Latest news with #TimothyCaulfield
Boston Globe
4 days ago
- Health
- Boston Globe
RFK Jr. wants to allow more experimental therapies, acknowledging health risks and threat of ‘charlatans'
'And of course you're going to get a lot of charlatans, and you're going to get people who have bad results,' he added. 'And ultimately, you can't prevent that either way. Leaving the whole thing in the hands of pharma is not working for us.' Advertisement Kennedy cited his own experience at a clinic in Antigua, where he said he received a stem cell treatment that 'enormously' eased his neurological condition, spasmodic dysphonia, which affects his voice and has few treatment options. Get Starting Point A guide through the most important stories of the morning, delivered Monday through Friday. Enter Email Sign Up If Kennedy does permit broader use of unauthorized or experimental therapies, he would be reversing long-standing efforts by the FDA to monitor and sometimes police the emerging field. Experts, including some who support alternative medicine, worry that without safeguards, an expansion of such treatments could undermine legitimate development of new therapies. The FDA now narrowly permits stem cell therapies to treat blood and immune disorders. Nearly a decade ago, the field was so loosely regulated that the agency pursued court actions to shut down rogue clinics using unauthorized treatments for a wide array of ailments. Some providers in the United States and in other countries continue to offer experimental stem cell therapies for everything from autism to Alzheimer's to erectile dysfunction. Advertisement The latest move reflects an expansion of Kennedy's drive to dismantle federal health policy to reflect his long-held views, which had so far focused mainly on vaccines, chronic diseases, food dyes and fluoride. A push to open up the field of unregulated stem cell infusions meshes with his oft-stated contention that the FDA is a 'sock puppet' for major drug companies and faces a crisis of distrust. Wellness industry products, he has claimed, are unfairly sidelined. A spokesperson for the Department of Health and Human Services did not respond to requests for comment. Kennedy's statements alarmed experts on the field of sometimes dangerous stem cell infusions -- who noted that many of Kennedy's allies endorse wellness products ranging from red-light therapy to magnetism. 'It's a complete abdication of protection of the public, letting these grifters go forward,' said Timothy Caulfield, a research chair in health law and policy at the University of Alberta in Canada. 'For him to say, 'There are problems with Big Pharma, so we want our opportunity to be bad actors too,' it doesn't make any sense.' One leading expert group, the International Society for Stem Cell Research, reviewed Kennedy's podcast statements and condemned the approach as potentially allowing products that are 'sometimes contaminated with pathogens and are often marketed with scientifically implausible claims.' 'It is critical that the FDA maintain its regulatory authority to protect Americans from these potentially harmful and deceptive products,' the society said in a statement. Advertisement On Thursday, a panelist appearing at an FDA meeting on cell and gene therapies raised a concern about 'snake oil' treatments. Dr. Vinay Prasad, the agency's director of the center for biologics evaluation research, responded, 'We have to regulate the bad actors. We can't let that taint what we do here at the FDA.' Kennedy, who also attended the event, voiced full support for the researchers and biotech executives working on gene therapies for rare diseases, including those who made history by creating a custom gene therapy for an infant named KJ. 'We're going to do everything in our power to sweep away the barriers from you getting those solutions to market and getting them funded, and do everything that we can to support you all,' Kennedy said. On Brecka's podcast in May, Kennedy cited other products that he'd like to see more of, including chelation treatment, which was discussed in a 2015 book edited by him that focused on widely debunked theories about mercury in vaccines and autism and cites 'evidence of chelation's benefits' from a few small studies. One 5-year-old Pennsylvania boy died in 2005 from cardiac arrest after a doctor tried to treat his autism with chelation. Neither Kennedy nor the FDA has released a formal plan to change agency standards for stem cell treatments, which have typically been reviewed by the agency as individual therapies to treat a specific disease. Widening overall access could also happen informally if the agency decided to relax enforcement, an approach the FDA used in the past to indicate that it wouldn't crack down on unauthorized products. During the pandemic, for example, the agency allowed providers to retrofit infusion pumps and ventilators to treat hordes of sick patients. Advertisement During