Lipitor For Kids

      72 Comments on Lipitor For Kids

This is so upsetting, I’m not even going to attempt to make wisecracks about it.  Pfizer has received approval in Europe to sell chewable Lipitor tablets to kids older than 10.  I’ve pasted the AP article below.

I generally think of personal-injury lawyers as the blood-sucking scum of the earth, but when the kids who take this liver poison end up with permanent muscle damage 15 years from now, I will cheer if Pfizer is successfully sued for billions of dollars.  Let the greedy scum punish the greedy scum.

Pfizer gets EU approval for kids’ cholesterol drug

TRENTON, N.J. — 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.


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72 thoughts on “Lipitor For Kids

  1. Sean

    I know you try to run a PG-13 blog, but all I can think to say is, ‘fuck me’.

    I’m only PG-13 in public, by choice. Believe me, I share both your sentiment and your expression of it.

  2. Stephanie

    This is disheartening on so many levels – mainly because children have no business taking statins. In the mean time, there are over 2 million children in the world living with HIV/AIDS of which only 10% receive any treatment. This is mainly because no pharmaceutical company has bothered to create an appropriate pediatric formulation that is effective, affordable, and accessible. I guess there’s no financial incentive for that.

    Anyone who thinks the FDA and its counterparts around the world are our great protectors should be seriously re-thinking that opinion right about now.

  3. Jo

    Another thalidomide-style scandal in the making. I’m shocked.

    I don’t know if I’m shocked, but I’m sure outraged.

  4. Richard Tamesis, M.D.

    It just goes to show that the EU government is just as stupid as their American counterparts. They claim to have more stringent rules to protect their citizens from the excesses of multinational corporations and financial institutions but this, the Greek meltdown and the banking fiasco in Iceland prove that they can be just as incompetent and uninformed about many things.

    Governments around the globe are stupid. It’s the nature of the beast.

  5. Sean

    I know you try to run a PG-13 blog, but all I can think to say is, ‘fuck me’.

    I’m only PG-13 in public, by choice. Believe me, I share both your sentiment and your expression of it.

  6. Cathryn

    “1997. FDA Modernization Act gives pharmaceutical companies a huge financial incentive—a 6 month patent exclusivity extension—if they conduct drug tests on children. The incentive can yield $900 million.”

    The above statement comes from my PowerPoint presentation on research ethics that I give to my graduate statistics students every semester. I’ve been doing this presentation for nearly 4 years now, and this article is just another example of Big Pharma getting their hooks into government for the cash cow.

    I’m predicting we will have kids suffering from heart attacks. This isn’t from any statistical prediction–just an eminent gut feeling. I remember how intense the chest pain I suffered–only to be told I was on “really good drugs” and that the “drugs can’t possibly be causing your chest pains.” Through the course of all their testing, I wasn’t having a heart attack. Amazingly enough, as soon as I got off the statin drugs, my chest pains started disappearing. Imagine that.

    And you recently posted how statin drugs don’t cross the gender-divide. Well…we’ll see more girls complaining of chest pains and other muscle pains but the so-called expert doctors will not believe it’s the medication causing them.

    It will be the same damn stupidity that got state governors to mandate the use of Gardasil–the drug that was tested on over 25,000 participants but less than 2000 were pre-teen girls. The same age group that are experiencing horrendous side effects from the vaccine and now want to include boys in the mandated vaccination program.

    The vaccine is effective against HPV types 16 and 18 and against HPV types 6 and 11. There are more than 100 HPV types and 30-40 can be sexually transmitted, with 15 HPV types associated with cervical cancer. The majority of women clear the HPV virus from their bodies naturally.

    Mandatory vaccination across the U.S. would make Gardasil an automatic blockbuster for Merck at a time when the patents on some of its best-selling drugs are expiring and it’s desperate to replace their revenue streams. Gardasil’s sales in 2006 were $235 million.

    And now we are telling our kids that they can’t make lifestyle choices that are healthier for them. We’re telling them that they have this horrid condition, need lifetime medication, and the purpose is to make Pharma rich.

    BTW–Pfizer Inc was sued by either Nigeria or Kenya for killing their children through their unethical research. If I’m not mistaken, Pfizer was also the company that used HIV-infected foster kids to test ADULT AIDS medication in New York state.

    Sorry this is long, but you got me boiling with anger with your post today. Not at you, obviously–but at Big Pharma.

    No apology necessary. I’m boiling as well.

