Wednesday, August 29, 2012

FDA Panel and Humira for Ulcerative Colitis

Some good news might be coming for our inflammatory bowel brother and sisters (those who suffer from ulcerative colitis). In a 15-2 panel decision the FDA recommended that Humira would be beneficial for people who take ulcerative colitis. Humira is already approved for six conditions including Crohn’s disease. The FDA usually follows usually follows the panel’s recommendation however they don’t have to like in the case of a breast cancer drug. We will have to wait until the end of the year though to see what the FDA actually decides.  Last November the FDA rejected Abbott (maker of Humira) application to be used for ulcerative colitis. The FDA claimed that the drug did not show that it helped patients.

 The FDA should know that drugs work differently in everyone and no two people are alike. This is why I believe once a drug is approved for safety by the FDA people and their medical professionals should determine if they should take the drug. Not only would this bring in more competition which would actually drive down the cost of drugs but would make patients more aware instead of blindly trusting the FDA.

What is bizarre is why the FDA has to approve whether or not a drug is effective. Patients and doctors are far better at doing this then the FDA panel. My question would be what 2 people on the panel voted not to approve Humira for ulcerative colitis? Do these people have any family members with ulcerative colitis? Do they know what it feels to have ulcerative colitis? If you said “No” to the two previous questions then go to the head of the class. People have a huge incentive over their health especially when it is seriously. I would be willing to bet that Crohn’s and ulcerative colitis patients are in the top 1% of knowledge of the population since they have a huge incentive in knowing how to get better. 

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