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by tvural 3322 days ago
Negative press like this probably contributes to the FDA being so conservative. They get none of the benefits when a great new drug is approved, but get scapegoated when they approve something dangerous even to small numbers of people. So they just approve as few drugs and medical devices as they can get away with - it's a massive misalignment of incentives.

One might think drugs would be more dangerous if the FDA were less conservative, but I suspect the opposite. If it takes you ten years and 2 billion dollars to release a new drug, and then you find out it has some terrible side effect in 0.1% of the population, you don't get to fix the problem. You might not withdraw it either, since the drug would still be a net good for society. And if one drug is approved instead of ten, patients are forced to stick to the flawed solution.

The far bigger problem than drugs with side effects is a lack of drugs. Around 1/3 as many drugs get approved today relative to 1970, and the costs of a drug approval have risen 5 times faster than inflation since then. Medicine has been an anti-technological field for the last few decades - it's doing less with more. The most valuable biomedical companies are the ones that have been around since the 1800s - one could imagine what computers would look like today if IBM were still the largest IT company.

6 comments

For the record, the 2 billion dollars figure is from the notorious tufts centre for the study of drug development, which is heavily pharma-backed.

It's a very, VERY controversial figure in the pharmacoeconomic literature, but has been accepted as gospel due to continuous repetition in shitty reporting.

Fairly good article discussing this: https://www.washingtonpost.com/news/wonk/wp/2014/11/18/does-...

Your stats are a tad dated - the FDA has far better (in terms of granularity) stats lately that show a pretty steady trend towards 'more approvals' in the past few years - this includes biosimilars and new molecular entities (novel drugs): https://www.fda.gov/downloads/aboutfda/centersoffices/office...
Sam Peltzman goes into great detail on this issue in his book "Regulation of Pharmaceutical Innovation."
Which is published by the American Enterprise Institute, a conservative think tank, known among other things, for climate change denialism of all sorts: 1) saying it will be minor / non-existent, 2) if it is real, it won't cost much to mitigate 3) bribing scientists as a last resort to get their alternative facts out.
We aren't talking about climate change or the AEI. What specific criticisms of the book to you have?
I read books to gain information. Books are convenient collections of facts where ideally the author has gone through the trouble of scholarship and synthesis. Thus, when I read any book, I like starting with a high bayesian prior of being able to trust the information in it, without having to fact check the statements. Indeed, this is the primary value I get from reading a book as opposed to looking stuff up myself.

Now, when the publisher is known for publishing lies and distortions, it reduces my bayesian prior that their publications are any good, particularly given the explicit stated mission of this institution is to push a given political viewpoint. It is not about the flavor politics: I don't read anything by left-wing think tanks either. It is hard to distinguish fact from fiction when one reads propaganda from an organization whose purpose is to produce intellectualized propaganda.

Thus, my criticism of the book is - I am not able to trust the author or the publisher, due to the publisher having broken that trust earlier by lying to me. The author made a bad choice by choosing a publisher who publishes propaganda. Too bad. Trust is a pre-requisite I have for taking someone's writing seriously. So there you go.

This is why we have reviews/ratings etc. We trust our fellow readers too, and try to extend the chain of trust.

AEI operates with so much of an agenda that it would be impossible for me to pick up that book and read it without the filter of AEI published it. I'd constantly be on guard for where the authors tries to inject "Regulation? Booooo, hisss" sentiments.
You didn't answer the question.
Yes, he did. It was specific. I have a similar opinion.

Because the publisher also engages in climate change denial and other such thing, it is hard to trust anything in This book - even though it is a different subject. I couldn't read it and trust any factual bits presented to me - the worst case scenario is that I get these "facts" mixed up with things that are from more credible places without having the time or inclination to fact-check everything in the book.

"The far bigger problem than drugs with side effects is a lack of drugs."

I'm not so sure about that. Arguably the market is actually oversaturated with drugs, and too many people rely on them to an absurd extent rather than changing behaviors and habits to improve overall health.

