THE PAIN CHRONICLE CBD is a common item in medicine chests across America. More than a third (33%) of consumers use it, according to a 2020 study conducted by Single Care.
With 64% unaided recall rate reported by Consumer Reports, it’s safe to say the majority of Americans are familiar with the product that many use to address sleep, pain and anxiety-related issues.
70% of study participants taking medications for a medical condition reported no adverse effects from CBD use.
Consumer Reports also noted that more than 64 million Americans tried CBD sometime between 2017 and 2019. Additional sources agree that the pandemic has driven that number even higher.
The pandemic increased use rates, according to market research firm High Yield Insights, which reports 9 million new users joined the ranks of the 13.4 million adults who regularly consume CBD.
Although these statistics provide evidence of product knowledge and popularity, they do not prove product safety.
That, according to the FDA, requires rigorous scientific study, supported by clinical trials.
Today, one such clinical study is in. The news is good, according to Validcare, an independent research firm commissioned to study liver toxicity associated with CBD use last year.
The 7-month study revealed “no clinical evidence of liver disease or increase in the prevalence of elevated liver function tests in any participants,” according to a Validcare statement which will be shared with members of the FDA’s Cannabis Product Council in response to its March 2020 report to Congress calling for “science-based data.”
The study’s investigators were surprised to discover almost 70% of study participants reported having a medical condition and taking medications for those conditions, without an increase in reporting adverse effect.
“This unexpected, positive finding makes the data even more compelling and provides significant data to consider secondary safety measurements in the general population,” says Dr. Keith Aqua, co-principal investigator of the IRP-approved clinical study.
Aqua and principal investigators are “encouraged” by the findings and are hopeful the study will provide the FDA with sufficient science-based data to take action on a safe regulatory path forward. Further study will be conducted across diverse populations and consumers with various medical conditions are planned, according to Aqua, a board-certified obstetrician/gynecologist and principal investigator of more than 300 pharmaceutical-sponsored clinical trials.
Investigators, who met with the FDA on March 15 to review the liver safety study results, are hopeful that a direct communication feed will be established to continue to deliver raw, blinded, aggregate data for its analysis.
The investigators plan to publish the study in a peer-reviewed journal, according to Aqua.
“This clinical study was performed with a collaborative spirit and provides the critical evidence that CBD consumers, the FDA and the cannabis industry as a whole need to feel confident about the safety of the products being produced by this innovative industry,” said Matthew Elmes, Ph.D., Director of Scientific Affairs for Care By Design.
A significant number of CBD manufacturers and brands supported the independent study by providing product and certificates of authenticity (COA), as well as helping recruit study participants. They include Asterra Labs, Care by Design, CBDistillery, CBD American Shaman, Charlotte’s Web, Columbia Care, Global Widget, HempFusion, Infinite CBD, Kannaway, Medterra CBD and SunMed CBD (Your CBD Store).
“There continues to be an increased need for science-backed data to aid in supporting very welcomed FDA regulation of this compound that has been used in medicine for thousands of years, but until recently, not allowed to be sold in the United States,” says Chase Terwilliger, CEO of Balanced Health Botanicals. “This is a major step for the hemp industry as a whole, and CBDistillery will continue to provide products, insight and resources where needed to ensure additional research can be done.”
Working together on such studies shows the long-term efforts CBD companies are making in the industry and with working with one another.
“These study results help support the work that we’ve been doing in Mexico and Brazil to study CBD’s safety and efficacy,” says Medical Marijuana, Inc. CEO Dr. Stuart Titus. “We hope to continue to participate in similar future studies so that the world can continue to have expanded access to high-quality botanical products. I am glad to see participating stakeholders with longer-term visions banding together to make industry-wide progress that ultimately will benefit end consumers. Our company is involved with similar research in Europe in conjunction with the European Industrial Hemp Association (EIHA).”
In addition to meeting the needs of regulatory agencies, the study is anticipated to help provide additional evidence and security to the medical community, according to CBD American Shaman CEO Vince Sanders.
“Physicians understandably rely on medical science and studies,” says Sanders. “So the fact that this (Validcare) IRP-approved clinical study will now be added to the many other studies and data that point to the therapeutic value of CBD is overwhelmingly positive news. It is our hope that physicians and practitioners will review the study results and find additional confidence in its data.”
