ALMOST ANYTHING CAN BE PURCHASED ONLINE. That can be great for consumers in terms of price and convenience, but when it comes to pharmaceuticals, the risk may not be worth the potential for savings. Many online pharmacies operate illegally and sell counterfeit drugs that, at best, lack the active ingredient the consumer seeks. At worst, they can lead to sickness or death from compromised chemicals or worsening of a condition that isn’t being treated. Some of the most counterfeited prescriptions are erectile dysfunction drugs, anti-malarials, cardiovascular drugs, and HIV medications.
The problem is sizeable. A University of California, San Diego study conducted in 2011 found that illegal online pharmacies generate $1 million to $2.5 million monthly.
Governmental organizations and companies are working to address the problem. One such effort was launched September 2011 by the European Alliance for Access to Safe Medicines (EAASM) to raise public awareness about online pharmacies and the risks associated with them. EAASM wanted a way to engage directly with the people propping up the illegal pharmaceutical industry—the customers. The organization also wanted to help consumers change their behavior and “get them back into the legitimate medical model,” according to Jim Thomson, EAASM chair.
EAASM took an unusual approach. Rather than simply discuss the risks, it wanted to illustrate them. EAASM created its own illegitimate online pharmacy: Medizin Direkt. They named the initiative
Counterfeiting the Counterfeiters. Here’s a look at the nature of the problem and how EAASM and others are fighting back.
With the high cost of medications, it’s not hard to understand why people seek bargains. Consumers in the United States cite lower prices as one of the main reasons for buying drugs online, Thomson says. Online pharmacies usually offer deals, especially for customers who buy in bulk. In Western Europe, however, cost isn’t as much of an issue because of nationalized healthcare. People in Europe are trying to avoid getting a diagnosis or having to see a doctor about an embarrassing condition, Thomson says.
Germans have been shown to have a particularly high rate of purchasing prescription-only medicines (POMs) online. A 2010 study from Pfizer found that 38 percent of Germans admitted to purchasing POMs online without a prescription. EAASM estimates that more than 16 million German prescriptions may have been filled with counterfeit medication.
EAASM conducted research to understand the scope and nature of the problem before launching the project. It began in 2008 with a study.
For the study, it weeded out obvious scams and examined 100 seemingly legitimate online pharmacies. EAASM found that 96 percent of the sites were operating illegally, unlicensed by any board of pharmacies, and not bound to any legal or safety regulations. More than 98 percent of the pharmacies had no verifiable pharmacists on staff and only 15 percent actually existed; the rest were nothing more than Internet Web sites. To see the quality of medications consumers would get from these sites, EAASM ordered several POMs from each one. Chemical analysis revealed problems with 62 percent of the medicines, “including medicines used to treat serious conditions,” according to a report of the findings.
“We got rid of the really obvious bad guys, so it was quite surprising that 62 percent of what we bought was fake or substandard,” says Thomson. Of the 38 percent of medicines that were genuine, EAASM reports that 16 percent were imported illegally.
Jeffrey Gren, director of the Office of Health and Consumer Goods at the U.S. Department of Commerce, says counterfeiters are using trace amounts of the medicine’s active ingredient in an effort to fool chemical detectors. Some counterfeits contain different drugs. Both Gren and Thomson spoke on the topic at the 7th Global Anti-Counterfeiting Forum in Washington, D.C., in November 2012.
“Even if it’s an exact duplicate, there are no chemical trials or tests to make sure the drug works [as] it’s supposed to,” Gren said.
Buying from online pharmacies carries risks beyond that of concerns about the medications, however. The rate of malware on these sites is very high, says Thomson. “You’re also risking your identity and risking your credit card details.” Another aspect of the illegal pharmacy industry is the difficulty of taking down rogue sites. A handful of major gangs own tens of thousands of domain names that they can use for illegal pharmacies, Thomson said. Just as quickly as authorities can take them down, operations can be moved to other domains.
A December 2011 World Health Organization survey of its 114 member states found that 66 percent of respondents had no laws regulating online pharmacies. Countries that did have such laws were twice as likely to prohibit online pharmacies as to allow them.
The problem is not country-specific, however. As with any cybercrime, online pharmacy fraud crosses international borders. To fight the problem, various bodies are coordinating their activities internationally. For example, the U.S. Food and Drug Administration, the London Metropolitan Police, the U.S. Department of Homeland Security, the Center for Safe Internet Pharmacies, INTERPOL, and several other international agencies have been working together for several years on what they call Operation Pangea (for 2012, it was Pangea V).
The goal of Pangea, an annual operation, is to track down producers and distributors of illegal medicines and seize the counterfeit material. Authorities specifically target online pharmacies. The 2012 operation culminated in October with the takedown of 18,000 illegal pharmacy Web sites and the seizure of more than $10 million worth of pharmaceuticals. The authorities discovered that some of the online pharmacies commandeered during Operation Pangea V were set up to steal money from buyers without supplying any product at all.
EAASM set up a decoy pharmaceuticals site called Medizin Direkt to target the German online medicine market. One of the goals of the project was to wake consumers up to the possibility that they were going to unwittingly buy fake medicines from an online site. EAASM took this approach because it had learned, through interviews, that people who bought medicines from illegitimate online pharmacies usually overestimated their ability to recognize counterfeits.
“There is absolutely no way to tell the difference. I’ve given fake packs to the security team of one major pharma company, and I asked them if it was real or fake,” Thomson says. “They said it was real, and I had a result from their lab telling me that forensically it was fake, so there’s no way they could tell the difference, but people [felt] they could.”
