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Bound by science, bent by politics: Inside the FDA's reversals and walk-backs as it grapples with the coronavirus pandemic – CNN

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The FDA had already put out a stark 1,000-word warning about the risks of hydroxychloroquine, a malaria drug some hoped would be an effective treatment for Covid-19. But this week, Trump suddenly announced he was taking the drug and falsely claimed there was no FDA warning.
Such is the life of a Food and Drug Commissioner in the Trump Era, in the year of the worst pandemic since 1918, with 1.5 million sick Americans and more than 95,000 lives lost.
Whether due to political pressure — a charge Hahn denies — or the natural burden of dealing with a global pandemic, the FDA has had to issue a number of high-profile walk-backs and revisions to its efforts to tackle Covid-19.
The agency’s initially strict regulations for diagnostic test developers were removed after complaints. Its emergency authorization for hydroxychloroquine was followed by a sharp warning about deadly side effects. It issued a pullback after letting faulty antibody tests flood the market. In April it changed its guidance to allow the use of Chinese-made KN95 masks in healthcare settings, only to reverse course in May and ban many of them. There were even issues with the FDA-authorized test the White House used to screen visitors.
“Some of the science and data aren’t perfect in emergency situations,” Hahn told CNN in an interview this week. “You make the best with the information you have at hand.”
To be sure, the coronavirus pandemic poses an unprecedented challenge to the nation’s foremost health regulator. The agency has to walk a tightrope between speed and safety, responding quickly to a fast-moving crisis yet maintaining its job of thoroughly vetting tests, drugs and devices that could save lives. The FDA, Hahn acknowledged, is adapting as more is learned about the virus.
But former FDA officials and drug safety experts worry that, in some cases, the FDA might be more devoted to placating Trump — and giving him quick wins to tout on television — than sticking to the science.
“The political engagement here is magnitudes above anything I experienced over my public health career,” said Dr. Stephen Ostroff, the FDA’s former chief scientist who twice served as acting commissioner. “You want to separate out those political dimensions so you can make data-driven decisions. It has been incredibly challenging. Some of the things that have ended up happening, like the enthusiasm for hydroxychloroquine, have been exceptionally unfortunate.”

Hydroxychloroquine rollercoaster

The tug-of-war between Trump and his public health agencies — including the FDA — has played out most publicly in the still-ongoing battle over hydroxychloroquine.
The anti-malaria drug has been on the market for decades, and was seen early on as a potential coronavirus treatment.
In March, Trump and Hahn were publicly out of sync: Trump promoted the drug and cited anecdotal success stories, while Hahn stressed the need for a “large, pragmatic clinical trial.”
According to a whistleblower complaint from Dr. Rick Bright, the former head of vaccine development at the Department of Health and Human Services, federal health officials were pressured to greenlight the widespread, unsupervised use of hydroxychloroquine to score a “short-term political victory” for Trump, even though FDA scientists weren’t satisfied by the data.
The White House, HHS and the FDA deny Bright’s allegations.
Nevertheless, the FDA granted an emergency use authorization (EUA) for the drug on March 28. This allowed a large donation from drug manufacturers to be used in the US, but only in hospitals or clinical trials — far short of what Trump wanted. While the EUA cited “anecdotal reports” that the drugs “may” work, that note of caution was often lost amid the President’s public promotions of the drug.
“It’s an impossible political situation,” one former top FDA official told CNN on the condition of anonymity. “They were fairly artful with their wording to make it clear they thought this was BS.”
Also of concern to health experts who spoke to CNN, the FDA quietly lifted bans on previously censured drugmakers in India, to hasten the flow of hydroxychloroquine and other drugs into the US. Some of these manufacturers had been flagged for repeatedly misleading the FDA about the quality of their products, with one inspection finding a “cascade of failure” as last summer.
“So, does the FDA believe these companies, that were trying to fool them in the past, suddenly became good manufacturers?” said Dinesh Thakur, a former pharmaceutical executive who became a drug safety whistleblower, leading to a $500 million settlement by his ex-company.
With the EUA in hand, Trump praised Hahn for moving quickly on hydroxychloroquine and other approvals. But within weeks, more studies came out suggesting the drug had no meaningful impact and could even lead to cardiac arrest. Finally on April 30, the FDA issued a science-heavy warning on hydroxychloroquine, stating unequivocally that the drug hasn’t been proven safe for Covid-19 patients and that it should only be used be used under direct supervision of doctors.
On Friday, The Lancet medical journal published the results of an observational study of 96,000 Covid-19 patients, which found that the drugs were linked to greater risk of often deadly heart problems. The study concluded that seriously ill patients who got Trump’s much-touted treatment plan of hydroxychloroquine combined with an antibiotic were more likely to die than people who got neither drug.
In an interview this week, Hahn defended his agency’s handling of hydroxychloroquine. He acknowledged the political climate surrounding the drug, but said, “I stand by our decisions because I think they are rooted in science and data, and we’ll continue to reevaluate.”
But some experts say it’s time for the FDA to pull the authorization.
“I just didn’t see it, and I still don’t see it,” said Ostroff, the FDA’s former chief scientist, referring to the efficacy of the drugs. “At this point, I’m not sure there remains a very strong rationale for keeping that EUA in place.”
Ostroff was one of a handful of former officials who shared this view in recent interviews, even though pulling the authorization won’t prevent doctors from prescribing the drugs off-label.
The FDA warning was a brave stand in the eyes of some Republican health experts, like former HHS Secretary Tommy Thompson, who served for four years under President George W. Bush.
“Politically, they’re getting pushed pretty hard on hydroxychloroquine, but they’re standing up and saying that it’s not a clear-cut decision,” Thompson told CNN in an interview. “You’ve got to applaud them for that. The desperation is there, but they’re saying it still needs to be discussed.”

