

Theory, Evidence and Examples of FDA Harm - monort
http://www.fdareview.org/harm.shtml

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Animats
The FDA requires that drugs be both safe and effective. It's the "effective"
part that bothers some people. Effectiveness has to be established by clinical
testing, which is expensive. Many new drugs fail, even after approval. The
gold standard for "effective" is "after 10 years, are patients significantly
better"?

The "natural"/"herbal"/"homeopathic" drug industry managed to get Congress to
exempt them from the "effective" requirement. There was a big right-wing push
for this. Rush Limbaugh had a financial stake in Zicam, which sells
homeopathic cold remedies, and used to promote it on his radio show.

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jmount
I'll give the FDA a lot of credit for things like blocking thalidomide from
the US in the 1950s and 1960s (looks like Richardson-Merrell was pushing hard
for US sales after it had already caused a disaster and been banned in
Germany)
[http://en.wikipedia.org/wiki/Thalidomide](http://en.wikipedia.org/wiki/Thalidomide)
. Like all things you have to balance the harm and good.

~~~
toolz
The FDA has a ton of power and resources. I would be highly surprised if they
didn't have a large numbers of victories, but in relation to their power and
resources it doesn't take much bias to find them lacking.

~~~
Houshalter
Even though they've stopped bad drugs, they've also stopped good ones. If you
look at the net benefit of the FDA it's negative. Not that we shouldn't have
any any drug approval process, just that the current one is too conservative.

The reason for the conservatism is simple. Everyone sees when bad drugs get
through. It gets media attention, there are lawsuits, laws are proposed to
retrospectively fix it, etc. But no one cares or even notices when a life
saving drug is delayed or prevented from getting to those who need it.

And so there will always be extreme bias towards conservatism and we need to
fight it.

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Elrac
Looking at SourceWatch, The Independent Institute looks to be an industry-
funded Tea Party Liberal think tank.
[http://www.sourcewatch.org/index.php/Independent_Institute](http://www.sourcewatch.org/index.php/Independent_Institute)

They may be right about what they say, but I wouldn't feel comfortable taking
their analysis without a grain of salt.

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datenwolf
Story time: I'm from Germany, co-founder of a company that builds lasers which
are marketed toward users in biomedical research. So when selling into the USA
we've to deal with the FDA twice: Because the application is medical and
because these things are lasers (little known fact: The FDA also oversees
laser safety regulations and enforcement).

In February I attended a conference in San Francisco and at the end of the
week came down with benign infection; anyway I was headed to a pharmacy
looking for some remedy; the first thing that had the label "FDA approved" on
it I took. Why? Because I know firsthand how strict the FDA is and that they
are a no-bullshit agency, so I knew that this thing surely was safe and be
effective.

BTW: Getting a new medical device FDA approved is not a very time consuming
process; at least not for diagnostic applications. It can be done in under
half a year, if your paperwork is thorough and your testing solid.

