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Posts Tagged ‘FOOD AND DRUG ADMINISTRATION’

YOUR CORONAVIRUS CZAR

In Bureaucracy, Business, History, Politics, Social commentary on March 16, 2020 at 12:09 am

On February 26, President Donald Trump appointed Vice President Mike Pence to lead a task force to combat the spread of the Coronavirus. 

In doing so, he rejected calls to appoint an outside medical expert.

This put the Federal medical establishment under a trusted sycophant—and gave Trump a convenient scapegoat if something went wrong.

So here’s what America is getting as its medical savior.

Michael Richard “Mike” Pence served as a Republican member of the House of Representatives from 2001 to 2013. He also served as Chairman of the House Republican Conference from 2009 to 2012.  His record included:

  • Voted, in 2007, to defund Planned Parenthood because it provides abortions.
  • Opposed, in 2009, giving American citizenship to children born to illegal aliens living within the United States.
  • Compared the U.S. Supreme Court’s upholding the Constitutionality of the Affordable Care Act to the September 11, 2001 terrorist attacks.
  • Voted to eliminate funding for climate education programs and to prohibit the Environmental Protection Agency from regulating greenhouse gas emissions.

In 2012, he ran for Governor of Indiana, won the election, and assumed this office in 2013.

As Governor, Pence: 

  • Signed legislation in 2015 that repealed an 80-year-old Indiana law requiring construction companies working on publicly funded projects to pay a prevailing wage.
  • Successfully lobbied in 2013 to limit reductions in sentences for marijuana offenses.

On July 15, 2016, Republican Presidential candidate Donald Trump announced on Twitter that he had selected Pence as his Vice Presidential running mate in the 2016 Presidential election.

But for all of Pence’s actions as Congressman and Governor, the one which may prove the most far-reaching may be this: His signing into law the Religious Freedom Restoration Act.

As Governor of Indiana, he did this on March 26, 2015. The law allows any individual or corporation to cite its religious beliefs as a defense when sued by a private party.

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Mike Pence

Officially, its intent is to prevent the government from forcing business owners to act in ways contrary to strongly held religious beliefs. Unofficially, its purpose is to appease the hatred of gays and lesbians by the religious Right, a key constituency of the Republican party.

Thus, a bakery can legally refuse to make a cake for a gay wedding or a restaurant can refuse to serve lesbian patrons.

And a hospital can refuse to provide care to a gay or lesbian patient. 

The bill was passed overwhelmingly by both chambers of the Republican-controlled state legislature.  

“Today I signed the Religious Freedom Restoration Act, because I support the freedom of religion for every Hoosier of every faith,” Pence said in a statement on the day he signed the bill.

“The Constitution of the United States and the Indiana Constitution both provide strong recognition of the freedom of religion but today, many people of faith feel their religious liberty is under attack by government action.”

Yet for all his praise for the bill, Pence signed it in a ceremony closed to the public and the press. The media were asked to leave even the waiting area of the governor’s office.

At least one unintended consequence of that legislation has already surfaced: The First Church of Cannabis.

The day after Pence signed the Act, church founder Bill Levin announced on his Facebook page that he had filed paperwork with the office of the Indiana Secretary of State.

Its registration had been approved—and Levin was ecstatic: “Now we begin to accomplish our goals of Love, Understanding, and Good Health.

“Donate $100 or more and become a GREEN ANGEL. Donate $500 or more and become a GOLD ANGEL. Donate $1000 or more and become a CHURCH POOHBA.”

This legislation has not only brought legal marijuana to Indiana. It may bring Sharia law as well.

Since 9/11, Right-wingers such as Rush Limbaugh and Sean Hannity have warned that Muslims are trying to impose Sharia (Islamic law) on America. And now Indiana’s legislators, in elevating religion above the law, may have laid the legal foundations for making that possible.

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Muslims demanding the imposition of Sharia law–on themselves and non-Muslims

What will happen when: 

  • Muslims in Indiana claim their right—guaranteed in Islamic religious law—to have as many as four wives?  
  • Muslims demand a taxpayer-funded “halal” non-pork food shelf at free food pantries for the poor? (Exactly this happened among Somali refugees in Minnesota in 2015.) 
  • Muslims demand that police departments cancel counter-terrorism courses by claiming that their materials are anti-Muslim? (Exactly this happened to several police departments in Illinois.)

