Don’t Let Fear Prevent You From Finding a Solution to a Problem

                               Photo by Aarón Blanco Tejedor on Unsplash



Have you ever been paralyzed by fear? How about experiencing anxiety (or fear) when tasked with a job at work to complete within a deadline? The latter question is probably the most relatable since it is the first question expressed in the context of work. Still, the point is has fear ever prevented you from finding a solution to a problem? I will share with you a situation that just happened which fits into the question at hand.

Instruments Break at the worst time possible

As I have mentioned before, I work at a university as an instrument manager in the Department of Chemistry. Which entails fixing instruments that are commonly found in forensic laboratories, pharmaceutical companies, and yes — on popular T.V. shows like “CSI: Crime Scene Investigation.”



The other day (last Thursday) I was called out to a laboratory class at the end of the day. An instrument was experiencing an issue. Usually, there is an easy solution to the problem I encountered. By this I mean, out of 100 times being called out for the specific problem, 95 times out of 100, the problem is usually solved by replacing a part which takes about 5 minutes to replace.



Next, is that the power to the instrument needs to be recycled. Which means to power the instrument down and restart the device. You would be surprised at the number of times that “recycling power” on the instrument is a solution to a problem. Unfortunately, the current problem demanded more of my attention. At the time, I thought, “Oh my goodness, this is going to be a problem that takes time to fix.”



At first, I thought, maybe if I shut down the instrument and restart the device in the morning, magically, the instrument will operate as usual, which is what I did leaving Thursday night. I returned on Friday morning and found that the instrument was still having the same problem. Damn — what now?



I should back up slightly and say that the laboratory class meets on every Tuesday and Thursday. There are less than 4 weeks left in the academic semester. And I need to find a solution fast to prevent students from not being able to finish their semester laboratory experiments. That means the professor teaching the laboratory will be ‘riding my rear end to fix the instrument every day’. Did I mention that one of the professors’ is my wife? The clock is ticking.



Anyways, Friday was a busy day. I assumed that I would have a chance to call the instrument company and ask for ‘technical support’ over the phone at some point during the day. Not a chance. Meanwhile, my stress is building up — knowing that next Tuesday (today) is coming around quickly with no solution in sight. At the same time, I was glad because I was super fearful that the problem would be too difficult for me to fix. Therefore, I enjoyed a great weekend and did not (at least try not to) think of the problem yet to be faced with a deadline — Tuesday.



Monday rolls around and I have to help another student with an experiment on a different instrument — which requires my constant monitoring. My colleague offers to look at the instrument while I am running an analysis. To no avail, she cannot find the solution either. Now I am stressing — since the next day is today — Tuesday and the class needs a working instrument.



I finally call the company at 3 pm on Monday. Why so late? Because of fear of failure. I talked to technical support which informed me that I would have to dig deeper into the instrument and clean internal parts. Otherwise, the next option was to spend $8000 to get the problem looked at. By now, the stress has reached a new height. Anxiety is building. What am I going to do?



Tuesday (today) comes around, and I decide to repeat the following statement to myself before going to work: “I am going to go in there and take apart the instrument. If I fail, at least I can say that I tried.”



I asked my wife: “Why didn’t you tell me the instrument was broken?”


She responded: “I knew that you were aware of the state of the instrument. And that you already put an unnecessarily large amount of stress on yourself. The last that you need is for me to stress you out further.”



What a wonderful wife I had. I informed her that she may not get to use the instrument since I was going to take it apart in the morning. She was alright with that possible outcome.

A Solution is Found — Easily

I went into work today and gathered up the tools to take the instrument apart. First, I turned the device off. Since the area in which I was going to be working was heated to around 250 Celcius. After letting the instrument cool down, I went to dig in. As I turned the first wrench, I found that a nut was loose. WOW. At first, I could not believe the information which my hand was sending me. I tried to loosen the nut again and found no resistance. Then, I tightened the nut and smiled at my colleague — hoping that the solution was that simple. Indeed it was. Simply by tightening a nut on a screw, the problem was fixed.



After stressing out over the last few days about the instrument being broken, I realized that taking action could have relieved my stress much sooner. But no. I was scared that I might not be able to fix the instrument. Therefore, I decided that putting off the inevitable was more manageable than tackling the problem to find a solution. How crazy is that?



Anxiety is real. Fear is real. The thought of solving a problem and failing is real too. Although, if no action is taken, then no solution is going to be found ever. Furthermore, part of life is failing. Failing sometimes promotes humbleness and shows us how to solve problems in a faster manner. If I fail, then calling the instrument company can sometimes shorten the ‘down-time’ of the instrument by discussing the problem with a technical engineer. By ‘down-time’ — I mean the time that an instrument lays broken and unable to be used by a student or faculty member.



By deciding to take action, the problem was solved much more quickly than I had imagined. The students were able to use the instrument during their normal laboratory meeting. My wife — one of the professors — was happy. Life is good, right? Yes and no. I learned a lesson that I continuously have to keep learning. Don’t let fear or anxiety prevent me from solving a problem.



When a problem is encountered in our lives, each of us should take action. Sitting around worrying only causes negative feelings/moods and is destructive toward our physiological health. Working toward a solution produces much less anxiety compared to sitting around and worrying about not taking action. Take action — don’t sit around worrying.



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My Husband Has Parkinson's Disease; I Can Smell It On Him!

Photo: Image by LawrenceLeeArt from Pixabay

A wife and her husband enter the doctor's examining room and sit quietly waiting for the doctor to arrive. Upon arrival, the physician asks nicely: "What can I help you with today?" To that the wife responds "Doctor, my husband has Parkinson's Disease; I can smell it on him" and stops talking abruptly after that. How is that for a self-diagnosis or diagnosis by Spouse?



The story did not precisely follow that flow, but researchers were able to confirm a wife's suspicion of being able to smell the presence of Parkinson's disease on her husband. Having that ability landed her in the study labeled as "super smeller." Researchers describe her ability in the study, published in ACS Central Science, as "Joy has an extremely sensitive sense of smell, and this enables her to detect and discriminate odors not normally detected by those of average olfactory ability." When the sebaceous glands in the upper back and forehead overproduce sebum (a waxy, lipid-rich) biofluid, a process known as seborrhea, the overproduction is associated with the non-motor symptom of Parkinson's Disorder.



Who would have known had Joy not been born and honed in on a very particular smell on emanating on her husband? Joy started realizing that the 'musky' odor was not unique to just her husband while attending Parkinson's Disease patient support groups. That is when she made the connection between the smell and Parkinson's Disease.