More than 90% of health care professionals received mentions or questions about CBD from their patients, according to a 2019 study conducted by Clinical Advisor. The survey included responses from hundreds of health care practitioners (HCPs) across a variety of specialties including primary care, psychiatry, pain management and neurology.
“This clinical CBD liver toxicity study provides licensed practitioners and physicians with the authentic scientific data they need,” says Nancy Angelini, the director of the doctor/practitioner division at HempFusion.”With it, they can confidently guide patient use and make science-based recommendations about CBD in their practices.”
Although Validcare cannot release costs, the backers’ investment in the clinical liver study was “considerable.”
Many brands plan to make additional investments in IRB-approved studies.
HempFusion recently announced its backing of a six-month, cardiology-marker clinical trial performed by Dr Harnick of Healthwise in New York. A second study will examine the impact of CBD compared to aspirin and the combined impact of CBD with aspirin regimens on inflammatory markers Thromboxane A2 in hospitalized COVID patients and released patients.
The three-month study is expected to provide significant and meaningful data to the scientific community and helps underscore the willingness and desire of CBD brands like HempFusion to support transparency and to bring relevant data to regulators, scientific and medical community for review, officials say.
“These studies start to build a body of data answering questions about what CBD can, and does do as well as what it cannot, and does not do,” says Angelini, who notes the majority of the best CBD brands want to debunk the hype and understand their products’ safety and efficacy.
“At the end of the day, it’s all about trust,” says Angelini, a licensed and well-regarded specialist in nutraceuticals and herbal medicine.
Industry officials offered major kudos to ValidCare as well as to U.S. Hemp Authority members CBD American Shaman, CBD Distillery, Charlotte’s Web, HempFusion, Kannaway and Medterra and other organizations including Asterra Labs, Care by Design, Columbia Care, Global Widget, Infinite CBD, and SumMed CBD (Your CBD Store), who funded and participated in the study.
“We support using clinical science to inform our nation’s health regulators, lawmakers, state and federal regulators but most importantly, we believe in using clinical science to build long-term consumer trust,” says Deanie Elsner, Charlotte’s Web CEO. “Relevant science and regulatory oversight should work hand-in-hand for the benefit of all Americans.”
This kind of study helps the overall industry, these experts noted.
“Asterra Labs was founded by veteran scientists from the pharmaceutical industry. So when we were made aware of the opportunity to participate, we did not hesitate to join this important study to support the safe use of our products by the millions of Americans who consume and find them beneficial,” says Kevin Sills, CEO, Asterra Labs. “We are very pleased with this study’s positive outcome and ValidCare’s work to support the industry.”
The timing of the study is critical and is hoped to be the first of many to follow.
“It’s a pivotal time for the hemp and CBD industry when it comes to regulation, and every brand in the industry is impacted. By working with Validcare, we were able to team up with competitive brands to let regulators know how serious we take this challenge and how important collaboration is within this science-based industry,” says Dr. Anthony Ferrari, the Chief Science Officer of SunFlora, an international CBD brand and creator of SUNMED products exclusively sold at Your CBD Store franchise locations. Ferrari reports that SunFlora is furthering its relationship with research institutions like Validcare and other leading medical universities in order to continue to elevate scientific knowledge surrounding CBD for the betterment of SunFlora and the industry as a whole.
Ultimately, this kind of effort helps consumers because it shows how the industry can work together, company executives agreed.
“As excited as we are about the results of the study that show the safety of using CBD, this is just the beginning of consumers’ awareness of how CBD can benefit their everyday life and brings credibility to the whole industry,” says Jay Hartenbach, CEO, Medterra, who notes that education on the effects of CBD is and will remain a cornerstone at Medterra.
Ultimately, the study answers the FDA’s call for more rigorous, clinical data around CBD use, according to Validcare Founder and CEO Patrick C. McCarthy, an attorney, and former Abbot Laboratories executive.
McCarthy expects favorable reviews from health practitioners, who he says “will appreciate the clear-cut evidence of CBD’s safety presented in the clinical study.”
Editor’s Note: Contact Validcare if interested in detailed data or to join cohort 2. For additional information email Validcare at email@example.com or call 844-825-4322 Author Jackie Berg is the publisher of the Health Hub, TheHUB Detroit, TheHUB Flint, and recipient of the Association of Women in Communications 2018 Vanguard award.