'Patients Are Bringing Us More of Their Own Data -- Can We Handle It?'

 These days, we're overwhelmed with data.

Every chart on every patient is packed full of data -- some of it incredibly useful and important, some of it just a lot of noise, some of it just copy-and-pasted and brought forward from the last note, and the one before that, and the one before that. Figuring out how to tame all this data is going to be critical as we move forward, and certainly smart systems that can see the forest for the trees will prove to be helpful in the not-too-distant future.

Our patients are doing a lot more self-monitoring. They're showing up for appointments with data from their smart watches, rings, scales, home blood pressure monitors, continuous glucose monitors, and more. They're going online and asking health-related questions of different AI systems, to find out what may be causing their symptoms, and what evaluations they should undergo.

Now, as you can see from the image below, patients are even able to get lab testing done without a doctor's prescription, with no one to explain what the results mean to them, or even if these were the right tests to get in the first place.

(Note the recent handwritten increase in the cost of a rapid COVID-19 PCR test to $249!)

Our patients are going to urgent care centers and emergency rooms and specialists' offices, getting reams and reams of testing done. Their insurance companies are sending homecare agencies to visit them to test them, to screen them, to generate more and more data to help inform them about their health (and help the companies maximize their health risk categorization). This often creates more work for us with all this data.

As I wrote recently, when patients arrive in our office, they update their demographic information and are then presented with a series of questionnaires that they're expected to answer, all of which generates data. And they've been interacting with the world out there, leading to claims on their insurance, which leads to still more data.

And then they come to see us for their very brief -- all too brief -- office visits, where we're expected to address their acute and chronic medical conditions, the list of symptoms and complaints they been saving up for us, and we're supposed to hunt down the answers to all of these other things, and hopefully make good use of all this data out there.

It feels like we all need a bigger peripheral brain, a better medical assistant helping us out, someone (something?) to corral all this stuff and put it in the right place, put it in the right order, and help us make sense of it all. Someday soon I hope that we will get to do more listening to our patients, more time for holding their hands, focus more on examining them, more on letting them turn to us for support and more doctoring. And that smarter systems will be in place to help grab all this data, line it up just right, and help us make sense of it all, to make sure nothing bad slips through the cracks.

If the electronic medical record says they're overdue for a mammogram, but there's a claim against their insurance for this year's mammogram that was done at an outside radiology facility, someone, or something, needs to reconcile those two things. If the trend in the data on their home blood pressure monitor or continuous glucose monitor or smart scale or sleep ring is suggestive of a particular medical condition, something should help us sift through all this stuff and bring it directly to everybody's attention in a timely manner.

And if that huge ream of paper they brought in to their visit, records from their prior physicians or a hospitalization that they had printed out for us, contains a hidden pearl, gem, or nugget, something we need to make sure doesn't get missed or ignored, that's when we need systems smart enough to read through all that and separate the useful data from the noise.

Maybe buried deep within those xeroxed pages is a report from the radiologist with a finding that warrants followup -- the thing that points us in the right direction. Maybe the combination of one of their answers to one of the questionnaires, coupled with a lab report from the last visit, cross-referenced to something they said during our history of present illness today, will point us to the answer.

We all wish we had all the time in the world to spend on every patient. We've all seen the studies that show how many hours we need in a day to take care of all the patients we see already.

In this new world of patient-centered care, with improved remote monitoring, with new sources of data that we're going to collect on our patients, maybe even in ways we haven't even dreamed of yet, the amount of stuff we will need to pay attention to is only going to rise exponentially. In some not-too-distant future, perhaps all our patients, maybe even everyone in society for that matter, will be continuously monitored for everything, and there won't be a single thing that won't get caught, won't get found early, won't get nipped in the bud. But that's a lot of data, that's a lot of watching, that's a lot of synthesizing that even the best of the best doesn't have the bandwidth for.

For now, it often feels like we're treading water, trying to keep from sinking, trying to keep ourselves and our patients from being inundated with all the questions we ask and all the answers we get.

It's likely right there in the data, we just need to get it all in, and then get it all out.

Fred Pelzman is an associate professor of medicine at Weill Cornell, and has been a practicing internist for nearly 30 years. He is medical director of Weill Cornell Internal Medicine Associates.

https://www.medpagetoday.com/opinion/patientcenteredmedicalhome/120906

Merck steps up as ‘meaningful competitor’ to Gilead with HIV pill approval

 

The newly approved HIV drug Idvynso will also help Merck diversify as loss of exclusivity looms over its top-selling product, the mega-blockbuster cancer drug Keytruda.

