Unacceptable Risk

Texas health officials say that mandatory childhood vaccinations against hepatitis B will prevent the spread of life-threatening illness. But which is riskier--the disease or the vaccine?

Like most people, Glenda Matheny didn't know much about hepatitis B, but when the family pediatrician recommended that her then-14-year-old daughter, Breonna, start receiving a three-dose vaccine against the virus, Glenda figured it had to be done.

Breonna handled the first shot without incident. But on January 17, 1995, immediately after she received her second dose of the vaccine, Breonna became extremely ill. Three days later, after her daughter's symptoms--headache, fever, nausea, and general weariness--failed to go away, Glenda took Breonna back to the doctor, who determined that the girl had suffered a "strong local reaction," as well as a "possible systemic reaction," to the hepatitis B vaccine.

The doctor opted not to give Breonna the third and final dose of the vaccine and assured her that the miserable symptoms she was experiencing were temporary and that she would feel just fine before too long.

But she didn't. After four months, Glenda recalls, "we were back to the doctor almost every day." Breonna was missing so much school that she had to withdraw from Houston's Bellaire High, where she was enrolled in the pre-international baccalaureate program for exceptional students. While her friends were meeting boys, going to dances, and otherwise enjoying their teen years, Breonna was taking a correspondence course at home.

And suffering. Breonna loved sports and was an especially good softball player, but after receiving the hepatitis B vaccine, her joints ached so relentlessly that it was futile to even try to play. Besides, just breaking a sweat would often cause Breonna to faint.

Breonna earned her high school diploma late last year. She scored in the high 1300s on her Scholastic Aptitude Test, but college will have to wait because Breonna is still very sick. Some mornings she wakes up with her face so swollen she hardly looks like herself. When that happens, Glenda knows that her daughter, who is 18 now, will probably spend the next three days in bed, too weak to do anything but sleep.

Glenda Matheny couldn't sleep, at least not until she knew what had happened to her daughter's health. She did a little of her own research and discovered, as have others, that hepatitis B actually posed very little risk to Breonna.

According to the Texas Department of Health, the overwhelming majority of the approximately 1,300 new hepatitis B cases reported each year in Texas occur in adults between the ages of 20 and 40, with the highest concentration--more than 60 percent--becoming infected between ages 25 and 30.

Children under the age of 14 account for an average of 37 new cases of hepatitis B each year in Texas. The reason for the low rate of infection among kids is simple: Hepatitis B is what is commonly referred to as a "lifestyle disease" that mostly strikes intravenous drug users, homosexual men, and heterosexuals with multiple partners.

Moreover, the chance of developing chronic hepatitis B, which can lead to cirrhosis and liver cancer, is low, somewhere between 5 and 10 percent for people more than 5 years old. Though younger children are at greater risk of chronic infection, which can lead to cirrhosis and liver disease later in life, as many as 95 percent of all hepatitis B infections pass without incident or serious illness. For most people, acute hepatitis B is typically no worse than a bout with the flu.

Clearly this is not information Glenda Matheny possessed when she agreed to have her daughter vaccinated against hepatitis B.

"The pediatrician had been my pediatrician when I was growing up," Glenda recalls. "He told me that because teenagers were at high risk, my daughter needed to be vaccinated. That was his medical recommendation, and I took it."

Even if she couldn't see it, Glenda Matheny at least had a choice. Most Texas parents don't, at least not since last August, when the state Department of Health began requiring that all children in the state be vaccinated against hepatitis B before they enter kindergarten. The mandate originated with the federal Centers for Disease Control and Prevention, which began recommending universal childhood immunization against hepatitis B in 1991.

Kristin Hamlet of the Texas Department of Health says the CDC recommendation came about after health officials realized they weren't reducing the chance of the disease in higher-risk adult populations.

"The initial strategy was to target adults who were at risk due to social behavior or through drug use or occupational exposures," Hamlet says. "But that wasn't really doing anything to lower the incidence of the disease, because you can't target these people. You can't tell who they are, and they don't tend to come in for preventive health care before they go out and expose themselves to infection."

Hamlet said the state's mandate makes sense because the CDC, which sets vaccine policy for the federal government, estimates that as many as 1.25 million people are chronic carriers in the United States, including about 30,000 children. "Those are the cases we don't have any way of preventing other than through childhood vaccination," Hamlet says.

