FDA: Help us become more transparent Updated // 1h 20m ago
One topic of debate has been how the agency can balance manufacturers’ proprietary concerns with the public’s desire to know about clinical trial results for drugs not yet approved.
Some critics have viewed the FDA as “a black box that makes important decisions without explaining them,” Commissioner Margaret Hamburg said at a news conference. “The agency can and should communicate with the public in a way that provides more clarity about the agency and its processes, not less.”
The (FDA) transparency task force will hold a public meeting June 24 in Washington, D.C., and another in the fall, Sharfstein said.
In the Federal Registry notice about the meeting, the FDA listed questions that it is specifically interested in pursuing, including:
•How can the agency better explain what it does?
•What should the FDA reveal about enforcement actions, product approvals and recalls?
•What tools should the agency use to provide more useful information?
•What, if any, legislative or regulatory changes are needed to make the FDA more transparent?
•What information should remain confidential?
[ . . . ]
Dorsen recommended that Congress amend the Federal Food, Drug, and Cosmetic Act to say that safety and effectiveness data aren’t trade secrets that must be kept confidential, Wolfe says.
My Note –
The separation of church and state makes sense because obviously the same thing happened historically in those two being intertwined that has happened with the US Food and Drug Administration getting into bed with businesses they were designed to regulate.
When the church and state were one and the same, there were abuses of power in both to salve the power to each as well as to assure there would never be accountability to either.
The same thing has happened as food manufacturers and pharmaceutical companies have been unduly influencing decisions made by the FDA.
There has been no real accountability, no truth, no transparency, a multitude of abuses of power and conflicts of interest that have cost people their lives, their health and their opportunities to enjoy a future. Both the processes and structures of power inside the FDA have been used by manufacturers to de-regulate their industries, to pass off faulty and dangerous products, to get a free license to market food and drug products that were inappropriate for consumption, and to receive approvals which should have been withheld.
There ought to be a competent separation between the FDA and those they would regulate, test and make determinations about or upon. To not do so, has created nightmarish results on the public whose tax dollars are paying for the FDA to insure their safety.
World Meteorological Organization
Executive Council – 61st session (EC-LXI)
Geneva, 3-12 June 2009
World Meteorological Organization, 7bis, avenue de la Paix, Case postale 2300, CH-1211 Geneva 2, Switzerland
Tel.: + 41(0) 22 730 81 11 / Fax: + 41(0) 22 730 81 81 –
Excerpt From Provisional Agenda –
In line with Regulation 185(6) presidents of technical commissions will present overviews of their respective Commissions focusing on matters requiring decision or resolution of the Council. Reports will be presented to review the priority issues to be addressed by the Commissions of JCOMM, CAS, CCl and CAeM at their forthcoming sessions. (Note: presidents are invited to make interventions under all agenda items to assist EC in its decision making.)
The Third Vice-President will present the report of the meeting held in Geneva in February 2009 and recommendations, proposals and draft resolutions pertinent thereto.
3. SCIENCE AND TECHNOLOGY DEVELOPMENT AND IMPLEMENTATION (Strategic Thrust)
Members will be invited to discuss reports and decision documents focussing on expected results (ER) 1 to 5.
Under this agenda item the Council will hear reports of more effective use of numerical weather prediction products, including from ensemble systems, and is invited to make decisions on related matters including the transfer from research to operations of new techniques and technologies to improve multi-hazard warnings.
Under this agenda item, the Council will be invited to discuss and decide upon:
· The proposed amendment to the Manual on Global Data Processing and Forecasting Systems (Volume 1, Global Aspects), endorsed by CBS through an Inter-commission mechanism with CCl, on the designation process for WMO Regional Climate Centres (RCCs) along with formal designation of qualifying centres as WMO RCCs, if any;
· The establishment of a coordinated mechanism to facilitate development and operational implementation of climate prediction and their applications for climate adaptation in countries;
· The Council will be briefed on latest developments toward organization of the World Climate Conference-3 (WCC-3) and the expected major outcomes;
· The First Vice-President will present the report of the Second meeting of the EC Working Group on Climate and Related Weather, Water and Environmental Matters held in Geneva on 11-13 February 2009 and recommendations, proposals and draft resolutions pertinent thereto.
The Council will be informed of the outcome of the thirteenth session of the Commission for Hydrology, held in November 2008 in Geneva, and provide guidance for the future achievement of the ER.
The session will discuss and decide on:
· Implementation of the WIGOS concept and in particular, recommendations resulting from the Executive Council Working Group on WIGOS and WIS related to the WIGOS Development and Implementation Plan (WDIP), WIGOS Concept of Operations (CONOPS), WIGOS pilot and demonstration projects initiated by technical commissions and regional associations;
· Further development and improvements in the WMO and WMO-sponsored Observing Systems addressing Weather, Water and Climate including the GOS surface-based and space-based sub systems, GAW, GCOS, GOOS, GTOS and related research networks;
· Standardization of instruments and methods of observation.
