PUBLIC CITIZEN HEALTH RESEARCH GROUP

SIDNEY M. WOLFE, M.D., EDITOR MARCH 2001 + VOL. 17, NO. 3 Is the U.S. Safe from Mad Cow Disease? Could We Be Safer?

1be following are excerptsfrom a w­ the extent of the risk to human health. victims blamed British and French offi­ port on the jim Iehrr!r Newshour on the [Variant] CJD has now killed 80 people cials for the meal exports, and BSE and epidemicofBovineSpongifonnEncepha­ in Britain. No one is sure how many [variant] CJD in France. A magistrate is lopathy (BSE, or Mad Cow Disease) in more have been infected; it can take now investigating possible manslaugh­ Europe, and a debate on the same~ years for the symptoms to appear. The ter charges against the officials .... Now, gram over the possibility ofan outbreak government report last October blamed the World Health Organization is warn­ ofdisease among humans and cows in the spread of mad cow disease on ing that BSE-infected meat may be in the U.S., featuring Peter Lurie, Deputy ground-up bits of infected cattle, fed to animal and bone meal that has been Director of Public Citizen :s- Health Re­ herds as extra protein for growth.... The sold to other parts of the world. searr;h Group. 1be program aiwd on bone and animal meal were banned in ]anuary26, 2001. Britain, but exported to Europe. Euro­ Elizabeth Farnsworth (Newshour An­ pean countries had banned imports of chor): To discuss the disease and the Paul Miller (Newshour reporter): The British beef in 1996, but their own cattle efforts to prevent its spread to this coun­ fight began in England in the late 1980s were becoming infected. In November, try, we tum to Dr. Murray Lumpkin, when cows acted strangely before dying families of two French [variant] CJD continued on page 2 and autopsies showed their brains looked like sponges. The cause was an abnor­ mal bit of protein called a prion. C 0 N T E N T S

Peter Smith (London School ofHygiene Still Hard to Swallow and Tropical Medicine): What hap­ Pharmaceutical companies overcharging Americans for drugs isn't new. pens in the disease is that protein Read a little history and some good suggestions for the future ...... 3 becomes malformed, misshapen, and Product Recalls then there seems to be a template 111e FDA is reassessing how to report their recalls so there are none. effect that works progressively through­ CPSC recalls include defective gun locks and toyvehicles ...... 5 out the body, transforming the shape of normal prion proteins into this ab­ It's the Calories that Count normal form. And eventually this accu­ A recent USDA report confirmed what we already knew: if you eat less mulates in the central nervous system and exercise more, you lose weight...... 7 and in the brain, leading to death. COX-2 Inhibitors Vioxx and Celebrex: Keep Staying Away The companies are trying to tell us these "me-too" drugs are safer than PaulMiller : 180,000 head of cattle were other drugs in their class. The evidence just doesn't show that...... 8 infected overall in Britain. And by 1996, scientists discovered that BSE prions Consumer Product Safety Commission Finally Sees the Light on could somehow jump species to hu­ Lead in Candles mans, causing a fatal brain disease This certainly comes under the category "It's about time." ...... 9 known as new variant CreutzfeldtJakob disease or CJD .... An investigation into Outrage of the Month A Discussion of Misleading Drug Ads the epidemic concluded the British gov­ You've seen them on TV and in print. How truthful are they? ...... 12 ernment had misled consumers about

VISIT IIL\LTII RESEARCH GROllP'S WEB SITI~ AT WWW.CITIZEN.ORG / IIRG/ MAD COW DISEASE, from page 1 Dr.PauiBrown: Yes, thatiscorrect.... Beef import it into this country. Now I'm not senior medical adviser in the products go into a lot of things. Gelatin saying it has happened, but the FDA has commissioner's office at the Food and goes into capsules that you swallow as so little in the way of regulatory authority Drug Administration [FDA]; Dr. Paul pills. But in the processing of many of over dietary supplements that I think this Brown, a senior research sdentist at the these products, any of the infectivity that is a hole we must close irnmediately.... The National Institutes of Health-he chairs a might have been there would be de­ dietary supplements can be made from committee that advises the FDA On Mad stroyed. So it's almost surely oral expo­ extracts from brain, and some people, Cow Disease; and Dr. Peter Lurie, deputy sure and not, for example, cosmetics. for reasons unclear to me, seem to ftnd director of the Health Research Group that a worthwhile thing to consume. The for the consumer organization, Public Elizabeth Farnsworth: What about problem is that the FDA and the USDA Citizen-he also advises the FDA. Dr. vaccines? don't have adequate... authority to moni­ Brown, I want to go back over the tor what is coming into the country. Very sdence, just briefly, of all this. You have Dr. Paul Brown: Well, vaccines are a few inspections are done. Probably only said there is a lot of uncertainty about sensitive issue because of course they're 1 percent of all material that enters the Mad Cow Disease. What can you say [is given to children. Anything that involves country is inspected. And companies known] certainly about its provenance children requires spedal care. By and that are making dietary supplements and also about how humans get it? large, vaccine exposure to anything that from cow brain, for example, have every might be infectious is so low as to be incentive to mislead the United States Dr. Paul Brown: Well, I think the only almost zero. In other words, when you Government. And it's that that worries thing that we can say for absolute give a vacdne, the fmal product does not me, that these kinds of materials ... could certain is that the human disease called contain bovine materials. But the viruses, enter. variant Creutzfeld-variant Creutzfeld­ for example, that are used to make the )acob Disease is the result of infection vaccine may have been grown in tissue Elizabeth Farnsworth: The problem you with Mad Cow Disease. Everything cultures that were fed with fetal bovine mentioned about some of the feed com­ else about this story is more or less serum. But it is a passing phenomenon ing into the country, do you think it could plausible speculation. that is almost surely diluted to the point be that some cows here could have BSE of near zero in the ftnished product. and it hasn't been recognized yet? Elizabeth Farnsworth: Even that it may come from rendered meat and bone Elizabeth Farnsworth: Okay. Dr. Lurie, Dr. PeterLurie: Well, certainly there is no meal products in feed? when you look at the situation in example of a cow in this country that has Europe, I mean, right now as we speak, BSE, nor is there an example of a human Dr. Paul Brown: Yeah, I think we'll slaughterhouses in Portugal are killing with a human version ofit in this country. never prove the historical origin of this 50,000 cattle. Cattle are being killed all But...we have FDA inspections done disease, but by far the most plausible over the place. What do you see-big very recently that show that ftrstly they've explanation is the material that you've danger, fairly slow spread, hysteria? only inspected about a third of the heard about, meat and bone meal, which What do you see? manufacturers of meal for cows. And is a product of rendered carcasses. And secondly, among those that they have in the rendering mix, all kinds of things Dr. Peter Lurie: I think we have a safety inspected up to a quarter of them do not go in it-carcasses from which every­ net in this country, but my concern is that have adequate procedures to prevent thing has been removed, livestock, road it has a certain amount of breaches in it the recycling of cow parts into the feed kill, dying pets, plate waste, it's a great and that we aren't as well protected as of other cows. mix of things. Among this-in this mix, we really could be. I think the vacdnes would be carcasses from sheep, and are perhaps an example of that, not so Elizabeth Farnsworth: Dr. Lumpkin, how sheep have a natural disease called much in that there is a large risk of that, good do you think the safety net is Scrapie, which has been known for at but the FDA asked the manufacturers to protecting Americans from Mad Cow least 250 years. And it's probable that not use materials that came from British Disease? around 1980, because of changes in the cows [since] 1993. But the manufacturers rendering process, some of the infectiv­ chose to ignore that recommendation Dr. Murray Lumpkin: I think it's like any ity of Scrape-infected sheep survived it from the FDA and they went ahead and other safety net, it is a safety net that has and got into cattle. did it anyway for at least seven years. So many components, redundandes that I think there are a number of holes we have been built into it, which are obvi­ Elizabeth Farnsworth: So cattle get it. need to close. Dietary supplements, I ously quite necessary. I think like any Cooking doesn't make any difference think, are another. Here we have an FDA type of an undertaking, it can always be in this case; it's not like other diseases that has practically no authority to ad­ improved. And for a lot of the reasons that you can get from meat. A human equately regulate dietary supplements. that you've heard from the other two eats it, the protein, the offending pro­ And it is actually possible that one could guests on the show today, we have tein then spreads to the human's brain. make a dietary supplement from ner­ indeed, been working to do that. Is that the idea? vous tissue from a British cow and continued on page 3