And when they claim that the Religious Freedom Restoration Act protects those rights? 

Now that Pence is Coronizavirus Czar, it’s essential to remember:

  • In 2001, when he ran for Congress, he posted on his campaign website: “Despite the hysteria from the political class and the media, smoking doesn’t kill.”
  • As a Congressman, Pence voted against legislation allowing the Food and Drug Administration to regulate the tobacco industry.
  • During a CNN panel in 2002 about abstinence education, Pence said: “Frankly, condoms are a very, very poor protection against sexually transmitted diseases.”
  • In 2015, Indiana had an unprecedented HIV outbreak. Although the Centers for Disease Control recommended clean needle exchanges, Pence, as governor, opposed this.

As the Coronavirus threatens to overwhelm the United States as it has Italy, the appointment of Mike Pence as America’s Dr. Marcus Welby is not an event to celebrate.

UP IN SMOKE: YOUR HEALTH

In Bureaucracy, Business, History, Law, Law Enforcement, Politics, Social commentary on September 12, 2019 at 12:07 am

Earlier this year, San Francisco City Attorney Dennis Herrera and Supervisor Shamann Walton co-authored a measure to ban the sale of e-cigarettes in the city until their safety had been reviewed by the Food and Drug Administration.

No e-cigarettes on the market have gone through such a review.

The San Francisco Board of Supervisors passed the measure in June—making San Francisco the first city in the country to prohibit the sale of e-cigarettes. 

It’s slated to go into effect in January, 2020. 

Now vaping company Juul Labs, Inc., is sponsoring Proposition C to overturn the ban.  

This would allow e-cigarettes to be sold in San Francisco with new regulations, which would

  • Cap the number of e-cigarette devices and nicotine cartridges a customer could buy in a single transaction; and
  • Require online sellers that ship to San Francisco residents to apply for a new permit.

The measure was written by The Coalition for Reasonable Vaping Regulation—which is financed by Juul.

So far, Juul has spent $4.3 million to promote the measure—more than has been spent on any other ballot measure this year.

Flyers promoting “Yes on C” have been plastered on apartment doors and taped to telephone poles. The airwaves are filled with similar ads promoting vaping as a “healthier alternative” to tobacco.

Aerosol (vapor) exhaled by an e-cigarette user using a nicotine-free e-cigarette.

Alexander Russy [CC BY 2.0 (https://creativecommons.org/licenses/by/2.0)%5D

In San Francisco, 15.4% of its inhabitants identify as LGBT. So Juul is promoting vaping as a healthier alternative for a population with higher-than-average smoking rates.

The company’s website boasts: “JUUL Labs was founded by former smokers, James and Adam, with the goal of improving the lives of the world’s one billion adult smokers by eliminating cigarettes.

“We envision a world where fewer people use cigarettes, and where people who smoke cigarettes have the tools to reduce or eliminate their consumption entirely, should they so desire.”

According to the Campaign for Tobacco-Free Kids:

  • Introduced in 2015, Juul e-cigarettes have skyrocketed in popularity among youth across the United States.
  • Public health officials have labeled their use “a youth e-cigarette epidemic.”
  • In 2018, e-cigarette use among high school students rose by 78%.
  • More than 3.6 million middle and high school students used e-cigarettes—an increase of 1.5 million students in one year.

VaporVanity.com [CC BY 2.0 (https://creativecommons.org/licenses/by/2.0)%5D

According to the Campaign for Tobacco-Free Kids, the reasons for the popularity of Juul’s e-cigarettes include:

  • They’re “sleek, high tech and easy to hide.”
  • They look like USB flash drives and can be charged in the USB port of a computer.
  • They come in flavors that appeal to youth—such as fruit, creme, mint, mango, menthol and cucumber.
  • They deliver nicotine more effectively and at higher doses than other e-cigarettes.
  • Although Juul claims that each “pod” (cartridge of nicotine liquid) contains as much nicotine as a pack of cigarettes, many teens don’t know they’re using a tobacco product.

Juul sales have grown dramatically and now comprise over 70% of the U.S. e-cigarette market.

But Juul faces a potentially devastating crisis: The Centers for Disease Control (CDC) and Prevention warned on September 6 that Americans should not smoke e-cigarettes.

