Wait, tampons weren’t being tested with human blood?

Mother Jones illustration; Getty Fight disinformation: Sign up for the free Mother Jones Daily newsletter and follow the news that matters. Until last week, no study had ever been published that tested period products—tampons, pads, discs, cups, and underwear—using human blood. A team of four women just changed that. On August 7, Dr. Bethany Samuelson Bannow and a group at Oregon Health & Science University in Portland released a study to test saturation and capacity levels in menstrual products in hopes of better understanding how to diagnose heavy menstrual bleeding, or HMB, which impacts millions of Americans. Why had it taken so long to test a product made to contain human blood with human blood? “I think with women’s health, including menstrual health, we’ve been a little bit behind the eight ball,” Dr. Bannow told me. “They didn’t even require women to be included in NIH studies until 1993. I think that that’s telling of what we prioritize as a society.” Providers trying to diagnose HMB depend on self-reporting, which can be subjective with people falling prey to myths and miseducation. A patient experiencing pain, fatigue, or other related symptoms will come in and ask: Is this normal? To tell if the bleeding is excessive, doctors try to ascertain how many period products are used per hour. But measurement is imperfect. Menstruators change out products for tons of reasons; and products may claim they can sustain a certain amount of “flow,” but their actual capacity is different. That is what Dr. Bannow hoped to make clear in her testing. The team took 21 different products and saturated or filled them with expired human-packed red blood cells. This isn’t an exact match to menstrual blood—which has clots and secretions—but it’s a lot closer than salty water. In their research, they found that how the companies were labeling the boxes did not match up with their results. The majority of menstrual products reported that they had greater capacity than the testing found. “[There is a] disconnect between who’s making the products and what their goals are, and those of us who are using them as a diagnostic method,” said Dr. Bannow, a hematologist who works with HMB patients, “I think [that] plays a role” in this being the first study to use human blood. Dr. Bannow and I spoke about their research, its implications, and how the stigma about period blood continues to stifle care. Could you tell me a bit about how you learned or found out that no studies testing period products with human blood had been published? In anticipation of another study, we did a little bit of a deep dive into the literature trying to figure out how much different period products should absorb. And that’s when I learned about The Tampon Task Force from the 80s. [Editor’s note: At the request of the Food and Drug Administration, industry leaders and other stakeholders convened as part of The Tampon Task Force in 1982 to create standardization across their products.] The FDA and The Tampon Task Force really set the standard of saline being the liquid used to test menstrual products. We really couldn’t find anything in the literature about using blood. A researcher named Nancy Reame reportedly tried heparinized blood, but the data wasn’t ever published. That’s when we sort of realized that this is an important frame that’s missing! How has the diagnosis and treatment process been complicated in the past by different understandings of absorption and saturation of period products? So there are two main sets of objective criteria that we can consider using for diagnosing heavy menstrual bleeding. The first is a great tool called the pictorial blood loss assessment chart, or PBAC, which has folks document their pads and tampons used over a cycle and how saturated they are. And then the other is just taking an in-office history, which also relies on pads and tampons. Typically, anybody who changes a pad or tampon more often than every two hours probably has HMB. But it’s all dependent on pads and tampons. This testing is all multiple decades old. Modern technology is so much better. I think we’ve been grossly underestimating HMB based on these old data and methods. It’s remarkable that there’s no across-the-board standard for these products. At the same time, it seems like these companies were misrepresenting the absorption or saturation levels. Is that what you all found? I wouldn’t go so far as to say they’re misrepresenting. We found something different than they did when using a different substance than they did. If I was testing somebody for diabetes, I have instruments in a lab, or in my office, that are standardized. When it comes to periods, we’re dependent on using these products that weren’t created with the goal of diagnosing HMB in mind. They’re created to help somebody who’s menstruating manage their periods. I think the bottom line isn’t so much that companies need to standardize things as we need to be aware as physicians and other health care providers just how much these products can hold. My friends are talking about switching from tampons and pads to alternative products like cups and discs. You note in the study that you’ve seen this as well in practice. ​​Yes! What do you think this shift will mean for the diagnosis and treatment of HMB and other conditions? Honestly, I think it’s gonna be better. The menstrual cups report the volume that it takes to fill them. The volume is the volume is the volume. I think it actually has the potential to make things a lot easier and more straightforward. A lot of the language that we use around menstrual bleeding is really vague. Even on these products’ websites, it’s talking about if your flow is light or medium. As a menstruator, I don’t really know what that means. Have you seen this vague language with your patients? It’s very vague, and it’s also very subjective. For example, I’ll have

