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Home , MMR vaccine, Neal Halsey, Polio vaccine

PART OiE of a two-part, series •6-

Ah issue of trus Misinformation and government foot-dragging are fanning fears.

^^^^^^^ his is the season of the shots, pneumonia and also to local outbreaks of Ninety percent of pediatricians and 60 when parents scramble for appoint- -preventable . percent of family doctors recently surveyed ments to bring their kids' immuni- A friend's doubts about vaccine safety by University of Michigan researchers said H zations up to date in time for school worried Suzanne Walther of Murfreesboro, they cared for at least one child whose par­ mm openings. The annual ritual is be- Tenn., who decided to search the Internet ent refiised . A study in Col­ B coming anything but routine for for information. "I just typed in the word orado found that unimmunized children • growing numbers of parents who feel '' and everything that popped up were 22 times more likely to contract P they're confronting a terrible dilem­ was antivaccine material," says Walther, who and 6 times more likely to contract ma: Do I expose my child and com­ decided as a result to postpone immuniza­ pertussis () than vaccinat­ munity to the risk of a serious ? Or tion of her infant, Mary Catherine. ed children. do I expose my child to the risk of one of She waited too long. On the eve of her "In the middle are parents who are those rare catastrophic reactions to the first birthday, Mary Catherine contracted trying to do the right thing," says Bruce Gellin, vaccine itself—reactions that I keep read­ B {Wo) meningitis M.D., a preventive-medicine specialist at ing about on the Internet? and landed in intensive care. It was the first Vanderbilt University and executive director Even for those who don't have small case the hospital had seen in eight years; Hib of the National Network for Immunization children or grandchildren, distrust of the meningitis has become rare since the 1987 Information, an independent source of scien­ vaccine program—one of America's most introduction of a vaccine against it. The dis­ tifically verified vaccine information. successfiil public-health initiatives—is cause ease had a significant chance of killing or for concern. It's contributing to a severe disabUng the baby; fortu­ underuse of the adult vaccines for flu and nately, she recovered.

JVSTA nS'Y PINCH Ih. Peter Ruhel ftf/ifivf' nf\U. Kino, N.Y., giviv ( arlic (iVrive Ai-r and lyi'aP Idipluhcria, , pertus^isi hoosten. Vaiiines have ipared (.ailie and her friends at Quality Iime S'unerr Sihool, Kalonah. \'.Y. (left), the risk of 11 serious childhood diseases.

