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Illegal Online Sales of Prescription Drugs Pose Threat, FDA Official Says

Posted on: Tuesday, 7 December 2004, 12:00 CST

Dec. 7--Perhaps you are embarrassed to ask your doctor for the drug you want -- Viagra, for example.

Maybe your doctor won't prescribe your medication -- Vicodin, say, a narcotic painkiller that is prone to abuse.

Or you're too busy to schedule an office appointment to get a prescription.

Or you're looking to save money.

Whatever your reason, you may have learned how to buy prescription drugs over the Internet. It's not difficult. E-mail advertisements with links to online pharmacies arrive daily in many mailboxes, and a search on Google or Yahoo! brings up an abundance of drug-selling sites.

A few are licensed and legitimate -- but many more operate outside the law. These are the so-called "rogue" sites, where, with nothing more than a valid credit card, a consumer of virtually any age can purchase virtually any prescription drug.

Don't, health officials say.

These are among the risks you would be taking:

--Since many of the sites require only completion of a simple questionnaire, you may receive the wrong drug or the wrong dosage.

--No one will monitor your use of the drug. Interactions with other medications can be fatal.

--The drugs you receive may be counterfeit -- with too much, too little, or no active ingredient. Your health could be endangered.

--The drugs may be outdated, having lost some potency.

--They may be damaged during shipment. Certain medications must be kept from heat or cold, not left on a loading dock.

--Disclosing personal details and a credit card number to a stranger may leave you susceptible to identity theft.

It's been estimated that billions of dollars worth of drugs are sold illegally every year over the Internet.

Hundreds, if not thousands, of sites are involved. Some are based in the United States. Others operate out of Fiji, Belize, Argentina, Turkey, and other foreign countries. The anonymity of the Web provides substantial protection against the Food and Drug Administration and other agencies with regulatory authority.

"It's a distinct public health threat," says William K. Hubbard, the FDA's associate commissioner for policy and planning, and one of that agency's key officials in the fight against illegitimate sites.

One day recently, an unsolicited e-mail arrived in this reporter's inbox.

It was sent by a "Karen Welch," a person the reporter did not know, and the subject was "Durvoset," a misspelling of the drug Darvocet, a narcotic painkiller popularly known as Darvon.

Opening the e-mail revealed a link to an online pharmacy that promised home delivery of drugs including Viagra, Valium, Xanax, Cipro, and dozens of other medications.

Clicking brought up www.grandrxbiz.com, which offered this enticement:

"Need prescription medication without a prior prescription? We ship quality medications overnight to your door. Lowest prices on brand name and generic drugs. Order from the convenience of your own home immediately, discreetly and hassle free. Try us today!"

Moving to the Darvon page revealed a picture of a Darvon pill and a description of the medication, whose chemical name is propoxyphene:

"This drug, which is structurally similar to methadone, has been widely abused and is tightly controlled."

But with grandrxbiz.com, control was a relative term.

The site offered "special prices" for 65-milligram doses of the drug, with the "best value" being 90 pills for $314; that, according to the site, was a savings of $51 over the "old price."

(A check at www.drugstore.com, a legitimate, licensed site, showed 90 Darvon pills selling for $57.84. The generic version was even cheaper: $22.99. And shipping was far less.)

The next step was clicking on the Buy Now button.

"You will be asked to complete a specialized form detailing your medical history and any current conditions or medications that you may be taking," the site advised. "All the questions that are asked on the form are the same type of questions your physician would ask you were you to make an office visit."

In fact, the questionnaire fell considerably short of what a doctor would do during an office visit. Some rogue sites do not even have a questionnaire: a valid credit card is the only requirement.

The grandrxbiz.com questionaire asked for date of birth, height, weight, and whether or not the customer smoked cigarettes. Under the "how is your blood pressure?" heading, five choices were presented: "normal,""high,""low,""controlled," and "do not know," hardly scientific measures. Did the customer consume more than two drinks of alcohol a day? Suffer from syphillis or sickle cell anemia? Herpes? Spinal cord injury?

And that was about the extent of it.

"There's no doctor-patient relationship established," says Bruce W. McIntyre, lawyer for the state Board of Medical Licensure and Discipline. "On most of these sites, the patient doesn't know who the doctor is and the doctor doesn't know who the patient is. And we don't think that's a good thing."

Like other such sites, grandrxbiz.com claimed that a doctor "fully licensed to practice in the USA" would issue a prescription, but there was no way to confirm this.

The American Medical Association, the Federation of State Medical Boards, and other professional groups all agree that a physical exam and a face-to-face visit with a doctor should precede the writing of any prescription. In many states (although not all), it is illegal to purchase drugs without a visit.