2 +March 2001 Still Hard to Swallow 1befollowing article was authored spending billions of dollars. tops. Brand name manufacturers were by Morton Mintz who reported on the What's surprisingly old is the prob­ charging pharmacists $18, and the retail pharmaceutical industry for The lem of excessively high drug pricing. price was $30. Washington Post from 1958 to 1988. In December 1959, the Senate judi­ His books include "By Prescription ciary Committee's subcommittee on an­ • For 100 capsules of the antibiotic Only" (1967) and" At Any Cost: Cor­ titrust and monopoly, led by Estes tetracycline, Bristol's production cost porate Greed, Women, and the Kefauver (D-Tenn.), launched an un­ was $1.67, its price to druggists $30.6o. Dalkon Shield" (1985, out of print). precedented investigation of the phar­ Consumers paid $51. 1bis article was also printed in The maceutical industry. Over the ensuing Washington Post Outlook Section on 2-1/2 years, the subcommittee exposed Then, as now, pharmaceutical manu­ February 10, 2001 and reprinted with pricing practices that repeatedly aston­ facturers and their allies claimed that permission of the author. ished the public-but may seem all too high prices were indispensable to fund familiar to consumers today. Some ex­ the research that produces constant hat's new about prescrip­ amples from the Kefauver report: advances in drug therapy. The subcom­ tion drug pricing is the mittee found, however, that the 22 W attention that it's been get­ • Eli lilly was selling 100 tablets of the largest pharmaceutical manufacturers ting in Congress, thanks partly to antibiotic V-Cillin to pharmacies in En­ were spending 24 cents of every rev­ busloads of elderly Americans going to gland for $6.50 and in Australia for enue dollar on promotion. This was Canada and Mexico to buy their medi­ $10.75, while charging pharmacies in approximately four times their spend­ cines at sharply lower costs. What's the United States $18. ing on research. relatively new is direct-to-consumer tele­ vision and print advertising of drugs, on • For 100 pills of the steroid pred­ Kefauver cited specific findings which pharmaceutical manufacturers are nisone, the production cost was $1.50, continued on page 4

MAD COW DISEASE, from page 2 think-how do you think we have Dr. Paul Brown: Well, I think what has Dr. Peter Lurie: ... the fact is that the been successful so far in preventing it, been talked about-that is, vigilance in FDA's own inspection records show and what more needs to be done? terms of imports of products from other that they have not inspected that many countries. I don't think we need to worry plants, and in many cases don't have Dr. Paul Brown: There are really [two] about a lot of products that have been adequate procedures there. And this things which have kept the US BSE-free, mentioned in passing here. Cosmetics, week's experience in Texas .. .is in fact, and ergo variant CJD-free. The ftrst was for example, really are not a problem. an example where material that very simply fortuitous. Foot and mouth dis­ Gelatin is really not a problem-not well might include recycled cow parts ease occurs here and there in the world because of where they come from, but appears to have been fed to some cows and at the outskirts of Europe. And because the processing involved in mak­ in Texas. So they have inspection because of the fear that foot and mouth ing the products would eliminate the records that show the holes, and now disease might enter this country, the infective agent. we have actual information from Texas USDA banned, in large measure, all that as best we can tell shows the imports of live cattle from Europe. A few Elizabeth Farnsworlh: Okay. Dr. implications of just that. The FDA is were brought in, but...this was in the Lurie, on that? doing a lot of work, but they're simply '80s. And those cattle have been slaugh­ not doing enough.... Remember that tered or are now quarantined. That was Dr. Peter Lurie: Well, I agree with all of that's how the problem began in Brit­ the ftrst thing. The second thing is that that. I think we also need to expand the ain. It began with some small number the USDA and the FDA really got on top testing that we do of potentially infected of infected cows. Their parts were of this problem very quickly. In point of cows. In this country, we've looked at recycled ... through the meal to other fact, because of a computing system that the brains ofabout 12,000 cows since the cows, and that's how the epidemic is present in this country, the BSE be­ beginning of the epidemic. Now that grew the way it did. It began with came a notifiable disease in this country France has finally recognized its prob­ exactly these kinds of breaches in before it even became a notifiable dis­ lem, they're looking at 20,000 cows per process. ease in Great Britain. week. Sol think, as asenior... Department of Agriculture official told me, we would Elizabeth Farnsworth: Dr. Brown, Elizabeth Famsworlh: What needs to be like to see an expansion of the ability to you're advising the FDA on this, too. watched out for now? What concerns test cows in this country. Until we do so, Where do you come down on the state you now? I'm not going to be completely reas­ of the safety net, and what do you sured.

