This is why I have no use for the FDA

[Sashahomeschoolmama]

Several years ago, after my second stint on life support, I was given a new asthma wonder drug. It was terribly expensive (at the time $200+ a month) but it was the strongest drug available.

So I took it. I scrimped and went without sometimes because I didn't want to be without this medication that helped keep my uncontrollable asthma better controlled.

A few years ago people started barking at the FDA that there needed to be warning labels put on the drug. The drug would cause the lungs to become dependent on it, then if the person stopped taking it the lungs would become worse (or something similar--I don't exactly remember since it was a few years ago).

GlaxoSmithCline balked and the FDA didn't press the issue.

Now this report (http://www.medpagetoday.com/AllergyImmunology/Asthma/12045) came out and the FDA is considering banning this medication. As it was new when I started it, and my second coma was September of 1999, that's been eight years (I think the average time a drug is on the market before being pulled is 7 years). That's eight years my body has become accustomed to having this medication that now, I'm told, I might not be able to get because it could hurt me even though I was told to make sure that I refilled my prescription every month because, without it, my uncontrollable asthma would be even more uncontrolled.

I have so little respect for this government agency. They have about as much credibility with me as a rent-to-own furniture store or a buy-here-pay-here car lot.

:mad:

[Sunnie]

If they didn't cave to pressure from the drug companies, they'd be better

[Sunnie]

what's the med? My mom might be on it.

[Sashahomeschoolmama]

Advair. Servent, Foradil, and Symbicort are the others Ironically, I was given Symbicort a couple of years ago and told that it was the safest of any asthma maintenance med.

[trylyn5]

My dh takes Advair. I've been seeing stuff for months now about its dangers. I really want him to get off of it. His asthma has gotten so much worse since he's been on it continuously. Before we moved to Indiana he'd only had to be on it a couple weeks in the spring for peak allergies in AK.

[Sunnie]

I think my mom is on Advair. I'll have to find out.

[haleysmom]

Wow... I used to work for an asthma and allergy specialist when I was pregnant with Haley. SOOOO many people are on Advair! :(

[Suzette]

Whe I was first prescrobed Advair, there was a lot of reading material in it, including a warning. This was maybe 4 years ago.
My dd is on it as well, and I always kind of questioned it because her asthma isn't that bad.
How scarey.

[chinapiggy]

Wow, what a scary situation to be in. What will they give you to take instead? I hope you find something to help your asthma. having trouble breathing has got to be a really scary thing.

[Ilovemonkeys]

Is Advair the one in the purple disc?

[Suzette]

Yes, ILM.

[ColleenF30]

Wow.....I used to take Advair.

[MrsGinCamarillo]

That's scary Sasha.

My husband uses these medications daily (and with no insurance I understand how expensive they are). He has tried (and failed) many other medications.

That's nuts.

[pawprint]

Wait, wait, wait. I take advair everyday. I can't breathe without it. They are banning the med? How the hell will I breathe? What. The. Fuck.

[pawprint]

You know what, I'm not a med person at all. But if they ban it I am so fucked. There has been nothing, nothing, nothing else that has kept me from wheezing. Not the 'rescue' albuterols, not the neb, nothing. I'd rather breathe while I'm alive and risk the chance of an asthma related death than live with wheezing for the rest of my life.

[NewMum]

My MIL is on this, and didn't know about the report. Thanks for sharing it with us.

[Ilovemonkeys]

My dd was put on it when she was little, like maybe 4 or 5 and she refused to take it.
I'm wondering why she was put on it now b/c her asthma symptoms only show up when she's sick or in the cold.

[pawprint]

I just called my GP, a complimentary medicine doctor whom I respect highly. He read the study and said he didn't think it was a very good one, and that advair appears to be less of a problem the just the straight salumedrol. He doubts it will be banned.

