From: "David Farber" <farber@cis.upenn.edu>
----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
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