Daily Archives: May 23, 2007

Video “The Order Of Death’, Soars Up Google Charts To Number One

Prison Planet | May 21, 2007

The Order of Death picks up where Dark Secrets: Inside Bohemian Grove leaves off. This new work exposes the connections between the Bohemian Club and Skull and Bones and other occult secret societies. Alex Jones explores the roots of the Grove and its links to occult networks dating back to ancient Egypt and Babylon.

[Googlevideo=http://video.google.com/googleplayer.swf?docId=2500924140588760933&hl=en]

This film delves deeply into the history of the Grove – where powerful men make decisions that affect the world but are completely hidden from public scrutiny. The Order of Death details how the Grove has been the backdrop for some of the most earth shattering events in human history including the development of the Star Wars program and the Manhattan Project.

Alex Jones’ documentary The Order Of Death has soared up the Google Video movers and shakers chart and now resides at number one, with nearly 300,000 views.

Heavy rollers in the movers and shakers category routinely break into the top 100 of the video charts, after which they go viral and are watched by hundreds of thousands more people.

Diabetes drug called potential death risk

USA Today | May 22, 2007

Nine months ago, the drug company Glaxo-SmithKline posted a study along with dozens of others on an obscure company website.

The study indicated that the company’s blockbuster diabetes drug, Avandia, raised patients’ heart disease risk by 30%. At about the same time, company officials say, they told the Food and Drug Administration what they had found.

That apparently wasn’t the first time Glaxo warned the agency about its drug. FDA’s Susan Cruzan confirmed Monday that the company had warned the agency of a potential safety problem at least as early as 2005.

Yet neither the company nor the FDA took additional steps to warn the public until Monday, when a fast-tracked study released on the Internet by a major medical journal prompted the agency to issue a Safety Alert warning of a “potentially significant” excess risk of heart attack and heart-related deaths.

Rep. Henry Waxman, D-Calif., immediately called a June 6 hearing of the House Oversight and Government Reform Committee to examine the FDA’s oversight of Avandia. It unleashed a swarm of questions from doctors and other politicians. In a floor statement, Sen. Chuck Grassley, R-Iowa, asked: “Do we have another Vioxx on our hands?”

The study that prompted the FDA to act linked Avandia to a 43% increase in the risk of heart attack and a 64% increase in the risk of death from all cardiovascular causes. The data were mainly Glaxo’s own, culled from 42 studies large and small, many of them posted on the company’s website.

“This is important because cardiovascular disease is the leading cause of death in diabetes and is responsible for between 65% and 80% of all deaths in diabetics,” says Steven Nissen of the Cleveland Clinic, lead author of the study released Monday by The New England Journal of Medicine.

“The reasons we give drugs to lower blood sugar is to prevent the complications of diabetes, the most important of which is heart disease. When a drug increases that risk, it can have profound public health consequences.”

Taken together, the studies involved more than 27,000 patients. There were 86 heart attacks and 39 deaths from heart disease among Avandia patients; there were 72 heart attacks and 22 deaths among patients not taking the drug.

Doctors in the USA wrote 13 million prescriptions for Avandia last year, generating more than $2 billion in sales, according to the medical research firm IMS Health.

Ronald Krall, Glaxo’s medical director, shot back that Nissen himself had carefully pointed out weaknesses in his analysis, not the least of which is that it mingles data from scores of different studies that weren’t designed to be lumped together.

Krall added that previous clinical trials, a review of data from an ongoing European trial and an analysis of 30,000 patients in a managed-care database found no reason for concern. “We are confident of the safety profile of Avandia and believe in its benefit for type 2 diabetic patients.”

Nissen concedes: “Our study has weaknesses. It was based on an analysis of publicly available material, not patient-level data for these trials. Nevertheless, we think the results will stand up over time.”

Is it Vioxx redux?

If Nissen’s research does stand up, Avandia may become the latest of a series of disgraced blockbusters whose risks have been found to outweigh their benefits. Baby boomers still are reeling from the loss of Vioxx, the infamous arthritis drug withdrawn in September 2004 for heart safety concerns.

Then there’s Pfizer’s $800 million gamble, torceptrapib, an experimental drug that appeared to be medicine’s best hope of clearing clogged arteries because it raised good cholesterol by 60%. Torceptrapib caused heart problems rather than preventing them. And hormone therapy for postmenopausal women caused the heart attacks it was intended to prevent.

But torceptrapib and hormone therapy don’t raise the same questions about drug regulation that have cropped up with Vioxx and Avandia, because regulators apparently knew of potential problems with Vioxx and Avandia long before they took action.

