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FDA investigating the safety of Benicar
 Moderated by: Prof Trevor Marshall Page:  First Page Previous Page  1  2  3  4  5  6  7  8  9  10  ...  Next Page Last Page  
 

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Prof Trevor Marshall
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 Posted: Sat Jul 3rd, 2010 06:47

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Yes, the videos are nearly ready :)

Bane
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 Posted: Sun Jul 4th, 2010 07:16

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Review of angiotensin II receptor inhibitors started

http://www.ema.europa.eu/pdfs/human/press/pr/27209310en.pdf

The Committee has begun looking at the possible risk of cancer in patients taking angiotensin II receptor inhibitors. This follows the publication of a meta-analysis reviewing nine randomised controlled trials involving almost 95,000 patients, which suggests that these medicines may be linked with a modestly increased risk of new diagnoses of cancer when compared with placebo or other heart medicines.


The CHMP will review the meta-analysis thoroughly, together with any other available non-clinical and clinical data (including data from clinical trials and epidemiological studies) on angiotensin II receptor inhibitors, to clarify whether there is an increased risk of cancer in patients taking these medicines. The Committee will also issue an opinion on whether a future change to the product information or risk-management plans for these medicines might be necessary.

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 Posted: Sun Jul 4th, 2010 12:43

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How long does the review? and Is there a plan B for negative news? If bad news comes How long does it take drugs to be collected. any idea ?

thank u



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Prof Trevor Marshall
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 Posted: Sun Jul 4th, 2010 15:11

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How long?
Look at Tom's post:

http://www.marshallprotocol.com/view_topic.php?id=13795&forum_id=39&jump_to=197165#p197165
 

jrfoutin
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 Posted: Sun Jul 4th, 2010 15:22

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Meta studies are good for some things, and not for others.

........

The entire class of inhibitors do not act the same.

Please reference kd chart, click here. 

........

Full 2006 transcript of FDA whitewater presentation:

http://mpkb.org/home/publications/marshall_fda_cder_2006

 

Best to all--Janet



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Bane
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 Posted: Mon Jul 5th, 2010 06:29

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FDA Drug Safety Podcast for Healthcare Professionals: Ongoing safety review of Benicar and cardiovascular events

http://www.fda.gov/downloads/Drugs/DrugSafety/DrugSafetyPodcasts/UCM217336.mp3

http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm217335.htm

Welcome, my name is Jennifer Shepherd, a pharmacist in the Division of Drug Information. I am updating you on the ongoing safety review of Benicar and cardiovascular events. The FDA is evaluating data from two clinical trials ROADMAP and ORIENT in which patients with type 2 diabetes taking Benicar, also known as olmesartan, had a higher rate of death from a cardiovascular cause compared to patients taking a placebo.

FDA's review is ongoing and the Agency has not concluded that Benicar increases the risk of death. FDA currently believes that the benefits of Benicar in patients with high blood pressure continue to outweigh its potential risks.

Benicar is in the class of drugs called angiotensin II receptor blockers or ARBs. These drugs and a closely related group of drugs called angiotensin-converting enzyme inhibitors (ACEIs) have been evaluated in many studies involving thousands of patients at high-risk for cardiovascular events, such as patients who had a previous heart attack or had heart failure. No increased risk of cardiovascular-related death has been reported in these trials and, in fact, some of these studies indicate ARBs and ACEIs are useful as treatments for certain patients at high-risk for cardiovascular events.

The Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study or ROADMAP was a randomized, double-blind, placebo-controlled, multicenter trial conducted in Europe. The trial included 4,447 patients with type 2 diabetes and at least one additional cardiovascular risk factor, but without overt evidence of nephropathy. Patients were randomized to receive either 40 mg of olmesartan or placebo daily. Patients were permitted to receive other antihypertensive medications, but not ACEIs or ARBs.

The primary objective was to evaluate whether olmesartan could delay the onset of microalbuminuria. The majority of patients had 3 to 5 cardiovascular risk factors and 80% of patients were using other antihypertensives. The mean duration of exposure to olmesartan was 39 months.

The Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial or ORIENT was a randomized, double-blind, placebo-controlled, multicenter trial conducted in Japan and Hong Kong. The trial included 566 patients with type 2 diabetes and overt nephropathy who were randomized to receive olmesartan 10 mg to 40 mg or placebo daily. Patients were permitted to take additional antihypertensives including ACEIs, but excluding ARBs. The primary composite endpoint was the time to first event of doubling of serum creatinine, end stage renal disease, and all cause death.

