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To: nickcarraway

1. Ebola does not occur frequently enough to make development of vaccines or antivirals cost effective for any company. This is why the few drug candidates that have been developed were developed with government funding.

2. It is impossible to efficacy test Ebola drugs in humans. They can be safety tested, but no one would volunteer for an efficacy study, which involves exposure to a quantity of virus sufficient to cause disease.

3. The FDA animal rule states that if an animal model for the disease exists and has been shown to be identical to the human disease, animal efficacy data can be submitted in lieu of human efficacy data for regulatory purposes. This sounds nice, but animal study results often differ from human study results. Plus, enough human data must exist to know that the animal data is a close enough proxy—and with Ebola being so rare, how do we collect that human data?


19 posted on 08/02/2014 5:15:33 AM PDT by exDemMom (Current visual of the hole the US continues to dig itself into: http://www.usdebtclock.org/)
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To: exDemMom
"They can be safety tested, but no one would volunteer for an efficacy study, which involves exposure to a quantity of virus sufficient to cause disease."

In the spirit of redemption, I would be ok with a program allowing those in prison with life sentences to volunteer as test subjects with the possibility of a commutation or pardon.

They would have to be made fully cognizant of the known risks and voluntarily choose to accept them, and the tests would have to be carefully monitored by an independent party to ensure they were not being conducted gratuitously or inhumanely. The subjects would have to be psychologically screened as well to make as certain as possible that their participation was in the spirit of atonement and willingness to sacrifice for the good of society and that their participation was not merely an extension of the risk driven aspects of their personality that got them into prison in the first place.

In short, if you have a prisoner who is facing a life sentence, who has shown genuine remorse and is willing to place his/her life on the line in the spirit of serving their fellow man, and some guarantor that the tests will be administered in a responsible and ethical manner, then there should be a mechanism in place to permit the clinical trials with the possibility of a commutation or pardon at the end of it (given that they survive).

22 posted on 08/02/2014 5:38:07 AM PDT by Joe 6-pack (Qui me amat, amat et canem meum.)
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To: exDemMom
I worked for five years at a pharmaceutical company in Baltimore as a payroll and accounts payable manager. The company only had one FDA approved drug during the time I worked there, a wafer designed to be implanted at Glioblastoma brain tumor sites and directly deliver chemotherapy drugs. It was a major development in treating that horrible and fatal brain cancer but that had a very limited use and it only slowed down the disease and was not a “cure”. They had several other drugs in various stages of development and clinical trials, some very promising like a new surgical sedative and an injectible drug for stopping heart attacks in progress and those and others in the pipeline had a greater potential for wider use and hence a stream of revenue. But the founders of this company were themselves neurosurgeons and former brain cancer researchers from Johns Hopkins and while they wanted the company to make money and understandably make money for themselves, they were also very deeply, passionately and very personally interested in and invested in treating and one day perhaps finding a cure for Glioblastoma multiforme.

What amazed me when I started working there was the actual costs involved in getting a drug from an idea in the lab to extensive lab testing to animal testing and the costs of even getting to preliminary clinical trials. Not to mention the cost of specialized lab equipment, clean rooms, etc. and the number of people involved and their wages. I used to manage weekly accounts payable check runs and it was not unusual for them to be over a million dollars sometimes with me cutting checks or performing wire transfers for $500k or more at a time to companies, some overseas in the UK and Netherlands who were performing primate and “beagle”, i.e. dog animal trials for us (evidently it was more cost effective and less restrictive than using US firms and yes, I winced at the thought of the animal trials but fully understood the necessity of it) and the human trials were also extremely expensive and were outsourced to independent companies in order to keep them “objective” and at "arms lenth" and also with another separate firm performing the independent analysis and tracking, all as IIRC, was required by the FDA.

And our semi-monthly payroll was well over a million dollars per pay and we were a rather small company – only about 300 people meaning the average salary was about 100k per year (although while I was making a very good salary, I was nowhere near that : ), ).

We had only a small animal lab with only mice and rats and even then, because of the animal rights activists, the eco-animal “rights” terrorists who had made threats, we had very tight security and armed guards at all the main entrances.

I remember one day processing an invoice for something called a “small mouse head impactor” and I asked one of the chief scientists who I’d become friendly with, just what is a “small mouse head impactor” and he told me it was basically a device that would neatly and effectively crack open the skull of a small mouse without damaging the underlying structures and brain. “Cool” I said and he offered to let me come into the animal lab with him one day to watch how it worked. Unfortunately I never had the opportunity to do that. : (

Most people and evidently many here, have no idea what the upfront costs are in developing a new drug or vaccine and the fact that many never get out of the lab or those that get out of the lab testing, out of animal testing, live alone making it to human clinical trials, often they end up not getting FDA approval and the whole process starts all over again without those costs ever being recouped.

And FWIW, the pharma I worked for was bleeding cash and one of the few things keeping us afloat, aside from the brain tumor wafer sales which did not cover our operating costs, was the contract work we were doing for the NIH and even with that we had a 20% reduction of force, i.e. a big layoff. A few years after I left, after one failed merger and another hostile takeover attempt, they were bought out by another bigger pharma and that happened because they just plain ran out of money to continue to operate.

The so called “big (evil) pharmas” make money because they are so large and diverse and have many profitable drugs and products in general use. With that, they can reinvest in new research in sometimes in novel drugs with limited market sale potential but even then there are limits in what these companies, with their shareholders and employees, are willing to invest in a product that will lose them money.

This is why the few drug candidates that have been developed were developed with government funding.

R&D costs money and a whole lot of it and very few researchers, biologists, biochemical scientists and even non-scientist, us lowly payroll/accounts payable mangers are willing to work for nothing or volunteer their time to develop a drug with limited use and no profit potential, so someone has to pay for it. This is one area where I think government funding is a worthwhile endeavor.

34 posted on 08/02/2014 7:14:31 AM PDT by MD Expat in PA
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To: exDemMom

And yet there are compounds that have shown effectivness POST exposure to ebola.

http://www.ncbi.nlm.nih.gov/pubmed/24583123

That particular compound is already in phase III clinical trials as an anti-influenza drug.


36 posted on 08/02/2014 8:07:04 AM PDT by Black Agnes
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