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Federal Agents Seize Erectile Monitors

The Fed’s say the penile product is a scam.

Federal Agents Seize FastSize Extenders and FastSize EQM Erectile Quality Monitors
Unapproved devices are adulterated and misbranded; safety and efficacy not established

At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized $346,954.43 worth of FastSize Extender devices and FastSize EQM Erectile Quality Monitor devices, as well as component parts used in the manufacture of the FastSize Extender. The FastSize Extender and the FastSize EQM Erectile Quality Monitor are manufactured and distributed by FastSize, LLC of Aliso Viejo, Calif.

The FastSize Extender and the FastSize EQM Erectile Quality Monitor are misbranded and adulterated because they, among other things, are unapproved and were manufactured under conditions that did not meet current Good Manufacturing Practices (cGMP) requirements. The seizure warrant was issued by the U.S. District Court for the Central District of California.

The FastSize EQM Erectile Quality Monitor device was promoted to measure penile axial rigidity (intercavernosal pressure) and to aid in the diagnosis of health related issues such as diabetes, high blood pressure, and heart disease. The FastSize Extender device was promoted to gain length, girth, and overall penile health improvement and to correct penile deformity caused by Peyronie’s disease. Because the devices are intended to diagnosis, cure, mitigate, treat or prevent diseases, they are subject to the regulatory authority of the FDA. The devices do not have approved applications for premarket approval for these uses.

During a recent inspection of the FastSize LLC manufacturing facility, inspectors noted significant deviations from cGMP regulations. Additionally, the devices are not properly listed with the FDA as required by law, and the firm failed or refused to furnish materials or information regarding the devices to federal inspectors as required under the Medical Device Reporting regulation.

China: Macro Risks

BEIJING, CHINA – Despite the global recession, China’s economy grew 8.7 percent in 2009, and the growth momentum continued in the first months of 2010, according to the World Bank’s latest China Quarterly Update released today.

The Update, a regular assessment of China’s economy, finds that massive investment-led stimulus was key in driving the economy last year. But real estate investment gained prominence more recently and household consumption growth has held up very well.

Exports declined in 2009 as a whole, even as China gained global market share. With imports strong, net external trade was a major drag on growth in 2009 and the external current account surplus declined sharply. Exports rebounded strongly through 2009, though, and exceeded pre-crisis levels in early 2010. In a heated real estate market, surging property prices triggered policy measures to expand supply and curb speculation.

“We project 9.5 percent GDP growth for this year, with a shift in the composition,” said Ardo Hansson, Lead Economist for China. “Government-led investment is bound to decelerate. But, exports are likely to continue to recover amidst a pick up in the global economy, real estate activity is likely to grow strongly this year, and consumption should remain solid.”

Inflation is on course to be significant in 2010, after being negative in 2009. But, with global price pressures likely to be subdued amidst large spare capacity internationally, China’s inflation is unlikely to reach high rates in 2010. We expect the external surplus to remain broadly unchanged this year.

Turning to policies, “the macroeconomic policy stance will have to be tighter this year than in 2009,” said Louis Kuijs, Senior Economist and main author of the Update. “Unlike in most other countries, overall output in China is close to potential. Thus, China needs a different macro stance than most other countries.”

According to the World Bank, the 2010 budget rightly implies a broadly neutral fiscal stance. Given the remaining uncertainty about the world economy, flexibility in its implementation is important. Inflation expectations can be contained by a tighter monetary stance and a stronger exchange rate, while monetary policy also has a key role to play in containing risks of asset price inflation. The case for a larger role for interest rates in monetary policy is strong. If policymakers remain concerned about interest rate sensitive capital flows, more exchange rate flexibility would help.

The Update notes that ensuring economic and financial stability includes mitigating risks of a property bubble and avoiding strains on local government finances. With regard to the property market, stability calls for an appropriate macro stance and improving the functioning of markets. Meanwhile, concerns about the affordability of housing for lower income people would be best addressed by a long term government support framework.

The Bank thinks the central authorities have rightly increased vigilance over lending by local government investment platforms. Given China’s solid macroeconomic position, the local finance problems are unlikely to cause systemic stress. But the flow of new lending to the platforms needs to be contained and local government revenues need to become less dependent on land transaction revenues.

In the presentations to the National People’s Congress, the government emphasized the need to adjust the structure of the economy. As China is preparing for the 12th Five Year Plan, the key overall objectives are making further progress in “rebalancing” the economy, enhancing efficiency gains, moving to a more sustainable spatial transformation of economic activity and employment, further changing the role of the state in the economy, and taking account of China’s interaction with the rest of the world.

