SIBO: Can Fasting Halt Runaway Bacteria?

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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 [1][2], 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[4]. 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.[5]. The MMC is so heavily bound up with SIBO that impairment in this area is considered a known cause of SIBO.[6] 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.”[7]

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.

 

[1]Schulz, T.J., and Schürmann, A. et. al. Pancreatic adipocytes mediate hypersecretion of insulin in diabetes-susceptible miceMetabolism2019; 97: 9 DOI: 10.1016/j.metabol.2019.05.005

[2] 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>.

[3] Tello, M. Intermittent fasting: Surprising updateHarvard Health Blog.  2020. <https://www.health.harvard.edu/blog/intermittent-fasting-surprising-update-2018062914156>. This blog contains several important primary references.

[4] 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/>.

[5] 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.

[6] Hasler, W. Physiology of the Gastrointestinal Tract (Fourth ed.) 2006.

[7] Cignarella, F. Intermittent fasting confers protection in CNS autoimmunity by altering the gut microbiotaCell Metab. 2018. 27(6): 1222–1235.e6. doi: 10.1016/j.cmet.2018.05.006

Will The Saharan Dust Storm Ruin our Lungs?

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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[1], 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.[2] ” 

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[3]. 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[4], 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.

[1] Wikipedia, accessed June 2020.

[2] 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.>.

[3] 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>.

[4] American Association for Cancer Research website. 

Accessed June 2020. <https://www.aacr.org/patients-caregivers/progress-against-cancer/air-pollution-associated-cancer/>.

Post Covid-19 Syndrome: Why Covid-19 May Linger

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Getting through Covid-19 seems to be easy for some of us. Although the long-term effects aren’t known yet, few people seem worried about long-lasting damage, especially if they never had severe symptoms.  Maybe people should be concerned: a hill of evidence is starting to accumulate, pointing to long-lasting damage from Covid-19. While it is not surprising that Covid-19 could infect any tissue throughout the body, given the ubiquitous distribution of ACE-II receptors, the real surprise might lie in how and why it pops out again

A likely place to find long-term damage is the brain, since there are many ACE-II receptors in critical areas such as the hypothalamus. Troubling reports of confusion, delirium, memory loss, fatigue, and depression, are some of the long-lasting effects patients are reporting. The viral fatigue can be the only symptom some people ever experience, and for others, it has proven to last for months after their other symptoms went away. For others, biochemical changes leading to chronic depression and anxiety might linger for weeks or months, potentially much longer. The delirium and confusion associated with the brain damage caused by Covid-19 can remain: in the words of one patient, “Covid has killed me” – a reference to the fact that she suffers debilitating confusion, can no longer walk, and suffers from soul-crushing depression.[1]

Perhaps one of the most interesting ways that Covid-19 intersects the brain and at the same time underscores the complex interconnection of the body’s systems concerns how it affects our breathing. In what has called “happy hypoxia” – or more accurately, silent hypoxia – nearly asymptomatic patients have had stunning, profound levels of oxygen deficit. While SPO2 levels below 80% can result in impaired cognition for most people, and below 75% typically results in loss of consciousness, some Covid-19 patients present with far lower levels – as low as 50% – yet seem fine.[2] Fine as in, they’re happily texting away, oblivious to any danger they might be in, and reporting no discomfort related to their breathing. It’s thought that this constellation of symptoms might be due to a lack of communication from the brain centers responsible for breathing. Although more research is needed to support the hypothesis, it could explain the profound hypoxia – and the utter lack of awareness that suffers have.

Other problems also occur and never go away – or they do so in such an asymmetrical fashion that sufferers can be held hostage by symptoms, even when they remit for the occasional good day. A special kind of post-traumatic stress disorder, post-intensive care syndrome, seems to haunt a great many survivors. Some of the condition is psychological: being treated in isolation and breathing with a mechanical ventilator can be extremely traumatic. But other components may be physical: sufferers complain of chest tightness and shortness of breath. Since many will have alveolar damage, and perhaps permanent scarring in their lungs, the seemingly reasonable question of whether these symptoms are primarily psychological becomes a chicken-or-the-egg type of ordeal. Furthermore, post-intensive care syndrome presents commonly as a hospital-acquired delirium. As one critical care fellow at UCSD reported, “I had one patient who came to our ICU recovery clinic, who told me that he was in a half-conscious state the whole time. He thought the nurses were hooking up poisonous snakes to his arms.” [3] About half of long-term (20 days or more) ICU patients seem to have some long-term affliction following their time in the hospital.

Regardless of the differences in manifestation, early March Covid-19 survivors are still showing the symptoms, in some cases, over 100 days later.[4] For many people, the most enduring symptom is intense bouts of viral fatigue. The fatigue often (but not necessarily) presents as irregularly occurring, sudden attacks of body-draining bone-weariness that make it impossible to do anything, sometimes even making it difficult to leave the house. Some sufferers report that it intensifies throughout the day, with milder morning symptoms that give way to debilitating fatigue, usually the afternoon or the evening. Sleeping provides only a brief respite, followed by day after day repetition of the cycle.

Nobody knows how long these things will go on, nor do we know who will get better and who will not. It bears repeating that most cases don’t result in serious disease, and many of us may never even know that we had it. In other words, Covid-19 is not worth panicking over. But it is worth taking seriously.

[1] Cormier, Z. June 22, 2020. Future. How Covid-19 Can Damage the Brain. https://www.bbc.com/future/article/20200622-the-long-term-effects-of-covid-19-infection.

[2]  https://www.nytimes.com/2020/04/20/opinion/sunday/coronavirus-testing-pneumonia.html.

[3] Edwards, E. March 28, 2020Post intensive-care syndrome’: Why some COVID-19 patients may face problems even after recovery < https://www.nbcnews.com/health/health-news/post-intensive-care-syndrome-why-some-covid-19-patients-may-n1166611>.

[4] From testimony on Good Morning Britain. June 24, 2020. <https://www.youtube.com/watch?v=nMbQlzqZZKs>.

Manufacturing Problems in China, Again

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This time it’s the lies that bind.In recent news, which has garnered some attention from the media but not nearly enough, hundreds of Chinese suppliers of medical equipment to U.S. have been discovered using false, faulty, or utterly implausible registration with the FDA. That would not be good any day of the week, but it gets comically worse. Some thirteen hundred plus companies were found using the same address to pawn their wares off on the U.S. FDA. The house is a three-bedroom brick shelter in Wilmington, Delaware, and neither the occupants nor landlord knew anything about any Chinese companies when they were interviewed. The edifice was little more than a ruse for these companies to import their goods into the U.S. using an agency known as CCTC, while the FDA has deemed it has “probable cause to believe CCTC is a fictitious corporation.”

Previous to the medical equipment debacle, federal health officials revoked U.S. authorization for masks made by over 60 Chinese manufacturers that failed to meet standards for the safety of health care workers.  Due to shortages caused by the influx of patients with Covid-19, the U.S. accepted donations of masks, gloves and protective equipment from China.  The Food and Drug Administration allowed the imports based on testing data from the companies, but new U.S. testing revealed the masks to fall far short of the reported test results.  The Chinese were modified N95 masks, which filter at least 95% of particles.  U.S. testing showed dozens of the Chinese masks failed to meet that 95% level, with some masks filtering as little as 20% of particles, according to the CDC.  More than masks and protective equipment are at stake, China is the world’s leading manufacturer for a multitude of products worldwide, from shoes and buttons to Christmas lights.

china_manuf

A seemingly unrelated anecdote further illustrates a lack of manufacturing oversight in China hails from the food industry. Luckin Coffee, which has been touted among the world’s fastest-growing coffee companies as the Chinese answer to Starbucks, has been the subject of a $311 million dollar accounting scandal. That number represents the dollar value of transactions that were forged by executives to inflate sales figures, and therefore stock prices. Boosting investor confidence under pretenses led to stock market devastation when the bubble burst; however: Luckin stocks fell from over $50 per share in January to $4.39 per share in maid April amidst the growing scandal.