“What did the FDA know and when?” says Yale cardiologist Harlan Krumholz. “That’s an open question. Here, somebody’s gone through data that’s existed for some time. What’s going on at FDA? What’s going on at the company?”

Stuart Seides of Washington Hospital Center echoed Krumholz’s concern. “One has to wonder why the FDA was sitting on this information,” he says, expressing concern that “an excess incidence of cardiac events had been sitting out there for the better part of a year and has not been brought to our attention.”

FDA’s Robert Meyer said Monday that the agency has not completed its review of the data posted on Glaxo’s website last August. “We wanted to do a more robust analysis,” he says. “What we’d like to do is complete our analysis and take this to a public discussion at an advisory committee meeting as soon as possible.”

FDA advisory committees consider a range of drug and device issues, but their opinions are not binding. It would be “a couple of months” before such a meeting could be held, Meyer says.

The agency could post a “black box” warning on the drug’s label — the strongest type of safety alert — or withdraw the drug from the market. In 2006, the FDA added a new warning about a potential increase in heart attacks and heart-related chest pain in patients taking Avandia. The warning stemmed from a trial in patients who already had congestive heart failure.

The new findings shook medical experts because Avandia is so widely used — and because the results challenge one of the pillars of diabetes treatment.

“It’s a shocker because the whole field has been built on the notion that if you increase insulin sensitivity, cardiovascular events would go down,” says Yale diabetes expert Silvio Inzucchi.

Avandia and its chemical cousin Actos, made by Takeda Pharmaceuticals, are central to the approach. They enable the body to make the most of the insulin it produces.

Thought to be safer

That’s critical for the 18 million people in the USA who suffer from type 2 diabetes. Diabetes occurs when the pancreas can’t produce enough insulin. Without insulin, cells can’t absorb the sugar they need for energy. Body tissues begin to break down. That’s why the disease can cause kidney failure, blindness, amputations, heart attacks and strokes.

Older diabetes drugs, such as sulfonylureas, force the pancreas to make more insulin. Another drug, metformin, reduces the amount of sugar produced in the liver.

Unlike older drugs, insulin sensitizers such as Avandia and Actos can be taken by people with kidney problems. They don’t cause dangerous plunges in blood sugar levels associated with some drugs, says University of Miami diabetes expert Ronald Goldberg.

The drugs aren’t without side effects, he says. Avandia and Actos can cause weight gain and swelling. Because they prompt the kidneys to retain water, they’re used cautiously in patients with heart failure, because weakened hearts can’t pump large amounts of fluid.

There’s another issue as well. Although Avandia, approved in 1999, has been shown to reduce blood sugar by about 60%, there’s no evidence to prove that the drug actually prevents heart attacks and strokes. Those studies would take much longer and require many more volunteers.

A study of Actos called PROactive, on the other hand, seemed to indicate the drug may protect the heart, though no one knows exactly how. Based on the results of that study, Yale researchers including Inzucchi are testing Actos to see whether it can prevent strokes. The Cleveland Clinic’s Nissen is carrying out a trial to see whether the drug can reduce artery blockages.

The new findings may, however, sweep Actos into the Avandia controversy. The FDA has asked Takeda to conduct an analysis similar to Nissen’s. “Ultimately, it would be nice to have that sort of data for other drugs as well,” Meyer says. Another member of the class, Rezulin, was pulled off the market in 2000 because of liver toxicity.

Nevertheless, if the Nissen analysis is shown to reveal genuine risks, Avandia “represents a major failure of the drug-use and drug-approval processes in the United States,” Bruce Psaty of the University of Washington and Curt Furberg of Wake Forest University wrote in a journal editorial.

Doctors urged worried patients not to stop taking the drug without talking to their doctors. “People should not panic,” says Seides, noting that just 158 people in the study suffered heart attacks, and only 61 deaths resulted from cardiovascular causes. He said quitting the drug abruptly may be dangerous, too, causing a sudden increase in blood sugar.

“The big question,” he says, “is whether the data here is sufficient for the drug to cease being used at all. That’s a difficult question.”

Immigration Bill is Camouflaged Amnesty

Washington Times | May 23, 2007

Why do our elected leaders care more for noncitizens than they do citizens?

That this bill is hundreds of pages long and was mostly crafted in secret without hearings and without input from the public should also make us wary.

