Author: Raymond McBride

Remove roadblocks to medical care by nurse practitioners in Indiana

As a physician who provides health care to Hoosiers every day, it’s clear that our state is facing a mounting crisis of care. There simply aren’t enough physicians to meet the skyrocketing patient demand, and many of us are retiring. For years, I’ve worked with advanced practice registered nurses (APRNs) to provide patients with safe, high-quality care. It’s time for the state legislature to remove the legislative roadblocks that prevent patients from choosing APRNs as their health care providers.

Across our state, the physician shortage is having detrimental effects on Hoosiers’ health. Health care costs are up and health outcomes are down. We hear every day that patients are having difficulty scheduling appointments for routine care. The lack of prenatal care is driving up infant mortality rates across our state. Kids devastated by the pandemic can’t get the mental health care they need. The status quo isn’t cutting it anymore and policymakers need to make a change.

Can the Fitplan App and Michelle Lewin’s Workouts Help You Level Up Your Fitness?

Gone are the days when the only fitness gurus around were Billy Blanks, Jane Fonda, and Kathy Smith. Now there are so many fitness influencers on social media and YouTube that it’s hard to choose which one can actually help you crush your fitness goals.


Michelle Lewin is one of the most popular fitness influencers on the internet, but are her app, Fitplan, and her YouTube channel the resources you should use to achieve your goals? Find out what Lewin has to offer and what makes Fitplan a valuable tool as you strive to be fit and healthy.


Fitplan and the Michelle Lewin Fitness Website

With over 15 million followers on Instagram, Michelle Lewin is an incredibly well-known fitness icon and model. However, her stardom isn’t limited to Instagram, as she has built somewhat of a fitness empire. In fact, she has both a workout app and YouTube channel, as well as a range of products that includes fitness equipment, supplements, workout clothing, and accessories.

What makes Michelle Lewin unique from many other fitness influencers is her journey and hardworking attitude. She started simply by working in a clinic in Venezuela, and she stays relatable, humble, and unpretentious during her videos.

Beyond her motivating attitude and inspirational story, here are the features of the Fitplan app and Lewin’s website that you should check out as you decide if she’s the trainer for you.

1. Fitplan Workout App

Fitplan is Michelle Lewin’s home and gym workout app. The app offers a bunch of awesome features including over 100 workout plans, an extensive collection of healthy recipes, and a global fitness community.

To get started on Fitplan, you first have to answer a set of questions so that the app can get an overview of your preferences and recommend some workout plans that are best for you. Don’t worry, you do have the option to change and update your initial filter choices whenever you like.

There are even more filters you can add to narrow down your search for the perfect workout. Some of them include fitness level, training type, focus area, and whether you’re looking for a full workout plan or merely a single workout.

You might like using a workout app because it makes it effortless to work out from the comfort of your own home, but that is what makes the Fitplan app different. Fitplan caters to both people who prefer to work out at the gym and people who prefer at-home workouts.

Download: Fitplan for iOS | Android (Free, subscription available)

Fitplan Workouts and Plans

The Fitplan app has a massive selection of training plans and single workouts, and the library continues to grow! If you’re considering committing to a lengthy workout plan, choose the workout frequency, duration, and training type that works best for you.

On the other hand, you can choose a workout plan based on your favorite trainers, like Scott Mathison, Jen Selter, and even Michelle Lewin herself.

There aren’t as many single workouts available on the Fitplan app, but they’re a nice option if you don’t want to dedicate yourself to a full-on workout plan. The single workout sessions range from 8-minute abs workouts to 90-minute chest and back routines with Jeff Seid.

Nutrition in the Fitplan App

Fitplan isn’t all about the workouts, the app also offers over 400 delicious, nutritious, and easy-to-make recipes. The recipes are from the Fitplan trainers themselves and include all the necessary nutritional information, like overall calories.

You can use multiple filters to find recipes based on course or your dietary preferences. So there’s something for everyone, whether you’re looking for the perfect side dish or a quick pre-workout meal.