But the actual reported incidence of the hepatitis B virus in Texas is low, especially among young children. Only 58 new cases were reported between 1993 and 1997 in kids younger than 5, according to state health officials. That's an average of less than a dozen new cases a year, with most of the cases occurring among infants born to infected mothers.

While young children are three times more likely to contract chronic hepatitis B than are older kids and adults, transmission of the virus from one child to another is uncommon: Fewer than five new cases of chronic hepatitis B occur among children annually in Texas.

The first hepatitis B vaccine appeared on the market in 1982, when Merck & Co. licensed Hepavax. Like most vaccines being produced at the time, Hepavax was manufactured using purified plasma from infected blood. Four years later, after fears arose that certain shipments of Hepavax may have been contaminated with the HIV virus, the company received FDA approval for Recombivax, the first genetically engineered vaccine. In 1988 SmithKline Beecham licensed its hepatitis B vaccine, Engerix, which, like Merck's product, is manufactured from a reproduced DNA strand of the virus.

But while the risk of hepatitis B appears minimal, the vaccine has been blamed for some 25,000 adverse reactions nationwide between July 1990 and October 1998, according to the federal Vaccine Adverse Events Reporting System, or VAERS, which collects anecdotal evidence from pediatricians, family physicians, and other health-care providers.

In 1996 Breonna was diagnosed as having chronic fatigue syndrome, an autoimmune disorder. Her doctor filed a VAERS report attributing Breonna's illness to a hepatitis B vaccine reaction. It was one of roughly 1,100 adverse reactions reported in Texas between July 1990 and October 1998, including 33 deaths, 370 emergency-room visits, and 93 hospitalizations. About 20 more vaccine recipients became "disabled," though the length and severity of the disabilities are difficult to discern from the available data.

The consensus from the CDC down to local health departments, however, is that serious adverse reactions are extremely rare. A recent CDC report concluded that fewer than 10 people per million will become ill from the vaccine, while 1,200 people out of every one million are at risk of death from hepatitis B-related illness.

Moreover, public-health officials who make and carry out vaccine policy in the United States say the mandatory vaccination of children is the only way to combat the spread of the virus among the higher-risk adult population.

"The notion of policy on this vaccine is, as it is with all vaccines, a trade-off between risk of the vaccine versus risk of the disease," says R. Palmer Beasley, dean of the University of Texas at Houston School of Public Health. "The trick is determining whether there is any causation [between the vaccine and the reaction]. The general belief has been--and I still believe this--that there are essentially no risks to the hepatitis B vaccine other than you get a needle and you get a little inflammatory action and it hurts for a few days."

But, citing the thousands of VAERS reports, parents groups and vaccine-safety advocates are raising questions about the safety of Recombivax and Engerix. The debate has intensified in recent months, starting in September, when the television newsmagazine 20/20 reported on the death and serious injury of a handful of American children who received the three-shot regimen. One month after the broadcast, France announced it was stopping its adolescent hepatitis B immunization program after studying the data on 800,000 immunizations.

Congress joined the discussion on May 18, when a House subcommittee held a public hearing in Washington, D.C., to begin to gather evidence and testimony on the vaccine's safety. Dozens of people, including the parents of children who had died or suffered serious illness after receiving the vaccine, urged the committee to ask Congress to fund studies that would determine the safety of Recombivax and Engerix, particularly in newborns.

That's not necessary, says Isabel Claxton of the vaccine-research division of Merck & Co. Claxton says it's hard to know what to say to people who believe their children were killed or injured by the vaccine.

"They want to find blame. They want an explanation for this, where there is no explanation. So they decided it was the vaccine," Claxton says. "I can't even begin to understand their grief, because I haven't been there myself. What I do believe--very strongly--is that you cannot say it was the vaccine; you cannot prove it was the vaccine. But think about the number of grieving parents we're saving through vaccination."

Clearly this is the view held by public-health officials like Palmer Beasley, who points out that roughly one billion people have received the hepatitis B vaccine worldwide. Any large number of "adverse circumstances" have probably occurred by chance alone, he says.

"Coincidence doesn't establish causation," says Beasley, who was an advisor to the World Health Organization's campaign to implement universal hepatitis B vaccinations in Taiwan. "I have personally administered thousands of hepatitis B immunizations, and I have never seen the kinds of severe reactions that are being reported. That's not evidence, that's just my experience."

