In today’s pharmaceutical manufacturing environment, we understand that delivering high-quality drug products into the market, while ensuring low cost of the drug manufacturing process is one of the top targets. Read More
Producing new drugs is a complex and time-consuming process. It takes years of trials, errors, and research to develop a compound of formula, not to mention the months or even years of waiting for it to be approved by legal authorities. And the process doesn’t end there. Once the approval is received, the marketing battle begins to beat the competition and get the space on the pharmacies’ front shelves and into doctors’ prescriptions. Read More
Because of the rising competition, businesses in the pharmaceutical industry feel the pressure to examine their costs of drug production processes closely. But reducing expenditures while maintaining the process efficiency and drug product quality is a challenge commonly faced by pharmaceutical companies. Read More
The time is gone when pharmaceutical companies could sit back and receive high-profit margins for their blockbuster patent-protected drugs. As more and more patents expire, original manufacturers lose a significant portion of their revenues to companies producing generic drugs. Healthcare Global found that generic drugs can reduce the original drug’s sale by up to 90%. Read More
The 1920s was a thriving time for scientific discoveries and innovations. It was especially instrumental in the world of medicine, as countless drug discoveries were made which have impacted pharmaceutical processes since then. Read More
Developing new drugs is a long and complex process. It requires years of research and testing, waiting on approvals by the regulatory bodies, and close monitoring of the post-approval marketing being done for the drug to receive the green light. Read More
Often touted for the long-term health benefits, fasting has come in vogue these last few years for treating several negative health states while improving lifespan.
There are as many kinds of fasting as ideological differences between people. Still, all of them share the general principle that eating is restricted to specific days of the week or hours of the day. Intermittent fasting is believed to increase insulin sensitivity , potentially helping reverse type II diabetes. There are multiple side-benefits: decreased blood pressure, reduced night-time hunger, slower aging, and a superior lipid profile. Some of these claims are substantiated more thoroughly than others, but an increasing number of them are quantitatively demonstrated in clinical studies.
Although seemingly unrelated, the subject of SIBO may prove to fall among those side-benefits – or for sufferers of the disease, it could easily become the main focus. SIBO, itself only recently under the attention of the medical profession, is short for Small Intestinal Bacterial Overgrowth. SIBO is a condition that usually involves relentless, stabbing, motile stomach pains, often exacerbated during eating. Adding insult to injury, the syndrome frequently features gas, bloating, sleep disturbances, diarrhea or constipation, as well as other gastrointestinal problems. All of this is thought to be caused by an out of control overgrowth of bacteria in the small intestine, “bad bacteria” that has run amok or bacteria that are not typically found in the human digestive tract.
Diet plays a considerable role in SIBO, either by initiating and fueling the bacterial overgrowth or tamping it down during treatment. As the ancient polymath Maimonides once said, “No disease that can be treated by diet should be treated with any other means.” SIBO is believed to be brought on by a combination of factors, two of which are strictly relevant to this discussion. The first is the kinds of foods that cause illness: simple carbohydrates that tend to fuel the overgrowth, including sugars, and a few complex carbs that bacteria inside the human body are unable to process. The second point of concern is timing. SIBO often strikes people who have frequent, sudden, and dramatic changes to eating patterns.
Intermittent fasting can target each of these issues. The emphasis on restricted times for eating is a strong central point that might help the body prune the overgrowth. By maximizing the time between feedings, the gut is afforded more opportunity to clean itself. Time for extra waves of peristalsis means we might be able to manually remove more bacteria along with the chyme, and time with an empty small intestine could mean that we have more time to starve whatever microbes are still hanging around.
The other point is diet, insofar as it relates to not feeding the bacteria that are present. Intermittent fasting is often coupled with other, healthful changes in the diet, but it is separable from those influences. After all, some people entirely refrain from eating two days a week, or even every other day of the week, and many of these people eat whatever they want on non-fasting days. Could this provide relief for those with SIBO?
