The COVID-19 pandemic has created a sense of urgency to generate new drugs and vaccines. In many cases, this urgency became a regulatory opportunity to bypass established regulatory pathways for new drugs.
While this has led to the fast emergence of many useful drugs and vaccines for COVID-19, it has also led to a general reduction in the quality of medical research from which to derive conclusions.
For example, according to Janet Woodcock, former director of the Food and Drug Administrations (FDA) Center for Drug Evaluation and Research, an FDA analysis found that 6% of clinical trials are yielding results the agency deems actionable.
The lack of regulation coupled with a sense of urgency has also led to overhype and rushed development of certain treatments, including cell-based therapies often sold as stem cell treatments.
While some of these products have undergone well-designed, adequately controlled trials, most are in the early stages. Some clinics are nevertheless offering these unproven and unlicensed treatments to people, promising to boost their immune system or overall health to protect against COVID-19.
Promoting and selling unproven and unlicensed treatments can harm public health and could lead many to undergo untested and potentially harmful treatments.
Recently, a group of researchers from the University of California, Irvine, the Georgia Institute of Technology, the University at Buffalo, NY, and the University of Melbourne in Australia, published a report outlining misinformation around cell-based treatments for COVID-19, calling for their stronger regulation.
Efforts to rapidly develop therapeutic interventions should never occur at the expense of the ethical and scientific standards that are at the heart of responsible clinical research and innovation, said Dr. Laertis Ikonomou, assistant professor of Oral Biology at the University at Buffalo, and co-author of the study.
Scientists, regulators, and policymakers must guard against the proliferation of poorly designed, underpowered, and duplicative studies that are launched with undue haste because of the pandemic, but are unlikely to provide convincing, clinically meaningful safety and efficacy data, said co-author Dr. Leigh Turner, professor of Health, Society and Behavior at the University of California, Irvine.
The researchers published their report in Stem Cell Reports.
Researchers conducted a study in August 2020 of 70 clinical trials involving cell-based treatments for COVID-19. They found that most were small, with an average of 51.8 participants, and only 22.8% were randomized, double-blinded, and controlled experiments.
The authors concluded that the cell-based interventions for COVID-19 were likely to have a relatively small collective clinical impact.
Cell-based treatments for COVID-19 are still at an experimental stage, Dr. Ikonomou told Medical News Today. There are tens of clinical trials, of varied complexity and rigor, that evaluate various cell types, such as mesenchymal stromal cells, for COVID-19 treatment.
Expanded or compassionate use of cell-based interventions has also been reported, but these individual cases are unlikely to tell us whether and how cell therapies could help with COVID-19 and do not substitute for the systematic clinical evaluation of cell-based products, he added.
A few completed phase 1/2 trials have shown a favorable safety profile, but larger size trials are required. Eventually, properly-powered, controlled, randomized, double-blinded clinical trials will help determine whether cell-based treatments are a viable therapeutic option for COVID-19 and its complications, he explained.
The urgency of the pandemic has made it easy to exaggerate early-stage research. The scientists highlight this is especially the case in press releases, where media professionals can over-hype findings and understate or omit limitations to gain more media coverage.
The researchers also say that even when online media include limitations and key aspects of studies, other communication channels can strip these away easily. What is left then gets amplified, as the public is desperate to see positive news.
To address this, the researchers say science communicators should ensure they have an accurate understanding of the information they report and highlight the required steps for the science to advance without exaggerating its speed.
The researchers also say that simply feeding the public more information in what is known as the information deficit model alone is insufficient. They also suggest science communicators should strive for an engaged or dialogue-based communication approach.
Over-hyping of promising treatments and in particular cell-based treatments has been a longstanding problem, and it did not first emerge with the COVID-19 pandemic, said Dr. Ikonomou. It has become a salient issue during these times due to the global nature of this health emergency and the resulting devastation and health toll.
Therefore, it is even more important to communicate promising developments in COVID-19-related science and clinical management [responsibly]. Key features of good communication are an accurate understanding of new findings, including study limitations and avoidance of sensationalist language, he explained.
Realistic timeframes for clinical translation are equally important as is the realization that promising interventions at preliminary stages may not always translate to proven treatments following rigorous testing, he added.
The researchers say that commercial investments by biotechnology companies to develop cell-based therapies for COVID-19 have led to well-designed and rigorous clinical trials.
However, some other businesses have overlooked the demanding process of pre-marketing authorization of their products. Instead, they made unsubstantiated and inaccurate claims about their stem cell products for COVID-19 based on hyperbolic reporting of cell-based therapies in early testing.
Some clinics advertise unproven and unlicensed mesenchymal stem cell treatments or exosome therapies as immune boosters that prevent COVID-19 and repair and regenerate lungs.
Often, these businesses make their treatments available via infusion or injection. However, one anti-aging clinic in California shipped its kits to clients, where they were to self-administer with a nebulizer and mask.
Such companies often market stem cell treatments via online and social media. In an initial review of many of these brands, the researchers could not find published findings from preclinical studies and clinical trials to support their commercial activities.
Instead, they found that these companies drew from uncritical news media reports, preliminary clinical studies, or case reports in which those diagnosed with COVID-19 received stem cell interventions.
Promoting such therapies that have not undergone proper tests for safety and efficacy have the potential for significant physical and financial harm.
Health experts have documented adverse events due to unlicensed stem cell products, including vision loss and autoimmune, infectious, neurological, and cardiovascular complications.
Early in the pandemic, scientific and professional societies, including the Alliance for Regenerative Medicine and the International Society for Stem Cell Research, have warned the public against businesses engaged in the marketing of cell-based treatments that have not undergone adequate testing.
The researchers highlight that it is unclear whether these warnings reached individuals and their loved ones or significantly affected public understanding of the risks of receiving unlicensed and unproven stem cell treatments for COVID-19.
They also indicate that it is unclear whether these societies and organizations have an important role in convincing regulatory bodies to increase enforcement in this space. Nevertheless, at the time of writing, the FDA and Federal Trade Commission have issued 22 letters to businesses selling unproven and unlicensed cell-based therapies.
And while many of these companies have ceased market activity, the presence of other companies continuing to pedal the same claims makes it clear that regulatory bodies must increase their enforcement.
Additionally, the researchers question whether warning letters are sufficient to disincentivize clinicians and others to sell unlicensed products. They write:
If companies and affiliated clinicians are not fined, forced to return to patients whatever profits they have made, confronted with criminal charges, subject to revocation of medical licensure, or otherwise subject to serious legal and financial consequences, it is possible that more businesses will be drawn to this space because of the profits that can be generated from selling unlicensed and unproven cell-based products in the midst of a pandemic.
The researchers conclude that regulators should increase enforcement against unproven and unlicensed therapies for COVID-19.
They also say that science communicators should report on scientific claims more realistically and include the public in more discourse.
In the U.S. and elsewhere, there are regulations and enforcement mechanisms that deal with harms caused by unproven and unlicensed cell-based interventions and false advertising claims, said Dr. Ikonomou. It may be preferable to implement existing regulations more vigorously than introduce new ones.
Stakeholders, such as scientific, professional, and medical associations, can contribute towards this goal with reporting and monitoring of cell therapy misinformation. There is a shared responsibility to combat cell-therapy related misinformation and disinformation that undercuts legitimate research and clinical efforts and portrays unproven interventions as silver bullets for COVID-19, he concluded.
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COVID-19: Researchers warn against overhyping early-stage therapies - Medical News Today
