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  #1   ^
Old Mon, Jun-08-15, 08:14
JEY100's Avatar
JEY100 JEY100 is offline
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Default 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:
A Food and Drug Administration advisory panel this week considers experimental cholesterol-lowering drugs whose approval could pave the way for blockbuster medicines with potentially billions of dollars in sales.

The panel is evaluating evolocumab from Amgen Inc. and alirocumab from Sanofi SA and partner Regeneron Pharmaceuticals Inc., new LDL-lowering agents that would be the first major additions to the coronary heart-disease medicine chest since statin pills were first prescribed in the late 1980s.

“This is the next big quantum leap in being able to control cholesterol and potentially reduce the risk of” heart attacks and strokes, said Bill Sasiela, who heads the cardiovascular and metabolic program at Regeneron.

Statins, such as Lipitor from Pfizer Inc. and Crestor from AstraZeneca PLC, will remain a backbone of efforts to lower “bad” LDL cholesterol and reduce the risk of heart attacks and strokes. Yet doctors have been looking for another option because millions of people with high cholesterol can’t tolerate statins or get their condition under control using the drugs.


[Really? Now doctors and drug companies admit this??]

Quote:
The new biotech drugs block a protein called PCSK9, which interferes with the liver’s ability to clear bad cholesterol. Both are injections that drug companies say patients will be able to give to themselves at home. Studies indicate their use dramatically lowers bad cholesterol levels in patients, and the companies say studies have shown the drugs to be safe.

One concern, which the FDA has discussed with companies, is whether use of the drugs could raise the risk for side effects such as memory impairment or delirium. The companies say they continue to study the matter, but that so far, testing doesn’t suggest a heightened and significant risk.

Also unclear is whether the cholesterol reductions seen in patients taking the new agents also reduces their risk of heart attacks and strokes, though the FDA typically accepts that sizable reductions in bad cholesterol translate into cutting the cardiovascular risks. Company-sponsored “outcomes” studies probing the issue are under way and expected to finish in 2017 or earlier.

Given the potential size of the market, the PCSK9 class could be among the industry’s biggest-selling new classes. Sales could reach as much as $10 billion a year world-wide, estimate analysts at brokerage firm Goldman Sachs Group Inc.

But the drug companies could face a fight from health plans and drug-benefit managers. The price of the drugs could approach $1,000 a month, according to analysts at Sanford C. Bernstein & Co. That could means billions of dollars in additional drug-reimbursement costs for payers, who have already begun making noises about taking steps to limit use.

“Managed pharmacy care, indeed the health care system, has never seen a challenge like this to our resilience in absorbing costs,” CVS Health Corp. executives wrote last February on the blog of the journal Health Affairs. “Action will take the form of compliance with clinical guidelines, and careful managed care oversight.”

The drug companies wouldn’t discuss their pricing plans, but touted the public-health benefits of preventing heart attacks and strokes. Helping patients achieve healthy cholesterol levels “will provide significant medical value,” said Jay Edelberg, who heads PCSK9 development at Sanofi.

“If approved, Repatha would provide patients and physicians with an important new treatment option for managing high cholesterol,” Sean E. Harper, Amgen’s research and development chief, said in a statement.

Drug companies have been angling for any competitive advantage with the new drugs. Sanofi and Regeneron got first dibs on FDA approval by paying $67.5 million for a voucher that moved up their decision date to late July, about a month ahead of the deadline for Amgen’s drug. The FDA isn’t bound by the recommendations of its advisory committees but usually follows them.

Last October, Amgen filed a patent suit against Sanofi and Regeneron asking a federal court to prevent sales of their drug. Sanofi and Regeneron say Amgen’s lawsuit lacks merit.

The companies also have been trying to make the case that the dosing regimen for their drug is superior to their rivals’. The companies have been using the brand names for their drugs, which they often don’t do until FDA approval. Amgen’s drug will be called Repatha, while Sanofi and Regeneron call theirs Praluent.

The prospects for PCSK9 sales are bright enough that Pfizer has been racing to catch up and be part of the conversation about the drugs. “Given the size and diversity of patients, we think there is an opportunity to be competitive,” said Geno Germano, who heads the Pfizer business that is developing a PCSK9 injection, pill and vaccine.

Last edited by JEY100 : Mon, Jun-08-15 at 09:24.
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  #2   ^
Old Mon, Jun-08-15, 09:09
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Nancy LC Nancy LC is offline
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It is just an outrage.
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  #3   ^
Old Tue, Jun-09-15, 07:17
Kinura Kinura is offline
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Nancy LC, I couldn't agree with you more!
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  #4   ^
Old Tue, Jun-09-15, 08:38
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JEY100 JEY100 is offline
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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/
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  #5   ^
Old Tue, Jun-09-15, 17:51
Lesliean Lesliean is offline
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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?
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  #6   ^
Old Wed, Jun-10-15, 04:27
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JEY100 JEY100 is offline
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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:
By THOMAS M. BURTON
Updated June 9, 2015 7:56 p.m. ET

A Food and Drug Administration advisory panel recommended that the agency approve the cholesterol-lowering drug Praluent, the first of a wave of such cardiovascular drugs expected to raise billions of dollars in revenue and perhaps alter the treatment of cardiovascular disease.