More research needs to be done, but the preliminary, anecdotal evidence provided by doctors shows that it works. By increasing the rate of the MMC – the migrating motor complex, a series of electromechanical waves that serve to “sweep house” during the long periods between meals – extended fasting helps the gut to reduce the bacterial overgrowth.. The MMC is so heavily bound up with SIBO that impairment in this area is considered a known cause of SIBO. Conversely, SIBO itself tends to reduce the duration of peak MMC activity, or eliminate the peak phase, so fasting may help initiate a positive-feedback boost where our gut health spirals upward.
Another important mechanism by which bacterial overgrowth might be attenuated by fasting is the regulation of the type of flora present. This, too, is the subject of ongoing research and not just for SIBO. One paper, studying the effects on patients with MS, examined the relationship between beneficial gut microorganisms and the brain. Several of their observations hint at myriad possibilities:
“A mechanism through which diet can influence immune responses is the gut microbiome, which is emerging as a critical contributor in numerous human diseases. Here we show that intermittent fasting (IF) ameliorated clinical course and pathology of the MS animal model, experimental autoimmune encephalomyelitis (EAE), leading to less inflammation, demyelination, and axonal damage. IF changed the gut microbiome resulting in increased bacteria richness and enrichment of the Lactobacillaceae, Bacterioidaceae, and Prevotellaceae families.”
Healthier gut microbiota is what is needed for SIBO. The improved balance of microorganisms, the drop in markers of inflammation, and neurological damage signal a truly enormous scope of benefits. Although the diet may not be suitable for everyone, it’s time for many more of us to try it. Friendlier bacteria and a healthier gut await.
 Peterson, C. et. al. Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes. Cell Metabolism, 2018. 27: 6. DOI: <https://doi.org/10.1016/j.cmet.2018.04.010>.
 Tello, M. Intermittent fasting: Surprising update. Harvard Health Blog. 2020. <https://www.health.harvard.edu/blog/intermittent-fasting-surprising-update-2018062914156>. This blog contains several important primary references.
 Palikuca, S. Intermittent fasting: Can we fast our way to better health? The Do. Jan 30, 2019. <https://thedo.osteopathic.org/2019/01/intermittent-fasting-can-we-fast-our-way-to-better-health/>.
 Pimental, et. al. Lower frequency of MMC is found in IBS subjects with abnormal lactulose breath test, suggesting bacterial overgrowth. Dig. Dis. Sci. 2002 Dec;47(12):2639-43. doi: 10.1023/a:1021039032413.
 Hasler, W. Physiology of the Gastrointestinal Tract (Fourth ed.) 2006.
 Cignarella, F. Intermittent fasting confers protection in CNS autoimmunity by altering the gut microbiota. Cell Metab. 2018. 27(6): 1222–1235.e6. doi: 10.1016/j.cmet.2018.05.006
There’s an enormous “Godzilla Dust Cloud” from the Sahara Desert that moving across the land. It has penetrated deep into the U.S. mainland, and worse, appears to be followed by a second wave of dust, billowing and roiling its’ way to Texas. How did this happen, and how dangerous is it?The how is the easy part.
Hot, raging convection-driven winds blowing over the dessert create plumes of dust up to 20,000 feet high, loading it into the aptly named Saharan Air Layer (SAL). The mix of dust in the SAL, buoyed by hot, dry air, can remain aloft thanks to high-altitude anticyclonic eddies that continually blow it around at heights of about 4 km above the surface, keeping the dust aloft for many thousands of kilometers. The third-largest desert (largest, if you don’t count frozen wastelands like Antarctica) sends forth about 60-200 million tons of mineral dust every year, which is more than all human activities combined. It’s enough to attenuate some hurricane seasons because the dust blocks out enough sunlight to cool the Atlantic Ocean’s surface.
