Tumor Has ItJun 1, 10:00 AM EDT / by Noor Al-Sibai400 Women Are Suing Pfizer Over Birth Control Shot That Allegedly Gave Them Brain TumorsThe pharmaceutical giant allegedly knew about the risks... but didn't warn patients.Jun 1, 10:00 AM EDT / Noor Al-SibaiImage by Beata Zawrzel / NurPhoto via Getty / FuturismRx/MedicinesRecent research has linked Pfizer's widely-used Depo-Provera birth control shot to massively increased risk of developing brain tumors — and hundreds of women are suing the pharmaceutical giant over it.According to a press release filed on behalf of the roughly 400 plaintiffs in the class action suit, the lawsuit claims that Pfizer and other companies that made generic versions of the injectable contraceptive knew of the link between the shot and the dangerous tumors, but didn't properly warn users.The suit follows a study published by the British Medical Journal last year that found that people who took the progestin-based shot for a year or more were up to 5.6 times more likely to develop meningioma, a slow-building brain tumor that forms, per the Cleveland Clinic, on the meninges, or layers of tissue that covers the brain and spinal cord.Though Pfizer attached warning labels about meningioma to Depo-Provera sold in Canada in 2015 and the UK, Europe, and South Africa after the 2024 study was published, no such label was deployed in the United States — a failure which according to the lawsuit is "inconsistent [with] global safety standards."In an interview with the website DrugWatch, one of the suit's plaintiffs, who was identified by the initials TC, said that she had been "told how great Depo-Provera was" and decided to start it after an unplanned pregnancy that occurred when she'd taken the since-discontinued birth control pill Ortho Tri-Cyclen Lo."I thought it would be more reliable and convenient since I wouldn’t have to take it daily," TC told the site, referencing the four annual injections Depo-Provera requires. "I had no idea it would lead to such serious health problems."After being on the contraceptive shot for three years — and experiencing intense headaches, months-long uterine bleeding, and weight gain — the woman finally consulted her doctor and was diagnosed with meningioma. She's since been undergoing treatment and experienced some relief, but even that experience has been "physically and emotionally draining" because she has to get regular MRIs to monitor the tumor, which likely isn't fatal but still greatly affects her quality of life."It’s a constant worry that the tumor might grow," TC said, "and the appointments feel never-ending."That fear was echoed by others who spoke to the Daily Mail about their meningioma diagnoses after taking Depo-Provera. Unlike TC, Andrea Faulks of Alabama hadn't been on the shots for years when she learned of her brain tumors, which caused her years of anguish.Faulks told the British website that she'd begun taking the medication back in 1993, the year after it was approved by the FDA in the United States. She stopped taking it only a few years later, but spent decades having splitting headaches and experiencing dizziness and tremors. After being dismissed by no fewer than six doctors, the woman finally got an MRI last summer and learned that she had a brain tumor — and is now undergoing radiation to shrink it after all this time."I know this is something I'm going to have to live with for the rest of my life, as long as I live," Faulks told the Daily Mail.Currently, the class action case against Pfizer on behalf of women like Faulks and TC is in its earliest stages as attorneys representing those hundreds of women with brain tumors start working to make them whole.Even if they receive adequate payouts, however, that money won't take away their suffering, or give them back the years of their life lost to tumors they should have been warned about.Share This ArticleImage by Beata Zawrzel / NurPhoto via Getty / FuturismRead This Next

The Flatiron Building, 25 Water Street, old Pfizer World Headquarters, Pearl House, 55 Broad Street—these are just a few New York addresses slated for office-to-residential conversion. Now add another one to list: 5 Times Square. Ernst & Young built 5 Times Square in 2002 for its headquarters, with Kohn Pedersen Fox (KPF) as the design architect, but the corporation vacated the premises in 2022. The vacancy rate has hovered around 75 percent ever since. Now, Gensler is converting 5 Times Square into a residential property fitted with 1,250 market rate and affordable homes. Gensler is also behind a number of other prominent office-to-residential conversions in New York today, including Pearl House and the old Pfizer World HQ, as reported by AN. 5 Times Square