Imagine receiving an IV for five days one year, three days the next and possibly never needing to take an MS treatment plan again. Sanofi would like that treatment option to be a reality for MS patients in the United States. The new drug by Genzyme called Lemtrada may give MS patients that option but at what cost? Side effect concerns and clinical trial protocols have the FDA scratching their heads.
How credible is a drug study if the patients know they are receiving the placebo or the new medication? I really don’t know myself but I pose the question because that is what is causing the FDA to stop and wonder. In addition, the medication is risky presenting the possibilities of rashes, bleeding and thyroid cancer. For this reason, if approved, Lemtrada will not be recommended as a first-line therapy drug.
At what point should patients be given the choice to balance for themselves the risks of a medication and the benefits to their lives? This is the fence the FDA now finds themselves straddling.
The Boston Globe Business site has the article, “Genzyme MS drug gets mixed review” at http://www.bostonglobe.com/business/2013/11/13/advisory-panel-says-genzyme-drug-trials-were-flawed-but-treatment-could-still-allowed-for-sale/gPrZ2sflKL8HfWq9yivoxL/story.html.