2. The Fitplan Blog

When you visit the Fitplan website, you’ll find a tab labeled Magazine. Click on it, and you’ll be taken straight to the Fitplan blog. The blog covers a handful of interesting categories including fitness, wellness, nutrition, and general news about Fitplan.

The fitness category features all you need to know about leveling up your workout game, like tips and tricks and inspiring member stories. Nutrition, of course, is all about what you put into your body. Here, you’ll find healthy recipes and essential information to help you on your nutrition journey.

The wellness category focuses on healthy habits for your physical and mental well-being. Why Exercising Makes You Happy and 5 Tips for Better Sleep are just a couple of the articles you should take a look at.

3. Michelle Lewin’s Zumba Workouts

Do you want to sweat to the beat? STRONG by Zumba is an online workout class that’s completely different from any other Zumba cardio dance workout class. This Zumba class doubles as an intense HIIT workout session where every beat of the music matches the individual exercise movements. You can either stream this collaboration between Lewin and STRONG by Zumba using Amazon Prime Video or buy the DVD online.

4. Michelle Lewin’s YouTube Channel

The Michelle Lewin YouTube channel has plenty of videos that can help you correct your exercise forms, cook up healthy recipes, and learn more about fitness tips and tricks. Unfortunately, the workout videos do not guide you through full, free guided workout classes.

Instead, compared to other fitness brands like Pamela Reif and Chloe Ting, Lewin only demonstrates each exercise in the routine, including how many reps and sets you should do.

Lewin centers more on providing full workouts and workout plans on the Fitplan app. So, the YouTube videos are nice if you’re looking for a simple demo of a workout routine, but it’s best to download and use the Fitplan app if you want ongoing guidance on workout routines and long-term plans.

Are Fitplan and Michelle Lewin’s YouTube Channel Helpful for Your Fitness Goals?

Crushing your fitness goals can sometimes be difficult. Perhaps you’re in a slump, or you simply don’t know where to start. Whatever the case may be, you probably need a little guidance on your journey to fitness.

Although Michell Lewin’s brand offers various YouTube videos, a line of products, and lots more, what is really great is her workout app, Fitplan. The app doesn’t just give you access to a workout plan that’s suited for your journey with step-by-step instructions. Fitplan also gives you that community aspect that is so important to keep you motivated!

With so many fitness influencers, icons, and gurus posting content online, it’s tough to pick just one. Of course, you don’t have to! But if you did want to choose one, Michelle Lewin and her app provide some of the best home and gym workout content around.

Is Your Phone a Medical Device?

Scholar argues that Congress and FDA should treat risky clinical artificial intelligence tools as medical devices.

When the U.S. Congress defined the term “medical device” in the Food, Drug, and Cosmetic Act, it mostly had in mind physical hardware products, such as knee replacements, pacemakers, and surgical instruments.

But today, patients and providers often rely on software tools to improve health. Examples include the Apple Watch’s electrocardiogram app and a smart camera that tells ophthalmologists whether a diabetes patient is at risk of blindness.

In a recent article, professor Sara Gerke of Penn State Dickinson Law proposes that Congress broaden the definition of a “medical device” to encompass risky products that rely on artificial intelligence (AI), and that the U.S. Food and Drug Administration (FDA) exercise regulatory oversight over the makers of some of these products.

Admittedly, FDA has adopted a regulation that treats as medical devices any software used for “medical purposes”—disease prevention, treatment, and diagnosis.

But not all software services related to health care serve medical purposes. FDA clarified in 2019 that software tools that only help users maintain “a general state of health or a healthy activity” are not medical devices. A smartphone app that monitors your exercise activity, for example, is currently not considered a medical device. Neither is software intended to reduce an individual’s risk of chronic diseases or conditions, such as an AI service that helps Type 2 diabetes patients eat a balanced diet for their condition.

In her proposal, Gerke calls for Congress to define such “clinical decision” software as medical devices. Doing so would include many risky AI-based health care products that FDA currently does not regulate, Gerke contends.

