FDA chief Scott Gottlieb steps down after nearly 2 years
By MATTHEW PERRONE
AP Health Writer
Wednesday, March 6
WASHINGTON (AP) — Food and Drug Administration Commissioner Scott Gottlieb is stepping down after nearly two years leading the agency’s response to a host of public health challenges, including the opioid epidemic, rising drug prices and underage vaping.
Gottlieb cited “the challenge of being apart from my family” in Connecticut when announcing his departure Tuesday in a note to FDA staff. He’ll leave next month.
President Donald Trump tapped Gottlieb in 2017 to “cut red tape” at the FDA. But Gottlieb bucked expectations by pushing the agency to expand its authorities in several key ways, including an unprecedented effort to make cigarettes less addictive by requiring lower nicotine levels .
The 46-year-old physician and former conservative pundit advanced his agenda while managing to maintain the support of the president, Republicans and key Democrats in Congress.
Still, he departs with his most sweeping plans unfinished, including the initiative to make cigarettes less addictive.
“Scott deserves very strong credit for his stance on tobacco, I only wish he would have seen some of those efforts through to fruition,” said Dr. David Kessler, who led the FDA from 1990 to 1997. “In the end you have to bring those things home.”
Harvard University professor Daniel Carpenter said Gottlieb benefited from comparisons with more unconventional, anti-regulatory Trump appointees.
“He could govern from a place of moderation and get all the more credit because so many other agencies and positions under the Trump administration were either falling apart or vacant,” said Carpenter, who has written extensively on the FDA.
In recent months, Gottlieb has come under fire for not acting more forcefully to address an explosion in teenage use of electronic cigarettes, especially those with candy and fruit flavors. Under Gottlieb, the FDA has emphasized vaping as a potential tool to wean adult smokers off traditional cigarettes. And in a widely criticized move, Gottlieb delayed key regulations on vaping devices until 2022, in part, to avoid over-regulating the industry.
Anti-smoking groups are now suing the agency to begin reviewing all e-cigarettes. While the FDA has proposed steps to keep e-cigarettes away from teenagers, including tightening restrictions on convenience store sales, it’s unclear whether they will be enough to reverse the trend.
The pushback against FDA’s approach to vaping threatens to overshadow what is by far Gottlieb’s most far-reaching plan. Gottlieb announced in July 2017 the FDA would seek to require tobacco companies to drastically cut nicotine in cigarettes, in a bid to help adult smokers quit. The agency has had the authority to regulate nicotine levels since 2009, though no previous FDA commissioner tried to use it. The agency is still in the early stages of writing regulations that would standardize nicotine in cigarettes.
Dr. Peter Lurie, a former senior FDA official under President Barack Obama, said Gottlieb embraced the agency’s regulatory powers where other Trump appointees tried to weaken their agencies.
“He tried to use its authority in an appropriate fashion,” Lurie said, noting the FDA’s recent announcements on dietary supplements and work to continue food inspections during the government shutdown.
Elsewhere, Gottlieb targeted drug industry tactics used to maintain sky-high prices on older drugs, calling them “shenanigans” and “deceptions.” For decades, FDA commissioners steered clear of the issue, noting that the FDA has no direct role in regulating U.S. medicine prices, which are set by drugmakers. But Gottlieb said the agency could help spur competition and reshuffled its review procedures to speed up approvals of lower-cost generic drugs.
Early in his tenure, Gottlieb identified the epidemic of opioid abuse and overdoses as the “biggest crisis facing the nation.” But there have been few clear victories against the problem for either the FDA or the Trump administration.
Drug overdose deaths hit their highest level on record in 2017 — the most recent year for which federal data is available. Fatal overdoses are largely driven by illegal opioids including fentanyl and heroin, though the epidemic was trigged by legal prescription painkillers like OxyContin.
As FDA Commissioner, Gottlieb boosted the agency’s inspectors at U.S. mail facilities to try and intercept illegal opioid shipments from China and other nations. It’s not yet clear whether that effort has reduced drug abuse or overdose rates.
Trump tweeted that Gottlieb “has done an absolutely terrific job,” adding “he and his talents will be greatly missed.”