But many panelists said the use of the drug should be limited to certain high-risk groups, such as people with very high cholesterol for genetic reasons because of a condition called familial hypercholesterolemia.

The committee voted 13-3 in favor of Praluent, from France’s Sanofi SA and Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. But enough panelists expressed caution about the evidence in the companies’ studies, and so it may take longer than the industry would like to get these medicines widely used.

Panel member Brendan M. Everett, director of the cardiology inpatient service at Brigham and Women’s Hospital in Boston, said he would limit the drug’s immediate use to certain patients with genetic high cholesterol. “I would not allow broader use,” Dr. Everett

The new injectable medicine is administered every two weeks, and is generically called alirocumab. It could help some patients who can’t tolerate or aren’t effectively treated with statin drugs such as Lipitor. Another such drug, Repatha from Amgen Inc., will go before the panel on Wednesday.

The panel’s recommendation late Tuesday boosted shares of Sanofi, which was up 3% in after-hours trading at $50.92. Shares of Regeneron had been halted in regular trading Tuesday pending news.

This new class of medicines is often called PCSK9-inhibitors, because they block a protein called PCSK9, which interferes with the liver’s ability to clear so-called bad cholesterol from the bloodstream. That cholesterol, called LDL, is linked to cardiac disease, albeit imperfectly.

Several members of the panel said that while statin drugs have been shown to lower cholesterol and reduce cardiac disease, it’s not clear if these new PCSK9 drugs will do the same. “I don’t believe we have enough data today,” said William R. Hiatt, a cardiologist at the University of Colorado School of Medicine. Statin drugs have been used by millions of people for more than two decades.

The committee’s chairman, Robert J. Smith of Brown University, also expressed the wider concern among several panel members that the effect of LDL “may be different for different patient groups.”

The two companies say they already have a study under way to see if cardiac outcomes improve with the drug, and results are expected in 2017.

The link between LDL and cardiac events like heart attack and stroke isn’t exact, although it has been shown to be significant in a number of cardiovascular studies previously.

One impediment to use of the drug, if it should win FDA approval, is its likely cost. Some Wall Street analysts say such drugs could cost about $1,000 monthly.

The FDA doesn’t always follow the recommendations of its advisory committees, but generally does so.

In clinical studies evaluated by the FDA and advisory committee, Praluent showed “no marked disparities in deaths, serious adverse events or adverse events leading to discontinuation” of the drug, wrote James P. Smith, deputy director of the FDA’s division of metabolism and endocrinology products in the agency’s drug center.

He wrote that there was some memory impairment in a greater incidence of patients with Praluent than in comparison-group patients, but that “was not characterized as serious” in the eight patients reporting this reaction. Also, there were more liver problems with Praluent, with 2.5% of patients suffering them, compared with 1.8% on placebo.

Regarding the effectiveness of the drug, most of the studies showed patients with the drug had their cholesterol lowered by approximately 40% to 60%.

Reviewers for the FDA, in a report for the panel, said the drug “demonstrates early and sustained” lowering of LDL cholesterol, “regardless of background lipid-modifying therapies and is generally well-tolerated.”

Various members of the expert panel, while saying they were overall comfortable with the data on the drug, expressed the concern that studies so far hadn’t gone on for long enough. Kenneth D. Burman, a professor of medicine at Georgetown University and a panel member, said “it seems probable that the drug will be safe over time,” but that, “We need longer-term studies.”

Write to Thomas M. Burton at tom.burton~wsj.com
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  #7   ^
Old Wed, Jun-10-15, 09:16
Kinura Kinura is offline
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Quote:
Originally Posted by JEY100
". . .the first of a wave of such cardiovascular drugs expected to raise billions of dollars in revenue and perhaps alter the treatment of cardiovascular disease. . ." ]


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?
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  #8   ^
Old Thu, Jun-11-15, 03:02
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JEY100 JEY100 is offline
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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.

Last edited by JEY100 : Thu, Jun-11-15 at 04:50.
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  #9   ^
Old Thu, Jun-11-15, 04:12
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cotonpal cotonpal is offline
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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
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  #10   ^
Old Thu, Jun-11-15, 05:09
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JEY100 JEY100 is offline
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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!