The study was conducted with 64 participants: 42 Parkinson's Disease Patients and 21 Control Patients. The patients were chosen from across 23 different geographical areas across the UK. The analysis went as follows: Patients were swabbed across their backs and foreheads to collect the sebum. The sample (sebum in gauze) was introduced into a Gas Chromatography-Mass Spectrometer (GC-MS). The GC-MS in our chemistry department is shown below:

Photo: Kayla Kaiser - FLCKR

The Gas Chromatography-Mass Spectrometer has two main components to the instrument. First is an oven in which a long column around 100 meters in length as shown below:

Photo: Kayla Kaiser - Flickr

In the images above, the column which is around 100 meters in length sits inside of an oven.  A sample (of a chemical mixture or single chemical) is injected into the column shown in the image above.  As the substances travel down the column, the mixture starts to separate into individual compounds based on their weights.  The heavier chemicals tend to fall behind, whereas the lighter chemicals start to progress ahead.  Time spent inside of the column allows separation of a chemical mixture based on properties such as mass.



As the mixture heads toward the end of the column, the next (second component) to the GC-MS is encountered, which is the Mass Analyzer.  The Mass Analyzer portion is to the left of the oven in the first image and is shown below:

The second component of the GC-MS instrument is the Mass Analyzer as shown above.   The GC-MS instrument has a Mass Analyzer which detects different masses of chemicals by breaking them down into ion fragments. The instrument software can then determine the molecular weight of a given chemical structure by analyzing the pieces which flow off of the separating column.  A typical chromatogram of a mixture of chemicals is shown below:

An example chromatogram generated by a CSUN student for the blog post.  Photo: Kayla Kaiser - Flickr

The study revealed the molecules present in Parkinson's Disease patients from the use of a similar GC-MS instrument.  From this instrument, the researchers were able to detect, identify, and quantify the following chemicals associated with Parkinson's Disease: eicosane, hippuric acid, and octodecanal were present in significant concentrations.


Whereas, other chemicals, such as perillic aldehyde were present in smaller amounts in patients with Parkinson's Disease. Joy was able to detect the differences in concentrations which led her to believe that these differences in odor were associated with the onset of Parkinson's Disease.



The study highlights the use of biomarkers (chemicals) as a non-invasive detection method of diseases such as Parkinson's Disease.  Joy has challenged scientific researchers to expand their arsenal of detection methods with her unique ability to act as a "Super Smeller."  Future plans include the use of canines as additional detectors of disease.  The present research has opened up new mechanisms by which Parkinson's Disease afflicts the human body. 



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"Just Make A Generic (Cheaper Version) Of The Drug"? Not So Easy...

Source: Kansas City Business Journal

The cost of prescription medications is among the most contested political issues right up there with the associated cost of health insurance.  Anytime health insurance is mentioned, just wait -- a discussion is about to unfold linking that to the cost of prescription medications.  Why are medicines so expensive?  Simple answer: the cost of bringing a new drug to market is around $1 billion along with around 20 years of research/approval process.  What?  Yes.  If you happen to have $1 billion laying around, then you too can create a new medication.  Well, not really.  But in theory (based only on cost).



With this being known, why are generic medications cheaper?  Further, why are generic medications not sought out sooner (i.e. released to marketplace sooner)?  The answer to the second question is that the first medication (the expensive) one has 'ownership rights' -- patent rights -- for a given number of years.  As to why after the patent expires, the generic medication cannot be rolled out sooner -- ask the Food and Drug Administration commissioner.  FDA Commissioner just resigned.  Although, before he resigned, he managed among other many changes to leave a public statement regarding the status of expanding access to generic medications.  Included in the statement are the reasons/parameters which are considered or serve as obstacles to the roll-out of generic medications.  These considerations might clarify for the public the complicated generic drug landscape.



Below is the statement taken from the FDA website on expansion of 'generic medications' into the marketplace:

As part of the FDA’s efforts to promote drug competition and patient access, we’ve advanced many policies aimed at making it more efficient to bring generic competition to the market. We’ve been especially focused on a category of medicines known as complex drugs. These are drugs that, by nature of their formulation, delivery systems or the complexity of their active ingredients, for example, are harder to “genericize” under traditional approaches. As a result, these complex drugs often face less competition.

As a category, there are a number of complex drugs that are no longer protected by patents or exclusivities that would forestall generic approval, yet they continue to face no generic competition owing to the difficulty of developing generics. The agency has advanced many new policies to help promote generic competition to complex medicines once patents and exclusivities have lapsed, and we’re planning additional policy steps in 2019.

To understand the challenges posed by complex generics, we need to go back to the pathway developed in 1984 under the Hatch-Waxman Amendments. This legislation put into place the framework for generic drug review at a time when brand drugs were often simple small molecules requiring straightforward and reproducible manufacturing processes. They were generally easy to characterize and evaluate through traditional methods, including human bioequivalence studies. In many cases, a drug’s activity correlated directly with how quickly it got into the bloodstream and how long the drug stayed in the body, so it could have its intended effect on the anticipated site of action.

In contrast, complex drugs involve cases where the drug is often harder to develop and manufacture because it has a complex formulation or complex active ingredient. In other cases, the drug acts locally on the tissue rather than through the concentration in the blood. This includes, for example, inhaled drugs that act directly on the lungs, a topical patch that is activated directly on the skin, or eye drops that act on the surface of the eyes. The therapeutic effect of these types of drugs does not necessarily correlate directly to the amount of drug in the blood, or it can be difficult to measure through the blood. They can raise other issues that make the traditional, metrics generally used to develop generic drugs harder to employ. In other words, it can be more difficult to meet the standards for generic approval.

In 2019, we’ll advance additional policies to promote generic competition for complex drugs. Among other steps, we intend to issue additional guidance documents for developing specific complex generic drugs, as well as address categories of complex drugs that are hard to copy because of their complex formulation or mode of delivery. This will include the publication of a series of guidances to address regulatory and scientific challenges that make it generally more difficult to develop complex generics. As part of this, we intend to issue draft guidance with recommendations on establishing active ingredient sameness. In addition, we’re going to help advance the development of new analytical tools and in vitro tests that may provide additional accurate, sensitive and reproducible tools to support approval of complex generic drugs. Better tools can reduce complex generic drug development time and cost and can inform regulatory decisions.

These are just some of the new steps that we’re going to be taking in 2019 to promote access to complex generic medicines.

These new policy efforts are aimed at ensuring that we provide as much scientific and regulatory clarity as possible with respect to complex generic drugs. This focus is critical because, first and foremost, these drug products provide important therapies to patients. We believe that they’re also becoming increasingly important to the economic stability of the generic drug industry. Being able to “genericize” a complex medicine can be a high-value opportunity for a generic drug developer.

