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  (Source: Wordpress)
The FDA meets today to discuss the pill's effectiveness

Children with a rare lung disorder, called pulmonary arterial hypertension, may begin taking Pfizer Inc.'s drug Viagra in order to treat blood pressure-related problems associated with the disorder. 

Viagra is a drug normally used for erectile dysfunction and also helps adults with pulmonary arterial hypertension gain the ability to exercise by relaxing the arterial wall, which leads to decreased pulmonary arterial pressure and resistance. It blocks an enzyme that regulates flow in the penis and lungs.

This medication works for pulmonary arterial hypertension because what this disorder does is increase the blood pressure in the pulmonary vein, artery or capillaries leading to fainting, dizziness and shortness of breath. It causes the right side of the heart to work harder, and Viagra releases this pressure.

U.S. regulators are looking for a way to test whether Viagra would be okay for children. Advisors to the Food and Drug Administration will meet July 29 to discuss this matter and see if Pfizer's study on the pill's effectiveness on children is "sufficient."

Pfizer conducted a study that consisted of 234 children who took Viagra. In most studies of adults with the disorder, they are asked to perform exercise tests. However, this was much too difficult for the children, so a different test where a catheter is inserted through the arteries (which measures blood flow) was conducted instead. This alternative test proved that the drug failed to show any differences when the children tried regular exercise tests, but when researchers used the alternative measure of blood flow, Viagra did prove to be beneficial. 

"It's a good option in pediatric patients because it is well-tolerated, in that it doesn't have as many side effects as some of the other options," said Chad Knoderer, a pediatric clinical pharmacist at Riley Hospital for Children in Indianapolis, who has used Viagra for children with the disorder before.

Pulmonary arterial hypertension affects 600 people a year, and if Pfizer meets FDA requirements, the drug will be on the market an extra six months without generic competition. The patent for the drug is expected to expire in 2012. 



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market extension is a bit sad
By GrandMareg on 7/29/2010 12:28:13 PM , Rating: -1
Pfizer is just doing whatever it can to extend how long it can keep Viagra on the market without competition.

1. find any condition
2. see if drug has any effect whatsoever on the condition
3. get a longer extension on a drug that isn't even that beneficial and has obvious side effects.

Am I missing anything?




RE: market extension is a bit sad
By Ticholo on 7/29/2010 12:31:44 PM , Rating: 2
Completely off-topic:

I wonder what you mean by "obvious side effects"... ;)


By bubbastrangelove on 7/29/2010 12:37:55 PM , Rating: 5
Side effects may include:

- Excessive use of peanut butter and prolonged absences of household pets
- Refusal to take part in standing activities
- Destroyed warm apple pies


RE: market extension is a bit sad
By Smilin on 7/29/2010 2:44:02 PM , Rating: 2
He's probably talking about the low incidence of blindness found during on-label use.


RE: market extension is a bit sad
By BruceLeet on 7/29/2010 1:14:44 PM , Rating: 4
Somebody pleease think of the children!


By Spivonious on 7/29/2010 1:23:16 PM , Rating: 2
hehe "longer extension"


RE: market extension is a bit sad
By sgw2n5 on 7/29/2010 1:25:44 PM , Rating: 1
This is absolutely correct, and a disgusting business practice.

Phizer has successfully conducted trials using "viagra" for treating this disorder as early as 2001. They sat on it for nearly 10 years (while children who could have used the medication were either dying or living in misery) and then when the patent is ready to expire on viagra, they "invent" a pill (basically a small dose viagra) that helps this disorder. They patent the "new" drug for another 10 years.

Companies only exist to make money, I get that, but this is beyond dirty.


By Spivonious on 7/29/2010 4:28:26 PM , Rating: 3
Perhaps if the U.S. copyright system made sense, this sort of corporate behavior wouldn't be encouraged.


RE: market extension is a bit sad
By PCR on 7/29/2010 1:48:35 PM , Rating: 2
Yes I think you are right, drug companies employ these tactics all the time. However, Viagra was initially being developed to treat pulmonary hypertension. During Phase I clinical trials it was discovered that Sildenafil (Viagra) could induce penile erections. In the end Pfizer decided to market it as an erectile dysfunction drug, it was a purely financial decision as not that many people suffer from pulmonary hypertension.

Viagra could very well treat pulmonary hypertension since it targets cGMP-specific phosphodiesterase type 5 enzyme (PDE5), this enzyme is mostly found in the arterial walls of the lungs. So theoretically it could induce vasodilation in the lungs.


RE: market extension is a bit sad
By Smilin on 7/29/2010 2:23:37 PM , Rating: 2
quote:
Pfizer is just doing whatever it can to extend how long it can keep Viagra on the market without competition.

It already has competition. But sure that's a reasonable thing for a company to do anyway.
quote:

1. find any condition
2. see if drug has any effect whatsoever on the condition
3. get a longer extension on a drug that isn't even that beneficial and has obvious side effects.

Am I missing anything?


Yes. #3 is all wrong.

You're talking about demonstrable benefits and the side effects are not out of line.

#1 and #2 are completely normal practice for drug companies and if they didn't do this it would be a shame.

Keep in mind that the on-label use of this drug is itself a side effect of it's behavior. The effects on the cardiopulmonary system are significant and relatively safe. The on-label use is one way to leverage the effects but there are surely others.

Why ignore a functional medical tool just because it's associated with making tools functional eh?

Would you suggest we deliberately ignore a potentially treatable medical condition just because people are uptight about sexuality? Grow up.


By Unspoken Thought on 7/30/2010 3:50:54 PM , Rating: 2
The first 2 would be great if it weren't for the fact that Big Pharma goes for the quickest fix and most amount of money. They disregard any potential drug if they don't have a patent on it. Drugs get passed in such a rushed manner by "organizations" such as the FDA who end up being run by lobbyist. All the above is "normal" practice. We've had recalls on drugs just because they appear to do something without even knowing how it works. SSRIs are a perfect example. We're the mice, only difference is we hand them cash and receive anal leakage in return. Thank you, come again. No pun intended.

I find humorous that inside the box for all of these prescription medications is a huge fold out with 50% chemical data and 50% side effects. I ask the individual if they even read it or just continue drinking the kool-aid.

quote:
Would you suggest we deliberately ignore a potentially treatable medical condition just because people are uptight about sexuality? Grow up.


You would be pretty good at writing fiction.


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