'' AUGUST 2001 O CONSUMER REPORTS 17 immunization decisions today A CWSE CALL Anti- are in their 20s and 30s. vaccine arguments "We're prisoners of our persuaded Suzanne own success," observes William Waltlier of Murfreesboro, Schaffner, M.D., chairman of =-1 Tenn., to postpone the Department of Preventive for haby Medicine at Vanderbilt Univer­ Mary Catlierine (in sity "When formerly dreaded striped romper). Just diseases have been pushed into liefoie Iter fii-tltii tlulny, the shadows—or eliminated— ilu />ii/>i iii»r/iii/(i/ii questipns about the vaccines 1 lll>U- IflM l>l I III I III! themselves spring up." />ri'i entabic Hih The next decade is likely to muungili'i Luilitl), ••be bring new vaccines against HIV, lili'Hltll lull\ genital herpes, type 1 diabetes, Epstein-Barr , cervical can­ cer, and streptococcus A and B, to name just a few under development. That will make oversight of the benefits and risks of vaccines more crucial. Improving the safety record of vaccines is no smaU task for 7Hr \NSWERMAS several reasons: Walther credits Dr. Bruce *• Since vaccines are given to Itillm of \underlnlt healthy people, serious risks are ('finernfKHbnvAlarv unacceptable. But what's "seri­ Catherine was treated, for The small but influential ous"? If a vaccine prevents 1,000 taking her ivncena vriauiJy antivaccine groups circulating deaths, are 10 vaccine-related the information that Walther and findrnganstier-, to Iter qucsliotis "i neiei Jilt like I injuries an acceptable trade-off? found are doing the nation both If you or your chOd is one of the a disservice and a service. Their was being blamed," WaMter *av* She i\ now an ardent 10, the answer is probably no. If best-known accusations—that a^porter<^ddMhood you are a public-health official, too many vaccines "overwhehn" immimizations. the answer isn't so obvious. the and that the *• Most childhood vaccines en­ MMR vaccine against measles, joy almost total protection from , and causes —appear the evidence behind the main arguments of product-liability lawsuits. While this has groundless, according to the latest research. the antivaccination activists. And we will kept manufacturers in the vaccine business, But the noise-making has shaken up the suggest ways in which consumers can bene­ it has also removed one important incentive Food and Drug Administration (FDA) and fit from immunization while minimizing to improve safety beyond current levels. the Centers for Disease Control and Pre­ risks. In an upcoming report this fall, we'll vention (CDC), the two agencies most con­ take a closer look at adult vaccines. HOW VACCINES ARE TESTED cerned with vaccine safety. Most vaccines come to market with an Our examination of the vaccine-safety THE PRICE OF SUCCESS incomplete safety record. A new vaccine is record has found that in some areas this Under the current schedule, children receive typically tested on 10,000 to 20,000 people shake-up is long overdue: 23 shots against 11 diseases before starting before the FDA approves it. That's enough *• There are significant gaps in tiie system for kindergarten. Before the vaccines were to study disease protection but not enough monitoring the safety of newly introduced introduced, the toll of 10 of these vaccine- to reUably detect rare complications. In and older vaccines. preventable diseases—, measles, 1998, tiieFD A Hcensed RotaShield, a vaccine • The guardians of vaccine safety have been mumps, pertussis, poHo, rubeUa (German to prevent an intestinal that was slow to address correctable problems, such measles), tetanus, , pneumococ- striking an average of 3.5 million babies in as the use of mercury as a in cus, and Hib—was nearly 2 million report­ tiie U.S. a year and killing 20. Of tiie 10,054 some infant vaccines. ed cases of disease per year, based on their babies vaccinated during the tests, 5 devel­ The adversarial treatment of the 150 or so peak year of incidence. Even the "mildest" oped a condition called intussusception, a Americans who apply each year for com­ vaccine-preventable disease, pox, life-tiireatening collapse of the bowel. Since pensation for adverse effects from vaccines claimed 100 lives each year intussusception can also occur spontaneously, < has angered many and provided recruits to But the youngest Americans who can it wasn't mathematically clear whether or > the antivaccine forces. remember diphtheria and whooping cough not the vaccine caused those cases. S In this report, weTl discuss where the are on Medicare. The youngest who can But within six months of the vaccine's £ vaccine-safety system has faUen short and remember polio and measles are in tiieir 50s introduction, after some 1.5 million babies g how it can be improved. We will examine and 40s, respectively. Most parents making had received it, monitoring studies found £

18 CONSUMER REPORTS O AUGUST 2001 Details on The 11 diseases prevented by childhood vaccines were bad ones, as this table demonstrates. The damage they caused far outweighed even the most trou­ blesome known vaccine-related complications. This chart shows the most common complications unique to each vaccine. In addition, any vaccine can cause minor reactions such as a mifcHever or pain at the site. And very occasionally, any vaccine (or one of its inactive ingredients) can cause an imme­ diate, serious allergic reaction known as . VACCINE YEAR OF PEAK ANNUAL 1999 CONSEOUENCES OF % OF CHILDREN KNOWN VACCINE IHTBODUCTION DISEASE TOTAL TOTAL NATURAL DISEASE VACCINATED SIDE EFFECTS Chicken pox 1995 4 million* N/A Encephalitis (2/10,000 cases), bacterial skin 59.4 Mild rash (1/20 doses) (varicella) , shingles (300000/year) DTaP 83.3 Prolonged crying, of 105 "F or higher Diphtheria 1923 206,939 1 Death (5 to 10/100 cases), muscle paralysis, heart failure Tetanus 1927 1,560* 40 Death (30/100 cases), fractured bones, Peripheral neuritis, pneumonia Guillain-Barre syndrome (temporary paralysis-rare) Pertussis 1926 (whole cell) 265,269 7,288 Death (2/1,000 cases), pneumonia (10/100 cases), Brain disease (0 to 10/1 million 1991 (acellular) seizures (1 to 2/100 cases) doses-whole-cell vaccine only) H influenzae B 1985 20,000* 71 Death (2 to 3/100 cases),,meningitis, pneumonia, 93.5 (childhood) blood poisoning, inflammation of epiglottis, skin or bone infections Hepatitis B 1981 300000* 7,694 Death from cirrhosis or liver (4000 to 88.1 5,500/year) MMR 91.5 Fever of 103 "F or higher (5 to 15/100 doses) Measles 1963 894,134 100 Encephalitis (1/1,000 cases), pneumonia (6/100 cases), death (1 to 2/1,000 cases), seizure (6 to 7/1,000 cases) Mumps 1967 152,209 387 Deafness (1/20,000 cases), Inflamed testicles (20 to 50/100 postpubertal males) Rubella 1969 56,686 267 Blindness, deafness, heart defects and/or Temporary joint pain retardation In 85 percent of children born to (25/100 adult doses in women) , mothers Infected in early Pneumococcal** 2000 93,000* New Meningitis (800 cases/year), pneumonia (77,000 New vaccine Fever over 100.3 "F (22/100 (childhood) vaccine cases), blood poisoning (15,000 cases) doses) Polio 1955 21,269 0 Death (2 to 5/100 case in children), 89.6 Vaccine-induced polio (oral (paralytic) respiratory failure, paralysis, vaccine only-1/2.4 million postpolio syndrome doses) Source: Centers for Disease Control and Prevention * Estimated "Journal of the American Medical Association, March 15,2000

