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Nearly 1 in 3 drugs have a significant safety issue after FDA approval

latimes.com

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Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval

#61

Post by amyjess »

refurb wrote: post #4

As someone who works in the industry, this shouldn't be much of a surprise. Most drugs have a very low incidence of serious side effects. Even over the counter products do. The reason they are approved is that they are so rare. A great example of a serious side effect is Toxic epidermal necrolysis (TEN) and Stevens–Johnson syndrome (SJS). There are many everyday drugs (ibuprofen, antibiotics, etc) that can cause this…

Last month, my doctor gave me a shot of toradol (for reasons I don't want to go into). The allergic reaction I got from that shot had me terrified I was experiencing the early symptoms of TEN at first.

I had hives all over my body, plus muscle pains all over my arms and legs (at its worst, I could barely hold a razor and needed a cane in order to shuffle around). You know what comes up when you search for bumps all over your body combined with pain? Yeah, TEN.

Fortunately it was just allergy-induced hives and myalgia, and I understand that the pain I went through functioned like an acute case of rheumatoid arthritis, but that was still nasty. I ended up in the emergency room twice. The first course of steroids they prescribed me wasn't long enough or strong enough: the hives never fully went away, and the myalgia came back as soon as I finished the prednisone. So I had to go back, and then they gave me a shot of decadron and put me on a two-week course of prednisone.

Yeah, that wasn't pleasant. At all. The side effects I suffered from the prednisone were awful and insidious, but at least it killed the allergic reaction.

Oh, and during that time, a friend of mine died, and her death was all over the local news because of how mysterious it was (they still haven't solved it or even released a coroner's report yet). April 2017 was terrible all around.

Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval

#62

Post by adrr »

mmstick wrote: post #53
adrr wrote: post #16

Earlier quoted context omitted.

Infant mortality and life expectancy are improving with modern medicine and diet. Most of our problems today stem from the over consumption of food and lack of physical activity. Cancer rates are at an all time low even though media makes it seem like everything(non caloric sweeteners, plastics, herbicides) around us causes cancer. https://www.cdc.gov/cancer/dcpc/data/race.htm

Except that the US, a major proponent of modern medicine, ranks very poorly compared to other nations in the infant mortality charts -- especially against countries that prefer natural non-western medicine, and life expectancy is clearly linked to financial status -- those that can afford health care. IE: where I used to live in Arkansas, the average life expectancy is 67, whereas in a rich state like Virginia, it's…

Everything is correlated to obesity. Arkansas has the highest obesity rate in the nation. When you look into our infant mortality rate it is linked in preterm births. Preterm birth is highly linked to obesity and is trending up.

http://sm.stanford.edu/archive/stanmed/2013fall/article2.htm...

Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval

#63

Post by [deleted] »

dcolgan wrote: post #51
criley2 wrote: post #35

Earlier quoted context omitted.

>if you want to be healthy, remove unnatural things from your body (sugar, medicines, sitting too much, etc), ?? What is "natural"? How do you define "natural"? Is there a single point in human evolution that you call "done" and emulating that discrete point is natural, and anything before or after is 'unnatural'? I always struggle to understand "natural" woo because it is, at its core, an undefined and meaningless w…

I think some nuance here is needed. My understanding of "natural" primarily comes from an understanding of evolutionary history. If humans have been doing something for millions of years, it is likely to be more "natural" and therefore not cause harm compared to recently invented things. But it is not a black and white thing, but rather a spectrum. Some examples: Trans fats were invented because they thought saturate…

[deleted]

Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval

#64

Post by hnhg »

dcolgan wrote: post #57
hnhg wrote: post #54

Earlier quoted context omitted.

So you're saying, if an anecdote fits your theory, it's proof, and forget searching too hard for anything that runs contrary to your beliefs? I think science works a bit better than this, and I put my faith in that.

A good hypothesis can be used to make predictions. I'm just saying with my foot issues that the heuristic of "subtractive medicine is better than additive medicine" was able to predict that removing padding from my shoes would make my problem go away. And it did. That does not prove anything but it worked here.

