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Not sure about that, but the more comments the better
obviously Amarin will be promoting Vascepa to lower high triglycerides no matter what the FDA says
Have you tried getting Kelly to do an article on the FDA and Amarin
See ihub post no 22633 re: lobbying firm
That would be good if you could find that out and publicize before December 20th
It's variable. Vascepa lowers mg LDL 10%, which is why I take it, my triglycerides being normal. I won't take statins, too toxic.
The CFRs you are "reading" are actually:
21 CFR section 314.50(a)(1) and 21 CFR section 314.50(d)(1)
Bio, where do you see in this that it has anything more to do with than the nursing mother label change?
very well-written and makes sense except where you say the FDA drastically broke a binding legal agreement with a phony reason and will get away with it.
wow! looks like the government is conceding that as long as they're telling the truth dug reps can promote off-label even if it causes drugs to be paid for by the government. Anchor proved Vascepa lowers high triglycerides and there are plenty of studies to allow reasonable promotion of this as a CV savior. who needs the FDA?
aren't most of the 90% companies without approved drugs or drugs that get pulled for safety issues? we have an approved drug that the label was not expanded for fear of too many scripts and increased Obamacare costs. with the new first amendment allowance of off label promotion things will get better, eventually.
I didn't bother to follow your analysis because you're saying Amarin and the FDA negotiated some deal and that can't be because Amarin claimed to be totally shocked by the Adcomm.
Yeah you're right the FDA Guidance does say to contact the review division of CBER or CDER prior to requesting a Type A meeting
sounds good
the story I got is that Amarin tried to skip up to a higher level of the FDA, not that they incorrectly filed papers.
I don't see why you keep discounting the importance of the agreement that was made between Amarin and the FDA. Also, at the CC Amarin said they had proof the science was known to the FDA prior to the agreement, i.e., nothing is new.
thanks, if you could find such a detailed analysis that described the FDA's legal requirements to break a SPA and courts' history it would be great, but since this has never happened or extremely rarely, it will be written after this thing is over.
i'm unable to download that, says firewall problem, can someone send it to my email: wmjenkins3938@aol.com
thanks
yes we need someone that would do well on tv contact the show and try to get on
i don't see problem with Amarin, its argumet based mostly on SPA and partly on FDA irregularities
Dr. Oz is a practicing physician professor at Columbia University, he is not affiliated financially with pharmaceutical companies.
I couldn't click on that, said firewall problem
Dr Oz promoting omega 3 for high triglycerides!
Publication: San Francisco Chronicle; Date: Nov 18, 2013; Section: Nation & World; Page: A7
Flawed cholesterol calculator overestimates
risk
NEW YORK TIMES
Last week, the nation’s leading heart organizations released a sweeping new set of guidelines for lowering
cholesterol, along with an online calculator meant to help doctors assess risks and treatment options. But, in a
major embarrassment to the health groups, the calculator appears to greatly overestimate risk, so much so that it
could mistakenly suggest that millions more people are candidates for statin drugs.
The apparent problem prompted one leading cardiologist, a past president of the American College of
Cardiology, to call on Sunday for a halt to the implementation of the new guidelines.
“It’s stunning,” said the cardiologist, Dr. Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic.
“We need a pause to further evaluate this approach before it is implemented on a widespread basis.”
New guidelines
The controversy set off turmoil at the annual meeting of the American Heart Association, which started this
weekend in Dallas. After an emergency session on Saturday night, the two heart organizations that published the
guidelines — the American Heart Association and the American College of Cardiology — said that while the
calculator was not perfect, it was a major step forward, and that patients and doctors should discuss treatment
options rather than blindly following a calculator.
Dr. Sidney Smith, the executive chairman of the guideline committee, said the associations would examine the
flaws found in the calculator and determine whether changes were needed.
“We need to see if the concerns raised are substantive,” he said in a telephone interview on Sunday. “Do there
need to be changes?”
The problems were identified by two Harvard Medical School professors whose findings will be published
Tuesday in a commentary in the Lancet, a major medical journal. The professors, Dr. Paul Ridker and Dr. Nancy
Cook, had pointed out the problems a year earlier when the National Institutes of Health’s National Heart, Lung,
and Blood Institute, which originally was developing the guidelines, sent a draft to each professor independently to
review. Both reported that the calculator was not working among the populations it was tested on by the guideline
makers.
Ridker and Cook saw the final guidelines and risk calculator Tuesday at 4 p.m., when a news embargo was
lifted, and saw that the problems remained.
Other experts said there has not been a real appreciation of the difficulties with this and other risk calculators.
Merits attention
In a response Sunday, Smith of the guidelines committee said the concerns raised by Cook and Ridker “merit
attention.”
But, he continued, “a lot of people put a lot of thought into how can we identify people who can benefit from
therapy.” Further, said Smith, who is also a professor of medicine at the University of North Carolina and a past
president of the American Heart Association, “What we have come forward with represents the best efforts of
people who have been working for five years.”
Asked to comment on the situation on Sunday, some doctors said they worried that, with many people already
leery of statins, the public would lose its trust in guidelines or the heart associations.
“We’re surrounded by a real disaster in terms of credibility,” said Dr. Peter Libby, the chairman of the
department of cardiovascular medicine at Brigham and Women’s Hospital.
What are patients and doctors to do? On Sunday, there seemed to be no firm answers, except that those at the
highest risk, like people who have had a heart attack or have diabetes, should take statins.
Page 1 of 1
http://digital.olivesoftware.com/Olive/ODE/SanFranciscoChronicle/PrintComponentVie... 11/18/2013
That sounds good
Before Obamacare you wouldn't do that or they'd forever label you and pay a fortune for insurance, but now good idea. I love Krispy Kreme
I'm not trying to get any hopes up but the SPA cannot be permanently rescinded unless either Amarin or a court agrees.
Unless Reduce-IT can prove otherwise.
But wasn't mineral oil part of the SPA approved on and agreed upon by the FDA and would become part of any legal wrangling between Amarin and the FDA?
decision has only been made to rescind SPA, label decision in December. But I believe putting pressure on FDA by as many as possible is better than it thinking there's no consequences to its actions
Associated Press reports half the cholesterol panel members in AHA guidelines have financial ties to makers of heart drugs.
If we got the modified approval you mention the stock would soar, the stock crashed because headlines said Amarin lost to FDA, a win with the details lost in the excitement would be big. Those modified details wouldn't really matter with the society guidelines, and now toxic statins are expected to double in sales after today's announcement from AHA, all lipid lowering drugs will ride this.
omg don't leave me hanging out there alone, I already faxed it to HHS OIG. I received the same email response from DOJ as eveyone else, curiously seems all at the same time. I'll send you a copy to where? But it's a combination of posts 21425 and 21443.
good idea but Larry King is pushing fish oil, maybe Dr Oz, Consumer Reports
fax with cover sheet to HHS OIG 1-800-223-8164
DOJ sent me email saying should go to HHS. Do you have contact number there?
did you have a sample letter to fax or each on his own?
I tried to post on Vascepa on WebMD and drugs.com but was never posted. The only one that posted was Medscape
All medical society guidelines are based on evidence based medicine, so that won't harm Vascepa. The FDA wants evidence based excuses not to approve.
and you think Obama wants a lawsuit that exposes his Obamacare as hurting patients to save a few dollars and his administration's involvement in this scandal