[Congressional Record Volume 143, Number 42 (Thursday, April 10, 1997)]
[Extensions of Remarks]
[Page E637]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




[[Page E637]]



      INFORMING DOD PERSONNEL OF EXPERIMENTAL DRUG ADMINISTRATION

                                 ______
                                 

                        HON. PATRICK J. KENNEDY

                            of rhode island

                    in the house of representatives

                        Thursday, April 10, 1997

  Mr. KENNEDY of Rhode Island. Mr. Speaker, I have come to the 
conclusion that trust and confidence in the American Government could 
very well have reached a low point. No one can dispute that citizen 
trust is vital to the health and well-being of our country and our way 
of life. We especially need the trust of the men and women of the U.S. 
military, those who have served, those who serve today and those who 
will serve in the future. The men and women in our Armed Forces are 
willing to risk their lives in defense of our national security 
interests, therefore we must continually work to ensure the bonds of 
trust endure in peace and in war time.
  Unfortunately, it appears that this trust has been called into 
question. One need merely read newspaper articles surrounding the 
Persian Gulf war to see what I mean:
  On February 28, the New York Times ran an article entitled: 
``Pentagon Reveals It Lost Most Logs on Chemical Arms: Missing From Two 
Sites: Gulf War Veterans Now Raise Questions of Cover-Up or Criminal 
Incompetence.''
  Allegations of cover-up and criminal incompetence indicate to me that 
we have our work cut out for us if we intend to earn back that trust. 
Just 3 days earlier, a New York Times headline read: ``Army Warned 
Early of Chemical Exposure in Gulf.''
  The article stated that the CIA gave the Army information more than 5 
years ago that some American troops may have been exposed to nerve gas 
from the destruction of an Iraqi ammunition depot following the Persian 
Gulf war. The article further stated that these CIA reports discredit 
the Pentagon's continued assertion that it became aware of the 
potential exposure only last year.
  And in today's Washington Post the headline of the lead article read: 
``CIA Knew In '84 of Iraq Poison Gas: Agency Official Apologizes To 
Persian Gulf War GIs.''
  Unfortunately, what we have here are glaring examples of why some of 
our troops and veterans may question the veracity of information 
provided by their own Government. It appears that this situation goes 
hand in hand with another major cause of mistrust: the unsolved 
mysteries of gulf war syndrome. Far too many of our troops who deployed 
to the gulf are suffering from undiagnosed illnesses that neither they 
nor their doctor can explain.
  I commend the President for his efforts aimed at finding answers and 
restoring this trust. He directed the Presidential Advisory Committee 
on Gulf War Veterans' Illnesses to investigate and search for a cause 
of the symptoms experienced by so many gulf war veterans; he convened a 
White House Panel; and he appointed Bernard D. Rostker, Assistant 
Secretary of the Navy, to lead the DOD's investigation into possible 
chemical agent exposure during the war.
  More can and must be done, however, to rebuild trust, to avoid 
repeating past mistakes, and to prevent future health consequences 
similar to those experienced during and after the gulf war. Our troops 
must be assured that when we send them into battle, they will be 
protected by the best military technology, the best leaders, and the 
best medicine. Protection also means proper education and training, as 
well as provision of critical information, including information about 
investigational new drugs that may be administered to our troops for 
their protection against chemical and biological threats.
  Unfortunately, for our troops, the threat of chemical and biological 
weapons have become an increasing reality. During Operation Desert 
Storm, the DOD sought to utilize two investigational vaccines, 
Pyridostigmine Bromide [PB] and Botulinum Toxoid [BT], to protect 
troops against chemical weapons. The FDA deemed these drugs 
investigational because they were not originally approved for the 
purpose DOD intended to use them. Under FDA regulations, use of such 
Investigational New Drugs [INDs] required informed consent by 
recipients, except where not feasible. Concerned with its inability to 
obtain informed consent during the exigencies of war, the DOD sought an 
exception from the FDA of its informed consent requirement. In 
response, the FDA established an interim regulation defining ``combat 
exigency'' as one instance where informed consent could be waived. The 
DOD subsequently applied for the exception and the FDA granted it, 
subject to certain conditions, including:
  1. Each BT vaccine was to be recorded in the individual's permanent 
immunization record.
  2. The DOD had to maintain a roster of all individuals receiving the 
investigational vaccines.
  3. Recipients were to report adverse reactions to the vaccines.
  4. Most importantly, the DOD had to provide individuals receiving the 
vaccines accurate, fair, and balanced information about the vaccines. 
The information was contained in leaflets produced by the FDA.
  Approximately 8,000 troops received the BT vaccine, while at least 
250,000 received PB. However, the DOD believes that only 40 percent, 
and that is on the high end of the scale, only 40 percent of those 
services members actually received information about the vaccines 
administered to them. This is unacceptable.

  Prior to Desert Storm, it was agreed that PB and BT constituted the 
best available preventative therapy against chemical agents our troops 
might face in the Persian Gulf. Even though the use of these 
investigational drugs could not have been avoided, failure to inform 
the troops about the drugs could and should have been avoided.
  The men and women who served in the Gulf War had a right to know that 
the vaccines administered to them were investigational.
  The same service members had a right to know about the side effects 
of the investigational drugs.
  Let me give you an example of the importance of this information to 
our troops. PB is known to cause gastrointestinal problems, cramps, and 
headaches; but these symptoms disappear after the drug is taken for a 
certain period of time. Some service members stopped taking PB once 
they experienced these symptoms, making them dangerously susceptible to 
chemical agents. Had they known about PB's symptoms and that these 
symptoms eventually would disappear, they may not have stopped using 
the drug and would not have put their lives in further jeopardy.
  In addition, some of our veterans who did not receive the information 
about the nature and side effects of the INDs may wonder today what 
lingering impact the drugs have on their health. With no information, a 
person has nothing to refute either misinformation or worst case 
scenarios. All of our military personnel have a right to know about the 
investigational inoculations they receive from the DOD. Today I rise to 
introduce legislation to ensure that this gulf war situation is not 
repeated, to ensure that in the future our troops are informed of 
investigational drugs, and to help ensure that our service members can 
and will trust their government.
  The legislation will require the DOD to inform service members about 
the use of experimental drugs. Specifically, the bill requires that the 
DOD inform individuals prior to, or no later than 30 days after 
administration.
  1. That the drug being administered is investigational;
  2. The reasons why the drug is being administered;
  3. The potential side effects of the drug, including side effects 
resulting from interactions of the drug with other drugs or treatments 
being administered to the individual.
  While information about investigational drugs will not prevent 
possible side effects, the information will ensure our troops know that 
the Government is not intentionally misleading them or seeking to hide 
information from them. They will know that we value their service to 
our country and that we too are doing our best to protect them. Through 
sharing of this information can we contribute to the process of 
rebuilding the bonds of trust.

                          ____________________