06Jun

Minority representation in clinical trials is an issue the coronavirus vaccine trials has brought out of medical publications and journals and into the broader media.

In just the last few weeks, discussions of the need to ensure Black, Hispanic, Asian and other ethnic minority participation in the trials have appeared on NPRABCCNBC and elsewhere.

“If Black people have been the victims of COVID-19, we’re going to be the key to unlocking the mystery of COVID-19,” Rev. Anthony Evans, president of the National Black Church Initiative, told the Los Angeles Times.

Recruiting minorities for clinical trials is not a new issue. Five years ago, the FDA’s Center for Drug Evaluation and Research began publishing demographic summaries of clinical trials. The reports are in response to a Congressional mandate “to report on the diversity of participants in clinical trials and the extent to which safety and effectiveness data is based on demographic factors such as sex, age, and race.”

A recent article on the pharmaceutical news site PMLive carried the headline “If our patients are diverse, why are clinical trials so white?” The article notes that, “Although 20% of the people living with multiple myeloma (cancer of plasma cells) in the US are African Americans, they only account for 6% of all patients in clinical trials.”

Clinical trial managers and researchers are making an effort to diversify their patient volunteers. Writing in Stat, Jocelyn Ashford, a patient advocate and trial recruiter, says creating an inclusive clinical trial requires engaging “the target community in discussions around the recruitment plan. By bringing these communities to the table early, we can hear their input instead of making assumptions about how to best reach them.”

In recruiting Black participants, she’s reached out to historically Black fraternities and sororities. “These organized groups of educated, social-minded individuals are looking to give back to their communities and can act as bridges to their parents, grandparents, and the Black community more broadly.”

Forbes last year suggested that a key to increasing minority representation is to make it easier for minorities to participate by designing ways to gather the data via wearables. It’s also important, says the Forbes article, that clinical trial investigators themselves be representative of different groups.

Citing a Clinical Research Pathways report on “Diversity in Clinical Trials,” Forbes observes that “patients from minority communities are more likely to enroll when they learn about studies from doctors in their own communities.”

For the earliest of the COVID trials, Moderna is getting help from Dr. Carlos del Rio, executive associate dean at the Emory University School of Medicine in Atlanta. He has a record of successfully recruiting minority trial volunteers, according to Kaiser Health News.

Said del Rios, “We’re trying to do our best to get out to the communities that are most at risk.”

Photo by Fadil Fauzi on Unsplash

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Jun 6, 2023

Grocery Pharmacies Are Closing As Chains Take Over

As Big Pharma and the entire pharmaceutical sector generally transforms (see our previous articles), so too is the way consumers buy their drugs and fill prescriptions.

For the first time since grocers set-up pharmacies inside their markets, the number of these grocery pharmacies is

declining. The Wall Street Journal says hundreds of regional markets “are closing or selling pharmacy counters, which have been struggling as consumers make fewer trips to fill prescriptions and big drugstore chains tighten their grip on the U.S. market.”

Consolidation has concentrated market share in CVS and Walgreens, which together accounted for more than 40% of all prescription revenue in 2018. Together, the two operate more than 20,000 retail locations. In 2015, CVS acquired 1,672 in store pharmacies from Target. Last year, Walgreens broadened its partnership with the giant Kroger grocery chain spurring speculation it could buy the grocer’s 2,270 in-store pharmacies.

Consumer’s have also changed how they fill prescriptions, switching to mail order and buying in larger quantities, less often.

The Journal explained that smaller grocers don’t have the clout to negotiate higher reimbursement rates from insurers, nor do they have the amenities like nationwide networks and walk-in clinics that the largest chains do. Their pharmacies tend to operate at or below break-even, but served as a customer convenience.

“There is the benefit of having a pharmacy relative to the grocery-sale lift and the convenience factor of having both in the store, but the economics do not work,” Raley’s CEO Keith Knopf told The Journal.

With the closing of these grocery pharmacies comes the loss of jobs. Reporting on the update of the Department of Labor’s Occupational Outlook Handbook last fall, Drug Channels said jobs for pharmacists is projected to be flat through 2028. But jobs for retail pharmacists will decline by 11,000. Hospitals, outpatient care centers and home healthcare agencies will add pharmacist jobs as will mail order services.

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Jun 6, 2023

Lies and Deceit Plague Clinical Trials

The publicity around the current COVID vaccine clinical trials has done much to make the public aware of the difficulties researchers face to ensure the safety and effectiveness of the therapy being tested.

Besides the now well-known need to recruit participants representing all age groups, races, and other demographics, clinical trial managers also have to be on the lookout to avoid what the pharma community has come to call “professional study subjects.”

These individuals are so eager to participate in a clinical study they lie about their medical condition, misrepresent their lifestyle, fail to disclose medications they take and may participate in more than one, even several studies simultaneously.

Eric Devine, PhD, assistant professor of psychiatry at Boston University School of Medicine, says, “I was doing clinical trials and I was running into people who were just lying to me. It was blatant when I looked at their medical records.”

Money is what motivates most professional study subjects, according to a Medscape report. Many trials pay participants, enabling some to earn thousands of dollars. One man who entered an Alzheimer’s trial legitimately earned $31,000.

Others may be driven to participate because of free medical treatment. The Medscape report mentions one woman who lied to get into a trial involving botulinum toxin. “I wanted to get into the study. I wanted free Botox, so I participated. And I got paid — so why wouldn’t I?”

study of the problem published in 2013 found 75% of the subjects who had participated in at least two trials in the previous year admitted concealing some important medical information:

  • 32% hid health problems
  • 28% concealed their use of prescribed medications
  • 20% failed to disclose their recreational drug use
  • 14% reported pretending to have a health condition in order to qualify.

Even when these professional study subjects have more altruistic motives, their deception can skew trial results. If enough of these types of study subjects manage to enroll – and the estimate is that as many as 25% of volunteers apply in a way that violates trial criteria – the results can be skewed.

Medscape says misrepresentation can be serious enough to “invalidate outcomes and even halt further research.”

Subject registries exist to attempt to catch the professional subjects. When detected, these individuals can be entered in a registry. Recently, these registries have begun to incorporate biometric data to foil the professional subjects who have used fake identification.

“That can sound very ‘Big Brother-ish’,” Devine says. “But think about the quality of our information — it can either be lifesaving or not. Do we really want to take a chance with medicine as a science, and leave it up to ‘Well, I hope we didn’t have too many professional subjects in this trial?’ “

Photo by Mehmet Turgut Kirkgoz on Unsplash

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