Addressing the challenges related to complex generics, and promoting more generic competition to these medicines, is a key part of our Drug Competition Action Plan, and the agency’s efforts to promote patient access and more affordable medicines.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

The generic drug approval process seems to have changed over the last few decades with the development of new types of medications.  Traditional routes of administration have changed.  Which is to say, become much more specific (precision medicine).  This change has caused an uproar among approval authority.  Old medicines use old approval processes.  New medicines require new approval processes.  Precision medicine will ultimately speed up the approval process by causing federal agencies such as the Food and Drug Administration (FDA) along with the National Institutes of Health (NIH) and the Department of Health and Human Services (HHS) to update review/approval/funding processes.



Currently, these changes are under consideration by federal agencies.  Recently, FDA Commissioner Scott Gottlieb gave an outgoing interview with the journal 'Politico' -- which is embedded below:





Ultimately, the new landscape brought about by changes in medicine along with the collection of medical data (All of Us - NIH trial) will result in better medical practices for the public.  Stay tuned, the future is exciting.





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Update: On FDA's Policy Agenda For Combatting Opioid Crisis

Source: Politico

Last week, news broke that the current Commissioner of the Food and Drug Administration -- Commissioner Dr. Scott Gottlieb was leaving surprised everyone around Washington D.C.   Commissioner Scott Gottlieb has done wonderful work on very difficult problems facing our society, including Food Safety, Cosmetics Safety, expanding access to medication, and the largest plague of all -- Opioid epidemic facing the United States of America right now.  Under his command, the FDA has started to come up with an action plan on the opioid crisis -- which can be found here.  The web page on the FDA website for opioids is more informative and easier to navigate -- check it out here.



He also has given his perspective on the growing opioid problem through official outlets (Twitter, Facebook, etc.) along with official statements on the problem like that below.  The statement below represents the most recent -- Feb. 26th and his last before he leaves office.  Although, the statement gives the public a good future guide into the routes of a solution which the FDA will pursue into the next few years.



With that in mind, here is the update taken from the FDA website directly shown below:

The opioid crisis is one of the largest and most complex public health tragedies that our nation has ever faced. It remains the biggest public health crisis facing the FDA. The toll of addiction, in lost lives and broken families, touches every community in America. Sadly, the scope of the epidemic reflects many past mistakes and many parties who missed opportunities to stem the crisis, including the FDA.

At the FDA, we’ve worked to learn from past mistakes, and we intend to make sure that we’re acting forcefully enough to address new threats that could extend this crisis. Addressing the opioid crisis is a top priority of the Secretary of Health and Human Services and the entire Administration. The FDA is a key part of that effort.

We’re a deliberative, science-based agency. We calibrate our policy and regulatory actions carefully, based on rigorous evidence that can often take many months and even years to collect. This defines our gold standard for regulatory decisions. But given the scope of this crisis, and its human toll, we’ve committed to act more quickly as we confront new risks. We’ve changed our approach and are taking a much more aggressive approach to regulatory action. At the FDA, we’ve committed to taking more rapid action in the face of new threats, like the growing prevalence of illicit fentanyl that’s contributing to overdose deaths, or the continued prevalence of prescriptions being written for durations of use that are too long for the clinical circumstances for which they’re intended. We’ve changed the way we’re tackling these issues and stepped up our intervention when it comes to opioids. In this epidemic, waiting for the accumulation of definitive evidence of harm left us a step behind a crisis that was evolving quickly, and sometimes furtively, in vulnerable communities that were too often being tragically ignored.

To address this crisis differently, and more definitively, we’ve taken decisive steps in recent years, and have additional actions already underway for 2019, with more steps planned to begin this year.

We’re committed to getting ahead of this crisis. We don’t want to look back five years from now, at an even larger crisis, with regret that there were more aggressive steps that we could have taken sooner. All options are on the table. Addressing this crisis is one of the FDA’s top public health priorities. With this statement, I want to assess some of the steps we’ve taken and outline the new actions we’ll be pursuing.

FDA Actions in 2018

Prescribers have a critical role to play, and we must make sure they have essential information about opioids through drug labeling. In the fall, we expanded the extended-release and long-acting (ER/LA) opioid analgesics Risk Evaluation and Mitigation Strategy (REMS) requirements to the immediate-release (IR) opioid analgesics intended for use in an outpatient setting. We’ve also updated the boxed warnings in the labeling for these products to include information about the REMS.

The REMS program was also expanded to require, for the first time, that training be made available to all health care providers, including nurses and pharmacists, who are involved in the management of patients with pain (in addition to doctors who prescribe these products). The content of the education was also broadened to cover information about acute and chronic pain management, safe use of opioids or other non-opioid or non-drug treatments, and material on addiction medicine and opioid use disorders.

The FDA also developed new solutions to address the unique risks of opioids in conjunction with our request for the market withdrawal of Opana ER in 2017. We will, as needed, continue to take strong regulatory steps to seek to limit or curtail access to certain drugs, based on formally assessing the risks associated with illicit use, as we did in the case of Opana ER with the risk of intravenous abuse. As part of our effort to consider the risks associated with the illicit use of opioids as one component of how we assess the overall risk and benefit of these medicines, we also worked with Congress to secure explicit authority to take action, as needed, on the basis of a consideration of these risks. This authority was included in the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. In 2018 we also opened a dialogue around the potential for evaluating the comparative benefits and risks of new opioids relative to other opioids already on the market. Going forward we’ve raised the question of whether there should be such a standard for new opioid approvals to offer some advantage over the existing armamentarium. We raised this question in the context of the approval of the sufentanil product Dsuvia. We plan continue to evaluate this concept in questions that we’ll ask as part of a public docket alongside a draft guidance document that we’ll be issuing to modernize the FDA’s framework for assessing the risks and benefits of opioid drugs.

To reduce the rate of new addiction we need to reduce exposure to opioids. This means rationalizing prescribing, which in turn means that not only must we take steps to make sure fewer prescriptions for opioids are written, but also that when these drugs are prescribed, it’s for a dose and duration of use that comports closely with the clinical circumstance and the medical need of the patient. This means no more 30 tablet prescriptions for a tooth extraction. To pursue these public health goals, we’re working with stakeholders like the National Academies of Science, Engineering, and Medicine to create a scientific framework for developing evidence-based prescribing guidelines that provide specific recommendations on the proper dosing and dispensing of opioids based on specific clinical indications (like outpatient surgeries).

This will help support evidence-based guidelines in areas where they do not currently exist. This report will be ready at the end of 2019. We’re also conducting a review of data from product applications, in collaboration with an academic partner, to identify where adequate evidence exists to inform new guidelines. We believe there are clinical circumstances where there’s already adequate evidence to create evidence-based prescribing recommendations, and we’ll pursue the development of these guidelines.

