Modulating the Vaginal Microbiome
Modulating the Vaginal Microbiome
Many challenges lie in wait before novel diagnostic and treatments become available for urogenital infections, not the least of which is dealing with regulatory agencies and policies long past their sell-by date. Currently in Europe, the word "probiotic" is banned, whereas in the United States, the Food and Drug Administration requires an investigational drug registration for a probiotic food to be tested to treat or prevent disease. These ludicrous situations are the result of outdated systems that state foods cannot prevent or treat disease, and regulators with no experience or understanding of probiotic concepts. When a regulator used to dealing with a chemical structure that is synthesized the same way repeatedly is presented with a bacterium whose multiplication and properties are not so readily "controlled," confusion ensues and the response is to halt the latter. This over-rides the fact that most chemicals approved for human use have major side effects are often marginally effective, and invariably their mechanism of action is not well proven. This serious situation is no longer about safety, which is the prime reason for regulatory agencies existing, as probiotics have a safety record that is very impressive. Rather, it is about money, politics, and control.
Without the ire and determination of the activists who brought human immunodeficiency virus/AIDS to the forefront of societal and governmental attention, probiotic solutions for urogenital infections in women will be delayed or banned until they fit into the drug-based regulatory systems. One way around this is for no claims to be made on product labels, and for the findings of scientific studies to be conveyed directly to consumers so that they drive the need for regulatory system changes, or they simply purchase food/supplement products knowing they were the ones used in the studies (which would have to be performed outside the United States).
It seems ironic that the major problems are regulatory and financial, rather than medical science. For so long, scientists have been criticized for failing to make medical breakthroughs after significant government investment in research. Yet now, with little government funding ever given to probiotic research, and primarily food companies, bacterial bulk manufacturers, and small supplement companies selling probiotics without the massive profit margins of pharmaceutical corporations, there is still sufficient evidence to support probiotic lactobacilli to improve vaginal and bladder health. Why then should it not be possible to inform the consumer what studies have been performed on a probiotic and what benefits it might convey?
The financial issue is most evident in diagnostic and pharmaceutical companies not spending their resources to come up with new products. Is it because the profits are deemed insufficiently large to warrant development, or is the internal creative pipeline inadequate? Only the industry can answer this.
For the medical community, inserting mandatory courses on the human microbiome into the medical curriculum and continuing education programs is critical to disseminate the findings of studies and to encourage lateral thinking in how patients are managed. A combination approach will likely be required, and when therapies are ineffective (including probiotics), the reasons need to be explored through understanding all the potential contributors (host, type of product, nonresponder status, microbiome, metabolome, comorbidities of therapies). Physicians, pharmacists, and other caregivers understand the issues of patient pain, discomfort and adverse quality of life, as well as how examinations and treatments are paid for, and which are permitted under various insurance schemes. This is a critical perspective that has to be considered if true change in practice is to be introduced.
In the meantime, medical research will continue and will provide an even more comprehensive understanding of the factors that influence urogenital health and disease. For the sake of women around the world, we can only hope that there is a convergence of knowledge from all sectors that results in new, effective, and affordable diagnostic, prevention, and treatment measures. It is too long overdue.
Challenges Ahead
Many challenges lie in wait before novel diagnostic and treatments become available for urogenital infections, not the least of which is dealing with regulatory agencies and policies long past their sell-by date. Currently in Europe, the word "probiotic" is banned, whereas in the United States, the Food and Drug Administration requires an investigational drug registration for a probiotic food to be tested to treat or prevent disease. These ludicrous situations are the result of outdated systems that state foods cannot prevent or treat disease, and regulators with no experience or understanding of probiotic concepts. When a regulator used to dealing with a chemical structure that is synthesized the same way repeatedly is presented with a bacterium whose multiplication and properties are not so readily "controlled," confusion ensues and the response is to halt the latter. This over-rides the fact that most chemicals approved for human use have major side effects are often marginally effective, and invariably their mechanism of action is not well proven. This serious situation is no longer about safety, which is the prime reason for regulatory agencies existing, as probiotics have a safety record that is very impressive. Rather, it is about money, politics, and control.
Without the ire and determination of the activists who brought human immunodeficiency virus/AIDS to the forefront of societal and governmental attention, probiotic solutions for urogenital infections in women will be delayed or banned until they fit into the drug-based regulatory systems. One way around this is for no claims to be made on product labels, and for the findings of scientific studies to be conveyed directly to consumers so that they drive the need for regulatory system changes, or they simply purchase food/supplement products knowing they were the ones used in the studies (which would have to be performed outside the United States).
It seems ironic that the major problems are regulatory and financial, rather than medical science. For so long, scientists have been criticized for failing to make medical breakthroughs after significant government investment in research. Yet now, with little government funding ever given to probiotic research, and primarily food companies, bacterial bulk manufacturers, and small supplement companies selling probiotics without the massive profit margins of pharmaceutical corporations, there is still sufficient evidence to support probiotic lactobacilli to improve vaginal and bladder health. Why then should it not be possible to inform the consumer what studies have been performed on a probiotic and what benefits it might convey?
The financial issue is most evident in diagnostic and pharmaceutical companies not spending their resources to come up with new products. Is it because the profits are deemed insufficiently large to warrant development, or is the internal creative pipeline inadequate? Only the industry can answer this.
For the medical community, inserting mandatory courses on the human microbiome into the medical curriculum and continuing education programs is critical to disseminate the findings of studies and to encourage lateral thinking in how patients are managed. A combination approach will likely be required, and when therapies are ineffective (including probiotics), the reasons need to be explored through understanding all the potential contributors (host, type of product, nonresponder status, microbiome, metabolome, comorbidities of therapies). Physicians, pharmacists, and other caregivers understand the issues of patient pain, discomfort and adverse quality of life, as well as how examinations and treatments are paid for, and which are permitted under various insurance schemes. This is a critical perspective that has to be considered if true change in practice is to be introduced.
In the meantime, medical research will continue and will provide an even more comprehensive understanding of the factors that influence urogenital health and disease. For the sake of women around the world, we can only hope that there is a convergence of knowledge from all sectors that results in new, effective, and affordable diagnostic, prevention, and treatment measures. It is too long overdue.
