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.
First of all, the scientist in the article (RTFA, please) is planning on using cross-breeding to attain the desired plant to avoid GMO activists. That is not a GMO technology. It is taking different existing, non-GMO chickpeas and breeding them with each other to make new ones. It is genetic change in the plants, but is of a type GMO activists approve of.
But with cross-breeding it may take decades or never succeed. The scientist does not control the genetic outcome with cross-breeding. Detailed systematic study of genetic variation is impossible. That impedes results.
And while the US has not had Europe's history of violence in the area, it could. Not wanting to take the risk is perhaps strongly cautious, but there is nothing irrational with not wanting to be the first. We have had violence in animal research protests, logging protests and other activist causes.
The technology presents interesting questions for search and seizure law in the U.S. Currently, in Carpenter v. United States, the Supreme Court is considering a case where warrantless cell phone tower data for over four months is an illegal search. Scotusblog has a page (the transcript is available as audio or video as the "Tr." or "Aud." under the "Argument" heading).
The key to Carpenter is that earlier cases held that there was no reasonable expectation of privacy in the metadata about a phone call since the phone company had it. The problem in this case is how much there was -- basically protracted surveillance via cell towers. Even though your license plate is in plain view on streets, perhaps the government cannot engage in protracted surveillance of it without a warrant.
It is not unusual for the U.S. government to try to maintain cost control on its data that is popular and therefore relatively expensive to provide. Sometimes, it seeks to have private partners take on distributing the data. At some point the Patent Office (an entirely user-fee operated organization, not taxes) worked with private companies to provide copies of patents to interested people in addition to the for-free U.S. Patent Office patent copies service. When the USPTO went online, it had to limit expense by providing a painful portal (download 1 page at a time). For-fee companies that the Patent Office shared data with would provide better electronic service at a price.
Had the Patent Office fully charged each patent applicant for its patent in the past? Yes. But it needs money to keep handing out the patents. It has to come from somewhere. Other pieces of the government face the same problem.
Why shouldn't the researchers bear the cost of accessing the data? To some extent it is the U.S. government moving money from one pocket (research grants) to the other (Landsat image fees). I think the out of pocket costs for the public would be minimal for the benefits obtained, so why not defray some of the costs from the users?
Ethan Siegal at Starts With A Bang (makes the point that https://www.forbes.com/sites/s...) makes the point that what is a planet should be considered in light of what we know about solar system evolution. According to that perspective, it does not appear that Pluto is a planet. If Pluto is a planet, then there are over 100 of them.
China is announcing all sorts of investments in science and engineering. Following through is uneven. They have huge numbers of scientists and engineers. As someone who got a Ph.D. in Chemistry at a top university back in the 1990s, I can tell you that the Chinese students that came here were top-notch, and many wanted to return to China.
We have been kept afloat by many of these Chinese students staying. I don't think the U.S. could have done what it has on Americans alone. How do we make sure our top people go into science? Even Justice Scalia noticed that too many top minds were going into law.
Yes, the peasants are revolting. Alas, this is what happens when their betters ignore them. Your distaste for them is what makes them cause problems for you. Perhaps those who think they are leaders should take the concerns of ordinary people into account when making their plans. That way, the ordinary people do not become so unhappy as to take matters into their own hands.
The job described, managing the scarcity of carpentry at a university, isn't completely pointless so is a bad example. Our economy is not so advanced that it can avoid scarcity of a lot of things. That is why we use price to regulate demand. Sometimes we manage scarcity through rationing or long lines to get service instead. If you don't want riots, you probably need someone to manage the rationed or delayed people.
In this particular instance, 2 carpenters would probably have been a better idea than 1 carpenter and an apologist. But for all I know, that area has a carpenter shortage. I don't think the guy who has to manage the big faculty egos is doing nothing.
The post is based on a false premise: that CO2 production is inherent in making concrete. There is already a process to not do that. Further, most of the CO2 is made from generating the heat to make the concrete. Most of that CO2 production is low-hanging fruit to eliminate.
