|
The Sleazy Side of Internet Pharmacies
The Sleazy Side of Internet Pharmacies
Pharmaceutical Commerce
By Suzanne Shelley
Jan 4,2007
It’s not just the goofy spam for fake sexual-enhancement drugs: illicit Internet pharmacies are a growing worry for FDA, the Drug Enforcement Administration (DEA), the Customs and Border Patrol, and state authorities across the country. The Internet is becoming a convenient avenue for criminals dealing in fake pharmaceuticals and, with the tightening of the conventional supply chain for drug distribution over the past few years, one of the most worrisome entry points for counterfeit drugs to enter the U.S. healthcare system.
DEA has an Internet Investigations Unit to monitor the distribution of controlled substances. “Perhaps the most potentially dangerous and increasingly used method for the diversion of controlled pharmaceuticals is through the Internet,” said Joseph Rannazzisi, deputy assistant administrator at DEA, in Congressional testimony last summer.
Since 1999, the National Assn. of Boards of Pharmacy (NABP) has instituted its Verified Internet Pharmacy Practice Sites (VIPPS) accreditation program; to date, a dozen organizations have been so approved. According to NABP’s executive director, Carmine Catizone, efforts are under way in several states to require VIPPS accreditation for out-of-state pharmacies and non-resident mail-order pharmacies. In addition to voluntary and potentially mandatory use of the VIPPS program, key stakeholders agree that more comprehensive state and federal legislation, aimed at regulating online pharmaceutical sales, is needed.
Last summer, Sen. Dianne Feinstein (D-CA) re-introduced a bill, S.3834, “The Online Pharmacy Consumer Protection Act of 2006,” co-sponsored by Senator Jeff Sessions (R-AL), which would provide criminal penalties for unlawfully dispensing controlled substances and prescription drugs over the Internet, and reinforce state legal oversight. The bill is unlikely to be addressed prior to the conclusion of 109th Congress, but is likely to be re-introduced in the next session.
“There’s substantial regulation over drugs in the legitimate supply chain, but there is little or no effective control over drugs purchased over the Internet. It’s like day and night, and U.S. consumers need to know what the risks are before they go online,” says Thomas Kubic, executive director of the Pharmaceutical Security Institute (Vienna, VA), which was established in 2001, and has among its members 22 research-based pharmaceutical manufacturers.
Besides supporting the Pharma-ceutical Security Institute, or FDA’s Counterfeit Drug Network, pharma companies can also deploy new services like the Dossier 4.0 from Integrichain, Inc. (Princeton, NJ), which uses Internet spidering tools to uncover suspicious trading activity by monitoring online pharmacies and the online sales sites of distributors—a rare case of using Internet tools against Internet crooks.
The ‘re-importation’ wrestling match
An inherent feature of the Internet is that it crosses national borders, which puts online pharmacies, dealing in both legitimate and illegitimate pharmaceuticals, beyond the reach of national authorities. In one of the latest incidents, in August 2006, FDA issued a warning, telling consumers not to buy prescription drugs from websites whose orders are filled by Mediplan Prescription Plus Pharmacy, or Mediplan Global Health, of Manitoba, Canada. According to the agency, preliminary lab results on confiscated shipments that were bound for the U.S. found counterfeit versions of numerous widely used prescription drugs — including Lipitor, Diovan, Actonel, Nexium, Hyzaar, Zetia, Crestor, Celebrex, Arimidex, and Propecia — that had been were shipped from Mediplan’s numerous online pharmacy operations.
However, foreign online pharmacies are also the smiled-on stepchild of legislators who favor allowing drug re-importation (still technically illegal under U.S. law). An amendment to the Homeland Security Act (passed in October) prohibits Customs and Border Patrol personnel from seizing personal supplies of pharmaceuticals being brought across the border; subsequently, Customs announced that it would no longer seize mail order prescriptions from Canada—in essence, re-opening the Canadian Internet pharmacy window.
“While they promise safe and genuine medicines at a lower price, operators of these websites are in fact, selling drugs of dubious origin, safety and efficacy,” says Kubic of the Pharmaceutical Security Institute. “Rogue pharmacies are nothing more than criminal enterprises selling snake oil, and shamefully profiting from the inherent vulnerabilities of the Internet,” adds Peter Pitts of the Center for Medicine in the Public Interest. “Some of the drugs they dispense are real but many are not, and there’s no way to be sure. Unfortunately, certain aspects of the Internet make it easy for these sites to bypass all the customary safety nets.”
The fact that rogue websites selling dubious drugs continue to prosper proves showman P.S. Barnum’s old adage that there’s a sucker born every minute. “These rogue outfits wouldn’t keep operating if they weren’t profitable” says Pitts. “Legitimate pharmacies are licensed for a reason. Sometimes a bargain is too expensive.” |
|
Donate
Please consider a tax-deductible contribution to CMPI. Your support is appreciated.
|
