When is the FDA going to mind their own business?

[jpeyton]

Obesity kills 300,000 people in the US each year. Shouldn't they issue a recall for McDonalds? Shouldn't they recall 99% of the pharmaceuticals on the market because of rare side effects?

This same thing happened with ephedra several years ago. Millions of people where using the natural supplement correctly, in moderation, keeping themselves hydrated, etc. Then some dumbass MLB player comes along (Steve Bechler), uses ephedra despite his long list of medical risk factors that should have raised a big red flag, used it on an extremely hot day working out in his full uniform without proper hydration, gets heatstroke, dies, and the FDA steps in to save more Darwin-award candidates by pulling the product.

FDA Recalls Hydroxycut

The Food and Drug Administration has issued a warning to consumers to stop using Hydroxycut dietary supplements because some have been linked to serious liver injuries, with one death reported to the agency.

Iovate Health Sciences Inc. is recalling its Hydroxycut products from the market. The popular, heavily advertised supplements promise weight loss and include such products as Max Drink Packets, Caffeine-free Rapid Release Caplets, and Max Aqua Shed. Not part of the recall are Hydroxycut Cleanse and Hoodia products. The recalled products contain several ingredients, among them herbal extracts, although the FDA said it?s not sure which ingredients or dosages could be causing the problems. Unused products should be returned to where they were purchased.

In all, one death due to liver failure was reported to the FDA, plus 23 instances of severe health problems including jaundice, elevated liver enzymes, liver damage (requiring a liver transplant), seizures and cardiovascular disorders. Liver injury symptoms include jaundice, brown urine, excessive fatigue, stomach or abdominal pain, and nausea.

Although the FDA says that bad reactions are rare, anyone using the products should stop immediately. Dr. Linda Katz, the interim chief medical officer of the agency's Center for Food Safety and Applied Nutrition, said those experiencing symptoms should check with their doctor.

No offense, but you could blindly throw a dart at the pharmacological dartboard and find an FDA-approved drug that has killed more than one person, or caused severe side effects in more than two dozen (especially with a sample size of tens of millions of users).

 

[Hacp]

Thats what regulation gets you. If one or two people out of millions die, there is suddenly a crisis and millions of dollars needs to be spent to fix it.

 

[sactoking]

Originally posted by: jpeyton
No offense, but you could blindly throw a dart at the pharmacological dartboard and find an FDA-approved drug that has killed more than one person, or caused severe side effects in more than two dozen (especially with a sample size of tens of millions of users).

The problem is that with FDA-approved drugs, the mortality and morbidity rates are known. With Hydroxycut being an unregulated supplement, mortality and morbidity are unknown. Since they're labeled as 'all natural' and mortality > 0, they have a responsibility to determine what mortality actually is.

 

[Modelworks]

It was probably hurting the profits to one of the pharmaceutical weight loss drugs or the surgeries.
Don't forget how much money the FDA receives in incentives from companies.

It is like the herb Kava. It is great stuff, I really like it whenever I need to relax. It has been used for thousands of years by people on the tropical islands. It makes people calm without bad side effects.
They are working to ban it in the USA citing it is dangerous, the backers are the drug companies because it is better than the drugs like xanax.
http://en.wikipedia.org/wiki/Kava

After thousands of years of use by the Polynesians and decades of research in Europe and the U.S., the traditional use of kava root has never been found to have any addictive or permanent adverse effects.

The other reason is ;

On 15 February 2006, the Fiji Times and Fiji Live reported that researchers at the University of Aberdeen in Scotland and the Laboratoire de Biologie Moleculaire du Cancer in Luxembourg had discovered that kava may treat ovarian cancer and leukemia. Kava compounds inhibited the activation of a nuclear factor that led to the growth of cancer cells. The Aberdeen University researchers published in the journal The South Pacific Journal of Natural Science that kava methanol extracts had been shown to kill leukemia and ovarian cancer cells in test tubes.[14] The kava compounds were shown to target only cancerous cells; no healthy cells were harmed. This may help explain why kava consumption is correlated with decreased incidence of cancer.

Can't make a drug out of something if you can buy it on the shelf.
The UK banned it

The ban on kava came into effect on January 13, 2003. The FSA insists that it was necessary to bring in laws banning the herb, saying it was ?the only means by which we can adequately protect public health.?

However, at the time of the ban, Professor Edzard Ernst, chair of Complementary Medicine at Exeter University, said it was too far-reaching. ?Kava is proven to be effective in treating anxiety and, looking at the total risk, it is safer than synthetic drugs. If we are going to ban kava today, then we should have banned Valium twenty years ago,? he said.

