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OK Steve, Let’s recap.
You interjected into a conversation where a Doctor incorrectly interpreted Cochrane data regarding statins in the primary prevention setting.
You acknowledged you were wrong and I was right in the interpretation of that data.
That same doctor called for a replication of the R-IT Trial.
I noted that R-IT results are a replication of JELIS and I further used the Total event analysis from the R-IT Trial to compare to his NNT in the Primary Prevention setting (corrected by me from his NNT of 18 to the correct NNT of 55 – using his data source).
You then take issue with me comparing 5 pt MACE Total event data to 3 point MACE first event data
Your criticism there has merit; I was sloppy. Score one for Steve. The point I was trying to make dealt with the replication aspect: To demand replication of an intervention that has a NNT of 6 (yes, on 5 pt Total event MACE) while at the same time being ignorant of the existence of JELIS would be arguably unethical (Of course with the caveat that you are wrong on the MO issue).
But let’s move to the main issue under debate where you assert that:
Someone brought to my attention a critique posted in 4 parts on twitter of my post here (the post that I am replying to).
Who in their right mind prepares multi-part critiques (inside joke - I miss those old days of civil discussions)
It's really quite straightforward. The doctor misinterpreted the Cochrane Review in preparing his slide 15.
To be clear: I am not debating the NNT for statins in Primary Prevention. sts66 asked how he got the NNT number 18. This is how he got it. All you have to do is look at the reference he posted on Slide 15.
All-cause mortality and fatal and non-fatal CVD events were reduced with the use of statins as was the need for revascularisation (the restoration of an adequate blood supply to the heart) by means of surgery (coronary artery bypass graft ) or by angioplasty (PTCA). Of 1000 people treated with a statin for five years, 18 would avoid a major CVD event which compares well with other treatments used for preventing cardiovascular disease.
If I receive permission to, I will share some pretty exciting 'news' with the board.
LOL, you should look at Layton Bioscience and see what arose from the dust of that company as a result of asset assignments.
Stuff like this gets dealt with most cleanly at the time of a buyout, when lawyers descend to clarify all details and filings, wherever there may yet be anything necessary to do. But this is where shorts excel, at creating confusion with longs... on basic details.
You linked to an old document. You have no indication there that that is still current just because it is still searchable.
Leave it to you to try to manufacture false confusion with an old loan assignment agreement from 2012...
No current outstanding debt is indicated in the annual report to either Four M or the GP behind the company, Dennis Mehiel. Four M did come up in regard to a 2017 request for valuation of the Sawston property. But the debt there appears to no longer be outstanding.
Ownership of key patents is shared between the various parties but assigned to NWBO.
How far do you need to read into this 80 page conspiracy theory to understand that their two Ph3 trials actually failed?
Thank god we are not going into ADCom with data like Dendreon had in 2007.
I would no doubt need to bring restraints and duct tape to make sure you remain silent in your chair during the entire day.
If this MA represents the highest wrung in EBM then woe to us all..I do not consider this (I don't know what to call it..paper seems too generous).
The fundamental appeal of meta-analysis, which partly explains its popularity, is the idea of integrating evidence from multiple sources to provide reliable answers to important questions. The evidence-based medicine movement in general promotes a systematic approach to assessing the quality of evidence, considering not only research design but also other characteristics of individual articles.3 Some evidence-based medicine hierarchies of evidence, however, assign the highest level (quality) of evidence to systematic reviews of randomized trials.4 Meta-analyses (and systematic reviews in general) are therefore sometimes automatically accorded a great deal of credibility. The placement of meta-analyses of randomized trials (and individual randomized trials) at the top of evidence hierarchies is controversial because some believe that it underestimates the value of other research designs and because detailed assessment of methodology is not taken into account.
Because it adds to the impression that there is nothing unique about Vascepa.
It reinforces the general notion that Omega-3’s are all the same.
Publication of this paper is a very positive for Vascepa.
A meta analysis is the highest rung in the EBM world.
It was to be expected that they update the OM3 meta analysis incorporating ASCEND and VITAL (and R-IT).
There is absolutely nothing in the paper that harms or takes away from the R-IT results. On the contrary it supports the results obtained.
Look at Figure 3. You can take a OM3 product and expect to realize a 3% relative risk reduction (SS no less due to the high N).
Or, you can take V and realize a 25% RRR (they show it as 24% on the figure, not sure why).
How can this be viewed as a negative for the Vascepa case?
what are your guesses on why Dr Budoff is doing this?
Surely he's no dummy.
Low-density lipoprotein cholesterol (LDL-C): 12% decrease (high dose), 7% decrease (low dose), 5% increase (placebo) (p<0.01 high dose)
Total cholesterol: 8% decrease (high dose), 5% decrease (low dose), 4% increase (placebo) (p<0.05 high dose)
Triglycerides: 16% decrease (high dose), 13% decrease (low dose), 6% increase (placebo)
what's the correct term for a trial for which interim results have been released?
FWIW, I stumbled across an example of the FDA asking the sponsor to keep the ADCOM quiet until posted in the Federal Register.
From Page 171 (link below)
Meeting minutes:
Purpose: FDA requested this teleconference to notify Eisai Inc about ODAC meeting.
