[Senate Hearing 110-472]
[From the U.S. Government Publishing Office]
S. Hrg. 110-472
ROGUE ONLINE PHARMACIES: THE GROWING PROBLEM OF INTERNET DRUG
TRAFFICKING
=======================================================================
HEARING
before the
COMMITTEE ON THE JUDICIARY
UNITED STATES SENATE
ONE HUNDRED TENTH CONGRESS
FIRST SESSION
__________
MAY 16, 2007
__________
Serial No. J-110-35
__________
Printed for the use of the Committee on the Judiciary
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COMMITTEE ON THE JUDICIARY
PATRICK J. LEAHY, Vermont, Chairman
EDWARD M. KENNEDY, Massachusetts ARLEN SPECTER, Pennsylvania
JOSEPH R. BIDEN, Jr., Delaware ORRIN G. HATCH, Utah
HERB KOHL, Wisconsin CHARLES E. GRASSLEY, Iowa
DIANNE FEINSTEIN, California JON KYL, Arizona
RUSSELL D. FEINGOLD, Wisconsin JEFF SESSIONS, Alabama
CHARLES E. SCHUMER, New York LINDSEY O. GRAHAM, South Carolina
RICHARD J. DURBIN, Illinois JOHN CORNYN, Texas
BENJAMIN L. CARDIN, Maryland SAM BROWNBACK, Kansas
SHELDON WHITEHOUSE, Rhode Island TOM COBURN, Oklahoma
Bruce A. Cohen, Chief Counsel and Staff Director
Michael O'Neill, Republican Chief Counsel and Staff Director
C O N T E N T S
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STATEMENTS OF COMMITTEE MEMBERS
Page
Feinstein, Hon. Dianne, a U.S. Senator from the State of
California..................................................... 15
Leahy, Hon. Patrick J., a U.S. Senator from the State of Vermont. 1
prepared statement........................................... 161
Sessions, Hon. Jeff, a U.S. Senator from the State of Alabama.... 3
Specter, Hon. Arlen, a U.S. Senator from the State of
Pennsylvania................................................... 2
WITNESSES
Califano, Joseph A., Jr., Chairman and President, The National
Center on Addiction and Substance Abuse at Columbia University,
and former Secretary, Department of Health, Education, and
Welfare, New York, New York.................................... 7
Haight, Francine H., Founder of RYAN's Cause, Laguna Niguel,
California..................................................... 5
Heymann, Philip B., James Barr Ames Professor of Law, Harvard Law
School, and Former Deputy U.S. Attorney General, Cambridge,
Massachusetts.................................................. 10
McLellan, A. Thomas, Chief Executive Officer, Treatment Research
Institute, Philadelphia, Pennsylvania, statement............... 14
Rannazzisi, Joseph T., Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, Department
of Justice, Washington, D.C., statement........................ 13
QUESTIONS AND ANSWERS
Responses of Joseph A. Califano to questions submitted by
Senators Leahy and Specter..................................... 27
Responses of Philip B. Heymann to questions submitted by Senators
Leahy and Specter.............................................. 38
Responses of A. Thomas McLellan to questions submitted by
Senators Leahy and Specter..................................... 45
Responses of Joseph Rannazzisi to questions submitted by Senators
Leahy, Durbin and Specter...................................... 51
SUBMISSIONS FOR THE RECORD
American Pharmacists Association, Washington, D.C., statement.... 85
Califano, Joseph A., Jr., Chairman and President, The National
Center on Addiction and Substance Abuse at Columbia University,
and former Secretary, Department of Health, Education, and
Welfare, New York, New York, statement and attachment.......... 89
Federation of State Medical Boards, James N. Thompson, M.D.,
President and Chief Executive Office, Dallas, Texas, statement. 111
Haight, Francine H., Founder of RYAN's Cause, Laguna Niguel,
California, statement.......................................... 116
Heymann, Philip B., James Barr Ames Professor of Law, Harvard Law
School, and former Deputy Attorney General, Cambridge,
Massachusetts, statement and attachments....................... 122
Marshall, Jon, Kentucky State Police, National Narcotic Officer's
Associations Coalition, Frankfort, Kentucky, statement......... 163
McLellan, A. Thomas, Chief Executive Officer, Treatment Research
Institute, Philadelphia, Pennsylvania, statement............... 169
National Association of Chain Drug Stores, Alexandria, Virginia,
statement...................................................... 173
Rannazzisi, Joseph T., Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, Department
of Justice, Washington, D.C., statement........................ 178
ROGUE ONLINE PHARMACIES: THE GROWING PROBLEM OF INTERNET DRUG
TRAFFICKING
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WEDNESDAY, MAY 16, 2007
U.S. Senate,
Committee on the Judiciary,
Washington, DC.
The Committee met, pursuant to notice, at 10:07 a.m., in
room SD-226, Dirksen Senate Office Building, Hon. Patrick J.
Leahy, Chairman of the Committee, presiding.
Present: Senators Leahy, Feinstein, Specter, and Sessions.
OPENING STATEMENT OF HON. PATRICK J. LEAHY, A U.S. SENATOR FROM
THE STATE OF VERMONT
Chairman Leahy. Good morning. Today the Committee will be
holding an important hearing on the growing problem of rogue
online pharmacies that illegally traffic in highly addictive
painkillers and other controlled substances.
You know, in many ways, the Internet has made our lives
better. I have been one of its biggest proponents for those
reasons. It removes the historic constraints from geography; it
provides access to information and knowledge that might
otherwise remain unavailable, especially to people like myself
who live in rural areas. Distance learning, access to medical
knowledge at the finest hospitals, and increased commercial
competition--these are all aspects of the Internet that are
important. Vermont businesses sell Vermont products throughout
the Nation and around the world through the Internet. At the
same time, the Internet has enabled Vermonters, and others,
better access to convenient and more affordable medicine, which
should be stressed.
But the online sale of pharmaceuticals presents a more
complicated and problematic aspect. Rogue online pharmacies
increasingly have become a source for the illegal supply of
controlled substances. Dangerous and addictive prescription
drugs are too often only a click away without the proper
constraints of local doctors and pharmacists.
Controlled drugs, such as pain relievers, tranquilizers,
stimulants, and sedatives, can be too easily bought illegally
over the Internet. Anyone--including children--can readily
obtain dangerous controlled substances from online pharmacies.
All they need is access to a computer and a credit card. The
check and security provided by our local pharmacists in local
pharmacies--those who have served Americans for generations and
helped us get well and keep us well--is not always replicated
online.
The 2006 National Survey on Drug Use and Health indicates
that almost 6 million people currently misuse prescription
drugs and, of them, more than two-thirds 4.4 million people--
abuse pain relievers such as OxyContin. Some celebrities have
been involved in high-profile cases, but I am more concerned
about the fact that people in every state and increasingly from
every age group and demographics are affected. When abused,
these drugs have enormous potential to cause harm and illness
and addiction, and as we are going to hear this morning from
one of our witnesses, tragically even death.
American teenagers are always particularly vulnerable to
Internet drug trafficking. Among young people, prescription
drugs have become the second most abused illegal drug. In fact,
if you exclude marijuana, more adults and teens report abusing
prescription drugs than all the other illicit drugs combined.
Too many American teenagers mistakenly believe that abusing
addictive narcotics is a safe way to get ``high.''
As we learned just last week, some drug companies have
themselves contributed to that dangerous impression by giving
consumers misleading information about the addictive qualities
of these drugs. Purdue Pharmacies, the maker of the powerful
painkiller OxyContin, and three of its corporate executives
pled guilty to intentionally misleading the public when it
promoted OxyContin as less addictive than narcotics. It is a
sad day when pharmaceutical companies act like tobacco
companies and mislead the public rather than alerting the
public to the risks associated with the use of its products.
We have legislation referred to this Committee that would
create potent new tools for law enforcement to prosecute those
who illegally sell drugs online and allow State authorities to
shut down online pharmacies even before they get started. And I
will work with the Senators from California and Alabama and
others on these matters.
As the longtime Co-Chair of the Congressional Internet
Caucus, I will ask the Caucus to consider the issue of the
growing danger that online pharmacies pose to youth.
Internet drug trafficking has presented another challenge
for law enforcement. If drug dealers came into our
neighborhoods selling these kinds of drugs, Americans would be
up in arms.
So I thank our distinguished panel of witnesses for
appearing today, and I also especially want to thank Senator
Specter for his work in connection with this hearing.
[The prepared statement of Senator Leahy appears as a
submission for the record.]
Senator Specter?
STATEMENT OF HON. ARLEN SPECTER, A U.S. SENATOR FROM THE STATE
OF PENNSYLVANIA
Senator Specter. Thank you, Mr. Chairman, for scheduling
this important hearing. The problem of drug addiction has been
with our society for decades. I first saw it in an intense
fashion when I was district attorney of Philadelphia four
decades ago, and the problem has been increasing in seriousness
and is a major problem in our society.
