The Food and Drug Administration is supposed to protect the people: from bad drugs, unsafe food, and greedy companies trying to make a profit at the people’s expense. But sometimes the FDA harms the people more than it helps them. Dr. Scott Gottlieb, a physician and resident fellow at the American Enterprise Institute, wrote an article in the Wall Street Journal criticizing the FDA for allowing patients to undergo fake surgeries as part of FDA testing (http://online.wsj.com/news/articles/SB10001424052702304680904579365414108916816). This is unethical for 2 reasons. First off, patients were exposed to unnecessary risks such as infection. Secondly, the medical device in question, Symplicity HTN-3, has already been approved and used in Europe. Not only did the FDA unnecessarily put American citizens at risk, but they also needlessly delayed an approved treatment from entering the market.
For most studies, the FDA has utilized the practice of giving patients placebo pills in order to test the efficacy of actual pills that may enter the market. The FDA has expanded this methodology, but for medical device-makers. This means some patients are being cut up, and exposed to infection, but without receiving the medical device. This is much more dangerous than a sugar pill. In essence, these patients are getting all the downsides, with none of the benefits. On The surface this seems like carrying out an effective experiment in order to get the best results. In most elementary science classes we were taught to control all variables in order to get the best results. This seems what the FDA is trying to do. However, Dr. Scott Gottlieb states that there are “…other scientific approaches also allow us to get rigorous evidence of safety and benefits, while enabling patients to get real rather than fake therapies. He goes on to say that 10 years ago the Food and Drug Administration would compare patients getting the new procedure to patients getting a different standard treatment for the same condition.[1] This way, both patients are getting treatment, while the government will be able to compare the effectiveness of the new treatment to the conventional treatment.
Even more startling, Symplicity HTN-3 has been already approved by European regulators. However, The FDA did not think that was enough, because the regulators did not use sham surgeries. It would be one thing if this medical device was completely new and had never been tested; yet the FDA insists on exposing patients to infection on a product that has been approved by regulators who are known to be especially stringent. So while I do understand there may be some situations in where sham surgeries are necessary – such as when it is a very small, non-invasive procedure or when the device is truly groundbreaking – this was not one of them. An opponent may counter that patients were aware that they might get a sham surgery. This is true. The FDA does let people know that they may either get the medical device implanted in them or that they may get a sham surgery. This does not change the fact that this is still unethical. Just because someone is told the consequences of something and still agrees to do it, does not make it ethical. For instance if one person paid another person $1,000 to jump off a cliff and the other person does, that does not make it moral even if that person agrees to it. Many of the patients who agree to the possibility of receiving a sham surgery, have no other choice. Other treatments aren’t working for them, and this method might be there only possibility of survival. It is worth it for them because this may be their only chance to get better. There choice is either live with a debilitating condition, or try a promising medical treatment but also have the risk of a sham surgery. These people should never have to make this choice. They could get this medical treatment without having to face a sham surgery and the risk of infection that accompanies it.
I realize that he FDA is trying to protect the safety of consumers. I understand that they are being cautious to protect our interests. But the FDA could do all of this without jeopardizing the health of patients or causing delays for a medical treatment. I’m not ruling out the possibility of sham surgeries for certain medical devices. But in this case, The FDA can rely on the work of European regulators as well as test the new medical device against existing treatments. By doing this the FDA would be able to uphold their duty of protecting patients without hurting them in the process.
I really learned a lot in this essay! I have to admit that before reading this, I knew nothing about the FDA, so this essay was really interesting to me. I also think that the flow of your logic was really clear. I would, however, be careful with not making the FDA seem as though it is doing something completely absurd with absolutely no reason. I imagine that their reasons are a little more complex than was exposed in this essay (although I know the word limit is tough).
Ben, I feel that your essay provided an interesting perspective to the issue of regulation by the FDA. However, it was very confusing when you started talking about Symplicity HTN-3 without going into any descriptions about it. I think it would have been good to explain what that is before explaining why it is bad. In your introductory paragraph you seem to imply that your essay will focus around Symplicity HTN-3, but you go on to talk about placebos. I feel that if you edited your thesis and your introduction paragraph to reflect a more broader picture about FDA regulations, that would be good. Overall, I feel that your essay brought up an interesting point, but it could be better with more information.