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Science Policy Around the Web – July 7, 2017

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By: Leopold Kong, PhD

Food Policy

Food and Microbiota in the FDA Regulatory Framework

More and more probiotic food products, or microbiota-directed foods, claiming to “improve” the body’s microbiota have been hitting the shelves, with sales valuing over US$700 million in the US alone and US$36.6 billion globally this past year. However, there is little framework regulating their ingredients or guaranteeing the scientific accuracy of their health claims that has resulted in costly legal action. For example, in September 2009, Dannon settled a US$35 million consumer class action suit challenging the claimed health benefits in their ads. A similar class action suit against Procter & Gamble’s Align probiotic has been certified and set for Oct. 16, 2017. A paper recently published in the journal Science calls for greater clarity in policy regulating probiotic products. Importantly, the authors urge that probiotics should be clearly classified as a dietary supplement, a medical food, or a drug. If classified as a dietary supplement, probiotics can make claims on nutrient content and effect on health, but not on treatment, prevention or diagnosis of disease. If classified as a medical food, probiotics must contain ingredients that aid in the management of a disease or condition, with “distinctive nutritional requirements”, that is scientifically recognized. Finally, if classified as a drug, probiotics will require clinical trials to prove its medical claims. An alternative, and perhaps cheaper, way forward is to regulate probiotics as a kind of over-the counter medical food, requiring testing only for their active ingredients that can be used in a variety of products. (Green et al., Science)

Antibiotic Resistance

Untreatable Gonorrhoea on the Rise Worldwide

Over 78 million people are infected with gonorrhea each year, a sexually transmitted disease that has traditionally been treated effectively with anti-microbials. However, recently published data from 77 countries show that antibiotic-resistant gonorrhea is getting more pervasive and harder to cure. “The bacteria that cause gonorrhea are particularly smart. Every time we use a new class of antibiotics to treat the infection, the bacteria evolve to resist them,” said Dr. Teodora Wi, Medical Officer, Human Reproduction, at the WHO. The data found widespread resistance to ciprofaxacin, azithromycin, and even to the last-resort treatments, oral cefixime and injectable ceftriaxone. New drugs are under development, including a phase III trial of a new antibiotic, zoliflodacin, launched by the non-governmental organization Drugs for Neglected Diseases Initiative and Entasis Therapeutics, a biotech company in Waltham, Massachusetts. Better prevention through education on safer sexual behavior and more affordable diagnostics will also be needed moving forward. (Amy Maxmen, Nature News)

Maternal Health

U.S. has the Worst Rate of Maternal Deaths in the Developed World

A recent six-month long investigation by NPR and ProPublica has found that more women in the US are dying of pregnancy related complications than any other developed country. Surprisingly, this rate is increasing only in the US, which stood at ~ 26.4 deaths per 100,000 births in 2015, translating to nearly 65,000 deaths annually.  This is three times worse than for women in Canada, and six times worse than for women in Scandinavian countries. Reasons include older new mothers with more complex medical histories, unplanned pregnancies, which are the case half the time in the US, greater prevalence of C-sections, and the fragmented health system. This is in contrast with progress in preventing infant mortality, which has reached historic levels in the US. Better medical training for maternal emergency and more federal funding for research in this area may improve the situation for American mothers. (Nina Martin and Renee Montagne, NPR)

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