Posts tagged with "Clinical trials"

Walgreens to launch business that will connect customers with clinical trials

June 20, 2022

Some Walgreens customers might soon get a new kind of message from the company, asking if they’d like to participate in a clinical trial, reports The Chicago Tribune.

Deerfield, Illinois-based Walgreens announced on Thursday, June 16, that it plans to launch a clinical trials business—in which pharmaceutical companies can hire Walgreens to help them find participants for clinical trials, which are used to evaluate the safety and effectiveness of new potential types of medications and devices.

Walgreens plans to use its rosters of customers and patients to find those who may match a trial’s criteria, and then ask those people if they would like to participate, said Ramita Tandon, chief clinical trials officer at the pharmacy chain.

As part of the new business, Walgreens also may help companies carry out clinical trials by conducting visits for participants at some of its stores, during which patients may fill out surveys or have blood taken, depending on the type of trial, Tandon said. It’s possible nurses, pharmacists, pharmacy technicians or doctors could help with those visits, depending on what’s needed, she said.

Walgreens leaders believe they can help companies get more clinical trial participants, and a more diverse range of participants, because Walgreens has customers in so many different communities.

Including participants from diverse racial backgrounds has long been an issue in clinical trials. In the U.S., 75% of 32,000 participants in the trials of 53 new drugs approved in 2020 by the U.S. Food and Drug Administration were White, according to FDA. Only 8% were Black, 6% were Asian, and 11% were Hispanic.

People from different backgrounds can react differently to some medications and devices, which is part of the reason it’s crucial to have trial participants from a variety of backgrounds, according to the FDA. Also, a lack of diverse participants may mean that people from certain racial and ethnic groups are not getting early access, through clinical trials, to drugs that could help them.

“The therapies that are coming out today are not very representative of the U.S. population,” Tandon said. “As we at Walgreens start to tap into our local communities, (we can) educate and empower these communities on the benefits of clinical trials. Not only are they participants in research, but this is yet another opportunity as a care option, (for) patients who may he exhausted other avenues in their care journey.”

She said Walgreens will be able to “mine the vast foundation of patients and consumers who come to our stores and pharmacies on a regular basis” to match potential participants to clinical trials.

Patient data will not be shared with pharmaceutical companies unless patients give consent to share it, and participation will be voluntary. Doctors will work with Walgreens to oversee the clinical trials, and Walgreens may be able to reach out to a patient’s primary care or specialty doctors if needed, Tandon said.

Research contact: @Walgreens

A long shot: Researchers speculate that a new supplement could extend our lifespan

September 5, 2018

Anti-aging products and regimens—from skin creams and vitamins, to exercise goals and diet plans—are part of an industry that is poised to generate about $200 billion by 2019, but to date, scientists have not concocted a longevity elixir that stands up to medical scrutiny. However, that may be about to change: A group of researchers is heralding a compound called nicotinamide adenine dinucleotide, or NAD+ for short, according  a recent report by TIME magazine.

“NAD+ is the closest we’ve gotten to a fountain of youth,” says David Sinclair, co-director of the Paul F. Glenn Center for the Biology of Aging at Harvard Medical School. “It’s one of the most important molecules for life to exist, and without it, you’re dead in 30 seconds.”

NAD+ is a molecule found in all living cells and is critical for regulating cellular aging and maintaining proper function of the whole body. Levels of NAD+ in people and animals diminish significantly over time, and researchers have found that re-upping NAD+ in older mice causes them to look and act younger, as well as live longer than expected. In a March 2017 study published in the journal Science, Sinclair and his colleagues put drops of a compound known to raise levels of NAD+ into the water given to a group of mice.

Within a couple of hours, the NAD+ levels in the mice had risen significantly. In about a week, signs of aging in the tissue and muscles of the older mice reversed to the point that researchers could no longer tell the difference between the tissues of a two-year-old mouse and those of a four-month-old one.

Now, Time reports,  scientists are trying to achieve similar results in humans. A randomized control trial (considered the gold standard of scientific research) from a different group of researchers published November 2017 in the journal Nature found that people who took a daily supplement containing NAD+ precursors had a substantial, sustained increase in their NAD+ levels over a two-month period.

Sinclair takes an NAD+ upper daily. Anecdotally, he says he doesn’t experience hangovers or jet lag like he used to, he talks faster, and feels sharper and younger. His father takes it too: “He’s 78, and used to act like Eeyore,” Sinclair told the news outlet. “Now he’s going on six-day hikes and traveling around the world.

“I’m not saying we’ve proven it works,” Sinclair adds. “But I can say that if it’s going to work, I hope to be the one to prove it.”

He has competition. Sinclair plans to take his NAD+ research through the U.S. Food and Drug Administration (FDA) approval process and eventually create a pill that could be prescribed by a doctor or purchased over the counter, but another company, called Elysium, is already selling a supplement called Basis that contains compounds known to boost NAD+ levels. (Basis is the supplement tested in the 2017 Nature study.)

Leonard Guarente, Elysium’s chief scientist and co-founder—who also directs the Glenn Center for Biology of Aging Research at MIT—says Basis is not intended to extend people’s life spans, but to help them stay healthier for longer.

Eight Nobel laureates are on the company’s scientific advisory board. “I don’t really mind how long I live provided the life is as good as it is now,” says board member Sir Richard Roberts, winner of the 1993 Nobel Prize in Physiology or Medicine (who is 74). “The only difference I’ve noticed is that the skin on my elbows is smoother than it used to be. Whether it’s Basis or something else, I have no idea.”

Elysium has chosen a faster path to market: By bringing Basis to market as a supplement, and not a drug, Elysium is not required to undergo years of clinical research and FDA approval processes. That decision, and the support of prominent scientists, has stoked criticism from some medical-community experts who wonder why Nobel laureates would attach their names to a supplement without much human research behind it. Elysium declined to confirm if the scientific advisory board members are paid.

Although Basis is already available for purchase, Elysium recognizes that further evaluation of its effects on the human population may be warranted—and the company currently is conducting clinical trials of the supplement.

Still to be determined: Whether NAD+ or Basis—or some other formulation still out there—will “live up to” their spreading word-of-mouth.

Research contact: david_sinclair@hms.harvard.edu