Gerke offers AI-based mortality prediction models as a telling example. These algorithms analyze a cancer patient’s medical records to predict likelihood of death within the next six months. Gerke argues that, because such algorithms do not directly relate to the prevention, treatment, and diagnosis of a condition, the current statutory definition of a medical device would likely not cover them.

Hospitals increasingly rely on tools such as cancer mortality prediction models in clinical decision-making, which Gerke claims could jeopardize patient safety. Gerke explains that “a model could lead to the cessation of a patient’s treatment if it incorrectly predicts the patient’s early death.”

Her proposed fix is simple: Congress should amend its definition of a medical device to include clinical decision-making tools that are intended for the “prediction or prognosis of disease or other conditions or mortality.”

Gerke also notes that many AI-based tools, including those used in health care, rely on “black box” machine learning models that hide the logic of how they reach their determinations. This opaqueness makes it difficult for providers and patients to review the tool’s recommendations independently.

Gerke first proposes a “gold standard” solution to the challenges that black-box medical algorithms pose: Congress can require the makers of clinical AI to use a “white-box” model—a transparent system that reveals how the clinical algorithms reach their decisions—whenever a white-box system would perform better than a black-box one.

But if companies can demonstrate that a black-box AI system for a particular product would perform better than a white-box one, then FDA should shift its focus to verifying the tool’s safety and effectiveness, argues Gerke. She suggests that FDA can better accomplish this verification if it regulates these black-box systems as medical devices.

Only then can FDA ensure that black-box algorithms in health care are safe and effective through clinical trials, according to Gerke. For this reason, she proposes that FDA adjust its regulation of these black-box products to match the standards it imposes on more traditional medical devices.

But beyond clinical trials, FDA can do more to bring clinical AI tools into compliance with the agency’s medical device rules and standards, Gerke argues.

FDA mostly takes enforcement action against the makers of AI-based medical devices through a discretionary approach that considers the level of risk that a particular device poses, Gerke explains. And in determining what counts as a “risky” AI-based tool, FDA emphasizes whether the tool allows for the user—whether caregiver or patient—to review independently the software’s decisions. If a tool does allow for independent user review of clinical decisions, then FDA usually will not take regulatory action against the tool’s manufacturer, Gerke describes.

Gerke proposes, instead, that FDA focus its regulatory oversight on two types of AI-based medical devices: those that make decisions on “critical or serious” health conditions, irrespective of whether providers or patients can independently review those decisions; and those that make decisions on “non-serious” health conditions, but do not allow for independent review of the software’s decisions by patients or providers.

This shift in focus would likely subject to FDA oversight, for example, mortality-prediction tools even when a physician or patient can independently review the tool’s prognoses before making decisions based on them, Gerke suggests. But lower-risk tools, such as general wellness products like asthma alert mobile apps, might not warrant such oversight under this proposal.

Both Congress and FDA can take decisive action to keep pace with the rising tide of AI-based health care products, Gerke concludes.

Big food companies slam government proposal for regulating “healthy” food labeling

As the federal government moves to change rules for what foods can sport “healthy” labels, manufacturers are pushing back.

Some of the biggest makers of cereals, frozen and packaged food have submitted dozens of claims to the Food and Drug Administration objecting to new rules that would exclude food with high amounts of added sugar and salt from being labeled as “healthy” on packaging. Some manufacturers have even called the regulations unconstitutional, saying they violate companies’ First Amendment rights. 

The FDA last fall moved to update its requirements around what foods can use the word “healthy” on packaging — the first change since the rule was implemented in the 1990s. The proposed changes would leave out high-sugar, low-fat products that currently are allowed to use the healthy label today, such as fruit-flavored low-fat yogurts and Raisin Bran cereal.

That’s unfair, many food companies gripe, complaining that the more rigorous nutritional standards would wrongly malign a range of popular foods. The rule “automatically disqualifies entire categories of nutrient dense foods,” Kellogg’s wrote in a February 16 comment on the agency’s proposal. 

