Cipro

WASHINGTON -- The first wave of pharmacy customers seeking Bayer's Cipro (ciprofloxacin) may be followed by a demand for other antibiotics recently deemed effective against anthrax.

The drug industry is stepping up to meet the increasing demand for Cipro and other antibiotics. Since the first cases of anthrax surfaced, consumers have been rushing to buy Cipro at their neighborhood pharmacies. In the New York area, some drug stores post signs saying they had Cipro in stock.

Among drug manufacturers, Johnson and Johnson is seeking U.S. Food and Drug Administration approval to add anthrax as an indication for Levaquin (levofloxacin), marketed by J&J affiliate OrthoMcNeil. The company said it has been in contact with the FDA since June 2001 discussing the anthrax indication, but has recently offered to donate up to 100 million tablets to the federal government "for use as it deems appropriate."

J&J chairman and chief executive officer Ralph Larsen said he offered the company's scientific, research, manufacturing, distribution and informational capabilities to the Health and Human Services secretary Tommy Thompson in an attempt "to be as helpful and resourceful as we can be during this time."

Eon Labs, a generic pharmaceutical company in Laurelton, N.Y., said the New York State Department of Health asked about its doxycycline supply on Oct. 18. Doxycycline capsules were approved to treat anthrax "in all of its forms" by Thompson in a public health advisory issued the same day. Also that day, Halsey Pharmaceuticals sent Thompson a letter saying it could meet increased doxycycline hydate demand with the help of $1.5 million in additional equipment and expedited FDA reviews.

The Bush administration asked Congress for $1.6 billion toward anti-bioterrorism initiatives. One-half would be earmarked for a national stockpile of antibiotics. After some reportedly strong-arm negotiating, Thompson bargained Bayer down to 95 cents a tablet for the government's total initial order of 100 million tablets of Cipro, down from the previously discounted price of $1.77 per tablet paid by the federal government. Bayer said it would rotate the government's inventory as part of the deal, adding an additional value of 30 percent to the deal for the government. As a further contingency, the agreement provides for the option of a second order of 100 million tablets at 85 cents and a third order at 75 cents each.

The purchase would be used to expand emergency stand-by supplies already helped in the National Pharmaceutical Stockpile maintained by HHS. The NPS includes both vendor managed inventory and 50-ton 'push packages' located in 12 secret locations in the United States. (Vendor managed inventory is one potential area where chain and community drug stores could be asked by the government to supply items to supplement the regional push packages.)

Wholesalers limit supply

Reports of spot-shortages of Cipro in pharmacies located near anthrax hot spots were followed by drug wholesalers capping retail orders to help stretch supply. McKesson spokesman Larry Kurtz said Cipro orders more than doubled in the past two weeks, from an average 40,000 bottles per month to 100,000 bottles in 10 days. Cipro orders from McKesson clients are now "filtered" Kurtz said, with orders limited to quantities resembling customers' pre-Sept. 11 levels.

"We became concerned that at some point people who need Cipro would be unable to get it, so filters were put in place," explained Kurtz. "Our mission is to get drugs to the people that really need them."

Cardinal Health also is feeling the pinch. "We're experiencing a low-stock situation nationwide," spokeswoman Donna Gaidamak said. "We're shipping it as soon as we receive it." Cardinal is limiting customers to "historical ordering patterns" of Cipro but allows some leeway. "We're ensuring our customers that we're working closely with Bayer to provide the products they need," Gaidamak said, believing the hoarding was worse in preparation for Y2K.

Newly merged wholesaler AmerisourceBergen declined to comment on the rush for Cipro or other drugs. "We clearly do have the ability to move drugs from distribution sites to places that may have a spike in demand," Mike Kilpatric, vice president of corporate and investor relations said. We've been able to get emergency shipments to fill in gaps in the past."

The American Medical Association is trying stop superfluous Cipro prescriptions at the prescriber level. "Taking unnecessary antibiotics contributes to the problem of antibiotic resistance, which is a major public health concern," AMA chairman Timothy Flaherty said. "Overuse of antibiotics can cause bacteria to become resistant to previously effective antibiotics. Antibiotic resistance causes significant danger and suffering for children and adults who contract infections that were once easily treated with antibiotics."

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