> More radically, it might be possible to repeal the 1962 Kefauver-Harris amendment to the Federal Food, Drug, and Cosmetic Act, a provision that requires drug developers to prove a medication's efficacy (rather than just its safety) before it can receive FDA approval. Since this more stringent authorization process was enacted, the average number of new drugs greenlighted per year has dropped by more than half, while the death rate from drug toxicity stayed constant. The additional regulation has produced stagnation, in other words, with no upside in terms of improved safety.
If that were to happen, we can expect that the drug market would become like the supplement market: full of pseudo-science and products that do nothing. Right now, supplement makers are prohibited from making specific medical claims; they can say something like "gives you energy," but they can't say "cures cancer." The only reason they don't is because they legally can't. (And even then they sometimes do, and sometimes get away with it.) If they were suddenly allowed to, we would not get a flood of new drugs from the current pharmaceutical companies. We would get a flood of sugar pills from the current supplement companies.
The "since" part of the paragraph is also a bit of non-sequitur. Before and after the 1962 provision, drug companies had to prove safety, so it's not a surprise the death rate from drug toxicity stayed constant. Proving efficacy is about preventing companies from exploiting the public by selling stuff that has no hope of ever working as advertised.
The blind spot of proposals like this is that they assume good-faith actors acting rationally. They completely ignore bad-faith actors willing to sociopathically exploit people.
How does this act relate to drugs targeted to specific genetic markers?
I think we're moving into an era when we need to consider that everybody is different, and a lot of cancers are different. This isn't like curing a bacteria, where (mostly) one-size fits all.
I wonder: is it possible to bring a drug to market that is ineffective and sometimes fatal to most people without a genetic marker, but is safe and will cure cancer for those with the marker?
Off-label uses of drugs don't need to show efficacy but don't suffer from that problem. Doctors prescribe off-label based on what consensus has shown works even without FDA approved studies.
>>If they were suddenly allowed to, we would not get a flood of new drugs from the current pharmaceutical companies. We would get a flood of sugar pills from the current supplement companies.
We would get a flood of data from human use of the drug, increasing the rate at which efficacy is discovered in drugs.
There may be paths to exploitation mitigation that do far less harm to the rate of good-faith experimentation.
The big hope for people who suffer from ME/CFS is an off-label use of an existing drug such as Rituximab.
Under the current system, drugs go through phase I trials to make sure that they are safe enough for doctors to prescribe. Then they go through phase II trials to get a feel for dosage and effect size for the intended indication. Then they fail at phase III because they compare poorly with an existing drug for that indication.
What determines whether ME/CFS patients get to try a drug, to see if it does anything for them? Phase I and II results. Fair enough.
But also Phase III. So the efficacy of the drug for a different indication plays a positive roll. If Rituximab were ineffective for leukemia, it would be forbidden to explore it for ME/CFS in a way that might later justify a big trial to check for efficacy. Given the side-effects of Rituximab, that is fair enough, but the law is equally restrictive on all that failed in Phase III. So drugs with mild side-effects that did nothing for the intended indication cannot be explored for ME/CFS.
That is sad. Those who believe that ME/CFS is due to a viral infection would love to try a failed anti-viral. Those who believe that ME/CFS is an auto-immune disease would love to try a failed treatment for Irritable Bowel Syndrome. Meanwhile, researchers tend to stay away from diseases with such unclear etiology.
But the efficacy requirement has worse implications. As wikipedia puts it
> Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment.
So a drug that passes Phase I and Phase II can be eligible or ineligible for off label exploration because of the efficacy of a different drug for a different indication.
You are missing the key point. Supplements are allowed because they are made of "Generally Recognized As Safe (GRAS)" ingredients. New drugs aren't, and that's the point. Experimental drugs are obviously risky.
As a libertarian, Reason annoys the bejesus out of me. As a human, journalists annoy the bejesus out of me.
The real test here is, are drugs more efficacious then prior to the legislation. If not, we need to review it. I'd argue repeal, others would argue replace. I'd look forward to vigorous debate, but first we have to do some actual work to figure out if this legislation is effective. If it is leave it alone. There's probably lots of other stuff we can look at to review, much of which is nothing but drag on the system.
