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Pfizer Gets Approval For Lipitor For Kids
AP ^ | 7/6/10 | LINDA A. JOHNSON

Posted on 07/09/2010 8:37:27 AM PDT by MissTed

The European Union has approved a new chewable form of cholesterol blockbuster Lipitor for children 10 and up with high levels of bad cholesterol and triglycerides, a type of blood fat, Pfizer said Tuesday.

The approval includes children whose high blood fats are due to an inherited disease that causes extremely high cholesterol levels, familial hypercholesterolemia.

New York-based Pfizer Inc. won U.S. approval for Lipitor use in children 10 to 17 with that condition in 2002.

Lipitor is the world's top-selling drug, with 2009 sales of about $13 billion, but its U.S. patent expires at the end of November 2011. Pfizer, the world's biggest drugmaker, will quickly lose most Lipitor revenue once generic competition hits, so the company has been trying to boost sales where possible before then.

Pfizer said last fall that it plans to apply for a six-month extension of its patent in European countries, after doing studies of Lipitor in youngsters.

As in the United States, the European Union allows drug makers to seek an additional six months of patent protection for medications if they test them in children, who generally are excluded from the drug studies performed to win approval for a new medication.

Pfizer already won such an extension for its crucial U.S. patent on Lipitor.

For blockbuster drugs, those extensions can easily bring hundreds of millions of dollars in additional revenue. Normally, they are for drugs that are widely used by different age groups.

Until recently, cholesterol drugs have been primarily taken by adults with heart disease, but their use has expanded to younger patients as more obese, sedentary teenagers and adolescents develop heart disease and diabetes.

Lipitor is approved to lower risk of heart attack and stroke, but can cause dangerous muscle pain or weakness, and it cannot be taken by patients with liver problems or by nursing or pregnant women.


TOPICS: Health/Medicine
KEYWORDS: bigpharma; cholesterol; niacin
Sad that kids need a cholesterol drug. How about getting some exercise instead??
1 posted on 07/09/2010 8:37:31 AM PDT by MissTed
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To: MissTed
Why in God's name are there 10 year olds need cholesterol drugs? In this case this is clearly a medication looking for a problem.

Next there'll be Cialis for 10 year olds...and those two bathtubs will each be equipped with a rubber ducky.

2 posted on 07/09/2010 8:41:23 AM PDT by Gay State Conservative (''I don't regret setting bombs,I feel we didn't do enough.'' ->Bill Ayers,Hussein's mentor,9/11/01)
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To: MissTed

Statin drugs are bad for everyone. Cholesterol is not the problem. It’s inflammation due to certain foods. People are being fooled by the drug lobby. There hasn’t been a cure for a major disease since polio. Too much money in drugs that treat symptoms. No money in drugs that cure.


3 posted on 07/09/2010 8:41:56 AM PDT by albie
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To: MissTed
Heard recently.....Millions of people have died and will die and their numbers are within the good to excellent range.

This is just another "pill for life" gig.

4 posted on 07/09/2010 8:42:43 AM PDT by Sacajaweau (What)
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To: MissTed
What is high cholesterol anyway?
It used to be 220 was good, then 200, then 180, then 160.........
Kids come on, most levels can be controlled with diet and exercises......if we really knew what good levels are.
5 posted on 07/09/2010 8:44:46 AM PDT by svcw (True freedom cannot be granted by any man or government, only by Christ.)
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To: Gay State Conservative
Next there'll be Cialis for 10 year olds...

Well they ARE pushing condoms in school even for the primary grades now.

6 posted on 07/09/2010 8:46:48 AM PDT by a fool in paradise (I wish our president loved the US military as much as he loves Paul McCartney.)
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To: albie

And polio is coming back to America thanks to illegal immigration ending our policy of screening those coming in at the borders.


7 posted on 07/09/2010 8:48:13 AM PDT by a fool in paradise (I wish our president loved the US military as much as he loves Paul McCartney.)
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To: albie

Although i would probably disagree with the polio comment...smallpox was eradicated after polio, you do get to the point. The issue is that you can’t “cure” a disease when the patient won’t stop exposing themselves to the cause. An umbrella isn’t a cure for rain, it just protects you. Only way to keep dry is to stay out of the rain.


8 posted on 07/09/2010 8:52:41 AM PDT by The_Sword_of_Groo (Counting the days until the US gets to apologize for Obama)
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To: MissTed

This is nuts. I am not going to phramaceutical bash but these kids need to work on their diet and exercise. They can burn fat very fast if they are not eating garbage.

Liptor is not very good on the liver.


9 posted on 07/09/2010 8:54:01 AM PDT by Frantzie (Democrats = Party of I*lam)
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To: a fool in paradise

TB is also coming back from Africa and Haiti - illegals.


10 posted on 07/09/2010 8:55:25 AM PDT by Frantzie (Democrats = Party of I*lam)
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To: albie
There hasn’t been a cure for a major disease since polio.

$10 worth of anti-biotics does a wonderful number on Lyme Disease IF you catch it early.
11 posted on 07/09/2010 8:55:25 AM PDT by Dr. Sivana (There is no salvation in politics)
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To: MissTed

There is no correlation between serum cholesterol and heart disease
there is one between low cholesterol and a host of other maladies


12 posted on 07/09/2010 8:58:40 AM PDT by kingcoal
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To: MissTed

I’m usually pro-big companies...However it seems like drug companies push drugs on younger and younger children....Parents need to take the doctors advice but use some common sense. For instance I have read that the ADHD drug Adderall can be prescribed to kids as young as 5.... GEEZ 5 year olds that have trouble paying attention and are hyper..Who would guess???


