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Associated Press: VA says it won’t stop use of unproven malaria drug on veterans with coronavirus
Hope Yen, The Associated Press | 18 hours ago
WASHINGTON — Facing growing criticism, the Department of Veterans Affairs said Friday that it will not halt use of an unproven malaria drug on veterans with COVID-19 but that fewer of its patients are now taking it.
In responses provided to Congress and obtained by The Associated Press, the VA said it never “encouraged or discouraged” its government-run hospitals to use hydroxychloroquine on patients even as President Donald Trump heavily promoted the drug for months without scientific evidence of its effectiveness.
Still, it acknowledged that VA Secretary Robert Wilkie had wrongly asserted publicly without evidence that the drug had been shown to benefit younger veterans. The VA, the nation’s largest hospital system, also agreed more study was needed on the drug and suggested its use was now limited to extenuating circumstances, such as last-ditch efforts to save a coronavirus patient’s life.
In the first week of May, 17 patients had received the drug for COVID-19, according to VA data obtained by the AP. The department declined to say how many patients had been treated with hydroxychloroquine for the coronavirus since January, but a recent analysis of VA hospital data showed that hundreds of veterans had taken it by early April.
“VA has not endorsed nor discouraged the use of hydroxychloroquine in COVID-19 patients and has left those decisions to providers and their patients,” the VA said. “While all drugs have the potential for adverse events and some drugs in particular, like hydroxychloroquine, are known to have specific risks, when they are used carefully and judiciously, they can be managed safely.”
As of Friday, 11,883 veterans had been confirmed to be infected with the virus and 985 had died, according to VA statistics.
Responding to written questions from Sen. Jon Tester, the top Democrat on the Senate Veterans Affairs Committee, the department admitted it had no studies or evidence to back up Wilkie’s claim that hydroxychloroquine had shown effectiveness in younger veterans in particular.
“The use of hydroxychloroquine for COVID has dropped off dramatically,” the VA said.
Trump repeatedly has pushed the malaria drug hydroxychloroquine with or without the antibiotic azithromycin, but no large, rigorous studies have found them safe or effective for COVID-19, and they can cause heart rhythm problems and other side effects. The Food and Drug Administration has warned against the drug combination and said hydroxychloroquine should only be used for the coronavirus in formal studies.
Two large observational studies, each involving around 1,400 patients in New York, recently found no benefit from hydroxychloroquine. Two new ones published Thursday in the journal BMJ, one by French researchers and the other from China, reached the same conclusion.
Tester, who received VA’s responses this week, said he remained concerned about the drug’s safety.
“Any drug used to treat patients with COVID-19, especially veterans living with debilitating preexisting conditions, must be proven safe and effective before it’s administered,” he said. “Given recent studies from both VA and other hospitals, hydroxychloroquine seems to fall short of those requirements.”
Major veterans organizations and Democrats, including Senate Minority Leader Chuck Schumer, had called on the VA to explain why it allowed the use of an unproven drug on vets. Last week, a whistleblower complaint by former Health and Human Services official Rick Bright alleged that the Trump administration wanted to “flood” hot spots in New York and New Jersey with the drug.
Jeremy Butler, CEO of Iraq and Afghanistan Veterans of America, said Friday that his group was heartened by the VA’s preliminary explanations and called it imperative that it release additional details. “It remains concerning that it took this long to begin to get answers to basic questions,” he said.
The analysis of VA hospital data, done by independent researchers at two universities with VA approval, was not a rigorous experiment. Researchers analyzed medical records of 368 older male veterans hospitalized with confirmed coronavirus infection at VA medical centers who died or were discharged by April 11.
About 28% of veterans who were given hydroxychloroquine plus usual care died, versus 11% of those getting routine care alone.
In its response to Congress, the department provided copies of some of its guidance issued to VA physicians on hydroxychloroquine from March to May. It made clear that hydroxychloroquine should be considered mostly for use in clinical trials or when medically appropriate after a full discussion with the patient about risks.
The VA did not explain the circumstances in which veterans in the recent analysis of hospital data were given the drug, only suggesting that “it is possible” they were prescribed as part of last efforts to save a patient’s life.
“Based on the principles of patient-centric care, it would be inappropriate to deny patients access to hydroxychloroquine under these dire circumstances,” VA wrote. It said it had followed the approach of the National Institute of Allergy and Infectious Diseases by “summarizing the medical literature regarding unapproved treatments for COVID-19 and making that available to VA clinicians in their shared decision-making with patients.” That guidance now includes preliminary studies on remdesivir, which has been federally approved for emergency use to treat COVID-19.
