Depending on what terrorists do next, America could be on the verge of a public health catastrophe. The administration is moving belatedly to develop stocks of antibiotics to treat anthrax. The government is also looking to procure 300 million doses of smallpox vaccine to inoculate a new generation against a weaponized disease that was wiped out in its natural form two decades ago. It is instructive to look at the role of two key players in this drama: the private drug industry and the public health system.
Last week, Bayer, the maker of Cipro, was resisting government efforts to use existing federal authority to order mandatory patent licensing, to enable other labs to manufacture an emergency supply. The generic version of Cipro is easily produced, for a tiny fraction of the $4.50 a dose or $350 per month that Bayer charges. Producers in India sell generic ciprofloxacin for about $10 for a monthly supply, and the drug is also made generically in Spain and Portugal.
Curiously, another antibiotic, doxycycline, is just as effective as Cipro in treating anthrax. But until this crisis, Cipro was the only drug approved by the FDA explicitly to treat anthrax exposure caused by inhalation of spores. This monopoly is also the result of efforts by Bayer.
According to Dr. Sidney Wolfe, director of Public Citizens Health Research Group, the government asked Bayer last year to present research that would lead to FDA approval of a drug for preventive treatment of persons exposed to inhalation anthrax. Bayer relied on government research (done by American bio-warfare scientists using animal subjects) which clearly showed Cipro and doxycycline, a generic antibiotic, to be equally effective.
But Bayer requested and got FDA approval for only Cipro. A month's treatment of doxycycline retails for about $20, or one-15th of what Bayer charges for Cipro.
At this writing, the FDA is on the verge of ordering mass production of generic Cipro and approving doxycycline as a preventive and treatment for exposure to inhalation anthrax. The FDA may also approve penicillin, which is apparently less effective.
Meanwhile, the trade association of brand-name drugmakers, known as PhRMA, is fighting a rearguard action. It has convened a Taskforce on Emergency Preparedness, made up of CEOs from the industry, to address the extra production needs. This sounds good, but PhRMA represents only brand-name drugmakers. It explicitly excludes makers of generic drugs, which are much cheaper, no less effective, and thus far less costly to consumers and taxpayers.
There is a name for this behavior. It's called war profiteering.
We should hardly be surprised. This is the same industry that mightily resisted supplying cheap AIDS drugs to Africa, until it was shamed by world public opinion and outfoxed by makers of generic equivalents in India and Brazil. The third world basically dared American and European drugmakers to take them to court, and PhRMA blinked first.
What is good enough for a public health emergency is also sound policy for everyday emergencies. Millions of people are denied medically necessary drug treatments because they have to choose between paying to fill exorbitantly expensive prescriptions and eating. Anyone forced to make such a choice faces a personal emergency. We need federal controls on drug prices and more production of generic drugs financed by public funds.
The other part of this story has to do with public health. For 20 years, public health has been a stepchild of federal policy, while both parties have supported increases in the budget for the National Institutes of Health.
What magic does NIH possess in an era of budget cuts? The drug industry loves it, since NIH finances the basic scientific research on which the industry relies to make its customized products (and exorbitant profits). Every time a particular disease comes into vogue as a public cause, the drug industry jumps on the bandwagon and gets another hike in NIH funding.
Certainly, it makes sense to lavish public money on basic research - but then taxpayers should not have to pay twice via high prices at the drugstore. Nor is it sound policy to favor research that helps the drug industry while short-changing public health and epidemiological efforts which can safeguard the health of broader populations at lower cost.
It shouldn't take a national emergency to grasp how out of whack our priorities have been. It's time to rein in drug company profits and rebuild our public health system, so all Americans can get the drugs and vaccines that we need at the lowest possible cost.
