Bad policies deliver their disasters when overtaken by events. A peace-in-our-time narcotic stupefied democracies for years while Hitler seized power and built Panzers. We are now four decades into another self-induced daze that will end in another great spasm of death.
When Jonas Salk announced his polio vaccine in 1955, humanity's century-long war against germs seemed all but over. Public sanitation had driven them out of the water supply. Vaccines and antibiotics had then chased them out of the lungs, fluids and intestines of the public itself. "The time has come to close the book on infectious disease," our surgeon general would announce in 1967. "We have basically wiped out infection in the United States."
Viewed in that context, the FDA amendments that President Kennedy signed into law in 1962, to regulate drugs in the peaceful, germ-free future, seemed to make good scientific sense. Cholera had indeed given way to cigarettes and cholesterol. The diseases of the future would be choreographed by lifestyle and genes, not germs. The drugs of the future would target cancer, arthritis and other problems rooted in human chemistry. The new killers would creep up rather predictably and evenly, on adults, not children. Widely prescribed, pill-a-day treatments might easily cause more harm than good. Just months earlier, a horrified world had discovered that one drug of the futurethalidomiderelieved morning sickness and helped people fall asleep; but it also halted the growth of a baby's limbs in the womb.
Polio ward with iron lungs.
Before thalidomide, when microbes were still the enemy, drugs got the benefit of the doubt. After, the unknown cure was officially more dangerous than the known disease. And thus, going forward, all new medicines would have to be examined very closely. There was no need to rush. Medicine didn't need Texas-Ranger drugs any more. The stunningly fast, violent and random bandits of diseasesmallpox, cholera, tuberculosis, typhoid and the restwere history.
But they weren't.
Germs are always future, always reinventing themselves in their ingeniously stupid and methodically random way. They have also contrived, of late, to get human sociopaths to add thought and order to the reinventing. When they get lucky, we won't be ready; for all practical purposes, getting ready was outlawed in 1962.
Scientists can now see a lot of bad germ chemistry coming over the horizon, because they understand how genes mix, match and change. Drug companies are extremely good at concocting me-too variations on basic chemical themesdrugs mutate to evade patents just as germs mutate to evade drugs. Cut loose, these skills would give us in-depth protection against the real threatnot yesterday's germs but tomorrow's. But "safe" and "effective," the two key standards in the 1962 drug law, have intelligible meaning only with a germ to fight, and infected patients in which to fight it.
The FDA positively requires real, live germsto supply the patients that can supply FDA-caliber evidence that the drug safely kills real germs in real patients. The agency also needs political support, which requires a germ-fearing culture. But when a good vaccine wipes out the disease that it targets, the disease can easily end up eclipsed by the vaccine's side effects, however rare or even imaginary.
Tort law compounds the problem. In 1958, a California court discovered that every vaccine is sold with an implied guarantee of safety and sound designanother stew of words that have meaning only in context. To give jurors that contextto give them a good sense of perspective an antibiotic needs what it eliminates: cankers, pustules, sputum, fevers, diarrhea, dementia and emaciation.
In the years since, grand new principles of freedom, privacy and personal autonomy have emerged to protect septic suicide and homicide. An infectious lifestyle, once a crime, is now a constitutional right. The bag lady sleeps next to the sewer. The mainliner shares needles in the abandoned row house. Prisons, tattoo parlors, foul locker rooms, drug dens, brothels, bathhouses and other sepulchers of freedom now incubate drug-resistant strains of tuberculosis, staph bacteria, gonorrhea and syphilis. Those germs are now drifting into rundown urban hospitals whose emergency rooms often provide primary care to the septic underclass.
To crown it all, government procurement and insurance programs establish de facto price caps, and neuter patents, on almost all important germ-fighting drugs. After the 2001 anthrax attacks, federal authorities scrambled to stockpile Cipro, demanded an excellent price, and made clear they would breach Bayer's patents on the antibiotic if push came to shove. The Canadian government initiated its price negotiations by announcing it would ignore Bayer's patents and order a million tablets of a generic version of the drug from another company. Just two years earlier, it was the Pentagon that had pressed Bayer to get the antibiotic officially approved for the treatment of inhalational anthrax.
With the anthrax attacks in mind, Congress did pass the 2004 BioShield law. The measure (to simplify only a bit) rescinds the 1962 FDA amendments completelybut only when the Pentagon says it needs the drug, and accepts full responsibility for prescribing it to whoever needs it, in uniform or out.
The development, composition, performance, manufacture, price and marketing of germ-killing drugs are now controlled as tightly as shoulder-mount missiles. The manufacturers operate like big defense contractors, mirror images of the insurers, regulatory agencies and tort-litigation machines that they answer to. And as a result, the germ side of the pharmaceutical industry has lost its dynamism, flexibility, resilience and reserve capacity. The whole edifice leans sharply toward the past. Insurers favor yesterday's drugs because the patents have expired. FDA licensing gives the licensed status quo a decade-long lead, at the very minimum, over anything now emerging from the lab.
Germs no longer need to be smarter than our scientists, just faster than our lawyers. Public authorities are ponderous, rigid and slow; the new germs are nimble, flexible and fast. Drug regulators are paralyzed by the knowledge that error is politically lethal; the new germs make genetic errorconstant mutationthe key to their survival. Germs use pigs, bacteria and each other as genetic mixing bowls. They discover ways (as one strain of HIV has apparently now done) to use our drugs as food. And they celebrate our Constitution. People as negligent with pills as they are with germs have already helped spawn drug-resistant forms of tuberculosis, by taking enough medicine to kill weaker strains, while leaving hardy mutants alive to take over the business. HIV patients who don't strictly follow the complex, unpleasant drug regimen used to suppress the virus become human petri dishes, in which microbes multiply and evolve to resist the fistfuls of antibiotics prescribed as a last resort.
Pentagon-scale government has trouble enough dealing with car bombers; government contractors will never be agile enough to keep up with germs. What we need is a robust, flexible, innovative, diverse and fragmented portfolio of drug companies, sinking a lot of new capital into highly speculative ventures, almost all of which will lose money, with just one or two ending up waved through by regulators, eagerly paid for by insurers, vindicated every time by judges and juries, lauded in the mass media, and so spectacularly profitable for investors that they crowd in to fund more.
It is hard to see how we will get there without a revival of our germ-fearing culture, and it may well take a horrible germ to revive it. How horrible? What might it look like?
Ponder this question. What would a watchmaker have donenot a blind one, but one with keen eyes and an excellent loupeif called upon to design a microbe that would thrive among people so fortified by so many vaccines, and armed with such a potent array of antibiotics, that their surgeon general, black umbrella in hand, had actually signed the articles of surrender on behalf of all the germs? Nature got there without the loupe.
It cooked up an all-purpose anti-vaccine, so tiny and gentle that it spread unnoticed for decades, and so innocuous that it never quite gets around to killing you at all. It leaves that to the old guardthe bacteria, protozoa and viruses that invade when your immune system shuts down, and feast on your brain, lungs, blood, liver, heart, bone marrow, guts, skin and the surface of your eyes. In its final stages, AIDS is truly horrible.
When a watchmaker has been pulling such stunts for four billion years, it is reckless to suppose that HIV was its last or worst. When sociopaths are most certainly now scheming to add malignant human vision to the random walk, it is criminally irresponsible for people in authority to assume anything but the opposite. HIV has been detected in human plasma collected from a patient who died in 1959. We would be far safer today if the people preparing to rewrite the drug laws as he lay dying had been more frightened of viruses they could scarcely imagine, than of thalidomide, tragically visible though it was.