[Congressional Record Volume 143, Number 18 (Wednesday, February 12, 1997)]
[Extensions of Remarks]
[Pages E226-E227]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




         LEGISLATION TO BAN THE USE OF PANTOPAQUE IN MYELOGRAMS

                                 ______
                                 

                        HON. JAMES A. TRAFICANT

                                of ohio

                    in the house of representatives

                      Wednesday, February 12, 1997

  Mr. TRAFICANT. Mr. Speaker, arachnoiditis easily qualifies as a 
disease of the nineties. It has been described as ``the greatest enigma 
in the field of spinal surgery'' with few surgeons ever having seen it, 
and even fewer knowing how to treat it. In simple terms, arachnoiditis 
means ``inflammation of the arachnoid,'' and is characterized by 
chronic inflammation and thickening of the arachnoid matter, the middle 
of the three membranes that cover and protect the brain and spinal 
cord.
  Arachnoiditis may develop up to several years after an episode of 
meningitis or subarachnoid hemorrhage--bleeding beneath the arachnoid. 
It may be a feature in diseases and disorders such as syphilis or it 
may result from trauma during a diagnostic procedure known as a 
myelogram. According to the Arachnoiditis Information and Support 
Network, more than 300,000 myelograms are performed in this country 
every year. Of the 12 million Americans who suffer from arachnoiditis, 
the cases resulting from myelograms could have been avoided.
  In a myelogram, a radiopaque dye is injected into the spinal 
subarachnoid space. After the x-ray examination, as much of the oil as 
possible is withdrawn; however, a small amount is left behind and is 
slowly absorbed. Studies have implicated the iodized oil contrast 
medium, Pantopaque, in arachnoiditis. Water-soluble dyes such as 
Amipaque, Omipaque, and Isovue were once thought to be safer for use, 
however, recent evidence proves they also cause arachnoiditis. In fact, 
Harry Feffer, Professor of Orthopedic Surgery at George Washington 
University states that patients who have had two or more myelograms 
stand a 50-percent chance of developing arachnoiditis. Numerous studies 
on animals have confirmed these findings.
  Symptoms of arachnoiditis include chronic severe pain and a burning 
sensation which may attack the back, groin, leg, knee, or foot and can 
result in loss of movement to almost total disability. Other symptoms 
include bladder, bowel, thyroid, and sexual disfunction, as well as 
headaches, epileptic seizures, blindness, and progressive spastic 
paralysis affecting the legs and arms.
  In the past few years, arachnoiditis sufferers and Members of 
Congress alike have repeatedly asked the FDA to recall the use of 
Pantopaque. The FDA has clearly not reviewed the safety of Pantopaque--
oil-based--as well as waterbased dyes, in spite of medical evidence. As 
a result, I have introduced a bill to ban myelograms involving the use 
of Pantopaque, Amipaque, Omipaque, or Isovue.
  This legislation is not a new idea. Since 1990, Britain and Sweden 
have banned the use of Pantopaque in myelograms. In fact, a class 
action suit is still pending in Britain consisting of 25,000 people, 
1,500 of which are nurses. In 1986, Kodak, the company that makes 
Pantopaque, voluntarily stopped distributing the drug in the United 
States, due to public pressure. Pantopaque has a 5-year shelf life. The 
last batch was due to expire April 1, 1991. However, the use of 
Pantopaque has continued, with the Arachnoiditis Information and 
Support Network having documented a case in September 1993 and 
hospitals stocking the dye as recently as April 1994. Undocumented 
cases of use continue.
  A large number of medical professionals do not know how to diagnose 
myelogram-related arachnoiditis, and when they do, they cannot treat 
it. Medical journals and case studies from around the world document 
the connection between radiopaque dyes and arachnoiditis. Despite this 
documentation, the medical profession as a whole has not been 
effectively informed and still persists in its use. Moreover, the lack 
of information prevents the physician from recognizing the disease or 
side effects of the residual dyes after the fact. The time has come for 
thorough research to study this painful, disabling condition. The 
legislation I have introduced today will direct the National Institute 
of Neurological Disorders and Stroke to estimate the number of 
Americans suffering from myelogram-related arachnoiditis and determine 
the extent of this relationship.
  Every year, chronic back pain is responsible for billions of dollars 
in lost revenues and millions more in health care costs. The American 
Journal reports that chronic low-back pain is estimated to cost $16 
billion annually in the United States. Occupational research finds that 
back injuries, pain, and complications cost an average of $15,000 per 
incident. According to The Power of Pain by Shirley Kraus, 100 million 
Americans are either permanently disabled or are less productive due to 
back pain. Those who do work lose about 5 work days per year, a 
productivity loss of $55 billion. Interestingly enough, these figures 
only refer to chronic back pain patients. Almost all arachnoiditis 
sufferers eventually become totally disabled, becoming permanent 
fixtures on

[[Page E227]]

the rolls of social security, disability, welfare, and medicaid.
  Arachnoiditis sufferers want to become functioning, contributing 
members of society again. The Traficant legislation will provide 
research for treatments for arachnoiditis sufferers, including 
treatments to manage pain. Pain-management treatments would enable 
sufferers to once again become active, working members of society.
  It's time to protect unsuspecting Americans from this debilitating 
and preventable condition. I ask Members of Congress to join me by 
cosponsoring my legislation.

                          ____________________