FDA Halts One of the First Human CRISPR Studies Before it Begins (technologyreview.com)

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FDA Halts One of the First Human CRISPR Studies Before it Begins (technologyreview.com)

Posted by msmash on Thursday May 31, 2018 @02:40AM from the baby-steps dept.

A trial planning to use the gene-editing tool CRISPR on sickle cell patients has been put on hold due to unspecified questions from US regulators. From a report: CRISPR Therapeutics, which is developing the therapy, sought approval from the US Food and Drug Administration in April to begin the study. The therapy involves extracting stem cells from a patient's bone marrow and editing them with CRISPR in the lab. Once infused back into the patient, the idea is that the edited cells would give rise to healthy red blood cells. But according to a statement on Wednesday from CRISPR Therapeutics, the FDA ordered the company not to proceed with its study until it answers questions about its CRISPR treatment.

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proper by iggymanz · 2018-05-31 02:45 · Score: -1

FDA once in a while does its job, amazing
1. Re:proper by Oswald+McWeany · 2018-05-31 02:53 · Score: 3, Insightful
  
  FDA once in a while does its job, amazing
  I disagree, in this case I think using CRISPR on humans might be a legitimate use. I don't agree with using it to try and edit the human genome to make taller offspring, or blue eyes, or 15 inch ding-dongs; but to cure a genetic disease... I think that's wonderful. Using CRISPR to cure certain defined genetic diseases is a far cry from designer-babies.
  This is an area that needs careful oversight but we shouldn't just dismiss a technology because we fear a slippery slope or because we think a beneficial technology is creepy.
  
  --
  "That's the way to do it" - Punch
2. Re:proper by iggymanz · 2018-05-31 02:57 · Score: 4, Insightful
  
  no you have improper understanding.
  Medicinal use of CRISPR sequences is in clinical trial stage only, in China and USA.
  It is not a proven or approved treatment anywhere on planet earth, nor will it be for a very long time
  Having the FDA raise the proper questions is not "dimissing". You seem to imagine they're holding up a line of dying patients
3. Re:proper by Anonymous Coward · 2018-05-31 03:05 · Score: 0
  
  So if the "cure" causes the patient to grow a third hand, or lose their eyesight, or cause bones to start growing in their brain, you are good with that eh? CRISPR is editing the sw for the body. A bug could be a very bad thing. We barely know how this stuff works even though we think we do. Would you have your 6 year old start making edits to the linux kernel?
4. Re:proper by Anonymous Coward · 2018-05-31 03:05 · Score: 2, Insightful
  
  That is true, and hard to accept.
  CRISPR brings promises of curing diseases that are right now causing terrible suffering and early death to billions of people.
  Everyone is in a hurry. Many people are desperate enough to submit to experimental treatments, because they are at the end of their rope. In such a situation, getting in front of such experimentation "feels" morally wrong.
  The common tendency to confuse morality and legality makes people experience confusion when they see the guardians of food and drugs standing in the way of important medical breakthroughs.
5. Re:proper by Anonymous Coward · 2018-05-31 03:07 · Score: -1
  
  To be fair our government alphabet agencies have proven themselves to be very untrustworthy, corrupt, biased, and not beneath doing things legal or illegal that might be 'holding up a line of dying patients'.
  CRISPR sounds promising.
  FDA optics need some work.
  But to be fair, I trust the FDA about as much as I trust the FTC, FBI, DHC, CIA, IRS, and DOJ, which lately is 'less than none, or negative trust'.
  They should get team Meuller to investigate.
6. Re:proper by Anonymous Coward · 2018-05-31 03:14 · Score: 0
  
  Aren't trials like this the very way we figure out how it works?
7. Re:proper by iggymanz · 2018-05-31 03:19 · Score: 1
  
  I knew several people that were diseased and desperate, and so participated in clinical trials for deadly ailments over the decades. Guess what happened to 100% of them?
  CRISPR may not be a breakthrough at all for humans
8. Re:proper by Anonymous Coward · 2018-05-31 03:27 · Score: 0
  
  Life is a sexually transmitted disease with a 100% mortality rate.
9. Re:proper by iggymanz · 2018-05-31 03:30 · Score: 1
  
  yeah but it can take 80 years or more to die for most in the USA
  meanwhile, going to clinical trial instead of normal treatments for deadly cancer will shorten your life even more in most cases.
10. Re:proper by Applehu+Akbar · 2018-05-31 03:35 · Score: 1
  
  FDA once in a while does its job, amazing
  But is FDA going to be forthright about its 'questions' right away so that a corrected trial can begin without undue delay, or is it going to drag its feet until we see this tech changing lives on other continents?
11. Re:proper by atrex · 2018-05-31 03:42 · Score: 3, Interesting
  
  Don't forget that another reason many patients are desperate enough to opt for clinical trials instead of normal treatments is because they can't afford the cost of the normal treatments while the cost for the trials is often waived.
12. Re:proper by rickb928 · 2018-05-31 03:50 · Score: 3, Insightful
  
