FDA approval?

[dragonpuff]

So does this... What's Missing on Your FDA Drug Warning Label: Corporate Influence over the Safety Process | Health and Wellness | AlterNet

This is why i never take a prescription that has been on the market for less than 5 years. In fact, all of the drugs i take right now (nicotine included) have been on the market in some form for at least 20 years. Due to the accumulation of data, i know exactly what i'm taking.

Remember that big scare about how the newer antidepressants can make kids suicidal? They knew that before they released it. Here is what i remember about their process of testing them; this is all of the top of my head btw, hence the lack of detail. I no longer have the links but this information is not too hard to find:

1) The company gathers depressed patients for the trial and groups them into a control (placebo) and an experimental (drug) group. Lets say there are 100 people in the experimental group for convenience's sake.

2) Fast forward a couple steps... they find that about 1/3 of the exp. group shows improvement in their symptoms, about 1/3 shows no change and the rest experience a worsening of their depression, with some now experiencing suicidal symptoms. For convenience's sake, we'll say that in this trial, 30 people are now more severely depressed.

3) The company decides that the risk of self-harm by these 30 individuals overrides their need to finish the trial. These 30 individuals are dropped from the study weeks before it is finished, for the sake of their health. This leaves 70 people to finish the trial.

4) Fast forward a few steps... now a report of the study is presented to the FDA. This reports indicates that there were 100 people included at the beginning of the trial and 70 finished (it is not unusual for many people to not finish a study, especially if it lasts a few months). As per protocol, only the results of the 70 people who were in the trial from start to finish are included in the report; the results from the 30 who dropped are not included because they did not finish the trial and, hence, are not representative of it.

In the end, all the FDA sees are the 70 people who did ok; the 30 who did not fare well are only mentioned and their (suicidal) side effects are never reported to the FDA. This is all perfectly legal.

 

[MrKai]

See what you guys are doing?

Let's look at some historical fact and tie it to conspiracy/confirmation bias.

For YEARS and YEARS, politicians, via pressure from activist and lobbying groups were on FDA's *...* about taking *too long* to approve drugs and treatments, putting "millions of lives at risk" via their "overly cautious approach" and other such nonsense. This really got a push in the mid-late 80's and came to a head in the early 90's.

FDA cited concerns that not being as stringent could allow drugs to make it to market that have not sufficiently been proven safe and via legal loopholes, etc, not remotely proven safe/not enough data to be sufficiently empirical.

Additionally FDA voiced concerns about advertising as well.

By the early-to-mid 90's this fight was lost...pharma ads were everywhere, companies sprang up to exploit this new market as what I've come to term as "pharma-whores" (I know...I worked for one developing direct-to-patient interactive kiosks designed for use in doctor's offices...at no charge to doctors or patients. Guess where most of the revenue came from?) by making sure advertising and marketing was compliant and targeted, drugs were given less "scary" names, etc.

Since this time we've seen and heard about more recalls and ridiculous side effects than most people can probably remember.

Now...is it POSSIBLE that all of the FDA's protestations were insincere? Sure. Given their history, mission and the facts on the table statistically and historically, is it the most LIKELY scenario?

Hardly.

Of course, since the FDA is "attacking" us (they really aren't) any "evidence" to show that they are being "unreasonable" because they have a bias towards their "puppetmasters" will hold more sway with a biased mind, regardless of how many facts contradict it

Drug safety doesn't work on the principle that "this thing is OBVIOUSLY less dangerous than THAT thing so what is the Big Effin' Deal"?

It works on the principle that proof is required, based on the scientific method. This still hasn't changed; the bar was simply lowered.

While it is a fair comparison to say "we KNOW cigarettes are Dangerous and we THINK eCigs are less so based on a handful of studies and chemical analysis" it has NOTHING to do with what the job of FDA is, what THEIR standard of proof is (and it is a LOT higher than what has been mentioned here...even if they've gone downhill, which, in their defense, they warned about...) or if or not eCigs *are in fact safe*.