MDHHS appeals ruling condemning aspects of its infant blood testing program

The Michigan Department of Health and Human Services is appealing a federal court ruling over its infant blood sampling program. It’s been longstanding state practice to screen blood samples from newborn babies for various medical conditions. Last month, a federal district judge found the MDHHS may have violated the U.S. Constitution while storing and distributing some of those samples and related data without informed parental consent. The argument rested on Fourth and 14th Amendment claims dealing with illegal searches and seizures as well as and equal protection. The court ordered the department to give the plaintiffs the option of having the samples and data returned or destroyed or to provide informed consent. Now, the state health department and its sampling facilities are appealing that ruling—saying the state is committed to protecting “the health and well-being of all Michigan’s residents.”

New blood test could ‘transform’ treatment for children with fever

A new blood test that would enable the commonest childhood illnesses to be diagnosed in less than an hour could “transform” medical care, doctors say. Currently it can take doctors hours, days or even weeks to identify which of 18 infectious and inflammatory diseases a child with a worryingly high temperature is suffering from. The delay means clinical teams cannot be sure whether the infant has group B streptococcus, respiratory syncytial virus (RSV), tuberculosis or another ailment. Doctors therefore cannot immediately distinguish between a bacterial infection, which may be life-threatening, and other, less serious illnesses. The new findings suggest that the test, developed by an international team of doctors and scientists, could enable sick children around the world to be diagnosed more quickly and receive better treatment by cutting the time health professionals have to wait for a blood test to be analysed. Professor Michael Levin, an expert in child health at Imperial College London who has helped to develop the novel approach, said that it could prove “transformative for healthcare”. “Despite huge strides forward in medical technology, when a child is brought into hospital with a fever, our initial approach is to treat based on the doctors’ ‘impression’ of the likely causes of the child’s illness,” he said. “As clinicians, we need to make rapid decisions on treatment, often just based on the child’s symptoms, information from the parents, and our medical training and experience. “But we may not know whether a fever is bacterial, viral or something else until hours or days after a child has been admitted, when their test results come back. Such delays can stop patients getting the right treatment early on, so there is a clear and urgent need to improve diagnostics. “Using this new approach, once it’s translated to near point-of-care devices, could be transformative for healthcare.” The diagnostic test works by analysing a patient’s “gene expression”, according to new findings by the team involved, which has been published in the Cell Press journal Med. The experts behind it used data from several thousand patients, including more than 1,000 children who had had an infectious or inflammatory disease, to identify which key genes were turned “on” or “off” in their response to a range of ailments. That gave them a molecular signature of disease. They then used machine learning to work out which patterns of gene expression corresponded to which particular diseases and pathogens and focused on 161 genes for 18 conditions. Dr Myrsini Kaforou, a senior lecturer in Imperial’s department of infectious diseases and a co-author of the paper, said: “This body of work has enabled us to identify the molecular signature of a wide range of diseases based on 161 genes, out of thousands of genes in the human genome. “By distinguishing between many diseases at the same time within the same test, we have developed a more comprehensive and accurate model that aligns with the way clinicians think about diagnosis. “With this initial proof-of-concept study, we’ve been able to show that our multi-disease, machine-learning diagnostic approach works.”