Say that the padding had worked, you might have rationalised it to to be that it's unnatural to walk on hard surfaces ("our ancestors never walked on concrete").

There are also probably many instances in your life where this hasn't worked, but you've cherry picked the example that does.

It's very likely that your body healed itself regardless of the padding. You might have just needed time. You've figured that it's removing the padding but it might not be a factor. It's why studies need decent sample sizes to make strong conclusions.

Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval

#65

Post by bluetwo »

bluetwo wrote: post #40

Every so many years there is a push by the industry for tort reform. They want to be legally protected from any damages as long as the FDA has approved the drug. Bookmark this article to remind yourself next time they make this push.

I have wonder why this was down-voted.

Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval

#66

Post by amyjess »

Alex3917 wrote: post #47
conanbatt wrote: post #31

Earlier quoted context omitted.

Or harder still, how many drugs never get to the public because of the expensive process of FDA approval that skyrocket costs and kill people without getting reasonably priced low-risk medicine.

> how many drugs never get to the public None. FDA approval isn't required to manufacture, sell, or purchase drugs. It's only required for companies that want to make marketing claims about the ability of drugs to treat various illnesses and conditions. As long as the drug you want isn't scheduled by the DEA, you're free to go online and order however much you want.

If it's not a controlled substance, you can buy all you want, but it's illegal to sell it unless it's been approved by the FDA.

Sure, if you want to order your meds from online pharmacies based in India and Vanuatu, you can (and I personally know people who order cyproterone acetate from these pharmacies because it's the best oral anti-androgen in existence but hasn't been approved by the FDA mostly out of laziness/cheapness), but you can expect to pay a lot of money. Oh, and you run the very small risk of having your meds confiscated by customs (they legally can't take action against you, because buying isn't illegal, but they can confiscate it because selling is illegal), but thankfully the government only has the resources to actively confiscate meds from online pharmacies one week per year (look up "Operation Pangea").

Even for a drug that's approved by the FDA, you'll be paying more to order the meds online than you will to go to a doctor, pay for the visit out of pocket, and have the prescription filled at Walmart (I have personal experience with this: because it's a pain in the ass to find doctors who will treat trans people, a lot of us start off ordering our meds from online pharmacies before we find a doctor, and it's not a huge deal because dosages are standardized, you can order private blood tests from certain labs, and official clinical guidelines are freely available for download -- but it's always cheaper to go through a doctor even if you're self-paying, the problem is finding a doctor in the first place).

Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval

#67

Post by ploxiln »

bhalperin wrote: post #13

Scott Alexander [1] has some useful (critical) comments: "significant safety issue" is not necessarily what it sounds like. [1] https://slatestarscratchpad.tumblr.com/post/160559317596/kit...

I hope no one minds if I copy some choice quotes from his comments here:

> Only three of the events were withdrawals, meaning that only 1.3% of approved drugs were recalled off the market.

> In 2006, the FDA added a boxed warning to warfarin, a blood thinner which at that time had been out 52 years, saying that if you took too much of it, it could make your blood too thin.

> Another example: antipsychotics are not FDA-approved for dementia. I don’t even know if any company has ever tried to get antipsychotics FDA-approved for dementia. Giving demented people antipsychotics is a bad idea if there’s any other option. But people do it anyway, and then the demented people get heart problems and die. The FDA eventually figured that out and put a boxed warning on antipsychotics not to give them to demented people if possible. This didn’t show up before approval because nobody wanted them to be given to demented people so there was no study about whether it was a good idea.

Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval

#69

Post by leekyle »

afarrell wrote: post #33
bhalperin wrote: post #13

Scott Alexander [1] has some useful (critical) comments: "significant safety issue" is not necessarily what it sounds like. [1] https://slatestarscratchpad.tumblr.com/post/160559317596/kit...

It is worth noting that Scott Alexander is an MD who is currently finishing his residency.

I was recently reading "American Sickness" by Elisabeth Rosenthal. She was talking about how an anti-nausea medication was taken off the market for safety issues because it caused heart issues at 50 times the dose usually taken. After doctors were forced to use Zofran instead, which costs at least 20 times more.
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