Paging Dr. Hahn

Food and Drug Administration Commissioner Stephen Hahn testifies before the House Energy and Commerce Committee's Health Subcommittee in the Rayburn House Office Building on Capitol Hill February 26, 2020 in Washington, DC.
When China reported a cluster of unknown respiratory illnesses in December — soon to be identified as Covid-19 — Hahn had been on the job just two weeks.
His nomination had sailed through the Senate in bipartisan fashion after a hearing focused heavily on the risks of flavored e-cigarettes, the most prominent public health challenge the administration faced at the time. The word “pandemic” was mentioned only twice at the hearing.
A radiation oncologist, Hahn worked as the chief medical executive at the University of Texas MD Anderson Cancer Center before joining the FDA. He acknowledged that he has been learning on the job, both about the novel coronavirus — as all health officials are — and about the ins and outs of the FDA.
That’s included learning how to guide the agency from his home while self-quarantining for 14 days earlier this month after coming into contact with someone infected with coronavirus.
Hahn says he has continued his usual routine of waking up at 4 a.m. and doing P90X — an at-home plyometrics and resistance workout — and brushed up on his reading in Italian when he needed a few minutes to unwind.
“I’m not going to argue that I’m happy that it happened,” Hahn said of his recent move to self-quarantine, but he said it served as a reminder that Americans still face great risk from the virus.

‘Open and honest counsel’

Hahn has managed mostly to fly under the radar, even amid waves of speculation about whether Trump is on good terms with many of the medical experts around him. The President has clashed with infectious disease expert Dr. Anthony Fauci; reportedly been on the brink of firing HHS Secretary Alex Azar; or been at odds with Dr. Robert Redfield, director of the Centers for Disease Control and Prevention.
Personable and unassuming, Hahn’s style couldn’t be further from Trump’s brash showboating. Still, the two men get along well, sources tell CNN.
“He’s fantastic,” Trump said of Hahn at a March briefing. “He has been working 24 hours a day. He’s been — he’s worked like, probably as hard or harder than anybody in this — in the group, other than maybe Mike Pence or me.”
Hahn has repeatedly and publicly denied that the President has pressured him to make decisions, such as authorizing hydroxychloroquine.
“I enjoy a very good relationship with the President. He asks for and he receives my open and honest counsel,” Hahn said.
Whether the President takes that counsel to heart is another question. Just this week, Trump publicly usurped FDA guidance with his own medical wisdom when he unexpectedly announced he was taking hydroxychloroquine to prevent coronavirus, even though there’s no proof it works, and the FDA is urging Americans against this course of action.
“Doctors are free to write prescriptions for unapproved indications of approved drugs, and that includes hydroxychloroquine,” Hahn said, declining to comment on Trump’s medical decisions, citing the fact that Trump said he consulted with and is being watched by the White House physician.

