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:
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:
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.
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.
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.
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.
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.
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.
(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.
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.
Hollywood gives us a picture (one example) of a typical day in the life of a systems engineer at the Jet Propulsion Laboratory. What does that picture look like? An example might be shown below:
Now compare that with the written description from an interview of a true systems engineer at the Jet Propulsion Laboratory in Pasadena as highlighted on the 'Science & Entertainment Exchange' website shown below:
What is a typical day like for a systems engineer at JPL?
The one thing I love about my job as a systems engineer is that there really is no such thing as a typical day. It changes dramatically over the lifecycle of a project, which goes like this. In the early phases of a project, the scientist community and NASA decide what it is that needs further study. Take Jupiter, for example. How was Jupiter really formed? Related to that question are things like: Does Jupiter have a core? How big is the core? What is the water vapor content of the atmosphere?
Next, a call for proposals is sent out and engineers work with scientists to figure out how to go about finding the answers. Can we use a telescope on Earth? Or do we need to send a spacecraft all the way to Jupiter? Can it just fly by the planet or does it need to go into orbit? Then, we come up with a specific design for the spacecraft and instruments. For the instruments: they are often selected through a parallel proposal process. For the spacecraft side: if a spacecraft is going all the way to Jupiter, we work through big design questions like: Does it need nuclear power? Or can we use solar power? If we use solar power, how big would the arrays need to be? Over time, we mature the design to a very high level of detail, then build parts, and assemble them. There are many points throughout the design process for testing things, performing analyses, etc., to ensure everything is going to come together smoothly and perform the way we expect. Eventually, we launch the spacecraft. Once we are in this operations phase, we are getting the data back from the instruments, but also managing the health of the spacecraft.
So far, I have worked on projects starting from the middle of the design phase through the final assembly, testing, launch, and operations phases. My job focuses a lot on troubleshooting and resolving design disconnects. For example, early in the design phase a telecom engineer might want 100 watts of power to make sure the signal back to Earth is very strong and easy to lock onto, but the power system may be providing only 500 watts for the entire spacecraft. The systems engineer’s job is to work with engineers from both of those areas (and the rest of the spacecraft too) to explore the trade space and figure out the best approach.
The description above implies the images below:
Source:JPL
Laboratories like the one above and below house teams of scientists who work collaboratively to think about all of the considerations for a given mission. A team which appears like the picture below:
The laboratory above (spacecraft factory) is a result of years of work by NASA engineers. Over the course of decades, space scientists have worked to optimize (perfect) the process of design, construction, testing, and launching/mission. According to the description above by the systems engineer, a day can take on many different forms. Which highlights a very important observation which frequently arises when non-scientists visit laboratories. The scientific process has many components which range from constantly sourcing out funding for various research projects to solving unexpected problems encountered during research and development.
Conclusion...
The traditional (old image) of a scientist or systems engineer is one that is not only outdated but has changed over the last few decades. What image do I speak of? The image of men chalking up the boards with equations has been replaced largely by computational methods. A scientist working alone in his/her laboratory day after day has been replaced by a more collaborative working environment -- diverse with different genders, race, and ethnic backgrounds. Which spurs different angles of creativity and ideas in solving a project at hand. Since funding is getting more hard to find, more consideration into each part of the process from planning to finalizing construction of a spacecraft is considered in more detail. The result is a more diverse and inclusive interdisciplinary research and design group of scientists who are more concerned about living in a better world and beyond.
We are inundated with a variety of news from a large amount of sources everyday. How do we make use of such information? How do we verify the deluge of information? In keeping with the tradition of educating the public on how scientists view various events portrayed in the media along with life in general (i.e. how do scientists think), a new piece of useful information has surfaced for readers to mull over. Scientists compare the misinformation in the news cycle to a viral infection.
In a past issue (December of 2017) of 'Science' magazine the following "letters" were sent into the Journal. The "letters" section is composed of chosen comments sent in by readers regarding earlier commentary/reporting from the science community which was published in an earlier issue. In the particular issue mentioned in the comments section -- there were a couple articles about the circulation of 'misinformation' in the mainstream news. The scientists drew parallels to the inoculation against an infection in biology:
The unprecedented spread of misinformation threatens citizens' ability to form evidence-based opinions on issues of societal importance, including public health, climate change, and national security. In his Editorial “Nip misinformation in the bud” (27 October, p. 427), R. Weiss argues that fact checking after misinformation has spread is often ineffective. Decades of research in cognitive science (1) have buttressed this concern by establishing the robust “continued influence effect”: Post-publication retractions and corrections often fail to eliminate the influence of misinformation. In some cases, they reinforce falsehoods simply by repeating them. The more exposure people have to a falsehood, the more truth-value they ascribe to it (2). The networked nature of online media enables misinformation to spread rapidly, much like a viral contagion (3). Accordingly, Weiss calls for a solution in which scientific facts reach the public before misinformation has a chance to spread and take hold.
A growing body of research suggests that this may be possible, but it must be done preemptively. This process of “inoculation” adheres to a biological analogy: Just as injections containing a weakened strain of a virus trigger antibodies in the immune system to help confer resistance against future infection, the same can be achieved with information. Recent studies find that misinformation can be used against itself: By preemptively warning people against misleading tactics and by exposing people to a weakened version of the misinformation, cognitive resistance can be conferred against a range of falsehoods in diverse domains such as climate change (4, 5), public health (6), and emerging technologies (7). In the battle against misinformation, it is better to prevent than cure. The benefit of inoculation is that it can spread, too, online and through word-of-mouth (8). News outlets and the public can help inoculate each other to achieve societal immunity against misinformation.
