Thursday, 2 March 2017

#PoliticalSpeak: ethical or unethical?

Is #EliLilly being unethical by not disclosing the results of their #Tabalumab trial. #PoliticalSpeak #MSBlog

Does the MS community deserve answers? Eli Lilly did a phase 2 trial of Tabalumab (LY 2127399) a drug that targets B-cells in pwMS 2012. They have yet to publish, or release, the results. 

Based on our hypothesis, we predict that this drug will make MS worse, by expanding the memory B-cell pool that we think is responsible for driving MS disease activity. Is it appropriate for Eli Lilly to keep this data undisclosed? 

Yesterday's post generated a lot of debate and the general feeling is that if this study was negative the results should be released so that the community can learn from them. It would be unethical to expose pwMS to another drug, or therapeutic strategy, targeting a similar mode of action to that of Tabalumab. Do Eli Lilly care about this? Do they realise that their actions, although passive, may have consequences for pwMS? 

Thank you for your support with the petition we started yesterday. We need more supporters to any chance of convincing Eli Lilly to disclose. I personally think we need politicians to come to the party and to draw up legislation to make it compulsory for Pharma companies to publish their results in full and to make the data available to the public after a certain period of time. The brave and altruistic people with MS who volunteered to participate in this study, they put themselves at risk so that other pwMS could benefit from a potentially new treatment. Surely the trial participants need to be shown more respect? 

If you care as much as we do about this issue please sign our petition. Thank you. 





Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple Sclerosis

Primary Outcome Measures:
  • Reduction in cumulative total gadolinium (Gd)-enhancing MRI lesions. [Time Frame: Baseline, 24 weeks ]

Estimated Enrollment: 245
  • Study Start Date: April 2009
  • Study Completion Date: June 2012
  • Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)

Eligibility
  • Ages Eligible for Study: 18 Years to 64 Years (Adult)
  • Sexes Eligible for Study: All

Inclusion Criteria:
  • 18 through 64 years of age diagnosed with relapsing-remitting multiple sclerosis (RRMS), who can walk without aid or rest for at least 200 meters (approximately 1/10 of a mile).
  • Women who can become pregnant must use birth control.

Exclusion Criteria:
  • Have had a live vaccination within 12 weeks before randomization, or intend to have a live vaccination during the course of the study.
  • Have had had recent surgery or are scheduled to have surgery during the study.
  • Are immunocompromised or have evidence of active infection (such as hepatitis, tuberculosis or, human immunodeficiency virus [HIV]).
  • Have been on certain drugs that are being studied for RRMS or have recently received prescription drugs to treat RRMS.
  • Have had a recent serious infection.
  • Have serious or uncontrolled illnesses other than RRMS.
  • Have clinically significant blood test values.
  • Have multiple or severe drug allergies.
  • Have contraindications for magnetic resonance imaging (MRI; "scanning") or claustrophobia (fear of an enclosed space) that cannot be managed.

ClinicalTrials.gov identifier: NCT00882999

Responsible Party

Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00882999 History of Changes
Other Study ID Numbers: 12778 H9B-MC-BCDJ
Study First Received: April 16, 2009
Last Updated: June 22, 2012

9 comments:

  1. Prof G Eli Lilly are no different to their fellow brethren in that they don't really care about people or patients or their families. It is all about the bottom line, the Company's share price and the senior executives bonus pool. Pharma Executives have taken over from Bankers as the bad boys of capitalism. Let's hope Trump sticks to his words and hauls them over the coals.

    ReplyDelete
  2. From: UKPublicAffairs [mailto:UKPublicAffairs@lilly.com]
    Sent: 02 March 2017 10:40
    To: Gareth Pryce
    Subject: RE: FAO Louisa Stevenson

    Dear Gareth

    Thanks for your email, I will of course pass on your comments and concerns.

    Best wishes

    Louisa.

    From: Gareth Pryce [mailto:g.pryce@qmul.ac.uk]
    Sent: 01 March 2017 15:37
    To: UKPublicAffairs
    Subject: [EXTERNAL] RE: FAO Louisa Stevenson

    Dear Louisa,

    Many thanks for your prompt reply.

