FRIDAY, FEBRUARY 14, 1997
TRAFICANT BILL BANS USE OF CERTAIN DYES LINKED TO DEBILITATING SPINAL DISEASE
Washington, D.C. -- U.S. Rep. James A. Traficant, Jr. (D--OH) has introduced
legislation to ban the use of certain water-soluble dyes in spinal x-ray
procedures. Scientific studies conducted this decade have linked the use of
these dyes to a debilitating spinal disease known as arachnoiditis. "The
medical evidence is clear. Banning the use of these dyes will help prevent
hundreds of thousands of new cases of this tragic disease," said Traficant,
who introduced similar legislation in the last Congress.
Traficant's bill, which he introduced last Wednesday, bans the use of
Pantopaque, Amipaque, Omipaque, or Isovue dyes in myelograms. 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ray examination, as much of the oil as possible is withdrawn.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; however,
recent evidence proves they also cause arachnoiditis.
Arachnoiditis literally 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 a syphilis or it may result from
trauma during 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. Dr. Harry Feffer of
George Washington University found 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 Food and Drug Administration to recall the use of
Pantopaque. "The FDA has clearly not reviewed the safety of oil-based
Pantopaque as well as water-based dyes, in spite of medical evidence," noted
Traficant. "That's why I've introduced this legislation."
Traficant's bill is not a new idea. Since 1990, Britain and Sweden have banned
the use of Pantopaque in myelograms. A class action suit is still pending in
Britain involving 25,000 people, 1,500 of which are nurses. In 1986, Kodak,
the company that makes Pantopaque, voluntarily stopped distributing the drug
in the U.S., due to public pressure. Pantopaque has a five-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 health 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 have documented the connection
between radiopaque dyes and arachnoiditis. Despite this documentation, the
medical profession as a whole has not been effectively informed and the dyes
continue to be used in myelograms. Moreover, the lack of information prevents
the physician from recognizing the disease or side effects of the residual
dyes.
In addition to banning the use of certain dyes in myelograms, Traficant's bill
directs 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
U.S. 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 five work days
per year, a productivity loss of $55 billion. These figures only refer to
chronic back pain patients. Almost all arachnoiditis sufferers eventually
become totally disabled -- permanent fixtures on the rolls of Social Security,
disability, welfare and Medicaid.
"Arachnoiditis sufferers want to become functioning, contributing members of
society again," said Traficant. "My legislation calls for research of
treatments for arachnoiditis sufferers, including treatments to manage pain.
This is key because 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."
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FILE h738.ih
HR 738 IH
105th CONGRESS
1st Session
To amend the Federal Food, Drug, and Cosmetic Act and the Public
Health Service Act with respect to myelogram-related arachnoiditis.
IN THE HOUSE OF REPRESENTATIVES
February 12, 1997
Mr. TRAFICANT introduced the following bill; which was referred to
the Committee on Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act and the Public
Health Service Act with respect to myelogram-related arachnoiditis.
[Italic->] Be it enacted by the Senate and House of
Representatives of the United States of America in Congress
assembled, [<-Italic]
SECTION 1. SHORT TITLE.
This Act may be cited as the `Myelogram-Related Arachnoiditis
Amendments of 1997'.
SEC. 2. ADULTERATED MYELOGRAMS.
Section 501 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 351) is amended by adding at the end the following:
`(j) If it is a myelogram involving the use of Pantopaque,
Amipaque, Omipacque, or Isovue.'.
SEC. 3. MYELOGRAM-RELATED ARACHNOIDITIS; ACTIVITIES OF NATIONAL
INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE.
Subpart 10 of part C of title IV of the Public Health Service Act
(42 U.S.C. 285j et seq.) is amended by adding at the end the
following section:
`MYELOGRAM-RELATED ARACHNOIDITIS
`SEC. 460A. With respect to individuals who have undergone the
diagnostic procedure known as a myelogram and who have subsequently
developed cases of arachnoiditis, the Director of the Institute
shall--
`(1) conduct or support a study to develop an estimate of the
number of such individuals in the United States;
`(2) conduct or support research to determine the extent to
which such cases are associated with the use of such procedure;
and
`(3) conduct or support research on treatments for such c
ases in such individuals, including treatments to manage
pain.'.