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.
Next there'll be Cialis for 10 year olds...and those two bathtubs will each be equipped with a rubber ducky.
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.
This is just another "pill for life" gig.
Well they ARE pushing condoms in school even for the primary grades now.
And polio is coming back to America thanks to illegal immigration ending our policy of screening those coming in at the borders.
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.
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.
TB is also coming back from Africa and Haiti - illegals.
There is no correlation between serum cholesterol and heart disease
there is one between low cholesterol and a host of other maladies
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???
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.
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.
Malaria in Florida too.
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.
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.
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.
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.
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