Melanoma 

Bioethical Concerns:

 

 

Bioethics is described as the ethics of medical and biological research. Ethics themselves are moral principles that guide our decision making. In the course of providing medical services, many questions are raised concernig how these resources are allocated. The FDA determines the testing a drug or procedure goes through before going on the market. In making that decision they have to weigh the need of sick patients against the risk of undertested drugs.

 

Of course, one line of reasoning says that if a patient needs care, and some undertested therapy exists that could help him or her, the patient should recieve treatment. Intuitively, this seems like a good decision. It would hardly be ethically justifiable to hold back medicine from a dying man...but there are two  important counterarguements that must be made here.

 

First, the purpose of the extensive testing required by the FDA is to insure that drugs presented to the American public are safe and effective. If some drugs pass examination based on need rather than proven effectiveness they could provoke unwanted side effects, worsening the condition of the patient. Additionally, less effective treatments could be approved for the needs of immidiate patients, and then future patients would only recieve the limited benefits of an undertested drug. Overall, approving treatments too early could lead to a market flooded with ineffective and harmful drugs.

 

With these things in mind the FDA created their accelerated approval program. Keytruda is now available to patients suffering from malignant melanoma, but only to thpse who have not responded to previous treatments of ipillimumab and BRAF inhibitors. In this way the government can provide care to patients in extreme need without sacrificing the quality of drugs on the open market. 

 

One final issue remains however. Treatments of this kind are highly expensive. Keytruda costs $12,500 a month, and Yervoy is only shortly behind at $11,000 a month. An arguement could be made that even though this is the only chance these patients have, they should not be forced to pay extrodinary fees for undertested medicine. In these kinds of cases companies like Merk (Keytruda's manufacturer) are holding people's lives in the balance, and charging the families of these dying patients thousands of dollars for treatment that has not been fully approved by the FDA. I personally believe that companies should at the very least refund families for unsuccessful treatments until the FDA has fully examined and approved their product.

 

Obama said, "As our nation invests in science and innovation and pursues advances in biomedical research and health care, it's imperative that we do so in a responsible manner."  No single arguement here is definitive and it is important that policymakers consider all of them before making decisions that could impact the lives of million of patients now and in the future.