MOST things are "safer" than cigarettes but are by no means remotely safe. That is the standard. If you want to change the rules, *then change the rules* the same way the AIDS, Cancer, Vaccine, Psych and OTHER lobbies did.

Just note that so far, fast-tracking science for the benefit of social issues has proven to be a Bad Idea™

OR

"It is really a conspiracy."



-K

 

[Acuity]

FDA Bans Flavored Cigarettes
Ban Includes Cigarettes With Clove, Candy, and Fruit Flavors

By Danel J. DeNoon
WebMD Health News
Reviewed by Louise Chang, MD

Sept. 22, 2009 --

As of today, it's illegal in the U.S. to buy or sell most flavored cigarettes.
However, the FDA ban does not include the most popular cigarette flavor: menthol. It does cover every other conceivable flavor, including candy, spice, herb, cola, fruit, and coffee flavors.

The flavored-cigarette ban is the FDA's first major anti-tobacco action since President Barack Obama signed the Family Smoking Prevention and tobacco Control Act in June. The law gives the FDA the power to regulate tobacco products.

The law doesn't let FDA ban cigarettes entirely. But Congress has stated that flavors make cigarettes more appealing to youth and increase their exposure to toxic substances.

As a result, the FDA now rules that flavorings designed to appeal to youths "are considered adulterated."

"Flavored cigarettes attract and allure kids into addiction," Health and
Human Services Assistant Secretary Howard Koh, MD, MPH, said at a news conference held to announce the ban.

Today's announcement gave center stage to Lawrence R. Deyton (pronounced DEE-ton), MD, who last week was named director of the FDA's new Center for Tobacco Products.

"Each day in the U.S., 3,600 young people between ages 12 and 17 initiate cigarette smoking and 1,100 young people become daily cigarette smokers," Deyton said at the news conference. "Flavors make cigarettes and other tobacco products more appealing to youth. Studies show 17-year-old smokers are three times as likely to use these products as are those over 25."

Deyton quoted at length from tobacco-industry memos making it clear that tobacco companies deliberately created the products in order to attract young people to cigarette smoking.

"As of today, manufacturers should no longer make, distributors should no longer distribute, importers should no longer import, and retailers should no longer sell these products," Deyton said. He promised that FDA would energetically enforce the ban, and urged citizens to help by importing any sale of flavored cigarettes to the agency.

Flavored Cigarette Ban: Fight Brewing?

An attempt by the tobacco industry to get around the ban by selling flavored tobacco products as cigars rather than as cigarettes is made more difficult by the new law, which defines a cigarette as any rolled tobacco product -- regardless of the wrapper -- "likely to be offered for purchase to consumers as a cigarette."

A sign that there may be a court battle brewing was the appearance at the news conference of Catherine Lorraine, the new tobacco center's lead lawyer. When pressed on exactly which flavored tobacco products would and would not be included in the ban, Deyton deferred to Lorraine.
"We want to draw attention to the portion of the [law's] definition of cigarette which specifically refers to the appearance of the product and how it is perceived and offered for sale," she said. "We will look at products on an individual basis."

More FDA Actions to Follow Flavored Cigarette Ban

The ban on flavored cigarettes is the first of several strong anti-tobacco actions promised by the FDA:

• By January 2010, FDA will require tobacco manufacturers to submit information about all ingredients and additives in tobacco products.
• By April 2010, The FDA will reissue its 1996 regulations aimed at reducing tobacco use among young people. This will include a ban on the use of tobacco-company logos at sports or entertainment events.
• By July 2010, the FDA will ban the use of the terms "light," "low," and "mild" on tobacco products.
• By July 2010, FDA promises to strengthen warning labels on smokeless tobacco products.
• By October 2012, the FDA says warning labels on cigarettes "will be revised and strengthened."

