Immune to Reason

Hundreds of thousands of Texas children, including 250,000 newborn babies, are routinely vaccinated against hepatits B each year. Why? Good question.

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'd 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 up 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.

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