General Mills goes further, arguing that the FDA’s “overly restrictive” rule violates companies’ rights to free speech.

“[T]he Proposed Rule precludes many objectively healthy products, including those promoted by the Dietary Guidelines, from engaging in truthful, nonmisleading commercial expression — and these overly restrictive boundaries for ‘healthy’ violate the First Amendment,” the packaged-food giant writes. 

General Mills has a slew of well-known brands, including Annie’s, Betty Crocker, Cascadian Farm, Pillsbury and Yoplait, as well as cereals Chex, Cheerios, Choco Puffs, Cinnamon Toast Crunch, Raisin Nut Bran and Wheaties.

The window for submitting public comments on the proposed rules closed earlier this month. The FDA will now review the feedback, though the timing of a final rule is uncertain.


FDA proposes new rules for plant-based milks

04:16

The Consumer Brands Association, whose members include Coca-Cola, PepsiCo, Hain Celestial and the Campbell Soup Company, took a similar tack, writing that “consumers have a First Amendment right to receive truthful information about products and manufacturers have a First Amendment right to provide it to them.” The group estimated that 95{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of foods currently on the market would not qualify for a “healthy” label under the government’s new requirements. 

KIND, the granola bar company, took issue with the FDA’s proposed limits on added sugars in foods, saying they “created a barrier for fruit, vegetable, and protein food innovation” and would lead to more companies using artificial sweeteners in their products to mimic the taste of sugar-sweetened food.

“Criteria for use of ‘healthy’ should not be so restrictive that they allow only a very limited number of foods to qualify, because this could lead consumers to conclude that other nutrient dense food choices are ‘unhealthy,'” the company added.

No label, no customers?

Conagra Brands, creator of the “Healthy Choice” brand of frozen meals, offered a blunt assessment: If it reinvents “Healthy Choice” to comply with the new rules, people won’t buy it, the company said. 

“Conagra cannot continue to invest in ‘healthy’ innovation if we are not able to meet the necessary taste, eating trends and affordability our consumers expect. If the food does not taste good, people will not buy it,” Conagra said. 


FDA hasn’t reviewed some food additives in decades

02:33

Many “Healthy Choice” items have been criticized for their high amount of sugar or salt. For instance, the “Healthy Choice Sweet and Sour Chicken” meal contains 21 grams of added sugar — 42{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of the current recommended daily value — while providing just 390 calories. 

“Meeting people where they are”

The American Frozen Food Institute said that restrictions on sodium would result in “nutritious frozen items being excluded due to a small amount of sauce that makes the item much more likely to be consumed.” 

“Consumers already know that whole fruits and vegetables are healthy and may not be consuming such products for a variety of reasons,” the Institute said, adding that the FDA should be “meeting people where they are.”

The Consumer Brand Association echoed this comment, writing: “Many consumers are constrained from preparing meals and snacks from ‘plain’ ingredients due to limited time, affordability, easy access to stores that sell these ingredients, kitchen resources, and cooking skills. And most consumers do not typically eat foods in a plain, unflavored form.”

Despite this industry’s grousing, many nutrition experts have come out in favor of the FDA’s revised guidelines. Requirements for the “healthy” label haven’t changed in the 28 years since it was first created, even as the public understanding of what’s nutritious has evolved. 

“We want to use policies that advocate for a healthier diet than we currently have, and that’s why we believe the healthy claims should be allowed only for foods that are truly healthy,” said Eva Greenthal, senior policy scientist at the Center for Science in the Public Interest. The CSPI mostly supports the new rules but says they allow too much refined grain and processed fruit.

Powerful marketing 

Under the FDA’s proposed rules, foods high in sugar, sodium or refined grains won’t be banned; rather, food makers won’t be allowed to label such products as “healthy,” which can be a powerful marketing claim.

“There are currently some products labeled ‘healthy’ that contain insane amounts of sugars,” Greenthal said. 

That’s a remnant of the low-fat craze of the early nineties, when processed-food manufacturers created a slew of supposedly low-fat snacks that contained high amounts of sugar and salt to compensate for the loss of taste. Since then, research has overturned the belief that all fat is bad for health while demonstrating the harmful effects of high sugar consumption. 

