Health

THE GREAT DRUG DEBATE

Canadian meds have become a political hot potato in the States. Who says they’re unsafe?

DANYLO HAWALESHKA November 1 2004
Health

THE GREAT DRUG DEBATE

Canadian meds have become a political hot potato in the States. Who says they’re unsafe?

DANYLO HAWALESHKA November 1 2004

THE GREAT DRUG DEBATE

Canadian meds have become a political hot potato in the States. Who says they’re unsafe?

Health

DANYLO HAWALESHKA

AS WITH ALL GOOD ADS, there is no confusing the message. “Recently the FDA ordered three medicines from ‘Canada,’ ” reads the large type at the top. “When they arrived one thing was clear. They weren’t from Canada.” Paid for by pharmaceutical giant GlaxoSmithKline, the ad takes a clever shot at Canadian online pharmacies. It’s been running since the summer in U.S. newspapers and magazines and is based on what happened when the U.S. Food and Drug Administration replied to spam from a website offering prescription savings from north of the border. The drugs arrived postmarked Dallas, with a return address in Miami. The company involved at first told the U.S. Food and Drug Administration it was based in the U.S., then later, Belize. The website turned out to be on a server in China, and the credit card payment went to St. Kitts in the West Indies. “Where did all these medicines really come from? And what exactly is in them?” the ad asks ominously. “Getting medicines from ‘Canada’ isn’t the answer. But it does raise a lot of questions.”

Therein lies the strategy of the big pharmaceutical companies, the FDA and the Bush administration. Question the safety of importing Canadian prescription drugs, and question it often—and protect a U.S. market worth a whopping US$200 billion a year, even from their own increasingly irate citizens.

In 2004, Canadian online exporters are expected to take a US$ 1.2-billion slice of that market. And while that’s less than one per cent, cheaper Canadian medicines have

turned into a giant headache for manufacturers, and a political hot potato in the U.S. presidential campaign. President George W. Bush says ordering drugs online is dangerous. Canadian drugs aren’t FDA-approved, so they could be unsafe, goes the refrain. But Democratic presidential candidate John Kerry wants drug imports to actually increase, and he has Bush waffling and Canadians worried about their own supply.

Paradoxically, drugs sold in Canada and the U.S. generally come from the same companies and their quality-controlled plants around the globe. Same drugs, only cheaper, so ordinary Americans, fed up with paying the highest drug prices in the world, have been hopping buses and trains to head north on organized shopping excursions, returning with 90-day supplies. While it’s illegal under U.S. law for patients to import medicine, the FDA has routinely turned a blind eye to the road trips. From there it

was just a hop, skip and click of the mouse to online sales.

But are they safe? In August, Lester Crawford, the FDA’s acting commissioner, went so far as to raise the spectre of drug-tampering terrorists trying to harm Americans through Internet sales. William Hubbard, the FDA’s associate commissioner for policy and planning, says drugs from Canada “are unapproved and therefore illegal, and more importantly, they could be unsafe.” Don Sancton, director of corporate affairs at Pfizer Canada Inc. in Montreal, also plays

ONLINE sales to

the States by Canada’s Internet pharmacies are expected to reach US$1.2 billion a year

Seniors in New York display their haul after a shopping spree in Toronto

the safety card. “It’s an open invitation,” says Sancton, “for counterfeit or substandard products that could come from anywhere.”

Sancton does have a point—counterfeit Viagra and Lipitor, the cholesterol drug, have popped up all over the world. But when it comes to legitimate Canadian drugs shipped to the U.S., the problem is not safety but greed, says Dr. Peter Rost, a vice-president at Pfizer’s head office in New Jersey. In September, Rost broke ranks with Pfizer, the world’s largest drug producer. Speaking, he said, as an ordinary citizen, he pointed out that European countries have sold pharmaceuticals among themselves safely for decades and there should be nothing to stop two sophisticated neighbours like Canada and the U.S. from doing the same. Staunching the flow of cheaper brand name drugs from Canada—where they can cost up to 80 per cent less than in the U.S. because of federal

regulations here and the weaker Canadian currency—is good only for short-term profits, argues Rost. Long term, he says, the companies risk alienating millions of customers. “It’s like peeing in your pants,” says Rost. “It’s warm and nice for a while, but then it gets real cold.”

