Cladribine trial issue: Merck back tracking on promise to supply rebif

[bvad]

Hi,

The cladribine trial in india has been stopped and Merck is refusing to supply rebif for 96 weeks to patients who converted to RR during the trial. They claim to have the right to cancel the trial but do they have the right to cancel the supply of rebif? How do I contest this? there is no insurance here for rebif and it costs a fortune..this has shattered me and my plans

[Redwings]

Hi bvad:
I'm sorry to read of this awful turn of events for you. Whether Merck has the right to cancel their promise of Rebif as part of the canceled cladribine trial depends on the laws in India that regulate clinical trials. Your best bet is probably to contact the regulatory agency in India that oversees drugs and clinical trials and ask for their guidance on this.

Generally speaking, though, it would be a bad business decision for a company to commit to something that will bring them no return on investment. So it isn't likely that Merck would have contractually committed to providing almost 2 years of free Rebif if the clinical trial were to be canceled and the study subjects were no longer providing the thing that they agreed to trade for the Rebif -- that thing being their participation in the trial.

The possibility of the trial being canceled might have been addressed in the contract you signed when you agreed to participate in the study. So you might be able to get a head start on finding out what Merck's obligations are by reading the document you signed. If not, then the drug regulatory agency in India may be able to give you more information.