Report Blasts FDA Safety Process

[jmjm530]

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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[lionesss]

Hope you are feeling better, got to watch those bugs when you are neutropenic.  Thankfully (in a way) my son is refusing to go to school and is now doing his education online, it means he aint bringing those school yard bugs home.  The doc told me if I get sick to go to the GP straight away.  I glare at sick looking people on the tram and move seats, LOL

No hurricanes here, I live in civilised Melbourne, where nothing exciting like that happens.  Phew!

[lionesss]

hello there. yes, I am still in the luxurious position of taking time of ($ still lasting, living very frugally) am at college tho, and that is enough, trying to squeeze in sleeping inbetween lectures and essays.  Thank god I am not working tho, I pride myself on being reliable and I wouldn't be at the moment.  My son aint helping much, but he aint giving me much grief either, which is  a BIG help.

[Mister beagle bailey]

I hear ya the horses are out of the barns.

Are you starting to feel normal again since you are off the meds?

Beagle

[slowsouthernstyle]

yes the drug was pulled by the pharma due to multiple pending lawsuits. anyone that would take this drug or the same thing under a different name is just asking for trouble. I have personal experience. I also wanted to say to the one that goes by the name New York girl that I was glad to hear that you are listening to your doctor about not extending your treatment beyond the given time for your genotype. I get the feeling some people on here take what others say as gospel and it really bothered me when some people were pushing to others that they should be going beyond the treatment time. These are very serious and potentially lethal drugs and can leave many many permanant damages to you.

slow

[goldyn]

Hows it goin glad to see you post, if i remember right you took some time off do you still have that luxury? Hows your son doing,is he helping you out a little.

[GoofyDad]

I certainly didn't mean to trivialize the pain experienced by those who had trouble with Vioxx. I was trying to point out that, IMO, FDA approval of this drug wasn't a misguided action. It took a study of (I think) 5,000 patients taking the drug for 18 mos to uncover 'potential' problems. All drugs have risks, including penicillin, ribavirin, and vx-950. Let's hope the FDA  doesn't hold up vx-950 approval waiting for a long-term study with thousands of cohorts.

As I pointed out, I don't believe the FDA yanked vioxx. That was a choice made by Merck, presumably due to litigation.

Beagle, For better or worse, China is far and above the fastest growing ecconomy in the history of the world. That's a done deal, the horses are out of the barn.

[slowsouthernstyle]

"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

[dyce]

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!

[Mister beagle bailey]

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

[lionesss]

Hi Beagle, oops sorry, yep, that would translate 11.2

[Mister beagle bailey]

That's great that your blood tests was good.  When you said that your hb is 112, did you mean 11.2?

Beagle

[Mister beagle bailey]

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

[lionesss]

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

[GoofyDad]

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.  

[Mister beagle bailey]

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

[slowsouthernstyle]

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

[can-do-man]

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.

[dyce]

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.

[can-do-man]

space says....... I say the FDA and lawyers are slowing down the meds we could be trying!!
----------------------------------------------------------------

I agree, At stage 4 if i want to risk a new drug then the FDA should stay out of it. To many people die every year because of all the red tape

[can-do-man]

As for long term sx effects, my hepatologist already warned me about that being possible. Even said some he thinks some is showing up. He didn't force me to take it. But me being a stage 4 not to many options. Thats why i wonder why some with no or very little damage jump right into this poison.

[Algernon]

Unfortunately, following the long term sides is pretty much up to us--just like monitoring our own treatment seems to be.

I plan on writing to Schering to ask if there have been any studies on long term side effects?   I won't wait by the mailbox for the answer...

[cuteus]

I believe there is a procedure in place by which providers report new side effects or adverse events to the Dept of Health and FDA. I think that consumers can do so also. It seems to me that if the number or address was made more accessible or known, that the data gathered from these reports could be used in the studies of the drugs approved, and assess possible problems before a fatality occurs.

[jmjm530]

Say you've invested X billion dollars into developing a drug and getting FDA approval. Now that drug is driving your companies bottom line with stockholders demanding ever increasing profit projections be met. So where exactly is the internal motivation to re-test your prodcut for safety? After all, you got FDA approval, didn't you.

-- Jim

[Mister beagle bailey]

I agree 100% with you on the FDA and conflict of interest.  It's not just vioxx and celebrex but a long list of drugs approved by the FDA and now are off the market and have law suits pending.

Would like to know who of the FDA is getting paid off for pushing these drugs to market.  This has been a problem for years and the gov. has done nothing to stop it.

Just like the gas problem we have today. I'm watching CNN news as I post and they are showing many Americans using bikes to get around and then shows China with more cars then ever on the road and hardly anyone there using bikes any more.  What is wrong with this picture and our country?  They also say the big oil comanies are shipping much of the oil to China and China is using so much oil that it has caused a imbalance in the market.
Correct me if I'm wrong, why do we have an embargo againist Cuba and the Cubans want freedom as they are always trying to flee and yet we trade and borrow millions of dollars a month from China the largest communist country in the world.  Before long they will own this country because of the money our gov. owes them, and we borrow the money to balance the federal budget.  What is wrong with this picture????

Sorry, just needed to sound off as I'm fed up with it all.

Beagle