Summit On Entrepreneurship

President Obama, together with the Department of State and the Department of Commerce, will host the Presidential Summit on Entrepreneurship at the Ronald Reagan Building in Washington, D.C., on April 26 and 27. Participants from over 40 countries on 5 continents have been invited to participate. The Summit will highlight the role entrepreneurship can play in addressing common challenges while building partnerships that will lead to greater opportunity abroad and at home.

At his June 4, 2009, speech in Cairo, President Obama announced that the U.S. Government would host a Summit on Entrepreneurship to identify how we can deepen ties between business leaders, foundations, and entrepreneurs in the United States and Muslim communities around the world.

Clean Energy Jobs

THE PRESIDENT: Good morning, everybody. It is great to be here at OPOWER. And just looking around, this looks like a fun place to work. (Laughter.) The work you do here, as we just heard, is making homes more energy efficient, it’s saving people money, it’s generating jobs and it’s putting America on the path to a clean energy future. And I understand last year that you doubled your workforce thanks to Bonnie — (applause) — you’re hoping to hire another hundred workers this year. And so this is a model of what we want to be seeing all across the country. Our goal for the economy is to show similar job growth in the months ahead.

This morning we learned that in February our economy lost an additional 36,000 jobs. Now, this is actually better than expected, considering the severe storms all along the East Coast are estimated to have had a depressing effect on the numbers. And it shows that the measures that we’re taking to turn our economy around are having some impact. But even though it’s better than expected, it’s more than we should tolerate.

Far too many Americans remain out of work. Far too many families are still struggling in these difficult economic times. And that’s why I’m not going to rest, and my administration is not going to rest, in our efforts to help people who are looking to find a job; to help business owners who want to expand feel comfortable hiring again. And we’re not going to rest until our economy is working again for the middle class, and for all Americans.

And that’s why my immediate priority is not only providing relief to people who are out of work, but also to help the private sector create jobs and put America back to work. Earlier this week, after breaking through a political logjam that some of you probably saw if you were watching TV, Congress passed and I signed into law a bill that extends unemployment insurance to help people who’ve been laid off get through these hard times. It also extended COBRA so that folks who’ve lost their jobs don’t lose their health insurance, and it extended financing for small businesses, and makes it possible for 2,000 furloughed transportation workers to go back to work.

So signing this bill and getting relief out the door swiftly is absolutely essential. But it’s only a temporary step. The relief I signed into law will last about a month. And that’s why I’m calling [on] Congress to extend this relief through the end of the year. And because the best form of economic relief is a quality job, I’m also calling on Congress to pass jobs measures that cut taxes, increase lending, incentivize expansion for businesses both large and small.

Now, both the House and the Senate have passed a bill that would give businesses a payroll tax refund for every person hired this year. And for companies that are considering expanding, this credit could help them decide to bring an extra employee or two this year. So for companies like OPOWER that are doing pretty well and already expanding, the tax credit may help them decide to hire even more workers more quickly. So instead of a hundred, maybe we get 110, 115. We’ll see. (Applause.)

This bill would also encourage small companies to expand by permitting them to write off expenses for new equipment. And while it’s by no means enough, this legislation is an important step on the road to recovery, and I look forward to signing it into law.

Now, even as we fight to help the private sector create more jobs, and even as we fight to bring about a full economic recovery, we know that there have been success stories all across America. OPOWER is one of those success stories. This is a company that works with utilities to help folks understand their energy costs and how they can save money on their energy bills. And for the press, if you weren’t able to hear, this board testifies to the number of kilowatt hours that have been saved, the amount of money that’s gone back into consumers’ pockets, and the amount of carbon that has been taken out of the atmosphere as a consequence of the great work that these people at OPOWER are doing.

Now, part of the reason I suspect you’re growing is that you’re doing your jobs well. But I also know that a big part of the reason is that you’re seizing the opportunities of the future. The jobs of tomorrow will be jobs in the clean energy sector, and this company is a great emblem for that. That’s why my administration is taking steps to support a thriving clean energy industry across this country — an industry that’s making solar panels, and building wind turbines, producing cutting-edge batteries for fuel-efficient cars and trucks, and helping consumers get more control over their energy bills.

