9/11: One Year Later  
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High Cipro Prices Bring Drug Patent Issue Home

Is the U.S. government willing to put American lives at risk to protect pharmaceutical company profits?
 
 
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"Be Prepared with Cipro!"

"Have Cipro by TONIGHT!"

Enter the name of the drug into a search engine, and dozens of companies promise to lay your fears to rest. Cipro -- a popular wide-spectrum antibiotic -- has become instantly famous since Sept. 11 as the most recommended treatment for the deadly inhaled form of anthrax.

Online pharmacies -- which previously did the bulk of their business selling "lifestyle" drugs like Viagra and Propecia -- are receiving thousands of orders for Cipro as the number of U.S. anthrax cases mount by the day. A spokesperson for Healthmeds.com told Wired News on Oct. 10 that the company was receiving hundred of orders per hour -- and that was before the reports this week that 31 people in the U.S. Senate office building tested positive for exposure to the bacteria.

But there's a problem: the drug costs a small fortune. Germany's Bayer AG holds the patent on Cipro -- one of the newest and most effective antibiotics -- until 2003. The going rate on the Web is $84 for 14 doses, or $6 per pill (plus extra for an "online consultation"). Given that the recommended regimen for people exposed to anthrax is two Cipro pills daily for 60 days, a full course costs a whopping $720.

At these prices, people in the U.S. are getting a sense of the dilemma faced by people with AIDS, whose antiviral drugs can run into the hundreds of dollars per week. And, not surprisingly, some of the worried well are now taking up the cry for cheap generic drugs.

On Oct. 16, Senator Charles Schumer (D-NY) urged Health and Human Services Secretary Tommy Thompson to purchase ciprofloxacin, the generic version of Cipro, for the nation's emergency drug stockpile. According to Schumer, purchasing the generic drug would both decrease costs and provide a larger and more stable supply. "We cannot just rely on Bayer to ensure we have a sufficient supply of Cipro," said Schumer. "[I]f we make arrangements to purchase it from multiple generic drug manufacturers, we'll have it if we need it." Schumer hopes assurance of a sufficient supply will reduce the public's anxiety and discourage personal hoarding and inappropriate use of the drug.

With some pharmacies already running short of Cipro, Bayer said it would triple its production of the drug -- working around the clock and reopening a closed factory -- and would be able to meet U.S. demand. But as the mini-outbreak spread this week, Bayer acknowledged that it may have to outsource some of its production.

Generic ciprofloxacin is already available in several countries, where it can cost as little as $20 for a two-month supply. At least five generic drug manufacturers have been tentatively approved to begin producing generic ciprofloxacin when Bayer's patent runs out. India's Ranbaxy Laboratories told Schumer that it could provide 20 million doses of generic ciprofloxacin at a "very attractive" price. On Oct. 16 Canadian generic drug producer Apotex, Inc. began producing 1 million generic ciprofloxacin pills under contract with Health Canada, saving the government CAN$1 million. Although the manufacturer lacks a license to circumvent Bayer's patent, company president Jack Kay told the Toronto Star, "They [Health Canada] said they don’t care, they need the drug." And on Oct. 17 the Canadian government announced it had overriden Bayer's patent for Cipro.

Meanwhile, the Bush administration has requested $1.5 billion for bioterrorism preparedness (a tenth of the amount allocated to bail out the airline industry), of which $643 million would go toward stockpiling drugs. Assuming the entire amount was spent on Cipro at the heavily discounted government bulk price of about $2 per pill, the allocation would buy roughly 321.5 million doses, enough for a full course of anthrax treatment for about 2.6 million people. At the Indian price of $20 for a full course of generic ciprofloxacin, or roughly 17 cents per pill, the government could purchase about 3.8 billion doses, enough to treat 31.5 million people for the same outlay. Apotex, the Candian generic drug producer, will sell the drug for $1.37 per pill.

Thompson said he wants to stockpile enough antibiotics to treat 12 million people, up from the current 2 million. With the sum requested, this goal can only be reached if the government purchases either generic ciprofloxacin or the two other drugs approved to treat anthrax -- doxycycline or penicillin -- which are already available as generics in the U.S. With the nation's public health system woefully underfunded, some are asking whether pouring millions of dollars into the coffers of pharmaceutical companies is the best way to protect the country from the bioterrorist threat.

Thompson has hesitated to approve the purchase of generic ciprofloxacin, claiming the U.S. does not have the legal authority to do so. Nonsense, counters James Love of Ralph Nader's Consumer Project on Technology (CPT). Love cites a federal law -- 28 USC section 1498 -- that allows the government to purchase products for official use from alternative sources with the payment to the patent holder of a royalty fee determined by a judge. The U.S. has used the provision numerous times for products ranging from drugs to electronics technology. "The law is already in place and very clear," says Love. "All Thompson has do to is act." Patent attorney Alfred Engelberg backed up Love's claim, stating, "The government has the right to procure whatever it needs for government purposes."

