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mariacallous · 24 days ago

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"I’m going to let him go wild on health,” former president Donald Trump said of Robert F. Kennedy Jr. at his Madison Square Garden rally in New York City this past weekend. “I’m going to let him go wild on the food. I’m going to let him go wild on the medicines.”

Kennedy, a former Democrat, suspended his presidential campaign in August and endorsed Trump. He has since launched the Make America Healthy Again campaign, an initiative focused on tackling chronic diseases that Trump has seemingly embraced in recent weeks. Given Kennedy’s anti-vaccination stance and conspiratorial leanings, some policy experts and former government officials are concerned about how his views could shape the nation’s health agenda.

Kennedy has long made false statements about the safety of vaccines and has touted disproven treatments for Covid-19, including ivermectin and hydroxychloroquine. On the campaign trail, he has railed against seed oils, blaming several chronic health conditions on their presence in processed foods.

How much influence Kennedy could have on national health policy will all depend on his role within a future Trump administration. Trump did not clarify his remarks at Sunday’s event, including what position he is considering Kennedy for. According to a CNN report that ran late Tuesday, Kennedy said Trump “promised him control of the public health agencies,” but in an email to WIRED on Wednesday, Steven Cheung, Trump’s campaign communications director, said that formal discussions of who will serve in a second Trump administration are premature.

Trump could be considering Kennedy to lead the Department of Health and Human Services, which has 80,000 federal employees, or one of the agencies within it, such as the Food and Drug Administration or the Centers for Disease Control and Prevention. It would be a departure from his previous top health picks, who had lengthy government or public health careers. For instance, Alex Azar, Trump’s HHS secretary, was deputy HHS secretary under George W. Bush and an executive at drugmaker Eli Lilly. Scott Gottlieb, a physician and investor appointed as FDA commissioner under Trump, had previously worked for the FDA and had served on the boards of pharma and biotech companies.

When asked to elaborate on Kennedy’s health priorities, Amaryllis Fox Kennedy, the former candidate’s campaign director and daughter-in-law, told WIRED: “Bobby aims to end conflicts and corruption at the agencies, ensure all testing is undertaken by scientists who have no financial interest in the outcome, and all results of all trials are released to the public. The free market will take care of it from there.” (The National Institutes of Health already requires results of clinical trials funded by the agency to be published to a government database.)

Jerome Adams, US surgeon general under Trump and current executive director of health equity initiatives at Purdue University, says that even if Kennedy were tapped to lead HHS, the FDA, or the CDC, it’s unlikely that he would ascend to one of those roles due to his lack of medical training and controversial views on public health issues. “Congressional approval is required for these positions, and his stances could be a barrier,” Adams says.

If Republicans control the Senate after next week’s election, though, that calculus could change. “The GOP has generally fallen into line in terms of supporting candidates that President Trump does,” says Genevieve Kanter, associate professor of public policy at the University of Southern California.

If chosen to be FDA commissioner, Kennedy would control the agency’s budget and priorities and could have a sizable impact by installing lower-level appointees who are sympathetic to his worldview. While the FDA commissioner does not single-handedly approve or authorize new drugs, Kantner says outside political pressure can certainly influence that process. Kennedy could also appoint members to FDA advisory committees, panels of outside experts that make recommendations to the agency on drug approvals and other regulatory matters. The FDA often follows the recommendations of advisory committees when making decisions on new drug approvals, but not always.

The FDA can also choose to not enforce some rules in certain circumstances—what’s known as enforcement discretion. Given his support for dubious and unproven therapies, such as stem cells and hyperbaric oxygen, an FDA under Kennedy, for instance, could choose to not go after companies that market unapproved treatments.

“When we think of the kind of person we want to be head of HHS or be FDA commissioner, someone ‘going wild’ isn’t exactly the first trait that comes to mind,” Kanter says. “It wouldn’t ease the public’s concern that we would see more food safety incidents and adverse events from poorly regulated drugs and devices from a lax administration that is known for embracing unscientific theories.”

Kennedy wouldn’t have free rein though. Existing laws and regulations govern how the agency works, and a new FDA commissioner wouldn’t be able to get rid of those quickly. “If you’re dealing with regulatory issues that have been long-standing and have lots of precedent, it’s just not possible to turn some of those things around or dismiss them overnight,” says a past leader of the FDA, who requested anonymity so that they could speak freely.