In 2018, the FDA also continued work with other federal and state partners on numerous other changes started over the past several years to achieve more appropriate prescribing. Rationalizing prescribing practices by providers remains a cornerstone of our effort to reduce the rate of new addiction. And reducing the rate of new addiction is a key element of our overall approach to address this crisis. These combined actions across many federal, state, and professional entities are having an impact. Since 2015, the estimated number of opioid analgesic prescriptions dispensed from U.S. outpatient retail pharmacies (which may be the most vulnerable to abuse or diversion of prescription products) have fallen by 24 percent. Notably, prescriptions of higher strength opioids (90+ morphine milligram equivalents/unit) have fallen even more steeply since 2015, accounting for less than 1 percent of all opioid analgesic units (e.g., tablets) dispensed in 2018.

Although the appropriate use of opioids from prescription claims data cannot be determined, the risk of overdose has been shown to be intertwined with increasing dose and duration of opioid analgesic use. Overall, the estimated total number of opioid analgesic prescriptions peaked in 2012, to 260 million prescriptions from 145 million in 1997. The estimated total morphine milligram equivalents (MMEs) per prescription peaked in 2010, at 950 MMEs, before falling to 905 MMEs in 2015. However, the rate of overdose death continues to increase. This is due in part to the increasing abuse of potent adulterated or illicitly manufactured fentanyl products purchased through online channels and sold as street drugs.

As the opioid crisis has evolved, so has the nature of the threat. Opioids are still too commonly prescribed and lawful prescriptions still contribute to the development of new cases of addiction. But illicit opioids are accounting for a sharply increasing fraction of the total exposure to these drugs, and fueling a growing addiction crisis. Within the scope of our work, we’re especially focused on illicit online purchases. The flow of drugs on the surface and dark web has become a significant part of the epidemic relative to prescription opioids. To address the evolving nature of this threat, since 2017, we’ve warned a total of 23 networks operating more than 450 websites for illegally marketing potentially dangerous, unapproved, and misbranded versions of opioid medications, including tramadol and oxycodone. Cutting off this illicit internet traffic is critical. We’ll continue to pursue all available means of enforcement to stop these online drug dealers.

In 2018 we also took actions to increase our interdiction work in the International Mail Facilities (IMFs). Specifically, as the nature of this epidemic has evolved to encompass greater flows and use of illicit opioid drugs, we’ve expanded our enforcement efforts to include increased interdiction work aimed at stopping the illegal flow of counterfeit and unapproved prescription drugs, which in numerous cases includes opioids.

The FDA expanded the capacity of import operations, made significant investments in our Office of Criminal Investigations, and our laboratories, including our Forensic Chemistry Center. These are important investments to help us identify and stop illegal drugs seeking to enter the U.S. including through the IMFs.

Over the last two months, the Office of Regulatory Affairs (ORA) and the Center for Drug Evaluation and Research (CDER) have made significant progress to stop the activities of sophisticated bad actors who attempt to evade FDA enforcement at the border.

Among these new steps, we’re pleased to report that we’re implementing one of the new authorities in Section 3022 of the SUPPORT Act related to restricting entrance of illicit articles containing active pharmaceutical ingredients (APIs). This new authority (new section 801(u) of the Federal Food, Drug and Cosmetic Act) allows the FDA to treat illegal imported articles as drugs when they meet certain requirements—and stop them as needed—even in the absence of certain evidence of intended use. ORA has updated its IMF procedures to support implementation of this new authority to help prevent illegal drugs from entering our country. We’re also working on new tools to identify analogues of APIs that present s significant public health concern, to make sure that this important new enforcement tool against illicit drugs has its intended effect. The FDA will begin applying the new 801(u) authority to any imported product entering the U.S. via international mail which is labeled to be or contains, or is found through laboratory analysis to be or contains, any of the ingredients identified as presenting a significant public health concern. These new steps will make our operations in the IMFs more efficient and allow us to improve our interdiction work.

By supporting appropriate opioid prescribing, education, and labeling we’re reducing excess quantities of opioid analgesics available for abuse or diversion and helping to reduce the rate of new addictions from prescribed opioids. By strengthening our enforcement and inspections of packages purchased online and entering the U.S. from abroad, we’re helping to staunch the trafficking of even more powerful and deadly drugs (like illegal Chinese fentanyl) and address the changing nature of this crisis. By increasing the accessibility of medication-assisted treatment (MAT), and reducing stigma associated with it, we’re helping those struggling with addiction to return to lives of sobriety in their communities with dignity.

These are just some of the domains that we’re working across as we address this crisis using all of our tools and authorities. We know we must treat opioids very differently than other drug classes, and Congress has supported us in that effort by granting us very specific new authorities related to opioids.

FDA Actions in 2019

These are just some of the steps that we took in 2018 to address this crisis. In 2019, we plan on taking new actions to build on these efforts, and also adapt our response to confront the changing nature of the threat. We’ll continue to aggressively and compassionately pursue new efforts to address this tragedy.

Reducing Misuse and Abuse of Opioid Drugs

The FDA continues to have a critical and unique role to play in preventing cases of new opioid addiction – helping to reduce avoidable exposure to opioid analgesics and thereby reduce the rate of new addiction.

We’re taking new steps to reduce exposure to opioid analgesics by helping to ensure that these drugs are appropriately prescribed, with dose, quantity and treatment durations that match the indication. Passage of the SUPPORT Act has provided the FDA with important new authorities to assist in our effort to reduce the risk of addiction and misuse associated with opioid analgesics. For example, the new law allows the FDA to require certain packaging be made available for opioids and other drugs that pose a serious risk of abuse or overdose if the FDA determines that such packaging may mitigate such risks. We plan to implement the initial steps to require unit of dose packaging in the first half of 2019. Specifically, the FDA is considering use of this new authority to mandate that certain solid, oral dosage forms of immediate-release formulations of opioid analgesics indicated for treatment of acute pain be made available in short-duration packaging for outpatient dispensing. Such packaging could reduce over-prescribing by giving providers a convenient option that contains only enough drug doses for up to a few days of opioid treatment at standard dosing. Our data suggests that for many acute pain indications where opioids are used, a day or two of dispensed drug is the appropriate quantity. Small quantities in blister packaging, that comport with evidence demonstrating that a day or two of medication is sufficient, could reduce the overall amount of dispensed drugs available for misuse, abuse, and diversion.

The SUPPORT Act also allows the FDA to require manufacturers to develop disposal technologies (such as a mail-back pouches) to get unused medications out of medicine cabinets. This is another new authority that we’re prioritizing for work in the first half of 2019.

