FREE MIXTAPE* Lets See What the #FDA is Making Open Source Today – How Bout YOU ?

There are alot of folks streaming into Washington DC for the innagural festivities this upcoming weekend. Many of them are there to support the work being done by President Obama. As well there are a few protesters who will join the crowds.  Gun Control and Anti Gun Control groups are gearing up their presentations. as well as those who don’t support the programs coming out of the second Obama presidency.   Today we look at just a couple of those issues that divided America on the Obama Presidency.

First we have this quite entertaining sing along video -

Next We think the story below proves our point that the country is in the hands of reptilian and Insecterians. Recently we posted videos from Conspiracy Theory with Jesse Ventura where the shape shifters were revealed on camera. So we’re convinced by this approval of a drug made from Insects Cells; For Humans.

There is no way we will be allowing our bodies to be a part of a study on changelings. We can see clearly that the only way to rid the planet of most of its population is by a mass extermination; carried out by biological methods – such as this insect cell vaccine that was just rushed through approval at the FDA. There is certainly something wrong with this picture and we’ve decided not to join the party. We can see no reason for introducing a biological Insect based vaccine into the mass population of humans. It certainly creates some concerns.

Read This and see how you feel afterwards :

 

FDA approves first flu vaccine grown in insect cells

Robert Roos * News Editor

Jan 17, 2013 (CIDRAP News) – The US Food and Drug Administration (FDA) has approved the first influenza vaccine produced with the help of an insect virus and recombinant DNA technology, an approach the agency says may make it possible to start production faster in the event of a flu pandemic.

Flublok, a trivalent (three-strain) vaccine developed by Protein Sciences Corp. of Meriden, Conn., was approved for adults ages 18 through 49. The only flu virus component it contains is hemagglutinin, the active ingredient, which is produced by infecting cultures of insect cells with a baculovirus that turns them into hemagglutinin factories.

Most flu vaccines use viruses grown in chicken eggs. However, in November the FDA approved Novartis’s Flucelvax, which uses flu viruses grown in mammalian cells, making it the first vaccine of its kind to gain US approval.

Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, called Flublok a technological advance. “The new technology offers the potential for faster startup of the vaccine manufacturing process in the event of a pandemic, because it is not dependent on an egg supply or on availability of the influenza virus,” she said in an FDA press release.

But the vaccine is similar to other licensed flu vaccines in that it uses hemagglutinin as the active ingredient or immune system target, according to a recent major report on flu vaccines. A number of flu experts have said that new kinds of flu vaccines with novel antigens are needed in order to provide broader, more enduring protection than today’s vaccines, which must be reformulated each year to keep pace with viral mutations. Today’s vaccines are generally about 60% effective in working-age adults.

In a press release, Protein Sciences called Flublok the first flu vaccine “to be made in a 100% egg-free system without growing influenza viruses—so the vaccine can be made quickly and without any of the infectious risk traditionally associated with vaccine manufacture.” The vaccine contains no thimerosal (a preservative used in some vaccines), antibiotics, or adjuvants, the company said.

The product contains 45 micrograms (mcg) of hemagglutinin for each of the three targeted flu strains, which is three times what most other flu vaccines contain.

Manon Cox, PhD, MBA, the company’s chief executive officer, told CIDRAP News that early studies of the vaccine showed that higher-than-standard doses induced better immune responses. The company eventually settled on 45 mcg as the optimal dose.

The FDA said Flublok was found to be about 44.6% effective against all flu strains in a controlled trial conducted at multiple US sites. The vaccine was given to about 2,300 people, while a similar number of volunteers received a placebo.

The vaccine’s safety was tested in about 2,500 volunteers, the FDA said. The most common side effects were pain at the injection site, headache, fatigue, and muscle aches, which are also common in recipients of conventional egg-based flu vaccines.

Protein Sciences said Flublok will be widely available for the 2013-14 flu season. The company also hopes to provide a limited supply this season, but no doses are available yet, said Cox.

She said a problem with the fill-finish stage of production is holding up the vaccine right now. The product “is sitting in a big refrigerator in McPherson, Kansas, and we’re waiting for the vials to be packaged and shipped to us,” she told CIDRAP News, noting that the fill-finish step is handled by a subcontractor.

Cox said the company is considering a price of about $30 per dose for the vaccine, but no decision has been made yet. “We’re very sensitive to the fact that most people feel vaccine should be provided for free,” she commented.

