Coronavirus:

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Roy
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Re: Coronavirus:

Postby Roy » Mon Apr 06, 2020 4:55 pm

chuck wrote:I spent the last ten years at Michigan working in Biomedical Engineering. While my primary job was IT support, I was involved with the senior design class. Almost ALL of the design projects involved microprocessor or full blown computer control for both diagnostic and theraputic devices. While 3rd world crank based AED's were possible, ANYTHING made for domestic use required a full 10 year review prior to FDA approval.

I'm not arguing against having the most technically advanced medical equipment possible. Sometimes, you're reduced to using CPR.

As for regulations, FDA or otherwise, they absolutely need to make sense. Ten years sounds like a ridiculously long time.
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HONDO74
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Re: Coronavirus:

Postby HONDO74 » Mon Apr 06, 2020 5:06 pm

Our last pandemic was 1918.

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Rufus T. Firefly
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Re: Coronavirus:

Postby Rufus T. Firefly » Mon Apr 06, 2020 6:10 pm

Roy wrote:
Rufus T. Firefly wrote:...I'd think that maybe they would declare [cemeteries] essential as there is real need.

I think that would depend on the capacity of the cemetery.


Or the size of the backhoe.
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Re: Coronavirus:

Postby Rufus T. Firefly » Mon Apr 06, 2020 6:11 pm

chuck wrote:.............ANYTHING made for domestic use required a full 10 year review prior to FDA approval.


I've never heard of devices taking that long for approval by the FDA. With that time line, it would be pointless to pursue any approvals for any device.
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Re: Coronavirus:

Postby chuck » Mon Apr 06, 2020 7:32 pm

Medical devices fall into three categories/classes. It takes 3-7 years to get approval/clearance. This does not include the initial typical design/development. It is a major concern for a company considering bringing any new device to market. Aka they will see no return on investment for a long time.

Another wrinkle in this is drug companies getting involved with patent fights with medical device companies. The drug companies view the disease/condition as "theirs" and will fight to protect "their" turf. The device may offer a true cure and have less severe side effects. The irony to me is that curing the patient is very, very, very low on the totem pole.

Re why this process takes so long, "do no harm". You have to make sure the device is safe.
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Rufus T. Firefly
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Re: Coronavirus:

Postby Rufus T. Firefly » Mon Apr 06, 2020 7:57 pm

chuck wrote:Medical devices fall into three categories/classes. It takes 3-7 years to get approval/clearance. This does not include the initial typical design/development. It is a major concern for a company considering bringing any new device to market. Aka they will see no return on investment for a long time.

Another wrinkle in this is drug companies getting involved with patent fights with medical device companies. The drug companies view the disease/condition as "theirs" and will fight to protect "their" turf. The device may offer a true cure and have less severe side effects. The irony to me is that curing the patient is very, very, very low on the totem pole.

Re why this process takes so long, "do no harm". You have to make sure the device is safe.


Well aware of the FDA and all the fun involved with dealing with those folks; I have multiple clinical trials in the past and approved drugs, along with what are now expired patents on the same. So, been there, done that.

Safety is just the beginning; it has to also work.......in some capacity.

As for curing patients, there's no market if you cure anyone. The solution is to reduce diseases to chronic conditions, reduce patients to what are essentially drug addicts, and create an endless source of income. Modern medicine, indeed.

One of the reasons I just gave up trying.
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Re: Coronavirus:

Postby chuck » Mon Apr 06, 2020 8:21 pm

Drug trials are a nightmare but there is a "silver lining". A lot of drugs developed to cure/deal with condition X sometime have better results with something unrelated, say condition Y. I can't remember what the drug Rogaine was originally intended to do but it made its mark in hair restoration. I think one of the drugs touted for "fibromyalgia" was originally developed as an anti-seizure medication. It's also why orphan drugs are often never brought to market. The target audience is too small a market to make back your money and you can't risk putting it in the public domain because someone may find a highly marketable/profitable clientele a few days after you do so.