Likewise, even in a leadership role at HHS or the CDC, Kennedy wouldn’t be able to easily affect vaccine policy. Vaccine recommendations are made by the Advisory Committee on Immunization Practices, which comprises outside medical and public health experts. Georges Benjamin, executive director of the American Public Health Association, says Kennedy could try to stack that advisory committee with people who are sympathetic to his views on vaccination, but those members are chosen through a rigorous nomination process.

“He could certainly change policy that way, but it takes a while and it won't be a secret. There are ways in which the public can push back, including taking a case to court,” he says.

Kennendy could have influence in other ways beyond direct control of a public health agency. Trump could potentially bring Kennedy on as a White House adviser, which wouldn’t require approval by the Senate.

“Without congressional vetting and oversight, there is potential for unchecked impact. RFK's views could shape health policies, raising concerns about misinformation and harm,” Adams says.

Karoline Leavitt, national press secretary for the Trump campaign, told WIRED in an email that if reelected, Trump will establish a “special Presidential Commission of independent minds and will charge them with investigating what is causing the decades-long increase in chronic illnesses.” She did not say whether Kennedy would be chosen for that task force.

Kennedy has also been sizing himself up for another position in a potential Trump cabinet: agriculture secretary. A longtime environmental activist, Kennedy has promised to take on big farms and feedlots, reduce pesticides, and fix what he presents as a food system captured by corporate interests. “When Donald Trump gets me inside,” Kennedy said in a video shot outside the Department of Agriculture headquarters in Washington, DC, “it won’t be that way any more.”

This platform is a continuation of Kennedy’s long history as an antagonist against the agriculture industry. In 2018, Kennedy and a team of attorneys won an initial $289 million settlement against Monsanto, representing a groundskeeper who developed cancer after being soaked with a herbicide made by the agrochemical firm. He also attempted to sue the pig farming company Smithfield because of its production of hog manure, although that case was thrown out by a federal judge.

Kennedy’s past makes him an unlikely candidate for agriculture secretary, according to Daniel Glickman, who served in the role during Bill Clinton’s presidency. “It’s hard for me to imagine, given Trump’s traditional base in the heartlands, that he would pick somebody who was an advocate for breaking up large farms and breaking consolidated agriculture,” says Glickman.

Like top posts at HHS, the USDA secretary position would need to be confirmed by a Senate vote. “I don’t think [Kennedy] is a slam dunk,” says Glickman.

Trump’s pick for USDA chief during his first term was Sonny Perdue, a former governor of Georgia and founder of an agricultural trading company. Most agriculture secretaries either have a background in the industry or politics—two crucial constituencies for the person who will be in charge of a department that employs nearly 100,000 and is made up of 29 agencies, including forestry, conservation, and nutrition programs. “The difference between Sonny Perdue and Robert F. Kennedy, Jr. is like night and day,” says Glickman.

If Kennedy were to be confirmed as agriculture secretary, he might struggle to enact the most radical parts of his program. He is an outspoken critic of pesticides, but the USDA is generally not in charge of regulating those, says Dan Blaustein-Rejto, director of agriculture policy and research at the Breakthrough Institute. Rather, the EPA regulates pesticides with public health uses.

Although he may not be able to directly influence pesticide regulations, Kennedy has said he would try to “weaponize” other agencies against “chemical agriculture” by commissioning scientific research into the effects of pesticides. The USDA Agricultural Research Service has a nearly $2 billion discretionary budget for research into crops, livestocks, nutrition, food safety, and natural resources conservation.

There are other levers that an agriculture secretary could pull, says Blaustein-Rejto. The USDA is investing $3 billion through the partnership for climate-smart commodities—a scheme that’s supposed to make US agriculture more climate-friendly. A USDA chief might be able to put their thumb on their scale by influencing the selection criteria for these kinds of programs. The USDA also oversees the Commodity Credit Corporation (CCC), which has a $5 billion fund that it uses to support farm incomes and conservation programs, and to assist farmers hit by natural disasters. It’s possible that a USDA chief could influence how these CCC funds are distributed by the agency.

