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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

#41

Post by yadongwen »

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…

Another example is Brigatinib (AP26113) which I'm familiar with. It's only approved recently because ~1% patients may get a severe side effect. But desperate patients who heard the news and cannot get it have managed to make their own based on the formula and the powder they made has saved hundreds of people's lives with metastatic lung cancer in the past a few years.

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

#42

Post by criley2 »

scrollbar wrote: post #37
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 will reflect your outrage back to you now: Why on earth would you NOT assume that institutionalized greed affects the results of medical science? Who is funding the science? What are their financial motives? Who conducts the research? What are their financial motives? Are incentives aligned to produce quality medical research with the patient's best interests in mind, or the bottom lines of medical companies (pharm…

>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 emotional histrionics and petty exaggeration.

AKA: I'm basically informed on this subject, unlike most of the commenters here.

>Who is funding the science? What are their financial motives? Who conducts the research? What are their financial motives? Are incentives aligned to produce quality medical research with the patient's best interests in mind, or the bottom lines of medical companies (pharma, medtech, even hospitals, etc.)?

What is GLP?

What is GMP?

What is a NME?

How many NME's does the FDA approve per year?

>I'm shocked and surprised at your shock and surprise. I don't think your arguments are irrational. I simply think they are naïve.

I'm not shocked or surprised at your response, it's a classic case of Dunning Kruger where you are so ignorant regarding medical science, the intense science based regulation of the FDA, and the business of creating drugs, biologics, devices etc, that you are inherently incapable of evaluating your or mine competency here. If you think I am naive, that is a real testament to the depth of your ignorance on this subject.

Back in university, we used this book to teach people the absolute and most basic fundamentals of this industry https://www.amazon.com/Drugs-Discovery-Approval-Rick-Ng/dp/0...

If you'd like me to answer your questions honestly, I'd be more than happy to take some time to source and answer your question from the perspective of someone who has studied this subject academically and participates in it professionally. But the book linked will discuss I believe every one of your ethical concerns.

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

#43

Post by orblivion »

criley2 wrote: post #36
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.

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?

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

#44

Post by openasocket »

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…

> 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

Is there anyone, in the world, advocating for getting surgery or taking medicine when the harm of not doing so is less than the potential complications? I'm pretty sure if a doctor did that it would be malpractice.

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

#45

Post by noir_lord »

orblivion wrote: post #38
noir_lord wrote: post #7

A more interesting question would be how many would have a significant safety issue without FDA approval. Given the complexity of the drugs, the body and the interaction with other medication I'm impressed it's only 1 in 3 particulary since as mentioned down thread only 1.3% get taken off the market (1 in 77).

You would also have to consider whether the drug companies would choose an alternate route for validating safety. I think they would care at least some amount about their reputation for safe products.

The Dutch (iirc) have a saying "The butcher certifies the meat".

Given the commercial pressures on a new drug, vast expenditure I'm happy another body is in the loop.

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

#46

Post by MrFantastic »

criley2 wrote: post #42
scrollbar wrote: post #37

Earlier quoted context omitted.

I will reflect your outrage back to you now: Why on earth would you NOT assume that institutionalized greed affects the results of medical science? Who is funding the science? What are their financial motives? Who conducts the research? What are their financial motives? Are incentives aligned to produce quality medical research with the patient's best interests in mind, or the bottom lines of medical companies (pharm…

>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.

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

#47

Post by Alex3917 »

conanbatt wrote: post #31
noir_lord wrote: post #7

A more interesting question would be how many would have a significant safety issue without FDA approval. Given the complexity of the drugs, the body and the interaction with other medication I'm impressed it's only 1 in 3 particulary since as mentioned down thread only 1.3% get taken off the market (1 in 77).

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.

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

#48

Post by makmanalp »

orblivion wrote: post #38
noir_lord wrote: post #7

A more interesting question would be how many would have a significant safety issue without FDA approval. Given the complexity of the drugs, the body and the interaction with other medication I'm impressed it's only 1 in 3 particulary since as mentioned down thread only 1.3% get taken off the market (1 in 77).

You would also have to consider whether the drug companies would choose an alternate route for validating safety. I think they would care at least some amount about their reputation for safe products.

Or, perhaps they might find it cheaper to instead launch massive PR and discrediting campaigns, deny there is any issue, settle lawsuits to silence complaints from individuals who don't have money and time to legally fight a billion dollar business. I'm not saying this'll definitely happen, but it has happened many times in the past, right?

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

#49

Post by JustSomeNobody »

orblivion wrote: post #38
noir_lord wrote: post #7

A more interesting question would be how many would have a significant safety issue without FDA approval. Given the complexity of the drugs, the body and the interaction with other medication I'm impressed it's only 1 in 3 particulary since as mentioned down thread only 1.3% get taken off the market (1 in 77).

You would also have to consider whether the drug companies would choose an alternate route for validating safety. I think they would care at least some amount about their reputation for safe products.

I'm totally sure Mylan,Turing Pharmaceuticals or Theranos would seek third party validation of their respective products.

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

#50

Post by dzdt »

theseatoms wrote: post #23
fictioncircle wrote: post #20

Earlier quoted context omitted.

> Insurance companies are the most aligned with your wellness financially. They want as many healthy people to pay in as possible. That is only true if they are forced to accept people blindly and without screening. Otherwise, they simply create a screening process centered around removing unhealthy people and preventing unhealthy people from enrolling.

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?
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