Some are completely legitimate. Others send your pills to you in a sandwich bag. The FDA says it has no way to tell the difference, but there are ways that consumers can.

It started with a modest troops of silver-haired bus-trippers, crossing the border into Canada to save 30% or more on Pravachol and Prevacid. Illegal, yes, but who would begrudge Granny's trying to keep her medicines affordable? Now it's escalated into a full-scale war involving people of all ages attempting to save on medicines of all kinds. Seniors' groups, mayors, governors and members of Congress on both sides of the aisle are pressing to legalize what an estimated 1 (one) million Americans are already doing openly--filling millions of prescriptions a year north of the border.

Prescription meds cost far more in the United States than anywhere else in the world because we're the only industrialized nation that doesn't use price controls to hold down costs. Limiting drug prices in this country--directly or by importing price-controlled medications from elsewhere--would deprive the pharmaceutical industry of billions in profits and, drug makers contend, stifle the costly research that spawns groundbreaking new medications.

The Pharmaceutical Research and Manufacturers of America also has long claimed that imported drugs are unsafe, even though many "U.S.-made" drugs are manufactured overseas. Although the Food and Drug Administration (FDA) has mostly ignored U.S. citizens who illegally cross the border with personal supplies of Canadian medications, it has sided with drug makers on the safety issue. "We know there are good drugs and bad drugs in Canada, but we can't tell you which ones are which," says William Hubbard, the FDA's Associate Commissioner for policy and planning. "We don't have the regulatory reach."

Advocates of importation tend to dismiss the FDA's safety concerns: "The agency is doing the bidding of the administration and the bidding of the pharmaceutical industry," says David MacKay, Executive Director of the Canadian International Pharmacy Association (CIPA). Indeed, the FDA has sometimes over-reached on its warnings about the safety of drugs that come from Canada. But as one examines the claims and counter-claims, some of the agency's concerns deserve a closer look.

Legitimate vs. Rogue Web Sites

The drugs you buy at a corner drugstore in the United States are FDA-approved. That means the FDA is satisfied that the drugs work and are safe, and that the agency has approved the drug maker's facilities and periodically inspects the plants, whether they're located here or in another country. Health Canada, the Canadian Federal Regulatory Agency, approves and inspects drug-making facilities much as the FDA does, and provincial pharmacy boards license and regulate pharmacies just as state pharmacy boards do in the United States.

No Canadian pharmacy can truthfully assure you that you're getting FDA-approved drugs, because any drug dispensed outside the United States is beyond the FDA's oversight. But, Canada's regulatory system is considered comparable to ours. When you walk into a Canadian pharmacy, you can be confident you're getting drugs approved by Health Canada. But when you buy over the Internet, it's harder to be sure whom you're doing business with.

Sadly, there seem to be plenty of consumers who will order drugs off any Web site that displays a maple leaf. For about a year, the National Association of Boards of Pharmacy (NABP), an umbrella group for state pharmacy regulators, has collected complaints about drugs mail-ordered from Canada. Typical claims include orders that are paid but never arrive, or that arrive from unexpected locations (including India and Thailand) and pills that are suspected placebos or counterfeits.

Most of the problems involve rogue Web-site operators that, despite the Canadian flag on the home page, have no connection to a licensed Canadian pharmacy. These are the same outfits that are spewing spam into our e-mail boxes to tout "Vi@gra" and "V1codin." Kiplinger's (one source where information for this article came from) visited several of the sites that prompted complaints to the NABP, and most bore the hallmark of a dangerous drug source: the claim that a prescription from your doctor isn't required.

From, or Through, Canada?

But the more difficult question is whether cautious consumers who take the trouble to check that they're buying from a licensed Canadian pharmacy can be sure they're getting Health Canada-approved meds. "If you walk into a Canadian pharmacy, you're going to get medication that is safe," says Carmen Catizone, Executive Director of the NABP. "If you order from the Internet, you have no way of knowing that's going to occur."

Catizone is opposed to importation but says he's in discussion with the National Association of Pharmacy Regulatory Authorities (the NABP's counterpart in Canada) about ways the two groups could ensure safe importation. He worries that drug wholesalers are bringing medications from Third World countries (where regulatory standards are not so tight and counterfeits are common) into Canada and then funneling them to pharmacies expressly for export to the United States.

Canadian trade figures indicate that the concern may be warranted. A Prudential Financial research report last fall revealed that pharmaceutical exports to Canada were up 300% from Bulgaria, 196% from Pakistan, 171% from Argentina, 114% from South Africa, and 101% from Singapore. Although those numbers are not concrete evidence of so-called trans-shipping, it suggests that it may be happening, sayd Diane Duston, the analyst who co-wrote the report.

Although it is illegal for a licensed Canadian pharmacy to export drugs that are not Health Canada-approved, it's not clear whether anyone is monitoring compliance with the law. Health Canada has said that it is the responsibility of the importing country to make sure its imports are safe.