Look, we have had restrictions for a long time. Export controls on technology are not widely known about or enforced. Most importantly, a foreign national within the U.S. learning the information is a regulated export: this is the "deemed export" rule. Making it about China is just noise. It isn't like North Korea or Iran are loved either.
One has to choose how to sequester carbon so it does not become CO2. The CO2 causing problems now was sequestered as carbon-containing compounds in geological formations containing petroleum and coal. Large amounts are also sequestered in limestone (CaCO3).
Limestone forms from CO2 when the CO2 dissolves in water and forms carbonic acid (just like in your carbonated soft drink) and the carbonic acid finds calcium or magnesium ions, which are found in rocks. The problem with the natural process is that the calcium and magnesium ions only become available very slowly. (To those willing to wait hundreds of millions of years, the solution to that extra carbon dioxide is coming!)
Tests in Iceland have been successful in converting about 95% of radioactively labeled CO2 into calcite. https://www.nytimes.com/2016/0.... If you can get calcium and magnesium bases into the ocean, you can neutralize the carbonic acid that is raising the pH and sequester the carbon. Climate change is not only atmospheric CO2 so a range of solutions is needed.
I suspect the Israelis are somehow monitoring this with great interest. They have the capabilities to have good performance in this area on both sides of the EW battle. And they would not be tipping their hand to either side.
Well, this is one in a long line of people applying for exemptions to laws because they are special. The usual answer is, no, you are not special. It isn't for the administrative apparatus to get rid of the law it administers, it is for the political body responsible for the measure to pass a corrective measure.
Presumably one would have to contact domain name holders through their registrars without knowing who the registrant is. The system is not transparent, but it is private.
It is true that in the past administrators have been selected principally on their ability to oversee and execute the programs of NASA. That left leadership on NASA's portfolio principally in Congress because the political skills to advance NASA's mission were a secondary consideration at best. This time, the political ability to advance NASA's mission was the principal concern. Will the oversight and execution of NASA's programs be compromised when left to secondary political appointees or careerists? I think that this is the experiment to find out.
Many think that NASA's prominence is slipping away without political push from repeated administrations. Personally, I am not as concerned about that as some because I'd rather explore our oceans than outer space. But I understand the concern of many including huge numbers of former astronauts. If you go to events at the Adler Planetarium in Chicago, it is not hard to meet former astronauts who despair at NASA's erosion over time.
Let's get one thing straight: the company that innovates cures has only a limited time frame for profiting from the risks they took in developing the cure or treatment.
Small molecule drugs are treatments. For a small molecule drug that time horizon is about 12 years (drug development after invention and regulatory approval time cuts it back from 20 years). Then the generics enter the market, and well, the profitability of treatment goes bye-bye.
The picture is better for biologic drugs because biosimilars are harder to get approved and cannot undercut the price of the innovator product as much because manufacturing costs are so high for biologics. The statutory exclusivity period is 12 years for biologics under the Affordable Care Act.
The genetic editing cure market is brand new. Yet it will be constrained by the same laws and market forces that constrain small molecule drugs and biologics. An innovator only has a limited time of profitability. For the innovator the time to profit from a cure and a treatment will be about the same. But the price that can be charged for a cure instead of a treatment will be much higher. The profitability of cures instead of treatments should be better for the innovator than the innovator, if not the market as a whole. Cures screw the generic companies, not the innovator.
The original poster provides information from the CNN article that shows deaths. It does not report that (1) the patient population is old, thus prone to death, and (2) that two follow-on studies found no difference in death rate between the drug and placebo. FDA is monitoring the reports of deaths, but unless someone does the science to find out whether the deaths of these old people are unusual you risk denying the patient population that benefits from the drug the relief from their disease.
It is good that the medical community is being made aware of the adverse event reports. Doctors and patients (or their guardians) should know this information in making a personal decision.This is not a drug category with good options as shown by the breakthrough drug designation.
Older movies are unwatchable unless you have watched enough older movies to be used to how they can dwell on scenes and give actors time to more fully project the characters. Current movies are made for viewers that have the attention span of a fruit fly on drugs. I expect that the young consider most of an even older great movie, Ben Hur, to be unwatchable.
