Archive for the ‘FDA’ Category

ZIKA AND THE DEMOCRATS

Friday, August 5th, 2016

 

Zika and the Democrats

Obama is sitting on money and methods to slow the virus. Instead he blames Congress.

Miami police office Michelle Albelo hands out cans of insect repellent on August 2.ENLARGE
Miami police office Michelle Albelo hands out cans of insect repellent on August 2. PHOTO: GETTY IMAGES

The Zika virus is only beginning to hit the U.S. mainland, but its political exploitation is already an epidemic. To wit, the Obama Administration that is sitting on money and methods to reduce the Zika outbreak is using the virus as a political bludgeon to elect more Democrats.

A Zika outbreak hit Miami this week, and the Centers for Disease Control on Monday advised pregnant women to get checked for possible exposure. Women in Miami are being told to cover up, stay indoors and wear insect repellant because the virus can cause malformed brains in the womb. These are sensible precautions, but it would be better if the government wasn’t dysfunctional in spending the money it has and eradicating the mosquitoes that carry the disease.

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WHY DOES THE IRS NEED GUNS?

Monday, June 20th, 2016

Why Does the IRS Need Guns?

After grabbing legal power, bureaucrats are amassing firepower. It’s time to scale back the federal arsenal.

Dr. Coburn is a physician and former U.S. senator from Oklahoma. He is the honorary chairman, and Mr. Andrzejewski is the founder and CEO, of OpenTheBooks.com, a repository of public-spending records.

EXCERPT FROM THIS ARTICLE:  On Friday, June 17, our organization, American Transparency, is releasing its OpenTheBooks.com oversight report on the militarization of America. The report catalogs federal purchases of guns, ammunition and military-style equipment by seemingly bureaucratic federal agencies. During a nine-year period through 2014, we found, 67 agencies unaffiliated with the Department of Defense spent $1.48 billion on guns and ammo. Of that total, $335.1 million was spent by agencies traditionally viewed as regulatory or administrative, such as the Smithsonian Institution and the U.S. Mint.

Some examples of spending from 2005 through 2014 raise the question: Who are they preparing to battle?

Special agents at the IRS equipped with AR-15 military-style rifles? Health and Human Services “Special Office of Inspector General Agents” being trained by the Army’s Special Forces contractors? The Department of Veterans Affairs arming 3,700 employees?

The number of non-Defense Department federal officers authorized to make arrests and carry firearms (200,000) now exceeds the number of U.S. Marines (182,000). In its escalating arms and ammo stockpiling, this federal arms race is unlike anything in history. Over the last 20 years, the number of these federal officers with arrest-and-firearm authority has nearly tripled to over 200,000 today, from 74,500 in 1996.

What exactly is the Obama administration up to?

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FEDS SPENDING MILLIONS TO ARM EPA, FDA, VA

Sunday, January 24th, 2016

 

FEDS SPENDING MILLIONS TO ARM AGENCIES

EPA, VA among those nabbing heavy armaments
By Kellan Howell – The Washington Times – Thursday, January 7, 2016

EXCERPT FROM THIS ARTICLE:
Some agencies like the EPA, U.S. Fish and Wildlife Service and the Bureau of Land Management have come under fire in recent years for conducting raid-like operations with heavily armed agents. In 2013 armed EPA officers raided the town of Chicken, Alaska. The agency said the raid was conducted to look for possible violations of the Clean Water Act.

As the U.S. engages in a national debate over the militarization of the police, federal data shows that government agencies charged with largely administrative roles are spending tens of millions of taxpayer dollars to purchase SWAT and military-style equipment.

Since FY 2006, 44 traditionally administrative agencies have spent over $71 million on items like body armor, riot helmets and shields, cannon launchers and police firearms and ammunition, according to federal spending data from watchdog group OpenTheBooks.com.

This comes in addition to the $330 million spent on such equipment in that period by traditional law enforcement agencies like the FBI, Secret Service and Drug Enforcement Administration.

Some examples of the purchases include:

• Nearly $2 million spent by the Department of Veterans Affairs on riot helmets, defender shields, body armor, a “milo return fire cannon system,” armored mobile shields, Kevlar blankets, tactical gear and equipment for crowd control.

• Over $300,000 spent by the Food and Drug Administration on “ballistic vests and carriers” in fiscal 2014.

