Enclosed is information I would like to have included in the
hearing record for the May 5, 1988, Subcommittee hearing on
"FDA's Regulation of the New Drug Versed". If you have any
questions, please let me know.

Thank you for your consideration of my request.

Sincerely,

the

JIM LIGHTFOOT

MEMBER OF CONGRESS

Enclosures

As you may know, the House Government Operations Human Resources
and Intergovernmental Relations Subcommittee, chaired by
Congressman Ted Weiss, held an investigative hearing on the drug
Versed (midazolam) on May 5 and May 10. The Subcommittee heard
from several physicians who had used this drug or were familiar
with its properties, as well as officials from the Food and Drug
Administration (FDA). I have enclosed a copy of the witness

list.

Generally, the witnesses from the first panel expressed concern
about the use of this drug. Several of the witnesses testified
that they had stopped using Versed or that their hospitals were
only permitting anesthesiologists to use the drug. In addition,
Dr. Sidney Wolfe, Director of the Public Citizen Health Research
Group, called for the prohibition of the use of Versed for
conscious sedation and for elderly individuals. They cited the
occurrence of respiratory or cardiac depression associated with
the drug as reasons for limiting its use.

In addition, questions were raised about the role of pharma-
ceutical detail representatives in informing physicians of a
drug's possible adverse effects, about the role of "Dear Doctor"
letters in informing physicians about new information pertaining
to a drug, and about the responsibility of a physician to review
information from a manufacturer or the FDA to ensure the proper
administration of a drug.

Recently, I received a letter from Dr. Donald R. Stanski,
Associate Professor of Anesthesia and Medicine at the Stanford
University School of Medicine, who had attended the May 5
hearing. His letter posed several questions relating to the
testimony received from the witnesses on the first panel. I
think his questions have a great deal of merit and are critical
to evaluating objectively the safe use of Versed. I have
enclosed a copy of his letter for your information.

Stanley B. Benjamin, M.D.

May 26, 1988

Page 2

In light of your experience with and knowledge of this class of drugs, your perspective on the use of Versed would be of interest to me. In addition, I would appreciate any comments you might have in response to Dr. Stanski's questions, which follow:

1)

2)

3)

4)

5)

Is the occurrence of respiratory depression with subsequent respiratory arrest and death with Versed an expected or totally unexpected side effect of this drug when used in conscious sedation techniques?

What responsibility does a physician have to both
recognize and treat side effects of drugs, i.e.
respiratory depression?

What is the professional responsibility of the physician to be aware of a new drug's action and use before actually administering it to a patient?

Is it acceptable to rely only on pharmaceutical company detail representatives for the necessary knowledge?

Why is it that Versed-associated depression and death have occurred only with gastroenterologists performing endoscopy, and not anesthesiologists who use the drug in perioperative settings?

Why were the side effects of respiratory depression, respiratory arrest and death not seen in any of the IND research performed by Roche and submitted to the FDA?

What are the clinical advantages of Versed compared to diazepam that are important for its continued use in medical practice?

Any additional thoughts you might have about Versed or efforts to limit its use would be welcome. Your comments will be helpful to me as the Subcommittee continues its investigation of this drug.

Stanley B. Benjamin, M.D.

May 26, 1988

Page 3

If you have any questions, please contact my staff member, Mary Vihstadt, at (202) 225-2738.

assistance.

Thank you in advance for your

I have had the opportunity to review your letter of May 26, 1988 in reference to the House Government Operations Human Resources and Intergovernmental Relations Subcommittee hearing on the drug Versed (midazolam). I am quite familiar with the current questions that have been raised in reference to this drug and I am extremely interested in assuring that this drug is given a "fair hearing".

In addition to other academic responsibilities at Georgetown University I run a very active endoscopic unit where approximately 4,000 endoscopic procedures per year are performed the overwhelming majority of them utilizing the drug Versed. In addition as Chairman of the American Society of Gastrointestinal Endoscopies Research and Development Committee I am currently working with the Food and Drug Administration to collect a larger data base on the use of this drug by gastroenterologists. We have been using this drug at Georgetown for approximately two years and find it to be a considerable improvement in terms of patient tolerance of the procedures that we perform. I would add prior to answering specific questions raised by Dr. Stanski that our experience has been a very favorable one both in terms of patient comfort and safety I believe reflecting the attention to patient monitoring that goes on in our unit.

In reference to Dr. Stanski's five questions:

1) Respiratory depression is an expected outcome of the drug Versed if large enough doses are used. When used anesthesiology the drug is specifically used to "induce" the patient with the

3800 Reservoir Road NW Washington DC 20007 219′′

202 687 8641