Are efforts to back infection prevention studies biasing long-term efforts?
Science depends on financial support and that is often provided through industry partnerships. Infection prevention and control programs are no stranger to this. The most common alliance, at least in terms of infection prevention terms, is with disinfection products.
Some hospitals work with a disinfection company to test out a new product, and bring attention to the successes (and sometimes failures) of both the product and the hospital being on the cutting edge of new infection prevention practices. It can be a successful marriage and usually is for the most part. Unfortunately, like any marriage, it can become toxic to the original focus—infection prevention efforts.
Recently, the relationship between the company Sage and Rush University Medical Center (UMC) in Chicago came under scrutiny. Their partnership began with the medical center testing the efficacy of Sage’s new chlorhexidine disinfecting wipe, which led to further donations. Chlorhexidine is a powerful disinfecting product that is typically used as a skin prep or general skin disinfectant. Rush UMC and Sage found that instead of sponge baths, a wipe-down with the Sage chlorhexidine wipe was twice as effective as preventing the spread of vancomycin-resistant Enterococcus (VRE). Over the years, their partnership yielded several studies and published articles. It has also become increasingly common to give patients chlorhexidine baths and now a majority of US hospitals follow this practice.
Although these kinds of partnerships are common and frequently beneficial to advancing new products and practices, they have sparked concern that instead of science leading industry, the industry is leading science. Many researchers are now calling attention to the real efficacy of this practice.
New York University’s Department of Microbiology professor, Martin Blaser, MD, noted in the Reuters investigative piece that the true effectiveness is impossible to tell. He emphasizes that while antimicrobial resistance (AMR) is a huge issue, we need to be sure that these practices and products are better and not just creating potential for further resistance and bottle-necking.
Indeed, the US Food and Drug Administration (FDA) has started to dig deeper into chlorhexidine as there has been an increase of allergic reactions. Although much of this draws attention to the growing trend of microbial resistance, it is important to note that there is a general lack of nationwide AMR surveillance and tracking mechanisms within the United States. Chlorhexidine continues to raise concerns over adverse reactions, which are in turn drawing attention to other products and partnerships that may be biasing the infection prevention environment. A Rush UMC infectious disease physician, Robert A. Weinstein, MD, was the lead author for many of the Sage studies, and recently, many of his articles have been called into question. While much of the Sage-Rush research focused on common use of chlorhexidine, the FDA only approved the wipes for cleaning before surgery.
So why the recommendation?
According to the investigative report, “Sage is not prohibited from informing medical professionals of scientific studies that tout the virtues of its wipes for off-label uses, leaving it up to the customer to decide whether or not to use them.”
A new lawsuit and growing scrutiny of incentivizing practices between Sage and many of its hospital partnerships have increased attention on the potential for biased research. Like any partnership, there are some that are more muddied and damaging than others. In truth, regardless of any marriage between healthcare infection prevention and industry, we can always go back to the basics: hand hygiene, personal protective equipment (PPE), environmental disinfection, etc.