WASHINGTON — Pharmaceutical companies are flooding the government with offers to provide free antibiotics to counter the effects of anthrax.
But there's one catch: Many of these offers are contingent upon government approval to market the drugs as antidotes for anthrax, on top of their general uses. Labeling and advertising the drugs that way would allow firms to tap into profits enjoyed by Bayer Corp. and its now-famous antibiotic Cipro.
In the last week alone, Johnson & Johnson, GlaxoSmithKline and Bristol-Myers Squibb Co. have offered the government free stashes of their antibiotics in exchange for an anthrax-specific approval from the U.S. Food and Drug Administration.
Some admit, however, that they still need to conduct additional tests to prove that their drugs treat anthrax in animals or humans.
Health law experts say they are disturbed by the conditional offers. The law already allows physicians to prescribe an approved drug for any use, with or without specific FDA permission, according to Lars Noah, a visiting law professor at Georgetown University.
This is a "thinly veiled effort to get some quid pro quo that, frankly, given the hysteria that's going to develop, could be quite a large marketing opportunity," Noah said.
Nonsense, say the drug companies.
"I think that's beyond cynical. . . . That's absolutely ridiculous," said Mariann Caprino, spokeswoman for Pfizer Inc. "I just can't believe anyone would think we're seeking a marketing opportunity in anthrax."
Pfizer, Abbott Laboratories and Pharmacia Corp. have asked for new anthrax labeling for their products but haven't made that a condition of their free or reduced-priced donations to the government.
Beyond the actual drug donations, the companies say, they are willing to lend the government their scientists to do research, and to allow government to use their laboratories and manufacturing plants.
In other signs of cooperation between the government and the drug industry, the two decided Friday to create a joint bioterrorism task force to explore future avenues of research.
Earlier this week, the federal government negotiated a deal to pay Bayer 95 cents per Cipro pill, about half of Bayer's previous government price of $1.77. Cipro has a retail price of about $5 per pill. Experts recommend that those under treatment take two 500 mg pills per day for 60 days.
On Friday, generic drug maker Ivax Pharmaceuticals Inc. announced that it had been awarded a federal contract to supply more than 1.2 billion tablets of generic doxycycline, which also can be used to treat anthrax.
"Filling this order is a top priority for us at this time of special concern for our country," said Rafick G. Henein, Ivax's president and chief executive.
Cipro was the first drug approved for use on patients with inhalation anthrax. Last week, the FDA said penicillin and doxycycline also can be used for that purpose.
The drug companies' eagerness to help comes after years of being accused by lawmakers, consumer groups and others of deliberately slowing the introduction of cheaper generic drugs when their patents expire. And senior citizen groups have accused them of pricing drugs out of reach. The industry has fought state laws that have attempted to create price controls.
"What they're trying to do [with their offers] is to put on a good public front, show that the drug industry is concerned and wants to do the right thing," said industry analyst Ira Loss. "Is this the right thing? Well, in a way it's kind of a hollow promise. But they're trying to show you that their heart is in the right place."
Pharmaceutical industry representatives say their actions are consistent with history. They exercised their patriotic duty during World War II when the government asked factories to speed production of penicillin.
"We have a long-standing tradition of meeting the needs identified by the government at a time of national emergency, and we are determined to fulfill our obligation this time as well," said Jeff Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America.
Donna Shalala, secretary of Health and Human Services under former President Clinton, said she believes the FDA will make its decision based on scientific facts.
"I have full faith in FDA's ability to consult with appropriate scientists and make a hard-nosed decision," said Shalala, now president of the University of Miami in Florida. Similarly, the Bush administration said it is not exchanging a positive FDA decision for free pills.
"They can give us a drug or not give us a drug--that's up to them," said Campbell Gardett, an HHS spokesman. "If they are submitting an application to FDA, then they should go ahead and make it."
Under normal circumstances, a labeling change could take the FDA months or even years to approve, depending on the evidence presented from controlled clinical trials. In the case of anthrax, there are no human trials--and only limited study on monkeys.
"Companies are just trying to curry favor with the government," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "There clearly is pressure. The question is whether or not it's resisted."
Drug companies say label changes inform doctors and patients how to use the antibiotics.
"Any company would say responsibly that without the proper information, [consumers] don't know how best to use" the product, said Dr. Michael Friedman, senior vice president for medical and public policy at Pharmacia.
Friedman, ex-acting FDA commissioner, said drug firms will continue to offer help and resources.
"We all recognize the magnification of power if we can work together," he said.