Journalists, of course, have no interest in the truth or doing work that doesn't involve twitter.
> Cancer deaths have fallen by a total of just 5 percent since 1950.
This is suuuuper misleading, to the point where I'm thinking that the author has an agenda.
Cancer deaths is the wrong metric to use, since population is always increasing and the proportion of people getting cancer is also changing over time.
You want to look at the cancer death rate instead, from 1991 to 2015 the cancer death rate decreased by 26%. It's also really important to take into account that mortality rates are _vastly_ different across different types of cancers and across genders -- in that same time period, the death rate for males with lung cancer decreased by 45%! [2]
Again, this article is misleading and probably has an agenda behind it. If you want to learn more about the history of cancer treatment, The Emperor of All Maladies is a great book.
This is Reason, so of course there is an agenda - the government needs to take it's meddling hands out of our free markets and let us sell whatever drugs to whoever we want!
The gist of the post was that cancer rates since 1990 have gone down primarily because smoking has declined, not because cancer treatment has improved.
Lost my son at 12 years old in 2013 (Bone Cancer) and lost my sister when she was 15 in 1996 (Brain Cancer). The fight for pediatric cancer research funding is worse. If you have a chemo for kids (All of kids cells are growing which makes it much more difficult to fight cancer) it has less side-effects and is effective for adults. If you have a new adult chemo it doesn't mean nothing for Pediatric. We went over 20+ years without one new Chemo till St. Baldrick's funded chemo for Neroblastoma came out a few years ago.
Bone Cancer does have funding, from dog owners. Bone Cancer my son has hasn't had a change in survival rates in 35 years. Fortuitously people have greater hope for a cure for dogs then sick kids and are putting millions into bone cancer research and we hope that once they finally have something we can start the 10 year process of testing for kids.
We wouldn't have done the trial for bone cancer. Reason is that when your in a trial you have to leave the tumor in the body so they can see the effectiveness. Bone cancer is extremely painful and is only curable through surgery. Why would anyone agree to leaving the painful hard tumor in your kids body???
My son had a 15% chance of surviving 5 years when he was diagnosed with bone cancer (It was in his whole left femur and both lungs, bone cancer for some reason grows in your lungs so you have crazy bone cells growing in your lungs). He made it past 4.5 years, but it grew into both legs, his neck, and hip and had countless surgeries, radiation and chemo and it all sucked. That the funding isn't there is a constant thought in your brain at all times. Heck American Cancer Society (Largest on the planet) gave a penny per dollar raised to pediatric cancer research and then cut funding to kids camps and family resources about 7 years ago so they could focus on adult research. They finally agreed to stop using pictures of kids sick on their fund raising efforts. So yeah it is frustrating.
You touch on the twisted point about medicine for dogs: there are often lots more treatments for them, at least as many as for humans. But this isnt because of funding. it is because nearly ever human treatmemt was once tested on dogs. And they arent all pets... or even sick. Sometimes the path to human testing leads through dark places.
Sorry to hear this. It's pathetic alright. Total prioritization failure.
I'm convinced that if some objective 'progress bar' existed, constantly put in front of the public's mind by media or by government diktat - then a firehose of resources would be put at the disposal of R&D, like X-Prizes for medical enterprises.
Very sorry for your loss. I lost my mother to a similarly deadly cancer two years ago, and this summer my wife was diagnosed at 20 weeks pregnant so both my wife's and daughter's lives were at risk. It is like a curse, having multiple cancers in one's close family.
stories like this makes me almost hate life. no kid and parents should suffer this way. I'm really sorry to hear about your loss, I hope you find peace and strength to get through the experience. I could only imagine what you might have went through, I'm sure it must have been real tough.
> One proposal, developed by American economist Bartley Madden, is "free-to-choose medicine." Once drugs have passed Phase I trials demonstrating safety, doctors would be able to prescribe them...