• Over $200,000 on body armor spent by the Environmental Protection Agency during the Obama administration years, versus just $30,000 in the three previous fiscal years.

• More than $28,000 by the Smithsonian Institution on body armor for its “zoo police and security officers” in fiscal 2012. (more…)

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THE OBSCENE GROWTH OF GOVERNMENT BUREAUCRACY

Tuesday, April 30th, 2013

April 28, 2013

Government as Entropy

By Daniel Payne

On May 15th, 1862, the thirty-seventh Congress passed into law the creation of the United States Department of Agriculture. Its purpose, as the law explained, was “to diffuse among the people of the United States useful information on subjects connected with agriculture in the most general and comprehensive sense of that word, and to procure, propagate, and distribute among the people new and valuable seeds and plants.”

How charming; how quaint. Over one hundred and fifty years later, the USDA is still going strong; from its humble beginnings; it now commands hundreds of billions of dollars in Federal funds and more than 100,000 personnel. What is it doing with all that manpower, and all that cash? Is it spreading “useful information” about agriculture? Is it passing out “new and valuable seeds and plants?” Are we getting the most bang for our agricultural buck?

Er, not quite, or rather not merely. As came to light this week, the USDA has distributed a flyer that assures Mexican immigrants that they can acquire food stamp benefits for their children without proper documentation — that is to say, illegal immigrants may still be eligible for an EBT card. The news is hardly surprising; what’s remarkable is that the USDA is actively advertising it.

But that’s what happens to bureaucracy over time. The USDA was founded on a relatively simple set of principles: promote American agriculture. That was it; that was pretty much its whole raison d’être. In one hundred and fifty years it apparently learned a few new tricks, the least of which is teaching people how to live off the public dole. The USDA now boasts an Assistant Secretary for Civil Rights, an Under Secretary for Marketing and Regulatory Programs, and an Economic Research Service, to name a few of its bureaucratic functions; it manages offices of Faith-Based and Neighborhood Partnerships, Tribal Relations, Communications, Nutrition Policy and Promotion, the Executive Secretariat, and many others; it hath pronounced on the “Harmonized Tariff Schedule” and “International Phyosanitary Standards” and lots of other fascinating topics.

How much of this is “useful information?” about agriculture? How much of it is regulatory folderol? (more…)

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MITT ROMNEY CHARTS A NEW COURSE FOR THE MIDDLE EAST

Tuesday, October 2nd, 2012

 

The Wall Street Journal

  • October 1, 2012

Mitt Romney: A New Course for the Middle

East

Restore the three sinews of American influence: our economic strength, our military strength and the strength of our values.

By MITT ROMNEY

Disturbing developments are sweeping across the greater Middle East. In Syria, tens of thousands of innocent people have been slaughtered. In Egypt, the Muslim Brotherhood has come to power, and the country’s peace treaty with Israel hangs in the balance. In Libya, our ambassador was murdered in a terrorist attack. U.S. embassies throughout the region have been stormed in violent protests. And in Iran, the ayatollahs continue to move full tilt toward nuclear-weapons capability, all the while promising to annihilate Israel.

These developments are not, as President Obama says, mere “bumps in the road.” They are major issues that put our security at risk.

Yet amid this upheaval, our country seems to be at the mercy of events rather than shaping them. We’re not moving them in a direction that protects our people or our allies.

And that’s dangerous. If the Middle East descends into chaos, if Iran moves toward nuclear breakout, or if Israel’s security is compromised, America could be pulled into the maelstrom.

We still have time to address these threats, but it will require a new strategy toward the Middle East.

The first step is to understand how we got here. Since World War II, America has been the leader of the Free World. We’re unique in having earned that role not through conquest but through promoting human rights, free markets and the rule of law. We ally ourselves with like-minded countries, expand prosperity through trade and keep the peace by maintaining a military second to none.

But in recent years, President Obama has allowed our leadership to atrophy. Our economy is stuck in a “recovery” that barely deserves the name. Our national debt has risen to record levels. Our military, tested by a decade of war, is facing devastating cuts thanks to the budgetary games played by the White House. Finally, our values have been misapplied—and misunderstood—by a president who thinks that weakness will win favor with our adversaries.

