Two weeks ago, a small Anglo-American biotech company announced that it had stopped recruiting volunteers for a set of clinical trials. On the face of it, that doesn’t sound like a homeland security issue for the U.S. government. Indeed, it doesn’t sound like any kind of issue for the U.S. government.
But it is, or at least it could be. In fact, the company, Acambis, is the recipient of a large government contract to produce a new and more sophisticated version of the smallpox vaccine. During the trials, the company discovered that both its new vaccine and the old vaccine may be responsible for a small increase in minor cardiac trouble: Suspected cases of myopericarditis, inflammation of the heart muscles, were discovered in three of 1,312 volunteers.
Those results may mean nothing at all, given the small sample. They don’t mean the new vaccine is any worse than the old one. They don’t mean that it won’t be used in a smallpox outbreak either, since there isn’t anything else. But the case still matters, since it points toward some difficulties the federal government may soon face as it becomes more involved in creating new vaccines and new drugs to combat bioterrorism.
For — like it or not — the federal government is now involved. To put it bluntly, there isn’t much of a market for vaccines against diseases that were technically eradicated, or for cures for diseases that have hardly been seen in decades. There’s hardly a market for flu vaccine, and flu is still with us. That means that people who are employed to worry about what would happen if someone infected with smallpox walked through Manhattan have been forced to create one.
The models for procurement available are limited. The one in use at the moment might be called the “defense contractor model”: The government funds the research on new vaccines and drugs. The government pays for the clinical trials, probably using small companies such as Acambis — or, in the case of a new anthrax vaccine, two companies in competition — because the big drug companies won’t want to be dependent on uncertain congressional appropriations. And when the trial fails, or if the drug doesn’t work, the government gets nothing out of it, and there isn’t a backup plan.
If the scenario involves a more sophisticated form of bioterrorist attack or a more complicated form of drug, the possibilities for disaster go well beyond wasted money. Here’s one: What if it were possible to create an anti-viral drug that cured smallpox, instead of a vaccine with side effects? If the government isn’t able to commit the resources needed to find that drug (and can’t figure out how to test it) the drug won’t come into existence, which is a disaster of one order. Here’s another one: What if the disease in question doesn’t exist yet, except in a petri dish? In that case, we won’t need a vaccine that we already know about, we’ll need the capability to do a rapid genetic analysis and create one. If we don’t have it, that’s a disaster of another order.
Partial solutions to these dilemmas are kicking around in Congress, tucked into the president’s Project Bioshield legislation (which hasn’t passed), as well as some slightly different solutions in other legislation (which is going nowhere quickly). There are some administration officials thinking about more. Some committees have been set up to think about it too — if, that is, committees can rightly be said to think.
What there isn’t, and can’t be, without a broader, louder national debate, is another, better model: a partnership between the pharmaceutical industry, say, and the Department of Health and Human Services that improves upon the partnership between the Department of Defense and Lockheed Martin. Perhaps that would involve incentives for industry, instead of government officials placing bets on particular projects. Or perhaps it would require the creation of new companies that are, in effect, creatures of HHS. Or perhaps the answer is funding, on a defense industry scale, for what might be politely called the “lean and mean” group in HHS that signs contracts with companies such as Acambis at the moment.
So far, the drug industry has stayed aloof from this discussion, at least in public, and no wonder: The industry may be wary of once again appearing to demand high profits at the nation’s expense. By the same token, Congress seems wary of appearing to be handing money over to the industry. But the standoff can’t go on indefinitely. Just as we’ve had to get over our objections to increased airline security, we may soon have to get over our objections to a new and cozy relationship between the government agencies that want to buy vaccines and the companies, large and small, that make them. Anyway, I’m working on getting over my objections, if only because the alternative — not having the vaccines when we need them — is too awful to contemplate.