A Senate Finance Committee inquiry revealed on Tuesday that police departments can get access to private medical information from pharmacies, no warrant needed. While HIPAA may protect some access to personally identifiable health data, it doesn't stop cops, according to a letter from Senator Ron Wyden, Representative Pramila Jayapal and Representative Sara Jacobs to the Department of Health and Human Services. None of the major US pharmacies are doing anything about it, either, the members of Congress say. 

"All of the pharmacies surveyed stated that they do not require a warrant prior to sharing pharmacy records with law enforcement agents, unless there is a state law that dictates otherwise," the letter said. "Those pharmacies will turn medical records over in response to a mere subpoena, which often do not have to be reviewed or signed by a judge prior to being issued."

The committee reached out to Amazon, Cigna, CVS Health, The Kroger Company, Optum Rx, Rite Aid Corporation, Walgreens Boots Alliance and Walmart about their practices for sharing medical data with police. While Amazon, Cigna, Optum, Walmart and Walgreen said they have law enforcement requests reviewed by legal professionals before complying, CVS Health, The Kroger Company and Rite Aid Corporation said they ask in-store staff to process the request immediately. Engadget reached out to the pharmacies mentioned in the letter about the claims. CVS said its pharmacy staff are trained to handle these inquiries and its following all applicable laws around the issue. Walgreens said it has a process in place to assess law enforcement requests compliant with those laws, too, and Amazon said while the law enforcement requests are rare, it does notify patients and comply with court orders when applicable. The others either haven't responded or refuse to comment.

The pharmacies mostly blamed the current lack of legislative protections for patient data for their willingness to comply with cop requests. Most of them told the committee that current HIPAA law and other policies let them disclose medical records in response to certain legal requests. That's why the Senate Finance Committee is targeting HHS to strengthen these protections, especially since the 2023 Dobbs decision let states criminalize certain reproductive health decisions. 

Under current HIPAA law, patients have the right to know who is accessing their health information. But individuals have to request the medical record disclosure data, instead of health care professionals being required to share it proactively. "Consequently, few people ever request such information, even though many would obviously be concerned to learn about disclosures of their private medical records to law enforcement agencies," the letter states. The letter also urges pharmacies to change their policies to require a warrant, and publish transparency reports about how data is shared. 

In a landmark decision, the FDA greenlit two new drugs for the treatment of sickle cell disease in patients 12 and older, one of which —Vertex’s drug Casgevy — is the first approved use of genome editing technology CRISPR in the US. Bluebird Bio’s Lyfgenia also is a cell-based gene therapy, however, it uses a different gene modification technique to deliver tweaked stem cells to the patient.

Both approvals cultivate new pathways for the treatment of sickle cell disease, which is an inherited blood disorder that is characterized by red blood cells that can’t properly carry oxygen, which leads to painful vaso-occlusive crises (VOCs) and organ damage. The disease is particularly common among African Americans and, to a lesser extent, among Hispanic Americans. Bone marrow transplants are currently the only cure for sickle cell disease, but they require well-matched donors and often involve complications.

While both drug approvals use gene editing techniques, Casgevy’s CRISPR/Cas9 genome editing works by cutting out or splicing in DNA in select areas. Patients first have blood drawn so that their own stem cells can be isolated and edited with CRISPR. They then undergo a form of chemotherapy to remove some bone marrow cells, so the edited stem cells can be transplanted back in a single infusion.

Both drug approvals are based on studies that evaluated the effectiveness and safety of the novel therapies in clinical patients. With Casgevy, study participants reported that they did not experience “severe VOCs” for at least 12 consecutive months during the 24-month follow-up. Similarly, patients on Lyfgenia did not experience a “pain crisis” for six to 18 months after the therapy.

The FDA's decision comes shortly after UK regulators, as well as the National Health Regulatory Authority in Bahrain both approved Vertex’s Casgevy. The approval for a CRISPR-based treatment creates opportunity for further innovation in the gene editing space — for treatments ranging from cancers to heart diseases to Alzheimer’s. “Gene therapy holds the promise of delivering more targeted and effective treatments, especially for individuals with rare diseases where the current treatment options are limited,” Nicole Verdun, director of the Office of Therapeutic Products at the FDA’s Center for Biologics Evaluation and Research said. Casgevy is still currently under review by the European Medicines Agency.

