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Online Drug Sales: Promise or Peril?

Some Drug Sites Offer Easy Prescriptions and Lower Costs, But Rogue Sites Could Threaten Consumer Safety

By Stacy Lu

C.T., a 65-year-old retiree, knew he was taking a risk when he used an Internet pharmacy based in Canada to get expensive medicine for glaucoma and high cholesterol after an interstate move left him uncertain about his health coverage.

But to him, savings from the purchase, from a site called Canadameds.com, were worth the gamble — he paid $173.05 with shipping, about half the retail price in the U.S. Even though the site verified the prescription with his doctor, C.T., as he prefers to be known, still wondered whether the deal was too good to be true. “You have to be careful,” he said. “You don’t know exactly what you’re getting. I guess what I probably should do is take the medication I got and show it to my doctor.”

More and more Americans are sacrificing a degree of certainty about their prescription purchases to take advantage of low prices online, where rogue sites compete with legitimate online pharmacies like Drugstore.com. Medco Health, the Web’s largest online pharmacy, racked up more than $1.4 billion in online sales in 2002.

In late July, Congress voted to allow Americans to import FDA-approved prescription drugs from Canada and much of Europe, a move that will probably increase Web sales exponentially if it becomes law. Americans purchased approximately $350-650 million worth of drugs from Canada over a 12-month period in 2002-2003, according to IMS Consulting, which provides research on the pharmaceutical industry.

But, after all, this is the Web. While online drug vendors may be changing the nature of the pharmaceutical industry — much in the way the medium has changed the travel industry — it’s not always safe to buy drugs in cyberspace. Many sites sell prescription drugs after a virtual “doctor’s consultation,” which means little more than filling out an online medical history form. Buyers risk a misdiagnosis, a dangerous interaction with drugs they may already be taking, and a potential loss of privacy, experts say.

For example, the U.S. Food and Drug Administration (FDA) has issued several warnings about potentially deadly drug interactions with Viagra, the popular drug for impotence. These warnings, however, are hardly prominent in the hundreds, perhaps thousands, of spam messages and sites selling the drug.

Further, buying medicines safely from online pharmacies overseas can be as tough as learning a new language. Web sites outside the U.S. may make false promises about a vitamin or herb classified as a dietary supplement at home, where ingredients must be labeled and manufacturers cannot legally claim efficacy for treating a specific disease. Some drugs requiring a prescription in the U.S. — those with codeine, for instance — can be purchased from overseas pharmacies or Web sites without one. Appearance, dosages and even product names can differ from country to country. And online drugs may come cheap but often with no guarantee the product is genuine.

And, unfortunately, those consumers most likely to take a gamble online are also the most vulnerable: the elderly, the ill, and those who can’t afford insurance. Research by the Centers for Medicare and Medicaid Services showed total spending on prescription drugs in the U.S. is expected to rise about 10 percent per year through 2012, much of it likely coming from the aging population, and an increasing percentage of that likely being spent online.

Those suffering from modern-day angst also are at risk. Case in point: The rush to buy the antibiotic ciprofloxacin (Cipro) after the anthrax scare following terrorist attacks on the U.S. in 2001. A study published in October 2002 by the American Journal of Medicine found 59 Web sites trying to sell Cipro the month after the October 4, 2001, outbreak. Twenty-three Cipro-selling sites sprung up in two weeks, none requiring a prescription. Widely available over-the-counter in many Third World countries, the drug is, indeed, a powerful antibiotic, but with side effects and potential interactions. Pills made outside stringent FDA guidelines sometimes are not as potent, possibly years old and past their prime, or even unsanitary.

“This speaks to the ability of the entrepreneurs to act incredibly quickly and to exploit public fear,” said Dr. Peter Lurie, co-author of the study and deputy director of Public Citizen’s Health Research Group, a nonprofit consumer advocacy organization.

Further, few consumers actually know or understand the laws involved in buying prescription drugs online, and those on the books seem rarely to be enforced. Some drug industry insiders and consumer groups say the FDA is avoiding what has become a politically tricky issue.

Dean Boyd, spokesman for U.S. Immigration and Customs Enforcement, said the scope of the problem is almost impossible to estimate and even more complex to solve. “Our seizures of illegally imported prescription drugs have been skyrocketing in recent years,” he said. “It’s difficult because…we need the cooperation of a host government. We can’t go in and close down [foreign-based] Web sites,” Boyd said.