US FDA approves Regeneron’s ultra-rare blood disease drug

Companies Regeneron Pharmaceuticals Inc Follow U.S. Food and Drug Administration Follow Aug 18 (Reuters) – Regeneron Pharmaceuticals (REGN.O) said on Friday the U.S. health regulator approved its drug to treat a rare blood disease. The company said its drug, Veopoz, was approved in adult and pediatric patients 1 year of age and older with the life-threatening CHAPLE disease. People with CHAPLE disease have mutated CD55 gene, which regulates the body’s mechanism for destroying microbes. Without proper gene regulation, the mechanism may start attacking normal cells of the body. In most patients, this results in a range of potentially life-threatening symptoms beginning in early childhood. The company did not immediately respond to a Reuters request for comment on the drug’s price. Reporting by Vaibhav Sadhamta, Khushi Mandowara and Pratik Jain in Bengaluru; Editing by Shilpi Majumdar Our Standards: The Thomson Reuters Trust Principles. Acquire Licensing Rights, opens new tab

US FDA staff raise no concerns about Otsuka, Medtronic blood pressure devices

Aug 18 (Reuters) – The U.S. Food and Drug Administration (FDA) staff reviewers said on Friday they found no safety and effectiveness issues with devices made by Otsuka Holdings (4578.T) and rival Medtronic Plc (MDT.N) for use in a blood pressure treatment surgery. The FDA staff’s assessment comes ahead of meetings of two independent expert panels next week, where they will make recommendations on whether or not to approve the devices for treatment. The surgery, known as renal denervation, is allowed in Europe and other parts of the world, but is not yet approved in the U.S., after initial studies of older devices used in the procedure failed key trials. The staff reviewers said the available safety data for the device made by ReCor, a unit of Otsuka Holdings, did not raise concerns, while pointing that there was limited long-term data. There was no specific comment on Medtronic’s device. ReCor’s device, a balloon-like structure inside a catheter, is inserted through a small cut into the kidney’s arteries and sends ultrasound energy to burn nerves that are believed to control blood pressure. On the other hand, Medtronic’s device is a spiral shaped catheter and generator combination that uses targeted radiofrequency energy to destroy select nerves. The devices are meant for patients whose hypertension, or high blood pressure, cannot be controlled with drugs. These devices have successfully met the main goal of reducing blood pressure as their makers re-designed their trials and reconstituted their patient groups after earlier tests failed. Details on the patient group were not available. Needham analysts expect the devices might see limited sales for the first few years as the companies take time to build a market. According to Medtronic, the market size could reach $500 million by 2026 and $2 billion to $3 billion by 2030. The FDA advisers will meet on Tuesday to discuss ReCor’s device and convene the day after to deliberate on rival Medtronic’s equipment. Reporting by Sriparna Roy in Bengaluru Editing by Vinay Dwivedi Our Standards: The Thomson Reuters Trust Principles. Acquire Licensing Rights, opens new tab

AbbVie explores the emotional side of rare chronic cancer in ongoing CLL video series

When fam­i­ly doc­tor Bri­an Koff­man found some bumps on the back of his neck, he ran some tests on him­self. Every­thing checked out ex­cept his white blood cell count, which was ex­treme­ly high. With­in a week, he was di­ag­nosed with chron­ic lym­pho­cyt­ic leukemia (CLL), but even as a physi­cian him­self, he still had a lot to learn about the rare blood can­cer. That’s one of the rea­sons why he and his wife found­ed the CLL So­ci­ety, and why he’s work­ing with Ab­b­Vie to make sure new and ex­ist­ing pa­tients can ac­cess in­for­ma­tion, treat­ment op­tions and qual­i­ty care. Unlock this article instantly by becoming a free subscriber. You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

Tri-State Area blood banks implement new donation guidance removing barriers for gay, bisexual men

