If it could happen to him, Rick Roberts says it could happen to anyone.
Roberts, who received counterfeit drugs from his local pharmacy in San Francisco several years ago, spoke to a group of local professionals at the Crowne Plaza hotel in Warwick on Sept. 9 in a seminar that tackled one side of the debate about prescription drug importation.
Roberts was infected with HIV in the early 1980s and was diagnosed with AIDS Wasting Syndrome in 2000. After a couple of different therapies failed, Roberts received a prescription for Serostim, a recombinant human growth hormone that needed to be injected daily. The cost for the drug was between $4,000 to $6,000 a month and he told the audience that he was lucky enough to have his insurance company approve a 12-month supply.
Several months into the treatment, he noticed a stinging at the injection sites, but it was several weeks before he questioned his pharmacist and was told to go home and check the drug’s packaging, because he might have received “some of the fake stuff.”
Roberts went online and found the U.S. Food and Drug Administration was in the middle of an investigation and warnings about counterfeit packages of Serostim were posted on both the FDA’s and the manufacturer’s Web sites. Months later, Roberts finally learned he had been injecting two different batches of counterfeits – one containing a fertility drug and another contained Serostim, but at one-sixth the prescription dosage.
The issue of buying prescription drugs from Canada in particular has gained prominence in Rhode Island over the summer, as the General Assembly approved controversial legislation allowing for cross-border drug importation from the north. Business advocates within the state and pharmaceutical giants like Pfizer and Amgen have spoken out against the practice, which they say not only hurts their ability to compete in the marketplace, but also comes with inherent safety risks.
“The safety issue I don’t think is secondary or a smoke screen or a red herring,” said Roberts. “It’s a real issue.”
The event was hosted by the Greater Providence Chamber of Commerce, the Rhode Island Pharmacists Association and the Rhode Island Technology Council in an effort to inform members of some of the problems associated with drug importation. The morning’s other featured speaker was Kristina Lybecker, a professor of economics from Drexel University in Philadelphia, who has been studying the issue of counterfeit drugs before it became a hot-button issue in the United States. Lybecker began her research studying the effects of drug trafficking in Third World countries.
Lybecker said there are many motivating forces behind parallel importation schemes. U.S. prices are 67 percent higher on average than Canada according to 2002 figures, chiefly because the Canadian government negotiates the prices for the entire country. Senior citizen groups in particular have turned to Canada, where the pedigree of drugs is assumed to be safe.
But besides a threat to innovation (not allowing companies to recoup their development costs for a new drug), Lybecker said there’s a threat to safety due to an unreliable supply and counterfeiting. She said dealers in prescription drugs know they can realize huge profit margins in the trade, while dealing with a cast of characters that is more savory than what they may find in the illegal drug market.
Lybecker said there are questions about where Canada’s pharmaceutical imports arrive from. From 2002 to 2003, the country increased its shipments from Iran from $49,000 to $1.41 million. During the same period, imports from Ecuador and Argentina nearly quadrupled, to $2.2 million and $720,000, respectively. Though not huge figures, Lybecker said it’s a noticeable bump. With so much cross-border cargo, she said it’s hard to follow the pedigree of prescription drugs, especially because Canadian standards are much different than those of the U.S. FDA.
While Lybecker said U.S. customers are essentially subsidizing pharmaceutical companies’ entry into foreign markets, she maintained that is the cost of innovation. In 2000, 60 percent of all pharmaceutical spending on research and development was spent in the United States (the United Kingdom was a distant second with 12 percent).
Lybecker also noted U.S. consumers are typically required to waive all their legal rights when purchasing drugs over the Internet from Canada with the click of a button and Canadian laws set maximums for liability settlements.
“Cross-border importation is not a solution to the problem,” Lybecker said. “Pharmacies, health care providers need to better reach out to certain populations in the near-term, but in the long run, the country needs to find a more permanent and safer solution than looking to Canada.”
Over the past three years, Roberts has testified at a number of criminal hearings and before federal regulatory boards about his experience with counterfeit medication. He said as far back as he can trace, the drugs were distributed through the secondary market, through a licensed wholesaler in Florida, then sold it to a licensed wholesaler in Las Vegas, who sold them to a secondary licensed distributor in New York. Once the lot was moved through an authorized dealer, the pedigree doesn’t have to be included in the next sale. The drugs were then sold to distributors who had contracts with the major pharmacies and got the fake product into seven states.
For his part, Roberts said he’s now well-known at his local pharmacy. He usually goes to a 24-hour store after midnight, so he can inspect all of his medication’s packaging at the counter and asks any questions he has of the pharmacist immediately.
“People have to be careful to really look at the product they’re getting – examine the package, the way the tablets break apart,” Roberts said. “The FDA is running as fast as they can, but the bad guys are always one step ahead.”