The testing tightrope

A lab technician dips a sample into the Abbott Laboratories ID Now testing machine at the Detroit Health Center. A lab technician dips a sample into the Abbott Laboratories ID Now testing machine at the Detroit Health Center.
The FDA’s struggle to hit the right balance between speed and efficacy was perhaps clearest when it came to testing.
As the CDC struggled to get its coronavirus test up and running in February, the FDA was proactive in troubleshooting. The agency sent an official to visit the CDC labs in Atlanta and determined contamination at the lab was likely causing the tests to malfunction.
But in the meantime, clinical labs were sitting on the sidelines, frustrated that the FDA’s regulations made it hard for them to get tests approved. More than a month after the first known US coronavirus case, the FDA finally loosened its rules and large commercial test-makers began bringing their diagnostic tests to market, allowing the US to — belatedly — scale up testing.
Since then, the FDA has issued a warning that one of the prominent tests it authorized — the Abbott ID Now test used by the White House — sometimes falsely indicates individuals are negative for the virus. The FDA is looking into the issue. Abbott has defended its test.
When it came to antibody tests — designed to check for prior Covid-19 infection — some former FDA officials said the agency went too fast in granting approvals.
In March, the FDA announced companies could sell antibody tests without providing evidence they actually worked. Since then, some tests on the market have proven to be inaccurate or fraudulent — a serious risk since people who get a false positive result may wrongly believe they have already had the virus, and potentially developed some immunity.
In May, the FDA pulled an about-face, updating its guidance to require companies to promptly submit antibody tests for approval. It arranged for the US government to independently validate the tests available.
If the FDA regrets the initial free-for-all of allowing unproven antibody tests on the market, Hahn isn’t letting on. The agency needed to get some tests out quickly, FDA officials said, and once a dozen or so had emergency use authorizations, the FDA tightened the rules.
“One of the lessons learned here is that this real-world evidence becomes very important in urgent situations,” Hahn said. “What we have to find is the right balance so that we can ensure that the right tests are on the market.”
Scott Whitaker, president and chief executive of medical technology association AdvaMed and a former Health and Human Services official during the Bush administration, defended the FDA’s leadership on testing.
“If they had not moved quickly to get more serology tests to market, they would have been criticized for being too slow,” said Whitaker, who has worked closely with Hahn on testing and capacity issues for his group’s members. “Before this crisis, they were dealing with a normal world and a normal FDA and their job of making sure products are safe and effective before they get to market. When the world changed then they changed, as they should have.”

Politics versus science

The whiplash at the FDA is symptomatic of a larger issue. What happens when a notorious science skeptic is President during a once-in-a-century pandemic?
Long before he entered the White House, Trump made a name for himself denying climate change and linking vaccines to autism. As President, he has claimed that windmills cause cancer and even suggested that ingesting disinfectant may help treat coronavirus.
With this backdrop, it’s no surprise that Trump has repeatedly clashed with the federal health officials and agencies that are charged with following science — not polls or public pressure.
“He chooses convenience over science,” said Michael Gerrard, a Columbia Law School professor who tracks what he says are anti-science actions by the Trump administration. “What we saw with hydroxychloroquine and the FDA is all quite consistent. It’s tragically not surprising.”
In some cases, Trump has even turned to celebrity doctors for advice.
Dr. Mehmet Oz, the highly controversial TV personality, has been informally advising Trump, according to The New York Times. And Trump even summoned Hahn to the White House to listen to a pro-hydroxychloroquine presentation in April from Fox News host Laura Ingraham and two physicians who regularly appear on her program, according to the Washington Post.
Exasperated by the idea of Fox News personalities lecturing the FDA chief, the former top FDA official who spoke to CNN on the condition of anonymity said, “I would have quit on the spot.”
Hahn’s colleagues, current and former, dismiss the notion that Hahn is carrying out Trump’s bidding, describing him as honest and transparent.
“Every position comes with some political realities to it,” said Dr. Ramesh Rengan, who has known Hahn for 15 years and is chair of the radiation oncology department at the University of Washington. But, he added, “He’s never taken the easier road. He’s taken the right road.”
This is not the first White House to lean on the FDA. There were high-profile partisan fights over the approval of emergency contraception during the Bush and Obama years, and dealing with pressure, both political and from industry, comes with the job.
But some experts say Trump has gone farther than his predecessors, and that some of the recent reversals and missteps under Hahn have tarnished the agency’s hard-won reputation.
“We took 100 years to build this reputation as a science-based, impartial regulator. That’s why everyone around the world trusts the FDA,” said Thakur, the pharmaceutical whistleblower who now focuses on global drug safety issues. “I get this is an emergency, and you need to respond to the public need, but we aren’t using science.”

