RX ROULETTE ON THE INTERNET

Ryan Haight was a 16-year-old honor roll student in La Mesa, Calif. He took
advanced placement classes and was active in sports.

On Feb. 12, 2001, he died from a mixture of hydrocodone, morphine, Valium
and Oxazepam (an anti-anxiety drug). Ryan obtained those narcotics from
Internet pharmacies. For some of the drugs, he didn't have a prescription.
Others he got from a doctor he never met. Ryan's tragic story illustrates
just how dangerous ordering drugs on the Internet can be.

As chairman of the Senate's Permanent Subcommittee on Investigations (PSI),
I have directed an investigation into the ease and safety of drug purchases
over the Internet, the results of which we will present today at a hearing
in Washington. Internet pharmacies threaten the two major premises
underlying American prescription-drug policy: First, for certain
medications, consumers need the advice and consent of a licensed expert who
is familiar with their case. Second, the manufacture and handling of drugs
should be highly regulated to ensure quality and safety. Internet
pharmacies jeopardize those principles by making it possible for any
individual to purchase virtually any drug without a prescription from
anywhere in the world.

Manufacturers of these drugs and the Web sites that sell them are often
beyond the reach of U.S. regulations, and act accordingly.

* * * The PSI investigation focused on several important questions: How
easy is it for a 12-year old child to order drugs over the Internet? What
types of drugs are shipped into the U.S.? What proportion of pharmaceutical
imports are counterfeit, falsely branded, of improper potency, adulterated,
or improperly stored?

What are the health consequences for an individual who uses such drugs?

The findings are disturbing:

. The sheer volume of pharmaceutical packages entering the U.S. is massive,
and we are not doing enough to protect consumers.

John F. Kennedy Airport in New York receives a whopping 40,000 drug
packages each day, while some 30,000 pharmaceutical shipments land in Miami
and Chicago receives at least 4,300 packages containing drug products every
day. U.S. agencies do not have sufficient resources to inspect a
significant proportion of this influx, and the vast majority of these
packages enter without the type of close government supervision over
quality of production and handling that Americans take for granted.

. The contents of these shipments are often dangerous.

In one inspection at JFK Airport, Customs found that nearly 30% of
pharmaceutical packages contained controlled substances, the most addictive
pharmaceutical drugs in the world.

Other examples included the date-rape drug GHB (which had been ordered by
teenagers), codeine-laced products, morphine, fake Lipitor, injectable
steroids from China. There were boxes of unidentified drug products and
counterfeit Viagra that differed considerably in strength from the labeled
dosage.

We have also found shipments of expired drugs and drugs that are listed on
Subpart H, which have exceptionally restrictive requirements for
prescriptions and have horrible side effects.

. Not only were the contents of the shipments hazardous, but their
packaging and labeling were also unsafe.

For example, drugs that needed to be insulated and temperature-controlled
were shipped without insulation and at room temperature. Other containers
were shipped without labeling, instructions or warning materials.

For those that did include such information, some were not in English.

. It is easy to purchase these drugs over the Internet. The General
Accounting Office (GAO), at PSI's request, used the Internet to purchase
numerous prescription drugs -- including highly-addictive narcotics and
other controlled substances. Notably, GAO purchased these narcotics without
a prescription and without visiting a doctor.

GAO also used the Internet to purchase from foreign pharmacies counterfeit
versions of American drugs and pharmaceuticals that have not been approved
by the FDA.

. Our investigation does contain some encouraging news for those using bona
fide American pharmacy operations and those of us who support the safe
importation of Canadian drugs to ease the costs of prescription
medications. The preponderance of problems with virtual pharmacies
uncovered by GAO investigators was associated with drugs that came from
foreign countries other than Canada. All of the drug samples GAO received
from U.S. and Canadian Internet pharmacies included dispensing pharmacy
labels that generally provided patient instructions for use; none displayed
evidence of mishandling and most included warning information.

. In today's unregulated environment, however, imports are not always what
they seem. Indeed, PSI has found that many rogue Internet pharmacies
disguise their products' countries of origin.

Our investigation confirmed that some "Canadian" Web sites are not actually
located in Canada, nor do they dispense drugs manufactured there. Rather,
these Web sites are just as likely to send drugs that are manufactured in
Fiji, Pakistan, China, India or Southeast Asia. These sites do not
guarantee what is in the drugs, much less how they are manufactured or stored.

* * * Now that PSI has identified some serious problems in the Internet
pharmacy industry, we must start fashioning solutions.

These are fixable problems, and we intend to develop solid recommendations
for my colleagues in Congress to ensure the safe access to drugs that
Americans have come to expect.

These recommendations could include empowering Customs to immediately seize
and destroy any package containing a controlled substance that is illegally
imported into the U.S.; providing new disclosure standards for Internet
pharmacies; barring Internet sites from selling or dispensing prescription
drugs to consumers who are provided a prescription solely on the basis of
an on-line questionnaire; and allowing state attorneys general to go to
federal court to shut down rogue Internet pharmacies.

Surely we don't want to play what some correctly call "Rx Roulette" with
the health of American consumers by blindly ignoring real safety concerns
about the drugs we allow to be imported from the vast unregulated Internet
pharmacy.

Ignoring those concerns can have tragic consequences, like the story of
Ryan Haight.