Is it time to bust the Cipro patent?

Activist Jamie Love accuses the Bush administration of putting corporate profits above public safety.

Published October 18, 2001 8:27PM (EDT)

In the middle of a public health panic over anthrax, a political fight has broken out between Sen. Charles Schumer, D-N.Y., and Bush administration officials. Schumer has called for the government to begin purchasing generic forms of Cipro -- the antibiotic most commonly used to treat anthrax -- against the wishes of Health and Human Services Secretary Tommy Thompson and Cipro manufacturer Bayer AG.

The fight has reignited a pre-Sept. 11 battle between Democrats and the Bush administration, which advocates say is too cozy with the pharmaceutical industry. "We cannot just rely on Bayer to ensure we have a sufficient supply of Cipro," Schumer said in a statement. "First, Bayer can only produce so much Cipro, and we should not put our best response to anthrax in the hands of just one manufacturer. Second, buying Cipro only from Bayer -- who charges a lot more than generic manufacturers would -- means we spend a lot more and receive a lot less. Hopefully, we won't even need to use the Cipro we already have on hand, but if we make arrangements to purchase it from multiple generic drug manufacturers, we'll have it if we need it."

The Canadian government has decided to override Bayer's patent, and allow other companies to produce generic forms of Cipro. Bayer spokesmen condemned the move and said the company was considering legal action. Thompson, meanwhile, remained steadfast in his decision not to lift the patent. In appearances on "The Today Show" and interviews with the Washington Post, Thompson said he would not force Bayer to allow other companies to produce generic forms of Cipro before their patent expires in 2003. "I do not believe we have the legal authority to do so," Thompson told "Today's" Matt Lauer Wednesday. "We're checking that out."

In light of the recent spike in demand, Bayer announced this week it would triple production of Cipro, but remained firm that it alone should retain the right to produce the antibiotic, which has been Bayer's biggest seller for the last several years. Though there were reports Thursday that Bayer was "considering" allowing other manufacturers to produce Cipro to meet the current demand, Bayer spokesman Michael Diehl said earlier this week the company saw "no reason to change as long as we can deliver ... and that's what we're doing." But the New York Times reported Thursday that it would take the company 20 months, working 24 hours per day, to produce the amount of Cipro Thompson says the government needs.

Some public health officials questioned whether it was even necessary to ramp up Cipro production, pointing out that other forms of antibiotics are just as effective as Cipro in treating anthrax. The public would be better served, they argue, through a reeducation plan rather than a tug of war over the Cipro patent. In an interview with the Washington Post, University of Michigan anthrax expert Philip Hanna said, "I don't know how Cipro got labeled in the first place as the drug of choice ... It's a great medicine for a number of different bacteria, but I don't know how it got labeled as the go-to medicine [for anthrax]."

Other experts are even warning that by taking Cipro -- and many people are taking it who probably don't have anthrax at all -- we run the risk of creating a strain of super anthrax that is immune to the antibiotic.

"We are already in a crisis where many pathogens are resistant to front-line medications," said Lawrence Gostin, professor of law and public health at Georgetown University, in an interview with the Associated Press. "This will add to the nightmare of drug resistance."

But Schumer, and other advocates, believe that increasing the supply on Cipro is necessary to quell the public panic about anthrax. One of the loudest voices in the call for the production of generic Cipro is Jamie Love, director of the Consumer Project on Technology.

That Love is in the center of this fight should come as no surprise. He has long accused the government of protecting the rights of pharmaceutical companies and their patents at the expense of public health. Love says the administration -- led by Thompson -- and pharmaceutical companies have historically put profit concerns over those of public health in their continued resistance to allow generic AIDS drugs to be distributed in Africa. Sensing a political opportunity, perhaps, Love has joined Schumer in the call for the government to step in and demand the generic production of Cipro -- no doubt to create a precedent to help Love's ongoing fight to make AIDS drugs more readily available.

Salon spoke to Love in his office in Washington Thursday afternoon.

What do you think about Secretary Thompson's position that we should not be creating generic forms of Cipro?

Well, let me get this straight. They say it would be a good idea to have medicine for 10 million people because there are people threatening to use biological weapons to kill millions of people. But Tommy Thompson doesn't think it's a good idea to send the wrong signal on patent rights. This is about the strongest statement I've ever seen as to the power of the idea of a patent. If you can put at risk the welfare of millions of Americans on the grounds you don't want to send the wrong signal on patent rights, that's quite a statement. It's really a new standard.

But Thompson has said he doesn't believe he has the authority to break the patent.

Well, he does. He absolutely has the authority. That authority, under 28 USC 1498, has been used in hundreds of cases far less important than this one. It's used for copyright and in the patent field, and it clearly states you can't sue U.S. government [to stop it] from using patented goods. It's used for all sorts of things by the Department of Defense, by the Department of Energy -- it's used all the time.

It's ludicrous for Thompson to suggest they can't use that authority. The way the law is written, it's so broad that his secretary probably has that authority. NASA uses it. If you do a Web search for 28 USC 1498, believe me, you'll get a million hits about. It's not as if we're smoking dope over here on this issue.

Five companies have actually received FDA approval to manufacture the product. Canada yesterday said they had a sufficient health emergency on their hand to order that the patent be broken. But Thompson won't budge.

You've butted heads with Thompson before on similar issues.

Absolutely. He's been the main obstacle in our fight to get affordable AIDS drugs in Africa. He's been a bigger problem for us than State or [the Office of the United States Trade Representative]. Even [U.S. Trade Ambassador Robert] Zoellickis is more moderate than Tommy Thompson. Tommy Thompson is the guy who proclaimed he was carrying Pharma's water when he killed the proposal to distribute AIDS drugs in Africa. He's the guy who complained because of the World Health Organization meeting in Zimbabwe to change patent laws. Tommy Thompson read the riot act to the WHO about that.

If the administration does decide to authorize generic production of Cipro, would Bayer be entitled to any compensation?

Absolutely. You have to pay. It's not free. The federal government would be on the hook for the compensation. They would have to pay whatever a judge says is reasonable compensation.

We think it's an untenable position. It's going to look rather stupid if anything terrible happens. Thompson's exposing people to unneeded risks. He might get lucky and have it not turn out badly. And that's what we're all hoping for. An unlucky result might be that me and every member of my family might be killed if there's a large anthrax attack in Washington D.C. and there isn't enough medicine to go around. I don't really appreciate him deciding for us that we shouldn't issue the license to get the damn drugs. He's the damn secretary of Health and Human Services. He should be trying to protect the American people. He's just afraid to break the patent. He says that the U.S. will respect the patent right, even if it means endangering public health. That's a hell of a lot of respect, I must say.

He seems to lack a little bit of guts. He's not lacking any legal authority, but does seem to be missing a bit in the courage department. He's afraid to say the truth -- he doesn't want to send the wrong signal on the patent issue, even if that means putting people in danger.

By Anthony York

Anthony York is Salon's Washington correspondent.

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