Online pharmacies allow patients to purchase medicine without having to go to the drug store. These sites give them direct access to information about the drugs and direct contact with the pharmaceutical companies thatwhich they didn't have before. The new technology, however, has a major drawback: it makes it a lot easier to buy prescription drugs without the advice or supervision of a doctor. Is it time for the federal government to move in and stop these abuses?

According to the 1938 Food, Drug, and Cosmetic Act, prescription drugs cannot be sold without direct involvement of a physician. But with the Internet, this "intervention" becomes a lot less direct. While many on-line pharmacies require that their customers supply either a hand-written or faxed prescription from a doctor, others have begun to introduce "virtual" physicians into the process. These online pharmacies only ask the patient to send a completed form over the Internet. Then, for an additional fee, a licensed physician determines the dosage and the type of medicine for the patient based on the information he or she has been given.

Two problems immediately arise. First, the patient may not be supplying the right information. Second, the doctor may not exist. In a country thatwhich has the strictest drug regulations in the world this radically short-circuits the traditional doctor-patient relationship. What happens when the patient decides on his own that more is merrier? In Illinois, a 52-year-old man with a heart condition who was taking the impotence drug Viagra suffered a heart attack and died after buying the drugs from an on-line pharmacy. Another online company, meanwhile, was sued recently for selling Viagra to a 16- year-old.

In a U.S. News survey, several companies selling Viagra and Propecia (for hair loss) were dispensing the medication without a physician; the only qualified doctor on the company's payroll was out-of-state. (The drug Propecia also has been associated in the mass media in recent months with allegedly greater-than-average health risks), as is the drug Xenical (weight reduction).) All of these drugs are widely purchased over the Internet, sometimes creating a complex network where the patient, the consulting physician, and the pharmacy are all in different states. Other "cure all" drugs are sold over the Internet, including beef tallow (for cancer), a Peruvian plant derivative (for AIDs), and magnetic devices (for high blood pressure).

With over 400 pharmacy sites already on the web - up from a few dozen five years ago - it's becoming increasingly difficult to enforce laws which prevent selling prescription drugs without a bona fide prescription from a licensed physician. The relationship between online pharmacies and physicians in these cases can be tenuous or impossible to verify, since many on-line pharmacies don't provide addresses or phone numbers of consulting physicians. When violations are traced, the penalties are usually minimal.

However, a number of steps have been taken to regulate on-line pharmacies. Bill Clinton, in this year's State of the Union Address, called for increased supervision of online health care and pharmacies. Pfizer, which manufactures Viagra, has complained that their heavily advertised drug is being distributed on the web without adequate safeguards. HR resolution 2763, now in committee, was introduced by Ron Klink (D-Pa.) in August 1999. This bill would amend the Food, Drug, and Cosmetics act by directing Internet pharmacies to reveal locations and the state and local jurisdictions in which they are licensed.

On One Hand...

The explosion of online pharmacies should be more tightly controlled by the federal government before people are hurt. Patients are being prescribed drugs without a doctor's exam, violating the keystone of modern medicine. Also, currently, there are few ways for a patient to distinguish legitimate sites from illegitimate ones. In some cases, the drugs being sold online are actually supplied by pharmacies outside the U.S., and they don't meet medical standards and are frequently stronger or weaker than the pills prescribed by the government. The U.S. government needs to especially crack down on companies that try to transport these drugs into our country illegally.

In many cases, online pharmacies encourage patients to "experiment" without the direct advice of a physician. This is a dangerous precedent and may result in patients without training researching and "prescribing" their own medication. The drugs are being supplied without a doctor considering a reliable medical history of the patient, the cornerstone of good medicine. Further, the patient is not monitored properly while he is taking the drugs. The Internet offers conveniences and information that weren't available before; but the government should make sure that online pharmacies aren't being used to get prescription medicine without the advice or intervention of a doctor, as the law and common sense dictate.

On the Other Hand...

Online pharmacies are already sufficiently regulated. While Internet sites need to be monitored, the government shouldn't claim any greater jurisdiction over the pharmaceutical industry. There is clearly a demand for the information and convenience that online pharmacies offer. The online pharmacy industry is thriving, and installing a bureaucratic watchdog would only create useless logjams. By its own admission, the FDA isn't equipped to cover the large number of online pharmacies on the Internet.

Legitimate online pharmacies - along with many of the pharmaceutical companies - all support self-policing as an alternative to increased federal regulation. State regulatory and law enforcement groups are already given the job of enforcing existing laws against unlawful Internet sellers. The National Association of Boards of Pharmacy has its Verified Internet Pharmacy Practice Sites (VIPPS) program, which provides customers with valuable information about the credentials of online pharmacies. The American Medical Association (AMA) has also adopted voluntary principles for ensuring that doctors who prescribe over the Internet follow minimum standards of care. These voluntary enforcement programs are the most effective way of monitoring online pharmacies, as they educate customers about the risks of online medical products. Instead of setting up a new level of litigation with the Klink Bill, the FDA should focus on coordinating the resources of existing agencies and educating the customer.

• In a study conducted in 1999 by the University of Pennsylvania, 9 out of 46 sites questioned offered the prescription drug Propecia (a baldness therapy drug) solely on the basis of a questionnaire sent by the customer

• When patients browse and search for prescriptions online, companies have access to the habits of their customers. They mine the data in aggregate form, and use it to provide more tailored messages and content. Using this data, a company can offer sun-screen to a patient using a medicine with a photosensitizing side effect. While companies are legally obliged to use this sort of profiling only with the consent of the customer, violations are hard to prosecute. The penalties for these invasions of privacy are few. According to the Health Privacy Project, only 13 states currently restrict disclosure of pharmaceutical information by pharmacies.

• The percentage of physicians using the Internet has doubled in the past two years - to 37 percent, according to the American Medical Association. 48 percent of online users would like to communicate with their doctor's office via e-mail, but only 3 percent are doing so, and only 11 percent know their doctor's e-mail address.

• A Salon.com investigation of online pharmaceutical sales pursued the name of a consulting physician on a bottle of Viagra that was purchased online. After receiving the bottle, the reporter writes that he called up the doctor whose name was on the bottle. He got a nurse, who told him that she dealt with "all the Viagra stuff."

Los Angeles Times; FDA Consumer; Pharmaceutical Executive eHealth Supplement; Salon.com