NY Blood Center uses mixed-reality glasses to attract younger donors NY Blood Center uses mixed-reality glasses to attract younger donors 00:42 GREENWICH, Conn. — Area blood banks are implementing new donation guidance from the Food and Drug Administration that removes barriers for gay and bisexual men who want to donate blood. At the American Red Cross in Greenwich, they’re seeing new faces donating critically needed blood, platelets and plasma. “We have had a number of people come in and say that they’re thrilled to be able to donate now. They’ve been waiting to donate,” said Stephanie Dunn Ashley, CEO of the American Red Cross Metro New York North Chapter. New guidance from the FDA removes barriers for men who have sex with men to donate. Screening questions now ask all donors about specific behaviors to assess the risk for recent HIV infection; sexually active gay and bisexual men are no longer singled out. “Doesn’t matter, sexual orientation, at all,” Dunn Ashley said. The FDA has been slowly loosening restrictions put in place in the ’80s over concerns about AIDS and HIV. The American Red Cross was among the first local blood banks to implement the new FDA guidance; they did it on Aug. 7. Other local blood banks are working to implement ASAP. The New York Blood Bank expects to have protocols in place in early September. “This is going to allow a lot more people who were previously ineligible, who are healthy donors, who are not having high-risk sex, to be able to donate,” said Cole Williams, of the organization Pride and Plasma. Williams pushed the FDA to update the guidance. He says men who have sex with men should know that those currently taking meds to treat or prevent HIV infection remain ineligible to donate. “We understand why the FDA has taken that. We support making sure that blood donations are not transmitting any infections,” he said. Blood banks say all donations are screened for infections, and the blood supply is safe. The FDA says the individual screening approach is in line with blood donation rules in the United Kingdom and Canada. More from CBS News Tony Aiello Tony Aiello serves as a CBS2 general assignment reporter with a focus on covering news and breaking stories in the Northern Suburbs. Twitter Facebook Thanks for reading CBS NEWS. Create your free account or log in for more features.

Ryan Crouser finds blood clots in leg, says safe to compete at worlds

Ryan Crouser plans to defend his shot put world title despite recently finding two blood clots in his leg. “The last 20 days have been some of the most frustrating and stressful of my life,” Crouser, a two-time Olympic gold medalist and world record holder, posted on social media Friday. “The medical team has been great, they explained the risks and did everything to mitigate them and left the decision to go to WC to me and my family. I made it to Budapest and will be competing. “The medical staff has me on anticoagulant/blood thinners so that it is safe to compete and minimize the risk of it worsening.” Crouser is set to compete Saturday, the opening day of the nine-day worlds in Budapest. He can become the first man to win four combined Olympic and world outdoor shot put titles. He will throw on what he called an “unfortunate travel timeline” and “imperfect preparation.” Crouser posted that he woke up with calf pain after a throwing session “that presented as a strain.” He trained through the pain for 10 days before getting a scan the day before he left for Budapest. It showed two blood clots in his lower leg. “Everything kicked into emergency mode at that point,” Crouser posted. “Biggest questions being ‘what’s the safest treatment?’ And ‘is WC even a possibility?’” Crouser posted that he didn’t have swelling, redness, heat or throbbing symptoms and that the clots were “more distal and smaller than what would typically show” on a muscular ultrasound. “I don’t believe there’s any way the medical team that has been working with me could have done any better job than what they have,” he posted.

Donate blood, win tickets to see Taylor Swift in concert

SALT LAKE CITY — There’s no such thing as Bad Blood when it comes to scoring tickets to see Taylor Swift in concert. Tickets to the superstar’s “Eras Tour” are harder to find than a four-leaf clover, but fans in the Salt Lake City area can score a free pair and help save a life at the same time. Anyone who donates blood or platelets at an ARUP location between now and September 2024 will be eligible to win two tickets to see Tay Tay when she brings her show to New Orleans. The “Eras Tour” is on its way to becoming the highest grossing tour of all time but it costs a pretty penny to get in, so taking a few minutes to donate blood can be a win-win for everyone involved. ARUP says the demand for blood is extremely high right now at the University of Utah Hospital and Huntsman Cancer Institute, so the donation center is hoping people who haven’t donated in a while will be intrigued by the possibility of winning tickets. Each time a person donates, they’ll receive additional chances to win. ARUP Blood Services has two locations open seven days a week and walk-in blood donors are welcome: 9786 South 500 West in Sandy 565 Komas Drive in Salt Lake City For more information, call 801-584-5272 or visit UtahBlood.org.