Greenthal sees the revised FDA guidelines as mostly positive, although she doubts it will have much impact on Americans’ eating habits.

“What we really need are mandatory labels that force companies to disclose information they otherwise conceal,” she said. “Companies are very quick to tell us if a product is high in fiber or vitamin C, but not when a product is high in saturated fat, sodium, or sugar. These are the products that are linked to heart disease, high blood pressure and diabetes.”

The CSPI recently petitioned the FDA to require food makers to prominently label these ingredients on the front of a food package.

“The FDA just needs to consider its mission, to protect public health, and use that as its guiding star as it faces industry pressure to prioritize industry interests over public health,” Greenthal said.

Idaho dropped Medicaid recipients instead of trying hard to track them down : Shots

Idaho dropped Medicaid recipients instead of trying hard to track them down : Shots

Idaho removed nearly 10,000 people from Medicaid in the pandemic’s first years when enrollees couldn’t be reached. The episode previews what could occur in other states after April 1, when a COVID-era coverage mandate ends.

Eric Harkleroad/KHN


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Eric Harkleroad/KHN

Idaho removed nearly 10,000 people from Medicaid in the pandemic’s first years when enrollees couldn’t be reached. The episode previews what could occur in other states after April 1, when a COVID-era coverage mandate ends.

Eric Harkleroad/KHN

During the first two years of the COVID-19 pandemic, while the federal government was trying to prevent people on Medicaid from losing health coverage, Idaho dropped nearly 10,000 people from the safety-net program.

Federal law generally banned states from dropping people, and federal officials said Idaho acted improperly. Idaho officials, however, said they didn’t think they did anything wrong.

The episode, revealed in documents KHN obtained through a public records request and in interviews with state officials, offers a preview of what could soon unfold across the United States for millions of people covered through Medicaid, the federal-state health insurance program for people with low incomes.

It shows how easily state bureaucracies can disenroll people they shouldn’t be disenrolling, leaving those people in financial and medical jeopardy. It also illustrates the potential for confusion and disagreement over what procedures states should follow before cutting off anyone’s benefits, particularly when enrollees can’t be reached.

Why millions on Medicaid are at risk of losing coverage in the months ahead

Why it could happen in other states starting April 1

A COVID-19 relief law Congress enacted in 2020 prohibited states from removing people from Medicaid except in a few narrow circumstances, such as if an enrollee died or moved out of state.

On April 1 of this year, after the prohibition expires, states will resume removing people who no longer qualify or do not furnish needed information. That process has come to be known as “the unwinding.” Some states see the end of the mandate as a chance to quickly winnow Medicaid rolls that have grown to record levels.

Idaho Gov. Brad Little was among 25 Republican governors who told President Joe Biden in a December letter, that, by keeping ineligible people on the Medicaid rolls, the mandate was “negatively affecting states.”

Idaho’s Medicaid program had nearly 450,000 enrollees at the start of this month. The state said about 150,000 of them no longer qualified or had not been in contact with the program during the public health emergency.

By the time recipients notice, ‘the damage will be done’

Nationally, as disenrollments ramp up, many officials are predicting a mess. The Department of Health and Human Services has predicted that nearly 7 million people still entitled to Medicaid benefits will lose coverage because they fail to complete renewals or state governments won’t be able to contact them.

People may not realize they’ve been dropped until they seek care.

6.8 million expected to lose Medicaid when paperwork hurdles return

Why pediatricians are worried about the end of the federal COVID emergency

“The damage will be done,” said Tricia Brooks, a research professor with Georgetown University’s Center for Children and Families.

Idaho terminated Medicaid benefits for more than 9,800 beneficiaries during the pandemic after mail the state sent them was returned as undeliverable and other attempts to confirm that they still resided in Idaho failed, according to emails obtained by KHN between the Idaho Department of Health and Welfare and the U.S. Centers for Medicare & Medicaid Services.