rises 575 feet in a 38 story envelope. Governor Hochul affirmed that, of the new 1,250 units, 313 of those will be affordable, or roughly a quarter’s worth. No changes need be made to the building envelope, city officials shared, because the floor plates are already “well-suited” for residential purposes. “Confronting a decades-long housing crisis requires creating new housing in every neighborhood at an accelerated pace—even here at the ‘Crossroad of the World’ in Times Square,” Mayor Adams said in a statement. “The transformation of 5 Times Square from an underutilized office building into 1,250 new homes capitalizes on hard-fought Adams and Hochul administration victories while fulfilling my plan to build 100,000 new homes in Manhattan over the next decade.” 5 Times Square totals approximately 1 million square feet. Of that number, over 900,000 square feet will be converted into residential space, while about 40,000 square feet will remain retail. The initiative is part of Mayor Adams’s Manhattan Plan, which seeks to add 100,000 new homes in Manhattan in the next decade. The conversion was made possible by an amendment to the 42nd Street Development General Project Plan, announced yesterday by Adams, Hochul, and the Empire State Development (ESD) Board of Directors. Deputy Mayor for Housing, Economic Development, and Workforce Adolfo Carrión, Jr. called 5 Times Square’s conversion “a game-changer for Times Square and Midtown, paving the way for the future of urban growth.” Construction should begin by the end of 2025 and complete in 2027.

The Food and Drug Administration plans major changes for how Covid vaccines are rolled out and who will be able to get the updated shots this fall. In a paper published Tuesday in the New England Journal of Medicine, the FDA commissioner, Dr. Marty Makary, and Dr. Vinay Prasad, the FDA’s new vaccine chief, wrote that any new Covid vaccine now must undergo placebo-controlled clinical trials — meaning some people would get the actual vaccine while others would get an inactive substance like a saline shot, to compare results. At a planned FDA vaccine panel meeting Thursday, agency advisers are expected to advise the vaccine makers about which strains to target for new shots. The new clinical trial requirement isn't expected to affect the fall rollout for older adults and other people at high risk for severe illness because drugmakers are exempt from additional testing for those groups. Makary and Prasad said in a question-and-answer session later Tuesday that annual shots for healthy children and adults would no longer be routinely approved. They also suggested that the vaccines may not be updated every year.“Instead of having a Covid strategy that’s year to year, why don’t we let the science tell us when we should change?” Prasad said. “The virus doesn’t have a calendar.”Previously, updated Covid vaccines had been cleared by the FDA similar to flu vaccines. The original Covid shots, from Pfizer and Moderna, approved in late 2020, went through placebo-controlled trials. Then, the drugmakers transitioned to smaller studies to test how well the updated shots triggered immune responses against the current variants circulating in the U.S.In the journal article, Makary and Prasad cast doubt on the flu vaccine model, noting that only a quarter of people in the U.S. get the updated shots each year, including less than a third of health care workers. In comparison, about 75% of health care workers get seasonal flu shots, according to data from the Centers for Disease Control and Prevention. The Covid shot policy, the officials wrote, “has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations.” “We reject this view,” they added. Dr. Jesse Goodman, a professor of medicine and infectious disease at Georgetown University and a former chief scientist at the FDA, agreed that people can understand their own health risks but was skeptical of the agency’s new approach, saying it limits people’s “freedom to choose.”“What about people with elderly or high risk relatives/housemates?” he wrote in an email. “What about people who are not at increased risk of severe disease who want to reduce their risk of infection or time off from work?”During the webcast, Prasad claimed that “there is no high-quality evidence that you getting a booster to visit your grandma protects your grandma.”Who will be able to get the Covid shots?Under the FDA’s new guidance, the drugmakers will need to run new trials that track participants for at least six months. The main goal of the trials should be to show that the shots help prevent symptomatic Covid, the officials wrote, with data showing at least 30% effectiveness. People who’ve had Covid in the past