The HIV has signed off on Merck’s daily pill Idvynso for the treatment of virologically suppressed HIV-1 in adults. The drug will hit U.S. shelves after May 11, according to a Tuesday news release.

The approval “could position Merck as a more meaningful competitor in HIV,” BMO Capital Markets told investors on Tuesday afternoon. The pharma “aims to market Idvynso as the new HIV anchor treatment.”

Indeed, Merck noted that Idvynso is intended “to replace the current antiretroviral regimen in those who are virologically suppressed,” particularly patients with no history of treatment failure or known resistance to doravirine.

Idvynso “is a complete regimen,” the pharma said. “Co-administration with other antiretroviral medications for treatment of HIV-1 infection is not recommended.”

Establishing Idvynso as a cornerstone drug in HIV care, however, “is likely an ambitious goal given Gilead’s longstanding dominance” in the space, BMO said. Gilead strengthen its HIV leadership further in June 2025 with the historic approval of Yeztugo, introducing a twice-yearly prophylactic option to the market. The company expects $800 million in Yeztugo sales this year.

Last year, Gilead brought in $20.8 billion in HIV sales, with the daily pill Biktarvy the top-selling product at $14.3 billion. BMO expects Merck’s new drug to have only “limited impacts to Gilead at most.”

The FDA’s approval is backed by data from two randomized and active-controlled studies looking at patients who had achieved virological suppression on Biktarvy treatment. Switching to Idvynso resulted in a non-inferior maintenance of viral suppression as staying on Biktarvy, Merck said.

“Idvynso expands therapeutic diversity beyond the currently available oral treatment options,” Merck CMO Eliav Barr said in a prepared statement.

Aside from challenging Gilead, Idvynso’s approval also “supports revenue diversification ahead of the Keytruda” loss of exclusivity, BMO said in its Tuesday note. The blockbuster cancer therapy is expected to lose key patent protections in 2028, though erosion could come at a gentler slope for Merck before hitting strongly in 2033, according to an analysis from Bloomberg Intelligence. This could mean up to $22 billion more Keytruda sales from 2030 to 2033.

Keytruda was the top-selling drug in 2025, earning $31.7 billion.

https://www.biospace.com/fda/merck-steps-up-as-meaningful-competitor-to-gilead-with-hiv-pill-approval

Lilly, Novo dip as proposed Medicare coverage for GLP-1 pilot thrown off balance

 

Two of the biggest insurance providers have expressed reluctance to participate in the government’s BALANCE program that would have made GLP-1 drugs more affordable to patients.

The Centers for Medicare and Medicaid Services has indefinitely postponed the pilot run of its new BALANCE financing model that would have improved patient access to weight-loss medicines. The delay, analysts say, could have a limited but nevertheless negative impact on the bottomlines of biopharma’s obesity frontrunners.

Eli Lilly ended Tuesday’s trading session nearly 2% lower than its previous closing price, while Novo Nordisk took a 4% hit.

The decision to postpone, which the agency announced in an email that has since been made public on LinkedIn, comes after CVS and UnitedHealth Group, two of the biggest insurance providers in the U.S., expressed reluctance to join BALANCE, according to reporting from Bloomberg News.

CVS has already declined to participate, according to the publication, while Bobby Hunter, chief of government programs at UnitedHealth, told investors during the company’s earnings call on Tuesday that “there are some notable challenges and outstanding questions with the currently planned structure.”

“We believe today’s announcement where CVS has declined to participate in CMS’ BALANCE program could have a limited, negative effect of up to ~$500M in peak incretin sales for Zepbound/Foundayo Medicare Part D sales,” Truist Securities told investors in an April 21 note. If all pharmacy benefit managers opt out of BALANCE, however, the revenue hit on Lilly could balloon to around $3.3 billion, the analysts said.

Still, this “potential future revenue impact would be offset if future Medicare Part D patients opted instead to purchase Zepbound/Foundayo through LillyDirect or comparable telehealth channels,” Truist added.

BMO Capital Markets likewise had a balanced view of the news. UnitedHealth’s comments on the call, according to the analysts, “are more reflective of a negotiating posture” rather than an outright refusal to participate. “Nothing in [UnitedHealth’s] response suggested a retreat from GLP-1 coverage,” the firm said.