But regardless of state law, a federation committee wrote four years ago, "Prescribing of medications by physicians based solely on an electronic medical questionnaire clearly fails to meet an acceptable standard of care and is outside the bounds of professional conduct."

Grandrxbiz.com dismisses that notion.

"Research and experience have shown that there is no reason to suggest that an in-person review of your medical history is any more significant than an online consultation," the site said. What's more, you can enjoy the entire process from the comfort of your computer; over the Internet... it is a safe, private and easy way to seek treatment."

The site is hardly alone in its sentiment.

A study this year of 68 Web pharmacies in 12 countries by the General Accountability Office found that 24 U.S.-based sites and 21 foreign sites did not require a prescription written by the patient's personal doctor. Among the drugs the GAO was able to buy without a valid prescription were Accutane, a drug for acne that can cause birth defects, and OxyContin, the painkiller to which radio host Rush Limbaugh became addicted.

The GAO also confirmed what the FDA and other agencies know: drugs are often shipped without FDA-approved labeling and instructions for use. They often arrive without proper warning information: possible side effects, for example, or the potential for addiction or misuse.

Moreover, many of the drugs are fake.

Testifying before Congress in March, the FDA's Hubbard spoke of the dangers: "Patients are at risk because they often don't know what they are getting when they purchase some of these drugs. Although some patients may purchase genuine product, others may unknowingly buy counterfeit copies that contain inert ingredients, legitimate drugs that are outdated and have been diverted to illegitimate resellers, or dangerous sub-potent or super-potent products that were improperly manufactured."

In one case that the FDA investigated, three overseas sites were found in February to be selling contraceptive patches that had no active ingredients. The agency persuaded the U.S.-based Internet service provider to cut off the sites.

In another case, the FDA in July tested samples from a site that billed itself as the purveyor of "Canadian Generics" (the site was actually based in Belize, selling drugs made in China). All of the tested Viagra, anti-cholesterol drug Lipitor, and sleep aid Ambien were fake.

The "Lipitor" pills had only 81 percent of the medicine's active ingredient. "While this may not present a problem in the short-term," the FDA wrote, "the fact that the patient is not being treated optimally would put the patient at increased risk for complications of high cholesterol, such as heart disease."

It is one thing to buy fake Viagra, quite another to buy a fake medication upon which health depends.

Hubbard said that no one knows how many Americans have been harmed or killed by counterfeit Internet medications. His agency has anecdotal evidence of damage: a woman in Oregon whose breast cancer progressed while taking what she thought was the anti-cancer drug Tamoxifen but was actually a fake.

In another instance cited by the FDA-approved watchdog group Institute for Safe Medication Practices, a woman arrived in an emergency room with bleeding gums, pain, amd swelling. The doctor suspected an overdose of wafarin, a blood thinner sold as Coumadan, but the woman denied using the drug. She was admitted to the hospital and it was only after doctors, fearing food poisoning, refused to let visitors bring her food that she said she had been taking the blood pressure drug ramiril, which she had bought in Mexico. But when the label was peeled off the bottle, a Coumadan label was uncovered. She had, indeed, overdosed on the blood thinner.

"Most people think they're doing something a little sketchy," Hubbard said, "so they don't tell their doctor or often anyone else. So when they're injured they don't report it -- because they think they have bought something illegal, which of course they have." The FDA, Hubbard noted, does not pursue prosecution of consumers for buying illicit Internet drugs.

State officials say they do not know of any Internet drug-buying sites based in Rhode Island. Nor has the pharmacy board received accounts of people being harmed, says Catherine Cordy, administrator of the Rhode Island Board of Pharmacy.

Overseas, however, counterfeit drugs -- not necessarily bought on the Internet -- have killed many. Fifty-nine children died in Haiti in 1996 after taking a counterfeit drug prescribed for fever, and 30 people in Cambodia died in 2000 after taking fake malaria drugs. A Chinese news channel reported that counterfeit drugs had killed more than 100,000 Chinese people in 2001, but the report was not independently confirmed.

According to Hubbard, the first rogue sites appeared in 1998.

The number grew "exponentially" at first, Hubbard says, although the total appears to have leveled off at several hundred, as best the FDA can determine. When states and the agency began to aggressively pursue U.S.-based sites, he says, many moved overseas, where they enjoy a greater degree of protection -- and where they are near the counterfeit manufacturers.

Operators are constantly closing old sites and opening new ones with new looks under new names. "They pop up every day," says Hubbard.

No one is sure how many counterfeiting operations exist, but they are largely located in Asia and South America and range from state-of-the-art factories to one-man shops. "Producing counterfeit drugs may not require building huge infrastructure or facilities," said a recent report by the World Health Organization. "They can be produced in small 'cottage' industries or in backyards or even under the shade of a tree."

