Posted on 10/20/2014 4:28:36 AM PDT by bert
We have technology to potentially control Ebola and other viral outbreaks today. But the federal bureaucracy refuses to catch up with 21st-century science. For example, diagnostic startup Nanobiosym has an iPhone-sized device that can accurately detect Ebola and other infectious diseases in less than an hour. Two other companies, Synthetic Genomics and Novartis, have the capacity to create synthetic vaccine viruses for influenza and other infectious diseases in only four days. Both firms can also share data about outbreaks instantaneously and make real-time, geographically specific diagnosis and vaccine production possible. These companies could start producing Ebola vaccine/treatments tomorrow — except that the Food and Drug Administration’s insistence on randomized studies and endless demands for more data means firms have to spend millions on paperwork instead of producing medicines. And for every small company drained by such tactics, many others conclude it’s not even worth trying. These advances aren’t available because the FDA is using 19th-century science to decide which medical technologies should be used in the 21st century.
(Excerpt) Read more at nypost.com ...
“I was refuting the statement that ‘we need studies to prove they work before we can use them’.
That hasn’t happened in the past, why is it happening now?”
This is the FDA policy
http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicsLicenseApplicationsBLAProcess/ucm133096.htm
Which doesn’t answer my question about the polio vaccine rollout in the 1950’s.
Did it undergo the same extensive ‘testing and studies’ before it was used to stop an epidemic?
Can you imagine the housewife protest marches if they’d been told ‘we have a vaccine, you can have it for your kids in another year or two...’.
Nicole Lurie is a political operative as well. She is, in fact, a physician, but her experience is in putting out political fires, not preventing health disasters.
Lurie managed health issues for ALCOA for quite a few years. If you know anything about aluminum smelters, you know that they were almost all hazardous waste sites. The smelter in our county polluted a wide area with PCBs, cyanide and fluoride and took more than twenty years to clean up. Yet, most of the residents of the county never knew about it. That is what Lurie did for ALCOA.
From your link:
” Caffeine is not only a habit forming drug but it is destructive to the tissues of the stomach, eyes, nerves and kidneys. In fact there is not a part of the body that is not injured by this drug.”
“Which doesn’t answer my question about the polio vaccine rollout in the 1950’s.
Did it undergo the same extensive ‘testing and studies’ before it was used to stop an epidemic?
Can you imagine the housewife protest marches if they’d been told ‘we have a vaccine, you can have it for your kids in another year or two...’.”
Actually it did take years. Polio cases started to really spike in 1942. They peaked in 1952 the same year Jonas Salk first tested his vaccine. Studies were done in 1952, 1953, 1954 and starting in 1955. It was over three years of studies before it was released, and thirteen years after the major spike in cases started to occur. In spite of those three years of studies still people were killed and paralyzed from the vaccine. Surely many more were helped than hurt but.....
But there weren’t any double blind controlled studies.
And I know 2 people who actually GOT polio (and not mild cases either) from the vaccine (live virus one). One spent time in an iron lung and the other had to relearn how to walk.
It is nice to see someone is actually going to links and doing a little reading. :-)
Since the human body is extremely complex, so is determining what aids or hurts health. Sometimes it is a matter of degrees, sometimes it is not.
Just for clarification, the scientific theory behind vaccines is, I believe, very valid. The implementation, with animal parts, dangerous preservatives, failure to handle allergies before hand, insufficiently inactivated biohazards etc., make it like roulette.
Why does this administration hire/ employ so many 'silencers', social media engineers, and political operatives?
Frieden, Klain, Lurie, Fauci, etc. who all have sold their soul for the sake of political agenda - where do they find all these people ?
This country can't trust this government to be honest based on past history and expeirience over the last 6 years.
Behind by choice
Stupidity by agenda driven example is called "OPEN BORDERS" !
Lurie was touted in an article that was put out by the University of Pennsylvania health services department. That is where I read about her background with ALCOA. guess who heads the health services dept at U of P? Ezekiel Emanuel.
“I know 2 people who actually GOT polio (and not mild cases either) from the vaccine “
Then we are in agreement. My point was, unlike the original post which was suggesting it is evil for the government to require proof of safety, that these things can be quite dangerous, and safety is important. Unfortunately, the short term studies done are often inadequate to determine safety. Which is even more in opposition to the original post.
NICOLE LURIE: Obama’s First Ebola Czar Was Embroiled In A Massive Scandal In 2011 And Still Holds Her Job
Post to me or FReep mail to be on/off the Bring Out Your Dead ping list.
The purpose of the “Bring Out Your Dead” ping list (formerly the “Ebola” ping list) is very early warning of emerging pandemics, as such it has a high false positive rate.
So far the false positive rate is 100%.
At some point we may well have a high mortality pandemic, and likely as not the “Bring Out Your Dead” threads will miss the beginning entirely.
*sigh* Such is life, and death...
Thanks for the ping!
I am sure that many people would have absolutely no problem with testing on prisoners. However, from an ethical point of view, prisoners are considered vulnerable populations who, due to the circumstances of their confinement, might agree to participate out of fear of reprisal. Right now, the cornerstone of clinical testing is "informed consent"--that is, consent without coercion and with full knowledge of the risks--which is very difficult to obtain from prisoners.