One VA document dated March 25 notes a few “very small cohort studies” showing possible “beneficial effects” but adds “these data have NOT been verified in randomized controlled trials and are extremely preliminary.”
The VA acknowledged to Congress that it had placed bulk orders for hydroxychloroquine from Feb. 1 to April 23 for 6.3 million tablets worth $208,000 in anticipation of a possible shortage of the drug, but that most of it was being used for approved uses, such as treating lupus and rheumatoid arthritis. It said it did not have breakdowns.
The department also said it planned further studies and clinical trials on hydroxychloroquine, including whether it could help prevent infection in veterans who were potentially exposed to COVID-19. It is in discussions with Novartis to have some VA facilities participate in a national clinical trial that will look at the effectiveness of hydroxychloroquine in combination with azithromycin in patients with moderate and severe disease.
Military Times: VA researching prostate cancer drug as potential coronavirus cure
Leo Shane III | 2 days ago
Veterans Affairs researchers are launching clinical trials to see whether a prostate cancer drug could help prevent adverse health effects from coronavirus in men, department officials announced Friday.
Researchers said the drug, degarelix (also labeled as Firmagon), has already shown promise in limited testing of about 200 veterans hospitalized in veterans medical centers for coronavirus complications.
More than 84,000 Americans across the country — including about 1,000 patients in VA care — have died from the fast-spreading virus in the last two months.
In a statement, VA Secretary Robert Wilkie said the new research is an important step towards “advancing knowledge of a potential treatment for those infected” with the virus. “We are here to do everything in our power to preserve and protect life.”
Degarelix is often used to treat advanced cases of prostate cancer by suppressing the body’s production of male hormones. Researchers working on coronavirus treatments have found that those same hormones may trigger the production of certain proteins which COVID-19 uses to enter lung tissue and cause severe health problems.
Researchers from the University of Alabama at Birmingham and Columbia University will work with VA staffers on the new clinical trials, which are expected to last at least four months.
Work will be led by staff at the West Los Angeles VA Medical Center but also include contributions from VA medical centers in New York and Washington state, as well as the Prostate Cancer Foundation/VA network of centers of excellence.
The study is focused only on men. Researchers said the drug would not likely be suitable for women because it could have the opposite effect it does on men, raising their problematic protein levels and putting their health at further risk.
White House officials on Friday announced plans to develop and widely distribute a vaccine for the deadly coronavirus by the end of 2020, an ambitious goal that scientists have said could be impossible to achieve.
President Donald Trump said the project, dubbed “Operation Warp Speed,” will “bring together the best of American industry and innovation, the full resources of the United States government, and the excellence and precision of the United States military.”
In recent months, Trump has suggested that scientists may be on the verge of finding breakthrough treatments for the virus, including specifically trumpeting the anti-malarial drug hydroxychloroquine as a potential cure. Food and Drug Administration officials in recent weeks have warned against its use, after studies showed it could worsen patients’ conditions.
Veterans Affairs officials have used that drug in past treatments of patients infected with the virus, and Wilkie has defended the move as a reasonable step for patients facing dire health outcomes.
More information on VA research work is available on the department’s web site.
Military Times: Changes to VA benefits operations forced by coronavirus could outlast the pandemic
Leo Shane III | 2 days ago
In a surprising twist, the forced closure of hundreds of Veterans Affairs benefits offices because of the coronavirus outbreak may actually be helping officials reach more veterans.
“(Since the closings) we’ve done tele-town halls for 12 states so far, and reached more than 350,000 veterans,” said VA Under Secretary for Benefits Paul Lawrence in an interview with Military Times this week.
“I talk for a little bit and then take questions. They’re good to hear, keep me apprised of what our veterans are talking about and what may have gone wrong so we can fix it.
“Ironically, they really have enabled me to touch a group of folks who aren’t on social media, print media, the places we usually go. It seems like we’re reaching an older generation of veterans, and telephone is the way they engage.”
Lawrence, who oversees the distribution of disability, education and other benefits to more than 7 million veterans and family members, said the success of the new telephone town halls have been a silver lining in the ongoing pandemic, which has forced about 97 percent of the Veterans Benefits Administration to work from home.
Department officials have seen an increase in worker productivity since that move, but Lawrence said he isn’t convinced that indicates a permanent change to off-site work would produce more efficiency.
“We’re seeing our employees’ availability and utilization at a higher percentage than usual, but that could be because they have no real (recreation) alternatives right now, and no one can go anywhere on vacation,” he said. “And they know our mission still matters, so these have been some of our more productive times.”