Public Citizen's Health Research Group + Healtb Letter + 3 DRUG PRICING ,from page 3 June, the industry spent a staggering the Senate floor, most Democrats and all that further undermined the research $54.5 billion promoting its wares to Republicans allied themselves with the rationale: health care professionals and consum­ industry in fierce opposition. Kefauver ers, according to the health care infor­ then offered a compromise: compulsory • Schering charged pharmacies $8.40 mation company IMS Health.) licensing would kick in only for those for 60 tablets of estradiol progynon, a Congress has failed to investigate the drugs found by the Federal Trade Com­ drug for menopausal disorders. Schering industry's often-repeated claim that it mission to have a wholesale price more bought the drug in bulk from Roussel of costs up to $500 million, on average, to than five times the cost of production. France, and therefore had done no bring a new drug to market (the figure The compromise, no less ferociously research of its own on it. The 60 tablets came from a 1991 paper by four econo­ opposed, also died. contained 11.7 cents worth of the drug. mists with ties to the drug industry). Or Compulsory licensing could still work Schering's markup was 7,079 percent. where sensible incentives for research to encourage profit but not profiteering. end and profiteering begins. Or how to But it has little appeal on Capitol Hill, • Rhone-Poulenc of France invented nurture research for therapeutic break­ where the Senate came close to passing the potent tranquilizers Thorazine and throughs and to fight great scourges like a bill to add three years to the 20-year Sparine, and licensed their manufacture AIDS, rather than for copycat medicines life of product patents on the allergy to pharmaceutical houses in other coun­ aimed only at gaining market share or drug Claritin and seven other "block­ tries that had contributed nothing to the for another drug for baldness. buster" brand name medicines. invention of either medicine. For 50 So, frozen as ever, we begin the 21st (Schering-Plough's net earnings on Thorazine tablets, Rhone-Poulenc century with pricing excesses continu­ Claritin in its first five years on the charged pharmacists in France 51 cents; ing unabated. market were $1.3 billion.) The bill was The British licensee charged 77 cents, It's unrealistic to expect meaningful, approved last year by the Senate Judi­ the West German licensee 94 cents; the structural pricing reforms from this Con­ ciary Committee and only faded away U.S. licensee (Smith Kline & French) gress or this White House. In the 1999- in light of the election battle over Medi­ charged $3.03. For 50 Sparine pills, the 2000 election cycle alone, the care drug benefits. U.S. licensee (Wyeth Laboratories) pharmaceutical industry made campaign A Congress wanting to take minimal charged 94 cents in Australia but $3 in contributions topping $23.4 million, fun­ pro-competitive action could consider a the United States. neled hundreds of millions of dollars to proposal from Benjamin Gordon, staff front groups and lobbyists, and report­ economist of the Senate Small Business In other words, the problems were edly spent more than $40 million on so­ Committee's monopoly subcommittee, the same we see today: medications called issue ads. who worked on an inquiry into the drug priced far higher than research and More likely is that last year's canceled industry from 1967 to 1977. Gordon production costs warrant, and priced bill authorizing re-importation of made­ suggested that government authorize the higher for Americans than for consum­ in-the-USA drugs from Canada and National Institutes of Health or some ers elsewhere. Mexico will be repaired and reenacted. other federal agency to develop, test and "What we are confronted with in the But that would treat the symptoms, not produce-but not sell-new medicines. [prescription] drug industry," Kefauver the underlying disease of monopolistic That agency's experience could provide concluded in the subcommittee's re­ drug pricing. a yardstick to compare the prices charged port, "is the existence of prices which by If lasting, reasonable drug pricing is by private manufacturers. There is prece­ any test and under any standard are ever to be obtained in this country, one dent for this in the Tennessee Valley excessive." remedy Kefauver advocated should be Authority, created during the New Deal, The senator urged several reforms. put back on the table. It's compulsory in part to help set standards for the Had they been enacted, consumers licensing. pricing of electric power. would have saved billions of dollars The United States is the only major With the aid of such a yardstick, annually for nearly 40 years. But they economic power that allows an inventor Gordon said in a recent interview, the were not. "Conservative congressmen, to patent a medicine (as opposed to the government could identify which patent­ responding to industry opposition" gut­ methods and processes used to produce monopoly medicines it bought for pro­ ted the price provisions of the Kefauver it). Kefauver's proposal was to give the grams such as Medicaid were excessively bill, Forlune magazine reported at the inventor a three-year monopoly; after priced. Then the government could time. that, the company would be compelled contract with other manufacturers to Congress, whether controlled by to license the medicine to other manu­ produce and distribute the medicines at Democrats or Republicans, has not facturers, who would have to pay the a more realistic price. troubled since the Kefauver investiga­ inventor royalties of up to 8 percent for To do this, the government would tion to dig deeply into why drug prices the life of the patent. The other manufac­ invoke a 52-year-old law, Section 1498(a) are so many times higher than produc­ turers would have to develop their own of Title 28 in the U.S. Code, which tion costs. Nor into the effects on drug production methods, though, since those empowers it to set the price it will .pay prices of the immense cost of promo­ patents would be unaffected. the owner of a patent on any invention, tion. (In the 4-1/2 years ending last When Kefauver's proposal reached continued on page 9

4 + Marcb 2001 Product Recalls january 11-February 12,2001

I> R lT c; S & I> I E T A R Y S lT P P L E M E N T S

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

There are no drug recalls to report this month because of a disruption in the production of the FDA Enforcement Report, the weekly publication from which we learn of recalls. The FDA has noted that "Due to a change in staffing, FDA's Office of Public Affairs (OPA) is reexamining the process for publishing the FDA Enforcement Report. As OPA restructures the Enforcement Report over the next few weeks, there will be some disruptions and changes in its production and distribution."

