As the "information superhighway" starts looking more like a shopping mall, drug stores on the Web are increasingly popular. In fact, some health industry professionals predict that drug sales online may rival the Internet marketing success of books and music.
In the past year, hundreds of pharmaceutical sites have popped up on the Internet, selling over-the-counter and prescription drugs and countless health and beauty aids. Most major pharmacy chains have set up Web sites for ordering products from their local outlets, and several "virtual pharmacies" have debuted in the past two months alone.
These outlets can be private and convenient, allowing consumers to buy any time without leaving home. Because they ship products from central distributors directly to customers, avoiding overhead costs of a storefront building, they sometimes offer significantly lower prices. They do not, however, always accept the prescription insurance plans that many patients use.
But next door to familiar and reputable names like Riteaid.com and Wal-mart.com, the snake oil salesmen also have set up shop. The vast potential of a worldwide market and the inability to regulate it have attracted some operations that skirt conventional medical practices.
Nonetheless, officials from the World Health Organization and the U.S. Food and Drug Administration took pains in recent interviews not to dismiss this new option, saying it is an outgrowth of the increasing use of the Internet, which has been extremely valuable in disseminating lifesaving medical information worldwide.
"This is a wonderful new media, accessible to everyone, which helps in many ways, in many circumstances," said Juhana Idanpaan-Heikkila, director of drug management and policies at WHO. "We know pharmacy companies try their best to follow all national rules and international ethical criteria."
The problem, he said, is distinguishing between reputable and not-so-reputable online pharmacies. "How are we going to deal with the information coming from any source, any company, any person wishing to make money?" he asked. "The Internet is there; you cannot control it and shouldn't. On the other hand, this freedom of information can be misused."
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The growth of drug sites has created an international bazaar, with many sites touting unproven herbal remedies or trendy prescription pharmaceuticals, such as Viagra, the drug to treat impotence, and Xenical, the diet pill just approved for use in the United States last week by the Food and Drug Administration. The products are pitched, sold and mailed directly to customers, often cutting out face-to-face visits with physicians and pharmacists from the process.
Conventional online sites work much like mail-order pharmacies. Patients send in prescriptions from their doctors, and the pharmacies mail the medications to the patients' homes. But a number of Internet sites also offer home delivery of prescription drugs either prescribed by an unseen online doctor or without a prescription altogether. Foreign-based sites will mail medications and self-treatments unapproved in the United States but available in their own countries. Other sites advertise products that U.S. health authorities have long rejected because they simply do not work.
While it is illegal in the United States for companies to market unapproved drugs, an individual can legally order and accept those drugs, as long as they are for his personal use, said FDA officials. Authorities can seize those drugs in the mail, however, and it is also illegal to receive controlled substances, such as narcotic drugs, without proper authority.
"We've always had these catalogues where people could buy from overseas, but it was a very small market," said Bill Hubbard, the FDA's acting deputy commissioner for policy. "And people who lived near Canada or Mexico could buy things more cheaply across the border. The Internet takes it up a big notch, making it so easy for people to get these products. If you're timid about going to a physician or don't want to pay a physician, the Internet is ready-made for you."
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Mainstream medical groups are unenthusiastic about some of these practices. Prescribing without a physical examination "is unethical but not illegal," said Nancy W. Dickey, president of the American Medical Association. The AMA has advised its members not to prescribe over the Internet and urged doctors to report others who do to their state medical boards.
States require licensed doctors to meet a "standard of care" for a physician-patient relationship that includes personal interaction. Nevada's Board of Medical Examiners recently specifically barred its doctors from making Internet sales unless they actually see the patient. Medical boards in Wisconsin and Colorado have taken disciplinary actions against doctors prescribing over the Internet to patients they have never examined. Other states have ongoing investigations and have sent "cease and desist" letters to Internet prescribers, according to the Federation of State Medical Boards of the United States. Some states do not even allow physicians to fax or e-mail prescriptions to drug stores.
Critics worry that without a face-to-face meeting with a doctor, customers can easily lie about their age and health status to get the regulated products they want.