So where is the evidence? Does it even exist?
Every few years, a committee of the Institute of Medicine, a research and advisory arm of the National Academy of Sciences, collects and reviews data on adverse vaccine reactions, as well as their possible causes. The committee's most recent report was issued in 1994, though it's difficult to determine what the committee members really thought about the potential dangers of receiving a hepatitis B vaccination.

On the one hand, the committee cited "biological plausibility" for a host of serious illnesses resulting from hepatitis B vaccine, including Guillain-Barre syndrome, multiple sclerosis, and rheumatoid arthritis. It even warned that the vaccines appeared to cause an allergic reaction called anaphylaxis that can be fatal. On the other hand, the committee said it didn't have enough evidence to make a definite connection between the vaccines and the adverse reactions.

Last year the scientific journal Vaccine published a review of the reported adverse reactions to hepatitis B immunizations. Like the Institute of Medicine, the authors came to the conclusion that, given the available information, the benefits of hepatitis B vaccines still far outweigh the potential risks. However, the authors offered this piece of parting advice: "In view of the campaign for universal hepatitis B vaccination in some countries, the appearance or exacerbation of autoimmune disease may become frequent and should be actively sought and reported."

"This whole thing about hitting the newborns with all these shots before they get out of the hospital is really kind of frightening," says Jane Orient, an Arizona physician who is executive director of the Association of American Physicians and Surgeons. "They are not doing the studies they need to do to put some of these fears to rest or verify there really is a problem.

"There are are so many unknowns that the children receiving these immunizations really are experimental subjects," Orient says. "They or their parents are not giving informed consent to this treatment, and that's supposed to be against international law under the Nuremberg protocol."

Dawn Richardson is executive director of an Austin-based group called Parents Requesting Open Vaccine Education, or PROVE. The organization is fighting expansion of the state's vaccine requirements and trying to convince legislators to allow parents the right to reject the existing mandates on philosophical and religious grounds. All things being equal, she believes most parents might want to know everything there is to know before immunizing their children, especially against a disease they are at minimal risk of contracting.

"If it's a disease that's highly infectious and highly debilitating to children, we ought to have a mandate," says Richardson, who suffered adverse reactions to vaccines as a child. "But the reality is that, for the parents I've talked to, the benefits of this vaccine don't outweigh the risks. So why is every newborn getting vaccinated?"

In late fall of 1996, 13-year-old Paul Viscontini became so ill during a family trip to Connecticut that his parents had to take him to the emergency room. The diagnosis was pancreatitis, a painful inflammation of the organ that helps the body digest food.

"This kid's been sick for nine or 10 months," the doctor told Paul's mother, Joan.

"You're off by a few weeks," Joan said.
"What happened?" the doctor asked.
And Joan replied, "He got the hepatitis B vaccine."

A few weeks before Christmas 1995, the family's pediatrician told Joan that Paul should receive the shot because he played basketball and, if things should get rough, he might come in contact with someone else's blood. Joan accepted that reasoning and gave her consent for Paul to receive the three-shot regimen.

At the time, the Viscontini family, who now reside in the East Texas town of Friendswood, lived in Holland, Pennsylvania. Paul was just a freshman in high school, but he had already established himself as one of the area's top swimmers, particularly in the endurance events. His daily training schedule included exhausting 3,000-yard workouts.

After he received his first shot, Paul came down with a bad cold. But because it was that time of year, Joan didn't think anything of it. On January 28, 1996, Paul received his second hepatitis B shot. Within hours, he was feverish, vomiting, and doubled over with abdominal pain. Within days, he had lost a noticeable amount of weight and had no stamina. At swim team workouts, he could barely make it across the pool.

Joan had no idea why Paul was so sick. Neither did the doctors. No one made the connection to the vaccine, partly because Paul's younger sister had also been immunized and had suffered no ill effects.

But after Paul received the third and final hepatitis B shot on July 31, 1996, there was no doubt in Joan Viscontini's mind. She did some research and read about the illness and injury that were being blamed on the hepatitis B vaccine. At one point, a physician noted that Paul's liver was enlarged and suggested the possibility that Paul might have actually been infected with the hepatitis B virus.