Discussion during the meeting:
FDA notified Eisai, Inc the following:
• There will be an ODAC meeting for NDA 201532, with tentative dates of September 1 or 2, 2010
• Reminded company that the Sept 2010 ODAC is NOT public at this time & information regarding this matter should not be disclosed until the FR publishes.
• Nicole Vesely will follow-up with a letter informing Eisai, Inc of their deadlines.
Call Concluded
Eisai, Inc (Contact person: Annmarie Petraglia) was notified that FDA has decided not to take NDA 201532 (eribulin mesylate) to the advisory committee. Applicant acknowledged, and no further question was asked by the applicant.
Call concluded.
Where is AVII? You cannot release any data other than stating the trial was continuing to 18 months.
Have you all forgotten the REDUCE-IT interims. NO efficacy data shared. NONE.
Not very long, must have been recently added because I know it wasn't there when I first reviewed the planner.
What they mean is that the two versions of standard of care -- aka: regular dosing and dose dense -- did not differ by methylation status, but MGMT methylation overall was associated with improved overall survival over unmethylated. Surely you remember this study.
Efficacy did not differ by methylation status. MGMT methylation was associated with improved OS (21.2 (methylated) v 14 months (unmethylated)
Here's the numbers again, Bongo Bongo Heads...
800,000 metric tons of global fish oil supply (800,000,000 kg)
13% of that is EPA
You can maybe (MAYBE) corner 10% of the global supply.
You need 4g x 365 to supply a patient for a year (1.46kg)
800,000,000 x 13% x 10% = 10,400,000 kg
10,400,000 / 1.46 = 7.123 million patients (about $10bn or so in revs)
MAYBE you can stretch that with heightened supply and greater market share capture to 10 million patients. MAYBE.
well said. I agree 100%
In addition, the low intensity statin subgroup is based on only 93 events (in both arms) out of 1600+ events. It was 48 for V and 45 for P.
What's this about?
Browsing through this years AHA talks (abstracts not yet out but titles are) I see this (emphasis mine):
November 17, 2019, 10:45 AM
PR.CVS.176. Omega-3 Fatty Acids, EPA and CVD Risk: No Longer a Fish Tale?
The publication of the REDUCE-IT Trial, which showed a 25% reduction in cardiac events with the addition of icosapent ethyl to statin treatment, has renewed interest in the use of omega-3 fatty acids. This session will review the JELIS and REDUCE-IT trials and provide potential mechanisms of benefit. It will also provide benefits of omega-3 fatty acids beyond cardiovascular risk reduction. These include benefit on albuminuria, musculoskeletal symptoms, joint replacement and cognitive function. Finally, it will have a talk on when to add omega-3 fatty acids to statin therapy which will be case-based.
The person who has looked at the placebo issue the most and longest is the Chair of the R-IT DSMB. His main job was to protect the patients in the trial; and that includes those on placebo.
Recall several years ago I shared a video of him discussing placebos, an entire hour long presentation on placebos.
I did some searching to see if he has said anything about R-IT now that it is complete.
He did not, but two of his residents have. They presented a Grand Rounds on the topic of R-IT.
https://internalmedicineiowa.org/2019/04/11/residents-deliver-grand-rounds/
That page contains some of the slides from their presentation. It's obvious they presented R-IT results and contrasted V with OTC fish oil. These doctors, albeit junior and still in post doc training, are under the mentorship of Brian O who was the Chair of the R-IT DSMB.
I don't see them singing the praises of R-IT if their mentor, who would be aware of any deep dark secrets, thought the trial flawed due to MO.
I offer this as anecdotal evidence of course.
German Hospital Exemption slips quietly away.
It used to be here under tumor vaccines.
Well, look on the bright side, maybe that's one less RA they need to submit a SAP to.
I don't remember anyone mentioning that TG in the placebo arm has actually decreased by 14 from baseline to finish:
AVII77 do the Adcom panel members also only get the questions 2 days in advance?
The FDA could not possibly have the thousands of people it would take to review 50 million pages of individual data points "down to the patient level"...They are just human beings and, in the end, after all is said and done, they must mainly refer to just what we have.
A - do you know what is the logic behind giving the ADCOM questions to the sponsor ONLY 2 days prior to the ADCOM?
For open advisory committee meetings that involve sponsor-prepared briefing materials, approximately 55 business days before the meeting is scheduled to occur, FDA intends to notify a sponsor that an advisory committee will consider an issue that is directly relevant to the sponsor. We will explain the meeting’s focus to the sponsor and also may advise the sponsor about the information it may wish to include in its briefing materials.
in which way FDA thinks this panel members are better than the ones from ADA, AHA, ACC, ICER who endorse V already.
Re Dr Burman ...LEADER trial on Medscape .
Voted in favor of drug despite the fact that voting was based on only I trial ( P3 I think ) where as FDA usually requires two P 3 trials
Kiwi
hope you're getting a lot of time on your Hobie Cat .
I just don't think they wait until 6-7 wks prior to approval , based on a Priority Review that they granted ...to suddenly think they should have an Adcom solely on MO.
Company has stated several times that they would be in negotiations with the FDA regarding the Label.
The issue appears to me to be more around getting the primary prevention indication on the label .
How does the R-IT data support having 1/4 -1/3rd of the adult US population on label .....unless he meant that primary non diabetics would be off label.
I wonder how something like this might work
home blood cholesterol tester