The fabricated figures from Luckin and FDA shenanigans with the CCTC both serve to underscore the sad state of oversight in China. A backlash against the falsification of data is informing calls for stricter regulatory oversight of securities when companies go public, and for a more rigorous auditing process to ensure that published data from Chinese companies are truthful. Domestic Chinese investors, no less than their international counterparts, want to have confidence that their holdings can weather audits without withering at the slightest inquiry. 

In the U.S. it is becoming apparent that the FDA needs to up its game to ensure that it is doing an adequate job of protecting its constituents. While it is true that the companies that exploited regulatory weaknesses in the American marketplace need to be held accountable for their actions, our laxity paved the way for them to find those weaknesses. The FDA’s relaxed enforcement in the wake of Covid-19 is one factor that has negatively affected the quality of goods in the American marketplace, but certainly not the only one. How many people know where their drugs are manufactured? In an age where the ins and outs of API manufacture are proprietary and concealed with trade secrets, how can we know where the medicines on our shelves come from – and more importantly, how do we ensure that our supplies are safe? 

There are two different kinds of safety involved here: freedom from defects and impurities (i.e., product quality) and reliability of sourcing (i.e., supply chain robustness). These issues raise questions about both. The cGMP paradigm is not about quality “tested into” a product, which might miss things. The paradigm is about quality built into a product, which according to the FDA website, “…includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.” 

This is not idealistic, it is possible, and it’s absolutely imperative that we do this if we want to have confidence in our life-saving medicines.   But are we doing it? 

Mitochondrial Uncoupling: If You Want to Live Longer, Look to the Skies

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Over the years an enormous amount of both scientific and pseudo-scientific speculation has been aimed at explaining prevailing trends in the lifespan of animals,and how we might apply those lessons to humans.

Since clear, observable trends exist with respect to various groups of animals and lifespan, if we can understand the underlying processes behind those trends, we might be able to extend and maximize our own lifespans.  The most obvious trend is body size versus lifespan, which is robust and repeatable, yet has some outliers that offer tantalizing grounds for speculation.

Figure 1 shows the trend between size and lifespan.  The trend lines, both of which have significant scatter, clearly show two trends, with the data broken down to illustrate the difference between flying and non-flying species.  The striking difference between species who can and cannot fly will be immediately available to anyone who has ever kept a parrot – some species can reliably outlive their human owners.

sizeA number of theories exist to explain the differences between these groupings – and why bats and birds live so much longer.  The authors of the study behind Figure 1 [1] point to the differences in predation vulnerability and argue that flying reduces predation and vulnerability to food shortages.  In that respect, flight offers some of the same advantages as large body size, resulting in the anomalously longer lifespans enjoyed by bats and birds.  The only problem with this hypothesis is that a Malthusian distribution should ensue, and when these populations explode to the very limits of their ecological carrying capacity, one would expect that these advantages would be nullified.  Yet the differences persist.

An alternative view is that animals adapted for flight have a chemical advantage related to flying.  Their tissues express larger quantities of mitochondrial uncoupling proteins, which allow the “leak” of H+ without producing ATP in the mitochondria.  This means that they can “throw away” excess energy produced when they are at rest, necessary because their cellular machinery is designed to process huge amounts of energy during periods of flight.  Tossing the protons made by oxidative respiration has the side benefit that reactive oxygen species (ROS) are destroyed, preventing cellular damage that accumulates over time and causes aging.  Birds therefore age slowly and maintain their youthful function throughout the vast majority of their years.

Other animals, including humans, might be able to benefit from research that targets these proteins.  A growing body of research aimed at treating obesity has a similar goal, and gene therapies that are aimed at stimulating “brown fat” promise to kill two birds with one stone.   Brown fat, a vascular active form of adipose tissue, burns fats rapidly in the presence of oxygen and uncoupling proteins to generate heat.  This is the fat that allows long-lived walruses and cetaceans to keep warm even with wet skin in freezing climates by using fat as nothing more than fuel for the furnace.  Through gene regulation to stimulate brown fat we might be able to reduce obesity and inflammation caused by ROS.

Current research is promising, with the side benefits that gene therapies that increase the activity of the brown fat also cause marked increase in muscle mass and strength, at least in lab mice[2][3].  Scientists at Virginia Tech have recently identified a small mitochondrial uncoupler, named BAM15, that decreases the body fat mass of mice without affecting food intake and muscle mass or increasing body temperature. The research of Santos and colleagues, published in Nature Communications on May 14, 2020, are especially promising for the treatment of obesity and diseases characterized by inflammation.

Although research on mitochondrial decoupling proteins is ongoing, recent progress is promising, and the implications for medicine are sky-high.

[1] Healy, et. al.  2014  Ecology and mode-of-life explain lifespan variation in birds and mammals.  Proc. Royal Soc. B.  DOI: https://doi.org/10.1098/rspb.2014.0298 or visit https://royalsocietypublishing.org/doi/10.1098/rspb.2014.0298.

[2] Weintraub, Arlene.  2020 Gene therapy cuts fat and builds muscle in sedentary mice on unhealthy diets.  Fierce Biotech. May 11. https://www.fiercebiotech.com/research/gene-therapy-cuts-fat-and-builds-muscle-sedentary-mice-unhealthy-diets.

[3] Tang et. al. 2020  Gene therapy for follistatin mitigates systemic metabolic inflammation and post-traumatic arthritis in high-fat diet–induced obesity.   Science Adv. 08 May 2020:Vol. 6, no. 19. DOI: 10.1126/sciadv.aaz7492 or https://advances.sciencemag.org/content/6/19/eaaz7492.

[4]  https://www.sciencedaily.com/releases/2020/06/200608132539.htm?utm_content=131524119&utm_medium=social&utm_source=twitter&hss_channel=tw-463200485

Will Big Pharma Sabotage its’ Own Re-Shoring?

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globe

The need to reshore American products has been recognized on a federal level for many decades, with legislation such as the original Buy American Act, dated to 1933.

The urgency has grown in recent years, with the burgeoning dependence of the United States on foreign medicines and medical equipment now constituting a huge strategic burden.  The issue has recently come to forefront because of  renewed distrust in supply chain stability thanks to Covid-19, however, and current legislation is upping the ante by including Big Pharma among the list of key players that need to be reformed.

The imperative to return American products home is primarily being addressed through legislation offering incentives aimed at making American businesses more competitive, imposing tariffs on foreign goods and offering tax benefits for American manufacturers.  Although 28% of registered worldwide pharmaceutical API manufacturing sites are located within the US, according to government statistics when we consider the sourcing of raw materials, various estimates suggest that the true foreign dependence is even higher.  Indeed, it is surprisingly difficult for consumers to determine the origin of their drugs and medicines, and many pharmaceutical companies are reticent about their suppliers given the proprietary nature of the information.

Figure2-2

President Trump’s proposed “Buy America” Executive Order, spearheaded by White House trade adviser Peter Navarro, was sidelined by the National Security Council before it could be signed last Friday.  Although the exact details of the order are under negotiation, it is clear that the future of the pharmaceutical industry is at a major crossroads: what happens when the order is signed will shape the manufacturing of pharmaceuticals worldwide.

