Sarepta issues statement on AVI-7537 anti-Ebola compound DoD funding freeze

Tony Plohoros, Principal at 6 Degrees, and a spokesperson for Cambridge, Massachusetts-based Sarepta Therapeutics, has provided Etopia News with a detailed and informative statement recounting the story of AVI-7537, a potential treatment for the Ebola virus.  Here’s what he had to say:

“Given the unpredictability of Ebola outbreaks and the associated obstacles in conducting clinical trials during an outbreak, especially in a foreign country, Sarepta’s Ebola compound, AVI-7537, has been developed according to the FDA’s Animal Rule, thus relying on an animal model to demonstrate efficacy. Significant efficacy has been demonstrated in five independent studies conducted in nonhuman primates (rhesus monkeys) challenged with lethal viral inoculums (approximately 1000 PFU/monkey) of Ebola virus (Zaire). Typical survival ranged from 60-80% versus 0% survival in untreated animals. 

“AVI-7537 has been shown to be safe and well tolerated in a completed Phase I single-ascending dose study.  In addition, since the company’s Ebola drug and Marburg drug share an identical backbone chemistry and preclinical, clinical, safety, toxicology, and pharmacokinetics indicate they behave similarly, Sarepta believes the Phase I multiple ascending dose study results for its Marburg drug candidate can be extrapolated to AVI-7537 to optimize the safe and efficacious dose and to better understand its expected outcomes with its use during an emergency. 

“In October 2012, DoD suspended development of AVI-7537 due to government funding constraints. Here’s a link to that announcement.

“Sarepta has been in contact with a number of government offices and with the WHO and has made clear that the company is committed to making the AVI-7537 it has on hand available to patients who might benefit from it as part of the U.S. government’s and any international efforts to respond to the outbreak.”

Gates Foundation contributes $1 million to fight Ebola, is considering “future investments” in anti-Ebola efforts

The Bill & Melinda Gates Foundation, long active in the fight against HIV/AIDS, malaria, and tuberculosis in Africa, has contributed $1 million to combat the recent outbreak of Ebola in West Africa, and is considering making “future investments” in support of anti-Ebola efforts, according to an e-mail received today by Etopia News.

The Media Relations team at the Foundation wrote:

“On July 18, 2014 the Bill & Melinda Gates Foundation awarded a $1 million grant to the US Fund for UNICEF in response to the Ebola outbreak in West Africa. These funds will be used to support UNICEF’s response in Guinea, Liberia, Sierra Leone, Guinea Bissau, Cote D’Ivoire, Senegal and Mali.

“The current Ebola outbreak is a serious health challenge that must be addressed in partnership with others. We are working with organizations like the WHO to understand the dynamics of the current epidemic and identify tools and strategies that can help global partners respond effectively to this and future outbreaks. These consultations will inform any future investments we might make.”

Democratic Representatives ask Republican Chairman to hold a hearing on Ebola

Three leading Democratic U.S. Representatives have asked the Republican chairman of the House Energy and Commerce committee to hold hearings about Ebola and the capability of the U.S. health care system to meet any threat from this rapidly-proliferating virus.

Those asking for the hearing are:  Henry A. Waxman, Ranking Member of the House Energy and Commerce Committee; Frank Pallone, Jr, Ranking Member of the Subcommittee on Health; and Diana DeGette, Ranking Member of the Subcommittee on Oversight and Investigations.

You can read their letter here.

Needless to say, they are worried about an Ebola outbreak in the U.S. and eager to find out more about the country’s state of preparedness for this eventuality.

Attempts to contact U.S. Representative Fred Upton, Chairman of the House Committee on Energy and Commerce, and ask him if he will hold these hearings, are on-going.

Read the original press release from the Democrats on the House Energy & Commerce Committee here.

UCLASS RFP will have to wait for a review at the highest level

Here’s what the U.S. Navy had to say this morning about the delay in issuing the final request for proposal (RFP) for the Unmanned Carrier-Launched Surveillance and Strike (UCLASS) airframe to the four eligible contractors (General Atomics, Northrop Grumman, Lockheed Martin, and Boeing) who want to build it:

“Defense officials will be including UCLASS in its ISR portfolio review to be conducted in conjunction with the normal budget review process this fall.  Determination regarding the release of the UCLASS RFP will be made based on the results of this review.”

One school of thought holds that the UCLASS should be primarily an ISR (Intelligence, Surveillance, and Reconnaissance) vehicle, while an opposing group believes that it ought to be a fully-weaponized, stealth, and penetrating one, capable of meeting the challenges posed by China’s increasingly-robust coastal defenses.

Now, what capabilities to ask for in the final UCLASS RFP will be determined within the context of the Pentagon’s overall intelligence, surveillance, and reconnaissance portfolio of systems and of that department’s overall budget.

News of this development were first reported on Friday, August 29^th, by USNI News, a web site operated by the very well-connected United States Naval Institute, in an article entitled “UCLASS RFP Delayed Again Following Pentagon Meeting."

A spokesperson for the Navy told Etopia News that one issue to be considered during the review would be “affordability.”

A more-capable UCLASS would cost considerably more than one dedicated primarily to ISR.  The Department of Defense is in the process of down-sizing itself, and so can’t really pursue the development of both types of UCLASS, nor can it decide to build a more-capable attack version without taking its overall spending limits, and limits on its spending on naval aviation, into account.