Most medical devices are one trick ponies. It either works or it doesn't. There is little chance that the new surgical support heart/lung machine is going to find a second life doing dialysis or robotic micro-surgery.
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Re: Coronavirus:

Postby Roy » Mon Apr 06, 2020 8:58 pm

Rufus T. Firefly wrote:As for curing patients, there's no market if you cure anyone. The solution is to reduce diseases to chronic conditions, reduce patients to what are essentially drug addicts, and create an endless source of income. Modern medicine, indeed.

Business psychopaths love addiction. It's their preferred business model. They speak of repeat business. This is where I point my finger at the Sackler family. Sara Lee, too. :evil:
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Re: Coronavirus:

Postby Rufus T. Firefly » Mon Apr 06, 2020 9:58 pm

chuck wrote:It's also why orphan drugs are often never brought to market. The target audience is too small a market to make back your money and you can't risk putting it in the public domain because someone may find a highly marketable/profitable clientele a few days after you do so.


Maybe. Most stuff is covered by patents so it's not really in public domain just because you obtained orphan drug status; you still own the drug through composition of matter claims. Most of my patents were dived into 3 divisionals of which one covered composition of matter/structure. Anyone else would have to license it from you. Use is too easily walked around.
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Re: Coronavirus:

Postby Rufus T. Firefly » Mon Apr 06, 2020 10:00 pm

Image
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Re: Coronavirus:

Postby MurphOnMillerAve » Mon Apr 06, 2020 10:08 pm

Stupid.

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Roy
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Re: Coronavirus:

Postby Roy » Mon Apr 06, 2020 10:40 pm

:lol:
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Re: Coronavirus:

Postby HONDO74 » Tue Apr 07, 2020 1:06 am

Boris Johnson's government reportedly believes the coronavirus may have accidentally leaked from a Chinese laboratory
https://news.yahoo.com/boris-johnsons-g ... 00701.html

The UK government reportedly believes the coronavirus outbreak may have started in a Chinese laboratory.

Most experts believe the outbreak began when animals passed COVID-19 onto humans in China.

However, some scientists believe an accidental leak is a plausible alternative theory.

Dr. Francis Boyle, who drafted the Biological Weapons Act has given a detailed statement admitting that the 2019 Wuhan Coronavirus is an offensive Biological Warfare Weapon and that the World Health Organization (WHO) already knows about it. Francis Boyle is a professor of international law at the University of Illinois College of Law. He drafted the U.S. domestic implementing legislation for the Biological Weapons Convention, known as the Biological Weapons Anti-Terrorism Act of 1989, that was approved unanimously by both Houses of the U.S. Congress and signed into law by President George H.W. Bush.

In an exclusive interview given to Geopolitics and Empire, Dr. Boyle discusses the coronavirus outbreak in Wuhan, China and the Biosafety Level 4 laboratory (BSL-4) from which he believes the infectious disease escaped. He believes the virus is potentially lethal and an offensive biological warfare weapon or dual-use biowarfare weapons agent genetically modified with gain of function properties, which is why the Chinese government originally tried to cover it up and is now taking drastic measures to contain it.

The Wuhan BSL-4 lab is also a specially designated World Health Organization (WHO) research lab and Dr. Boyle contends that the WHO knows full well what is occurring.

Dr. Boyle also touches upon GreatGameIndia‘s exclusive report Coronavirus Bioweapon – where we reported in detail how Chinese PLA Biowarfare agents working at the Canadian lab in Winnipeg were involved in the smuggling of Coronavirus to Wuhan’s lab from where it is believed to have been leaked.

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Re: Coronavirus:

Postby webenda » Tue Apr 07, 2020 4:22 am

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Re: Coronavirus:

Postby robert. » Tue Apr 07, 2020 8:00 am

Rufus T. Firefly wrote:
As for curing patients, there's no market if you cure anyone. The solution is to reduce diseases to chronic conditions, reduce patients to what are essentially drug addicts, and create an endless source of income. Modern medicine, indeed.
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