[Suzette]

I found this article:
http://cbs11tv.com/health/asthma.medicine.safety.2.880570.html

This might be one of those situations where the patient and health care provider should decide together what the best plan of action is.
I made an appt for my dd to discuss with her dr about possible going off Advair. She takes Singulair as well. Then I'll have to figure out what to do for myself as my asthma is a little more severe than hers.

[Suzette]

OOP! Just saw Paw posted simlar info!

[JudyJudyJudy]

I'm sorry, Sasha and others. When this was recommended for Jacob a few years ago, I researched it and decided that I didn't think the benefits outweighed the risks for him. This type of thing is one of the many reasons that I wish I could afford to see a very good naturopath. I'm very skeptical of pharmaceuticals anyway, though. While I do realize there is no choice in some situations, I think there are many instances where more harm than good is done with medications.

[SingingMom]

I'm going to stick my neck out here and say...

I am not upset with the FDA. They are poorly funded and have little enforcement power. Now, you understand, my experience with them comes from the medical devices side of things, which is a little different from pharmaceuticals. For one thing, there's a lot less money in it, in general. So the excitement level is lower.

Now, if you have some ideas about how to restructure the FDA and fund it differently, and possibly also fund research in this country differently, I'm open. But the laws they enforce are loopy, to say the least.

[JudyJudyJudy]

SM, you might find this to be interesting:

http://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/independent.html

[SingingMom]

I did, indeed. Thanks. I, personally, think it's an obvious conflict of interest to fund the FDA with user fees.

We also really, really need better toxicity models. There's some work I'd LOVE to do...

[Meredith]

Wow... I used to work for an asthma and allergy specialist when I was pregnant with Haley. SOOOO many people are on Advair! :(

I know. :( When I was a pharmacy tech, we went through that stuff like crazy.

[JudyJudyJudy]

I did, indeed. Thanks. I, personally, think it's an obvious conflict of interest to fund the FDA with user fees.

We also really, really need better toxicity models. There's some work I'd LOVE to do...
That does sound like interesting work!

[Meredith]

I just saw a segment on the news just now about Serevent and Foradil. I *think* they said that the FDA has changed their recommendations regarding their use for asthma. I'll see if I can find a link to the segment.

ETA: Story (http://www.foxcarolina.com/betterhealthcarolinas/18252889/detail.html#-)

[pawprint]

I'm sorry, Sasha and others. When this was recommended for Jacob a few years ago, I researched it and decided that I didn't think the benefits outweighed the risks for him. This type of thing is one of the many reasons that I wish I could afford to see a very good naturopath. I'm very skeptical of pharmaceuticals anyway, though. While I do realize there is no choice in some situations, I think there are many instances where more harm than good is done with medications.


I totally agree. I love my naturopath to death, but this is just one thing we haven't been able to fix with anything non-allopathic. I agree that it shoudl be my choice. If I could control it another way I would.

[Ilovemonkeys]

YEs they did say on the news tonight that they've decided that advair will stay.

[pawprint]

Thank goodness.

[Iconoclast]

Now, if you have some ideas about how to restructure the FDA and fund it differently, and possibly also fund research in this country differently, I'm open. But the laws they enforce are loopy, to say the least.

Start w/ making drug rep calls on physicians illegal. Outlaw all gifts and incentives from drug comanies to MDs, hospitals, health agencies. Outlaw "samples."

Require 3rd party research evaluations completely devoid of conflicts of interest.

The FDA is completely corrupt. I don't believe a word that comes out of thier lying, stealing, cheating collective mouth. Ever.

[trylyn5]

Start w/ making drug rep calls on physicians illegal. Outlaw all gifts and incentives from drug comanies to MDs, hospitals, health agencies. Outlaw "samples."

Require 3rd party research evaluations completely devoid of conflicts of interest.

The FDA is completely corrupt. I don't believe a word that comes out of thier lying, stealing, cheating collective mouth. Ever.


I completely agree with this

[JudyJudyJudy]

Start w/ making drug rep calls on physicians illegal. Outlaw all gifts and incentives from drug comanies to MDs, hospitals, health agencies. Outlaw "samples."

