Politics

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

Published

2 years ago

May 22, 2020

Harry Miller

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.

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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Politics

CNN Poll: Most Americans are concerned about the US and 'burned out' on politics – CNN

Published

45 mins ago

May 17, 2022

Harry Miller

(CNN)Americans across political lines are united in their generally negative feelings about the US and its politics, according to a new CNN Poll conducted by SSRS, with Democrats particularly unlikely to express political enthusiasm.

Just 14% of Americans say they’re either excited (4%) or optimistic (10%) about the way things are going in the country, with 65% calling themselves concerned and another 21% saying they’re scared. Only about one-quarter, 23%, call themselves “fired up” about politics, with 53% describing themselves as burned out. And roughly one-third, 32%, say they feel their side is currently losing more than winning in politics, with just 9% feeling that they’re mostly on the winning side.

Democrats are modestly more positive than Republicans on the state of the country: 19% of Democrats describe themselves as optimistic or excited, compared with only 9% of Republicans who say the same. But Democrats are less likely to feel fired up than Republicans (25% vs. 33%) and more likely to say their side is losing (43% vs. 31%).

There are ideological divides as well, with liberals 16 percentage points likelier than conservatives to say they’re mostly losing and 10 points likelier to described themselves as burnt out by politics. And fears for the state of the country also correspond to political engagement: 33% of those who are scared about the US describe themselves as fired up about politics. By contrast, just 19% of those who say they’re concerned also describe themselves as fired up, and that number is just 13% who say they’re optimistic.

The economy continues to be at the forefront of most Americans’ minds. A 59% majority say economic issues are the most important issue to the country, compared with 30% who are more concerned with domestic and social issues, 3% who are most focused on foreign policy, and 7% saying another issue is their top concern.

While economic concerns dominate across party lines, they’re most pronounced within the GOP. Three-quarters of Republicans say that economic issues are the most important, compared to a more modest 54% among independents and 50% among Democrats. Significant minorities of Democrats (43%) and independents (30%) are more focused on social or domestic issues, while just 19% of Republicans say the same. There’s an ideological divide here as well: Among conservatives, 70% say economic issues are most important and just 21% say that social and domestic issues are; among liberals, a narrow majority call social and domestic issues their top concern (51%) with 41% choosing economic issues. Few across party or ideological lines care most about foreign policy.

Among the full public, the survey finds, Republicans hold a narrow edge in trust to handle the types of issues Americans say they care most about. By a 5-point margin, 35% to 30%, Americans say they trust the Republican Party more than the Democratic Party to handle such issues. More than one-third, 35%, trust neither party.

Those who prioritize economic issues — a heavily Republican-leaning bloc — give the GOP a 24-point lead, 46% to 22%, to handle those issues. Those who prioritize social and domestic issues — a bloc of mostly Democratic-aligned Americans — favor the Democratic Party by a 30-point margin, 49% to 19%.

Around 8 in 10 partisans on both sides trust their own party, while two-thirds of independents say they don’t have faith in either party to handle the country’s biggest issues.

The CNN poll was conducted by SSRS on May 12 and 13 among a random national sample of 1,000 adults surveyed by text message after being recruited using probability-based methods. Results for the full sample have a margin of sampling error of plus or minus 4 percentage points. It is larger for subgroups.

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In defense of office politics – Smartbrief

Published

13 hours ago

May 17, 2022

Harry Miller

(Image credit: Pexels)

“Office politics” often gets a bad rap. It’s thought of as the domain of catty gossip, shady backroom deals or sycophantic compliments reminiscent of the movies “Office Space” or “9 to 5.”

Thankfully, in real-life, office politics is often much tamer — and also unavoidable for anyone with the ambition to advance.

Why? Because, at its core, office politics is about relationships with colleagues and decision-makers. And nurturing those relationships can go a long way toward advancing your career goals.

What is office politics?

While politics is often derided as purely a popularity contest, there are actually two components — being popular and getting things done.

Let’s think about “real” politics for a moment. You can be very good at getting things done, but if you’re unpopular, you’re not going to be elected in the first place. On the other hand, if you get elected because you’re popular, but fail to accomplish anything, you’ll probably find yourself voted out in the next election.

In office politics, exactly as in “real” politics, you can often get small things done without the support of others. But the more impactful your goals, the more you need to get other people on board to make them happen.

Liked + Trusted + Respected = Influence

To have influence, colleagues need to like you, trust you and respect you.

If you’re not liked, well, that’s pretty much curtains for influencing decisions, unless you’re already the boss. It’s worth noting that to be liked, you must first be known.

If you’re liked, but not respected, you might be involved the discussion, but your view won’t carry any weight. We could call this “Charlie Brown syndrome” after the classic Peanuts character.

If you’re respected but not trusted (think of a well-qualified politician whose agenda you dislike), you may be consulted on an issue but colleagues may have misgivings about your motives.

To influence behavior and decisions in the office requires all three. Liked + Trusted + Respected = Influence.

Can office politics drive value?

Everything we do at CareerPoint is based on our philosophy that career success is driven by the value you create for your employer.

We talk about value creation by referencing eight drivers of value. You could think of these as the atomic elements of employee value. It’s a framework you could use to analyze almost anything in relation to HR or career advancement. Why? Because anything that affects your value as an employee influences both the success of your career and the success of your company.

What we know as “office politics” touches on several of these value drivers, but let’s focus on just two: Relationships and positioning.

