Hydroxychloroquine Sulfate

President-elect Donald Trump has picked Robert F. Kennedy Jr. to be his next HHS secretary, likely giving the government’s most powerful healthcare post to a vaccine skeptic whose controversial views would be a huge break with decades of US health and scientific policies. “For too long, Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation and disinformation when it comes to public health,” Trump said in a social media post announcing the selection. Kennedy is a longtime anti-vaccine crusader and environmental advocate who dropped out of the presidential race to endorse Trump in August. His “Make America Healthy Again” platform — a riff on Trump’s campaign slogan — emerged as a priority from various members of the former president’s camp, including Trump himself. HHS is a massive agency that oversees nearly $2 trillion in federal spending. Its sub-agencies include the governance of Medicare and Medicaid, drug and food regulation at the FDA, the sprawling scientific work of the NIH, and numerous other bodies overseeing everything from public health to biodefense. Last month, Kennedy gave a preview of what his leadership of the agency would mean. In a post on X, he said that “FDA’s war on public health is about to end,” and calling for stopping what he called the suppression of “psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma.” Biotech stocks fell on reports of the pick, with the Nasdaq Biotech Index declining 2.4% at the close. Shares of vaccine makers fell as well, with Moderna $MRNA dropping 5.6% after the news broke and Pfizer $PFE down 2.6%. Trump has promised to give Kennedy wide latitude on healthcare issues. “I’m gonna let him go wild on health,” Trump said at an October campaign event in Madison Square Garden in New York. “I’m gonna let him go wild on the food. I’m gonna let him go wild on the medicines.” A name mentioned as a possible FDA pick under a Kennedy HHS is Casey Means, a Stanford-trained physician-turned-wellness advocate who might prove to be almost as controversial as Kennedy. Means, like Kennedy, has raised questions about the safety of vaccines, implying a link to autism. Such a link has never been proven, and an older study that has been the basis of many of those claims has been retracted and debunked. In addition to Kennedy’s anti-vaccine views, he has threatened to eliminate portions of federal health agencies and push out or discipline staff. “If you work for the FDA and are part of this corrupt system, I have two messages for you: 1. Preserve your records, and 2. Pack your bags,” Kennedy said in the October post on X . He has also espoused a number of more mainstream positions, including calling for a focus on wellness and the prevention of chronic disease, overhauling regulations for direct-to-consumer pharmaceutical ads, having Americans pay no more than other developed nations for drugs, and eliminating many pollutants and additives from the food supply, according to an opinion piece he wrote for the Wall Street Journal in September . But many of those views have been overshadowed by Kennedy’s embrace of conspiracy theories, such as his apparent support for the idea that high-altitude airplane contrails are in fact a government program to disperse chemicals. (They are actually condensed water.) Those positions could make for a less-than-certain Senate confirmation process, since they would almost certainly include a thorough review of his many controversial positions that are at odds with much of the healthcare establishment, as well as a number of recent personal scandals . Kennedy would hardly be the only controversial choice for the Trump administration. This week, he said he had chosen former Rep. Matt Gaetz of Florida to be his attorney general . Gaetz has been the subject of an ethics complaint over allegations of sex trafficking, as well as a fierce Trump ally and critic of the Department of Justice. Editor’s note: This story has been updated throughout with new details.