Counterfeit drugs can be made with little more than cheap inert ingredients, coloring, and a pill-presser.

But while one-man shops flourish, "organized criminal elements are being lured into counterfeit prescription drugs because it's actually a better deal for them than smuggling in heroin or cocaine," says Hubbard. "They're less likely to get caught. And we don't have any authority to go to these countries and arrest them."

High profit margins are another motive.

A fake Viagra tablet containing only starch or glucose -- essentially, a sugar pill -- costs less than a dime to make, according to Shepherd. "You can sell it to wholesalers for four or five dollars."

In one notable case, Vineet "Vincent" Chhabra, 33, the chief operator of a group of rogue sites based in Florida, was charged with more than 100 counts of running a criminal enterprise, money laundering, illegal distribution of controlled substances, and selling wrongly branded drugs over state lines. According to prosecutors, Chhabra, his sister, and other members of the ring sold some $125 million in drugs from 1998 until their arrest in 2003 -- making millions in profits, which they spent on luxury automobiles, houses, a jet, a grand piano and jewels. In September, Chhabra pleaded guilty to the controlled substance charges and was sentenced to 33 months in prison.

In the only known case in Rhode Island of action against someone involved in Internet drug commerce, the state Board of Medical Licensure and Discipline in 2001 stopped Dr. Martin P. Feldman from writing invalid Internet prescriptions. Feldman was reviewing online questionnaires and earning $5 to $10 for writing each prescription. The Board reprimanded Feldman, placed him on probation for three years, required him to take an ethics course, and assessed him a $500 administrative fee.

"Rhode Island is such a small state that other physicians who may have been similarly inclined may have figured out this may not be such a good idea," says board lawyer McIntyre. "Although it can be financially lucrative." McIntyre estimated that a hard-working doctor could earn thousands of dollars a day just by writing prescriptions.

Like many sites, grandrxbiz.com provides no mailing or office address, no telephone number, no other identifying information that would indicate where it is based, no names of doctors.

The site has a contact form for e-mail, however, and almost two weeks agao, this reporter sent a message: "Can you please tell me where you are located? And what are the names of your licensed doctors?" The form asked for this reporter's address, telephone and e-mail, and they were given.

"Your request is now being processed," the site replied when the Send button was clicked. "We will contact you as soon as possible. Thank you."

No response.

A second e-mail was sent.

But no response was ever received.

A check with the Internet's WHOIS directory, which records information about Web sites when they are registered, turned up an administrator's name, an e-mail address, a telephone and fax number, and a street address -- in Riga, Latvia, an Eastern European country that was once part of the Eastern bloc.

An e-mail sent to the administrator, admin [at] sanita77.biz, bounced back as undeliverable, and another sent the next day returned with the same message: "Sorry, I couldn't find any host named sanita77.biz." But that domain name had been registered by someone in Spain, according to WHOIS, and an e-mail was sent to the administrator there.

No reply was ever received.

A telephone call placed to the number WHOIS listed for grandrxbiz.com in Latvia brought this automated response: "Your call did not go through. Please try again." The next day: another try, another automated response.

Finally, this reporter attempted to track down "Karen Welch," who sent the original spam. A message enquiring who she was and the nature of her connection to grandrxbiz.com was composed and sent with the reply button. The e-mail was returned, "user unknown."

Welch's e-mail address was with a service called salerno.net, a domain name owned by Web host netidentity.com, located in Reno, Nev., according to WHOIS. A call to the firm brought a recording stating that no questions were answered by phone. An e-mail to the netidentity address elicited no reply.

Last week, this reporter again clicked on the original e-mail advertisement sent by "Karen Welch."

This time, it brought up another site: www.ourmedshere.com.

Although the picture of a male doctor had replaced a picture of a female physician (and, a few days later, a picture of a couple replaced the female doctor), the site seemed a virtual copy of grandrxbiz.com, down to the prices for Darvon, the questionnaire, and the wording of certain passages.

The WHOIS registry listed a different administrator and different street address for ourmedshere.com -- but the same telephone number and city as for grandrxbiz.com.

So where are grandrxbiz.com and ourmedshere.com located? Who are their doctors? Are they really doctors? Who owns the sites?

Who knows?

Readers with experiences of any kind with prescription drugs who would like to share their stories are encouraged to send them to G. Wayne Miller, gwmiller@projo.com. This is the second in an occasional series on the subject.

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To see more of the The Providence Journal, or to subscribe to the newspaper, go to http://www.projo.com.

(c) 2004, The Providence Journal, R.I. Distributed by Knight Ridder/Tribune Business News. For information on republishing this content, contact us at (800) 661-2511 (U.S.), (213) 237-4914 (worldwide), fax (213) 237-6515, or e-mail reprints@krtinfo.com.

Source: Providence Journal

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