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Is the Crackdown on Illicit Online Pharmacies Working?

In August 2001, MD Net Guide reported on the then emerging phenomenon of Internet-based, rogue pharmacies that sell prescription drugs to patients without requiring a prescription or via a prescription from a physician who had never met the patient requesting the drug. We noted that there seemed to be few simple solutions to this complex problem. Three years later, we revisit the topic in this article, offering an update on efforts that have been made to curb the practice of selling medications through these illicit pharmacy sites, whether they’ve been successful, and what to expect in the near future.

But while “virtual examinations” are open to falsification, are a poor substitute for an in-person consultation with a physician, and are therefore deemed unacceptable to many healthcare professionals, worse still are sites that require no examination and no background check of any sort. The Canadian site Minto Pharmacies cheerfully advertises on Yahoo and Google its willingness to sell allergy medications without a prescription. The site, like many of its kind, takes advantage of asymmetrical legislation in the US and Canada to sell drugs to the former from the latter. Further complicating the situation and adding to the danger of purchasing drugs through a pharmacy in another country—even a country like Canada that has a formulary of approved drugs very similar to that of the US—is the newly reported fact that it is hard to tell where the drugs you purchase are actually coming from (www.fda.gov/cder/consumerinfo/border.htm). The FDA earlier this year warned that drug manufacturers from countries like India and the Philippines rent warehouses in Canada to store and ship poor quality drugs that Americans often buy through Internet pharmacies. Tom McGinnis, an FDA spokesman, was quoted in a February 5, 2004 report as saying, “Prescription drugs that enter the country through Canada or other foreign countries via the Internet are not regulated or subject to federal safety requirements. The drugs might be expired, improperly handled, unapproved or, even worse, counterfeit.” Also, the drugs may never arrive; if they do, and the patient is injured, there is no recourse to seek restitution. However, not all online pharmacies are dangerous or necessarily unethical.

In 1999, the National Association of Boards of Pharmacy (NABP) developed the Verified Internet Pharmacy Practice Sites (VIPPS) program. VIPPS-certified pharmacies—including online pharmacies—must comply with the licensing and inspections requirements of the state in which they’re located as well as those of each state to which they dispense products. They must also be compliant with patient rights to privacy, authentication, and security of prescription orders, adhere to a recognized quality assurance policy, and provide meaningful consultation between patients and pharmacists. VIPPS pharmacy sites will have the VIPPS hyperlink seal on their site, which links visitors the NABP VIPPS website containing verified, NABP-maintained information about the pharmacy. Patients interested in purchasing their prescriptions online can go to the VIPPS site to access a roster of approved online pharmacies; we encourage physicians to make patients aware of these sites (see the roster on the next page). Efforts to create and enforce regulated, certified pharmacies, coupled with physician and governmental efforts to promote awareness of these sites while alerting consumers of the dangers of non-approved sites, have at least created a viable alternative to illicit online pharmacies for well-meaning patients, but consumers who seek to obtain drugs without a prescription are still going to look for and use these rogue sites. What else is being done to combat the problem?

Consignment Carriers and Credit Card Companies
Congressional and FDA investigators are asking shipping services to identify illicit Internet pharmacy transactions. Susan Rosenberg, a spokeswoman for UPS, said the shipping service “does not accept anything it knows to be illegal” but does not have the resources to check out every company it does business with. “With 13.5 million packages a day, it’s not practical,” she said. Still, as of March 2004, investigators were discussing voluntary actions by FedEx and UPS that could stem the flow of imports and counterfeit products into the US (www.pharmtech.com/ pharmtech/article /articleDetail.jsp?id=87726). In late July, DEA Deputy Administrator Karen P. Tandy stated that “Both FedEx and UPS continue to support DEA investigations with valuable tracking information on origin and destination of shipments.” Legislators have also asked the General Accounting Office to examine the role of major credit card companies in facilitating the sale of drugs through the Internet. Visa said that it would begin requiring online drug merchants who accept Visa to post their permanent address on the site. Attempts to require such disclosure for Internet pharmacies have repeatedly faltered in Congress. UPS told congressional staff that it issues “cease and desist” letters to any Internet pharmacy that does not require prescriptions for drug sales and ships via UPS. The DEA also met in early 2004 with some carriers and credit card companies, including MasterCard International and FedEx. FedEx spokeswoman Kristin Krause said the company also is “moving aggressively” against websites that illegally use its logo. However, tracking Internet drug sales is difficult, because FedEx cannot open every package, said Krause. “They could be moving drugs that are medically needed.”

