The answer is not to make decisions based on emotional hysteria.  The answer
is to make sure that people are educated as to the risks of the drug before
it is made available.  After that, it should be their decision whether or not
to take it.  If someone is terminally ill and there is no hope or cure for the
disease they have, then they should have the right to try whatever drug they
want so long as they are provided with all the information about that drug.

I'm curious as to what you would say to the woman who had cancer and said that
thalidomide saved her life.  Would you have denied her the drug and let her
die?   How would you explain that to her family?

--Dena Bruedigam

my $ 0.02 worth,
H.

Thalidomide is making a "comeback" because it is now being touted as a
wonder drug for illnesses such as AIDS, Leukemia, and Diabetes. The
reasoning is as follows: there are many {*filter*} that are teratogenic,
yet that doesn't mean that thousands of people should be deprived of
something that would potentially cure or alleviate their suffering. In
the U.S, we have more restrictions and ample warnings would be given.

Personally, I believe there are many things that we can do and many
more resources (such as natural healing modalities) that we can
utilize without resorting to such dangerous chemicals.

One thalidomide victim is enough justification to have such a drug
banned forever.

Any other thoughts, opinions, criticisms?

--Henry

 > > Personally, I believe there are many things that we can do and many

Patrick

: Thalidomide is making a "comeback" because it is now being touted as a
: wonder drug for illnesses such as AIDS, Leukemia, and Diabetes. The
: reasoning is as follows: there are many {*filter*} that are teratogenic,
: yet that doesn't mean that thousands of people should be deprived of
: something that would potentially cure or alleviate their suffering. In
: the U.S, we have more restrictions and ample warnings would be given.

: Personally, I believe there are many things that we can do and many
: more resources (such as natural healing modalities) that we can
: utilize without resorting to such dangerous chemicals.

: One thalidomide victim is enough justification to have such a drug
: banned forever.

: Any other thoughts, opinions, criticisms?

: --Henry

        I heard it said that the toxicity of thalidomide was limited to one
of the stereoisomers only, whereas the therapeutic activity was largely in
the other. Is this true? If so, is it possible to selectively synthesise one
and keep it from racemising under storage?

        I would be concerned if thalidomide re-entered general use as there
would be a great chance that the wrong person could come in contact with the
dosage form. However, that said, we currently have {*filter*} available with
known or assumed teratogenic capabilities (for example, finasteride and
whatever retinoid is currently in favour). The manufacturers of such products
provide the prep in blister packs and the packs come with big warnings all
over them. This policy could be applied to thalidomide with effect and the
previous poster does allude to this. However, the thalidomide issue is
not only one of science but also one of emotion and it would be insensitive
now to widely reintroduce the drug.

        This is not to say that those who could benefit from thalidomide
should be deprived it. But this must be done on a named patient basis under
specialist care, after suitable alternative avenues have been explored and
ceased upon the production of an appropriate therapy. We cannot protect
everyone all of the time and it would be naive to suggest that we could. An
accident will eventually occur. But there again, that accident could just as
easily happen with another drug with the level of use envisaged. What would
be tragic is if the lessons of the past were not heeded and patient selection
was not performed with diligence. Informed consent from the patient is
another thing I should throw into the above.

        It should be noted that one is also at risk from some of the various
"natural healing modalities". Some are far from safe. I have heard that some
of the herbal remedies tried in ezcema are fairly harsh on the liver, for
example. One must be extra vigilant when such treatments are administered
as often the same weight of data is not available for the clinician.

        No human invention, be it drug or otherwise, is without its drawbacks.
Thalidomide and benoxyprofen are cases in point. Thalidomide is
especially tragic as it appears to have conferred an hereditary abnormality.
That alone must preclude a return to general use. Even if it were safe to
use in people other than women of childbearing age or potential then the risk
of accidental exposure is probably too high for most of us to accept.
However, there must be a case for those groups in society who are terminally
ill or suffering great agonies that cannot be adequately relieved by other
means. That level of use would be acceptable to me. And even this must be
ceased in the event of a safer alternative.

        These opinions are of course my own. It is a very interesting issue
and I'm sure I will not be the only contributor to this discussion. Sorry
to waffle on for so long but I'm trying to clarify myself and not rubbish
another's point of view even if it differs from my own.

Ian Baxter,
Aston Uni, Birmingham, UK.

PS- I would love some clarification on the stereochemistry. Am I mistaken?
Also, what is the collective feeling out there regarding the victims of such
tragedies and the compensation / support they receive. From what I remember
of the benoxyprofen (Opren) tragedy and still hear on the news from time to
time about thalidomide, the system of support is in this country at least
far from satisfactory.  

-Paul

--
David Rind

I saw it too, it's really mind boggling, and disturbing.

: Thalidomide is making a "comeback" because it is now being touted as a
: wonder drug for illnesses such as AIDS, Leukemia, and Diabetes. The
: reasoning is as follows: there are many {*filter*} that are teratogenic,
: yet that doesn't mean that thousands of people should be deprived of
: something that would potentially cure or alleviate their suffering. In
: the U.S, we have more restrictions and ample warnings would be given.