“Against this backdrop, we think the move in Lilly and Novo shares could be overdone,” BMO added in its note.

BALANCE is the CMS’ proposed payment model for GLP-1 drugs, under which the agency would negotiate directly with manufacturers on behalf of state Medicaid offices and Part D plans. The goal is to make these drugs more affordable and accessible to patients. State agencies had until January 1, 2027, to signify their intent to participate in BALANCE, after which the program would kick in.

CMS had planned an interim measure called Bridge, running from July 1, 2026, through the end of the year that would provide eligible Part D beneficiaries access to certain GLP-1 drugs before BALANCE goes live. With the delay on Tuesday, Bridge has now been extended to December 31, 2027, according to the CMS’ email.

https://www.biospace.com/policy/lilly-novo-dip-as-proposed-medicare-coverage-for-glp-1-pilot-thrown-off-balance

Ionis’ antisense drug stabilizes ultra-rare disease ahead of FDA decision

 

The pivotal study of zilganersen in Alexander disease missed a secondary endpoint, but analysts expect the FDA to approve the asset given the unmet need and overall data.

Ionis Pharmaceuticals shared more data Tuesday on its ultra-rare disease drug prospect zilganersen, providing more evidence of efficacy amid preparations for the biotech’s first independent launch in neurology.

In September, Ionis reported that its investigational antisense oligonucleotide significantly improved gait stability in a pivotal Phase 1–3 study in Alexander disease (AxD), achieving the primary endpoint. AxD is a rare neurological disease that affects about 300 people in the U.S., Kyle Jenne, Ionis’ chief global product strategy officer, said during the company’s 2025 earnings call in February. The FDA accepted Ionis’ filing for priority review last month.

Researchers presented more data from the trial at the American Academy of Neurology annual meeting, showing “statistically and clinically meaningful stabilization of motor function” and a consistent trend toward benefit across key secondary endpoints.

The previously reported 33.3% increase in gait speed over placebo in the 10-meter walk test at week 61 reflected stabilization in the zilganersen cohort and declining performance in the control arm, William Blair analysts said in a Tuesday note to investors.

Secondary endpoints favored zilganersen, although the molecule’s effect on patients’ most bothersome symptom (MBS) fell short. The MBS—which was not disclosed—improved in 42.1% of patients taking the study drug and worsened in 56.3% of people on placebo, but the result was not statistically significant.

William Blair analysts said the MBS miss likely drove nominal statistical significance in the Patient Global Impression of Change, a self-assessment of a patient’s condition. The miss may have implications for the FDA review, though “We believe FDA regulatory flexibility will be at play, especially around which key secondary endpoint the agency will anchor to, given the miss on MBS,” the firm said.

Despite the missed secondary endpoint, the analysts said they are confident the FDA will approve the drug by the Sept. 22 deadline. This position reflects the high unmet need in AxD and the consistent improvements in health outcomes compared to placebo in the clinical trial. Zilganersen is the first investigational medicine to demonstrate a disease-modifying impact in AxD, according to the company’s September 2025 press release.

William Blair forecasts peak zilganersen sales of $295 million in AxD, while Jenne said on Ionis’ earnings call that the biotech expects more than $100 million in peak sales for the program. Focusing on about a dozen centers, Ionis plans to launch the drug with a very modest-sized team, Jenne added. Ionis will partner zilganersen outside the U.S., CEO Brett Monia said during an investor event in February.

Capabilities established to commercialize zilganersen could give Ionis a launchpad for bringing more neurology products to market. Ionis expects to report Phase 3 data on obudanersen for the treatment of Angelman syndrome next year and to launch the product in 2028. Citing a 2016 study, Ionis said in its February business update that the condition affects more than 100,000 people in major geographies.

https://www.biospace.com/drug-development/ionis-antisense-drug-stabilizes-ultra-rare-disease-ahead-of-fda-decision

Pentagon: It would take 6 months to clear mines in Hormuz

 The United States Department of Defense notified the US Congress that clearing the Strait of Hormuz of Iranian mines could take up to six months, the Washington Post reported on Wednesday, citing officials familiar with the discussion.

According to the report, a senior Pentagon official shared the timeline with the members of the House Armed Services Committee during a classified briefing yesterday, with the time frame reportedly causing concerns among both Democratic and Republican representatives about the gas and oil prices remaining high even after a potential peace deal between the US and Iran is reached. The report added that the operation would only be carried out after the war ends.