>
> More radically, it might be possible to repeal the 1962 Kefauver-Harris amendment to the Federal Food, Drug, and Cosmetic Act, a provision that requires drug developers to prove a medication's efficacy (rather than just its safety) before it can receive FDA approval.
Personally I'd be in favour of letting seriously ill people try whatever they want. However I would not be in favour of allowing companies to charge for drugs which had not yet been proved effective.
Providing drugs for free might give companies more data to help develop (or potentially prove safety, efficacy) but generating revenue here is too open to abuse.
A lot of these kind of proposals share the same basic misconception: they assume that once a company identifies a drug candidate, then it's because it works, and the regulatory hurdles it needs to clear to be approved are just bureaucratic paperwork. But the actual evidence of the drug approval process is that said model is completely the opposite of reality. Most drug candidates--around 90%--ultimately fail. Half of all candidates advanced to Phase III (the main efficacy trial) fail. Any serious proposal needs to start from the basis that a drug probably won't work, until proven otherwise.
There is, as it turns out, an existing market segment for drugs that are safety-only-no-efficacy-required approval status. It's the herbal supplement industry, and it makes Big Pharma look like saints in comparison. There's been plenty of exposes showing that many supplement companies can't even be bothered putting the active ingredients in their products.
>Providing drugs for free might give companies more data to help develop (or potentially prove safety, efficacy)
It's a nice thought, but you generally can't have patients and doctors opting-in for unproven treatments and expect the resulting data to stand up to any sort of scrutiny. To glean useful data, one would require a really, really large-n study population and clear impacts from use of the drug that are so pronounced they drown out nearly all other confounding factors (e.g. studies on the health impact of cigarettes) -- and expecting an unproven, last-resort type drug to attract a study population this large is just unrealistic.
One proposal, developed by American economist Bartley Madden, is "free-to-choose medicine."
Physicians are extremely serious about medical ethics, and lawyers are very conscientious about conflicts of interest. What is wrong with the economic profession, that they talk and talk without any real-world considerations. We saw why Theranos tried to sidestep FDA authority, and with that experience fresh in mind that fellow wants to abolish efficicacy testing. Here, have some homeopathic globuli!
Maybe at the time, from 40's to 70's, (1) there were low hanging fruits. It's reasonable to think the discovery process has become harder and (2) we didn't know much about how a fast clinical trial could go wrong [1]
Yes, this was a ridiculous article. In addition, the FDA actually has fast-track approval for drugs in areas with no good treatment and any drug showing exceptional efficacy will make it through the approval process very quickly.
To summarize: two proposals:
1. Once drugs have passed Phase I trials ... prescribe them
2. repeal ... a provision that requires drug developers to prove a medication's efficacy
>In 1971, three decades after Gilman's discovery, the U.S. government declared a "war on cancer." Since then, we have spent nearly $200 billion in federal money on research to defeat the disease. But we haven't gotten much bang for our buck: Cancer deaths have fallen by a total of just 5 percent since 1950. (In comparison, heart disease deaths are a third of what they were then, thanks to innovations like statins, stents, and bypass surgery.)
People live a lot longer than in 1950, which gives them more years to get cancer. This is why you have to report age-diagnosis-specific outcomes and not merely incidence or prevalence.
What is the author even talking about, saying there is no progress in cancer therapy? Hanahan doesn't even mention immunology in the "Hallmarks of Cancer" (that's an influential review article from 2000), and less than ten years later it's a huge field of research, with several very powerful drugs in the clinic.
> Cancer deaths have fallen by a total of just 5 percent since 1950. (In comparison, heart disease deaths are a third of what they were then, thanks to innovations like statins, stents, and bypass surgery.)
Not sure if this takes into account x year survival rates.
The article could have done a post-mortem of the 20-year taxol approval. It sounds obviously wrong, but I'd like to know how it could be done right.
Cancer can be very complex, and treatment based on assumptions can shorten lives and kill fertility when another treatment would have been appropriate.
I think the whole reason why cancer deaths aren't receding as fast as we'd like them to is exactly that heart disease deaths, and violent deaths (anything from murder to suicide to a car accident) are receding quickly. Therefore, people live longer, and get cancer with higher probability.