An unexpected finding observed in both trials was a greater number of deaths from a cardiovascular cause, such as heart attack, sudden death, or stroke, in the Benicar-treated patients compared to placebo. In ROADMAP, there were 15 cardiovascular related deaths in the Benicar group compared to 3 in the placebo group. In ORIENT, there were 10 cardiovascular-related deaths in the Benicar group compared to 3 deaths in the placebo group. The summary of findings from these trials can be found in tables which are available in the full drug safety communication on the FDA website at http://www.fda.gov.

To evaluate the possible association with olmesartan and increased cardiovascular-related death, FDA plans to review the primary data from the two trials and the total clinical trial data on olmesartan. Also, the Agency will evaluate additional ways to understand the findings from ROADMAP and ORIENT, in light of information supporting the use of ARBs and ACEIs in certain patients at high risk for cardiovascular events.

At this time, FDA recommends that Healthcare Professionals be aware that:
  1. FDA has not concluded that Benicar increases the risk of death. The Agency is reviewing information related to the safety concern and will update the public when additional information is available.
  2. FDA believes the benefits of Benicar in patients with high blood pressure continue to outweigh the potential risks.
  3. In the ROADMAP and ORIENT trials, there were a greater number of cardiovascular-related deaths in the Benicar group compared to the placebo group.
  4. Additional information about ROADMAP and ORIENT can be found at http://www.clinicaltrials.gov.
  5. Other controlled clinical trials evaluating Benicar and other angiotensin II receptor blockers have not suggested an increased risk of cardiovascular-related death.
  6. Recommendations in the drug label should be followed when prescribing Benicar.
  7. Adverse events involving Benicar can be reported to the FDA MedWatch program at http://www.fda.gov/medwatch.

Bane
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 Posted: Mon Jul 5th, 2010 06:44

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ARBs and Cancer -- Are We Looking at Junk Science?

http://www.medscape.com/viewarticle/724008

 

copy this link into google and do a search, you should be able to see it without being registered?

Last edited on Mon Jul 5th, 2010 06:51 by Bane

Prof Trevor Marshall
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 Posted: Mon Jul 5th, 2010 07:51

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"You have to start out with some biological reason why that might happen"
total focus on Angiotensin receptors...
"Studies for FDA" "large numbers of experimental animals, mostly mice and rats and occasionally rabbits to see whether there is any increase in cancers"

Sigh. Well, cancer was detected during the FDA studies in hamsters, but that was discounted as it didn't appear in rats, mice or rabbits. That is detailed in the FDA approval documents. Second, they obviously haven't Googled for my 2007 DMM poster:

http://AutoimmunityResearch.org/transcripts/dmm2007-harvard.pdf

And of course none of the experts has any clue as to what is really happening....

..Trevor..

Deedee
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 Posted: Mon Jul 5th, 2010 09:02

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Bane, I signed in to watch the video you posted above from medscape

http://www.medscape.com/viewarticle/724008 and it is very persuasive.

I would just like to recommend to anyone that is frightened by the news reports to watch the video. The speaker is Henry R. Black, MD,
Clinical Professor of Internal Medicine, New York University School of Medicine, New York, NY; Director, Hypertension Research, Center for the Prevention of Cardiovascular Disease, New York University School of Medicine, New York, NY.

He explains why the information from the clinical trials that generated the study of the safety of Benicar is flawed and he states the individual data and the pattern of the cancers were not consistent. He said the study needs to be dissected very, very carefully.

He noted that the populations in the study were from all over the world, and the groups were compared to people (presumably in the US) of ages 65 to 69 (the average age in the study). He noted populations from different parts of the world and incidents of cancer will differ widely. He said this is not comparative data and called this "irresponsible" and junk science.

He said that to cause alarm over Benicar is "irresponsible and dangerous, and can causes patient harm."

Take the time to sign up and watch the video. Thanks, Bane.

Looking forward to viewing your presentation, TM.

Last edited on Mon Jul 5th, 2010 09:07 by Deedee



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Bane
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 Posted: Mon Jul 5th, 2010 09:14

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Deedee wrote: Bane, I signed in to watch the video you posted above from medscape

http://www.medscape.com/viewarticle/724008 and it is very persuasive.

