From: eugene.leitl@lrz.uni-muenchen.de
Date: Mon Jan 17 2000 - 15:22:06 MST
From: "David Farber" <farber@cis.upenn.edu>
-----Original Message-----
From: Suzanne Johnson [mailto:sjohnson@cncdsl.com]
Sent: Monday, January 17, 2000 2:56 PM
To: farber@cis.upenn.edu
Subject: Re: IP: Internet pharmacies
I read this article with interest when it appeared in the paper version of
the NYT. Yet, I was puzzled by some of the statements, which seemed to not
account for some of what we are seeing happen here in California.
Specifically, the California Medical Assn. has sent mailings to its member
physicians regarding the problem of patients being able to get
prescriptions on-line without a physicians okay. They cite Drugstore.com
as one of the primary offenders...which would seem to be at odds with what
was reported in this article. A friend of mine, who is a physician in CA,
has received mailings from the CMA detailing the problem. He also reports
having heard a discussion program on NPR in which one of the folks
interviewed was a 16 year old boy who managed to get a prescription for
Viagra from Drugstore.com . When asked about this, a Drugstore.com
representative replied that apparently the physician who checks
prescription requests "overlooked" the age information by mistake.
(Apparently, to get a prescription from Drugstore.com one needs to fill out
a form requesting the medication. The form is then supposed to be a
reviewed by a physician and the prescription filled.) The CMA feels that
visits to real life physicians have been made unnecessary.
So, to me, it would appear that this could turn into a political battle of
large special interest groups.
My own feeling is that, while I wish there were a better way to get most
prescriptions filled, I seriously worry about what is happening with drug
resistant bacteria. Misuse of antibiotics seems to be giving rise to an
increasing number of these resistant bacteria...and obtaining antibiotics
without a prescription and misusing them, will only make the problem worse
(it's bad enough with antibiotic prescriptions obtained FROM physicians).
Interestingly, the 1938 Food, Drug and Cosmetic act cited in the article
below was passed before antibiotics became available on a large scale basis.
So, there may be no easy answers here..but if medical groups and Si Valley
VC types square off against each other...I'm not sure there would be ANY
winners.
Suzanne
At 06:27 PM 1/11/00 +0000, you wrote:
>
>
>----Original Message-----
>From: VPostrel@aol.com
>To: farber@cis.upenn.edu
>Subject: Internet pharmacies
>Date: Tuesday, January 11, 2000 12:40 PM
>
>I published the following in the NYT on 1/3/00. I am curious about the
>deafening silence with which the Internet community has greeted this issue.
I
>have my theories as to the reasons, but am curious about others'.
>
>Sometimes the Patient Knows Best
>
>By Virginia Postrel
>
>January 3, 2000
>
>LOS ANGELES -- The Internet's abundance -- of information, goods, tastes
>and sources of authority -- creates unparalleled opportunities for
>individuals to get exactly what they want. But this plenitude threatens
>political and cultural authorities who believe in telling individuals
>what they can have rather than letting them choose for themselves. It
>was inevitable, therefore, that the growth of the Internet would lead to
>complaints that its diversity undermines media standards, traditional
>morality and political authority. It was inevitable that the Internet
>would face calls for censorship.
>
>And it was equally inevitable that the Internet would clash with
>American pharmaceutical regulations. The United States government
>approaches patient choice in medication as Singapore does free speech:
>its pronouncements sound reasonable and tolerant until you threaten its
>prerogatives.
>
>The Internet ethos of diversity and competition runs exactly counter to
>uniform, gatekeeper-oriented medical culture -- the technocratic
>philosophy of the "one best way" embodied in our pharmaceutical
>regulations. On the Net, medical information is abundant and pharmacies,
>domestic and foreign, operate on many different models.
>
>Now President Clinton is calling for new laws to require pharmacy Web
>sites to get licenses from the Food and Drug Administration before they
>can go online. He also wants large new federal fines, up to $500,000 per
>sale, for selling prescription drugs "without a valid prescription."