    My colleague has used Lilly’s online portal (all clearly detailed in the blog posts I attached) to make a data request.

    So when requested it is "out of scope"

    "Whether favourable or unfavourable, Lilly posts the results of all Lilly-sponsored Phase II, Phase III and Phase IV clinical trials of Lilly marketed products conducted anywhere in the world that were initiated on or after October 15, 2002"

    When asked specifically, it was said that "this standard only applies to marketed compounds".

    Which is not really in the spirit of what was intended, I would suggest.

    I hope Eli Lilly may reconsider their stance on this matter and I hope you might pass on our concerns to your relevant colleagues.

    Best wishes

    Gareth


    From: UKPublicAffairs [mailto:UKPublicAffairs@lilly.com]
    Sent: 01 March 2017 15:01
    To: Gareth Pryce
    Subject: RE: FAO Louisa Stevenson

    Dear Gareth

    Lilly uses an online portal to facilitate requests from legitimate researchers for clinical trial data – you can access this portal at www.clinicalstudydatarequest.com

    Best wishes,

    Louisa


    From: Gareth Pryce [mailto:g.pryce@qmul.ac.uk]
    Sent: 01 March 2017 11:15
    To: UKPublicAffairs
    Subject: [EXTERNAL] FAO Louisa Stevenson

    Dear Ms Stevenson,

    You may be interested in this. Some colleagues of mine have been attempting to access some clinical trials data from Eli Lilly with no success. Some background on this can be found here. We feel that this data can tell us something fundamental in the development and treatment of multiple sclerosis and we feel very strongly that the data for the trial should be made available in a timely manner as a matter of urgency.

    http://multiple-sclerosis-research.blogspot.com/2017/03/politicalspeak-become-activist-and-sign.html

    http://multiple-sclerosis-research.blogspot.com/2017/02/tabalumab-ly-2127399-trial-in-243.html

    http://multiple-sclerosis-research.blogspot.com/2017/02/whats-happening-with-clinical-trial-data.html


    Best wishes


    Gareth Pryce PhD
    Centre for Neuroscience and Trauma
    Blizard Institute
    Barts and The London School of Medicine and Dentistry
    4 Newark Street
    London
    E1 2AT
    Tel: 020 7882 2487

    ReplyDelete
    Replies
    1. Well done MD2, very polite, diplomatic and totally open and honest to draw EL attention to the blog posts and petition :-)

      Delete
    2. Thanks Judy. Hopefully all the activity will spur them into action.

      Delete
  3. Things are moving at the legislation level - I just found this information on clinicaltrials.gov : https://www.federalregister.gov/documents/2016/09/21/2016-22129/clinical-trials-registration-and-results-information-submission
    Results should be registered within 1 year of completion, with a possible delay of 2 years if necessary. Starting January 2017. (and they introduce penalties for delays). I guess this is good news for the future.

    ReplyDelete
    Replies
    1. It depends whether this will apply to getting access to all the data from the trial and whether this also applies to therapeutics that are abandoned after the trial and which are not to be taken forward. I suspect it will still be possible to weasel out of providing the full data.
      The devil is in the detail!

      Delete
  4. The BBC Facebook page asked people what they would like investigated, so I told them.

    'It would be good if you could look at why Eli Lilly are refusing to share the results of their Tabalumab trial with the scientists at Barts. Their failure to disclose is unethical and disrespectful to the people who risked their health in the trial. Releasing the data could prevent others going through needless trials, and could also help scientists move closer to finding out what Multiple Sclerosis is and how it can be treated. I would like you to look at how Pharma are getting away with deliberately blocking progress in treatments for MS. If anyone took part in that trial please contact Prof Gavin Giovannoni, Barts.'

    ReplyDelete
    Replies
    1. Nice one Julie, well done. Brilliant news the petition has so far found 7 people who took part in trial :-) (even if some were marked in error, likely to be some genuine)

      Delete

Please note that all comments are moderated and any personal or marketing-related submissions will not be shown.