The emails, sent last spring and summer, detail Idaho’s rationale for the terminations, CMS’ concerns, and the state’s efforts to restore benefits.

CMS officials maintained that, when Idaho’s mailings were returned with no forwarding address or an out-of-state forwarding address, the state didn’t do enough to make contact with the beneficiaries and ensure they no longer lived in Idaho.

“CMS appreciates the state’s efforts to come into compliance,” Sarah O’Connor, a CMS official, wrote on Aug. 18 of last year.

In meetings with CMS, Idaho officials were told the state could not kick people off if it didn’t make “physical contact,” Shane Leach, administrator of the Division of Welfare at Idaho’s Department of Health and Welfare, recounted in correspondence with CMS.

“What they were saying early on,” Leach told KHN, “is, basically, we didn’t do enough outreach to really prove that this person was no longer in Idaho and not eligible for Medicaid.”

He added: “My perspective is, we did our due diligence.”

Many calls and letters went unanswered, Idaho says

For the first two years of the pandemic, when Idaho received returned mail with an out-of-state forwarding address or no forwarding address — possibly indicating the enrollee no longer lived in Idaho — Leach said state officials would call them.

A lot of the calls went unanswered, he said.

“They’re really concerned about physically talking to the person or having them say, ‘Yes, I’m in another state,'” Leach said of CMS. “And so that’s where they said, ‘OK, well, you need to reinstate those individuals.'”

“We felt like we were following the guidance,” said Jennifer Palagi, a deputy director at the Idaho health department.

CMS guidance in August 2021 stated that returned mail alone was not reason enough to disenroll Medicaid beneficiaries during the public health emergency. But if CMS had issued a written version of the standard to which it was holding Idaho — in which disenrollments would be justified only if the state made contact with the enrollee — Medicaid consumer advocates and other specialists said they were unaware of it.

CMS declined to answer several questions about the Idaho situation.

“CMS is committed to working with states to ensure continuity of coverage for eligible individuals, including those for whom the Medicaid agency receives returned mail,” Bruce Alexander, director of CMS’ office of communications, said in a written statement to KHN.

According to the batch of emails obtained by KHN, Idaho in March 2022 did change the state’s procedures after discussions with CMS. By July, the state Medicaid agency had reinstated benefits for 6,400 people the state couldn’t get hold of.

In one of the emails the Idaho Medicaid agency sent to CMS last July, the state said it was reviewing the extent to which it needed to pay medical bills the program had originally rejected.

It’s a long-standing problem — and about to get bigger

The inability to reach Medicaid enrollees has been a long-standing problem. The paperwork that agencies send people to fill out often goes unreturned. Some ends up at the wrong address. Up-to-date phone numbers or email addresses may not be available to state and county workers.

Red and blue states look to Medicaid to improve the health of people leaving prison

“In a perfect situation, a member responds to give you their current address, a phone number, an email address, etc.,” said Jack Rollins, director of federal policy for the National Association of Medicaid Directors. “But that is not the case for a lot of situations.”

And that’s bound to become a larger problem, consumer advocates say, after the pandemic-era enrollment mandate ends this spring. On Jan. 27 of this year, CMS detailed to health agencies in all states the minimum they’ll need to do to reach a Medicaid recipient who hasn’t responded to a mailed form: Before ending benefits, a state must try to obtain up-to-date contact information and attempt to reach the person through at least two means, such as by mail, phone, email or text message, if those means are available.

Still, “there’s just a lot of variation in terms of what that could look like,” said Farah Erzouki, a senior health policy analyst for the Center on Budget and Policy Priorities, a think tank in Washington, D.C.

If any state isn’t following the rules, Georgetown University’s Brooks said, it can take months to fix the problems — all while people’s benefits hang in the balance.

“This is what we want to avoid,” Brooks said. “We don’t need to spend the next three years after ‘the unwinding’ trying to get people back on who should not have been disenrolled.”

KHN (Kaiser Health News) is an editorially independent, national program of KFF (Kaiser Family Foundation).