MIT researchers developed an ingestible capsule that can monitor vital signs including heart rate and breathing patterns from within a patient’s GI tract. The scientists also say that the novel device has the potential to also be used to detect signs of respiratory depression during an opioid overdose. Giovanni Traverso, an associate professor of mechanical engineering at MIT who has been working on developing a range of ingestible sensors, told Engadget that the device will be especially useful for sleep studies.

Conventionally, sleep studies require patients to be hooked up to a number of sensors and devices. In labs and in at-home studies, sensors can be attached to a patient’s scalp, temples, chest and lungs with wires. A patient may also wear a nasal cannula, chest belt and pulse oximeter which can connect to a portable monitor. “As you can imagine, trying to sleep with all of this machinery can be challenging,” Traverso told Engadget.

MIT

This trial, which used a capsule made by Celero Systems —A start-up led by MIT and Harvard researchers— marks the first time ingestible sensor technology was tested in humans. Aside from the start-up and MIT, the research was spearheaded by experts at West Virginia University and other hospital affiliates.

The capsule contains two small batteries and a wireless antenna that transmits data. The ingestible sensor, which is the size of a vitamin capsule, traveled through the gastrointestinal tract, and collected signals from the device while it was in the stomach. The participants stayed at a sleep lab overnight while the device recorded respiration, heart rate, temperature and gastric motility. The sensor was also able to detect sleep apnea in one of the patients during the trial. The findings suggest that the ingestible was able to measure health metrics on par with medical-grade diagnostic equipment at the sleep center. Traditionally, patients that need to get diagnosed with specific sleep disorders are required to stay overnight at a sleep lab, where they get hooked onto an array of sensors and devices. Ingestible sensor technology eliminates the need for that.

Importantly, MIT says there were no adverse effects reported due to capsule ingestion. The capsule typically passes through a patient within a day or so, though that short internal shelf life may also limit how effective it could be as a monitoring device. Traverso told Engadget that he aims to have Celetro, which he co-founded, eventually contain a mechanism that will allow the capsule to sit in a patient’s stomach for a week.

Dr. Ali Rezai, the executive chair of the West Virginia University Rockefeller Neuroscience Institute, said that there is a huge potential for creating a new pathway through this device that will help providers identify when a patient is overdosing according to their vitals. In the future, researchers even anticipate that devices could incorporate drugs internally: overdose reversal agents, such as nalmefene, could be slowly administered if a sensor records that a person’s breathing rate slowed or stopped. More data from the studies will be made available in the coming months.

In a landmark decision, the UK’s Medicines and Healthcare products Agency (MHRA) approved the use of a gene-editing therapy called Casgevy for patients with sickle cell disease and beta thalassemia — both of which are hereditary disorders related to genetic mutations of the red blood cells. The treatment, manufactured by Vertex, is the first-ever approved therapy that utilizes CRISPR-based gene editing technology to treat eligible patients.

The UK approval of the novel therapy is informed by two previous global clinical trials that indicated the treatment's efficacy. 97 percent of patients using Casgevy were relieved of severe pain associated with the blood disorders for at least 12 months after treatment during the trials. The results suggest that the gene editing treatment could replace the current standard for care. Stem cell therapy and bone marrow transplants are currently the only pathways to cure sickle cell disease and beta thalassemia, however, they involve a lot of risks.

Both sickle cell disease and beta thalassemia are blood disorders characterized by defective red blood cells that can’t carry oxygen, and require patients to get monthly blood transfusions that can be costly and time-consuming. Casgevy works by specifically targeting the genes in the bone marrow stem cells that produce faulty blood cells. For the treatment to work, a patient’s stem cells need to be extracted from their bone marrow, edited in a lab and then re-infused into the patient.

Despite its promising outlook, CRISPR-based therapies may not be easily available to the general public. Gene editing is an expensive endeavor. The Innovative Genomics Institute (IGI) estimates that the average CRISPR-based therapy will cost between $500,000 and $2 million per patient. The IGI has built out an ‘Affordability Task Force’ to tackle the issue of expanding access to these novel therapies.

