Medical, S.830 WILL WEAKEN FDA's ABILITY TO REGULATE

Al Feu
#1 / 26

S.830 WILL WEAKEN FDA's ABILITY TO REGULATE

The Senate, without public input, is getting ready to vote on S.830, which
was written in large part by industry representatives who want to weaken
the FDA's ability to regulate food, {*filter*} and medical devices.

This law will not only weaken federal regulations (such as those which
prohibit cooking.net">food and drug manufacturers from making false health claims), it
will also wipe out state laws which have been enacted to protect consumers
and patients.

I urge everybody who reads this to call their U.S. Senators (Capitol
Switchboard: 800-962-3524) and urge them to oppose this dangerous bill.
Also, please call that same number, ask for the Senate Document Room and
request a copy of the bill (100+ pages) so you can read for yourself how
Senate Republicans are "stealing" the protections currently in place
regarding food/drug labeling and product regulations.

--

Al Feuer
North Miami, Florida 33168-6501

Sat, 25 Dec 1999 03:00:00 GMT

Steven B. Harr
#2 / 26

S.830 WILL WEAKEN FDA's ABILITY TO REGULATE

Quote:

>The Senate, without public input, is getting ready to vote on S.830,
which
>was written in large part by industry representatives who want to
weaken
>the FDA's ability to regulate food, {*filter*} and medical devices.

>This law will not only weaken federal regulations (such as those which
>prohibit cooking.net">food and drug manufacturers from making false health claims),
it
>will also wipe out state laws which have been enacted to protect
consumers
>and patients.

>I urge everybody who reads this to call their U.S. Senators (Capitol
>Switchboard: 800-962-3524) and urge them to oppose this dangerous
bill.
>Also, please call that same number, ask for the Senate Document Room
and
>request a copy of the bill (100+ pages) so you can read for yourself
how
>Senate Republicans are "stealing" the protections currently in place
>regarding food/drug labeling and product regulations.

>--

>Al Feuer
>North Miami, Florida 33168-6501

A lot of those "protections are killing you, Al, you just don't
know it. They stiffle profits in areas where least research as been
done, and the lack of profits in turn further stiffles research. A
vicious circle. The entire field of medical research is pretty much
running at a tiny fraction of the pace it would if there was no FDA.
Medical device manufacturers have moved offshore, or sell only to
foreign countries. Nobody complains because they think they're dying
of a disease, not from lack of medical progress.

Take a look at the progress in the computer industry in the last 20
years. There's no reason on Earth why medical progress can't be that
fast. There is one main reason why it hasn't: the FDA.

Steve Harris, M.D.

Sat, 25 Dec 1999 03:00:00 GMT

David Wrig
#3 / 26

S.830 WILL WEAKEN FDA's ABILITY TO REGULATE

Quote:

> Take a look at the progress in the computer industry in the last 20
>years. There's no reason on Earth why medical progress can't be that
>fast. There is one main reason why it hasn't: the FDA.

Well, if my operating system crashes, as far as I know, nobody dies or
gets cancer.

These are my opinions only, but they're almost always correct.
"My theory of evolution: I think Darwin was adopted."
-- Steven Wright (no relation)

Sat, 25 Dec 1999 03:00:00 GMT

Steven B. Harr
#4 / 26

S.830 WILL WEAKEN FDA's ABILITY TO REGULATE

Quote:

>> Take a look at the progress in the computer industry in the last
20
>>years. There's no reason on Earth why medical progress can't be that
>>fast. There is one main reason why it hasn't: the FDA.

>Well, if my operating system crashes, as far as I know, nobody dies or
>gets cancer.

> These are my opinions only, but they're almost always correct.
> "My theory of evolution: I think Darwin was adopted."
> -- Steven Wright (no relation)

On the other hand, if you do nothing on your computer, nobody dies
or gets cancer. But we do die of disease. In the US, 2 million people
die every year of things that would mostly be treatable if we knew
enough. You can't NOT gamble here. Everybody in this country sits on
death row, including you and me. We're doing research, however, at a
pace which suggests we all think we're immortal. And aging is sort of
like the proverbial weather-- everybody complains, but nobody does
anything about it.

Steve Harris, M.D.