Lawrence said his staff has begun discussing whether they’ll keep using more remote-working options in the future, but dismissed the chances of large-scale changes away from brick-and-mortar benefits offices.
“Our veterans still need to come in there for some questions,” he said. “And for a lot of veterans, social isolation isn’t a good thing. So we want to be there.”
But for now, the remote work operations remain the norm. VA officials have discussed opening more hospital work areas and non-medical space in coming weeks, but those decisions will depend on how local and national infection rates proceed.
As a result, deadlines for some veterans benefits applications have been extended, and department officials have waived some in-person exams on those applications. The department’s benefit’s hotline — 1-800-827-1000 — is fielding about 25,000 calls a day.
“We invested in our telework capabilities several years ago, so a lot of the recent changes are working out well for us,” Lawrence said.
And he promised that the telephone town halls will stay in place even after state lockdowns are lifted.
Lawrence said even though the open question lines from veterans invites some “uncertainty,” he has been excited with the response, especially among folks who tell him they don’t usually reach out to VA.
“The secretary has made it an emphasis to get those hard-to-reach veterans,” he said. “This has really turned out well in that sense.
“I’ve already started asking my staff how we keep this going in the future.”
Washington Post: Military faces another potential coronavirus toll: Budget cuts
By Missy Ryan | May 15, 2020 at 12:44 p.m. EDT
As the novel coronavirus has swept the globe, Pentagon officials have scrambled to adjust everything from basic training to submarine deployments to prevent the pandemic from taking a lasting toll on the military’s ability to respond to adversaries.
But the covid-19 crisis could yield a different sort of long-term impact on the military, one outside the Pentagon’s ability to control: a possible reduction in military spending resulting from the country’s emerging economic meltdown.
Pentagon leaders are requesting a defense budget of $705 billion for fiscal 2021, representing half of the federal government’s discretionary spending and probably once again ensuring that U.S. military spending is far greater than that of any other country.
But current and former officials say a sustained reduction, even if modest, could make it harder for the Pentagon to achieve its long-deferred goals of modernizing military operations and competing more effectively with China at a time when the United States remains tied down in insurgent conflicts in Afghanistan and the Middle East.
Lawmakers have already approved more than $2 trillion in emergency stimulus spending in measures that are designed to provide a lifeline to revenue-starved states and that have generated debt concerns among fiscal conservatives.
Robert Hale, who served as Pentagon comptroller during the Obama administration and is now an adjunct senior fellow at the Center for a New American Security, said forecasting of a severe economic downturn — including high deficits and high unemployment — could result in a “modest decline” in defense spending in the order of 2 to 3 percent in real terms.
“That will still be very hard for the Pentagon to handle,” Hale said, as it heads into what was already supposed to be a “bow wave” period of large outlays on next-generation bombers, tanker aircraft and other big-ticket items.
The Pentagon spending cuts are expected to be far smaller than those that followed the triggering of automatic budget caps in 2013, called sequestration. But even reductions of a smaller scale could disrupt the department’s plans to implement a 2018 strategy that prioritizes retaining dominance over “great power” competitors.
Even before the pandemic, Pentagon leaders had warned of difficulties ahead as they projected a flattened budget following an increase of about 20 percent between fiscal years 2016 and 2020.
Making the case for the Pentagon’s 2021 budget proposal in early March, Defense Secretary Mark T. Esper told lawmakers that the requested spending level required “many tough decisions to ensure our highest priorities were adequately funded.”
Now, the situation looks far more dire. Speaking in a briefing hosted by the Brookings Institution last week, Esper said he was concerned that the stimulus spending would exacerbate the United States’ debt problem and potentially “throw us off course” at the Defense Department.
“So there is concern there that that may lead to smaller defense budgets in the future at the critical time at which we need to continue making this adjustment, where we look at China, then Russia, as our long-term strategic competitors,” he said.
Reduced spending could represent what experts called a “double whammy” at a time when the military may also be facing a challenge to readiness resulting from the virus, which has delayed or precluded trainings worldwide and reduced the number of recruits.
According to Todd Harrison, director of defense budget analysis at the Center for Strategic and International Studies, fiscal patterns since the late 1970s show that periods of high deficits have been followed by cuts to defense budgets, from big reductions during President Ronald Reagan’s second term in office to the deep declines resulting from sequestration beginning in 2013.
“If we see 2 to 3 percent [cuts] a year over five years, then DOD is going to have to go back and take a new look at its strategy,” Harrison said. While China and Russia would remain top priorities, secondary missions in Africa or Latin America could face more significant cuts, he said.