It is a real eye-opener to sit in on institutional review board (IRB) meetings and listen to the discussions, or to read a journal of medical ethics. It is really difficult to design an ethical clinical trial. It is challenging even to design ethical animal trials.
But since the majority of the potential testers are poor Africans, politics and "optics" become dominant.
There are a lot of problems with testing experimental drugs in this situation.
You don't know if the drugs will work. The best case scenario is that if the drugs don't work, they at least won't harm the patient further. But we don't know that. A few years ago, a drug that was perfectly safe in animals was injected into clinical trial volunteers and made them instantly and severely ill. They were in critical condition for a while, and had permanent effects from the drug--one guy lost his fingers.
Aside from safety issues, there are ethical issues. A few decades ago, Africa was seen as a source of unlimited test subjects for medical experimentation. Now, even in the face of this on-going crisis, there is still a strong suspicion among Africans that we only see them as guinea pigs.
I would love to see a safe and effective drug for Ebola. The reality is that it will be very difficult to achieve that.
Right. However, if it’s completely of the prisoner’s free will it would be okay, right? I’m saying the prisoners that are on death row, or in prison for life. The murderers, rapists, etc. I mean, you could just tell them we’re doing some research, and if anyone would volunteer that would be great. Don’t give them incentive, and only offer to the worst of the worst. People that are never going to see the outside of a prison. Some would say yes. Then move them to a research facility, have armed guards. Don’t force them into anything, show them exactly what the virus or ailment will do to their bodies. Then let them decide. Take ebola for example, show the volunteers videos, tell them exactly what is going to happen. If they refuse, send them back to the prison. Some won’t, some will realize they aren’t getting out, and if they can help find a cure for any ailment that they are at least doing something good for someone, somewhere. Some murderers I’m sure get remorseful, wishing they could do anything to ease their guilt, some would do it just to stay in a comfy place for awhile. Of course they have to know that the cure may not work, some would be just for research of the virus itself, they would have to understand that it would be painful, and they have a high likelihood of dying. The ones that are really sorry for whatever they did are the ones that would do it. The ones that don’t care wouldn’t. But at least instead of sitting around being useless violent criminals could be productive.
This would be a great trade off to bypass FDA regulations and start testing years of research quickly. Instead of having to go through years of studies, paperwork, and red tape to be allowed to test on humans. However, I realize this could lead to a number of really terrible scenarios. I could see people using it to farm human guinea pigs. It would have to be highly monitored in a controlled environment.
I believe there needs to be some way to test medicines quickly. Because the regulations slow modern medicine to a crawl. Who knows what promising medicines are out there buried under stacks of paperwork and red tape. It seems like this could work, at least in my head. I don’t think I understand the complexities surrounding this subject. So if this seems like crazy talk to you, I would understand.
I think it could work. But I recognize what it could lead to. You seem to know much more about this then me. Would it be possible? Polio was not cured after years of research, and animal trials to get to human trials. The doctor risked his life, and the lives of his family. Guess what? He bypassed possibly decades getting to human trials and saved millions of lives. However there were not all these regulations involved.
If I were to do illegal testing on a group of unknowing people with anything from cancer cures to bio-weapons, Africa would be on the top of my list. There are very evil men and women in this world, and I wouldn’t be surprised if it has happened. I wouldn’t be surprised if Americans were involved. It does seem strange that poor African countries endure so much in the way of horrible ailments. But that can be trumped up to superstition, paranoia of doctors and medicine, starvation, sanitary conditions, and a whole host of conditions that super bugs thrive in. But Ebola and HIV did appear nearly out of nowhere. Remote village for Ebola where the spread could be easily contained and controlled, and who knows where AIDS came from. It certainly does make a man think.
Whale.to is not a valid scientific site and has no legitimate information about vaccine safety.
I can't pretend to know the motivation of anti-vaxxers--maybe they think the earth is overpopulated, so are trying to turn people away from vaccine use as an indirect way to kill people. However, I do know that anti-vax activists rarely use real science when advocating against vaccine use.
Vaccines are a medical wonder, and have saved the lives of countless millions.
There is a small risk from developing a polio-like disease from the vaccine. In areas where polio is endemic, that risk is judged acceptable, since the live attenuated vaccine gives stronger immunity than the killed vaccine, thus is more likely to stamp out a polio outbreak or epidemic. When polio is eradicated from an area, the purpose of a vaccine is to prevent reintroduction, not stamp out an outbreak, so the risk changes and the killed vaccine is used, even though it induces weaker immunity. Combination vaccine regimens have been tried, too, using the killed and then the attenuated to induce strong immunity and avoid the small chance of vaccine-induced polio.
Polio vaccines studies are still on-going, btw. A search for "polio vaccine" just now on PubMed returned over 7,000 articles.
It is because of weak testing standards in the past that allowed unsafe drugs to be approved that we now have the multi-phase clinical trial process. We test now because, in the past, anyone could sell anything claiming it to be a cure, and many people were injured or died from those snake oils. Where the testing process has proven inadequate, the procedures and regulations have been revised to address the inadequacies.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.