Doctors in China Lead Race to Treat Cancer by Editing Genes
npr.org
npr.org
What we don't want are regulations that make it impossible to get the research started. What we want are regulations that ensure that new drugs and treatments sold on the markert actually work. This is exactly the opposite of the situation in the US today.
You'll have to explain how being critical of fraudulent results "hurts us, not China", unless you're implying the criticism isn't valid, but from what I've read it's a very real concern in research coming from China.
That doesn't make any sense. If the criticism is accurate, then it hurts the criticized party because it's true, whether or not they accept the criticism.
> It increases your confidence in yourself without any corresponding increase in you real performance
You don't need to increase your performance if the other side is lying about how well it's doing and you know it. Your confidence in yourself is well-founded in this situation.
>In this case, public perception of superiority might lead to the US keeping its drug trials slow and expensive, reducing the amount of medical technology invented there compared to China.
If China is actually producing a significant amount of fraudulent research, then their development will be hindered by their own fraud, which is the point. If their technological development is premised on fraudulent research, it won't advance.
You seem to think this is just a matter of opinion that can be freely ignored. You seem to have a completely backwards understanding of the concept of criticism.
It is a matter of opinion - public opinion - which is what ultimately drives how the FDA works. If the US public is clamoring for them to get their ass into gear, eventually they will.
http://www.aaronkharris.com/presumption-of-stupitidy https://sivers.org/ss
In the grandparent commenter's case, he is saying that everyone is focusing on the negatives of Chinese research when there are some useful lessons regarding regulation that could possibly be ported to the US.
"To obtain permission to market a drug, the manufacturer must satisfy the FDA that the drug is both safe and effective. Additional testing often enhances safety and effectiveness, but requiring a lot of testing has at least two negative effects. First, it delays the arrival of superior drugs. During the delay, some people who would have lived end up dying. Second, additional testing requirements raise the costs of bringing a new drug to market; hence, many drugs that would have been developed are not, and all the people who would have been helped, even saved, are not.
In addition, because FDA approval is mandatory, industry and medicine must heed FDA standards regardless of their relevance, efficiency, and appropriateness. Not all testing is equally beneficial. The FDA apparatus mandates testing that, in some cases, is not useful or not appropriately designed. The case against the FDA is not that premarket testing is unnecessary but that the costs and benefits of premarket testing would be better evaluated and the trade-offs better navigated in a voluntary, competitive system of drug development.
Three bodies of evidence indicate that the costs of FDA requirements exceed the benefits. In other words, three bodies of evidence suggest that the FDA kills and harms, on net. First, we compare pre-1962 drug approval times and rates of drug introduction with post-1962 approval times and rates of introduction. Second, we compare drug availability and safety in the United States with the same in other countries. Third, we compare the relatively unregulated market of off-label drug uses in the United States with the on-label market. In the final section, before turning to reform options, we also discuss the evidence showing that the costs of FDA advertising restrictions exceed the benefits."
http://www.fdareview.org/05_harm.php
This may not be the most neutral source, but it at least raises some interesting points.
Unfortunately, we disregard the ethical challenge in not trying.
Pembrolizumab, for example, is an FDA approved first line therapy for all cancers expressing high microsatellite instability or mismatch repair which is a highly conserved attribute among people who smoke and drink, one of the main reasons for why China has such an abnormal amount of cancer in their population in addition to additional extraneous factors like rampant pollution, due to their extreme carcinogenic effects.
This article seems to imply that the risk aversion taken by the FDA is resulting in lives not being saved, but is incorrect in it’s assertions. Especially since the utilization of CRISPR is still at a stage of, what is in my opinion, the creation of an unnacceptable mutational burden, immunotherapies like pembrolizumab which work to inhibit receptors through the usage of monoclonal antibodies are the best forms of treatment. In no way do I doubt the potential of gene editing and the good it can do, however, when I say this. The point is though, is that when you rush things too quickly, it inevitably ends up hurting the patient.
Two hours away by bullet train... Something you don't hear in the US. A 21st century infrastructure paying dividends.
Now that they can’t rely on condemned prisoners anymore (at least they’ve promised the ban is for real this time), bullet train infrastructure is quite useful.
> prisoners be given the option of donating organs upon their death
> another suggests that condemned prisoners be offered the option of trading a kidney or their bone marrow in exchange for a commuted sentence of life in prison without parole
> Application of the death penalty is spasmodic and seemingly discriminatorily applied, which would suggest that these types of proposals would be coercive to particular classes of individuals--minorities and the poor.
There are so many things that would be sensible policy (i.e. using organs of dead people) were it not for the surrounding hazards they create: incentive to give death penalties, wealthy people abusing, greater chance of weak defenses, etc.