The last thing U.S. drug makers want are prices set by the government, as in Canada. Hence a concerted effort to discredit the Canadian industry, argues David MacKay, executive director of the Canadian International Pharmacy Association (CIPA), which represents about 35 of the country’s roughly 120 mail-order operations (the biggest are centred in Winnipeg, Vancouver and Calgary). The GlaxoSmithKline ad, says MacKay, tars Canadian exporters and overlooks the industry’s safety standards and clean record. “The last time I checked,” says MacKay, “Belize wasn’t a province in Canada.”

The manufacturers argue high prices fund the research and development for new drugs or, as the GlaxoSmithKline ad declares, “Today’s medicines finance tomorrow’s miracles.” That may be so. But it’s also true that drug companies spend more on marketing than on R & D, and the majority of new drugs aren’t really new but “me-too” knock-offs— similar to ones that are already popular.

Recently, Bush started making noises— albeit faint ones—about allowing drug imports from Canada. During his second debate with Kerry, he said he hadn’t ruled out the possibility. But it’s worth noting that, during the 2000 presidential campaign, Bush said facilitating imports seemed a good idea. Since then, his government has opposed imports with every administrative fibre in its body. Last year, the House of Representatives voted in favour of imports from Canada and Europe, but Republican majority leader Bill Frist stalled the initiative in the Senate.

Another odd thing about this drug fight is that the White House’s reticence comes as at least two dozen states and a handful of large cities are looking at formal ways to import Canadian medicines, to reduce the cost of their drug benefit programs. Five already have laws in place to facilitate imports. Kerry, meanwhile, is making political hay out of Bush’s sudden willingness to import flu vaccine from Canada to compensate for an unexpected shortage in the States. “That sure sounds strange coming from a president who banned importing safe drugs from Canada,” says Kerry, who now even has a television ad ridiculing Bush’s so-called flipflop on vaccines.

If elected, Kerry is promising to direct the FDA to certify the safety of Canadian pharmaceuticals. He would then allow individuals, pharmacists or wholesalers to import whatever is available. Last week, however, a coalition representing 14 organizations in Canada—including the Canadian Pharmacists Association, the Arthritis Society and

CARP, a lobby group for those over 50— called for a halt to exports, fearing shortages and price hikes in Canada. Federal Health Minister Ujjal Dosanjh responded by saying the Canadian drug supply is secure.

At the same time, however, Health Canada has been rattling CIPA’s cage. Federal officials, says MacKay, have threatened to come down on the exporters at the first sign of problems in Canada. “We’re not going to do this on the backs of Canadians,” says MacKay. “Our industry would be over at that point.” CIPA members, who are responsible for about 80 per cent of drug exports to the U.S.—almost all through individual prescriptions—have steered clear of bulk-export contracts with U.S. cities or states. But other online exporters are sniffing at the opportunity. Opening the market further to U.S. states, or even the Costeos and Wal-Marts of the world, adds MacKay, would be ruinous for exporters because Canada simply doesn’t have enough drugs to supply that kind of surge in U.S. demand.

As things stand, CIPA members play a kind of cat-and-mouse game to gather up their own supplies. Blacklisted by the drug companies that don’t want to undercut themselves, exporters buy excess medicines from other local pharmacies or partner with a British pharmacy that then fills the order and ships it directly to the customer. The FDA’s been sending cautioning letters to the states and cities that want to import in large numbers. And it’s been doing spot checks at mail-sorting stations. But as there are millions of pieces of mail with individual prescriptions flooding in, regulators are largely overwhelmed—thanks to patients like Debra Herschman of Oak Park, Calif., 50 km northwest of Los Angeles.

Herschman, 54, has been disabled and unable to work as a trial lawyer for six years. The single mother of a 13-year-old boy suffers from arthritis and chronic pain, among other ailments. She had Blue Cross insurance, but her monthly premiums shot up from US$415 to US$700 between 1997 and last year. She also had to pay a deductible and an additional fee for each prescription. She couldn’t afford it.