Courts do not routinely have paper records these days. The federal courts have been electronic since 2004, starting with one court docket in 1996. Illinois, for example, has been mandatory since 2016. Georgia has some e-filing in its courts. Courts simply do not have the space to store the paper any more.
I remember being a tourist in China. The good old CITS had the van/bus stopping to visit various shopping locations between historical or cultural stops. This would fit right into their model.
Wockhardt has FDA approval for a generic. I am not sure if Wockhardt would enter the market because of this. All they have to do is make it and sell it to lower the price.
You can find information like this at Drugs@FDA, with the lovely link https://www.accessdata.fda.gov.... If you search for NIACOR and then look under the result for therapeutic equivalents, you find the approved Wockhardt product has been approved as Application No. 081134 since 1992.
After it was revealed that the FCC comments were largely fake, the White House decides to try to get its petitions website in order. That is a rational response. It must be the Russians behind it. It could not be Trump.
I don't think the principal difference between shogi and chess is board size. In Shogi, you can place the pieces you capture onto the board as your own pieces. Having paratroopers is a lot different.
This action by Apple shows why a company wants patents even if it does not run around enforcing them all the time. It is a war chest for when someone else sues you. Sue IBM for patent infringement? IBM has tens of thousands of patents to sort through to counterattack.
If you are going to get calcium from sedimentary rocks then limestone is your source. But being at the meeting of the North Atlantic and European plates Iceland has access to volcanic (igneous/metamorphic) rocks. They get their calcium from basalt. https://www.washingtonpost.com...
If you wait long enough for erosion to liberate calcium from volcanic rocks the CO2 in the oceans will form limestone. Typically, this is river runoff. https://earthobservatory.nasa.... Alas, waiting hundreds of millions of years isn't going to fight global warming so the Icelandic project is kind of hurrying things along.
Slashdot Mirror
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...
First of all, the scientist in the article (RTFA, please) is planning on using cross-breeding to attain the desired plant to avoid GMO activists. That is not a GMO technology. It is taking different existing, non-GMO chickpeas and breeding them with each other to make new ones. It is genetic change in the plants, but is of a type GMO activists approve of.
But with cross-breeding it may take decades or never succeed. The scientist does not control the genetic outcome with cross-breeding. Detailed systematic study of genetic variation is impossible. That impedes results.
And while the US has not had Europe's history of violence in the area, it could. Not wanting to take the risk is perhaps strongly cautious, but there is nothing irrational with not wanting to be the first. We have had violence in animal research protests, logging protests and other activist causes.
The technology presents interesting questions for search and seizure law in the U.S. Currently, in Carpenter v. United States, the Supreme Court is considering a case where warrantless cell phone tower data for over four months is an illegal search. Scotusblog has a page (the transcript is available as audio or video as the "Tr." or "Aud." under the "Argument" heading).
The key to Carpenter is that earlier cases held that there was no reasonable expectation of privacy in the metadata about a phone call since the phone company had it. The problem in this case is how much there was -- basically protracted surveillance via cell towers. Even though your license plate is in plain view on streets, perhaps the government cannot engage in protracted surveillance of it without a warrant.
It is not unusual for the U.S. government to try to maintain cost control on its data that is popular and therefore relatively expensive to provide. Sometimes, it seeks to have private partners take on distributing the data. At some point the Patent Office (an entirely user-fee operated organization, not taxes) worked with private companies to provide copies of patents to interested people in addition to the for-free U.S. Patent Office patent copies service. When the USPTO went online, it had to limit expense by providing a painful portal (download 1 page at a time). For-fee companies that the Patent Office shared data with would provide better electronic service at a price.
Had the Patent Office fully charged each patent applicant for its patent in the past? Yes. But it needs money to keep handing out the patents. It has to come from somewhere. Other pieces of the government face the same problem.