Please continue to report adverse drug reactions to the FDA by calling (800) FDA-1088. The FDA web site is wwwfda.gov.

C 0 N S lT .\1 E R P R 0 D lT C T S

Contact the Consumer Product Safety Commission (CPSC) for specific instructions or return the item to the place of purchase for a refund. For additional information from the Consumer Product Safety Commission, call their hotline at 1-800-638-2772. The CPSC web site is http://www.cpsc.gov.

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Busy School Bus Toys; On some units, the yellow "awning" piece Busy School Bus item number 5527 with date codes 91671 through above the bus door can break loose, posing a choking hazard to young 91883; 12,500 sold nationwide from June 1999 through January 2001; children Playskool, Pawtucket, Rhode Island (888) 510-1561 www.hasbro.com/ consumer/safety.html

Bicycles; Because pedals are too low to the ground, they fail to meet Model year 2001 Torker Blaster 16-inch Boy's bicycles in red, black, federal bicycle standards. Children can lose control when a pedal blue, or chrome, and Sunflower 16-inch Girl's bicycles in yellow, pink strikes the ground, causing falls and injuries or florescent green; 1400 sold at bicycle stores nationwide from September-December 2000; Seattle Bike Supply, Kent, Washington (800) 283-2453

Gun Locks; Under certain conditions, these locks can open without Locks resemble a bicycle cable lock and have a red cable with a black the use of a key which can give unauthorized access to a firearm padlock. Red vinyl bands around the top and bottom of the locks read, "PROJECT" and "HOMESAFE"; 400,000 distributed nationwide by law enforcement agenices from September 1999 through October 2000; Adstar Inc., Merrick, New York (800) 726-6444

Jeans and Overalls (children's); Small decorative metal appliques BABY GUESS and GUESS GIRLS labels sizes 6 months through 6X; on the legs of the garments can come loose and separate, posing a 11,000 sold nationwide from October-December 2000; Designer choking hazard to young children Classics LLC, Keasbey, New Jersey (888) 626-4939

Jumpsuits (Infants); A ribbon that runs through the zipper pull tab 100 percent cotton interlock jumpsuits with teddy bear, bunny or puppy can detach, resulting in a potential choking hazard. Consumers should embroidery design on the front; or cotton/polyester blend velour immediately remove and discard the ribbon. The garment then can be jumpsuits with a teddy bear or bunny embroidery design on the front, worn without the ribbon sold in sizes Small, Medium, and Large; 600,000 sold nationwide from May-December 2000; The William Carter Co. (Carter's), Morrow, Georgia (888) 339-2129 www.carters.com

continued on page 6

Public Citizen's Health Research Group + Health Letter + 5 C 0 N S l i Y1 E R P H 0 D l i C T S cout.

Same l!( l'nuluct: l'ro/Jiem Lot #; Quauli~l' 11111/ Di~lrilmliou: .llmu~j(tc/111'<'1'

Kid's Meal Toys; Suction cup on the toy can come off, presenting a "Planet Discovery" plastic disks (about 2 to 3 inches in diameter) with a choking hazard to young children suction cup (about 1.5 inch in diameter) on the back. The toys depict all of the planets plus the moon and the sun. Toys were distributed with Chick-fil-A kid's meals-nationwide during January 1999 and January 2001; Chick-fil-A Inc., Atlanta, Georgia (866) 736-5914

Lamps; Electronic component inside the plug can overheat, present­ Floor lamps are sand colored, 4 feet tall and have flexible gooseneck ing a fire and burn hazard arms to adjust the position of the fluorescent lights. Labels indicate "OTI -LITE TRUECOLOR FLOOR LAMP"; 1560 sold at craft, hobby and fabric stores, including Hancock Fabrics nationwide from November through December 2000; Environmental Lighting Concepts, Tampa, Fla; (800) 842-8848

Miler Saws; Bolts on saws can loosen and the blade could detach, 12-inch saws, model numbers 3660 TY1 and 3680 TY1; 6,400 sold at posing a risk of lacerations home centers and hardware stores nationwide from January 1992 through December 1993; Black &Decker (U.S.) Inc., Towson, Maryland (888) 771-4540

Miler Saws (Recall to repair); Bolts can loosen and the blade could 12-inch saws, model numbers DW704 TY1 and DW705 TY1; 112,000 detach, posing a risk of lacerations sold at home centers and hardware stores nationwide from January 1992 through December 1993; DEWALT Industrial Tool Co., Baltimore, Maryland (888) 1n -4540 www.dewalt.com/us/articles/ press_release.asp?ID=249

Motocross Motorcycles; Rear brakes on these motorcycles can fail 2001 KX series model numbers KX65, KX85, KX100, KX125, KX250 and KX500; 18,000 sold nationwide from May-November 2000; Kawasaki Motors Corporation, U.S.A., Irvine, California (866) 802- 9381 www.buykawasaki.com

Sweatshirts (girls); Children can get entangled and strangle in hood Navy blue Ocean Pacific long-sleeve hooded sweatshirts; 6,600 sold at drawstrings that catch on objects Upton's, Lamont's, Gottschalks, and Sports Authority stores nationwide from August-October 1999; Trends Clothing Corp., Hialeah Gardens, Florida (800) ?-TRENDS

Tot Rider Walkers; Cover on walker's removable music center can Model 14302; 3,356 sold nationwide from February 2ooo-January break off, allowing small parts to fall from the product, creating a 2001; Kolcraft Enterprises, Inc., Chicago, Illinois (800) 453-7673 potential choking hazard to young children

Toy Vehicles; Small parts can break off of the toy vehicles, posing a Multicolored plastic airplanes, cars, dump trucks, trains and fire choking hazard to young children engines sold under the PLAYGO brand name. Each vehicle has a battery-operated, detachable remote control with a 40-inch cord. Enclosed in cab of each vehicle are 1/4 inch multicolor balls; 290,000 sold nationwide from June 1995 through December 1998; Supreme Toys (H.K) Ltd., Hong Kong (800) 567-1774

