SE, NJoy vs FDA -- Discussion

[ezmoose]

That was addressed before in the big thread. However...

What's even more curious is the fact that FDA and the nation's biggest health organizations (the alphabet groups) find racing pulse, dizziness, slurred speech, mouth ulcers, heartburn, coughing, ........, and sore throat more dangerous to the public than cancer, emphysema, heart disease, COPD and death!

I did have heartburn once since taking up vaping, but I believe pizza was the culprit! Maybe the FDA should ban pizza!

 

[Vocalek]

That was addressed before in the big thread. However...

What's even more curious is the fact that FDA and the nation's biggest health organizations (the alphabet groups) find racing pulse, dizziness, slurred speech, mouth ulcers, heartburn, coughing, ........, and sore throat more dangerous to the public than cancer, emphysema, heart disease, COPD and death!

But gee, why should the American Cancer Society be concerned about cancer; why should the American Heart Association be concerned about heart disease, and why should the American Lung Association be concerned about COPD and emphysema, which are lung diseases?

What about proven "safe" medications from the FDA?

Adverse Reactions: Adverse reactions reported in association with the use of Nicorette include both local effects and systemic effects representing the pharmacological action of nicotine.

Local Side Effects: Mechanical effects of gum chewing include traumatic injury to oral mucosa or teeth, jaw ache, and eructation secondary to air swallowing. These side effects may be minimized by modifying chewing technique. Oral mucosa changes such as stomatitis, glossitis, gingivitis, pharyngitis, and aphthous ulcers, in addition to changes in taste perception, can occur during smoking cessation efforts with or without the use of Nicorette.

Systemic Side Effects: Although the type of systemic adverse drug effects seen in clinical trials are similar from one trial to the other, the incidence of individual effects vary considerably from trial to trial. In 2 well-controlled clinical trials (1 performed in the United States and 1 in England) designed to evaluate the safety and efficacy of Nicorette this variation was evident.

Due to its inherent variability, the list of adverse event incidences can be used only as an indication of the relative frequency of adverse events reported in representative clinical trials. It cannot predict expected incidences of these effects during the course of usual medical practice.

In addition to the reported effects in clinical trials, the following events have been reported: Cardiovascular: edema, flushing, hypertension, palpitations, tachyarrhythmias, tachycardia, chest pain; CNS: confusion, convulsions, depression, euphoria, numbness, paresthesia, syncope, tinnitus, weakness; Dermatologic: erythema, itching, rash, urticaria; Gastrointestinal: alteration of liver function tests, constipation, ........; Respiratory: breathing difficulty, cough, hoarseness, sneezing, wheezing; Other: dry mouth, systemic nicotine intoxication.

Reports of myocardial infarction, congestive heart failure, cerebrovascular accident and cardiac arrest, including death have been received. A cause and effect relationship between these reports and the use of Nicorette has not been established.

Rare reports of miscarriage have been received and a relationship to drug therapy as a contributing factor cannot be excluded.

In addition, rare reports of an apparent severe allergic reaction have been received.

RxMed: Pharmaceutical Information - NICORETTE

I'm not dissing Nicorette. My point is that if all the above possible adverse effects were considered too trivial to prove Nicorette unsafe, then why try to claim that the side effects FDA listed would prove that electronic cigarettes are too unsafe to use?

 

[Our House]

My point is that if all the above possible adverse effects were considered too trivial to prove Nicorette unsafe, then why try to claim that the side effects FDA listed would prove that electronic cigarettes are too unsafe to use?

HEY LOOK:

"racing pulse, dizziness, slurred speech, mouth ulcers, heartburn, coughing, ........, and sore throat"

4 of those are side effects of nicotine use and 4 of those are side effects of quitting tobacco cigarettes!

GEE, WHAT A SURPRISE! Thanks FDA for pointing out a complete tautology. How on earth are these symptoms unique to ecigs?? You're subject to 4 of them even if you quit smoking cold turkey!

 

[Vaporer]

Elaine,
About every other line in that brief seems to just cry out. If you had the time , you could write a short story as you went through it.
Your approach to the scenerios would be a riot to read.....

 

[ezmoose]

Everyone has had an adverse reaction to a commonplace substance in their life. Some people are Lactose Intolerant; should that be generalized to the public and used to justify banning milk? I think not!

I happen to be allergic to alcohol; whenever I drink, I break-out in handcuffs! So I don’t drink anymore. I don’t preach to others who can enjoy a social drink successfully!

 

[mpetva]

Does anyone know if the lawyer for e-cig side pointed out (or HOPEFULLY WILL point out) that the same damned side effects are common to all FDA approved cessation products etc?

 

[JustJulie]

Court accepted the alphabet soup group amicus brief. No surprise.

 

[Elendil]

THat doc has been copied over to the docket thread

 

[JustJulie]

THat doc has been copied over to the docket thread

Gracias.

 

[JustJulie]

No movement on the docket today.

 

[JustJulie]

Appendix filed today by FDA. I am doing this from my phone. Will upload document tonight. Not expecting it to be exciting.

 

[Vocalek]

Oh good. Maybe the Appendix to the FDA brief will clear up the "Ibid" mystery for me.

