The FDA's Deadly Policies

As Milton Friedman once said, "I don't think the state has any more right to tell me what to put into my mouth than it has to tell me what can come out of my mouth." Of course, the state doesn't agree and the FDA's whole raison d'ĂȘtre is to tell us what we can put into our mouths.

Now consider Andrea Sloan, a vibrant woman fighting advanced ovarian cancer. She has been through countless therapies that have kept her cancer in remission, but it has returned once more. Now her doctor informs her that she has run out of options. "We had the conversation where he told me to get my affairs in order." In other words, prepare to die.

In the midst of this despair, she learned of an experimental drug, named BMN 673, which is being developed by the California biotech company, BioMarin. According to Dan Spiegelman, chief financial officer: "As a phase two small patient study goes, it's as good as it gets. We think our numbers stack up well at this level. The drug is clearly the most potent of the compounds we're talking about." BMN 673 may yet help Sloan with her ovarian cancer.

Of course, any drug, even an approved and marketed drug, has risks. Sloan understands these risks and still wants to try BMN 673. "I just want a chance to live a long and healthy life and I'll continue fighting until I get it." In other words, she's going to die anyway, so why not try a drug that might possibly work? A chance of living is always better than no chance.

There's one big problem. The FDA has not approved BMN 673 and BioMarin is not offering BMN 673 under a so-called compassionate use program. Now, you might blame BioMarin for not offering this new drug to Sloan and perhaps BioMarin deserves to be rebuked. But BioMarin is only a player in the drug development game and it is the FDA that wrote the rules. The FDA does allow companies to give experimental drugs to people in certain life-or-death situations. However, if Sloan suffered some sort of problem or, worse, died while taking BMN 673, it could preclude the subsequent development and FDA approval of BMN 673.

Companies know how difficult and dangerous the FDA's drug approval process is and they respond rationally by behaving conservatively. This is an example of that behavior. If Milton Friedman got his way and the state didn't tell us what we could put into our mouths, I have no doubt that Andrea Sloan would already be on BMN 673 therapy. This is just another example of how the FDA's policies kill Americans, all the while presenting BioMarin as the bad guy who says "no."

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