[Ip-health] AlterNet: High Cipro Prices Bring Drug Patent Issue Home

[love@cptech.org]

http://www.alternet.org/story.html?StoryID=11760 

High Cipro Prices Bring Drug Patent Issue Home 
Liz Highleyman, AlterNet
October 19, 2001

"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.