 

[bamacre]

http://www.cnn.com/2009/POLITI....scientists/index.html

WASHINGTON (CNN) -- Nine scientists at the Food and Drug Administration have written a letter to President-elect Barack Obama and his transition team, alleging gross mismanagement at the agency that has "placed the American public at risk."

The agency is "fundamentally broken" and "failing to fulfill its mission," according to a copy of the six-page letter obtained by CNN.

The scientists work in the FDA's Center for Devices and Radiological Health, which regulates items ranging from rubber gloves and contact lenses to heart stents and mammogram machines.

The scientists claim that "the scientific review process for medical devices at FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk."Video Watch the FDA come under fire »

"Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around," the letter said. "Disturbingly, the atmosphere does not yet exist at FDA where honest employees committed to integrity and the FDA mission can act without fear of reprisal."

Among the charges:

? Scientists and doctors have been threatened and told, on occasion, to ignore FDA regulations.

? Devices have not been properly labeled.

? Managers without appropriate experience have been given authority to make final decisions about device regulation and have done so while ignoring serious safety and effectiveness concerns.

? FDA experts have been excluded from product meetings because manufacturers felt that they were "biased."

? Manufacturers have been allowed to market their products without FDA approval.

An internal investigation of the charges, the scientists said, has resulted "in absolutely nothing: No one was held accountable, no appropriate or effective actions have been taken, and the same managers who engaged in the wrongdoing remain in place and have been rewarded and promoted."

In a statement, the Food and Drug Administration told CNN, "We have been working very closely with members of the transition team and any concerns or questions they have on any issue, we will address directly with the team. Separately, the agency is actively engaged in a process to explore the staff members' concerns and take appropriate action."

Congress is also looking into the allegations.

 

[OCGuy]

When is Obama going to put pressure on them to do so?

 

[Corn]

Originally posted by: jpeyton
Obesity kills 300,000 people in the US each year. Shouldn't they issue a recall for McDonalds? Shouldn't they recall 99% of the pharmaceuticals on the market because of rare side effects?

This same thing happened with ephedra several years ago. Millions of people where using the natural supplement correctly, in moderation, keeping themselves hydrated, etc. Then some dumbass MLB player comes along (Steve Bechler), uses ephedra despite his long list of medical risk factors that should have raised a big red flag, used it on an extremely hot day working out in his full uniform without proper hydration, gets heatstroke, dies, and the FDA steps in to save more Darwin-award candidates by pulling the product.

FDA Recalls Hydroxycut

The Food and Drug Administration has issued a warning to consumers to stop using Hydroxycut dietary supplements because some have been linked to serious liver injuries, with one death reported to the agency.

Iovate Health Sciences Inc. is recalling its Hydroxycut products from the market. The popular, heavily advertised supplements promise weight loss and include such products as Max Drink Packets, Caffeine-free Rapid Release Caplets, and Max Aqua Shed. Not part of the recall are Hydroxycut Cleanse and Hoodia products. The recalled products contain several ingredients, among them herbal extracts, although the FDA said it?s not sure which ingredients or dosages could be causing the problems. Unused products should be returned to where they were purchased.

In all, one death due to liver failure was reported to the FDA, plus 23 instances of severe health problems including jaundice, elevated liver enzymes, liver damage (requiring a liver transplant), seizures and cardiovascular disorders. Liver injury symptoms include jaundice, brown urine, excessive fatigue, stomach or abdominal pain, and nausea.

Although the FDA says that bad reactions are rare, anyone using the products should stop immediately. Dr. Linda Katz, the interim chief medical officer of the agency's Center for Food Safety and Applied Nutrition, said those experiencing symptoms should check with their doctor.

No offense, but you could blindly throw a dart at the pharmacological dartboard and find an FDA-approved drug that has killed more than one person, or caused severe side effects in more than two dozen (especially with a sample size of tens of millions of users).

Isn't this what you liberals live for? Governmental control of the stupid masses?

 

[sandorski]

Some decisions are purely political. That situation was likely so, due to the high profile person who became its' victim. It's not necessarily the fault of the FDA though, Public Outcry is often the biggest factor in spurring such a decision. "Public Outcry" is usually not very Reasonable and very emotional, but it carries a lot of weight and though it is often ignored by Politicians/Regulators, sometimes it's just not worth the potential hassle of doing the Reasonable thing.

 

[sandorski]

Originally posted by: Corn

Originally posted by: jpeyton
Obesity kills 300,000 people in the US each year. Shouldn't they issue a recall for McDonalds? Shouldn't they recall 99% of the pharmaceuticals on the market because of rare side effects?