Why shouldn't the researchers bear the cost of accessing the data? To some extent it is the U.S. government moving money from one pocket (research grants) to the other (Landsat image fees). I think the out of pocket costs for the public would be minimal for the benefits obtained, so why not defray some of the costs from the users?
Ethan Siegal at Starts With A Bang (makes the point that https://www.forbes.com/sites/s...) makes the point that what is a planet should be considered in light of what we know about solar system evolution. According to that perspective, it does not appear that Pluto is a planet. If Pluto is a planet, then there are over 100 of them.
China is announcing all sorts of investments in science and engineering. Following through is uneven. They have huge numbers of scientists and engineers. As someone who got a Ph.D. in Chemistry at a top university back in the 1990s, I can tell you that the Chinese students that came here were top-notch, and many wanted to return to China.
We have been kept afloat by many of these Chinese students staying. I don't think the U.S. could have done what it has on Americans alone. How do we make sure our top people go into science? Even Justice Scalia noticed that too many top minds were going into law.
https://abovethelaw.com/2009/1...
Yes, the peasants are revolting. Alas, this is what happens when their betters ignore them. Your distaste for them is what makes them cause problems for you. Perhaps those who think they are leaders should take the concerns of ordinary people into account when making their plans. That way, the ordinary people do not become so unhappy as to take matters into their own hands.
The job described, managing the scarcity of carpentry at a university, isn't completely pointless so is a bad example. Our economy is not so advanced that it can avoid scarcity of a lot of things. That is why we use price to regulate demand. Sometimes we manage scarcity through rationing or long lines to get service instead. If you don't want riots, you probably need someone to manage the rationed or delayed people.
In this particular instance, 2 carpenters would probably have been a better idea than 1 carpenter and an apologist. But for all I know, that area has a carpenter shortage. I don't think the guy who has to manage the big faculty egos is doing nothing.
Sorry, forgot the link:
https://phys.org/news/2012-04-...
The post is based on a false premise: that CO2 production is inherent in making concrete. There is already a process to not do that. Further, most of the CO2 is made from generating the heat to make the concrete. Most of that CO2 production is low-hanging fruit to eliminate.
This is just more chicken little chicken shit.
Look, we have had restrictions for a long time. Export controls on technology are not widely known about or enforced. Most importantly, a foreign national within the U.S. learning the information is a regulated export: this is the "deemed export" rule. Making it about China is just noise. It isn't like North Korea or Iran are loved either.
One has to choose how to sequester carbon so it does not become CO2. The CO2 causing problems now was sequestered as carbon-containing compounds in geological formations containing petroleum and coal. Large amounts are also sequestered in limestone (CaCO3).
Limestone forms from CO2 when the CO2 dissolves in water and forms carbonic acid (just like in your carbonated soft drink) and the carbonic acid finds calcium or magnesium ions, which are found in rocks. The problem with the natural process is that the calcium and magnesium ions only become available very slowly. (To those willing to wait hundreds of millions of years, the solution to that extra carbon dioxide is coming!)
Tests in Iceland have been successful in converting about 95% of radioactively labeled CO2 into calcite. https://www.nytimes.com/2016/0.... If you can get calcium and magnesium bases into the ocean, you can neutralize the carbonic acid that is raising the pH and sequester the carbon. Climate change is not only atmospheric CO2 so a range of solutions is needed.
I suspect the Israelis are somehow monitoring this with great interest. They have the capabilities to have good performance in this area on both sides of the EW battle. And they would not be tipping their hand to either side.
Well, this is one in a long line of people applying for exemptions to laws because they are special. The usual answer is, no, you are not special. It isn't for the administrative apparatus to get rid of the law it administers, it is for the political body responsible for the measure to pass a corrective measure.
Presumably one would have to contact domain name holders through their registrars without knowing who the registrant is. The system is not transparent, but it is private.
It is true that in the past administrators have been selected principally on their ability to oversee and execute the programs of NASA. That left leadership on NASA's portfolio principally in Congress because the political skills to advance NASA's mission were a secondary consideration at best. This time, the political ability to advance NASA's mission was the principal concern. Will the oversight and execution of NASA's programs be compromised when left to secondary political appointees or careerists? I think that this is the experiment to find out.