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Associated Press/Hassene DridiAn American school adjacent to the U.S. Embassy in Tunis, Tunisia, on Sept. 15. Protesters burned the school the day before.

By failing to maintain the elements of our influence and by stepping away from our allies, President Obama has heightened the prospect of conflict and instability. He does not understand that an American policy that lacks resolve can provoke aggression and encourage disorder. (more…)

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VIDEO – STOP THE U.N. AND AGENDA 21

Monday, November 28th, 2011

A RALLY IN WASHINGTON STATE BY TEA PARTY ADVOCATES TO STOP THE U.N. BY DEFUNDING

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THE AVASTIN DENIAL

Monday, November 21st, 2011
The Wall Street Journal

  • NOVEMBER 19, 2011

A chillingly blunt assertion of regulatory power against a drug for breast cancer.

  • The extraordinary Avastin saga has become a kind of randomized controlled trial, pitting the Food and Drug Administration’s power against potentially life-saving drugs for terminally ill patients. The results are proving that the former is far stronger, with FDA Commissioner Margaret Hamburg’s decision yesterday to withdraw the biologic medicine as a treatment option for women with metastatic breast cancer.

In a 69-page decision, Dr. Hamburg quashed the drug maker Genentech’s last appeal, claiming (in the first person throughout) that FDA approval requires “credible, objective evidence.” But there is no credible or objective definition for that term of art other than what the FDA claims it means at any given time for any given drug, as she goes on to detail. It is merely another way of imposing a blanket government abstraction over the individual choices of a patient and her physicians.

Editorial Board Member Joe Rago on the FDA’s decision to revoke the breast cancer drug Avastin and his interview with John Lechleiter, CEO of the drug maker Eli Lilly & Co.

In 2008, Avastin was initially cleared for breast cancer in combination with chemotherapy under “accelerated approval,” the FDA program that was created in response to the AIDS crisis to speed drugs for incurable illnesses and other medical needs to market. But accelerated approval is despised by the FDA bureaucracy and the New England Journal of Medicine crowd because it uses nontraditional standards to judge medical benefits.

Avastin was first approved on the basis of progression-free survival, or PFS, the time women live without their disease spreading or worsening. In 2009 Genentech applied to convert to full approval, with new studies that also showed PFS improvements, even if they were less statistically robust than the initial trials. At that point cancer drugs chief Richard Pazdur moved to reassert the FDA’s political culture of delay and control, rigging the re-review against Avastin and emphasizing safety risks.

1avastin

Bloomberg NewsAvastin (more…)

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THE FOOD POLICE – TIME TO STOCKPILE LUCKY CHARMS?

Wednesday, August 10th, 2011
Published on The Weekly Standard (www.weeklystandard.com)

Time to Stockpile Lucky Charms?

The Obama administration targets food marketed to children.

Kate Havard

August 8, 2011, Vol. 16, No. 44

The Obama administration is after your Lucky Charms, or at least your children’s. The public comment period closed on July 14 for a set of “voluntary” guidelines for the marketing of food to children. If adopted, these rules will transform the advertising of breakfast cereals.

Put forward by an interagency working group, the guidelines will establish nutritional standards that most cereals flunk—and not just those of the “Chocolate Frosted Sugar Bombs” variety. Corn Flakes will not be advertisable to children, along with Raisin Bran, Special K, Rice Krispies, and Wheaties. Plain Cheerios squeak by the proposed 2016 rules but fall foul of the “ultimate goal” for sodium effective in 2021.

While cereals are the most obvious targets of the guidelines, all foods marketed to children will have to meet the proposed nutritional standards. Many don’t. Peanut butter (both smooth and crunchy) has too much saturated fat. Jelly has too much sugar. Forget about apple-cinnamon instant oatmeal and Mott’s apple sauce.

These foods may still appear in grocery stores, but not in brightly colored packages adorned with cartoon characters. Toucan Sam, Cap’n Crunch, and Tony the Tiger will have to retire.