The session will discuss and decide on:
· The further development and implementation of WIS and ICG-WIS and relevant CBS-XIV and EC WG-WIGOS&WIS outcomes, including in particular the further development of regulatory and guidance material, governance matters especially the process for designation of WIS centres (GISC & DCPC), the preliminary identification of potential GISCs and DCPCs and initial 2008/2009 operations. The Council will discuss and decide on directives for further improvements of the GTS, as the WIS part for operation‑critical data including high-priority warnings and related information, including in developing areas. It will also discuss and decide on directives for the involvement in WIS development and utilization of WIS services by all WMO Programmes at the global, regional and national levels;
· The further development of WMO metadata and data representation policy and systems for data and products from WMO and related systems, taking account of evolving requirements from various user communities.
4. SERVICE DELIVERY (Strategic Thrust)
Members will be invited to discuss reports and decision documents focussing on ERs 6 to 7.
Under this agenda item the Council is invited to discuss and make decisions on key issues including: the roles of NMHSs in disaster risk reduction, regional capacity building projects to improve early warning capability, and strengthening partnerships in multi-hazard warning and disaster risk reduction.
10.1 Scientific lectures and discussions
According to the decision by EC-LX, arrangements have been made for a scientific lecture to be delivered on “Adaptation to a variable and changing climate: challenges and opportunities for NMHSs“.
Insurance Rates in Atlanta Could Go Up
Updated 6/2/2009 10:59:31 AM
Posted By: Jennifer Leslie
ATLANTA — Insurance rates inside the city of Atlanta could go up because of fire department budget cuts.
A new study shows the city’s fire safety rating has dropped, which means homeowners could be required to pay as much as ten percent more.
For the first time since 1974, a private rating agency called the ISO or Insurance Services Office has taken a hard look at fire safety in the city of Atlanta, and the findings are discouraging.
[ . . . ]
“If all of their built fire stations were occupied and fully staffed, they would have great coverage,” Oxendine said. “The problems is, some have been closed, and there are also brownouts.”
The city now has three months to improve it’s score or homeowners could be the ones to pay the price.
[ . . . ]
Tuesday, June 2, 2009, 10:17pm EDT
Hummer reportedly to be sold to China’s Sichuan Tengzhong
Dayton Business Journal
General Motors has found a buyer for Hummer, a brand that was once a must-have accessory for the rich, but that came to symbolize the company’s (not to mention the nation’s) attachment to gas-guzzling mega machines.
And the buyer, the New York Times reports, is a machinery company in western China, The Sichuan Tengzhong Heavy Industrial Machinery Company Ltd., based in Chengdu.
[ . . . ]
The Times reports that Sichuan Tengzhong is a privately owned company known in China for making road equipment from highway construction to maintenance machinery and that it had been moving into manufacturing heavy-duty trucks. If the deal is completed, it would mark the first large-scale U.S. automotive acquisition by a Chinese company.
Levine reports that no Hummer dealerships will be closed, and that U.S. domestic production of Hummers will actually be boosted because the company will be moving production from a Port Elizabeth, South Africa, plant to Shreveport.
The Chinese company will buy a brand that started as the military’s Humvee and morphed into a civilian dream machine. But GM is saying that the sale could save more than 3,000 U.S. jobs in manufacturing, engineering and at Hummer dealerships around the country. And it says the deal is expected to close by the end of the third quarter.
GM claims in its release that the buyer will “aggressively fund future Hummer product programs.”
GM will also keep building Hummers for the Chinese company, on a contract basis. That means that GM’s assembly plant in Shreveport, La., will continue to contract assemble H3 and H3T through at least 2010.
[ . . . ]
The deal doesn’t include Hummer’s military vehicles or technology. AM General of Indiana runs that end of the business. AM General sold the rights to make civilian Hummers to GM in the 1999.
The deal’s announcement comes a day after GM filed for bankruptcy protection and outlined plans to offload nameplates so that the company could focus on more profitable brands like Chevrolet, GMC, Buick and Cadillac. Among GM brands left for sale now that there’s an apparent Hummer deal are Saab and Saturn. GM wants to sell those brands by the end of 2009. The company plans to shut down its Pontiac nameplate altogether.
[ . . . ]
When GM looked into selling Hummer last summer, the company thought it could get as much as $500 million for the brand, the New York Times Dealbook reports. But that price has likely fallen as auto sales have plummeted.
Hummer sales are down 67 percent in the first four months of this year.
Kent Bernhard Jr. of bizjournals, compiled this report.
