Do go back and search "Ebola" in the box at upper left (and read all the comments), to get caught up here, if you haven't been reading his fine commentary, right along. We introduce a public domain graphic for this series, as well -- and claim fair use of the derivative and insignificant portion of the imagery included, as part of our graphic. The movie (its people and studios and producers) don't (as far as we know) endorse "our" Birdman's views (or mine, for that matter!). . . But there you have it. Installment No. One of the Birdman Chronicles, herewith:
. . . .12.20.14 @ 1:28 PM EST | Birdman said. . .
Tragic indeed. I agree the studies need to get started in West Africa. A 7.5 hour FDA workshop on Ebola Immunology and a press release from the WHO this morning reveal the complexities with these trials in choosing assays and endpoints and dealing with many different funding organizations and governmental regulatory agencies. Everyone wants to do it their way. . . .
12.10.14 @ 7:40 AM EST | Birdman said. . .
Considering that many non-profits/US Government agencies are and will pay for the expensive clinical trials, process development and manufacturing of clinical trial doses this leaves relatively "minor" funding requirements from pharma. This endeavor will not result in a financial loss for the major players and will, as you have stated, get them major "brownie points". . . .
More on that last point -- including FDA priority review vouchers, tomorrow. Until then, enjoy your Saturdays, one and all -- and our sincere thanks go out to the Birdman. Please keep enlightening us!
1 comment:
Wow, my own avatar; never had one of them before. I am honored albeit undeserving.
This virus/disease (ebola/EVD) is just the tip of the iceberg. With human encroachment into the formally uninhabited jungles of the world more of these formally unknown diseases will appear in increasing numbers over the next decades and centuries. A mechanism must be developed to deal with these emerging infectious diseases, as well as the intentional use of biological warfare agents by unethical individual/entities or governments.
A wonderful book by Kendall Hoyt "Long Shot" Harvard University Press 2012 captures the history and the critical need for governmental/private collaborations for vaccine development. Today, more often than not, private/public companies will not embark on vaccine/drug development unless a profit can be made.
If you have ever had to deal with a Board of Directors/investors you would quickly understand the complexities of this matter. This profit may be financial, but not always. Good luck convincing the Board that non-financial profits (good publicity) are good for the company! We often must remind the skeptical public that not all decisions in Pharma are profit driven; WE ARE WORKING TO SAVE LIVES.
The US Government has seen the writing on the wall and has formulated a number of groups to plan for the un-plan-able. This involves rapid development and deployment technologies/platforms for dealing with situations like this ebola outbreak. Many of the systems are still in their infancy, but, they are beginning to work as planned.
It is only because the US and Canadian Governments had supported the development of ebola vaccines over the past decade and because the US Government has divisions like NIAID, PHEMCE and BARDA that supplied funding to allow manufacturing and clinical trials underway in West Africa so quickly, that we are in the place we are today; on the brink of employing vaccines to curtail the outbreak. The monies supplied to NewLink/Merck are only a small portion of the investment made by the US Government to prepare for and deal with possible/actual disasters. They should be applauded for their efforts.
Thanks to the Biotech/Pharma companies and the Governmental/Non-Governmental agencies/groups for their contributions and collaboration that will help to end this ebola outbreak and ameliorate/prevent future outbreaks! These relationships must be maintained and collaborations increased. The privatization of science over the past decade has led to diminishing basic research and increasing interest in profitability through Intellectual Property. Science must be "opened up" again so we can proceed with issues that benefit society, not only investors.
OK. I'm off my soapbox. Thanks for the venue and Merry Christmas/Happy Holidays!
Post a Comment