And that’s also why earlier this week I urged Congress to enact a new initiative we’re calling Homestar that would offer homeowners rebates for making their homes more energy-efficient — rebates worth up to $1,500 for individual home upgrades and up to $3,000 for retrofitting their entire home. So if they’re getting this good information from OPOWER and they see that, boy, that drafty window is costing me a couple of hundred bucks a year, they’re now going to have an incentive to go to Home Depots or go to Lowes to hire a certified contractor and make the changes that will ultimately pay for themselves, improve our environment, and improve our economy.

I want to thank, by the way, your home state senator, Mark Warner, for his great work on Homestar in the Senate.

Think about the way that the rebates we’re talking about could help spur private sector job growth. It could not only help businesses like OPOWER to help consumers make their homes more energy efficient, it’s also going to create business for the local contractors and the companies hired to upgrade homes. These companies then, in turn, have to purchase supplies and that creates business for retailers. These retailers would need to restock their shelves, and that creates business for manufacturers. And almost all the goods that are required to make homes more energy efficient are actually produced right here in the United States of America. It’s very hard to ship an energy-efficient window across an ocean.

So, yes, people who are out of work right now need some immediate relief. Yes, we need to extend unemployment insurance and COBRA to help Americans weather these tough times. And, yes, we’ve got to do everything we can to help the private sector create jobs right now.

But even as we do, we also need to replicate the success of clean energy companies like OPOWER. We need to invest in the jobs of the future and in the industries of the future, because the country that leads in clean energy and energy efficiency today, I’m absolutely convinced, is going to lead the global economy tomorrow. I want that country to be the United States of America. I want companies like OPOWER to be expanding and thriving all across America. It’s good for consumers. It’s good for our economy. It’s good for our environment.

It’s wonderfully exciting to be here. And I think when you look at this group that’s gathered here, you can see the future in this company. So thanks for the great work you guys are doing. Let’s see if we can replicate your success all across the country.

Thank you very much, everybody. (Applause.)

Volcker and Reform Defeated

by Stephen Michael Apatow

I would like to extend a special thanks [1] for facilitating international peer reviewed discussion of subject matter associated with the global economic crisis.

As noted in the paper “Financial Market Legitimacy Critical for Sustainable Global Recovery” [2], containment of the damage caused by regulatory failures facilitated by the Glass-Steagall repeal and deregulation of OTC derivatives, is critical.

Today the article “The Coming Pan-European Sovereign Debt Crisis: What Country Is Next?” [3] has focused international attention on non-performing assets (NPA) [4] and their relation to Denmark, Spain, France, United Kingdom, Ireland, Italy and Sweden. We are currently seeking a NPA statistical analysis for all 192 United Nations member countries and would like to focus your attention to the paper “The Global Financial Crisis: Analysis and Policy Implications” [5] published by the Congressional Research Service in the United States.

In the article “NASAA President Tells Crisis Investigators To Take Three Steps,” [6] Denise Voigt Crawford, Texas Securities Commissioner and president of the North American Securities Administrators Association (NASAA), told the federal investigative panel in her testimony that three actions should occur to prevent further potential crisis:

(1) Restore provisions of Glass-Steagall, (2) reinstate state oversight of Rule 506, and (3) boost state regulation of advisors.

Retroactive implementation (to 1999) of commercial banking regulatory standards, for all combined commercial/investment banking and insurance entities (including capitol requirements), are vital for containment of the unregulated OTC derivatives distortions that caused the global economic collapse. In conjunction with these emergency economic response actions, efforts to conduct unmet needs analysis on the grassroots level in the United States [7], would be constructive to duplicate in every UN country. [8]

In the hope of progress,

Stephen Michael Apatow
Founder, Director of Research and Development
Humanitarian Resource Institute
Phone: (203) 668-0282

Start With Science

Meeting Tomorrow’s Challenges

U.S. Department of the Interior, U.S. Geological Survey — In a fiscally responsible budget that emphasizes cost containment, management efficiencies and program savings, the President’s proposed $1.1 billion budget for the U.S. Geological Survey (USGS) in fiscal year 2011 reflects his commitment to use science as the basis for natural resource management decisions.

“Science is a cornerstone for sound decision making,” said Marcia McNutt, USGS director. “Today’s complex, interrelated natural resource issues—such as climate change, energy conservation and development, and water quality and availability—demand that policy makers and managers start with timely, unbiased science. The President’s budget supports that vital perspective.”

Because of the significant role USGS plays in climate change monitoring and adaptation, energy, ecosystems, and other priorities, the 2011 budget represents an increase of $21.6 million from the FY 2010 enacted level. Major USGS program increases proposed are summarized below. For more detailed information on the President’s proposed USGS FY 2011 budget, visit the FY 2011 Budget and Related Information Web site.