According the the film, and several articles I read, it's here already,
with or without the FDA approval.  If there is a ban, there is the black
market. And the most of disease that Thalidomide  can be used are terminal
or hard to cure disease, there will be surely lots of people try to get it
no matter what the cost is.

: Personally, I believe there are many things that we can do and many
: more resources (such as natural healing modalities) that we can
: utilize without resorting to such dangerous chemicals.

Well, may be or may not be, there are probably more than hundreds of
chemicals in pharmacutical industry were approved for human consumption
also have severe side effect. and they were approved none the less for
particular treatment.

: One thalidomide victim is enough justification to have such a drug
: banned forever.

Again, it depends on the point of view of individual, whoever suffer from
AIDS , cancer, MS, RA.. may think differently.

A total ban may not be the perfect solution, unless it can be banned totally
from the earth surface, otherwise people can get it oversea, smuggle it in
at black market, without prescription and caution from physician, and it will
become more dangeous situation.

Or we can be the ostrich to bury one's head in the sand, ban it in USA, and
let whoever need it to get it and take it on their own risk. If being caught,
put them in jail, right ?

John

: Thalidomide is making a "comeback" because it is now being touted as a
: wonder drug for illnesses such as AIDS, Leukemia, and Diabetes. The
: reasoning is as follows: there are many {*filter*} that are teratogenic,
: yet that doesn't mean that thousands of people should be deprived of
: something that would potentially cure or alleviate their suffering. In
: the U.S, we have more restrictions and ample warnings would be given.

: Personally, I believe there are many things that we can do and many
: more resources (such as natural healing modalities) that we can
: utilize without resorting to such dangerous chemicals.

: One thalidomide victim is enough justification to have such a drug
: banned forever.

: Any other thoughts, opinions, criticisms?
Clearly you have not taken care of a child with chronic graft versus host
disease who is gasping her life away because the "safe" {*filter*} you want to
leave us with don't do anything.  Thalidomide can cause birth defects,
but used properly, it may be a god-send to many people that you would
doom in the name of "safety".

 : --Henry

--
------ Call the skeptic hotline 1-900-666-5555 talk to your own personal .
\    / skeptic 24 hours/day.                                            . .
 \  /             Just say no to victimless crimes.                    . . .

A>More needs to go into approval of an agent than the feeling that it "mi
A>help" with a disease.  Efficacy must be proven and a reasonable side-ef
A>profile must be seen.  Approval of an agent for a single indication doe
A>exclude its use for other indications at the doctor's discretion and as
A>60 minutes expose showed, not all women who took the medication had it
A>prescribed for them.  This same thing can and does happen here in the U
A>That is the basis of any apprehension many individual have toward
A>thalidomide's possible FDA approval.  Personally, until thalidomide is
A>to be more effective at improving the quality of lifeof  individual wit
A>than the available alternatives, I don't see a need to risk approval.
A>
A>my $ 0.02 worth,

Agree that a comprehensive NDA process is indicated with thalidomide
(saw 60 Minutes last night, too).  Based just on its usefulness in
Hansen's disease (AKA "leprosy") I think a US approval may be justified.

We certainly have {*filter*} with much greater teratogenicity potential in
wide use in the US today (misoprostol is a good example) because the
benefits they afford far outweigh the risks involved.  Again, the use
and availability of misoprostol are controlled specifically to prevent a
child-bearing woman from taking it and either {*filter*}ly aborting her
fetus (with dire effects to herself) or doing severe teratogenic damage
to it.  Misoprostol hasn't made the news.  Neither has chloramphenicol,
although it carries what many would consider an unacceptable risk of
causing aplastic anemia, and (I may be out of date here) the only
disease for which it ever was a specific is Rocky Mountain spotted
fever (for which there are now much more active antibiotic agents).  
But chloramphenicol has not been withdrawn, and 60 Minutes has not done
a segment on it.

I think that we need to look at thalidomide in view of its ability to
modulate the immune response and not be guided by what was a failure,
not of the drug per se, but of the then practically nonexistent
mechanism for tracking adverse effects, reporting them, and acting on
them in Europe in the early 1960s.  A good general-audience book on this

disaster is "Suffer the Children" by the (London) Sunday Times editorial
research team.

Hope this helps
Vance Frickey
Ingenium Software

Contemplating this a bit more, thalidomide should be kept on an
experimental level and on a case by case basis. While doing so, they
must tweak it and GREATLY decrease the risk to women who may bear
children either intentionally or accidentally. The public, at large,
will not accept anything less. Would you?

--Henry

The whole tradgedy of the Britsh thalidomide incidents is that it was used
specifically to treat pregnancy related conditions.  There are MANY {*filter*}
which are either teratogens, or are treated as such because their teratogen-
icity is undetermined.  Hell, most of the medicines in a drug store would
be useless if we only used ones proven to be safe for use by pregnant women.

-Bret Wood

-Bret Wood

Does your heart go out for an AIDS or Cancer patient?

I say that Thalidomide should be evaluated just like any other drug to
see what it is for. The past mistakes should be remembered, but they
should not make the drug a taboo.

P.S. I read about the children in Brazil over a year ago in Newsweek (or
was it Time).