With the Internet and technological advances, we now find
that drugs are accessible by the rogue pharmacies, and the
problem is one of enormous importance. It came into sharp view
in Philadelphia in 2006 when there was a DEA bust of a major
Internet drug ring run from Philadelphia by two foreign
graduate students at Temple University and 25 co-conspirators
who were arrested in four different countries.
It is possible to have legitimate purchase of drugs over
the Internet, but there were only 12 such DEA registered
pharmacies. Most of the other Internet pharmaceutical sales in
the United States are legally suspect. Federal law mandates
that there is a prescription before dispensing the drugs, which
we all know, but that is avoided. The Center on Addiction and
Substance Abuse discovered over 3 years the total number of
websites been selling prescription drugs has increased
enormously. The regulation of online pharmacies and doctors
consists of a very patchwork arrangement so that it is the
subject which requires, I do believe, Federal legislation, so I
am glad to see such a distinguished panel here today.
We very much appreciate your presence, Mrs. Haight, with
the situation that your son, Ryan Thomas Haight, died of an
overdose of narcotics he had purchased on the Internet without
a prescription.
We have a very distinguished array of experts, and,
regrettably, we are not going to have a very extensive array of
Senators--not necessarily distinguished even when present,
except for Senator Leahy and Senator Sessions. But it is a
very, very busy day on Capitol Hill.
I am going to have to excuse myself to return to
deliberations which are underway on the immigration issue. We
have had more than two dozen meetings of lengthy duration,
mostly in excess of 2 hours, where 12 Senators sit still--that
is, we sit still; our jaws are not still--as we try to work
through an extraordinarily difficult legislative issue.
Then that is compounded by the problem that we are having a
series of votes at 10:30, and votes come ahead of everything
else. That is our basic paycheck in the United States Senate,
what our voting record is. But I have staff here who will be
following the proceedings very closely, and I am sorry to miss
the testimony, because this is an extraordinarily distinguished
panel.
Chairman Leahy. During this, as the votes start, we will
stop and start. Some of you are familiar with that.
Senator Sessions has worked hard on this. Jeff, did you
want to say anything?
Senator Sessions. If you do not mind, Mr. Chairman.
Chairman Leahy. Go ahead.
STATEMENT OF HON. JEFF SESSIONS, A U.S. SENATOR FROM THE STATE
OF ALABAMA
Senator Sessions. I will not be long, because we do have a
distinguished panel and we want to hear from them. But I am
glad that with your leadership and, really, with Senator
Specter last year, we have had a good chance to move this
important legislation forward. I am convinced that it is good
legislation. As a former Federal prosecutor who prosecuted a
great many drug cases, it is amazing to me that with the
regulations we have in so many different areas that even a
teenager with very little effort can order drugs, controlled
substances, off the Internet. It just undermines this entire
system that we have.
I remember after I ceased being United States Attorney
representing an individual who was a young person that had a
knee injury, started taking pain pills. He was going all over
town. There was nothing he would not do. He was president of
his class. But he just had to have these drugs. The addiction
is very powerful. Some people think it is because it is a
prescription drug, the addiction is not as powerful or cocaine
or some of the other drugs. It is a powerful addiction, and
people do things that destroy them, and they cannot seem to
stop. And being able to obtain large amounts of drugs off the
Internet allows that addiction to continue and delays the
intervention that can be life saving.
The bill that Senator Feinstein and I have introduced--and
I certainly appreciate her leadership. She understands this
issue very well. She has had a personal experience with people
who have tragic losses as a result of prescription drug abuse
through the Internet, and it is a pleasure to work with her.
I was interested to note and am pleased to note that in the
Washington Times today, there is an op-ed by John Horton, a
former Assistant Deputy Director of the White House Drug Policy
Office, and Kristi Remington, a former Deputy Assistant
Attorney General in the Justice Department, which endorses the
legislation Senator Feinstein and I have offered. And they note
in their article that, ``The Online Pharmacy Protection Act,
which will be considered today by the Judiciary Committee,
brings the law regulating the sale of controlled substances
into the Internet age and is a vitally important tool in our
Nation's anti-drug efforts. It should be sent to the full
Senate for passage.'' They note that, ``Ms. Feinstein and
Senator Sessions have ensured the bill takes into account
legitimate issues concerning telemedicine and the practice of
covering practitioners, but in each case, a physician who is
familiar with the patient, can determine whether medication is
truly necessary or if the person is possibly acquiring the
prescription drug because of an addiction.''
So thank you, Mr. Chairman, and I would offer this article
for the record.
Chairman Leahy. Thank you. It will be included in the
record.
Would you please stand, all of you, and raise your right
hand? Do you solemnly swear that the testimony you will give in
this matter will be the truth, the whole truth, and nothing but
the truth, so help you God?
Ms. Haight. I do.
Mr. Rannazzisi. I do.
Mr. Califano. I do.
Mr. Heymann. I do.
Mr. McLellan. I do.
Chairman Leahy. We will begin with Ms. Francine Haight. I
have already chatted with her briefly and, again, I commend you
for your courage in being here.
She is the founder of RYAN's Cause, Reaching Youths Abusing
Narcotics. It is a nonprofit organization dedicated to
educating parents, families, and communities on issues
concerning the Internet and drug abuse. Ms. Haight founded
RYAN's Cause after her 18-year-old son, Ryan Thomas Haight,
tragically died from an overdose of prescription drugs which he
had purchased through the Internet.
Ms. Haight has told her story around the country to help
educate and bring public awareness to the danger of sales of
drugs on the Internet. Her son's story was mentioned in the
recently aired HBO series ``Addiction.'' In June of last year,
Ms. Haight was a sponsor to the first national candlelight
vigil out at DEA headquarters in Arlington, Virginia, for those
that died from the drugs.
Ms. Haight, I know this is not an easy time for you, but I
just want you to know how much we appreciate the fact you have
come here from California to speak, and please go ahead.
STATEMENT OF FRANCINE H. HAIGHT, FOUNDER OF RYAN'S CAUSE,
LAGUNA NIGUEL, CALIFORNIA
Ms. Haight. Good morning. My name is Francine Haight, and
thank you for inviting me to testify at this hearing about a
very important topic that tugs at my heartstrings every day.
Many of the speakers here today will give you statistics and
numbers, but I am here to put a face to those numbers. And I am
very sad that today that face is my son, Ryan Thomas Haight.
Unfortunately, he was a victim of illegal sales of
pharmaceuticals through the Internet.
Ryan was born on December 28, 1982, and died on February
12, 2001, from an overdose of prescription drugs he had
purchased on the Internet. He was only 17 when he purchased
these drugs, and he was only 18 when he died.
He was an incredible boy. From the time he was little, I
always believed that he would make a difference in this world.
He was intelligent and excelled in school, was an A student and
maintained a 4.0 or above during his years in high school. He
looked forward to going to college.
He was athletic, loved the thrill of competition, played
Open Junior Tennis tournaments, and went on to play varsity
tennis for Grossmont High School in La Mesa, California. He
loved to ski, snow ski, water ski, kneeboard, and he attempted
all sports with great enthusiasm.
But Ryan also loved using the computer. He was thrilled to
find out that he could chat online, that he could receive and
send e-mails, and that he learn and talk about educational and
current events. He learned to surf the Internet. It was a
perfect place for him to use for his papers in school or to
seek information he was curious about. He used the computer to
play games, and he enjoyed trading baseball cards on eBay. But
on February 12, 2001, that all stopped.
On February 12, 2001, I found Ryan in his bed, lifeless. I
tried to resuscitate him, but could not bring him back. Ryan
had died. And I was in shock. Just the night before, we had
dinner together after he came home from working at a nearby
retail store. That night I had kissed him and said good night,
and he said, ``I love you, Mom.'' Those were the last words I
would hear from him. Ryan died from an overdose of the
prescription drug Vicodin. He also had a small amount of Valium
and morphine. And I thought, How? How did he get these drugs?
After one of his friends told me that he got them on the
Internet, we gave our computer to the DEA to investigate. And
through their investigation, they found how Ryan had ordered
the drugs.
Ryan had made up a story. He had said he was 21. He said he
had been in a car accident and had back pain, and he made up a
doctor's name, Dr. Thomas, which happened to be his middle
name. Dr. Robert Ogle, whom Ryan never saw and was never
examined by, prescribed them, and an Internet pharmacy, Clayton
Fuchs of Mainstreet Pharmacy, delivered them to our home. I was
in shock. I thought, How could this be possible? I am a
registered nurse; Ryan's father is a physician. We know that
all controlled substances have to be accounted for. We count
each and every drug that we give when we administer it to a
patient. They are under lock and key. How could he get these
off the Internet so easily? At a time when we were worried
about our children being exposed to pornography and predators,
marijuana and alcohol, we did not know that drug dealers were
in our own family room.
After a long investigation and trial, Dr. Robert Ogle and
Clayton Fuchs, who together made millions by their drug
dealings, were prosecuted by the United States Attorney in
Dallas and are now in Federal prison. I attended the sentencing
of Clayton Fuchs, and although it does give me some peace that
justice was served, it does not bring Ryan back. I am still
shocked at the ease and availability of buying controlled
substances on the Internet. I receive e-mails every day from
13-year-old children to adults that they are just overwhelmed
by the problems that they see happening from drugs being sold.
