire hazard to 348-5004 or email Homier at [email protected] consumers

Fireworks; "TNT" Reloadable Tube; The firework device has a Black base with a multicolored PVC material tube; each product is sold defective base and can break during launch. If reused, the launching with six shells with fuses. Product labeled "Model No. CP983 ," "Item device could then send fireworks in unintended directions, possibly No 460070," "TNT," and "#1 SELLING BRAND"; 22,700 units sold at causing injury firework display stands and tents and retail operations in those states where the sale of consumer fireworks is legal from June 2003 through July 2003; American Promotional Events Inc., Florence, AL; (800) 243-1189

Food Choppers. Consumers can cut their fingers and hands while Little Red Chef; 7,300 sold nationwide from February 2002 through using the product July 2002; ave Inc.; West Chester, PA; (800) 455-2259; www.qvc.com

Food Slicers; The exposed slicing blade on top of the unit can cut a Little Red Chef, also known as The Kitchen Magic Food Slicer; 32,000 consumer's fingers or hand during use sold from August 2000 through May 2003 through ave, TV direct sales, and trade promotion shows nationwide; Ontel Products Corp ., Fairfield, NJ; Send an email requesting a protective blade cover to [email protected] or write to Ontel Products Corporation, 21 Law Drive, Fairfield, New Jersey, 07004

continued on page 8

Public Citizen's Health Research Group + Health Letter + 7 C 0 N S U M E R J> R 0 D U C T S nmt.

Nawe of Produt'l; Pro/Jiew Lot#; Quantity aud Distrilmtiou; Mauujill'lllrl'l" Infant Car Seats/Carriers; When the seat is used as a carrier, the Cosca Arriva and Turnabout; 1.2 million car seats/carrier sold nation­ plastic handle locks can unexpectedly break or release from the carry­ wide from September 10, 1997 through December 2000; Do rei ing position, causing the seat to unlatch or flip forward Juvenile Group; Columbus, IN; (800) 880-9435; www.djgusa.com

International Adapter Plugs; The adapter plug can separate, Black or white plastic adapter plugs have names of specific countries exposing live electrical conductors, posing an electrocution and shock or regions where the plugs are intended for use written on the side, hazard to consumers including "NORTHERN EUROPE," "GREAT BRITAIN," "NO. AMERICA," "AUSTRALIA," and "SO. EUROPE"; 29,000 sold at catalog and retail stores nationwide; sold in sets of five from April 2002 through June 2003; Franzus Company LLC, Beacon Falls, CT; (800) 706-7063 or email at [email protected]

Mobile Crib Toys; If batteries used in the mobile leak, the caustic Sparkling Symphony(tm); Activated by remote control; 233,000 sold liquid can seep out of the battery compartment, posing a risk of chemi­ at discount department stores and toy stores nationwide from cal burns to babies December 1999 through December 2001; Fisher-Price, East Aurora, NY; (800) 357-9460; www.service.mattel.com

Rear Projection Televisions; If capacitors short circuit due to a Models 50A62, 51 H83, and 57H83; 3,400 sold nationwide from April very high electrical surge, such as from a lightning strike, the metal 21, 2003 through May 8, 2003; Toshiba America Consumer Products, parts on the television could present a shock or electrocution hazard. Inc., Wayne, NJ; (877) 290-6064; www.tacp.toshiba.com/service/ In addition, the metal jacks on the back of the television or another safety_notice.asp metal box attached to the television could present a shock or electro­ cution hazard as a result of the capacitors' failure

Snowmobiles; The Start/RER switch for the SDI models and the Start Ski-Doo(r), model year 2003, Legend(tm) and Grand Touring(tm) SOl switch for the V-1 000 models may be defective and V-1000 models; 548 sold nationwide from December 2002 through January 2003; Bombardier Motor Corporation of America; Grant, FL; (800) 375 -4366

"Spit Smatter" Spray Foam; The aerosol cans can forcefully break Comes in a pressurized can and emits a colored foam based on one of apart, posing a risk of serious injury to nearby consumers six brands: "Original Smatter," "Blueberry Smatter," "Banana Cream Smatter," "Lemon Meringue Smatter," and "Fatter Smatter." Brand name printed on can and word "Nickelodeon" printed on orange trig­ ger mechanism; 1.3 million sold at discount department and toy stores nationwide from February 2002 through June 2003; JAKKS Pacific Inc., Malibu, CA; (800) 554-5516; www.jakkspacific.com

