Tag: pharmaceutical industry

RFK Plans to Take on Big Pharma. It’s Easier Said Than Done

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But the administration would likely face legal challenges if it proposed additional restrictions or an outright ban on pharma ads, says Jim Potter, executive director of the nonpartisan Coalition for Healthcare Communications. “The courts view advertising as a form of commercial speech, and they’ve ruled in a series of cases dating back to the 1970s that banning advertising violates First Amendment protections of freedom of speech,” he says. “If the administration wanted to unilaterally impose new rules, they would be on shakier legal ground today than in past years.”

That’s because the US Supreme Court last summer overturned the longstanding Chevron doctrine, which allowed federal agencies some latitude in how they interpreted ambiguous laws. The Supreme Court ruling shifts power from agencies like the FDA to the courts.

Ballreich and Weissman worry that Kennedy’s support of raw milk, vitamins, and disproven treatments for Covid-19, including ivermectin and hydroxychloroquine, could lead to the agency approving medicines that lack scientific evidence.

“I think when Robert Kennedy talks about fighting corruption and Big Pharma monopolies, that is going to translate into reducing standards at FDA to enable the authorization and promotion of ineffective and dubious therapies, drugs, herbs, whatever,” Weissman says.

As HHS secretary, Kennedy would not be directly responsible for approving new drugs or treatments. That job falls to the FDA’s Center for Drug Evaluation and Research, which more often than not approves drugs based on the recommendations of independent advisory committees. But in a handful of controversial cases, the agency has approved drugs against this expert advice, such as when it greenlit Exondys 51, a drug for Duchenne muscular dystrophy, in 2016. FDA advisers said there was not enough evidence to show that the drug had actual clinical benefits.

RFK has also called for more scrutiny of vaccines, which already must be tested on thousands of healthy volunteers for several years before being licensed. This skepticism could play out in fewer vaccines making it to the market and more postmarket monitoring of approved vaccines.

Working with Mehmet Oz, Trump’s pick to lead the Centers for Medicare and Medicaid Services, Kennedy could push to get questionable treatments or medical devices covered by Medicare, the federal health insurance program for people aged 65 or older and those with disabilities.

But Kennedy’s anti-pharma stance could be tempered by congressional Republicans, who have been historically reticent about more regulation, and Trump’s other appointees. The incoming president has made a more conventional pick for FDA commissioner in Marty Makary, a pancreatic surgeon and public policy researcher at Johns Hopkins. Meanwhile, Vivek Ramaswamy, founder of the pharmaceutical company Roivant Sciences and a Republican presidential candidate, has been tapped to lead the Department of Government Efficiency, or DOGE, a planned presidential advisory commission under the second Trump administration.

“There are huge question marks with the Trump administration and its approach to pharmaceuticals in general,” Ballreich says. “It’s hard to know how this is really going to shake out.”

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December 12, 2024
Mark Cuban’s War on Drug Prices: ‘How Much Fucking Money Do I Need?’

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When Mark Cuban is feeling spicy, he’ll always let you know. The billionaire businessman, basketball owner, and Shark Tank empresario lit up WIRED’s The Big Interview event on Tuesday, dropping hot takes about Elon Musk, the pharmaceutical industry, and why he thinks “couch fucking” and Gary Gensler’s crypto policy cost Kamala Harris the election.

Chatting with WIRED senior writer Lauren Goode, Cuban touted the trajectory of Cost Plus Drugs, the pharmaceutical company he cofounded in 2022. By offering transparency on costs and pricing policies, Cuban says his company has been able to disrupt the drug industry, offering consumers drugs like Droxidopa for something like $20 per month versus the more than $3,000-a-month uninsured patients were being quoted.

“We’ve lowered the price of [one of our 2,500 medications] every single weekday for 18 months,” Cuban boasted, saying the company has also found great success in publishing its entire price list, something that’s always been incredibly hard to obtain from other drug providers for consumers and researchers alike.

Now, Cuban says, studies have come out showing that if Medicare bought, for instance, nine specific drugs from Cost Plus Drugs instead of their other sources, the government would save billions of dollars, something that not only shows the bloat of the healthcare system but also the tangible effect that one well-funded company can have.

It’s not that Cuban’s not making money on Cost Plus Drugs, either, because he is. He could be making more, he told Goode, but as he put it, “How much fucking money do I need? I’m not trying to land on Mars.”