The Congress was also reportedly told that Iran placed over 20 mines in the Strait of Hormuz and the surrounding area, with some of them being laid using small boats, and others floated remotely using GPS.

https://breakingthenews.net/Article/Pentagon:-It-would-take-6-months-to-clear-mines-in-Hormuz/66126654

Brain injuries surge from e-bike and scooter crashes in NYC — 2-hour window is most dangerous

 Hit the brakes.

Researchers are ringing alarm bells about a surge in brain and spine injuries from electric bike and scooter crashes “at a scale we haven’t seen before.”

But it’s not just urban riders who are suffering the consequences of a fast roll, as pedestrians are getting caught in the crosshairs as well.

A new study has shown an alarming increase in brain and spinal injuries for e-bike and scooter riders and pedestrians.Helayne Seidman for the NY Post

E-bike injuries have been on the rise. In 2022, there were 23,500 across the US — up 3,033% from five years earlier. Scooter crashes shot up 568% in the same period.

Now a new study found that use of small electric vehicles accounted for 6.9% of all trauma patients admitted to Bellevue hospital in Manhattan between 2018 and 2023.

Published in Neurosurgery and led by NYU Langone Health researchers, the study analyzed more than 900 patients treated for injuries related to electric bike or scooter use at the Kips Bay hospital.

Nearly a third of those patients suffered traumatic brain injury, and 30% needed intensive care.

What was notable to the researchers, though, was that the 69 pedestrians in the study suffered the most severe outcomes, experiencing brain injuries at almost double the rate of riders.

The most common cause of incidents was collision with a motor vehicle, accounting for nearly half of the patients.

Nearly 7% of patients admitted to a New York City hospital for trauma injuries were related to e-bike or scooter crashes.Robert Mecea

The study also found that the majority of riders went without a helmet, which has been linked to a significantly higher chance of injury.

Injuries peaked in the evenings, specifically at 6 and 8 p.m., suggesting a correlation with food delivery traffic.

Roughly 20% of patients — both riders and pedestrians included — who were tested for alcohol were intoxicated. For riders, this was linked to both worse brain injuries and lower helmet use.

Dr. Hannah Weiss, the study’s lead author, knows the problem all to well, warning that it’s happening at a scale that’s never been seen before.

During shifts, she told Gothamist, she’d hear: “Another patient fell off an e-bike, another patient fell off a scooter. Pedestrian hit by e-bike, pedestrian hit by scooter.”

“It became so much more frequent during my first couple of years of residency,” she said. But a few simple measures could break the trend.

“The data point to actionable solutions — helmet use, safer bike lane design, and enforcement — that could prevent many of these injuries and better protect both riders and pedestrians,” she said in a press release.

Mayor Zohran Mamdani eased up on police enforcement of reckless e-bike drivers last month, despite multiple injuries and fatalities for both riders and pedestrians, according to the NYPD.

E-bike crashes also surged by 21.5% between 2024 and 2025, according to data collected by the office of Councilman Frank Morano.

A Department of Transportation spokesperson also claimed that roughly 1.2% of pedestrian injuries were from e-bike crashes in 2025.

https://nypost.com/2026/04/21/health/brain-injuries-are-surging-from-e-bike-and-scooter-crashes-in-nyc/

2 critical Iran lifelines the US has left largely untouched — just as cease-fire talks stall

 The cease-fire with Iran, though extended, could end any day now. Meanwhile, Iran has fired on tankers, opened and closed the Strait of Hormuz within hours and rejected Washington’s core demands.

The Islamic Revolutionary Guard Corps, not Iran’s civilian government, is calling the shots. And a senior US official confirmed this week what the numbers have shown all along: “Iran has no money. They’re broke. We know it. And they know we know it.”

If that is true, a deal is closer than the chaos suggests. But only if Washington uses the right instruments.

During a public rally at Tehran’s Enghelab Square on Tuesday, April 21, 2026, a missile identified as “Khorramshahr-4” was displayed in support of Iran’s negotiating team, while US President Trump extended the cease-fire at the request of a Pakistani mediator.Behnam Tofighi/UPI/Shutterstock

The air campaign produced real results. Iran’s nuclear infrastructure was damaged, its navy destroyed, its proxy network disrupted. Those are real and significant gains.