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Bike Share a Victim of Anti-Urban Identity Politics – Raise the Hammer

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Bike Share a Victim of Anti-Urban Identity Politics

Strategy only makes sense if we’re all trying to build on our common values and interests, and the zero-sum politics of resentment are antithetical to common values.

By Ryan McGreal
Published May 28, 2020

With 1,000 bikes, 26,000 active members and 350,000 passenger trips a year, Hamilton Bike Share is a bargain at a gross annual operating cost of $700,000. But Hamilton City Council cannot resist the atavistic urge to put identity politics ahead of strategic planning.


Hamilton Bike Share hub at Chedoke Golf Course

After yet another ultramarathon session of ocean-boiling hyperbolic bikeshedding over a project with utterly miniscule costs – we are talking, after all, about 0.02 percent of the city’s annual budget – Council deadlocked on whether to fund the continued operation of Hamilton Bike Share for the rest of the year.

Instead, Councillors voted to spend an unknown amount of money to warehouse the bikes once the system shuts down on June 1. Amazingly, the motion by Ward 3 Councillor Nrinder Nann would have funded the system using money already earmarked for local spending in wards 1, 2 and 3.

That is to say, the councillors opposed to this motion voted to overrule the wards 1-3 councillors spending money from their own dedicated ward capital reserves to keep the program running.

This is a gross double standard and the kind of anti-urban hypocrisy that has been drearily common over the past two decades since amalgamation.

Legacy of Anti-Urban Resentment

The most vocal anti-urban sentiment has been from angry suburban leaders who never wanted to get bolted onto Hamilton through amalgamation (but were happy to have Hamilton subsidize their infrastructure through regional government, of course).

But amalgamation – which was imposed on all of us by the Conservative Mike Harris government – has left the old city subject to the one-way whims and caprices of anti-urban resentment and grievance, which suburban councillors openly embody and shamelessly encourage to this day.

The framing of every issue in us-vs-them terms is deliberate and debilitating for a city trying to build common ground and move forward.

In the face of such grievance-based identity politics, strategic plans don’t matter. Strategy only makes sense if we’re all trying to build on our common values and interests, and the zero-sum politics of resentment are antithetical to common values.

Likewise, the facts don’t matter. This decision isn’t about making the most cost-effective use of scarce resources, it’s about driving a wedge into the body politic and pandering for rhetorical points against the ‘other’, no matter the actual cost.

Nor is consistency a factor. Many of the councillors complaining that bike share doesn’t serve their wards are the same councillors who only agreed to allow it in the first place as long as it didn’t go in their wards.

Stubborn Refusal to Learn and Grow

Facts and arguments need to take root in a worldview to influence our decisions. The angry, anti-urban worldview that drives Hamilton’s identity politics is stony ground indeed. It is the place where so many transformative ideas go to die.

Anti-urban resentment is a failing strategy for Hamilton as a whole, but it works well for the cynical politicians who stoke it. Keeping their constituents misinformed and bitter keeps them employed even as it harms the city as a whole – including their constituents, who deserve better.

On the rare occasion where an inclusive urban project actually goes ahead and is successful, that just makes the aggrieved anti-urban haters even more bitter and resentful. It certainly doesn’t inspire them to reconsider their opposition to it.

For example, how many lower-city one-way dead zones do we need to convert into vibrant two-way people places before the haters finally acknowledge that city streets work better when they are more inclusive?

How many new protected two-way cycle tracks have to fill up with cyclists before we are willing to acknowledge that there is a huge latent demand for safe cycling infrastructure?

Identity Politics Trumps Strategy

Bike Share was widely (by the haters) expected to be a total failure. Instead, pound for pound it has been one of the most successful systems in North America: built and operated on a shoestring budget, it achieved 26,000 active members and 350,000 trips a year.

