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August 09, 2005

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Tamiflu ordered as office supply

By JEFF NESMITH in Washington , DAVID WAHLBERG in Atlanta
The Atlanta Journal-Constitution
Published on: 08/08/05
Washington — Multinational corporations are being advised to stockpile the crucial influenza drug Tamiflu at a time when governments and international health agencies are frantically trying to buy the drug in preparation for a feared pandemic of avian flu.

International SOS, a London-based company that provides medical evacuations and other medical and security services to 6,400 corporations, says it is advising clients such as the Coca-Cola Co., Motorola Inc. and Exxon Mobil Corp. to consider stockpiling Tamiflu in order to protect employees and keep overseas businesses operating during a pandemic.

"The rationale with most companies so far is, look, we have an obligation to protect our own people within our company and to protect the business and keep it operational," said Dr. Miles Druckman, a vice president of International SOS.

Corporate stockpiling of the highly sought — and probably scarce — drug raises concerns that private money would trump the U.S. pandemic flu plan's priority recommendations for who should get the medication. And it provokes ethical questions about private employees getting protection when key medical personnel, for instance, might not.

The U.S. Centers for Disease Control and Prevention, based in Atlanta, has estimated a "medium-level" pandemic could sicken 90 million Americans and kill more than 200,000.

Only one source

Federal researchers reported last month that Tamiflu — an antiviral drug currently made by one company in one overseas plant — was effective against the strain of avian influenza that health experts fear is close to evolving into a pandemic of human disease similar to one that caused the deadly 1918 "Spanish flu" pandemic.

The avian influenza, which has ravaged millions of chickens and other wild and domesticated fowl, has already begun infecting people in Southeast Asia, sickening at least 114 so far and killing 58 — most of them from contact with affected birds.

Substantial person-to-person infectivity has not been confirmed, authorities say. If the H5N1 influenza strain now circulating among birds evolves into a disease capable of spreading among humans, Tamiflu would be the only effective treatment for months, until a vaccine could be produced and distributed.

Government scientists said late last week they believe the H5N1 vaccine that has been in clinical trials will be effective against the virus, but full production cannot begin until an epidemic is under way and the exact pandemic strain identified. That process could take another six months.

But Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said a critical issue is whether enough vaccine can be manufactured to meet demand if a pandemic develops.

Demand raises price

Tamiflu's status as the sole treatment for avian flu has increased competition for the limited supply of the drug. With demand growing, the price of Tamiflu has climbed above $10 a pill in some places, said Druckman.

Tamiflu can be used to treat or prevent regular flu and avian flu. Used as a treatment to lessen the severity and duration of the illness, it must be started within 48 hours of the appearance of symptoms, with a recommended two pills daily for five days. Used to prevent flu in the event of a pandemic, it would likely be given to select groups of people — such as key health care workers and some high-risk patients — once a day for about six weeks.

Hoffmann-La Roche Ltd., the company that manufactures the entire global inventory at a single plant in Switzerland, has little "surge capacity" to meet growing demand, experts say.

Roche has greatly expanded its European production, however, and plans to start making Tamiflu in as many as six plants in the United States this fall — in part to meet the U.S. government's recently announced goal of purchasing 20 million treatment courses of 10 pills each, said Roche spokesman Terence Hurley.

For months, U.S. officials have said they would stockpile only 2.3 million treatment courses of Tamiflu. That would cover less than 1 percent of Americans, far less population coverage than many other nations' stockpiles.

Priority list

The Tamiflu purchasing issue comes as Mike Leavitt, the U.S. health and human services secretary, finalizes the agency's pandemic flu plan, to be released soon. It outlines who would get vaccine and drugs first if a pandemic strikes, from health care workers and morticians to those at risk with chronic illnesses.

Druckman acknowledged that some companies may encounter widespread criticism by buying up scarce supplies of the only drug that can save lives in a pandemic.

"There are a lot of issues that you are dealing with when you look at Tamiflu stockpiling," he said. "How do you do this so that it is as accessible as possible, but also with the understanding that you're not going to be able to treat the whole country?"