should still be included in the trial to better reflect the general population, they said. Drugmakers can still use smaller studies, known as immunogenicity studies, to get approval for adults 65 and up, as well as children and adults with at least one medical condition that puts them at higher risk for Covid. The FDA said many people are considered at high risk, including pregnant women and those with obesity or who have mental health conditions such as depression. Other conditions linked to severe Covid illness include diabetes, heart disease and asthma. “Ultimately, these studies alone can provide reassurance that the American repeat-boosters-in-perpetuity strategy is evidence-based,” the officials wrote.Estimates, they said, suggest that 100 million to 200 million people in the U.S. will have access to the updated vaccines.The FDA’s mandate comes ahead of Thursday’s vaccine advisory committee meeting, where outside experts will discuss which strains should be included in the next round of Covid shots. In briefing documents published earlier Tuesday, FDA staff members wrote that updating the vaccines to more closely match currently circulating strains may “provide added benefit” in anticipation of an uptick in cases during the fall and winter.The change means it will be near impossible for Pfizer and Moderna to complete the new trials in time for the fall season. Aside from running the trials, the drugmakers will still need to design the trials and enroll participants, which can also take several weeks or months.A medical professional prepares a Pfizer Covid-19 vaccine booster shot in Freeport, NY., on Nov. 30, 2021.Steve Pfost / Newsday via Getty Images fileThe data would then need to be analyzed and signed off on by the FDA. It’s also unclear what the change will mean for healthy children and adults who want to get the updated shots. Dr. Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA’s vaccine advisory committee, said people considered at “low risk” can still be harmed by the virus.“Low risk doesn’t mean no risk,” he said. “I mean, anybody can be hospitalized and killed by the virus.”Goodman questioned why the FDA was making the change instead of the CDC’s independent vaccine advisory committee, known as the Advisory Committee on Immunization Practices, which typically makes recommendations on who should get the Covid shots. “It is not clear why there was a compelling reason for FDA to step in and preempt that usual and publicly transparent consultative process,” he said. Kennedy's influence on vaccine rulesA change to the way Covid vaccines are updated was expected. Earlier this month, Health and Human Services Secretary Robert F. Kennedy Jr. mandated that all new vaccines must undergo placebo-controlled clinical trials. Until Tuesday, it wasn’t clear whether HHS considered Pfizer’s and Moderna’s updated shots “new vaccines,” requiring new clinical trials.Former government health officials feared that the FDA, under Kennedy, was moving to slow-walk vaccine approvals.Over the weekend, the FDA approved Novovax’s vaccine after weeks of delay. In an unexpected turn, however, the agency limited the use of the shot to people 65 and up and teens and adults with at least one medical condition that puts them at risk of severe illness. Typically, it’s the CDC that makes recommendations about who should get the vaccines. Makary had warned about changes to the way vaccines are tested and approved, saying last week that the agency would soon “unleash a massive framework.” Kennedy has long opposed vaccines, including the Covid shot. In 2021, he submitted a citizens’ petition requesting that the FDA revoke the authorization of the Covid vaccines. The same year, he called the Covid shots “the deadliest vaccine ever made,” citing rare cases of myocarditis in young men. Studies find that the risk of myocarditis is higher — and typically more severe — in people with a Covid infection than after the vaccine. Last week, at a Senate Health, Education, Labor and Pensions Committee hearing, Kennedy also falsely claimed that the only vaccines tested against a placebo were the Covid shots. The move prompted committee chair Bill Cassidy, R-La., to later pause the hearing to correct Kennedy.“For the record, that’s not true. Rotavirus, measles and HPV vaccines have been [evaluated against a placebo], and some vaccines are tested against previous versions. So just for the record, to set that straight,” said Cassidy, who is a physician.Kennedy isn’t the only health official who has been critical of the Covid vaccines. Makary; Prasad; Dr. Tracy Beth Hoeg, a special advisor to Makary; and Dr. Jay Bhattacharya, the head of the National Institutes of Health, have, as well.