New Energy Frontier
$3.0 million

The USGS will work closely with Department of the Interior bureaus to provide the scientific information needed to make decisions concerning permitting, implementing, and operating wind facilities on public lands by using USGS research, modeling, and monitoring to assess the ecological impacts to fish and wildlife. In 2011, USGS efforts will begin in the Great Plains and offshore Cape Cod region and will work toward developing an assessment methodology that can be applied nationwide.

Climate Change Adaptation
$11.0 million

Management and policy decisions made in response to climate change impacts must be informed by science. The USGS will continue to assist the Department of the Interior in the development of regional climate science centers that provide climate change impact data and analysis geared to the needs of the fish and wildlife management community, in partnership with other Federal, State, university and other non-governmental partners. Additionally, the USGS will continue to assess biological carbon sequestration options and develop decision-support tools through the USGS Global Change program.

$9.0 million

Water shortages and water-use conflicts have become more commonplace in many areas of the United States. Water is essential to the economic security of individual communities and the economic vitality and environmental health of our nation as a whole. The USGS will begin an assessment of the availability and use of water resources in the United States in FY 2011. The information will provide tools to address a new set of water resource challenges, including aging infrastructure, rapid population growth, depletion of groundwater resources, water quality impairments associated with land uses, and climate variability.

Treasured Landscapes: The Chesapeake Bay
$3.6 million

President Obama issued an Executive Order in May 2009 directing Federal agencies to use their expertise and resources to protect and restore the Chesapeake Bay and its watershed. The USGS will support restoration strategies by providing tools and science for assessing climate change impacts and adaptation, for conserving landscapes, and for restoring habitats, fish and wildlife, in partnership with the Fish and Wildlife Service and the National Park Service.

Increasing Resilience to Natural Hazards
$4.0 million

The USGS Multi-Hazards Demonstration Project in Southern California will continue to support emergency planning by developing earthquake early warning capabilities and conducting impact analysis of environmental, human-health and ecosystem responses to earthquakes and other hazards. This project will be expanded into the coastal communities of Alaska, and the USGS will invest in earthquake, tsunami and volcano science to support community planning in the Pacific Northwest. Additionally, the USGS proposes to add a volcanic earthquake detection role to the USGS National Earthquake Information Center, which will provide critical early warning to give observatories and affected communities time to plan and prepare for an eruption.

Landsat Data Continuity
$13.4 million

Scientists, educators and the general public around the globe use USGS Landsat data for a wide array of activities ranging from supporting disaster relief efforts to making agricultural crop assessments to identifying sites for cell phone towers. The USGS will accommodate ground-system requirement changes for the Landsat Data Continuity Mission associated with moving the Operational Land Imager to a free-flying satellite and the addition of a Thermal Infrared Sensor on board the spacecraft. These activities are required to meet the mission launch in December 2012.

Coastal and Marine Spatial Planning
$4.0 million

The Department of the Interior has substantial coastal and ocean resource management responsibilities and a critical role in implementing the Administration’s National Ocean Policy. USGS mapping, monitoring and research provide information to assess the status and vulnerability of ocean, coastal and Great Lakes resources. The USGS will engage with other Department of the Interior bureaus and Federal agencies to make available an information framework that provides critical information for coastal and marine planning.

GDP for the Fourth Quarter of 2009

Statement by Chair of the Council of Economic Advisers Christina Romer on the Advance Estimate of GDP for the Fourth Quarter of 2009

The latest GDP report is the most positive news to date on the economy. The data show that the total output of the U.S. economy increased strongly in the fourth quarter of 2009. Real GDP (that is, GDP adjusted for inflation) increased at an annual rate of 5.7 percent. The change from the first quarter of 2009, when GDP fell at an annual rate of 6.4 percent, is truly extraordinary; indeed, the three-quarter swing in growth rates was the largest since 1981.

While positive GDP growth is a necessary first step for job growth, our focus must remain on getting Americans back to work. That GDP rose strongly in the fourth quarter of last year while employment fell and the workweek increased only slightly emphasizes the need for policy actions designed to help spur private sector job creation. The President is announcing today the specifics of his plan for a small business jobs and wages tax cut. This policy is designed to encourage businesses to respond to rising demand and output by taking the plunge and hiring new workers again.