Right, it would make much more sense to talk about cancer diagnosis or survivability by a certain age, like 50 or 60. By 70-90 most people have been exposed to so many carcinogens the likelihood of some sort of cancer is near guaranteed.
Progress is slow because much of the long hanging fruit has been picked
Cancer is much more difficult and complicated than other types of diseases
Clinical trials bypass the FDA but very seldom result in cures or improved survival. It's not like people with advanced cancer are being denied experimental treatments, but the problem is for every success that gets media attention, the vast majority of these treatments do nothing or are even harmful
>"Progress is slow because much of the long hanging fruit has been picked
Cancer is much more difficult and complicated than other types of diseases"
Or maybe the people researching it haven't been doing a very good job and have generated a bunch of irreproducible (even in principle) results:
https://news.ycombinator.com/item?id=17702380
Trying to make sense of a topic when the literature is filled with incorrect facts would be quite difficult and complicated.
It’s actually really easy force research to move faster, but to do so people basically must throw caution to the wind, and gamble with the possibility of extremely unpleasant outcomes, on top of also not surviving.
Being less safe is as simple as operating outside the conventional protections that regulatory bodies use, in order to safeguard ethics.
If that’s not your priority, and you want to press your luck, feel free to take your chances, so long as you acknowlege your adoption of the risks that ride along with that decision.
Break the law, in favor of searching places others dare not go. It’s uncharted territory, out where there’s no lifeguard. Maybe it seems timid to shy away from risk in a dire situation, but honestly, push hard enough, and I’m sure enterprising people will ignore their own safety in pursuit of impatience.
Reason is an unserious publication with an ironic name. The author of this particular article has a financial interest in pushing untested medicine on the suffering. Cancer is a catch-all for a number of different diseases (having a few similarities) that require different treatments. The author chooses to ignore the average age of the population, the size of the population, the diet of the population, and obesity within the population when pulling out statistics. The regulatory framework surrounding medical treatment and drug testing exists BECAUSE people were being harmed by untested medicine.
>why these highly experimental approaches (e.g reprogramming immune cells) can't be done in animals with cancer
They absolutely are, all the time. Animal testing is relatively cheap (esp. for mice) and widespread in biotech. It's generally hard to get an IND approval (step 1 of human testing) without successful animal tests.
Animal models, unfortunately, aren't super effective at predicting human outcomes.
“In 1971, Congress passed the National Cancer Act, which established 69 geographically dispersed, NCI-designated cancer research and treatment centers. James Watson—one of the discoverers of the structure of DNA and at the time a member of the National Cancer Advisory Board—objected strenuously to the move. In fact, DeVita in his memoir remembers the Nobel winner calling the cancer centers program "a pile of shit." Watson was fired that day.”
Watson didn’t understand congress rarely approves anything that durant supply pork to a majority of districts.
My understanding is that they won't approve a cancer drug unless it's strictly as or more effective than existing drugs, even if it's efficacy to side effect ratio is more favorable.
What are the options in regular (preventive maintenance ) cancer screening? Cancer is horrible and I feel like by the time we discover the cancer - when it presents itself as a symptom - it can be too late. I realize in general preventive medicine seems to be rarely practiced and medical costs are insane (especially in the US), but is it scientifically feasible to detect most cancers early if proper screening were done on a regular basis?
The HPV Vaccine (and consequent drop in cervical cancer rates - [1]) certainly seems like an improvement. Similarly, the near fanatical application of sunscreen, reduction in cancer causing chemicals, etc. I would have thought would have brought the cancer rate down as well.
[+] [-] scott_s|7 years ago|reply
If that were to happen, we can expect that the drug market would become like the supplement market: full of pseudo-science and products that do nothing. Right now, supplement makers are prohibited from making specific medical claims; they can say something like "gives you energy," but they can't say "cures cancer." The only reason they don't is because they legally can't. (And even then they sometimes do, and sometimes get away with it.) If they were suddenly allowed to, we would not get a flood of new drugs from the current pharmaceutical companies. We would get a flood of sugar pills from the current supplement companies.