"I said, 'Doesn't all this give you guys a clue that something is happening with that shot?'" Joan recalls. "They didn't want to hear it. They said that very, very few people have bad reactions. It was extremely rare, they said."

By the time classes started that fall, Paul was so sick he could barely make it through the school day. When an outbreak of the flu occurred, his teachers were particularly worried about Paul and sent him home. As his condition worsened, Paul's parents became frantic. One day, his father, Sal, was so frustrated and upset by his son's weight loss that he threatened to have Paul hospitalized where they could pour liquefied food down his throat.

"This was a very normal, very healthy kid," Joan says. "One doctor said it was because he was lifting weights too much, then another said it was in his head. But 13-year-old boys just don't start dropping 15 to 20 pounds for no good reason."

Eventually Paul was diagnosed with Crohn's disease, an autoimmune disorder that strikes the bowels and intestines. Did the vaccine trigger the disease? Joan is convinced it did. Yet, she says, not one physician--not even the specialists at Texas Children's Hospital, where Paul still receives monthly checkups--has bothered to investigate the possibility.

Joan says the doctors and specialists who have examined Paul have suggested that she's a "crazy, hysterical mother" for trying to convince them that the vaccine was responsible for his illness. Joan admits that watching her child deteriorate for unknown reasons "almost drove us off the deep end." And so did her attempt to talk reasonably with doctors who had no answers but somehow knew it couldn't have been the vaccine that made her son ill.

About six months ago, Paul's condition suddenly started improving. He began to eat everything in sight. His stamina returned. He has since shaved 15 seconds off his best time in the butterfly, and recently he ran a mile in under six minutes.

Paul will be ready for college in another year or so. Joan has heard about proposals in some states that will require college freshman to receive a hepatitis B booster immunization before they can attend class. Joan says that if that's the case, her son won't be attending college. "There's no way," she says, and you can tell she means it, "I will ever allow him to receive another shot."

Meanwhile, she's afraid other parents will have to go through the same maddening experience she did before someone decides to get to the bottom of all the adverse reactions that are being blamed on the hepatitis B vaccine.

"I object to [public-health officials] not doing the proper studies before giving it to kids," she says. "But until people start standing up to be counted, that's never going to happen."

In Texas, children must receive 33 doses of nine different vaccines before they can attend school, including three shots of DTP (diphtheria, tetanus, and pertussis); three shots of MMR (measles, mumps, and rubella); four doses of oral polio vaccine; four injections of HbCV (influenza); and three doses of hepatitis B vaccine.

With few exceptions, Texas' vaccine requirements mirror the recommended immunization schedule issued every year by the federal Centers for Disease Control. Texas, like most states, quickly adopts the CDC's every recommendation as a mandate. And why not? The cost is largely borne by the federal government, which buys the vaccine from the manufacturer and sells it to the states at reduced prices. States that administer enough vaccinations to meet certain compliance levels set by the CDC are rewarded with grants. In some states, including Texas, parents eligible for public assistance face cuts in benefits if their children are not fully vaccinated.

"I call it vaccination without representation," says Michael Belkin, a Wall Street analyst-cum-vaccine-safety-advocate from New York, whose newborn daughter died 12 hours after receiving the hepatitis B vaccine. "No one is representing the interests of children or their parents."

Indeed, the CDC doesn't even wait until a new vaccine is licensed for commercial use before recommending that it be administered to the nation's children. In early 1998, for example, the CDC's Advisory Committee on Immunization Practices voted unanimously to add a vaccine against rotavirus to the federal regimen after the manufacturer, Wyeth-Lederle, assured committee members that approval from the Food and Drug Administration was in the works.

"Children's vaccines, once they are licensed, are automatically shoved into the mandatory vaccine schedule," says Barbara Fisher, executive director of the National Vaccine Information Center, a watchdog group that bills itself as the oldest and largest vaccine-safety group in the country. Pressure from Fisher's group over contaminated lots of DTP vaccine in the 1980s led to the creation of the National Childhood Vaccine Injury Act, a federal no-fault program that has paid out more than $1 billion in compensation for vaccine-related injuries and death.

But while the act has been a good thing for vaccine-injured people, it has also helped protect the drug companies that manufacture the vaccines from liability. The act authorizes an excise tax on certain vaccines, which is set aside to fund the compensation program. According to Isabel Claxton, of Merck's vaccine division, the compensation act is needed to protect the existing vaccine supply. Right now, there are only two U.S. vaccine manufacturers: Merck & Co. and Wyeth-Lederle, a company based in Europe. The rest, Claxton says, couldn't stand the heat from safety advocates.