If we could solve the slippery slope problem, so may things would be possible.
On the one hand, thats a great news and I certainly don't want to be the person to lose my life due to lax regulations. But on the other hand, we should also consider the lost opportunity due to progress not made either due to regulatory obstacles (like biomedical research for cancer cure discussed here) or insufficient public funds (due to overspending on public works to minimize fatalities).
Ultimately, the question boils down to how much dollar value we as a society want to put on human life. A very high value will have obvious apparent benefits but lots of non-obvious costs.
I’d be inclined to agree with you if we all had the same chance of risking our lives for the greater good and we could mutually agree on what the odds should be, but I feel like that’s why we’be come to the conclusion that it’s probably best if people didn’t die on a construction site for the same of innovation. (Also, I’d bet negligence is probably a more proper cause.)
Clinical trials for cancer are less fraught with the ethical problems of the construction worker since presumably the patient is that desperate for a cure, but we have general standards for these things like IRBs, protocols, and physicians trained to “do no harm” just to make sure the final product is safe and won’t guarantee a sooner death.
Also, while we may be at a disadvantage since we can’t just throw money at the problem, we’re still making remarkable progress: https://ghr.nlm.nih.gov/primer/therapy/availability
>The treatment Wu is testing involves taking a sample of blood from each patient. A lab at a biotech company two hours away by bullet train extracts T cells from the blood. Scientists then use CRISPR to knock out a gene in the T cells known as PD-1. This engineering feat modifies the T cells so that they zero in on and attack the cancer cells, once they're infused back into each patient.
On the contrast, metabolic treatment is tough from the standpoint that it requires strict discipline by the patient to adhere to the protocol, but the "side effects" may actually enhance overall health at the cellular level. It's a treatment that at the very least could be melded with the current standard of care to achieve better outcomes, and yet there's very little awareness of it, possibly because there's not a lot of money in it for hospital systems.
What an exciting time to be alive.
If any student comes to me and says he wants to be useful to mankind and go into research to alleviate human suffering, I advise him to go into charity instead. Research wants real egotists who seek their own pleasure and satisfaction, but find it in solving the puzzles of nature.
--Albert Szent-Györgyi
My [indefensible] impression is that altruistic culture is a strong part of the reason why the quality of biomedical researchers is so poor, and cancer research funding is so often near-fraudulent.
Anyway, I don't see how it's avoidable. There'll be kudos, prestige, more grant money, etc for people who make advances, so there's going to be a race element to it as well.
What about competition makes it some universal good? The entire field of game theory exists because direct competition creates paradoxes and dilemmas, and cooperation can result in greater rewards for everyone involved.
More specifically, doesn't anybody else remember the numerous scientific misconduct scandals that have plagued China? In their race to be first they've been willing to sacrifice research integrity to get there. When we see 40% of biomedical papers from China having problems (http://retractionwatch.com/2017/05/18/four-10-biomedical-pap...) I'm not entirely sure I'd trust their result claims.
You're criticising a strawman. Nobody said it was a universal good.
I said it was unavoidable (it is intrinsic to the research process), and I said (in various comments) that it's a good thing (i.e. a net positive), including that there's clear historical evidence of this.
No, it isn't. It's intrinsic to our research culture and that's wildly different.
Look, competition gets us things like Microsoft Windows and iOS. Cooperation gets us things like BSD and Linux. Competition gets us the Google Play App store. Cooperation gets us the Debian repository.
> and I said (in various comments) that it's a good thing (i.e. a net positive), including that there's clear historical evidence of this.
Except you don't cite anything.
What about the fact that essentially nobody does repeat experiments because they're all busy racing for original research? (https://en.wikipedia.org/wiki/Replication_crisis) What about the fact that people often select studies based on what will attraction attention, rather than what will actually best advance the field. Boring and uninteresting but extremely important research topics get ignored because they don't result in glory for the university or researcher. We're emphasizing the importance of breakthroughs over incremental research while simultaneously not reproducing those studies to confirm their findings!
That is how a culture of competition over cooperation in research and science harms our ability to solve problems and conduct research.
So first, which of those two competitors, BSD and Linux, was the wasted effort, then?
And, using Macs, Windows, and Linux all on a regular basis: based on that example I can't help but be fairly pro-competition. Windows is a far smoother experience to set up than Linux. Photoshop and Lightroom beat the hell out of Gimp/Darktable/Krita/whatever. Office similarly doesn't really have effective competitors. Those things all got good through competitive pressure, having to beat out the alternatives in order to be good enough for people to pay for.