A bill that allows medical clinics to sell unproven treatments has been passed in Montana.  Under the legislation, doctors can apply for a license to open an experimental treatment clinic and recommend and sell therapies not approved by the Food and Drug Administration (FDA) to their patients. Once it’s signed by the governor, the law will be the most expansive in the country in allowing access to drugs that have not been fully tested.  The bill allows for any drug produced in the state to be sold in it, providing it has been through phase I clinical trials—the initial, generally small, first-in-human studies that are designed to check that a new treatment is not harmful. These trials do not determine if the drug is effective. The bill, which was passed by the state legislature on April 29 and is expected to be signed by Governor Greg Gianforte, essentially expands on existing Right to Try legislation in the state. But while that law was originally designed to allow terminally ill people to access experimental drugs, the new bill was drafted and lobbied for by people interested in extending human lifespans—a group of longevity enthusiasts that includes scientists, libertarians, and influencers.   These longevity enthusiasts are hoping Montana will serve as a test bed for opening up access to experimental drugs. “I see no reason why it couldn’t be adopted by most of the other states,” said Todd White, speaking to an audience of policymakers and others interested in longevity at an event late last month in Washington, DC. White, who helped develop the bill and directs a research organization focused on aging, added that “there are some things that can be done at the federal level to allow Right to Try laws to proliferate more readily.”  Supporters of the bill say it gives individuals the freedom to make choices about their own bodies. At the same event, bioethicist Jessica Flanigan of the University of Richmond said she was “optimistic” about the measure, because “it’s great any time anybody is trying to give people back their medical autonomy.”  Ultimately, they hope that the new law will enable people to try unproven drugs that might help them live longer, make it easier for Americans to try experimental treatments without having to travel abroad, and potentially turn Montana into a medical tourism hub. But ethicists and legal scholars aren’t as optimistic. “I hate it,” bioethicist Alison Bateman-House of New York University says of the bill. She and others are worried about the ethics of promoting and selling unproven treatments—and the risks of harm should something go wrong. Easy access? No drugs have been approved to treat human aging. Some in the longevity field believe that regulation has held back the development of such drugs. In the US, federal law requires that drugs be shown to be both safe and effective before they can be sold. That requirement was made law in the 1960s following the thalidomide tragedy, in which women who took the drug for morning sickness had babies with sometimes severe disabilities. Since then, the FDA has been responsible for the approval of new drugs.   Typically, new drugs are put through a series of human trials. Phase I trials generally involve between 20 and 100 volunteers and are designed to check that the drug is safe for humans. If it is, the drug is then tested in larger groups of hundreds, and then thousands, of volunteers to assess the dose and whether it actually works. Once a drug is approved, people who are prescribed it are monitored for side effects. The entire process is slow, and it can last more than a decade—a particular pain point for people who are acutely aware of their own aging.  But some exceptions have been made for people who are terminally ill under Right to Try laws. Those laws allow certain individuals to apply for access to experimental treatments that have been through phase I clinical trials but have not received FDA approval. Montana first passed a Right to Try law in 2015 (a federal law was passed around three years later). Then in 2023, the state expanded the law to include all patients there, not just those with terminal illnesses—meaning that any person in Montana could, in theory, take a drug that had been through only a phase I trial. At the time, this was cheered by many longevity enthusiasts—some of whom had helped craft the expanded measure. But practically, the change hasn’t worked out as they envisioned. “There was no licensing, no processing, no registration” for clinics that might want to offer those drugs, says White. “There needed to be another bill that provided regulatory clarity for service providers.”  