Wednesday, June 27, 2012

Gideon Softer: FDA Killing Crohn’s Patients (And Others)

I came across this op-ed in the Wall-Street Journal recently in a case about how a young man who was diagnosed with Crohn’s was fighting for his life. What is even worse is that the author (young man who has Crohn’s passed away last year). The author Gideon Sofer enrolled in a clinical trial after having half of his intestine removed. Sofer was enrolled in a clinical trial for stem cell therapy made by a company called Osiris Therapeutics. The drug called Prochymal had already shown promising results in Phase II and Sofer was entering the Phase III trial. However, clinical trials are randomized and double blinded so the patient and doctor has no idea what drug they are getting. In a short period Sofer became worse yet had no idea if he was getting the treatment or placebo. He and his doctors tried to get Osiris to get more information but the FDA doesn’t allow that. Even though Prochymal had “fast track” status from the FDA in 2007 the drug is still not on the market meanwhile Crohn’s patients and patients with other illnesses can benefit from the drug.

The problem with the FDA is that no drug is too safe for them. Every drug does contain risks and side effects the question is what tradeoffs are people willing to make. I would be willing to bet that a typical Crohn’s patients has much more knowledge about Crohn’s disease than anyone on the FDA panel that approves the drug. Real people are suffering and the FDA controls what patients can use or not use. I would rather see the FDA first check to see if the drugs were safe and then allow patients to determine if they worked. Patients are not uninformed fools. When people make decisions they often go to a doctor (sometimes even two or three), do research, and talk to loved ones. What is even more interesting is that the FDA has made it harder today for a drug to become approved even though we more information than we have ever had about the human body. Everybody has different genetics, biology, and chemistry within their body and to make a blanket statement about a group of people who suffer from the same thing is ridiculous. Even people with rare diseases often don’t have the same exact symptoms which makes the case for how every individual is different and when the FDA claims a drug isn’t effective they forget that some people have benefitted.

Also have you ever wondered why Remicade and Humira are not cheap? Since the FDA limits what drugs enter the market they have a monopoly on what drug companies can offer. Drug companies invest billions of dollars into each drug they research and develop yet only a very tiny percent get approved. So in essence when you pay for the cost of a blockbuster drug you are also paying for the drugs that didn’t work since the drug company is trying to try to recoup some of their investment. If more drugs were approved it would create more competition which would lower the prices of all drugs and in the long run help patients with their illnesses. Also because drugs are not approved information is suppressed about what drugs work or don’t work. This helps to retard progresses in our understanding in how drugs interact with the body.

The tragic case of Gideon Sofer teaches us that the FDA does more harm than good and it’s power should be limited and given to the millions of patients that suffer from not only Crohn’s but other chronic and deadly diseases. The FDA needs to realize knowledge is power and they do an incredible job of suppressing progress. 

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