Love and his fellow treatment advocates are intimately familiar with U.S. patent law, having fought for the past two years to make generic AIDS drugs available in poor countries. The Health GAP Coalition -- an advocacy organization that includes CPT, Doctors without Borders and ACT UP -- has been working on the issue since 1999, when they began hounding Al Gore during his presidential primary campaign to demand that he back down on threats to impose trade sanctions on South Africa if it implemented a law allowing the purchase of cheap generic AIDS drugs.

The debate came to a head last March when a consortium of 39 major drug companies, under tremendous public pressure, dropped their lawsuit against the South African law. Activists claimed a further victory in June when the U.S. agreed to withdraw a trade complaint against Brazil, which maintains an extensive program to produce and provide inexpensive generic drugs to all its residents with AIDS.

If the U.S. can legally purchase generic drugs, why can't poor countries do so as well? In fact, the World Trade Organization's Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement allows countries facing a national emergency to produce or purchase generic copies of patented drugs, a provision known as compulsory licensing. But pharmaceutical companies -- often backed by the U.S. government -- have continued to argue that generic drugs infringe on their intellectual property rights. The drug patent issue has been a major point of contention in recent protests against the WTO and the Free Trade Area of the Americas (FTAA) agreement. The Bush administration is currently pushing to limit compulsory licensing in future trade agreements.

Love and Nader fired off a letter to Thompson on Oct. 18 urging him to immediately authorize the purchase of generic ciprofloxacin and any other drugs needed to confront the current crisis. "By failing to act, you are putting Americans at risk," read the letter. "Your official responsibility is to protect the public's health, and not to defend large profiteering pharmaceutical companies, which are already making a fortune because of our country's current problems."

In Love's view, Thompson fears that any move to license generic ciprofloxacin will endanger the administration's negotiating position in intellectual property discussions at the upcoming WTO meetings in Doha, Qatar. "Thompson is willing to risk the lives of Americans in the face of a biological attack to protect the U.S. trade position at the WTO," asserted Love. "Rather than send the wrong signal to countries in Latin America, Africa, and Asia, he's willing to leave Americans exposed." Thompson has said the U.S. is talking to Bayer about voluntarily licensing generic ciprofloxacin, thereby avoiding a compulsory license precedent.

AIDS activists have accused patent-holding drug companies of promoting a form of "medical apartheid," whereby wealthy people can purchase the medications they need while poor people are forced to do without. Love sees a similar situation developing in the U.S. "Families who cannot afford the hundreds of dollars per month per family member for [Cipro] risk not having access to this product, should the need arise," Love and Nader write. "This is an unethical and unnecessary form of rationing."

Public health officials have urged individuals not to stockpile the drug, insisting that antibiotics can be delivered anywhere in the country within 12 hours (assuming planes are flying and roads are open). But some people are worried this may be too late. Anthrax must be treated before symptoms appear, which can take anywhere from two days to eight weeks after exposure. According to a consensus statement published in the Journal of the American Medical Association in May 1999, "A delay of antibiotic treatment for patients with anthrax infection even by hours may substantially lessen chances for survival." Given how long people must wait when they visit a public hospital emergency room or try to make an appointment with an HMO doctor, it's no surprise many feel more secure with a stash of Cipro in their own medicine cabinet.

Noting that Bayer stands to make "hundreds of millions if not billions of dollars" in the wake of the Sept. 11 attacks, Love and Nader have asked the government to examine the current law and make any necessary changes to "ensure that firms cannot exploit the current situation or engage in bio-terrorism profiteering." Bayer did not return AlterNet's call by press time, but spokesperson Mark Ryan told Germany’s Der Spiegel newspaper on Oct. 17 that the company had not yet had time to formulate its position on Schumer's proposal. On the issue of AIDS drugs, however, pharmaceutical companies have argued that they need to make large profits on successful patented drugs in order to fund research and development of new medicines.

After effectively mobilizing support for generic AIDS drugs over the past year, treatment advocates are concerned that the Sept. 11 terrorist attacks have put AIDS on the back burner. They are hoping the Cipro debate will return the spotlight to the issue and bring its importance home to the American public.

Health GAP’s Sharonann Lynch drew the connection between Schumer's call for compulsory licensing of generic ciprofloxacin and the access barriers to essential drugs for AIDS. "We need an end to medical apartheid whereby 95 percent of the world's people with HIV/AIDS do not have access to life-extending medicine, care and treatment," she stated. Along with generic drugs, AIDS activists are also calling for more money for the U.N.'s Global AIDS and Health Fund.

Last Spring, pharmaceutical companies suffered a major public relations blow when they appeared to be putting profits before lives in South Africa. Now, Americans have a keen sense of their own vulnerability as they face the prospect of not having access to the drugs they need to protect themselves from a bioterrorist attack. Amid the current climate of panic and patriotism, AIDS activists believe that it would be fitting indeed if today's widespread calls for national unity and international solidarity could help generate the will to provide affordable essential medications for the world's neediest citizens.

"We have to expand our response and our compassion beyond the Sept. 11 tragedy," said Lynch. "As the richest country in the world, we must refuse to leave aside the immense suffering that is preventable with our collective humanity and our collective action."

Liz Highleymanis a freelance writer based in San Francisco.