We’re also taking new steps to consider a framework to allow us to formally evaluate each candidate opioid in the context of how a novel opioid might fit into the overall therapeutic armamentarium that’s available to patients and providers, and address the question we’re frequently asked as to whether new opioid drugs should offer some comparative benefit over existing drugs. This process could include seeking revisions to statutory authorities to allow us to change the weight we give to meaningful therapeutic differentiation for proposed new opioids, including relative safety or effectiveness advantages over existing treatments.

We also plan to pursue new efforts to continue to evaluate the effectiveness of REMS programs for opioid products, including methods for data collection and assessment tools. Recently, we’ve heard concerns around the REMS program associated with one class of opioid products, transmucosal immediate-release fentanyl (TIRF) medicines, and whether the REMS program is working as intended. This is a topic that was raised by the FDA as the focus of an August 2018 public advisory committee meeting.

These products are medically important for a specific group of patients experiencing breakthrough pain that may not be managed by their around-the-clock opioid pain medicine. But these medicines also pose serious risks. That’s why the agency has sought to ensure that the TIRF REMS program is achieving its public health goal of assuring safe use and mitigating the risks of misuse, abuse, addiction, overdose, and complications due to medication errors. The agency has been actively assessing the recommendations of our advisory committee on the effectiveness of the REMS and necessary changes. Based on these recommendations, and our analysis of our own data, the FDA will soon share next steps, including modifications intended to strengthen the current TIRF REMS. The prescribing of the TIRF products has decreased dramatically from peak years in 2014 and 2015. Nonetheless, substantial risks remain if these powerful drugs are not used properly and in appropriately indicated patients. The goal of the changes we will make to the TIRF REMS programs will be to make sure the program is working to mitigate the known risks of these medicines and that these drugs are being prescribed only to opioid-tolerant patients, and that those patients understand the risks and how to use TIRF medicines safely.

Support Addiction Recovery and Reduce Overdose Deaths

To help those suffering from opioid use disorder, the FDA is prioritizing new efforts to advance the development and use of safe and effective MAT. This includes new guidance aimed at supporting the development of novel medicines as well as novel medical devices such as digital health tools, advancing new policies to promote the adoption of safe and effective MAT, and working with partner organizations/stakeholders to reduce the stigma associated with MAT.

Reducing overdose deaths also requires broadening the availability of naloxone. One potential way to improve access to naloxone is to make it available for over-the-counter (OTC) sale. FDA-approved versions of naloxone currently require a prescription, which may be a barrier for people who aren’t under the care of a physician or may fear a stigma associated with seeking access to the medicine or are fearful of admitting to issues with substance abuse. Having naloxone widely available, for example as an FDA-approved OTC product, would be an important public health advance, and a need that we’ve been working on at the FDA.

To encourage naloxone manufacturers to enter the OTC market, the FDA took an unprecedented step of developing a model Drug Facts Labels (DFL) with easy-to-understand pictograms on how to use the drug. We proactively designed, tested and validated the key labeling requirements necessary to approve an OTC version of naloxone and make it available to patients. These steps put into the public domain much of the regulatory work needed to take naloxone OTC. One of the key components for OTC availability is now in place so that sponsors can use it to obtain approval for OTC naloxone and increase its access. These efforts should jumpstart development of OTC naloxone and promote wider access to this medicine. This year we are seeking to work with industry partners who are interested in developing these OTC naloxone products.

Research and Innovation in Non-Addictive Pain Treatments

Another critical part of our efforts for 2019 is new steps to promote the development of drugs to treat pain that are not addictive. To advance these goals, in 2019, we’ll be issuing updated guidance outlining the appropriate clinical endpoints and clinical trial approaches for the development of non-opioid drugs for use in the treatment of acute and chronic pain. We’ll also advance new steps to promote the development of abuse-deterrent formulations of opioids by exploring new methods for analyzing and evaluating abuse-deterrent features; further evaluating the nomenclature used to describe these abuse-deterrent features; and facilitating development of science for generic versions of these products.

Strengthen Enforcement Against Illicit Opioids

The FDA will continue to strengthen its enforcement activities that target those who unlawfully market or distribute illicit opioids and other unapproved drugs. We’ll step up our efforts aimed at the interdiction of opioids being illegally shipped into the United States and will continue to increase the number of investigators, both civil and criminal, in the IMFs.

Among other new steps we’ll take in 2019, the FDA is working in partnership with U.S. Customs and Border Protection (CBP) to expand information sharing and maximize each agency’s inspection and detection capabilities at the border to protect the public from illegal and potentially harmful products entering the U.S. This includes real-time sharing of data obtained by scientists using field-based screening tools to test samples that are seized at the IMFs and at the border. We’re working closely with our partners at CBP in this program.

Right now, seizures of opioids like fentanyl are typically reported in pounds of drug product seized. But that doesn’t give a full picture of the total amount of drugs that are being illegally shipped into the U.S. because these weight-based measures don’t account for potency. Some of the drugs being illegally brought into the U.S. may consist of fentanyl premixes ready for pressing into tablets, while others are super-potent formulations of compounds like fentanyl. By additional testing to develop a chemical profile of more seized samples, we can develop a better picture of the illicit drug trafficking landscape, which can better inform our policy work.

We’re also going to be expanding our collaboration with internet stakeholders to crack down on illicit drugs sold online. In April, we’re also planning our second Online Opioid Summit. The first Online Opioid Summit held last June initiated an open and candid dialogue with key internet stakeholders to discuss ways to take robust action to reduce the availability of opioids online. Since the initial Summit was announced, internet stakeholders have taken concrete steps to prevent the illegal sale of opioids through their platforms and services. Important actions came about as a result of this collaborative dialogue with key stakeholders.

For example, Google now deindexes websites based on our warning letters that cite the unlawful sale of opioids to U.S. consumers. Social media platforms such as Facebook and Instagram redirect users who are looking to buy opioids online to the Substance Abuse and Mental Health Service Administration National Helpline. We look forward to the second Online Opioid Summit to build on these efforts with additional, innovative steps to protect the public from opioids that are illegally being sold via the internet.

As part of the 2019 budget, the FDA also received $20 million to create a large-scale data warehouse to improve our analytic capabilities to better evaluate social and clinical trends that are affecting the trajectory of the opioid crisis. This warehouse can facilitate data analytics, including machine learning algorithms, to help better assess vulnerability points in the population through predictive analytics, identify early trends that may be contributing to the epidemic, and target early regulatory changes to address the changing opioid epidemic.