The crack, presumably directed at Elon Musk, was just one of several remarks Cuban made about the billionaire X owner. For one, he spoke about his own move from X to Bluesky in recent months, saying that he thinks it’s an overall “existential moment” for Musk’s platform.

Because of Bluesky’s troll-blocking capabilities and what Cuban calls more engagement-friendly policies, he says he’s found it much easier to engage there, whether it’s Kamala Harris, cryptocurrency or the Dallas Mavericks basketball team, in which he owns a minority stake. “If you want to know what Elon thinks, Twitter’s amazing,” Cuban joked, but added that he thinks Bluesky is more of a true “social network” in comparison.

Mark Cuban and Lauren Goode at The Big InterviewPhotograph: Tristan deBrauwere

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December 3, 2024
The Maker of Ozempic Is Trying to Block Compounded Versions of Its Blockbuster Drug

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Drugmaker Novo Nordisk is taking action to curb the massively popular compounded semaglutide industry, which provides copies of its blockbuster weight-loss drugs Ozempic and Wegovy to patients—often for much lower prices.

The Danish pharmaceutical company is lobbying the US Food and Drug Administration to add semaglutide to the agency’s Demonstrable Difficulties for Compounding (DDC) lists, which would block compounding pharmacies from producing dupes of the drug. In a filing posted by the agency on Tuesday, lawyers for Novo Nordisk reason that semaglutide belongs on these lists “due to the complexities associated with their formulations,” among other reasons.

“These drugs are inherently complex to compound safely, and the risks they pose to patient safety far outweigh any benefits. Novo Nordisk’s aim with this nomination is to ensure that patients receive only FDA-approved, safe, and effective semaglutide product,” says Novo Nordisk director of media relations Jamie Bennett.

FDA press officer Amanda Hils told WIRED via email that the agency “is reviewing the petition and will respond directly to the petitioner.”

If granted, the designation would have seismic implications for the compounding industry—and for the likely millions of people currently taking compounded GLP-1 drugs.

Injectable GLP-1 drugs including semaglutide and tirzepatide have been in shortage since 2022 because of their huge popularity. In the US, when the FDA declares that a drug is in shortage, certain licensed pharmacies are permitted to make “compounded” versions of the medication, which are mixed in-house and are supposed to contain the same active ingredients as the original drug.

Telehealth providers have capitalized on the GLP-1 drug shortage, offering patients compounded versions via quick virtual appointments. The practice has created tension with the pharmaceutical companies that make the brand-name drugs, since the compounded versions are sold at much lower prices. Ozempic and Wegovy can cost around $1,000 a month without insurance, while compounded semaglutide is advertised for as low as $100 a month online.

Unlike generic medications, which are manufactured after drug patents expire, compounded medications are not subject to FDA approval before hitting the market. This means that the FDA cannot vouch for the safety, effectiveness, or quality of compounded drugs before they’re sold to patients. The FDA has received multiple reports of adverse side effects, including hospitalization, related to possible dosing errors associated with compounded semaglutide products.

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October 23, 2024
After Shark Tank, Mark Cuban Just Wants to Break Shit—Especially the Prescription Drug Industry

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What do you mean by that?

Because your insurance company, whoever it may be, uses a PBM, a pharmacy benefit manager. The PBM has negotiated with a pharmacy what the reimbursement rate is. Except they basically said, “Here’s what we’re going to reimburse you.” [His Apple Watch buzzes.]

You can go ahead and check that.

It’s my son. [Speaking into watch.] We’ll do a late lunch. Don’t worry about it. Go ahead and have fun. [Back to the interview.] He’s playing basketball.

Nice.

So, with the PBMs, there’s no negotiation. Particularly for the small independent pharmacies, they take it or leave it. And: “Oh, by the way, you are not allowed to say anything about this contract at all.” Period. The number one rule of health care contracts is you don’t talk about health care contracts. So instead of breaking even, the pharmacy might lose $20 to $30 on every brand subscription they’re doing. The idea is, they’ll make it up on toilet paper and other stuff. Well, that doesn’t work.

And the drug manufacturer?

The PBMs also negotiate with the manufacturers, but they lose out as well. They have no idea who is using their medications, what the demographics are, what the adherence is. So the PBM will offer to do analysis for them, and then sell the manufacturer access to the data for their own drug.

Then the trade association for the PBM says, “Look at the bad guys!” It’s so convoluted and opaque.