"All the other companies that did research and development and manufacturing and distribution of vaccines dropped out in the 1980s because of issues like this," says Claxton. "One dose of our mumps, measles, and rubella vaccine takes 13 months to get to the market--13 months--from the petri dish to the pediatrician's office. For a lot of companies, it wasn't worth the time to continue in that environment of the 1980s, which was so litigious."

Maybe so. But there's little doubt that the coordinated, worldwide effort to eliminate disease through immunization has certainly made it worthwhile to be in the vaccine business today. In 1990 vaccines were a $500 million market. Today, they're worth well over $1 billion to just a handful of conglomerates, including manufacturers of the two most widely used hepatitis B vaccines, Merck and SmithKline Beecham. Wyeth-Lederle, which manufactures one of the longest-running vaccines on the U.S. market, oral polio, has experienced a 300 percent increase in revenue since 1986.

While ostensibly a public-health initiative, the process by which new vaccines are developed and used is dominated by commercial interests. Public entities such as the National Institutes of Health help shape basic research priorities, but there is very little government investment in the type of applied research that produces the technology. That work is almost exclusively being performed by pharmaceutical companies--which, of course, base their priorities on the potential for profit.

"The federal government says it wants improved, better, and safer vaccines," says Ronald C. Kennedy, a microbiologist and immunologist at the University of Oklahoma Health Science Center. "But the reality of it for researchers is, you never get funded. One way you can, though, is to go to the drug companies that have the patents and try to get them to support the work."

Not that long ago, vaccines, by definition, were not designed for long-term profitability. That started to change with the measles epidemic of 1989 and 1990, which involved more than 45,000 reported cases, half of which were unvaccinated school children. More than 100 Americans died from measles in these two years, according to the U.S. Department of Health and Human Services. Stunned public-health officials, who long believed measles to be under control, started rethinking the national immunization strategy and decided that vaccinating only those people at highest risk of contracting a disease wasn't working.

In the last decade, the CDC has added a handful of new vaccines to the federal schedule, including hepatitis B, chicken pox, rotavirus, and hepatitis A. Kennedy says that while many public-health officials believe this to be the best strategy against infectious diseases, to carry it out they need the cooperation of manufacturers who may have a slightly different set of priorities.

"Early on, if you're a drug company, you don't make a lot of money off vaccines," Kennedy says. "Essentially, you didn't have return customers. I think what happened was that some of these companies got very smart and realized that their repeat customers could be infants, and that if you started mandating certain things, like requiring vaccines before school, that was good, and you could make money with vaccines."

That may be true, says Isabel Claxton of Merck & Co., but the decision to implement widespread immunization against hepatitis B was based solely on public health.

"We don't have any secret moles at the CDC," Claxton says. "We wish we did sometimes, but that's not the way it happens. Public health has no commercial interest in this. We have a commercial interest in this, but [public-health officials] are very protective of influence from industry."

But since it was formed in the mid-1980s, the CDC's Advisory Committee on Immunization Practices has been dominated by members who, according to financial disclosure statements, had research contracts with the same drug companies whose products they were recommending for use in American children. In 1991, two prominent researchers on the committee were pressured to resign by a national vaccine-safety group after it was learned that they had provided expert testimony on behalf of vaccine manufacturers involved in lawsuits.

Prominent members of the Houston scientific community have been instrumental in the development of the hepatitis B vaccine, as well as being strong advocates for universal immunization of newborns and children. Invariably, they, too, have ties, direct and indirect, to drug companies.

F. Blaine Hollinger, a professor of molecular virology at Baylor College of Medicine, is a prominent blood-borne-disease expert who, in his own estimation, "knows as much about this vaccine as anyone around." Indeed, Hollinger has been involved in hepatitis B vaccine development from the beginning and has made numerous contributions to the scientific literature on the subject.

In the late 1970s and early 1980s, Hollinger led a team of Baylor scientists working on something called a virus-derived polypeptide vaccine. The team had gotten so far as to immunize chimpanzees--an extremely costly exercise that, if successful, invariably leads to clinical trials on humans. A 1981 journal article by Hollinger and his colleagues reported that the chimp trial "provided evidence for the efficacy of this vaccine."

