Monday, 7 November 2016

The Guest post that would have been great Annette Langer-Gould vents some spleen on Off label prescribing

On Prof G there was a link on 29 Oct that didn't actually feed to the article, he posted snippets but read the whole thing.

Stand up for Rituximab

Annette M. Langer-Gould, MD, PhD, Kaiser Permanente Southern California
In the article, Reducing costs while enhancing quality of care in MS, Kister and Corboy urge neurologists to do their part to improve the affordability of MS medications. 
The unaffordability of MS medications is driven by the outrageous prices that are in no way tied to the benefits these medications provide. 
The experiences they share include a few simple strategies to lower costs without diminishing quality of care. The one with the most impact is the use of rituximab- the forerunner to ocrelizumab that will likely be FDA approved and available for a ridiculously high price in 2017. 
The biggest barriers to implementing rituximab use are: 
1) most insurance carriers deny coverage because it is not FDA approved for MS;
2) neurologists are afraid of legal action if they prescribe a non-FDA approved product and 
3) the drug companies are incredibly good at marketing their products with glossy ads to promote brand bonding, enticing many prominent neurologists with speaker fees, dinners, first-authorship on New England Journal articles for studies they didn’t design, conduct, analyze and so on. (ProfG didn't mention this;-)
Biogen and Roche are already busy creating false distinctions between ocrelizumab and rituximab as they did for Lucentis and Avastin and frightening neurologists into believing they would be harming their patients or at risk of litigation if they use rituximab. 
Off-label prescribing is what neurologists do all the time, the only legal risk is if ocrelizumab had been proven to be superior or safer than rituximab, data that do not exist and a study Roche and Biogen would be afraid to conduct. 
The Swedish and Kaiser Permanente neurologists negotiated with their medical centers to allow the use of rituximab in their highly active patients when natalizumab was not an option.
 Use of rituximab has increased dramatically in Sweden and Kaiser Permanente as the highly favorable efficacy/safety profile and high patient satisfaction becomes clearer. 
Pharma tried to pressure the Swedish government to halt this use of rituximab, which was met by outrage from their neurologists. 
Swedish health care authorities reviewed the extensive use of rituximab in MS and deemed it scientifically sound and legal. I urge all neurologists to stand up for their patients as the Swedish neurologists have done and help your patients get access to rituximab.

6 comments:

  1. Biosimilars for rituximab and Avastin are coming and Roche is not going to give up its fight for cashing in on ocrelizumab. I am glad that the Swedish neurologists show some common sense and are fighting back. The pricing of new drugs is just hideous.

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  2. I assume Prof G had a selective attention deficit disorder. A quick search shows he has 3 NEJM publications, one as a first author. Are you (and Annette) suggesting he had no input into these papers?

    Gold R, Kappos L, Arnold DL, Bar-Or A, Giovannoni G, Selmaj K, Tornatore C, Sweetser MT, Yang M, Sheikh SI, Dawson KT; DEFINE Study Investigators. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med. 2012 Sep 20;367(12):1098-107. Erratum in: N Engl J Med. 2012 Dec 13;367(24):2362.

    Giovannoni G, Comi G, Cook S, Rammohan K, Rieckmann P, Soelberg Sørensen P, Vermersch P, Chang P, Hamlett A, Musch B, Greenberg SJ; CLARITY Study Group. A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis. N Engl J Med. 2010 Feb 4;362(5):416-26.

    Polman CH, O'Connor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH,
    Phillips JT, Lublin FD, Giovannoni G, Wajgt A, Toal M, Lynn F, Panzara MA, Sandrock AW; AFFIRM Investigators.. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):899-910.

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    Replies
    1. Re: "I assume Prof G had a selective attention deficit disorder."

      No I always copy small sections as excerpts of articles otherwise we would be in breach of copyright law.

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    2. Re: "..suggesting he had no input into these papers?"

      No not at all the amount of background work that goes into these papers, particularly for the NEJM is not trivial.

      Re: Annettes comments ".... for studies they didn’t design, conduct, analyze and so on." are simply incorrect.

      I was on the original oral cladribine advisory board that help Serono make the decision to buy in the IP for oral cladribine. I was on the trial steering committee that modelled the dose to use for the trial, designed the trial, set-up and run the trial, etc. I was a site PI and recruited and consented patients into the trial. I helped Merck-Serono with the EMA submission presented to the SAG (scientific advisory committee) and CHMP and helped with the EMA appeal. I have also been involved with resubmission of oral cladribine to the EMA.

      I probably have more institutional memory around the oral cladribine development programme than most Merck employees who work on oral cladribine at present.

      I didn't quote that section because it is simply incorrect. I have learnt, mainly from personal experience, that most if not all sweeping generalisations are incorrect. It is better not to make generalisations as you are bound to offend someone.

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    3. Oops Maybe this is why I dont get invited to meetings.

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  3. I am suggesting.....of course not...there would have been input, but one can ask how much the authors control the content of the papers?

    In addition who controls whether clinical trial information is published or not...Whilst looking up outputs, why not see how many ECTRIMS/AAN abstracts containing ProfG are converted into papers. or Why be personal. How about Kappos, Hartung Comi etc etc.?

    There are loads of stuff, however should we trawl through this information source?

    As a basic scientist we live in a different world.... Have been busy writing papers over the weekend

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