
7 Drugs That Big Pharma Withdrew and Hopes You’ve Forgotten About - azuajef
http://www.alternet.org/personal-health/7-drugs-big-pharma-withdrew-and-hopes-youve-forgotten-about?akid=14384.2563486.NeU6SR&rd=1&src=newsletter1058949&t=8
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themartorana
It's interesting to watch the dichotomy here, and how the FDA can't win for
trying. When something slips by, the FDA is fast-tracking dangerous drugs.
When Europe gets a new "miracle" drug before we do, the FDA is killing people.

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bearbin
HN Guidelines:

> If the original title begins with a number or number + gratuitous adjective,
> we'd appreciate it if you'd crop it. E.g. translate "10 Ways To Do X" to
> "How To Do X," and "14 Amazing Ys" to "Ys." Exception: when the number is
> meaningful, e.g. "The 5 Platonic Solids."

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ourmandave
Whenever my doctor says they have a new version of a prescription I always
pass.

I've seen way to many ads on tv from law firms asking if I or a loved one has
been injured by new drugs. (Call the 800 number and you're heirs might receive
a $1.50 settlement check in 10 years.)

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Aelinsaar
My favorite? Prilosec (Omeprazole, a proton pump inhibitor to reduce stomach
acid) was running to the end of its useful life for (Then AstraZeneca) Pfizer.
What to do? Nexium!

[http://www.chemistry-blog.com/2010/10/18/nexiums-dirty-
littl...](http://www.chemistry-blog.com/2010/10/18/nexiums-dirty-little-
secret/)

~~~
ceejayoz
Yep. Another common tactic is to bundle an expiring patent with a cheap OTC
med like acetaminophen or ibuprofen and call it something new.

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Aelinsaar
Evergreening needs to be regulated, it's such an obvious abuse of the existing
system.

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jrapdx3
Some of the drugs on the list are _very_ familiar to me. Meridia, Redux were
developed for obesity treatment. Redux had the same liabilities as
fenfluramine which back in the 90's was being very carelessly prescribed by
inexperienced practitioners resulting in unnecessary fatal outcomes. OTOH
fenfluramine had been on the market for decades without notable difficulties
until overprescribed.

Similarly PPA was a very old drug but bad outcomes were noticed after it was
used extensively without proper medical supervison.

Serzone was a different story. It was an unusual antidepressant drug insofar
as it had many active and a great many inactive metabolites which made its
effects less predictable. After millions of prescriptions worldwide, a handful
of fatalities associated with hepatic toxicity slowly came to light. When a
Canadian study reported 18 such cases the pattern became clear and ultimately
Serzone use was discontinued.

However it's not unprecedented that drugs can be metabolized to compounds that
are extremely toxic to the liver. It is a very rare phenomenon because having
the exact genetically determined combination of liver enzymes to produce the
toxic product is strictly a matter of chance. There's a huge number of
cytochrome enzymes that are highly variable subject to random genetic
variation. Once in a while a person is born with a particular set of
unfavorable variants when in comes to a specific compound.

The issue is that very rare events, e.g., 1/100000 cases requires huge number
of exposures before the adverse events can be correlated with use of the drug.
The FDA tries to assure safety, but prior to marketing it's not possible to
rule out the "one in a million" sort of event. That's the reason it's vitally
important to report side-effects, especially serious or life-threatening
incidents to the FDA.

No question that all drugs have side-effects and therefore should be used
knowledgeably and conservatively. But we must remain vigilant, there is
_always_ a chance of unanticipated outcomes, often for the worse, though
occasionally for the better.

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marricks
Is there any future where we can imagine that this gets better and not worse?
It seems like the pharma lobby has more and more power these days as it gets
more and more money. There seems to be little incentive for it to be fixed as
most people don't seem sufficiently outraged.

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dave2000
Yes but it's not possible whilst everything is done to make short term profits
for a small number of people at the very top 1% of society.

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Feneric
Sometimes it seems like the FDA spends more time and effort regulating
peripheral health devices like smart watches than it does regulating the food
and drugs that 1) it's named for, and 2) that people actually ingest.

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ceejayoz
The FDA is explicitly trying to _avoid_ regulating things like smart watches.
They're all but begging companies like Fitbit to be careful in their marketing
to avoid forcing the FDA to act on the claims.

[http://www.theverge.com/2015/6/24/8836049/fda-regulation-
hea...](http://www.theverge.com/2015/6/24/8836049/fda-regulation-health-
trackers-wearables-fitbit)

~~~
Feneric
Perhaps I should have been more careful saying "like smart watches" then. I
meant devices in general ranging the gamut from NiBP machines to SpO2 machines
to smart watches. Most of these have far less impact on far fewer people than
drugs or food, and yet the FDA spends a huge amount of resources regulating
them, even trying to walk through software development methodologies. This is
something I've seen first hand working at several sites that make such
devices. So perhaps they're trying to scare a few particular vendors out of
that specific arena, but on the whole they've got that industry tangled in a
huge amount of bureaucracy.

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iofj
They don't even mention some real disasters:

[https://en.wikipedia.org/wiki/Thalidomide](https://en.wikipedia.org/wiki/Thalidomide)

