Hacker News Board Hacker News, browsed like a classic message board
Live data from Hacker News

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

latimes.com

Post reply on HN
Print view View original

51–60 of 167 posts

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

#51

Post by dcolgan »

criley2 wrote: post #35
dcolgan wrote: post #2

In one of my favorite books, Antifragile, Nassim Taleb argues that health is largely subtractive - if you want to be healthy, remove unnatural things from your body (sugar, medicines, sitting too much, etc), and only undergo surgery, go to the hospital, or take medicine in very serious cases where the harm of not doing something outweighs the potential complications. Especially since hearing more about more about how…

>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 saturated fat, which was consumed by humans for a long time, were not healthy, and this new thing was supposed to be better. Then it was found to cause all kinds of problems and are now banned in many places. Here I think it was pretty cut and dry.

An anecdote I've found others corroborate: I used to have foot pain. Some people suggested orthotic insoles, but I also found the barefoot shoe proponents saying that shoes without any padding at all (more "natural") work better. Five years later I never have any foot pain. The Vivobarefoot or Vibram Fivefingers shoes are definitely not something that was around a million years ago, but the principle is the same.

In healthcare, an example in the book is how many people are prescribed statin drugs if their cholesterol is too high, even if there is no other visibly problematic symptoms. Taleb would argue the far better solution is to improve the person's diet, or just wait and see if something happens, than to start taking a drug that isn't.

The author once strained his back lifting weights. The doctor suggested an expensive and invasive surgery. Instead he just rested for a while and the problem went away. On the other hand, my mom recently had neck surgery to replace several vertebrae. She'd been in pain for years and nothing could fix it. So in this case I think Taleb would agree that the risk of a dangerous surgery might be worth it in that case.

An extreme example from the book: in the early 20th century children were given doses of radiation to treat acne. We obviously look at this and scoff, but it is the same idea.

> Why on earth would you conflate the profit motives of healthcare middlemen to imply that the science behind medicine isn't credible?

I'm looking at the profit motives to see where I should be cautious. I feel like this very site is where I've read many articles about how scientific studies had bias because of funding from the companies invested in a certain answer. From what I can see, if you follow the money, you can explain a great deal of the behavior of large institutions.

So I'm not at all advocating ludditeism or against science. Rather I'm against scientism (I think the word he uses in the book) - the belief that science has all the answers and that newer things are inherently better than older things just because they are. They may in fact be better, but not always. Sometimes atheists I meet are just as close-minded as the religious.

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

#52

Post by criley2 »

orblivion wrote: post #43
criley2 wrote: post #36

Earlier quoted context omitted.

It's not farfetched in the least to have one entity approve the drugs based on roughly $1 billion dollars over 10 years[1] worth of research. What's more farfetched to me is allowing private, profit-motivated corporations the unfettered ability to produce this expensive research. Fortunately the all-but-oppressive regulation of the FDA from GLP and GMP to insanely rigorous science-based four phase system of testing i…

I will admit that some of us may be inappropriately dismissive of the usefulness of regulators. However pointing to how long it takes and how much money is spent could just as well imply inefficiency as rigor. You say that we don't need competing regulation agencies because this one is rigorously scientific. By what mechanism, would you say, does this singular institution maintain quality?

>By what mechanism, would you say, does this singular institution maintain quality?

Interesting question, quality is such a foundationally important and vital subject for the FDA. Hard to answer, it's like asking what does Microsoft do to maintain software quality? The answer has to be long and in depth... And in this case, the FDA is over 100 years old, born out of atrociously horrendous food and chemical accidents in America, so this is a century-old organization founded out of a desire to improve quality in food and drugs (Upton Sinclair's 1906 book The Jungle is considered important reading when understanding the FDA's mission)

So with the FDA (with CDER, the drug/med device/biologic/etc side of the FDA), the basic question they ask (and require all this work to prove is): Is your drug better than existing treatments and placebo treatments?

So, fundamentally, they have an ethos which only grants approval not for equivalence, but scientifically proven, double blind tested superiority to existing approvals. This is an ethos that less is more. That only quality matters. That a business should go bankrupt before 1 bad drug is approved.

But beyond that, to look into the question of quality, that's a great question that is very important to the core of the FDA's mission.

I would point, in recent decades to the emergence of "phase 4" trials -- post-release trials.

Now it is not enough to get approved, now we continue to test the efficacy and safety of the drug after it goes to market, and can and have pulled drugs (that cost billions in losses for companies) which seem to pass initial 3 phase approval but which, in market, demonstrates a lack of safety or efficacy, has side effects that change the calculus against existing treatments, or similar.

Also, another angle of quality is enforcement. What happens if GLP, GMP, safety, efficacy, is violated? You might be happy to learn that the fines that the FDA levies are some of the largest fines against businesses in history. Outside of BP-Gulf and the 2008 mortgage fines, the FDA sweeps the list of billion-dollar-level fines.

So you have a core commitment to quality at every level. An ethos continued from founding seeking scientifically provable superior quality at every judgement. GLP and GMP in the labs and factories which are the most rigorous site regulation you'll find in America. The 4 phase system of trials, including post-market data. And the most aggressive corporate enforcement arm in America, with an impressive list of profit-busting fines that no other regulator can stand next to.

