Latest news with #FederalDrugAdministration
CNBC
29-05-2025
- Business
- CNBC
This start-up is lowering the chances of passing on life-threatening diseases to your children—but it will cost you
Biotech start-up Orchid is one of the few companies offering in-vitro fertilisation (IVF) patients the option to screen their embryos for severe genetic diseases before their pregnancy begins. "This technology is going to totally reshape how people have children," Orchid's CEO Noor Siddiqui told CNBC's The Edge in an interview. "I think it's going to become an option that more and more people will choose because there's just the opportunity to avoid a lot of catastrophic outcomes, and they don't want to roll the dice on their child's health," Siddiqui added. During IVF, a woman takes fertility hormones to suppress her natural menstrual cycle and increase the number of eggs in her ovaries. Once her eggs are collected, they are mixed with the sperm and fertilized in a lab. The viable embryos are then transferred to the uterus. Siddiqui says that Orchid has developed a new technology that sequences 99% of an embryo's entire genome before implantation in the womb and screens for over 1,200 monogenic conditions, as well as some polygenic diseases. "When you have an embryo sample, you have about 125 cells on day five, and the embryologist at the IVF lab sends us about five of those cells, and in those five cells, you only have about 10,000 times less than the amount of DNA that you would have in a blood or saliva sample. So, what we had to invent is a new amplification protocol, as well as a new computational pipeline," Siddiqui said. The embryo screening process takes between two and three weeks, after which patients receive a whole genome embryo report. Orchid's counselors go through the report and help patients decide which embryo to move forward. Despite having been cleared by the Federal Drug Administration as a laboratory developed test (LDT) and backed by geneticists like George Church and Carlos Bustamante, Orchid's procedure has failed to convince some. "These tests, in general, cost money, often not covered by insurance. And so increasingly, breast cancer, for instance, is becoming more a disease of the poor because people can afford to undergo IVF and screen out breast cancer mutations when they've had a family history of breast cancer. I think that raises a problem ethically," bioethicist and Columbia University professor Robert Klitzman told The Edge in an interview. Orchid currently charges $2,500 per embryo screening. That's in addition to the IVF process which, according to the U.S. Department of Health and Human Services, ranges from $15,000 to $20,000 for a single cycle and sometimes requires several attempts. To mitigate the costs, the company has a philanthropic program that patients on low incomes can apply for. Orchid's technology is now available nationwide in the U.S. except in New York state, where Orchid had applied for a license to operate at the time of the interview. Learn more about Orchid's technology by clicking the video above. IVF was conceived as a reproductive method for people with infertility issues, but over the past decade, other patient groups have turned to it to prevent passing on genetic conditions to their child.
Yahoo
26-05-2025
- Health
- Yahoo
RFK Jr.'s FDA Head Wants Diabetics to Get Cooking Classes Over Insulin
The head of the Federal Drug Administration says diabetics should get a recipe book instead of insulin. 'Maybe we need to treat more diabetes with cooking classes, not just throwing insulin at people,' FDA Commissioner Marty Makary said on Fox News' Sunday Futures. 'You know, scientists have been waving the flag for years, saying you've got to look at this body of scientific data, and the modern medical establishment really has been disconnected.' Repeated studies over more than a century have shown insulin is a safe and effective treatment for diabetes, though medical professionals also recommend controlling blood sugar through diet, according to the American Diabetes Association. Makary further used his Sunday appearance on Fox to promote a new report from the Trump administration's Make America Healthy Again Commission, released earlier this week, which called for federal agencies to urgently examine a variety of perceived threats to children's health. 'This report is a fresh new approach that really calls for a transformation of our healthcare system from a reactionary system to a proactive system,' Makary said. 'I could not be more excited about it.' These include vaccines and exposure to harmful chemicals, all longstanding bugbears for Health and Human Services (HHS) Secretary Robert F. Kennedy. Kennedy has come under repeated fire for misrepresenting or pushing bogus claims about the role of those factors in various adverse health conditions. Kennedy has courted controversy in particular for his long-running attempts to link vaccines to autism, which he has ordered HHS to investigate. The Health Secretary has also pressured the Centers for Disease Control to stop recommending fluoride in drinking water because of baseless claims the chemical may be connected to cancer and neurological impairments. In addition, Kennedy has also called on the FDA to begin phasing out synthetic dyes used to enhance color in foods.