13 posted on 07/09/2010 9:03:15 AM PDT by jakerobins
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To: MissTed

The reality here is that this gains an extension on patent exclusivity for this new “indication” The use of these drugs in children is very risky, in that cholesterol is important for the body to make sex hormones and other hormones which use cholesterol as a building block. There are some very sad genetic disease cases of juveniles that have coronary disease already at age 12, say. This would slow the progression of that kind. The viciousness of the genetic disease would override the possibility of interaction with the developing child’s hormone creation in the risk/benefit calculation. Technically this is a very small number of patients/children. But Pfizer will push this to “fat” kids or the type II diabetics that are expressing diabetes in high school when they might normally develop diabetes (typeII) in their thirties. You are right, kids need exercise but gaming, modems, and in fact the school system eliminated organized exercise in school some time ago. Get your kids into an outside active exercise of some kind, and keep them away from fast food- no doubt about any of this in the juvenile obesity/diabetes epidemic- and no, I’m not the food police.


14 posted on 07/09/2010 9:04:44 AM PDT by John S Mosby (Sic Semper Tyrannis)
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To: Frantzie

Before kids are going to have a decent diet and exercise parents are going to have to be parents, teaching and guiding. Course when the parents don’t eat in a healthy style, the kids are not going to either.

Schools that drop recess also drop an opportunity for kids to get some activity in their day.

I met a 5 year old the other day that is just Miss Tubby. When it was time to eat she refused milk, juice, and water, demanded and got soda that Mom brought along, and had put in the frige. And yes mom is overweight, and the two aunts that were there are morbidly obese.


15 posted on 07/09/2010 9:07:43 AM PDT by handmade
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To: Frantzie

Malaria in Florida too.


16 posted on 07/09/2010 9:10:15 AM PDT by a fool in paradise (I wish our president loved the US military as much as he loves Paul McCartney.)
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To: John S Mosby
The use of these drugs in children is very risky, in that cholesterol is important for the body to make sex hormones and other hormones which use cholesterol as a building block.

That's okay, they want to give girls birth control pills from day one of puberty. They have fertility drugs they can sell them in another 15 years of life.

17 posted on 07/09/2010 9:11:42 AM PDT by a fool in paradise (I wish our president loved the US military as much as he loves Paul McCartney.)
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To: Gay State Conservative
In this case this is clearly a medication looking for a problem.

I disagree. People who suffer from familial hypercholesterolemia have high levels of LDL cholesterol because their liver cannot remove the LDL from the blood stream properly. Men suffering from this problem regularly have heart attacks in their 40's. However, this drug may be aimed at a much smaller group who are homozygous (they inherited the mutated gene causing hypercholesterolemia from both parents) and, therefore, have a much more severe form of hypercholesterolemia. These individuals will typically suffer heart attacks well before they turn 30.

The article doesn't make clear who this drug is approved for or under what circumstances MD's will be prescribing it to children. It is clear that this article has brought out those who think the drug companies exist to prolong disease instead of curing it (which is stupidity on parade) and those who refuse to grasp the fact that a high level of LDL cholesterol is absolutely correlated to CHD.

The vast majority of people suffering from high levels of serum cholesterol will not be able to significantly reduce or manage it through diet and exercise. The liver will continue producing it anyway. Statins are popular because they save lives. Of course, all medicines come with risks along with the benefits. Ain't no way around that fact.

18 posted on 07/09/2010 9:51:45 AM PDT by Mase (Save me from the people who would save me from myself!)
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To: Gay State Conservative; MissTed
Thirty years ago I had friends whose 5 YO son started having "problems." After having a battery of tests run at Texas Children's in Houston, he was diagnosed as having "High cholesterol."

This was a skinny, very active kid. I don't have a clue as to what medications he was given but he was put on a very strict diet.

I saw him about 2 years ago with his wife and child...and don't have a clue if he still has the problem or not...but he's still thin.

My point is...it had nothing to do with lack of exercise or being over-weight.

19 posted on 07/09/2010 10:31:01 AM PDT by lonestar (Barry is furious the big spill wasn't caused by EXXON...would have nationalized it by now.)
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To: MissTed

This is insane. And of course they don’t tell anyone about the possible co-Q-10 deficiencies that can cause its own heart problems.

It’s crazy to see stuff like this. I have a product that by using a specific blend of soluble fiber, it “gloms onto” cholesterol, where it is naturally eliminated through the bowels. And it’s got 8 clinical studies on it (on the product itself) to back it up.

Putting kids on statin drugs, when there are super-effective natural alternatives without side effects, is irresponsible.


20 posted on 07/09/2010 10:49:19 AM PDT by Suz in AZ
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To: handmade

The parents have no clue that if you put garbage (sugar & other c*ap) into your body then it is bad for you. You see them at the grocery store with food stamp credit cards but the worst sugary junk food.

Morbidly obese is becoming a more common pharse in the vocabulary. I have cut down going out to eat to save a few buck but also to avoid seeing fat people at the trough. I totally avoid fat food places but I would go to Chick Filet sometimes. I notice too many fatties there so I stopped.

Other places like Cracker Barrel attract them plus fast food. The worst is those - all you can eat Chinese buffetts. Total garbage food loaded with all sorts of fillers and they are filled with illegal alien chinese employees. I went to one - once and it was horrible. They attract people who want to eat like pigs.


21 posted on 07/09/2010 10:49:58 AM PDT by Frantzie (Democrats = Party of I*lam)
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To: Frantzie

You are right on- the parents don’t know/care. Part of that comes from decades of kids raising themselves.

Mostly I have cut way back on eating out simply to have more control over what is in what I eat. You can not trust what menus say. I don’t think I am radical, but that mental image of my arteries reacting to the trans fats etc goes a long way to influence my eating habits.

Plus I was raised with a huge garden and all that offered stright out of that garden.


22 posted on 07/09/2010 3:36:23 PM PDT by handmade
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