Quote:
CONTENTS

INTRODUCTION: Our enthusiasm for everything medical ix

ASSUMPTION #1: ALL RISKS CAN BE LOWERED 1
Disturbing truth: Risks can’t always be lowered—and trying creates risks of its own

ASSUMPTION #2: IT’S ALWAYS BETTER TO FIX THE PROBLEM 28
Disturbing truth: Trying to eliminate a problemcan be more dangerous than managing one

ASSUMPTION #3: SOONER IS ALWAYS BETTER 51
Disturbing truth: Early diagnosis can needlessly turn people into patients

ASSUMPTION #4: IT NEVER HURTS TO GET MORE INFORMATION 84
Disturbing truth: Data overload can scare patients and distract your doctor from what’s important

ASSUMPTION #5: ACTION IS ALWAYS BETTER THAN INACTION 117
Disturbing truth: Action is not reliably the “right” choice

ASSUMPTION #6: NEWER IS ALWAYS BETTER 139
Disturbing truth: New interventions are typically not well tested and oft en wind up being judged
ineffective (even harmful)

ASSUMPTION #7: IT’S ALL ABOUT AVOIDING DEATH 162
Disturbing truth: A fixation on preventing death diminishes life

CONCLUSION: Seeking medical care is not the most important thing you can do for your health 184
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  #11   ^
Old Sun, May-07-17, 11:04
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JEY100 JEY100 is offline
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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:
A new “hugely expensive” cholesterol drug does not improve overall survival chances for patients with heart disease and should be withdrawn from use, experts have said.

A coalition of doctors last night called on patients to be told that evolocumab, which was hailed as a “game changer” and “better than statins”, does nothing to prevent fatal heart attacks and strokes.

Fresh analysis of data shows the injectable medicine is costing the NHS more than £645,000 for every minor heart attack or stroke it delays, however a trial conducted by Amgen, which manufacturers the drug under the name Repatha, also showed a higher death rate among those taking it than in the placebo patient group.

Amgen says the 5 per cent higher death rate, which is not technically “statistically significant”, is explained by the relatively short duration of the trial - 2.2 years - and that a longer study would have shown a survival benefit.

But campaigners argue it is precisely because the death rate was higher among Repatha patients that the trial was wound up early.

Rival pharma company Pfizer abandoned its trial of a similar PCSK9 inhibitor drug last year, conceding it was “not likely to provide value to patients”.

Dr John Abramson, an expert in healthcare at Harvard Medical School, said: “In terms of the effect of these drugs on UK citizens, there is no evidence on this data that there is a death benefit in people at high risk of cardiovascular disease. “I think people should know that - it’s a hugely expensive drug.”

The injectable medicine, which is prescribed for people with a high cholesterol for whom statins are not working, costs £4,400 per patient per year.

Unlike statins, which slow the production of cholesterol, drugs like evolocumab block a protein which hampers the liver's ability to clear cholesterol from the blood.

The Amgen-sponsored trial of 27,000 people found it could lower cholesterol by almost 60 per cent compared with existing treatments.

Despite this, the NHS, which was told it should provide evolocumab by the National Institute for Health and Care Excellence (NICE) last year, would have to treat 74 people for two years with the drug to delay a single stroke or heart attack. These could be very minor events.

Sir Richard Thompson, former President of the Royal College of Physician and physician to the Queen, said: “You have to contrast the enormous expense and the difficulty of injecting this medicine with an amazingly small benefit to patients.

“Is it really worth it?” Amgen said Repatha decreases low-density lipoprotein, or “bad”, cholesterol to “unprecedented low levels” and that there was a “well established relationship between LDL-C reduction and cardiovascular events”.

There is, however, a controversy over the extent to which LDL cholesterol contributes to cardiovascular ill health. One of those campaigning against the orthodox view of a causal link is NHS Consultant Cardiologist Dr Aseem Malhotra.

“NICE needs to urgently revise its recommendations on the prescription of the drug to include information that the drug will not prevent a fatal heart attack or increase a patient’s lifespan by one day,” he said.

British researcher Dr Zoe Harcombe said it would have been a “disaster” for Amgen if the trial had continued and the higher death rate among the evolocumab cohort had reached statistical significance.

As well as an absent mortality benefit, researchers have said that the Amgen trial, which used participants in a range of countries, showed evocolumab did not benefit the European patients.

Professor Sherif Sultan, President of the International Society of Vascular Surgeons, said there was “no evidence of benefit to UK patients”, describing the NICE guidelines as “crazy”.

However, a spokesman for Amgen disagreed, saying: “We remain confident that Repatha is a clinically effective and cost-effective treatment in the very high risk patient group stipulated by NICE."

A spokesman for NICE, which claims to enjoy an unspecified commercial discount from evolocumab, said the organisation could not comment because of the general election campaign.

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?

Last edited by JEY100 : Sun, May-07-17 at 11:35.
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