Government versus Patients

This is from a Wall Street Journal op-ed:

I have been battling non-Hodgkin's lymphoma, an incurable blood cancer, for the past nine years… a cancer vaccine developed at Stanford University 15 years ago gives 90% of patients very long remissions and cures some entirely. Unlike chemotherapy, there are no severe side effects.

But I couldn't get the vaccine because the Food and Drug Administration required another trial that would take nine more years. Over-regulation has kept this treatment from patients for 21 years, as some 24,000 lymphoma patients died each year.

Comments (6)

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  1. Devon Herrick says:

    The Food and Drug Administration (FDA) is very risk averse. The calculus of FDA approval is that when Americans die because the FDA has not yet approved a certain drug, the FDA is not blamed for the death. However, whenever someone dies from an adverse side-effect, people blame the FDA for not being more careful when it reviewed the drug. Even when the benefit-to-risk ratio is very high, the FDA would prefer to err on the side of caution.

  2. John R. Graham says:

    I wrote about this a little while back, in a paper titled “Leviathian’s Drug Problem,” and concluded that the FDA’s over-cautious approach is implicated in 200,000 deaths annually. The FDA needs competition in approving new drugs. Unfortunately, the political incentives are in the wrong direction. Dr. Hamburg has indicated that she will be even more prone to making these deadly errors.

  3. Joe S. says:

    Why are you guys mincing words. The FDA kills people. There should be a requirement that the letters “FDA” always be accompanied by a warning label.

  4. Brian W. says:

    The FDA’s decision to avoid risk isn’t always their decision to make. I can’t think of many risks that are greater than dying from cancer. When someone’s life and health are at stake, shouldn’t individuals be empowered to decide what risk they are willing to bear?

  5. hoads says:

    Better to prevent life saving and extending drugs from coming to market than to have to impose restrictions on Medicare/Medicaid funding of expensive drugs when your ultimate goal is to acquire control of an entire healthcare system and eventually balance the age of the population. Don’t want to do anything in the meantime that might make constituents distrust government funded healthcare.

  6. Kartik says:

    The FDA, like Health Canada, is a pain in the rear.