Friday, 15 April 2016

Off to AAN 2016...you 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.


2013
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


2016
Giancarlo Comi, Bruce Cree, Patricia Coyle,Hans-Peter Hartung, Patrick Vermersch, Doris Damian, Fernando Dangond

2013
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

2016
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.

2013

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.

2016
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.

2013
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

2016
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:-)

24 comments:

  1. Illuminating as ever, it's a murky business indeed and a lot of neuros are making a lot of money on the side. Now this might not be corruption per se but to my mind it's a few steps down the road and certainly sounds some alarm bells.
    As MD says the cladribine stuff is recycled for marketing purposes and perhaps should be relabelled as "Advertisement" ;-)
    Never been to an AAN or ACTRIMS but my one visit to ECTRIMS and viewing the lavish pharma stands left me with an overstimulated area postrema.

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  2. This is all looking good for Movectro; unfortunately, there isn't the wealth of data out there that will be necessary to support the generic form of cladribine. Pity! Maybe Merck should rename their drug Phoenixtro; after Phoenix the mythical bird that lived for five or six centuries in the Arabian desert, after this time burning itself on a funeral pyre and rising from the ashes with renewed youth to live through another cycle?

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    1. The credit for the resurrection certainly does not lie with Merck, the true heroes lie rather closer to home. I'm sure you all know who I'm talking about. They will of course be air-brushed out of history.

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    2. We know the guys who really deserves the credit for the resurrection of Cladribine are really close, even here in this blog.

      Now comes the Big Pharma and "take credit" all with "ghost writers" corroborating his attempts to re-launch something before she gave no credit to the market ... and curious that the very Big Pharma now with the help of neuros own "famous" give more fuel to the fire for conspiracy theories.
      Example: has a "doctor" "wacko and greedy" here in Brazil that created a "protocol" of treatment for MS based on doses "horsy" Vitamin D3 associated with intake of plenty of water and a totally free calcium diet. The guy does not submit such a protocol it to any clinical trial, "everything is based on your clinical practice." What is the main justification for this it, and convince their patients to follow him? "Scientific research cost too much. It is very difficult conesguir both public and private funding for this. In addition to Big Pharma has no interest to support and finance a study of a substance that does not have to be patented" ...

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  3. Who is paying for Prof G to attend the AAN? A ghost funder with deep pockets? I hope he is going to declare this income on his tax return.

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    1. The funding is via messrs Mossack and Fonseca in Panama ;-)

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    2. Re: "Who is paying for Prof G to attend the AAN?"

      Queen Mary University London is paying for me to attend. I use academic discretionary funds to pay for myself to attend meetings.

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    3. Re: "I hope he is going to declare this income on his tax return."

      If was paying for this meeting myself it would go onto my tax return as a legitimate tax deductible expense. As a medical doctor money spent on CME (continuing medical education) is tax deductible. As I am not paying for this meeting out of my own pocket it won't appear on my tax return. I hope this answers your question.

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    4. Just to clarify CME is no longer tax deductible in the UK.

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  4. Re: "Ghost writers"

    Ghost writers are not allowed any more it is against international guidelines. All the abstracts, posters and presentations were drafted by professional medical writers employed by Merck; none of them are ghosts. The authors then have the opportunity to correct and make alterations to the content of the abstracts and posters.

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  5. Re: "Advertising"

    No, not according the official definition of advertising:

    1. The activity of attracting public attention to a product or business, as by paid announcements in the print, broadcast, or electronic media.
    2. The business of designing and writing advertisements.
    3. Advertisements considered as a group: This paper takes no advertising.

    As far as I know the AAN does not charge you to submit and present data. Presenters however do have to pay to attend the meeting. In comparison, the sponsored Pharma stands at the AAN would qualify as advertising.

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  6. Ghost writing is becoming popular, especially in grant writing in order to avoid the obvious pit falls...

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    Replies
    1. Good point, maybe if we had some on the blog there would not be so many spelling mistakes

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  7. casper has a name, but he's still a ghost

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  8. I've just seen this article about a breakthrough to be presented at AAN on Tuesday. Is it something to get excited about?

    "New York, NY– April 15, 2016 – Dr. Saud A. Sadiq, Director and Chief Research Scientist at the Tisch MS Research Center of New York (Tisch MSRCNY)will be presenting on Tuesday, April 19, 2016, the extraordinary results from his FDA-approved stem cell clinical trial for MS at the American Academy of Neurology’s 68th Annual Meeting in Vancouver, BC, Canada. Dr. Sadiq will deliver the highly anticipated news during a session titled “Remyelination and Repair in Multiple Sclerosis (MS) Data Blitz Presentations.”

    The presentation reveals data from the Phase I trial showing that the novel stem cell treatment was safe and well-tolerated with no serious adverse events reported. What’s more, the cutting-edge protocol of this trial created at Tisch MSRCNY allowed for the delivery of brain-like neural cells within 30 minutes of harvesting, a technique not seen anywhere else in the world.

    “Repair and regeneration is possible. We have a patient who no longer needs her cane, one who has transitioned from a motorized scooter to taking steps with a walker and another who has discontinued their bladder medication as those symptoms have dramatically improved. This is the first treatment that improves established disability in patients with progressive MS and shows us there is hope that a future treatment is possible,” stated Dr. Saud A. Sadiq.

    Due to these unprecedented results, the FDA has already advised Tisch MSRCNY to begin preparations for Phase II of this important trial to establish efficacy of stem cells as a reparative therapy. This is expected to commence at the end of 2016, once funding is secured."

    http://www.tischms.org/news/stem-cells-show-reversal-disability-multiple-sclerosis-american-academy-neurology-aan-2016

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    1. I had seen that they were talking I wonder it you are going to give the same big up to the clemastine data to be presented by Ari Green. The problem with this post is that it sounds like an advert "once funding is secured" Are we being used to publise this. Maybe...I think Dr Sadiq and the Tisch centre gets more mentions than any other place.

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    2. The overblown tone of the above press release is really off-putting. Phase I trials are not designed to determine efficacy, they are needed to test safety and tolerability. According to the press release, Phase I was successful - the procedure was found to be safe. This is sufficient to proceed with Phase II, which should be adequately powered to show the effect efficacy of treatment.
      Was clemastine trial already a Phase II? It's a known drug, safety must have been established previously.

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    3. clemastine was phase II I know the presentation is on 19th but have not found the abstract

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    4. https://www.google.co.uk/search?q=clemastine+phase+II+AAN&gws_rd=cr,ssl&ei=fmoSV97zLcWC6ASOtbPwDQ
      this so needs work!

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  9. Please report on the new alemtuzumab data, don't forget it in the rush to big up your Movectro stuff.

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    Replies
    1. What new data?
      Will big up movectro:-0

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    2. Isn't the 10 yr camms report coming?

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    3. when it comes up we can report on it

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