The process of testing and then approving a new drug can be quite different from the marketing of that drug after it has been released. The new fat-blocking drug orlistat (Xenical) provides a case in point.
On April 26, 1999, the U.S. Food and Drug Administration (FDA) announced that it had approved orlistat (Xenical), "a new drug to treat obesity," noting that "orlistat is the first drug in a new class of non-systemically acting anti-obesity drugs known as lipase inhibitors." The FDA statement read, in part, as follows:
- "Unlike other obesity drugs, orlistat prevents enzymes in the gastrointestinal tract from breaking down dietary fats into smaller molecules that can be absorbed by the body. Absorption of fat is decreased by about 30 percent. Since undigested triglycerides are not absorbed, the reduced caloric intake may have a positive effect on weight control."
- "The recommended dose of orlistat is one capsule with each main meal that includes fat. During treatment, the patient should be on a nutritionally balanced, reduced-calorie diet that contains no more than 30 percent of calories from fat. Orlistat is indicated for obese patients with a body mass index (BMI, a measure of weight in relation to height), of 30 or more, or for patients with a BMI of 27 or more who also have high blood pressure, high cholesterol, or diabetes. A person who is 5´5" in height and weighs 180 pounds would have a BMI of 30."
- "Because orlistat reduces the absorption of some fat-soluble vitamins and beta carotene, patients should take a supplement that contains fat soluble (A, D, E, and K) vitamins and beta carotene. The most common side effects of orlistat are oily spotting, gas with discharge, fecal urgency, fatty/oily stools and frequent bowel movements."
Less than two months after the FDA approved orlistat (Xenical), an online drugstore stated that, to order some Xenical, you simply had to fill out and submit an online consultation form. The online drugstore explained that:
- " Your online consultation form will be sent to a qualified and licensed medical doctor. The doctor will review your medical history/personal profile and decide if Xenical is the appropriate treatment for your problem. If appropriate the doctor will write a prescription which will be sent to a qualified pharmacy. The pharmacy will then fill and ship the medication to you....There is an on-line consultation fee of $75 for all approved prescriptions."
This online offer is far from unique. One search using the word "Xenical" in the Excite! search engine yielded 2953 hits. The first hit started something like an old-style street vendor with these words:
- "XENICAL - Get Xenical, the new weight loss pill, Xenical for sale."
Orlistat (Xenical) is by no means alone as a prescription drug now being marketed online without a real visit with a physician. There are many other prescription drugs already being hawked online. They include "lifestyle" drugs such as Viagra (sildenafil citrate) for erectile dysfunction, Propecia (finasteride) for hair loss, and Preven (Emergency Contraceptive/Birth Control Kit). The online drug offerings also include relatively new and popular drugs such as the antihistamine Claritin (loratadine) for allergy and the Cox-2 inhibitor Celebrex (celecoxib) for arthritis.
The basic issue is not whether prescription drugs will be sold online. That is already well underway. But is filling out and submitting an online consultation form an adequate medical consultation? Is it as good as seeing a doctor in person? Whether prescription drugs will be prescribed responsibly and sold responsibly online is what is at stake.