While this situation underscores the necessity for re-shoring American manufacturing of pharmaceuticals, the biggest opposition to the movement is coming from pharmaceutical lobbyists on Capitol Hill.  Perhaps this is unsurprising, given the enormous disruptions that changing the system would cause, and the fact that many of the losers would be large, powerful corporations with pronounced sourcing from overseas.  Nevertheless, the Pharmaceutical Research and Manufacturers of America (PhRMA), which is the largest pharma lobbying group present, has proffered an argument that re-shoring proposals will “… not only overestimate the potential feasibility and underestimate the time and effort it would take to make such changes, but also misunderstand that a diverse pharmaceutical supply chain is precisely what enables the industry to respond quickly and make adjustments in its supply chain sourcing during natural emergencies and global public health crises.”

Some of this rhetoric is true:  the process will definitely be expensive and difficult.  Some of this is false: parallel supply chains increases the robustness of the worldwide supply.  In fact, redundancy is a key element to airplane safety, and by analogy, it’s plain to see that parallel sources are far more secure than relying on a potentially distant source in an emergency.  This resistance is troubling, since the truth is staring us in the face:  global supply chains are not always reliable.  Imports from China for critical medicines and pharmaceuticals are being cut off entirely due to Covid-19.  This dependence has placed lives at risk since 90 percent of the generic medications that Americans use daily are imported.

The reluctance of  Big Pharma to reduce an unhealthy and greedy dependence on cheap labor and materials will have serious consequences for American healthcare as well as national security.  China’s dominance of the pharma supply chain is highly dangerous to the United States.  Pharmaceutical production must be reshored and even expanded in order to develop secure and safe supply chains for medications, vaccines and medical devices. This crossroads brings us to a critical question: will the United States commit its financial might to developing American pharmaceutical manufacturing capabilities, or will pharma itself stand in the way?

Cow Hearts: Beefy Benefits for Humans

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heart2According to the CDC, heart disease is the leading cause of death in the U.S., killing more than 600,000 Americans each year.

  • More than five million Americans are diagnosed with heart valve disease annually.
  • Heart valve disease can occur in any single valve or a combination of the four valves, but diseases of the aortic and mitral valves are the most common.
  • Calcific aortic stenosis is the most common form of aortic stenosis (AS).
  • While up to 1.5 million people in the U.S. suffer from AS, approximately 500,000 within this group of patients suffer from severe AS. An estimated 250,000 patients with severe AS are symptomatic.
  • Without an aortic valve replacement (AVR), as many as 50 percent of patients with severe AS will not survive more than two years after the onset of symptoms.

Aortic valve stenosis — or aortic stenosis — occurs when the heart’s aortic valve narrows. This narrowing prevents the valve from opening fully, which reduces or blocks blood flow from your heart into the aorta and onward to the rest of your body.

heart picRecent advances in the treatments for aortic valve stenosis[1] seem to be tipping doctors and patients increasingly towards xenografts for treatment.  Traditional treatment regimes have involved open heart surgery, focused on the replacement of the damaged aortic valve with a mechanical replacement.  The move away from these highly invasive operations has been prompted largely by a single, increasingly attractive development: Transcatheter Aortic Valve Replacement, or TAVR.

The new method of TAVR was only approved as recently as August 2019 for low-risk patients, as new research began to overturn the idea that mechanical heart valves were superior for patients with significant post-operative life expectancy.  The old thinking went like this: since mechanical heart valves do last longer, these valves could provide patients with a lower risk of failure, complications or repeat surgery.  The problem is that some of these assumptions are no longer true, and in many cases, “biologic valves are better even in the young patient.”[2]

The only true representation of the above claims is the fact that mechanical heart valves last longer.  That’s absolutely true; a valve made from titanium or other high-strength, highly impervious material can last for decades.  Unfortunately, these materials increase the risks of blood-clots since platelets have an affinity for collecting on non-biogenic surfaces.  These blood clots can result in thromboses, heart attacks and strokes.

The current treatment regimen is at best an uneasy compromise, because patients are assigned a life-long regimen of anti-coagulants that must balance the risks of clots against the risks of fatal bleeding, hemorrhagic stroke and other complications from the anti-coagulants.  The mortality and morbidity due to surgical complications and failure of the mechanical valves are complicating factors as well.

TAVR addresses some of these problems with short-term mortality by significantly reducing the risks of open heart surgery.  The minimally-invasive procedure begins by inserting a catheter into the femoral artery (or another blood vessel) and threading it up into the aorta.  Once there, in the increasingly common valve-in-valve (VIV) procedure, a collapsible replacement valve can be delivered right inside the aortic valve and then expanded.  Once it’s inside the valve, the new valve holds everything open during systole, meaning output resistance drops and the heart doesn’t have to work as hard.  The new valve will also close more effectively, so blood doesn’t continually wash back and forth, which further eases stress on the heart.

TAVR heart valves are typically made from cow pericardium[3], which also eliminates the platelet adhesion problems seen with mechanical valves.  Some people can go off of blood thinners, and not have to worry about their potential side effects.  The primary disadvantage of TAVR valves is their limited lifespan of 10 to 12 years.  New refinements are addressing this problem: recent studies have shown the chances of having problems with repeat surgeries and TAVR for failed bio-prosthesis valves are either the same, or slightly better for redo TAVR[4].  In another study of approximately 50 patients who had redo TAVR due to failing bio-prosthetic valves, every patient survived to discharge, with only one serious bleed and one minor, non-disabling stroke[5].  In fact, the lower risk of early- and mid-term morbidity associated with TAVR means that for many people, the procedure offers the best chance to live their best lives – living with the highest quality and lowest risk of disability.

[1] Source for stenosis diagram: Michigan Medicine, Frankel Cardiovascular Center.  https://www.umcvc.org/conditions-treatments/aortic-stenosis.

[2] Expert Analysis. 2015 Surgical Aortic Valve Replacement: Biologic Valves Are Better Even in the Young Patient. American College of Cardiology.

[3] Source for TAVR diagram: TCTMD.com

[4] Maxwell, Y.R. 2018.  Valve-in-Valve TAVR: Mortality, Adverse Events Similar to Redo Surgery at 30 Days. TCTMD/the heart beat.  < https://www.tctmd.com/news/valve-valve-tavr-mortality-adverse-events-similar-redo-surgery-30-days>.

[5] Barbanti, et al. 2016. Circ. Cardiovasc. Interv. (9):e003930.  Outcomes of Redo Transcatheter Aortic Valve Replacement for the Treatment of Postprocedural and Late Occurrence of Paravalvular Regurgitation and Transcatheter Valve Failure.  < https://pubmed.ncbi.nlm.nih.gov/27578840/>. DOI: 10.1161/CIRCINTERVENTIONS.116.003930

Thanks for the Plague, California!

By | Uncategorised | No Comments

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Because if hiding dead bodies isn’t a conspiracy, we don’t know what is.The bubonic plague (and its’ siblings, the septicemic and pneumonic plagues) is alive and well in the Western United States.  In fact, in the most plague-stricken region in the United States (Northern New Mexico) several cases pop up every year.  Even with modern antibiotics, nearly 1 in 6 plague patients will die – which is still better than no treatment at all, since some forms are 99% fatal if untreated.

Thanks to horizontal gene transfers and other mechanisms, soon antibiotics may not even help: one recently isolated strain of the plague was found to be resistant to eight antibiotics, including all of the three primary treatments for plague.  Even more disturbing, a Nevada woman who eventually died was treated for a bacterial infection in early 2017 that was resistant to every antibiotic available in the United States.  Yersinia pestis typically hides out in long-term environmental reservoirs, which may provide more opportunities for horizontal gene transfer and makes eradication of the plague almost impossible in the Western U.S. (or other countries).  This makes the average 10 to 20 annual cases in the U.S. largely unavoidable.cycleThe plague is not native to U.S. soil and its’ presence here was neither inevitable nor even especially difficult to avoid.  The plague made landfall in San Francisco’s Chinatown, where deaths started occurring around 1900.  Under the direction of the governor of California, Henry Gage, the bodies of plague victims were hidden for at least two years.  In fact, over 100 deaths were concealed, and newspapers reported that the plague “Did not, nor ever did exist in California.”  The San Francisco Examiner even ran an article :Why San Francisco is Plague-Proof.”