"Certainly a patient can come into a doctor's office and lie," said Dale Austin, deputy executive vice president of the Federation of State Medical Boards. "But the doctor can see their approximate age, their obesity, listen to their heart, take a blood pressure reading. On an Internet questionnaire, you can be anyone you want."
The AMA's Dickey said Internet drug sales that bypass a doctor's examination are most dangerous for the elderly, "because they are more likely to have ... a conflicting chronic disease that could pose risks." People on long-term medications are also vulnerable to adverse drug interactions, she said. Viagra, for example, can lower blood pressure to dangerous levels in people already taking blood pressure medicine for hypertension.
There is also growing concern about the availability of some narcotics on the Internet, said Dickey. At least one site offers Tylenol III with codeine without a prescription. The U.S. Drug Enforcement Administration is grappling with these issues, said spokesperson Ragene Waite.
Regulators and health organizations such as the FDA, the AMA, the World Health Organization and the National Association of Boards of Pharmacy (NABP) have watched the growth of Internet pharmaceutical sales with apprehension for consumer safety. They express frustration at trying to regulate and police the borderless territory of cyberspace where no agency has total authority.
"The medium has attracted a visible band of unlicensed and unscrupulous entrepreneurs who are interested only in a quick profit, often at the patient's expense," according to a statement from the National Association of Boards of Pharmacy. "These sites frequently operate for a short time at one Web site address before disappearing and setting up shop under another name to escape detection."
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Encouraged by the FDA, the Boards of Pharmacy association is launching a program to help consumers find reputable online outlets. The association offers certification to sites that apply and meet certain standards. Then it will post a list of those with valid licenses on its Web site (www.nabp.net ), and verified pharmacy sites can display a special seal from the association.
The FDA, which can regulate products in the United States but cannot necessarily control how they are sold, has issued consumer warnings and import alerts about various unapproved or adulterated products available through the Internet.
In January, the FDA warned the public about deadly "dietary supplements" containing gamma butyrolactone (GBL) being touted as a muscle builder and sex enhancer. It said these illegally marketed, unapproved products had killed one consumer and caused severe reactions in 54 others, including coma, unconsciousness and seizures. The FDA asked manufacturers to recall the products. Yet some sellers still advertise GBL on the Internet.
Two years, ago the FDA was able to shut down a Web site selling hazardous home abortion and female self-sterilization kits. Since the site was being run out of Bogota, Colombia, the FDA had no jurisdiction there. But the site had a contract with a U.S. Internet service provider that required adherence to all U.S. laws, explained Dwight Rawls, senior operations manager at the FDA's Office of Criminal Investigation. The FDA informed the service provider it was violating the law by aiding the distribution of an unapproved drug and could possibly be liable for injuries linked to the product. The service provider dropped the Web site.
Customs and postal agents have intercepted packages of illegal products ordered online, but many packages still make their way through the mails. Online pharmacies selling unapproved drugs typically include in their advertising a caveat explaining that they are not responsible for the drugs being delivered, such as this one from the Viagra-Global.com Web site: "We cannot accept any liability for the nondelivery of any products due to the actions of any government once shipment has left our port of exit."
"The public are enthralled by the ease and privacy" of Internet drug sales, said Austin, of the medical boards federation. "But some of the safeguards are missing and can be of grave concern to their health and their pocketbooks, too."
The World Health Organization has considered the problems of Internet drug sales, but international action is nearly impossible because of different prescription standards in each country. Nonetheless, WHO urged its member countries to apply their particular laws to Internet pharmacies and to cooperate in blocking illegal cross-border sales. WHO is working on guidelines to help consumers evaluate Web sites.
"With the freedom of the Internet, the world is the market, not just the United States," said William A. Stallknecht, a pharmacist for the Texas-based Pill Box Pharmacy stores, which delivers online. "There is no control, and there can't be, because no one can open your mail for you every day."
The best safeguard is information, he said, and people are better informed today about medical issues than ever before. "You have to look out for yourself because you care more about your own health than any doctor or government does. It's the old caveat emptor."