Inquiries for additional comment from the Navy, and for comment from U.S. Representative Randy Forbes, who is on record calling for a more robust model of UCLASS, and from Northrop Grumman, one of the four contractors who will eventually get the classified RFP, had not been answered as of the time this paragraph was written, at 4:22 pm on Tuesday, September 2, 2014.

There hasn’t yet been much public discussion of the issue of how capable to make the UCLASS, which has significance within the context of planning for any military confrontation with China, for example over the status of Taiwan.  The development by China of anti-ship ballistic missiles means that carrier groups, the heart of U.S. offensive power, need to stay further than they might like from possible combat zones.  A stealthy, weapons-rich UCLASS airframe might provide capabilities central to success in an anti-access/area denial scenario (A2/AD) that might develop during a U.S.-China confrontation over Taiwan.

A “Jubilee” Economic Program from the Northeast

A cohort of experts on economics believes that the world needs more infrastructure, mortgage restructuring/forgiveness, and global re-balancing and de-levering, in order to avert economic catastrophe and restore the world economy to growth.

One of them, Richard Vague, recently (July 15, 2014) published a book, “The Next Economic Disaster:  Why It’s Coming and How to Avoid It.”  You can purchase it at Amazon at:

http://www.amazon.com/gp/product/0812247043/ref=s9_psimh_gw_p14_d0_i1?pf_rd_m=ATVPDKIKX0DER&pf_rd_s=center-2&pf_rd_r=1435Y2STQBK4Z8Q7D2JZ&pf_rd_t=101&pf_rd_p=1688200382&pf_rd_i=507846&gclid=Cj0KEQjwjtGfBRCN4-LU9ODG1-wBEiQAy_Xp7873gYc6xElTAcVI8FgzpWrQZzXCM7ugEMIhU-bb_E4aArv78P8HAQ

Mr. Vague, a very perspicacious and adroit banker, was recently a guest on Bloggingheads.tv, where he was interviewed about this book by NonzeroFoundation President Robert Wright, the humane, polymath, and brilliant principal host of the show.  You can watch that interview at:

http://bloggingheads.tv/videos/30533

Richard Vague also co-authored a piece along these lines with Robert Hockett, a law professor at Cornell University Law School.  You can find it here:

http://www.interdependence.org/wp-content/uploads/2013/04/Debt-Deflation-and-Debacle-RV-and-RH1.pdf

It’s called “Debt, Deflation, and Debacle:  Of Private Debt Write-Down and Public Recovery”

Professor Hockett also co-authored a related piece with Daniel Alpert of Westwood Capital and Nouriel Roubini, Professor of Economics, New York University.  It’s called “The Way Forward:  Moving From the Post-Bubble, Post-Bust Economy to Renewed Growth and Competitiveness.”

You can find it at:

http://newamerica.net/publications/policy/the_way_forward

The message contained in these documents boils down to a call for more infrastructure, the restructuring of private debt (debt forgiveness, or “Jubilee”) with the banks absorbing their losses over 30 years, and “global reforms that can begin the process of restoring balance to the world economy and can facilitate the process of debt de-levering in Europe and the United States.”

Your correspondent spoke by phone this morning with Robert Hockett about the political state of play regarding the adoption of such a “Jubilee” economic program, one calling for more spending on infrastructure, private debt-restructuring/forgiveness, and “global reforms that can begin the process of restoring balance to the world economy and can facilitate the process of debt de-levering in Europe and the United States.“

 He said that implementation of these reforms was being spearheaded by municipalities such as Richmond and San Francisco, California, and Newark and Irving, New Jersey, where local officials contemplate using their power of eminent domain to take over properties and restructure their private mortgage debt.

He didn’t think Congress would act on these policy recommendations, as it was “paralyzed” by partisan gridlock.

So far, he thought, there had been “no serious federal effort” along the lines he and his fellows were recommending. 

He expressed disappointment in President Obama, saying that he lacked “the courage of his convictions,”   He said he thought that the President “intellectually agrees” with their argument and that he’d vote for it as a Senator, but that, as President, “I don’t think in his heart of hearts” he’s committed to winning over the country and the Congress to this vision.  “He’s so disdainful and disinclined.” 

While distancing himself from any support for the substance of President Reagan’s policies, Hockett expressed admiration for the way the Gipper, when confronted by a recalcitrant Tip O’Neill leading the Democrats in Congress, “pushed forward,” urging people to write letters, trying to sway “public opinion” that eventually brought the Democratic Congress around to passing the Republican President’s proposed legislation. 

“Obama just doesn’t have that spine.” 

Queries sent to President Obama and Senator Warren

Etopia News has reached out to the Office of Massachusetts Senator Elizabeth Warren, and to the White House, asking for comment on the proposals put forth by Richard Vague, Robert Hockett, Daniel Alpert, and Nouriel Roubini.  There’s been no response from either of them yet.

As an added inducement to respond, there were attached to the White House inquiry links to video footage from the Etopia Collection featuring excerpts from an August 8, 1995, interview with Barack Obama before “you guys could pronounce my name,” as he puts it today, in hopes that they might reach the President’s own eyes and ears and give him a chance to recollect about who he was 19 years ago.  You can watch them, too, at:

http://www.youtube.com/watch?v=HW1d9xT7j8I

and

http://www.youtube.com/watch?v=ZjzPirAp0vM

(Sincere thanks to Sherle Schwenninger, who directs the New America Foundation's Economic Growth and American Strategy Programs. He is also founding director of the World Economic Roundtable, a program that brings together thought leaders from business, finance, and public policy in regular meetings to remap the global economy after the Great Recession.  He facilitated the connections that made this article possible.)