End the FDA.
Nearly 1 in 3 drugs have a significant safety issue after FDA approval
91–100 of 167 posts
Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval
#92Earlier 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…
I'm sure you're well read and educated. I won't ever be as knowledgeable on the subject as you.
I have the benefit, though, of not having my entire livelihood and career dependent on my faith in the systemic health of mainstream medicine.
Maybe you're right. Honestly based on the tone of your initial comment, I have written off your impartiality, and so have little desire to learn from you. I'm sure you feel the same towards me. So here's to coming to a stalemate while putting other people down on the Internet. Maybe that's the important learning point, for me.
Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval
#93Negative 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.
Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval
#94Earlier quoted context omitted.
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?
In that case, assuming you are fired from your work, you can get a continuation of your insurance under COBRA. See https://en.wikipedia.org/wiki/Consolidated_Omnibus_Budget_Re... The short answer is you can get a continuation of your same health plan for a certain period of time, but you have to pay more because your employer isn't subsidizing your premiums. Generally this extension lasts for 18 months, though if you…
I've gone through this; you should be aware that COBRA is a retroactive continuation of your coverage, from the day you leave your job, but it's not actually continuous. It can take weeks for the paperwork to go through, and during that time you effectively have no coverage. I found this out because I was scheduled for a surgery the week after leaving my job, and while checking in the hospital told me they couldn't verify my insurance. I was delayed about an hour while trying to convince them that I'd applied for (and paid for) COBRA already, and that I was, or would be, covered for the surgery that day. Eventually the department head allowed me to be checked in, but I'd gotten lucky.
Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval
#95[deleted]
Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval
#96The 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…
An idea that I've had, for an approach to reduce the cost of drug development, would be to give the FDA the job and resources of carrying out the entire clinical trial process. They would be responsible for choosing which drugs to trial, running the trials, evaluating the results, and publishing the results. The pharmas would do the basic research, but they'd have to come up with a convincing argument that their new drug was worthwhile before the clinical trials could start.
I'd hope that this would reduce costs because it eliminates all of the oversight that the FDA needs to do now to make sure the trials are being run properly, and that bad results aren't being hidden from view. It lets the FDA scientists control the whole process, and it would let the FDA short-circuit the process in cases where the scientists are satisfied by their counterparts in other countries approval of a drug. By giving adequate funding to the FDA, this approach would also allow the FDA to run trials on non-patentable drugs, nutrients, and remedies, which rarely happens today and could lead to much lower-cost treatments overall.
The other big aspect of this idea is that the FDA publishes results. I'd have them publish a journal for medical professionals which includes notices of new drugs being considered for trials, the current trial schedule, reports on on-going trials, overviews of completed trials, and announcements for drugs that have been approved that includes usage guidelines for doctors. I'd also have them maintain a website targeted towards patients that includes handouts and detailed information for patients, similar to what's on Wikipedia, drugs.com, webmd, etc, but all centralized, searchable, and from a well-trusted official source. If the FDA takes care of all of that, then we can ban drug advertising. Doctors won't need it because they'd get the journal (which would be free), and patients don't need it because they'd have the website. So that eliminates a huge cost that the pharmas are incurring, and will no longer need to recover from sales.
I don't know how feasible this is; I'm not an insider in the system. It would be a major shift in policy and a major budget increase for the FDA, so politically it'd be very difficult to accomplish. But if the end goal can work, then the political fight would be worth it.
Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval
#97Scott 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.
Residents are in a pretty good spot to write things like this. Fresh enough to have their fingers on the pulse. But, just becoming seasoned enough to pick out WTFs.
Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval
#98Negative 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 we…
"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.
Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval
#99As 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…
And that's why only Doctors can hand out prescriptions and they are trained to evaluate the risk for you. So this system should actually work fine.
Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval
#100As 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…
And that's why only Doctors can hand out prescriptions and they are trained to evaluate the risk for you. So this system should actually work fine.
Of course, I've noted that pharmacists often have a better idea about interactions than doctors do; i've been stopped taking medications concurrently because I find dangers when picking up my prescription. Perhaps doctors shouldn't have this privilege! I shouldn't have to double check my own doctor.