Many think that NASA's prominence is slipping away without political push from repeated administrations. Personally, I am not as concerned about that as some because I'd rather explore our oceans than outer space. But I understand the concern of many including huge numbers of former astronauts. If you go to events at the Adler Planetarium in Chicago, it is not hard to meet former astronauts who despair at NASA's erosion over time.
Let's get one thing straight: the company that innovates cures has only a limited time frame for profiting from the risks they took in developing the cure or treatment.
Small molecule drugs are treatments. For a small molecule drug that time horizon is about 12 years (drug development after invention and regulatory approval time cuts it back from 20 years). Then the generics enter the market, and well, the profitability of treatment goes bye-bye.
The picture is better for biologic drugs because biosimilars are harder to get approved and cannot undercut the price of the innovator product as much because manufacturing costs are so high for biologics. The statutory exclusivity period is 12 years for biologics under the Affordable Care Act.
The genetic editing cure market is brand new. Yet it will be constrained by the same laws and market forces that constrain small molecule drugs and biologics. An innovator only has a limited time of profitability. For the innovator the time to profit from a cure and a treatment will be about the same. But the price that can be charged for a cure instead of a treatment will be much higher. The profitability of cures instead of treatments should be better for the innovator than the innovator, if not the market as a whole. Cures screw the generic companies, not the innovator.
The original poster provides information from the CNN article that shows deaths. It does not report that (1) the patient population is old, thus prone to death, and (2) that two follow-on studies found no difference in death rate between the drug and placebo. FDA is monitoring the reports of deaths, but unless someone does the science to find out whether the deaths of these old people are unusual you risk denying the patient population that benefits from the drug the relief from their disease.
It is good that the medical community is being made aware of the adverse event reports. Doctors and patients (or their guardians) should know this information in making a personal decision.This is not a drug category with good options as shown by the breakthrough drug designation.
Older movies are unwatchable unless you have watched enough older movies to be used to how they can dwell on scenes and give actors time to more fully project the characters. Current movies are made for viewers that have the attention span of a fruit fly on drugs. I expect that the young consider most of an even older great movie, Ben Hur, to be unwatchable.
Courts do not routinely have paper records these days. The federal courts have been electronic since 2004, starting with one court docket in 1996. Illinois, for example, has been mandatory since 2016. Georgia has some e-filing in its courts. Courts simply do not have the space to store the paper any more.
I remember being a tourist in China. The good old CITS had the van/bus stopping to visit various shopping locations between historical or cultural stops. This would fit right into their model.
Wockhardt has FDA approval for a generic. I am not sure if Wockhardt would enter the market because of this. All they have to do is make it and sell it to lower the price.
You can find information like this at Drugs@FDA, with the lovely link https://www.accessdata.fda.gov.... If you search for NIACOR and then look under the result for therapeutic equivalents, you find the approved Wockhardt product has been approved as Application No. 081134 since 1992.
After it was revealed that the FCC comments were largely fake, the White House decides to try to get its petitions website in order. That is a rational response. It must be the Russians behind it. It could not be Trump.
I don't think the principal difference between shogi and chess is board size. In Shogi, you can place the pieces you capture onto the board as your own pieces. Having paratroopers is a lot different.
This action by Apple shows why a company wants patents even if it does not run around enforcing them all the time. It is a war chest for when someone else sues you. Sue IBM for patent infringement? IBM has tens of thousands of patents to sort through to counterattack.
Blowback can be a bitch.
If you are going to get calcium from sedimentary rocks then limestone is your source. But being at the meeting of the North Atlantic and European plates Iceland has access to volcanic (igneous/metamorphic) rocks. They get their calcium from basalt. https://www.washingtonpost.com...
If you wait long enough for erosion to liberate calcium from volcanic rocks the CO2 in the oceans will form limestone. Typically, this is river runoff. https://earthobservatory.nasa.... Alas, waiting hundreds of millions of years isn't going to fight global warming so the Icelandic project is kind of hurrying things along.