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This is a pretty interesting article. Bacteriophages are largish viruses that look sort of like a moon lander or stick squid. They are often fatal to bacteria they attack. This article describes one instance where they were used to treat someone dying of an post-surgical antibiotic-resistant bacterial infection. However, even as the combined bacteriophage treatment was killing the bacteria, they appeared to be evolving resistance to them. It’s amazing reading about the “warfare” that takes place in the microscopic world.

Also interesting was the way the researchers got around the regulators by modifying the phage genome by deleting genetic code rather than adding to, or replacing it.

https://www.statnews.com/2019/05/08...neered-viruses-may-have-prolonged-teens-life/
 

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Trump signs 'right-to-try' allowing gravely ill patients to bypass FDA for experimental medicines


  • President Donald Trump and Vice President Mike Pence had been major supporters of the "right-to-try" legislation, which would bypass drug regulators to give gravely ill patients access to experimental medicines.
  • Proponents say this gives patients hope they would not otherwise have.
  • Critics say the legislation undermines the FDA's authority to regulate drugs and could leave patients vulnerable to medicines that might not work or may even be harmful.
Angelica LaVito | @angelicalavito
Published 2:00 PM ET Wed, 30 May 2018

Updated 5:13 PM ET Wed, 30 May 2018

President Donald Trump signed the controversial "right-to-try" bill into law on Wednesday, which bypasses drug regulators to give gravely ill patients access to experimental medicines.

The legislation allows patients with life-threatening conditions to ask drugmakers for medicines that have cleared some testing but still haven't been approved by the Food and Drug Administration. Previously, patients would need to ask the FDA for access to experimental treatments.

Trump and Vice President Mike Pence had been major supporters of passing the measure, which proponents say gives patients hope they would not otherwise have. Last week the House of Representatives approved the bill, the same version the Senate passed in August.

It allows certain patients to ask drugmakers for medicines that have passed Phase 1 of the FDA approval process but haven't been approved yet and are still undergoing testing. Patients must have exhausted other options and be unable to participate in a clinical trial. Drugmakers aren't obligated to give patients the requested experimental medicines.

Critics say the legislation undermines the FDA's authority to regulate drugs and could leave patients vulnerable to medicines that might not work or may even be harmful. The agency already runs an "expanded access" program where seriously ill patients can apply to gain access to experimental treatments.

Commissioner Scott Gottlieb has said the agency grants 99 percent of these requests. In a statement Wednesday, Gottlieb said the FDA is ready to implement the "right-to-try" legislation.

"The FDA is dedicated to achieving the goals that Congress set forth in this legislation, so that patients facing terminal conditions have an additional avenue to access promising investigational medicines," he said.

While signing the bill Wednesday, Trump said he never understood why passing this bill was hard since it can take years for drugs to undergo clinical trials.

"Right to try. That's such a great name," Trump said. "Some bills, they don't have a good name. Really. But this is such a great name, from the first day I heard it. Right to try. And a lot of the trying is going to be successful. I really believe that. I really believe it."


https://www.cnbc.com/2018/05/30/trump-signs-right-to-try-legislation-on-experimental-medicines.html
 

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Bacteriophages have been around for a very long time. Russia has used them in the place of antibiotics and the treat antibiotic resistant infections for many years. So they are way ahead of us on this. People from the US that were given no hope for treatment have gone to Russia and have been completely cured. If I remember correctly, many bacteriophages come from poop.
 

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Exactly why I stay clear of all farm raised seafood. Farms add antibiotics by truckloads because they have to from all the over crowding and nasty conditions.


This is a pretty interesting article. Bacteriophages are largish viruses that look sort of like a moon lander or stick squid. They are often fatal to bacteria they attack. This article describes one instance where they were used to treat someone dying of an post-surgical antibiotic-resistant bacterial infection. However, even as the combined bacteriophage treatment was killing the bacteria, they appeared to be evolving resistance to them. It’s amazing reading about the “warfare” that takes place in the microscopic world.

Also interesting was the way the researchers got around the regulators by modifying the phage genome by deleting genetic code rather than adding to, or replacing it.

https://www.statnews.com/2019/05/08...neered-viruses-may-have-prolonged-teens-life/
 

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Trump signs 'right-to-try' allowing gravely ill patients to bypass FDA for experimental medicines


  • President Donald Trump and Vice President Mike Pence had been major supporters of the "right-to-try" legislation, which would bypass drug regulators to give gravely ill patients access to experimental medicines.
  • Proponents say this gives patients hope they would not otherwise have.
  • Critics say the legislation undermines the FDA's authority to regulate drugs and could leave patients vulnerable to medicines
Of course the bureaucrats would be against it. It takes some of their power away. It has always seemed dumb to me that people with no hope are prevented from trying something that could benefit them. These people are going to die anyway. Letting them be test subjects, if they wish to, just makes sense.
 
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