Hemagglutinin for Flublok is produced by infecting insect cells with a baculovirus that has been altered to contain the gene for hemagglutinin. Baculoviruses infect a few insect species and are commonly found on green vegetables but do not grown in mammalian cells, according to previous reports.

Most conventional flu vaccines consist of whole, killed flu viruses or viral fragments that contain several proteins, not just hemagglutinin (though one vaccine uses a live, weakened virus).

Cox said it took a very long time to develop Flublok and gain FDA approval, in large part because the agency had many questions about the safety of the new production technology.

“It took 20 years to go from proof of concept to convincing the agency that this would work,” she said.

Although the vaccine is highly purified, it contains some residual proteins of nonhuman origin, Cox noted. “All the evidence was that it was safe,” she said. “There were no signs that our new cell line wasn’t good enough. It’s always very hard to prove a negative.”

Early development of the vaccine was supported by the National Institute for Allergy and Infectious Diseases. In 2009, the company won a contract from the US Biomedical Advanced Research and Development Agency, part of the Department of Health and Human Services, for late-stage development.

Cox said the company is preparing to launch a trial of the vaccine in people 50 and older, with the hope of winning FDA approval for that age-group late this year. The agency had concerns about hypersensitivity reactions seen in some over-50 participants in a previous trial, although such reactions were twice as common in a comparison group that received a conventional flu vaccine, she explained.

Protein Sciences also plans to run a trial of Flublok in children ages 6 to 18 in the 2013-14 flu season, with the hope of winning FDA approval for that age-group the year after that, Cox said. Earlier, the vaccine was tested in very young children who had never had flu before, and it was found to be not very immunogenic, she noted.

As for the promise of faster production startups with Flublok, Cox said, “In 21 days after we have the genetic sequence [of the target virus], we are able to get it into production, so that’s a substantially shorter time to do it than in cell culture or in eggs.” But she noted that later steps, such as filling and finishing vaccine vials, can cause delays.

Nicholas Kelley, PhD, a coauthor of a lengthy analysis of flu vaccines published last year, agreed that the new vaccine promises to allow faster production startups.

“It can be produced and scaled up on a larger scale and faster than a mammalian cell culture vaccine,” he said. But he added that in comparison with other flu vaccines, “there’s no difference in how well it works.”

Kelley is a research associate at the University of Minnesota’s Center for Infectious Disease Research and Policy, which publishes CIDRAP News. He helped write The Compelling Need for Game-Changing Influenza Vaccines, a lengthy report on the whole flu vaccine landscape, published last October.

The report notes that alternative flu vaccine production platforms such as mammalian cell culture and insect cell culture improve on conventional egg-based technology in that they are likely to shorten the production time and are less prone to contamination. It cites Flublok as an insect-cell–based vaccine.

“However, as long as such vaccines continue to be directed toward the HA [hemagglutinin]-head antigen, they will have little potential to improve vaccine effectiveness or to provide broad, durable protection against disease,” the report states.

The FDA noted that the shelf life for Flublok is 16 weeks from the data of manufacture. That compares with about 1 year for most flu vaccines.

Cox said the 16-week shelf life “has to do with our worst-case production lots in 2007,’” adding, “Since then we got data indicating it’s feasible to get a shelf life of 9 to 12 months, but we didn’t want to give new information to the agency [FDA] at this moment” for fear of causing further delays. She said the company hopes to get the listed shelf life changed soon.

We think that anyone who is smart enough to know better will not want to be injected with this new experimental vaccine. No Thank You FDA, we can block those Flu germs all by ourselves. Next we have this piece about your DNA and why it may soon be an open book for any and everyone.

Discovered: Even your DNA won’t be private anymore; 

Personal genomes are everyone’s business now. Anyone who’s generously given their DNA to genomic research under the assumption that their personal biological code would be kept confidential might be in for a surprise.

The Whitehead Institute for Biomedical Research’s Yaniv Erlich and his colleagues were able to connect “anonymous” DNA with specific individuals using just an Internet connection and other publicly available information. “We are not trying to start a panic,” says Erlich. “We are trying to illuminate some of the gaps in privacy we have right now and initiate a public discussion.” For more on the dangerous implications of publicly revealed personal genomes, read The Atlantic‘s recent magazine piece “Hacking the President’s DNA.” [Wired]

Can you imagine that Your Very DNA Will be open to anyone ?  

This is not the type of thing that we should be ignoring. especially since we know that the information on the internet will basically connect your dna to you.  this needs some serious discussion and it needs to start now.  Next we have a short look at what really pushed our buttons this week – Medical Marijuana Arrests going Wayyyyy UP – in states with a medical marijuana  law in place.  President Obama said he wouldn’t tie of the courts with Medical Marijuana cases – yet we see this huge jump in seizures, arrests and imprisonment – on Medical Marijuana.  Not a Good Look Mr President, Really Doh  -

Marijuana Possession Arrests Exceed Violent Crime Arrests

Americans are shifting on marijuana. More than half of them think itshould be regulated like alcohol and cigarettes, 18 states have passed legislation approving it for medical use and Washington State and Colorado have legalized it for recreational use, but it remains illegal under federal law. And the arrests continue — one every 42 seconds, and 86 percent of those are simply for possession, according to the Marijuana Policy Project.

In 2011, marijuana possession arrests totaled 663,032 — more than arrests for all violent crimes combined. Possession arrests have nearly doubled since 1980, according to an FBI report, while teen marijuana use recently reached a 30-year high.

President Obama said last month that going after recreational pot users in states where it is legal is not “a top priority” for his administration, which echoes a promise he made in 2008 not to interfere with states’ medical marijuana laws. Since then, his administration has aggressively targeted dispensaries that are in compliance with state law.

Taxpayers have shouldered the cost of arresting and incarcerating hundreds of thousands of people for the possession of marijuana, often in small quantities for personal use. Some national estimates put the annual cost of marijuana arrests above $10 billion, and low-level arrests for marijuana possession cost New York City alone $75 million in 2010. New York Gov. Andrew Cuomo proposed decriminalizing possession of 15 grams or less — even when flashed in public view — last week in his State of the State address.

“Every year, this process needlessly scars thousands of lives and wastes millions of dollars in law enforcement resources, while detracting from the prosecution of serious crime,” Cuomo said. “It’s not fair, it’s not right. It must end, and it must end now.

Next we have to consider the real stink behind Obamacare – Outsourcing

Yes we said Outsourcing. Recently we were enlightened to the reality of who will be actually answering the calls and placing people into plans. Indian Telemarketing Firms seem to have outbidded and won the right in certain states to deliver the services. Can you imagine this ? Americans who are unemployed and some who are actually the victims of loosing their jobs to outsourcing, will be talking to the very people who took their jobs; to get help choosing healthcare ? This is really a bad look Obamacare folks. we would have hoped for more but maybe the jobs that were rumored to be created within the us insurance sector may after all just end up being outsourced. Check This Out and if you are intrigued, click the title link to see the whole story.

 Obamacare Opens Outsourcing Window for Infosys: Corporate India

Infosys Ltd. (INFO)India’s second-largest software exporter, is tapping demand from U.S. President Barack Obama’s push to overhaul the nation’s health-care system to include an additional 30 million Americans.

The Bangalore-based company has won four state contracts, one valued at more than $100 million, and is vying for business in four more before a 2014 deadline to build online exchanges that will link customers to insurance plans, said Ashok Vemuri, the head of the company’s unit in the Americas. Obama plans to expand medical coverage through the Affordable Care Act, which includes setting up marketplaces where consumers can evaluate and select service providers.

Obama’s Stand

Obama’s stand against outsourcing, promising a ban on tax breaks for American companies that move jobs overseas, may prompt states to find software providers based in the U.S. In 2010, former Ohio Governor Ted Strickland banned state agencies from purchasing outsourced services.

After Governor John Kasich took office in 2011, he continued the policy while allowing for a waiver application if the only way to obtain the services is from outside the U.S., Kasich spokesman Rob Nichols said in a telephone interview.

“From a policy standpoint, you want a quality product that’s easy to use,” said Ezekiel Emanuel, a former White House health-care policy adviser and one of the architects of the Affordable Care Act. “An issue as important as health care is no place to get caught up in the politics of outsourcing.”

The president’s rhetoric on outsourcing may not deter companies seeking to tap insurers and states for business that Technology Holdings forecasts will expand 9 percent a year to $15 billion by 2016.

As a consolation to those who will not be splashing out this weekend in DC we give you Banned In America – Wacka Flocka Flame

Download to Your Hearts Desire – Legally

Hopefully we’ll be able to spur some consciousness in DC this time around, and get the President to realize that those promises he made are still waiting to be fulfilled. There is no way for the US Voters to be put on hold. We believe that now is the time to reinforce that to the entering administration. They maybe be a so called “Lame Duck Administration” – but the people are still paying for first class service.

With that we say Obama Administration, Get To Work !