FDA Mission ~ FAIL!!!!

[SheerLuckHolmes]

This was posted in another thread and I felt it needed its own for disscussion:

I just saw this internal report on the state of the FDA from 2007 - sounds like they have their hands plenty full without having to worry about e-cigs:

http://www.fda.gov/ohrms/dockets/AC...2_01_FDA Report on Science and Technology.pdf

FDA Mission Statement​

[FONT=Verdana,Verdana][FONT=Verdana,Verdana]"The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable ~ FAIL!!!!!;
and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. ~ FAIL!!!"

If only mission statements WERE taken to heart by everyone at the FDA.
[/FONT][/FONT]

 

[Thyestean]

mhm ... and the tooth fairy exists too

 

[BigJimW]

It's been well known that the FDA is over burdoned. Now they have cigarettes tossed on them. Policing the PV will be a money sink for them as well. Not that I particularly care about what happens to the FDA.

 

[Kurt]

If possible, I think this document should be somehow posted outright here, rather than through a link that the FDA can have blocked or removed.

This also applies to journal articles that get found by the media, like Dr. E's research paper, and the TSNA on surfaces article, which I have. Unlike most here, I would imagine, I have access to most academic journal articles in their original published form.

If a mod can tell us how to have pdf's here directly, rather than links that not all would have access to, then we can see the real article, rather than read how the media want to spin it. Surely this must be possible here, but attaching the pdf document gives an "exceeds quota" error.

 

[BigJimW]

The world looks to FDA as a leader — to integrate emerging understandings of biology with medicine, technology and computational mathematics in ways that will lead to successful disease therapies. Today, not only can the Agency not lead, it cannot even keep up with the advances in science.

Holy crap. The FDA finally got something right for a change!

 

[Kurt]

And this is why the big companies get dangerous products pushed into market, and the little guys get extorted.

 

[CES]

this is my favorite:

"Rapid changes in biological sciences and bioinformatics are exceeding the capacity of current FDA science capabilities to keep pace and adequately support the Agency’s safety mission. The FDA lacks sufficient expertise to understand the impact of product use, to maintain ongoing currency with their evolution or to evaluate the sophisticated products produced. In addition, the FDA has no consistent strategy to acquire that expertise." ...."This is an especially important deficiency because genomics as well as proteomics, metabolomics, combination products (drug or biologic and a device) and other emerging sciences and technologies are creating larger amounts of data than current technologies in support of product design, testing, and production and for ongoing safety analysis."


um, isn't that (bolded) where they're trying to put e-cigs? and with the inability to distinguish between imports of road salt and table salt that is in an earlier portion of the report, how on earth are they even finding e-liquid shipments to seize? dumb luck?

I'd post the pdf, but am feeling a tiny bit paranoid about making a direct post of the document...

 

[BigJimW]

If possible, I think this document should be somehow posted outright here, rather than through a link that the FDA can have blocked or removed.

If a mod can tell us how to have pdf's here directly, rather than links that not all would have access to, then we can see the real article, rather than read how the media want to spin it. Surely this must be possible here, but attaching the pdf document gives an "exceeds quota" error.

http://www.moonport.org/documents/2007-4329b_02_01_FDA_Report_on_Science_and_Technology.pdf

Here ya go.

 

[Kurt]

http://www.moonport.org/documents/2007-4329b_02_01_FDA_Report_on_Science_and_Technology.pdf

Here ya go.

Thanks, but I have it. My point was more about research articles that I have access to, but others do not, and have to depend on stupid CNN spin to get any info. The recent TSNA-on-surfaces PNAS article, for example. Or Dr. E's NJoy = no nic article. I'm sure the science types here would like to see original publications in their entirety. If we can't do it on ECF, and you want me to email them to you to post on moonport, PM me. I'm hoping we can put them here though.

 

[CJsKee]

Excellent!!! Thanks, Jim...

 

[deewal]

Thanks, but I have it. My point was more about research articles that I have access to, but others do not, and have to depend on stupid CNN spin to get any info. The recent TSNA-on-surfaces PNAS article, for example. Or Dr. E's NJoy = no nic article. I'm sure the science types here would like to see original publications in their entirety. If we can't do it on ECF, and you want me to email them to you to post on moonport, PM me. I'm hoping we can put them here though.

That should read Or Dr. E's NJoy = no nic Smear.
Look and Listen to the Videos he's made (if you hav'nt already done so)
All i hear is Regulation,Regulation, Regulation. He is not here to do a "fair and unbiased Study" He's here for more Ammunition for the FDA, The Media and his own career Advancement. Propylene Glycerol effects need more study and Regulation. Which brings me to the point of my post here.
Can You or Big Jim (he must have it) point me to the Press Statement made by the FDA's Spokesperson (a woman?) where the Anti-Freeze accusation was made or assumed ? Did That Spokesperson actually say Anti-Freeze or was it the Media that assumed it?