The reason: Hundreds of people have become sick and at least six people have died from lung disease related to vaping.

Serious adverse effects of vaping include corneoscleral lacerations or ocular burns or death after e-cigarette explosion. Less serious adverse effects of vaping include eye irritation, blurry vision, dizziness, headache, throat irritation, coughing, increased airway resistance, chest pain, increased blood pressure, increased heart rate, nausea, vomiting, and abdominal pain.

According to a news story on the September 6 edition of the PBS Newshour:

“As many as 450 people, including 215 cases formally reported to the CDC, in 33 states have reported possible pulmonary disease after using e-cigarette devices, liquids, refill pods and cartridges.”  

“Symptoms of this pulmonary disease include shortness of breath, fatigue, fever and nausea or vomiting.” 

“While this investigation is ongoing, people should not use e-cigarette products,” said Dana Meaney-Delman, who oversees the CDC investigation. 

The Annals of Internal Medicine report that at least 10.8 million adults are estimated to use e-cigarette products in the United States.

Of those, 15% said they had never smoked cigarettes. 

Many chemicals and additives are present in e-cigarettes. And medical professionals don’t know what chemicals, or combinations of chemicals, could lead people to sicken and/or die.

The office of the U.S. Surgeon General warns: Besides nicotine, e-cigarettes can contain such harmful ingredients as:

  • Ultrafine particles that can be inhaled deep into the lungs;
  • Volatile organic compounds;
  • Heavy metals, such as nickel, tin and lead;
  • Flavorants such as diacetyl, a chemical linked to serious lung disease.

And while Juul touts its product as a safe alternative for those who want to quit smoking, the advice offered by the CDC is totally different: “Adult smokers who are attempting to quit should use evidence-based smoking cessation treatments, including counseling and FDA-approved medications.”

Many critics of the San Francisco moratorium have argued: “Even if people can’t get e-cigarettes legally, they’ll get them illegally. Or they’ll buy them in bay Area cities that don’t ban them.”

And that is true.

As with any banned product for which there is big demand, legions of suppliers—legal or illegal—will happily keep them supplied.

At best, cities, states and the Federal Government will pass laws regulating where e-cigarettes can be smoked.

Meanwhile, those who want to risk their health inhaling—and exhaling—poisonous vapors will do so. They cannot be stopped—except when their bodies give out.

Which, for legions of e-cigarette smokers, is now starting to happen.

THE QUEEN OF GREED

In Bureaucracy, Business, History, Law, Politics, Social commentary on November 27, 2015 at 11:55 am

“Thirty years after her death, Ayn Rand’s ideas have never been more important.

“Unfettered capitalism, unregulated business, bare-bones government providing no social services, glorification of selfishness, disdain for Judeo-Christian morality—these are the tenets of Rand’s harsh philosophy.”

So reads the jacket blurb for Ayn Rand Nation: The Struggle for America’s Soul, by Gary Weiss.

“The timing of this book couldn’t be better for Americans who are trying to understand where in the hell the far-out right’s anti-worker, anti-egalitarian extremism is coming from,” asserts Jim Hightower, New York Times bestselling author of Thieves in High Places.

Ayn Rand Nation introduces us to the godmother of such Tea Party craziness as destroying Social Security and eliminating Wall Street regulation. Weiss writes with perception and wit.”

For those who believe that Rand’s philosophy is the remedy for America’s economic and social ills, a 2013 60 Minutes news story sounds a warning.

New England Compounding Center (NECC) pharmacy, based in Framington, Massachusetts, is under criminal investigation.  The reason: Shipping, in the fall of 2012, 17,000 vials of a steroid to be injected into the joints or spines of patients suffering chronic pain.

But instead of relieving pain, this steroid–contaminated with fungal meningitis–brought only agony and death.

The vials went out to thousands of pharmacies scattered across 23 states.

Forty-eight people have died, and 720 are still fighting horrific infections caused by the drug.

Just as Ayn Rand would have wanted, the pharmacy managed to avoid supervision by the Food and Drug Administration (FDA).

NECC was one of thousands of pharmacies that Congress exempted from FDA oversight. The reason: By law, they are allowed to make custom drugs for just one patient at a time.

But within a few years, NECC went national–and vastly expanded the quantities of drugs produced.