Over the last few months, Ryan's story has been told in a
documentary called ``Online Nightmares,'' and it was produced
by E Entertainment. It has aired about 15 times, and since then
the mail that I get is just overwhelming in my mailbox. This is
an ongoing problem.
After Ryan died, it took me almost 3 years to get enough
strength to do what I am doing, and I started RYAN's Cause--
Reaching Youths Abusing Narcotics. And I have done a lot of
news and gone out, and I just hope that it will raise awareness
of this growing problem among our teens in hopes to prevent
other families from suffering such a devastating loss.
I am here today because I want to help fight this war
against drugs and too many people are dying.
Congress needs to attempt to counter the growing trend of
prescription drug abuse by passing a bill, the Ryan Haight
Internet Pharmacy Consumer Protection Act or perhaps by adding
Ryan's bill as a noncontroversial amendment to the prescription
drug user fee which governs FDA issues and prescription drug
review and addresses the safety issue incumbent in drug sales.
I am a parent that belongs to a club that I never wanted to
join. I am an ordinary person who could be your neighbor, your
coworker, or member of your house of worship. But drugs took my
son from me, and some days the grief is still unbearable. Drug
abuse is an equal opportunity killer. It is not confined to one
kind of neighborhood, one socioeconomic group, or one kind of
child. Ryan was the boy next door. We need to do everything we
can to protect our children. Tighter regulations on the sale of
controlled substances on the Internet will not totally solve
the drug problem, but I guarantee you it will help and it is a
good place to start.
Thank you for allowing me to speak and for listening to
this very important issue. Ryan continues to make a difference.
I just did not know he would be so far away.
[The prepared statement of Ms. Haight appears as a
submission for the record.]
Chairman Leahy. Thank you very much, Ms. Haight. We were
talking about your testimony last night at home. My wife is a
registered nurse, and she is struck by what you said about
having to account for all narcotics, and she remembers how
careful those are checked and double-checked. You are
absolutely right.
Joseph Califano is the Founding Chairman and President of
the National Center on Addiction and Substance Abuse, CASA. It
is an independent, nonprofit think tank affiliated with
Columbia University. He is an adjunct professor of public
health at Columbia University's Medical School and School of
Public Health and a member of the Institute of Medicine of the
National Academy of Sciences. He has extensive experience in
Government. He joined the Kennedy administration in 1961,
served as general counsel of the Army and Special Assistant to
the Secretary and Deputy Secretary of Defense. From 1965 to
1969, he served as Special Assistant for Domestic Affairs to
President Lyndon Johnson. From 1977 to 1979, he was Secretary
of Health, Education, and Welfare in the Carter administration.
He is a graduate of Holy Cross and Harvard University Law
School.
Mr. Califano, thank you for being here. Please go ahead.
STATEMENT OF JOSEPH A. CALIFANO, JR., CHAIRMAN AND PRESIDENT,
THE NATIONAL CENTER ON ADDICTION AND SUBSTANCE ABUSE AT
COLUMBIA UNIVERSITY, AND FORMER SECRETARY, DEPARTMENT OF
HEALTH, EDUCATION, AND WELFARE, NEW YORK, NEW YORK
Mr. Califano. Thank you, Mr. Chairman, for the invitation
to testify today. The National Center on Addiction and
Substance Abuse at Columbia University has studied the Nation's
problem of controlled prescription drug abuse and has
documented for 4 consecutive years the Internet availability of
these drugs.
In 2005, CASA released its landmark report, ``Under the
Counter: The Diversion and Abuse of Controlled Prescription
Drugs in the U.S.'' This report revealed that our Nation is in
the throes of a growing epidemic of controlled prescription
drug abuse involving opioids like OxyContin and Vicodin,
depressants like Valium and Xanax, and stimulants like Ritalin
and Adderall.
From 1992 to 2002, prescriptions written for such
controlled drugs increased more than 150 percent, 12 times the
rate of increase in our population and almost 3 times the rate
of increase in prescriptions written for all other drugs.
Mirroring this increase in prescriptions has been an
increase in the abuse of these drugs. From 1992 to 2003, the
overall number of Americans abusing controlled prescription
drugs rose 94 percent, 7 times faster than the increase in the
U.S. population. The number of 12- to 17-year-olds who abused
controlled prescription drugs jumped 212 percent, more than
triple.
In 2003, the number of Americans who abused controlled
prescription drugs exceeded as you said, Mr. Chairman, the
combined number abusing cocaine and all other illegal drugs
except marijuana, and they are on course to exceed abuse of
marijuana on the track they are on. Abuse of controlled
prescription drugs has grown at a rate twice that of marijuana
abuse, 5 times that of cocaine abuse, 60 times that of heroin
abuse.
Particularly troubling are the implications for our
children. From 1992 to 2002, new abuse of prescription opioids
among 12- to 17-year-olds was up an astounding 542 percent,
more than 4 times the rate of increase among adults. In 2003,
nearly 1 in 10 12- to 17-year-olds abused at least one
controlled prescription drug; for 83 percent of them, that drug
was an opioid. Teens who abuse controlled prescription drugs
are twice as likely to use alcohol, 5 times likelier to use
marijuana, 12 times likelier to use heroin, 15 times likelier
to use Ecstasy, and 21 times likelier to use cocaine, compared
to teens who do not abuse such drugs.
In 2005, 15.2 million Americans abused these drugs
including more than 2 million teens. The explosion in the
prescription of addictive opioids, depressants and stimulants
has, for many children, made their parents' medicine cabinet a
greater threat than the illegal street drug dealer. But,
perhaps the most wide open substance supermarket in the world
is the Internet. The Internet has become a pharmaceutical candy
store, its shelves stacked with an array of addictive
prescription drugs offering a high to any kid with a credit
card at the click of a mouse.
For 4 years now, at CASA, in collaboration with Beau Deitl
& Associates, we have been tracking online access to controlled
prescription drugs. In the first quarter of each year, we have
devoted 210 hours to documenting the number of Internet sites
advertising and dispensing controlled drugs. These findings are
a snapshot of availability at a given point in time and show
trends from year to year. They do not capture the total number
of sites advertising or selling controlled prescription drugs
online, which may be many times the numbers I am using now.
Today CASA is releasing the fourth in its annual series of
reports entitled `` `You've Got Drugs!' IV: Prescription Drug
Pushers on the Internet.'' Here are the report's disturbing
findings. From 2006 to 2007, there has been a 70-percent
increase in the number of sites advertising or selling
controlled prescription drugs over the Internet, from 342 to
581; a 135-percent increase in the number of sites advertising
controlled prescription drugs; a 7-percent increase in the
number of sites selling controlled prescription drugs. Eighty-
four percent of the sites selling controlled prescription drugs
do not require a prescription from the patient's physician, and
most of the remaining 16 percent of sites that ask for a
prescription simply ask that it be faxed, allowing a customer
to forge it or use the same prescription many times to load up
on these drugs.
There are no controls--no controls--to stop the sale of
these drugs to children. Over the 4-year course of our
analysis, the number of selling sites has climbed from 154 to
187. Since there are no controls preventing sale of these drugs
to children, all a child needs is a credit card number and
access to a computer and ``You've Got Drugs!'' Efforts to crack
down on this illegal trafficking are complicated by outdated
Federal law written before the Internet and inadequate State
laws.
There is a mechanism in place for certifying Internet
pharmacy practice sites. It is the National Association of
Boards of Pharmacy, which verifies Internet pharmacy practice
sites. However, the process is voluntary. Of the 187 sites
found selling in 2007, only two were certified.
The widespread threat to the public health demands that
Congress now take action to: clarify Federal law to prohibit
the sale or purchase of controlled prescription drugs online
without an original prescription issued by a DEA-certified
physician based on a physical examination and evaluation; and
require certification of online pharmacies to assure that they
meet rigorous standards of professional practice.
The Feinstein-Sessions bill is a step in the right
direction and an important step. We have a few suggestions to
strengthen it that we can discuss with your staff, but we
really applaud, Senator Feinstein and Senator Sessions, what
you have done in introducing this bill.
The report we are releasing today makes other
recommendations that I hope you will consider.
Mr. Chairman, just in closing, substance abuse and
addiction--involving prescription drugs, alcohol, nicotine, all
of it--is the Nation's most serious domestic problem. It is
implicated in most crimes, most killing and crippling
illnesses, most domestic violence, most child abuse, most
homelessness, poverty, most teen pregnancy, and the wildfire
spread of AIDS and other sexually transmitted diseases. I have
titled my book on this subject ``High Society,'' and I will
give you one simple fact. We Americans are 4 percent of the
world's population; we consume two-thirds of the world's
illegal drugs.
This problem is all about kids. A kid who gets through age
21 without smoking, using illegal drugs, or abusing
prescription drugs or alcohol is virtually certain never to do
so. Over the past 12 years, the fastest growing drug abuse
among our Nation's children involves prescription drugs. I
applaud the work of this Committee to curb the availability of
these drugs. We will do anything to help.