Source:
WebMD
webmd.com/smoking-cessation/news/20090922/fda-bans-flavored-cigarettes

 

[NJDrew]

This is why i never take a prescription that has been on the market for less than 5 years. In fact, all of the drugs i take right now (nicotine included) have been on the market in some form for at least 20 years. Due to the accumulation of data, i know exactly what i'm taking.

Remember that big scare about how the newer antidepressants can make kids suicidal? They knew that before they released it. Here is what i remember about their process of testing them; this is all of the top of my head btw, hence the lack of detail. I no longer have the links but this information is not too hard to find:

1) The company gathers depressed patients for the trial and groups them into a control (placebo) and an experimental (drug) group. Lets say there are 100 people in the experimental group for convenience's sake.

2) Fast forward a couple steps... they find that about 1/3 of the exp. group shows improvement in their symptoms, about 1/3 shows no change and the rest experience a worsening of their depression, with some now experiencing suicidal symptoms. For convenience's sake, we'll say that in this trial, 30 people are now more severely depressed.

3) The company decides that the risk of self-harm by these 30 individuals overrides their need to finish the trial. These 30 individuals are dropped from the study weeks before it is finished, for the sake of their health. This leaves 70 people to finish the trial.

4) Fast forward a few steps... now a report of the study is presented to the FDA. This reports indicates that there were 100 people included at the beginning of the trial and 70 finished (it is not unusual for many people to not finish a study, especially if it lasts a few months). As per protocol, only the results of the 70 people who were in the trial from start to finish are included in the report; the results from the 30 who dropped are not included because they did not finish the trial and, hence, are not representative of it.

In the end, all the FDA sees are the 70 people who did ok; the 30 who did not fare well are only mentioned and their (suicidal) side effects are never reported to the FDA. This is all perfectly legal.

I might just add that from my understanding, the study must state why the 30 participants dropped out and the FDA is allowed to request all available data about the 30 participants who left the study.

 

[dragonpuff]

I might just add that from my understanding, the study must state why the 30 participants dropped out and the FDA is allowed to request all available data about the 30 participants who left the study.

But does the FDA actually request the data? They are a very busy agency and may think they have better things to do with their time.

Also, something i forgot to mention earlier; these studies to prove efficacy are done on patients with depression. Any worsening of their mental state is often attributed by the company as a "natural" worsening of their illness, as depression does characteristically wax and wane.

In other words, the fact that these people are already depressed is held up as proof that it wasn't the drug that made it worse, even if it clearly was. Make sense?

 

[Acuity]

This was the dumbest f*#king thing I have EVER read! I pay taxes for this *****?

 

[quovadis]

Mr kai, makes valid points, although we prefer not to hear them because we are in denial.

For example electrical products require ETL and UL.
Even a mattress we sleep on is regulated by California Bureau of home furnishings, and have to be fire resistant. )

It's true, that most e-cig suppliers here are not large companies and would not be able to afford approval or federalization.

Just imagine if my company started buying a Chinese appliance tomorrow and selling it on the USA market?
Ul would be crawling in my back yard.

I imported many European grey market cars into the USA, and it's taken me up to 6 years to get them federalized with the DOT and EPA.

these are my experiences at least!!:8-o

 

[warbdan]

It's still bull, if electronic cigarettes didn't work, the FDA wouldn't give them a first look.

 

[rothenbj]

Mr kai, makes valid points, although we prefer not to hear them because we are in denial.

For example electrical products require ETL and UL.
Even a mattress we sleep on is regulated by California Bureau of home furnishings, and have to be fire resistant. )

It's true, that most e-cig suppliers here are not large companies and would not be able to afford approval or federalization.

Just imagine if my company started buying a Chinese appliance tomorrow and selling it on the USA market?
Ul would be crawling in my back yard.