This same thing happened with ephedra several years ago. Millions of people where using the natural supplement correctly, in moderation, keeping themselves hydrated, etc. Then some dumbass MLB player comes along (Steve Bechler), uses ephedra despite his long list of medical risk factors that should have raised a big red flag, used it on an extremely hot day working out in his full uniform without proper hydration, gets heatstroke, dies, and the FDA steps in to save more Darwin-award candidates by pulling the product.

FDA Recalls Hydroxycut

The Food and Drug Administration has issued a warning to consumers to stop using Hydroxycut dietary supplements because some have been linked to serious liver injuries, with one death reported to the agency.

Iovate Health Sciences Inc. is recalling its Hydroxycut products from the market. The popular, heavily advertised supplements promise weight loss and include such products as Max Drink Packets, Caffeine-free Rapid Release Caplets, and Max Aqua Shed. Not part of the recall are Hydroxycut Cleanse and Hoodia products. The recalled products contain several ingredients, among them herbal extracts, although the FDA said it?s not sure which ingredients or dosages could be causing the problems. Unused products should be returned to where they were purchased.

In all, one death due to liver failure was reported to the FDA, plus 23 instances of severe health problems including jaundice, elevated liver enzymes, liver damage (requiring a liver transplant), seizures and cardiovascular disorders. Liver injury symptoms include jaundice, brown urine, excessive fatigue, stomach or abdominal pain, and nausea.

Although the FDA says that bad reactions are rare, anyone using the products should stop immediately. Dr. Linda Katz, the interim chief medical officer of the agency's Center for Food Safety and Applied Nutrition, said those experiencing symptoms should check with their doctor.

No offense, but you could blindly throw a dart at the pharmacological dartboard and find an FDA-approved drug that has killed more than one person, or caused severe side effects in more than two dozen (especially with a sample size of tens of millions of users).

Isn't this what you liberals live for? Governmental control of the stupid masses?

Since he's complaining about it, I suspect not.

 

[MikeMike]

ya, just because there were some retards we should ban guns too!

i love how you are so anti gun, but yet, will blindly defend the FDA... there is no difference, you are saying that the retards who dont know how to properly use something, are no reason to get something banned..

 

[Fern]

So we have complaints that the FDA is over-cautious and needlessly banning stuff (e.g., ephedra)

Then we see Bamacre's post with an article complaining the FDA is is too lenient (in a criminal way) and releasing products to the public.

Then we've seen a lot complaints that the FDA is taking way too long to approve new helpful, lifesaving medications.

Either these complaints are baseless, or this is the most disfunctional, worthless - wait, strike that - or this is a normal example of government efficiency.

Kinda gets me all 'tingly' that national health care will be coming soon.

Fern

 

[bamacre]

Originally posted by: Fern
So we have complaints that the FDA is over-cautious and needlessly banning stuff (e.g., ephedra)

Then we see Bamacre's post with an article complaining the FDA is is too lenient (in a criminal way) and releasing products to the public.

Then we've seen a lot complaints that the FDA is taking way too long to approve new helpful, lifesaving medications.

Either these complaints are baseless, or this is the most disfunctional, worthless - wait, strike that - or this is a normal example of government efficiency.

Kinda gets me all 'tingly' that national health care will be coming soon.

Fern

It's just plain corrupted. Shocking?

And we wonder why all the health care companies were giving campaign donations to politicians pushing UHC, instead of those opposing it.

 

[BoberFett]

We don't need you libertarians screwing things up. What we need is better people in the FDA.

 

[OCGuy]

Are you worried about fitting in to your banana-hammock for the beach this summer?

 

[Moonbeam]

Isn't this what you liberals live for? Governmental control of the stupid masses?

I don't see it this way. I believe the average person has a difficult life to live in the competitive society we have created and that as a result, they have little time or energy left over to educate themselves on the huge number of issues out there that can affect them. I think, therefore, it is good that people with more time and knowledge, and positions or responsibility in the government can look our for them to some degree to protect them from others, who, in there competitive drive, may find opportunities to take advantage of the normal desires of the unsuspecting. Food supplements offer the answers to every major health concern people can imagine or want, but they are all pretty much scams. As you would protect your children from cunning predators, I would protect my fellow citizen, if I can. That is one reason I vote for liberals.

 

[Modelworks]

Originally posted by: Moonbeam
Isn't this what you liberals live for? Governmental control of the stupid masses?

I don't see it this way. I believe the average person has a difficult life to live in the competitive society we have created and that as a result, they have little time or energy left over to educate themselves on the huge number of issues out there that can affect them. I think, therefore, it is good that people with more time and knowledge, and positions or responsibility in the government can look our for them to some degree to protect them from others, who, in there competitive drive, may find opportunities to take advantage of the normal desires of the unsuspecting. Food supplements offer the answers to every major health concern people can imagine or want, but they are all pretty much scams. As you would protect your children from cunning predators, I would protect my fellow citizen, if I can. That is one reason I vote for liberals.