Aside from costliness, gene editing therapies offer huge promise to innovate treatment pathways for rare conditions including neurodegenerative diseases, cancer and muscular atrophy. More importantly, this landmark approval for Casgevy “opens the door for further applications of CRISPR therapies in the future,” Prof Dame Kay Davies, a scientist from the University of Oxford, said. And new iterations of gene editing technologies may even surpass CRISPR in the future.

Casgevy is still being reviewed by regulatory agencies for safety standards in other countries, including the United States and Saudi Arabia. A marketing application, the first step towards approval for the therapy, was recently validated by the European Medicines Agency.

In a trial run by Verve Therapeutics, a Cambridge–based biotech company, researchers discovered that a single infusion of a gene-editing treatment called VERVE-101 was able to reduce cholesterol levels in patients. This treatment was tested in individuals with hereditary conditions that made them susceptible to developing clogged arteries and heart attacks. Scientists were able to use CRISPR editing techniques to tweak liver gene cells. The researchers “turned off” a cholesterol-raising gene called PCSK9, which is found in the liver, in order to lower LDL-C — sometimes called "bad" cholesterol — which causes plaque to build up in arteries in the first place.

PCSK9 was lowered by as much as 84 percent in the cohorts that received higher infusion rates of the treatment. At those higher treatment doses, Verve scientists said that the reduction of those LDL-C-related proteins lasted 2.5 years in previous studies on primates.

Verve Therapeutics

From a clinical standpoint, this gene editing therapy has the potential to disrupt the current standard treatment for high cholesterol. The current go-to's include prescription statins and PCSK9 inhibitors, but they require strict adherence and can have bad side effects like muscle pain and memory loss.

CRISPR, while seemingly miraculous, is a long way from replacing daily medications though. According to Nature, two of the 10 participants in the study suffered from a “cardiovascular event” that coincided with the infusion. Verve says one was not related to the treatment at all and the second was “potentially related to treatment due to proximity to dosing.” The use of a gene-editing technology will always carry some risk because the edits could occur elsewhere in the genome.

Before a single infusion therapy for high cholesterol can reach consumers, the FDA mandates that the treatment will need to be studied for up to 15 years. Verve recently received FDA clearance for an Investigational New Drug Application for VERVE-101, meaning that the company can begin to conduct trials in the US. The current trials in New Zealand and the United Kingdom will look for willing clinical trial participants to expand the study.

A Parkinson’s patient can now walk 6km (3.7 miles) thanks to an implant targeting the spinal cord. The Guardian reports that the man — 62-year-old “Marc” from Bordeaux, France — developed severe mobility impairments from the degenerative disease. “I practically could not walk anymore without falling frequently, several times a day,” he said in a press release announcing the breakthrough. “In some situations, such as entering a lift, I’d trample on the spot, as though I was frozen there, you might say.” Wearing the spinal implant allows him to walk “almost normally” as the research team eyes a full clinical trial.

Marc underwent a “precision neurosurgical procedure” two years ago at Lausanne University Hospital (CHUV), which helped facilitate the research. The surgery fitted him with an electrode field placed against his spinal cord and an electrical impulse generator under the skin of his abdomen. Although conventional Parkinson’s treatments often target brain regions affected by the loss of dopamine-producing neurons, this approach instead focuses on the spinal area associated with activating leg muscles for walking.

The procedure used a personalized map of Marc’s spinal cord, identifying the specific locations signaling leg movements. He wears a movement sensor on each leg that tells the implant he’s trying to walk; it then switches on and sends electrical impulses to the targeted spinal neurons, adapting to his movement in real-time.

GABRIEL MONNET via Getty Images

“In response to precise stimulation of the lumbar spinal cord, I’ve observed for the first time remarkable improvements of gait deficits due to Parkinson’s disease,” project supervisor Jocelyne Bloch, professor and neurosurgeon at CHUV Lausanne University hospital, said in a webinar discussing the patient’s success. “I really believe that these results open realistic perspectives to develop a treatment.”