Kennedy has also argued that corporate interests have captured the US’s dietary guidelines, and he pledged to remove conflicts of interest from USDA groups that come up with dietary guidelines. US dietary guidelines are developed jointly by the USDA and HHS and are updated every five years, giving the agriculture secretary limited opportunities to influence any recommendations.

“If RFK is in a high-level policy role, I expect to see a lot more talk about ultra-processed foods, but I’m not sure what that would actually entail when it comes to the dietary guidelines,” says Blaustein-Rejto.

The experts WIRED spoke with largely think Kennedy’s more extreme positions will likely be constrained by bureaucracy. But the message that elevating a vocal vaccine skeptic and conspiracy theorist would send remains a serious concern ahead of a potential second Trump administration.

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wlwsuperheroine · 1 year ago

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In my head the best modern world interpretation of princess bubblegum is her being a pharma/biotech start up CEO but the company kept getting bigger and bigger until it affected her personal life including her relationship with marceline

She was a chemistry major and later did a pharmaceutical sciences masters degree alongside an MBA

#no I’m not projecting you’re projecting #women in stem 🙏#princess bubblegum #bonnibel bubblegum #marceline #princess bonnibel #bubbline #adventure time

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wintersbiotechnology · 4 months ago

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#CONO1000 #health #medicine #biotech pharma company

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oidracremedies · 2 months ago

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General PCD Pharma Franchise in Chhattisgarh - Gnova Biotech Chhattisgarh, with its rapidly growing healthcare sector and increasing demand for quality medications, is emerging as a hotbed for entrepreneurs looking to invest in the pharmaceutical industry. A General PCD pharma franchise in Chhattisgarh offers a lucrative opportunity for those who wish to enter the pharma business and capitalize on the state’s healthcare needs. With its diverse population, expanding infrastructure, and both urban and rural markets, Chhattisgarh provides the perfect environment for establishing a profitable pharma franchise.

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beardedmrbean · 1 year ago

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Oct. 3 (UPI) -- Ten U.S. drug manufacturers have agreed to participate in the initial round of the first-ever pricing negotiations between Medicare and the nation's pharmaceutical giants, the Biden administration announced Tuesday.

The highly anticipated Medicare Drug Price Negotiation Program was set to enter its next phase after the Centers for Medicare & Medicaid Services invited the drugmakers to voluntarily join the program in August.

The move comes as President Joe Biden seeks to fulfill a campaign promise to make prescription medicines more affordable for millions of aging Americans.

The drugs on the list are among the most commonly used to treat everything from heart failure, blood clots, diabetes, arthritis, and Crohn's disease, however, average Americans often cannot afford to buy the drugs, Biden said in August when the drug cost reform effort kicked off.

Previously, the White House said the drugs are among the top 50 prescription medications that seniors fill the most at retail pharmacies under Medicare Part D.

The companies electing to participate include Bristol Myers Squibb, Boehringer Ingelheim, Janssen Pharmaceuticals, Merck Sharp Dohme, AstraZeneca, Novartis, Immunex, Pharmacyclics LLC, Jannsen Biotech and Novo Nordisk.

Collectively, the companies' drugs brought in $50.5 billion from prescriptions covered under Part D between June 1, 2022, and May 31, 2023, with consumers paying $3.4 billion in out-of-pocket costs, according to a statement from the Department of Health and Human Services.

"Drug companies that manufacture these drugs have indicated that they will participate in negotiations with Medicare during the remainder of 2023 and in 2024, and any agreed-upon negotiated prices will become effective beginning in 2026," the statement said.

The pricing program is being funded through the Inflation Reduction Act of 2022, which expanded Medicare's authority to negotiate out-of-pocket drug costs, including a $2 monthly cap on certain generic drugs used to treat chronic conditions, as well as a $35 price cap on insulin.

The pandemic-era legislation contains a broad range of actions to mitigate high drug prices, including a plan that adds commercial health insurers to a requirement that forces drug companies to pay rebates to Medicare whenever medicine prices rise faster than inflation.

Merck and Johnson & Johnson have filed multiple lawsuits in an effort to declare Biden's plan unconstitutional.

Biden has vowed to continue to pursue lower drug costs, arguing his pricing plan was working to help struggling Americans while the pharmaceutical industry raked in billions in record profits.

