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Presented by PhRMA: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy. | | | | | |  | | By Adam Cancryn and Sarah Owermohle | Presented by |  | | | With Rachel Roubein Editor’s Note: POLITICO Pulse is a free version of POLITICO Pro Health Care's morning newsletter, which is delivered to our s each morning at 6 a.m. The POLITICO Pro platform combines the news you need with tools you can use to take action on the day’s biggest stories. Act on the news with POLITICO Pro.
| | | — The Biden administration has shipped only 20 percent of the Covid-19 doses it pledged to send abroad by the end of the month. — FDA officials decided to approve the Alzheimer’s drug Aduhelm over the objections of agency experts, according to new documents. — Tens of thousands more Medicare beneficiaries living in nursing homes died in 2020, when compared with the prior year, as Covid-19 ran rampant through the country. WELCOME TO WEDNESDAY PULSE. Your authors (and editor) are unapologetic cat people, but this is a bit much. Send tips and reasons 15 cats are bad for your health to acancryn@politico.com and sowermohle@politico.com. | | | | A message from PhRMA: The way insurance covers your medicine is too complicated. See how we can make the system work for patients. Not the other way around. | | | | | | WHITE HOUSE FALLS BEHIND ON VACCINE SHIPMENTS — President Joe Biden in May announced plans to deliver 80 million doses to other countries by late June. But officials have struggled to navigate shipping logistics and faced delays in hammering out legal agreements necessary to shield manufacturers from liability, POLITICO’s Erin Banco reports. The administration has since shifted its goal to simply allocating, not shipping, 80 million doses this month. The delay comes as developing countries are grappling with a new Covid-19 variant. The spread of the highly transmissible Delta variant has upped the urgency of distributing vaccines to low- and middle-income countries. Though the U.S. has not detailed what specific countries have received doses so far, the administration is planning to send the first 14 million vaccines it directly donates to countries to a range of “regional priorities and partner[s],” including Haiti, the Dominican Republic and Bangladesh. FDA APPROVED ALZHEIMER’s DRUG DESPITE DOUBTS — Several statisticians inside the FDA’s Office of Biostatistics warned it wasn’t clear the drug Aduhelm was an effective treatment for Alzheimer’s, according to documents released Tuesday, POLITICO’s David Lim and Lauren Morello report. The agency opted to greenlight Aduhelm anyway, sparking a backlash over its thin evidence and sky-high price tag. Three FDA advisory committee members have since resigned over the decision. And lawmakers on Capitol Hill, including critical Senate swing vote Sen. Joe Manchin (D-W.Va.), have blasted the approval, further complicating acting FDA Commissioner Janet Woodcock’s candidacy for the permanent role. HHS WATCHDOG: NURSING HOME MORTALITY SPIKED IN 2020 — The death rate for Medicare beneficiaries in nursing homes jumped by 32 percent last year , an increase equal to nearly 170,000 more deaths in 2020 than in 2019, according to a new HHS inspector general report. Overall, more than 22 percent of Medicare beneficiaries who lived in nursing homes died in 2020, as Covid-19 ravaged facilities across the country. The pandemic’s impact was particularly acute in April 2020, when nearly 1,000 more Medicare recipients died per day, compared with the year prior — even though the overall nursing home population was smaller. “Overall, Medicare beneficiaries in nursing homes were almost twice as likely to die in April 2020 than in April 2019,” the inspector general wrote.
| | | | DON'T MISS THE MILKEN INSTITUTE FUTURE OF HEALTH SUMMIT: POLITICO will feature a special edition of our Future Pulse newsletter at the 2021 Milken Institute Future of Health Summit. The newsletter takes readers inside one of the most influential gatherings of global health industry leaders and innovators who are turning lessons learned from the past year into a healthier, more resilient and more equitable future. Covid-19 threatened our health and well-being, while simultaneously leading to extraordinary coordination to improve pandemic preparedness, disease prevention, diversity in clinical trials, mental health resources, food access and more. SUBSCRIBE TODAY to receive exclusive coverage from June 22-24. | | | | |
| | | WOODCOCK TESTIFIES IN HOUSE VAPING HEARING — The acting FDA commissioner is set to appear before a House Oversight subcommittee this morning to discuss the agency’s efforts to wrangle the e-cigarette industry and tamp down on teen vaping. Sen. Dick Durbin (D-Ill.), an ardent critic of the e-cigarette industry and especially flavored vapes, is also testifying. Remember that? Vaping was the big public health crisis before the coronavirus pandemic; nearly every question in former FDA commissioner Stephen Hahn’s November 2019 confirmation hearing revolved around the topic. But with the pandemic taking center stage last year, the issue faded from view and FDA extended industry deadlines to submit flavored products to stay on the market. FIRST IN PULSE: HOUSE DEMOCRATS PRESS HHS FOR MORE COVID THERAPIES — A cluster of lawmakers led by Rep. Bobby Rush (D-Ill.) is calling on HHS Secretary Xavier Becerra to boost investment into antiviral therapies for people already infected with Covid-19, pointing to spreading variants and the possibility of future pandemics. There’s an equity angle, too; people of color are disproportionately hospitalized with severe Covid-19, which in turn necessitates more medical treatment, the representatives wrote in a letter on June 17. That said: The Biden administration announced that same day