The definition of “marketing to children” is broad. A television show is deemed “targeted to children” if 20 percent of the audience is 18 or under. Any child-oriented theme, like education or parenting or T-ball, cannot be mentioned in the advertising of foods that don’t meet the standards. Frosted Flakes will no longer be allowed to sponsor Little League baseball. The Coca Cola Company will have to give up its Coca Cola Scholars Foundation (which provides $3.4 million a year in scholarships) or perhaps rename it after one of the company’s bottled waters. General Mills’s “Box Tops for Education” program will be barred from kid-friendly cereals. The slogan “Choosy moms choose Jif” will be forbidden as too “targeted.” (more…)

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BREAST CANCER – A SECOND AVASTIN OPINION

Sunday, July 24th, 2011
The Wall Street Journal

  • JULY 23, 2011

Oncologists vs. the FDA on the breast cancer drug.

  • The humanitarians urging the Food and Drug Administration to withdraw Avastin for women with terminal breast cancer claim there is no other choice: The evidence shows Avastin doesn’t work, so too bad. But how to square that view with the highly respected medical group that—reading the same evidence—recommends preserving Avastin as a treatment option?

The National Comprehensive Cancer Network is a consortium of 21 leading U.S. oncology programs that issues practice guidelines on the basis of “sound, evaluative clinical information,” according to its mission statement. Last week, the NCCN’s breast cancer panel reaffirmed its position that Avastin is “an appropriate therapeutic option” for some patients in combination with chemotherapy. The vote was 24 in favor, with one abstention. No members were opposed.

The FDA’s expert panels have now reviewed Avastin three times. All three have rejected it, though the first vote was overruled by the FDA leadership in 2008 to give the biologic drug provisional approval. Cancer division chief Richard Pazdur moved to revoke approval last year after a negative re-review of the evidence, and a final decision is now pending following an unprecedented appeal hearing last month by Avastin’s maker, the Roche subsidiary Genentech.

Yet the NCCN has now reviewed Avastin for breast cancer four times since adding it to the compendium in 2005, and each time it has reaffirmed its support. One reason for the group’s divergence with government is that it fields practicing oncologists from institutions like Dana-Farber/Brigham and Women’s Cancer Center at Massachusetts General Hospital, the University of Texas’s M.D. Anderson and Memorial Sloan-Kettering in New York. They understand the benefits that Avastin can provide to some (but not all) women in controlling their disease, and the NCCN’s advice is appropriately qualified.

The FDA, by contrast, favors statistical purists who think in the abstractions of controlled trials, and its conflict-of-interest rules are meant to exclude doctors who have experience treating specific cancers in the real world. For the FDA, believe it or not, being an expert in breast cancer fatally compromises your objectivity in ruling on a breast cancer drug. The oncologists also don’t carry Dr. Pazdur’s political agenda to increase his agency’s power over cancer drug approvals.

Genentech is merely asking for Avastin to remain available for metastatic breast cancer while it conducts an additional trial to add to the evidence about which patients Avastin does help. FDA Commissioner Margaret Hamburg hasn’t said when she’ll make a final decision. If you were a patient, would you rather trust a federal regulator or some of the best cancer doctors in the country?

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THERE’S NO ‘AVERAGE’ CANCER PATIENT

Tuesday, June 21st, 2011
The Wall Street Journal

  • JUNE 20, 2011

What the late Stephen Jay Gould could teach the FDA.

On June 28, the Food and Drug Administration (FDA) will hold a hearing to decide the fate of Avastin, a drug taken by thousands of women fighting late-stage breast cancer. Many of these women have pleaded for continued access to the drug, which they consider a matter of life and death.

But this case is really about what will guide decisions on treatment options—the best judgment of doctors and their patients, or the policy preferences of the FDA.

Last year, the FDA began the process of revoking Avastin’s approval for breast cancer. Some leading oncologists applauded the decision, arguing that, for the average patient, Avastin doesn’t work very well and has significant side effects.

Patient advocates and thousands of women who credit their survival to Avastin argue that it’s unfair for the FDA to remove one of the few available options for patients diagnosed with terminal cancer. They’re right.

Avastin originally hit the market in 2004 to treat other cancers, and in 2008 the FDA conditionally approved it for breast cancer. Initial testing showed that, on average, Avastin didn’t lengthen patients’ overall survival time. But it did slow tumor growth, giving many patients a longer “progression-free” survival. What this means is that dying patients get a precious few extra months of quality time they can spend with family and friends, travel rather than being confined to a bed, or get their personal effects in order.

Scientist Stephen Jay Gould lived another 20 years after being diagnosed with lung cancer.

conko

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