Tuesday, June 2, 2009, 3:57pm EDT | Modified: Tuesday, June 2, 2009, 3:58pm
Nuti: NCR to have fewer than 50 in Dayton
Dayton Business Journal – by Urvaksh Karkaria DBJ Contributor
* North Carolina Commerce Secretary Keith Crisco budgets $127k for trade-show trip
After NCR Corp. transitions its headquarters to Georgia, the company will have less than 50 employees remaining in Dayton, said Bill Nuti, NCR chief executive officer, in an exclusive interview with the Atlanta Business Chronicle.
The decision to move the headquarters was as much about consolidation and cost saving as it was about Georgia’s $60 million incentive package, its demographics, infrastructure and skilled workforce.
The relocation will save the Fortune 500 company “tens of millions of dollars” over the next decade, Nuti said.
NCR’s (NYSE: NCR) decision to locate in Georgia, will bring more than 2,100 jobs including nearly 900 to a manufacturing operation in Columbus, Ga. That facility will be NCR’s first manufacturing plant in the United States since the 1970s.
NCR is consolidating corporate jobs from not just Dayton, but from several other U.S. locations, Nuti said, declining to disclose the cities. NCR will employ less than 50 in Dayton, where it will maintain a data center and sales and service operations. The company currently has roughly 1,200 employees in Dayton, where it has been headquartered since 1884.
NCR’s executive offices, however, will remain in Manhattan, Nuti confirmed.
“That center surrounds our largest and most major customers in the world in the banking industry,” he said. “That’s where we host many of our customers in the financial services base.”
E-mail firstname.lastname@example.org. Call (937) 528-4400.
“It’s fair to say we have come a long way from the days when NCR’s top leaders stepped forward to help save our city from the depths of the 1913 flood to the day when they won’t even return a phone call,” Whaley said.
The company’s total investment in Georgia is valued at $30 million and its annual payroll will exceed $150 million.
NCR employs about 22,000 people worldwide.
Associated Press Writers Dionne Walker in Atlanta and James Hannah in Dayton, Ohio, contributed to this report.
On the Net:
* NCR Corp.: http://www.ncr.com
From Associated Press report
(also from that article – )
Georgia’s unemployment rate is at 9.3 percent, above the national average of 8.9 percent.
But the Dayton area has lost thousands of auto-related jobs, including 2,000 in December when General Motors Corp. closed its SUV plant in suburban Moraine. In addition, thousands of jobs have disappeared from nearby Wilmington as cargo carrier DHL Express prepares to pull out of the area.
NCR has already been moving into Georgia.
In October 2008, NCR announced that it would relocate key parts of its customer service operation in Peachtree City in Atlanta’s southern suburbs. That center is expected to create 916 jobs over about two years.
Nuti said the company’s large presence in Georgia — combined with Atlanta’s “great logistics and infrastructure” — sealed the deal.
“We already had a larger infrastructure and more employees in Georgia than we had in Dayton,” Nuti said Tuesday.
About 2,800 NCR employees currently work in the metro Atlanta area while roughly 1,250 work in Dayton. NCR’s retail business is already based in Duluth.
Moving the company’s headquarters will bring 1,250 jobs to Duluth, Ga., a suburb north of Atlanta. The company will also set up a manufacturing center in Columbus, Ga., that will employ an additional 870 people over the next five years.
Ohio didn’t go down without a fight. Gov. Ted Strickland cobbled together an 11th hour $31.1 million incentive package. But that came nowhere near the roughly $60 million in tax breaks Georgia used to lure the company south. Most of the credits were from a new mega-tax credit Georgia Gov. Sonny Perdue signed into law just last month to attract big companies to the state.
After weeks spent slashing billions of dollars from the state’s recession-ravaged budget, Perdue was clearly thrilled to finally deliver some good economic news .
[from – ]
NCR Corp. moving headquarters to Georgia from Ohio
By SHANNON McCAFFREY – 5 hours ago
Atlanta Terrorism Case Shows Global Reach of Potential Plots
Alleged Casing Video of Washington, DC Key Evidence
By JASON RYAN
June 2, 2009
An Atlanta terrorism case which begins this week details the intricate threads behind several international terrorism investigations that were unfolding in 2005 and 2006 that had FBI officials and counterterrorism officials around the world on high alert due to multiple convergences in the U.S. and abroad.
Ahmed, now 24 years-old, was arrested in March 2006, and his alleged accomplice Ehsanul Islam Sadequee was arrested in April of 2006 on charges that they provided material support to Lashkar e-Tayyiba, a Pakistani terrorist group. While Ahmed’s trial will be decided by a federal judge, not a jury, Sadequee’s jury case will go to trial this August.
