>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."
>***************************************************************************
***
>********************
>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.'.
>
----
Jim Lubin
jlubin(AT)eskimo.com
Bothell, WA, USA <http://www.eskimo.com/~jlubin>
disAbility Resources: <http://www.eskimo.com/~jlubin/disabled>