FDA Reviews of New Cholesterol lowering drugs
Since this is the Wall Street Journal, no surprise that this story is positively gleeful about new drugs in the pipeline and that a month's supply will cost $1000! and be a $10 Billion blockbuster! What is notable that already 39 comments, many pointing to the side effects of statins and the futility of lowering LDL to actually Reduce CVD.
http://www.wsj.com/articles/fda-que...rugs-1433583182 Quote:
[Really? Now doctors and drug companies admit this??] :) Quote:
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It is just an outrage.
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Nancy LC, I couldn't agree with you more!
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Found that Dr. Malcolm Kendrick article...it was back at the end of 2013. This "experimental drug" is not exactly speeding through the review process:
http://drmalcolmkendrick.org/2013/1...atins-part-two/ |
http://www.amgen.com/media/media_pr...leaseID=1913411
Shows lower ldl-c but no mention of ldl-p number or types. Side effect neurocognitive not related to ldl reduction? Makes me wonder if the brain and neurological system needs the ldl? |
All over the evening news of its approval yesterday, in restricted cases. That's really jumping the queue! Many concerns expressed, but not to worry, just a touch of memory impairment. :-(
http://www.wsj.com/articles/fda-pan...erns-1433884972 Quote:
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Kind of says it all. "billions of $$$" and perhaps . . . maybe it will alter the treatment of. But does "alter the treatment of" have anything to do with improved outcomes? |
That is what is so appalling...how can they approve this when the results of lowering LDL on cardiac events isn't even known? Until 2017 or 2018.
Answer, most of the FDA budget is funded by private industry. Dr Mercola may be somewhat extreme on some issues, but US citizens should realize in early 1990s we allowed the fox to guard the FDA henhouse. http://articles.mercola.com/sites/a...t-increase.aspx And all drug companies need to do, to have a drug approved before efficacy is known, is to pay a substantial user fee plus in this case, an extra jump the line fee. |
Gilbert Welch, in his new book "Less Medicine, More Health" says that unless a new drug "is truly one of those rare breakthroughs" one should avoid new drugs. He says "I don't want a new drug; I want an old drug. Not one that is outdated, mind you, but one that has been road tested - one that's been around for a while."
And then there's Malcolm Kendricks who says to never treat a number. This new drug is clearly best avoided, especially since, as Janet pointed out, it's ability to decrease cardiac event is still unknown. Jean |
I just got his new book from a library download. Here are the seven assumptions. Newer is not Not always better certainly applies with this drug!
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NHS wasting tens of thousands a year on ‘wonder’ drug for stroke and heart attacks which does not work, experts claim
http://www.telegraph.co.uk/news/201...-heart-attacks/ Quote:
Huh? what would a NICE comment on a drug have to do with the general election? It would save the NHS money..isn't that a good thing for either party? |
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