Yahoo
21-04-2025
- Health
- Yahoo
Could seashells help replace plastics? California researchers think so
Consumers cut up plastic soda can rings before putting them in the trash because they know they could end up in the ocean. But what if that waste did not have to be harmful to the sea turtles and other marine life? Inspired by the coronavirus pandemic, which exacerbated the use of single-use plastics, University of Southern California Professor Eun Ji Chung used her biomedical engineering expertise to look for a potential solution. "I started creating these habits at home where we're starting to reuse things and, you know, I kind of went overboard, but I also started kind of thinking about just our lab and then also just plastics in general," Chung said. During graduate school, Chung helped develop orthopedic biodegradable implants, such as bone screws. These implants received Federal Drug Administration (FDA) approval and are used on patients today. She thought this concept could apply to other materials, but instead of medicinal use, it could be used for items we use every day. Un Offers 'Roadmap' To Reducing Plastic Pollution By 80% By 2040 "I was thinking about seashells and how they have a hard, stiff material and how that is very similar to some of the materials that are found in our bones, like the ones that I developed during grad school for orthopedic applications," Chung said. Earlier this month, Chung's lab published its findings about the new plastic alternative they developed by adding calcium carbonate from seashells into poly (1,8-octanediol-co-citrate) (POC), an FDA-approved biodegradable material used in orthopedic devices. Because the mineral calcium carbonate, which gives seashells their hardness, is already naturally occurring in the ocean, the new material, called POC-CC, is considered biocompatible if it were to end up in the sea. To make sure the material could hold heavy items, Chung's lab fine-tuned the polymerization conditions to hold the volume of soda cans. "We wanted to make sure that, number one, the contents were environmentally friendly, and it could degrade, and the degradation products were not harmful to marine life, and that it also had kind of material properties that would be useful," Chung said. Chung's lab at USC developed several prototype drink holders out of POC-CC and incubated them with green algae in simulated ocean water for six months. The team found that the material was biocompatible with marine microorganisms and would not harm marine life like microplastics currently do. "Unfortunately, a lot of our plastics go into the ocean for one reason or another, but that would create at least some sort of potential 'waste product' that actually is not really waste at all, and it's very friendly to the marine environment, and it wouldn't be harmful," Chung said. Most Plastic Recyling Ends Up In The Trash, Greenpeace Report Finds The lab is already working on improving the new material by using another naturally found material in the ocean, from crustacean shells, to speed up the degradation process. Chung is excited to see where this new research goes next. "It was a moment of creativity that I'm so grateful for that academia allows me to kind of satisfy," she said. While this concept was out-of-the-box for a biomedical engineering lab, Chung said the same thinking can be applied to all fields of engineering. "At the end, we're about use, right? Making it useful for human life."Original article source: Could seashells help replace plastics? California researchers think so
Yahoo
29-03-2025
- Health
- Yahoo
Top FDA vaccine expert blasts RFK Jr. as he's forced out
A top Federal Drug Administration (FDA) official resigned from his post Friday, marking the third high-ranking employee to leave the agency this year amid a worsening outbreak of measles. Dr Peter Marks, the director for the agency's Center for Biologics Evaluation and Research, submitted his resignation letter to FDA Acting Commissioner Sara Brenner, citing Health and Human Services Secretary Robert F Kennedy's 'misinformation and lies' on vaccines. 'It has become clear that truth and transparency are not desired by the secretary,' Marks wrote. 'Efforts currently being advanced by some on the adverse health effects of vaccination are concerning.' Marks joined the FDA in 2012 as the center's deputy director, before becoming director in 2016. His roles involved enhancing the safety of the country's blood supply, advancing cell and gene therapy and responding to public health emergencies. He spearheaded Operation Warp Speed during the COVID-19 pandemic, a federal effort dedicated to vaccinating against the virus. Despite his work, he was offered the chance to resign or be fired, two anonymous sources told The Washington Post. Earlier this week, the same outlet reported that David Geier, a vaccine skeptic, had been tapped to lead a study of possible links between autism and immunizations. Marks raised concerns about the undermining of vaccine science, particularly relating to measles outbreaks in the US. Kennedy has said that receiving a measles vaccine is a personal choice, and has boosted the use of vitamin A as a treatment. While vitamin A can be beneficial for someone who has become unwell, experts say it is not a replacement for vaccination to prevent measles. 'It is unconscionable with measles outbreaks to not have a full-throated endorsement of measles vaccinations,' Marks told The Post. Measles had been eliminated from the US since 2000. Last year, it killed more than 100,000 unvaccinated children in Africa and Asia. Marks said he worked to address Kennedy's concerns over vaccine development by hearing from the public and implementing various public meetings and engagements with the National Academy of Sciences, Engineering and Medicine. 'Though rarely followed by a single fever-related seizure, or very rarely by allergic reactions or blood clotting disorders, the vaccine very simply does not cause autism, nor is it associated with encephalitis or death,' Marks said of the measles vaccine. 'It does, however, protect against a potential devastating consequence of prior measles infection.' Though Marks said he will no longer be part of the agency's mission, he hopes that in the coming years that 'the unprecedented assault on scientific truth that has adversely impacted public health in our nation comes to an end so that the citizens of our country can fully benefit from the breadth of advances in medical science.' Marks is the third top leader at the FDA to resign this year. The agency's drug chief Patrizia Cavazzoni and human foods chief Jim Jones also left their posts. Kennedy was confirmed last month following an at-times heated confirmation hearing. During the hearing, Kennedy downplayed his opposition to vaccines, telling congressional members he is not anti-vaccine but rather 'pro-safety.' 'I believe that vaccines play a critical role in health care,' he said. Vermont Senator Bernie Sanders, an Independent, challenged Kennedy, asking him if he agrees with evidence stating vaccines do not cause autism. Kennedy responded: 'If you show me those studies, I will absolutely —' Sanders cut him off, saying: 'That is a very troubling response because the studies are there. Your job is to have looked at those studies as an applicant for this job.'