On FDA’s more day-to-day responsibilities, Gottlieb continued a multi-decade, bipartisan shift toward faster, more streamlined product reviews for drugs and medical devices. That issue has long been the top priority for the powerful pharmaceutical and device industries, which spend millions lobbying Congress and the federal government annually to ensure speedy market access for their products.
FDA approvals for first-of-a-kind drugs, generic drugs and medical devices hit all-time highs last year.
Gottlieb has long been a favorite of the industry, due to his focus on cutting unnecessary regulations and speeding product approvals. He served in the FDA under George W. Bush and then spent nearly a decade as a conservative commentator at the American Enterprise Institute, while also working as a venture capitalist and industry consultant.
AP Food and Health Writer Candice Choi in New York contributed to this report.
Follow Matthew Perrone at AP_FDAwriter
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
First lady prods media to cover opioids as much as ‘gossip’
By DARLENE SUPERVILLE
LAS VEGAS (AP) — First lady Melania Trump prodded the news media on Tuesday to spend as much time highlighting the opioid epidemic at it devotes to “idle gossip or trivial stories.”
Mrs. Trump said she wished the media would talk about the epidemic more “and educate more children, also adults, parents, about the opioid crisis that we have in United States.” She spoke during a town hall-style discussion in Las Vegas about the epidemic that claimed nearly 48,000 American lives in 2017. “They do it already, but I think not enough.”
The first lady suggested the epidemic should be leading the news when host Eric Bolling — who addressed her as “Lady M” — asked what else the media could do.
“I think it should be on every media and the front pages of the newspaper, and I’m sure a lot of people would follow and go home and talk with the children and educate them, so they are responsible adults and they show them how drugs can be dangerous,” she said. Her audience of several hundred people, including entertainer Wayne Newton, was seated in a theater where Elvis Presley once performed at the Westgate hotel and casino.
Mrs. Trump used the event to close a two-day, three-state promotional tour for her “Be Best” initiative, which includes a focus on babies born dependent on opioids. Bolling, a former Fox News host, lost his only child, 19-year-old son Eric Chase, to an accidental drug overdose in September 2017.
During remarks before she answered questions from Bolling, the first lady encouraged the public to look beyond the raw numbers and see the opioid crisis as a “human story.”
She also challenged the news media during those remarks “to devote as much time to the lives lost, and the potential lives that could be saved, by dedicating the same amount of coverage that you do to idle gossip or trivial stories.”
“When we see breaking news on TV, or the front pages of newspapers — it is my hope that it can be about how many lives we were able to save through education and honest dialogue,” Mrs. Trump said.
She said she teaches her own 12-year-old son, Barron, “how drugs are dangerous. It will mess up your head. It will mess up your body and nothing comes positive out of it.”
The discussion included lighter topics as well. Asked what her family’s choice for a group meal might be, she said “spaghetti.”
As for how much cooking she does, the first lady said she leaves that to the “professionals” at the White House, adding that there’s “really no time” for her to cook.
The first lady participated in a similar conversation led by Bolling last November at Liberty University in Virginia.
President Donald Trump has declared the opioid crisis a public health emergency and his administration is spending billions of dollars to fight it.
Follow Darlene Superville on Twitter: http:://www.twitter.com/dsupervilleap
Criticizing Israel Isn’t Anti-Semitic. Here’s What Is.
Pro-Israel politicians don’t speak for young Jews like me. They shouldn’t pretend to.
By Sarah Gertler | March 5, 2019
Weeks ago, when the first accusations of Anti-Semitism were being leveled against Representative Ilhan Omar, I was deeply agitated.
Not long ago I saw her address these accusations at a local town hall. She reminded the world that, as a Black Muslim woman in America, she knows what hate looks like — and spends her life laboring against it. Her words were clear, bold, and unflinching.
When members of Congress not only continued to gang up and falsely smear Omar as Anti-Semitic, but even created a House Resolution painting her words as hateful, I wasn’t just agitated. I was absolutely disgusted.
Omar has criticized the U.S. government’s support for Israeli actions that break international law. And she’s spoken out against the role money in politics plays in shoring up that support.
Neither is Anti-Semitic.