that vaccinated babies had a 21 -times higher main way of tracking unexpected complica­ Mercury in vaccines. Even minuscule chance of intussusception than normal tions is through a federal program called the doses of mercury can impair the cognitive within the first few weelcs after their shots. Reporting System development of babies and young children. The vaccine is no longer in use. (VAERS). But this system has major draw­ Just this year, the FDA warned pregnant and The obvious way to catch such problems backs: It's voluntary (except for manufac­ nursing women and very young children to before marketing is to vaccinate more test turers), and reports don't necessarily mean avoid certain mercury-containing fish. Yet subjects. But the price of new vaccines is al­ that the adverse reaction is truly associated until last year, the same agency permitted ready high—a single dose of the newest, a with the vaccination. the use of childhood vaccines containing vaccine against childhood pneumococcal To compensate for these failings, the mercury in quantities that many, including disease, costs $58—and testing more sub­ government also finances a smaller but Consumers Union, consider unsafe. jects would drive costs still higher. Moreover, more complete program, the Vaccine Safety Mercury is a major constituent of thi- it's hard to recruit enough volunteers even Datalink, that uses the comprehensive merosal, a preservative that for the past for the modest-sized trials. "Everybody wants records of several large managed care orga­ 70 years has been added to multidose vials more babies studied, but whose babies are nizations to track vaccine outcomes. Addi­ of vaccines to inhibit bacterial growth. these going to be? Your baby or somebody tional safety research programs are under There has never been a scientific study of else's baby?" asks Kathryn Edwards, M.D., a development as well. the safety of using this product in chil­ Vanderbilt University pediatrics professor dren's vaccines. Nevertheless, its use con­ who has worked on many vaccine research TWO SAFETY LAPSES tinued until 1999, when die FDA added up projects. In two recent cases, vaccine-safety agencies vaccine-related thimerosal exposure for Once a vaccine goes on the market, the were slow to act on emerging problems: the first time, as part of an agencywide