“The underlying factor is that the company got greedy and overextended and we got sloppy, and something happened,” John Connolly, a lab technician for the company, told 60 Minutes, the CBS news magazine.

And, also as Rand would have wanted, the four family members who founded the pharmacy were enriched by it–receiving over $16 million in wages and profits, from December 2011 through November 2012.

Bankruptcy records show the family members racked up $90,000 on corporate American Express credit cards, including charges made after the company shut down in early October.

A month before the first steroid death, Connolly says he warned his supervisor: “Something’s gonna happen, something’s gonna get missed and we’re gonna get shut down.”

His supervisor just shrugged.

NECC was shut down by the authorities.  Barry Cadden, the president and lead pharmacist of the company, was subpoenaed by Congress to testify.  In true gangster fashion, he pleaded the Fifth.

He claimed he didn’t know how the contamination started.

In May, 2015, a federal bankruptcy judge approved the establishment of a $200 million compensation fund for victims of the meningitis outbreak.

This would have outraged Ayn Rand, who believed that greed was sacred–and should not be punished, whatever its consequences.

Which brings us back to Ayn Rand Nation.

Among the themes explored in Weiss’ book:

  • Atlas Shrugged–Rand’s 1957 novel–depicts a United States where many of society’s most productive citizens refuse to be exploited by increasing taxation and government regulations and go on strike. The refusal evokes the imagery of what would happen if the mythological Atlas refused to continue to hold up the world.  The novel continues to influence those who aren’t hard-core Rand followers, who are known as Objectivists.
  • Ayn Rand’s novels dramatically affirm such bedrock American values as independence, creativity, self-reliance, and above all, a permanent distrust of government.
  • In Rand’s 1936 novel, We the Living–set in Soviet Russia–her heroine, Kira Argounova, tells a Communist: “I loathe your ideals; I admire your methods.” Objectivists believe in defending capitalism with the same ruthless methods of Communists.
  • In Rand’s ideal world, government would control only police, armies and law courts.  To her, a   government which performs more than these three functions is not simply impractical or expensive: it is evil.

Many of those who embrace Rand substitute rage for logic: Tea Partiers are furious about the 2008 Wall Street crash, yet they blame the government for it.

(Ironically, in a way, they are right: The government can be blamed–but not for too much regulation of greed-fueled capitalists but too little.)

Weiss asserts that Tea Party members resent the social and economic realities facing the nation, but lack a coherent intellectual framework to help them focus and justify their rage.  But Objectivists have–and offer–such a framework.

Thus, Tea Partiers form the ideological part of the right wing, and the clarity–and fanaticism–of their views gives them a power far out of proportion to their numbers.

Weiss believes that Rand is presenting a moral argument for laissez-faire capitalism, which means eliminating  Social Security, Medicare, public road system, fire departments, parks, building codes–and, above all, any type of financial regulation.

Weiss maintains that Rand’s moral argument must be directly confronted–and defeated–with moral arguments calling for charity and rationality.

Given the fanaticism of Tea Partiers and the right-wing Republicans they support, success in countering Rand’s “I’ve-got-mine-and-the-hell-with-everybody-else” morality is by no means assured.

GREED? THY NAME IS AYN

In Business, History, Politics, Social commentary on March 13, 2013 at 12:00 am

“Thirty years after her death, Ayn Rand’s ideas have never been more important.

“Unfettered capitalism, unregulated business, bare-bones government providing no social services, glorification of selfishness, disdain for Judeo-Christian morality—these are the tenets of Rand’s harsh philosophy.”

So reads the jacket blurb for Ayn Rand Nation: The Struggle for America’s Soul, by Gary Weiss.

Related image

“The timing of this book couldn’t be better for Americans who are trying to understand where in the hell the far-out right’s anti-worker, anti-egalitarian extremism is coming from,” asserts Jim Hightower, New York Times bestselling author of Thieves in High Places.

Ayn Rand Nation introduces us to the godmother of such Tea Party craziness as destroying Social Security and eliminating Wall Street regulation. Weiss writes with perception and wit.”

For those who believe that Rand’s philosophy is the remedy for America’s economic and social ills, a 60 Minutes news story sounds a warning.

