San Francisco Chronicle - November 2, 2004
Sabin Russell, srussell@sfchronicle.com.

Soon enough, a Winnipeg pharmacy that sells all kinds of prescription medicines to Americans over the Internet -- in violation of U.S. law -- was willing to ship him 400 doses of French-made flu vaccine for about $10.50 each.

On Thursday night, in the same sort of plastic foam container used to fly fresh fish across the country, 40 vials of vaccine nestled in ice packs were winging their way to San Francisco.

The next day, 66-year-old emphysema patient Rick Borgwardt received his potentially lifesaving jab of cross-border flu vaccine at O'Keefe's California Pacific Medical Center offices on Castro Street.

"I am a particularly high-risk individual," said Borgwardt, a retired San Francisco resident who breathes with the aid of a portable oxygen tank. "But I am just one of thousands."

But the vaccine almost never made it to San Francisco. It arrived only after a three-week struggle that touched on many of the prickly issues surrounding the importation of often-cheaper Canadian drugs.

Borgwardt says he has no concerns about the safety of the vaccine from Canada. "In Canada, we trust," he said.

The U.S. Food and Drug Administration, however, casts a cold eye on such drugs, even those originally made in America for the Canadian market and subsequently reimported back to the United States.

Under Canadian government price controls, most prescription drugs are substantially cheaper than like products sold in the U.S. market -- and American policymakers worry that cross-border sales would undercut the profits that finance drug company research in the United States.

Without FDA supervision, the agency also argues, there is no way to know whether drugs sold in the United States from Canada are real or counterfeit, have been stored properly or -- if they were manufactured outside the United States -- are potent and free from impurities.

Therefore, both the Bush administration and Clinton's before it have battled efforts by municipalities, states and Congress to permit re- importation of low-cost Canadian drugs.

But under pressure from senior citizens, who are the major consumers of prescription drugs, U.S. government resolve has been bending. During the presidential debates, Sen. John Kerry pledged to open up U.S. markets to Canadian prescription medications; President Bush said it might happen in December, after the FDA determines whether such drugs are safe.

This fall's sudden flu shot shortage may be accelerating the process.

The crisis itself underscores the multinational nature of the pharmaceutical industry: On Oct. 5, British regulators pulled the license of a Liverpool factory owned by Chiron Corp. of Emeryville, dooming 48 million doses of influenza vaccine -- half the U.S. supply.

Now, the Bush administration is shopping the world for extra flu vaccine.

Health and Human Services Secretary Tommy Thompson last week said his agency was in final negotiations for 1 million doses from ID Biomedical, in Canada, and 4 million more from GlaxoSmithKline, in Germany.

The FDA must first conduct inspections of the Canadian and German plants, and Americans who receive the foreign drugs will have to sign waivers acknowledging the unorthodox process used to obtain them. If all goes as planned, the 5 million doses will be shipped to the United States by mid- December.

O'Keefe's San Francisco patients are getting their flu shots now. Convinced that the drugs made by Aventis Pasteur in France are no different from those it made in Pennsylvania, he does not intend to make his patients sign any waivers for their French-via-Canada vaccine.

But until Thursday evening, it looked as if they would have had to wait for their flu shots like millions of other anxious Americans.

A jovial, white-bearded doctor with an aversion to red tape, O'Keefe set out to find a Canadian supplier on Oct. 7, just two days after Chiron announced the loss of its vaccine -- the brand O'Keefe had ordered for his practice, which includes patients with HIV, cancer and other chronic diseases.

He found the vaccine he wanted at www.Canadadrugmart.com, a Winnipeg Internet pharmacy that will ship flu vaccine only to doctors' offices.

The 10-dose vials of Vaxigrip were made in Lyon, France, by Aventis Pasteur, the same international medical giant responsible for the other half of the U.S. flu vaccine supply. So the vaccine was problematic on two counts: it was being shipped from Canada and was made in France, at a plant the FDA had never inspected.

For more than a week after O'Keefe placed his order, the vaccine was delayed while the San Francisco doctor shopped for a company willing to ship it. The Canadian pharmacy regularly air freights prescription drugs to the United States but had never sent refrigerated flu shots. On Oct. 20, the pharmacy finally sent off the vaccine -- which was then detained by U.S. Customs at the Federal Express hangar in Memphis.

After eight days of telephone calls -- to the White House, to Tommy Thompson's office and to the press -- the federal officials relented.

"It was held briefly, per standard procedure, because it appeared the product may have been stored, maintained or shipped in a way that could compromise the integrity of the vaccine," said an FDA official who asked to remain anonymous.

The vaccine was finally released with a caution to O'Keefe that "its safety and effectiveness cannot be ensured," he said.

With his flu vaccine now comfortably injected into his arm, Borgwardt says he is grateful for the Canadian drug, but angry it was so difficult to acquire.

"We're not like folks in Washington state or Maine, where border crossing is pretty easy," he said. "I didn't like the runaround."

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