Many New Drugs Did Not Have Comparative Effectiveness Information Available at Time of FDA Approval

Science Daily ^ | May 03, 2011 | Science Daily Staff

[TennesseeGirl]

Only about half of new drugs approved in the last decade had comparative effectiveness data available at the time of their approval by the U.S. Food and Drug Administration, and approximately two-thirds of new drugs had this information available when alternative treatment options existed, according to a study in the May 4 issue of JAMA. http://www.sciencedaily.com/releases/2011/05/110503161400.htm

[TennesseeGirl]

"The researchers note that although comparative efficacy data meeting their minimal criteria were available for approximately half of all newly approved NMEs, they did not assess the extent to which the publicly available data are informative enough to provide a basis for prescribing and coverage decisions."

[TennesseeGirl]

You might be interested in reading this, although, it’s like preaching to the choir...”Why Society Is Running Out of Vital Medications” http://www.theatlantic.com/life/archive/2011/05/why-society-is-running-out-of-vital-medications/238168/

[Eva]

I’ve been questioning the FDA move to advise against giving toddlers triaminic or other cold medicines. My 2 1/2 year old grandson just started day care and has been sick almost since the day he started. The cold gets so bad that it ends up in his ears and now even his eyes. If you don’t give the kids a little cold medicine, they just keep getting sicker and they don’t get any sleep, the parents don’t get any sleep and it creates a vicious cycle. Now on top of it, he has pink eye and is constipated and miserable. He won’t eat, he doesn’t sleep and and now he is refusing liquid because he knows that they put the medicine in the juice or water.

The FDA says no cold medicine.

[brytlea]

Yes, but cold meds only treat symptoms. Why is he staying so sick?

[tiki]

Because none of the other kids are getting Triaminic either and they’re wiping their snot all over the place.

I don’t care, when I can’t breath, I want something that alleviates the symptom and when I’m in pain, I want something that alleviates the pain even if it doesn’t cure me.

[Eva]

Ear infections run in our family. When the eustachian tube fills up with mucus, the ear gets infected. Keeping the eustachian tube clear is important. My guess is that the ear infection never completely clears and he just catches everything that is going around at school/day care.

That’s why treating the symptoms is sometimes very important. On top of it all, the child is very difficult, extremely intelligent and manipulative. He started reading at the same time he started talking.

[algernonpj]

Just talk to people who have asthma and were once well controlled using CFC inhalers. The replacement HFA inhalers, mandated to 'save the ozone hole', are an inferior product that were never properly tested.

Here is an FDA instruction for use of HFA inhalers, to those who are taking these medications because of difficulty breathing:

"It is important to remember that it is the deep breath that you take with each puff that gets the medication into your lungs, not the force of the spray. "

[Mase]

The FDA says no cold medicine.

The reason the FDA did what they did was because some parents weren't following the directions and caused adverse reactions in their children and in some cases, death. These medicines work just fine if the directions are followed. We continued to use these medicines despite their warning because it was the only way to give our kids some relief so they could get the sleep they needed to get better. The FDA is a behemoth of bureaucracy that is mostly interested in CYA -- just another government agency trying to save us from ourselves.

[brytlea]

Tiaminic won’t keep the other kids from wiping snot all over the place, it will just make them feel well enough to go to daycare.

[brytlea]

That’s what I was wondering (ear infections). We had the same problem with 2 of my 3 boys (altho they didn’t go to daycare as I was fortunate not to work when they were small). Fought it until we finally did tubes. I feel for you all. I don’t know if they do tubes in the ears as commonly nowadays (I know they change their ideas about this stuff) but back then, it sure was the magic bullet.
For awhile it seemed like one or the other was on antibiotics almost all the time (those two were only about 15 months apart in age).
We had a wonderful allergist (they also both had asthma) who helped a lot. Fortunately both outgrew most of it and are healthy and successful men today, but man, it was tough when they were little, and I used to hate people who sent their kids to school sick (when they were in preschool) because I knew they would catch whatever it was!

[brytlea]

So, are the medications still available, just not labeled for kids? I hate that the govt won’t even let parents raise their own kids anymore.

[Eva]

I told my daughter to go ahead and use the cold medicine. I told her to use the triaminic at half the dose that is recommended for four year olds. I recommended the triaminic because it was what I used when she was a little.

I figured that was the reason behind the FDA ruling because they even made a feature movie about it, the mother gave the kid cold medicine to put the child to sleep so she could go out. When she came home, the child was dead and she reported that the child had been kidnapped.

Sometimes relieving the symptoms is a necessary step in the cure.