We are submitting our report along with my statement for
the record, and we really appreciate, Senator Leahy, you and
this Committee attending to this incredibly important problem.
[The prepared statement of Mr. Califano appears as a
submission for the record.]
Chairman Leahy. Thank you very much, and the report will be
part of the record.
Professor Philip Heymann is currently the James Barr Ames
Professor of Law at the Harvard University Law School.
Professor Heymann has served at high levels in both the State
and Justice Departments during the Kennedy, Johnson, Carter,
and Clinton administrations, including serving as the Deputy
Attorney General for the Justice Department from 1993 to 1994.
He served as the Assistant Attorney General in charge of the
Criminal Division from 1978 to 1981. He spent a lot of time in
this room, I might add. He was Acting Administrator of the
State Department's Bureau of Security and Consular Affairs,
Deputy Assistant Secretary of State for the Bureau of
International Organizations, and numerous other high-level
positions in Government. He was also a former associate
prosecutor and consultant on the Watergate Task Force. He also
helped establish the Keep Internet and Neighborhoods Safe
project and developed proposals to reduce illegal Internet
prescription drug sales to youth. He is a graduate of Yale
University and Harvard Law School and clerked for former
Supreme Court Justice John Harlan.
Professor, the floor is yours.
STATEMENT OF PHILIP B. HEYMANN, JAMES BARR AMES PROFESSOR OF
LAW, HARVARD LAW SCHOOL, AND FORMER DEPUTY ATTORNEY GENERAL,
CAMBRIDGE, MASSACHUSETTS
Mr. Heymann. Thank you very much, Mr. Chairman and members
of the Committee.
With Mathea Falco, the Director of Drug Strategies, who is
sitting behind me, we assembled a group of people from the
major facilitators of this traffic and from the major
enforcement agencies. On page 6, we list them in short:
Verizon, AOL, AT&T, Earthlink, Microsoft, Comcast, Google,
Yahoo!, UBS, Morgan Chase, MasterCard, Visa, Paypal; UPS, DHL,
FedEx, the DEA with Joe as their representative, the Department
of Justice, and so on.
Because we wanted to address one aspect of this problem--
which has been so well described that I am not going to repeat
it. We find it of the same size and importance and danger that
the others have described. But we saw in it the prospect of a
new form of sale of contraband which is, we think, the world of
globalization merged with the world of Internet. And we think
that is going to change everything, limiting the reach of drug
law enforcement no matter how important that may be, too.
The fact of the matter is the Internet service provider may
be in the Ukraine, the drugs may be in Somalia, the credit card
user--the seller of the drugs, the receiver of the money may be
in Turkmenistan. We are dealing with a brand-new world out
there, and the aspect of this problem that engaged us was the
international aspect--not yet the largest, probably. Most
people probably get their prescription narcotics out of their
parents medicine cabinet. But it will be the largest, and it
will be the future. And we wanted to tackle the future, and we
did in six full-day meetings.
Now, the secret, we discovered, was that we could--that
this traffic in Internet globalized contraband can only take
place with the cooperation of credit card companies, Paypal,
Internet service providers, search engines. If you think of it
from the beginning, a search engine is out there advertising
the sale of the drug. You cannot get to the advertisement--I am
sorry. You click on the Google advice, and it will send you to
thousands and thousands of responses to the search by OxyContin
without prescription. And they will all be selling it without
prescription at all. Of course, it is just as bad if they use a
phony prescription, but they will not even bother to use a
phony prescription. It will be sent in in a brown bag that
looks like 2 trillion others coming into the customs offices in
New York, and it will get through. And if it does not get
through, the drugs will be replaced.
So what can you do about this? The Judiciary Committee is
looking at a brand-new problem, a brand-new dimension of a very
old problem--a massive dimension--and it will be the same with
everything that can be sold over the Internet, and it will be
worldwide.
OK. Here is what you can do. There is no reason why
Internet service providers should be putting--they can easily
remove from your household Internet connection anybody who is
promising to sell OxyContin, Vicodin, any of a list of drugs,
without prescription. It is no burden to them. They know how to
do that. They are doing it now as to other things, such as
pornography. They can do it in a minute. No cost.
Google and Yahoo! and Microsoft can, when somebody puts in,
as I did on Mother's Day, ``Buy OxyContin without
prescription,'' and got 800,000 responses, including a chat
room run by Google where you can talk to friends about where to
buy OxyContin without prescription. When anybody searches for
OxyContin without prescription, there can be a banner at the
top of the Google, Yahoo!, or Microsoft search saying it is
illegal to buy this without prescription. That message ought to
come right away.
MasterCard, Visa, Paypal, American Express should trace
anybody who is offering to use their credit card as a device to
pay for the purchase of one of these prescription narcotics
without a prescription. They can do that, too. They do it if
somebody is misusing their credit card. They do it if someone
is cheating on their credit card. They can do it in a minute,
no problem.
So why aren't they doing it? In other words, we have
powerful local companies, thankfully local, facilitating the
sale of powerful narcotics to children over the Internet. They
say they have two big problems. One problem is they do not know
who they are dealing with. The other problem is that they are
worried about legal liability.
With this large group--and without them necessarily all
agreeing with all of our recommendations, by a long shot, but
generally in the same ballpark--we put together a model bill
that would solve those two problems by: No. 1, creating a
small, inexpensive but technically sophisticated organization,
an Internet monitoring group that would go onto the Internet
and see who is advertising the sale of powerful narcotics
without a prescription, and notify the Internet service
providers, the search engines, the carriers, like Federal
Express, and the credit card companies. That would send them
all into action, and we would not have to worry about their not
being able to know. We can tell them who, if the Congress will
create this small unit.
Second of all, they need a safe harbor from liability if
they act on the basis of the recommendations of the Internet
monitoring group.
With those two things, the only thing that we think is--
right now we believe that the finance companies are bound by
Treasury regulations to act vigorously to stop the use of
credit cards in these sales. We believe that the Internet
service providers are serious about their willingness to do
this on their own, but we do not like the idea of not
monitoring them and the finance companies.
We, therefore, propose that there be an annual accounting
to the Congress of the number of children--we take those
figures every year--who are continuing to use narcotics over
the Internet and an annual accounting of the cooperation of
these large companies in their delivery.
Thank you, and sorry for being over.
[The prepared statement of Mr. Heymann appears as a
submission for the record.]
Chairman Leahy. That is all right. It is an important
subject, and I have allowed time for everybody to go over.
Senator Feinstein is leaving for a vote that has started,
and I don't know whether, Senator Sessions, if you want to go.
I am going to stay here and ask some questions. I will go to
vote. When she comes back, she will reconvene it, or whichever
one of us gets back first, we will reconvene it.
Joseph Rannazzisi is the Deputy Assistant Administrator for
the Office of Diversion Control at the Drug Enforcement Agency.
He is responsible for overseeing and coordinating major
diversion investigations, establishing drug production quotas
and conducting liaisons with the pharmaceutical industry,
international governments, State governments, other Federal
agencies, and local law enforcement agencies. He has a degree
in pharmacy from Butler University, received his J.D. degree
from the Detroit College of Law at Michigan State University.
He is a registered pharmacist in the State of Indiana.
Thomas McLellan, Ph.D., is a professor of psychiatry at the
University of Pennsylvania and Founder and Executive Director
of the Treatment Research Institute in Philadelphia. He has
published more than 300 articles and chapters in addition
research, recently became the editor-in-chief of the journal
Substance Abuse Treatment. Dr. McLellan is well known for his
leading role in creating the Addiction Severity Index and the
Treatment Services Review, two of the most widely used
instruments in the field of substance abuse. His work at TRI is
dedicated to reducing the devastating effect of alcohol and
other drug abuse on individuals and families. He is a graduate
of Colgate, Bryn Mawr College, and Oxford University.
They will be available to answer questions. Their
statements will be placed in the record. Under our rules, it
did not arrive in time for statements to be given at this
hearing.
[The prepared statements of Mr. Rannazzisi and Mr. McLellan
appear as submissions for the record.]
Chairman Leahy. Ms. Haight, if I might--and, again, I
emphasize, as both Senator Feinstein and Senator Sessions have
said to me, I know this is painful. First, let me compliment
you for speaking out. Those of us who can speak out from
theoretical knowledge or reading the statistics is one thing.
You speak out from personal knowledge. I think that is a far
more compelling story. Unfortunately, I believe there are other
people that could give the same kind of testimony, as you have
discovered.
What is the most important thing young people should know?
Assuming somebody is actually watching this, what is the most
important thing they should know about the dangers of
purchasing prescription drugs over the Internet?
Ms. Haight. Well, first of all, I think quite a few of the
kids today, they are not aware of how prescription drugs are
very dangerous and that they can cause death or addiction. And
the kids really need to be aware and be educated upon
prescription drugs because they are mostly afraid of cocaine or
meth and those type of drugs and thinking that they are
dangerous. And there has been a lot of education out there
about that. But prescription drugs really is kind of the new
trend for our youth to be using, and so I think it is really
important that they are educated how dangerous these drugs
really are.