Part of the rapid growth in real GDP was due to a substantial rise in inventory investment. This inventory bounce, though likely to be transitory, is a normal part of healthy recoveries. As firms’ confidence in the future increases, their desire to run down inventories wanes. This change in behavior is often a powerful force for growth early in a recovery. Other components of GDP also rose strongly: business investment in equipment and software rose at an annual rate of 13 percent and residential investment rose at a 6 percent rate. And consumer spending rose at a rate of 2 percent. This broad-based rise in GDP was surely fueled in part by the tax cuts and investment spending in the Recovery Act and other rescue actions, but some appears to be the result of private sector demand returning.

As always, it is important not to read too much into a single report, positive or negative. There will surely be bumps in the road ahead, and we will need to continue to take responsible actions to ensure that the recovery is as smooth and robust as possible. Nonetheless, today’s report is a welcome piece of encouraging news.

Strange Matters

Department Of Energy, Washington, D.C. — The result from a years-long effort at DOE’s Jefferson Lab (known as the G-Zero experiment) to measure strange matter in the proton has revealed that strange matter doesn’t magnetize the proton or distort its charge distribution all that much. The effect is surprising small, since many of the early theoretical calculations suggested the possibility of larger values.

The proton’s main building blocks are up and down quarks, which are bound together by the strong force. The strong force energy inside protons also gives rise to a “sea” of quark pairs that bubble up out of the strong force energy and almost immediately melt away again. Pairs of up quarks and pairs of down quarks are the most likely to appear briefly in this sea. The next-heaviest quarks, strange quarks, are also thought to be present.

G-Zero scientists set out to measure what effect the temporary strange quarks had on the proton’s structure. The experiment successfully measured the influence that strange quarks exert on the electric and magnetic fields—seen as the distribution of charge and magnetization inside the proton. Experimenters found that the strange quark influence was small—amounting to less than 10% of the proton’s charge distribution and magnetization.

The Asteriod Threat

Dave Dearborn’s mission is to keep us safe from incoming asteroids.

Dearborn, a physicist in DOE’s Lawrence Livermore National Laboratory, serves on a research panel, spearheaded by the National Academy of Sciences, tasked with evaluating methods to divert potentially hazardous objects—those that could hit Earth in the next 100 years.

“An object of this size would have approximately 1 billion tons of mass,” says Dearborn, of LLNL’s’s Science and Technology Principal Directorate. “If it traveled at 30 kilometers per second, it would have explosive power equivalent to 100 billion tons of TNT.” In the event a 1-kilometer-size asteroid impacted Earth, the energy released would have global-scale effects.

The panel is considering several diversion technologies, but for Dearborn, nuclear explosives provide the best solution for dealing with catastrophic asteroids.

Dearborn has extensive experience in designing and testing nuclear and conventional explosives and leads the effort to model the impact of a nuclear explosion on an object’s trajectory in space.

NASA is evaluating impactor technology as a possible solution to diverting asteroids. These devices are designed to collide with the asteroid and change its momentum.

“Tests during NASA’s Deep Impact mission showed that impactors can divert smaller bodies, such as asteroids up to approximately 300 meters in size,” says Dearborn.

Another diversion method is the gravity tractor. In this deflection scheme, the gravitational attraction between the asteroid and a spacecraft allows the spacecraft to move the asteroid off course over time, a process that could take years or even decades.

According to Dearborn, this method may be advantageous for only about 5 percent of asteroids and would require major advances in technology before a spacecraft could carry out the mission successfully. Lasers have also been proposed, but even the most powerful lasers in existence would have to function over thousands of years to have any effect.

Methods that rely on elaborate launching stations or that add components to spacecraft could require putting an extra 20 tons of material into deep space. Conversely, nuclear explosives, with their high energy-to-weight ratio, would need comparatively less material to do the same job.

Not everyone shares Dearborn’s enthusiasm and confidence in using nuclear explosives to deflect asteroids. Yet, in the face of skepticism, Dearborn remains resolute. “Part of my job is to respond to criticism and to dispel myths related to the use of nuclear explosives,” he says.

Ultimately, Congress, the National Science Foundation, and NASA will use the information to determine the most effective strategy for deflecting asteroids.

Unearthed: Egyptian Cat Goddess

Egypt’s Supreme Council of Antiquities announced the finding of a 2000-year-old temple that is believed to for the Egyptian cat goddess, Bastet.

Egyptian Cat Goddess, Bastet

The photo was released by Egypt’s supreme council of antiquities showing the ancient cat-goddess Bastet found amongst the temple’s ruins in the Kom el-Dekkah area of the Mediterranean port city of Alexandria. Archaeologists have unearthed a Ptolemic temple dating back more than 2,000 years.