Vax safety fact check

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Nov 01, 2024 View in browser   By Lauren Gardner and David Lim With Carmen Paun, Ruth Reader and Erin Schumaker Driving the Day Trump transition co-chair Howard Lutnick, shown here with the former president, has made several questionable claims about vaccine safety and regulation. | Adam Gray/AFP via Getty Images VACCINE SAFETY SPOTLIGHT — If the Trump campaign wanted to pivot from Robert F. Kennedy Jr.’s anti-vaccine rhetoric to his “Make America Healthy Again” ideas, the focus is squarely back on the pharma front. Trump transition co-chair Howard Lutnick said on CNN Wednesday night that Kennedy “is not going to be in charge of HHS.” But he suggested Kennedy could get a role examining health and vaccine data in a second Trump administration, recounting a recent conversation he had with the campaign surrogate. “Why do you think vaccines are safe? There’s no product liability anymore,” he said to host Kaitlan Collins. “They’re not proven anymore.” “They started paying people at the NIH, right?” Lutnick continued. “They pay them a piece of the money for the vaccine companies. So all of these vaccines came out without product liability.” Brian Hughes, a senior adviser on the Trump campaign, said Trump will establish a “special presidential commission” charged with investigating chronic illnesses. “President Trump has said he will work alongside passionate voices like Transition Co-Chair Howard Lutnick and RFK Jr. to have an administration that fixes the failures of the last 4 years and restores our nation's greatness,” Hughes said in a statement. What to know: Some of Lutnick’s claims are worth further scrutiny. We break down three of them: — “[Vaccines are] not proven anymore.”  The reality: Vaccines are safe but not free of side effects. The FDA approves vaccines for use in the U.S. after studying reams of data on their safety and effectiveness. Because they’re preventive measures largely given to healthy people — many of them children — scientists agree vaccines are held to a higher standard than most other drugs. “There’s no hiding, especially in the vaccine world,” said Dr. Paul Offit, a vaccine inventor and pediatric infectious disease specialist at the Children’s Hospital of Philadelphia. Surveillance systems that track adverse events from vaccines can help federal officials and scientists quickly detect a spike in reactions, Offit said, pointing to their identification of myocarditis — inflammation of the heart muscle — as a rare side effect of messenger RNA Covid vaccines in certain populations. While some health experts would like to see more data collected on vaccine side effects — particularly the underlying biological mechanisms — the scientific evidence generated by clinical trials is publicly presented and considered by the FDA and independent advisers. — “They started paying people at the NIH.” The reality: The FDA collects fees for reviews — not the National Institutes of Health as claimed. Congress moved to a user-fee system to fund roughly half of the agency’s activities in 1992. But that doesn’t mean the FDA will rubber-stamp a company’s application — or won’t eventually pull a medicine off the market. Offit noted that the Johnson & Johnson Covid vaccine was linked to a potentially fatal blood-clotting condition thanks to federal surveillance. “J&J paid for that review,” he said. “The vaccine was off the market within a year and a half. So, he’s wrong." — “These vaccines came out without product liability.” The reality: Product liability isn’t absolute, but it’s close. Patients must exhaust injury claims under the National Vaccine Injury Compensation Program before they can pursue legal action against a vaccine maker or a health provider. But Supreme Court precedent from a 2011 vaccine injury case that ruled in a drugmaker’s favor makes those non-VICP lawsuits tough to win for plaintiffs because they have to prove both causation and fault, said vaccine injury lawyer Renee Gentry. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. We hope you enjoy the last weekend before the election! Send tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM). In the Courts The 3rd Circuit Court of Appeals heard arguments challenging the Biden administration's Medicare drug price negotiation program. | Andrew Harnik/AP JUDGES PRESS PHARMA, DOJ ON IRA — A three-judge panel of the 3rd Circuit Court of Appeals considered arguments Wednesday challenging and defending the Biden administration’s Medicare drug price negotiation program. Judges homed in on the federal government’s dual roles of market participant and market regulator in Medicare and questioned why Congress didn’t just set the prices for the drugs themselves (your host is thinking of 535 reasons why not, but she digresses). Ghost of lawsuits past: Jones Day’s Yaakov Roth, representing Bristol Myers Squibb, argued that the program amounts to an unconstitutional “taking” of private property for public use. He drew parallels to National Federation of Independent Business v. Sebelius — the case that spurred the Supreme Court to uphold the Affordable Care Act’s individual mandate but strike down its Medicaid expansion scheme. Roth worked for plaintiffs on that case, in which the high court agreed that the law’s tying of continued Medicaid funding to the program’s expansion in states was unconstitutional. “Congress designed this program in a way that lets it treat [half of the U.S. prescription drug market], to hold all of that hostage as leverage to force manufacturers to provide … the drugs that are picked for the program at below market prices, and that confirms that this is the type of unconstitutional condition that the Supreme Court has invalidated across numerous different contexts,” Roth said, including NFIB. “And it’s the same structure here, and that’s our fundamental objection.” Eye on the FDA FDA, VA JOIN FORCES ON AI — The FDA is experimenting with how it validates artificial intelligence through a new partnership with the VA. The two agencies are teaming up to launch a virtual health AI lab. They announced the partnership at the Veterans Health Administration Innovation Experience conference in Chicago on Wednesday. FDA Commissioner Robert Califf called the joint venture the “first intergovernmental health AI laboratory” that will test AI. The lab will allow the agencies to quickly check AI products to ensure they don’t have safety problems. It could also offer the FDA more insight into how regulation can play a role in ensuring the products’ safety. The FDA has issued discussion documents and guidance on artificial intelligence since 2021. To date, the agency has authorized more than 1,000 AI products. But it has slow-rolled its launch of rule proposals to give companies the runway to innovate. The VA also has AI experience through its National AI Institute, which has tested more than 120 AI tools. What's next: The agencies are finalizing details for a virtual lab, which will still require at least six months of work, according to industry blog Nextgov. Industry Intel GOODRX STARTS OPILL DTC PROGRAM — GoodRx is getting into the over-the-counter business, launching an e-commerce platform to sell OTC drugs that will be shipped to customers. The company’s first product offering is the birth control pill Opill — which the FDA gave OTC status in July 2023. Pharma Worldwide MORE MARBURG SHOTS TO RWANDA — The Sabin Vaccine Institute has shipped approximately 1,000 doses of its experimental Marburg vaccine to Rwanda, it said Thursday, as the authorities in the African country expand a clinical trial there. The shots will go to people considered to be at risk for contracting the lethal virus, including mine workers. Half will receive the vaccine immediately, while the other half will receive it after 21 days, the incubation period for the disease caused by the Marburg virus. The trial expansion to mine workers comes after Rwandan authorities traced the outbreak origin to fruit bats in a mine near Kigali, the country’s capital. The doses are in addition to 1,700 already delivered to Rwanda, which have been used to vaccinate 1,500 health care workers to date, Sabin said. Why it matters: With 66 confirmed cases, this is one of the largest Marburg virus disease outbreaks to date. The virus, similar to Ebola, can kill nearly 9 in 10 people it infects, but Rwandan authorities have managed to keep the case fatality rate to 2.3 in 10 people. So far, 15 people have died. Document Drawer The FDA is holding a public meeting on Nov. 20 to discuss the reauthorization of the Over-the-Counter Monograph Drug User Fee Program. The FDA approved a modification to the Risk Evaluation and Mitigation Strategy for opioid analgesics. WHAT WE'RE READING STAT’s Mario Aguilar explores the clinical utility of Apple’s new AirPod hearing aid feature. Paul Mango is helping the Trump campaign plan the HHS transition, POLITICO’s Chelsea Cirruzzo and David report.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

To change your alert settings, please log in at https://login.politico.com/?redirect=https%3A%2F%2Fwww.politico.com/settings This email was sent to edwardlorilla1986.paxforex@blogger.com by: POLITICO, LLC 1000 Wilson Blvd. Arlington, VA, 22209, USA Unsubscribe | Privacy Policy | Terms of Service