  OK, this is weird, but bear with me.
  My dog has experienced a total loss of nasal turbinates, cause unknown, he is a rescue. Subsequent to this he was diagnosed with nasal angiofibromas, benign, but ultimately destructive of the nasal cavity and probably will end with infiltration of the cranial cavity and euthanasia.
  Now the oncologist would very much like us to pursue treatment, focused radiation, and then monitor for recurrence, primarily because there is very little known about these conditions. Few dogs receive documented treatment, and so the vet industry doesn't really know how the treatments work, outcomes are indeterminate, and such.
  All they want is for us to pay $8,000+ for treatment, with neither any assurance of success, nor any prognosis, and certainly no assurance that a relapse or recurrence won't come, and soon.
  And he's the most lovely dog, but I would not pay this for a car repair with similar conditions - *might* fix it, far exceeds objective value, might happen again.
  It seems as if this canine oncology practice would love for us to pay to advance the current understanding of this condition. But we were close to asking, if it's so interesting to them, could they perhaps discount the treatment? But nothing about the appointment led us to believe this was anything but a business decision. We've decided no.
  We decided to not make our dog the test case. He's probably going to have a shortened but happy life, and we will not let him suffer unnecessarily, which is, to say, very little. He could have been put down in the shelter, so this is a win, and he's such a lovely dog.
  While the lure of CRISPR therapy is undeniable, the risks are substantial. The FDA has good reason to demand substantial safeguards, information, and explanations. Look at some of the recent revelations regarding lab tests (Theranos), multiple drug trials ending in failure, fabricated results, etc. Gosh, it seems as if you can't readily trust the industry in general.
  This will bump into the 'right to try' movement, but I'm inclined to accept the FDA's reluctance as reasonable. This is a big deal, not as simple as trying it to 'see what happens'. No, it is not.
  
  --
  deleting the extra space after periods so i can stay relevant, yeah.
13. Re:proper by fafalone · 2018-05-31 03:51 · Score: 1
  
  I don't agree with using it to try and edit the human genome to make taller offspring, or blue eyes, or 15 inch ding-dongs; but to cure a genetic disease... I think that's wonderful.
  
  Can we define stupidity as genetic disease? Just look at the consequences of it...
14. Re:proper by rickb928 · 2018-05-31 03:55 · Score: 1
  
  Various psychological conditions are suspected of being hereditary. And there is no more dangerous condition than to be diagnosed with one that renders you incapable of being a mentally functional human being. For that, they can take your liberty for your lifetime. Without question. And never permit you to be cured.
  
  --
  deleting the extra space after periods so i can stay relevant, yeah.
15. Re:proper by sinij · 2018-05-31 03:59 · Score: 1
  
  Life expectancy for sickle cell patients is something like 20 years. Most are lucky to make it to what we consider middle age.
  
  See: https://patient.info/health/si...
16. Re: proper by Anonymous Coward · 2018-05-31 03:59 · Score: 0
  
  But to be fair, I trust the FDA about as much as I trust the FTC, FBI, DHC, CIA, IRS, and DOJ, which lately is 'less than none, or negative trust'.
  I think that is too much trust. Can you go exponential on your negative?
17. Re: proper by Anonymous Coward · 2018-05-31 04:05 · Score: 0
  
  If CRISPR is a miracle one and done cure, expect lots of dragging of feet. How can you charge for a lifetime of pharmaceuticals when the cure is a DNA edit away? Companies that paid their dues to the FDA and various politicians will find rules they can throw in the way of progress.
  This may not be the miracle cure, but I am hopeful that the diseases that age us and destroy our minds will be solved in the next 20 to 30 years. If only we can get the roadblocks out of the way of innovation.
18. Re:proper by michelcolman · 2018-05-31 04:10 · Score: 4, Informative
  
  Meanwhile Chinese researchers, not bothered by any of those morality concerns, carry on perfecting the technology. I wonder who's going to be first to market...
19. Re: proper by Anonymous Coward · 2018-05-31 04:12 · Score: 0
  
  Exactly. The first thought I had was whatever this study is might cause an established pharma company to lose profits. After all, we're talking potential cures here, not profitable "treatments".
  True? Probably not, but the corruption in the medical industry pretty much pushes money as the top reason anybody does anything, actual patients be damned.
20. Re:proper by Catbeller · 2018-05-31 04:18 · Score: 1
  
  I don't think rational thought has much to do with it. Humans pattern match, they don't really think much.
  The FDA is covering its ass, and in so doing will cause the deaths of...millions? With the capabilty here, they will literally make millions of people live and die in agony, to cover their mandate and "save" us.
21. Re:proper by JackieBrown · 2018-05-31 04:24 · Score: 1
  
  Usually you have to be relatively sure there are not crazy side effects before you can start human-trials.
22. Re:proper by cayenne8 · 2018-05-31 04:24 · Score: 1
  
  meanwhile, going to clinical trial instead of normal treatments for deadly cancer will shorten your life even more in most cases.
  Shouldn't that choice be ultimately up to the patient in question?
  It is their life, it should be their choice....
  
  --
  Light travels faster than sound. This is why some people appear bright until you hear them speak.........
23. Re:proper by cayenne8 · 2018-05-31 04:28 · Score: 1
  
  We decided to not make our dog the test case. He's probably going to have a shortened but happy life, and we will not let him suffer unnecessarily, which is, to say, very little. He could have been put down in the shelter, so this is a win, and he's such a lovely dog.
  Good luck with your pup....great story to hear!!
  I lost mine a few short years ago...she lived to be almost 16yrs.
  I"m contemplating if I'm ready for another one...they DO bring such joy into your life.
  Enjoy yours while you have him...
  