When it was time for the site to go live, Medizin Direkt was promoted heavily for nine weeks in fall 2011. EAASM purchased thousands of Google AdWords and loaded the site with keywords that would lead to their fake pharmacy. They bought banners on all kinds of Web sites from news to sports to healthcare sites and sent 2.5 million e-mails from purchased lists.
Pharmaceutical companies, including Pfizer and Eli Lilly, allowed EAASM to use their brand names and pictures on the site, as did the major payment card companies. Their logos are on “all the crooked Web sites anyway. So one more that actually wasn’t crooked wasn’t a big leap of faith for them,” Thomson said.
The homepage was designed to look like a typical online pharmacy with features like stock photos of people and medications, Visa and MasterCard logos, a place to “contact a doctor,” and even an icon at the bottom of the page indicating that the pharmacy was “verified.” The page featured medicines for some of the most searched conditions, including HIV, erectile dysfunction, and sleep disorders.
For the nine weeks from September 26 to November 27, the site attracted more than 360,000 visitors; in fact, the site did such a good job of attracting its target audience that 85 percent of people searching for online pharmacies in Germany during that time period ended up at the Medizin Direkt Web site.
Visitors came to the Medizin Direkt site from more than 112 countries.
Teachable moment. Once a potential shopper clicked anywhere on the page, they were directed to a page warning about the dangers of buying medicine online. The page included advice on buying medicine safely online and links to legitimate online pharmacies.
The warning message was viewed about 195,000 times by a total of about 142,000 unique visitors, meaning that many of the visitors had returned to the Web site. Around 19,000 viewed additional advice linked on the warning page and about 14,000 looked over the list of legitimate pharmacies.
If only 7 percent of those who came to the EAASM site had made a purchase, the annual revenue for Medizin Direkt would have been between €12 million ($15 million) and €35 million ($46 million), according to EAASM’s final report. “It is easy to see how a criminal counterfeiting enterprise operating multiple Web sites could make vast sums, with potentially lethal consequences,” the report concludes.
As most consumers won’t have the benefit of a pretend site that redirects them to a warning, the question is: how can consumers guard against being duped?
It’s not easy, Thomson warned attendees at the conference. There aren’t many ways for a customer to verify if an international pharmacy is legitimate.
Counterfeiting tactics vary, so there is no single feature that can distinguish a fake site from a real one, he said. And counterfeiters are attentive to details that can make a site seem legitimate. “Some have even set up fake customer service departments.”
But there are some red flags to watch for and some precautions that anyone seeking pharmaceuticals online can take.
They should look out for strange URLs or redirects, and they should also take note if the pharmacy name doesn’t match the pharmacy’s Web address. “If you’re going to buy medicine online, this is a sure-fire indicator that things are not well,” says Thomson.
Another red flag is if the pharmacy claims that its drugs are from European countries, such as Britain, Germany, or Ireland. That’s a red flag because even in Britain, the drugs don’t come from Britain, Thomson says.
Potential buyers might also want to check the site LegitScripts, mentioned earlier. This is an online registry of legitimate online pharmacies that have been independently verified. LegitScripts is operated by an organization of the same name, which was founded by former Office of National Drug Control Policy staffer John Horton. The company also publishes investigative reports on online pharmacy networks and has a free certification program for pharmacies.
An example report on the site shows that Canadian Health and Care Mall, which claimed to operate out of Canada, was actually a network of 7,000 fake pharmacies run by cells in Eastern Europe. “Web sites in this network often take orders and send nothing at all, or if they do ship a product to the recipient, it is completely substandard or fake product,” says the report.
EAASM says that efforts like Legit- Scripts will have a major impact on helping people buy drugs safely online. Other tips from EAASM include steering clear of sites willing to sell POMs without proof of a prescription, sites offering bulk discounts, or medicines with inconsistent packaging. Patients should contact a local pharmacist if they have questions about a medication they bought online.
At the anticounterfeiting forum, Libby Baney, who is with The Alliance for Safe Online Pharmacies (ASOP), spoke on some of the other efforts being undertaken to combat illegal pharmacies. She also called for increased collaboration among stakeholders.
ASOP is an advocacy-based coalition of stakeholder organizations that runs awareness campaigns for consumers and companies, conducts research, and lobbies lawmakers. ASOP also works with the U.S. FDA on the awareness campaign Be-SafeRx, which was launched shortly after Operation Pangea V.
ASOP recently worked to get H.R. 4095 (The Online Pharmacy Safety Act) introduced in the U.S. House of Representatives in February 2012. The bill would have established a registry of safe online pharmacies (similar to what LegitScripts now does), and it would have required a person to have at least one in-person visit with a doctor to obtain a prescription. The bill never passed.
EAASM would also like to see policymakers develop processes by which online pharmacies are regularly audited or verified and fake pharmacy Web sites are removed. As with any cybercrime, the global nature of the sites and the lack of physicality would make enforcement of any such initiatives difficult. EAASM also says that search engines need to step up and create policies that keep fake Web sites from showing up in search results, perhaps a more achievable goal than audits and shutdowns.
In 2013, EAASM will do another Web site campaign that will target people who shop online with mobile devices. The warning message page will have additional information for buyers on support groups and nationally available resources for getting medicines safely.
Carlton Purvis is an assistant editor at Security Management.