Federal investigators are targeting physicians who help Internet sites sell drugs to buyers without legitimate prescriptions.
"The Internet has brought drug dealers from the back alleys directly into every American home wired for e-mail and the World Wide Web," Karen Tandy, administrator of the Drug Enforcement Administration, recently testified before the Senate Governmental Affairs Permanent Subcommittee on Investigations.
Such Web sites are heavily advertised through spam e-mail and on the Web, selling as much as $50 million annually per site in some cases, the DEA estimates.
Web sites, such as Medexplorer.comLegalMedsOnline.com
Physicians associated with such Web sites typically have a business relationship with a pharmacy and almost never have a valid doctor-patient relationship under accepted medical practices, Ms. Tandy said. "Acting together, the physician and pharmacist dispense controlled substances [to those] without a legitimate medical need, resulting in widespread self-medication over the Internet.
Often the physician will ask the patient only three or four questions before prescribing the drug, Michael Schaff, a lawyer specializing in health care and corporate law in Woodbridge, N.J., said in an interview. To Mr. Schaff, it's illogical how a physician could make a diagnosis without seeing the patient.
To date, Justice Department investigations have discovered 14 deaths or overdoses and 15 people who have entered addiction rehabilitation or sustained injuries from drugs obtained illegally over the Internet, Ms. Tandy said.
The Government Accountability Office, in its analysis of drugs from 68 Web sites around the world, found that some Internet pharmacies pose safety risks for consumers and have unreliable business practices. While some in the United States and Canada required the patient to provide a doctor's prescription, other sites provided prescriptions based on their own medical questionnaire or had no prescription requirement.
Doctors not involved in Internet pharmacies face another threat: They have no way to know how many Web sites a patient might be using to obtain drugs, said James Saxton, chair of the healthcare liability and litigation practice group of the American Health Lawyers Association. From a medical liability perspective, "this is a disaster waiting to happen," he said.
More than 90 active investigations involving the diversion of pharmaceutical controlled substances over the Internet are underway, covering 537 Web sites, Ms. Tandy said. In the current fiscal year, the DEA has shut down 25 Internet pharmacy organizations and seized $3.3 million and 3.2 million dosage units. "Eleven million dollars is pending forfeiture," she said.
The Food and Drug Administration also has been investigating Internet pharmacies and referring cases for criminal prosecution and initiating civil enforcement actions against online sellers of drugs and other FDA-related products, John M. Taylor, FDA's associate commissioner for regulatory affairs, testified at the Senate hearing.
A number of state laws regulate the practice of pharmacy and medicine to protect patients from harm resulting from the use of unsafe drugs and the improper practice of medicine and pharmacy, Mr. Taylor said, adding that the statutes may not have enough teeth to efficiently regulate online pharmacies. In addition, many states have not yet fully determined how to address the issues that arise from online prescribing. As a result, the attempt to stop some physicians and online pharmacies from issuing prescriptions without an exam aren't always successful.
Other testimony before the Senate investigations panel addressed what Internet portals are doing to crack down on illegal Internet pharmacies.
Representatives from Yahoo! Inc. and Google Inc. described their efforts to ensure that their advertisers engage in best practices approved by the National Community Pharmacists Association. Both online providers use SquareTrade, an online trust infrastructure company that verifies that the online pharmacy and its pharmacist are appropriately licensed.
Yahoo! specifically prohibits online pharmacies from advertising FDA schedule II drugs, testified John Scheibel, Yahoo's vice president for public policy.
The DEA is also working with search engines and Internet service providers to warn consumers about dangerous drugs. "We have also established a link to the DEA's homepage to allow citizens to report suspicious Internet pharmacies," Ms. Tandy said.
For the law to fully catch up with the Internet, Congress should enact legislation that would set parameters for all of the states on how to legally administer these drugs online, suggested Rose Hager, a health care lawyer with Kathleen L. DeBruhl & Associates LLC in New Orleans.
Internet pharmacies will be around for some time, she said. "You won't be able to stop it."
Mr. Saxton agreed, but noted that a multimillion-dollar verdict against a Web site and its participants could have a chilling effect on this type of activity