Aa
Aa
A
A
A
Close
Avatar universal

Report Blasts FDA Safety Process

This has been posted earlier but I thought it deserves its own thread, especially in light of the drugs many of us are on.

Ever wonder why there's so little information available on the long term effects of the drugs we take? Well, who is going to do the studies? Keep in mind most studies are funded by drug companies. Conflict of interest?

Full article here: http://tinyurl.com/oa6wa

Some snippets:

The report backs up calls by some lawmakers for restructuring at the agency in the wake of highly publicized safety problems with popular drugs like Merck`s Vioxx and Pfizer`s Celebrex.

FDA lacks a clear and effective process for making decisions about, and providing management oversight of, postmarket drug safety issues,' stated the report, issued by the Government Accountability Office.

We observed that there is a lack of criteria for determining what safety actions to take and when to take them,' the GAO concluded.

The current structure causes an inherent conflict of interest, lawmakers charge, in which officials who`ve previously deemed a new drug safe may be reluctant to go back on their judgments later.

We suggest that the Congress consider expanding FDA`s authority to require drug sponsors to conduct postmarket studies when additional data are needed,' the GAO stated.



.
27 Responses
Sort by: Helpful Oldest Newest
Avatar universal
"On Vioxx, it was voluntarily pulled by manufacturer based on problems in some patients when used long term. I believe it could safely be prescribed today, and I believe the FDA would be OK with that."

I wonder how the families that lost loved ones due to this awful drug would feel about the above mentioned statment

slow
Helpful - 0
Avatar universal
Good morning lioness, been good thankyou and my hmg a week ago was 11.3 so we're almost identical there. Ya I do shot 9 fri. and now I'm battlin another bug the kids brought in. How have ya been doin, Did the hurricane effect ya any? I'm off to work , it's 5.30 am here , so I'll cya!
Helpful - 0
Avatar universal
Good morning,

I can't sleep so here I am.  Your HGb of 11.2 is geat, not bad at all.  Wish I had those #'s.  Your where I was before I started meds.

Beagle

Helpful - 0
Avatar universal
Hi Beagle, oops sorry, yep, that would translate 11.2
Helpful - 0
Avatar universal
That's great that your blood tests was good.  When you said that your hb is 112, did you mean 11.2?

Beagle
Helpful - 0
Avatar universal
I'm having a problem sleeping and so here I am.  I was one of thoses who was on celebrex and had many problem with it.  Don't know if I would take it today.  
I agree that China isn't tooling SUV's but I not saying that China disrupted the oil markets.  It showed on CNN how China is getting most of the out source jobs and how their factories are working around the clock, and how much oil it imports.

What part of the country are you from?  

Beagle
Helpful - 0
Have an Answer?

You are reading content posted in the Hepatitis C Community

Top Hepatitis Answerers
317787 tn?1473358451
DC
683231 tn?1467323017
Auburn, WA
Learn About Top Answerers
Didn't find the answer you were looking for?
Ask a question
Answer a few simple questions about your Hep C treatment journey.

Those who qualify may receive up to $100 for their time.
Explore More In Our Hep C Learning Center
image description
Learn about this treatable virus.
image description
Getting tested for this viral infection.
image description
3 key steps to getting on treatment.
image description
4 steps to getting on therapy.
image description
What you need to know about Hep C drugs.
image description
How the drugs might affect you.
image description
These tips may up your chances of a cure.
Popular Resources
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.