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

#53

Post by mmstick »

adrr wrote: post #16
dcolgan wrote: post #2

In one of my favorite books, Antifragile, Nassim Taleb argues that health is largely subtractive - if you want to be healthy, remove unnatural things from your body (sugar, medicines, sitting too much, etc), and only undergo surgery, go to the hospital, or take medicine in very serious cases where the harm of not doing something outweighs the potential complications. Especially since hearing more about more about how…

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 87. What's the difference? Ability to afford health care.

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

#54

Post by hnhg »

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…

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.

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

#55

Post by dcolgan »

raverbashing wrote: post #21
dcolgan wrote: post #2

In one of my favorite books, Antifragile, Nassim Taleb argues that health is largely subtractive - if you want to be healthy, remove unnatural things from your body (sugar, medicines, sitting too much, etc), and only undergo surgery, go to the hospital, or take medicine in very serious cases where the harm of not doing something outweighs the potential complications. Especially since hearing more about more about how…

Sugar is natural (though HFCS is not) The first cartoon tells everything I think about this: http://www.newyorker.com/cartoons/bob-mankoff/cave-cuisine

I would argue that yes, sugar is natural, but the degree that people tend to eat sugar these days is unnatural. I'd argue that is the root problem. And to respond to the first image of the comic, that nobody lives past 30, some things I've read suggest that was more due to infant mortality skewing the average, deaths from war, and deaths from what today would be preventable diseases. If an ancient person avoided those three things, they lived quite a long time, and didn't get cancer or heart disease.

I have no exact sources for those last few assertions, it's just what I remember reading (I think also in the Antifragile book).

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

#56

Post by maxerickson »

grandalf wrote: post #27

The idea that we should all simply trust one entity to "approve" drugs is pretty farfetched. I think there should be multiple "stamps" of approval from a variety of entities that consumers can use to determine whether they want a particular drug... Why not have stamps from the FDA, insurer groups, physicians groups, etc.

Insurance companies all evaluate drugs before putting them on their formulary and doctors do at least a little bit before they start writing a prescription.

So there ya go.

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

#57

Post by dcolgan »

hnhg wrote: post #54
dcolgan wrote: post #51

Earlier quoted context omitted.

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…

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.

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

#58

Post by tracker1 »

criley2 wrote: post #35
dcolgan wrote: post #2

In one of my favorite books, Antifragile, Nassim Taleb argues that health is largely subtractive - if you want to be healthy, remove unnatural things from your body (sugar, medicines, sitting too much, etc), and only undergo surgery, go to the hospital, or take medicine in very serious cases where the harm of not doing something outweighs the potential complications. Especially since hearing more about more about how…

>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…

> Why on earth would you conflate the profit motives of healthcare middlemen to imply that the science behind medicine isn't credible?

Because marketing often distorts the results or outright lies. It's not necessarily the science that is the problem, but the marketing and approach in pharmaceutical sales that will push this. This has been, on occasion, reflected in terms of studies, efficacy and results in terms of manipulation of data.

Personally, I feel that compulsory licensing models as part of a dual-sourcing (at least two manufacturers for any drug) would help resolve or reduce a lot of the issues surrounding this. As well as reverting to some prior legal and cultural issues in terms of how marketing of prescription medications is done. TV/Youtube/Dr.Office advertising has gotten pretty horrible, and does very little to actually help people.

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

#59

Post by criley2 »

MrFantastic wrote: post #46
criley2 wrote: post #42

Earlier quoted context omitted.

>Why on earth would you NOT assume that institutionalized greed affects the results of medical science? Because I studied medical science and research for many years, have family in the medical field, and write medical software for a living. Or rather, I understand very clearly how greed and the capitalist motivation affects health care, as it's literally my life. But with a realistic understanding comes the end of e…

Then you should be familiar with how generations were lied to and told that Fat caused heart disease and low-fat/high carb was the best way to eat. Research funded by the Sugar Industry.

>Then you should be familiar with how generations were lied to and told that Fat caused heart disease and low-fat/high carb was the best way to eat.

I'm familiar enough with the FDA to know the difference of the Office of Food and Vet and the Office of Med Product and Tobacco.

Why don't you go research what CDER is, and try to determine whether or not diet guidance has anything at all to do with CDER and the actual topic of this thread.

"Research funded by the Sugar Industry."

Outrage porn funded for free, peddled by you.

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

#60

Post by theseatoms »

dzdt wrote: post #50
theseatoms wrote: post #23

Earlier quoted context omitted.

If an insurance company can "remove" you when you become unhealthy, then they weren't providing insurance in the first place.

What do you think happens when insurance is provided through your employer and you develop a health problem that interferes with your ability to do that job?

You likely lose your job and your healthcare insurance, at least after some period of time, I'm assuming. (Fortunately I can't speak from experience.)

So you did not, in fact, have insurance against a very bad situation. All the more reason to eliminate employer-based health insurance tax incentives. I don't buy anything else through my employer. Why should I be insuring against my future medical bills through them?

It obscures my effective insurance premia (via a lower salary), on top of the already obscured price of healthcare, since most insurance policies cover so many incidental, non-catastrophic medical costs.

Post reply on HN