that it will spend $3 billion to develop antiviral therapies for Covid-19 and potentially other coronaviruses. The plan was in the works during the Biden transition and was set in motion with the American Rescue Plan, a source familiar told POLITICO last month. | | | |   | | | | | Milken Institute Future of Health Summit | | A NEW ERA FOR DRUG COSTS? Everyone wants drug pricing reforms to happen already — even the drug industry. The uncertainty around what could happen, from incremental Medicare changes to the sweeping reforms of H.R. 3, has even made investors hesitant to back pharmaceutical companies, Leerink analyst Geoffrey Porges said during a Milken drug pricing panel discussion moderated by Sarah on Tuesday. PhRMA Chief Operating Officer Lori Reilly also acknowledged during the panel later that the drug industry needs to make concessions to lower drug costs for patients. “As long as we ensure that those costs go to patient ability to access their medicines, and keep the balanced ecosystem that we believe is in place today as it relates to innovation, we're absolutely willing to partner with anyone to have those conversations,” she said. Reilly also defended Aduhelm’s $56,000 annual price tag, saying the rapid development of Covid-19 vaccines exemplifies how the costly research and development process "rewards innovation and risk-taking.” “The system … has delivered, whether it's in the oncology space or for rare diseases, diabetes, and many others — the types of treatments that, quite honestly, patients are waiting on,” Reilly said. COVID INEQUITIES LAID BARE HEALTH SYSTEM FAILURES — Disproportionate hospitalizations and deaths among Black people and other communities of color during the Covid-19 pandemic exposed broken funding and incentives that have long permeated health care, said panelists during a Milken discussion Tuesday on equitable biomedical research. “Black people died during Covid because their hospitals are underfunded,” said Kevin Mahoney, CEO of the University of Pennsylvania Health System. “Covid is a locally treated disease.” And the ramifications of underfunding health providers extend beyond times of crisis, said Lynne Richardson, a professor of emergency medicine at the Icahn School of Medicine at Mount Sinai, once the epicenter of the pandemic in New York. “You have to build capacity, you have to invest in research infrastructure, because that is how we're going to diversify participation in clinical trials,” she said. Emergency departments in particular are where disparities appear, day after day. “We would love it if everybody in an emergency department actually had an emergency,” Richardson said, instead of problems that could have been prevented if the health care system hadn’t failed them. ‘MY PEOPLE ARE DYING’ — Africa has been slow to see the benefits of rapid advances in science like record-breaking coronavirus vaccine production, as another Milken panel, titled Vaccines: Global Coordination and Equitable Distribution, explored. “How can I say science has been a miracle to my people who are dying?” Strive Masiyiwa, a telecom executive who is the African Union’s special envoy to the African Vaccine Acquisition Task Team, said during that discussion. He slammed rich countries that bought up the vaccine supply for 2021 and the pharmaceutical companies that sold it to them, leaving no significant supply for African countries, Carmen Paun reports. He also criticized COVAX, the global vaccine equity effort, for delivering fewer than 30 million doses to the entire continent of Africa, despite promises of much more. José Manuel Barroso, who chairs the board of Gavi, one of the organizations running COVAX, defended the effort as the only one to distribute shots equitably. “I don’t think it’s fair to put the blame there,” he said.
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| | | TRUMP HHS ALUM STARTS FIRM TO COMBAT 'WOKE' ACTIVISTS — A new public affairs shop headed by Trump-era HHS official Jack Kalavritinos will help corporations respond to and counter what he described as “woke” liberal pressure campaigns. The firm, JK Strategies, will advise clients on their environmental, social, governance and corporate social responsibility strategies — areas that Kalavritinos contends have become targets for groups trying to get companies to adopt more progressive policies. “Activists are now becoming more aggressive in trying to enlist companies as foot soldiers in their efforts to transform society,” Kalavritinos wrote in a Tuesday Newsmax op-ed . “Resistance to left-wing pressures is always appropriate, as long as it’s coupled with the proper tone.” Kalavritinos told PULSE that other Trump alums, including former senior HHS official Catherine Bird, will be working with the firm. | | | | A message from PhRMA: Getting to what you pay for medicines shouldn’t be a maze. Let’s make out-of-pocket costs transparent, predictable and affordable. And let’s do it without sacrificing access to medicines and innovation. See how we can make the system work for patients. Not the other way around. | | | | | | In an analysis of the fiscal impact of lowering Medicare’s eligibility age to 60, conservative health experts led by Lanhee Chen estimate the policy would enroll 18 million more people and add roughly $32 billion to the federal deficit in 2022. More than 150 health care workers in a Texas hospital system resigned or were fired for not complying with the company’s vaccine mandate, one of the first implemented by a U.S. health system, the Washington Post’s Dan Diamond reported. At least seven mental health app companies are valued at more than $1 billion, but with hype growing, companies are scrambling to prove to consumers that their apps work, Jenny Gold writes in Kaiser Health News. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