We can't predict the future, what paths will be useful and what ones won't, well enough to scrap it.
Competition has its downsides and has to be corralled, but cooperation can lead to waste just as easily. Groupthink. Missed opportunities. Unexplored areas in the solution space because we guess wrong.
That’s what I responded to. Vital. Few willing to take risks.
To fight cancer!
Also, the motivations I mentioned apply, to some extent, to the funding bodies.
Ideology isn’t required here.
But that is not enough. Cancer is quite a formidable foe. one researcher in a lab can only do so much. as you say, science is collaborative. but getting medicines approved requires more than just government or philanthropic funding. it requires collaboaration with for-profit entities: venture funding, and big pharma r&d budgets. that money requires profitability. and in business, speed matters. competition can be very healthy in regards to pushing researchers to the next level
oncology is one of the most funded areas of research not just because it impacts a lot of people. it is also one of the most profitable. fda incentives reduce the cost of drug development, and drug developers can charge high prices because they are creating a lot of clinical value. this is perhaps a cynical viewpoint, but if you look at the leading causes of death in the US, and the diseases with the most VC / pharma funding, only cancer is in both groups
as further evidence of the importance of profits in funding decisions: cancer consistently ranks in the top two disease areas in terms of VC and pharma investment. it receives about double the next fields (infectious disease) in terms of pharma investment, VC investment and FDA approvals
however, cancer funding is in third place in terms of NIH funding, with roughly 1/3 the funding of neuro / neuropsych disease and less funding than infectious disease. cancer is well funded largely because of profit motives, and profit-driven groups are the ones that get cancer drugs out of the lab and to patients. not ideal, but thats the status quo
Also, I think the reasons you give are exactly why you should want there to be races involved, because they will help speed progress. You said they weren't vital to doing the research, and I concede that, but you haven't argued that progress will happen at the same or a faster pace without competition.
Science works best as a collaborative effort, and races breed insular teamwork. There is already tons of money tomfoht cancer, not in the least because of the fame and fortune awaiting anyone making signifanct inroads to curing cancer.
So what does this additional “race” crap add that isn’t already there?
and
> Science works best as a collaborative effort, and races breed insular teamwork.
The answer to these is easy: history clearly shows that competition makes a big difference, in both science and technology.
Have you considered also that these collaborations often occur within a larger framework of competition between competing groups?
> fame and fortune awaiting anyone making signifanct inroads to curing cancer.
As I said in an earlier reply to you, this is a reason why competition is intrinsic. It's not a choice about whether you want it or not, it's going to happen, and the quoted part of your comment is pretty much admitting that.
> some poxy “race” ... a much less significant “race” aspect ... what does this additional “race” crap
you keep describing it in pejorative terms, without explaining why it is supposedly so bad. The only thing I can see is you mentioning "races breed insular teamwork". Do you have any evidence that races actually slow down progress, or is it just that you find the idea of them distasteful?
And I'll ask again, what has competition (there being races) have to do with ideology?
You're selling the evidence short [1][2]. Commercial, political and basic research opportunities compete for resources from the same well. Competition increases the tap to basic research. That, in turn, increases output. (Up to a point [3].)
[1] http://www.jstor.org/stable/2094753?seq=1#page_scan_tab_cont...
[2] http://www.mba.intercol.edu/Entrepreneurship/UT%20Computer%2...
[3] http://eprints.rclis.org/23682/1/Current-socio-published-non...
Edit: I suppose having races is positive hype-marketing machine, hopefully playfully tapping into our dopamine reward systems.
The fact that the US unnecessarily hamstrings cancer research over dubious moral qualms clearly indicates that yes, treating cancer is itself insufficient motivation in this country.
Spoiler alert: I wouldn't want any other country to follow the example of China. Sometimes, human lives are more important than KPIs and being first...
Some interesting parts:
> The Chinese ministry of health has to approve all gene-therapy clinical trials in China, but these regulations appear relatively relaxed. According to the WSJ, at Hangzhou Cancer Hospital, for example, a proposal to test a cancer treatment that modifies patients’ immune cells was approved in a single afternoon. One member of the hospital’s approval committee told the WSJ that she did not really understand the science laid out for her in a 100-page document, but was told that the side effects were mild. This was enough for her to give it the go-ahead.
...
> China is taking the lead in the global race to perfect gene therapies.
> Scientists have genetically engineered the cells of at least 86 cancer and HIV patients in the country using Crispr-Cas9 technology since 2015, the Wall Street Journal reports (paywall). Although no formal scientific papers have been written about these experiments, doctors told journalists at the WSJ that some patients have improved. There have also been least 15 deaths, seven of which were in one trial.
86 (!!!) patients.