So the new legislation addresses “how clinics can set up shop in Montana,” says Dylan Livingston, founder and CEO of the Alliance for Longevity Initiatives, which hosted the DC event. Livingston built A4LI, as it’s known, a few years ago, as a lobbying group for the science of human aging and longevity. Livingston, who is exploring multiple approaches to improve both funding for scientific research and to change drug regulation, helped develop and push the 2023 bill in Montana with the support of State Senator Kenneth Bogner, he says. “I gave [Bogner] a menu of things that could be done at the state level … and he loved the idea” of turning Montana into a medical tourism hub, he says.  After all, as things stand, plenty of Americans travel abroad to receive experimental treatments that cannot legally be sold in the US, including expensive, unproven stem cell and gene therapies, says Livingston.  “If you’re going to go and get an experimental gene therapy, you might as well keep it in the country,” he says. Livingston has suggested that others might be interested in trying a novel drug designed to clear aged “senescent” cells from the body, which is currently entering phase II trials for an eye condition caused by diabetes. “One: let’s keep the money in the country, and two: if I was a millionaire getting an experimental gene therapy, I’d rather be in Montana than Honduras.” “Los Alamos for longevity” Honduras, in particular, has become something of a home base for longevity experiments. The island of Roatán is home to the Global Alliance for Regenerative Medicine clinic, which, along with various stem cell products, sells a controversial unproven “anti-aging” gene therapy for around $20,000 to customers including wealthy longevity influencer Bryan Johnson.  Tech entrepreneur and longevity enthusiast Niklas Anzinger has also founded the city of Infinita in the region’s special economic zone of Próspera, a private city where residents are able to make their own suggestions for medical regulations. It’s the second time he’s built a community there as part of his effort to build a “Los Alamos for longevity” on the island, a place where biotech companies can develop therapies that slow or reverse human aging “at warp speed,” and where individuals are free to take those experimental treatments. (The first community, Vitalia, featured a biohacking lab, but came to an end following a disagreement between the two founders.)  Anzinger collaborated with White, the longevity enthusiast who spoke at the A4LI event (and is an advisor to Infinita VC, Anzinger’s investment company), to help put together the new Montana bill. “He asked if I would help him try to advance the new bill, so that’s what we did for the last few months,” says White, who trained as an electrical engineer but left his career in telecommunications to work with an organization that uses blockchain to fund research into extending human lifespans.  “Right to Try has always been this thing [for people] who are terminal[ly ill] and trying a Hail Mary approach to solving these things; now Right to Try laws are being used to allow you to access treatments earlier,” White told the audience at the A4LI event. “Making it so that people can use longevity medicines earlier is, I think, a very important thing.” The new bill largely sets out the “infrastructure” for clinics that want to sell experimental treatments, says White. It states that clinics will need to have a license, for example, and that this must be renewed on an annual basis.  “Now somebody who actually wants to deliver drugs under the Right to Try law will be able to do so,” he says. The new legislation also protects prescribing doctors from disciplinary action. And it sets out requirements for informed consent that go further than those of existing Right to Try laws. Before a person takes an experimental drug under the new law, they will be required to provide a written consent that includes a list of approved alternative drugs and a description of the worst potential outcome. On the safe side “In the Montana law, we explicitly enhanced the requirements for informed consent,” Anzinger told an audience at the same A4LI event. This, along with the fact that the treatments will have been through phase I clinical trials, will help to keep people safe, he argued. “We have to treat this with a very large degree of responsibility,” he added. “We obviously don’t want to be killing people,” says Livingston.  But he also adds that he, personally, won’t be signing up for any experimental treatments. “I want to be the 10 millionth, or even the 50 millionth, person to get the gene therapy,” he says. “I’m not that adventurous … I’ll let other people go first.” Others are indeed concerned that, for the “adventurous” people, these experimental treatments won’t necessarily be safe. Phase I trials are typically tiny, and they often involve less than 50 people, all of whom are typically in good health. A trial like that won’t tell you much about side effects that only show up in 5% of people, for example, or about interactions the drug might have with other medicines. Around 90% of drug candidates in clinical trials fail. And around 17% of drugs fail late-stage clinical trials