  7. Stephanie

    This is disheartening on so many levels – mainly because children have no business taking statins. In the mean time, there are over 2 million children in the world living with HIV/AIDS of which only 10% receive any treatment. This is mainly because no pharmaceutical company has bothered to create an appropriate pediatric formulation that is effective, affordable, and accessible. I guess there’s no financial incentive for that.

    Anyone who thinks the FDA and its counterparts around the world are our great protectors should be seriously re-thinking that opinion right about now.

  8. Matt Stone

    I never thought I would ever be caught dead taking a statin, but if they come in blue raspberry, I don’t know if I can resist!

    High birth weight is also a risk factor for heart disease, obesity, and type 2 diabetes. Pretty soon women will all be given C-sections to get those kids out sooner and at a lower weight…. What’s that? That already happened? Crap.

    From 7% to 31% of births, in just a matter of years.

  9. Phyllis Mueller

    I can’t tell from reading this press release whether approval was limited to children/teens with hypercholesterolemia either here or in the EU. I tend to think the approval is not limited, since (if I’m remembering what I read about this previously) the number of people who have actual hypercholesterolemia is not big.

    Very troubling news.

    Even the risk from hypercholesterolemia is exaggerated, as Dr. Ravnskov details in his book.

  10. monasmee

    Constitutional attorney Jonathan Emord, who has defeated the FDA seven times in federal court, discusses how the government is complicit with the drug industry in exploiting the public in his new book “Global Censorship of Heath Information.”

    I’ll have to find that one.

  11. Jo

    Another thalidomide-style scandal in the making. I’m shocked.

    I don’t know if I’m shocked, but I’m sure outraged.

  12. Graybull

    No Personal Injury lawyers needed……just Prosecuting Attorneys. All involved should be prosecuted for felony chid abuse.

    Agreed.

  13. Richard Tamesis, M.D.

    It just goes to show that the EU government is just as stupid as their American counterparts. They claim to have more stringent rules to protect their citizens from the excesses of multinational corporations and financial institutions but this, the Greek meltdown and the banking fiasco in Iceland prove that they can be just as incompetent and uninformed about many things.

    Governments around the globe are stupid. It’s the nature of the beast.

  14. Cathryn

    “1997. FDA Modernization Act gives pharmaceutical companies a huge financial incentive—a 6 month patent exclusivity extension—if they conduct drug tests on children. The incentive can yield $900 million.”

    The above statement comes from my PowerPoint presentation on research ethics that I give to my graduate statistics students every semester. I’ve been doing this presentation for nearly 4 years now, and this article is just another example of Big Pharma getting their hooks into government for the cash cow.

    I’m predicting we will have kids suffering from heart attacks. This isn’t from any statistical prediction–just an eminent gut feeling. I remember how intense the chest pain I suffered–only to be told I was on “really good drugs” and that the “drugs can’t possibly be causing your chest pains.” Through the course of all their testing, I wasn’t having a heart attack. Amazingly enough, as soon as I got off the statin drugs, my chest pains started disappearing. Imagine that.

    And you recently posted how statin drugs don’t cross the gender-divide. Well…we’ll see more girls complaining of chest pains and other muscle pains but the so-called expert doctors will not believe it’s the medication causing them.

    It will be the same damn stupidity that got state governors to mandate the use of Gardasil–the drug that was tested on over 25,000 participants but less than 2000 were pre-teen girls. The same age group that are experiencing horrendous side effects from the vaccine and now want to include boys in the mandated vaccination program.

    The vaccine is effective against HPV types 16 and 18 and against HPV types 6 and 11. There are more than 100 HPV types and 30-40 can be sexually transmitted, with 15 HPV types associated with cervical cancer. The majority of women clear the HPV virus from their bodies naturally.

    Mandatory vaccination across the U.S. would make Gardasil an automatic blockbuster for Merck at a time when the patents on some of its best-selling drugs are expiring and it’s desperate to replace their revenue streams. Gardasil’s sales in 2006 were $235 million.

    And now we are telling our kids that they can’t make lifestyle choices that are healthier for them. We’re telling them that they have this horrid condition, need lifetime medication, and the purpose is to make Pharma rich.

    BTW–Pfizer Inc was sued by either Nigeria or Kenya for killing their children through their unethical research. If I’m not mistaken, Pfizer was also the company that used HIV-infected foster kids to test ADULT AIDS medication in New York state.

    Sorry this is long, but you got me boiling with anger with your post today. Not at you, obviously–but at Big Pharma.

    No apology necessary. I’m boiling as well.

  15. Matt Stone

    I never thought I would ever be caught dead taking a statin, but if they come in blue raspberry, I don’t know if I can resist!

