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Date Posted: 03:31:27 12/16/03 Tue
Author: Observer
Subject: Re: Online drugs a health risk, officials warn
In reply to: Billy 's message, "Online drugs a health risk, officials warn" on 03:29:51 12/16/03 Tue

Some consumers hail the explosion of unregulated online pharmacies, but health officials warn of dangers
By Pete Alfano
Star-Telegram Staff Writer

Carmen Catizone, executive director of the National Association of Boards of Pharmacy, says health care is "inaccessible."



The white FedEx envelope arrived in broad daylight only 48 hours after the order was submitted on the Internet.

Inside was a plastic pill bottle, just like the ones you get when a prescription is filled at a neighborhood pharmacy. The label read: Xanax, 1 milligram, (30 pills).

It was a month's supply of a drug used to treat anxiety -- a highly addictive substance that should be taken only under a doctor's care.

How this powerful medication and other potent drugs came to be delivered illegally to a Texas home is a cause of concern to health authorities in several states. Some may investigate.

No doctor saw the "patient." They didn't talk on the phone. Instead, the patient filled out a token online questionnaire to request the drug.

The patient could have been a child, and no one would have known.

It wasn't; it was the Star-Telegram.

The questionniare was supposedly reviewed by a doctor named Nancy Melendez. But no one by that name is licensed in Florida, where Speed Scripts of Miami filled the order. Florida authorities aren't even sure she exists.

But if authorities find the doctor who wrote the prescription, it could result in the loss of her or his license. The pharmacy could also face punishment. Florida -- like most states and licensing boards -- considers it substandard medical practice to write prescriptions without a face-to-face consultation. And pharmacies that fill such orders may face disciplinary action as well.

They aren't the only ones who can be held accountable.

Every day, thousands of Americans are breaking the law by ordering potentially harmful and addictive prescription drugs from what the federal government considers renegade Web sites engaged in the newest form of drug trafficking.

These are not certified pharmacy sites such as CVS, Eckerd and drugstore.com, which are licensed and strictly regulated.

The renegade sites write, fill and sell prescriptions for hundreds of medications such as Viagra, Xanax, Prozac, Percocet, Zoloft, Vicodin, Didrex, Cipro, Ambien and Valium.

There are no back alleys to slink down to score these drugs; they aren't smuggled to consumers under the cover of darkness.

Many Americans with Internet accounts and e-mail addresses receive dozens of unsolicited e-mails hawking the drugs every day.

"Free online consultation. 100 percent safe and confidential. No waiting or embarrassment. Discreet packaging. We write, fill, ship," says Pharmacy Discounts.

"No prescription required. No lengthy forms to fill out," boasts Offshore Pharmacy.

As easily as these online drug pushers find you, it is almost impossible to track them down or to find the prescribing doctor and the pharmacy that filled the order. Web site operations are cloaked in secrecy, often shutting down one day and re-emerging the next under a different name.

During the course of several weeks, the Star-Telegram made four online purchases of prescription drugs: Xanax; the weight loss medication and stimulant Didrex; the narcotic pain killer Ultracet; and the antidepressant Prozac.

Four Web sites were used. Each required completing a short questionnaire. The drugs all arrived within 48 hours of being ordered.

This doesn't surprise Susan Winckler, vice president for policy and communications for the American Pharmacists Association, but it dismays her.

"Why are health care professionals, with obligations to protect patients' health, not showing more discretion?" asked Winckler, who is a lawyer and pharmacist.

It was a rhetorical question.

It's about the money.

Doctors who write online prescriptions can earn thousands of dollars a month. For each one they sign, they may earn $20 or more.

Pharmacies that ask few questions and fill the orders can also profit.

But it's the Web sites that are really cashing in on what authorities believe is a multimillion-dollar-a-year business fueled by the fact that most patients will regularly order refills.

"If I had a choice of selling heroin or crack, I'd go online and sell illegal prescription drugs on the Internet," said Carmen Catizone, executive director of the National Association of Boards of Pharmacy.

Easy access

Visiting these Web sites is like being a kid in a candy store.

Consumers can eliminate their doctors from the health care equation and choose a drug of their liking. Already, Americans have been turning to medical Web sites for self-diagnosis; now, in theory, they can order drugs online to heal themselves.