  --
  Light travels faster than sound. This is why some people appear bright until you hear them speak.........
24. Re:proper by mysidia · 2018-05-31 04:38 · Score: 1
  
  I don't agree with using it to try and edit the human genome to make taller offspring, or blue eyes, or 15 inch ding-dongs
  I suppose the FDA are only able to interfere with this study BECAUSE this is a study related to a product for curing a disease or treating a medical condition, and the FDA approval is required for medical treatments.
  Using CRISPR to design offspring traits or interesting ideas that someone is going to pursue, and i'm sure it could be a "thing" eventually after we as a civilization actually learn enough about genetics to reliably and repeatedly make such child customizations... Fine to disagree and not use the tech yourself, since when developed everyone with a lot of cash to burn would have their own personal choice to choose to Use it or Not use it for themself, when having their kids. Also --- since "editing the genome of offspring to have blue eyes in the lab" is not a product or procedure designed to remedy any disease or address any medical condition (Not a "medical treatment"); the FDA will likely have zero authority to discourage or regulate it, since tailoring eggs and sperm in the lab to achieve certain desired attributes for your baby is not medical --- And i'm sure the lobbyists for companies that will emerge before this becomes a concern will not allow the situation to change, providing the corps. do a sufficient job at quality control to ensure they won't have tailored babies born with "defects".
25. Re:proper by cayenne8 · 2018-05-31 04:41 · Score: 1
  
  I don't agree with using it to try and edit the human genome to make taller offspring, or blue eyes, or 15 inch ding-dongs;
  
  Why not?
  I mean, one of the primary driving goals of human parents is to do their best to give their offspring the BEST potential to do well in their life....
  If they couldn't start ahead of the curve and give them physical traits (height, brain capacity, disease resistance, heck even traits towards attractiveness)....why not?
  It is just taking what parents do now to a higher step.
  
  --
  Light travels faster than sound. This is why some people appear bright until you hear them speak.........
26. Re:proper by mysidia · 2018-05-31 04:44 · Score: 1
  
  Medicinal use of CRISPR sequences is in clinical trial stage only, in China and USA.
  Perhaps.... but what counts as "Medicinal use" ?
  Is using the tool to alter cells in a test tube and then re-inject only altered cells back into the body a "Medicinal" use?
  Don't think so..... Medicinal treatment would suggest injecting
  a CRISPR formulation to modify DNA in the cells that are inside the human body while being modified.
27. Re:proper by ShanghaiBill · 2018-05-31 04:48 · Score: 3, Insightful
  
  Meanwhile Chinese researchers, not bothered by any of those morality concerns ...
  China has moral concerns. They just reach a different conclusion. After weighing the potential benefits to millions of potential beneficiaries against the risk to a handful of patients (who are informed consenting adults), I don't think their conclusion is wrong.
  The West is cautious about medical experimentation because of historical abuses such as the Tuskegee experiments, and Nazi experiments. The Chinese don't have the same cultural baggage.
28. Re:proper by Anonymous Coward · 2018-05-31 05:06 · Score: 0
  
  i have crohns, i would happily take one of the current experimental treatments if i lived close enough to a testing center... anything beats my current treatment regimen even if it shorts my lifespan considerably its still a chance to not be bound to a toilet.
29. Re: proper by Anonymous Coward · 2018-05-31 05:12 · Score: 0
  
  You compare your dog to a car, and then expect to be taken seriously?
30. Re:proper by Anonymous Coward · 2018-05-31 05:19 · Score: 0
  
  FDA once in a while does its job, amazing
  I disagree, in this case I think using CRISPR on humans might be a legitimate use. I don't agree with using it to try and edit the human genome to make taller offspring, or blue eyes, or 15 inch ding-dongs; but to cure a genetic disease... I think that's wonderful. Using CRISPR to cure certain defined genetic diseases is a far cry from designer-babies.
  And your vision of this future utopia is a far cry from reality. It's cute that you still assume modern medicine is being used to cure disease, or increase life expectancy. That's not the goal of any country that is overcrowded already and fighting to sustain enough resources for the current population. I more expect CRISPR being abused to create genetic diseases. We're doing OK today with shit like HPV spread very well across the masses which will ultimately funnel trillions into the Cancer Industrial Complex over the next few decades and help cull the population, but if greed ultimately determines it wants more and faster, manufacturing disease that creates faster results is certainly an option.
  Go ahead. Call it impossible. Call it delusional. Call it fucking batshit insane. Call it whatever you want. Then look at history.
  
  This is an area that needs careful oversight but we shouldn't just dismiss a technology because we fear a slippery slope or because we think a beneficial technology is creepy.
  Need oversight? Take a number and get in line. You'll be assigned appropriate resources right after the snow-cone maker is delivered to Hades.
31. Re:proper by arth1 · 2018-05-31 05:32 · Score: 2
  
  Meanwhile Chinese researchers, not bothered by any of those morality concerns, carry on perfecting the technology. I wonder who's going to be first to market...
  Morality concerns would be the only reason to pursuing these kinds of treatments at all.
  If amoral, you let the less fortunate suffer and die, replace them with new humans, and trust evolution to reward the winners by their genes propagating more.
  Personally, I'm midway between the two, which some might find extreme enough. I'm all for offering saving of lives and reducing severe suffering, as long as it is always conditional on mandatory sterilization, and as long as suicide and infanticide are also presented as options.
32. Re:proper by Anonymous Coward · 2018-05-31 05:35 · Score: 0
  
  One of the few times pet insurance is a really great idea.
33. Re: proper by Anonymous Coward · 2018-05-31 05:39 · Score: 0
  
  You compare your dog to a car, and then expect to be taken seriously?
  Rickb928 did not compare his dog to a car.
34. Re:proper by Oswald+McWeany · 2018-05-31 05:57 · Score: 1
  
  I don't agree with using it to try and edit the human genome to make taller offspring, or blue eyes, or 15 inch ding-dongs;
  Why not?
  I mean, one of the primary driving goals of human parents is to do their best to give their offspring the BEST potential to do well in their life....
  If they couldn't start ahead of the curve and give them physical traits (height, brain capacity, disease resistance, heck even traits towards attractiveness)....why not?
  It is just taking what parents do now to a higher step.
  Well, for one, that would be creating a permanent over-class and servant-class, unless it was available for everyone. For another, it would subject children to the whims and fashions of the day. Thirdly, and most importantly, if this were available for everyone it would impact the diversity of the human genome which could have long lasting consequences beyond our possible knowledge. A fashionable gene could end up putting the entire human population at risk at being wiped out by a single disease.
  