While Hollinger and company were injecting chimps with polypeptides, Merck & Co. was pressing ahead with the development of a plasma-derived vaccine. Ron Kennedy was a student of one of Hollinger's collaborators. He recalls that Merck "had an interest very early on" in the polypeptide research and that company scientists paid numerous visits to Hollinger's lab at Baylor.

"Because Merck was developing their own set of vaccines, they wanted to know more about our technology to see if it was complementary or competitive with ours and to see if they could get in on it early," Kennedy says.

Apparently Merck did not view Hollinger's work as a threat to its own research. In 1982 the company licensed Hepavax, its plasma-derived vaccine. Meanwhile, Merck continued to develop what would eventually be the state of the art in immunizations: molecularly engineered vaccines.

That research paid off when Recombivax, the first recombinant DNA vaccine, was approved by the Food and Drug Administration in 1985. The following year it was licensed for commercial use and replaced Hepavax as the hepatitis B vaccine of choice.

By then Hollinger had all but abandoned the polypeptide research. He says that, although he and his colleagues continued to have a "real interest" in the technology, "the recombinant vaccine was doing an excellent job, and therefore there probably wouldn't be a market for this other vaccine. So we decided not to continue to pursue it."

At that point Hollinger contracted with Merck to perform prelicensing clinical trials on Recombivax. Since then, Hollinger has received research funding from Merck and has given expert trial testimony on behalf of both Merck and SmithKline Beecham after they were sued by people or their families alleging they had been injured by the vaccine.

Meanwhile, two of Hollinger's colleagues, Gordon Dressman and Jim Sparrow, continued the polypeptide research and in 1988 were awarded a patent. By then, however, Recombivax and SmithKline's Engerix dominated the hepatitis B vaccine market, and there was little interest in carrying out the additional research necessary to license the polypeptide technology.

Hollinger says vaccine researchers are in a Catch-22 situation, which often leads to the perception that they are beholden to the manufacturers. As it is, researchers have little choice but to partner with drug companies, which have lots of cash earmarked for drug development but may not necessarily have the technical expertise to do it themselves.

"The NIH would not fund a vaccine study," Hollinger says. "Who else is going to do the clinical trials? You want and need credible researchers to do these trials."

Hollinger rejects the notion that researchers would accommodate their commercial backers by ignoring the scientific evidence that a particular vaccine may not be safe and effective.

"Let me tell you, the only thing a scientist has going for him is his credibility," he says. "If I lose my credibility, I have nothing. I am not a scientist, and I can't be a scientist."

Few people would question Hollinger's expertise and commitment to preventing illness, particularly one as excruciatingly painful as liver cancer. Nor would most people argue that vaccines that fight dangerous infectious diseases shouldn't be made available to the public. No one likes to be sick, and everyone hates to see a sick kid.

Yet it's difficult to ignore the role of both the scientist and the drug companies in shaping the public awareness that allows states such as Texas to implement vaccine mandates with relatively little opposition. Toward that end, vaccine manufacturers have recruited, or set up themselves, nonprofit organizations that lobby government officials to institute vaccine mandates. Invariably, the boards of directors of these organizations are stacked with scientists who are advocates for universal immunization programs.

Consider, for example, an organization called Hepatitis Foundation International, a New Jersey-based nonprofit whose board of directors includes Blaine Hollinger and Palmer Beasley of UT-Houston. The group's motto is: "Each of us needs to be actively involved in protecting and maintaining our own health. Knowledge is our best weapon."

Apparently, though, the universal vaccination of children against viral hepatitis is a very close second. From the moment it was formed in 1995, Hepatitis Foundation International has breathlessly reported on the progress of, and need for, a vaccine against hepatitis A, which most recently was linked to shellfish harvested from polluted waters. Not coincidentally, perhaps, the foundation's "educational mission" is funded with contributions from drug companies, including SmithKline Beecham, which at the time was trying to get FDA approval for HAVRIX, a hepatitis A vaccine.

Moreover, while Hollinger was lending his name and scientific credentials to Hepatitis Foundation International, he was helping carry out the clinical trials for HAVRIX. In October 1997 Hollinger and his colleagues--who included David Krause, a research scientist employed by SmithKline Beecham--published a report that recommended the universal immunization of children for hepatitis A. The report came less than a year after the FDA approved HAVRIX and SmithKline licensed the vaccine for commercial use.