> too many people rely on [drugs] to an absurd extent rather than changing behaviors and habits

It's not that simple. If I go to school and someone gets me sick, you wouldn't "this is your fault, you shouldn't have such bad habits like going to school." Furthermore, what are these good behaviors and habits? I can find a million articles on the internet telling me that cold showers are a good habit and another million saying hot showers are a good habit - which one is objectively right?

Yes, there are people who decide to use drugs instead of making simple changes (e.g. my friend who drank a large bottle of Jack in a day and needed to get his stomach pumped - he should have just vented to a friend about his girl issues). But there are so many other people out there who don't fit that description, and there isn't any true scottsman with objectively perfect behaviors and habits. So I don't think it's unreasonable to help people out with more options for drugs that may be better for some people than what we already have.

> can find a million articles on the internet telling me that cold showers are a good habit and another million saying hot showers are a good habit - which one is objectively right?

The one that works for you? We are all different, depending on ethnicity, medical history, and a million other factor your diet, life style and life choices will affect your health differently.

How do you define "works for you"? For example, say I take cold showers and decide "this makes me cold; I don't like it" and then start taking hot showers everyday. But then imagine that one day, we find a link between hot showers and cancer.

How was I supposed to know that cold showers would have been better for me? Should my "bad habit" really be blamed?

I'll fully agree with the other replies. To add to the other things posted:

The other thing with drugs is that there are quite a few diseases and afflictions, quite a few of which need special drugs. Some drugs don't work so well for some folks as others. Migraines and seizures are like this. Sometimes, we have new drugs because they generally come with fewer side effects than the old drug it theoretically replaced, yet the old drug is still in production because it still works better than the new on in them.

More like saturated with endless variations of the same drug.

The pharmaceutical industry likes to release a new variants of popular drugs in order to keep them patented. They then advertise to doctors and other involved parties in an attempt to convince them that the "new" drug is better than the old one.

It is possible to have too many and not enough drugs at the same time.

trust me: you think so until someone you care about develops a disease with no treatment.
While I understand what you want to say, wording is a bit poor. Quite a few extremely useful new drugs without any good equivalent are/were released too - for example in last 2 years we can actually cure Hepatitis C and get it out of the body for good! Till now it was almost a death sentence with high probability of liver cancer down the road.

(I know it since my fiancee is a doctor and she accidentally stabbed herself with needle from a patient who is extremely contagious with Hep C, so we did our research. luckily she didn't get it, the stab was quite shallow).

Or new drugs that enable HIV patients to lead +- normal life - they were not here 10 years ago. There are some overused and overprescribed medicines (painkillers, antibiotics in 3rd world countries being handed out like skittles).

There's definitely more that can be done behaviorally - the solution to obesity today probably looks more like eating better than taking diet pills. But this is the anti-technological solution that can only be pushed so far, like trying to solve the energy crisis by telling everyone to drive smart cars.

Also, there's often nothing you can do behaviorally. Even people with near perfect behavior will eventually get Cancer or Alzheimer's or Heart Disease. Most of the drugs approved to treat these diseases are something like band-aids that decrease your risk 10% or allow you to live a couple months longer. Maybe too many people are making drugs that work barely well enough for the side effects to be worth it. But almost anything that can get past the FDA will work economically, since there are usually very few alternatives from the buyer's perspective.

Quite all drugs have said effects I have to take BP pills and a couple of Christmas's ago I was doing a full roast dinner for the family, I accidently took a double dose and fainted at the table due to low blood pressure - that's a safety issue but a fairly trivial one compared to the benefits of controlling hyper tension
277 days ago you wrote, "Medical research sucks as it is, and longevity research is inherently time-consuming. There are ways to ease this, like testing treatments on mice first, but I don’t see an easy way around the need to apply the test to humans and wait many years to see the results."

Why the change in heart?