What is Anti-Semitic is the cacophony of mainstream media and politicians saying that criticizing U.S. policy toward the state of Israel is the same as attacking Jewish people.
Like most American Jewish youth, I grew up knowing Israel. During holidays, I sang prayers about Eretz Yisrael, the land of Israel. In Hebrew school, I learned about the country’s culture, its cities, its past prime ministers. At my Jewish summer camp, we started every day with the Israeli national anthem, Hatikvah.
My image of Israel was a rosy one. When I finally visited it in college, I was spellbound by the lush landscapes and sparkling cities, certain I would one day move to this golden ancestral home myself.
All this emotional buildup made it all the more sickening when, in the years that followed, I learned the realities of the Israeli occupation.
The modern state of Israel was established by Zionists — a nationalist movement started by European Jews with the aim of creating a “Jewish state” as a refuge for persecuted Jews.
It’s true that Jews have faced centuries of brutal persecution in Europe. But the Zionists’ project shared unmistakably European colonialist roots.
In 1948, Israel’s war of independence led to the Nakba, an invasion driving 700,000 Palestinians from their homes. These Palestinians were never allowed to return, creating a massive refugee population that today numbers over 7 million.
While I was able to travel freely up and down Israel, the Palestinians who once lived there are legally barred from returning. While I wandered the marketplaces trying stews and shawarmas, Palestinians in Gaza can’t afford even the gas to cook their food because of the Israeli blockade.
Zionism didn’t create an inclusive Jewish refuge either. In fact, the diverse Mizrahi — or Arab — Jewish population that was already thriving in Palestine was pushed out of Israeli society as Ashkenazi — or European — Jews became the elite class.
What it did create is an imperialist stronghold that continues to break international law by building settlements deeper and deeper into Palestinian territory, giving Jewish Israelis superior legal status to Arab Israelis and Palestinians, and attacking all who protest.
Since Israel’s origin, the U.S. has supplied tens of billions of dollars of military aid and ardent political support. Congress consistently ignores dozens of UN resolutions condemning Israeli abuses, and year after year gives it more resources to violently oppress impoverished Palestinians.
Pro-Israel lobbying groups’ considerable political influence has even pushed Congress to consider bills punishing Americans who support Palestinian rights. (Around half of all states already have such laws.)
More broadly, they rely on calling critics with false claims of Anti-Semitism — especially when the criticism comes from a person of color, as we’ve seen with Angela Davis, Marc Lamont Hill, and Michelle Alexander before Rep. Omar.
I, along with an increasing number of young American Jews, want to discuss U.S. support of Israel. Talking foreign policy is not Anti-Semitic.
What is Anti-Semitic — always — is saying that all Jews support violence and imperialism.
Sarah Gertler is the Newman Fellow at the Institute for Policy Studies. Distributed by OtherWords.org.
A Modest Proposal: Don’t Start a Nuclear War
No one wants a nuclear war, ever. Why don’t we have a policy against starting one?
By Olivia Alperstein | March 5, 2019
In a matter of minutes, as easily as sending a tweet, a sitting U.S. president could decide to launch a nuclear attack, without anyone else’s approval or authorization. In a matter of minutes, millions of lives would be lost, and millions of futures halted permanently.
At my organization, Physicians for Social Responsibility, we believe that we must prevent what we can’t cure. And there’s no cure for a nuclear war.
No nation on earth, including the United States, would have an adequate emergency response in the event of a nuclear exchange. Most Americans don’t want us to ever engage in a nuclear war, and the vast majority of us certainly don’t want the United States to be the ones to start a nuclear war.
The United States, like every other nation, has a vested interest in avoiding a nuclear conflict.
Yet unlike other countries, we currently have no policy against starting a nuclear war — or what experts call a “No First Use” policy.
This opens the door to a possible preemptive nuclear strike. That weakens our national security, and it puts all our health and safety at risk — for a nuclear war no one (except maybe President Donald Trump and John Bolton) wants.
Luckily, some people in Congress are looking to change the reckless status quo. This year, Rep. Adam Smith and Sen. Elizabeth Warren introduced legislation that would establish a “No First Use” policy for nuclear weapons in the United States.
