Milton Friedman on the missing consequences of slow FDA approvals

[guest]

Despite the fact that this interview is several years old, Milton Friedman says something very, very interesting. For those of you who don't know Milton Friedman, he was a professor of economy and was one of the most famous advocates of libertarianism in the world.

In this interview he is asked if the FDA is a good institution because it did not approve thalidomide which caused birth defects. Not approving it was a very good thing because in Europe for example, thalidomide was approved and did a lot of harm. Friedman however also says that the FDA is a bad institution and should be abbolished. I'm not here to discuss if the FDA is a necessary institution but I want to pinpoint towards the dilemma in which the FDA is stuck and which negatively influences treatment possibilities.

It is always better for the FDA not to approve a drug or to take things very slowly. Why? Imagine drug XY wants to get approval and it gets approved by the FDA. Unfortunately drug XY causes fatal side effects in some patients. If this comes out, everyone at the FDA who was responsible for approving the drug is in big trouble for having made a wrong decision.

Now imagine the following. We have drug XZ and this drug treats a disease. It gets approval after 10 years and after 20 years we come to the conclusion that it is a great drug and has no severe side effects even in long term use. In these 10 years before the approval, many people died or suffered because they did not receive treatment. Now please tell me, who will be held responsible for the deaths and the suffering of people who did not get treatment because the FDA did not approve the drug? I can give you the answer, no one.

It starts at 4:20:

[video=youtube;KUDV0YII6lk]http://www.youtube.com/watch?v=KUDV0YII6lk&feature=related[/video]

And this is the problem we encounter in XMRV as well. It is always easier to keep the status quo for governmental institutions because they cannot be held responsible for it.

Claiming that XMRV is a human pathogen has wide consequences because if it is not, you made a fool out of yourself and your scientific reputation is screwed for the rest of your life. However, if you say that contamination is likely(!) the cause of all positive studies, you are on the safe side. Even if XMRV is a pandemic no one will fire you and no one can sue you and with all the quacks in these government health institutions you will always have friends to keep you in the business.

 

[Esther12]

I disagree with Friedman on this. I want a more serious, cautious and evidence based approach to CFS.

I'm more concerned about the casualness with which misleading versions of CBT have been promoted for CFS than any delay in putting patients on anti-retrovirals. If patients want to push to take anti-retrovirals on their own initiative, that's one thing, but I really don't think doctors should be recommending or promoting anti-retrovirals for CFS at this point. The evidence is still frustratingly ambiguous (I feel like it must still be December - we've got no solid news yet!) and I think there's still a genuine and quite widespread belief that all XMRV research could be mistaken, rather than just a fear of acknoledging a difficult reality.

Maybe this is a result of my own experiences, but I feel that there's already too much of a willing to 'do something, anything' within medicine, and I'd prefer to see that restrained.

 

[guest]

I disagree with Friedman on this. I want a more serious, cautious and evidence based approach to CFS.

As you know we currently have the FDA and the approach towards CFS is not very scientific. It makes no sense for companies to put money into CFS drug development because it is very unlikely (look at Ampligen) that these drugs will be approved. Your wish towards a more serious and evidence based approach has nothing to do with the FDA.

If patients want to push to take anti-retrovirals on their own initiative, that's one thing, but I really don't think doctors should be recommending or promoting anti-retrovirals for CFS at this point.

As long as doctors don't push patients into a anti-retroviral therapy and as long as patients can decide freely I see no problem with this.

Maybe this is a result of my own experiences, but I feel that there's already too much of a willing to 'do something, anything' within medicine, and I'd prefer to see that restrained.

What do you mean by "too much willing to do something within medicine"? This definitely is not the case with CFS. 9 out of 1o doctors won't prescribe anything for CFS except CBT maybe. If you would like to restrain these treatment approaches I guess it also would be fair for these people to sue you in case these treatments work and they weren't granted access because someone liked a more cautious approach to CFS for everyone?

As Friedman says, your liberty ends where the liberty of another person begins and the treatment of CFS certainly is within the bounds of an individuals liberty.