The Best Biodefense

Protecting drug patents can protect our long-term health

A few grams of anthrax sent through the U.S. mail have killed four people, infected nearly a score more, and caused thousands to take prophylactic antibiotics. However, it is the panicky response to the anthrax attacks by some of our leaders in Congress and the administration that could cause much greater harm to American health in the future.

Last month Senator Charles Schumer (D-N.Y.) called for seizing the patent on the anthrax-fighting antibiotic Cipro, manufactured by the German pharmaceutical company Bayer. Bayer's patent runs until 2003, but Schumer wants to hand it over to a number of generic drug companies so that they could manufacture more of the drug more quickly. Schumer declared in The New Yorker, "One company should not be able to stand in the way of the health needs of a nation." He added that Bayer "should not be reaping profits from this crisis." Ralph Nader and Jamie Love, in a letter to Health and Human Services Secretary Tommy Thompson, accused him of "putting Americans at risk" by not seizing Bayer's patent.

In the meantime, Thompson persuaded Bayer to sell Cipro for 95 cents per tablet, down from its pre-war discounted price of $1.77 per tablet. Thompson denies shaking down Bayer by threatening to lift its patent during the negotiations, but they did take place against the background of Schumer's proposal.

So why not force Bayer to give the government its patent? Aren't we in a public health emergency? Well, no. First, it turns out that Cipro is not at all essential to successfully treating the strain of anthrax that was sent through the mail. In fact, most anthrax strains can be killed off by penicillin and doxycycline, older antibiotics that are much cheaper than Cipro. So there are plenty of drugs available to treat those exposed to anthrax and the Department of Health and Human Services is contracting to buy a lot more for the National Pharmaceutical Stockpile.

Then why the focus on Cipro? Because the U.S. Food and Drug Administration (FDA) in the 1990s, fearing bioterrorism, specifically asked Bayer to submit an application for approval of Cipro as a treatment for inhalational anthrax. Bayer honored the FDA request and the agency approved Cipro as an anthrax treatment in August 2000. Proving the adage that no good deed goes unpunished, Bayer is now in the crosshairs of Schumer, Nader, and Love.

Meanwhile, generic drug manufacturers of penicillin and doxycycline, seeing no obvious and immediate market for the treatment of anthrax—there hadn't been any cases in the United States since 1978–had reasonably chosen not to conduct the expensive trials required to receive approval from the FDA. Nevertheless, researchers knew that both drugs were effective against most strains of anthrax.

But Cipro and other antibiotics are just a small part of the arsenal that could one day soon be deployed in defending America against biowarfare. Just consider what's in the pipeline now that could be used to protect Americans against infectious diseases, including bioterrorism. A Pharmaceutical Manufacturers and Research Association survey found 137 new medicines for infectious diseases in drug company research and development pipelines, including 19 antibiotics and 42 vaccines.

With regard to anthrax, instead of having to rush a sample to a lab where it takes hours or even days to culture, biotech companies have created test strips using antibody technologies that can confirm the presence of anthrax in 15 minutes or less, allowing decontamination and treatment to begin immediately. Similar test strips are being developed for the detection of smallpox as well.

The biotech company EluSys Therapeutics is working on an exciting technique which would "implement instant immunity." EluSys joins two monoclonal antibodies chemically together so that they act like biological double-sided tape. One antibody sticks to toxins, viruses, or bacteria while the other binds to human red blood cells. The red blood cells carry the pathogen or toxin to the liver for destruction and return unharmed to the normal blood circulation.

In one test, the EluSys treatment reduced the viral load in monkeys one million-fold in less than an hour. The technology could be applied to a number of bioterrorist threats, such as dengue fever, Ebola and Marburg viruses, and plague. Of course, the EluSys treatment would not just be useful for responding to bioterrorist attacks, but also could treat almost any infection or poisoning.

Further down the development road are technologies that could rapidly analyze a pathogen's DNA, and then guide the rapid synthesis of drugs like the ones being developed by EluSys that can bind, or disable, segments of DNA crucial to an infectious organism's survival. Again, this technology would be a great boon for treating infectious diseases and might be a permanent deterrent to future bioterrorist attacks.

Seizing Bayer's patent now wouldn't just cost that company and its stockholders a little bit of money (Bayer sold $1 billion in Cipro last year), but would reverberate throughout the pharmaceutical research and development industry. If governments begin to seize patents on the pretext of addressing alleged public health emergencies, the investment in research that would bring about new and effective treatments could dry up. Investors and pharmaceutical executives couldn't justify putting $30 billion annually into already risky and uncertain research if they couldn't be sure of earning enough profits to pay back their costs.

Consider what happened during the Clinton health care fiasco, which threatened to impose price controls on prescription drugs in the early 1990s: Growth in research spending dropped off dramatically from 10 percent annually to about 2 percent per year. A far more sensible and farsighted way to protect the American public from health threats, including bioterrorism, is to encourage further pharmaceutical research by respecting drug patents. In the final analysis, America's best biodefense is a vital and profitable pharmaceutical and biotechnology industry.