Off to AAN got it all in 2013...More about Marketing than New Science?

What did they do in 2013 that they didn't in 2016...maybe write the abstract:-)..Scaramozza & Nathalie out...Fernando in (See below)

Ghost writing (someone writing but not declaring it) or use of a commercial writer (same a ghost writing but they don't hide themselves) is a common occurrence in clinical science, and was not something I had ever heard about until encountering my clinical colleagues.

A scientist would not dream of using and god forbid paying for a ghost writer. The fun part is writing up data, the irritating thing is dealing with the "third reviewer" as they rip this apart, but employing a professional writer who has not been near the project or the lab... no way. Further more tossing away loads of money on paying some one to write-up your work could be better spent on paying for a student for months etc.

Journals now ask what is the contribution of the individuals on the paper, with a view of excluding people riding on the coat tails of the work. This still happens as it is politics of science and those people provide the infrastructure for the work to occur...however a ghost writer is a different kettle of fish.

Trying to get clinicans to agree on anything is like herding cats:-), so companies employ writers to write about the data and graphs, made by professional presentation makers, the clinicans can then tinker with this draft. For many years this practise went by unnoticed, but with the drive for transparency these people had to be acknowledged.

So when we look at the posters at ECTRIMS and AAN you will find that somewhere it will be stated that someone made the poster etc. This is because the presenters are too busy (too Lazy) to make them themselves. This way the companies can control content and orchestrate the content and make them look corporate and so we have the cookie-cutter parade of posters that are corporate marketing devices that should be shown in the marketing stands and not the science sessions.

However,  it provides the device for different people to be schlepped to the meeting to present the work and so sometimes the order changes. But if the work was done, then the names should stay the same? Shouldn't they? New names should not appear and others should not disappear?. 

Maybe you get a mention for designing the colour code of the poster:-), when all those registrars that did all the hard work get nothing.

However in the future it looks like in the name of transparency this
more and more will need to be declared. The disclaimer that get whizzed through in the first nano second of a meeting is going to get a monetary value.

At the moment even I am being asked to agree that anything a company gives me is made transparent. When I actually get paid by them then may be I will sign something to allow them to hunt through my finances, but what is going to be covered? 

The amount of consultancy paid (I'm sure the tax man will already know about this for the honest ones).

However, what if they include the amount  (which I am led to believe will be the case) they spend on travel to meetings, hotels, lunches which is simply an expense, but also the amount they pay on ghost writers, slide makers, poster makers, ...then the dollars will soon rack up and many neuros will find it hard to resist the statement that they are in the pocket of pharma.

Who will be the first million dollar neuro...Prof Kappos?, ProfComi?....ProfG??

I suspect to many it will be water off a duck's back and maybe something to aspire to and they won't care about being labelled as a pharma mouth piece but for one business class flight from London to Boston could be the same as 250 trips from Harvard to Cambridge-based company.

Will the costs be broken down from personally taxable verse non-taxable or will this be lumped together as the taxmans eyebrows get mentioned and will neuros want to be names on posters that they haven't made?

Anyway what is the difference between 2013 and 2016 at the AAN? 

In 2013 it was throw-away data where the PIs were allowed to report on the studies that Merck canned. In 2016 it is marketing ready for the re-launch.

Oral Cladribine Safety Profile in Patients with a First Demyelinating Event: Top Line Results from the Phase III ORACLE MS Study (P01.177) Thomas Leist, Giancarlo Comi, Bruce Cree,  Patricia Coyle,  Mark Freedman, Hans Hartung,  Patrick Vermersch, Amelia Orejudos, Nathalie Lachenal, and Matthew Scaramozza

P3.035 - Efficacy of Cladribine Tablets in ORACLE Study Patients Who Retrospectively Met 2010 McDonald Multiple Sclerosis (MS) Criteria at Baseline. Mark Freedman, Thomas Leist,
Giancarlo Comi, Bruce Cree, Patricia Coyle,Hans-Peter Hartung, Patrick Vermersch, Doris Damian, Fernando Dangond

Safety and Efficacy of Oral Cladribine in Patients with Relapsing-Remitting Multiple Sclerosis: Results from the 96 Week Phase IIIb Extension Trial to the CLARITY Study (P07.119)
Gavin Giovannoni, Giancarlo Comi, Stuart Cook, Kottil Rammohan, Peter Rieckmann, Per Soelberg-Sorensen, Patrick Vermersc, Anthony Hamlett, Matthew Scaramozza, and Nathalie Lachenal