Why hide such a deadly disease from the public?  Greed, pure and simple: Gage and his officials feared the loss of revenue during quarantine, and an even more significant loss of revenue if consumers stopped buying California produce, which was by then a burgeoning $25 million dollar industry.  Despite the attempts by the governor to silence the medical community and corrupt the media, a handful of champions of public health eventually succeeded in ridding the city of the plague.  Two of the city’s most prominent physicians, Wilfred H. Kellogg and Joseph Kinyoun, Chief Bacteriologist and Chief Quarantine Officer,  made valiant efforts to protect the public welfare that did not immediately come to fruition.  After discovering Yersinia pestis in the blood and lymph smears from infected corpses, these doctors made recommendations to contain the outbreak.  The response from California State officials was swift and merciless:  the doctors were fired and massive, devastating smear campaigns were launched against them in the local media.

Still, by 1903 the political tide started to turn against the Governor, and after repeated outbreaks in 1906 and 1908, the plague was eradicated from the city of San Francisco.  The same newspapers that had denied that the Black Death had ever descended on San Francisco now gleefully declared that it had been eradicated.

Unfortunately, while the cleanup-up was a win for San Francisco, lasting damage had been done to the Western United States.  Local populations of mammals, including rats and squirrels had already been infected within the first several years due to the critical delays in treating and containing the outbreak.  Over half of all plague related deaths in the United States now take place in a region that had nothing to do with the introduction of the disease.  Free-ranging animals have spread the disease, until at last, it found its’ greatest permanent reservoir in the United States: The Gunnison and black-tailed prairie dogs of northern Arizona, New Mexico, southern Colorado and Utah.

These regions overlap with the distribution of plague hotspots in the United States, and not just for humans either: over 90% of the inhabitants of an infected prairie dog town will usually die in a single outbreak.  Fleas jump from their dying hosts in favor of dogs (who seem to be plague-resistant) and enter homes where they kill both humans and cats (who seem to be especially vulnerable).  Thus, Henry Gage’s legacy repeats itself, claiming more lives every year, and reminding us that the consequences of inaction during a pandemic are severe, while the consequences of actions taken to deliver misinformation during a pandemic are abominable.

[2] Tansy, T. Plague in San Francisco: Rats, Racism and Reform.  2019  Nature. https://www.nature.com/articles/d41586-019-01239-x.

[3] Plague Ecology and Transmission. United States Center for Disease Control (CDC) webpage.  See infographic, vide supra. https://www.cdc.gov/plague/transmission/index.html.

Anti-Vaxxers a Top Health Threat

By | Blog

A new threat to the health and safety of children has recently begun to take center stage: diseases that were once thought eradicated have reemerged into public consciousness.  These diseases have been aided and abetted by the irresponsible and dangerous behavior of people opposed to vaccines, otherwise known as anti-vaxxers. Read More

Toxoplasma Gondii: The Brain Hitchhiker

By | Uncategorised | No Comments

kitty3Toxoplasmosis is a widely known disease that results from infection with the Toxoplasma gondii parasite, one of the world’s most common parasites. Infection usually occurs by eating undercooked contaminated meat, exposure from infected cat feces, or mother-to-child transmission during pregnancy.  Estimates suggest that about 1/3 of the entire human population of the Western world is harboring the parasite in the form of “benign cysts” concentrated mostly in the brain.

The parasite can form cysts anywhere almost: hearts, lungs and eyeballs are common hiding places, but the brain is the preferred hangout for this organism.  If you are a cat lover, chances are high you are already infected, courtesy of your cat.  Cat brains are a natural repository for the adult protists, which reproduce inside our feline friends and spread from cat feces.  This is not to say that won’t infect any warm-blooded animal that they are capable of, but the only hosts truly necessary for their continued survival are felids, according to the CDC website.  Once infected, they usually infect you for your entire lifespan, mostly asymptomatically.toxo

The most interesting thing about the infection, though, is that the cysts hijack our brains, producing subtle but measurable and influences on behavior.  Scientists have suspected that the success of Toxoplasma is due in part to its’ ability to change rats and mice behavior, and causing them to stop fearing cats.

In a now famous study, it was demonstrated that mice, which have a morbid fear of cats and a strong fear reaction to cat odor, tend to lose that fear and unequivocally show a preference for cat odor after being infected with the parasite.

Mice aren’t the only ones whose brains can be hijacked, though: there’s a good chance that the parasite in your head may be at least partly responsible for the shots you call, too.  A growing body of research indicates that the manipulation theory, as it is called in medical and biological journals, extends to human in several ways.  Latent toxoplasmosis in humans has been associated with serious neurological disorders, including schizophrenia, intermittent explosive (rage) disorder and suicide.

In addition, research shows infection by Toxoplasma gondii, directly affects the production of dopamine, a key chemical messenger in the brain.  Dopamine is a natural chemical which relays messages in the brain controlling aspects of movement, cognition and behaviour. It helps control the brain’s reward and pleasure centres and regulates emotional responses such as fear. The presence of a certain kind of dopamine receptor is also associated with sensation-seeking, whereas dopamine deficiency in humans results in Parkinson’s disease.

Infection changes the way that your brain processes information, slowing reaction times (more traffic accidents) and changing your preferences for a great many things, from risk aversion to tidiness to extraversion.  The effects of Toxoplasma infection on an individual depend on genetics, with some genotypes immune to infection and less likely to experience effects, and gender.  To take one example, the effect on personality has been summed up after analyzing multiple studies, each with well over a hundred (and often several hundred) subjects.

According to Effects of Toxoplasma on Human Behavior, significant differences in personality factors were found between Toxoplasma-infected and -uninfected subjects in 9 of 11 studies, and these differences were not the same for men and women. After using the Bonferroni correction for multiple tests, the personality of infected men showed lower rule consciousness and higher vigilance. Thus, the men were more likely to disregard rules and were more expedient, suspicious, jealous, and dogmatic. The personality of infected women, by contrast, showed higher warmth, suggesting that they were more warm hearted, outgoing, conscientious, persistent, and moralistic.

Even sexual characteristics and preferences might be affected.  In one photograph study, men who harbor infections are consistently rated as being more dominant and masculine looking then men who don’t have infections – on the basis of photographs alone.  Toxoplasma increases expression of the genes coding for testosterone in men, and the effect is large enough to be seen by the naked eye and borne out by physical measurements, including a noticeable 3 cm boost in average height.

Although the mechanisms by which this parasite seems to influence its’ hosts are still being elucidated, its’ clear that it touches our lives in ways we never before imagined.  How much of “them” is really “us”?

Anti-Cancer Gut Bacteria

By | Uncategorised

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The human microbiome is the subject of a burgeoning field of research.  The effect of gut microflora, and especially bacteria, has in the last few years been linked to anxiety, depression, gastrointestinal and autoimmune diseases, and numerous other disorders. Read More

New Genetic Test for Antimicrobial Resistance

By | disease, research, antibiotic

how-bacteria-work-360x240You’ve most likely taken an antibiotic at least once in your lifetime. From treatments for painful strep throat or ear infections as a child, to burning urinary tract infections or itchy skin infections, antibiotics are one of the most highly utilized and important medication classes we have.  Soon, your doctor may have a new weapon in their arsenal to diagnose and target treatment:  scientists at American University have developed a rapid, highly sensitive genetic test to determine whether bacteria carry a gene that causes resistance to two common antibiotics. Their research, published in BMC Infectious Diseases, demonstrated that the new test works as accurately as culture-based methods but gives results in minutes, not hours or days.