I wish I could believe the president and those senators who claim their agreement on immigration legislation will “fix” the problems of open borders and illegal aliens. I can’t, because the public has had no input into the measure; the last time Congress “fixed” the problem, it got worse; and it appears Democrats and Republicans care more about harvesting votes for their respective parties than doing what’s best for their fellow citizens.

The bill would allow for the hiring of 18,000 additional border patrol agents, construction of 370 miles of fence and 200 miles of vehicle barriers, ground-based radar, camera towers and aerial vehicles. Employers would have to electronically verify new hires within 18 months and all existing employees within three years. The priority of border security first, legalization second sounds good.

Only after the border is secured, say the senators and White House, will the guest-worker program kick in. Again, I wish I could believe this, but when it comes to immigration, I don’t trust either party. It’s a safe bet that once the U.S. government legalizes the illegals, many will not abide by the conditions. What then?

The president can say the Senate measure isn’t amnesty, but that doesn’t make it something else. Many who broke our laws to get here will be allowed to stay.

A new immigrant category called the “Z Visa” will be introduced. Z-1 covers illegal aliens who got here and started work before Jan. 1, 2007. Z-2 is for parents and spouses of illegals who qualify under the Z-1 category. Z-3 is for the children of illegal aliens qualifying under the Z-1 category.

As the Heritage Foundation’s Brian Darling has written, “Z Visa” holders can remain in their “Z” status indefinitely, meaning they never have to pursue a “pathway to citizenship.” They would also be allowed to get Social Security numbers and benefits from some welfare programs. And, writes Mr. Darling, “There is no cap on the number of amnesty recipients in the draft language.”

Z Visa holders can’t vote, but who doubts that a liberal judge will rule such a ban unconstitutional? Only in America can one violate the law and then appeal to the law and the Constitution for undeserved rights.

The draft language requires illegals to return “home” for a year or two before applying for citizenship, but who will enforce that provision? No president will suffer the political fallout from a mass deportation of lawbreakers, especially after they’ve been on “Oprah” with their babies, crying their eyes out. Neither am I betting that imposed fines will be paid.

That this bill is hundreds of pages long and was mostly crafted in secret without hearings and without input from the public should also make us wary. So should Massachusetts Democratic Sen. Edward Kennedy’s enthusiasm for it. Each time Mr. Kennedy embraces a Republican, the Republican usually gets his pocket picked. Worse, Republicans don’t seem to mind.

Radio talk show host Rush Limbaugh predicted last week that if the Senate draft legislation becomes law “there is an 80 percent chance that Hillary Clinton will be the next president of the United States … we are doomed in ’08.” He predicted this would be “the last straw as far as the Republican base is concerned in being able to trust Republicans that it elects to represent them.”

Why do our elected leaders care more for noncitizens than they do citizens? There is no constitutional right to come to America; nor a right to become a U.S. citizen. Do we let robbers keep the money if they break into a bank? Isn’t this the message we have been sending to illegals: If you can get here, you can have all sorts of goodies previously reserved for people who abide by the law?

Former Attorney General Edwin Meese thinks the only way to solve the illegal immigration problem is for lawmakers to “uphold the principle that the rule of law requires the fair, firm and equitable enforcement of the law.” He would avoid granting amnesty to those who’ve lived and worked in the United States illegally and ensure that any temporary-worker program is short term.

Mr. Meese knows something about the subject. He admits 1986 legislation that attempted to stem the tide of illegal immigration by combining amnesty with increased workplace enforcement of immigration law failed.

The stakes are enormous, for the country and for the future of the Republican Party. It’s not worth passing this measure just so both sides can claim “victory,” if the victory is a Pyrrhic one.

Ron Paul’s Internet Support Way Ahead of Anyone

Caucus.blogs.nytimes | May 21, 2007

Representative Ron Paul, the Texas Republican who is running for president, may be barely registering in public opinion polls, but his supporters are making their presence known on the Internet. They were particularly energized after the second Republican debate, held last week in South Carolina.

There, Mr. Paul asserted that American foreign policy might have helped incite the terrorist attacks of Sept. 11. Rudolph W. Giuliani, the former mayor of New York, swiftly rebuked him as holding a fringe view.

Mr. Paul’s followers responded with support, in all the ways by which success is measured in cyberspace: in online polls about who won the debate, in the numbers of friends on MySpace and viewings of videos on YouTube. His was the most-searched name on Technorati, ahead of Paris Hilton’s.

Mr. Paul, the only candidate in the field opposed to the Iraq war, is also its only adherent of Libertarianism, whose followers have found a home in the wild west of the Web.