In late December the FDA denied the immediately approval of the new MS treatment drug, Lemtrada, due to the design flaw of not including a double-blinded component and the potential for serious side effects. Since then the group MoveOn.org has a petition requesting the FDA to reconsider their decision and approve the drug allowing patients the option to decide for themselves. The drug has been approved around the world including Canada.
Lemtrada works by killing white cells preventing them from attacking the myelin. The drug studies of Lemtrada showed efficacy in early relapsing-remitting MS patients. It improved disabilities for up to five years after the five days of IV. It was not effective in secondary progressive MS. Thirty percent of people on Lemtrada developed new autoimmune diseases, most related to the thyroid. However, it is considered significantly better than the interferon beta medications.
My thoughts on the topic are that the FDA is there to protect us from harmful drugs. Though Lemtrada evidently demonstrated well in controlling MS by considerably reducing relapses and disability, the side effects are real and potentially life threatening. If the FDA approves the drug and gives the patients the choice, then possibly those less informed would believe the FDA approval means the drug must be safe.
For those wishing to sign the petition simply go to MoveOn.org and read the directions. For more information on the debate over Lemtrada look up: