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Posts Tagged ‘probiotics

Science Policy Around the Web – October 26, 2018

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By: Mohor Sengupta, Ph.D.

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Source: Pixabay

Environmental Problems

A 14-year-long oil spill in the Gulf of Mexico verges on becoming one of the worst in U.S. history

In the year 2004, hurricane Ivan leveled an oil production platform in the Gulf of Mexico, owned by Taylor Energy. Its striking magnitude destroyed the colossal platform which had drilled into several oil wells. The result was a huge mound of muck, filling the broken steel structure and leaking oil. To date, efforts to seal off the leakage have not been successful.

Taylor Energy at first denied that there was any leakage and then underreported the extent of the leakage. According to current estimates, about 700 barrels of oil are leaking per day, with each barrel holding 42 gallons of oil. The company has kept this information a secret for many years, and few people are aware of the actual level of spillage. The Taylor Energy spillage in fact pre-dates the Deepwater Horizon oil spill (also called the BP leak), so far the largest marine oil spill in history at 168 million gallons. While BP has coughed up $66 billion for fines, legal settlements and cleanup, Taylor Energy is a comparatively smaller operation and financially too cash-strapped to afford cleanup on such a large scale.

In these actions Taylor Energy flouted both the EPA’s Oil Pollution Act of 1990, which mandates that spillage must be reported to the U.S. Coast Guard National Response Center (NRC), and the Clean Water Act of 1972, which created a structure for regulating water pollutants. Taylor Energy was taken to court by environmentalists, and Taylor Energy and the NRC have been jointly found accountable in presenting false numbers and data. In an assessment submitted to Taylor Energy in 2009 by Waldemar S. Nelson and Company, a private firm, risks involved in ingesting fish from the affected area were discussed. A recent and independent analysis by the Justice Department showed that the original estimate of 1 to 55 barrels of leakage per day provided by NRC was inaccurate. After several spillage tests Oscar Garcia-Pineda, the author of the article, concluded that his results didn’t tally with those reported by NRC and the actual rate of spillage was 48 to ~1700 barrels per day.

These disturbing findings have arrived at a delicate time for environmental protection policy. Earlier this year, the Trump administration proposed a wide expansion of leases to the oil and gas industry. This would render all off-shore areas on the continental shelf, including those along the Atlantic coast, amenable to drilling. Oil and gas representatives are lobbying for this cause and have provided financial justifications including billions of dollars’ worth of annual economic growth, increased jobs and lower heating costs. However, multiple governors representing states across the four planning areas, from Maine to the Florida Keys, are opposed to this proposal.

Reports show that on average there are 20 uncontrolled releases of oil per 1000 wells under state or federal governments. In Louisiana alone, approximately 330,000 gallons of oil are spilt from off-shore and on-shore rigging platforms. With changing climate patterns, hurricanes on the Atlantic are predicted to be more intense in future, and given the government’s plans to extend rigging along the Atlantic coast, a bleak prospect looms ahead.

(Darryl Fears, Washington Post)

Health Supplements

The Problem with Probiotics

The healthy balance or maintenance of the natural flora of the gut, also called the gut microbiome,is essential for a healthy digestive system. Antibiotics have been shown to disrupt the gut-microbiome, resulting in diseases such as diarrhea and infections with Clostridium difficile. As an antidote, it has been common practice to pop in “good bacteria”, or probiotics, while on antibiotic treatment. These probiotics are essentially a mixture of supposedly healthy gut microbiota and are meant to replace those disrupted by the antibiotic.

Although people commonly take probiotics, this class of product is not regulated by the FDA and there are rising concerns about the standard of manufacture and quality of these commonly sold over-the-counter health supplements. Most recently, Dr. Pieter A. Cohen cautioned against overlooking the harmful effects of widely marketed probiotics in his recent article published in “JAMA Internal Medicine”.

There have been several studies discussing the benefits of probiotics, so much so that the journal “Nutrition” recently published a systematic review of systematic reviews. In a nutshell, all the studies ever done on efficacy of probiotics have produced very limited positive results and only pure microbial strains were used as the probiotic supplement in these studies. On the other hand, there has been no evidence to show that probiotics have been beneficial in treating conditions such as Crohn’s Disease, chronic diarrhea, ulcerative colitis or liver disease, all related in some way to the gut microbiome.

Safety assessment studies have found probiotics to be contaminated with unwanted microbial strains, and without FDA regulation of the manufacturing process production doesn’t often follow a well-defined pipeline. It is not known what kinds of health hazards might be caused by these contaminants, warns Dr. Cohen, and they can be lethal. In a notorious case, the death of an infant was attributed to a contaminated dietary supplement.

Unfortunately, none of these events have deterred Americans from using probiotics. Almost four million people, or 1.6 percent of adults in the United States used probiotics in 2012 and the global market for probiotics is steadily on the rise. In this situation, it is of great importance for dietary supplements be given the rigorous assessment and quality control checks that a prescription drug undergoes. There should be increased efforts to make consumers aware of adulterations in probiotics.

(Aaron E. Carrol, New York Times)

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Written by sciencepolicyforall

October 26, 2018 at 12:36 pm

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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