    High birth weight is also a risk factor for heart disease, obesity, and type 2 diabetes. Pretty soon women will all be given C-sections to get those kids out sooner and at a lower weight…. What’s that? That already happened? Crap.

    From 7% to 31% of births, in just a matter of years.

  16. Phyllis Mueller

    I can’t tell from reading this press release whether approval was limited to children/teens with hypercholesterolemia either here or in the EU. I tend to think the approval is not limited, since (if I’m remembering what I read about this previously) the number of people who have actual hypercholesterolemia is not big.

    Very troubling news.

    Even the risk from hypercholesterolemia is exaggerated, as Dr. Ravnskov details in his book.

  17. monasmee

    Constitutional attorney Jonathan Emord, who has defeated the FDA seven times in federal court, discusses how the government is complicit with the drug industry in exploiting the public in his new book “Global Censorship of Heath Information.”

    I’ll have to find that one.

  18. Graybull

    No Personal Injury lawyers needed……just Prosecuting Attorneys. All involved should be prosecuted for felony chid abuse.

    Agreed.

  19. Alexia

    Because handing them meds instead of changing their diets is a genius idea.

    Yup, that’s how to bring down those triglycerides … with drugs.

  20. mezzo

    Follow the money, as usual. This is so depressing. And mind you: I never for a moment thought that our European governments (in Brussels and nationally) are one bit smarter than the American one. Their stupidity may bear a European mark but it is stupidity all the same. Germany can’t even manage to put a cap on the price of drugs, so German health insurance companies pay up to ten times more for drugs than their counterparts in Austria. And our health costs are exploding anyway. Obviously we all underestimated the power of Big Pharma. I am not usually somebody who believes in conspiracies, but this sounds almost like one. Treat children with statins, make them lose their ability to think and turn them into beings that not only require lifelong medication but will have lost the powers to raise critical questions and think for themselves. Brave New World. I can hear Aldous Huxley rotating in his grave.

    Governments all around the world are stupid and corrupt. The American government appeared smarter than most others at one time, but only because judges back then took the Constitution’s limits on government seriously, which in turn limited the capacity for the stupidity and corruption.

    Tired of being constrained by the Constitution, presidents began appointing judges who believed in a “living, breathing Constitution,” which is a bull@#$% theory they concocted so they can “interpret” it to mean whatever the hell they want it to mean … which means, essentially, we have no actual Constitutional limits on government anymore. The only thing keeping goverment in check now is the potential anger of the voters.

  21. Alexia

    Because handing them meds instead of changing their diets is a genius idea.

    Yup, that’s how to bring down those triglycerides … with drugs.

  22. Hans Keer

    One assuring thought is that eventually the shore will turn also this ship. In not so many years from now we will have the next ice age, ice will cover Europe’s Eiffel Tower and the human population and with it the power of big pharma will luckily be forced back.

  23. Bryan Rankin

    “I hate to imagine where these kids are gonna be in fifty years :(”

    I imagine that they will be dead before then.

  24. mezzo

    Follow the money, as usual. This is so depressing. And mind you: I never for a moment thought that our European governments (in Brussels and nationally) are one bit smarter than the American one. Their stupidity may bear a European mark but it is stupidity all the same. Germany can’t even manage to put a cap on the price of drugs, so German health insurance companies pay up to ten times more for drugs than their counterparts in Austria. And our health costs are exploding anyway. Obviously we all underestimated the power of Big Pharma. I am not usually somebody who believes in conspiracies, but this sounds almost like one. Treat children with statins, make them lose their ability to think and turn them into beings that not only require lifelong medication but will have lost the powers to raise critical questions and think for themselves. Brave New World. I can hear Aldous Huxley rotating in his grave.

    Governments all around the world are stupid and corrupt. The American government appeared smarter than most others at one time, but only because judges back then took the Constitution’s limits on government seriously, which in turn limited the capacity for the stupidity and corruption.

    Tired of being constrained by the Constitution, presidents began appointing judges who believed in a “living, breathing Constitution,” which is a bull@#$% theory they concocted so they can “interpret” it to mean whatever the hell they want it to mean … which means, essentially, we have no actual Constitutional limits on government anymore. The only thing keeping goverment in check now is the potential anger of the voters.

  25. Bruce

    Now, who wants to invest in my chewable to help block the muscle pain from the Lipitor?
    The only side effect of this is toe fungus. BUT, I’m already working on a liquid that will take care of the toe fungus. The only side effect of that is…etc. etc. etc. (Yul Brenner, King and I)

    Now you’re thinking like a Pfizer executive.

