#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)

  • 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

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