Tree Wound and Grafting Compound; Pressure can build inside Pint, quart and gallon cans filled from November 11, 1996, through the can and forcibly discharge the compound, which can cause May 5, 1999. Five-digit date (written as year, month, day) is stamped temporary skin irritation on back of can's label. For example, "8112r means the can was filled on November 27, 1998; 35,000 sold nationwide at hardware and nurseries from November 1996 through August 1999; The Tanglefoot Co., Grand Rapids, Michigan (800) 215-0938 [email protected]

continued on page 7

6 +March 2001 It's the Calories-that Count

he desire to lose weight is a and The New Pritikin Program). There are, however, some impor­ near obsession in modern The report found that one can lose tant nutritional distinctions between T America. And no wonder: 50 weight with any of these diets, even in the diets. According to the USDA, the percent of Americans are considered to the absence of exercise, as long as only diet that is nutritionally adequate be overweight, a percentage that has caloric intake is reduced to about 1,400 is the moderate-fat diet. In contrast, the been increasing for 30 years. It is to 1,500 calories/day. If that sounds other two diets are deficient in various therefore no surprise that we are sub­ like good news, consider the follow­ essential vitamins and minerals. High­ jected to a daily barrage of quick-fix ing: the average American consumes fat, low-carbohydrate diets are low in solutions: diets guaranteed to remove 2,200 calories/day! Of course, you can vitamins E, A, thiamine, B6, and folate unwanted pounds and transform the reduce your caloric intake to less than as well as calcium, magnesium, iron, couch potato into a supermodel almost the 1,400 to 1,500 calories/day and still zinc, potassium and dietary fiber. They overnight. No fewer than 700 weight lose weight if you supplement your are also high in saturated fat and cho­ loss books have been published since diet with even moderate exercise. (A lesterol. Very low-fat diets are deficient 1997 and the combination of book practical approach to weight loss com­ in vitamins B12 and E and provide sales, diet pills, nutritional supplements bining a moderate amount of exercise insufficient zinc. Of the three diets, and weight loss programs yields a tidy with modest dietary changes is de­ moderate-fat diets have been shown $33 billion in revenue to often-unscru­ scribed in the November 1999 issue of most convincingly to improve choles­ pulous entrepreneurs. the Health Letter.) terol profiles. But is there any science behind the The USDA's main conclusion is suc­ Overall, therefore, the safest and extravagant claims? The U.S. Depart­ cinct: "Diets that reduce caloric intake most effective way to reduce weight is ment of Agriculture (USDA) recently result in weight loss." This simple state­ to adhere to a moderate-fat diet: con­ released a report assessing all studies ment directly addresses some of the sume no more than 30 percent of of the major diets in the scientific myths perpetrated by the diet industry. calories as fat, limit protein to 20 per­ literature, weighing the reports accord­ The diets may have more in common cent of the diet and consume complex ing to their quality. Their conclusion than the hype suggests inasmuch as all carbohydrates, fruits, vegetables and may sound familiar: the best way to involve caloric restriction. And if the grains in relatively larger quantities. lose and maintain weight loss is to Atkins diet seems to lead to particularly Many people interested in weight reduce caloric intake and to exercise rapid weight loss, it is probably be­ loss hope that there is some simple, faithfully. cause in the short term the diet leads to comfortable, and quick road to lose the The USDA report grouped the diets more loss of water than body fat. This unwanted pounds and keep them off. into three categories: high-fat, low­ water weight is regained as soon as In reality, the road is blocked by calo­ carbohydrate diets (e.g., Dr. Atkins' dieting stops. Unfortunately, most of ries. Eating a little less and exercising a New Diet Revolution, Protein Power the available data have been gathered little more, on a regular, sustained and Life Without Bread); moderate-fat from relatively short term studies, so basis is the only way around the road­ diets (e.g., USDA Food Guide Pyramid, there is little information on how to block. DASH diet and Weight Watchers); and maintain appropriate body weight. low-fat and very-low-fat diets (e.g., Dr. Dean Omish's Program for Reversing Heart Disease, Eat More, Weigh Less

C: 0 N S l1 :\·1 E R P R 0 D P C T S cont.

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Wooden Pull Toys; Wooden pegs can come off of these toys, posing Dog pull toy is 10 inches long and 5 inches high. Dog's legs are achoking hazard to young children attached to wooden wheels with small pegs. Ablack string with a large wooden ball on the end is connected to the front of the toy; 2,900 sold at Pottery Barn Kids store in Corte Madera, California, and Pottery Barn Outlet stores in Virginia, Texas, Georgia, Tennessee and Ohio from June 2000 through January 2001; Pottery Barn Kids, San Francisco, California (866) 428-6467

Public Citizen's Hc:alth Research Group + Health utter + 7 COX-2 Inhibitors Vioxx and Celebrex: Keep Staying Away-It Gets Worse