Finally, as part of our effort to clamp down on illicit sales of opioids – which includes our work to close down illegal portals on the internet and expand our presence in the IMFs – we’re also doing more to secure the legitimate supply chain. This means doing more to hold distributors responsible for securing the drug supply chain. As part of this effort, we recently announced that the FDA issued its first warning letter under the Drug Supply Chain Security Act (DSCSA) to McKesson Corp. for violations highlighted by a concerning tampering incident that involved opioid medications. Under the DSCSA, manufacturers, repackagers, wholesale distributors and dispensers – which are mainly pharmacies – are all required to have systems and processes in place to quarantine and investigate suspect and illegitimate medications. These systems must be in place to respond rapidly to notifications of illegitimate products and to notify trading partners and the FDA when illegitimate products are discovered. The warning letter to McKesson outlines violations observed during inspections that took place this past summer, including failing to: sufficiently respond to notifications that there was illegitimate product in their supply chain; quarantine and investigate suspect products; and maintain records of investigations of suspect product and disposition of illegitimate product as the law requires. This action is part of a broader policy effort to improve the security of the drug supply chain and prevent diversion of opioids. We’ll continue efforts to ensure manufacturers, repackagers, wholesale distributors, dispensers and others responsible for maintaining the supply chain are taking measurable steps under the law to appropriately track and trace opioid medications as these products move through the supply chain, and to respond to incidents involving illegitimate products to protect the public health.

These are just some of the new steps we’ll advance in 2019 as we continue to confront this crisis. Looking back across modern times, this is perhaps the biggest public health tragedy ever created through the deliberate actions of people. The opioid crisis took hold over the course of decades of action and inaction. Now, its scope is so large, and so devastating, its toll is self-evident. It will, unfortunately, take years of aggressive action to reverse its course for good. We won’t lose our focus on this fight.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

The opioid problem has expanded in scope along with the multiple avenues by which to treat it.  There is no 'one size' fits all approach.  As stated above the statement, education needs to be done at all levels of an organization starting with the top and working down to the orderly on a given ward.  If everyone understands the problem from their perspective, then there will be that many more tests, examination/inspections done to ensure that the emerging problem is being dealt with at various levels in various manners.



The FDA is not the only soldier in the fight.  Other federal organizations like the National Institutes of Health are funding studies to learn how to better treat chronic pain while reducing addiction to pain treatment.  Specifically, the National Institute on Drug Abuse (NIDA) has a wonderful and easily navigable web page -- click here -- with descriptions of the problems facing society around opioids, types, and videos to give a comprehensive perspective on both the problem and possible solutions to the growing crisis.



Regardless of the organization, there will always exists bureaucratic obstacles toward implementing solutions quickly on the local level.  Therefore, the crucial soldiers in the fight are of three classes: (1) health care workers (2) family and (3) community.  When healthcare workers are involved in treating/finding a solution to the opioid crisis, usually that occurs after person or persons from their communities have landed in their care in the hospital.  But as we all know, the problem started way before this.  Which is why the last two classes of people are extremely important.  Community members can help take care of the community.



If drug use is an issue, then form community groups to watch out and combat the problem.  Don't accept that the problem has to be the normal condition.  Of course, that is easier said than done.  Retaliation is a big problem -- the drug trade pays well.  Family members can offer support/care by helping their respective family members suffering from opioid addiction.



Last but not least, even though the last effort is the healthcare staff -- when the overdose patient arrives at the hospital with a critical need for care.  How the healthcare staff responds to the needs to patients who have chronic pain will determine the long term consequence of the opioid crisis.  If there is a genuine need to treat chronic pain with powerful medications, then so be it.  But the chronic pain needs of patients lay across a wide spectrum of treatment.  Which still can be optimized with new medical techniques and technology which is being developed as we speak.



The FDA will miss Commissioner Scott Gottlieb's direction after he leaves.  He has pushed the needle of progress forward on a variety of issues thus far.  He should be commended for his service.  Hopefully the remaining staff at the FDA continue to push progress on the listed agenda items in the introductory paragraphs along with the issues mentioned in the statement above from the FDA website.  There is certainly enough that the FDA can do to protect society moving forward.



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Study Shows Eating Organic Produce (Pesticide Free) Reduces Exposure To Pesticides After One Week?

Source: Food Revolution

The food revolution is steering people toward purchasing food from locally sourced food which is typically labeled as "organic."  Implied in the purchase is that the "organic" label means that the produce was grown without using pesticides.  Activists have long since been shouting about pesticide exposure due to eating non-organic produce.  A new study out of the Journal "Environment Research" provides evidence of exposure in question.



I ran across the study (linked) in an article from the website "Friends of the Earth" titled "New study: Pesticide levels in children and adults drop dramatically after one week of eating organic" briefly explaining the finding:

WASHINGTON, D.C. – A groundbreaking peer-reviewed study published today in the journal Environmental Research found that switching to an organic diet significantly reduced the levels of synthetic pesticides found in all participants – after less than one week. On average, the pesticide and pesticide metabolite levels detected dropped by 60.5% after just six days of eating an all-organic diet.

The study, Organic Diet Intervention Significantly Reduces Urinary Pesticide Levels in U.S. Children and Adults, found significant reductions in pesticides that have been associated with increased risk of autism, cancers, autoimmune disorders, infertility, hormone disruption, and Alzheimer’s and Parkinson’s diseases. The most significant declines involved organophosphates, a class of highly neurotoxic pesticides linked to brain damage in children: the study found a 95% drop in levels of malathion and a nearly two thirds reduction in chlorpyrifos. Organophosphates are so toxic to children’s developing brains that scientists have recommended a full ban.

 The participants of the study were four families from diverse areas across the United States.  Study participants were given a controlled diet of organic food for six days straight while being monitored by urinalysis.  The key findings of the study are shown below:

(1) A 61% drop in chlorpyrifos, a neurotoxic pesticide known to damage children’s developing brains. Exposure is associated with increased risk of autism, learning disabilities, ADHD, and IQ loss.

(2) A 95% drop in malathion, another neurotoxic organophosphate pesticide and a probable human carcinogen according to the World Health Organization.

(3) A 83% drop in clothianidin, a neonicotinoid pesticide. Neonicotinoids are associated with endocrine disruption and changes in behavior and attention, including an association with autism spectrum disorder. Neonicotinoids are also a main driver of massive pollinator and insect losses, leading scientist to warn of a “second silent spring.”

(4) A 43-57% drop in pyrethroids, a class of pesticides associated with endocrine disruption and adverse neurodevelopmental, immunological and reproductive effects.

(5) A 37% drop in 2,4-D, one of two ingredients in Agent Orange. 2,4-D is among the top five most commonly used pesticides in the U.S. and is associated with endocrine disruption, thyroid disorders, increased risk of Parkinson’s and non-Hodgkin’s lymphoma, developmental and reproductive toxicity and other health issues.