Last year, like clockwork, the CDC added the hepatitis A vaccine to the recommended immunization schedule for children, and several states, including Oklahoma, have instituted mandates.

"For what?" roars Ron Kennedy, the University of Oklahoma immunologist. "How many kids are out there shucking oysters? And hepatitis B is even harder for them to get. How are they going to get it? Not from IV drug use, not from sex."

Hepatitis Foundation International isn't the only nonprofit organization pushing for universal childhood vaccinations with help from the manufacturers. All Kids Count was formed in 1991 by the Robert Wood Johnson Foundation, which has a $3 million endowment from the estate of the former chairman and CEO of pharmaceutical giant Johnson & Johnson. Since then, All Kids Count has provided $9 million in grants to about 20 cities to set up vaccine tracking systems to ensure maximum immunization rates among children.

Such systems are being vigorously opposed by the National Vaccine Information Center, the Virginia-based vaccine-safety group. Barbara Fisher, the center's executive director, says tracking systems are not only a violation of patient privacy, but will inevitably lead to more vaccine mandates. It's not surprising, she says, that drug companies support vaccine registries, which have also been set up as pilot programs in several states with grants from the CDC.

"Congress needs to give emergency funding to independent scientists to take an unbiased look at these vaccines," Fisher says, "instead of putting the research in the hands of the CDC, who have already decided to force every child to take them."

As it did everywhere else, the debate over hepatitis B policy in Texas grew louder and more contentious after the September 1, 1998, 20/20 report on the safety of the vaccine. Three days before the show aired, the Harris County Department of Health issued a "public-health alert" giving local health officials a heads-up to the upcoming broadcast on "the alleged adverse reactions that have been attributed to the vaccine."

Included in the packet was a "fact sheet" prepared by Blaine Hollinger that defended the vaccine's safety record while emphasizing the need for the routine immunization of children. After the broadcast, the accuracy of the information in those fact sheets was publicly challenged by a scientist featured on the 20/20 broadcast, who, it turns out, is also employed by Baylor College of Medicine.

Bonnie Dunbar, a molecular biologist and immunology researcher at Baylor, has been an outspoken critic of the hepatitis B vaccine, which is manufactured by a technique that reproduces the DNA strand of the virus. It is the first of its kind to be so widely used. Dunbar began to question the safety of the vaccine after two scientists in her lab became seriously ill after immunization. One of those researchers was Dunbar's brother, Bohn, who is permanently disabled with a disorder similar to lupus that several examining physicians say was triggered by the vaccine.

Dunbar suspects that some people are vulnerable to the synthetic proteins in the hepatitis B vaccine. She's trying to get funding to conduct research into a relatively new phenomenon called molecular mimicry, which suggests that the body's immune system may mistake the foreign proteins in a vaccine with natural proteins. When that happens, the immune system launches an attack on the healthy cells and tissues it's supposed to protect.

Dunbar believes molecular mimicry may be one reason the hepatitis B vaccine seems to trigger autoimmune disorders such as Guillain-Barre syndrome, multiple sclerosis, and chronic fatigue syndrome in some people. And she's worried that 36 states, including Texas, have mandated the use of the vaccine in children without a better understanding of molecular mimicry.

"I would challenge any colleague, clinician, or research scientist to claim we have a basic understanding of the human newborn immune system," Dunbar argues. "It is remarkable to me that newborn infants, especially those not at risk for the hepatitis B disease itself, are being administered multiple injections of this vaccine and there have been few clinical trials to evaluate the potential long-term effects."

Blaine Hollinger adamantly disagrees with Dunbar on the vaccine's safety record and says her theory that molecular mimicry can trigger serious adverse reaction requires a "huge leap of faith." He suggests--without mentioning her by name--that Dunbar may be biased against the vaccine not because it allegedly hurt her brother, but because Bohn Dunbar is seeking damages from the manufacturer, as well as through the government's vaccine-injury compensation program.