Counting on a flattened budget, Esper last year ordered a review to identify ways to streamline global military operations and make room for expanded emphasis on China. But potential trimming of U.S. activities in Africa have already raised objections on Capitol Hill, an indication that future attempts to cut missions or weapons programs are likely to encounter congressional resistance.
With less money, those trade-offs could become more dramatic. “They just have to be more ruthless,” Harrison said.
Mackenzie Eaglen, a former congressional adviser on defense matters who is now at the American Enterprise Institute, said there had already been some bipartisan support for constraining defense spending before the covid-19 crisis, potentially including from the president himself. Earlier this year in his State of the Union address, President Trump proclaimed that the military had been “completely rebuilt.”
While it’s not clear when lawmakers will make constraining high deficits a political imperative, Eaglen noted, “there are more than just debt pressures on the budget,” she said.
Sen. Jack Reed (R.I.), the ranking Democrat on the Senate Armed Services Committee, said he anticipates “acute pressure” on the defense budget, driven in part by sustained unemployment, increased savings and decreased consumption. “So you’ve got all these huge pressures that you’ll have on the budget, and that will translate to the defense budget,” he said in an interview.
That could be intensified by a possible shift among Americans’ priorities, who in recent decades have associated national security threats largely with terrorist threats overseas. Now, defense spending could become a renewed target.
“I think what you will see is much more of a focus by the American people on, you know, how will you protect me and my hometown,” Reed said. “Now, I think with the pressure on budgets, it’ll be more difficult, probably, to build as fast or as much as they wanted to do.”
Other lawmakers say defense cuts are not inevitable. “The world’s not going to be any safer after COVID,” Rep. Mac Thornberry (Tex.), the top Republican on the House Armed Services Committee, said in a call last week with reporters.
“I think it’s a mistake for DOD or anybody to just reflexively say, ‘Oh my gosh, we’ve had to spend all this money on COVID, so I’m sure we’re going to get another 20 percent cut to our budget,’ ” he said. “That should not be the way they plan.”
Budget experts said that if lawmakers decide to trim military spending, the Pentagon could try, as it has done in the past, to allay the impact by slowing weapons procurement, potentially including decisions to purchase fewer of expensive items such as the F-35 Joint Strike Fighter, or by attempting to accelerate plans to retire older jets or ships.
Hale said the economic situation could have financial silver linings for the military. For example, the military typically spends about $15 billion a year on fuel, but the global oil prices collapse could reduce those costs, he said.
Budget experts said the Pentagon is likely to stick with its pre-coronavirus projections for its fiscal 2022 budget proposal, which the department is now finalizing and which would be included in an overall administration request next year.
Bloomberg: Fed chief Powell warns US recovery could stretch through end of 2021
By ALISTER BULL | Bloomberg | Published: May 17, 2020
The U.S. economy will recover from the coronavirus pandemic, but the process could stretch through until the end of next year and depend on the delivery of a vaccine, said Federal Reserve Chairman Jerome Powell.
“Assuming there’s not a second wave of the coronavirus, I think you’ll see the economy recover steadily through the second half of this year,” the U.S. central bank chief said in an excerpt of an interview conducted Wednesday and aired on Sunday on CBS’s “Face the Nation” show.
“For the economy to fully recover, people will have to be fully confident, and that may have to await the arrival of a vaccine,” he said.
More than 36 million Americans have lost their jobs since February as the economy shuttered to limit the spread of the virus. Countless companies, especially small businesses, are hurtling toward bankruptcy, while states and cities are confronting gaping budget shortfalls that could provoke a massive second wave of layoffs from the public sector.
The Fed chief said people should never “bet” against the American economy, but he took care not to promise a swift, so-called V-shaped rebound.
“This economy will recover. It may take a while,” he said. “It could stretch through the end of next year. We really don’t know.”
Powell’s remarks follow his grave warning Wednesday that the U.S. economy faces lasting harm from the pandemic if the government doesn’t step up. The comments add support to calls for more congressional spending as Democrats push for a fresh $3 trillion in virus aid on top of a record $2.2 trillion package agreed upon in March. On Friday, the House passed the measure, though it has no future in the Republican-led Senate.
Powell can expect questions on the scale and timing of additional fiscal relief when he appears before the Senate Banking Committee on Tuesday. He also will be asked to tell Americans what to expect. For all his caution, the Fed chief also had a message of hope.
“I would just say this: In the long run, and even in the medium run, you would not want to bet against the American economy.”