I would just like to recommend to anyone that is frightened by the news reports to watch the video. The speaker is Henry R. Black, MD,
Clinical Professor of Internal Medicine, New York University School of Medicine, New York, NY; Director, Hypertension Research, Center for the Prevention of Cardiovascular Disease, New York University School of Medicine, New York, NY.

He explains why the information from the clinical trials that generated the study of the safety of Benicar is flawed and he states the individual data and the pattern of the cancers were not consistent. He said the study needs to be dissected very, very carefully.

He noted that the populations in the study were from all over the world, and the groups were compared to people (presumably in the US) of ages 65 to 69 (the average age in the study). He noted populations from different parts of the world and incidents of cancer will differ widely. He said this is not comparative data and called this "irresponsible" and junk science.

He said that to cause alarm over Benicar is "irresponsible and dangerous, and can causes patient harm."

Take the time to sign up and watch the video. Thanks, Bane.

Looking forward to viewing your presentation, TM.


Deedee there are two studies being discussed in this thread, the one i mention is on telmisartan, not olmesartan.

This one:

Common blood pressure drugs may raise cancer risk

http://www.reuters.com/article/idUSTRE65C2C120100613

 

the one on olmesartan is this one

 

UPDATE 2-FDA looking into death risk from Daiichi's Benicar

http://www.reuters.com/article/idUSN1113920620100611

Last edited on Mon Jul 5th, 2010 09:19 by Bane

Deedee
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 Posted: Mon Jul 5th, 2010 09:42

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Thanks, Bane, I see that now. The study that generated the cancer-increase concern was based on the drug Telmisartan, a different ARB. He mentioned another ARB, too. The video just groups them all together for discussion as ARB drugs.

Last edited on Mon Jul 5th, 2010 09:43 by Deedee



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 Posted: Mon Jul 5th, 2010 09:46

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He mentioned Candesartan, which has no VDR effect and Telmisartan, which is the strongest VDR antagonist (switcher off) I have ever seen... I have for years told people to stay away from Telmisartan (Micardis) at all costs...
 

Bane
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 Posted: Fri Jul 9th, 2010 02:12

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EMA to review ARBs and cancer, infuriating experts, who point to missing data and adverse consequences

http://www.theheart.org/article/1091359.do

At the same time, hypertension experts are up in arms about the paper, calling it deeply flawed. They contend that it is extremely unlikely that ARBs are associated with an increased risk of cancer—one physician even says he has data that, if added to the analysis, would wipe out any cancer signal. Overall, they say, the media splash this paper has made could cause irreparable damage to the reputation of ARBs, which they consider vital tools in their armamentarium, and may unfortunately prompt many patients to stop taking the medicines, putting themselves at increased risk of cardiovascular and renal events.

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 Posted: Sun Jul 11th, 2010 06:11

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Dr. Trevor Marshall wrote

Posted: Sat Jul 3rd, 2010 07:47

Yes, the videos are nearly ready


Queston: Are these videos available now? (Just wondering)


Thanks :D



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Deedee
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 Posted: Sun Jul 11th, 2010 06:24

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Sunset:
http://www.marshallprotocol.com/forum39/13818.html



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Prof Trevor Marshall
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 Posted: Sun Jul 11th, 2010 09:19

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You can always see the latest posts by using this URL:
http://www.marshallprotocol.com/recent.html

or by clicking on the "Recent" tab at the top left of the forum.
 

Bane
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 Posted: Tue Jul 20th, 2010 03:44

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What's The Evidence for the Link Between ARBS and Cancer? Ileana Piña Talks With Ilke Sipahi

 

http://www.medscape.com/viewarticle/725043?src=rss

Copy this link/video to Google, you should be able to see it without registering.

Deedee
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 Posted: Tue Jul 20th, 2010 05:31

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Thanks, Bane. Very interesting. Interesting too, is that it always gets down to the funding, doesn't it?



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 Posted: Sun Jul 25th, 2010 14:57

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This article was released today and may help explain multiple allergy response and why some people need a lot of medication with little bebefit.
http://www.physorg.com/news199082379.html



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jrfoutin
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 Posted: Wed Jul 28th, 2010 09:14

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Bacteria get energy from glucose/sugars/etc.

Suggested reading at MPKB.org:

Carbohydrates and sugars


Per FDA investigating the safety of Benicar" topic of this thread, we might want to keep the topic on track.



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