I imported many European grey market cars into the USA, and it's taken me up to 6 years to get them federalized with the DOT and EPA.

these are my experiences at least!!:8-o

Plus in Pennsylvania you need to get cosmetology certification to cut hair. Yes, we can create laws for just about everything to protect everyone so that we won't ultimately die of something.

I totally understand the need for some control over this thing. I personally don't buy juice from China simply because I feel I have better options and a higher level of faith in the more, shall I say, manufacturing regulated societies. Yes, I trust businesses in the US, UK, etc. more than the unknowns from the Far East, but that has to do more with living here. I had more faith in foreign auto makers for years. By my experience, my faith has been well founded although I currently have as many US built autos in my drive as foreign.

I don't believe anyone on this board would or should argue for no oversight. I'd feel better if we weren't running in the Wild West on this. However, that being said, I don't want this turning into a ban and 10 years of FDA approval process to bring this product back to the light of day (OR NOT, due to outside forces). If that happens, a lot of us will die reverting backward or end up in jail breaking the law (you know, that new growth industry we've built in this country).

 

[b_rad]

Wow great thread people. I think I just added a few IQ points after reading this!

 

[HaploVoss]

It is the same old argument for me... the FDA needs to have regulations of their own (they need to be regulated so to speak) and have categorized testing standards that everyone has to adhere to. They also need to make it affordable if they are going to require certain things so that the next Joe Schmoe who comes up with the next e-cig or what have you is able to afford to go through all the testing necessary.

As it stands, there is far too much preferential treatment on some companies vs. others in timelines and testing requirements equaling approval rates. Whereas in other cases you have companies that work for years and years to meet FDA regs, testing shows ok, but they keep getting sent back over and over again until they go bust.

Something needs to be done to reign in the FDA a bit. They do serve a valuable purpose I won't deny that, but they are far too.... hmmmmm.... self motivated? It is not a matter of conspiracy it is simply a matter of records. They have wildly swinging biases that contradict one another on any given day.

If they want to set rules and regulations down, then they need to be held accountable for them, and they need to make them attainable for at least small businesses, etc. Hey - that's the Obama way right? Equal opportunity for all.

- Hap

 

[NJDrew]

But does the FDA actually request the data? They are a very busy agency and may think they have better things to do with their time.

Also, something i forgot to mention earlier; these studies to prove efficacy are done on patients with depression. Any worsening of their mental state is often attributed by the company as a "natural" worsening of their illness, as depression does characteristically wax and wane.

In other words, the fact that these people are already depressed is held up as proof that it wasn't the drug that made it worse, even if it clearly was. Make sense?

Yes they do. If they feel it needed they will request it. Although they are a busy agency, they pretty thoroughly review each submission they get. If they still feel unsure of an application, they call an advisory committee meeting to give them some additional input. Ultimately if they feel the benefit out weighs the risk, they will approve it with very strong warnings on the labeling. It is then up to your doctor to prescribe it if he/she feels it is the best option for you. Trust me there is no money in "big/evil pharma" killing you. The FDA and the Pharmas put out questionable medications all the time. Its not because they dont care. For some patients with very severe conditions need the strongest and often most dangerous medications available. It is up to the doctor to only prescribe it when absolutely necessary.

As far as depression goes, I think a certain amount of latitude is given to anti-depressants because the way the brain reacts to any medication is not 100% certain. Medication to treat any mood disorder is a pure gamble in my personal opinion. With that being said im not a doctor, so take it at face value.