[ . . . ]
At a September 2007 speech before the Council on Foreign Relations, FBI Director Robert S. Mueller III described the links between the cases: “While examining his computer, authorities discovered the surveillance videos of the Washington targets that had been filmed by the two subjects from Atlanta. Investigators also found that Tsouli had been in steady communication with the plotters in Canada , Denmark , Bosnia , and the United States….He used his computer skills to develop a global virtual network for terrorists and their supporters. And it took a global network of law enforcement and intelligence agencies to unravel these disparate plots and bring those responsible to justice.”
[ . . . ]
Shortly after Ahmed was arrested in the United States on March 23, 2006 Sadequee was arrested in Bangladesh by their security services and the FBI in late April 2006. With the clock ticking and word of their arrests spreading in early June 2006, Canadian authorities arrested 17 individuals who were associated with the group that Ahmed and Sadequee had met.
Sending the videos to Tsouli may be the most relevant part of the government’s charges of supporting terrorists in the case.
[ . . . ]
In a May 9, 2009 motion, the government noted, “An e-mail sent by Defendant shortly after the September 11, 2001 terrorist attacks, to a known Taliban conduit, in which Sadequee expressed his desire to join the Taliban in their violence jihad against U.S. forces in Afghanistan.”
At a bond hearing in May, an attorney for Sadequee told the judge the video clips were short cell clips taken from his cell phone: “Mr. Sadequee can take a cell phone and take a picture of the Washington Monument and ended up sending it to a website doesn’t make him dangerous. It simply doesn’t.”
My Note – I was walking home today and there was a table with this Clear WiMAX information and products by the Publix grocery. It is interesting.
This is apparently the Atlanta launch with the other pre-launch cities of Portland and Baltimore being made jointly. The home company base is supposedly Las Vegas, but I haven’t looked it up yet.
This is part of their current deal but there is something about a guaranteed $55 a month for life promotion – for some ClearWiMAX service package. It turns out that there is a two-year contract required with a $120 penalty for breaking that contract before its expiration.
I also found the page about the company in Atlanta handling this to be very interesting – Its called “Evolving Office” – I included their info below – sounds pretty nifty but I haven’t finished checking it all.
My only question is why aren’t they showcasing the E3 gaming show in Los Angeles these last few days? That seems a little odd . . .
Home Internet, DirecTV & Voice Package
Home Unlimited + DirecTV + VOIP – $99.95
(Two year contract required – $120 contract default fee)
see brochures that I brought home
Who is Wimax Atlanta?
WimaxAtlanta.net is owned by Evolving Office. We provide Google Advertising services to help small to medium sized businesses sell their products online.
WimaxAtlanta.net is a venture between the partners of Evolving Office as a proof of concept to current and future customers. We help grow the Clearwire and Clear WiMAX customer base one new customer at a time via network marketing, free web marketing, paid advertisements and good old fashioned face to face salesmanship.
If your business needs help with selling your products online please call 800-250-6524.
“Evolving Office – Evolving Business Beyond Brick and Mortar”
Armored truck drops more than $300,000
June 2, 2009 — Updated 2332 GMT (0732 HKT)
* Story Highlights
* Improperly secured Brinks truck drops more than a dozen bags of money
* Money ranged from coins to $100 bills
* Two bags containing about $60,000 still missing
* Brinks gives T-shirt, anniversary coin as reward
A Brinks armored truck inadvertently strewed more than a dozen bags of money on the ground in front of the Syracuse Antiques Exchange on Friday, according to Sgt. Tom Connellan of the Syracuse police department.
The bags slipped out of an open door on the side of the truck. Apparently oblivious, the driver proceeded to his intended destination, a Brinks facility a few blocks away.
NEW YORK (CNN) — Two good Samaritans returned more than $275,000 that tumbled out of an improperly secured armored truck in Syracuse, New York, last week. But some not-so-good Samaritans seem to have walked away with another $60,000 that fell onto the street.
By Jason Kessler
My Note –
When there is a t-shirt in it for the reward of helping round up $300,000 in cash and returning it – there is something out of scale and twisted there. Just my opinion, but they aren’t very encouraging to honesty, decency and honoring the “be the good guy’ thing. Or maybe Brinks doesn’t have the profits to do that considering how many banks they are charging a small fortune to safely transport their funds for them . . . Hmmm . . . . . .
And a note about my last post before this one –
I know somebody who got lost using a GPS to go across the street from here. It is not an exaggeration. The location to pick up the pizza we had ordered could be seen from the end of the driveway coming out into the street from my condo. Twenty minutes later and nearly to Roswell, Georgia from here they came back without finding the Pizza Hut which was actually across the street a block away within walking distance. They were using the GPS to direct their efforts instead of listening to the directions I gave them in the first place.
So, there you go.