What about the provincial regulators? "If everyone is doing what they're supposed to be doing, the products shipped to the U.S. should be Health Canada-approved," says Ronald Guse. Guse is the Registrar of the Manitoba Pharmaceutical Association, which licenses pharmacies in Manitoba, where roughly half the exporting pharmacies are located. "We haven't had any information to show that products coming from Canada are not Health Canada-approved," Guse told Kiplinger's. "But I can't say all products from Canada are Health Canada-approved."

Drug Makers Fight Back

The pressure to feed the mounting demand in the United States for affordable drugs is especially keen now that several pharmaceutical companies, including AstraZeneca, GlaxoSmith-Kline and Pfizer, are withholding supply to Canadian pharmacies and distributors that deal primarily with the U.S. customers. "We began directly notifying a group of Internet pharmacies last August that they would no longer get Pfizer products," says Pfizer spokesman Jack Cox, who adds that Canadian pharmacies are violating the terms of their contracts when they export Pfizer drugs to the United States. (Popular Pfizer products include Celebrex for arthritis, Lipitor for high cholesterol, Norvasc for high blood pressure and Zoloft for depression.)

The crackdown has created shortages, and pharmacies that export to the United States are scrambling to fill orders. "What we used to locate in 15 minutes of phone calls now takes a few people all day, trying to figure out supply," says Billy Shawn, president of The Canadian Drugstore. Internet pharmacies are still managing to supply their U.S. customers. Some stocked up in anticipation of being shut off, and others are quietly buying drugs from brick-and-mortar pharmacies that primarily cater to Canadians. But the pharmacy-to-pharmacy trade that keeps Internet operations in stock is now threatening to create shortages for Canadians.

Some Internet pharmacies are telling patients to ask their doctors about brand-name generic alternatives to Pfizer products, says MacKay, CIPA's executive director. Others are beginning to steer U.S. customers to sources outside of Canada. Crossborderpharmacy.com, for example, includes a note on its home page inviting customers to "save even more on drugs from the U.K." McKay says CIPA condones such referrals as long as the location of the source pharmacy is disclosed. And so far, at least, U.S. drug makers apparently are not cracking down on British pharmacies that ship to the States.

Pharmacy Flaws

In May, Minnesota became the first state to tap Canada's drug supply for state employees, waiving co-pays for those who fill their prescriptions through a Canadian pharmacy. The state expects to save $1.4 million a year in drug costs. Minnesota Governor Tim Pawlenty has also put up a Web site to steer consumers directly to selected licensed pharmacies, and others have followed suit. In December, two surveyors from the Minnesota Board of Pharmacy visited eight licensed Canadian pharmacies to help select the ones to be included on the Web site. The surveyors' report lists 32 examples of "poor pharmacy practices" they observed on their tour.

Many of the infractions were trivial, such as sending medications with the prescription labels unattached (to avoid covering up the manufacturer's label) and sending containers without child safety caps (which some people don't want or need anyway). But other shortcomings were more troubling:

* At one pharmacy with an automated prescription-filling process, each pharmacist checked 100 to 300 prescriptions per hour. "We have no doubt that safety would be compromised" at that rate, the report concludes.

* In one pharmacy (the only one not aware the surveyors were coming), the ratio of six technicians processing prescriptions to one pharmacist on duty far exceeded provincial standards, which would have allowed just two technicians.

* Only one pharmacy had a thermometer in its refrigerator to check that labeled storage requirements were being met for refrigerated products.

The report concluded that one pharmacy, Total Care Pharmacy, in Calgary, Alberta, "far surpassed the other seven in many aspects of overall pharmacy practice." Three others "may provide acceptable pharmacy services to Minnesota residents with some modifications to their current practices." But four "would not currently provide accdeptable pharmacy services to Minnesota residents." Gov. Pawlenty chose to list two pharmacies on his side: Total Care and Granville Pharmacy, in Vancouver, B.C.

Substitute Drugs

Patients who fill their prescriptions in Canada sometimes get drugs equivalent to, but not exactly the same as, the drugs they would get at a U.S. pharmacy. In some cases, the difference is in name only: the heartburn and acid-reflux drug called Prilosec in the United States, for example, is called Losec in Canada, but both are the brand-name drug produced by AstraZeneca. (Prilosec was a popular export to the United States until it became available over the counter here last year.)

But patients sometimes receive generic equivalents, such as pravastatin for Pravachol and sertraline for Zoloft, that are not available as generics in the United States. Such Canadian generics are Health Canada-approved but do not bear the FDA's stamp of approval. If an FDA-approved generic does exist, however, you can probably buy it cheaper at a local pharmacy than across the border.