Water Heaters with S.I.T. temperature controls; A potential GSW water heaters with S.I.T. model 650 AC4 gas/temperature burn hazard from ignition flashback or an increase in tank water controls; temperature control knobs on GSW propane water heaters red temperature and control knobs on GSW natural gas water heaters blue; found on GSW Water Heaters with serial numbers ranging from 0202694162 to 0304507825; 13,000 sold in USA and Canada at regional appliance distributors from February 2002 through April 2003; GSW Industries Inc., Fergus, Ontario, Canada; (800) 263-3502; www.gsw-wh.com

8 +August 2003 Do Not Use Finasteride (PROSCAR, PROPECIA) For Preventing Prostate Cancer

he results of a major study men included in the final analy­ and placebo groups, the number of examining the effect of finas­ sis. In 4,368 men given finas­ men who need to be treated with Tteride (PROPECIA, PROSCAR) teride, 803 cases (18.4%) of finasteride to prevent one case of in reducing the risk of prostate prostate cancer were diag­ prostate cancer can be calculated: 16 cancer was released early, June 24, nosed. In the group of 4,692 men must be treated for seven years 2003, on the web site of the New men receiving the placebo, to prevent the detection of one case England journal of Medicine 1,147 men (24.4%) developed of prostate cancer. (www.nejm.com). The results of the prostate cancer. (As discussed In other words, 16 men must be study were mixed, with the increased below, most of these are low­ treated for seven years to prevent risk of high-grade cancer caused by grade cancers of little clinical one case of prostate cancer; we can the drug outweighing the decreased significance.) not predict which one of the 16 men risk of cancers that may be of little will benefit; and the other 15 men clinical significance. face the risks of using the drug, Finasteride is sold by Merck & which may be substantial. Company, Inc. of West Point, PA as At the end of the study, 5.1 Proscar for the treatment of sympto­ .. finasteride may percent of men receiving the placebo matic benign prostatic hyperplasia and 6.4 percent of those taking finas­ (enlarged prostate) and as the life­ accelerate the growth of teride who had biopsies of their style drug Propecia for male pattern prostate glands had developed high baldness. high-grade cancers, grade cancers. This is an increase of The study is known as the Prostate 1.3 percent. High grade prostate Cancer Prevention Trial (PCPT) and which may pose a cancers are known to behave aggres­ was sponsored by the U.S. Public sively. Health Service and the National threat to life and health Because the difference in the Cancer Institute, one of the National percentage of high grade cancers Institutes of Health. if they are not treated between the finasteride and placebo The rationale for trying finasteride groups is known, a number analo­ to reduce the risk of prostate cancer successfully. gous to the number needed to treat, is the mechanics by which the drug the number needed to harm can also works. Finasteride inhibits the be calculated. This number is 77. In enzyme 5 alpha-reductase that is other words, at the end of seven responsible for converting the male years of taking finasteride, for every hormone testosterone to the more The results were reported in the 77 taking the drug one additional potent dihydrotestosterone. The study and in the news media as man will develop a high grade theory is that lowering the level of a 24.8 percent relative reduction cancer. the more potent hormone in the in prostate cancer risk after The table accompanying this arti­ prostate would reduce the risk of seven years. Regular readers of cle summarizes the other adverse prostate cancer. Worst Pills, Best Pills News know effects and the effects on the urinary In the PCPT trial, 18,882 men 55 that the reporting of a relative systems of the men who participated years of age or older with normal risk reduction can be mislead­ in the PCPT trial. physical examinations and prostate­ ing unless it is reported along The editorial appearing in the specific antigen (PSA) levels of 3.0 with the absolute risk reduction same issue of the New England nanograms per milliliter or lower between the finasteride and journal of Medicine as the PCPT were randomly assigned to receive placebo groups. In the PCPT trial, written by a urologist from the finasteride, five milligrams per day, study, the difference in the risk Memorial Sloan-Kettering Cancer or a placebo for seven years. This of developing prostate cancer Center, addressed the important type of study design is the scientific between the finasteride and question "What should we advise the "gold standard" for showing a cause placebo groups was six percent public and our patients?" about using and effect relationship between a (24.4% - 18.4% = 6.0%). finasteride to prevent prostate treatment and an outcome. cancer. His conclusion was "On By knowing the absolute risk balance, finasteride does not seem to At seven years there were 9,060 reduction between the finasteride continued on page 10

