jimnyc
03-18-2020, 02:27 PM
Worthy of it's own thread as well. I don't know about others, but this one is one that scares the crap out of me the most. IMO you have drugs that your body/life are dependent on. And then you have drugs that are narcotic type, of which where you may have withdrawals without. I take a few psych meds that my doc said could always be swapped around and no issues. I also take alprazolam aka xanax, and I hope he tells me the same about that one. That's a narcotic. I believe valium and a few others would work in replacement. But I'd rather stay on what works right now and not have to deal with any of that. And man, what are those 20 drugs, and are they potentially life threatening for anyone?
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The Next Coronavirus Nightmare: There's a Drug Shortage on the Horizon
Dr. Scott Gottlieb, the former commissioner of the Food and Drug Administration, weighs in on how to tackle the coronavirus pandemic and what the future holds for those Americans who haven't been infected by the virus.
Dr. Scott Gottlieb, the former commissioner of the Food and Drug Administration, is a resident fellow at the American Enterprise Institute. He is a contributor to CNBC and serves on the board of a number of health technology and biotech companies.
Heilbrunn: Are there any existing drugs that you think could help address this crisis in the near term?
Gottlieb: When it comes to therapeutics, it’s a three-pronged strategy. The first is to develop a vaccine. That’s probably two years away. I think we have to be realistic and understand that it’s probably two years until we can get a vaccine. Maybe longer. We’ve never developed a vaccine to a coronavirus, there are certain things we don’t fully understand. There is a certain complexity involved in the kinds of vaccine platforms that we are trying to use now. It’s a very novel technology.
The second strategy is looking at antivirals that can work directly against the virus. That is really going to be a game of looking at what is on the shelf, what antiviral drugs currently exist that might be able to be repurposed to this task—and that’s drugs like Remdesivir, which is being developed by a company called Gilead. There are a number of other antiviral drugs that are being tested against coronavirus that have been shown to be active in vitro, meaning in test tubes, that are now being studied in vivo in animals as well as human trials.
The third leg of this strategy is to try to develop an antibody-based prophylactic. This would be an antibody that targets some feature of the virus that can be used as a prophylactic in people and, in this case, a lot of the people who are trying to develop these products are targeting what is called a spike protein. The spike protein is a part of the virus that the virus uses to gain entry into human cells. One of the companies that is pretty far ahead in developing this kind of product is Regeneron. Regeneron also was able to develop an antibody-based prophylactic that was successful in Ebola. They also had one that they were developing against MERS (Middle-East Respiratory Syndrome) that they had studied in large primates, I believe. This is a company that has shown they can do this and they are currently developing a product against coronavirus. The virtue of this kind of a product is that it would basically be a monthly injection, that you would use it for either frontline healthcare workers or patients who are vulnerable—nursing home patients or immunocompromised patients, maybe people who are going to chemotherapy, people with significant heart disease or lung dysfunction. You give it to them monthly and it would be a prophylactic that could protect them against coronavirus.
...
Heilbrunn: Given how reliant we are on overseas drug manufacturing, at a time of crisis like we are now, what about the safety of the drug supply? Should Americans be worried about accessing medicines in the coming months or is that not a huge concern?
Gottlieb: I think that is a point of concern. I think there is a real risk that we see a series of drug shortages out of what is going on globally. The FDA has talked about twenty sole source drugs from China that are at risk because they are only produced in China. I think the list of drugs that could be at risk is much larger than that. It’s not just drugs that are exclusively manufactured in one location, but drugs where a partial proportion of the total supply is manufactured in one location. If 20 or 30 percent of all the available drug is manufactured in a location offsite, that is enough to sustain a pretty significant shortage of that drug. Because you don’t have a lot of excess capacity in that system where other manufacturers can just easily make it up. But it’s a complicated supply chain and there are disruptions throughout the supply chain because this is a global crisis. In China, a lot of what’s manufactured are the chemicals and inputs that go into drugs, so it gets shipped to India, and the active pharmaceutical ingredients, the actual chemical that is the drug gets manufactured in India, and that API (active pharmaceutical ingredient) get shipped to parts of Europe or other parts of the world and gets tableted, turned into drugs. That’s a complicated supply chain. And at every point in that supply chain, you have had epidemic spread or you’re probably going to have epidemic spread. India looks very suspect right now and there is the potential for disruptions.
The other thing to think about when we are talking about diagnostic screening and rolling that out on a mass scale is that there are shortages of reagents used to extract the RNA from the samples, the actual viral RNA that is in the sample, such as a nose swab. There are reportedly shortages of the reagents needed to extract that RNA and test that sample. There are also reports of the potential for shortages of the actual swabs used to swab people’s noses to get the same itself.
