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T A B L E+T A L K
What exactly is on Monica's dress? Discuss the most famous cocktail dress in history in the Headlines area of Table Talk

D A I L Y+Q U O T E
Another Globe columnist in hot water

R E C E N T L Y
Just do it, Bill
By Fred Branfman
The president should tell the truth
(08/06/98)
Clinton's sexual scorched-earth plan
By Jonathan Broder and Harry Jaffe
The White House may be ready to declare a "total war" on Congress over the Lewinsky case
(08/05/98)
New JFK death film
By Scott McLemee
New Zapruder film doesn't solve JFK case
(08/04/98)
Author asks: When did Jones and Clinton meet?
By Lori Leibovich
Mystery at the Excelsior Hotel
(08/03/98)
A new kind of strike
By David Bacon
The first auto strike over GM's global investment strategy
(07/31/98)
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_______________( O R_.O T H E R_.D R U G S )
______IT USED TO TAKE A REAL DOCTOR TO
______ISSUE A PRESCRIPTION -- BEFORE THE WEB.
news
- - - - - - - - - - - - - - -
BY GREG CRITSER
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.
N E X T+P A G E+| Conflict of interest? "Absolutely not. Goodbye."

T A B L E+T A L K What exactly is on Monica's dress? Discuss the most famous cocktail dress in history in the Headlines area of Table Talk D A I L Y+Q U O T E Another Globe columnist in hot water R E C E N T L Y Just do it, Bill By Fred Branfman The president should tell the truth (08/06/98) Clinton's sexual scorched-earth plan By Jonathan Broder and Harry Jaffe The White House may be ready to declare a "total war" on Congress over the Lewinsky case (08/05/98) New JFK death film By Scott McLemee New Zapruder film doesn't solve JFK case (08/04/98) Author asks: When did Jones and Clinton meet? By Lori Leibovich Mystery at the Excelsior Hotel (08/03/98) A new kind of strike By David Bacon The first auto strike over GM's global investment strategy (07/31/98) - - - - - - - - - - - - - - - - Browse the Newsreal Archives - - - - - - - - - - - - - - - -
		Click here for Viagra _______________( O R_.O T H E R_.D R U G S ) ______IT USED TO TAKE A REAL DOCTOR TO ______ISSUE A PRESCRIPTION -- BEFORE THE WEB. - - - - - - - - - - - - - - - BY GREG CRITSER 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. N E X T+P A G E+\| Conflict of interest? "Absolutely not. Goodbye."