Even in lower doses, nicotine can cause elevations in blood pressure and
heart rate. Id. ¶ 14 (JA 549). Short-term side-effects reported from use of “electronic cigarettes” include racing pulse, dizziness, slurred speech, mouth ulcers, heartburn, coughing, ........, and sore throat. Ibid.

Reported to whom? Reported where?

If I understand the referencing system, "Ibid" means that they are using the same source for this assertion as for the previous one, is that correct? But the first sentence sounds as if it came out of a medical journal article while the second sentence sounds like a summary of first-person reports. Oh, but then again, it does look quite similar to the list of side effects for Nicorette.

 

[yvilla]

Oh good. Maybe the Appendix to the FDA brief will clear up the "Ibid" mystery for me.

Reported to whom? Reported where?

If I understand the referencing system, "Ibid" means that they are using the same source for this assertion as for the previous one, is that correct? But the first sentence sounds as if it came out of a medical journal article while the second sentence sounds like a summary of first-person reports. Oh, but then again, it does look quite similar to the list of side effects for Nicorette.

Elaine, yes the appendix should reveal it to you.

The "Id" just before the "Ibid", refers to the immediately previous reference, but at a specified different page of the appendix. So looking just a bit further up in the brief from where you quoted, we see that they are citing to "Woodcock Decl. ¶ 4(JA 546)."

Which would be paragraph 4 of Janet Woodcock's declaration (probably an affidavit submitted from her, as part of the FDA's case), and to be found in the Joint Appendix at page 546. Then, the first "Id" citation would be to her declaration at paragraph 14, on page 549 of the appendix, and so you should also find the "Ibid" reference in that same paragraph 14 of Woodcock's trash talk.

 

[JustJulie]

Well, looks like we won't have easy access to the Appendix . . . since it's more than 500 pages, it was filed in paper form (and not electronically). The attached is the notice filed by the FDA to that effect.

 

[ezmoose]

I think I may have found the source of the "side-effect" claims the FDA is making in their appeal.

"The FDA, lacking data that e-cigarettes pose a health hazard, was so desperate, it called on consumers to phone in adverse side effects of e-cigarettes so they could begin to build a case against them and proceed with their intended ban. They neglected, however, to request smokers who successfully quit using the e-cigarette to also call in."
http://www.acsh.org/healthissues/newsID.1821/healthissue_detail.asp

Granted, this is an older article and it may have already been discussed on this forum; however, it's new information for me and I like writing out my thoughts. Besides, I'm too lazy to see if it's already been beat to death! lol

I've edited this post four times now for errors (format, grammar, spelling...). No wonder, it’s 2:30am AST. I’d better hit the hay; right after I hit the ENI! lol

 

[Vocalek]

Elaine, yes the appendix should reveal it to you.

The "Id" just before the "Ibid", refers to the immediately previous reference, but at a specified different page of the appendix. So looking just a bit further up in the brief from where you quoted, we see that they are citing to "Woodcock Decl. ¶ 4(JA 546)."

Which would be paragraph 4 of Janet Woodcock's declaration (probably an affidavit submitted from her, as part of the FDA's case), and to be found in the Joint Appendix at page 546. Then, the first "Id" citation would be to her declaration at paragraph 14, on page 549 of the appendix, and so you should also find the "Ibid" reference in that same paragraph 14 of Woodcock's trash talk.

So If I wanted to work this same scam, first I would put down all my totally unsupported accusatons on paper and swear to them. Then my lawyer would file a brief that cites references to my affidavit as evidence. Would that be an accurate description of the process?

Wow. Next time I write a blog, I'll have to quote myself.

 

[yvilla]

You got it Elaine, that's the way it works! ;-)

Woodcock is the FDA's "expert", the other side can and I'm sure did present opposing evidence, and it's up to the court to decide who to believe and to credit in arriving at its decision. Classic war of the experts, found in litigation of all kinds.

 

[beebopnjazz]

I thought ALL Federal filings were required to be electronic pdf files?

Well, looks like we won't have easy access to the Appendix . . . since it's more than 500 pages, it was filed in paper form (and not electronically). The attached is the notice filed by the FDA to that effect.

 

[JustJulie]

I thought ALL Federal filings were required to be electronic pdf files?

There are some exceptions:

ECF-8. Exceptions to Requirement of Electronic Filing And Service

<snip>

(C) Exhibits, attachments, or appendix items that (1) exceed 500 pages or 1500 kilobytes; (2) are not in a format that readily permits electronic filing, such as odd-sized documents; or (3) are illegible when scanned into electronic format may be filed in paper form. Documents filed pursuant to this subsection must be served by an alternative method of service authorized by FRAP 25, and the filer must file electronically a notice of paper filing.

(D) Upon motion and a showing of good cause, the court may exempt a party from the electronic filing requirements and authorize filing by means other than use of the CM/ECF system. See D.C. Cir. Rule 25(b).

I am so sorry about the below link . . . I just can't make it look right.

http://www.cadc.uscourts.gov/internet/home.nsf/Content/Administrative%20Order%20Regarding%20Electronic%20Case%20FilingEffective%20June%208%202009/$FILE/Admin%20Order%20ECF%20May%202009.pdf

 

[Thulium]

This should hopefully work better: Administrative Order Regarding Electronic Case Filing