He said companies may view their stockpiles as a way of "augmenting" national pandemic preparation efforts in countries where they operate.

Ben Schwartz, senior science adviser for the National Vaccine Program Office of the Department of Health and Human Services, said the government is concerned that corporate purchases of Tamiflu could threaten the nation's response to a flu pandemic.

"Our ability to purchase drugs nationally depends on having that drug available," said Schwartz, an architect of the U.S. pandemic flu plan. "If companies purchase it, that will potentially decrease what is available."

Schwartz raised another concern: the shelf life of Tamiflu. Since the drug expires after five years, companies might buy it from distributors two or three years after manufacturing, and it could go stale and cost the companies a lot of money, he said.

But Hurley, of Roche, said corporations that buy Tamiflu now to prepare for pandemic flu could use it for regular flu each winter.

Druckman said International SOS will launch a Web site, accessible only to the firm's clients, to track developments involving influenza and Tamiflu.

"Many companies are now kind of waking up to the fact that this is a serious issue," he said. "Typically, it'll be corporate security people. Their issue is business continuity — 'How are we going to assure that our employees are adequately prepared and protected in the best possible way if there is the evolution of a pandemic?' "

He said "there are quite a few variables at play. Obviously cost comes into play, as well as just purely the stock — what inventory is out there around the world in order to meet what the plan is."

Some epidemic experts said most of the Tamiflu inventory has been bought up years in advance. It's not clear how many companies have actually purchased Tamiflu already.

"The problem is the pipe is only so big and no one can make the pipe any bigger," said Michael Osterholm, director of the University of Minnesota Center for Infectious Disease Research and Policy.

He said Roche has "orders from some countries that extend out years."

Alternative plan

Researchers in two prominent journals predicted last week that an avian flu outbreak among humans could be contained if strict measures were taken quickly.

But Osterholm, who has urged more aggressive preparations for avian flu, said the likelihood that Tamiflu might not be available quickly enough points to a flaw in those predictions: they assume every countermeasure can be deployed swiftly, without complications.

"We need comprehensive disease surveillance, rapid detection, extreme ability to control population movement and a collateral surveillance system that can pick up any people who move from one location to another," he said. "We hardly have that anywhere in Asia right now."

Laurie Garrett, a health writer and fellow at the Council on Foreign Relations, said corporations "are worried about their overseas employees, and that's perfectly reasonable.

"The reason they are trying to build their own stockpiles is there's a tremendous shortage and they know it," she said.

She said Roche has "been very slow to respond to a real outcry from [the World Health Organization], the U.S. government and other governments who are saying, 'We need a lot more Tamiflu than you guys are cranking out.'

"The amount of hoarding, if you will, that may occur in corporations is a pittance compared with what governments are trying to obtain," she said.

Roche spokesman Hurley said Friday that 25 countries, including the United States, have placed orders for Tamiflu as part of national pandemic preparation efforts and that five others have signed "letters of intent."

Increasing output

Roche is filling "pandemic stockpile orders on schedule," he said, and is wrapping up negotiations about donating a "large quantity" of Tamiflu to the World Health Organization for possible use in an effort to contain an initial human outbreak of the disease.

He said the company doubled the output of its Swiss Tamiflu factory between 2003 and 2004 and will double it again this year.

"We have also built a U.S.-based manufacturing supply chain, that when launched later this year, will result in an increase in total Tamiflu capacity of nearly eightfold over 2003 production," Hurley said in an e-mail response to questions.

He declined to say where individual plants in the chain, which have not yet received FDA approval, will be located.

"Six U.S. sites are involved in the process," he said. "It's a combination of existing Roche facilities and approved third-party vendors."

Hurley said Roche officials knew about International SOS, but so far there has been no direct contact between the two companies.

Dr. Julie Gerberding, director of the CDC, has faced criticism from two House committees over the agency's purchase of only 2.3 million courses of Tamiflu and its plans to buy only another 5 million.

But HHS Secretary Leavitt last month told state and local health officials the country would obtain 20 million courses of antiviral drugs. An HHS spokesman said Friday there are no plans to increase this amount.

Posted by dymaxion at August 9, 2005 02:11 PM

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