The Independent
29-03-2025
- Health
- The Independent
Top FDA vaccine expert blasts RFK Jr. as he's forced out
A top Federal Drug Administration (FDA) official resigned from his post Friday, marking the third high-ranking employee to leave the agency this year amid a worsening outbreak of measles. Dr Peter Marks, the director for the agency's Center for Biologics Evaluation and Research, submitted his resignation letter to FDA Acting Commissioner Sara Brenner, citing Health and Human Services Secretary Robert F Kennedy's 'misinformation and lies' on vaccines. 'It has become clear that truth and transparency are not desired by the secretary,' Marks wrote. 'Efforts currently being advanced by some on the adverse health effects of vaccination are concerning.' Marks joined the FDA in 2012 as the center's deputy director, before becoming director in 2016. His roles involved enhancing the safety of the country's blood supply, advancing cell and gene therapy and responding to public health emergencies. He spearheaded Operation Warp Speed during the COVID-19 pandemic, a federal effort dedicated to vaccinating against the virus. Despite his work, he was offered the chance to resign or be fired, two anonymous sources told The Washington Post. Earlier this week, the same outlet reported that David Geier, a vaccine skeptic, had been tapped to lead a study of possible links between autism and immunizations. Marks raised concerns about the undermining of vaccine science, particularly relating to measles outbreaks in the US. Kennedy has said that receiving a measles vaccine is a personal choice, and has boosted the use of vitamin A as a treatment. While vitamin A can be beneficial for someone who has become unwell, experts say it is not a replacement for vaccination to prevent measles. 'It is unconscionable with measles outbreaks to not have a full-throated endorsement of measles vaccinations,' Marks told The Post. Measles had been eliminated from the US since 2000. Last year, it killed more than 100,000 unvaccinated children in Africa and Asia. Marks said he worked to address Kennedy's concerns over vaccine development by hearing from the public and implementing various public meetings and engagements with the National Academy of Sciences, Engineering and Medicine. 'Though rarely followed by a single fever-related seizure, or very rarely by allergic reactions or blood clotting disorders, the vaccine very simply does not cause autism, nor is it associated with encephalitis or death,' Marks said of the measles vaccine. 'It does, however, protect against a potential devastating consequence of prior measles infection.' Though Marks said he will no longer be part of the agency's mission, he hopes that in the coming years that 'the unprecedented assault on scientific truth that has adversely impacted public health in our nation comes to an end so that the citizens of our country can fully benefit from the breadth of advances in medical science.' Marks is the third top leader at the FDA to resign this year. The agency's drug chief Patrizia Cavazzoni and human foods chief Jim Jones also left their posts. Kennedy was confirmed last month following an at-times heated confirmation hearing. During the hearing, Kennedy downplayed his opposition to vaccines, telling congressional members he is not anti-vaccine but rather 'pro-safety.' 'I believe that vaccines play a critical role in health care,' he said. Vermont Senator Bernie Sanders, an Independent, challenged Kennedy, asking him if he agrees with evidence stating vaccines do not cause autism. Kennedy responded: 'If you show me those studies, I will absolutely —' Sanders cut him off, saying: 'That is a very troubling response because the studies are there. Your job is to have looked at those studies as an applicant for this job.'