  --
  "That's the way to do it" - Punch
35. Re:proper by Anonymous Coward · 2018-05-31 05:59 · Score: 0
  
  FDA once in a while does its job, amazing
  I disagree, in this case I think using CRISPR on humans might be a legitimate use. I don't agree with using it to try and edit the human genome to make taller offspring, or blue eyes, or 15 inch ding-dongs; but to cure a genetic disease... I think that's wonderful. Using CRISPR to cure certain defined genetic diseases is a far cry from designer-babies.
  This is an area that needs careful oversight but we shouldn't just dismiss a technology because we fear a slippery slope or because we think a beneficial technology is creepy.
  I also would be concerned about a mother that wanted her son to be gene-edited to have a 15 inch ding-dong.
36. Re:proper by kellymcdonald78 · 2018-05-31 06:04 · Score: 1
  
  The problem is that depending on the stage of a trial, a single death (regardless of it being caused by the new medication/procedural or just the fact that the patient is already dying from the condition), can derail the entire trial and prevent or delay a new treatment from coming to market (did patient X die from the treatment or the condition). Yes the person is rolling the dice hoping that it comes up box cars, but if it comes up snake eyes thousands of others can be affected
37. Re: proper by Anonymous Coward · 2018-05-31 06:05 · Score: 0
  
  Nope. Not only is their decision making capacity impaired, the vast number of con artists and frauds in the industry endanger all of us.
  Sorry, but Law and Order exposed the truth about the alleged truth over three decades ago.
38. Re:proper by iggymanz · 2018-05-31 06:06 · Score: 0
  
  as society we've already made the choice that doctors, medicines and treatments will be vetted. so no, the patient doesn't get to support a quack (legally). yes there are shortcomings and abuses in the system, different topic
39. Re:proper by iggymanz · 2018-05-31 06:15 · Score: 1
  
  eh, "medicinal" only means healing. The mechanism and protocol could be anything.
  It is unknown at this point if CRISPR use can heal *anything* in humans.
  we're far, far from what the headlines imply. I see silliness that are variation on "Governments not keeping up with the wonderful power of CRISPR" . Oh noes, this live-saving tech is only restrained by powerwork!
  er no, there is no treatment for humans using CRISPR sequence. no known benefit. no healing of any disease.....only clinical trials exist and the results not published yet. nor peer reviewed,
40. Re:proper by Anonymous Coward · 2018-05-31 06:25 · Score: 0
  
  > yeah but it can take 80 years or more to die for most in the USA
  "for most in the USA"? Please, most Americans can't actually afford to live that long. America's health care model is so fucked compared to the modern world.
41. Re:proper by Anonymous Coward · 2018-05-31 06:42 · Score: 0
  
  This is totally incorrect, and the link you gave doesn't support your claim at all.
  Sickle-cell is an evolutionary adaptation that protects an individual from malaria, so in some areas (before modern medicine) it would increase a person's lifespan and chances of reproducing. In modern times, it's a chronic condition that does come with health risks but is in no way a death sentence.
42. Re:proper by gtall · 2018-05-31 09:05 · Score: 2
  
  Yes, they do, they just choose to ignore it. They were subject to Japanese scientists experiments which were just as ghastly as the Nazis. Then there is the abject horror of the Mao years.
43. Re: proper by Anonymous Coward · 2018-05-31 09:20 · Score: 0
  
  Havenâ(TM)t we learned anything from the last four zombie apocalypses? No? Nothing?
44. Re:proper by Anonymous Coward · 2018-05-31 10:00 · Score: 0
  
  meanwhile, going to clinical trial instead of normal treatments for deadly cancer will shorten your life even more in most cases.
  Shouldn't that choice be ultimately up to the patient in question?
  It is their life, it should be their choice....
  Nope. Too many quacks and frauds involved who will sell poison and claim it is a cure under the auspices of choice. Law and Order covered this over three decades ago.
  Besides, all of those "clinical trials" want the government to sanction them, and prevent me from executing the bastards in the streets.
  Now who's choice is that?
  Sorry, but unless you want to give me the right to rid the world of these pests, you'll have to accept the FDA.
45. Re:proper by booboo · 2018-05-31 20:35 · Score: 1
  
  So rather than fix the process just let people continue to die out of fear of fucking it up for everyone else? That's ridiculous.
46. Re:proper by booboo · 2018-05-31 20:44 · Score: 1
  
  This is a confusing comment. Medicine has advanced, and many effective treatments were first validated for efficacy and safety through a clinical trial. That's really the only way we know how to do this at the moment. Of course many clinical trials have not had the desired effect and many have had a net negative impact on the patient. That sucks, but what alternative is there?
47. Re: proper by booboo · 2018-05-31 20:56 · Score: 1
  