Rest - https://nationalinterest.org/feature/next-coronavirus-nightmare-theres-drug-shortage-horizon-134147?page=0%2C2
--
The Next Coronavirus Nightmare: There's a Drug Shortage on the Horizon
Dr. Scott Gottlieb, the former commissioner of the Food and Drug Administration, weighs in on how to tackle the coronavirus pandemic and what the future holds for those Americans who haven't been infected by the virus.
Dr. Scott Gottlieb, the former commissioner of the Food and Drug Administration, is a resident fellow at the American Enterprise Institute. He is a contributor to CNBC and serves on the board of a number of health technology and biotech companies.
Heilbrunn: Are there any existing drugs that you think could help address this crisis in the near term?
Gottlieb: When it comes to therapeutics, it’s a three-pronged strategy. The first is to develop a vaccine. That’s probably two years away. I think we have to be realistic and understand that it’s probably two years until we can get a vaccine. Maybe longer. We’ve never developed a vaccine to a coronavirus, there are certain things we don’t fully understand. There is a certain complexity involved in the kinds of vaccine platforms that we are trying to use now. It’s a very novel technology.
The second strategy is looking at antivirals that can work directly against the virus. That is really going to be a game of looking at what is on the shelf, what antiviral drugs currently exist that might be able to be repurposed to this task—and that’s drugs like Remdesivir, which is being developed by a company called Gilead. There are a number of other antiviral drugs that are being tested against coronavirus that have been shown to be active in vitro, meaning in test tubes, that are now being studied in vivo in animals as well as human trials.
The third leg of this strategy is to try to develop an antibody-based prophylactic. This would be an antibody that targets some feature of the virus that can be used as a prophylactic in people and, in this case, a lot of the people who are trying to develop these products are targeting what is called a spike protein. The spike protein is a part of the virus that the virus uses to gain entry into human cells. One of the companies that is pretty far ahead in developing this kind of product is Regeneron. Regeneron also was able to develop an antibody-based prophylactic that was successful in Ebola. They also had one that they were developing against MERS (Middle-East Respiratory Syndrome) that they had studied in large primates, I believe. This is a company that has shown they can do this and they are currently developing a product against coronavirus. The virtue of this kind of a product is that it would basically be a monthly injection, that you would use it for either frontline healthcare workers or patients who are vulnerable—nursing home patients or immunocompromised patients, maybe people who are going to chemotherapy, people with significant heart disease or lung dysfunction. You give it to them monthly and it would be a prophylactic that could protect them against coronavirus.
...
Heilbrunn: Given how reliant we are on overseas drug manufacturing, at a time of crisis like we are now, what about the safety of the drug supply? Should Americans be worried about accessing medicines in the coming months or is that not a huge concern?
Gottlieb: I think that is a point of concern. I think there is a real risk that we see a series of drug shortages out of what is going on globally. The FDA has talked about twenty sole source drugs from China that are at risk because they are only produced in China. I think the list of drugs that could be at risk is much larger than that. It’s not just drugs that are exclusively manufactured in one location, but drugs where a partial proportion of the total supply is manufactured in one location. If 20 or 30 percent of all the available drug is manufactured in a location offsite, that is enough to sustain a pretty significant shortage of that drug. Because you don’t have a lot of excess capacity in that system where other manufacturers can just easily make it up. But it’s a complicated supply chain and there are disruptions throughout the supply chain because this is a global crisis. In China, a lot of what’s manufactured are the chemicals and inputs that go into drugs, so it gets shipped to India, and the active pharmaceutical ingredients, the actual chemical that is the drug gets manufactured in India, and that API (active pharmaceutical ingredient) get shipped to parts of Europe or other parts of the world and gets tableted, turned into drugs. That’s a complicated supply chain. And at every point in that supply chain, you have had epidemic spread or you’re probably going to have epidemic spread. India looks very suspect right now and there is the potential for disruptions.
The other thing to think about when we are talking about diagnostic screening and rolling that out on a mass scale is that there are shortages of reagents used to extract the RNA from the samples, the actual viral RNA that is in the sample, such as a nose swab. There are reportedly shortages of the reagents needed to extract that RNA and test that sample. There are also reports of the potential for shortages of the actual swabs used to swab people’s noses to get the same itself.
Rest - https://nationalinterest.org/feature/next-coronavirus-nightmare-theres-drug-shortage-horizon-134147?page=0%2C2