[Greg Lopes, a spokesperson for the Pharmaceutical Care Management Association, a trade group, told WIRED, “PBMs have a proven track record of securing savings on prescription drugs for patients.” He added that drug companies “are solely responsible for setting and raising prescription drug prices.”]

OK, so you saw how these entities bought up drugs and controlled the market. Why didn’t you, a billionaire, take that approach with other drugs? Why didn’t you say, I’m going to buy all the insulin in America?

Well, we looked at manufacturing insulin. We developed our own glargine [synthetic] insulin, and I spent $5 million or more, I don’t even know. But that was right when Biden made sure Medicare plans were covering insulin for up to a $35 copay. So it made no sense to do it at that point.

You told Texas Monthly that you don’t care if you don’t make a fortune off of this. Is that still true?

I want to make it so it’s self-sustained. I don’t want to subsidize it the whole time. But I don’t need to make money.

Do you see Cost Plus Drugs as altruistic?

No. I see it as fun with a huge impact. Altruism is like, “Great, I feel good because I’m helping people. I gave money and da-da-da-da-da.” Disrupting an industry that everybody hates, that’s fun. I’m getting emails and letters, if not every week, every two weeks, saying, “Oh my God, my grandma’s alive.” I just got a note from someone who wrote, “You saved me $15,000 a year on my cancer medication. I would be dead if it weren’t for you.”

Photograph: Michelle Groskopf

What’s interesting is—and I’m not going to say midlife crisis—it does seem like you’re at least thinking about your legacy now.

But if I was 25 and this opportunity came up—

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September 12, 2024
The FDA Just Rejected a Bid for MDMA’s Approval to Treat PTSD

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The US Food and Drug Administration has rejected a first-of-its-kind proposal to use the psychedelic drug MDMA, also known as ecstasy or Molly, as a treatment for post-traumatic stress disorder.

Drugmaker Lykos Therapeutics had asked the FDA to approve the drug in combination with talk therapy. The company said Friday that the regulatory agency has requested an additional Phase 3 trial so that the safety and efficacy of the therapy can be further studied. The decision comes after an FDA advisory panel in June concluded that there wasn’t enough evidence to recommend its approval.

Lykos said it plans to request a meeting with the FDA to ask for reconsideration of the decision and to further discuss the agency’s recommendations. “The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades,” said Lykos CEO Amy Emerson in a company statement. She added that conducting another Phase 3 trial would take several years.

As many as 13 million Americans suffer from PTSD in any given year, according to the National Center for PTSD. Just two drugs have been specifically approved to treat the disorder, with the latest being greenlit by the FDA in 2000. The lack of options has turned combat veterans into unlikely advocates for MDMA-assisted therapy. In the days leading up to the FDA decision, veterans groups and members of Congress from both parties pressed for its approval.

In a letter to President Biden, more than 300 veterans and representatives of veterans service organizations wrote that MDMA-assisted therapy “offers desperately needed hope for veterans and their families, with the potential to save and drastically improve countless lives over the coming years.”

A bipartisan group of more than 60 members of the House of Representatives and 19 senators also voiced their support for the therapy this week. “Given the substantial burden of PTSD and the current treatment limitations, the possibility of new, more effective therapies is particularly meaningful,” the lawmakers wrote in a letter to FDA commissioner Robert Califf.

There has been increasing interest in recent years in using MDMA and other psychedelics to treat severe mental illness. But with the FDA decision, MDMA will remain a federally prohibited substance listed as Schedule I drug, defined as those that have “no currently accepted medical use and a high potential for abuse.”

During a nine-hour meeting on June 4, Lykos representatives made their case to an independent panel of FDA advisers. The company’s clinical trial data showed that more than 86 percent of study participants who underwent MDMA-assisted therapy experienced a measurable reduction in the severity of their PTSD symptoms, and 71 percent improved enough that they no longer met the criteria for a diagnosis. In a placebo group, 69 percent improved and nearly 48 percent no longer qualified for a PTSD diagnosis.

Despite the positive results, advisory committee members cited concerns about the reliability of the clinical trial data, the long-term efficacy of the treatment, and the standardization of the talk therapy given during the MDMA sessions. One major question raised by the advisory committee was the extent to which the talk therapy contributes to the treatment benefit.

The panel overwhelmingly voted that there wasn’t enough evidence to recommend approval. Just two of the 11 committee members agreed that MDMA-assisted therapy is effective based on the evidence Lykos presented, and only one thought its benefits outweighed the risks. The FDA usually follows the recommendations of advisory committees but is not obligated to do so.