hen Vioxx and Celebrex amount of serious GI complications patients). This increased number of were approved about ~o with Vioxx compared to naproxen, heart attacks was also accompanied by W years ago, we were qUJte there were several other problems, an increase in other thrombotic (blood skeptical about the claims that they beyond the wrong choice of naproxen clotting) adverse effects such as strokes were much safer in the gastrointestinal for comparison, which make the find­ and blood clots in the legs as well as (GI) tract than other, older nonsteroi­ ings not really applicable to the general problems with hypertension in the dal anti-inflammatory drugs (NSAIDs). population of people using Vioxx. First, Vioxx group compared with the At the time of approval, neither Merck the study was limited to people who naproxen group. (Vioxx) nor Pharmacia (Celebrex) had had rheumatoid arthritis, a disease for Although the Celebrex study did not done the comparative long term, higher which Vioxx is not even approved. find a significantly elevated number of dose randomized trials in which the Second, almost 60 percent of the people heart attacks in those using that drug newer COX-2 inhibitor drug would be in the study were simultaneously using compared with those using the older compared to the least dangerous of steroids such as prednisone as adjunc­ NSAIDs (ibuprofen or diclofenac), there these older drugs such as ibuprofen tive treatment for their rheumatoid ar­ was also cause for concern about heart (Motrin) to find out if there is a statis­ thritis. Since steroids themselves can toxicity with that drug. FDA Cardicr tically significantly lower amount of cause ulcers, this distorts the findings. Renal division reviewer Dr. serious GI complications such as per­ We agree with the conclusions of Throckmorton found that "the inci­ forations, ulcers or bleeding with the FDA's Office of Postmarketing Drug dence of adverse events related to COX-2 inhibitor drug. In addition, we Risk Assessment that the 73 deaths cardiac ischemia (decreased blood flow were worried, as we are about any new seen with celecoxib [Celebrex](36) or to the heart) was higher in the celecoxib drug that does not have an important rofecoxib [Vioxx](37) from gastrointes­ [Celebrex] group ... and was most pro­ advantage over existing drugs, about tinal bleeding, obstruction, perforation nounced in the group of patients not hidden dangers. This is especially true or stenosis show that the current label­ taking ASA (aspirin)" as a cardiovascu­ for the COX-2 inhibitors since they ing for the two drugs "reflect[s] the risk lar protective drug. In these patients affect so many different parts of the of fatal gastrointestinal bleeding, ob­ the rate of myocardial infarction was body. struction, perforation or stenosis." also highest in the celecoxib group (0.2 percent) compared with users of the GIToxicity Cardiovascular Toxicity other two drugs (0.1 percent). For all Prior to recent FDA advisory com­ In a recent study published in the patients, on and off aspirin, there was mittee meetings, the two companies Proceedings of the National Academy a higher incidence of atrial fibrillation, submitted new studies which they of Sciences, the ability of rabbits to a cardiac arrhythmia, in the celecoxib hoped would convince the FDA to withstand temporary experimental corer group than in either of the other two allow the labels of their drugs to state nary artery occlusion was significantly groups, again more pronounced in the that they were safer, as far as GI impaired by treatment with celecoxib group not taking aspirin. The author toxicity, than the older NSAIDs. which completely blocked the concluded by stating that "the data do Pharmacia played more by the rules cardioprotective effects of the COX-2 not exclude a less apparent prcrthrom­ and conducted randomized studies in enzyme. The authors of that study botic [blood clot forming) effect of which Celebrex was compared with concluded that COX-2 enzyme is a celecoxib, reflected in the relative rates either ibuprofen or diclofenac, the two "cardioprotective protein." Therefore, of cardiac adverse events related to NSAIDs with the least GI toxicity. The it is implied, drugs which block this ischemia." study failed to show a significantly cardioprotective enzyme, such as COX- lower amount of these serious GI ad­ 2 inhibitors, may neutralize its protec­ Once again, a seemingly magic bul­ M verse effects for Celebrex, compared to tive effects. let appears to have self-destructed as the other drugs. Cheating, somewhat, In Merck's study comparing Vioxx research reveals the larger context in Merck decided that Vioxx would prob­ to naproxen, there was a highly statis­ which it operates-the risks as well as ably appear to have a more favorable tically significant five-fold increase in the benefits. The benefits of COX-2 safety profile if it was compared to a heart attacks in the overall Vioxx group inhibitors as far as reducing GI toxicity more-dangerous-than-ibuprofen/ (0.5 percent) compared to the naproxen appear to have been grossly exagger­ diclofenac-NSAID and they chose group (0.1 percent). This amounted to ated and oversold. Years after the re­ naproxen as the comparator drug for approximately 20 heart attacks with search on these benefits was done, a their study. Although the Merck study Vioxx (out of 4047 patients) compared rapid accumulation of evidence on did find a statistically significantly lower with 4 with naproxen (out of 4029 continued on page 10

8 + Marcb 2001 Consumer Product Safety Commission Finally Sees the Light on Lead in Candles

t took two Public Citizen petitions the self-serving entreaties of industry and voted 3-0 to grant Public Citizen's petition. and over a quarter of a century, but agreed to a voluntary ban. Not surpris­ lheagencynow has to gothrougha public I lhe Consumer Product Safety Com­ ingly, before the decade was out, U.S. rulemaking process that could take more mission (CPSC) seems finally to have manufacturers resumed production of than a year. In the meantime, Public Citizen acted responsibly. On February 13, 2001, the toxic chemical. is urging consumers tonotbuyanycandles the Commission voted unanimously to In early 2000, Public Citizen did a with metal wicks (lead-wicked candles grant Public Citizen's petition (see April, study documenting the presence of lead cannot be readily distinguished from wicks 2000 issue of the Health Letter) to ban the wicks in candles sold by major retailers made from other metals) and to not bum sale of candles with lead wicks. in the Baltimore-Washington area. The or return to the store any metal-wicked Lead is a known health hazard, par­ study, subsequently published in the candles they may have purchased already. ticularly for fetuses and young children. journal of the American Medical Asso­ This pattern of events echoes what Numerous studies have linked the chemi­ ciation (see the August, 2000 issue of the we have often seen before with other cal to brain damage, developmental dis­ Health Letter), showed that 30 percent of regulatory agencies. All-too-often, agen­ orders and low IQ. Public health candles had wicks containing metal cores cies fail to exert their legitimate authority authorities have agreed for decades that (mostly zinc and tin) and that 10 percent and instead fall for empty promises from any unnecessary exposure to lead should of these had enough lead to produce industry. The lead-wicked candle case is be avoided. room air lead levels 10-36 times those one of the best recent examples of the Someunsaupulousmanufacturersuse permitted by the Environmental Protec­ folly of taking this path-the agency, lead or other metals in candle wicks to tion Agency. With ongoing exposure, after removing the accumulated egg from keep thewickuprightwhile manufactur­ these candles could raise a child's blood its face, has fmally realized that the ing and burning the candle. In Europe, level well beyond those established as candle industry could not be trusted and no manufacturers use metal wicks, so dangerous by the U.S. government. reversed itself. But why must it take 27 clearly they are unnecessary. It seems the CPSC has finally seen the years of needlessly exposing children to Yet, when Public Citizen fltSt peti­ light. In December 2000, Commission staff this toxin to finally bring the agency to its tioned CPSC to ban candles with lead recommended that lead wicks be banned senses? wicks in 1973, the agericy succumbed to and in February the CPSC Commissioners