Sun, 26 Dec 1999 03:00:00 GMT

David Wrig
#5 / 26

S.830 WILL WEAKEN FDA's ABILITY TO REGULATE

Quote:

> On the other hand, if you do nothing on your computer, nobody dies
>or gets cancer. But we do die of disease. In the US, 2 million people
>die every year of things that would mostly be treatable if we knew
>enough. You can't NOT gamble here. Everybody in this country sits on
>death row, including you and me. We're doing research, however, at a
>pace which suggests we all think we're immortal. And aging is sort of
>like the proverbial weather-- everybody complains, but nobody does
>anything about it.

I do -- upstairs, I have this painting of me that looks worse and
worse every year, while I stay the same.

These are my opinions only, but they're almost always correct.
"My theory of evolution: I think Darwin was adopted."
-- Steven Wright (no relation)

Sun, 26 Dec 1999 03:00:00 GMT

Steven B. Harr
#6 / 26

S.830 WILL WEAKEN FDA's ABILITY TO REGULATE

Quote:

>> On the other hand, if you do nothing on your computer, nobody
dies
>>or gets cancer. But we do die of disease. In the US, 2 million
people
>>die every year of things that would mostly be treatable if we knew
>>enough. You can't NOT gamble here. Everybody in this country sits
on
>>death row, including you and me. We're doing research, however, at a
>>pace which suggests we all think we're immortal. And aging is sort
of
>>like the proverbial weather-- everybody complains, but nobody does
>>anything about it.

>I do -- upstairs, I have this painting of me that looks worse and
>worse every year, while I stay the same.

> These are my opinions only, but they're almost always correct.
> "My theory of evolution: I think Darwin was adopted."
> -- Steven Wright (no relation)

You cad. One day, all of it will come due at once, just like in
Lost Horizon and She. No more of the sacred Nipee pollen and pineal
for you.

Dr. Basil Halward

Tue, 28 Dec 1999 03:00:00 GMT

Valerie Whittie
#7 / 26

S.830 WILL WEAKEN FDA's ABILITY TO REGULATE

Quote:

> Take a look at the progress in the computer industry in the last 20
> years. There's no reason on Earth why medical progress can't be that
> fast. There is one main reason why it hasn't: the FDA.

As a participant in the computer industy, I do not feel comfortable with
the idea that it should be a model for medical science. Too often "faster"
is perceived as "better". In this climate, the quality of products shipped
by computer companies is often extremely poor.

It is true that over time, and taken as a whole, the industry evolves
toward standards and a few good products that have sufficient market share
to pay for quality. In the mean time, we spend a great deal of time and
money on technology that doesn't live up to its marketing and technical
vision statements. Do we really want to deploy medical solutions in this
manner?

It is more likely that if the medical and computer industries become more
similar it will be largely due to the maturing of the computer industry. I
believe that as societal awareness of how computer technology impacts
critical privacy, health, and financial issues, it will face more
regulation and litigation. I think that it is highly likely that serious
mishaps related to the arrival of the Year 2000 will establish legal
precedents that will produce a greater conservatism in computer
development.

Coupled with changes in the medical industry, maybe the two fields will
progress at similar rates -- but in neither case is it likely to be as fast
as the last 20 years in the computer industry.

--
Valerie Whittier

Principal Software Engineer (medical application)
Attorney (non-practicing)

Wed, 29 Dec 1999 03:00:00 GMT

Valerie Whittie
#8 / 26

S.830 WILL WEAKEN FDA's ABILITY TO REGULATE

Quote:

> death row, including you and me. We're doing research, however, at a
> pace which suggests we all think we're immortal. And aging is sort of

Are you suggesting that if we do enough research we WILL be immortal? I
think that if we believed that, there may be more urgency to medical
research.

Quote:

> like the proverbial weather-- everybody complains, but nobody does

Do we even know what we want to do about it within the constraints of its
inevitability and our mortality? Our technical advances usually produce new
sets of problems to solve. It is not always clear that we are really better
off doing something than nothing, but inevitably we do something apparently
because human technical progress is as inevitable as aging and death.