The naval blockade announced after last weekend’s failed Islamabad talks is cutting off 90% of Iran’s seaborne trade.

Yet even as the US prepares to board additional Iran-linked dark fleet tankers in international waters, the IRGC’s ability to hold out remains intact, because Washington has left two critical financial lifelines largely untouched.

Cut off oil funds

The first is Kharg Island. Kharg handles 90% of Iran’s crude exports, roughly 1.5 million barrels a day, worth about $140 million daily at current prices.

Iran’s defense budget channels over half of those oil revenues to the military, with the IRGC taking the largest cut. That money pays 190,000 personnel. The blockade squeezes Iran’s imports and has made outbound shipments far riskier, but it does not touch Kharg’s loading terminals, storage tanks or the pipelines connecting the island to the mainland.

Washington has struck Kharg’s weapons. It has not struck Kharg’s wallet. Those are not the same target.

Forcing Iran to shut production due to lack of storage would risk long-term reservoir damage, including permeability loss, water coning and formation compaction — effects that could permanently reduce future output and cash flow.

The second lifeline is a floating reserve of roughly 200 million barrels of Iranian crude sitting on tankers near China, about five months of export supply that the IRGC stockpiled before the war as a financial cushion.

Stronger measures

The blockade and planned boardings do not yet fully neutralize it. As long as that reserve exists, the IRGC can sustain its current position for months without a single new barrel moving through Hormuz.

If the cease-fire expires without a framework agreement, two steps would change the IRGC’s calculus in ways nothing deployed so far has managed.

The first is a targeted strike on Kharg’s loading equipment, the trucks, pumps, manifolds and loading arms that move oil from storage onto tankers. Under normal conditions, this equipment can be repaired in weeks. Under sanctions, with spare parts unavailable, the timeline stretches to months.

Because these facilities directly fund IRGC military operations, they may constitute legitimate military objectives under the Law of Armed Conflict, subject to full legal review. Former CENTCOM commander Gen. Kenneth McKenzie said publicly this month that Kharg is legally defensible and that striking it would shut down Iran’s oil export capability.

The target is identified. The legal case looks solid. The capability is ready.

The second step is less conventional but potentially more powerful. Washington should designate the entire floating reserve under IRGC sanctions, extend the blockade’s intercept authority to cover any tanker attempting delivery and offer China a structured escrow arrangement. Proceeds from Iranian crude purchases would be held in a neutral account pending verified IRGC compliance.

While the US is preparing to board additional dark fleet vessels, physical seizure of tankers in Chinese-adjacent waters is not operationally realistic without Chinese cooperation. The financial mechanism achieves the same result without a naval confrontation in sensitive waters.

The complexities are real. Chinese acquiescence is not guaranteed, and the legal framework requires careful construction, but Beijing could be incentivized with eased US tariffs, technology concessions and guaranteed alternative oil supplies at competitive prices.

The concept does not need to be executed immediately to be effective. It needs to be communicated to the IRGC as a tool Washington is prepared to use.

Ideology vs. survival

An institution watching its financial cushion come under credible threat, with its payroll bank already struck and its export revenues blocked, faces a fundamentally different calculation than one that believes its reserves are safe.

The IRGC negotiating in Islamabad is harder and more ideologically driven than the leadership Washington dealt with in 2015. But ideology and institutional self-preservation are not the same thing. Even radical institutions protect their finances when those finances are directly threatened.

Iran’s military payroll bank, Sepah Bank, has already been struck and is under sustained cyberattack. The pressure is building. The question is whether Washington completes the squeeze before the floating reserve buys Iran another round of talks without real concessions.

The blockade is necessary, but it is not enough. If the cease-fire ends without a deal, two decisive targets remain that Washington has not yet pressured: Kharg’s loading infrastructure and its floating reserve.

Both directly hit the IRGC’s financial lifelines and appear legally sound under the Law of Armed Conflict. The analytical and targeting case for each is strong.

Washington knows Iran is broke. The question is whether it uses the tools that prove it.

Capt. Lance B. Gordon (US Navy, ret.) is a retired US Navy intelligence officer and US Army War College and New York University School of Law graduate. From RealClearDefense.

https://nypost.com/2026/04/21/opinion/the-2-critical-iran-lifelines-the-us-has-left-largely-untouched-just-as-cease-fire-talks-stall/