Agencies join forces to stop rogue online pharmacies

Government officials are stepping up efforts to shut down Internet outlets that offer painkillers and other prescription drugs without physician oversight.

By Kathleen Phalen Tomaselli, amednews correspondent. Dec. 22/29, 2003.

A Baltimore internist suspected one of her chronic pain patients -- a 60-year-old woman -- of abusing pain meds. The situation left Dana Simpler, MD, perplexed. She was cautious in prescribing to this patient. Still, the telltale signs were clear, leaving her to wonder where and how the patient was getting the drugs. "We were having trouble understanding how this was happening. She was not going to buy them on a street corner. And we were controlling her prescriptions."

Or so Dr. Simpler thought.

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What she didn't know was that the woman was ordering narcotics and muscle relaxants over the Internet. "She was so sick she ended up in the hospital with a drug overdose," said Dr. Simpler. "We worry about drug dependence with chronic pain patients; at least when we are prescribing we can control it. But when patients are taking your prescription painkillers, Internet painkillers and mixing in some muscle relaxants, it's trouble. It's a very dangerous situation."

Rogue online pharmacies are illegally hawking everything from Viagra to hydrocodone without valid prescriptions or physician oversight. And it is increasingly viewed as both a patient care and public health threat that is drawing government action.

According to the Food and Drug Administration Office of Criminal Investigations, approximately 90 cases are under way in which the FDA, the Drug Enforcement Administration and state, local and foreign governments are joining forces. "We've taken aggressive steps to shut down these sites when they operate in the United States," said FDA Commissioner Mark B. McClellan, MD, PhD, in November to the Drug Information Assn. in Canada. "And we are taking more steps at the border as well."

Still, one must only go to Google, type in "no prescription codeine" and hundreds of sites appear. Fifty-three out of the first 100 offer opiates without a prescription, said Robert Forman, PhD, a researcher at the Treatment Research Institute, University of Pennsylvania, Philadelphia. "When I first tried it, my jaw dropped."

The bottom line: Safety checks on which physicians rely within the prescription drug continuum seem under attack. "The potential for bad outcomes is almost unlimited," said Todd Williams, MD, a family physician and pharmacist in Georgetown, Ohio. "There needs to be some rapid, widespread permanent stoppage to illegal Internet medications."

Government agencies have stepped up efforts toward this goal.

On Dec. 3, following a lengthy investigation by the FBI, FDA OCI and the DEA, a federal grand jury returned a 108-count indictment against 10 individuals and three companies, charging them with illegally selling controlled substances and other prescription drugs over the Internet.

"This case is a dangerous new spin on an old problem," says United States Attorney Paul J. McNulty. "Drug trafficking in cyberspace is just as harmful to public safety as drug trafficking is on street corners. The advent of the Internet does not mean doctors and pharmacists can bypass rules concerning the dispensing of prescription drugs."

Additionally, in October, the DEA, with help from the FDA, suspended registrations for C & H Wholesale, Lifeline Pharmacy and RX Network. (One of the owners was also named in the December indictments.) These Miami-based Internet providers were allegedly distributing schedule III and IV weight-loss drugs and sleep aids without valid prescriptions or doctor contact. Despite several attempts by AMNews, they could not be reached for comment.

"Diet drugs are potentially among the most dangerous drugs and must be used with great care," said Dr. Williams. "Weight-loss medications are speed and could cause stroke, heart attack, high blood pressure."

Meanwhile, in Clanton, Ala., The Norfolk Men's Clinic, an Internet drug distributor, was closed and its operator sentenced to 6½ years in jail, after an investigation involving the FDA, DEA, the Alabama Board of Medical Examiners and the Chilton (Ala.) County Sheriff's Office. Clinic customers ordered drugs via the Internet. Bogus prescriptions were written, and a local doctor rewrote the orders for filling at a Clanton pharmacy. The doctor was acquitted but was sanctioned by the Alabama Board of Medical Examiners, fined $5,000 and suspended for 90 days.

The slipstream

Detection and enforcement is difficult because dealers slip in and out of cyberspace and are increasingly moving out of the country. "There are jurisdictional complications," said Dr. Forman. "The Web site might be in the United States, then the money goes to a second country and the drug is dispensed from a third."

Take Lori Weems, attorney for the Florida Pharmacy Assn. After researching Internet pharmacies, she decided to see how they operate. Online she found the diet drug phentermine. After filling out a health questionnaire -- as a thin, petite person -- and paying with a credit card, she got the drugs 10 days later. Although she didn't request it, a refill followed. Additionally, an online solicitation for Xanax prompted Weems to place an order with a South Florida online company. She never talked to a doctor, but a signed prescription, written from a physician in Curaçao, was in her package of Xanax, which was mailed to her from the Netherlands.

"People are dying," said Weems. "This is very alarming. These sites are not pharmacies ... there needs to be some tracing; who is filling these prescriptions?"

Free samples and confiscation guarantees are also common. Online purveyors offer free samples of hydrocodone. If you like the sample, pay $5 cash and they'll send you 20; then 40; then 60. "I can't believe narcotics are prescribed over the Internet," said Dr. Simpler, who has gotten an e-mail offer for Vicodin. "People are being solicited through the Internet. We have prescriptions because there are risks associated with these drugs."

Benjamin Littenberg, MD, an internist and professor of medicine at the University of Vermont, Burlington, said he can think of two reasons other than addiction why patients might order online: convenience and cost. "If it is cost, that is a side effect of a lack of adequate prescription drug coverage in this country," he said. "If it is convenience, we've done a bad job of making ourselves accessible."

Dr. Littenberg offered these reasons not to order online: It takes the physician and local pharmacist out of the safety loop, and patients don't know what they are getting. "If patients self-prescribe, these are dangerous medications, and side effects can be mildly annoying to rapidly fatal."

In reaction to increasing pressure from the FDA, search engines like Google, Yahoo and MSN have announced they will no longer take ads from unlicensed online pharmacies. And a legitimate online pharmacy, drugstore.com, is pushing its Safe Shopper public awareness campaign to educate the public about these rogue operations.

"Some drugs and diseases don't mix," said Michael Zimring, MD, a Baltimore internist. "When patients start playing around and getting medications on the Internet, they are potentially killing themselves."

ADDITIONAL INFORMATION:

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Information from the U.S. Drug Enforcement Administration on recent actions against three Florida-based illegal online pharmacies (www.usdoj.gov/dea/pubs/states/newsrel/mia102203.html)

Tips and warnings for consumers from the Food and Drug Administration on buying medicines and medical products online (www.fda.gov/oc/buyonline)