"There is no reason why Americans should be forced to pay more than any developed nation for life-saving prescriptions just to pad Big Pharma's pockets," Biden said at the time.

When the pricing negotiations conclude, the Centers for Medicare & Medicaid Services will announce the prices of the selected drugs on or before September 2024, however, the new drug prices won't go into effect until 2026.

From there, the government will select up to 15 more drugs covered under Part D for 2027, and up to 15 more drugs for 2028, including drugs covered under Part B and Part D.

The program will add up to 20 more drugs each year after that, as required by the Inflation Reduction Act.

#nunyas news #about damn time #now to see if this bites europe in the butt

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biotech-gnova · 6 months ago

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Allopathic PCD Pharma Franchise In Tamil Nadu

Tamil Nadu, a state renowned for its industrial growth and healthcare infrastructure, presents a thriving market for the pharmaceutical industry. With an increasing demand for quality healthcare services and medications, the state offers immense potential for entrepreneurs looking to invest in the pharmaceutical sector. One of the most promising business models in this sector is the Allopathic PCD (Propaganda Cum Distribution) Pharma Franchise. This model allows entrepreneurs to distribute a wide range of allopathic medicines under an established brand, ensuring both profitability and community health benefits. Let's explore the opportunities, benefits, and steps to start an Allopathic PCD Pharma Franchise in Tamil Nadu.

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nuadox · 1 year ago

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Horseshoe crab blood is vital for testing intravenous drugs, but new synthetic alternatives could mean pharma won’t bleed this unique species dry

- By Kristoffer Whitney , Jolie Crunelle , Rochester Institute of Technology , The Conversation -

If you have ever gotten a vaccine or received an intravenous drug and did not come down with a potentially life-threatening fever, you can thank a horseshoe crab (Limulus polyphemus).

How can animals that are often called living fossils, because they have barely changed over millions of years, be so important in modern medicine? Horseshoe crab blood is used to produce a substance called limulus amebocyte lysate, or LAL, which scientists use to test for toxic substances called endotoxins in intravenous drugs.

These toxins, produced by bacteria, are ubiquitous in the environment and can’t be removed simply through sterilization. They can cause a reaction historically referred to as “injection fever.” A strong concentration can lead to shock and even death.

Identifying LAL as a highly sensitive detector of endotoxins was a 20th-century medical safety breakthrough. Now, however, critics are raising questions about environmental impacts and the process for reviewing and approving synthetic alternatives to horseshoe crab blood.

We study science, technology and public policy, and recently published a white paper examining social, political and economic issues associated with using horseshoe crabs to produce LAL. We see this issue as a test case for complicated problems that cut across multiple agencies and require attention to both nature and human health.

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Protecting horseshoe crabs will require persuading the heavily regulated pharmaceutical industry to embrace change.

An ocean solution

Doctors began injecting patients with various solutions in the mid-1800s, but it was not until the 1920s that biochemist Florence Seibert discovered that febrile reactions were due to contaminated water in these solutions. She created a method for detecting and removing the substances that caused this reaction, and it became the medical standard in the 1940s.

Known as the rabbit pyrogen test, it required scientists to inject intravenous drugs into rabbits, then monitor the animals. A feverish rabbit meant that a batch of drugs was contaminated.

The LAL method was discovered by accident. Working with horseshoe crabs at the Marine Biological Laboratory at Woods Hole, Massachusetts, in the 1950s and ’60s, pathobiologist Frederik Bang and medical researcher Jack Levin noticed that the animals’ blue blood coagulated in a curious manner. Through a series of experiments, they isolated endotoxin as the coagulant and devised a method for extracting LAL from the blood. This compound would gel or clot nearly instantaneously in the presence of fever-inducing toxins.

Academic researchers, biomedical companies and the U.S. Food and Drug Administration refined LAL production and measured it against the rabbit test. By the 1990s, LAL was the FDA-approved method for testing medicines for endotoxin, largely replacing rabbits.

Producing LAL requires harvesting horseshoe crabs from oceans and beaches, draining up to 30% of their blood in a laboratory and returning the live crabs to the ocean. There’s dispute about how many crabs die in the process – estimates range from a few percent to 30% or more – and about possible harmful effects on survivors.