Public Citizen's Health Research Group+ Health Letter+ 9 FINASTERIDE, from page 9 ADVERSE EFFECTS REPORTED IN THE PCPf TRIAL- NUMBER AND be an attractive agent for the chemo­ PERCENTAGE OF MEN EXPERIENCING AN ADVERSE EFFECT prevention of prostate cancer." We agree. ADVERSE EFFECT FINASTERJDE GROUP PLACEBO GROUP The editorial went on to say that Sexual and Other Adverse Effects although finasteride was shown to reduce the incidence of cancers, and Reduced volume of ejaculate 5,690 (60.4%) 4,473 (47.3%) that because the study required that Erectile dysfunction 6,349 (674%) __2,Rl6 (61.50/rJ) prostate biopsy be recommended for Loss of libido 6,163 (65.4%) 5,635 (59.6%) all men, this may have led to the Gynecomastia (breast enlargement in males) 426 (4.5%) 261 (2.8%) overdetection of cancers of little clin­ ical significance: Effects on the Urinary System Enlarged prostate 488 (5.2%) 823 (8.7%) We do not know the malignant Increased urinary urgency potential of such cancers and or freguency 1,214 (12.9%) 1,474 (15.6%) have no evidence that any Urinary incontinence 183 (1.9%) 208 (2.2%) benefits would be worth the Urinary retention 398 (4.2%) 597 (6.3%) risk associated with treatment. Prostate surgery performed Furthermore, the study results (transurethral resection of the prostate) 91 (1%) 180 (1.9%) suggest that finasteride may Prostatitis 418 (4.4%) 576 (6.1%) accelerate the growth of high­ Urinary tract infection 90 (1%) 126 (1.3%) grade cancers, which may pose a threat to life and health if they This table is adapted from a table in the New England journal of Medicine on the are not treated successfully. PCPTtrial. Finally, the effects of finasteride on sexual function lessen the taking finasteride long term to What You Can Do attractiveness of the drug as a control the symptoms of enlarged You should not be using finas­ preventive agent [see the table prostate. The editorial suggests that teride at this time to reduce the risk accompanying this article]. these men be monitored carefully for of developing prostate cancer the development of cancer by peri­ because of the increased risk of The Health Research Group has odic physical examinations and developing high grade aggressive consistently held the position that following PSA blood levels. tumors. before any drug can be recommend­ Unfortunately, the definition of peri­ If you are now using finasteride ed to prevent cancer, or any other odic was not given and we are not long-term to manage the symptoms disease, in otherwise healthy people, aware of the optimal time for moni­ of enlarged prostate you should it must be almost entirely free of toring the possible development of discuss the result of the PCPT trial adverse effects. aggressive prostate cancer in men with your physician. The editorial also raised the ques­ taking finasteride long term for the tion of what to tell men who are symptoms of enlarged prostate.

OUTRAGE, from page 12 GAO reviewed the history of the Food and Drug Administration the "legal" grounds for non-disclo­ Taxol CRADA and uncovered a approved Taxol for the treatment of sure, evidently takes precedence remarkably one-sided deal - with ovarian cancer, BMS relied upon six over the public's right to know how taxpayers clearly on the short end. studies, five of which had been its government conducts its business. It is fair to say that without the conducted by the NIH. BMS went on Recently, however, the General NIH there would have been no to conduct additional studies, partic­ Accounting Office (GAO) lifted the Taxol. The agency identified a ularly for other cancer indications. lid of secrecy on one of these component of the Pacific Yew as Between 1993 and 2002, BMS CRADAs - and the contents were having anti-tumor activity as long grossed a tidy $9 billion in Taxol not pretty. The drug in question was ago as 1963 and identified the chem­ sales worldwide. From 1977 to 1997, Taxol, an extract of the bark of the ical responsible for this activity back when the CRADA ended, the GAO Pacific Yew, now marketed by in 1971. In 1983, the NIH began the estimates that the NIH spent $183 Bristol-Myers Squibb (BMS) to treat first of several clinical trials of Taxol; million in research on Taxol. The vast breast, ovarian, lung and AIDS-asso­ BMS was essentially absent from the majority of this actually took place ciated cancers. At the request of scene until it signed a CRADA with after the CRADA took effect. Senator Ron Wyden of Oregon, the the NIH in 1991. When in 1992 the continued on page 11