For Americans on Medicare, people without prescription insurance and those looking to buy drugs their doctors won't prescribe, the explosion of online pharmacies is a godsend.

For many, this beats doing business the old-fashioned way -- scheduling an appointment with a doctor, wasting time in a waiting room and then having the doctor's attention for only a few minutes.

"The health care system is inaccessible," Catizone said. "You wait three weeks to see a doctor for 10 seconds. Then you wait 45 minutes for prescriptions."

For some, buying online at discounted prices is a counteroffensive against a health care system that some say is plundering Americans of their hard-earned money while padding the pockets of drug makers and insurance companies.

Even those who worry about the risks inherent in buying drugs from online pharmacies understand why the Web sites are popular.

"People are doing it because the cost of drugs is out of control," said Peter Pitts, the Food and Drug Administration's associate commissioner for external relations.

Thus, operators of unregulated Web sites portray themselves as altruistic leaders of a populist revolution.

"This is patient-driven," said Max Kravitz, a lawyer for the Chhabra Group. The company reported that it recently sold its share of www.usaprescrip-tion.com, which filled the Star-Telegram's order for Didrex.

"Medical consultation over the Internet is an evolving business and an inevitable wave of the future," Kravitz said in November.

Since that interview, federal agents arrested Vincent Chhabra, owner of Chhabra Group, along with his sister, his uncle, five doctors and a pharmacist. A 108-count indictment issued earlier this month charged them with illegally selling addictive diet and sleeping pills over the Internet. Prosectors said Chhabra sold 2 million pills yearly to customers as far away as the United Kingdom and made $125 million.

In the November interview, Kravitz said that consumers are redefining the doctor-patient relationship. "Millions of patients know the inherent dangers of self-diagnosis and self-treatment. But they want privacy, convenience and autonomy. They want to take more responsibility for their health care choices," he said.

Government and medical officials are appalled when they hear that.

"This is all leading people to believe that prescription drugs are consumable goods and we choose them like the food we eat," Winckler said. "It starts with a premise that a patient is willing to know and accept the risk involved. And I don't think that's true."

"I believe there are some consumers who don't know the risks they're taking."

Drugs from unregulated sites might be substandard or superpotent -- that is weaker or stronger than it says on the label. Some are called "mimic" drugs, the prescription drug version of a Gucci knockoff.

Some are formulated differently than the original drug, some are outdated, and some are imported from overseas, Canada or Mexico in violation of federal law.

Some are counterfeit, or placebos.

Even if drugs are authentic, patients may not be aware of potential interactions with other medications.

They may also misinterpret their symptoms.

Dale Austin, senior vice president of the Federation of State Medical Boards in Euless, cited a study showing that some men who ordered products to enhance sexual performance suffered from more serious disorders such as urinary-related cancers and even coronary disease.

Ordering Viagra to improve sexual performance may delay the diagnosis, thus increasing the health risks. And men who take Viagra and nitroglycerin, which is commonly used to treat the chest pain known as angina, are increasing their chances of a heart attack.

Another issue is one that government agencies do not like to discuss. It is possible that terrorist organizations could set up an online pharmacy Web site and peddle prescription drugs to raise money.

Or they could tamper with drugs and send them to unsuspecting consumers.

The spread of anthrax through the postal system two years ago set the precedent.

And while a physician may prescribe drugs in low dosages or for a short duration to see how they work, consumers can use the Internet to purchase large quantities of the most potent pills take them indiscriminately.

"Ordering these drugs is like playing Russian roulette," said Dr. Tim Gorski of Arlington, president of the Dallas/Fort Worth Council Against Health Fraud. "Maybe you get the right drug; maybe it just looks like it. How many chambers does the gun have?"

Safety concerns

Before prescribing a medication, a physician will weigh why a patient needs it against possible risks or side effects. A physician will also consider possible drug interactions and ask about allergies to any medications.

Questionnaires used by online pharmacies deal with some of these considerations, relying on customers to be truthful. But the Star-Telegram's requests for prescription drugs were approved for the flimsiest reasons.