Require 3rd party research evaluations completely devoid of conflicts of interest.

The FDA is completely corrupt. I don't believe a word that comes out of thier lying, stealing, cheating collective mouth. Ever.
I absolutely agree.

[PiccoloRose]

That's really terrible! My aunt is on Advair. She can't breathe without it. As it is she still has a lot of trouble breathing on it, but nothing like before.

[Meredith]

I absolutely agree.

Me three.

[Coconuts71]

Advair. Servent, Foradil, and Symbicort are the others Ironically, I was given Symbicort a couple of years ago and told that it was the safest of any asthma maintenance med.The report I heard on the radio said that was one of the ones they weren't going to mess with. It was the two that were only one medication, not two together. Unless I heard wrong.

[Coconuts71]

I just called my GP, a complimentary medicine doctor whom I respect highly. He read the study and said he didn't think it was a very good one, and that advair appears to be less of a problem the just the straight salumedrol. He doubts it will be banned.

Yes. This is what I heard on the radio.

[naturalJen]

Iconoclast is 100% correct. The FDA without a doubt is bought & paid for by corporations and special interests group etc. They fire their own researchers who stand in the way of profits and report data (side effects, injury and deaths) that is contrary to their true agenda. Profitability over the value of human life. I have zero respect for them. Look at aspartame and its background. Google the testing on lab rats. It is pure poison. Now it's in every bubblegum so our children can start early on it. Check labeling.

The FDA's latest piece of work is Melamine levels in infant formula. Over 90% of U.S. infant formulas tested positive for melamine. This has killed many infants in China and pets worldwide with renal failure. What is the FDA's response? Melamine is safe at 1 part per million. Are you kidding me??? The true lack of moral oversight in the FDA is killing us slowly for the love of money and power.

They make me sick.

From the FDA's website: http://www.fda.gov/oc/opacom/hottopics/melamine.html
November 28, 2008: FDA’s ongoing investigation continues to show that the domestic supply of infant formula is safe and that consumers can continue using U.S. manufactured infant formulas. FDA has concluded that levels of melamine alone or cyanuric acid alone, at or below 1 part per million (ppm) in infant formula do not raise public health concerns. FDA has updated its interim risk assessment, issued in early October, with this information: http://www.cfsan.fda.gov/~dms/melamra4.html.

The FDA has been collecting and analyzing samples of domestically manufactured infant formula for the presence of melamine and melamine-related compounds. To date, FDA tests have found extremely low levels of melamine in one infant formula sample and extremely low levels of cyanuric acid in another. The levels were so low (well below 1 ppm) that they do not pose a health risk to infants: http://www.fda.gov/oc/opacom/hottopics/melamine/testresults.html.

Melamine is not naturally occurring and is not approved to be directly added to food in the United States. However, melamine is approved for use as part of certain food contact substances. Low levels of melamine are present in the environment and trace amounts may occur in certain food commodities as a result of approved uses.
Parents using infant formula should continue using U.S. manufactured infant formula. Switching away from using one of these infant formulas to alternate diets or home-made formulas could result in infants not receiving the complete nutrition required for proper growth and development.
--------------------------------
I know this is a tad off topic but still in line with anti-FDA sentiment so I apologize for that. It's just that it bugs me at how criminal they truely are. And for those who may notice. Yes this is my first post. I was a member here 7 years ago and continued to post until she was two and I went back to work. I am back now because I am pregnant, 20 weeks and I am pretty sure it's smooth sailing. *fingers crossed* No more miscarriages for me. :)

[JudyJudyJudy]

Great post, Jen. Congratulations on your pregnancy.

[SingingMom]

I understood that the melamine they found in the formula turned out to be residue from a cleaner used on the manufacturing equipment. Are you suggesting that

1. American formula manufacturers are deliberately adulterating formula with melamine? Because no one has seen that yet, AFAIK.

2. The levels detected are, indeed, hazardous?

I skimmed over the FDA link you included and didn't find anything shocking.