10 +August 2003 OUTRAGE, from page 10 alone. federal investment, questions remain What does the NIH (and the The GAO report suggests a likely regarding the extent to which NIH public) have to show for all these NIH motive for resisting disclosure of used its broad authority in its negoti­ years of government creativity and its royalty rates that transcends legal ations with BMS on the royalty investment? A paltry $35 million, niceties. What if taxpayers actually payments ... " The time is long over­ according to the GAO. Even this knew what a lousy deal the NIH had due for either the GAO or the minimal cost to BMS has been negotiated on its behalf? Congress itself to answer these recouped many times over from the Under the circumstances, the remaining questions by conducting a Federal government itself; through GAO's conclusion is remarkably more wide-ranging investigation into its Medicare program, the U.S. spent pallid: "In light of the significant Nll-I's royalty practices. $687 million on Taxol between 1994 and 1999. And what of the royalty rate that the court deemed so secret that it had to be shaded from public disclo­ sure? The GAO, which can examine documents not available to the public (with the apparent exception of the records of the Dick Announcing Cheney/Enron Energy Task Force), learned that the government received a feeble 0.5% royalty rate, Worst Pills, Best Pills News Online based on worldwide sales, well below what Public Citizen believes -The fastest way to get the latest private companies negotiating with each other typically are granted. drug warnings In a further twist, Florida State University (FSU) also had a licensing To learn more about a subscription to agreement with BMS, ironically based Public Citizen's Worst Pills, Best Pills News on NIH-funded research. These investigations had led to a method Online, visit www.worstpills.org. for the synthesis of Taxol that less­ ened dependence upon the uncom­ Log on today and read a FREE mon Pacific Yew. Under yet another issue of the newsletter. shortsighted Federal law, the so­ called I3ayh-Dole Act of 1980, univer­ Subscribe today and get 40°/o sities that develop patentable tech­ nologies using NIH research funds OFF the cover price. can license the technology to the private sector in exchange for royal­ To receive the 40% off discount, you '11 be ties. Even though FSU's patent was asked to enter the discount code: HLAUG3. merely for a synthetic pathway to produce Taxol, as opposed to the NIH's multiple clinical trials first proving the effectiveness of Taxol, FSU collected royalties at a rate of about 4.2% of worldwide sales - worth about $65 million in 2000

Public Citizen's Health Research Group + Health Letter + 11 OUTRAGE OF THE MONTH Taxol: How the NIH Gave Away the Store

he old-growth trees and luxu­ to facilitate the commercialization of riant, rolling lawns give the technologies developed at the NIH. T National Institutes of Health In exchange for licensing its technol­ (NIH) campus in Bethesda, MD the What if taxpayers ogy to a private company, the NIH outward appearance of an insurance can collect royalties based on sales. company's sprawling headquarters. actually knew what a Because of concern that NIH was Appearances can be deceiving. The not adequately bargaining for higher campus is home to as concentrated a lousy deal the NIH royalty rates and believing that the focus of medical brainpower as you terms of those licensing agreements are likely to encounter anywhere on had negotiated on its should be made public, Public the planet. Several of the great Citizen brought suit against the NIH discoveries of modern medicine have behalf? in 2000. Incredibly, the Federal taken place here - from unglam­ District Court for the District of orous basic science research to drugs Columbia ruled that, even though for AIDS and cancer. taxpayers (through the NIH) are While some of the research may be brought to market profitably. In parties to the agreements, they are not lead to commercial products, their efforts, the companies are aided not allowed to learn these royalty pharmaceutical companies eye the by the Federal Technology Transfer rates. In modern America, the confi­ work being conducted at NIH like Act of 1986 that established contracts dentiality of commercial information, hawks, continually on the lookout for called Cooperative Research and tasty morsels of technologies that can Development Agreements (CRADAs) continued on page 10

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12 +August 2003