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Clinical trials are down the street

The ideas and innovators shaping health care
Mar 23, 2023 View in browser
 
Future Pulse

By Ben Leonard, Carmen Paun, Ruth Reader and Erin Schumaker

THE LAB

The entrance to a Walgreens is seen.

Come to Walgreens for your clinical trial. | Michael Dwyer/AP Photo

“Clinical trials are in the Flintstone era.”

Ramita Tandon, Walgreens’ chief clinical trials officer

Clinical trials are coming to the corner store and strip mall.

Walgreens, Walmart and CVS are getting into the business and have built-in advantages.

Selling point: Clinical trial investigators and sponsors have long struggled to recruit a sufficent number of participants — especially those from diverse populations.

The big chains are betting that their ubiquitous stores and troves of patient data can give them an advantage in expanding access to trials and recruiting patients.

Their pharmacies are well positioned to do so, said Caleb Alexander, a professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health, given that most Americans live near them.

Game plan: Walgreens launched its clinical trial business last summer, and Walmart rolled out its Walmart Healthcare Research Institute in October. CVS did so in mid-2021.

Ramita Tandon, Walgreens’ chief clinical trials officer, told Ben that her company has converted many locations to clinical trial centers.

“There are opportunities to find better ways to design and execute clinical trials and make them more accessible,” she said.

Profit potential: Trials are a lucrative business, with the global market sitting at more than $50 billion, according to some estimates.

Walmart is already turning a profit, said John Wigneswaran, the company’s chief medical officer, and it’s signed deals with the “top five pharma players.”

Even so: “It’s not obvious for the barrier of trust in the health care system and clinical trials, how someone like CVS or Walgreens is necessarily better positioned” than others, said Carri Chan, the faculty director of Columbia Business School’s healthcare and pharmaceutical management program.

Still, despite the chains’ advantages, it’s a challenge to convince people reticent about participating in trials to do so, Tandon said.

Wigneswaran said Walmart is being “intentional” about the sponsors it works with to ensure diversity.

 

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WELCOME TO FUTURE PULSE

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This is where we explore the ideas and innovators shaping health care.

The New York Times, on whose Covid tracker the American elite whiled away many a nervous hour during the pandemic, is ending its data-gathering effort. The paper will rely henceforth on the Centers for Disease Control and Prevention's numbers for cases, deaths, hospitalizations and vaccinations.

The Times' daily report is no longer possible, the paper announced, because many states and localities are no longer producing reliable figures.

Unfortunately, the CDC's vaccination data is also flawed, as Krista Mahr discusses with Ruth in today's Pulse Check podcast.

Share any thoughts, news, tips and feedback with Ben Leonard at bleonard@politico.com, Ruth Reader at rreader@politico.com, Carmen Paun at cpaun@politico.com or Erin Schumaker at eschumaker@politico.com.

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CHECKUP

A patient is seen by a nurse.

Your test results have arrived. | William Thomas Cain/Getty Images

Good news or bad, patients say they want their test results pronto.

That’s according to a new survey of more than 8,000 patients published in JAMA Network Open. It found that 96 percent of those surveyed want their results immediately, even if a doctor hadn’t reviewed them. That figure stayed essentially the same even if their results were out of the ordinary.

Why it matters: HHS has defended rules it imposed last fall preventing providers from withholding patient data, and touted the JAMA study's findings suggesting patients support that policy.

Congress asked the agency to bar information-blocking in a 2016 law, but the American Medical Association and other groups protested the rules, warning that they made it difficult for doctors to talk through results with patients.

The doctors’ case: The AMA has cited a survey it commissioned that shows about two-thirds of patients want their doctors to walk them through “life-changing” results.

The group has asked for flexibility — perhaps a “few hours or a few days” — in the case of bad news to talk with a patient in person or over the phone.

“Research that asks different questions yields different findings. In this instance, ‘non-normal’ results are distinct from those that show debilitating, life-limiting or terminal illnesses,” AMA President Jack Resneck Jr. told Ben. “Physicians are not surprised that our patients are eager to get abnormal cholesterol results immediately, while many want to hear about a life-threatening cancer diagnosis in a timely manner but from a physician.”

Defending the rules: Some patient advocates and HHS think exceptions could do more harm than good by slowing down a search for a second opinion or other resources.

“Information is empowering to patients and … can relieve worry,” said Robert Turer, assistant professor of emergency medicine at the University of Texas Southwestern Medical Center, in an interview with HHS' Office of the National Coordinator for Health Information Technology.

WORLD VIEW

In this photo taken on Sept. 10, 2010, a health worker wraps a baby that was born minutes before as the mother looks on at the government maternity hospital in Katmandu, Nepal. In Nepal and across the world are success stories in the battle against maternal mortality. But as the U.N. hosts a September 2010 summit to review progress in easing the world's humanitarian crises, it faces a troubling reality: hundreds of thousands of   pregnant women still die unnecessarily every year. (AP Photo/Gemunu Amarasinghe)

USAID is stepping up efforts to save mothers' lives. | AP

A mother dies somewhere in the world every two minutes, according to the U.S. Agency for International Development.

But care offered before, during and after childbirth could prevent nearly all those deaths, USAID said in its new strategy to save mothers’ lives.

The agency plans to do so by helping 25 low-income countries, including Bangladesh, the Democratic Republic of the Congo, Haiti and Nigeria, increase the coverage and quality of their health services.

USAID Administrator Samantha Power gave some specifics. The agency plans to:

— Help the countries it’s supporting hire more health workers and find ways to get patients who live in remote areas to health care facilities. An emergency transport system supported by USAID and the Vodafone Foundation in Tanzania has led to a nearly 40 percent drop in maternal mortality rates, Power said, and it’s now expanding to Kenya.

— Improve data tools to know who is not getting care and try to meet their needs.

— Train health workers to perform safe and effective obstetric surgeries or to quickly diagnose and treat malaria and other diseases.

How we got here: Deaths due to complications from pregnancy or childbirth declined by more than a third globally between 2000 and 2020, according to UNICEF, going from 342 deaths per 100,000 live births to 223 deaths per 100,000 live births.

But progress has slowed, and the world is not on track to achieve the UN’s goal of reducing the maternal mortality ratio to less than 70 per 100,000 live births by 2030.

“We haven't done nearly enough to reach historically marginalized communities or to affirm the sexual and reproductive health and rights of every woman and girl,” Power said at a briefing on the new strategy. “And we haven't focused enough on whether that care is actually effective and actually safe.”

 

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