the first Trump administration, the agency's commissioner, Dr. Scott Gottlieb, escalated enforcement against stem cell providers whom he described in 2017 as 'unscrupulous actors who have seized on the clinical promise of regenerative medicine.' The FDA followed through with lawsuits seeking to stop some stem cell providers, including one case that the government won on appeal in the fall. In that case, the agency alleged that one provider, the California Stem Cell Treatment Center, was offering a drug without FDA approval by taking stem cells from a person's fat, manipulating them and infusing them as a remedy for Alzheimer's disease, cancer and arthritis. The agency classifies stem cell treatments as a 'biologic' and approves them much like a drug after careful studies of safety and effectiveness. But the FDA does make exceptions: It does not regulate some treatments if providers say they are extracting and then reinserting a person's cells with minimal manipulation. In March, Kennedy convened a meeting with leaders in the stem cell field. Two people who attended said the gathering was a fact-finding effort to explore a safe way to increase access. To Dr. Noah Raizman, who attended the meeting on behalf of the American Academy of Orthopaedic Surgeons, Kennedy's new pronouncement 'sounds a little more casual and a little bit more emboldened.' In the podcast, Kennedy said that consumers should be able to navigate the industry's claims. 'We don't want to have the Wild West,' Kennedy said. 'We want to make sure that information is out there. But we also want to respect the intelligence of the American people -- the capacity of people who explore the outcomes that are going to benefit them the most.' Advertisement In recent years, stem cell treatments have caused harm in the United States and abroad. Experts at the Pew Research Center tallied more than 350 cases of side effects including life-threatening blood infections, heart attacks and tumors. One Boston neurosurgeon discovered a huge mass of bloody tissue in the lower spine of a man who had received unproven stem cell treatments in Mexico, China and Argentina. Three patients were blinded after stem cell treatments at a Florida clinic. The FDA prevailed in getting a court order to stop the clinic from operating. The field of stem cell treatments is so complex that the Harvard Medical School created a free course to help doctors navigate patient questions, said Insoo Hyun, the director of life sciences at the Museum of Science in Boston. More than 110 stem cell clinical studies are advancing under regulatory oversight. In one, scientists at the National Institutes of Health are using retinal cells developed from patients' blood to try to treat vision loss in older adults -- and follow them for 15 years. In another study aimed at helping patients with Parkinson's disease, researchers at a biotech company in California are exploring the safety of infusing dopamine-producing neurons in a region of the brain that controls the body's movements. A Chinese company is studying a treatment for heart failure that involves transplanting cardiac muscle cells into the heart. Some providers sidestep the costly, yearslong process of careful work that can lead to an FDA approval. Among them is Dr. Chadwick Prodromos, a Chicago doctor who offers stem cell treatments in Antigua. Kennedy welcomed him warmly at the March meeting, Raizman recalled. Reached for comment, Prodromos' office said that he was in Antigua doing treatments and was not available. Advertisement In an April interview on YouTube, Prodromos said that he was still in touch with the FDA about stem cell treatments that could help people 'without allowing scams and things that aren't valid. And you know, it's a tricky proposition.' A website for Prodromos' clinic says that he and colleagues offer injections in Antigua into the joints, back, neck, scalp, penis and pelvic floor for an array of conditions including autism, thinning hair and lupus. He uses AlloRX cells, which are derived from the umbilical cord, in a manner that in the United States would require an FDA-cleared clinical trial. People can seek out unregulated treatments using their own cells that are processed, purified and amplified in different ways. They can also find treatments using others' cells that vary widely in quality and sterility. Some low-quality clinics process cells in a back room, which is the opposite of a clinical-grade cell processing site. Hyun said he recently toured one in the Netherlands that used specialized air filtering, layers of gowns and a ban on bacteria-laden cellphones in their sterile area. 'It's kind of like you're entering a space station,' he said. Ultimately, Caulfield said, many unauthorized stem cell providers adopt the language of biotech and regenerative medicine, post glowing patient testimonials and exploit patients who are desperate for a cure. This article originally appeared in .