Today there are five FDA-licensed LAL producers along the U.S. East Coast. The amount of LAL they produce, and its sales value, are proprietary.

Bait versus biotech

As biomedical LAL production ramped up in the 1990s, so did harvesting horseshoe crabs to use as bait for other species, particularly eel and whelk for foreign seafood markets. Over the past 25 years, hundreds of thousands – and in the early years, millions – of horseshoe crabs have been harvested each year for these purposes. Combined, the two fisheries kill over half a million horseshoe crabs every year.

There’s no agreed total population estimate for Limulus, but the most recent federal assessment of horseshoe crab fisheries found the population was neither strongly growing nor declining.

Conservationists are worried, and not just about the crabs. Millions of shorebirds migrate along the Atlantic coast, and many stop in spring, when horseshoe crabs spawn on mid-Atlantic beaches, to feed on the crabs’ eggs. Particularly for red knots – a species that can migrate up to 9,000 miles between the tip of South America and the Canadian Arctic – gorging on horseshoe crab eggs provides a critical energy-rich boost on their grueling journey.

Red knots were listed as threatened under the Endangered Species Act in 2015, largely because horseshoe crab fishing threatened this key food source. As biomedical crab harvests came to equal or surpass bait harvests, conservation groups began calling on the LAL industry to find new sources.

Biomedical alternatives

Many important medicines are derived from living organisms. Penicillin, the first important antibiotic, was originally produced from molds. Other medicines currently in use come from sources including cows, pigs, chickens and fish. The ocean is a promising source for such products.

When possible, synthesizing these substances in laboratories – especially widely used medications like insulin – offers many benefits. It’s typically cheaper and more efficient, and it avoids putting species at risk, as well as addressing concerns some patients have about using animal-derived medical products.

In the 1990s, researchers at the National University of Singapore invented and patented the first process for creating a synthetic, endotoxin-detecting compound using horseshoe crab DNA and recombinant DNA technology. The result, dubbed recombinant Factor C (rFC), mimicked the first step in the three-part cascade reaction that occurs when LAL is exposed to endotoxin.

Later, several biomedical firms produced their own versions of rFC and compounds called recombinant cascade reagents (rCRs), which reproduce the entire LAL reaction without using horseshoe crab blood. Yet, today, LAL remains the dominant technology for detecting endotoxins in medicine.

A sample of horseshoe crab blood. Florida Fish and Wildlife Commission, CC BY-NC-ND

The main reason is that the U.S. Pharmacopeia, a quasi-regulatory organization that sets safety standards for medical products, considers rFC and rCR as “alternative” methods for detecting endotoxins, so they require case-by-case validation for use – a potentially lengthy and expensive process. The FDA generally defers to the U.S. Pharmacopeia.

A few large pharmaceutical companies with deep pockets have committed to switching from LAL to rFC. But most drug producers are sticking with the tried-and-true method.

Conservation groups want the U.S. Pharmacopeia to fully certify rFC for use in industry with no extra testing or validation. In their view, LAL producers are stalling rFC and rCR approval to protect their market in endotoxin detection. The U.S. Pharmacopeia and LAL producers counter that they are doing due diligence to protect public health.

Change in the offing

Change may be coming. All major LAL producers now have their own recombinant products – a tacit acknowledgment that markets and regulations are moving toward Limulus-free ways to test for endotoxins.

Atlantic fisheries regulators are currently considering new harvest limits for horseshoe crabs, and the U.S. Pharmacopeia is weighing guidance on recombinant alternatives to LAL. Public comments will be solicited over the winter of 2024, followed by U.S. Pharmacopeia and FDA review.

Even if rFC and rCR don’t win immediate approval, we believe that collecting more complete data on horseshoe crab populations and requiring more transparency from the LAL industry on how it handles the crabs would represent progress. So would directing medical companies to use recombinant products for testing during the manufacturing process, while saving LAL solely for final product testing.

Making policy on complex scientific issues across diverse agencies is never easy. But in our view, incremental actions that protect both human health and the environment could be important steps forward.

Kristoffer Whitney, Associate Professor of Science, Technology and Society, Rochester Institute of Technology and Jolie Crunelle, Master's Degree Student in Science, Technology, and Public Policy, Rochester Institute of Technology

This article is republished from The Conversation under a Creative Commons license. Read the original article.