  26. Hans Keer

    One assuring thought is that eventually the shore will turn also this ship. In not so many years from now we will have the next ice age, ice will cover Europe’s Eiffel Tower and the human population and with it the power of big pharma will luckily be forced back.

  27. Jan

    There was a segment on Good Morning America just today about having children tested for cholesterol and the possibility of doctors prescribing statins for them. I was in the kitchen, listening and commenting acidly on the whole mess when my husband walked in and asked me what was wrong.

    “They want to give statins to kids now,” I told him.

    “Not MY kids,” he responded.

    Amen to that – my oldest stepdaughter suffers from horrible IBS after being prescribed Accutane as a teenager (her mother’s doing). When is the medical community going to pull their heads out of their collective behinds?

    Probably not until they stop finding money in their behinds.

  28. Beatlr

    Tom,

    I will never take a statin myself, but this article seems to be for hypercholesterolemia only. Wasn’t this one of the exceptions to take a Statin? (thought I read that in The Great Cholesterol Con and some other articles)

    I think I know the answer to this already, as Statins merely treat the test results, and don’t necessarily weed out the smaller LDL particles.

    Thought I’d ask.

    The article says it’s approved for kids, including those with hypercholesterolemia; it doesn’t say whether chewable Lipitor is limited to them. What kids with hypercholesterolemia and high trigycerides need is to eliminate grains and sugars from their diets. Even among those with very high cholesterol, the risk of heart disease is much higher as a comparison, but not especially high in real terms. For example, in the MRFIT study:

    Lowest cholesterol group: 0.3% died of a heart attack
    Highest cholesterol group: 1.3% died of a heart attack

    By comparing those numbers to each other, the MRFIT researchers were able to say that high cholesterol quadruples your chances of dying from heart disease. But the proper way to look at the numbers is this:

    Lowest cholesterol group: 99.7% did not die of a heart attack
    Highest cholesterol group: 98.7% did not die of a heart attack

    Keep in mind we’re comparing people with cholesterol below 160 to people with cholesterol above 300 — often WAY above 300. Now add in the fact that statins show no benefit for females, and no benefit for overall mortality rates in several trials. For this, we’re going to give kids a drug that produces nasty side effects in perhaps 30% of the people taking them?

  29. Josh Goguen

    At least your comment section helps to give hope.

    Based on rather ho-hum coverage in the media, I’m afraid those of us who are outraged are quite a little minority.

  30. Paul451

    Arent we coming close to the end of the patent on Lipitor? That explains the push for it into markets where it doesnt belong. I’m expecting Pfizer to make a deal with Coca-Cola any day now. Say hello to Lipi-Coke!

    Or Pepsi-tor … the choice of a new generation.

  31. Bryan Rankin

    “I hate to imagine where these kids are gonna be in fifty years :(”

    I imagine that they will be dead before then.

  32. Bullinachinashop

    Europeans have such mixed-up priorities; They’ll give this medicine to kids, but they’ll ban GE vegetables. No wonder the EU is in so much trouble!

  33. Bruce

    Now, who wants to invest in my chewable to help block the muscle pain from the Lipitor?
    The only side effect of this is toe fungus. BUT, I’m already working on a liquid that will take care of the toe fungus. The only side effect of that is…etc. etc. etc. (Yul Brenner, King and I)

    Now you’re thinking like a Pfizer executive.

  34. D.

    Lipi-Coke and Pepsi-tor? More likely Dr. Peppitor, keep it in the medical community.

    The whole idea of giving kids statins disgusts me. The sad thing is that parents will blindly go along with whatever the doctor says, (too many think that the doctor is a god and knows best) and the doctor will be convinced by the drug reps that statins are in the best interest of the kids. And the drug companies are raking in the big bucks.

    I’m afraid that sums it up.

  35. Jan

    There was a segment on Good Morning America just today about having children tested for cholesterol and the possibility of doctors prescribing statins for them. I was in the kitchen, listening and commenting acidly on the whole mess when my husband walked in and asked me what was wrong.

    “They want to give statins to kids now,” I told him.

    “Not MY kids,” he responded.

    Amen to that – my oldest stepdaughter suffers from horrible IBS after being prescribed Accutane as a teenager (her mother’s doing). When is the medical community going to pull their heads out of their collective behinds?

    Probably not until they stop finding money in their behinds.

  36. Elle

    “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.”

    Okay, maybe I’m just a cynical b*** but I wouldn’t put it past them to test on kids just for the patent extension.

    Neither would I. That’s the motivation behind all the combo drugs as well; a combination can produce a new patent.