The "since" part of the paragraph is also a bit of non-sequitur. Before and after the 1962 provision, drug companies had to prove safety, so it's not a surprise the death rate from drug toxicity stayed constant. Proving efficacy is about preventing companies from exploiting the public by selling stuff that has no hope of ever working as advertised.
The blind spot of proposals like this is that they assume good-faith actors acting rationally. They completely ignore bad-faith actors willing to sociopathically exploit people.
[+] [-] drewg123|7 years ago|reply
I think we're moving into an era when we need to consider that everybody is different, and a lot of cancers are different. This isn't like curing a bacteria, where (mostly) one-size fits all.
I wonder: is it possible to bring a drug to market that is ineffective and sometimes fatal to most people without a genetic marker, but is safe and will cure cancer for those with the marker?
[+] [-] ikeboy|7 years ago|reply
[+] [-] CryptoPunk|7 years ago|reply
We would get a flood of data from human use of the drug, increasing the rate at which efficacy is discovered in drugs.
There may be paths to exploitation mitigation that do far less harm to the rate of good-faith experimentation.
[+] [-] alan-crowe|7 years ago|reply
Under the current system, drugs go through phase I trials to make sure that they are safe enough for doctors to prescribe. Then they go through phase II trials to get a feel for dosage and effect size for the intended indication. Then they fail at phase III because they compare poorly with an existing drug for that indication.
What determines whether ME/CFS patients get to try a drug, to see if it does anything for them? Phase I and II results. Fair enough.
But also Phase III. So the efficacy of the drug for a different indication plays a positive roll. If Rituximab were ineffective for leukemia, it would be forbidden to explore it for ME/CFS in a way that might later justify a big trial to check for efficacy. Given the side-effects of Rituximab, that is fair enough, but the law is equally restrictive on all that failed in Phase III. So drugs with mild side-effects that did nothing for the intended indication cannot be explored for ME/CFS.
That is sad. Those who believe that ME/CFS is due to a viral infection would love to try a failed anti-viral. Those who believe that ME/CFS is an auto-immune disease would love to try a failed treatment for Irritable Bowel Syndrome. Meanwhile, researchers tend to stay away from diseases with such unclear etiology.
But the efficacy requirement has worse implications. As wikipedia puts it
> Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment.
So a drug that passes Phase I and Phase II can be eligible or ineligible for off label exploration because of the efficacy of a different drug for a different indication.
[+] [-] raverbashing|7 years ago|reply
- What is the false negative rate for currently mandated FDA mandated efficacy studies?
- How can studies be improved so it identifies good/bad drug candidates better and quicker?
[+] [-] bryanrasmussen|7 years ago|reply
[+] [-] gowld|7 years ago|reply
[+] [-] valuearb|7 years ago|reply
[+] [-] r_smart|7 years ago|reply
The real test here is, are drugs more efficacious then prior to the legislation. If not, we need to review it. I'd argue repeal, others would argue replace. I'd look forward to vigorous debate, but first we have to do some actual work to figure out if this legislation is effective. If it is leave it alone. There's probably lots of other stuff we can look at to review, much of which is nothing but drag on the system.
Journalists, of course, have no interest in the truth or doing work that doesn't involve twitter.
[+] [-] iooi|7 years ago|reply
This is suuuuper misleading, to the point where I'm thinking that the author has an agenda.
Cancer deaths is the wrong metric to use, since population is always increasing and the proportion of people getting cancer is also changing over time.
You want to look at the cancer death rate instead, from 1991 to 2015 the cancer death rate decreased by 26%. It's also really important to take into account that mortality rates are _vastly_ different across different types of cancers and across genders -- in that same time period, the death rate for males with lung cancer decreased by 45%! [2]
Again, this article is misleading and probably has an agenda behind it. If you want to learn more about the history of cancer treatment, The Emperor of All Maladies is a great book.
[1] https://www.cancer.org/latest-news/understanding-cancer-deat... [2] https://www.cancer.org/latest-news/facts-and-figures-2018-ra...