because of safety concerns. Even those that make it all the way through clinical trials and get approved by the FDA can still end up being withdrawn from the market when rare but serious side effects show up. Between 1992 and 2023, 23 drugs that were given accelerated approval for cancer indications were later withdrawn from the market. And between 1950 and 2013, the reason for the withdrawal of 95 drugs was “death.” “It’s disturbing that they want to make drugs available after phase I testing,” says Sharona Hoffman, professor of law and bioethics at Case Western Reserve University in Cleveland, Ohio. “This could endanger patients.” “Famously, the doctor’s first obligation is to first do no harm,” says Bateman-House. “If [a drug] has not been through clinical trials, how do you have any standing on which to think it isn’t going to do any harm?” But supporters of the bill argue that individuals can make their own decisions about risk. When speaking at the A4LI event, Flanigan introduced herself as a bioethicist before adding “but don’t hold it against me; we’re not all so bad.” She argued that current drug regulations impose a “massive amount of restrictions on your bodily rights and your medical freedom.” Why should public officials be the ones making decisions about what’s safe for people? Individuals, she argued, should be empowered to make those judgments themselves. Other ethicists counter that this isn’t an issue of people’s rights. There are lots of generally accepted laws about when we can access drugs, says Hoffman; people aren’t allowed to drink and drive because they might kill someone. “So, no, you don’t have a right to ingest everything you want if there are risks associated with it.” The idea that individuals have a right to access experimental treatments has in fact failed in US courts in the past, says Carl Coleman, a bioethicist and legal scholar at Seton Hall in New Jersey.  He points to a case from 20 years ago: In the early 2000s, Frank Burroughs founded the Abigail Alliance for Better Access to Developmental Drugs. His daughter, Abigail Burroughs, had head and neck cancer, and she had tried and failed to access experimental drugs. In 2003, about two years after Abigail’s death, the group sued the FDA, arguing that people with terminal cancer have a constitutionally protected right to access experimental, unapproved treatments, once those treatments have been through phase I trials. In 2007, however, a court rejected that argument, determining  that terminally ill individuals do not have a constitutional right to experimental drugs. Bateman-House also questions a provision in the Montana bill that claims to make treatments more equitable. It states that “experimental treatment centers” should allocate 2% of their net annual profits “to support access to experimental treatments and healthcare for qualifying Montana residents.” Bateman-House says she’s never seen that kind of language in a bill before. It may sound positive, but it could in practice introduce even more risk to the local community. “On the one hand, I like equity,” she says. “On the other hand, I don’t like equity to snake oil.” After all, the doctors prescribing these drugs won’t know if they will work. It is never ethical to make somebody pay for a treatment when you don’t have any idea whether it will work, Bateman-House adds. “That’s how the US system has been structured: There’s no profit without evidence of safety and efficacy.” The clinics are coming Any clinics that offer experimental treatments in Montana will only be allowed to sell drugs that have been made within the state, says Coleman. “Federal law requires any drug that is going to be distributed in interstate commerce to have FDA approval,” he says. White isn’t too worried about that. Montana already has manufacturing facilities for biotech and pharmaceutical companies, including Pfizer. “That was one of the specific advantages [of focusing] on Montana, because everything can be done in state,” he says. He also believes that the current administration is “predisposed” to change federal laws around interstate drug manufacturing. (FDA commissioner Marty Makary has been a vocal critic of the agency and the pace at which it approves new drugs.) At any rate, the clinics are coming to Montana, says Livingston. “We have half a dozen that are interested, and maybe two or three that are definitively going to set up shop out there.” He won’t name names, but he says some of the interested clinicians already have clinics in the US, while others are abroad.  Mac Davis—founder and CEO of Minicircle, the company that developed the controversial “anti-aging” gene therapy—told MIT Technology Review he was “looking into it.” “I think this can be an opportunity for America and Montana to really kind of corner the market when it comes to medical tourism,” says Livingston. “There is no other place in the world with this sort of regulatory environment.”