--
Valerie Whittier

Principal Software Engineer (medical application)
Attorney (non-practicing)

Wed, 29 Dec 1999 03:00:00 GMT

Valerie Whittie
#9 / 26

S.830 WILL WEAKEN FDA's ABILITY TO REGULATE

Quote:

> > Take a look at the progress in the computer industry in the last 20
> >years. There's no reason on Earth why medical progress can't be that
> >fast. There is one main reason why it hasn't: the FDA.

> Well, if my operating system crashes, as far as I know, nobody dies or

They might if your operating system was embedded in a piece of medical or
transportation equipment.

So, it could be argued that we tolerate this risk in software and so should
tolerate it in medicine. However, in the case of embedded computers,
software failures may be treated more generally as "equipment" failure (and
the extent to which it is tolerated depends on the extent to which
equipment is regulated in the field in which it is deployed).

It really isn't fair to compare the pace of computer progress to medical
progress because computers are general purpose tools. This has allowed for
a great deal to be learned by addressing low risk problem domains. It is
difficult to separate medical issues from significant safety concerns.

--
Valerie Whittier

Principal Software Engineer (medical application)
Attorney (non-practicing)

Wed, 29 Dec 1999 03:00:00 GMT

Steven B. Harr
#10 / 26

S.830 WILL WEAKEN FDA's ABILITY TO REGULATE

Quote:

>> death row, including you and me. We're doing research, however, at
a
>> pace which suggests we all think we're immortal. And aging is sort
of

>Are you suggesting that if we do enough research we WILL be immortal?
I
>think that if we believed that, there may be more urgency to medical
>research.

>> like the proverbial weather-- everybody complains, but nobody does

>Do we even know what we want to do about it within the constraints of
its
>inevitability and our mortality? Our technical advances usually
produce new
>sets of problems to solve. It is not always clear that we are really
better
>off doing something than nothing, but inevitably we do something
apparently
>because human technical progress is as inevitable as aging and death.

>--
>Valerie Whittier

>Principal Software Engineer (medical application)
>Attorney (non-practicing)

Look, there's absolutely nothing, so far as I can tell, in the laws
of physics which demand aging and death (unless you're talking about
the end of the universe, and even that's pretty iffy, because it will
probably just run down, with free energy supplies getting smaller and
smaller, but still available).

A good mechanic can keep your car going basically as long as you
want to pay him. Of course, eventually it becomes a philosophical
question as to when it stops being the same car. But the same would
happen to your identity if your memories were replaced. If it were
possible to repair your brain and somehow keep or save memories, "you"
would be functionally immortal. I not only see no reason it can't
happen, I rather expect and predict that technology will get there in a
century or two. Cloning was science fiction until this year, remember?
Technology marches on.

Steve Harris, M.D.

Thu, 30 Dec 1999 03:00:00 GMT

Steven B. Harr
#11 / 26

S.830 WILL WEAKEN FDA's ABILITY TO REGULATE

Quote:

>It really isn't fair to compare the pace of computer progress to
medical
>progress because computers are general purpose tools. This has allowed
for
>a great deal to be learned by addressing low risk problem domains. It
is
>difficult to separate medical issues from significant safety concerns.

Medical progress hasn't kept up with progress in transportation or
communications, either. And the pace of medical progress is
declining, particularly since medical instruments got clamped down on
by the FDA a couple of years back. There is no reason on Earth why we
don't have an implantable $10,000 artificial heart right now, except
cowardace. The government decided we don't want one.

Steve Harris, M.D.

Thu, 30 Dec 1999 03:00:00 GMT

Anonymo
#12 / 26

S.830 WILL WEAKEN FDA's ABILITY TO REGULATE

Quote:

> Look, there's absolutely nothing, so far as I can tell, in the laws
> of physics which demand aging and death (unless you're talking about
> the end of the universe, and even that's pretty iffy, because it will
> probably just run down, with free energy supplies getting smaller and
> smaller, but still available).

> A good mechanic can keep your car going basically as long as you
> want to pay him. Of course, eventually it becomes a philosophical
> question as to when it stops being the same car. But the same would
> happen to your identity if your memories were replaced. If it were
> possible to repair your brain and somehow keep or save memories, "you"
> would be functionally immortal. I not only see no reason it can't
> happen, I rather expect and predict that technology will get there in a
> century or two. Cloning was science fiction until this year, remember?
> Technology marches on.

> Steve Harris, M.D.