The danger to human health is a different matter, trickier to pin down. Moreover, it’s something that people are accustomed to since the dust cloud is a regular occurrence on the U.S. East Coast, particularly the Southeast. Our familiarity is not necessarily helpful in this case. Large particles typically settle out before the clouds reach the U.S., so we don’t get the kind of clouds that usually block out the sky and make shutting down the economy necessary (this happens during the Saharan dust season in the Canary Islands, near the coast of Africa). Instead, the particles that reach us are much too small to see, as the results of an eight-year study published in the journal Epidemiology show:
“This multiyear analysis clearly shows that the contribution of Saharan dust to size classes <2.5 μm is dominant in terms of numbers and substantial in terms of mass. Over the entire particle size range, 99.5% of the number and 38% of the mass are <2.5 μm during Saharan dust events. ”
Airborne particles smaller than 2.5 um are a huge problem, and most of the time, we’re not aware that we’re breathing them. For most people, in small doses, the effects set in gradually and unnoticed: a little coughing is seen as usual, for example, during the wintertime, with so many suffering from the seasonal illnesses that go around. They’re too small to see, cannot usually be tasted or smelled, and irritate our lungs very severely, but the effects come on slowly and usually slip below our radar. The consequences from the Saharan dust inhalation are probably worse than we imagined; the more general implications of breathing in particles of this size range are devastating for humankind.
The first thing to know about inhaling these microscopic particles, which are just a tad larger than the optical limits of a compound light microscope, is that they don’t just get into your lungs. Of course, they penetrate the lungs deeply, and some of them may sit there, but others manage to enter your bloodstream. They contribute to irritation of the blood vessels, where they are strongly linked to non-fatal heart attacks. These might not kill you, but you probably wouldn’t want one, and anyway, the research is at an inchoate stage, and it would be unsurprising if soon we found out that fatal heart attacks could be provoked as well. They also are linked to cardiac arrhythmias, even in otherwise healthy people.
The most obvious target is even more badly compromised. Lung function is decreased, with an absolute risk of premature for people who have heart or lung disease. Lung disease sufferers can also expect to have trouble breathing, shortness of breath, and irritation of the airways. Asthma suffers have been shown to have aggravated symptoms, and now with Covid-19 affecting sufferers’ lung function, even more people are going to have acute problems with PM 2.5.
But the most significant risk of all associated with PM 2.5 is probably cancer. Probably, because there isn’t enough data yet – but what information do exist show a relationship to many different kinds of cancer. Lung cancer is strongly associated, but its mortality risk increased less than many other cancers – and the range of cancers impacted is enormous. According to the AACR, in a massive three-year study of over 66,000 residents of Hong Kong, for every ten ug increase in exposure, the combined risk of dying from any form of cancer rose 22%, and lung cancer specifically rose 36%. But even more surprisingly, the risk of breast cancer increased 80%, and fatal upper G.I. tract cancers rose 42%. Shocking, but the numbers don’t lie, they merely highlight that the bloodborne particulates wreak inflammatory havoc throughout the whole organism (after all, although it’s beyond the scope of this blog, it’s not just humans that are affected).
The best thing that can be said about this problem is that we’re not powerless to stop it. Inside the home, HEPA air purifiers can make a considerable impact in removing PM 2.5. As a consequence of Brownian motion, they release incredibly tiny PM 0.3 and under particles more easily than they do the somewhat larger particles. A true HEPA filter can remove 99.97% of particles 0.3 um in diameter, but even the so-called “HEAP-type” air filters can remove 99% of um 2.0. Outside the home, we need to work on ways to decrease air pollution. We might not be able to stop the Sahara from coughing forth dust every year, but 30% of the world’s dust is anthropogenic, and that dust is made by humans, where humans live.
Cleaning up that 30% could have a considerable impact, and go a long way towards improving human health.
 Wikipedia, accessed June 2020.
 Sajani, et al 2010 Only Coarse Particles from the Sahara? doi: 10.1097/EDE.0b013e318258c23f, < https://journals.lww.com/epidem/fulltext/2012/07000/Only_Coarse_Particles_From_the_Sahara_.18.aspx#:~:text=Over%20the%20entire%20particle%20size,range%20of%201%E2%80%932.5%20%CE%BCm.>.
 US EPA website. Accessed June 2020 Health and Environmental Effects of Particulate Matter (PM). < https://www.epa.gov/pm-pollution/health-and-environmental-effects-particulate-matter-pm>.
 American Association for Cancer Research website.