From CNN.com Today/Eissenberg study with feedback

[snowpig]

How exactly does the FDA define "safe and effective" you ask.
I assume that is a rhetorical question.

But it seems at this point they define it as... "Who is give to us the monies"

To get a new drug approved by the FDA, it must be demonstrated in a single clinical trial to be more effective than a placebo. That is all.

For 'enhancements' and newer versions of existing drugs, the replacements also do not have to be shown to be better than the drug they are replacing. Rather, again, they only have to prove they are better than the placebo.

This allows the pharmaceutical companies to make perhaps only trivial changes and get new 20-year patents, which of course is really the only purpose of the 'new and improved' enhancement.

BTW most of those 'new' drugs being patented by drug companies are actually researched and created by taxpayer-funded National Institutes of Health and associated academic studies. That's right, your money is paying for billions of dollars worth of drug research, but Congress (the Bayh-Dole Act, among others) specifically allows investor-owned pharmaceutical companies to own the patents and reap the profits from selling the drugs.

Check out some writings of Dr. Marcia Angell, M.D. at Harvard Medical School, former editor-in-chief of the New England Journal of Medicine.

What a society.

But on a positive note, here is some long awaited news for the poor drug industry: FDA Finally Approves Prescription Placebo.

Steve

 

[yvilla]

But on a positive note, here is some long awaited news for the poor drug industry: FDA Finally Approves Prescription Placebo.

Steve

Wow, that's great news. This new drug should be perfect for the vast majority of the troubling and worrisome side effects of ecig use I've seen posted about here!

 

[(So) Jersey Girl]

How exactly does the FDA define "safe and effective" you ask.
I assume that is a rhetorical question.

No, not really.

 

[(So) Jersey Girl]

To get a new drug approved by the FDA, it must be demonstrated in a single clinical trial to be more effective than a placebo. That is all.

For 'enhancements' and newer versions of existing drugs, the replacements also do not have to be shown to be better than the drug they are replacing. Rather, again, they only have to prove they are better than the placebo.

This allows the pharmaceutical companies to make perhaps only trivial changes and get new 20-year patents, which of course is really the only purpose of the 'new and improved' enhancement.

BTW most of those 'new' drugs being patented by drug companies are actually researched and created by taxpayer-funded National Institutes of Health and associated academic studies. That's right, your money is paying for billions of dollars worth of drug research, but Congress (the Bayh-Dole Act, among others) specifically allows investor-owned pharmaceutical companies to own the patents and reap the profits from selling the drugs.

Check out some writings of Dr. Marcia Angell, M.D. at Harvard Medical School, former editor-in-chief of the New England Journal of Medicine.

What a society.

But on a positive note, here is some long awaited news for the poor drug industry: FDA Finally Approves Prescription Placebo.

Steve

Thanks Steve, but this only shows how the FDA defines "effective." What do they consider "safe?"

Interesting articles.

 

[Kilroy]

"Safe" means "does not threaten the health" of taxation, BP or BT

 

[DC2]

No, not really.

Well, in that case...

By "safe" I assume they mean at least as safe as Chantix, which is FDA approved and may cause you to commit suicide. And by "effective" I assume they mean at least as effective as all of the FDA approved smoking cessation products which don't work worth a crap.

So based on the FDA's own criterion for "safe and effective" I would have to say that as long as they don't kill you, or make you want to kill yourself, and they don't work worth a damn, they should qualify.

I didn't mean to be flippant, but when you think about it, there is no other way to reply.

 

[BigJimW]

It's been suggested that we make the site look "crappier."

Easy to do. Just hire John Banzhafs web designer.

 

[(So) Jersey Girl]

Well, in that case...

By "safe" I assume they mean at least as safe as Chantix, which is FDA approved and may cause you to commit suicide. And by "effective" I assume they mean at least as effective as all of the FDA approved smoking cessation products which don't work worth a crap.

So based on the FDA's own criterion for "safe and effective" I would have to say that as long as they don't kill you, or make you want to kill yourself, and they don't work worth a damn, they should qualify.

I didn't mean to be flippant, but when you think about it, there is no other way to reply.