Vancouver Sun
08-05-2025
- Health
- Vancouver Sun
Only 7 in 10 Ontario kids vaccinated against measles, rates falling elsewhere. Here's why
Public confidence in vaccines has dipped since COVID's first surges, the proportion of parents 'really against' routine childhood immunizations has grown and one third of Canadians believe the discredited claim that the measles vaccine causes autism, surveys show. That percolating pushback is contributing to gaps in immunization coverage: only seven out of 10 kids aged seven in Ontario were reported to be fully immunized against measles in the 2023-24 school year. Rates plummeted below 50 per cent in some health units, despite catch-up programs to deal with a backlog of children who missed shots during COVID disruptions. The gaps threaten to widen and feed a resurgence of vaccine-preventable diseases like the ongoing outbreak of measles, say those who study the phenomenon. Start your day with a roundup of B.C.-focused news and opinion. By signing up you consent to receive the above newsletter from Postmedia Network Inc. A welcome email is on its way. If you don't see it, please check your junk folder. The next issue of Sunrise will soon be in your inbox. Please try again Interested in more newsletters? Browse here. But vaccine hesitancy goes beyond autism. The motives of parents opting out are 'often far more complex and nuanced than the pro-side would like to admit,' according to the authors of a recently-published paper on English-speaking Canada's growing anti-vaccine movement. It may make for a quicker and easier narrative to say it's all about misinformation and a notoriously flawed study that was eventually withdrawn, 'and convince people that it was a mistake and that there is nothing to be concerned about,' said co-author and University of Guelph historian Catherine Carstairs. However, 'it's become much grittier and more complicated, and maybe requires different kinds of interventions,' she said. Growing vaccine hesitancy, and outright refusal, is also symbolic of a broader issue, said the University of Alberta's Timothy Caulfield — 'the rise of an anti-science ethos that is impacting society.' The controversies and polarizations surrounding the COVID vaccines also had an ideological spillover effect on vaccines more generally, Caulfield said. In the U.S., political liberals became more positive towards non-COVID shots like MMR (measles, mumps and rubella), influenza and chickenpox while conservatives became more negative . Ontario has now claimed more measles cases since last fall than all of the United States. So far, the majority have been concentrated in specific health units, but measles is so highly infectious it can easily leak out to vulnerable pockets with less-than-optimal vaccination rates. As criticism of Ontario's handling of the outbreak intensifies, Premier Doug Ford Wednesday said getting children vaccinated against measles is a 'no-brainer' and that the province has sufficient supplies of vaccines available. 'I encourage anyone and everyone,' Ford told reporters. 'You need to get your kids vaccinated, because if not it just starts spreading.' Cases in Ontario reached 1,383 this week, Dr. Kieran Moore, Ontario's chief medical officer of health, told Radio-Canada, an increase of 140 over the previous week. Moore anticipates the province will see 100 to 150 new cases a week until summer. 'I'm happy that (local public health units) are able to keep the numbers to 100 to 150 Ontarians that are getting infected on a weekly basis. To me that's tremendous, hard and difficult work,' he told Radio-Canada. At least 84 outbreak cases in Ontario have required hospitalization; eight were admitted to intensive care. Among those hospitalized, 80 were unvaccinated, including 63 children. Alberta, meanwhile, is ramping up measles vaccination clinics in south and central zones where most of the 265 cases reported as of Monday are located. Canada's outbreak has been traced to a large gathering with guests from Mennonite communities in New Brunswick last October and has continued to spread in Ontario, with related cases reported in Alberta, Manitoba, Prince Edward Island and Quebec. A single case was reported in Halifax, N.S., this week, in an adult who had travelled to the U.S. Measles has been eliminated in Canada since 1998; endemic transmission, meaning a disease is constantly circulating, 'no longer happens in Canada,' according to the federal government's measles monitoring report , though sporadic cases can occur, usually due to travel to regions where measles is circulating. However, Canada hasn't seen close to the current numbers since the 752 cases recorded during a Quebec outbreak in 2011. The vast majority of cases today are among unvaccinated children and youth. Most (90 per cent) were exposed in Canada. The bulk of cases — 84 per cent — are in Ontario, where only seven in 10 (70.4 per cent) of seven-year-olds were said to be fully immunized against measles in the 2023-2024 school year , a dramatic drop compared to pre-Covid years. In 2019-2020, 86 per cent of Ontario kids aged seven were fully immunized against measles. In the 2013-2014 school year, 94 per cent were. Measles is considered one of the most, if not the most, transmissible, airborne viruses affecting humans. An infected person can pass the virus on to 15 to 18 others who haven't been vaccinated or who aren't immune due to past exposure to the