|
|
| Author |
Message |
TC
medicine forum Guru
Joined: 02 May 2005
Posts: 1814
|
 Posted: Thu Jun 09, 2005 2:47 pm Post subject:
FDA official: Safety system broken down
|
|
|
http://news.webindia123.com/news/showdetails.asp?id=87128&cat=Science
FDA official: Safety system broken down:-
WASHINGTON | June 09, 2005 7:11:28 PM IST
A top U.S. Food and Drug Administration official says much still
remains to be done by the government to uncover the dangers in drugs
already on the market.
The warning was issued to a medical advisory board in Washington by Dr.
Janet Woodcock, FDA's deputy commissioner of operations, the New York
Times reported Thursday.
Woodcock, who has been asked to suggest safety improvements because of
recent well-publicized drug industry troubles, said the government's
safety system needs to be fixed, the report said.
The keystone of the current system is the prescriber and that person is
the one who decides if the benefits of a drug outweigh the risks for
that patient, Woodcock said. This system has obviously broken down to
some extent, as far as the fully informed provider and the fully
informed patient.
She said one way for the FDA to resolve problems with drugs on the
market is to take advantage of electronic health records from
managed-care organizations.
She also said physician and hospital errors are major contributors to
the current problem.
-------
TC |
|
| Back to top |
|
 |
Sbharris[atsign]ix.netcom
medicine forum Guru
Joined: 28 Apr 2005
Posts: 1218
|
| Posted: Thu Jun 09, 2005 3:59 pm Post subject:
Re: FDA official: Safety system broken down
|
|
|
| Quote: | The keystone of the current system is the prescriber and that person is
the one who decides if the benefits of a drug outweigh the risks for |
that patient, Woodcock said.<<
COMMENT:
Woodcock is wrong. The FDA makes such a decission long before the drug
even becomes available to provider and patient, and does it without
knowing the patient, and without suffering the patient's problems. And
that IS the problem.
SBH |
|
| Back to top |
|
|
Robert
medicine forum Guru
Joined: 28 Apr 2005
Posts: 1700
|
| Posted: Thu Jun 09, 2005 5:33 pm Post subject:
Re: FDA official: Safety system broken down
|
|
|
"Sbharris[atsign]ix.netcom.com" <sbharris@ix.netcom.com> wrote in message
news:1118339943.397048.112730@g49g2000cwa.googlegroups.com...
| Quote: | The keystone of the current system is the prescriber and that person is
the one who decides if the benefits of a drug outweigh the risks for
that patient, Woodcock said.
COMMENT:
Woodcock is wrong. The FDA makes such a decission long before the drug
even becomes available to provider and patient, and does it without
knowing the patient, and without suffering the patient's problems. And
that IS the problem.
SBH
You are obviously correct Steve on the first part. Efficacy must be proven |
and safety must be proven for FDA approval before any doctor or patient sees
it unless involved in a clinical trial.
Insurance companies will not pay for the drug otherwise as far as I am aware
of. If such approval did not exist then the patient would have to pay for it
out of pocket and if that were to happen the price for the drug would
actually go down I believe.
The FDA and drug companies work together for obvious reasons. If the FDA
weren't there the drug companies would invent their own so called
independent body giving the blue seal of approval that they can market as
"safe" and "effective".
It provides relative safety for the patient and a marketing device for the
drug manufacturers. |
|
| Back to top |
|
|
TC
medicine forum Guru
Joined: 02 May 2005
Posts: 1814
|
| Posted: Thu Jun 09, 2005 6:01 pm Post subject:
Re: FDA official: Safety system broken down
|
|
|
Robert wrote:
| Quote: | "Sbharris[atsign]ix.netcom.com" <sbharris@ix.netcom.com> wrote in message
news:1118339943.397048.112730@g49g2000cwa.googlegroups.com...
The keystone of the current system is the prescriber and that person is
the one who decides if the benefits of a drug outweigh the risks for
that patient, Woodcock said.
COMMENT:
Woodcock is wrong. The FDA makes such a decission long before the drug
even becomes available to provider and patient, and does it without
knowing the patient, and without suffering the patient's problems. And
that IS the problem.
SBH
You are obviously correct Steve on the first part. Efficacy must be proven
and safety must be proven for FDA approval before any doctor or patient sees
it unless involved in a clinical trial.
Insurance companies will not pay for the drug otherwise as far as I am aware
of. If such approval did not exist then the patient would have to pay for it
out of pocket and if that were to happen the price for the drug would
actually go down I believe.
The FDA and drug companies work together for obvious reasons. If the FDA
weren't there the drug companies would invent their own so called
independent body giving the blue seal of approval that they can market as
"safe" and "effective".
It provides relative safety for the patient and a marketing device for the
drug manufacturers.
|
There's the rub: "relative safety".
Your idea of relative safety is not the same as my idea of relative
safety which is not the same as Pharma's idea of relative safety which
is not the same as the FDA's idea of relative safety which is not the
same as patients' idea of relative safety which is not the same as.....
TC |
|
| Back to top |
|
|
Jeff
medicine forum Guru
Joined: 25 Mar 2005
Posts: 1313
|
| Posted: Thu Jun 09, 2005 11:35 pm Post subject:
Re: FDA official: Safety system broken down
|
|
|
"Robert" <Robertitsme@hotmail.com> wrote in message
news:eYudnQ3UucE2BDXfRVn-1g@got.net...
| Quote: |
"Sbharris[atsign]ix.netcom.com" <sbharris@ix.netcom.com> wrote in message
news:1118339943.397048.112730@g49g2000cwa.googlegroups.com...