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Merck Backs Out of Vaccine Commitment to Africa

By | Uncategorised

 

Merck’s decision may leave more than 2 million children in West Africa unvaccinated and vulnerable to rotavirus in 2020.

At the same time Merck cut the vaccine supplies to West African countries, they began delivering RotaTeq to China.  Each vaccine will likely cost more than $40 per dose.  When asked if there was a connection between the launch in China and Merck not fulfilling their West African commitment, a Merck spokesperson wrote:

When faced with supply constraints, such as this, we evaluate all options to determine how we can fulfill the agreement we made with UNICEF and GAVI-eligible countries to the best of our ability, while at the same time meet the binding contract demands we have with other countries. The product we have allocated to China is what has been approved for use in that country to fulfill the terms of a binding agreement we signed with a local vaccine company in 2012. As I’m sure you can appreciate, the details of that contract is proprietary to Merck; as such, we cannot confirm the number of doses nor discuss price.

“Kids should not be denied vaccines just because they belong to a poor country.”-Dr. Mathuram Santosham at Johns Hopkins University

Where does that leave the kids in West Africa? UNICEF, which delivers vaccines to poor countries worldwide, says it’s trying to help the West African countries switch to another vaccine.  The World Health Organization prequalified two new rotavirus vaccines manufactured in India earlier this year:  Rotasil and Rotavac.  Both vaccines are available to Gavi at a cost of less than $2 per dose.

Unfortunately, the switch will not be quick-or easy.  Prequalification of a vaccine is the beginning of a long process, including a regulatory actions that must occur.   The process is daunting, with more than a few moving parts that require time and money.  New vaccines may be tested in small pilot programs, health care workers have to be retrained on vaccine administration, clinics need the ability to store and transport the new vaccine.  That will require possibly up to five years for the vaccine to be widely available in West Africa, says Frederick Cassels, at the nonprofit PATH, which helped develop Rotasil and Rotavac.  Even just a delay of a few years would put millions of babies at risk for rotavirus, says Johns Hopkins University’s Santosham. “We all as a community should come together and make sure these kids get this vaccine.”

According to Merck, their third quarter 2018 worldwide sales were $10.8 billion.  Good for Merck-really.  More profits mean more research, and more lives saved overall.  Most reasonable people realize that companies need to make a profit to stay in business, and that includes pharmaceutical companies.  But the pharmaceutical industry is not like other industries that sell tires or pizza.  Due to the nature of the business, pharmaceutical industry profits are made off of illness and disease–this requires a level of sensitivity and responsibility to the community that the local pizza joint does not need to make.

What level of responsibility do pharmaceutical companies owe to the people?  Has Merck denied their responsibility to the community and turned their back on the poor children of Africa?  Can a company be both profitable and ethical, or are those incompatible values?  These are questions that need consideration, since we live in a world with expanding need, and shrinking resources. 

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HIV Controlled by Antibody Therapy

By | Uncategorised
Today, an estimated 1.1 million people are living with HIV in the United States, and improvements in antiretroviral therapy have turned HIV into a manageable condition.  Thanks to better treatments, people with HIV are now living longer—and with a better quality of life—than ever before.  Yet even the most effective drugs only suppress the virus, which hides in the body, ready to rise to dangerous levels should a patient stop their medication regime. To continue suppression of HIV, patients must adhere to strict daily medication schedules, which can be burdensome and expensive.   Read More

Latest Research Offers Alternative to Addictive Opioids

By | Uncategorised

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The misuse of and addiction to opioids—including prescription pain relieversheroin, and synthetic opioids such as fentanyl—is a growing national crisis affecting public health and creating an enormous burden on the healthcare system.  The Centers for Disease Control and Prevention estimates that the total economic impact of prescription opioid misuse in the United States is $78.5 billion a year, including healthcare, lost productivity, addiction treatment, and criminal justice involvement.

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How Does Talking to Babies Make Them Smarter?

By | social issues, children, education, parenting
Young children who are regularly engaged in conversation by adults may have stronger connections between two developing brain regions critical for language, according to a study of healthy young children that confirms a hypothesis registered with the Open Science Framework. This finding, published in JNeurosci, suggests that talking with children from an early age could promote their language skills. Read More

New TB Study Has Hopeful Results

By | disease, research
Tuberculosis (TB), an infectious disease targeting the lungs, is the second biggest killer, globally.  In 2015, 1.8 million people died from the disease, with 10.4 million falling ill, despite the development of vaccines and effective drug treatment.  At one point, the United Nations predicted that TB would be eliminated worldwide by 2025, but treatment options remain surprisingly sparse.  The only vaccine for TB was developed nearly a century ago, and offers limited protection.  Even worse,  patients are becoming increasingly resistant to available drugs. Read More

Can an Asthma Drug Reverse Dementia?

By | Uncategorised

dementia_istock_000029744938_largeDementia is a term describing a variety of diseases that develop when nerve cells in the brain die or become impaired. The death of neurons causes changes in memory, behavior, physical capabilities and personality. In many of these diseases, such as Alzheimers, the associated changes often prove to be fatal. Read More

Louisiana Hepatitis C Cost Proposal

By | legal, legislation

Biosimilars: Growing Pains in a New Arena

By | Uncategorised

dna_3One of the key strategies for enhancing access to affordable medicines posed by the Trump administration involved establishing the pathway for the development and approval of high-quality biosimilar therapies.  Yet, out of 11 approved products, only three biosimilars are on the market eight years after the enactment of legislation streamlining the process.  If current trends continue, it may be months or years before Americans gain access to these medications.

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New Research on Spinal Cord Injury

By | Uncategorised
Spinal-Cord-Injury
The spinal cord is very sensitive to injury, and unlike other parts of your body, lacks the ability to self repair when damaged, making spinal injuries potentially devastating. A spinal cord injury — damage to any part of the spinal cord or nerves at the end of the spinal canal (cauda equina) — often causes permanent changes in strength, sensation and other body functions below the site of the injury.  An injury can occur when there is damage to the spinal cord from trauma, restriction of blood supply, or compression from a tumor or infection. There are approximately 12,000 new cases of spinal cord injury each year in the United States, most frequently in males. Read More

Preventing CTE & Head Trauma

By | ethics, social issues, legal, sports

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Football is an iconic American sport, but despite the national interest in watching football, professional athletes experience a lack of protection when it comes to brain injuries. It is not uncommon for football players at any level to experience a traumatic head injury at some point during their career. For some, the injuries come in the form of a concussion, which makes up 7.4% of all head injuries sustained from playing football.

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Long Acting Treatment for Schizophrenia May Offer New Hope

By | Uncategorised

image showing the confusion of schizophrenia

Schizophrenia, Latin for “split mind,” is a chronic, severe and disabling brain disorder, affecting an estimated 2.4 million American adults and their families.  The hallmark of schizophrenia is disorganized thinking, which can manifest as positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal).  Although schizophrenia is not as common as other mental disorders, the symptoms can be very disabling. In the past, there were different classes of schizophrenia, also known as ‘subtypes’. Disorganized schizophrenia, catatonic schizophrenia and schizoaffective disorder have since been absorbed into the larger diagnosis of schizophrenia, but are still used to describe the widely varied ways schizophrenia can manifest from person to person.  Read More

Right To Die

By | ethics

candle-2038736_1920The right to die issue – or death with dignity – as it has been named in the press and by advocacy groups, is a controversial topic. On one side of the argument some people are concerned that passing ‘death with dignity’ statutes and legalizing suicide might expose the most vulnerable groups of people in society. On the other side, some people suffering terminal illness are concerned with exercising their right to bodily autonomy, and deciding when and where that ends.

