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?

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.

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