P3.028 - Clinical Efficacy of Cladribine Tablets in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS): Final Results from the 120-Week Phase IIIb Extension Trial to the CLARITY Study Gavin Giovannoni,Giancarlo Comi, Stuart Cook, Peter Rieckmann, Kottil Rammohan, Per Soelberg-Sørensen, Patrick Vermersch, Emily Martin, Fernando Dangond

CLARITY-EXT demonstrated that in a majority of patients, the clinical benefits (relapse and disability) of cladribine 3.5mg/kg given in Years 1 and 2 may be maintained for at least 4 years, with decisions on further treatment based upon monitoring during this period

Safety and Tolerability of Cladribine Tablets in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS): Final Results from the 120-Week Phase IIIb Extension Trial to the CLARITY Study Stuart Cook,Giancarlo Comi,Peter Rieckmann,Kottil Rammohan,Per Soelberg-Soerensenn,Patrick Vermersch, Emily Martin,Fernando Dangond,Gavin Giovannoni

Overall, safety and tolerability in CLARITY Extension were consistent with that seen in CLARITY.


Oral Cladribine as Add on to IFN β Therapy in Patients with Active Multiple Sclerosis: Results from the Phase II ONWARD Study (P07.099) Xavier Montalban, Bruce Cohen, Thomas Leist,  Harold Moses, Anthony Hamlett, Matthew Scaramozza, and Nathalie Lachenal

No new or unexpected safety issues were found. The combination therapy appeared effective; however efficacy analyses were not powered. An excess of grade 3 lymphopenia, compared with that reported in previous cladribine studies was observed which may be partly attributable to the concomitant administration of IFN-β.

P3.029 - Efficacy of Cladribine Tablets as Add-On to IFN-beta Therapy in Patients with Active Relapsing MS: Final Results from the Phase II ONWARD Study Xavier Montalban, Bruce Cohen, Thomas Leist, Harold Moses, Christine Hicking, Fernando Dangond

Objective: In patients with active relapsing MS with breakthrough disease while on IFN-β therapy (including SPMS with ongoing relapses), treatment with cladribine tablets added on to IFN-β demonstrated significant efficacy benefits. These results support the demonstrated efficacy of cladribine tablets in RRMS shown in CLARITY.

Oral Cladribrine Treatment Reduces Brain Atrophy Rates in Relapsing-Remitting Multiple Sclerosis: Exploratory Analysis of the CLARITY Study (P07.112) Nicola De Stefano, Antonio Giorgio,  Alessandro De Leucio, Anthony Hamlett, Matthew Scaramozza, and Bettina Stubinski

P2.114 - Magnetic Resonance Imaging (MRI) Outcomes in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) Treated with Cladribine Tablets: Results from the 120-Week Phase IIIb Extension of the CLARITY Study Comi Giancarlo,Gavin Giovannoni, Stuart Cook, Kottil Rammohan, Per Soelberg Sørensen, Patrick Vermersch, Emily Martin, Fernando Dangond,Peter Rieckmann

P3.058 - Slowing of Disability Progression Based on 6-Month Confirmed EDSS in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) Treated with Cladribine Tablets in the CLARITY Study: A Post-Hoc Subgroup Analysis. Stuart Cook,Kottil Rammohan,Peter Rieckmann,Per Soelberg Sørensen, Patrick Vermersch,Christine Hicking, Fernando Dangond,Gavin Giovannoni

Treatment with cladribine 3.5 mg/kg significantly reduced the risk of 6-month confirmed EDSS progression over 2 years in RRMS patients.

So more data to support the use of generic cladribine before Movectro gets a license and stops this from occurring.

So who at the AAN reviews this for NEW content?..I guess the guy who received the fat cheque from Merck:-)

Maybe if spent more time was spent writing the EMA application rather than re-cycling old abstracts then Movectro would be available now. 

Hey Ho. Another year on and another billion in revenue lost so no urgency then:-)

CoI None. ProfG is author....OK his name is on the posters, wonder if Emily or Christine wrote them:-) Only joking:-)

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