At www.fastpillsonline.com, where the purchase of the anxiety drug Xanax was made, the final question was: "Please explain the specific medical reason for ordering this medication. The physician must know the exact nature of your medical problem in order to prescribe this medication. This cannot be left blank."

Other Web sites had similar questions.

Here's what the Star-Telegram wrote:

Xanax, from www.fastpillsonline.com: "I've been having some anxiety."

Didrex, from www.usaprescription.com: "I want to have them available if I gain weight."

Ultracet, from www.vico-din.com-online.us: "I'm having some pain in my knee."

Prozac, from www.On-linePharmacy.com: "I want to see if this is easier than getting them from a pharmacy."

Would your physician prescribe these medications based on the reasons given?

The online companies didn't hesitate. In short order, the requests were processed and approved. Then, the bottles show, each prescription was filled by a licensed pharmacy -- Ultracet in Huntingdon Valley, Pa.; Prozac in Union, N.J.; and Didrex and Xanax at pharmacies in Miami.

All arrived in a standard FedEx envelope.

Each had a prescribing doctor. But none of the doctors is licensed in the state that filled the prescription.

"It's just not good patient care," said Austin, whose Federation of State Medical Boards represents all state boards and helps determine the effectiveness and integrity of medical licensing and discipline systems.

"The doctor-patient relationship protects the patient. I don't think the public appreciates the risks."

Austin said that he cannot envision any circumstances under which reviewing an online questionnaire would be an acceptable standard of medical care.

But much of the debate about the legality of selling prescription drugs on the Internet revolves around the questionnaire.

Proponents of online pharmacies say that questionnaires satisfy the legal and ethical requirement for a doctor-patient relationship.

"The law in every state for purposes of medical malpractice makes it very clear that what creates a physician-patient relationship is a contract where the patient conveys information to the doctor and requests advice and treatment and the doctor makes a diagnosis," Kravitz said.

Yet online, how would a physician know if a patient were lying about his or her identity, gender, age, medical condition or history?

And how would a patient know whether licensed or qualified doctors were actually reviewing these questionnaires? Catizone, of the National Association of Boards of Pharmacy, cited one instance in which a retired veterinarian living in Argentina signed Viagra prescriptions.

Buyer beware

Two years ago, Dr. Robert C. Ogle of Rockwall approved a prescription for hydrocodone, a form of the narcotic painkiller Vicodin. Ryan Haight of La Mesa, Calif., requested the drug on Nationpharmacy.com, listing his age on the questionnaire as 22.

A Los Angeles Times story chronicled what happened.

Haight lied about his age. He was 17.

He took the drug along with an antidepressant and morphine for back pain.

It was a deadly cocktail.

His death led to an investigation.

A spokeswoman for the Texas State Board of Medical Examiners said that Ogle has surrendered his license.

Ogle pleaded guilty to one count of conspiracy to distribute a controlled substance and one count of money laundering. He is scheduled to be sentenced Jan. 14, according to the U.S. Attorney's Office in Dallas. Haight's parents have sued.

Ogle is not the only doctor who has violated the board's Internet prescription policy. According to the board of medical examiners, Texas doctors R.L. Nelms, Kenneth Speak, Ernesto Cantu and David L. Bryson lost their licenses for violations.

But cases like these represent the tip of the online prescription drug iceberg, and most sellers, physicians and pharmacies go unpunished.

One reason prosecution is difficult is because rules and regulations setting the standard of practice for doctors and pharmacies are not uniform across the country.

All states have standards dealing with doctor-patient relationships and pharmacy practices. In some states, violating those rules is a crime. In other states, it represents an ethical breach, and the licensing board determines disciplinary action.

Those who provide services for unregulated online pharmaceutical sites often say they are not breaking any laws if such laws exist.

"There's so much gray area," said Cindy, a pharmacist for Speed Scripts of Miami, which filled the Xanax prescription sent to the Star-Telegram. She didn't want to give her last name because of possible reprisals.

"There are no pharmacy laws that say you can't fill Internet prescriptions. And what constitutes a valid doctor-patient relationship is vague. I would love for them [the state and federal agencies] to tell me what they want from us."

Another reason prosecution is rare is that government agencies and professional licensing boards say they don't have the resources to investigate. And it's a challenge, they say, to track online pharmacies hiding in cyberspace.