 

[Mac]

I submit that if in fact e-cigs must be held to pharmacutical standards then tobacco cigarettes must be as well. The government is unwilling to do so because of the billions in taxes they would lose. Is the picture becoming clear? There is a product on the market that we know kills. It is cheap and readily available. It is extremely addictive. Now you think the FDA should ban a product that lessens that harm because it contains the same drug? Your logic is severely flawed. The fda is corrupt. Real cigs kill. e-cigs don't. Anyone trying to get them banned is a murderer.
nuff said

 

[dragonpuff]

Yes they do. If they feel it needed they will request it. Although they are a busy agency, they pretty thoroughly review each submission they get. If they still feel unsure of an application, they call an advisory committee meeting to give them some additional input. Ultimately if they feel the benefit out weighs the risk, they will approve it with very strong warnings on the labeling. It is then up to your doctor to prescribe it if he/she feels it is the best option for you. Trust me there is no money in "big/evil pharma" killing you. The FDA and the Pharmas put out questionable medications all the time. Its not because they dont care. For some patients with very severe conditions need the strongest and often most dangerous medications available. It is up to the doctor to only prescribe it when absolutely necessary.

As far as depression goes, I think a certain amount of latitude is given to anti-depressants because the way the brain reacts to any medication is not 100% certain. Medication to treat any mood disorder is a pure gamble in my personal opinion. With that being said im not a doctor, so take it at face value.

Actually, there is some money in them killing you (not intentionally of course): if they can just get and keep a drug on the market for a few years before its pulled, that's millions of dollars for big pharma.

As far as them giving some latitude to antidepressants because the brain reactions are not "certain," two points:
1) No drug reaction is certain. I can take an ibuprofin for a stomach ache and not know whether it's going to help it or make it worse by causing indigestion, but one thing i do know is that ibuprofin is unlikely to kill me. I can't say the same for newly approved pharmaceuticals.
2) My antidepressant analogy is just an example; they do this with almost all new drugs and hold up that uncertainty principle as an excuse when things go wrong. Another good example of this problem is Chantix.

As far as leaving it up to my doctor, that's not always wise with a brand new drug, because they are not always given all the information in the beginning. I've had a doctor tell me straight to my face that my current problem could not possibly be caused by the medication he prescribed because it was not on the list of side effects he was given (i'm not even kidding). Several months later, guess what showed up on the revised side effect list? My point is, when it comes to new drugs, doctors don't even know how they will affect you until they've been on the market for awhile.

What i mean to say is that when studies come up showing difficulties like i mentioned in my previous post, then marketing of the drug should be put on hold until further testing is done, instead of putting it on the market, letting thousands of people get sick, and then put a black box warning on it. Despite what these studies clearly showed, these antidepressants were on the market for years before the warnings were introduced. Those warnings should have been there on the outset, because they knew this before!

The exact same thing happened with vioxx; clinical studies showed cardiac problems associated with the drug, but they were blamed on "preexisting medical conditions" and the drug was released anyway. Look what happened.

I think the FDA is a very important agency, but it is broken and needs to be fixed. Many life-saving drugs (like the e-cig) are shelved because small companies don't have $1 billion to put into required testing, while drugs that have proven dangers are being fast-tracked into approval, without any warnings initially available to the people who will be taking them, because rich companies have a little more to throw into the pot.

I have a problem with this situation.

 

[dragonpuff]

I would just like to add that i know full well that all the potential adverse effects cannot be fully known before a drug is brought to market, because the sample size of the studies is simply too small to reflect how millions of people react.

That said, i reiterate that if they know of a potential problem beforehand, instead of them making excuses for it so that it can be released, it should be further investigated; then if it is released with this problem as a possibility, there should be a warning on it right away.

 

[Fr0st8it3]

Government is making allot of money off people with mouth/throat/lung cancer... Atleast this is the case in America where health care is crap...

 

[greenie]

...but to paraphrase my man Brian Dunning of Skeptiod fame:

"What is good enough for you is NOT good enough for the FDA."

This is generally because as laypersons, we just aren't trained to ask the same questions they are...especially if we have a bias. In theory certainly, and statistically in practice, the FDA and their equivalents around the world are skeptical of *everything* and view a thing as a sum of its parts.

So while it would *seem* reasonable to say "if a PV is sold without nic, just flavors, then boom, problem solved, Bob's yer uncle!"