New England Compounding Center (NECC) pharmacy, based in Framington, Massachusetts, is under criminal investigation.  The reason: Shipping, in the fall of 2012, 17,000 vials of a steroid to be injected into the joints or spines of patients suffering chronic pain.

But instead of relieving pain, this steroid–contaminated with fungal meningitis–brought only agony and death.

The vials went out to thousands of pharmacies scattered across 23 states.

Forty-eight people have died, and 720 are still fighting horrific infections caused by the drug.

Just as Ayn Rand would have wanted, the pharmacy managed to avoid supervision by the Food and Drug Administration (FDA).

NECC was one of thousands of pharmacies that Congress exempted from FDA oversight. The reason: By law, they are allowed to make custom drugs for just one patient at a time.

But within a few years, NECC went national–and vastly expanded the quantities of drugs produced.

“The underlying factor is that the company got greedy and overextended and we got sloppy, and something happened,” John Connolly, a lab technician for the company, told 60 Minutes, the CBS news magazine.

And, also as Rand would have wanted, the four family members who founded the pharmacy were enriched by it–receiving over $16 million in wages and profits, from December 2011 through November 2012.

Related image

Bankruptcy records show the family members racked up $90,000 on corporate American Express credit cards, including charges made after the company shut down in early October.

A month before the first steroid death, Connolly says he warned his supervisor: “Something’s gonna happen, something’s gonna get missed and we’re gonna get shut down.”

His supervisor just shrugged.

NECC was shut down by the authorities.  Barry Cadden, the president and lead pharmacist of the company, was subpoenaed by Congress to testify.  In true gangster fashion, he pleaded the Fifth.

He claims he doesn’t know how the contamination started.

Which brings us back to Ayn Rand–and, more specifically, Ayn Rand Nation.

Among the themes explored in Weiss’ book:

  • Atlas Shrugged–Rand’s 1957 novel–depicts a United States where many of society’s most productive citizens refuse to be exploited by increasing taxation and government regulations and go on strike. The refusal evokes the imagery of what would happen if the mythological Atlas refused to continue to hold up the world.  The novel continues to influence those who aren’t hard-core Rand followers, who are known as Objectivists.
  • Ayn Rand’s novels dramatically affirm such bedrock American values as independence, creativity, self-reliance, and above all, a permanent distrust of government.
  • In Rand’s 1936 novel, We the Living–set in Soviet Russia–her heroine, Kira Argounova, tells a Communist: “I loathe your ideals; I admire your methods.” Objectivists believe in defending capitalism with the same ruthless methods of Communists.
  • In Rand’s ideal world, government would control only police, armies and law courts.  To her, a   government which performs more than these three functions is not simply impractical or expensive: it is evil.

Many of those who embrace Rand substitute rage for logic: Tea Partiers are furious about the 2008 Wall Street crash, yet they blame the government for it.

(Ironically, in a way, they are right: The government can be blamed–but not for too much regulation of greed-fueled capitalists but too little.)

Weiss asserts that Tea Party members resent the social and economic realities facing the nation, but lack a coherent intellectual framework to help them focus and justify their rage.  But Objectivists have–and offer–such a framework.

Thus, Tea Partiers form the ideological part of the right wing, and the clarity–and fanaticism–of their views gives them a power far out of proportion to their numbers.

Weiss believes that Rand is presenting a moral argument for laissez-faire capitalism, which means eliminating  Social Security, Medicare, public road system, fire departments, parks, building codes–and, above all, any type of financial regulation.

Weiss maintains that Rand’s moral argument must be directly confronted–and defeated–with moral arguments calling for charity and rationality.

Given the fanaticism of Tea Partiers and the right-wing Republicans they support, success in countering Rand’s “I’ve-got-mine-and-the-hell-with-everybody-else” morality is by no means assured.

REPUBLICANS: HANDS OFF BUSINESS, HANDS ON YOUR SEX LIFE

In Bureaucracy, Politics, Social commentary on August 29, 2012 at 12:02 pm

Want to know the true–as opposed to the official–Republican position on “smaller government”?

These two Huffington Post headlines say it all:

D.C. ABORTION BILL FAILS IN HOUSE–July 31; and

KEVIN McCARTHY: DOMA DEFENSEe IS OUR RESPONSIBILITY–August 1

Consider the first story:

On July 24, House Republicans voted on a bill, centered on Washington, D.C., that would make abortion illegal after 20 weeks of pregnancy.