[+] [-] tyingq|7 years ago|reply
Longer lifespans means more people dying of cancer. Something eventually gets you..."natural causes" isn't really a thing.
[+] [-] kiliantics|7 years ago|reply
[+] [-] simulate|7 years ago|reply
http://slatestarcodex.com/2018/08/01/cancer-progress-much-mo...
The gist of the post was that cancer rates since 1990 have gone down primarily because smoking has declined, not because cancer treatment has improved.
[+] [-] baldfat|7 years ago|reply
Bone Cancer does have funding, from dog owners. Bone Cancer my son has hasn't had a change in survival rates in 35 years. Fortuitously people have greater hope for a cure for dogs then sick kids and are putting millions into bone cancer research and we hope that once they finally have something we can start the 10 year process of testing for kids.
We wouldn't have done the trial for bone cancer. Reason is that when your in a trial you have to leave the tumor in the body so they can see the effectiveness. Bone cancer is extremely painful and is only curable through surgery. Why would anyone agree to leaving the painful hard tumor in your kids body???
My son had a 15% chance of surviving 5 years when he was diagnosed with bone cancer (It was in his whole left femur and both lungs, bone cancer for some reason grows in your lungs so you have crazy bone cells growing in your lungs). He made it past 4.5 years, but it grew into both legs, his neck, and hip and had countless surgeries, radiation and chemo and it all sucked. That the funding isn't there is a constant thought in your brain at all times. Heck American Cancer Society (Largest on the planet) gave a penny per dollar raised to pediatric cancer research and then cut funding to kids camps and family resources about 7 years ago so they could focus on adult research. They finally agreed to stop using pictures of kids sick on their fund raising efforts. So yeah it is frustrating.
[+] [-] rocmcd|7 years ago|reply
'Frustrating' doesn't do enough justice, based on your story. I'm terribly sorry for your loss.
[+] [-] sandworm101|7 years ago|reply
[+] [-] bachbach|7 years ago|reply
I'm convinced that if some objective 'progress bar' existed, constantly put in front of the public's mind by media or by government diktat - then a firehose of resources would be put at the disposal of R&D, like X-Prizes for medical enterprises.
[+] [-] propter_hoc|7 years ago|reply
[+] [-] jaequery|7 years ago|reply
[+] [-] sofon|7 years ago|reply
Personally I'd be in favour of letting seriously ill people try whatever they want. However I would not be in favour of allowing companies to charge for drugs which had not yet been proved effective.
Providing drugs for free might give companies more data to help develop (or potentially prove safety, efficacy) but generating revenue here is too open to abuse.
[+] [-] jcranmer|7 years ago|reply
There is, as it turns out, an existing market segment for drugs that are safety-only-no-efficacy-required approval status. It's the herbal supplement industry, and it makes Big Pharma look like saints in comparison. There's been plenty of exposes showing that many supplement companies can't even be bothered putting the active ingredients in their products.
[+] [-] sithadmin|7 years ago|reply
It's a nice thought, but you generally can't have patients and doctors opting-in for unproven treatments and expect the resulting data to stand up to any sort of scrutiny. To glean useful data, one would require a really, really large-n study population and clear impacts from use of the drug that are so pronounced they drown out nearly all other confounding factors (e.g. studies on the health impact of cigarettes) -- and expecting an unproven, last-resort type drug to attract a study population this large is just unrealistic.
[+] [-] dithering|7 years ago|reply
[+] [-] HarryHirsch|7 years ago|reply
Physicians are extremely serious about medical ethics, and lawyers are very conscientious about conflicts of interest. What is wrong with the economic profession, that they talk and talk without any real-world considerations. We saw why Theranos tried to sidestep FDA authority, and with that experience fresh in mind that fellow wants to abolish efficicacy testing. Here, have some homeopathic globuli!
[+] [-] dlojudice|7 years ago|reply
[1] https://en.wikipedia.org/wiki/Thalidomide
[+] [-] tyu100|7 years ago|reply
[+] [-] babkayaga|7 years ago|reply
How is this different from Right to Try act? https://edition.cnn.com/2018/05/30/politics/right-to-try-don...