Really? Is it that simple for ya? Here is how something like that is looked at scientifically and skeptically:

"So...what is the PV made of? What about the heating element? Does the heating element break down over time? Does the heating element assembly contain components that upon breaking down, could release harmful chemicals into the vapor stream?"

"What's in this flavoring, exactly? Does the flavoring have any components in it that react with the components of the device? How about when the temperature rises? Are any on the chemicals in the flavoring known to have solvent properties against the components of the vaporizer? What about the filling? What is it made of? Do any of the flavoring components react with the filling above a certain temperature?"

Etc.

Think about it. Most of these questions are really unknowns. I have been loathe to point this out because my intent is not to scaremonger.

However I do believe it is a *little* naive and irresponsible to say "eCigs are safe/safer than X" because an eCig isn't really well-enough defined to be able to make this claim empirically.

The best and most honest answer, based on information we have at this time, is an agnostic one: "we don't really know".

That said...I used to smoke like a chimney so obviously I'm not *that* bright

I *hope* that none of the above is going on deep inside my eCigs but I can't say that I know for sure. No one has really asked these questions and the impression I get is that a lot of people with lay-knowledge don't want these questions answered.

I'm not sure how I feel about that part yet.

-K

I realize my statement was on the surface. Perhaps the FDAs own bias takes the e-cig the same way you made conjectures about my simple lay biased post.

I might be an ignorant layman BUT I did do a little data diving below the surface on the e/cig before I made a purchase as I am sure many here did the same.

I am sure someone with your scientific practical knowledge already knows the stock holders of a main Chinese supplier had an independent scientific study done on the 'sum of the pv parts 'and the results are out there for anyone to see.

Based on those reports vs the knowledge of the death rates of cigarette smokers I took a risk vs risk decision and determined for myself that any assumed risk of the pv has not been substantiated or proven. No in fact the findings of the study I read shows' no direct harm to humans' So I ordered IT instead of buying a pack of Marlboro red.

Analouge cigs are determined to kill by the FDAs own warning yet they are still available for purchase. I don't mean to say this as if it were a justification. No I say it to point out the two facedness of pretending the FDA is all about peoples protection. I am sure for all original intents the FDA has our back. *cough* But there is another side of the coin that allows for many horrible products in which the sum of their parts are shown to be very harmful or deadly. I don't get that part and that is the part people are talking about here. It isn't circular logic to point out obvious discrepancies in the system.


The safety of pg is a documented fact. Food colorings are already used in many products AND the safety of certain colors above others is a search able fact too.Did anyone notice how your farm raised salmon is injected with a red dye? I think the sum of that part sucks yet the FDA says it is safe.Independent scientists from Science Journal: In January 2004, the journal Science warned that farm raised salmon contain 10 times more toxins (PCBs, dioxin, etc.) than wild salmon. The study recommends that farm raised salmon should be eaten once a month, perhaps every two months as they pose cancer risks to the human beings yet the FDA says farm raised salmon is perfectly safe. The independant scientists said this,"The team also took issue with the FDA's standards, which Carpenter said are outdated and focus too much on the economic implications of restrictions and not enough on the long-term health effects of PCBs and dioxins, which build up in body fat and linger there for decades."

My point with all that is the FDA doesn't seem to be all that scientific and so with the points of others when they talk about what the FDA allows and how that is at odds with the known facts about the e-cig and what is the status quo of the FDA.

Does the FDA care so much about inhalant toxicity?
As far as I can tell there are many products on the market that lead to inhalant toxicity and abuse like charcoal barbecue grilling and whipped creme topping.

I am glad the FDA determined the sum of those parts were dangerous and toxic but I do see they are still available for my purchase and left up to my good sense on the safe way to use them.

When you witness the mechanisms of the FDA it really is obvious it is not so much about us being naive or irresponsible in regards to the e-cig. It's about the lack of consistent standards and what appears to be no rhyme or reason as far as FDA safety.