The Texas State Board of Pharmacy was surprised to learn of the four pharmacies that were listed on the bottles of prescription drugs sent to the Star-Telegram: Speed Scripts of Miami; Prescriptions and Travel of Miami; Universal Pharmacy Solutions of Huntingdon Valley, Pa.; and EZ Rx of Union, N.J.

None has a nonresident Texas license.

That means these pharmacies -- if they indeed filled the prescriptions -- not only may face disciplinary action in their home state but also are in violation of Texas law, said Gay Dodson, executive director of the Texas State Board of Pharmacy.

"You cannot send controlled substances through the mail based on filling out an Internet questionnaire," she said. "And you can't ship to Texas unless you have a nonresident license."

Those who violate the law can lose their licenses. For unlicensed pharmacies, Dodson said, the state attorney general may pursue an injunction preventing those pharmacies from shipping to Texas.

The other three pharmacies could not be reached by the Star-Telegram. Calls were sent to messaging systems.

Cindy of Speed Scripts said she talks to hundreds of people a month: "They are totally legitimate, people who can't get to a pharmacy. But as with any business, you'll always have some bad apples in the group."

There are calls for Congress to take action, but both houses have been reluctant to censor the Internet, a symbol of freedom of speech.

For their part, drug manufacturers say there is little they can do to shut down the Web sites, although they are concerned about what consumers may be getting.

For example, not everything being sold as Viagra, which is probably the most advertised drug on the Internet, is the drug patented by Pfizer.

Rich Widup of Viagra's global security department said the company has three main wholesalers that distribute Viagra in the United States and internationally. He suspects many of the Web sites are selling a similar drug, not the one made by Pfizer.

What does the company do? Pfizer, like all drug makers, does not track its products from the warehouse to the pharmacy shelves.

"Pfizer is dealing with a public education outreach campaign to inform the public that we are not behind the spam they are getting," Widup said. "There is a lot of fraud out there."

Thus the Internet is Dodge City for prescription drug peddlers.

Officials, such as Catizone of the national boards of pharmacy, wonder why authorities shut down Napster, the Web site where consumers could download music for free, but leave pharmacy sites virtually untouched.

Some say authorities have been caught napping because caution flags were raised in the late 1990s about Internet sales of prescription drugs.

"For years, there have been pharmacies and doctors who diverted controlled drugs and written prescriptions for profit," said Betsy Willis, drug operations chief for the Drug Enforcement Administration.

"The Internet has made it easier."

Authorities contend that progress is being made, albeit slowly.

State medical and pharmacy boards are revising their regulations, clarifying language and closing loopholes.

Some states are exploring new statutes.

And states are also cooperating with one another.

In February, two people were convicted in Alabama of illegally offering prescription drugs through a Web site called Norfolk Men's Clinic in Clanton, Ala.

They were charged with conspiracy to commit violations of the Federal Food, Drug and Cosmetic Act; conspiracy to commit money laundering; mail fraud; dispensing misbranded drugs; and operating a drug repackaging facility that was not registered with the FDA.

The Alabama case, government agencies said, is a model for prosecuting other unregulated online pharmacy operators.

Public education and stricter regulation are also needed, they said.

Several proposals are being studied. One is a nationwide injunction that would shut down a Web site in all 50 states when any state takes action.

Another would require all Web sites dispensing prescription drugs to post a physical address and phone number and to list names and contact information for licensing doctors and pharmacists involved.

Still another would require a written prescription from a patient's doctor just as certified online pharmacies do.

"We don't want it to be seen as a condemnation of the Internet," said Austin, of the Federation of State Medical Boards. "There are some valuable aspects to online communication with your physician, a lot of pluses."

But any legislation would not guarantee total protection for consumers. Even improved health care benefits and lower costs for prescription drugs probably won't drive all the desperadoes out of Dodge.

The bottom line, authorities say, is that consumers should exercise caution and good judgment.

In other words, caveat emptor, let the buyer beware, when purchasing prescription drugs from unregulated online pharmacies.

Rx: Online prescriptions

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  • Deadly pills traced to Rockwall doctor -- Billy, 23:31:44 12/17/03 Wed
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