DRUG PRICING ,from page 4 must first establish the patent's validity. hospitals. For example, Allen said, a with two qualillcations: the invention This can be extremely difficult, as Carter­ prescription for Prilosec that cost an must be used for governmental pur­ Wallace found out. Seeking a generic average customer $114.56 cost a large­ poses, and a reasonable royalty must be version of Miltown, the government scale buyer $59.10; the figures for Zoloft paid to the patent owner. invoked 1498(a), and the company sued. were $220.45 vs. $115.70. That the law could achieve huge But after a years-long battle with the The GOP-controlled House Com­ savings for the taxpayers was dramati­ Justice Department, a court ruled the merce Committee held no hearings on cally illustrated in a 1971 speech by patent invalid in 1972. the bill, and it died. But Allen, encour­ monopoly subcommittee chairman Only after proving validity can the aged by having 152 co-sponsors (al­ Gaylord Nelson (D-Wis.). While the manufacturer go to the next step: trying though none were Republicans), plans Veterans Administration was buying to show that the government's price is to re-introduce it. the tranquilizer meprobamate in Den­ unreasonable. To do this a drug manu­ His bill aside, the proposals for struc­ mark for $1.55 per 500 tablets, he facturer would have to disclose produc­ tural reform of drug prices are old ~ pointed out, Carter-Wallace was charg­ tion costs. Brand name medicine because the structural problems are .'::I ing U.S. pharmacists $26 for the same manufacturers hate that idea. old. The arguments against the reforms quantity of meprobamate under the A promising new idea came from are old, too. ButwhynotanewKefauver­ brand named Miltown. Rep. Thomas H. Allen (D-Maine), who type investigation? A subpoena-empow­ Section 1498(a) could be used to in 1999 proposed a bill that would allow ered congressional committee could target any brand name medicine with pharmacies to buy drugs for Medicare determine where sensible incentives very low production costs but very high beneficiaries at the best price paid by end and profiteering begins. What, ex­ prices. A drug manufacturer contend­ the government. As things stand, the actly, is the case that the leaders on ing that the government's price is un­ beneficiaries pay retail prices that, on Capitol Hill, Republican or Democratic, reasonable can sue the United States. average, are nearly twice those paid by might make against such an inquiry? To succeed in court, however, the owner Medicaid, the VA, and big HMOs and Maybe they should tell us.

Public Citizen's Health Research Group + Health Letter + 9 COX-2 INHffiiTORS,from page 8 evidence of statistically significant re­ In addition, the evidence which is risks is occurring. For an important duction in serious GI toxicity for rapidly accumulating about the heart enzyme which is close to ubiquitous in celecoxib. This should take the form of damage caused by these drugs must be the body, it is less than surprising that a box warning (for all the drugs) which mentioned in this cardiovascular box blocking its activity in one part, the should be placed at the beginning of warning. gastrointestinal tract, must be balanced the label. against the apparently harmful effects A second box warning about car­ What You Can Do of blocking its critical functions in diovascular toxicity needs to be added. In light of the above discussion, we other parts of the body. It should warn of the lack of platelet continue to advise the patient-protec­ We strongly urge the retention of aggregation inhibition of the drugs tive five-year-rule for these drugs, as the NSAID class-warning label for these which protects those at risk from an we do for all other new drugs that are drugs, possibly adding that there is no increased occurrence of heart attacks. not breakthroughs. Do Not Use.

OUfRAGE,jrom page 12 Sidney Wolfe: Well, you have to dustry consultant): No, and I don't analyze what the picture is portray­ think that the companies feel that Charles Gibson: But are you saying ing. Of course it's subjective up to a way. Direct-to-consumer advertising that those-that the pictures over­ point, but there's also the audio that of prescription drugs is the most state, in other words the fellow row­ is going on, often at the same time. heavily-regulated advertising on tele­ ing the boat and riding around and It's interesting that the risks usually vision. Every word, every nuance is stuff, that-that gives an image that get the audio treatment, and mean­ looked at by the FDA. It's the only the drug will do more than it really while across the screen is flashing the advertising that I know of which lists can? benefit treatment and that, in many the risks associated with the products cases, doesn't equate to final bal­ in addition to the benefits. And so I Sidney Wolfe: Yes, I think one of the ance. And it's many big-selling drugs, think that the consumer should be standards that the FDA uses is, is not just Claritin-an allergy drug assured that what they see on televi­ there fair balance between the state­ which I think you're going to men­ sion, generally, is very accurate and ment of the benefits of the drugs and tion in a couple minutes, but lots of very, very balanced. There are in­ the statement of the risks. And in drugs have been caught with illegal stances in which there is a lack of many cases, as you would expect an promotion. balance, and the FDA moves very, advertiser to do, they overstate the very quickly and steps in and re­ benefits and understate the risks ... and Charles Gibson: Wayne Pines, let me moves those ads from television. lead people to believe that this drug turn to you. I know the FDA oversees is going to do much more that it really this but it's interesting, I find that they Charles Gibson: Mr. Pines, do the is and leave ... can't really punish these drug mak­ drug manufacturers submit these ads ers, they can just warn them. Does in advance to the FDA? Charles Gibson: But isn't that awfully that give the drug makers, in effect, subjective when you're saying, "The license to say almost anything? Wayne Pines: Very often they do. pictures may tell a better story than They're not required to, but very the drug really can promise"? Mr. Wayne Pines (pharmaceutical in- continued on page 11

THE PUUUC Cmzi!N HEALTH RES PARCH CROUP Editor ...... Sidney M. Wolfe The Health Research Group was co-founded In 1971 by Ralph Nader and Sidney Wolfe in Matu~glng Editor ...... PbyUts McCarthy l-lutltl1 l_..ettcr Washington, D.C. to fight for the public's health, and to give consumers more control Staff Reuarcbers ...... Peter Lurie over decisions that affect their health. Benita Marcus Adler Copyright C> Health Letter, 2001 Gloria Ruby Material in the Health Letter may not be re­ Published Monthly by printed without permission from the Editor. lnfontu~tton Spectaltst ... jennifer L Howard Public Citizen Health Research Group Send letters and requests to HEALTH LETTER, Contributing Editor ...... Wtlltam Hines All rights reserved. ISSN 0882-598X Editor, 1600 20th St., NW, Washington, D.C., Production Mgr...... Krtsty L jackson 20009. Proofreader ...... • Ben~ Marcus Adler Annual subscription price is $18:QO (12 is­ sues). Mall subscriptions and address changes to Health Letter, Circulation Department, 1600 20th St., NW, Washington, D.C., 20009. Our Web site address is www.dttlx:n.org,/llra.

