Pharmacy News

FDA lacks proof of Canadian drugs harm

WASHINGTON - Although they've been warning Americans about the dangers of prescription drugs from Canada for nearly a year, U.S. Food and Drug Administration officials can't name a single American who's been injured or killed by drugs bought from licensed Canadian pharmacies.

"We don't have that," said Tom McGinnis, the FDA's director of pharmacy affairs. "I can't think of one thing off the top of my head where somebody died or somebody got put in the hospital because of these medications. I just don't know if there's anything like that."

Neither does Canada.

Health Canada, which regulates Canada's prescription industry, "does not have any information that would indicate that any Americans have become ill or have died as a result of taking prescription medications purchased from Canada," said Jirina Vlk, a spokeswoman for Health Canada.

That doesn't mean there are no such cases, nor does it mean that all drugs from Canada are safe. But the absence of documented harm strongly suggests that medications obtained from licensed Canadian pharmacies are safe, and raises questions about whether the FDA may be overstating the risk of buying less expensive Canadian drugs.

FDA Commissioner Mark McClellan, in a speech last week in Canada before a group of drug information experts, said the agency had found "thousands of examples of unapproved and potentially unsafe medicines" coming into the United States from "many countries, including from Canada."

In a subsequent news conference in Ottawa, McClellan was more specific, according to news reports, saying there were "lots of examples of unsafe drugs coming into the United States from Canada."

A recent report by the Congressional Research Service - the Library of Congress expert that Congress turns to for objective information - supports the safety of drugs from Canada. It found that medications manufactured and distributed in Canada meet or surpass quality control guidelines set by the FDA.

Concern that the FDA may be misleading consumers has hurt its credibility among some Capitol Hill lawmakers, who say the agency is carrying water for the powerful drug industry.

"There's no question in my mind that the (FDA) is too dependent on the pharmaceutical industry for their attitudes and decision-making," said Rep. Dan Burton, R-Ind., who chairs a House subcommittee that's studied the Canadian drug issue. "I had four hearings and I asked (FDA Associate Commissioner William Hubbard) to give me examples where people have been damaged by Canadian pharmaceuticals and re-importation, and he couldn't even give me one, not one."

In response to Burton, Hubbard cited examples of people who got the wrong drugs from Canadian pharmacies. While that's a danger, U.S. pharmacists make similar errors. Hubbard also told Burton that the FDA thinks many people don't report adverse incidents that result from Canadian drugs.

That's because they fear being prosecuted for violating federal laws against foreign drug imports, said Carmen Catizone, the executive director of the National Association of Boards of Pharmacy, a Park Ridge, Ill., group that represents state boards appointed by U.S. and Canadian governors.

In testimony before the Senate Commerce Committee, Catizone said injuries from bad drugs might not surface for years, and then might not be linked to Canadian drugs.

McGinnis said FDA warnings about bad drugs from Canada were valid and reflected the "buyer beware" caution that's justified when people buy drugs via the Internet. "A lot of Internet pharmacies that claim to be Canadian aren't even based in Canada," McGinnis said.

PharmacyChecker.com, a for-profit online service that advises consumers on Internet pharmacies and drug prices, recently studied 20 Canadian Internet pharmacies and found only six that met its standards for safety. Among the factors considered were affiliation with an actual bricks-and-mortar pharmacy, the ability of customers to reach the outlet by phone and safeguards to protect credit card numbers and medical information.

With U.S. spending on Canadian drugs expected to hit $1.4 billion this year, the FDA has warned consumers against counterfeit, tainted or mislabeled drugs from Canada. This reflects the fact that neither government takes responsibility for the safety of cross-border drug purchases.

"Looks can be deceiving," one FDA announcement read. "The medicine you buy across the borders may be unsafe or ineffective. Don't risk your health."

However, in only two publicized cases have U.S. buyers been injured after taking Canadian drugs. In each case, the drugs weren't the problem. The problem was that the Canadian pharmacist made a mistake in filling the prescription.

Studies indicate that such errors also occur in about 3 percent of the 3 billion-plus retail prescriptions filled annually in the United States, said Mike Cohen, a pharmacist and president of the Huntingdon, Pa.-based Institute of Safe Medication Practices, a nonprofit group that's working to reduce medical errors.

In one case, according to Catizone's Senate testimony, an Illinois woman who ordered an asthma inhaler for her child got the wrong drug. Contacted later, Catizone said he could provide no further details of the case.

In the second case, a Canadian pharmacy mistakenly sent Jan Baross of Portland, Ore., hypertension medication instead of the breast cancer drug Tamoxifen. Baross purchased her drugs through Medicine Shoppe Canada, a storefront in Alberta that forwarded her prescription to the Canadian pharmacy that filled the order.

The incorrect medication caused coughing spells so violent that Baross dislocated a rib, according to her attorney, R. Dale Dixon. In September, she reached an out-of-court cash settlement with the pharmacy. No wrongdoing was admitted, Dixon said.

The suit was complicated, he continued, by a small detail: Baross had signed the liability waiver required by some companies that forward prescriptions to Canadian pharmacies. Catizone noted that there's no liability waiver when people buy drugs from U.S. druggists.