Lykos said it will “work diligently in the coming months to address FDA’s concerns and to take advantage of agency processes to resolve scientific disagreements.”

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August 9, 2024
A Pill That Kills Ticks Is a Promising New Weapon Against Lyme Disease

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If you have a dog or cat, chances are you’ve given your pet a flavored chewable tablet for tick prevention at some point. What if you could take a similar pill to protect yourself from getting Lyme disease?

Tarsus Pharmaceuticals is developing such a pill for humans—minus the tasty flavoring—that could provide protection against the tick-borne disease for several weeks at a time. In February, the Irvine, California–based biotech company announced results from a small, early-stage trial showing that 24 hours after taking the drug, it can kill ticks on people, with the effects lasting for up to 30 days.

“What we envision is something that would protect you before the tick would even bite you,” says Bobby Azamian, CEO of Tarsus.

Lyme disease is a fast-growing problem in the United States, where approximately 476,000 people are diagnosed and treated for it each year, according to the most recent data from the Centers for Disease Control and Prevention. That number is likely an overestimate, because many patients are treated after a tick bite even if an infection isn’t confirmed, but it underscores the burden of Lyme disease on the health care system—which researchers at the CDC and Yale University put at nearly $1 billion per year.

The disease is caused by the bacteria Borrelia burgdorferi, which gets passed to humans through the bite of an infected tick. In most cases, a tick has to be attached for around 36 to 48 hours before the bacteria can be transmitted. Symptoms include fever, headache, fatigue, and a characteristic skin rash that looks like a bullseye.

Without a vaccine for Lyme disease on the market, current prevention includes using insect repellents such as DEET and permethrin and wearing closed shoes, long pants, and long sleeves when in a tick-infested area.

“We’ve seen increasing rates of tick-borne diseases over the years, despite being told to do tick checks, use DEET, and impregnate your clothes with permethrin,” says Paul Auwaerter, a professor of medicine at the Johns Hopkins University School of Medicine who studies Lyme disease.

A more effective treatment strategy would be welcome, Auwaerter says, especially because Lyme disease can sometimes cause serious health issues. Antibiotics are usually effective when taken early, although about 5 to 10 percent of patients can have lingering symptoms for weeks or months. If left untreated, the infection can spread to the joints and cause arthritis. It can also become established in the heart and nervous system, causing persistent fatigue, numbness, or weakness.

The experimental pill that Tarsus Pharmaceuticals is testing is a formulation of lotilaner, a drug that paralyzes and kills parasites by interfering with the way that signals are passed between their nerve cells. Lotilaner is already approved as a veterinary medicine under the brand name Credelio to control fleas and ticks in dogs and cats.

“Our animals have better options than we do for tick prevention,” says Linden Hu, a professor of immunology at Tufts Medical School who led the Tarsus trial. “There are quite a few drugs and vaccines available for dogs and cats, but there’s nothing for us.”

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March 15, 2024
A Study at the Center of the Abortion Pill Battle Was Just Retracted

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Scientific publisher Sage Journals has retracted three papers on abortion—including a controversial 2021 study on mifepristone, the medication at the center of a US legal battle.

The 2021 study found that mifepristone, one of two pills used in a medication abortion, significantly increased the risk of women going to the emergency room following an abortion. The study, along with another retracted paper from 2022, was cited by US District Judge Matthew Kacsmaryk in the April 2023 ruling that invalidated the Food and Drug Administration’s approval of the drug.

Mifepristone was approved in 2000 by the Food and Drug Administration, the federal agency that evaluates the safety and efficacy of drugs, and has been used by at least 5.9 million women in the US since then. The drug blocks a hormone called progesterone that’s needed for a pregnancy to continue. It’s used alongside another pill, misoprostol, to induce an abortion within 10 weeks of pregnancy.

The three retracted studies were published in the journal Health Services Research and Managerial Epidemiology in 2019, 2021, and 2022. In July 2023, Sage issued an “expression of concern” about the 2021 paper, saying it was launching an investigation into the article.

According to Sage, a reader contacted the journal with concerns about misleading presentations of data in the 2021 article on mifepristone. The person also questioned whether the authors’ affiliations with pro-life advocacy organizations, including the Charlotte Lozier Institute, present conflicts of interest that the authors should have disclosed in the article.