Far from mollifying the critics, its success just made them hate it even more. Bike Share has had a target on its back since the day it launched.

How do you reason with bad faith? How do you negotiate with malice? How do you build on a foundation of cynicism, grievance and deliberate misinformation? After close to two decades of caring about what happens in this city, I am no closer to a workable answer now than I was in 2003.

This city is broken. I have no idea how we can fix it. But until we do, every new project faces a hurricane of resistance, every existing project lives in existential jeopardy and each tiny step we take upward is on a slurry of unstable land that is itself inexorably sliding backwards.

Ryan McGreal, the editor of Raise the Hammer, lives in Hamilton with his family and works as a programmer, writer and consultant. Ryan volunteers with Hamilton Light Rail, a citizen group dedicated to bringing light rail transit to Hamilton. Ryan wrote a city affairs column in Hamilton Magazine, and several of his articles have been published in the Hamilton Spectator. His articles have also been published in The Walrus, HuffPost and Behind the Numbers. He maintains a personal website, has been known to share passing thoughts on Twitter and Facebook, and posts the occasional cat photo on Instagram.

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Liberals' ability to avoid Parliamentary scrutiny plays into system of 'image politics,' critics say – National Post

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OTTAWA — The Liberal government has avoided months of parliamentary scrutiny during the COVID-19 pandemic, instead using televised daily briefings with the prime minister to further its system of “image politics,” an expert in democratic process says.

The Liberals and New Democratic Party agreed earlier this week to suspend parliamentary proceedings until September 21, equipping Prime Minister Justin Trudeau with a “tremendous amount of power over the summer,” said Kathy Brock, professor at Queen’s University.

The decision comes after Trudeau has for months appeared in the House of Commons on a limited basis, instead using his daily briefings outside Rideau Cottage to announce major new spending measures and take questions from the media.

He for sure prefers the Rideau Cottage model

“This government is very focused on messaging and image politics and that meant that it wanted to respond to the needs of Canadians when the pandemic came up,” said Brock, who has served in various advisory roles to all three major political parties over the last 30 years.

“But when they started to face criticism for not acting as quickly as possible, the prime minister turned to the easiest tool, which is having briefings with the media outside Rideau Cottage,” she said.

The approach has been met with criticism by opposition parties and parliamentary experts, who say politicians have not had adequate time to press the Trudeau government on some of its largest spending measures, which now top an estimated $150 billion. They also say the government overreached in an earlier attempt to equip itself with the authority to tax, spend and loan money with almost no parliamentary oversight for nearly two years, well beyond the expected timeframe of the pandemic.

Other observers point out that Parliament would typically rise for the summer months regardless, and that “hybrid” forms of Question Period, which include virtual questions and answer sessions, have continued for the past few months.

“The cut-off in June is not an aberration,” said Lori Turnbull, professor of political science at Dalhousie University. However, she questioned “why there’s such a desire” to close off access to other forms of scrutiny, like private members bills or written questions to Parliament.

Turnbull, like others, has been surprised by the Liberals’ ability to secure the support of opposition parties to restrict in-person sittings of Commons.

“Sometimes I forget that this is a minority government,” she said, “It’s incredible what this government has done. We usually see more push and pull between the opposition and the government.”

The NDP has faced criticism for making an agreement with the Liberal party to suspend Parliament because it allows for the government to sidestep proper scrutiny.

NDP House leader Peter Julian pushed back against those claims in an interview Thursday, saying the deal secured four sitting days in the House of Commons during the summer — a provision that other parties were not pushing for.

“There’s been a lot of exaggeration,” Julian said.

Sometimes I forget that this is a minority government

The NDP opposed a Conservative proposal that would have had regular in-person sittings in the Commons well into June, in which a select group of roughly 50 people would attend in order to maintain social distancing measures. The proposal would have allowed Parliament to exert its full powers before summer break, but Julian argued it would have needlessly excluded the majority of MPs in Canada.

“I think it’s a very Ottawa-centric interpretation,” he said.

A spokesperson for Liberal House leader Pablo Rodriguez reiterated that all parties agreed to the March 13 motion to suspend Parliament until April 20. The agreement with the NDP allows for the continuation of a special COVID-19 committee that meets several times a week, but is not afforded the regular powers of the House.

