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FDA to weigh looser rules on unproven peptides touted by RFK Jr., MAHA

The Food and Drug Administration will hold a meeting in the summer to consider easing restrictions on more than a half-dozen peptide injections, a group of unapproved therapies that have become popular among wellness influencers, fitness gurus and celebrities.

The meeting announcement Wednesday follows repeated pledges by Health Secretary Robert F. Kennedy Jr. to loosen regulations on peptides, which are often pitched as a quick way to build muscle, heal injuries or appear younger. There’s little research behind those claims and most peptides have not been reviewed for safety by the FDA.

Kennedy has discussed using peptides for his own injuries. And some major supporters of his Make America Healthy Again movement are big proponents of them, including Gary Brecka, a self-described “longevity expert” who sells various peptide formulas through his website.

The FDA said in a federal notice Wednesday that it will ask a panel of outside advisors to review seven peptides at a meeting in July, specifically whether they should be added to a list of substances that can be safely produced by pharmacies. In the meantime, the agency said it would soon remove the chemicals from a restrictive list reserved for unapproved, high-risk drugs. The peptides under discussion include some of the most popular among influencers, such as BPC-157, which is marketed to heal injuries and reduce inflammation.

“The Wild West is about to become wilder,” said Dr. Peter Lurie, a former FDA official who now leads the Center for Science in the Public Interest. In an interview, Lurie said allowing peptides on the market without clinical testing poses a “profound threat” to FDA’s decades-old system for vetting drugs.

“I don’t see why one would take the path of a proper drug approval if there is now this less rigorous, alternative path to market,” he said.

Under President Biden, the FDA added nearly 20 peptides to the federal list of substances that should not be produced by compounding pharmacies — businesses that mix medications that aren’t available from drugmakers.

At the time, the FDA’s panel of pharmacy advisors voted overwhelmingly that the peptides did not meet the criteria for substances that can be safely compounded. And FDA regulators agreed, saying later that the substances “present significant safety risks,” because most have not been extensively tested in humans.

Many of the FDA advisors and internal staff who oversaw those decisions no longer work for the agency. The FDA’s pharmacy panel currently has a number of vacancies, which Kennedy could fill before the July meeting.

Kennedy previewed Wednesday’s move in an interview with podcast host Joe Rogan. Both men have repeatedly spoken about peptides and claimed to have benefited from their use.

RFK Jr. claims personal benefit from peptides

“I’m a big fan of peptides,” Kennedy told Rogan. “I’ve used them myself and with really good effect on a couple of injuries.”

Given Kennedy’s statements, Lurie said it was doubtful the drugs would receive real scrutiny from FDA.

“Everybody knows the outcome that the secretary wants,” Lurie said. “I don’t believe for one moment that what’s going on here is an honest investigation of whether these products should be compounded.”

Scott Brunner of the Alliance for Pharmacy Compounding said the coming meeting will be the start of a “protracted process.” Even if the panel votes to make the peptides available, and the FDA agrees, the agency will still have to draft and publish rules on the change, he noted.

Peptides are essentially the building blocks of more complex proteins. Inside the human body, peptides trigger hormones needed for growth, metabolism and healing.

In recent years peptides have become widely known through the blockbuster success of GLP-1 medications, which the FDA has approved for treating obesity and diabetes. Other FDA-approved peptides include insulin for diabetics and hormone-based drugs for several medical conditions.

But many of the peptides promoted online have never been approved, making them technically illegal to market as drugs. Several peptides, such as BPC-157 and TB-500, are banned by international sports authorities as doping substances.

But that has not stopped them from gaining a foothold in the burgeoning marketplace for wellness hacks and alternative remedies.

“I think this is a disaster in the works,” said Dr. Eric Topol of Scripps Research Translational Institute, who has studied the issue. “These peptides have no data to support their safety and efficacy.”

Meanwhile, some dietary supplement makers have begun mixing peptides into capsules, protein powders and gummies. At a recent FDA meeting, the industry argued for expanding the federal definition of supplements to permit the use of newer ingredients such as peptides in their products.

Safety risks were cited previously

When the FDA added a number of injectable peptides to its list of restricted substances in 2023, it cited safety risks including cancer and liver, kidney and heart problems.

That triggered pushback from wellness entrepreneurs, compounding pharmacies and their allies in Washington.