That's the way I was looking at it. But apparently those who are calling for the FDA to ban e-cigs until they are proved to be "safe and effective" have something else in mind totally. That is why I wanted to know how the FDA defines these terms.

From Steve's answer, we know a drug has to be more effective than the placebo in order to be approved by the FDA. However, the last article he linked shows that placebos can be more effective than the drugs they are tested against! The more I try to figure this out, the more confused I get.

 

[rothenbj]

That's the way I was looking at it. But apparently those who are calling for the FDA to ban e-cigs until they are proved to be "safe and effective" have something else in mind totally. That is why I wanted to know how the FDA defines these terms.

From Steve's answer, we know a drug has to be more effective than the placebo in order to be approved by the FDA. However, the last article he linked shows that placebos can be more effective than the drugs they are tested against! The more I try to figure this out, the more confused I get.

Steve's second link was a spoof. That might help a bit.

As far as the comment about getting FDA approval, it's not nearly as simple as that paragraph makes it sound. You can be talking millions of dollars and up to 10 years to push a drug through. It also helps to be a BP company.

 

[(So) Jersey Girl]

Steve's second link was a spoof. That might help a bit.

As far as the comment about getting FDA approval, it's not nearly as simple as that paragraph makes it sound. You can be talking millions of dollars and up to 10 years to push a drug through. It also helps to be a BP company.

I was really tired when I read that last night! Doesn't take much to confuse me!

Still, it would help to have some idea what the FDA means by "safe," even if it is a simplistic explanation like the one for "effective" (given their track record).

 

[MadScientistVapor]

What stupidity inspired this article?

 

[snowpig]

That's the way I was looking at it. But apparently those who are calling for the FDA to ban e-cigs until they are proved to be "safe and effective" have something else in mind totally. That is why I wanted to know how the FDA defines these terms.

From Steve's answer, we know a drug has to be more effective than the placebo in order to be approved by the FDA. However, the last article he linked shows that placebos can be more effective than the drugs they are tested against! The more I try to figure this out, the more confused I get.

Yeah, I was just teasing with that Onion article, sorry for confusing you Jersey Girl. As for 'safe', well I think that has been through a variety of definitions over the years.

Up until just a few years ago, most pharmaceutical clinical trials did not allow women, minorities, or the elderly to participate. The drug companies did not want the extra 'complications' from testing these particular folks, so trials of safety and effectiveness were based on adult white males.

Yes, the statement I made about proving effectiveness is simplistic. But in reality that is the minimum that is required, and proof against a placebo should be all that is required for approval of electronic cigarettes' efficacy. IF this is approached as an NRT or similar, which many of us do not see as reasonable. As for safety, I can't say what the thresholds would be.

Steve

 

[(So) Jersey Girl]

Yeah, I was just teasing with that Onion article, sorry for confusing you Jersey Girl. As for 'safe', well I think that has been through a variety of definitions over the years.

Up until just a few years ago, most pharmaceutical clinical trials did not allow women, minorities, or the elderly to participate. The drug companies did not want the extra 'complications' from testing these particular folks, so trials of safety and effectiveness were based on adult white males.

Yes, the statement I made about proving effectiveness is simplistic. But in reality that is the minimum that is required, and proof against a placebo should be all that is required for approval of electronic cigarettes' efficacy. IF this is approached as an NRT or similar, which many of us do not see as reasonable. As for safety, I can't say what the thresholds would be.

Steve

No apology necessary. Like I said, it doesn't take much to confuse me.

It seems that no one, including the FDA, can adequately define what "safe and effective" means. Yet they are calling for electronic cigarettes to be proven "safe and effective" knowing that the definition is nonexistent and meaningless.

 

[Thulium]

The problem is the FDA can't really tell you what "Safe and Effective" means even though that is basically their only job. My biggest fear of the FDA having regulatory control over e-cigs as a "combo" product is the fact that they have not even created the regulatory standards that they expect companies to have already adopted. Considering that the new regulations on even traditional tobacco products haven't all been decided yet even though the tobacco companies were supposed to have adopted in 2009...I suspect that the FDA might get around to actually publishing the regulatory standards for e-cigarettes sometime between never and whenever a BT or BP company brings an e-cig to market.