Also, they need to be educated that some of these drugs on
the Internet are not what they are. A lot of them can be
counterfeit. They have actually found that some drugs have been
laced with heroin. Some drugs are twice the potency of what
they say they are because they want them to become addicted.
These drug dealers want them to come back and buy.
Chairman Leahy. Do we change the law then? Do we have to
change the law to protect the public from these kinds of
online--
Ms. Haight. Yes, and, therefore, we need a law. And these
doctors that are writing prescriptions are saying, hey, it is
not illegal.
Chairman Leahy. You would like to see us make it illegal?
Ms. Haight. Absolutely. Absolutely. We need to do
everything we can to protect our youth, and adults as well,
that are finding themselves in this situation.
Chairman Leahy. Mr. Rannazzisi, would you agree with that?
Mr. Rannazzisi. Yes, absolutely. The perception of
children, the perception of adults that controlled substances
that are pharmaceutical are safe and effective because they are
manufactured--or safe because they are manufactured by a drug
company is really -it is a misperception that could be deadly.
We have seen this over and over again. There was a study done
where a large percentage of adolescents showed--basically
reported that they thought--their perception was that these
drugs were safe to take, where they would rather take those
drugs than cocaine or heroin. So that perception is out there.
So that is absolutely correct.
Chairman Leahy. Secretary Califano?
Mr. Califano. I think that what Joe just said is absolutely
right. We survey teens every year. We have been surveying 12-
to 17-year-olds for 11 years, Mr. Chairman, and it is quite
clear that they think these drugs are safer than street drugs.
They do not understand that they aren't.
I think it is very important, in addition to law, the kind
of legal suggestions that Professor Heymann made, which are
very similar to the ones in the CASA report released today to
also think parents are very important here. I think parents
have really got to understand they are the front line, until we
get a law passed, in terms of how their kids use the Internet,
what they are using the Internet for. And it is very difficult.
It is very difficult, but they--
Chairman Leahy. Well, and I think there, I think if parents
are watching this, this may be an eye opener to them, what is
available there. If we have prescriptions to be filled, we go
to the same pharmacy. They make it easy. You can call up on a
touch-tone phone or a computer, but it is a pharmacy and it is
the same pharmacist, it is with the records. We will get
questions asked when we go there, and I am delighted to see it.
I mean, they know who I am. They will ask for an ID just the
same. And I think this should be done. And a lot of parents are
used to that same thing.
I think this may be an eye opener to a lot of parents. You
know, we have--going on computers, these kids are pretty smart,
and it is pretty easy to hide what they are doing, the chat
rooms, the number of chat rooms. The professor raised about on
OxyContin, I mean, the back-door way you can go. Professor, I
assume you feel we should be changing the law to make this
tighter.
Mr. Heymann. Mr. Chairman, we believe that the law should
be changed and tightened, and certainly the doctors who issue
prescriptions without ever seeing the patient should be subject
to sanctions of some sort. But we keep seeing the end game as a
question of companies spread across the globe dealing highly
anonymously with kids in--
Chairman Leahy. Azerbaijan.
Mr. Heymann. And the only way to deal with that is to
enlist the cooperation--and I think it will be forthcoming--of
the search engines, the Internet service providers, and the
financing companies.
Chairman Leahy. But don't you need something beyond just a
banner that says ``Caution, this is an illegal"--I mean, you
have got to have the site blocked, don't you?
Mr. Heymann. That is correct. The banner comes from the
search engine. The Internet service provider should block the
site at the request of any parents.
Chairman Leahy. I think it should be blocked, period, I
mean, if you are doing it this way.
Mr. Heymann. It should be blocked, period. There is some
remote First Amendment problems. It is easy, otherwise.
Chairman Leahy. I think we can handle that part. I yield to
nobody in the defense of the First Amendment, but I think there
is a way of doing that. I think you are getting very close to
yelling ``Fire'' in a crowded theater here.
Dr. McLellan?
Mr. McLellan. One thing I would like to add is that in a
sort of darkly paradoxical way, it is safer to buy drugs over
the Internet; at least the drugs are much more dangerous than
commonly perceived. But if your choices are to go--I live in
Philadelphia--to 52nd and Baltimore and purchase something from
a thug versus have it delivered into the comfort and privacy of
your home with virtual certainty, it is safer.
So in many ways, it is an enticement to start drug use, and
that is something that I think has not been brought out. A lot
of policy in this country is considered around starting drugs,
like cigarettes and marijuana. There are kids today starting
drug abuse with Vicodin, starting drug abuse with OxyContin,
because it is easier.
Chairman Leahy. Thank you. Doctor, I am not trying to cut
you off, but I just got handed a note I have 4\1/2\ minutes to
get to the floor to vote. We will stand in recess until either
Senator Feinstein or I come back, and we will pick up where we
left off.
[Recess at 10:56 a.m. to 11:04 a.m.]
STATEMENT OF HON. DIANNE FEINSTEIN, A U.S. SENATOR FROM THE
STATE OF CALIFORNIA
Senator Feinstein. [Presiding.] We will reconvene the
hearing and continue on.
Mrs. Haight, I just want to say welcome. It is wonderful to
have you here again. As you know, it was the death of your son
that really brought my attention to this issue. And as Mr.
Califano has continued on with it, we see how extensive it is
and how many people are able to really receive drugs that
otherwise would require the prescription of a physician. So I
thank you, and although Ryan is not with us, he has made a
major contribution to this effort. I want you to know that.
Mr. Califano, I think your report is excellent. I would
certainly recommend it to everyone to take a look at this and
read it. And Senator Sessions and I have put forward a bill
which, as you say, does certain basic things. I believe I would
be supportive of adding that banner that you spoke of, Mr.
Heymann, to the legislation, and I will talk with Senator
Sessions about doing that, see if we can do it. As you know, we
have changed some sentences in this. I think you have raised
what for me is a very disturbing part of this, and that is, the
world community is now such that the Internet facilitates all
kinds of criminal enterprises as well as legitimate
enterprises, and Government becomes not able to regulate.
I had to leave to vote, and it was a big vote. This is a
vote on Iraq. If any of you have any other suggestions of how
Senator Sessions and I might tighten up our legislation, the
floor would be open to you.
I will start with you, Dr. Heymann.
Mr. Heymann. Thank you very much, Senator Feinstein. Of our
recommendations, the banner is in some sense the least
important. Again, our total focus is on the international
aspect. That is where we think it is going, where it
substantially is, and we think that is the growth area, and we
are very anxious, careful to urge you not to close one of two
doors and just let the traffic go through the second door. That
will not reduce anything.
Our most important recommendation is that a monitoring
group inform MasterCard, Visa, American Express, Paypal
whenever it finds their logos at the bottom of an offer to sell
a prescription drug over the Internet without prescription.
Senator Feinstein. In other words, that our bill create
this group and empower this group to at least inform--is this
what you are saying?
Mr. Heymann. We think that one the financing companies are
informed, present Treasury regulations require them to take
action to stop the transaction and to report the transaction to
law enforcement, the purported transaction.
Mr. McLellan. And they do it every day.
Mr. Heymann. And they do it. But they say--we do not
believe that they know who it is--they are not monitoring the
website with the rigor--the websites, the Internet, with the
rigor that they have to if we are going to make it dangerous
for someone to sell in exchange for a credit card payment.
So we would like perhaps Treasury to make it perfectly
clear that that is required whenever they get information, a
lead that someone is selling narcotics without a prescription
over the Internet using their credit card, and we would like to
have an organization, a very small one--we called it an
Internet monitoring group--whose full-time business it would be
to monitor the Internet and, with the push of a button, send to
the credit card companies, to Paypal--to the Internet service
providers, too, because we want something from them--
information about who is offering to sell without a
prescription.
Senator Feinstein. I would invite Senator Sessions to
become involved in this, too, and sort of open it up. My
concern is the term ``monitoring group,'' which is not an
official organ of Government, that it seems to me it would be
the responsibility of a Government agency to do this and be
empowered with authority to even shut down the site?
Mr. Heymann. Shutting down the site is, let's say, our
second most important option. But that will be less useful
because it will quickly be replaced. And to monitor sites even
now will require a medium sophisticated program because
apparently most of the sites are hijacked websites. I was
working on it with Mathea Falco a month or two ago, and we
played it out, and the site turns out to be the University of
Oregon. Somebody has just hacked into the University of Oregon,
put up there an offer to sell drugs, and so you have to get
behind that offer, which will only, I am told, last for hours.
It is a hijacked front. You have to get behind that to who is
the real seller, and for that it takes a medium sophisticated
program.
Senator Feinstein. Yes, sir, would you like to add
something? Then Mr. Califano.
Mr. McLellan. If I could just add to that, the Treatment
Research Institute has worked with Drug Strategies and Harvard
in doing this, and we think the simplest of all strategies is
to simply follow the money. The reflex impulse is to close
something down and have a Government action. Please keep in
mind now 88 percent of these sites and the figures behind the
sites are offshore in countries where it is not necessarily
illegal for them to sell drugs to Americans. It is illegal for
us to buy.