10 +March 2001 OUTRAGE, from page 10 do another one. There are no penal­ the visual is someone that's taking a often they do just to get the FDA's ties at all for any of this. The FDA drug that's so great that they can roll views on the ads. Yes, they do. doesn't have the ability to put civil around in hay. I mean, one of the monetary penalties. They have rarely, things these ads don't tell about are Sidney Wolfe: I just wanted to com­ if ever, used criminal sanctions, even alternative treatments that may be ment on that. They are heavily-regu­ for repeat violations. So we've got a just as safe or safer and less expen­ lated except: A, the FDA doesn't have real law enforcement problem here. sive or prevention, like staying away specific regulations just for direct-to­ from things that cause allergies. But consumer ads. They go for the ones­ Charles Gibson: Let me go to Mr. you heard-you saw the benefits, they're using the ones that were Pines again. Or. Wolfe mentions 14 and you heard, read as fast as pos­ designed for doctors. And, B, their times Flonase cited, 11 times Claritin sible, a list of risks. I think that most staff is really too small, and, C, they was warned by the FDA, three cita­ of the people would come away from have to submit these things within 15 tions on Celebrex. That doesn't that that ad-would get the image of the days of the time they run them. Wayne seem as if the drug manufacturers are hay and rolling in the hay and taking is right that for at least the TV ads, sort of skating on thin ice here? this drug and probably wouldn't re­ they often, but not always, submit member very much about the risk. them in advance. Of the first 25 TV or Wayne Pines: ~ell, I don't think that The FDA did a study showing that TV radio ads that ran after the barrier they are skating on thin ice. I think ads are much less likely to convey was lifted in '97, though, 60 percent that the drug companies are being risk information. of them were found to be illegal. So responsive to the FDA. In many cases, that, obviously, then-maybe it's as you mentioned earlier, it's a matter Charles Gibson: Let me give Wayne better now, but still, lots of illegal TV of do-whats. It's a matter of image. Pines the last word here. ads are going on which means that It's a matter of subjectivity. And in they really aren't cleared or some­ advertising and trying to compress in Wayne Pines: I don't think anybody times the FDA looks at them and tells 60 seconds all the i~formation that a would think that you can play bas­ them to do something, and they don't consumer needs about a prescription ketball better or roll in the hay by pay attention to what the FDA tells drug is very, very difficult, and it's taking a drug. That's an advertising them. very, very challenging. But overall, I approach. Every single ad contains just want to say, every single ad, the risks. What consumers need to Charles Gibson: You should respond. without exception, without excep­ understand is that the advertising is Mr. Pines, go ahead._ tion, contains the risks associated accurate, and, basically, what the with the products. There have been advertising is trying to do, is to in­ Wayne Pines: Well, let me just say some ads that have been counterpro­ form the consumer about the drug that the number of ads that are found ductive that have annunciated the and encourage a dialogue with the violative are a small percentage of risks so drastically that consumers doctor. Ultimately, it's up to the doc­ the ads that actually run. And once an have actually been turned off from tor to decide whether the drug is ad is found to be violative, compa­ using the product. right for the patient. nies move very, very quickly, the next day, to remove those ads from Charles Gibson: Let me play one of Sidney Wolfe: Under pressure from television ... and replace them with these ads. This is a Claritin ad, again patients. Four hundred and eighty acceptable advertising. that was cited by the FDA. And you violations of the law in the last four mention how difficult it is to get in all years is really unacceptable. The cur­ Sidney. Wolfe: But then the next the side effects in a short commercial. rent status of advertising on televi­ month, they'll come back again. The Take a look here. (Clip shown from sion and print of direct-to-consumer fact that there have been 14 times that Claritin TV Commercial.) They have ads are unacceptable. Patients should ads for Flonase or Flovent, of the to squeeze in the side effects there. be getting objective information when same chemical used for either allergy They do it, sometimes, in almost they get a prescription filled, some­ or asthma, 14 times these ads have FedEx commercial speed. thing the industry stopped. been found illegal. So they just stop the one when once they're caught, Sidney Wolfe: Charlie, that's a little and they come back the next month, bit what I was saying before is that

Public Citizen's Health Research Group + Healtb Letter + 11 0 lT T R A G E 0 F T H E M () N T H A Discussion of Misleading Drug Ads

The following is a transcript of Wayne Pines of APCO Worldwide, a Well, there have been a series of Good Morning America, ABC News pharmaceutical industry consultant, Celebrex ads that have gotten into which featured Dr. Sidney Wolfe, and Dr. Sidney Wolfe, director of the trouble. I think the main reason for Editor ofthe Health Letter in a debate Public Citizen's Health Research those ads and for most of the ads is with Wayne Pines of APCO World­ Group, and I welcome both of you. that they overstate the benefits, they wide. Thesegmentwasairedon]anu­ If I could, let me start with one of imply that the drug is much better ary 3, 2001. these ads where the FDA has warned that it is and with Celebrex, flaunt the marketers of this drug a couple­ FDA approval for treating pain, for Charles Gibson, co-host: Well, you three times, actually. This is a Celebrex instance. It's approved for arthritis. see them just about anytime you turn ad. And then I'm going to come back But I think that the image that you on your TV, prescription drug ads and ask you about it. Let's take a look. get, and that's what television ads that promise relief from everything are, it's an image, overrides the other from arthritis to postnasal drip, but (Clip shown from Celebrex TV com­ kinds of information that should be are they exaggerating their claims? mercial) in there. Over the last four years The [Food and Drug Administration] alone, there have been 480 ads that FDA says, in some cases, they are and Charles Gibson: Sidney Wolfe, let me have run for doctors and patients, has warned numerous companies, start with you. That seems fairly be­ many of them on television, that have including the makers, for instance, of nign, what I'm seeing there. Why did been found illegal, that violate FDA the nasal spray Flonase, warned 14 the FDA have objection? laws or regulations. So this is a very times. common practice, and the compa­ For both sides on this issue, we are Dr. Sidney Wolfe (Director, Public Citi­ nies just keep repeating. joined now from Washington by zen Health Research Group): continued on page 10

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12 +March 2001