Consider these recent developments:
C. Everett Koop finally chucked the saint act and formed an alliance with Rite Aid, the drug store chain, to sell prescription refills on the Internet.
Long's Drugs announced it is moving online.
One of Bill Gates' top lieutenants, Peter Neupert, resigned to join a venture with Amazon.com called Drugstore.com.
I visited a Web site, not any of the above, and easily bought a bottle of Viagra without speaking to any doctor.
These events are all linked to the most important trend in modern health care: the growing desire of American consumers to dictate exactly what medications they want, when they want them, traditional physician approval be damned.
The apostle of this movement may well be New York physician Steven Lamm. Over the past few years Lamm, an assistant professor at the NYU School of Medicine, has authored a number of books touting 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 proclaimed in his most recent book, "Younger at Last."
And just how does one obtain this medicine? First, find a compliant 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," he writes. "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 Food and Drug Administration recalled the drugs for causing severe heart problems.
Apparently unrepentant, Lamm now has a new book, "The Virility Solution," touting, as its cover proclaims it, "The Amazing Drug Viagra." In it he proclaims that "all adults are entitled to a fulfilling sex life," that there is "a new medical miracle" and that, in addition to Viagra, a drug called Vasomax is "effective and well-tolerated." This is despite the fact that Vasomax wasn't submitted to the FDA for review until two weeks ago. It's still illegal to market it for erectile dysfunction. Oops. That double-blind study thing again.
The doctor and his co-writer, Gerald Couzens, laid literary claim to the Viagra story more than a year before the drug was approved by the FDA. In March 1997 their agent, Herb Katz, knowing that Lamm was engaged in clinical trials for 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 dealmakers did not, or at least would not: Lamm, as a clinical investigator for Vasomax, now had an apparent conflict of interest -- he 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 sponsor, Zonagen Inc.? How about to the human guinea pigs to whom he administered the drug?
Both Lamm and Zonagen, which recently applied to the FDA for approval for Vasomax, refuse to say. Unfortunately for the consumer, the FDA has still not figured out how to implement recent financial disclosure laws pertaining to clinical trials. Some disclosure is required if the trial involves government money or is carried out through a public institution, but even then the institution is not required to make such disclosures public.
That leaves much of the onus for reporting at the discretion of
entrepreneurs like Lamm and his friends in the publishing industry.
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 because Pfizer, the drug's maker, is a brilliant marketing organization. The company has refined the art of publicizing a "blockbuster drug" in stages, not unlike the way Hollywood releases a summertime action flick. That, of course, is all fair play in the course of pure market capitalism.
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 the Drugstore.com, or, in this case, a small button at the bottom of Lamm's Web site titled "thepillbox.com." Click on it and you
land on a page sporting a giant bottle of Viagra and asking the question: What quantity would you desire? What strength?
Take your pick and you automatically move to the next page. "If you do not have a prescription click here." Click. "For $85 you will receive a
physician consultation, which will enable you to receive your Viagra."
Click.
"Please sign this waiver of liability."
Click.
Next comes a short list of questions: Do you have trouble getting and
maintaining an erection? Yes or no. Do you currently take any nitric oxide
medications? 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. In a few days, a bottle of Viagra
will land on your doorstep, no physician contact. This
is exactly what happened to me last week.
Shocked, I immediately e-mailed Lamm about his affiliation with
thepillbox.com. 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." So fear not.
But few in the medical community would agree with that assessment. 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 yes-or-no questions on a
cheesy Internet questionnaire. This is what I got for $85.
"This is clearly pushing the envelope way past the limits," says 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."
Still unbelieving, I called the doctor whose name appeared on the bottle. 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 operators of thepillbox.com, the San Antonio pharmacy
that Lamm's webmaster had assured me was "the best." I got its genial
proprietor, Bill Stallknecht, to explain his operation. It turns out that
thepillbox.com initially put up its Web site to advertise its specialty: custom
compounding of pharmaceuticals for hard-to-treat patients. It got a few calls from highly specialized physicians.
Then Stallknecht began getting queries about Viagra. He decided to
advertise 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, I realized that Lamm might be right after all.
Perhaps the right to minimize contact with the medical system as we know
it, or to simply be allowed to find ways to legitimately experiment on
ourselves, should be stuck onto that ever-growing list of patient's rights.
After all, some of the biggest users of thepillbox.com's Viagra service
have been physicians.
Why was that? I asked Stallknecht.
"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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