Tom Abate looks at vaccines.
SCARED INTO ACTION
Diseases that kill millions are neglected amid push for new vaccines to combat bioterrorism
Tom Abate Monday, October 8, 2001
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Prompted by fears of bioterrorism, America has rediscovered the virtues of vaccines.
Senior government officials have promised to stockpile vaccines against smallpox and other potential bioterror agents, and fund research on other ways to ward off infections that terrorists might spread. Our sensitivity to potential bioterror is so high that a lab in Florida spotted a rare anthrax infection that might have gone undetected earlier.
But in our new national obsession with preventing these theoretical casualties, we continue to ignore millions of real deaths that occur around the world each year. The poor at home and abroad continue to die from tuberculosis, malaria and other ailments that could be prevented without any gee-whiz science, if only we made vaccines a priority.
"As a society we really don't put much value on vaccines," said Dr. Donald Burke, director for the Center for Immunization Research at Johns Hopkins University. "The current global market for vaccines is only $3 billion. A single blockbuster drug like Viagra can be worth billions."
If any good comes of America's phobia with bioterror, it will be the rehabilitation of the vaccine industry. We have rediscovered preventive medicine in hopes of warding off bioterror. Now if only we could redirect this born-again fervor toward everyday ills.
Burke said he teaches a class on vaccine policy that looks at the"natural history of vaccines." While a disease is prevalent -- or in the case of bioterror, when the fear of it is rampant -- people demand protection at any cost. Over time, as the vaccine controls or eradicates the disease, the pendulum swings, he said.
"If you're a parent in America today where we haven't seen the childhood diseases that were around 40 or 50 years ago, it's natural to assume this isn't a threat to your child," Burke said.
So people become more sensitive about side effects. Vaccines are dispensed so widely that side effects are bound to occur. And because vaccines are given to healthy patients, any risk seems too great when the threat seems small.
"The initial bar that measures safety against efficacy is extraordinarily high," said Boyd Clarke, chief executive of Aviron, a Mountain View company that is testing a flu vaccine that can be dispensed through a nasal spray instead of an injection.
During the past 15 years, the FDA has steadily demanded more patients be tested prior to winning approval for a new vaccine, Clarke said. In 1986, the hepatitis B vaccine was approved on tests of 549 patients. Aviron has tested its flu vaccine on 24,000 patients and is still answering questions about safety.
But it isn't fair to blame regulators -- they're in a bind. The FDA was embarrassed in 1999 when the rotavirus vaccine was withdrawn from the market. American Home Products had created the vaccine to prevent diarrhea and tested it on more than 10,000 patients. It was administered to one million children in the United States during an 11-month period before AHP pulled it after two children died and more than four dozen needed surgery to correct an intestinal obstruction that occurred after vaccination.
What's the lesson? Perhaps AHP fielded the vaccine in the wrong country. Serious rotavirus infections are rare in the United States, causing fewer than 40 deaths a year. In the developing world, however, 600,000 children a year die as a result of rotavirus infections.
It would be easy to say in retrospect that AHP should have introduced the vaccine in the Third World. But poor countries couldn't hope to pay the $38 per dose that AHP had charged for its vaccine.
"Many of the traditional vaccines sell for literally pennies a dose," said Michael Kremer, a Harvard economist and Brookings Institution fellow. "If the new vaccines cost even $1 or $2, the countries don't buy them."
The worst fallout of the rotavirus fiasco is that a vaccine that could save 600,000 lives a year is sitting on the shelf because it would look bad for AHP to sell a vaccine abroad that it deemed unsafe at home.
"Part of the risk of being in the vaccines business is that very rare adverse events may not turn up until the vaccine has been administered widely, " said John Donnelly III, a senior director in the vaccines division at Emeryville's Chiron Corp.
In the late 1970s and early 1980s, vaccinemakers stopped making shots for children after a rash of product liability lawsuits. Congress responded in 1986 with a law that limited liability for developers of pediatric vaccines.
Now the Biotechnology Industry Organization wants to extend such liability limits to vaccines for adults. This would make sense in the context of developing potential vaccines against biological terror agents.
But BIO President Carl Feldbaum is talking about reforms that affect more than vaccines against terror agents. Biotech companies are developing experimental vaccines to help fight cancer. They have not yet been approved by the FDA, and BIO is concerned about what standards of safety and efficacy will be required.
"We're not talking about a free ride with the FDA," Feldbaum said. "We're talking about expediting those vaccines we don't have but need, such as in oncology."
Biotech critics are leery. "If industry is talking about lowering standards,
I think that is a dangerous conversation to have," said Dr. Sidney Wolfe, a medical expert with Public Citizen, a Washington, D.C., watchdog group.
But the more I learn about bioterror vaccines the more I wonder who is lowering what.
For instance, BioPort Corp. in Lansing, Mich., is the only company in the United States licensed to make the anthrax vaccine. It was first approved in 1970 -- an eternity ago in terms of biotech science -- and recertified in 1986.
Two years ago, however, after BioPort renovated its anthrax vaccine factory,
the FDA found so many flaws in its manufacturing processes that the plant still lacks the seal of approval that an ordinary vaccinemaker would need to sell a flu shot.
This is the same anthrax vaccine that became controversial when it was administered to soldiers deployed to the Persian Gulf in the early 1990s. Several hundred soldiers refused to take the shot even at the risk of being court-martialed.
Nevertheless, BioPort is getting so many inquiries from civilians who want to buy a dose of vaccine that it refers callers to a recorded message saying it can only sell to the military.
Meanwhile, the FDA has been preparing test guidelines for new bioterror treatments. Since scientists can't ethically expose a healthy human to anthrax or smallpox to see if the vaccine works, the FDA is preparing guidelines that would permit approval based on showing that a vaccine prevented infections using "animal efficacy data." Presumably that means seeing if primates survive exposure to infectious agents.
What an interesting concept. An expedited process for creating medicines against potential infections. Meanwhile, people are dying of AIDS, cancer and other diseases. Where's the real risk? Where should we really be rushing? What vaccines should be most important?
Look for BioScope every Monday in the Business section. Send your biofeedback to Tom Abate by e-mail, tabate@sfchron icle.com; fax, (415) 543-2482; or phone, (415) 777-6213 |
