WASHINGTON, June 6 (UPI) -- U.S. pharmacy boards have begun certifying online drugstores, but they have refused to certify Canadian Web sites that ship drugs into the country, leaving American seniors who use the sites with no way of knowing if they are purchasing legitimate or safe products.
The debate over this issue likely will heat up in the coming weeks as Congress begins to grapple with providing a drug benefit to seniors through Medicare, which could result in lower costs for the elderly and spare them from having to turn to Canada, where pharmaceuticals often cost 40 percent to 50 percent less than in the United States.
An increasing number of seniors have begun crossing the border to buy pharmaceuticals, and those who live away from the border states have begun utilizing Web sites that claim to be located in Canada and that offer to ship the products directly to U.S. addresses. Canadian Web sites rake in $1 billion per year from drugs sold to the United States, according to some estimates.
However, the unregulated nature of the Internet means consumers cannot know with whom they really are interacting and the consequences of such ignorance can be serious.
The Illinois-based National Association of Boards of Pharmacy said it is aware of at least one case in which a woman got the wrong drug after using an online Canadian pharmacy.
The case involved a "woman who was suffering from breast cancer in Oregon who received the wrong medications for three months," Carmen Catizone, executive director of NABP, told United Press International.
The woman is working with the board of pharmacy in British Columbia to seek restitution, but she might have no legal recourse, Catizone said. This is because many of these Web sites require users to sign a statement waiving their legal rights against the company.
"There's nothing to protect consumers," Catizone said.
The NATB recently launched a certification program for online pharmacies to assure consumers the sites are legitimate and trusted sources of medications. NABP has licensed this program to their Canadian counterpart, the National Association of Pharmacy Regulatory Authorities, in Ottawa, which recently began the certification process for Canadian Web sites.
Unfortunately, "no pharmacy that ships pharmaceuticals from Canada to the U.S. would qualify because in doing so they're breaking the law," Catizone said.
"(Thus) consumers couldn't be ensured that any online pharmacy (offering Canadian drugs to U.S. citizens) is a legitimate source," he added.
The practice is technically illegal, but the Food and Drug Administration has turned a blind eye to it and has taken little action to prevent Canadian online pharmacies from shipping medications into the United States. FDA also has not done much to prevent Americans from crossing the border and returning with medications.
The Canadian National Association of Pharmacy Regulatory Authorities declined to comment on this story.
The pharmaceutical industry has used cases such as the Oregon woman's to highlight the dangers of Americans both crossing the border and using the Internet to obtain cheaper drugs from Canada. Consumer groups and congressmen, however, have accused the industry of being more worried about losing profits than about the safety of patients.
"Reimportation is like playing Russian roulette with the lives of principally elderly patients," said Jeff Trewhitt, spokesman for the Pharmaceutical Research and Manufacturers of America, a trade group representing major drug manufacturers.
There is no assurance the drugs have been stored or shipped under the right conditions, which is "potentially a problem," Trewhitt said, and added an online pharmacy might not even be located in Canada.
Others are not so sure the issue presents a major risk.
The pharmaceutical industry's argument about the dangers of Canadian pharmaceuticals "is false," said Dave Lemmon, spokesman for Sen. Debbie Stabenow, D-Mich., who co-sponsored legislation approved by the Senate last year allowing for the importation of drugs from Canada.
"It's a preposterous claim and one they try to perpetuate to scare people," he added.
The industry sells the same drugs in Canada, "so either they're selling unsafe drugs to Canadian consumers" or the drugs are safe, Lemmon said. "They can't have it both ways."
Canada's regulatory system is similar to the America's in its requirements for quality assurance. So, there is likely to be little, if any, difference in the products, according to a study conducted by the Congressional Research Service.
"There's no difference in how the drugs are being shipped or stored," Lemmon said.
Larry Sasich, a pharmacist and research analyst with Public Citizen's Health Research Group, noted Canada's licensing requirements for pharmacists "are very, very similar to" U.S. requirements.
"There's a possibility for problems with the drugs" because the consumer has no way of knowing if they're getting the products from a legitimate source, Sasich conceded. He said, however, the pharmaceutical industry's main interest is maintaining exorbitant prices for drugs sold in the United States, which are among the highest in the world.
The industry is "operating for the interests of their member companies because they have the goose that laid the golden egg down here (in the United States) because they've been able to charge here whatever they want to charge," he said. "So every prescription filled in Canada is money off the bottom line of the product sold in the U.S., so there's certainly a little bit of conflict there."
Lemmon added: "All of the U.S.-based pharmaceutical companies already do importation from Canada. Almost all of them have facilities in Canada where medicines are produced and then they are reimported into this country for sale in the U.S."
Trewhitt said no companies were doing this.
"One of (the industry's) biggest fears is they don't want the 43 million Medicare participants pooling together and negotiating price controls," Lemmon said.
There is a law already on the books that allows drugs from Canada or elsewhere to be reimported back into the United States, but it never has been implemented. This is because the law requires the Secretary of Health and Human Services to vouch for the safety of the imported drugs and, so far, the current secretary, Tommy Thompson, and the former secretary, Donna Shalala, have refused to take on that responsibility.
Thompson said in 2001 one of the reasons he opposed reimportation was it would increase the likelihood of counterfeit drugs entering the United States.
This is something about which the pharmaceutical industry has expressed concern, as well, and this particularly applies to Internet sites, Trewhitt said.
"You don't know whether or not (the drug being offered by the Web site) is really the medicine that's being claimed," he said. "If it's not really a medication that's being regulated by Canadian authorities ... it could be counterfeit," meaning it may contain toxic materials or be ineffective.
All the parties agree the solution to this lies in providing drug coverage for seniors, even if they disagree on the details.
U.S. drug prices appear to be exorbitantly high, but the pharmaceutical industry maintains this is only because "the price in Canada is artificially low," Trewhitt said.
"They have arbitrary government price controls that don't take into account the high cost of research and development," he added.
The only way to get lower drug costs for seniors, then, is for Congress to pass a law stipulating pharmaceutical coverage for the elderly, Trewhitt said.
The Bush administration, Republicans in the U.S. Senate, and industry all favor a plan allowing market competition and allowing seniors to join a preferred provider organization under Medicare to obtain the drug benefit.
In legislation crafted by the Senate Finance Committee this week, an equal drug benefit also would be provided under traditional fee-for-service Medicare, a deviation from the Bush plan, which would give higher drug benefits to those joining PPOs. Negotiations are underway so the bill can hit the Senate floor later this month.
Sasich said this "would not do consumers any good at all" because it does not guarantee coverage or that seniors would wind up with lower drug costs, he said.
"Until someone invents a drug that can grow a spine for the Congress of the U.S." and they pass a meaningful drug benefit program for seniors, it will leave the elderly with no choice but to go to Canada for their drugs, Sasich said.
That leaves seniors with no assurance they are getting safe drugs.
"It's really unfortunate the way we treat senior citizens in this country when other countries much smaller than us do a much better job of ensuring something that we all agree is important to these people's lives," Sasich said.
