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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.
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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.
.
Hi guys, I havent been here a while, but have popped in to read some interesting threads.
On long term effects, I rang hep nurse before i started tx and she said there is a study that did long term follow up and found out the most significant was hypothyroidism. Otherwise, everyone was ok. This tx is comparatively new, so maybe more things will come to light, hope not.
The thread below was interesting as just came back from Dr and found out my HB has now slipped down to 112. She said that she expects everyones HB to drop by 20, and would be concerned if it didn't. I am neutropenic too, but my ALT is nice and low. The Dr is happy with my bloods, even tho I am a bit tired and skinny.
A hello to Dyce, we started tx at the same time. Hope everything is going ok for you
On long term effects, I rang hep nurse before i started tx and she said there is a study that did long term follow up and found out the most significant was hypothyroidism. Otherwise, everyone was ok. This tx is comparatively new, so maybe more things will come to light, hope not.
The thread below was interesting as just came back from Dr and found out my HB has now slipped down to 112. She said that she expects everyones HB to drop by 20, and would be concerned if it didn't. I am neutropenic too, but my ALT is nice and low. The Dr is happy with my bloods, even tho I am a bit tired and skinny.
A hello to Dyce, we started tx at the same time. Hope everything is going ok for you
Agreed that China has the US economy by the shorthairs due to US reliance on their buying our bonds.
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 wouldn't be afraid to take it (sensibly) myself.
On China and oil. Dunno what they showed on TV, but most of China ain't tooling around in SUVs, I promise you. Why do you say China disrupts the oil markets? Barrel over barrel, US consumption grows faster than China's. We accomplish this feat with less than 1/4 their population.
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 wouldn't be afraid to take it (sensibly) myself.
On China and oil. Dunno what they showed on TV, but most of China ain't tooling around in SUVs, I promise you. Why do you say China disrupts the oil markets? Barrel over barrel, US consumption grows faster than China's. We accomplish this feat with less than 1/4 their population.
I agree, I decided to treat because I wanted to live. As I'll be 59 yrs old in 2 weeks, I'm not concerned of what may or may not kill me 10, 20 years from now from the meds I'm taking to kill this virus. I'm a geno 2B,Stage 0 grade 1 and could have waited for better treatment,but decided to get rid of this thing once and for all. It was a personel choice for me,as it should be for all.
Beagle
Beagle
I agree that people have to educate themselves about the harmful drugs they use for hep treatment and it would go alot smoother if the FDA kept thier noses out of it. maybe people like me would stand a chance at remission if it did
slow
slow
And i have no problem with that. You had very good reasons why to treat. Its the ones that don't do their homework and treat this like a headache. Thinking i'll take two tylenol and it will be gone. I have no problem with anyone who decides to tx as long as they realise what their getting into.
I being grade 1 strge 0 choose to tx cause of the immune system always amped up fightin the virus. I've been fightin this thing for 20 years and the systen is startin to wear down. The bx 7years ago showed grade 0 stage 0, in jan this year, the above. Imflamation breeda fibrosis, and I started to experience hepatic symptoms, plus I started leaning toward possible diabetes. Who knows if in say a couple more years if I'll have health insurance, this economy is gettin shakey. I have 2 daughters and they"ll need thier pappy down the road, so I choose not to wait. I put off tx for 15years and figure the tx is better than years ago. My liver enzyemes have returned to normal now and maybe I'll beat this, if not maybe with the new stuff down the road. Most the hepatic sx's are now gone and I'm pittin up with the med. sx's now but I think it will be worth it in the long run.
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