...That's why Judge Leon's decision is important: If the FDA is allowed to regulate e-cigs as a drug, they can drag their feet on every step of the process basically as long as they want. If, however, they regulate e-cigs as a reduced harm tobacco product, they would not be able to ban them unless and until they fail safety standards.

 

[(So) Jersey Girl]

The problem is the FDA can't really tell you what "Safe and Effective" means even though that is basically their only job. My biggest fear of the FDA having regulatory control over e-cigs as a "combo" product is the fact that they have not even created the regulatory standards that they expect companies to have already adopted. Considering that the new regulations on even traditional tobacco products haven't all been decided yet even though the tobacco companies were supposed to have adopted in 2009...I suspect that the FDA might get around to actually publishing the regulatory standards for e-cigarettes sometime between never and whenever a BT or BP company brings an e-cig to market.

...That's why Judge Leon's decision is important: If the FDA is allowed to regulate e-cigs as a drug, they can drag their feet on every step of the process basically as long as they want. If, however, they regulate e-cigs as a reduced harm tobacco product, they would not be able to ban them unless and until they fail safety standards.

That's what I thought. There are no established standards, so the decision to pass or fail something is arbitrarily decided by some FDA idealogue.

 

[Bill Godshall]

(So) Jersey Girl wrote:
"There are no established standards, so the decision to pass or fail something is arbitrarily decided by some FDA idealogue."

The FDA's Drug and Device office has detailed premarket "safety" standards and testing requirements for products, but about the only folks who understand them are the well paid researchers, lawyers and consultants who work for the drug and medical device companies (and those who work for the FDA).

That (and the required clinical trial for product efficacy) are key reasons it costs lots of money to introduce new drugs and medical devices onto the market, and why these products can be very expensive.

The FDA has been lax, however, with postmarket "safety" surveillance and taking action even after many consumers file complaints about drugs and medical devices. This appears partly due to a lack of funding and staff at FDA, but it also appears that many officials and staff at the FDA have developed close ties with drug companies and those who work for them.

 

[(So) Jersey Girl]

(So) Jersey Girl wrote:
"There are no established standards, so the decision to pass or fail something is arbitrarily decided by some FDA idealogue."

The FDA's Drug and Device office has detailed premarket "safety" standards and testing requirements for products, but about the only folks who understand them are the well paid researchers, lawyers and consultants who work for the drug and medical device companies (and those who work for the FDA).

That (and the required clinical trial for product efficacy) are key reasons it costs lots of money to introduce new drugs and medical devices onto the market, and why these products can be very expensive.

The FDA has been lax, however, with postmarket "safety" surveillance and taking action even after many consumers file complaints about drugs and medical devices. This appears partly due to a lack of funding and staff at FDA, but it also appears that many officials and staff at the FDA have developed close ties with drug companies and those who work for them.

I feel like I'm beating a dead horse with this, but all I'm trying to learn is, generally, how does the FDA define "safe" when it comes to approving a drug/device? I don't need details. My idea of "safe" may differ from yours, and I'm pretty sure it differs from the FDA's.

The FDA's track record with postmarket "safety" surveillance speaks to itself IMO. The lack of funding to investigate complaints could be easily solved, but that's a different subject entirely.

 

[TropicalBob]

This is hardly the place to come for an FDA definition. Bill explained the complexities. Ask the FDA and see what you get.

Your idea of safe means nothing to them.

 

[DVap]

This is hardly the place to come for an FDA definition. Bill explained the complexities. Ask the FDA and see what you get.

Your idea of safe means nothing to them.

And by the same token, their declaration of "safe" is meaning less and less to the public.

 

[(So) Jersey Girl]

And by the same token, their declaration of "safe" is meaning less and less to the public.

Exactly. It's one thing to declare something is safe and another thing to define what safe means. As a result the FDA continues to lose credibility and public confidence.

The reason I want to know how the FDA defines safe is because I recently had conversations with a couple of smokers who, upon seeing my PV, stated they had considered switching to e-cigs but changed their minds when they learned they are not FDA approved as safe and effective. They couldn't explain what this means and so far neither can I. It got me thinking about how this terminology is being tossed around, especially by opponents of e-cigs.