  > And he's the most lovely dog, but I would not pay this for a car repair with similar conditions - *might* fix it, far exceeds objective value, might happen again.
  Sorta.
  I think the size of the investment is coloring the decision here. What if it was a $75 treatment? Would anyone be morally opposed to funding experimentation then?
48. Re:proper by iggymanz · 2018-06-01 03:42 · Score: 1
  
  not saying there is alternative, my point only that this type of gene therapy is at that early stage where unknown if it will even benefit a human at all for any disease for which it is in testing. The headline makes it sound like there is a magic cure with hordes of dying people being pushed away by FDA bureaucrats, which is nonsense.
49. Re:proper by Anonymous Coward · 2018-06-01 03:49 · Score: 0
  
  meanwhile, going to clinical trial instead of normal treatments for deadly cancer will shorten your life even more in most cases.
  Shouldn't that choice be ultimately up to the patient in question?
  It is their life, it should be their choice....
  Nope. Too many quacks and frauds involved who will sell poison and claim it is a cure under the auspices of choice. Law and Order covered this over three decades ago.
  Besides, all of those "clinical trials" want the government to sanction them, and prevent me from executing the bastards in the streets.
  Now who's choice is that?
  Sorry, but unless you want to give me the right to rid the world of these pests, you'll have to accept the FDA.
  nothing changes in over 3 decades?
50. Re:proper by kellymcdonald78 · 2018-06-03 06:29 · Score: 1
  
  It's not a process issue, its a case of potentially adding a whole bunch of extraneous and erroneous data into a trial that could derail, or delay the introduction of a new treatment E.g. A team is in the process of trialing a new treatment for pancreatic cancer. A desperate patient suffering from stage 4 pancreatic cancer wants access to the treatment because, after all, what have they got to lose. The patient gets the treatment, but they still unfortunately die. Now the trial team has a problem. Did the treatment kill the patient? Did they just get the treatment too late? Was their some other factor?. Since much of the data generated during a trial is statistical in nature, you can't just say, "well ignore this guy" because maybe it did identify a legitimate issue with the treatment.
Comment removed by account_deleted · 2018-05-31 02:45 · Score: -1, Offtopic

Comment removed based on user account deletion
Stupid FDA by Anonymous Coward · 2018-05-31 02:47 · Score: 0

If I want to turn myself into some kind of vampire bat-man that feeds on human blood to sustain my nocturnal life, I have every right to do it, and then to turn to a life of vigilantism for the fun of beating people up and stealing their vital fluids.
No government will stop me, because I am vengeance, I am the night, I am the MAN-BAT!
1. Re:Stupid FDA by Oswald+McWeany · 2018-05-31 02:55 · Score: 1
  
  If I want to turn myself into some kind of vampire bat-man that feeds on human blood to sustain my nocturnal life, I have every right to do it, and then to turn to a life of vigilantism for the fun of beating people up and stealing their vital fluids.
  No government will stop me, because I am vengeance, I am the night, I am the MAN-BAT!
  Vigilantism is illegal in most countries; as is non consensual consumption of other people's bodily fluid. You should be ashamed of yourself Man-bat. I will spend the rest of my days hunting you down.
  
  --
  "That's the way to do it" - Punch
2. Re:Stupid FDA by jedidiah · 2018-05-31 03:00 · Score: 1
  
  Chances are that if you need this kind of treatment you are already a vampire man-bat. You just use an IV instead of your teeth.
  
  --
  A Pirate and a Puritan look the same on a balance sheet.
3. Re:Stupid FDA by Anonymous Coward · 2018-05-31 03:00 · Score: 0
  
  Would you settle for being a ManBearPig?
4. Re: Stupid FDA by Anonymous Coward · 2018-05-31 03:47 · Score: 0
  
  Nope, the government has an illegal monopoly over justice in most countries, and the imposition of rightful punishment for transgressions does not require consent or otherwise no man would go to prison except those lazy schmucks who use incarceration as an excuse to avoid life.
  My system you will find is far better, quick and sudden like the strike of a bat feeding on its prey.
5. Re: Stupid FDA by Anonymous Coward · 2018-05-31 03:51 · Score: 0
  
  The only need I have is to right the wrongs of this benighted world with the power of my fists of justice.
6. Re: Stupid FDA by jedidiah · 2018-05-31 03:56 · Score: 1
  
  That won't help you in the slightest if you need someone else to open a vein for you.
  
  --
  A Pirate and a Puritan look the same on a balance sheet.
7. Re: Stupid FDA by Type44Q · 2018-05-31 03:57 · Score: 1
  
  illegal monopoly
  Immoral? Sure. Evil? Now question; just study history. Illegal?? Me thinks you need to look up the definition of that one.
8. Re: Stupid FDA by Anonymous Coward · 2018-05-31 04:09 · Score: 0
  
  Sadly, being half man and half bearpig does not grant the power of flight.
9. Re: Stupid FDA by Anonymous Coward · 2018-05-31 04:12 · Score: 0
  
  It is a common assertion for the government to declare that when they do it, it is not illegal, however there is no reason to succumb to their deliberate fallacy.
  All have the right to judge, and that includes the judgment against the government. There is a tendency to ignore this, but it is also something declared in the substance of their own existence which perennially becomes renewed.
  Now that you know the truth, join me, with the power of the red-breasted robin the most vicious of the feathered friends.
10. Re: Stupid FDA by Anonymous Coward · 2018-05-31 04:14 · Score: 0
  
  Alan, is that you?
11. Re: Stupid FDA by Anonymous Coward · 2018-05-31 05:09 · Score: 0
  
  That's why the fangs, did you forget already?
Measure twice, cut once by SlaveToTheGrind · 2018-05-31 02:55 · Score: 3, Insightful

I'm generally not big on layers of bureaucratic red tape, but for an emergent technology like this it seems absolutely appropriate to take an extra cautious approach for the moment.
1. Re:Measure twice, cut once by bill_mcgonigle · 2018-05-31 04:44 · Score: 1, Informative
  
  Why do you think you're at all qualified to determine the level of caution that is prudent? The FDA's over abundance of caution has caused, to date, 15 million unnecessary deaths, and that's the middle estimate. They grossly over reacted to the thalidomide scare by causing one and a half Nazi Holocausts worth of death and suffering. Sickle cell anemia may not be immediately fatal, but it does cause suffering, and people should be free to choose what is done with their own bodies.
  