While the efforts of these companies and organizations to help reduce the trade in shady online pharmaceuticals represent a good start, it may not be realistic to depend solely on the actions of the carriers and credit card companies. Perhaps going to the source is the best option.

Drug Makers
Earlier this year, the House Energy and Commerce Committee, in letters to each company, asked Eli Lilly and Co, GlaxoSmithKline, Johnson & Johnson, Pfizer, and Serono—five of the nation’s top drugmakers and companies whose products have been the target of counterfeiting and diversion—to explain what they have been doing to stop counterfeit drugs from entering the marketplace. “Despite the best efforts of many companies, the counterfeit drug problem is getting worse every day,” said committee spokesperson Ken Johnson. “If we’re going to turn the tide, clearly it will take a greater cooperation between the private sector and the federal government.”

Each of the companies’ spokespersons said they welcomed the request, and those for Serono and Johnson & Johnson said their companies had already added tracking devices to product lines that had been experiencing counterfeiting. The two companies, along with Lilly, said they have also tightened their distribution systems. Pfizer has also followed suit, instituting a similar plan, and GlaxoSmithKline, as of January 15, was pursuing security measures, which included the possibility of tracking its pill bottles electronically.

While the postal carriers, credit card companies, drug makers, and Internet search engines clearly play an important role in hampering the activities of online rogue pharmacies, it will likely take greater government oversight to truly make a dent.

Government Actions
The FDA and the DEA are the two biggest players on the federal level with a role in the fight against rogue online pharmacies, but they aren’t going it alone. Although both are able to help eliminate access to foreign-based sites, their contributions are mostly at the national level.

International
The sale of drugs to US residents via foreign websites is an extremely challenging area. Although the DEA and the FDA have made some headway in closing down illegal online pharmacies, jurisdictional issues exist when it comes to sellers based in other countries. Thailand, for example, is an increasingly popular haven for these sites. This problem is apparent in the story of a reporter from a Connecticut news station who ordered a drug said to be similar to Vicodin from a Thai site for $100. He received a bag of 50 tablets and asked a pharmacist from the Yale New Haven Hospital to test the medication. Although it was a potent painkiller, it showed no resemblance to Vicodin and could have caused very dangerous side effects to a user. While it would certainly seem reasonable to prosecute the site supplying the drug, “there are jurisdictional complications,” says Robert Forman, PhD, a treatment researcher at the University of Pennsylvania. “The website might be in the US, then the money goes to a second country, and the drug is dispensed from a third.”

Further hindering the problem is the fact that the very architecture of the Internet itself can hide the source of the product and provide some anonymity to companies selling and shipping the product. All parties involved in the transaction can be dispersed around the globe with no need to ever meet in person. Thus, the regulatory and enforcement issues cross state, federal, and international jurisdictional lines. Although the FDA may technically have jurisdiction over someone in a foreign country who sells a drug in violation of the Food, Drug, and Cosmetic Act to a US resident, from a practical standpoint, the FDA and allied federal agencies (Department of Justice, etc) have a difficult time enforcing the law against sellers out-side US borders. As a result, the FDA must resort to requesting foreign governments to take action against the sellers operating within their borders or working with US Customs and Border Protection to stop imported drugs at a port-of-entry.

National
The DEA is currently increasing staffing and resources dedicated to improving its capacity to identify and stop illicit Internet pharmacy operations, and working more closely with agencies and companies both in and outside the government to coordinate and improve its efforts. The DEA is also engaged in renewed efforts to track down illicit Internet pharmacies and the organizations behind them using sophisticated technology, via $6.3 million in funding from Congress.