"All I can say is that the people who are making accusations about the safety of this vaccine should look at their own house," says Hollinger, who says he was one of the first people to receive the hepatitis B vaccine, which has also been administered to his wife, children, and grandchildren with no negative effects. "The studies that look at this--and there are continuing reviews of this issue--have really not found anything that suggests there is an enhanced risk of connective tissue disorder, such as multiple sclerosis or Guillain-Barre syndrome, in patients who have received the vaccine vs. those who have not. I think that's the bottom line."

Not everyone in the medical and scientific community sees it that way. In April, Jane Orient, the Arizona physician, sent a letter to Texas legislators to criticize the state's hepatitis B mandate, citing the "very serious side effects" associated with the vaccine. In the opinion of the Association of American Physicians and Surgeons, she wrote, the vaccine poses more potential problems than does the disease, and much-needed research on the safety of the vaccine "may be delayed if policy-making and research programs are tainted with conflicts of interest."

In a recent interview, Orient said that corporate medicine is destroying a fundamental medical ethic: the obligation of the individual physician to treat patients to the best of his or her knowledge and judgment. Orient says those who make public-health policy are "trying to change the basic ethics of medicine from doing what's best for the individual patient to doing what they perceive is the best for society.

"They always compare it to polio. They say, 'Look what happened with polio,'" she says. "But polio was voluntary. No one made you take it. It's a whole different story when you're forcing them to take the vaccine for a disease that's not easily transmitted and does not have devastating consequences," Orient argues. "Hepatitis B in children is usually very mild."

The theory espoused by Orient and others that American children are being subjected to an experiment isn't as wacky as it sounds--especially when the notion is considered alongside the public-health sector's ever-expanding policy on hepatitis B, which seems to have less to do with the actual threat posed by the virus than with how many immunizations are administered.

The hepatitis B virus represents at least three firsts in U.S. immunization policy. It's the first "adult behavior" disease for which children are routinely immunized; it's the first vaccine for a disease that, relative to almost everyone else in the world, Americans aren't at high risk to contract; and it's the first genetically engineered vaccine to appear on the CDC's recommended schedule of childhood immunizations.

Until about 1990 the CDC hadn't made much of a federal case out of hepatitis B, focusing on the spread of the virus among health-care workers, intravenous drug users, and gay men. When the CDC announced its "comprehensive strategy" for eradicating hepatitis B through universal childhood vaccination in 1991, the agency cited unpublished in-house studies that concluded that vaccinating only high-risk groups had failed.

The CDC justified its new strategy by claiming that the disease had infected an estimated 200,000 to 300,000 people each year between 1980 and 1981, and that approximately 4,000 to 5,000 people die each year from hepatitis-related liver disease.

The accuracy of those estimates is questionable. Between 1988 and 1992, the number of hepatitis B cases reported nationwide decreased by 50 percent, according to the CDC's National Health and Nutrition Evaluation Survey. Moreover, infection rates among children under the age of 16 constituted only a small percentage of the total. Also, numerous scientific studies, including one commissioned by the World Health Organization, reported that the incidence of hepatitis B around the world was at an all-time low, primarily because those at highest risk had modified their behavior in response to the HIV pandemic.

The agency's subsequent expansion of its recommendations regarding hepatitis B also defied reason. For example, in 1993, 63 percent of hepatitis B cases occurred in adults. Yet two years later the CDC expanded its recommendation to include mandatory hepatitis B vaccination for 11- and 12-year-olds. In 1997 the agency expanded its recommendations yet again, this time to all people under age 18.

Today, public-health officials are optimistic that hepatitis B will someday be eradicated through universal childhood immunization. But less than two years ago, before most states, including Texas, implemented their vaccine mandates, the CDC itself suggested that perhaps the strategy they had once relied upon--targeting high-risk groups--really hadn't failed at all.

In an October 1997 issue of Morbidity and Mortality Weekly Review, a publication of the CDC's infectious-disease division, the agency reported what many people have always believed was true: "Hepatitis B continues to decline, primarily because of a decrease in the number of cases among injecting drug users and, to a lesser extent, among both homosexuals and heterosexuals of both sexes."

Glenda Matheny is happy to hear that, but understandably it makes her angry. Why didn't the people who now force every child in Texas to be vaccinated against hepatitis B--the people who, as public-health experts, presumably want to protect children--know this?

"As a parent, I should have been made aware that my daughter really wasn't at risk," Glenda says. "But now I realize that they really don't know the full implications of what they're doing with this vaccine.

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