  --
  My God, it's Full of Source!
  OUTSIDE_IP=$(dig +short my.ip @outsideip.net)
2. Re:Measure twice, cut once by SlaveToTheGrind · 2018-05-31 05:17 · Score: 1
  
  Why do you think you're at all qualified to determine the level of caution that is prudent?
  Setting aside the fact that I didn't say I personally was qualified, are you suggesting that the manufacturer standing to profit from the therapy is in a better position to determine the prudent level of caution? Usually we prefer not to let the fox totally guard the henhouse.
  
  The FDA's over abundance of caution has caused, to date, 15 million unnecessary deaths
  If you'd prefer to nuke or effectively neuter the FDA, then call your congresscritter and advocate for that. Good luck.
3. Re:Measure twice, cut once by Kulahan · 2018-05-31 05:19 · Score: 1
  
  people should be free to choose what is done with their own bodies.
  But these people aren't really free to choose. They have a "gun" to their head in the form of a sickness, and they're being told to do whatever it takes at *any* cost to cure it. They're ripe for being taken advantage of by well-meaning scientists hoping to solve their problem
  There absolutely needs to be someone to step in and say "Hold up, let's make sure this is a smart approach first." You could tell these people that sucking on a tube of U-238 will cure them and they'd give it a try. Hell, people will give it a try to solve something as silly as baldness, let alone cancer or some disease that causes extreme, life-long suffering.
4. Re:Measure twice, cut once by Anonymous Coward · 2018-05-31 05:52 · Score: 0
  
  They grossly over reacted to the thalidomide scare
  Well in Canada where we allowed thalidomide to be used for a brief time, we had 24,000 people born with deformities who the government is still dealing with in courts and payouts, not to mention the 123,000 babies who died before birth due to the drug. And we're 1/10th the population...
5. Re:Measure twice, cut once by Bruce+Perens · 2018-05-31 06:22 · Score: 1
  
  I don't know if you actually know you're doing it, but this is a classical fascist tactic. Immediately attack the questioner that they are incompetent to assess the issue. State that only specialists can do it, and the involvement of the interested public is inappropriate. This is of course used to protect a medical technique that may combine extreme risk with low efficacy. It will make someone a ton of money, potentially at the cost of some number of poor people being killed or having their health made worse.
  The FDA's job is to protect us from quack medical techniques and practitioners. THEY ARE NOT DOING IT. Most doctors, that is MOST, prescribe off-list medicines, those which are not FDA-recommended for the disease in question. This should be illegal. No one person, regardless of their medical education, should have the power to make that sort of decision.
  Many quack practitioners practice with state or federal licenses on the borderlines of medicine with no scientific backing for their efficacy, like chiropractic, osteopathy, aromatherapy, etc. We also have nostrums for sale like oscillococinium actually for sale in pharmacies. And there is no regulation of supplements.
  So, now people are going to get to hack the human genone with minimal or monitoring of the individual case by anyone but the doctor in charge. What could go wrong with that?
  
  --
  Bruce Perens.
6. Re:Measure twice, cut once by Anonymous Coward · 2018-05-31 06:37 · Score: 0
  
  At least now we won't need a teleporter malfunction to get a brundelfly.
7. Re:Measure twice, cut once by sg_oneill · 2018-05-31 09:18 · Score: 1
  
  15 million unnecessary deaths
  Serious cite needed on this. I cant find *any* reference to this claim online, even the kook anti-govt sites. In fact the only page on the net with this claim, according to google, is this very thread.
  So give us a cite for that, or its reasonable to conclude, you just made that up.
  
  --
  Excuse the Unicode crap in my posts. That's an apostrophe, and slashdot is busted.
Painful Trials by Anonymous Coward · 2018-05-31 02:59 · Score: 0

I'd hate to conduct animal testing on this procedure.
Perhaps CRISPR is a terrible name by Anonymous Coward · 2018-05-31 03:03 · Score: 0

I'm sure these guys could come up with a name that doesn't make people instantly think of the electric chair.
1. Re:Perhaps CRISPR is a terrible name by Anonymous Coward · 2018-05-31 03:35 · Score: 0
  
  Equating 'crisp(e)r' to 'electric chair' is on you.
2. Re:Perhaps CRISPR is a terrible name by Tempest_2084 · 2018-05-31 03:39 · Score: 1
  
  Actually it makes me think of the drawer that keeps lettuce cool in a refrigerator.
Re:Man I saw CRISPR and thought it said CRISPER by Anonymous Coward · 2018-05-31 03:04 · Score: 0

whats ur deal wierdo
Allow Human trials on terminal patients by rojash · 2018-05-31 03:09 · Score: 2

I think they should allow Human trials on terminal patients
Please Ignore This Post by Anonymous Coward · 2018-05-31 03:10 · Score: -1

0862 a777 9d57 eaee c14f 05af bc1c 51f9 10af 49d7 b968 cd81 e7b6 6335 6715 d72f c748 6bd3 ca16 c496 6d86 f539 dfa5 0380 aa42 4614 d44c 1704 aa0f 60c1 a4c5 0589
1. Re:Please Ignore This Post by crimson+tsunami · 2018-05-31 03:20 · Score: 1
  