AUGUST 2001 O CONSUMER REPORTS 19 study of mercury-containing products. the injectaBt, that can­ Vaccine Information Center, the most At the time, three vaccines routinely not cause polio. During that 20-year period, prominent of the antivaccine groups. given to newborns and infants, hepatitis B, there were eight to nine cases of vaccine- While Fisher's argument—that the per­ Hib, and DTP, contained thimerosal. An associated paralytic polio each yean average-sized baby given vaccines con­ tussis vaccine caused an increase in epileptic "Why did it take 20 years to make the and learning-disabled children—appears taining the maximum concentration of change?" says John Salamone, a Virginia thimerosal was being exposed to 187 baseless, her activism led to the creation of a parent whose 11-year-old son developed compensation system for vaccine victims and micrograms of mercury, more than twice paralytic polio from his second dose of oral what the Environmental Protection Agency prompted the CDC to plan a major expan­ vaccine. "It was an egregious act by the gov­ sion of programs to study vaccine safety. deems safe for very young children. (Expo­ ernment." sure didn't exceed the much looser FDA Other arguments and suppositions of Some vaccine experts agree that die vac­ guideline, which Consumers Union be­ antivaccine activists, Fisher included, are cine's safety should have been considered lieves is too high.) either incorrect or misleading. Here are die sooner "The decision could have been made main ones: Nevertheless, the FDA and CDC allowed 10 years earlier," says , M.D., Vaccines "overwhehn" the immune sys­ with thimerosal-containing director of die Institute for Vaccine Safety at vaccines to continue—while coop­ tem and cause it to turn against itself. Vac­ erating with manufacturers to cre­ cines work by stimulating the produc- ate thimerosal-free versions as I tion of protective antibodies. So the idea quickly as possible. Not until early I that multiple vaccines can "overstress" I the immune systems of infants seems it' I reasonable. It's behind the belief tiiat the POLIO FROM VACCINE I measles component of the measles- David Salamone, now I mumps-rubella (MMR) vaccine has age 11, got polio from caused an epidemic of autism. the oral vaccine he In fact, vaccines tax the immune sys­ received as a baby more tem much less dian natural diseases, says than a decade after the Halsey A natural infection can lead to last case of wild" polio the stimulation of as many as 25 to 50 in the U.S. His father, John, spearheaded the separate immune responses. "When we successful effort to force give something like the , a switch back to the safer we're giving only two antigens," says killed-virus injectable Halsey "The immune system's potential . is enormous. It can respond to 10 mil­ lion to 100 million antigens." Vaccines are as dangerous as the dis­ eases. The statistics can be misleading. In 1999, nearly 12,000 vaccine "adverse events"—established or presumed, and mostly mild—^were reported to govern­ in 2001, more than a year and a half after . ment health officials. That same year, the the issue first surfaced, were all childhood Salamone believes the turning point vaccines made without significant amounts diseases themselves caused only 6,777 cases came when affected families appeared of thimerosal. of illness or injury But that does not mean before the CDC committee that sets im­ that vaccines are a poor risk. Vaccine-associated poUo. The oral polio munization policy "Until these doctors vaccine in use from 1960 on had an advan­ Except for poHo, vaccine-preventable saw these kids in wheelchairs, they never diseases are still around. The Colorado tage over the original killed-virus Salk vac­ put faces on what they were doing," he says. cine. The live, weakened virus it contained study that documented an increased risk of replicated and spread from person to per­ measles and pertussis among unvaccinated THE ANTIVACCINE ARGUMENT son, immunizing many who were exposed children also found that vaccine refiisal puts This is not the only example of how vocal to it even though they weren't vaccinated the community at risk, because vaccines parents and antivaccine activists have themselves. This so-called herd is don't "take" in everybody who gets them. pushed government agencies to improve why experts expect that polio will soon be The researchers found more measles and vaccine safety In 1985 Barbara Loe Fisher, a the second disease in history, after smallpox, whooping cough among vaccinated chil­ Washington, D.C., mother whose son devel­ to be eradicated from the globe. dren in schools with many unvaccinated oped neurological and cognitive disorders children than in schools where nearly all But the oral vaccine has a little-known after his pertussis vaccination, wrote "A children had been vaccinated. downside: In about 1 in every 2.4 million Shot in the Dark." The book was a well- If someone gets sick soon after getting doses, the ingested virus mutates back into researched history and indictment of a a virulent form capable of causing disease. a vaccine, the shot is to blame. This idea is vaccine that even its supporters concede at the root of the most contentious vaccine- Since 1979, the only cases of polio in the caused an unusual incidence of reactions, U.S. have been caused by the oral vaccine. safety issues: the alleged links between from fever to seizures, because it was made Yet not until 1999 did the CDC's vaccine , brain damage, and i from whole, killed whooping-cough bacte­ policy-making group vote to swdtch back to multiple sclerosis. Some antivaccine web i ria. Fisher went on to found the National sites feature accounts of lively toddlers who, ;

