Lemtrada

[cdemuth]

Should the FDA approve this new MS therapy next month?

[Marco]

I hope Lemtrada is not approved. Patients should not be on medications improperly tested by the drug manufacturer. The drug company had quality problems with both the drug trial and interpreting the data derived from the trials. This has some parallels to accountants "cooking the books." If it is determined that test results and/or submitted information was fraudulent or doctored then appropriate criminal charges should be filed.

The FDA should maintain high quality standards and not approve Lemtrada without additional testing. There are people that are upset with the FDA, but I believe their anger should be redirected towards Genzyme. At minimum, the drug company should be forced to perform another Phase III trial to determine what, if any, benefits Lemtrada shows in a properly conducted test. Additional testing will also confirm potential life-threatening risks the drug presents.

[spacedive]

Yes. I've maintained a full time job since I got on Lemtrada.