Please keep in mind also that there are issues of
entrapment and less than perfect boundaries about authority for
the Government agencies. That is why we specifically suggested
a nongovernmental group provide actionable evidence. If you had
somebody going on a site and actually attempting to purchase
and the credit card number were exercised by that company, that
is actionable evidence. And in hearings that were conducted by
Professor Heymann, we have heard nothing but support from the
credit card companies, the delivery agencies, the whole chain
of supply, the money supply. So we think that may be the
strongest, if imperfect, way of bringing this to a restricted
end.
Senator Feinstein. Mr. Califano, did you want to say
something?
Mr. Califano. I share your concern. I would not have it as
an independent agency. I think if something like this is going
to be done, it should be done by Government that is going to be
responsive, not a private agency.
I do want to second something that Phil said, though. If
you notice in our CASA report, just on the sampling of sites we
took, of the 152 sites we identified in 2004, by 2005 all but
29 of them were gone. As we have done this in that 210-hour
period, in the course of just those 210 hours, sites disappear
and pop up again. So that is a very difficult problem.
I do think that it should be against the law to have on the
Internet any pharmacy that has not been certified, and I think
that alone can have a substantial impact here. And there is a
system in place for certifying pharmacies, and that can be
helpful.
I think the other parts of your law are--I think it is a
good statute, and my instincts would be to give a good portion
of this authority to the DEA, which is the right agency to go
after this stuff. I think it is terribly important. And I also
think there is an education campaign here that is important,
that we need, whether through the Internet or other places, to
educate parents and children about the dangers of abusing these
prescription drugs. That is one thing.
I think we need to have the Food and Drug Administration be
required to press these pharmaceutical companies to formulate
these drugs in ways that make them much harder to abuse.
OxyContin, all you have to do is crush it, and you could snort
it, and you have got your heroin high. That is an inexcusable
kind of approval, and I think also when there are addictive
drugs that are being allowed to come on the market, before they
come on the market, the Food and Drug Administration should
have a plan--require the pharmaceutical company to have a
detailed plan about what to do on the first indication of
abuse. That was not true with respect to OxyContin. The plan
came afterwards.
Aside from all the criminal conduct of those individuals, I
think things like that are necessary as well.
Senator Feinstein. Thank you.
Mr. Rannazzisi, do you have a comment to make on this,
specifically whether it be a Government responsibility or some
private entity?
Mr. Rannazzisi. Well, ma'am, we reviewed that proposal, and
at this moment in time we are not prepared to provide a
recommendation or comment. But I would like to get back to
something that we have discussed before with certification in
the pharmacies.
We look at this as two separate problems. There is a our
domestic problem and our international problem. Obviously, we
have no regulatory control over international pharmacies, and
most of these are not even pharmacies. They are just storefront
operations. But we do have regulatory control over the domestic
pharmacies, and as we talked about certifying, DEA does not
certify pharmacies to operate on the Internet. DEA registers
pharmacies to procure and dispense controlled substances
pursuant to a legitimate or valid prescription.
If you look at the first placard up there, that is a
comparison of a brick-and-mortar pharmacy, your normal brick-
and-mortar pharmacy that operates in your community every day.
That is an average number. They dispense about 88,000 tablets
of hydrocodone a year, hydrocodone combination products. Now,
if you look at the 2.9 million, that is a rogue Internet
pharmacy. Now, remember, a rogue Internet pharmacy is a DEA
registrant. Somewhere down the line on that Internet site, they
are going to have to get their drugs, if they are domestic,
from a brick-and-mortar pharmacy that is servicing that
Internet site. The 2.9 million is the average. We took 34 known
and suspected Internet pharmacies and looked at their purchase
records for 2006. Nearly 99 million hydrocodone combination
products were sold out of those pharmacies 99 million. So you
could see the great difference.
If you look at the second placard, the cyber pharmacies, as
compared to the brick-and-mortar pharmacies, your average
brick-and-mortar pharmacy does about 89 percent of
noncontrolled substances as compared to 11 percent of
controlled substances. Now, if you look at those cyber
pharmacies, about 95 percent--they are not full-range
pharmacies 95 percent of their sales are controlled substance
sales as compared to about 5 percent, about 425 prescriptions a
day. So you could see there is a major difference between the
brick-and-mortar cyber pharmacies and--
Senator Feinstein. What are you saying? I mean, do not
mince words. What are you saying?
Mr. Rannazzisi. What I am saying is that those are rogue
pharmacies that are dispensing outside the scope of good
practice. They are doing something illegally.
Senator Feinstein. So are you saying do not worry about
them, just let them continue?
Mr. Rannazzisi. No. I am saying that we have to do
something about, yes, absolutely, and we are.
Senator Feinstein. I am sorry. I am not aware of what you
are doing.
Mr. Rannazzisi. OK. For starters, we are starting to look
at their purchase records. Every Internet pharmacy that we have
seen has a purchase footprint. We know based on their sales
that they are Internet pharmacies. So what are we doing? In
addition to going after them criminally, we are also going
after them--we are taking their registrations--
Senator Feinstein. How many have you gone after criminally?
Mr. Rannazzisi. Organization-wise, I could not tell you the
exact number. I could get back to you on the exact number.
Senator Feinstein. Yes, we would like to have the number.
Mr. Rannazzisi. Absolutely. But I can tell you that we have
been shutting these pharmacies down using our regulatory
authority and immediate suspension authority. We have gone
after them and immediately taken their registration so they
cannot dispense and procure controlled substances.
Senator Feinstein. Let me just say something. I introduced
this bill with Senator Sessions in 2004. We have heard nothing
from you. There is no comment on the bill, there are no
suggestions, there is nothing--which indicates to me that it is
an agency that is not taking this very seriously, to be very
candid with you.
Mr. Rannazzisi. Well, I take exception to that, ma'am. We
do take it seriously. In fact, you know, as you can see, using
our regulatory authority, we are shutting these down. We are
going after the distributor instead of the--
Senator Feinstein. I would like to know how many you have
shut down, and today you cannot answer that question.
Mr. Rannazzisi. I will give you an exact number.
Senator Feinstein. I appreciate that.
Senator Sessions, would you like to take over? I know a
second vote has been called. Or perhaps we should recess again?
Senator Sessions. I may not be able to come back after this
vote, so I would appreciate the opportunity to share a few
thoughts with the panel.
Senator Feinstein. You go ahead.
Senator Sessions. And thank you for your work on this
legislation, your commitment to it. These charts up here are
stunning to me. I thought it was bad, but it is worse than I
thought.
Senator Feinstein. It is.
Senator Sessions. That is a stunning, stunning chart, and I
really should not be surprised based on the experience that I
have had in which you see people want these drugs, they learn
how to make money off of them, they may be personally addicted
to them, they just want to try them, whatever.
Senator Feinstein. Senator, will you continue then?
Senator Sessions. Yes.
Senator Feinstein. I will go and vote and try and come
back. Senator Leahy may be back in the interim.
Senator Sessions. Thank you.
Senator Feinstein. Thank you.
Senator Sessions. [Presiding.] All right. Let me ask this.
Mr. Rannazzisi, you talked about--I believe, Mr. Heymann, you
served as Deputy Attorney General. I remember him here a number
of times, know his experience. He has indicated that there are
sites up all over saying ``OxyContin without a prescription.''
Now, how can you get OxyContin without a prescription? I mean,
how can this be? Publicly or all over the Internet, hundreds of
sites, apparently.
Mr. Rannazzisi. From our experience, those sites are
probably operating overseas because OxyContin or oxycodone
products are Schedule II. The level--
Senator Sessions. Which means they have to have a--
Mr. Rannazzisi. A written prescription.
Senator Sessions. And if you go to a physician and the
pharmacy, they account for every single pill.
Mr. Rannazzisi. That is absolutely correct.
Senator Sessions. Everything is done to the nth degree. The
prescriptions have to be maintained and kept so your people
can--now, Mr. Secretary, Mr. Heymann, you have been through
this Government rigmarole over the years. Both of you have. I
am aware of how hard it is for the DEA to get a foreign country
to cooperate or move quickly against these sites. It is just a
nightmare for agencies. Could the State Department, if they
made it a high priority, a condition of good relations or
trade, is it a feasible thing to think that we could pressure
these companies in the foreign countries?
Mr. Califano. I think the odds of the State Department
giving this a high priority are very, very low, and I will just
give you--I go all the way back to the Johnson years. When we
first saw heroin coming out of the ghettos and into broader
society, I talked to Dean Rusk, and I said, you know, ``We have
got to do something with Turkey.'' That is where all the heroin
was coming from in 1967. And he said, ``Well, we have to be
very careful about Turkey. We need Turkey as an ally in the
cold war, and we have to be very measured in our response.''
The same attitude existed when I was Secretary of HEW. In
that 2\1/2\ years, trying to get the State Department--with
someone as distinguished and as special as Cyrus Vance being
the Secretary--we could not get the State Department to give
this subject any priority.