“Our current nuclear strategy is not just outdated — it is dangerous,” said Smith and Warren. “By making clear that deterrence is the sole purpose of our arsenal, this bill would reduce the chances of a nuclear miscalculation and help us maintain our moral and diplomatic leadership in the world.”
No First Use is all the more critical now that vital multilateral arms treaties, like the landmark Intermediate Range Nuclear Forces (INF) Treaty between U.S. and Russia, are being ditched in favor of “out-innovating” everybody else, as Trump put it in his last State of the Union address.
Not content with our already out-sized nuclear arsenal, the United States has put the first so-called “low-yield” nuclear weapons into production as well. Misleadingly named, these weapons contain the destructive power of thousands of tons of TNT. To an adversary, they would be visually indistinguishable from high-yield submarine-launched warheads.
If it sounds like a James Bond villain is hard at work manufacturing an absolute worst-case scenario, you’re not far off. But in the real world, we won’t be able to rely on a martini-sipping spy to save the day.
So much is at stake here — not least for young people like me, who didn’t grow up practicing “duck and cover” drills during the Cold War, as if hiding under a school desk would protect any of us in the event of a nuclear attack.
Young people like me didn’t jump-start a nuclear arms race, but we’ll still pay the price. Our future is still ahead of us. We shouldn’t have to inherit a world threatened by nuclear weapons — or by the sheer expense of them.
A 2017 Congressional Budget Office report estimated that it would cost $1.2 trillion over the next 30 years to update, sustain, and modernize existing nuclear forces. That’s money that could fund vital infrastructure, health care, jobs, housing, and education programs, and much more — money we’re wasting on weapons that would destroy our future.
No one wins a nuclear war. Everyone loses. The United States can and must lead by committing to an official policy of No First Use of nuclear weapons— for all our health’s sake.
Olivia Alperstein is the Media Relations Manager at Physicians for Social Responsibility. Distributed by OtherWords.org.
Worse Than the Wall
The agencies that separate families, abuse children, and deport innocent people should be just as toxic as Trump’s wall.
By Karla Molinar-Arvizo | March 5, 2019
The current administration has bent over backwards to force-feed its anti-immigrant agenda to the American public. That agenda remains broadly unpopular, but they’ve tried every trick in the con artist book to impose it anyway.
Despite years of hysterical anti-immigrant propaganda, most Americans continually report positive views of immigrants and immigration in opinion surveys. Yet we’ve been faced with constant threats of government shutdowns or made-up “national emergencies” if we don’t give the administration money for a wall most of us oppose.
While politicians debate these things, real people die.
Jakelin Caal Maquin, a 7-year-old, was separated from her father, kept in a cage, and died in Border Patrol custody. Felipe Gomez Alonzo, an 8-year-old, died just weeks later in custody in New Mexico.
Roxana Hernandez, a trans woman seeking asylum from Honduras, died in ICE custody last spring, with an autopsy showing signs of abuse. Thousands of migrants, in fact, have reported sexual abuse and other mistreatment in ICE and CBP custody.
When big injustice occurs, a bigger plan for resistance must follow. To be effective, we must recognize where the core of the injustice lies.
This is true of policy, too. And the inescapable conclusion is that funding for the agencies that detain, abuse, deport, and sometimes kill migrants needs to be every bit as toxic as many Democrats regard funding for the wall.
The American public recognizes this. The administration’s “zero tolerance” and family separations policies drew protests across the country and political spectrum. And despite an anti-immigrant advertising blitz by Republicans late last year, voters repudiated this brutal extremism in the midterm elections, flipping seat after seat in the House of Representatives (and a Senate seat in the border state of Arizona).
Most people understand that the wall is just a symbol, a waste money on a fabricated crisis. But the crisis created by agencies that persecute immigrants, families, and people looking for a better life is all too real.
As funding for agencies like ICE and CBP has increased, so have deportations — chiefly among immigrants with no criminal record, according to many on-the-ground studies.
Unfortunately, Democratic leaders in Congress have kept this funding on the table in their negotiations with the administration. They’re funding agencies that accomplish in real life what the wall is supposed to do symbolically: keep out people looking for a better life.