In a retraction notice published on February 5, Sage said an independent reviewer with expertise in statistical analyses evaluated the concerns and concluded that the article’s presentation of the data in certain figures leads to an inaccurate conclusion. The reviewer also found that “the composition of the cohort studied has problems that could affect the article’s conclusions,” according to Sage.

As part of the publisher’s investigation, Sage said, two subject matter experts conducted an independent post-publication peer review of the three articles and found that they “demonstrate a lack of scientific rigor.” In the 2021 and 2022 articles, the reviewers found problems with the study design and methodology, errors in the authors’ analysis of the data, and misleading presentations of the data. In the 2019 article, the experts identified unsupported assumptions and misleading presentations of the findings.

“The retractions are not scientifically warranted as is easily demonstrable to any trained, objective scientist,” James Studnicki, the lead author on all three studies, told WIRED via email.

Studnicki, the vice president and director of data analytics of the Charlotte Lozier Institute, shared with WIRED a copy of a point-by-point rebuttal he and his coauthors submitted to Sage in response to the retractions.

In the 2021 study on mifepristone, Studnicki and his coauthors used data from Medicaid claims of 423,000 medication and procedural abortions between 1999 and 2015. Of those, over a quarter visited a hospital emergency room within 30 days of the abortion. During the study period, they found that emergency room visits associated with medication abortion rose much faster when compared to rates following a surgical abortion.

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February 7, 2024
A Startup Has Unlocked a Way to Make Cheap Insulin

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Now some key patents have expired, and the US Food and Drug Administration has paved the way for biosimilar versions of insulin—so-called because they’re almost identical to another product already on the market. For a product to be biosimilar, it must be highly similar in structure to the original and work just as well in patients.

Owen’s company, founded in 2020, has designed supercharged E. coli-like bacteria that can produce much greater amounts of insulin than existing strains used in insulin production. To do that, the company struck up a collaboration with Sergej Djuranovic, a professor of cell biology and physiology at Washington University School of Medicine in St. Louis. In 2019, Djuranovic’s lab discovered a sequence of amino acids—the building blocks of proteins—that could make a gene produce far more proteins than is usual. He and his colleagues found that the sequence worked in bacterial, yeast, and even human cells.

“This sequence of certain amino acids will boost up protein production, and it’s purely because the protein is being made more efficiently,” Djuranovic says.

In theory, the sequence could be used to pump out large amounts of any protein, including insulin. Being able to produce insulin more efficiently is why rBIO thinks it can drive the cost down.

A 2018 study estimated that it costs roughly $2 to $4 to produce a vial of synthetic insulin. Owen says rBIO can do it even more cheaply, since its process yields more of the drug.

“New technologies that will make it even less expensive are certainly good, but they’re not going to be huge game changers right away,” says Robert Lash, a diabetes expert and chief medical officer of the Washington, DC-based Endocrine Society. Ultimately, he thinks more competition will be better for patients. “The more companies that are making insulin and the more options patients have available, the less expensive it’s going to become over time,” he says.

Even with the FDA’s blessing, few players outside the big three insulin manufacturers have broken into the market. In July 2021, the drug Semglee from Mylan Pharmaceuticals and Biocon Biologics became the first biosimilar insulin approved by the FDA, as an interchangeable product for Sanofi’s Lantus insulin. Later that year, the agency approved Rezvoglar by Eli Lilly as a biosimilar for Lantus, made by Sanofi. The three major insulin makers have also come out with unbranded versions of their own brand-name insulins.

Utah-based Civica, a nonprofit pharma company, announced plans in 2022 to manufacture and distribute its own low-cost insulin, pledging to cap prices at $30 per vial and $55 for a box of five cartridges. Last year, California entered into a contract with Civica so that the state could produce its own affordable insulin.

Owen says rBIO is aiming to reduce the cost of insulin by 30 percent. Its product, R-biolin, is designed to be a copy of Novo Nordisk’s Novolin, an insulin that starts acting within 90 minutes and lasts for 24 hours. This month, Novo Nordisk lowered the list price for several of its branded and unbranded insulins, including Novolin. It now charges $48.20 for a vial and $91.09 for a FlexPen of Novolin.

The Houston startup still has to prove whether its insulin works as well as Novolin, and even then, rBIO will have little control over the price patients end up paying. Like other manufacturers, rBIO would sell its insulin to pharmacy benefit managers. “We still think we can lower the cost significantly,” Owen says.

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February 2, 2024