Long-Term Use of NRT

[Vocalek]

On October 27, the FDA is holding a public hearing on Long Term Use of NRTs. I have sent off a request to speak. If I am not selected, I will be able to submit written testimony.

I would like to hear from NRT users in this forum. What points do you think should be made regarding whether the FDA should leave the NRT directions as-is (use the product for about 12 weeks to wean down & off nicotine) or to approve NRT products for long-term use?

They might be thinking of just allowing a longer time-frame for the weaning, or they might actually be considering the concept of nicotine maintenance via pharmaceutical products.

The public hearing comes inside of a 2-day workshop on the topic.

Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy (NRT) Products; Public Workshop
DATE: October 26-27, 2010
TIME: 8:30 a.m. to 5:00 p.m.
LOCATION: Radisson Hotel, Reagan National Airport, 2020 Jefferson Davis Highway, Arlington, VA 22202
CONTACTS: Mary C. Gross, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6178, Silver Spring, MD 20993–0002, 301–796–3519, email: mary.gross@fda.hhs.gov
FDA, Center for Drug Evaluation and Research (CDER) is announcing a scientific workshop that will focus on the risks and benefits associated with the long-term use of nicotine replacement therapy (NRT) products

Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy (NRT) Products; Public Workshop

http://edocket.access.gpo.gov/2010/pdf/2010-21894.pdf

 

[BCB]

Well, I don't know how you could make a case for leaving NRT directions the way they are. They have an abysmal success rate, so obviously it's time to look at ways to change the plan. For a start, SHOW the long-term benefits of long term smokeless products. That's a pretty fair comparison for the risks/benefits of long term NRT use. We have decades of data from Swedish Snus. Then compare the risks to those of continued smoking. No brainer--we're halfway there.

I think one reason e-cigs and snus are successful is because the user gets to decide what flavor and what level of nicotine to use. The user makes the plan, rather than having a proscribed plan defined by "professionals." WE are the professionals in this arena. WE are the ones who have been self-titrating our dose for years without their help and apparently with amazing accuracy. Some people on this forum report using higher strength snus/ejuice in the morning, then a much lower strength before bed. We alter our dosages depending on stress levels and our environment, just as we always did with cigarettes. Many smokers have disregarded the NRT "plan" once it became apparent it wasn't working. I talked to one man who has been chewing nicorette gum for 10 years. He doesn't smoke, but he wouldn't even CONSIDER life without his nicotine gum.

Since it's obvious that many of us benefit greatly from nicotine and have no desire to quit nicotine, it seems that to simply ACCEPT that concept would be step 1.
With that in mind, the best help the FDA could deliver would be to show us a graph that accurately delineates the relative safety of all nicotine products, cigarettes, cigars, pipes, the FDA smoking cessation products as well as e-cigs, USA snus, Swedish snus, chewing tobacco, snuff, etc. Labeling of products with the exact mg of nicotine in each also helps the consumer when purchasing products to self-titrate continued use or make a successful plan for cutting back on nicotine if that's what they want to do.

Is that the kind of input you wanted, Elaine? I wasn't sure if I was correctly answering the question you were asking.

I sure hope you are selected as a presenter! You rock!

 

[Vocalek]

Yes, absolutely. And your mind is running the same track as mine. I think that the only evidence that has been gathered on long-term use of nicotine without the smoke is all the research on smokeless products, with the safest being Swedish snus. I can't seem to find any long-term studies of using NRTs. And if nicotine from a tobacco product greatly reduces harm from smoking, why wouldn't NRT? Possibly because in order to reduce the harm, people have to be willing to use the product. I think FDA must consider allowing higher dosage products, too, not just extend the amount of time that use of the current produts is "approved".

 

[four2109]

I don't think Pharma wants to address long term use issues. I've read some real horror stories about Commit Lozenges increasing addiction and rotting teeth.

 

[Stubby]

The thread is a bit outdated, but not by much so I'll bite.

First off I don't use NRT products but the idea of long term use is interesting. I've known several people who have used gum for years. What strikes me is this would be the first step towards the government recognizing the concept of tobacco harm reduction. This would be long term replacement of smoking with a reduced harm product as opposed to abstinence only. It's a step in the right direction. It makes it harder to make an argument against smokeless tobacco products and e-cigs for long term use. It gets us out of the whole quit or die mentality.

Of course the problem is that no doubt BP would love it as it expands the use of gum and patches, but the push would be to stop it right there and not follow through to the logical conclusion of including non-pharmasutical products. But..... it makes it harder for them to make a valid argument as they have already somewhat embraced the concept of harm reduction.

So from the way I see it.... go for it.

 

[BCB]

Elaine, Bill Godshaw, and others testified and it sounds like most of the presenters were in favor of long-term nicotine replacement. You can read about it and see Elaine's presentation in the "campaigning" section of this forum. It's called FDA Public Hearing, dated October 8, 2010. I don't know how to link it or I'd do that for you.

 

[Tinky]

I enjoyed reading this thread. I always wondered if there were others out there still on gum, lozenges, and patches. I quit analogs around 2004 but I haven't gone a single day w out nicotine. I started Vaping last Thursday firstly thinking it would be cheaper than the gum, patches, and lozenges and secondly because I was worked up to 24-34mg nico intake daily and it was started to make my have funky heartbeats at night. I'm pleasantly down to 18mg cart per day and I LOVE vaping...honestly...don't know if I will ever quit. Still researching..looking for studies to read on the aspect.

2weeks recommended use...I've lmbo over that a time or two! Rooting for you Vocalek!!!!!!!!