Last year several members of Congress, including Republican Sen. Tommy Tuberville of Alabama, sent letters to Kennedy asking him to lift limits on peptide production.

Some in the compounding industry argue that FDA restrictions have given rise to an illicit market of imported chemicals from China and other countries, which are not subject to U.S. drug standards.

Kennedy has echoed those concerns.

“With the gray market you have no idea if you’re getting a good product,” Kennedy told Rogan. “And a lot of this stuff that we’ve looked at is just very, very substandard.”

Perrone writes for the Associated Press.

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Newspapers weigh in on election; Obama loses support since 2008

Do newspaper endorsements for president still matter? Certainly not as much as they once did, but that doesn’t stop most newspapers (including this one) from exercising their 1st Amendment right to spout off about their choice of candidate, and it doesn’t stop the presidential campaigns from breathlessly reporting each and every endorsement as if it were handed down by the Oracle of Delphi.

So who’s winning the endorsement race?

That all depends on how you look at it.

According to Editor & Publisher, the longtime bible of the newspaper business, the tally as of Saturday was 112 for Republican Mitt Romney and 84 for President Obama. That list didn’t include papers from Sunday, when many delivered their endorsements, but it suggested a shift from 2008, when E&P;’s final tally showed daily newspapers — which historically have skewed Republican — endorsing Obama over Republican John McCain by a better than 3-2 margin, 296 to 180

The American Presidency Project at UC Santa Barbara has also been tracking endorsements, but it limits its list to the 100 largest newspapers. On average, they tend to have more liberal editorial pages, presumably reflecting their locations in Democratic-leaning big cities. As of Sunday, the project showed 33 endorsements for Obama and 27 for Romney. (Although most newspapers have issued their endorsements by now, a significant number are apparently waiting for the final week of the campaign.)

The tally reflects some notable gains for the GOP, however. According to the American Presidency Project, nine of the 100 top newspapers have switched sides from Obama to Romney since 2008, whereas only one went the other direction.

Among those abandoning the president was his Arlington Heights, Il., Daily Herald in his home state, which cast its lot — albeit a bit hesitantly– with Romney on Sunday.

“We believe that Barack Obama and Mitt Romney are good and decent men who care about the country,” the newspaper wrote. “We believe each possesses extraordinary skills and talent. But, philosophically, it is clear that one trusts government too much; the other appears to trust it too little.” The editorial went on to criticize “the tone of Obama’s relentless insinuations that wealthy Americans refuse to pay their fair share. That tone is divisive and damaging for the nation and for our economy. It creates villains and victims, and unfairly so.” That, it said, was, “ultimately, the point where we must break with him.”

The San Antonio Express-News was the only one of the big papers to go the other way. It had endorsed McCain in 2008. This year, it said that while Obama has “had his failings,” such as a failure to pursue immigration reform and to tackle the debt crisis, “These shortcomings … don’t justify a change in leadership, particularly when many of Mitt Romney’s proposals — such as an across-the-board 20 percent cut in taxes and the elimination of unspecified itemized deductions — invite skepticism.”

Concluded the Express-News: “No candidate has all the right policies — that includes Barack Obama. But having weathered the challenges of the last four years, we believe he is in a better position to guide the nation over the next four years — and has earned from voters the privilege to do so.”

It is probably in the nature of newspaper editorials to stop short of adulation and unbridled enthusiasm. That certainly is the case with virtually all the endorsements of Obama and Romney, very few of which are wholehearted.

The Chicago Tribune (owned by the Tribune Co., which also owns The Times) endorsed Obama, but its editorial page editors said, “On questions of economics and limited government, the Chicago Tribune has forged principles that put us closer to the challenger in this race, Republican Mitt Romney. We write with those principles clearly in our minds. Romney advocates less spending, less borrowing — overall, a less costly and less intrusive role for government in the lives of the governed.” So why not just endorse Romney? The Trib concluded that he had been “astonishingly willing to bend his views to the politics of the moment: on abortion, on immigration, on gun laws and, most famously, on healthcare.”

And several newspapers that did endorse Romney expressed the hope that, if elected, he would turn out to be the moderate Romney, not the “severe” conservative he presented himself to be in the Republican primaries.

“Let us stipulate,” said the Houston Chronicle, the largest newspaper to switch from Obama in 2008 to Romney this year. “The Mitt Romney we are endorsing is the Massachusetts moderate who worked successfully alongside an 88 percent Democratic majority in the state Legislature to produce what the Obama administration says became its model for national healthcare reform.”

Not everyone was so equivocal. The New York Post, never known for mincing words, did not choose this occasion to begin.

“Four frustratingly long years ago, a war-weary and economically battered America took a flier on a savior,” the Post wrote.

Next paragraph, in full: “It didn’t work out.”

Some newspapers that endorsed candidates in 2008 decided not to pick anyone this year. The Oregonian, in Portland, supported Obama four years ago, during a campaign in which he held one of his largest rallies in that city. The paper sounded a bit miffed this year when it said it wasn’t endorsing anyone this time around because the candidates hadn’t campaigned in Oregon. “The access and close observation that inform our endorsements for state and local offices and Congress do not apply in a national race; our CNN-level view of the presidential race is similar to everyone else’s,” the paper said.

The New York Times was the largest of the nation’s newspapers to endorse a candidate. It concluded Saturday that Obama “has formed sensible budget policies that are not dedicated to protecting the powerful, and has worked to save the social safety net to protect the powerless.” Romney, it said, “has gotten this far with a guile that allows him to say whatever he thinks an audience wants to hear. But he has tied himself to the ultraconservative forces that control the Republican Party and embraced their policies, including reckless budget cuts and 30-year-old, discredited trickle-down ideas.”

The two largest newspapers in the country, the Wall Street Journal and USA Today, do not usually issue formal endorsements, although the Journal has made no secret of its strong preference for Romney.

The Los Angels Times, for what it’s worth, endorsed Obama and followed up with an explanation from Editorial Page Editor Nick Goldberg of why the newspaper endorses anyone at all, given its mandate to be nonpartisan and unbiased in its news articles. The article contained one reminder of the historically less-than-awesome power wielded by newspaper endorsements: The Times’ first endorsement, in 1884, was for Republican James G. Blaine.

Remember him?

mitchell.landsberg@latimes.com

Twitter: @LATlands



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Will there be a Detective Hole season 2? Stars weigh in on Netflix crime drama

We spoke exclusively to Detective Hole creator Jo Nesbø and lead star Tobias Santelmann about the Netflix crime drama’s future

Netflix has only just dropped its thrilling new crime drama Jo Nesbø’s Detective Hole but some viewers are already keen to know if there will be another series.

The nine-part detective series is adapted from best-selling crime author Nesbø’s The Devil’s Star and takes Netflix viewers on quite the ride.

Detective Hole follows troubled detective Harry Hole (Tobias Santelmann) as he races against the clock to track down a serial killer before they can strike again.

At the same time, Harry is locked in a dangerous cat-and-mouse game with crooked fellow police officer Tom Waaler (Joel Kinnaman).

Will there be a Detective Hole season 2?

In an exclusive interview with Mirror publishers Reach Plc, creator Nesbø, lead actor Santelmann and Beate Lønn star Ellen Helinder addressed the future of the show.

Nesbø said: “No plans yet [for a season two]. Right now, we’re just concentrating on getting this TV series out to the audience and we’ve been working on this for three years now.

“So, just the thought of starting all over again right now is a bit premature and we’re so exhausted right now that we want a vacation.”

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However, Harry Hole star Santelmann said: “I’m ready. You might be exhausted.”

Nesbø jokingly added: “You’re ready? Then I’m ready too for season two.”

The crime author admitted that he hadn’t yet thought about the direction he’d like to take the show in or which Harry Hole novel a possible season two might take.

Meanwhile, actress Helinder, who portrays the brilliant forensics officer Beate, shared her hopes for more seasons of Detective Hole: “Just to keep working with these amazing people and develop the characters even more.

“There’s so much to find in these people, who work within the law enforcement.

“Even more the morality, the ethical dilemmas and how is Harry going to cope with everything? Who is Beate? I would like to explore her backstory.

“I think this ability that she has for facial recognition is so cool, just for her to keep tracking cases and doing her thing.”

Given Jo Nesbø’s Detective Hole has only just been released, Netflix will be keeping an eye on the viewing figures before making any renewal decisions.

The Devil’s Star is just one of 13 Harry Holes books that Nesbø has written, so there is plenty of content for the programme-makers and indeed the author, who also served as the screenwriter on the Netflix series, to draw on.

Jo Nesbø’s Detective Hole is streaming on Netflix now

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