It is one thing to have the government advise us of what we should do, it is an entirely different thing when they order us what to do.

If I want to take a drug I should have the right to sign a paper saying.

"I realize the potential dangers of this drug and understand any illness resulting from it is my choice."

I'm guessing many people don't even know how the FDA was put in control. Look up fda massengill sulfur in google. It was to protect consumers from stupidity not to become a doctor prescribing advice itself.

 

[jpeyton]

Originally posted by: Hacp
Thats what regulation gets you.

Originally posted by: Corn
Isn't this what you liberals live for? Governmental control of the stupid masses?

Originally posted by: MIKEMIKE
ya, just because there were some retards we should ban guns too!

Disagreeing with an FDA decision doesn't mean I'm going to sell the condo, buy a farm in Crawford and have lunch with Karl Rove.

It just means I disagree with their decision.

 

[Moonbeam]

Nobody is ordering you what to do. Somebody is ordering others not to take advantage of you.

You may decide you want to drive on the right side of the highway too but a statement you will accept responsibility isn't going to be issued to you.

 

[Modelworks]

Originally posted by: Moonbeam
Nobody is ordering you what to do. Somebody is ordering others not to take advantage of you.

You may decide you want to drive on the right side of the highway too but a statement you will accept responsibility isn't going to be issued to you.

Driving and medicine is not a comparison.

If I want to take a drug or if I want to drink 190 proof liquor it is NOT the governments right to tell me otherwise. They should tell people it isn't wise, but they should not be taking the final decision out of the hands of the individual.

 

[bamacre]

Originally posted by: Moonbeam
Isn't this what you liberals live for? Governmental control of the stupid masses?

I don't see it this way. I believe the average person has a difficult life to live in the competitive society we have created and that as a result, they have little time or energy left over to educate themselves on the huge number of issues out there that can affect them.

Well when they work 4-6 months of the year to just pay taxes...

I think, therefore, it is good that people with more time and knowledge, and positions or responsibility in the government can look our for them to some degree to protect them from others, who, in there competitive drive, may find opportunities to take advantage of the normal desires of the unsuspecting.

Maybe we can ditch the General Hardware and Technical Support forums and create a government agency to help people decide what laptop to buy and help them with computer problems. Because, you know, with the corruption and bad advice given at those forums, there's just no way the government could do a worse job.

Food supplements offer the answers to every major health concern people can imagine or want, but they are all pretty much scams. As you would protect your children from cunning predators, I would protect my fellow citizen, if I can. That is one reason I vote for liberals.

LOL, I'm sure that's why some vote for Republicans.

 

[Mursilis]

Originally posted by: Moonbeam
Nobody is ordering you what to do.

So if (theoretically) want to treat my glaucoma with some MJ which my doctor has prescribed, the feds won't tell me stop!?! Wow, hadn't known that!

 

[bamacre]

Originally posted by: Mursilis

Originally posted by: Moonbeam
Nobody is ordering you what to do.

So if (theoretically) want to treat my glaucoma with some MJ which my doctor has prescribed, the feds won't tell me stop!?! Wow, hadn't known that!

Or if you want an antibiotic, they order you to go see a doctor.

And when the gov't needs you to pay for their corrupted FDA, they do tend to order you to pay for it.

 

[Moonbeam]

Are you your brother's keeper?

 

[Harvey]

Originally posted by: jpeyton

Topic Title: When is the FDA going to mind their own business?

Clue -- It IS minding its business.

Even some luddite conservatives can understand the meaning of a menu at Micky D's. Even rocket scientists and other geniuses in other fields can be hard pressed to understand the meanings and implications of test data for pharmaceuticals.

The FDA is charged with ceritfying the efficacy and safety of pharmaceuticals and ensuring that doctors who prescribe them know enough about to make informed choices when prescribing them for their patients.

They are further charged with recalling them in the public interest when newer information indicates the possibility that previously approved pharmaceutical substance or product may present a hazard to public safety.

That's their job. Somebody's got to do it. Their motivation should NEVER be to maintain and enhance the profits of the pharma companies at the expense of public health an safety.

My greatest concern has been that their scientific and ethical mandate has been corrupted by greed, especially during the Bush administration. I hope Obama's adminstration reverses that trend.

 

[JD50]

Originally posted by: BoberFett
We don't need you libertarians screwing things up. What we need is better people in the FDA.

I see what you did there.

:thumbsup: