Today, Kevin explains how the Wikileaks documents prove that aliens are here on earth and that we are heading towards a new world order and one world currency.
Ethics Committee Recommends Censure for Charlie Rangel
Jack Camp Stripped of Judgeship for Helping Stripper Buy Cocaine, Pot
FDA Is Criticized for Training Deals
Watchdog Says FDA Risked Integrity
U.S. Reviews FDA Scientists’ Complaints
Duke Cancer Researcher Quits as Papers Questioned
I Am Julian Assange
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December 15th, 2010
The Wall Street Journal
By: Alicia Mundy
Congress’s watchdog arm has criticized the Food and Drug Administration for creating the appearance of favoritism toward a Boston company that won lucrative first rights to sell a generic drug after providing free consulting work to the agency.
On Tuesday, a congressional committee plans to release a report by the Government Accountability Office that says the FDA risked giving the appearance that it had compromised its integrity because of its dealings with the company, Momenta Pharmaceuticals Inc.
Winning the first right in July to sell the generic version of the blood thinner Lovenox has already meant hundreds of millions of dollars in sales for Momenta and its partner, Novartis AG’s Sandoz unit.
Also critical of the FDA’s actions are Momenta’s rivals—including Teva Pharmaceutical Industries Ltd., the world’s largest generic drug manufacturer, and Amphastar Pharmaceuticals Inc.—as well as a recently retired official in the FDA’s generic-drug division. The drug companies’ applications are still awaiting FDA action.
The controversy centers around Momenta’s performance of months of free work for the FDA during a high-profile investigation of tainted Chinese drug imports in 2008. At the same time, agency officials were reviewing the company’s application to sell the generic version of a blockbuster blood thinner.
As a result, “agency officials ran the risk of undermining public confidence in the integrity of FDA’s operations,” including heparin-related drug approvals, the report says, according to a copy reviewed by The Wall Street Journal.
In response to the report, requested by Rep. Joe Barton (R., Texas), the FDA said it needed to draw on Momenta’s expertise to find the cause of the tainted Chinese imports, but it acknowledged it should have considered potential conflicts of interests and done more to disclose them.
The FDA has said its reliance on Momenta’s free work had nothing to do with its approval of the company’s drug ahead of competitors’.
Momenta said it conducted the investigation for the FDA in the interest of public health, not because of its drug application.
Momenta’s newly approved product is a generic version of a fast-acting form of heparin. Until the July approval, Sanofi-Aventis SA’s Lovenox drug had a monopoly on that market, with world-wide sales last year that topped $4 billion.
Since Momenta and Sandoz won FDA approval for their rapid-acting heparin in July, the drug’s sales have topped $300 million.
The small biotech company doesn’t have other marketed products.
Teva officials told the Journal that the company met with the FDA in October and raised questions about possible bias. It has said its application, which was filed two years before Momenta’s, is stuck in bureaucratic limbo, and that it received delayed notice when the FDA changed the terms for evaluating the drugs.
Amphastar filed the first application to make generic Lovenox in 2003. It says the FDA told it in late 2007 that it met the standards for “sameness” but then the standards changed. The company sued the FDA in October, alleging favoritism.
Richard Adams, a former official in the FDA’s generic-drug division who retired this year, agreed with the bias allegation . “Everyone closely involved saw that it was stacked and the whole direction was toward Momenta,” he said.
Momenta’s chief executive, Craig Wheeler, has said that the company’s science for copying complex drugs such as Lovenox surpasses that of other companies. Its scientists have spent more than a decade developing ways to pinpoint the molecular structure of Lovenox, he said.
The FDA turned to Momenta for help in early 2008, when it was trying to figure out what was tainting a widely used older form of heparin. Hundreds of people were suffering severe shock after taking the drug, which was linked to 81 U.S. deaths that year.
The FDA said that Momenta’s researchers did an excellent job identifying the contaminant. “This successful effort to protect public health would not have been possible without the unique expertise and extraordinary efforts of the outside scientists,” it wrote in a response to the GAO.
Rep. Barton criticized the FDA for failing to name the culprit for the tainted heparin and said the report shows the agency’s “fundamental weakness” in dealing with the surge of Chinese medical imports.
October 28, 2010
By: Stephanie Kierchgaessner and Richard Waters
The top US consumer protection agency has dropped an inquiry into data collection breaches by Google, even as regulators in Europe and Canada have stepped up their scrutiny of the internet giant’s privacy policies.
David Vladeck, the director of the bureau of consumer protection at the Federal Trade Commission, said the FTC had decided to drop its investigation into Google’s allegedly inadvertent collection of consumer data in 2007 because it was satisfied that Google had adequately addressed the issue internally.
The FTC decision marks the end of at least one major probe into the most damaging privacy breach to hit the company to date. But the company is still facing ongoing investigations by individual state attorneys general in the US, and regulators in Spain and Canada both last week concluded that Google had broken local laws while investigations are underway in other countries.
Google admitted for the first time last week that the cars it had used to photograph residential streets for its Street View mapping service had illicitly collected some personal e-mails and passwords from the homes it passed. The breach was first announced in May.
At that time, however, the company said it had only collected “fragments” of information. Mr Vladeck said the revelation had caused “concern” among FTC staff because Google had only discovered the 2007 breach in response to a request from data protection authorities in Germany.
But in a letter to a Google attorney posted on the commission’s website, Mr Vladeck said Google’s decision to improve its internal processes to address the FTC’s concerns, including the appointment of a new director of privacy for engineering, gave staff enough assurances that the company had addressed the issue. FTC chairman Jon Leibowitz declined to comment on the decision.
“Google has made assurances to the FTC that the company has not used and will not use any of the payload data collected in any Google product or service, now or in the future,” Mr Vladeck said. “The assurance is critical to mitigate the potential harm to consumers from the collection of payload data.”
Google said it was pleased by the news. But the decision was met by outrage from privacy advocates.
Marc Rotenberg, director of the Electronic Privacy Information Center, accused the FTC of making its decision based solely on Google’s own representations, without making any “independent” determination on whether the company had broken privacy rules.
Jeffrey Chester, another privacy watchdog, said he believed the FTC was giving Google a pass in part because of the White House’s close relationship with the company. Even though the FTC is the top consumer protection agency in the US, it has limited statutory authority to take enforcement action against companies.
The commission is due to unveil a new set of voluntary privacy guidelines in coming weeks. Mr Leibowitz has said that addressing the rampant collection of personal data by internet companies is a top priority.
August 4, 2010
By: Don Thompson
Politicians’ tweets and status updates should be held to the same standards as paid advertising that voters see on television, hear on radio or find in their mailboxes, California’s campaign watchdog agency says in a report being released Monday.
It’s become necessary as politicians in California and elsewhere announce their candidacies and major campaign policies through Twitter, YouTube and a host of social networking sites, said FPPC Chairman Dan Schnur.
He said California’s 36-year-old Political Reform Act needs rewriting to keep up with the times.
“Our goal here is to meet the new challenges of 21st Century technology,” Schnur said. “There’s no way that the authors of the act could have anticipated that these of types of communicating a campaign message would ever exist.”
The report, compiled by a commission subcommittee, outlines possible hurdles to regulating online content, such as how to include full disclosure of who is behind a message in a 140-character tweet or a text.
Any changes the commission makes to state law should give regulators the flexibility to respond to swiftly evolving technologies, the report says.
The commission will consider the report at its Aug. 12 meeting. If the five-member commission orders its staff to propose regulations or legal changes it could be months before they take effect, potentially pushing new rules past this political season.
Campaigns would face the same disclosure rules they do now, such as saying who is behind an ad and who paid for it, but for the first time they would apply to communications on the Internet and other forums.
The subcommittee’s recommendations draw a line between paid political activity and unpaid, grassroots volunteer efforts. Political commentary by individuals unconnected to a campaign would not be affected. Nor would sending or forwarding e-mails, linking to websites or creating independent websites.
“People tweeting about someone is typically not something you would regulate,” said Barbara O’Connor, professor emeritus of communications and the former director of the Institute for the Study of Politics and Media at California State University, Sacramento. “When it becomes an ad, it’s a different story. When it becomes an ad it really is a replacement for a 30-second spot for a new generation.”
The recommendations include requiring tweets and texts to link to a website that includes the full disclosures, although some people feel the disclosure should be in the text itself no matter how brief, O’Connor said. She testified before the subcommittee but hadn’t seen its report.
California Republican Party Vice Chairman Jon Fleischman, who writes the conservative FlashReport blog, told the subcommittee that requiring even one character in a tweet be used for disclosure would be a burden on free speech, according to the report.
Bloggers who accept payment to present their opinion in favor of or against a candidate but do not disclose their ties to a campaign are becoming increasingly common in California, but the report does not recommend regulating them — for now. The subcommittee urged bloggers to voluntarily disclose on their websites if they are being paid.
If that doesn’t work, it said regulators or lawmakers may need to step in.
Like California’s current regulations, federal campaign watchdogs regulate only paid political advertising, according to the National Conference of State Legislatures. Other states also are just beginning to consider whether their disclosure laws are sufficient to cover modern communications.
April 28, 2010
by Dana Tyler
Is it or isn’t it? How do you know when organic packaged food really is organic?
A watchdog group filed several complaints Tuesday saying what you see is not necessarily what you get.
You buy organic, thinking it has to be healthier for you because you believe it’s grown or processed without chemicals that will hurt you and the environment.
“I believe what I see, but I also think you have to be an educated consumer and you have to take responsibility to look at what you eat. It goes both ways,” organic food shopper Stacey Lender said.
Organic food shoppers, read labels closely.
“It says USDA organic. Who’s checking that? Is everything kosher, so to speak?” shopper David Altman said.
The Cornucopia Institute, a Wisconsin-based farm policy research group, is checking things out and Tuesday filed a legal complaint with the U.S. Department of Agriculture, saying three food companies — Oskri Organics, Organic Bistro and Newman’s Own Organics — are deceiving consumers by misrepresenting the words “organic” or “organics.”
“Organic Bistro, for instance, uses organic vegetables and grains, but does not use organic chicken, organic turkey,” Cornucopia’s Charlotte Vallaeys said.
On Tuesday night Organic Bistro said its labeling clearly informs consumers about what they’re purchasing.
So what’s in a name? The Cornucopia Institute says everything when it comes to calling something organic. The organization says process foods labeled as organic must contain 95-100 percent organically produced raw or process agriculture products.
Ed Burke stocks Newman’s Own Organics at Fairway Market and stands by the tough scrutiny organic food products undergo.
“The report is suspect in my mind,” Burke said. “I don’t buy it.”
“We certainly respect Newman’s Own for generous donations to charity, but when it comes to labeling of organics we believe that they can certainly do better,” Vallaeys said.
She said the Newman’s Own cookies use conventional sugar, canola oil, and cocoa. The company founded by the late actor and his daughter responded Tuesday saying “For seventeen years Newman’s Own Organics has been certified by Oregon Tilth, an independent third party certifier accredited by the USDA’s National Organic Program.”
On Tuesday night the USDA said it’s committed to the integrity of the organic seals and continues to place greater emphasis on compliance.