“We believe it is a responsible plan that ensures accountability and transparency, and respects public health advice,” the spokesperson said in a written statement.

Candice Bergen, Conservative House leader, said there has been a push for months by the Liberal government to avoid regular parliamentary sittings. MPs in recent weeks had been sitting in-person on a limited basis once a week.


Conservative House leader Candice Bergen.

Sean Kilpatrick/The Canadian Press/File

“I was clear with Pablo that we felt Parliament needed to resume,” Bergen said. “But that was clearly not what the government wanted and they found a dance partner in the NDP.”

She said Trudeau has instead opted to convey the Liberals approach to COVID-19 through the televised briefings at his official residence, where media ask daily questions.

“He for sure prefers the Rideau Cottage model,” Bergen said, adding that media “is not a substitute for the official Opposition.”

Brock, at Queen’s University, said the Rideau Cottage meetings give Trudeau more time to craft his own message on a daily basis, unimpeded, while taking only a select number of questions from journalists.

“It certainly operates in the Liberals’ favour, because they’re receiving media attention and it seems very positive because they’re responding to a crisis,” she said. “But it means that they aren’t getting tough questions to the same extent on other, lesser known files.”

• Email: jsnyder@postmedia.com | Twitter:

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Keep Politics Out of Reopening Houses of Worship – The New York Times

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Credit…Chris Delmas/AFP via Getty Images

To the Editor:

Re “Firing Salvo in Culture Wars, Trump Wants Churches Open” (front page, May 23):

Last Friday was not the first time we have witnessed a politician attempting to ingratiate himself with faith communities. Through the years, leaders from both major political parties have sought the support of houses of worship in their electoral campaigns.

Certainly those of us who devote our lives to religious leadership would like to consider our work “essential.” And we eagerly await the day when we can welcome our congregants back to their spiritual homes. While we can pray to God anywhere at any time alone or with others, and while the internet has provided a viable and meaningful vehicle for gathering our members in this time of physical distancing, nothing could ever replace the power of in-person congregational worship.

But religious communities must not become political pawns for a president seeking to placate his evangelical base. In Judaism, the saving of life supersedes all other religious responsibilities. The decision whether or not to reopen houses of worship belongs in the hands of local authorities alone, guided by health concerns, not political ones.

Joshua M. Davidson
New York
The writer is the senior rabbi at Temple Emanu-El.

To the Editor:

The cynicism of President Trump’s call to governors to open the churches is staggering. I am a Catholic who attends Mass every day. I have always loved the ritual of the Mass, and I rejoice and celebrate as I gather with friends old and new who enrich my life. I will return joyfully to my church when our governor deems it safe to do so, not when it is politically expedient for our president.

John T. Dillon
West Caldwell, N.J.

To the Editor:

President Trump asks all governors to immediately open up churches and allow in-person worship — without testing. Yet everyone who meets with Mr. Trump must first be tested.

So, what’s good for the gander ain’t good for the goose. If he truly believes that in-person worship is safe, let’s see him go to these churches (or restaurants or theaters) without testing — and let’s see him mingle with the folks not wearing masks.

Marc R. Stanley
Dallas

Credit…From left: Zack DeZon for The New York Times; Andrew Seng for The New York Times

To the Editor:

Re “The Star of the City Sells Itself,” by Michael Kimmelman (Critic’s Notebook, Arts pages, May 7):

OK, the Brooklyn Bridge is wholly in New York City and joins two of its boroughs. And it was something of an engineering achievement. Book after book has been written about it; it appears in a wealth of movies.

But the great bridge in the New York area is the George Washington.

When I sought to read a book on the George, I discovered that there were none. Participating in a symposium at Columbia University on American icons, and listening to others drone on about the Brooklyn, I asked “What about the George?” There was complete silence. Then one participant said, to almost universal laughter, “But look where it goes,” the suggestion being that since the George crosses to New Jersey, it couldn’t possibly be important.

The George is also the gateway to Interstate 80, on which one may travel in a straight line to San Francisco. New Yorkers think of themselves as sophisticated compared with New Jerseyans, but they can often be decidedly parochial.

Michael Aaron Rockland
Morristown, N.J.
The writer is the author of “The George Washington Bridge: Poetry in Steel” and a professor of American studies at Rutgers.

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