  OK
Very Hard to Measure Safety by Artagel · 2018-05-31 03:16 · Score: 4, Informative

One problem with these gene-editing treatments is that it is very hard to measure the safety of the treatment. It could be that the company tried to show how it would measure safety, but FDA wasn't satisfied with the process.
Chemical and Engineering News (probably behind a paywall) has an article about how companies are trying to come to a consensus on how to measure safety. https://cen.acs.org/pharmaceut...
A huge problem here is that DNA breaks all the time in our cells and gets repaired. That is the exact process CRISPR leverages to make its edits. So, how do you tell a natural break and mis-repair from a misdirected CRISPR edit. Not an easy thing to tell. FDA wants the applicant to show safety, not for someone else to show dangerousness. Proving a thing that is very difficult to measure in the first place is a great challenge, and may keep these treatments from advancing at FDA.
The Europeans have a similar issues with their beta-thalassemia trial. https://www.bionews.org.uk/pag...
1. Re:Very Hard to Measure Safety by Anonymous Coward · 2018-05-31 03:34 · Score: 0
  
  Then travel to China - where money talks and they DO.
  I though dogs had all sorts of CRISPR therapys, so why whinge when the alternative is worse.
  I would rather the FDA check cost effectiviness and success percentages to patients can make informed decisions.
Re:Man I saw CRISPR and thought it said CRISPER by Anonymous Coward · 2018-05-31 03:24 · Score: 0

You misspelled you're
Comment removed by account_deleted · 2018-05-31 03:26 · Score: 0

Comment removed based on user account deletion
Not necessarily by Anonymous Coward · 2018-05-31 03:44 · Score: 1

FDA once in a while does its job, amazing
That depends entirely on the line of questioning. If it is something along the lines of "we have reason to suspect this may pose a risk to patients due to scientific evidence A, B, and C (citations provided)" then yeah, it's a good thing.
If it is something along the lines of "Aren't you violating God's mandate by editing His(tm) perfect genome and the fate He(tm) has decreed for these patients," which is not something I'd put past this administration (and how interesting that the question(s) are secret), then no, this is anything but a good thing.
Either way, we can expect China et al to step into the breach and progress the technology, leaving the US in their dust like they did with Stem Cell research under W.
1. Re:Not necessarily by arth1 · 2018-05-31 05:48 · Score: 1
  
  That depends entirely on the line of questioning. If it is something along the lines of "we have reason to suspect this may pose a risk to patients due to scientific evidence A, B, and C (citations provided)" then yeah, it's a good thing.
  I think the bigger question is what the risks are to society and humanity, both if it goes wrong and if it goes right.
Re:Man I saw CRISPR and thought it said CRISPER by Type44Q · 2018-05-31 03:55 · Score: 1

If you're not at all amusing in person - and we both know you're not - what the fuck makes you think any of that would be funny in print??
Off the coast by Anonymous Coward · 2018-05-31 04:00 · Score: 0

I don't understand in today's world of multi billion dollar corps why they don't buy a decommissioned cruse ship and park it 25 miles off the coast of CA and do whatever the hell they want on the boat. Want to risk the CRISPR treatment, take a boat ride out to international waters and make it happen.
Risk borne by patient by Okian+Warrior · 2018-05-31 04:05 · Score: 1

FDA once in a while does its job, amazing
That depends entirely on the line of questioning. If it is something along the lines of "we have reason to suspect this may pose a risk to patients due to[...]
The FDA is a bureaucracy responsible for the safety of patients, but bears none of the costs of that safety.
It is in the FDA's interest to make the safety bar so high that medical progress is stifled, so long as safety is its primary goal. Medical companies are always at odds with the FDA, trying to negotiate more sane procedures and reliances.
Taking this article as an example, the patients are completely cut out of the equation. The patients might have a terminal disease with a projected survival of a few years, or might have an awful quality of life - and yet, they cannot choose to try this treatment. They cannot bear the risks from their own choices. The FDA lets patients die rather than have the possibility of an unsafe treatment.
It's ridiculous.
(And for a suggested alternative, let the FDA regulate *products*, not tests. Let the companies do studies and experiments on people willing to take part, and only step in when the treatment becomes publicly available. Add in a bit of legal protections and a standard value of human life - $5 million, say - and medical treadments would advance very quickly.)
The FDA doing it's job... by Anonymous Coward · 2018-05-31 04:07 · Score: 0

This is the reason it exists as an organization, to protect the public and our health. I haven't agreed with everything they've done, and I'm not a huge fan of over-regulation. But, stopping and asking for more details before proceeding on something as new and potentially dangerous to the entire species as CRISPR is the correct approach.
So what about the anti-GMO activists? by Anonymous Coward · 2018-05-31 04:14 · Score: 0

Wasn't this the same thing that someone claimed they were going to stop looking into because "the GMO activists" could send a LOT of nasty emails and put them off their work? If so, I guess it proves that the complaint was a load of bollocks from the off, then. It was they were going to be asked by the FDA about it, and didn't want to answer.
Then ask. NOW. by Catbeller · 2018-05-31 04:15 · Score: 1

IF the FDA uses its usual deliberate speed, we'll have CRISPR treatments, oh, after I die from something that could have been treated with CRISPR.
If they have questions, ASK THEM. QUICKLY. Get answers, get out of the way.
1. Re:Then ask. NOW. by Dorianny · 2018-05-31 04:27 · Score: 1
  
  The aim is to keep you from dying faster or living what time you have left in a significantly worst condition because the "treatment" is dangerous and ineffective. Just ask all the idiots that went to countries with lax oversight to get themselves injected with the last "miracle cure," stem-cells
2. Re:Then ask. NOW. by Anonymous Coward · 2018-05-31 06:00 · Score: 0
  
  Everyone is dying. There are no guarantees and you have agency in your own life. If people can choose to commit suicide (which they do), there's no reason to prevent people from making choices that may or may not be medically sound. Most people are stupid (statistically). There's no stopping it. The mommy state that tries to protect people from themselves is not a bottomless pit of authoritarian protectionism and this seems well below that line.
Halt the FDA by micahraleigh · 2018-05-31 04:16 · Score: 1

The FDA is a massively expensive formality, an obstacle of saving lives with allegations of corruption all over the place.

