23 October 2004

The Vaccine Bailout

Canada is the go-to place when the United States finds itself in a medical jam. President George W. Bush said as much during the third presidential debate.

Perhaps the administration is softening the line that our northern neighbors might be a place that originates unsafe drugs.

During the last presidential debate, moderator Bob Schieffer of CBS News noted that the U.S. suddenly had "a severe shortage of flu vaccine. How did that happen?"

Replied Bush: "Bob, we relied upon a company out of England to provide about half of the flu vaccines for the United States citizens, and it turned out that the vaccine they were producing was contaminated. And so we took the right action and didn't allow contaminated medicine into our country.

"We're working with Canada to hopefully -- that they'll produce a -- help us realize the vaccine necessary to make sure our citizens have got flu vaccinations during this upcoming season."

It was a remark not missed by Canadians. "There is massive hypocrisy on the part of the Bush administration," Jillian Claire Cohen, an assistant professor of pharmacy at the University of Toronto, told The Seattle Times this week. "They are very hesitant to allow cheaper, safe drugs from Canada, but when it serves their purposes, all of a sudden they turn to Canada."

While purchasing drugs from Canada is illegal, the U.S. Food and Drug Administration hasn't been going after Americans who do. Some of the 65 million Americans without drug coverage or who can't afford the drugs here have ordered from Canadian pharmacies -- so many that the market for sales to the U.S. has been estimated at more than $1 billion.

In an earlier debate, Bush was asked why he had blocked the importation of drugs from Canada that cost less than American counterparts -- even if from the same manufacturer. "I haven't yet," said Bush, adding, "It may very well be here in December you hear me say I think there's a safe way to do it."

There's a safe way to do it now. Canadian pharmacies and drug companies are regulated as tightly as U.S. companies. Report after report has found Canadian drugs as safe as American drugs.

And that's why Congress passed a law in October 2000 that directed the U.S. Department of Health and Human Services to issue rules allowing the importation of drugs from Canada and certain other countries with approved pharmacies and wholesalers. Congress reaffirmed that position last year in Medicare legislation.

But the administration has hidden behind a clause requiring that imports have "no additional risk" to public health.

U.S. Rep. Gil Gutknecht, RMinn., who sponsored the drugimportation bill in the House that easily passed last year, said he had spoken to officials "at the highest levels of the Bush administration" in an attempt to win support for it. The White House's official position was "strongly opposed" to the bill.

And again this week, the safety of Canadian drugs and those of other industrialized countries was declared safe. Jerry Avorn, drug safety specialist with the Harvard Medical School, said inspections and anti-counterfeiting measures were just as good in those countries as in the United States. Carmen Catizone, president of the National Association of Boards of Pharmacy, a state regulators' group, agreed.

Avorn told Bloomberg News that the "U.S. Food and Drug Administration already does have in place a mechanism for certifying products made overseas and could use this same approach." Overseas inspections would be possible with additional staff and funding, he added.

Jirina Vlk, a Health Canada spokeswoman, told The Associated Press that there shouldn't be any problem with Canada selling flu vaccine to the U.S. "We have similar standards." She added that if U.S. Health and Human Services Secretary Tommy Thompson declared a health emergency, Canadian inspectors could substitute for the FDA inspections.

Any chance of him expanding that to include prescription drugs?

The Ledger

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