[+] [-] psychometry|7 years ago|reply
People live a lot longer than in 1950, which gives them more years to get cancer. This is why you have to report age-diagnosis-specific outcomes and not merely incidence or prevalence.
[+] [-] HarryHirsch|7 years ago|reply
[+] [-] ryanackley|7 years ago|reply
> Cancer deaths have fallen by a total of just 5 percent since 1950. (In comparison, heart disease deaths are a third of what they were then, thanks to innovations like statins, stents, and bypass surgery.)
Not sure if this takes into account x year survival rates.
[+] [-] tmikaeld|7 years ago|reply
Which a lot of holistic doctors have picked up on and some clinics even treat cancer patients in.
Like this clinic in Japan: https://www.saisei-mirai.or.jp who have published several studies and papers on their treatments.
But yeah, why is it being ignored?
[+] [-] dekhn|7 years ago|reply
[+] [-] axus|7 years ago|reply
Cancer can be very complex, and treatment based on assumptions can shorten lives and kill fertility when another treatment would have been appropriate.
A webcomic author updated their blog about their experience: https://www.erfworld.com/blog/view/60504/rob-lindas-1st-anni...
[+] [-] anovikov|7 years ago|reply
[+] [-] TheBeardKing|7 years ago|reply
[+] [-] paulpauper|7 years ago|reply
Cancer is much more difficult and complicated than other types of diseases
Clinical trials bypass the FDA but very seldom result in cures or improved survival. It's not like people with advanced cancer are being denied experimental treatments, but the problem is for every success that gets media attention, the vast majority of these treatments do nothing or are even harmful
[+] [-] nonbel|7 years ago|reply
Cancer is much more difficult and complicated than other types of diseases"
Or maybe the people researching it haven't been doing a very good job and have generated a bunch of irreproducible (even in principle) results: https://news.ycombinator.com/item?id=17702380
Trying to make sense of a topic when the literature is filled with incorrect facts would be quite difficult and complicated.
[+] [-] tenYearsGone|7 years ago|reply
Being less safe is as simple as operating outside the conventional protections that regulatory bodies use, in order to safeguard ethics.
If that’s not your priority, and you want to press your luck, feel free to take your chances, so long as you acknowlege your adoption of the risks that ride along with that decision.
Break the law, in favor of searching places others dare not go. It’s uncharted territory, out where there’s no lifeguard. Maybe it seems timid to shy away from risk in a dire situation, but honestly, push hard enough, and I’m sure enterprising people will ignore their own safety in pursuit of impatience.
[+] [-] MisterBastahrd|7 years ago|reply
Thalidomide is just one example.
[+] [-] agumonkey|7 years ago|reply
[+] [-] nybble41|7 years ago|reply
lack of regulation = people make their own choices, take risks, and sometimes suffer the consequences
too much regulation = people die because you killed them
Freedom comes with risk, even at times the risk of death. It is not your place to decide how much risk other people are allowed to take.
[+] [-] alexandercrohde|7 years ago|reply
However, I appreciate the spirit of constant vigilance against the lethargy of bureaucracy, even if I know nothing myself firsthand on this topic.
[+] [-] mjewkes|7 years ago|reply
They absolutely are, all the time. Animal testing is relatively cheap (esp. for mice) and widespread in biotech. It's generally hard to get an IND approval (step 1 of human testing) without successful animal tests.
Animal models, unfortunately, aren't super effective at predicting human outcomes.
[+] [-] valuearb|7 years ago|reply
Watson didn’t understand congress rarely approves anything that durant supply pork to a majority of districts.
[+] [-] tlear|7 years ago|reply
Like a bunch of cavemen staring sky and imagining a bear and wondering why some light move around unlike others.
[+] [-] EamonnMR|7 years ago|reply
[+] [-] bproven|7 years ago|reply
[+] [-] michaelbuckbee|7 years ago|reply
1 - https://www.sciencealert.com/the-hpv-vaccine-has-halved-cerv...