I don't know whether it's possible or not, but even if it is, would it be a good
idea? I'm not saying it should be banned, but if one had to choose between
spending a lot of money to keep oneself alive or using it to raise children,
wouldn't it be more sensible to do the latter? If just a few people choose to
stay alive longer I suppose there'd be no problems, but if nobody dies, where
are the kids going to live? And certainly it would be better to have kids than
to stop having them and just keep the present (at the time this became possible)
population alive, wouldn't it? Without {*filter*} reproduction there'd be no change
in the genetic composition of humans which in the long run I would think would
hurt the human race's chances of survival. I'm no expert on this but I'd be
interested in your thoughts.

Thu, 30 Dec 1999 03:00:00 GMT

Anonymo
#13 / 26

S.830 WILL WEAKEN FDA's ABILITY TO REGULATE

Quote:

> Look, there's absolutely nothing, so far as I can tell, in the laws
> of physics which demand aging and death (unless you're talking about
> the end of the universe, and even that's pretty iffy, because it will
> probably just run down, with free energy supplies getting smaller and
> smaller, but still available).

> A good mechanic can keep your car going basically as long as you
> want to pay him. Of course, eventually it becomes a philosophical
> question as to when it stops being the same car. But the same would
> happen to your identity if your memories were replaced. If it were
> possible to repair your brain and somehow keep or save memories, "you"
> would be functionally immortal. I not only see no reason it can't
> happen, I rather expect and predict that technology will get there in a
> century or two. Cloning was science fiction until this year, remember?
> Technology marches on.

> Steve Harris, M.D.

I don't know whether it's possible or not, but even if it is, would it be a good

idea? I'm not saying it should be banned, but if one had to choose between
spending a lot of money to keep oneself alive or using it to raise children,
wouldn't it be more sensible to do the latter? If just a few people choose to
stay alive longer I suppose there'd be no problems, but if nobody dies, where
are the kids going to live? And certainly it would be better to have kids than
to stop having them and just keep the present (at the time this became possible)

population alive, wouldn't it? Without {*filter*} reproduction there'd be no change

in the genetic composition of humans which in the long run I would think would
hurt the human race's chances of survival. I'm no expert on this but I'd be
interested in your thoughts.

Thu, 30 Dec 1999 03:00:00 GMT

Larry Wolf
#14 / 26

S.830 WILL WEAKEN FDA's ABILITY TO REGULATE

Quote:

> >The Senate, without public input, is getting ready to vote on S.830,
> which
> >was written in large part by industry representatives who want to
> weaken
> >the FDA's ability to regulate food, {*filter*} and medical devices.

> >Al Feuer
> >North Miami, Florida 33168-6501

> A lot of those "protections are killing you, Al, you just don't
> know it. They stiffle profits in areas where least research as been
> done, and the lack of profits in turn further stiffles research. A
> vicious circle. The entire field of medical research is pretty much
> running at a tiny fraction of the pace it would if there was no FDA.
> Medical device manufacturers have moved offshore, or sell only to
> foreign countries. Nobody complains because they think they're dying
> of a disease, not from lack of medical progress.

> Take a look at the progress in the computer industry in the last 20
> years. There's no reason on Earth why medical progress can't be that
> fast. There is one main reason why it hasn't: the FDA.

> Steve Harris, M.D.

I hope that you will keep this in mind during your next impassioned
debate with one of the alternative medicine true believers...

It will not only be your research which is released from overview.
It will also be the abilities of the quack community who will get to
exercise their superior marketing skills. Perhaps you
will indeed see an analog to the computer industry and those who
hype will run those who engineer out of business.

We can all look forward to the medical version of the generic
"shrink-wrap" software license. "This is a piece of plastic for
which you gave $400.00. Under no circumstances can we be held liable
for you thinking that it should contain a working program. If it
works, we have rights that you have not even thought about. If it
does not, too bad." ... and no, the fact that we have spent 6 billion
bucks trying to convince you that it is the wonder of the age does not
effect this warranty one iota.

--larry

Thu, 30 Dec 1999 03:00:00 GMT

#15 / 26

S.830 WILL WEAKEN FDA's ABILITY TO REGULATE

Fri, 19 Jun 1992 00:00:00 GMT