Scare Tactics

Although there are clearly reasons to be cautious about ordering drugs online from Canada, the FDA tends to overplay the dangers, which undermines the credibility of its safety warnings. In a three-day "blitz" inspection last year, the FDA intercepted 1,982 packages at mail facilities and courier hubs around the United States. The examinations turned up 1,728 "unapproved" drugs. Unapproved includes all drugs that have been handled outside the FDA's regulatory system, including "foreign versions" of FDA-approved drugs, such as drugs approved by Health Canada in testimony before Congress in March. However, FDA Commissioner Mark McClellan (who now heads the Centers for Medicare and Medicaid Services) emphasized the worst offenses, such as "drugs shipped loose in sandwich bags, tissue paper or envelopes," along with controlled substances, steroids and drugs that have been withdrawn from the U.S. market.

Are those products coming from licensed Canadian pharmacies? "We don't know how much of what we see is from licensed pharmacies," says Hubbard. But packages sent from legitimate Canadian pharmacies are labeled with a pharmacy name and address. If the FDA wanted to differentiate between what was coming from legitimate pharmacies and what was coming from elsewhere, it could. The agency seems content, however, to leave the impression that the risk of ordering meds from a questionable Web site is the same as the risk of ordering from a licensed pharmacy. "I don't know if the risk of getting inferior drugs is 1% or 10% or 90%," Hubbard says, "but it's a risk, and it's not fair that senior citizens have to take it."

Those knowledgeable enough to seek out legitimate Canadian pharmacies see the risk differently. "Everything we do, including getting out of bed in the morning, entails risk," says David Funderburk, legislative counsel for the TREA Senior Citizens League. "Seniors should have the right to assume the minuscule risk of using a drug obtained from Canada, rather than suffer the risk of not havingt the prescription drug to take at all."

The End Game!

The U.S. House of Representatives has already passed legislation to legalize imports for personal use. But even if importation becomes legal, Canada isn't the answer to the larger problem of how to meet the needs of the many Americans who can't afford the drugs that have been prescribed to them. "Canada cannot just be a big drugstore for the U.S., says David Certner, Director of Federal Affairs for AARP. "Canada is still a small country, and it's not that difficult for the drug industry to limit supply."

The real objective, importation advocates in the States say, is to put pressure on pharmaceutical companies to lower prices in the United States. Although the Medicare prescription-drug benefit set to take effect in 2006 will help some seniors, there is little confidence it will solve the problem. "For those who can't afford drugsw here, there is already a health-safety issue," says Certner. "We need to balance the FDA's concerns against the fact that hundreds of thousands, if not millions, right now are going to Canada or purchasing drugs over the Internet."

* * * * *

I am the Senior Issues Host here at Bella. I am also Bowling and Veterans Host here. I am a 50% service-connected Korean, Vietnam veteran. And just as important, I am a Senior and I thank God I do not have to take any drugs manufactured by any of those DRUG GIANTS who are cutting off supplies to Canadian pharmacies. SHAME ON THEM!

Take time from your daily activies, all of you, and say a pray, or two, or three, for the owners and Boards of Directors for those drug manufacturers who have the capability, and possibly the integrity and ability to DO SOMETHING FOR THE SENIORS IN AMERICA, rather than to fill their greedy pockets. Do a little research, and take the time to see what kind of homes these CEOs live in. You can bet your bottom dollar they do not live like you do, and they do not have to count pennies, like you do. They also evidently do not take time to look at the figure they see in the mirror, to COMPREHEND exactly what they are doing to people like you and me, by pocketing profits at the expense of seniors all over the country who could use their support.

If I owned a drug company like Pfizer, you know what I would do? I WOULD NOT cut off supplies to a country like Canada, so that Americans who cannot afford drugs sold in the U.S and manufactured by my company. What I would do would be to go there and to places where MY products are sold, AND to nursing homes, hospitals, and elsewhere, where seniors I am taking advantage of, are FORCED TO EXIST, partially because of prices my drugs cost.

I urge all Seniors reading this to talk to your doctor and check on the generic equivalent for any drug made by these greedy giants. And then go buy them and turn your back on Pfizer and those others. If you all band together and enough of you do it for a long enough time, these giants will realize that even GOLIATH can tumble when the right stones are tossed at them.

Do unto others as you would have them do unto you! Ah, yes, wouldn't it be nice if the CEO of Pfizer and the other drug giants would remember that and adhere to it? But, what they don't know WILL hurt them down the road.

If you buy drugs on the Internet, and I don't blame you, because the savings is worth it, do your research, do your homework, and they can be safe and the final cost will be worth it. And you know what, you WILL FIND that you do not have to take the drugs made by Pfizer and the others because a source I contacted told me there is an ALTERNATIVE to EVERYONE THEY MANUFACTURE, which is safe and will work well enough to provide you relief.

Hang in there, God Bless, remember, God knows where you are at, and so do I.