Here is a short video from the article describing the study (less than 2 minutes in length:

What should citizens take home from this study?


The study above is fascinating, but not all that surprising.  Why?  First, the chemical structures of pesticides are designed to 'adversely impact' the biochemical pathways of insects/bugs not humans.  The proteins to which the pesticide chemicals bind to are not present in humans.  Does that mean that pesticides are totally alright to eat -- not necessarily.  Second, pesticides are mostly water soluble and can be washed off prior to using in food preparation.  More will be written about pesticide and the mechanisms behind them inside both the human and insect body.   Meaning -- I will look into this and get back to you.



For the time being, eating an organic diet which is pesticide free shows a significant drop in pesticide levels.  Although, the fact that pesticide concentration drops off significantly in such a short period of time implies that the our bodies are great at removing the pesticides quickly (breaking them down into metabolites in urine).  What would be interesting to see out of this study is the concentration of pesticides in the bloodstream over time within the participants.  That would be an interesting parameter to observe to comment on selective/non-selective binding.  The longer the pesticide circulates, the greater opportunity for non-selective binding exists.



The study suggests that each of us should immediately switch to an organic based diet.  I would be careful in switching to purchasing just organic produce.  Just because the label says that the produce is 'pesticide free' does not mean that the produce was grown without the use of pesticides.  Be sure (as a cautionary note) to wash all produce before using the items in food preparation.  Nevertheless, the study shows direct correlation of urine concentration and the use of pesticides in agriculture.



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Hurricane Maria Destroys Puerto Rico's Science Programs Then Presents Unusual Research Opportunities?

Source: Union of Concerned Scientists

The devastation caused by Hurricane Maria is still being revealed nearly a year and a half after the storm ripped through the island.  Of course, anyone who has lived through a disaster like this will tell you that the island will probably never recover.  Not to mention that the loss of life can never be replaced.  With that being said, any community (or island) must find the courage to recover and re-establish life as it were if possible.  

Under normal conditions, agencies such as FEMA (Federal Emergency Management Agency) would provide sufficient funds to help the island start the journey toward recovery.  Unfortunately, we do not live in normal conditions at the current moment under the current administration.  Funding agencies are being stressed beyond reach for existing funds and when this occurs, areas like scientific research usually suffer the most. 

How Did Maria Impact Science?

At the very least, the lightest impact (which actually may not be true due to PTSD), the lab members may undergo treatment to make sure that there are no residual medical issues after a storm has hit the island.  Of course, if you have no laboratory staff: graduate students, undergraduate students, postdoc's, professional researchers -- then you have no lab.  Meaning, all the best equipment can occupy the lab, but without scientists to run and monitor the instruments, then there is no lab.



The second critical component of any scientific laboratory are the scientific instruments and infrastructure in which these along with the supplies (beakers, tubing, cell cultures, glove boxes, etc.) needed to conduct good/sound science.  This is sometimes the perceived most critical component of any scientific laboratory.  Although, I would argue that the scientists which occupy any laboratory are the most critical components to any scientific instruments.  I have yet to see any scientific instrument just start collecting data by itself without any scientist's intervention/initiation.

A recent article in 'The Scientist' titled "Science in Puerto Rico Still Recovering After Hurricane Maria" details some of the disastrous consequences to a scientific laboratory after a storm of a magnitude such as Hurricane Maria.  The human damage alone can be irreplaceable not to mention the buildings and local municipal utility grid.  And when the destruction to the infrastructure is considered, parameters such as mold and water damage can set a laboratory recovery back several months to years:

Giray’s lab is among 14 or so in the Julio Garcia Diaz biology building, which was among those severely damaged, particularly as it was already undergoing roof repairs when the storm hit. Water seeped in through the roof and windows, damaging costly research equipment, furniture, and lab materials. Toxic mold thrived in the moist, hot climate, creating hazardous conditions that made the building uninhabitable. Power outages cut off researchers’ freezers and fridges, destroying precious genetic and tissue samples for good. The damages are estimated to range from $250,000 up to $2.5 million dollars per lab in that building, says Giray, a behavioral biologist whose main focus is honeybees.

Even more important are samples which are collected outside of the laboratory or purchased for several thousand dollars which are sensitive to temperature/humidity/vibrational fluctuations:

Some of the casualties from the hurricane are less easy to restore: “Collections take much longer time and may never be replaced,” says Giray’s colleague Riccardo Papa, who lost almost all of his DNA samples documenting the diversity of butterflies across South America when his lab’s –80 °C freezer lost electricity. Papa, an evolutionary biologist, didn’t have a lab again until a week ago, and until recently has been meeting with his students and postdocs at coffee shops or places around campus to discuss research. He has been able to do some experiments and genetic analyses in another building. Repairs are still underway for the damaged insectary, in which his team raises butterflies.

Research must go on.  With or without the infrastructure.  Here in California, after the Northridge Earthquake in 1994, FEMA set up temporary 'mobile homes' to serve as both classrooms and temporary offices along with laboratories in certain circumstances.  To hear that 'group meetings' were still being held at coffee shops is a testament to the pace of recovery.  In a majority of cases after a disaster, classroom recovery comes first, then eventually research laboratories.  Although, it is worth remembering that each research laboratory group is made up of students and research professors who take years (applying for individual grants/writing publications) to acquire the appropriate funding to purchase research scientific instrumentation.  Therefore, to put a price on the total loss in the event of a disaster like Hurricane Maria proves extremely difficult.



The total cost to a researcher is really unknowable for years to come.  Some researchers never recover and decide to shut down their laboratories after such a storm.  Which leaves current graduate students without an end in sight to their degrees (M.A. and PhD).  Additionally, staff (professional researchers) might quickly find themselves out of work and have to leave regions like Puerto Rico and find work elsewhere.  Which means transplanting their families and children's education to a different geographical location.  The cost can be severe not just to the researcher themselves.



More can be written in future articles on this theme of disasters and research laboratories.  Either together or separately.  The total cost to a geographical location from a disaster such as Hurricane Maria can only be estimated at the beginning (a very rough approximation).  The price tag evolves over time with the disbursement of emergency funds by organizations such as FEMA along with other federal organizations or the Congress.  The terrible destruction to a scientific institution is terrible to say the least.  Restoring science should be a high priority among others on the island of Puerto Rico.

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3 very interesting research projects for Fluid Dynamics Research

Source: Termoflow

Have you ever been on the road inside a small car only to be passed by a large semi-tracker truck?  Further, as you are passed, the driver experiences a lateral (right or left) push from the trucks passing?  This push is the wind flow which is being pushed to the side by the diesel truck's inefficient air flow.  One major consequence of this inefficient air flow is the production of wind resistance (or a drag force) -- which drives down the miles per gallon (fuel efficiency) a given vehicle can get.