20 CONSUMER REPORTS O AUGUST 2001 Consumep after receiving their MMR shot, turned into cine. "They said one pair should be enough. RBDOPtS neurologically impaired preschoolers. They asked why he needed physical thera­ But are vaccines really to blame? To date, py once a week." New Cap Buying C^ide two expert panels, one convened by the Vaccine-victim advocates say the pro­ American Academy of Pediatrics and the gram's accumulated $1.6 billion balance is 2001 other by the National Academy of Sciences, evidence of its lack of generosity. The gov­ ow can you find the best model in this have studied the MMR vaccine and autism. ernment says the surplus is the result of the H year's auto market? Consumer They found that autism cases did not development of ever-safer vaccines. Reports New Car Buying Guide 2001 will increase along the same trend lines as lead you through the choices with reviews increases in the percentages of children who RECOMMENDATIONS and recommendations based on the latest tests. received the MMR vaccine. Both expert •• Consumers should ask for the safest vac­ groups have concluded that although more cines. The whole-cell , needs to be learned about autism—and childhood vaccines containing thimerosal as above all about the apparent increase in the a preservative, and the oral polio vaccine numbers of autistic children—the MMR may still be in the distribution system. Tell vaccine is almost certainly not to blame. your doctor not to use these vaccines. NEWCAR -mniiG GUIDE For now, the most Ukely explanation for Be sure to let the doctor know if the child the seeming link is pure coincidence. Many has a fever, diarrhea, or other significant childhood neurological and developmental medical symptom at the time of an immu­ problems first emerge at an age when chil­ nization appointment. The doctor may rec­ dren are getting vaccines frequently. ommend postponing the immunization. If this occurs, it's critical to promptly make up COMPENSATING THE INJURED the missed vaccine doses. For additional Inside this 256-page guide, you'll find: When the pertussis vaccine controversy sur­ information, consuh the CDC's Contra­ • Top picks for 2001 faced in the U.S. in the mid-1980s, vaccine indications for Childhood Immunization • Guide to the latest safety features document, available on the Internet at manufacturers threatened to get out of the • Step-by-step guide to buying and business rather than risk ruinous lawsuits. www.cdc.gov/nip/recs/contraindications.pdf. leasing (Today, there are only four major childhood- *• Ask the doctor which post-vaccination • 20-year trends in auto reliability vaccine manufacturers in the U.S.: Glaxo symptoms are normal—and which warrant • Price-saving strategies for buying car SmithKline, Aventis Pasteur, Wyeth Lederle, medical attention. Mild fever and fussiness insurance and Merck 8c Company.) are common consequences of vaccine- • Auto sites on the Internet, plus how As a result, the federal Vaccine Injury induced immune reaction. But a high fever to do your online research quickly Compensation Program was created in or seizure is out of the ordinary. and efficiently Plus: 1988. Funded by a small tax on every lot of • Seek information from reUable sources vaccine, it is in essence a no-fault insurance such as the CDC {www.cdc.gov/nip), the • Four-wheel drive vs. all-wheel drive, plan against childhood-vaccine injuries. how to make your test-drive count, National Network for Immunization In­ and more! The program set up a list of conditions formation (www. immunizationinfo.org), • The newCR SAFETY ASSESSMENT - such as vaccine-associated polio that, based the Immunization Action Coalition (www Consumer Reports sums up track- on scientific evidence, seem to be vaccine- .immumze.org), and the Vaccine Education test results and crash-test data to related. Anyone with a condition on the Ust Center {www.vaccine.ciiop.edu). Be aware make it easy to spot which models is entitled to compensation for "pain and that some groups with official-sounding are safer. suffering" and for ongoing medical expens­ names, such as the National Vaccine Infor­ On sale now wherever books and es. The trade-offt giving up the right to sue mation Center and Parents Requesting magazines are sold, or manufacturers and doctors. Open Vaccine Education, are actually anti­ mail the coupon below: "With respect to manufacturers and vaccine networks. physicians, the system has been an unqual­ Policy-makers should continue—and ade­ I To order Consumer Reports New Car Buying ified success," says Peter Meyers, a law pro­ quately finance—improvements in tracking [ Guide 2001, please send a check or money fessor who heads the vaccine-injury law and analyzing vaccine injuries. This includes order for $9.95 plus $3.50 shipping and clinic at George Washington University. expanding state immunization registries handling, payable to Consumer Reports. "But it's been a much more mixed record (with proper privacy safeguards), which are Prod#P741 402107 with respect to consumers." are invaluable for researching safety con­ "It's very difficult to bring a claim under cerns. Vaccine-safety guardians need to keep this program," Meyers says. "The govern­ faith with parents by taking prompt action NAME (PLEASE PRINT) ment is very aggressive. If there are any tech­ when possible problems or concerns surface. nical loopholes, they raise them. They fight • The Vaccine Injury Compensation Program ADDRESS APT. everything to the bitter end." should use some of its burgeoning surplus to Even claimants who win compensation become more user-friendly. And physicians can run into trouble. "I have had to fight to and health educators must deal fiilly and CITY STATE ZIP get my son two pairs of braces a year, to respectfUly with the vaccine-safety concerns •»««^ CONSUMER REPORTS keep up with his growth," says Salamone, of patients and parents. It's no longer enough <»•• P.O. Box 10637, Des Moines, IA 50336-0637 whose son contracted polio from the vac­ to say, "Trust us, we're the experts." (£) (Please allow 4 weeks for delivery) .J—I

AUGUST 2001 O CONSUMER REPORTS 21