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Psychopathy as a Disability?

By | mental health

eery-1648250_1920.jpgPsychopathy is a hotly debated topic in the psychiatric community and in society at large. The nature of psychopathy is a frightening one and the root causes of the personality disorder are largely unknown. A person who is diagnosed as being a psychopath may exhibit symptoms such as reckless spending, violence towards animals and arson, ordinarily starting from a very young age. Psychopathy is generally understood by most people to be characterized by diminished capacity for empathy towards other people and living beings.

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Joyce Brown & 5150s

By | ethics, mental health

schizophrenic-2934770_1920Psychiatric care is a difficult field for many patients and providers to navigate. The ethics of psychiatry are constantly changing and are held under great scrutiny. In the eyes of the public, treating mental illness is not as straightforward as treating physical illness.

People with severe mental illness are more likely to be subject to homelessness, violence and unemployment. For many people with psychotic disorders, they’re likely to experience an involuntary psychiatric hold – known as a 5150, which enables them to be held in a psychiatric hospital for evaluation and potentially to be held longer if they’re deemed incapable of checking themselves out or caring for themselves.

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Insomnia: The Hidden Costs of Poor Sleep

By | Uncategorised
Insomnia is a common problem for people of all ages, with a number of people suffering from an inability to sleep.  Based on estimates derived from population-based studies, approximately 30% of adults worldwide report symptoms of insomnia: difficulty initiating or maintaining sleep, waking up too early or poor quality of sleep.  Common comorbidities associated with insomnia are psychiatric disorders, with an estimated 40% of all insomnia patients experiencing a coexisting psychiatric condition.  Among these psychiatric disorders, depression is the most common, and insomnia is a diagnostic symptom for depressive and anxiety disorders.

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Ketamine and Depression

By | Uncategorised

Depression is one of the most life-threatening mental illnesses in the United States today. Treatment resistant depression, which does not respond readily to talk therapy or medication — the most frequently prescribed treatments for major depression — can lead to self loathing, isolation and thoughts of suicide. Suicide is currently among the leading causes of death in America.  Even medication can have drawbacks, with first line therapies often taking as long as 6 to 8 weeks before being effective.

Faced with the long timeline of drug therapy and unwanted side effects, patients with severe depression sometimes turn to nontraditional treatments such as electroconvulsive therapy and perhaps surprisingly, ketamine therapy — a drug known as ‘Special K’ by recreational drug users. A staggering 70% of patients responded to ketamine therapy for treatment of depression in one study performed.  The study examined the use of intravenous ketamine  for depressed patients at imminent risk of suicide, and with the rapid response shown by patients, makes ketamine a potentially attractive “rescue medication” for depressed patients in need of immediate relief. Read More

Ebola Virus: Finally a Vaccine?

By | medicine, vaccination

 

The Ebola virus, discovered in 1976 near the Ebola River that can cause a severe and often fatal disease called Ebola virus disease (EVD).  Since the first discovery in 1976, there have been sporadic outbreaks of EVD, with the most recent one in 2013-2016 affecting West African countries, mainly Guinea, Sierra Leone and Liberia.  Fruit bats are the most likely reservoir of the Ebola virus.  Ebola is deadly in about 70% of those infected with Ebola; the 2013-2016 Ebola outbreak in West Africa claimed more than 11,000 lives. Read More

High Potency Compounds-Taking on the Challenge

By | Uncategorised

 

As a pharmaceutical or biotech company, if you haven’t had to deal with high potency API (HPAPI) compounds yet, chances are you will eventually.  Approximately 25 percent of drugs in development worldwide are classified as highly potent, with this percentage expected to grow over the coming years; the global HPAPI market is expected to reach nearly $26 billion by 2022.

HPAPIs are a rapidly growing segment of the pharmaceutical industry, primarily due to an increased focus on targeted therapeutics, especially in oncology.  A compound is classified as highly potent if it has an occupational exposure limit (OEL) of ≤10μg/m3, a daily therapeutic dose of ≤10mg/day or if a 1 mg/kg/day dose produces serious toxicity in laboratory animals.

25% of drugs currently in development worldwide are highly potent.

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The Days of Clean Sheeting for Cost of Goods are Over.

By | Uncategorized

image showing person buried under paperwork

We have all been there when we need to determine various costs and where they come from.  We stare at spreadsheets, trying to gather the necessary data, critical and nonessential, and using our calculations to determine how we can lower costs.  This approach is not only time consuming, but inaccurate and inefficient, but what are the alternatives?

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DASH Diet: A Potential Treatment for Depression?

By | mental health, health

Physical health and mental health are definitively linked, and have been for some time. However, the extent that diet and exercise has on mental health remains unknown. There are anecdotes of certain diets lowering blood pressure by seemingly impossible amounts, diabetics claiming to be cured by their lifestyle and even claims of going into cancer remission as a result of a person’s diet.  None of these claims have been seriously substantiated, but recently a diet known as the DASH diet has been linked to lower blood pressure and decreased risk of depression.  Is it possible that something as simple and straightforward as your diet can affect your mental health? Read More

Flu Outbreak Worse This Year

By | healthcare, flu, vaccination

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This year’s flu season has been unprecedentedly aggressive in comparison to recent years, causing levels of panic in the United States on the level of the H1N1 outbreak that occurred in 2009. Also known as swine flu, H1N1 caused rising levels of fear on a global level, with magazine covers publishing headlines about the epidemic and leading the World Health Organization to address the matter publicly, declaring it a pandemic.

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Is Excel Holding You Back?

By | Data Management, Cost Analysis, healthcare

image demonstrating the problem with Excel spreadsheetsIs Excel a dated method of data crunching that is holding back rather than advancing your company? CFOs from Fortune 500 companies are insisting that staff stop using Excel. What does that mean for the pharmaceutical industry, and why is there push back against the popular spreadsheet software? Finance chiefs say the ubiquitous spreadsheet software that revolutionized accounting in the 1980s cannot kept up with the demands of contemporary corporate finance units. After all, just like hair metal bands, the 80s are long gone and pharmaceutical companies need to advance with the times.

Spreadsheets have been a necessary and advantageous tool in a huge number of industries. Excel has revolutionized accounting and driven decision making, but as business becomes more complex and global, Excel cannot bear the expectations and demands of many companies.

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Left Behind: Native American Healthcare

By | healthcare

image depicting native american dreamcatchersFor many Native Americans, receiving healthcare can be a difficult ordeal. Poverty runs rampant on reservations throughout the United States, with one charity named One Spirit putting the number of Lakota families living under the poverty line in South Dakota at a staggering 90%. Even acquiring heating and basic living necessities is difficult for many of these families, reducing healthcare to a secondary concern. Native American people are at high risk for unnecessary death due to an intersection of unique situations such as isolation and poverty levels.

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Autoimmune Disorder Treatment on the Horizon

By | autoimmune disorders, development

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Over 23.5 million Americans are afflicted with autoimmune diseases, including rheumatoid arthritis (RA)an autoimmune disease affecting approximately 1.3 million Americans.  In a case of mistaken identity, the body’s immune system mistakes its own tissues for foreign invaders, such as bacteria or viruses and develops antibodies to destroy the “invaders” in the synovium.  Currently, there is no cure for rheumatoid arthritis and the treatments are often saddled with a variety of side effects, some as severe as the disease.

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Technology & Pharma: An Unexpected Intersection

By | technology

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The pharmaceutical industry is currently in an era of change and in some senses is being upended by these changes, thanks to the development of new technology. Patients are rapidly becoming more empowered to do their own research and make decisions about their healthcare. One of the recent technological developments in the healthcare industry enabling this is the rise of the ‘health app’. Apple products have their own integrated health app that tracks statistics such as weight, heart rate, significant medical dates and other information. 

