But even the GAO couldn't justify that claim. Doctors now order vaccine directly from the manufacturers. In fact, both the Defense and Veterans Affairs departments recently canceled their own plans for distributing vaccines to the children of military families because they found the pharmaceutical industry already did it more cheaply than they could. HHS Secretary Donna Shalala declined congressional offers to provide extra money for the VFC program--but only if she preserved the drug industry's role as distributor of the vaccines.
The GSA, which has no experience with handling biological materials, soon drew harsh congressional criticism for its decision to store a large portion of the national supply of the temperature-sensitive vaccines at its Burlington, New Jersey, warehouse, next to rooms where the agency stores paint, turpentine, and other highly flammable materials. Sen. Dale Bumpers (D-Ark.) said that it would be "foolish in the extreme to proceed on schedule," and that because of the GSA, the program would be "an unmitigated disaster."
The critics won. In late August, the administration abandoned plans to use the GSA and the Burlington warehouse. Sources speculate that the job of storing and shipping the vaccines will be given to state agencies where they exist and remain with the manufacturers otherwise.
"We were ready to go. We did a lot of hard work, but we still took a lot of cheap shots. I guess it's just politics," GSA official Hap Connors said sullenly. Indeed, the GSA probably was ready--nobody said storing the vaccines would be the hard part--which is why the attempt to save face or the program by getting rid of the controversial New Jersey warehouse is "just politics." That change will do nothing to address the substance of the GAO's damning criticisms.
First, the VFC program won't work. The GAO report found that the government was way behind in arranging purchase contracts with the vaccine makers, unprepared to process orders from the doctors intended to receive the vaccine, unprepared to test whether its new delivery system could ensure the potency of the temperature-sensitive vaccines (the only problem potentially solved by ditching the GSA), and unable to detect or prevent fraud and abuse. "Our review indicates that it is unlikely that [the government] can fully implement the VFC program by October 1, 1994," the report stated.
Second, the VFC program wouldn't work even if it did work. Because the VFC program failed to collect good baseline data, and because its effects will be nearly impossible to separate from other government immunization initiatives, we'll have no way to compare the cost and effectiveness of the VFC program to the current system. But if the GAO were betting, the agency would bet against it. "It is unlikely that the provision of free vaccines through the VFC will boost coverage in the most affected groups, for whom vaccines are already free, or among other groups when previous experience strongly suggests that this is not an important consideration for the parents....If coverage increases, it may be in spite of the VFC program, the report concluded.
But since when is reality ever allowed to stand in the way of government plans? As the attack on pharmaceutical firms began in February 1993, Clinton strategist James Carville candidly told The Wall Street Journal, "We'll be trying to change the health-care system. Those who get in your way you try to run over by saying they are putting their self-interest against the national interest.
Lest anyone think that only the pharmaceutical companies got caught in the headlights of the Clinton machine, it should be remembered that their health is often directly responsible for our own. Because the VFC program will be added to existing programs, the federal government now will be buying not just one third, but about 80 percent of the nation's childhood vaccines at a forced discount price. That will surely detract from research and development budgets, both by reducing available funds and by stifling the incentive to develop new products. And cutting R&D doesn't seem to be in anyone's long-run interest.
Vaccine technology, stagnant for years, saw a renaissance in the '80s. Two new vaccines were added to the standard series, and new vaccines on the horizon include varicella, chicken pox, otitis media, respiratory syncytial virus, and rotavirus, the cause of an often lethal infant diarrheal disease.
More important, many immunologists believe they are close to developing a single dose inoculation that will protect against all major childhood diseases. Right now, full immunization requires 15 doses delivered during at least four doctor visits--and that's just before age 2. A single dose vaccine will end the necessity of multiple doctor visits. That inconvenience, not cost, is the primary barrier to higher immunization rates.
Credit for those technological advances must go to the pharmaceutical companies, many of which increased their R&D budgets more than fourfold during the '80s. Private industry spent about $11 billion on pharmaceutical research last year, more than the federal government's National Institutes of Health. The forced discounts of the Clinton program may make such high R&D spending impossible. And unfortunately, like so many other government programs, its major harms will go unseen. We don't know how many people already die each year because the snail-paced FDA keeps lifesaving drugs off the market, and we won't know how many children will die in the future because the VFC program kept new vaccines from ever even reaching the FDA approval process. But we do know it will happen.
So not only won't the VFC program work, it will also violate the primary dictate of the Hippocratic Oath: "First, do no harm." That should be sobering medicine for anyone who still wants to rush comprehensive government-run health reform "this year."
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