Herschman’s doctor told her about Universaldmgstore.com in Winnipeg. She priced her drugs, then went to her local pharmacist to comparison shop. A three-month supply of Lipitor, Prevacid for chronic heartburn, Zyrtek for allergies, and Zanaflex,

a muscle relaxant, would have cost her US$1,500—almost three times what Universal charges. Herschman told the clerk she was considering buying Canadian. Her reaction, recalls Herschman, was, ‘“Well, it says right here in our manual, that’s illegal.’ ” Herschman’s reply? “Call the police and have them arrest me. Then I won’t have to worry about how much anything costs.” In June, the U.S. General Accounting Office released a report that went a long way toward vindicating Canadian online pharmacies. The investigative branch of Congress, the GAO placed 90 orders for 13 different drugs from 68 websites in the United States, Canada and other countries, including India, Pakistan and Thailand. While all 18 Canadian pharmacies required a prescription, only five of the 29 U.S. outlets did. It was worse in the other countries, where all 21 websites did not require a prescription supplied by the patient. The GAO noted most of the drugs from Canada were unapproved for the U.S. market, but that “the chemical composition of all were comparable to the product we had

KERRY IS making

hay out of Bush’s sudden willingness to import flu vaccine from Canada in light of the U.S. shortage

ordered.” Translation: the drugs were fine.

Provincial regulators license and inspect Canadian online pharmacies, which also follow their own set of safety guidelines. All require a prescription from a U.S. doctor. First-time customers—whether they’re online or phoning in an order—are required to complete a medical questionnaire. A Canadian doctor co-signs all orders. The pharmacies do not ship controlled substances, including amphetamines, benzodiazepines (Valium, for example), or narcotics such as codeine and morphine. CIPA suggests patients look for the provincial pharmacy licence number on each website, and phone the province’s regulator for confirmation.

Still, not everyone’s satisfied with the precautions. Physician colleges, which regulate doctors’ conduct, frown on the practice of co-signing prescriptions without seeing the patient. Colleges in British Columbia, Alberta, Manitoba, Ontario, Quebec and New

Brunswick have either fined doctors or issued warnings, or are conducting disciplinary hearings to discourage the practice.

The drug company blacklist has forced some Canadian suppliers to obtain part of their inventory from European countries and other nations with high regulatory standards. But some may be going farther afield. Last December, in the New England Journal of Medicine, Dr. Abigail Zuger noted there’s been little evidence of patients being harmed by drugs from Canada. Just one case was made public when an Oregon woman sued Edmonton-based Medicine Shoppe Canada, alleging the Canadian pharmacy sent her the wrong drug. The parties settled out of court. However, the risks could increase, Zuger warned, because drug manufacturers have cut supplies to online operations, forcing them to seek out inventory from less developed countries where standards are much iffier.

Prescription brand name medicines for chronic diseases can easily chew through US$2,000 a month. Sometimes that forces patients to take just half their recommended dose, or skip their meds entirely to buy food or pay rent. “There are people’s lives at stake,” says Rost. “If they don’t take drugs, they don’t work—and in the richest country in the world, that’s outrageous.”

At 66, Shirley Andsager collects US$11,000 a year in social security benefits. “If I had to live on that, I couldn’t,” says Andsager, who is divorced and lives alone. To supplement her income, the resident of Hutchinson, Kan., runs a daycare for six children out of her home. She takes Fosamax to combat osteoporosis and Xalatan eyedrops to prevent glaucoma. As with Herschman, Andsager’s doctor recommended Universal Drugstore in Winnipeg. Andsager now saves 37 per cent on one drug and 42 per cent on the other, making a significant impact on her quality of life. “It means I can make a car payment if I have to, or if the TV breaks down, I’ve got some money to fix it,” she says. “I’m able to go out and eat with friends, instead of saying, ‘Oh, I can’t go. I don’t have 10 extra dollars.’ ”

Failing health almost always demands that patients pay some kind of financial cost. In the fight for cheaper drugs, Canadians want supplies protected, and Americans ask only for a fair price. f?l

With Leah Bowness