Doctor challenges CDC claims on hand sanitizer against coronavirus

WASHINGTON (SBG) – A crusading Atlanta-based physician is challenging a powerful institution in his home city -- the Centers for Disease Control and Prevention (CDC) -- over its official recommendations for which kinds of hand sanitizer Americans should use to protect themselves from the coronavirus.

Dr. Kirk Kimmerling, a practicing dentist and health-care entrepreneur, has waged a quiet campaign to persuade CDC to expand its guidelines to include hand sanitizers beyond those manufactured with ethanol and isopropanol, a form of alcohol. The agency's refusal to do so, he told Sinclair, "places enormous strain" on the supply chain for hand sanitizer both for the general public and in health-care settings, such as hospitals.

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Current CDC guidelines, last updated March 18, state that the agency only recommends hand-rub hygiene products that consist of 60 percent ethanol or 70 percent isopropanol as their active ingredients. "CDC does not have a recommended alternative," the agency's website says.

But Kimmerling -- and other federal agencies and many Americans in and out of the health-care industry -- do have an alternative: It's called benzalkonium chloride (BZK), an ammonium compound that is already widely used used on agricultural equipment, oil wells, and water systems, in swimming pools and decorative ponds, laundry products, hair conditioner, and soaps.

First discovered in 1935 by Gerhard Domagk, a Nobel laureate from Germany, BZK was soon heralded as an effective disinfectant and antiseptic; within twelve years, the first product manufactured with it was registered in the United States. According to the National Institutes of Health, the domestic uses for benzalkonium chloride include fabric softeners, personal hygiene and cosmetic products, such as shampoos, conditioners, and body lotions, ophthalmic solutions and medications administered nasally. "Additional registered uses," NIH reports, "include applications on indoor and outdoor surfaces (walls, floors, toilets, etc.), agricultural tools and vehicles, humidifiers, water storage tanks, products for use in residential and commercial pools, decorative ponds and fountains, water lines and systems, pulp and paper products, and wood preservation."

In a preliminary risk assessment issued in 2006, the Office of Pesticide Programs at the Environmental Protection Agency's Antimicrobials Division cleared the compound for additional registrations, noting that "products containing [BZK] can be used as general cleaners, disinfectants, and deodorizers in the home." That summer, EPA published final conclusions that endorsed the preliminary findings, provided that firms enacted suitable "risk mitigation measures."

Less than a year ago, the Food and Drug Administration went even further, green-lighting the over-the-counter sale of BZK-manufactured hand hygiene products. While citing the need for more study on the issue, the agency announced: "FDA does not intend to take action to remove hand sanitizers containing these...active ingredients from the market."

AT CDC, however, there has been a notable reluctance to endorse the compound. "Benzalkonium chloride, along with both ethanol and isopropanol, is deemed eligible by FDA for use in the formulation of healthcare personnel hand rubs,"" the CDC website notes. "However, available evidence indicates benzalkonium chloride has less reliable activity against coronavirus than either of the alcohols."

In support of that last claim -- that BZK products are "less effective" than the alcohol-based ones in combating the coronavirus -- the Atlanta-based agency links to a scientific paper published this month in The Journal of Hospital Infection. Co-authored by four German scientists, the study is entitled "Persistence of coronaviruses on inanimate surfaces and their inactivation with biocidal agents" -- but its findings do not exactly match what CDC said about them.

"Data obtained with benzalkonium chloride at reasonable contact times [with the virus] were conflicting," the paper said. "Within 10 minutes [of contact] a concentration of 0.2% revealed no efficacy against coronavirus whereas a concentration of 0.05% was quite effective."

"If we could adopt this benzalkonium chloride, or BZK, in the health care setting," Kimmerling told Sinclair in a Skype interview from his dental practice -- where he was still working on patients as of Thursday -- "it would relieve the tremendous stresses and strains on the alcohol-only hand-antiseptic supply chain.

"It seems that the CDC is failing, similar to what we've seen in other issues with the CDC, and that's why they're sidelined by the Trump administration."

Kimmerling produced correspondence showing that his efforts to persuade CDC had resulted in a telephone call to his office on March 16 -- two days before the last updating of the CDC guidelines regarding hand sanitizer products --from Nikki Romanik, an assistant to CDC chief of staff Kyle McGowan. In the call, Romanik told Kimmerling she had circulated his petition to "experts within CDC" for review. "She also stated that CDC does not test individual commercial products," according to a written account by Kimmerling.

Contacted for this story, a CDC spokesman did not dispute the timeline of events contained in Kimmerling's correspondence. “There was an internal discussion as a result of the letter from Dr. Kirk Kimmerling," confirmed CDC spokesman Benjamin Haynes. "The changing and timing of the online FAQ was coincidental and not related to this discussion.

"CDC guidelines are, and always will be based on the best available science. We continue to evaluate our guidance based on new and emerging data. There is no plan at this time to change the current recommendation."

Kimmerling suggested that that financial support provided to the CDC Foundation by GOJO Industries -- maker of Purell, by far the dominant product in the billion-dollar global hand sanitizer market -- might explain why the Centers for Disease Control has taken a different posture toward benzalkonium chloride than other federal agencies.

According to its website, the CDC Foundation is a nonprofit organization and "the sole entity created by Congress to mobilize philanthropic and private-sector resources to support" the work of CDC. The foundation also notes that "with support from GOJO," it was able to launch a hand hygiene campaign in 2016 called Clean Hands Count.

GOJO Industries, on its website, maintains a video featuring the company's top hygiene and public health scientist, Dr. Jim Arbogast, debunking what he calls the "myth" that alcohol-based hand-sanitizers and non-alcohol-based ones "are the same." "The truth," Arbogast says in the video, is that "the active ingredient is important, but the total formulation affects the microbial efficacy."

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A spokesman for GOJO did not respond to an inquiry seeking to ascertain the scope of the firm's financial support to the CDC Foundation. Haynes, the CDC spokesman, told Sinclair: "The CDC Foundation does not provide input on our scientific recommendations.”