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Online Drug Shopping Made Easy?

By | ethics

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The names of the top pharmacies in the world will come as no surprise to most:  CVS, Walgreens, Amazon.

Wait, what?  Amazon?

CNBC recently reported that Amazon may be considering the sale of prescription drugs online, a lucrative market of approximately $560 billion annually. Breaking into the U.S. prescription drug market could be the start of huge financial gains for Amazon, but many people are wondering how they would manage the transition from sales of primarily unregulated items, into selling products from one of the most highly regulated industries.

Analysts at Leerink Partners, an investment bank specializing in healthcare, predict Amazon will be involved in prescription drug sales by the year 2019. This idea is not new for Amazon, with a previous attempt at an online site named drugstore.com, which is no longer open. Read More

States in Crisis Sue Opioid Manufacturers

By | lawsuit, opioid crisis, legal, opioids

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Mississippi and Ohio are two states that have been hit hard by the recent opioid crisis affecting the nation, with over 200,000 Ohioans addicted to opioids.  Mike DeWine, the Attorney General, filed a lawsuit in May of 2017 against 5 separate pharmaceutical companies alleging that the companies “helped unleash a health crisis that has had far-reaching financial, social, and deadly consequences in the state of Ohio”.  This makes Ohio the second state to file suit against pharma companies, with Mississippi the first state.  They allege that the manufacturers knowingly marketed opioids while minimizing the risks of addiction, while simultaneously overstating the benefits.

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Do Benzos Cause More Harm Than Good?

By | benzodiazepines, addiction, benzos, harm

worried-girl-413690_1920.jpgBenzodiazepines are a commonly prescribed medication for anxiety, seizures, and a myriad of other medical conditions. However, this medication doesn’t come without its faults, of which there are many serious ones. Benzodiazepines such as Ativan and Xanax are potentially addictive after only a short period of time, and are highly sought after by drug addicts and even patients who aren’t psychologically addicted but are physically dependent on the medication.

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Snake Oil and Social Media

By | social media, regulation, drug promotion

In 2017, advertising and promoting products is a minefield.  The availability of detailed and extensive information on consumer spending habits provides countless ethical pitfalls that are only magnified when the product in question is a drug.  In the past only magazine ads and TV commercials were utilized for drug advertising, now we have an array of choices that don’t always feel like marketing, but more like a conversation with a good friend.

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Not So Nobel Awards

By | humor

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Why do old men have big ears? Can smiling at a crocodile affect your desire to gamble?  And most importantly, can cats act as both a liquid and a solid?

These are the questions that keep us awake at night.  Fortunately, there are scientists working diligently on these puzzles, as well as many other weird and curious questions.  Their efforts have not gone unnoticed, and most recently were celebrated at the 2017 Ig Nobel Awards, a scientific recognition of the strangest and most obscure scientific experiments or studies done in that year.

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Personalized Medicine: The Future of Genetic Testing?

By | genetic sequencing,, drug development

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You’re feeling under the weather, with a cough that just won’t go away, so you decide to visit your doctor.  After a few minutes of one-on-one time, with some poking and prodding, you may be walking out of the office with a prescription in hand and on the way to feeling better.  How much more personal does it get? Perhaps not surprisingly, it can get a lot more personal, and it has nothing to do with your doctor, and everything to do with science.

In our current system of medicine, your treatment plan has very little to do with you specifically; most likely it is the exact same treatment your doctor would give to anyone with the same condition.  Medicine today is based on “standards of care,” the most prudent course of prevention or treatment for the general population.  With medication treatment for depression, for example, those standards may mean treatment with an SSRI (selective serotonin reuptake inhibitor), followed by a second trial if the first one fails. If the second treatment fails, doctors and patients move on to the next one and the next in a trial and error approach.

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AI Innovation in Pharma

By | Uncategorized

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Artificial intelligence is more than just a concept for the newest blockbuster movie, it is moving into mainstream science and the pharmaceutical industry as well.  The Korea Pharmaceutical and Bio-pharma Manufacturers Association has recently announced the launch of a team focused on purchasing artificial technology for drug development.  Artificial intelligence computing systems can be used to analyze molecular interactions, and predict drug efficacy and side effects.  The technology can be utilized to guide and optimize clinical trial planning, greatly reducing the timeline for new drug development.

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Exercise Can Prevent Dementia; Why Pharma Companies Should Care

By | Pharma and Politics

 

Alzheimer’s is a progressive, neurodegenerative disease characterized by memory loss and impaired cognition, with as many as 5.4 million Americans living with the disease.  Today Alzheimer’s disease is the sixth leading cause of death in the United States and the 5th leading cause for those 65 and older.  The symptoms of Alzheimer’s slowly creep into our lives and affect loved ones in profound ways.  Throughout the years, research and medications have helped, hindered and or even prevented some of the serious symptoms, but currently, there is no cure.

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Cost versus Quality: Is Manufacturing in India Worth It?

By | Business

image detailing the importance of maintaining high quality in drug manufacturingSix months into an administration’s promise to curb drug prices, the cost of drug development remains high.  As companies scramble to reduce costs, they are moving manufacturing overseas, enticed by lucrative savings.  The question remains: are drug companies really saving money or are reduced costs in production aligned with quality, timeline and regulation issues?

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Social Media and Pharma: The Good, the Bad and the Ugly

By | Business

Over the past decade, there has been a huge shift in the way that businesses and consumers use social media.  Society is undergoing rapid and dramatic change, fueled by an exponential rate of technological innovation.  This has an enormous impact on the pharmaceutical industry which is in a unique position to reap the benefits of increased sales, revenue and power by augmenting their technological capital.  One of the most effective methods to leverage this change is using social media, which leads us to the question:

Can social media be a game changer for pharma? Read More

5 Reasons Why Your Data Management System is Failing You

By | Data Management

 

Pharmaceutical companies are one of the major beneficiaries of emerging technologies.  From innovative ideas for developing new drugs to customer engagement, drug manufacturers are increasingly resorting to cutting edge digital technology to streamline business and improve efficiency.  Nowhere in pharma is the boom in technology more beneficial than in data management, an area where many drug companies struggle to organize and manage massive quantities of information.image illustrting the relationship between pharma and poor data management systems

As the regulatory landscape increases in complexity, the demand for improved 

data management and analytics will increase as well.  With all the new challenges that these trends create, digital data management is an innovation that pharma companies should have in their toolbox.

Below are the top five reasons that your current data management system is failing your company: Read More

Can Higher Drug Prices Lower Healthcare Costs?

By | Pharma Pricing, Pharma and Politics

Of course, if you can get the same medication for less, that is better, but what if switching to a newer more expensive drug actually saved money?  Recently I had the pleasure of moderating a panel at the Outsourced Pharma conference in Boston that was focused on cost and price pressures in the pharma industry. Based on the nodding heads in the audience, I think it is fair to say that our industry has an image problem.  While I cannot and will not try to defend some of the more recent high-profile cases that have garnered media attention, there is certainly a case to be made that not all pricing is gouging patients.Image showing the relationship between healthcare costs and pharma

Last week the Chicago Tribune highlighted a Blue Cross Report that squarely blames pharma companies for high drug prices.  According to the report, member plans spent 73 percent more on prescription drugs in 2016 than in 2010, attributed to “large year-over-year price increases” for new drugs that are protected from competition by patents.  in addition, the report highlighted the increase in consumer spending on drugs noting that consumers have been paying 3 percent more a year, out-of-pocket, for all prescription drugs but 18 percent more a year for patented drugs.”

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Cost vs Price: How Can You Maximize Value?