The keystone of the current system is the prescriber and that person is
the one who decides if the benefits of a drug outweigh the risks for
that patient, Woodcock said.
COMMENT:
Woodcock is wrong. The FDA makes such a decission long before the drug
even becomes available to provider and patient, and does it without
knowing the patient, and without suffering the patient's problems. And
that IS the problem.
SBH
You are obviously correct Steve on the first part. Efficacy must be proven
and safety must be proven for FDA approval before any doctor or patient
sees
it unless involved in a clinical trial.
Insurance companies will not pay for the drug otherwise as far as I am
aware
of.
|
Many insurance companies pay for chiropractic, naturopathy and other
conjecture-based mediciations. The also pay for medications that are
technically not medically necessary, like Viagra and Levetra.
Also, the insurance companies don't always pay for drugs that are FDA
approved, especially if there is a similar one already on their formulary.
| Quote: | If such approval did not exist then the patient would have to pay for it
out of pocket and if that were to happen the price for the drug would
actually go down I believe.
|
Actually, unless a drug is approved by the FDA, it cannot be sold as a drug
for humans or other animals.
| Quote: | The FDA and drug companies work together for obvious reasons. If the FDA
weren't there the drug companies would invent their own so called
independent body giving the blue seal of approval that they can market as
"safe" and "effective".
|
Actually, food supplements (think conjecture-based medicine, aka alternative
medicine) can be marketed as safe and effective if they have been proven to
be safe and effective.
| Quote: | It provides relative safety for the patient and a marketing device for the
drug manufacturers.
|
Jeff |
|
| Back to top |
|
|
Robert
medicine forum Guru
Joined: 28 Apr 2005
Posts: 1700
|
| Posted: Fri Jun 10, 2005 12:00 am Post subject:
Re: FDA official: Safety system broken down
|
|
|
"Jeff" <kidsdoc2000@hotmail.com> wrote in message
news:t76qe.1915$VK4.1875@newsread1.news.atl.earthlink.net...
| Quote: |
"Robert" <Robertitsme@hotmail.com> wrote in message
news:eYudnQ3UucE2BDXfRVn-1g@got.net...
"Sbharris[atsign]ix.netcom.com" <sbharris@ix.netcom.com> wrote in
message
news:1118339943.397048.112730@g49g2000cwa.googlegroups.com...
The keystone of the current system is the prescriber and that person
is
the one who decides if the benefits of a drug outweigh the risks for
that patient, Woodcock said.
COMMENT:
Woodcock is wrong. The FDA makes such a decission long before the drug
even becomes available to provider and patient, and does it without
knowing the patient, and without suffering the patient's problems. And
that IS the problem.
SBH
You are obviously correct Steve on the first part. Efficacy must be
proven
and safety must be proven for FDA approval before any doctor or patient
sees
it unless involved in a clinical trial.
Insurance companies will not pay for the drug otherwise as far as I am
aware
of.
Many insurance companies pay for chiropractic, naturopathy and other
conjecture-based mediciations.
That's correct Jeff. The reason behind that is most back pain gets better on |
it's own and rather than seeing a medical specialist which costs much more
they have found it cheaper to tell them to go to alternate care.
The also pay for medications that are
| Quote: | technically not medically necessary, like Viagra and Levetra.
That's correct but those are FDA approved and are very expensive. |
Naturopathy is much more cheaper including tiger penis soup or rhino
testicles.
| Quote: |
Also, the insurance companies don't always pay for drugs that are FDA
approved, especially if there is a similar one already on their formulary.
They certainly wouldn't pay for a non FDA aprroved drug including research |
drugs.
There are many statins, blood pressure meds etc on the market that most of
the time they will pay. Some insurance don't want to pay for newer drugs
sometimes like Medicare.
| Quote: |
If such approval did not exist then the patient would have to pay for it
out of pocket and if that were to happen the price for the drug would
actually go down I believe.
Actually, unless a drug is approved by the FDA, it cannot be sold as a
drug
for humans or other animals.
Drugs sold in Canada are cheaper. People are buying viagra from Pakistan. |
Just give them a credit card number.
I was giving a scenario in which the FDA were to be abolished then the drug
companies would set up their own organization because drugs would flood the
market and prices would go down.
| Quote: |
The FDA and drug companies work together for obvious reasons. If the FDA
weren't there the drug companies would invent their own so called
independent body giving the blue seal of approval that they can market
as
"safe" and "effective".
Actually, food supplements (think conjecture-based medicine, aka
alternative
medicine) can be marketed as safe and effective if they have been proven
to
be safe and effective.
That's why they do it is to advertise that it is FDA approved. |
It is solely a marketing ploy as they don't need to do that.
| Quote: |
It provides relative safety for the patient and a marketing device for
the
drug manufacturers.
Jeff
|
|
|
| Back to top |
|
|
Google
|
|
| Back to top |
|
|
|
|
The time now is Sat Jan 10, 2009 2:02 am | All times are GMT
|
|
Credit Cards Help | Internet Advertising | Free Credit Reports | Loans | Internet Advertising
|
|
Copyright © 2004-2005 DeniX Solutions SRL
|
|
Other DeniX Solutions sites:
electronics forum,
Science forum
Unix/Linux blog
Unix/Linux documentation
Unix/Linux forums
|
Powered by phpBB © 2001, 2005 phpBB Group
|
|
FAQ
Search
Memberlist
Usergroups
Register
Profile
Log in to check your private messages
Log in
Forum index
»
Medicine forums
»
nutrition