Foreign Drugs Made Easy

There’s no arguing the Web offers a powerful lure — a direct line to unapproved, hard-to-find and often cheaper drug substances. Importing prescription drugs by mail is technically illegal, although officials almost always look the other way. Consumers may legally import a prescription if the product is not an FDA “scheduled substance” — a habit-forming or narcotic drug — and if it meets a bevy of criteria. Consumers are permitted to import a three-months’ dose for personal use if the product is for a serious condition and is unavailable in the U.S., isn’t considered a health risk, and is being taken under a physician’s supervision. The loopholes weren’t intended for importing cheaper foreign versions. (For a full list of criteria, click here, and see “Guidance on Personal Use.”)

Prescription drugs from Canada, a popular option for years for border-crossing Americans, are a hot item on the Internet because they’re considered safe and are generally cheap. In Canada, a government agency regulates drug quality and prices. And the U.S. dollar is strong north of the border, where some medications, such as cancer drugs, are subsidized.

Jeremy Cockerill, president and pharmacy manager at UniversalDrugstore.com of Winnipeg, estimates the company has nearly 100,000 American customers since launching on May 1 of last year. Among the site’s most popular drugs are Lipitor, to lower cholesterol; Celebrex, for arthritis pain relief; and tamoxifen, for breast cancer.

Savings can be substantial. On the U.S.-based Drugstore.com, Nolvadex, the namebrand of tamoxifen, costs $640.98 for 180 20mg tablets. At UniversalDrugstore.com, the price is US$80.36 — a difference of approximately $3.11 a pill. Even generic tamoxifen is cheaper by 61 cents per pill.

“This industry is going to be around until they do something about the prices down there [in the U.S.],” Cockerill said.

Some groups in the U.S. medical community don’t object to consumers buying drugs from Canada. For example, United Health Alliance (UHA), a local consortium of health providers in Bennington, Vt., started a Web service called MedicineAssist three years ago to help local patients, particularly the elderly, afford their treatment plans — using Canadian online pharmacies. The first 145 people to use the service saved an estimated combined total of $59,000, said Elizabeth Wennar, president and CEO of the Alliance.

Some find the easier availability of non-FDA-approved drugs on the Web critical. Vigabatrin, under the brand name Sabril, is used to treat infantile spasms. While available in many other countries, Sabril has been linked to visual field defects and hasn’t been approved by the FDA. But to many consumers — particularly parents of children with tuberous sclerosis complex, a genetic condition that can cause seizures — it’s worth the risk. There are some medications available in the U.S. to treat the affliction, but families have had mixed success, said Linda Creighton, program manager of outreach and advocacy for the Tuberous Sclerosis Alliance.

Families want the riskier Sabril. Families tell Creighton, “‘If I have my choice of my child’s infantile spasms stopping or him losing his peripheral vision, I’ll take the vision loss,'” she said.

Some Crackdowns on Bogus Claims, Treatments

Though much of the Web remains something of a frontier when it comes to online shopping, government agencies have made some high-profile crackdowns in the online drug market. In 1999, the U.S. Federal Trade Commission, the FDA, and Health Canada (Canada’s federal drug oversight agency) started an effort called “Operation Cure.All” to address some bogus Internet health claims. A recent action charged two companies with making bogus medical claims for a dietary supplement “Seasilver,” among them that it could cure 650 different health problems, including cancer, AIDS, diabetes and obesity. Numerous Web sites still sell the product, though without the false claims.

Operation Cure.All last year participated in a “health claims surf” along with an international network of consumer-protection law-enforcement agencies to track down sites potentially committing fraud. The FTC identified more than 280 sites making questionable claims for health-related products or services.

Online chat rooms, boards and auction sites are other sources of drugs and supplements. Lisa Suchart, of Houston, Texas, bought fertility drugs from an Italian drugstore for in vitro fertilization (IVF) treatment after reading about the store on an infertility bulletin board at Babycenter.com. She estimates she saved about $2,300, and her doctor checked the drugs for authenticity.

“Any little bit helps when you’re going out of pocket. IVF is a long sad road, and a lot of people cannot afford to do it,” she said. “I needed a little bit more [medications] and I bought them from someone over the bulletin board.” The IVF procedure didn’t work, but Suchart did eventually get pregnant using a different method.

There may soon be better ways to tell who’s doing an honest business. For example, the United Health Alliance is working with other healthcare groups on an accreditation process for mail-order pharmacies. The National Association of Boards of Pharmacy, which helps state regulatory boards develop and maintain standards, has a Web pharmacy verification program that stipulates proper licensing and procedures, as does its Canadian equivalent, the National Association of Pharmacy Regulatory Authorities.

Certainties are few at the moment, but online drug sales will surely continue to grow.

“You can’t hold people hostage in this country,” UHA’s Wennar said. “There is a question about what’s legal, and what’s right to do.”