The patient says he could walk practically normally with the stimulation after several weeks of rehab. He now wears it for around eight hours daily, only turning it off when sleeping or lying down for a while. “I turn on the stimulation in the morning and I turn off in the evening,” he said. “This allows me to walk better and to stabilise. Right now, I’m not even afraid of the stairs anymore. Every Sunday I go to the lake, and I walk around 6 kilometres. It’s incredible.”

The researchers caution that there’s still a vast chasm between tailoring the approach to one person vs. optimizing it for wide-scale use. Co-leads Grégoire Courtine and Bloch are working on a commercial version of the neuroprosthetic in conjunction with Onward Medical. “Our ambition is to provide general access to this innovative technology to improve the quality of life of Parkinson’s patients significantly, all over the world,” they said.

Michael J. Fox Foundation

In the meantime, research on six new patients will continue in 2024. The team says a “generous donation” of $1 million from the Michael J. Fox Foundation for Parkinson’s Research is funding the upcoming work. In 2021, the actor’s organization announced it had contributed over $1.5 billion to Parkinson’s research.

At least 15 visitors at Yuga Labs’ Apefest, a celebration of the marvels of Bored Ape Yacht Club NFTs, may have experienced serious eye injuries. Bloomberg reports that multiple people attending the NFT event in Hong Kong last weekend say they experienced vision problems, which they suspect stemmed from the event’s stage lighting. Some of the attendees claim doctors subsequently diagnosed them with photokeratitis (aka “welder’s eye”), caused by exposure to ultraviolet (UV) light.

“Woke up in the middle of the night after Apefest with so much pain in my eyes that I had to go to the hospital,” the user Crypto June posted on X (via Coin Telegraph). “Doctor told me it was due to the UV from stage lights.” User @docwagmi suspected that the “ape friends” reporting problems appeared to have been “up close with us front stage.” 

@crypto_birb / X

Meanwhile, Adrian Zduńczyk wrote on X, “To all my friends who suffer now: go get your eyes checked. You’ve likely most literally got your eyes burnt with UV like I did, which requires medications, eye drops, eye protection, antibiotics and specialist care. Don’t ignore this health hazard. Without proper treatment, it may cause long lasting vision impairment and other serious damage.” Zduńczyk wrote that seeking medical attention quickly appears to have spared him long-term damage. “My vision was tested as close to perfect with no serious cornea damage, luckily.”

Yuga Labs briefly addressed the issue on X, saying it’s “aware of the eye-related issues that affected some of the attendees of ApeFest,” while claiming it’s “proactively reaching out to individuals since yesterday to try and find the potential root causes.” The company downplayed the number of people reporting issues, adding, “Based on our estimates, we believe that much less than 1% of those attending and working the event had these symptoms.” The NFT company advised attendees experiencing symptoms to “seek medical attention just in case.”

X users seemed none too pleased with Yuga Labs’ PR response:

The potentially dangerous incident echoes one in 2017 when attendees of a HypeBeast party reported eye damage. The event’s DJ later reported that the lighting contractor used Philips bulbs that emit UV-C, often used as a disinfectant.

At least 15 visitors at Yuga Labs’ ApeFest, a celebration of the marvels of Bored Ape Yacht Club NFTs, may have experienced serious eye injuries. Bloomberg reports that multiple people attending the NFT event in Hong Kong last weekend say they experienced vision problems, which they suspect stem from the event’s stage lighting. Some of the attendees claim doctors subsequently diagnosed them with photokeratitis (aka “welder’s eye”), caused by exposure to ultraviolet rays.

“Woke up in the middle of the night after ApeFest with so much pain in my eyes that I had to go to the hospital,” the user Crypto June posted on X (via Coin Telegraph). “Doctor told me it was due to the UV from stage lights.” User @docwagmi suspected that the “ape friends” reporting problems appeared to have been “up close with us front stage.” 