Senator Sessions. Secretary Shultz was not very interested
in it, either.
Mr. Califano. Secretary Shultz was not interested in it.
And I dare say that if you went to Condoleezza Rice and said,
you know, ``We are getting killed by all this stuff coming
in''--it is prescription drugs. It is all illegal drugs, the
marijuana, the heroin, the cocaine pouring in here, heroin from
Afghanistan. We are going to have the cheapest heroin in the
history of the country because of what is happening, the way it
is coming out of there. If you said, ``Make that a priority,''
I do not think it is real. That is why I think we need
something like this statute--
Senator Sessions. Now, you think it is impractical--Dr.
McLellan, you nodded, and I think Professor Heymann--to expect
that we could solve this problem in that fashion. We probably
should not go into the details of it because our time is short.
But is it being shipped from these foreign countries?
Mr. McLellan. One of the things that is being missed is it
is not just registered pharmacies in Afghanistan. Remember,
they are called ``rogue pharmacies.'' These are little
factories that are making Vicodin and OxyContin knock-offs. By
all means, they have opiate in them, but they are very
difficult to regulate, too. And as Phil said, they pop up and
they shut down.
I repeat, taking nothing away from all the typical Federal
ways to go at this, I suggest right now follow the money. Get
the source of the dollars and squeeze that neck with the
cooperation of existing--and they are very cooperative. The
credit card companies, the banks behind those companies, and
the delivery agencies want to stop this.
Senator Sessions. Well, we have a group of people--a small
group, maybe--who think the Internet is a crime-free zone; that
is, nothing is a crime on the Internet. And it is religion with
them and that to mess with it at all is a heresy of some kind,
a sinful act. But do not want to mess up the Internet and turn
it into a lawsuit-creating mishmash of regulations and all.
Professor Heymann, your idea was that the credit card
companies could work with this in a way that they would be
happy with?
Mr. Heymann. The answer, Senator, is yes. But we simply do
not think that law enforcement--we think DEA has the least
chance of being effective as a law enforcement agency operating
in the Ukraine or in Somalia because it would require an
extradition for DEA to make a case. So, first of all, we will
not get any cooperation. Second of all, DEA's concern is making
a case before an American court.
The State Department will also have difficulty, but now and
then it may very well be able to press the Ukraine or Somalia
to bring a case against a rogue seller in those places. But we
think the problem is one of scale. My calculation is that every
year, just OxyContin and Vicodin are going to more than half a
million high school students. Every year.
Senator Sessions. A half a million?
Mr. Heymann. Half a million. And so we have to find a way
to deal with that problem with scale. One case is not going to
help much. That is why we want the credit card companies to
systematically go after everybody who is--and they are trained
to do this. They are doing it under money-laundering
legislation that you have passed, and they are very good at it,
and they are very accustomed to it. We want them to track down
which is the bank that is making payment to a dealer. And if
they find the bank, they can have a contract, which it is very
hard for us to regulate a bank, the United States to regulate a
bank in the Ukraine.
Senator Sessions. My vote time has expired. I hope I have
not missed it. If you do not mind, we will return, I am sure.
Mr. Heymann. I would appreciate that, Mr. Sessions.
[Recess at 11:28 a.m. to 11:46 a.m.]
Chairman Leahy. [Presiding.] You know, it is interesting.
This is an example of C-SPAN. While I was on the floor voting--
and this last vote is still going on--I had two or three
Senators in both parties come up to me and talk about this
hearing and what they have been seeing, some of the information
they are getting and saying, ``We have got to talk with you and
with Senator Feinstein and Senator Sessions about this.'' They
did not realize what the problem is. So in case you are
wondering, even with this back and forth whether it carries, it
does.
Now, we have learned today--and this is a question for
everybody on the panel. We have learned today about online
rogue pharmacies. They are using electronic forms rather than
in-person consultations to give out bogus prescriptions for
prescription drugs, including highly addictive painkillers. And
it appears that one of the loopholes used by what are, I think
we would all agree, unscrupulous online pharmacies that allow
access to drugs illegally on the Internet.
I want to emphasize that the drug store my family and I go
to, and others, if you have tight controls in there, it can be
very helpful, both to be able to go online or to call and use a
touch-tone phone. But what Senator Feinstein has done is
introduce legislation to require in-person consultation with
doctors for any purchase of controlled drugs over the Internet.
I cannot imagine how that would in any way inconvenience--it
certainly would not inconvenience anybody in our family. I
think Senator Feinstein's legislation could be a first step in
attacking the serious problem.
So let me ask the person from DEA, do you support
legislation to require in-person consultations for
prescriptions used to buy controlled drugs over the Internet?
Mr. Rannazzisi. DEA, the Department of Justice, and the
administration are looking at all different measures that could
be implemented. At this point in time, we are not prepared to
make a recommendation of a specific measure.
Chairman Leahy. When will you be?
Mr. Rannazzisi. I cannot give you an answer right now, sir.
I could tell you right now that all levels of the Department,
the Domestic Policy Council, HHS, we are all looking at this
together. We are having regular meetings to discuss these
issues.
Chairman Leahy. Do you have any recommendations that have
been made?
Mr. Rannazzisi. Not at this point in time, sir, no.
Chairman Leahy. Thank you.
Secretary Califano?
Mr. Califano. Let me just note--and it is in our CASA
report we are releasing today. This is the American Medical
Association. ``Physicians who prescribe medications via the
Internet shall establish or have established a valid patient-
physician relationship. The physician shall obtain a reliable
medical history and perform a physical examination on the
patient.''
Chairman Leahy. So by this you would agree with Senator
Feinstein?
Mr. Califano. There is no question about that. The four
elements of a doctor-patient relationship are that the patient
has a medical complaint, that a medical history is taken, that
a physical examination has been performed, and that some
logical connection exists between the medical complaint, the
medical history, the physical examination, the drug prescribed.
So it is right on. And the Federation of State Medical Boards
agrees with you, too, Senator Feinstein.
Chairman Leahy. Professor Heymann?
Mr. Heymann. As I remember Senator Feinstein's proposal, it
requires at least one meeting, one live meeting with a doctor.
That seems to me to be exactly right.
Chairman Leahy. Ms. Haight?
Ms. Haight. Yes, I agree with that totally. That is how it
has always been in hospitals.
Chairman Leahy. Dr. McLellan?
Mr. McLellan. Well, I think it is completely appropriate
for all legitimate pharmacies, all legitimate physicians, and
especially those in the United States. I remind you that more
than 80 percent of everything we are talking about has
essentially nothing to do with the United States--
Chairman Leahy. I understand. I am trying to figure out,
though, what kind of laws are in place that make it easier to
block those others, which goes to what Professor Heymann has
said about the First Amendment things. You are going to have to
have certain legal requirements if you are going to block
activity which then becomes illegal and do it constitutionally.
Mr. Heymann. Senator Leahy, our answer to that was to have
Internet access blocked for sellers of prescription narcotics
only at the request of the households. In other words, any
Internet service provider would have to ask every household to
which it provides Internet service, ``Do you want this to be
blocked?'' If they said yes, they would then block any further
offers to sell drugs.
Chairman Leahy. How many did you find on Mother's Day when
you went on?
Mr. Heymann. Well, they have not done that yet, but I
literally--you know, the Google number at the top--
Chairman Leahy. Someone has a BlackBerry nearby.
Senator Feinstein. Me. Sorry.
Chairman Leahy. You are getting a lot of supportive
testimony, Senator Feinstein. Do not block that.
[Laughter.]
Chairman Leahy. Go ahead.
Mr. Heymann. The google number at the top was 800,000. I
looked and my search was for ``Buy OxyContin without
prescription.'' It was not Vicodin. It was not steroids. It was
a single drug, though many of them would overlap. And I only
looked at the first 20 or 30, but each of them looked to me
like a purchase--like an offer to sell a highly addictive
narcotic to anybody without bothering with a prescription.
Chairman Leahy. Well, the thing that gets me--I mean, I
want to find some way to stop it. I think everybody agrees,
parents would agree, we do not want pornography to go to our
kids. But kids can move around pretty quickly, usually a lot
better than parents can, on the Internet because they live on
it. I told the story of a 4-year-old grandson wanting to do an
interactive--I think it was Disney or something like that, a
perfectly appropriate thing where you could draw pictures, do
interactive things. He wanted to use the computer to do it. And
I said, ``Fine, but I have to get the site for you,'' because I
wanted to make sure that is exactly the site. The site came up,
and he said, ``Yes, that is the one,'' took the mouse out of my
hand and said, ``I better take over now because it gets very
complicated.''
[Laughter.]
Chairman Leahy. You mentioned OxyContin. We know how they
misrepresent how addictive their drugs were in marketing and
advertising. The press has been full of this, especially the
last couple of weeks. According to court records, the makers of
the drug, Purdue Pharmaceuticals, agreed to pay more than $600
million in fines and penalties. And three of its top executives
admitted they were responsible for misleading those who bought
and prescribed the drugs.
