Marjorie and Rita,
IN spite of my agreement with you on most things I have to take issue
with you on the FDA The FDA is imperfect and my need some
reorganization but to privatize the FDA is opening it up to even more
abuses than it may be subject to now. The pressure to rush untested
drugs to the market by drug companies will be unbelievable as will the
pressure from we consumers pushed on by high expectations of
the manufacturers. Remember Tocapone and the fact that that got on
the market even after testing.
For those of us feeling desperate I suggest getting involved in a
study. Be one of the first people to try a new drug or procedure
prior to its general release to the public.is admirable and
necessary.. But putting a drug on the market with less knowledge
than we have now in the hands or ill trained and ill-prepared MD's
invites disaster. Many MD's get the majority of their information about a
new drug from the drug manufacturer and will not monitor a new drug
adequately,
The issue of the release from Rush about Kordower's research with the
monkeys
and use of viral vectors to produce GNDF is a preliminary step in
the research process. It may or may not bear fruit. A monkey
and a person certainly are different from each other and the monkey model
of PD is also different. It would be ridiculous to fan our hopes by
stating that a cure for PD has been found, but it is promising
research. There have been deaths involved with research into this
area of genetic therapy. It is not innocuous.
But Marge and Rita if you want to participate in a clinical trial
and you meet the criteria I want to encourage you to contact a major PD
research center and make it known that you wish to participate in drug or
surgical trials. (I have taken part in one drug study and
2 surgery protocols. ) I think it is better to get
a new drug or procedure in controlled conditions than expose the
public to the risk of premature release and perhaps tragic results.
I am not saying that the FDA is doing the best job that can be done
but in their absence, I am not prepared to trust the Drug and
equipment manufacturers to be objective or do the right thing by the
public. In spite of the fact that I hold some stock in Medtronic -
like most multinational corporations I have more trust in
them to take care of my interest as a stock holder more than
my interest as a user of their product. Unless a drug is
potentially life-saving 18 months is not too long to wait to
maximize safety and efficacy. IMHO, if the participation in
the safety and efficacy studies are open to those that want to
participate.
Just my random thoughts about a few items being discussed here on the
list.
Charlie
ps Rush website
www.rush.edu
At 11:25 AM 11/2/00 -0500, you wrote:
No Rita,
Not Gratis,
In all reality everyone who purchases
a drug pays twice, once as a taxpayer,and once as a consumer.
Do away with the FDA ,as an entity under US Department of Health
and Human Services, and set it up with a group of scientists or as
a private enterprise, using the funding currently paid to the FDA.
Drug Companies pay
to have drugs tested too, get them in on a re-evaluation of the
FDA.
There just has to be a better way,and the history of the FDA
proves they are too slow!!!
The average time for approval from the FDA is 18 months,
All PWP's know what 18 months does to their bodies,
especially after they have had it a number of years.
How many new drugs do you think are sitting there waiting
for FDA approval which would be of use to us now?
Things have changed since the FDA was set up in 1906 , and if
one reads the History of the FDA you'll see it takes them too
long to get anything done, always has!
I'm including this for persons who don't have research
capabilities:
This is from Encarta 1998, which I have in my computer.
There are many, many books written on the history of the FDA
is someone cares to read more about it, go to your favorite
library.
If they don't have a book on it, they will be happy to do an
ILL (inter library loan) for you, and they will gladly find titles
of books for you on the History of the FDA.
<SNIP>
The Federal Food, Drug, and Cosmetic Act was enacted in 1938 requiring
that
new drugs be safe for humans; however, it did not require that
manufacturers prove their drugs' effectiveness. It would be 24 years
before
legislation was passed that would require proof of the efficacy of
new
drugs (the Kefaver-Harris Amendments, 1962). Enforcement of this law
was
entrusted to the FDA.
Two laws enacted in the 1960s strengthened the FDA's efforts to reduce
drug
abuse. The Drug Abuse Control Amendments of 1965 provided penalties for
the
illegal sale or possession of stimulants, sedatives, and hallucinogens,
and
the Narcotic Addict Rehabilitation Act of 1966 set up a federal program
for
addicts that provided them with the option of receiving treatment for
their
drug problems in place of a prison sentence.
In 1970 the Comprehensive Drug Abuse Prevention and Control Act
established
rules for manufacturing and prescribing habit-forming drugs. It
stipulated
that physicians can prescribe all drugs, but a special license is
required
to prescribe drugs with a high abuse potential. This license is issued
by
the Drug Enforcement Administration.
The Anti-Drug Abuse Acts, signed into law in 1986 and 1988, set up
funding
for the treatment of drug abuse and for the creation of
law-enforcement
programs to fight the illegal sale of drugs. These acts also
detailed
severe punishments for individuals selling and possessing drugs
illegally.
Harsh penalties for using anabolic steroids (hormones that promote
the
storage of protein and the growth of tissue that are sometimes abused
by
competitive athletes) were included in the 1988 act, along with the
requirement that all alcoholic beverages be labeled with warnings
about
alcohol's potentially dangerous effect on the body. The 1988 act
also
established the Office of National Drug Control Policy to develop an
action
plan that would involve the public, as well as private agencies, in
eliminating the illegal sale of drugs; in helping individuals who use
drugs
to stop; and in preventing nonusers from ever starting to use
drugs.
The U.S. government and its regulatory agencies continually monitor
the
development and use of all drugs sold in the United States to ensure
that
the American public has access only to drugs that are safe and
effective.
Recently, the FDA introduced legislation requiring warning labels on
all
over-the-counter medication after research indicated that the
nonaspirin
pain reliever acetaminophen can cause liver damage when taken in high
doses
with large quantities of alcohol.
>END>
Maybe it's possible that the FDA has too much to do, and not enough
help,
but it certainly
needs to be brought up to speed, 18 months for approval is unacceptable
in
this century.
just me,
Marjorie
68/58/55
At 09:39 AM 11/02/2000 -0500, you wrote:
Marjorie said.......
"MOHO, the FDA gives a new meaning to the expression "Slower
than molasses
on a cold day in January". Also in my own humble opinion, the
FDA should=20
be removed from
Federal Control and turned over to a private group of scientists!!!!!
But=20
then no
one ever asked me for my opinion!"
and Rita asks.......Who is going to pay for the FDA program if the
taxpayers
don't?
Someone must foot the bill.....where will the private group of scientists
get
the money?.......or is this just to be a "gratis" thing that is
added on to
the research platter?
Rita Weeks 56/11
Charles T. Meyer, M.D.
Middleton, WI
PD DX 12 years (at age 44)
Age 56