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Viagra to your door via the Internet 

Wednesday, Aug 12 1998
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Consider these recent developments:

C. Everett Koop finally chucked the saint act and formed an alliance with Rite Aid, the drugstore chain, to sell prescription refills on the Internet.

Longs Drugs announced it is moving online.

One of Bill Gates' top lieutenants, Peter Neupert, resigned to join a venture with Amazon.com to be called Drugstore.com.

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And I visited a Web site - not any of the above - and easily bought a bottle of Viagra, without speaking to a single doctor. (Or to anyone at all.)

These events are all linked to perhaps the most important trend in modern health care: the growing desire of American consumers to decide exactly what medications they want, when they want them, traditional physician approval be damned.

The prime apostle of the patient-as-doctor movement may well be New York physician Steven Lamm. Over the past few years, Lamm, a practicing internist and assistant professor at the New York University Medical School, has authored a number of books extolling the wonders of "breakthrough" medications that improve lifestyle.

"Today, it's actually possible to lower age barriers, make our minds and bodies even better, and maintain that hard-won competitive edge through a combination of breakthrough medical discoveries and the aggressive use of what I call Vitality Medicine," Lamm proclaims in his last book, Younger at Last.

And just how does one obtain this medicine? First find a cooperative doctor, Lamm says. "In your search, you are going to come across physicians who may initially be skeptical of any medication, technique or new technology that has not already been proven to be successful with an indisputable double-blind study," Lamm says. "This would not be the right physician for you."

Instead, he advises, find one who has "a willingness to 'experiment' with new drugs and techniques." Certainly Lamm is willing to experiment with his readers. In Thinner at Last, he proclaimed the diet combination known as Fen-Phen to be safe and effective - only a few months before the FDA recalled the drugs for causing severe heart problems. His new book, The Virility Solution, which touts "The Amazing Drug Viagra" as "a new medical miracle," names another impotence drug, Vasomax, as "effective and well-tolerated" - despite the fact that Vasomax wasn't even submitted to the FDA for review until a month ago. It's still illegal to market it for erectile dysfunction. (That double-blind-study thing again.)

The doctor and his co-writer, Gerald Couzens, first jumped on the Viagra story more than a year before the drug was approved by the FDA. In March 1997 their literary agent, Herb Katz, knowing that Lamm was one of a number of doctors engaged by Zonagen Inc., to run clinical trials of Vasomax, approached Simon and Schuster editor Fred Hills with an idea for a "virility book." Hills signed on, but with one key proviso: There would only be a book if one of the drugs passed FDA approval. Lamm agreed.

The keen mind will here discern something the deal makers did not, or at least would not: Lamm, as a clinical investigator for Vasomax, now had a financial interest in the successful outcome of a drug he was supposed to be objectively "studying." Did he disclose that to the drug's developer, Zonagen Inc.? Both Lamm and Zonagen, which recently applied to the FDA for approval of Vasomax, refuse to say. (Some disclosure is now legally required when a trial involves government funding or is carried out through a public institution; but even then, the disclosure need only be made to the institution, not to the public.)

Did Lamm ever think he had a conflict of interest? "Absolutely not," the doctor finally told me in a terse phone interview. "But now I have to go. I elect not to talk to you. I choose that. I elect not to answer your questions. You can do what you want, but I elect to choose not to answer you."

Lamm's response didn't surprise me; press coverage of the Viagra phenomenon has largely been confined to questions like "Does it work?" and "Will it kill me before I come?" This is due in large part to a brilliant marketing strategy by Pfizer, the drug's manufacturer, which has refined the art of publicizing a "blockbuster drug" in stages, not unlike the way Hollywood releases a summertime action flick.

But what happens when a physician, a person bound to "first do no harm," becomes a cog in the wheel of commerce? What happens when the good name of, say, NYU Med is used for purposes that might best be called enlightened shilling?

Back arrow to Lamm's own self-promotional Web site (www.virilitysolution.com - more than 32,000 visitors since May 11), from which one can obtain autographed copies of The Virility Solution. From here, a link entitled "About Wellness" leads to www.thepillbox.com, site of the Pillbox Pharmacy of San Antonio, Texas, and an animated banner: "This month's special: Viagra."

Click here. What quantity would you desire? What strength? (The pillbox.com sells the drug for about $10 a tablet, pretty much the going rate.) "If you would like an Online Consultation with a licensed physician to obtain a Viagra Prescription," the text directs, "if appropriate to your medical condition and history, click here." Click. "There will be an $85 charge for this physician consultation." Click.

After signing a "waiver of liability," one proceeds to a short list of questions: Do you have trouble getting and maintaining an erection? Yes or no. Do you currently take "any medication classified as a nitrate in any form" (e.g., nitroglycerin)? Yes or no. What other medications do you take? Fill in the blank.

Then comes the most important question: What is your credit card number? Fill that in and click one last time, and in a few days, a bottle of Viagra will land on your doorstep, no physician contact, no questions asked. This is exactly what I did last week.

A first-time prescription for a new, non-emergency drug issued with absolutely no direct contact with a qualified physician? Even the loosest interpretation of Title 21, the government code that regulates the prescription process, calls for a relationship between patient and physician and/or a consultation based on the "usual course of his professional practice." In this case, the relationship was a cyber-bit. The "usual course of professional practice"? Five questions on an Internet questionnaire and an $85 charge.

"This is clearly pushing the envelope way past the limits," said Gay Dodson, chief of the Texas State Board of Pharmacy, which has opened an investigation of thepillbox.com. "A pharmacist can't generate a script. It has to be a physician. And that physician has to have a relationship with the patient."

Shocked at how easy it had been to obtain the drug over the Internet, I immediately e-mailed Lamm about his apparent affiliation with the Pillbox Pharmacy. His self-described "Webmaster," Scott Harrison, answered. "We have no financial connection with [thepillbox.com], save a link they put up for the book on their site," he told me. "They are the only legitimate Viagra-dealing pharmacy on the Web."

Still amazed, I called Dr. Ron Nelms, of San Antonio, whose name appeared on the bottle as prescribing physician. I got a nurse, who told me she dealt with "all the Viagra stuff." But what if I had a problem, and I wanted to talk to my doctor? Did she have my file? No. "But anyway," she concluded cheerily, "there's only a few side effects you can get with Viagra."

"What if I have one that isn't on your list?"

"Eh, well, the doctor, eh, he takes care of all the Internet orders in the morning. You'll have to talk to him. What did you say your name was?"

I then called the Pillbox Pharmacy and asked its genial proprietor, Bill Stallknecht, to explain his operation. It turns out that the pharmacy originally went online to advertise its specialty: custom compounding of pharmaceuticals for hard-to-treat patients. Then Stallknecht began getting queries about Viagra. He decided to create a service to pre-order the drug, in advance of its approval by the FDA. The idea was to "get the orders early," then get the official prescriptions. "Then the form that the customer fills out, you know, 'yes this or no that,' gets downloaded to the lab, then gets sent over to the doctor, who reviews it and then passes it back to us," Stallknecht told me. Sometimes the doctor even says no. "There's a lot of 'em that he kicks right back out."

Listening to Stallknecht, currently a Libertarian candidate for Congress in Texas' 23rd District, I began to think that it possibly wasn't the worst thing to minimize contact with the medical system as we know it, or to simply be allowed to experiment on oneself. Indeed, said Stallknecht, some of the biggest users of the Web site's Viagra service have been physicians.

Why was that?

"Ahh, you know," Stallknecht said with a chuckle. "I mean, if you were a doctor, would you want to go fill your own script for Viagra at the next-door pharmacy?

"Doctors, you know, they can be real shy."

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