Do we need to change how we regulate these kinds of
painkillers? We will go one, two, three, four, five. Go ahead,
Mr. Califano.
Mr. Califano. I would make a note of a couple of things.
One, a quarter of these sites we know claim to be in the
United States. That has been consistent over the 4 years we
have done this sample. About half of them say they are
overseas, and about a quarter of them are unknown origin. So
there are sites in the United States.
Two, with respect to what happened with Purdue Pharma, my
own view is if those guys had been street drug dealers, they
would be in jail, and they did just as much damage as street
drug dealers. So they walked.
And, last, vis-a-vis Senator Feinstein's point, I would
like to quote--we have a quote from Joe Rannazzisi in our
report that we are releasing today, and let me read it. ``A
legitimate doctor-patient relationship includes a face-to-face
consultation where a licensed physician can examine the
physical symptoms reported by a patient before making a
diagnosis and authorizing the purchase of a prescription
medicine. Filling out a questionnaire, no matter how detailed,
is no substitute for this relationship.'' And I realize he does
not have authority to support in a formal way what you propose
in your bill, but that certainly supports it.
Mr. Heymann. We think that there has to be somewhere--and I
am about ready to concede to Senator Feinstein and to Joe that
perhaps it should be a governmental responsibility. There has
to be someone who is monitoring the Internet to see if
somebody--to see the long list of people who are offering to
sell prescription narcotics without a prescription.
Once that is done--and I suggest you put it in the Office
of Justice Programs, Senator Feinstein. I do not think it is
DEA because it is not law enforcement, and the law enforcement
is the focus for DEA. And Mr. Califano has already commented on
the likelihood that the State Department would be very
vigorous. It will not be very vigorous. I would give it to OJP,
the Office of Justice Programs, and tell them to set up a small
unit. We are talking about five, ten people. A few thousand
dollars will create the programs, and then whenever they get
information, send it to the credit card companies and expect
the credit card companies to cutoff the credit and track down
who is getting it, and send it to the Internet service
providers and expect the Internet service providers to add it
to their list that is cutoff from any family that does not want
these ads coming into their house.
Chairman Leahy. I have actually gone beyond my time. I am
on Senator Feinstein's time. I am going to hand it over to her.
Does anybody wish to add very, very briefly to what was said?
[No response.]
Chairman Leahy. OK. Thank you.
Senator Feinstein, I cannot thank you enough for bringing
up this subject, and I can assure you we will work on it, and
the Committee will followup on it.
Senator Feinstein. [Presiding.] Well, thank you very much,
Mr. Chairman, and thank you for having the hearing because I
think it was very constructive. I myself think that we have to
develop this second part of it, and we will proceed to do so.
I do not know what is wrong with DEA, but something is. All
during the methamphetamine discussion, which has gone on for 10
years from when I introduced the first bill in 1996 to the last
bill that we did with Senator Talent, I have asked for DEA
help, and DEA is nowhere. And now once again, on this issue,
which clearly by your own chart is a big issue and clearly by
the statement that Secretary Califano read, you have got to
agree with it. And yet I do not know whether it is partisan or
what it is, but I cannot get help on these matters from DEA. So
I would like to just publicly ask for help. I would welcome
DEA's suggestions. I know Senator Sessions will as well. We
would like to make this as strong a bill as possible; that
people who sell drugs illegally over the Internet without a
physician's prescription, without a physician visit, should be
prevented from doing so; and if they continue, shut down. That
is my view, and we are trying to get as close to that as we
possibly can.
I do not know that the Internet should be able to
facilitate acts which are not legal in this country. But when
you have young people who, as Senator Leahy testified and Mrs.
Haight testified with her son, are so facile on the Internet,
are young, want to try anything, can have exposure to a whole
illegal field of very powerful drugs, it is extraordinarily
dangerous.
Dr. Heymann, I am amazed. This was on Mother's Day that you
pulled up 800,000 sites? Or was it hits?
Mr. Heymann. Let me send you what I pulled up, Senator
Feinstein.
Senator Feinstein. Well, could you define for me again what
it was?
Mr. Heymann. I put into Google, ``Buy OxyContin without
prescription.'' I believe the number was 800,000 hits. In an
instant, 800,000 hits. I looked through the first 20 to make
sure we were not picking up a lot of other things, and the
first 20 were overwhelmingly offers to sell OxyContin using a
credit card to whoever pushed a button on that website.
Senator Feinstein. Do you remember how many of these were
in country as opposed to out of country?
Mr. Heymann. You cannot tell from the website, though Dr.
McLellan has some judgment on that.
Mr. McLellan. Yes, in fact, our group was the group that
discovered this. Dr. Robert Forman had the first article about
this, and we have been tracking it scientifically since then.
And, by the way, 800,000 is about the same number for that
substance since 2002. And I say that because, to the credit of
DEA and the credit of a lot of law enforcement, there have been
a lot of busts in this country, and they have knocked out huge
rings, and it does not stop because they pop up just as fast.
The market is overwhelming. There is a very brisk business in
this, and it is not going to go away simply by local law
enforcement.
You can tell the registry of a site by digging into, you
know, where it is--that takes a lot more work. It is almost not
worth it because literally tomorrow, if you stopped my website
today, literally tomorrow, and in another country, in the snap
of a finger, I would have another one up.
Senator Feinstein. And the drug, Dr. Heymann, that you were
looking for was OxyContin?
Mr. Heymann. It was OxyContin, and Vicodin would have been
many more, I suspect. Many more than 800,000. It was OxyContin.
Senator Feinstein. All right. Does--
Mr. McLellan. Two million nine hundred thousand.
Senator Feinstein. Two million nine hundred thousand?
Mr. McLellan. For Vicodin.
Senator Feinstein. Hits for Vicodin?
Mr. McLellan. If you put ``No prescription Vicodin''--
Senator Feinstein. Would you turn on your microphone,
please?
Mr. McLellan. Sorry. If you put the words ``No prescription
Vicodin'' in Google, right here, right now, you will have no
less than 2,500,000 hits.
Senator Feinstein. So, clearly, I mean--
Mr. McLellan. And 88 percent of them are direct offers to
sell. I should just say one quick thing. Remember, a telephone
is a computer. Now it is clear that if you have a purchase and
you give them your website, they will text message you. Some of
these pharmacies will text message you, ``Need a refill?'' And
if the kid says ``Yes,'' you get billed in ring tones, almost
as though they are trying to make it impossible for Mom and Dad
to check as to what is actually being bought.
Senator Feinstein. Clearly, there is a big problem, and
clearly, DEA ought to be producing some solutions. I would like
to ask for those solutions. I would like to ask, respectfully,
for DEA's views, any suggestions you might have as to how we
can take actions which can effectively stop this. I just hate
to think that we have to throw up our hands and say it cannot
be stopped.
Mr. Rannazzisi. Ma'am, if I may, we have never said that it
cannot be stopped, and we will provide any technical advice
that you need, and I think we have to your staff in the past.
But the fact remains that when you do a search like that, most
of those are portals or informationsites. When you get right
down to it, when you get right down to the anchor sites that
are selling the drugs, there are far fewer than 800,000, or
whatever the number is. And domestically those sites are being
serviced by one pharmacy or two pharmacies or a hundred
pharmacies. Each pharmacy is servicing--I do not know how many.
They could be servicing 30, 40, 50 websites. So the key is not
the sites. The key is those pharmacies. The key is to hit the
pharmacies and to shut them down. The sites are going to
regenerate.
Senator Feinstein. Well, then, why doesn't DEA shut them
down in this country?
Mr. Rannazzisi. We are. We are using our regulatory
authority--
Senator Feinstein. Again, I have asked you how many have
you shut down, and you cannot give me a number.
Mr. Rannazzisi. And I told you, ma'am, I will give you an
exact number that we have shut down.
Senator Feinstein. I was just handed your written remarks,
which during 2006, SOD has coordinated over 90 investigations
resulting in the arrest of 64 individuals and the seizure of
approximately 14 million dosage units of controlled substances
and approximately $30.9 million in United States currency.
Mr. Rannazzisi. Yes, ma'am. You wanted the number of
pharmacies.
Senator Feinstein. So at least you were doing something.
Mr. Rannazzisi. Well, in all of our investigations, we
follow the money, and we put people in jail. That is what our
job is. But you wanted an exact number of pharmacies that we
shut down, and I told you I would get back to you on that.
Senator Feinstein. OK. Fair enough. Fair enough.
Mr. Rannazzisi. OK.
Senator Feinstein. I think the other thing is any
suggestions DEA might have for legislation which is aimed at
shutting them down. I recognize the Constitution, I recognize
the difficulties, but we have to find a way to do this.
Mr. Rannazzisi. Yes, ma'am.
Senator Feinstein. I think that is probably it, unless
somebody else has something that they would like to say. I
would like to thank you all very much. I know some of you came
from long distances, and it is very much appreciated.
So thank you, and this hearing is adjourned.
[Whereupon, at 12:05 p.m., the Committee was adjourned.]
[Questions and answers and submissions for the record
follow.]
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