>Determining what's "valid" would put the federal government in the
>business of regulating medical practice. To enforce these new rules, the
>administration would give the F.D.A. subpoena powers and $10 million in
>fiscal 2001.
>
>The Clinton initiative would greatly expand federal control over
>cyberspace while nationalizing state-level pharmacy regulations and
>common law standards of medical care. High-profile,
>venture-capital-backed Internet pharmacies like Drugstore.com and Planet
>Rx.com support the initiative's general philosophy and goals but have
>expressed concern about whether new federal powers are necessary. They
>favor stricter enforcement of existing laws. These sites operate within
>traditional procedures, requiring a prescription from the patient's
>personal physician.
>
>But other online pharmacies let customers fill out questionnaires about
>their health and get prescriptions from doctors without in-person exams.
>
>These sites range from shadowy operations without known addresses to
>well-established brick-and-mortar businesses like the Pill Box, a
>five-store chain based in San Antonio. They tend to specialize in
>so-called lifestyle drugs like the anti-impotence treatment Viagra and
>the anti-baldness drug Propecia.
>
>The Food and Drug Administration calls them rogue sites, and government
>officials claim they victimize customers. Janet Woodcock, director of
>the F.D.A.'s Center for Drug Evaluation and Research, told a House
>committee in July: "A system of drug regulation was established in this
>country that has served us well. But even with this system in place,
>there are those who still try to sell unapproved or unsafe drug
>products, and the Internet provides them with new opportunities for
>reaching unsuspecting and vulnerable consumers and undermining
>established safeguards,"
>
>Fraudulent operators exist, of course, but their products and practices
>are well covered by existing laws. The threat to the power of regulators
>comes from sites that benefit customers who don't feel well served by
>the established system. A significant number of Americans obviously
>prefer the privacy and convenience of a Web-based medical consultation
>to the invasiveness and hassle of a physician visit.
>
>While they may go to the doctor for diagnosis and treatment of
>conventional illnesses, these consumers don't see their sex lives or
>baldness as requiring physical exams. Regulators also tend to idealize
>in-person exams, as though every doctor took a careful history and
>thoroughly examined a patient before prescribing any drug.
>
>The White House claims that "in cyberspace, consumers have no way of
>telling whether an online pharmacy is a legitimate operation." This
>isn't true. Brand reputations, contact numbers and street addresses, and
>a pharmacy association certification program are all indicators that a
>business is sound.
>
>The F.D.A. itself offers useful advice to help consumers evaluate
>pharmacy sites. The real issue is that not all consumers agree on what
>is "legitimate."
>
>Internet pharmacies return to consumers the choice promised by
>supporters of the 1938 Food, Drug and Cosmetic Act. That law established
>federal requirements for drug safety and labeling but exempted
>prescription medicines from the labeling rules.
>
>The bill was sold as a way to help consumers make informed choices about
>their medications, not as a way to transfer those choices to physicians,
>drug makers and regulators. The goal, W. G. Campbell, then head of the
>F.D.A., told a Senate committee, was merely "to make self-medication
>safe."
>
>The government broke that promise. As the Massachusetts Institute of
>Technology economist Peter Temin recounted in "Taking Your Medicine,"
>his 1980 book on drug regulation, "The agency moved within six months of
>the bill's passage to curtail self-medication sharply and thereafter
>used a substantial and increasing proportion of its drug resources to
>enforce its imposed limitations." The agency created a new class of
>medicines that could be sold only by prescription -- a category that has
>greatly expanded over the succeeding decades. In doing so, Mr. Temin
>wrote, it "appointed doctors as the consumers' purchasing agents."
>
>The Internet partially restores patients' rights to choose how they buy
>their medications and from whom. No wonder the drug censors are so
>upset.
>
>Virginia Postrel (vpostrel@reason.com)
>Editor, Reason
>Author, The Future and Its Enemies
>Columnist, Forbes
>www.dynamist.com | www.reason.com
>(310) 391-2245 (voice) | (310) 390-8986 (fax)
>
>2nd Annual Reason Dynamic Visions Conference, February 19-21, 2000
>http://www.reason.com/dynamic/dynamic2000.html
>
>
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