“We will stand for a commitment to protect little babies that have no other people to protect them,” shouted its author, Trent Franks (R-Ariz.). “By the grace of God, we’re going to do that!”

The bill was defeated on a vote of 220 to 154.

And on August 1, House Majority Whip Kevin McCarthy (R-Calif.) said that he and his fellow Republicans had a duty to defend the so-called Defense of Marriage Act (DOMA).

DOMA is a federal law passed in 1996 that defines marriage as a union between one man and one woman.

In March 2011, Attorney General Eric Holder deemed it unconstitutional and refused to further defend it.

McCarthy, House Speaker John Boehner (R-Ohio) and House Majority Leader Eric Cantor (R-Va.) then hired outside counsel to defend the law on behalf of the House of Representatives.

So far, Republicans have spent at least $742,000 doing so.

But on July 31, they marked their fifth consecutive loss in federal court when a Connecticut judge threw out the law as unconstitutional.

It speaks volumes about the priorities of the radical right generally and the Republican party in particular.

On one hand, when it comes to causes they support, Rightists demand a hands-off” approach to government regulation.

As they see it, corporations should be allowed to

  • pollute as much as they want;
  • pay their employees as little as they want;
  • avoid paying workers compensation or unemployment;
  • pay little or no taxes;
  • churn out useless or even unsafe goods;
  • put out deceptive advertising;
  • discriminate against job-seekers and employees as much as they want.

Thus, agencies such as the Environmental Protection Agency, the Equal Employment Opportunity Commission, the Food and Drug Administration and the Internal Revenue Service should be abolished.

And since Medicare and Social Security serve an aging population that’s not made up of millionaires, Rightists want these programs shut down. Remember the roar of approval that went up at a Republican debate over the thought of an uninsured patient being left to die?

But when it comes to causes they dislike, only the most punitive government measures will do. Thus:

  • The Drug Enforcement Administration should have its budget and agent-force greatly expanded, to go after pot-smokers and pill-poppers.
  • The FBI should declare all-out war on the pornography industry.
  • Abortion should be re-criminalized–especially at the Federal level. Doctors who perform abortions and patients who get them should be executed or hauled off to lengthy prison sentences.
  • Certain forms of birth control–such as those that prevent an unfertilized egg from attaching itself to the womb–should be criminalized.
  • The right to divorce should be sharply restricted–especially for women.
  • Homosexuals should not only be forbidden to marry, but should be rounded up and shipped off to concentration camps, where they will be prevented from “contaminating” heterosexuals.

And when Rightists call for “downsizing government,” they do not include the military. How else could President George W. Bush have waged an unprovoked war against Iraq under the lie that it held “Weapons of Mass Destruction”?

When Rightists campaign for office, they ignore or downplay the inherent contradiction between these two different sets of priorities.

It’s like the story of an ancient arms-peddler who claimed to offer a spear that could penetrate any shield–and a shield that could repulse any spear.

At first, his listeners were excited. Who could resist the promise of weapons that would make their user invulnerable?

Then an old man stepped out of the assembled mob and pointed out the contradiction: Either the spear could penetrate the shield, or the shield could deflect the spear. But one of them had to prove false.

The question was: Which one?

The same holds true when Rightists campaign for office.

A current joke neatly sums up the real philosophy of the right wing movement:

Some Republicans say they’re moving to Canada because the Supreme Court upheld Obamacare.

They may not know that Canada also has socialized medicine.

So here’s another suggestion:

A country that has:

  • No universal healthcare.
  • Few entitlement programs.
  • A low, flat tax system.
  • A deep reverence for God.
  • Faith-based government.
  • Extremely strict limitations on abortion.
  • Marriage is strictly defined as a union between a man and a woman.
  • Homosexuality is a sin and punishable by death.
  • Enforcement of appropriate dress codes.
  • Tattoos and piercings are widely banned.
  • Death penalty–which they relish using.
  • Strong private school system with religious focus.
  • Widespread oil drilling.
  • Non-existant environmentalist movement.
  • Growing nuclear program.
  • Culture that promotes the family and appropriate roles for men and women.

Where, you ask, is this conservative paradise?

Is this Heaven?

Is this Nirvana?

Actually, it’s Iran.

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