virus. There are no specific anti-virals against measles. In serious cases, the virus can attack the fatty protective sheath that wraps around the nerves in the brain and spinal cord. One in 1,000 children infected can develop post-infectious encephalomyelitis, or swelling of the brain, that can lead to permanent neurological deficits like deafness, paralysis or difficulty thinking or speaking. Two doses of vaccine are considered about 97 per cent effective against infection. But vaccine coverage is falling below 95 per cent, the threshold needed for herd immunity to prevent infections. Why are more parents rejecting routine childhood shots? A 2024 Angus Reid pol l found that one in six (17 per cent) parents of kids under 18 reported they are 'really against vaccinating' their own children, up from four per cent in 2019. Last fall, three in 10 Canadians told Research Co. they still believe a connection exists between the MMR vaccine and autism, the lingering legacy of a fraudulent 1998 paper by British scientist Andrew Wakefield. 'Wakefield's ascent to the pinnacle of despicableness all started with one small and staggeringly shoddy study,' Caulfield, a U of Alberta professor of law and health policy, wrote in his new book, The Certainty Illusion: What You Don't Know and Why It Matters. A lot of parental concern is really about the number of overall vaccines that children are receiving these days While Wakefield's data-distorted study was eventually retracted, 'the Wakefield zombie marches on,' Caulfield wrote. 'Those pushing a particular agenda keep the study in the public eye,' he said, and the retraction, paradoxically, makes the study seem even more legitimate, because 'it fits into the broader anti-vaccine idea, that Wakefield was persecuted for bravely speaking the truth. 'The fake science imparts science-y credibility, while the retraction feeds a fake narrative. Zombies are hard to kill,' Caulfield wrote. Vaccine skepticism didn't originate with Wakefield, he and others said. 'Vaccine hesitancy and resistance has a long history in Canada,' Carstairs and her co-author, master's student Kathryn Hughes, wrote in their paper published in Canadian Historical Review. A national anti-vaccine league formed in 1900 in opposition to compulsory smallpox shots. The modern-day anti-vax movement began in the 1980s, Carstairs and Hughes wrote, led by a 'small number of people with alternative understandings of health and medicine, and by parents who believe their children were harmed by vaccination.' 'A lot of parental concern is really about the number of overall vaccines that children are receiving these days,' said Carstairs, who grew up in the 70s and 80s. The number of vaccines since 'has really escalated, which, as a pro-vaccination person, I think is great,' she said in an interview with National Post. 'But I can see why for many parents they sort of feel, 'Wow, is this getting to be too much?' Especially when diseases like chicken pox are seen as something they might have had as children themselves, or their parents had, and don't seem particularly serious, not thinking about the long-term consequences of shingles' or other complications, she said. 'Until recently, there wasn't much reason for parents to be concerned about their kids getting the measles. It was declared eradicated in Canada.' Today's intense parenting style, which focuses on nurturing the 'individuality' of each child, also 'feeds against the idea that I think we should be looking at,' Carstairs said. 'Which is, 'This isn't about your child. This is about protecting the entire population. That's why you need to get vaccinated.'' Many parents opposed to vaccination also harbour a sense 'that maybe we've gone too far along a technological path, and maybe that there's better, more natural ways of coping with illness,' Carstairs said. Caulfield, who considers the word natural 'the mother of all health halos,' said vaccine hesitancy — 'a trend that is costing lives' — is being partly energized by the rise of the wellness industry and its framing of vaccines as unnatural. 'There has been this middle-ground fallacy playing out where completely absurd things about vaccines are now taken as not as absurd,' Caulfield added. 'They've been normalized.' The phenomenon is also being fuelled by opposition to 'Big Pharma,' 'big science' and 'big health care,' Caulfield said. 'Science communicators have to be nimble and respond to how the public is talking about these issues,' he said. 'Public institutions, researchers, clinicians and public health officials always need to listen. They need to recognize missteps. They need to look at evidence and improve. Always. 'But any misstep has now been weaponized as a justification of full-scale distrust. The reality is misinformation has created distrust.' National Post with a file from Canadian Press Our website is the place for the latest breaking news, exclusive scoops, longreads and provocative commentary. Please bookmark and sign up for our daily newsletter, Posted, here .
CBC
30-01-2025
- Politics
- CBC
How do you know if the news you consume is true?
Canada Research Chair Timothy Caulfield's new book, The Certainty Illusion: What You Don't Know and Why It Matters, explores how people can become more discerning and critical news consumers. He says the ability to understand where information comes from and being able to learn and change opinions has never been more important.