 

[Kurt]

Deewal, you may be right about how you are interpreting the study, but that wasn't my point. I simply want original article pdf's to be made available without a link to another site. That's all. I can get them, but I don't know the way of posting them here. The vast majority of ECF members cannot get the actual articles, and are dependent on however the media is spinning them. And spin they will, such as Dr. E's work as distorted by CNN. His study is just one of many that have been discussed here, but only in the context of media stories, not the original peer-reviewed article.

 

[yvilla]

Can You or Big Jim (he must have it) point me to the Press Statement made by the FDA's Spokesperson (a woman?) where the Anti-Freeze accusation was made or assumed ? Did That Spokesperson actually say Anti-Freeze or was it the Media that assumed it?

Dee, from the FDA's own press release:

"The FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. These tests indicate that these products contained detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed."

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173222.htm

And here is a link to the FDA's "warning" page to consumers about ecigs, that states about the same:

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm173401.htm

And this is the FDA "home" page for ecigs, with links to the above and more:

http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm

 

[deewal]

Deewal, you may be right about how you are interpreting the study, but that wasn't my point. I simply want original article pdf's to be made available without a link to another site. That's all. I can get them, but I don't know the way of posting them here. The vast majority of ECF members cannot get the actual articles, and are dependent on however the media is spinning them. And spin they will, such as Dr. E's work as distorted by CNN. His study is just one of many that have been discussed here, but only in the context of media stories, not the original peer-reviewed article.

Yes Kurt i understand and If the pdf's are in the Public Domain i can't see why anyone should object. If they are Private Documents that you have somehow got hold of i.e not already posted on the Web then SJ may not allow it for fear of being sued.
I also have a Press release which has already been posted on the Web and is still there. It is relevant to the Anti-Freeze accusation made by the FDA and like you, I need to have my facts right because if they did indeed use the word Antifreeze then they have some more questions that need to be answered as it concerns thousands if not hundreds of thousands of Citizens in the US.

 

[deewal]

Dee, from the FDA's own press release:

"The FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. These tests indicate that these products contained detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed."

FDA and Public Health Experts Warn About Electronic Cigarettes

And here is a link to the FDA's "warning" page to consumers about ecigs, that states about the same:

</title> <meta content="MSHTML 6.00.2900.5921" name="GENERATOR" /> <script type="text/javascript"> function changeImagesArray(array) { var d = document; var img; for (var i=0; i<array.length; i+=2) { img = null; var n = array; if (d.images) {img =

And this is the FDA "home" page for ecigs, with links to the above and more:

</title> <meta content="MSHTML 6.00.2900.5921" name="GENERATOR" /> <script type="text/javascript"> function changeImagesArray(array) { var d = document; var img; for (var i=0; i<array.length; i+=2) { img = null; var n = array; if (d.images) {img =

Great yvilla. Thanks. Now what ingredient of the E-Cig would contain "a chemical used in antifreeze that is toxic to humans"?

 

[yvilla]

Great yvilla. Thanks. Now what ingredient of the E-Cig would contain "a chemical used in antifreeze that is toxic to humans"?

As I understand it, DEG is a potential contaminent of PG. The USP standard for PG allows a certain trace amount of DEG. And just recently, in fact, the FDA asked the standards making body to revise it's PG standards, as follows:

"Based on a request from of the Food and Drug Administration (FDA) in February, 2009, USP has revised and strengthened its monographs for four pharmaceutical excipients used in drug formulations-Propylene Glycol, Sorbitol Solution, Sorbitol Sorbitan Solution, and Noncrystallizing Sorbitol Solution. These efforts are to assist in preventing future diethylene glycol (DEG) and ethylene glycol (EG) adulteration."

Hot Topics: USP Propylene Glycol and Sorbitol Solution Information

 

[lonercom]

Great yvilla. Thanks. Now what ingredient of the E-Cig would contain "a chemical used in antifreeze that is toxic to humans"?

According to the report, that would be Diethylene Glycol. Found in small quantities and only in one sample.

 

[yvilla]

According to the report, that would be Diethylene Glycol. Found in small quantities and only in one sample.

But, the point is that DEG is not and never was an "ingredient" in any ecig liquid. Its presence in that one cartridge can only be understood as an unintended contaminent, that may be prevented in future with quality control and care in ingredients sourcing.

 

[Kurt]

But, the point is that DEG is not and never was an "ingredient" in any ecig liquid. Its presence in that one cartridge can only be understood as an unintended contaminent, that may be prevented in future with quality control and care in ingredients sourcing.

As it is also found in trace amounts in food stuffs, and allowed by the FDA. Wasn't the amount found actually below the max amount allowed? Correct me if I'm wrong here.