Nurturing relationships

Of all the categories of relationships that drive value for a company, none are more significant than customer relationships. If customers like, respect and trust you, they are more likely to highly value your services, keep buying them and recommend them to others. They’re also likely to be patient with you when things go awry, as things inevitably do.

The value of customer relationships can be tremendous and long-lasting. In a law firm, a single relationship can be worth tens of millions of dollars. Relationships are so important that when a partner moves from one firm to another, they often take the relationships with them. In fact, it’s hard to think of an industry where good customer relationships can’t move the dial on company success.

This means good customer relationships are a source of influence for employees. If customers highly regard you, the business won’t want to lose you and ought to value your opinion. If, on the other hand, no customer would notice or care if you left, your influence on decisions and events will be more limited.

Positioning yourself for advancement

The value driver most closely aligned with office politics is the one we’ve named Positioning. It’s all about navigating office politics to position yourself for advancement. After all, you could be the hardest working and most valuable employee in the business but fail to secure advancement if you don’t understand the politics.

The best way to think about this is to imagine a meeting of your company’s management team. Your potential promotion is being discussed. What do you want everyone to say and do?

Obviously, you want everyone to say that you are the best choice for the role. But will they?

There’s nothing you can do at this moment. It’s too late to influence any further.

In some ways, the discussion is a culmination of everything you’ve said and done since you’ve joined the company. The decision will be made largely on how the participants feel about you and the idea of you in a new, more influential role.

This is no idle abstraction. This is exactly how most advancement decisions are made. If you want to advance, the advocacy of every person around the table is what you’re solving for in the game of office politics.

5 tips for becoming an effective office politician

Here are five quick tips you can use to help build trust, respect and likeability in your workplace.

Get involved with projects and initiatives outside of your team and department whenever possible. This will help you begin to widen your network.
Avoid overusing email with new connections. It’s impossible to establish a relationship over email. Use the phone or arrange a quick Zoom/Teams/Webex meeting.
Aim to impress every single new person you work with, both inside and outside the organization. First impressions count and impressing people is often easier than you think. Just be reliable, responsive and helpful. Do things faster or better than they expect.
You don’t build influence by being a weathervane who simply goes along with everything, but you don’t build influence by opposing everything, either. The middle course is to articulate your position clearly, call the pros and cons as you see them, accept that others will see it differently and get on board with decisions you don’t agree with.
Do favors for people when it helps them without expecting anything in return. If you are generous by nature, you will build a network of influence and appreciation, and you’ll be seen as a team player. This network will help you get things done down the line.

Remember, no matter how much you hate it, office politics is a part of office life we all have to contend with. Instead of avoiding it, put your best foot forward, take smart risks, make mistakes, and learn from them.

To find out how CareerPoint can help you and your team navigate office politics and create the win/win relationships you need to succeed, visit CareerPoint’s website today.

Originally from the west coast of Scotland, Steve McIntosh is a recovering accountant (ICAEW), HR professional (GPHR) and MBA (University of Oxford). After starting his career with global accounting firm KPMG in 1998, Steve founded offshore financial services recruitment firm CML in 2004, which he led as CEO for 16 years.

In 2020, he founded CareerPoint.com, the virtual coaching platform that helps companies and their people get ahead of the curve. With customers and coaches in more than 30 countries around the world, CareerPoint is well on its way to achieving its twofold mission to help a million young people advance in their careers and level the playing field for underrepresented groups.

McIntosh is a “zealous convert” to the value of HR as a driver of business value and the author of “The Employee Value Curve: the unifying theory of HR and career advancement helping companies and their people succeed together.“

If you liked this article, sign up for SmartBrief’s free email newsletters on HR and leadership. They’re among SmartBrief’s more than 250 industry-focused newsletters.

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Czechc Republic: President grants 103 citizens permission to join the Ukrainian military

Published

1 day ago

May 16, 2022

Daniel Itai

Prague, Czech Republic- As the war between Ukraine and Russia rages on, the Czech Republic has now become the latest country to offer military support to Ukraine.

According to the Czech Republic Presidency, President Milos Zeman has granted 103 citizens a special exemption, allowing them to join the Ukrainian military.

Some 400 volunteers had applied for a waiver with the goal of fighting for Ukraine against Russia.

The country requires special permission signed by the President and the Prime Minister to serve in a foreign military force. Otherwise, they face prosecution at home and potentially a five-year prison term.

In addition, the Defense Ministry then reviews each case individually in cooperation with the Interior Ministry and the Foreign Ministry before forwarding the paperwork to the President’s Office for approval.

At the same time, the United States House of Representatives has overwhelmingly approved a US$39.8 billion package of military and other assistance to Ukraine.

“Ukrainian people are fighting the fight for their democracy, and in doing so, for ours as well. With this aid package, America sends a resounding message to the world of our unwavering determination to stand with the courageous people of Ukraine until victory is won,” said House Speaker, Nancy Pelosi.

The package is expected to provide US$6 billion for weaponry, intelligence support, training and other defence assistance to Ukrainian forces, as well as US$8.7 billion to replenish American equipment sent to the country. It will also allocate US$3.9 billion for European Command operations, including intelligence support and hardship pay for troops in the region.

In addition, Legislation also set aside US$13.9 billion for the State Department, with the bulk going toward the Economic Support Fund to help Ukraine’s government continue to function, another US$4.4 billion for emergency food assistance in Ukraine and around the world as well as US$900 million to assist Ukrainian refugees, including housing, English language, trauma and support services.