@crypto_birb / X

Meanwhile, Adrian Zduńczyk wrote on X, “To all my friends who suffer now: go get your eyes checked. You’ve likely most literally got your eyes burnt with UV like I did, which requires medications, eye drops, eye protection, antibiotics and specialist care. Don’t ignore this health hazard. Without proper treatment, it may cause long lasting vision impairment and other serious damage.” Zduńczyk wrote that seeking medical attention quickly appears to have spared him long-term damage. “My vision was tested as close to perfect with no serious cornea damage, luckily.”

Yuga Labs briefly addressed the issue on X, saying it’s “aware of the eye-related issues that affected some of the attendees of ApeFest,” while claiming it’s “proactively reaching out to individuals since yesterday to try and find the potential root causes.” The company downplayed the number of people reporting issues, adding, “Based on our estimates, we believe that much less than 1% of those attending and working the event had these symptoms.” The NFT company advised attendees experiencing symptoms to “seek medical attention just in case.”

X users seemed none too pleased with Yuga Labs’ PR response:

The potentially dangerous incident echoes one in 2017 when attendees of a HypeBeast party reported eye damage. The event’s DJ later reported that the lighting contractor used Philips bulbs that emit UV-C, often used as a disinfectant.

The Chan Zuckerberg Initiative is opening a research center in New York City dedicated to developing new techniques for early disease detection and treatment. CZ Biohub NY, as it’s being called, will work with Columbia, Rockefeller and Yale universities to better learn how immune cells detect and attack specific diseases, and eventually use this insight to engineer cells that could do the job more precisely.

The charitable organization headed by Priscilla Chan and Meta CEO Mark Zuckerberg has committed $250 million to the effort, according to STAT, alongside investments of $10 million each from the State of New York and New York City. In a blog post announcing CZ Biohub NY, the Chan Zuckerberg Initiative said it will start by focusing on cancers and other diseases that often go undetected until they’ve advanced to the point of being difficult or impossible to treat. That includes “ovarian and pancreatic cancers; neurodegenerative diseases, including Parkinson’s and Alzheimer’s; as well as aging and autoimmunity,” CZI says.

CZ BioHub NY aims to get to the bottom of how immune cells work, down to their ability to spot tissue-specific changes that can be among the earliest indications of a disease’s onset. Then, its researchers hope to be able to create cells that can sniff out these abnormalities even earlier than they’re currently able, and be sent to the disease sites directly for more effective treatment. These bioengineered immune cells would “scout, report, and repair damage to our cells before it leads to serious illnesses,” said Chan.

The New York hub is the latest in CZI’s growing network of research institutions, and joins three others that have been established in San Francisco, Chicago, and Redwood City. All have pledged to break ground on their respective scientific goals within a time frame of 10-15 years. Now, according to STAT, the New York biohub just needs to secure a site to work out of.

In a study from Oxford University, researchers found that by using a combination of wearable sensor data and machine learning algorithms the progression of Parkinson’s disease can be monitored more accurately than in traditional clinical observation. Monitoring movement data collected by sensor technology may not only improve predictions about disease progression but also allows for more precise diagnoses.

Parkinson’s disease is a neurological condition that affects motor control and movement. Although there is currently no cure, early intervention can help delay the progression of the disease in patients. Diagnosing and tracking the progression of Parkinson's disease currently involves a neurologist using the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) to assess the patient's motor symptoms by assigning scores to the performance of specific movements. However, because this is a subjective, human analysis, classification can be inaccurate.

In the Oxford study, 74 patients with Parkinson’s were monitored for disease progression over a period of 18 months. The participants wore wearables with sensors in different regions of the body: on the chest, at the base of the spine and on each wrist and foot. These sensors — which had gyroscopic and accelerometric capabilities — kept tabs on 122 different physiological measurements, and tracked the patients during walking and postural sway tests. Kinetic data was then analyzed by custom software programs using machine learning.

Oxford

The sensor data collected by the wearables were compared to standard MDS-UPDRS assessments, which are considered the gold standard in current practice. That traditional test, in this study's patients "did not capture any change" while the sensor-based analysis "detected a statistically significant progression of the motor symptoms" according to the researchers.

Having more precise data on the progression of Parkinson's isn't a cure, of course. But the incorporation of metrics from wearables could help researchers confirm the efficacy of novel treatment options.