Patients losing out amid slump in NHS clinical trials, warn top clinicians | Medical research

The state of clinical trials in the NHS is “much worse than it has been in years” with patients losing access to cutting-edge cancer and dementia treatments, one of the UK’s most senior clinicians has warned.

Sir John Bell, the regius professor of medicine at the University of Oxford and a government life sciences adviser, said the UK’s approach needed “a full overhaul, top to bottom” to prevent a collapse in the number of clinical trials being conducted in the NHS.

“I don’t think there’s any doubt that companies are choosing not to evaluate their drugs in the UK,” he said. “The risks [to patients] are much bigger than have been alluded to.”

The intervention comes after the government launched an independent review led by the former health minister James O’Shaughnessy into why the NHS had seen a 44{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} drop in participants recruited to commercial clinical trials in the past five years. The UK is rapidly losing ground to countries such as Spain, Poland and Australia, falling from fourth to 10th internationally for phase III trials.

Prof John Bell.
Prof John Bell says patients get access to groundbreaking treatments and the NHS makes money from conducting commercial trials. Photograph: Sophia Evans/The Observer

Reduced access to trials is particularly concerning for patients with limited routine treatment options, such as the roughly 3.5 million people living with rare diseases and patients with dementia and advanced cancer.

Beyond clinical benefits, the NHS makes money from conducting commercial trials. “You get the drugs for free, you get the treatment for the control arm for free, the NHS rides for free for everyone in the trial and pharma pays pretty well to get these trials done,” said Bell.

However, Bell said bureaucracy that had been simplified during the pandemic to fast-track trials had “crept back into the system and ossified” and the overstretched NHS workforce was losing capacity for research. “The system needs a pretty serious revamp,” said Bell. “[The government] is not going to fix this by just turning the handle a bit harder.”

Official figures show just 52{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of trials in the NHS are running to schedule – a significant improvement in recent months but still some way from the target the Department of Health has set for 80{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} trials being delivered to time and target by June.

The department has directed funders to shut down any trials that have missed their target to start recruiting by more than 90 days, with one in 10 trials being monitored under its Reset Research programme set to close prematurely. Five hundred trials have been closed under the initiative since May last year.

Other senior clinicians also raised concerns. Prof James Rowe, a senior dementia researcher at the University of Cambridge and consultant neurologist, said the UK’s lengthy approvals process could leave clinicians and their patients frozen out of international multicentre trials.

“If it’s going to take you 12 months to get started in the UK, by the time you get the green light the trial is effectively closing for recruitment internationally. It could be futile to begin the work to set up,” he said.

“It’s a great pity as there’s fantastic progress in the dementia world. There are 300 clinical trials for dementia worldwide. The UK should be at the forefront of this, not putting up barriers.”

Prof Paul Stewart, the vice-president (clinical) of the Academy of Medical Sciences and of the University of Leeds, said research tended to be viewed as a luxury rather than an integral part of the NHS’s mission.

“As I reflect on my 40-year career in the NHS, there have always been challenges, but now the crisis has come to a head in terms of a research capacity issue. The current environment is extremely challenging,” he said.

Dr Ian Walker, of Cancer Research UK, said the pandemic continued to “cast a long shadow” over clinical research. “As backlogs for diagnosis and treatment grow, NHS staff face more pressures and protecting time for research is increasingly difficult,” he said. “If this pattern continues, it means slower progress towards brand new treatments for cancer.”

George Freeman, the minister at the Department for Science, Innovation and Technology, said: “Commercial clinical trials are absolutely vital to both our UK life sciences sector and widening NHS patient access to innovative medicines all across the UK. The UK has traditionally been a strong global location for trials, as demonstrated most recently through the groundbreaking Covid recovery trial which was set up in record time and was the world’s largest randomised controlled trial for Covid-19.

“However, our life sciences sector has reported a 44{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} fall in recruitment of patients to commercial clinical trials between 2017 and 2021 – so it is vital that we act to rebuild competitiveness.”