Karen Tandy also feels that it will be necessary for the DEA “to address the problem of illicit Internet pharmacies within the regulatory structure of the Controlled Substances Act.” Requiring online pharmacies to obtain a special DEA registration or to report the nature or volume of their business in controlled substances—not currently required—would allow the DEA “to identify legitimate online pharmacies and persons operating and promoting them, to gather information pointing to patterns of abuse, and to punish rogue online pharmacies,” she says.

One of the DEA’s partners in fighting to curb the activities of illicit online pharmacies is the FDA, which “has long been engaged in taking steps to minimize the dangers to public health posed by the sales of drugs on the Internet.” Since 1999, the FDA has been implementing an Internet Drug Sales Action Plan, which includes engaging in public outreach and education, partnering with professional organizations, coordinating action with state and other federal agencies, cooperating internationally, and enhanced enforcement tailored to the Internet environment. For details of the Internet Drug Sales Action Plan, visit the URL above.

The Office of National Drug Control Policy (ONDCP) is also contributing, with its $138 million National Drug Control Strategy, which seeks to reach out to medical professionals, consumers, businesses involved in online commerce, pharmaceutical companies, and pharmacies by combining education and enforcement. The strategy— indicating how tough this battle really is—aims to cut illegal prescription drug use 10% by 2006 and 25% by 2009.

Also on the national level is “The Ryan Haight Act,” introduced in late may by Sen. Dianne Feinstein (D-CA). Named after a teenager who died in 2001 from an overdose of drugs purchased from an Internet pharmacy, the bill is aimed at an estimated 500 illicit online pharmacies. If passed and signed into law by the President, it would prohibit online pharmacies from distributing medications based solely on a questionnaire, provide states with the authority to pursue charges against online pharmacies suspected of wrongdoing even if in another jurisdiction, and require pharmacies to identify their business, pharmacist, and physician to consumers but still allow people with valid prescriptions from their doctors to buy medications on the Internet.

Results of the Good Fight
Much work still needs to be done in erasing these sites from Internet searches. MD Net Guide performed a search through Google for “Minto,” the Canadian pharmacy discussed above, and its site www.allergy-medications.com popped up as the fifth result. A Google search for “online pharmacy” produced 4,660,000 results, while the same search via Yahoo produced 6,370,000.
In our August 2001 issue, we discussed the site ForeignDrugs.com, (formerly found at www.foreign drugs.com)—a site that offers visitors a guide to a variety of pharmacies, in Mexico and other foreign nations, that will sell drugs without a prescription. Today, although this particular site no longer exists, surfers typing this address into their browser are redirected to a different site: Pillstore.com. Visitors to this site are told in the FAQ section that “the Internet has changed the way we live. A lot of the new services that were never in existence a few years ago, are now commonplace.” Indeed. Visitors can still obtain, merely by filling out an online “consultation” questionnaire, a wide variety of weight loss pills, muscle “relaxers,” sleep aids, pain relievers, antidepressants, and, of course, the ubiquitous array of men’s sexual health medications.

In 2003, as a result of its online investigations, the DEA seized nearly $2.5 million in computers, cash, real-estate, and bank accounts, following $2.6 million seized in 2002. As of March 2004, the DEA had 95 open investigations involving the online sale of controlled substances without a prescription. As of late July, the Agency had 91 active investigations involving the diversion of controlled pharmaceutical substances using the Internet, which covered 537 websites. During its current fiscal year, the DEA has shut down 25 Internet pharmacy organizations, caused the forfeit of more than $3.3 million ($11 million pending), and seized 3.2 million dosage units.

Finally, investigations by the FDA have also lead to the prosecution of or other actions against the following sites or companies, which are/were involved in the online sale of prescription medications: genapharm.com, Rx Clinic, Kwikmed, Inc, Cymedic Health Group, Inc, Viagra.au.com, Rx Depot Inc, CanaRx, and Expedite-Rx. For specifics on each case, visit the above URL.

While the fight against illicit online pharmacies has come a long way since we first reported on it in 2001, only a small dent has been made. The participation and collaboration of federal agencies such as the DEA, FDA, and ONDCP, state government, physicians and other healthcare providers, and educators will be necessary to get the upper hand on prosecuting the guilty parties and warning patients of the dangers of purchasing medications online.

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