  37. Beatlr

    Tom,

    I will never take a statin myself, but this article seems to be for hypercholesterolemia only. Wasn’t this one of the exceptions to take a Statin? (thought I read that in The Great Cholesterol Con and some other articles)

    I think I know the answer to this already, as Statins merely treat the test results, and don’t necessarily weed out the smaller LDL particles.

    Thought I’d ask.

    The article says it’s approved for kids, including those with hypercholesterolemia; it doesn’t say whether chewable Lipitor is limited to them. What kids with hypercholesterolemia and high trigycerides need is to eliminate grains and sugars from their diets. Even among those with very high cholesterol, the risk of heart disease is much higher as a comparison, but not especially high in real terms. For example, in the MRFIT study:

    Lowest cholesterol group: 0.3% died of a heart attack
    Highest cholesterol group: 1.3% died of a heart attack

    By comparing those numbers to each other, the MRFIT researchers were able to say that high cholesterol quadruples your chances of dying from heart disease. But the proper way to look at the numbers is this:

    Lowest cholesterol group: 99.7% did not die of a heart attack
    Highest cholesterol group: 98.7% did not die of a heart attack

    Keep in mind we’re comparing people with cholesterol below 160 to people with cholesterol above 300 — often WAY above 300. Now add in the fact that statins show no benefit for females, and no benefit for overall mortality rates in several trials. For this, we’re going to give kids a drug that produces nasty side effects in perhaps 30% of the people taking them?

  38. Josh Goguen

    At least your comment section helps to give hope.

    Based on rather ho-hum coverage in the media, I’m afraid those of us who are outraged are quite a little minority.

  39. Andrew

    You’d get more coverage if you started your own cult.

    I don’t have the right mix of traits. Cult leaders use charisma to sell illogical nonsense. I’m logical and nearly devoid of charisma.

  40. Paul451

    Arent we coming close to the end of the patent on Lipitor? That explains the push for it into markets where it doesnt belong. I’m expecting Pfizer to make a deal with Coca-Cola any day now. Say hello to Lipi-Coke!

    Or Pepsi-tor … the choice of a new generation.

  41. Bullinachinashop

    Europeans have such mixed-up priorities; They’ll give this medicine to kids, but they’ll ban GE vegetables. No wonder the EU is in so much trouble!

  42. Jamie

    As Jan mentioned above, looks like the idea of testing all kids in the U.S. is making the rounds: http://www.msnbc.msn.com/id/38203670/ns/health/ Apparently even when prescribing statins to kids with first-degree relatives who have high cholesterol, they are still missing a potential group of kids who also would test with high cholesterol. When will the madness end?! I think they even suggest that this tactic will save money in the long-run due to reduced incidences of heart disease?

    Good lord. Anyone who tries to give one of my daughters a statin had better be armed.

  43. D.

    Lipi-Coke and Pepsi-tor? More likely Dr. Peppitor, keep it in the medical community.

    The whole idea of giving kids statins disgusts me. The sad thing is that parents will blindly go along with whatever the doctor says, (too many think that the doctor is a god and knows best) and the doctor will be convinced by the drug reps that statins are in the best interest of the kids. And the drug companies are raking in the big bucks.

    I’m afraid that sums it up.

  44. Dan

    “For blockbuster drugs, those extensions can easily bring hundreds of millions of dollars in additional revenue.”

    Anything to make a buck. That crap is bad enough for adults and who knows what it will do to children. There is no scientific evidence on high cholesterol in children and later heart disease, but when did that ever stop the medical-pharmaceutical establishment????

    What’s worse, it could come to the point where parents are charged with child neglect for refusing to give them statins, when giving them statins is the real child abuse.

    I may have to join one of those no-doctors religions so I can legally refuse medical advice for my kids.

  45. Leta

    Oh, fuck me running. Sorry for going R rated here but my God.

    It is shit like this that makes me defend trial lawyers, despite the slippery slope that puts me on.

    (For the record, as a Michigander, the only time I voted Republican for governor was when the Democrats ran Jeffery Feiger, the most bizzaro, Sideshow Bob-ian trial lawyer of them all.)

    I am not a litigious person, but in this case, the sooner somebody sues, the better.

    Just saw Feiger on the Stossel show this week. He explained that he’s actually a warrior, fighting for the people. Of course, most warriors don’t make tens of millions of dollars in the course of their campaigns.

  46. Kate

    Last I heard, there were no good numbers on what “normal” cholesterol for kids is. Oh wait, Pfizer says it’s exactly the same for adults, so it MUST be true.

    Well, clearly the health of the children is their only concern.

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