By | Data Management

Recently, in a forum setting, a panel discussion touched upon cost versus price and how best to address the potentially touchy issues of cost versus pricing. With recent consumer outrage over drug pricing and demands for cost controls, this is a hot button issue for both drug companies and the people they serve.
image showing the realtionship between cost and pricing in drug pricing 

A great deal of attention has been placed on the price of drugs; some have even called price increases gouging, but to paraphrase a panel commentator – ‘Beats’ headphones have margins on their products much hihger than pharma and nobody seems to care about that.”  Although this is a true statement, to be fair, nobody’s grandma has ever died without their “Beats.”  Perhaps there is a way to let grandma have her Beats AND her heart medication.  With that statement in mind let’s explore the top three ways to optimize both cost and pricing:  choosing the right CMO, maximizing communication, reducing errors and celebrating innovation.

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Patients: Pharma’s New Partners?

By | Data Management, Pharma Pricing

Value-based healthcare models have upended traditional patient care, becoming the wave of the future. How can pharma effectively ride this wave?

The pharmaceutical industry is facing rapid and comprehensive change, spearheaded by a new trend in consumerism, a move towards a value-based economy. This move puts the patients firmly in the driver’s seat and presents increased opportunities and challenges, requiring drug companies to work more closely with patients than ever before.image demonstrating relationship between patients and pharma  According to a recent report by PwC Health Research Institute, pharma’s new strategic partner may very well be patients.

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Standardizing Laboratory Data: Next Great Idea or Necessary Evil?

By | Data Management

A very close and trustworthy colleague in the industry has stated that the magic of the lab is the absolute random, disarray of work that leads to producing the best drugs.  The way that different pharma companies operate during the drug development process and the way they collect, analyze and distribute the data is unique to that company.image illustrating the effect of standardizing pharma and healthcare data

Result: The successful drugs we have today.

On the other hand, industry pressure, government regulations and financial responsibilities have pharma looking inward to see how changes in the drug development and manufacturing process can be streamlined and efficient.  A common answer to the problem of efficiency is standardization.  There are multiple benefits of standardized data:  better communication, savings of time and resources, ease of comparison and enhances collaboration between scientists and outside partners.  According to Nicola Tambascia of Clinipace, more regulatory agencies worldwide are beginning to require standardized data as part of the submission process. Read More

Direct to Consumer Pharma Marketing – Good or Bad?

By | Pharma and Politics

There are only two countries in the world that allow for the marketing of pharmaceutical products directly to potential patients, the United States and New Zealand.  One must wonder why, if it such a great idea, that it isn’t more commonly allowed.  Well maybe it isn’t such a good idea, or maybe there is a compromise.image showing the amount of information available through marketing

In 2015 US pharmaceutical companies spent 5.2 billion dollars on direct to consumer (DTC) marketing.  Proponents of DTC contend that the ads inform patients about diseases and possible treatments and encourage people to seek medical advice. Opponents contend that ads misinform patients, promote drugs before long-term safety profiles can be known and stigmatize normal conditions like wrinkles and low testosterone. Read More

Five Tips To Make Your Data Work For You

By | Data Management

 

“Scientists spend greater than 50 percent of their time searching for data that already exists.”

-Allotrope Foundation

Does your data have a purpose? If not, you may be missing an opportunity–or worse, wasting your time collecting random bits of information. Here are the top five tips to ensure that your data is working for you.image illustrating the importance of data management in pharma submissions

Integrity

Integrity is a key component of putting your data to good use.  Technology has improved exponentially over the years to allow for document organization, data management and overall informatics control.  Control is the key when it comes to data integrity.  The ability to control your data is fundamental in guaranteeing the integrity of your data; a critical component of regulatory submissions and documentation.  Choosing the right tools to control data is imperative.  Not all tools require validation, but a solution should have the ability to trace data for consistent recall for submission and filing purposes.  Control your data and it’s integrity, and you will save yourself untold amounts of time and headache when it’s time to submit your documents.

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Is the Patient the Most Difficult Aspect of Healthcare?

By | Uncategorized

 

The pharmaceutical and medical industries are in the business of saving lives.  As a scientist, there is little to compare to the satisfaction of knowing that you have contributed to advancement in the treatment of an illness affecting millions of people.  I imagine that physicians feel much the same way, and take great pride in their work when they have a positive impact on their patients.  There is no doubt that the correct diagnosis and effective treatment are essential to a patient’s survival and quality of life, and pharmaceutical companies and doctors work hand in hand in this regard.EKG trace with a heart

 

A large percentage of illness is directly caused by the choices of the patients themselves.  Statistics from the Center for Disease Control (CDC) support the idea that patient behavior is the single largest contributor to health.  According to the CDC, up to 40% of annual deaths from each of five leading U.S. causes are due to “modifiable risk factors.”  In addition, patients often do not understand or follow their doctor’s recommendations:  after leaving an appointment, 50% of patients do not know how to follow the instructions of their healthcare provider.  In case this seems like a problem with a new diagnosis, people with chronic conditions only take 50% of prescribed doses of medication.

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Data Integrity and the Increasing Complexity of Your Data

By | Data Management

In this day and age there are multiple organizations whose sole purposed is to collect, organize and interpret your data.  Data has never been more critical, and the use and interpretation of it become even more important every day.  But how can we capitalize on using every bit of our data to increase our output effectively?image emphasizing the importance of data integrity

To ensure safety and efficacy, any data associated with a pharmaceutical product must be “attributable, legitimate, contemporaneous, original, and accurate.”

-Darren Barrington-Light, Biopharm International

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Recent Opioid Deaths Not Driven By Legal Narcotics

By | medicine and law

Problems with Prescriptions

Recent restrictions on opioid prescriptions have attempted to stem the national tide of abuse and overdoses; two-thirds of the overdose deaths in the United States are related to opioids.  New Jersey just passed one of the nation’s strictest laws in efforts to address the crisis.  Multiple states have passed laws limiting opioid prescriptions and more states seem poised to follow suit.  Recently, President Trump created a commission headed by New Jersey’s Governor Christie to study the epidemic and suggest policy changes. Read More

Five Tips To Effectively Manage Drug Manufacturing Costs

By | Pharma Pricing, Cost Analysis

“OUR INDUSTRY IS POISED TO TRANSLATE OUR MOST PROMISING SCIENTIFIC BREAKTHROUGHS INTO MEANINGFUL TREATMENTS CAPABLE OF TACKLING THE MOST URGENT AND VEXING MEDICAL CHALLENGES OF OUR TIMES.  WE STAND COMMITTED TO DRIVING PROGRESS FOR PATIENTS TODAY – AND HOPE FOR TOMORROW.” – KENNETH C. FRAZIER, CHAIRMAN & CEO, MERCK

Inspirational words, and worthwhile goals to aspire to in manufacturing drugs to improve the lives of countless people.Somewhere in between the idea and the bottle of pills on the shelf, there is the process of manufacturing drugs and the costs associated with that endeavor.  With the increased scrutiny of the public in regards to the cost of drugs, keeping the cost of manufacturing controlled is more important than ever before. Read More

Want to Practice Medicine? Become a Lawyer

By | Pharma and Politics

Before you think I’m jaded, let me share a little perspective.  Some years ago I was an undergraduate, working as an Emergency Medical Technician in a rural emergency room, a bright-eyed aspiring doctor to be.  During a break in the action of a long night shift I was chatting with the MD and he asked me point blank “why do you want to be a doctor?”  I was caught by surprise, and I mumbled something about helping people in need–isn’t that the only real reason to go to medical school?image illustrating the relationship betwen medicine and legislation

The MD looked me straight in the eye and told me,

“if you want to practice medicine, go to law school.”

Life changes, as life has a way of doing, and I never attended medical school after all–I earned a graduate degree in chemistry and I am very happy with my choices.  But thinking back on that conversation, I think the doctor was right.

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