While politicians talked, Eduardo Samaniego was deported.
At just 16, Eduardo immigrated alone to the United States to look for a better life for his family, knowing he’d have no chance to enter legally. Eduardo worked full time, enrolled himself in high school, and excelled academically. He made himself known not only because he was kind, hopeful, and spirited, but because he believed in justice and making his community a better place.
Then ICE took him.
They placed him in solitary confinement for months, which mental health professionals consider a form of torture. The boy that had seem unbreakable by life’s challenges was broken by the injustices ICE inflicted on him. It got so bad he chose to accept “voluntary departure” to Mexico.
Day after day these agencies keep taking people, families keep being separated, and people keep dying — and they’ll keep doing it if we keep funding the agencies that are responsible. Instead of playing games on the wall.
Fortunately, a growing number of Americans are demanding strategies that actually protect families — and honor the majority of Americans who welcome their immigrant neighbors. As the last election showed, if leaders don’t catch up, they’ll be held accountable.
Karla Molinar-Arvizo is the New Mexico Fellow at the Institute for Policy Studies.
It’s Not Just Our Planet That Needs a Green New Deal — Our People Do Too
We stood up to our senator to save our future. Will you join us?
By Hannah Estrada, Michael Estrada | March 5, 2019
Should the richest country on earth invest to keep the planet we all share inhabitable? We believe the answer is yes — and fast. Unfortunately, not all lawmakers seem to agree.
Last month, our group, Youth Vs. Apocalypse, asked California Senator Dianne Feinstein to support the Green New Deal. She declined. The video of the encounter went viral.
Viral videos come and go. But this cause can’t become last yesterday’s leftovers, because this issue will determine everyone’s tomorrow. We know that this moment is pivotal for the survival of the human race.
To put it simply, if we don’t act now, we’ll leave the next generation a dead and a uninhabitable planet. Science says human activity is the dominant cause of observed climate change — we are the reason the Earth is dying — and we have barely a decade left to stop it.
Since we created this problem, we must find the solution. The Green New Deal is the first step.
The Green New Deal, a resolution proposed by Representative Alexandria Ocasio-Cortez and Senator Ed Markey, addresses the related crises of climate change, inequality, and declining life expectancy in the United States. It aims not only to address our climate crisis, but to include communities, like many of ours, that have historically been left out of the conversation.
It’s a 10-year mobilization that will bring our country’s greenhouse gas emissions to net zero, provide millions of family-sustaining jobs, invest in sustainable infrastructure and industry, build community resilience, and boost the economy.
That’s important. It’s not just our planet, but our people that need a Green New Deal.
It’s no secret that one job is no longer enough to support a family in this country. We need this investment in jobs with sustainable wages and fair benefits. We need to stop the transfer of jobs overseas. And we need a safety net for those whose income is dependent on the fossil fuel industry.
Not to mention we need clean air, clean water, housing, education, and adequate health care. It saddens us to say that a significant portion of the population goes without these things everyday.
Some might say that the Green New Deal is too costly. It would be even more costly not to enact it.
The longer we wait to take action, the more costly and devastating the crisis becomes. By 2050, wildfires will increase greatly, taking out whole communities and neighborhoods. Hurricanes will become more intense and frequent, leaving mass destruction behind.
By not acting, we risk $1,000,000,000,000 — that’s $1 trillion — worth of damage to public infrastructure and real estate on our coasts alone.
Beyond that, how can we put a price tag on life? How can we not afford to take care of our own people? How we can deny clean air and water to our own neighbors? Life is not a luxury that can be bought. Life is priceless.
It’s hard to understand the effects of a changing climate and even harder to understand how to combat it. But we cannot let people become ignorant to this issue. Not when we’re risking so much.
Half the battle is understanding the problem — the other half is taking action.
We believe that our activism will decide whether or not we live — and we want to live. So tell your own representatives to support the Green New Deal. Tell them it’s for your brothers and sisters, your nieces and nephews, your kids. And for you.
Hannah Estrada, 15, and Michael Estrada, 17, are members of the youth-led climate justice group Youth Vs Apocalypse. Distributed by OtherWords.org.