If the FDA told me to eat undercooked meat would I do it. No way !

Did the FDA write The Jungle expose that uncovered the unsanitary practices of food handling? No, it was a private citizen, Upton Sinclair.

How many medical/pharmeceutical breakthroughs happen in over regulated Europe? None.

Does it do anything? Maybe, but better off without it.
I disagree: Five foot three inch man. by Anonymous Coward · 2018-05-31 04:19 · Score: 0

I think people should be able to design their children. A five foot three inch man and a five foot even woman may want more for their child.
See, height matters in ALL aspects of human society. It's a subconscious reaction because deep down, we're monkeys and we respond to the alphas. And height makes one an alpha.
And intellect too. The US Army won't take anyone with an IQ lower than 85. Why? Because people with that low of an IQ cannot be trained for anything. That's 10% of the population.
A world like that great sci-fi movie Gattaca? Let's go!
1. Re:I disagree: Five foot three inch man. by Oswald+McWeany · 2018-05-31 04:32 · Score: 0
  
  I think people should be able to design their children. A five foot three inch man and a five foot even woman may want more for their child.
  See, height matters in ALL aspects of human society. It's a subconscious reaction because deep down, we're monkeys and we respond to the alphas. And height makes one an alpha.
  I wouldn't call being short a curse, except in extreme cases of dwarfism, shorter individuals within any given population live longer than taller individuals. That 5'3" man is going to live longer. Also, being 5' for a woman in a reproductive sense IS an advantage. Men overwhelmingly prefer shorter women. (there are exceptions of course, but shorter women in general get more male attention.
  
  --
  "That's the way to do it" - Punch
2. Re:I disagree: Five foot three inch man. by butchersong · 2018-05-31 05:29 · Score: 1
  
  I could be wrong but I believe men prefer shorter women than them. They don't that I know of prefer short women.
3. Re:I disagree: Five foot three inch man. by iggymanz · 2018-06-01 05:21 · Score: 1
  
  nah, most of us are beta and lower regardless of height. we have a sawed-off runt running the city of Chicago (into the ground I might add)
Holding out by Anonymous Coward · 2018-05-31 04:27 · Score: 0

I'm holding out for the CRSPN-GLOVR treatment. It is our density.
Comment removed by account_deleted · 2018-05-31 04:45 · Score: 0

Comment removed based on user account deletion
This is why we can't have nice things..... by scrout · 2018-05-31 04:48 · Score: -1

Just move the fuck over the border to Mexico or another country. My medical treatment is a matter between me and my doctor. Yes, it could kill me, still my decision. FUCK OFF FDA.
Why not? by mi · 2018-05-31 05:15 · Score: 1
I don't agree with using it to try and edit the human genome to make taller offspring, or blue eyes, or 15 inch ding-dongs
You don't, eh? So much for the:
- privacy;
- keeping government out of bedrooms;
- women's right to choose
--
In Soviet Washington the swamp drains you.
You cannot stop something that hasn't started yet by nospam007 · 2018-05-31 06:18 · Score: 1

So the article is just about some bureaucratic mumbojumbo like _always_ when such trials start.
I guess form 643a got stuck in the mail and now we get a crappy story here.
Tell us when they cured the guys but not every step to get the authorization to begin.
Or... by Anonymous Coward · 2018-05-31 06:36 · Score: 0

shades of "Cancer. The Forbidden Cure".
https://www.youtube.com/watch?...
Slight delay on SCD not withstanding by Toxiz · 2018-05-31 09:18 · Score: 1

The more interesting part is the following, from a CRISPR press release: The planned initiation of a Phase 1/2 trial of CTX001 in Europe in adult patients with transfusion dependent Beta-thalassemia is unchanged, and the companies expect to initiate the trial in the second half of 2018. Therefore, ex vivo CRISPR gene-edited therapies are actually about to go into trails. The SCD treatment has hit a very small bump in the road, which is expected and less of a story.
Sounds like another Theranos by Anonymous Coward · 2018-05-31 16:13 · Score: 0

This company and their claims sounds exactly like Theranos. Anybody remember Theranos? The company that FAKED the capabilities of their product?
FDA is 100% right when halting the "experiment" until they answer questions and show proof that can be duplicated.
BTW, Why is the CEO of Theranos still walking on the streets? She committed fraud in the most heinous of ways and possibly caused many deaths due to the fake results the company provided.
Any agency's motives are open to question by serutan · 2018-05-31 21:18 · Score: 1

The more coupling there is between corporations and the federal agencies that are supposed to regulate them, the less you need a tinfoil hat to wonder if influential companies might use the FDA to obstruct research that could result in products that threaten their business. We live in an age of medical maintenance, not cures. How long has it been since the last eradication of a major disease? I have to wonder if we'll ever see cures for diseases such as diabetes that support multi-billion dollar maintenance industries.
And...? by martinfb · 2018-06-01 06:01 · Score: 1

So what are the reasons?
What about "Right to try"?

--

Self-importance and self-indulgence is the root of ALL evil.