Donald Trumps victory in the U.S. presidential election Tuesday means change is coming for federal health agencies and the industries they regulate. Its just not quite clear yet how dramatic that change might be.Trump has pledged to make America healthy again and, in embracing Robert F. Kennedy Jr., a well-known critic of vaccines and pharmaceutical companies, has signaled such a campaign could feature unorthodox or disruptive ideas.I'm going to let him go wild on health, Trump said in a campaign speech in New York last month. I'm going to let him go wild on the food. I'm going to let him go wild on medicines.The potential for Kennedy to have a role overseeing or advising on healthcare policy is focusing the drug industrys attention on how Trump might treat the Food and Drug Administration.In his first term, Trump picked more traditional choices Scott Gottlieb and then Stephen Hahn as his FDA commissioners. And while he and his administration leaned on the agency to make decisions on unproven COVID-19 treatments like hydroxychloroquine, they also put Operation Warp Speed into action, accelerating the development of safe and effective coronavirus vaccines.I think a Trump administration will pay a lot of attention to the FDA, said Holly Fernandez Lynch, an associate professor of medical ethics and health policy at the University of Pennsylvania. Obviously, the FDA was high on President Trumps radar screen last time around because of COVID.A drug policy agenda influenced by Kennedy in Trumps second term may look different. Speaking with NPR Tuesday, Kennedy said hes been instructed to rid regulatory agencies of corruption, return them to evidence-based science and end what hes termed the chronic disease epidemic. Hes also previously said on X that he hopes to promote what some physicians consider fringe areas of medical science like stem cell injections and nutraceuticals.If you work for the FDA and are part of this corrupt system, I have two messages for you: 1. Preserve your records, and 2. Pack your bags, Kennedy wrote.His focus on undoing what he deems to be regulatory suppression could have an ally in Trump. Fernandez Lynch noted Trumps recent emphasis on the right to try legislation he signed into law in 2018 is indicative of Trumps view of the agency.The fact that he keeps bringing it up suggests that he continues to think it's a big deal, said Fernandez Lynch. I do think that it gives a lot of insight into his mindset around the value of FDA or its perceived lack of value [to him].Keeping that mindset in frame suggests he would push FDA to go even deeper [in promoting] the flexibility theyre already exerting, she said.Still, analysts expect Kennedy would have difficulty winning Senate confirmation for roles leading the FDA or its parent agency, the Department of Health and Human Services. In the NPR interview, Kennedy said its not yet decided what his role might be. Other candidates might be favored for the FDA and for HHS.None of us know who's going to be appointed, said Jeffrey Jonas, the former CEO of Sage Therapeutics and currently a partner at Cure Ventures. So the question is going to be: Is [Kennedy] going to be the only voice in the room? Or is he going to be brought in to represent a particular point of view on health and drugs?The drug industry is arguably the most highly regulated industry in the world. It's really not a job for amateurs or politicians, Jonas added. We have to hope that this administration, and every administration, appoints people who are familiar with the science in an apolitical manner.While biotech leaders may view Kennedy with some trepidation, theyre more optimistic about what a Trump administration might mean for the federal governments scrutiny of mergers and acquisitions.Pharmaceutical company dealmaking plays an important role within biotech. Acquisitions generate returns for biotech investors and recycles capital as well as talent into startups working on new ideas. They can also, some argue, increase companies market power and snuff out competitors.Industry M&A has been a particular target of the Federal Trade Commission under current chair Lina Khan, a Biden administration appointee. The agency scrutinized Amgens $28 billion buy of Horizon Pharmaceuticals, tightened merger guidelines and, most worryingly for many in biotech, took the unusual step of blocking an early-stage licensing deal.With regard to FTC, theres a good chance that changing leadership there will be a positive for biotech, Daphne Zohar, the CEO of Seaport Therapeutics and previously head of PureTech Health, wrote in an email.Jonas, of Cure, holds a similar view. For many of us, our view is the FTC has been very arbitrary in its application of the rules and regulations, he said. I think a change at that office will be a benefit to the investment community, to the biotech community and, frankly, for patients and innovation.Khan's current term ends in 2028. But the president gets to designate the FTC chair, and Trump will have an opportunity to replace Commissioner Rebecca Kelly Slaughter, whose term will end in May 2025.Beyond personnel, a Trump administration could change how the federal government approaches drug pricing. In his first term, Trump floated a number of policies to cut drug costs that either failed to advance or were thwarted by legal action. Among them was a favored nations policy designed to link Medicare reimbursements to prices paid abroad. That plan is one way to control prices on a macro level, said Jonas, so that'll be one area people will be watching.“However, he appeared to back away from that idea in recent months, with his campaign telling Statin October that there is “no push“ to revive the policy.Since Trump left office, the Biden administration has also enacted the Inflation Reduction Act, which for the first time granted Medicare the authority to negotiate drug prices. Its unclear how the incoming administration might adjust implementation of the law.“The range of possible outcomes for the industry on drug pricing policy in a second Trump term is quite substantial, and the outlook for the new Medicare drug price negotiation program is perhaps the best case in point,“ wrote Rick Weissenstein, an analyst at Cowen, in a client note.A second Trump term could also rekindle scrutiny of U.S. firms ties to Chinese companies. His administration may additionally seek to limit the availability of the abortion pill mifepristone, which the FDA under the Biden administration has sought to defend.I expect a Musk-ian deregulation of the industry, which could offer some positive elements in our efforts to bring medicines to patients as long as we maintain strong scientific standards, said John Maraganore, the former CEO of Alnylam Pharmaceuticals and now a board member of several biotechs. '