 

[deewal]

I suffer from osteoarthritis and there is no Cure as the bone in my Spine and lower back have crumbled. My Doctor told me there was nothing that could be done and i will have to be on Painkillers, quote "for the rest of my days" Nice way of putting it eh? Anyway to get to the point one of the Painkillers i was prescribed was Diclofenac and it worked but after a few days made my gut so sore that i asked my Doctor was there anything else i could take instead. He told me that there was a Gel Form of Diclofenec that could be rubbed on my back and the drug entered the body through the skin. So i have been using that for about a year or so and today when i took out the tube to rub some on I took a look on the label and this is the list of ingredients.
Voltaren Emulgel Ingredients: Diclofenac diethylammonium gel 11.6 mg/g equivalent to diclofenac sodium 10mg/g (1% w/w/) Voltaren Emulgel contains isopropyl alcohol as a preservative. Other non active ingredients: diethylamine, carbomer 934P, cetomacrogol 1000, cococaprylate/capate, liquid paraffin, fragrance, propylene glycol and water.
Then i had a Google and found this.

Public release date: 22-Oct-2007
John Gilardi
41-61-3243018
Novartis Global Media
Voltaren Gel receives FDA approval as first topical prescription treatment for osteoarthritis pain
First US approval for a prescription NSAID (non-steroidal anti-inflammatory drug) treatment that can be applied directly to site of osteoarthritis pain

Voltaren Gel is the only prescription topical medication proven to significantly reduce osteoarthritis pain in both the knees and the joints of the hands

Offers highly effective pain relief with minimal drug absorption throughout the body – shown to be 94% less than comparable oral diclofenac treatment
Parsippany, New Jersey, October 22, 2007 – Voltaren® Gel (diclofenac sodium topical gel) 1% has received US regulatory approval as the first topical prescription treatment that patients can apply directly to sites of pain associated with osteoarthritis.
The US Food and Drug Administration (FDA) granted the approval to Novartis for Voltaren Gel, which is a non-steroidal anti-inflammatory (NSAID) medication, for use in treating pain associated with osteoarthritis in joints amenable to topical treatment, such as the knees and those of the hands.
Osteoarthritis is a chronic condition characterized by the breakdown of cartilage in the joint.
Clinical trials have demonstrated Voltaren Gel to be highly effective in treating osteoarthritis pain in the hands and knees, which are the body’s most commonly affected joints. It is the first prescription topical osteoarthritis treatment to have proven its effectiveness in both the knees and joints of the hands through clinical trials. Voltaren Gel delivers effective pain relief with a favorable safety profile as its systemic absorption is 94% less than the comparable oral diclofenac treatment.
“Voltaren Gel is proven to be effective for osteoarthritis of the hand and knee and has a favorable safety profile. The combination of benefit and safety provides a welcome new treatment approach for osteoarthritis, offering patients an alternative to oral therapies,” said Roy Altman, MD, Professor of Medicine in the Division of Rheumatology and Immunology at UCLA in Los Angeles and Past President of the Osteoarthritis Research Society International. “Voltaren Gel delivers the proven efficacy of diclofenac with significantly less systemic absorption, minimizing the risk of side effects.”
The efficacy and safety of Voltaren Gel were studied in more than 900 patients with knee or hand osteoarthritis. The US approval was based on several studies, including the results of two randomized, double-blind, placebo-controlled efficacy studies and a 12-month safety study.
Voltaren Gel was shown to significantly reduce pain in hand and knee osteoarthritis, with pain relief sustained through the end of treatment. After six weeks of treatment in an efficacy study of patients with osteoarthritis of the hand, results showed that pain levels were reduced by nearly half (46%). In a 12-week study in patients with osteoarthritis of the knee, Voltaren Gel showed a 51% reduction in pain.
“Voltaren Gel represents an important clinical milestone – it is the first prescription topical treatment in the US shown to relieve osteoarthritis pain and to clinically prove efficacy in treating both the knees and hands,” said Jorge Insuasty, MD, Senior Vice President, Research and Development, Novartis Consumer Health, Inc. “Patients now have the option to effectively treat osteoarthritis pain directly at the source with favorable tolerability.”
Approximately 21 million people in the US have osteoarthritis,(1) and the aging population in the US means 72 million more will be at risk for developing the condition by 2030.(2) Osteoarthritis is a chronic, painful condition that often leads to working limitations and reduced overall health.

My Question is
How could the FDA approve a product which contains an ingredient that is found in Anti-Freeze ? Especially when they are saying they don't know the long term effects of that Ingredient. I'm Shocked. 8-o I hope the Press don't get wind of this or the FDA might have to Ban my Painkiller as well as my E-Cig. Below is the full press release. Read it all. Dig the Important Safety Information. Next time anyone talks about Propylene Glycol, Anti-Freeze and the FDA's uncertainty of the effects i'm going to show them this.
Voltaren Gel receives FDA approval as first topical prescription treatment for osteoarthritis pain

Just one of the many places you can buy it without a prescription
Voltaren Emulgel 120g - Strand Arcade Pharmacy Online | Colostrum | D-Mannose | Mega V
Dr. E made a point of mentioning the unknown effects of Propylene Glycol also in his Videos as a reason for Regulation.
If this is safe enough to rub into my skin to be absorbed by my body (in thr general region of my Kidney's) then they must have tested and know the safety of it or they would'nt have Approved it. Would They?
Propylene Glycol is a Nonmedicinal Ingredient of Voltaren.
Here's a review.http://www.reviewstream.com/reviews/?p=68154