| | |
---
More drug-safety questions increase doubts about FDA <-- 30,000 Vioxx deaths
More drug-safety questions increase doubts about FDA <-- 30,000 Vioxx deaths -- Posted by WK on 12-19-04 21:13
http://www.usatoday.com
More drug-safety questions increase doubts about FDA
Is anyone watching the store?
Consumers ask that question when it appears that no one is accountable
for how a business is being managed. It's a question many now ask
about how the Food and Drug Administration (FDA) monitors drug safety.
On Friday, the maker of Celebrex announced that the pain reliever
might be linked to increased risks of heart attacks and strokes - the
same issues that caused Vioxx, a drug in the same class, to be
withdrawn. More than a dozen of the world's most popular medicines
have been challenged this year by new studies and scientists who say
the FDA is failing to protect the public.
The stakes couldn't be higher. Vioxx alone may have caused more than
30,000 deaths, David Graham, an FDA whistleblower and safety expert,
told Congress last month.
To be sure, all drugs carry risks. But how much trust can Americans
have in the FDA when a government survey finds that two-thirds of its
scientists lack confidence that the agency adequately monitors safety,
and 18% say they'd been pressured to recommend a drug over their
reservations?
The FDA's job is to make sure the benefits outweigh the risks and that
physicians and patients are aware of both. But the agency often
operates in the dark, particularly after a drug is approved, putting
the public at risk. It has seven times the number of employees working
on new-drug approvals than it does on safety issues after a drug is
OK'd.
Potentially lifesaving new drugs ought to get fast review, but several
changes in the system are needed:
Give FDA authority to demand targeted studies to resolve safety
questions and funds to perform adequate research. Adverse effects of
drugs may not be known for years. Yet the FDA waits for drugmakers to
volunteer data instead of demanding that they track how drugs perform.
Create an independent drug-safety board. Critics say the FDA is too
cozy with drugmakers and has a conflict of interest in monitoring
safety. The attitude is that "they approved the drug, so there can't
possibly be anything wrong with it," Graham says.
Bring stability to FDA leadership. The agency has had a permanent
chief only 17 months of the past four years. The lack of stable
leadership means the agency doesn't move as quickly and efficiently as
it should.
The first step in a cure is acknowledging the problem. Instead, the
FDA is in denial. Some strong medicine will be needed to regain public
confidence.
Re: More drug-safety questions increase doubts about FDA <-- 30,000 Vioxx deaths -- Posted by Harvey R. Stone on 01-27-05 11:04
You make some good points. You could say some of the same things about
Soc.Sec, NASA, the FDA,, All of the state department,,,, what should you
learn from this and will you learn anything,,,,, the answer is up to you
and an open mind.
My thoughts,,,,, all of us that too much faith in what "the gov" will
do for us must ask ourselves
is that much trust justified. All of gov. must be brought up todate and
the pro. politicians must go and fresh ideas applied to remain healthy and
ready for tomorrow.
Harv
"WK" wrote in message
news:tlncs0prni0ldmrus29hjejala1evl2d2d@4ax.com...
>
> http://www.usatoday.com
>
> More drug-safety questions increase doubts about FDA
>
> Is anyone watching the store?
>
> Consumers ask that question when it appears that no one is accountable
> for how a business is being managed. It's a question many now ask
> about how the Food and Drug Administration (FDA) monitors drug safety.
>
> On Friday, the maker of Celebrex announced that the pain reliever
> might be linked to increased risks of heart attacks and strokes - the
> same issues that caused Vioxx, a drug in the same class, to be
> withdrawn. More than a dozen of the world's most popular medicines
> have been challenged this year by new studies and scientists who say
> the FDA is failing to protect the public.
>
> The stakes couldn't be higher. Vioxx alone may have caused more than
> 30,000 deaths, David Graham, an FDA whistleblower and safety expert,
> told Congress last month.
>
> To be sure, all drugs carry risks. But how much trust can Americans
> have in the FDA when a government survey finds that two-thirds of its
> scientists lack confidence that the agency adequately monitors safety,
> and 18% say they'd been pressured to recommend a drug over their
> reservations?
>
> The FDA's job is to make sure the benefits outweigh the risks and that
> physicians and patients are aware of both. But the agency often
> operates in the dark, particularly after a drug is approved, putting
> the public at risk. It has seven times the number of employees working
> on new-drug approvals than it does on safety issues after a drug is
> OK'd.
>
> Potentially lifesaving new drugs ought to get fast review, but several
> changes in the system are needed:
>
> Give FDA authority to demand targeted studies to resolve safety
> questions and funds to perform adequate research. Adverse effects of
> drugs may not be known for years. Yet the FDA waits for drugmakers to
> volunteer data instead of demanding that they track how drugs perform.
>
> Create an independent drug-safety board. Critics say the FDA is too
> cozy with drugmakers and has a conflict of interest in monitoring
> safety. The attitude is that "they approved the drug, so there can't
> possibly be anything wrong with it," Graham says.
>
> Bring stability to FDA leadership. The agency has had a permanent
> chief only 17 months of the past four years. The lack of stable
> leadership means the agency doesn't move as quickly and efficiently as
> it should.
>
> The first step in a cure is acknowledging the problem. Instead, the
> FDA is in denial. Some strong medicine will be needed to regain public
> confidence.
>
>
Related
Discussion:
Better helath (1 posts)
by Richard Esquivel - Last post on: 06-23-04 18:39
All natural liquid vitamins/food supplements. Go to:
www.Ritchies.healthyoudeserve.com
---
MAF Anti-Spam ID: 20040616110935L1b7JdP0
... (Read More)
Well water contamination (1 posts)
by kr0 - Last post on: 03-10-05 11:36
Apparently there have been a number of issues with contamination of ground
water that has been affecting water wells and causing health problems. Much
of this seems to have been a result of chemical contamination resulting from
various sources. If you check out
http://www.lawyersandsettlements.c... (Read More)
potassium deficiency & diabetic (2 posts)
by chinkiak@yahoo.com - Last post on: 09-25-05 04:58
The doctor in hospital says that the blood pressure tablet given to my
mum by the GP, which she has been taking for a year plus cause
potassium deficiency in her body. She is diagnosed to have diabetes
last october. I wonder potassium deficiency indirectly lead to
diabetes? By the way, she's ove... (Read More)
Buying low carb foods online?? (15 posts)
by Mike Shmayer - Last post on: 10-04-04 10:28
Has anyone successfully tried any of the low carb foods that are sold
online? I live in a small town, and can't find very many products
locally. One place that caught my eye was www.nosugardaddy.com .. has
anyone tried this place, or can recommend another online vendor to
look into?
Thanks
... (Read More)
Top
Discussions From Our Archives
Half of all men and 1/3 of women due to get cancer
Cherries May Help Fight Diabetes
Other
Discussion Categories
Diabetes Symptoms
|
|