All vehicles suffer to some extent from the inefficient air flow surrounding a vehicle.  Some more than others.  Although, a large (and I mean large) amount of interest has been devoted in the form of research to minimize (and improve) air flow across a given object (to generalize it).  For those who are unaware of the study of 'Fluid Dynamics', the following can serve as an introduction:

In physics and engineering, fluid dynamics is a subdiscipline of fluid mechanics that describes the flow of fluids—liquids and gases. It has several subdisciplines, including aerodynamics (the study of air and other gases in motion) and hydrodynamics (the study of liquids in motion). Fluid dynamics has a wide range of applications, including calculating forces and moments on aircraft, determining the mass flow rate of petroleum through pipelines, predicting weather patterns, understanding nebulae in interstellar space and modelling fission weapon detonation,

Fluid dynamics offers a systematic structure—which underlies these practical disciplines—that embraces empirical and semi-empirical laws derived from flow measurement and used to solve practical problems. The solution to a fluid dynamics problem typically involves the calculation of various properties of the fluid, such as flow velocity, pressure, density, and temperature, as functions of space and time.

Before the twentieth century, hydrodynamics was synonymous with fluid dynamics. This is still reflected in names of some fluid dynamics topics, like magnetohydrodynamics and hydrodynamic stability, both of which can also be applied to gases.[1]

With the working introduction given above, the study of 'fluid dynamics' is now more comprehensible.  Still, the variety of projects which the study of fluid dynamics covers is incomprehensible.  Nearly any given situation which involves moving parts different mediums can be understood and broken down into a research project categorized under fluid dynamics.  Why?  Chances are that there is a 'fluid' or  lubricant involved in the workings.



Further, as highlighted below, most objects which move through the world can be understood at the level of a project under the category of fluid dynamics.  The video below highlights 3 research projects that are share the field of fluid dynamics research:

Amazing to say the least.  I love really interesting research project.  Of course, I love to learn just about anything.  The first project which is being tackled by Marguerite Matherne a graduate student studying in Dr. David Hu's lab at Georgia Tech.  Her project involves looking deeper into the process of transporting pollen back to the beehive by bees.  Pollen is composed of proteins which would not normally just adhere to one another.  Therefore, the bee needs to suspend the pollen into nectar to form a suspension.



What properties of this suspension allow the bee to transport the 'maximum' amount of pollen back to the beehive?  The viscosity of the suspension needs to be just right in order to complete the journey (and not fall apart).  Although, the drag force of the shaped pollen cannot exceed the force exerted by the bee in flying back to the beehive.  Otherwise the trip would be impossible.  As shown in the video, the research covers these parameters along with others relevant to the process.  Nevertheless, the project is unique and important to the survival of the bee population -- not to mention helping humans with fruit crops by spreading pollen among crops.



The second research project which was developed by and carried out by Dr. Giorgio-Serchi at the University of Edinburgh -- is devoted to understanding the forces (fluid dynamics) generated by sea creatures resulting in movement across a given area.  How do the framework of the structure interact with the fluid to produce forward movement?  If we could see at the molecular scale, the picture might be much greater in difficulty, therefore, making models (using computer simulations) is suitable for a research project at the moment.



Last but not least, researcher Daria Frank is working with Dr. Paul Linden at Cambridge University to better understand oil plumes.  Specifically, as in the case of the Deepwater Horizon Oil spill, the oil disperses in a plume with an initial angular momentum (angular momentum due to the Earth's spinning around an axis).  The project is to characterize the parameters of the rising oil plume and compare those parameters to a storm passing over the Earth's surface.



Comparing an oil spill -- a swirling plume (in the presence of water -- fluid) versus a storm -- a spinning top (fluid is air).  What are the differences?  What are the similarities?  The information gathered will better place the oil/gas industry in a better position to combat challenges -- especially in the face of a disaster.

4 Accessible Examples

Shown below are 4 different examples of research projects which would be encompassed under the category of fluid dynamics research.  The examples are very accessible to each of us, since each represent real life examples frequently encountered in society.  As you progress through the examples, think of questions that you would ask regarding the dynamics surrounding the object's environment.


Example 1: Fluid flow around a race car:

Source: Rodrigonemmen

What are the most relevant methods for dealing with fluid dynamics surrounding the air flow of a car?  How do magnetohydrodynamics figure into the solution?  How do different materials play into the dynamics of air flow across a car?  What about the development of heat spots across a vehicle?  What type of instabilities contribute to turbulent air flow across a car?  What type of equations are necessary to model the air flow?  Partial differential equations?  In order to understand the system better, the solutions involve introducing a method which is a combination of methods. 



Example 2: Fluid flow through an human artery

Source: Di Cardilogy

How does the flow of blood through the vessels of arteries and blood vessels affect the dynamics inside of the heart during a cardiac cycle?  How does the build up of plaque on the side of an artery wall contribute to turbulent flow within the artery?  How does the plaque weaken the artery wall leading to atherosclerosis?  What are the overall dynamics of the arterial system?  How does one build up site of plaque contribute to overall flow within the entire system?  These are a just a few of the questions being entertained by such researchers in the field of fluid dynamics in medicine/engineering.



Example 3: Fluid flow around a bicycle

Source: Insightreplay

What are relevant parameters for cyclists?  Weight of the bicycle?  Weight of the cyclist?  If you shave your leg and arm hair, does that really cut time off of a ride?  What about body shape?  What about the shape of the frame?  Is there an optimal shape of each component which will result in reducing air flow across the system?  These are just a few questions that the cycling industry has had to deal with over the years.  Fluid dynamics could certainly contribute to answering a few of them.



Example 4: Fluid flow around a golf ball

Source: Symscape

Most of us at one point or another have seen a game (or part of) of golf on the television or screen of a smart device.  What are the relevant parameters which play greatly into reducing the turbulence of air build up behind the ball?  In a previous blog post, I show how the 'dimples' on the surface of golf balls play a tremendous role in reducing the drag force on the golf ball.  Golf ball companies are very interested in reducing drag force overall to any degree.  Golfers dream of having complete flight stability during a game to better place their ball in a desired location.




Overall, these 4 examples serve us well in introducing the field of fluid dynamics.  Now, as each of us carry on in our busy days, feel free to pause a moment and look around yourself at your environment.   Find an example where the field of fluid dynamics could make a change -- a positive one.  There are many examples, each of us must be willing to think critically about the underlying parameters which dictate the performance and/or operation of a given phenomena.  Enjoy!



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