The concept of preemptively warning people will work in theory. In fact, depending on the culture from which the person is from, preemptive action might work more effectively. Different countries have different models of regulatory procedures - for instance - which make such actions work in much different ways.
Here in the United States, the regulatory system appears to be at the moment more of a 'reactionary' system rather than a 'proactive' system. Which means that preemptive measures do not necessarily work very effectively. That is, of course, not to say that in our country every resident believes this to be true. There will be a sizable percentage on which preemptive knowledge might work quite well on informing. Although, over the range of the entire population, this kind of warning appears not to work as well as in other countries. Why? I have no idea at the moment.
The terrible aspect of the news is that there are inherent dangers associated with the class of chemicals -- which are well known. This is a blatant example of a reactionary system. Why not put in place measures to replace this class of compounds with another class of chemicals which are less harsh on humans along with the environment? Another related 'reactionary' measure instituted in the United States is the Chemical Safety Board. The Chemical Safety Board is charged with investigating the aftermaths of tragedies (chemical hazardous spills, fires, accidents, etc.). Why not have a 'proactive' system in place? Currently, the fate of the Chemical Safety Board is in jeopardy -- read about that here.
The regulatory system in other countries -- say Britain for example -- is built on the 'preemptive' system. Instead of 'reacting' to a given tragedy, the British will put in place laws and regulation -- voted on by parliament - which are 'proactive' in nature rather than 'reactive'. Therefore, a 'preemptive' strike would work quite well over in that part of the world. Why there is such a large difference in different parts of the world is beyond my understanding at this time. If you (the reader) has any inputs (ideas) on this difference, please feel free to contribute in the comments section below.
Conclusion...
The United States is made up of a regulatory system which is 'reactive' in nature rather than 'proactive'. I would love to see the system change in the near future. How to change the system exactly I do not have the solid idea? Although, any change in the United States definitely has to build from the ground up through voting/speaking out to our respective political representatives who make/create law/regulations on our behalf. Additionally, a better informed society is willing to take a risk and become 'proactive'. That is not to say that we are a nation of 'dummies'. I believe that each of us could educate ourselves on a range of matters which in turn would create a better country - that might resemble a proactive rather than a reactive system.
Of course, in order to do so takes time and effort on each of our parts. What have you done to make the world a better place? What steps are you taking to help inoculate the public against 'fake news'? Rather than spend your time upset, take action to reduce the spread of fake news. Here on this site, I try to bring to light news about issues in hope of communicating the importance of understanding the issue. At least to provide a platform from which the reader (you) can further investigate the matter in greater depth. The path is yours to pursue to educate yourself and others. Inoculate yourself by educating yourself.
Of the many unanswered questions that exist around the current election cycle, very few are as important than questions surrounding current scientific research and the funding for the future.
Why should the public vote/influence an increase in science funding?
Why do I suggest the importance of such research is so high?
The range of issues that are tied to science funding is enormous. Most people do not realize what issues are encompassed by science funding. If you (the reader) are one that ties research funding only to important issues like - space or defense - then I ask you to please read everything below. The reason is that the range of issues affected by science include climate science (flooding from Hurricane Matthew) to research into better treatments for eradicating the Zika Virus or Ebola Virus.
Additionally, what about the homeless problem that plagues the United States which includes many victims to serious mental health issues and impact the veterans among others roaming the streets without help. Before you go to the voting polls tomorrow, please read the information below which might or might not influence your vote. Either way, after reading the blog post below, you will definitely be better informed. Last but not least, I will provide direct evidence of the wonderful job that artists such as Beyonce, Jay Z, and Leonardo DiCaprio are doing to elevate science and the need to get out and vote -- which is super inspirational.
Note: various words or phrases are hyperlinked to earlier posts on the subject or other research articles. Please read widely and inform yourself on Science Issues.
Pending Issues Which Need To Be Addressed
Just look at the current state of affairs around the nation and the world along with the issues raised in the blog post below. Then we can talk about the importance of such issues. Currently, the entire East Coast of the United States is recovering from the dramatic flooding and winds which struck when Hurricane Matthew swept through and wreaked havoc on the region.
Any discussion of the funding for the destruction and the recovery?
Has the East Coast rebuilt all of the damaged structures?
Not in the least. Why not? If the same lack of attention toward science research into the issues exist today, where will we be as a nation in 4 or 8 years? This is why the issues of science are serious and need to be entertained before we head to the voting polls next week. At this point, you might be wondering the following question:
What are the most critical issues at hand that are associated with science for the candidates to express their views toward?
A recent article from the website "BioscienceTechnology" titled "Coalition Presses US Presidential Candidates to Address Science Issues" offered commentary on the "Top 20 Questions" from the nonprofit organization "ScienceDebate." The author chose to offer up six of the 20 questions as necessary to provide an example. The six sample questions are shown below:
1) Many scientific advances require long-term investment to fund research over a period of longer than the two, four, or six year terms that govern political cycles. In the current climate of budgetary constraints, what are your science and engineering research priorities and how will you balance short-term versus long-term funding?
2) Mental illness is among the most painful and stigmatized diseases, and the National Institute of Mental Health estimates it costs America more than $300 billion per year. What will you do to reduce the human and economic costs of mental illness?
3) Strategic management of the US energy portfolio can have powerful economic, environmental and foreign policy impacts. How do you see the energy landscape evolving over the next 4 to 8 years, and, as President, what will your energy strategy be?
4) Public health efforts like smoking cessation, drunk driving laws, vaccination, and water fluoridation have improved health and productivity and save millions of lives. How would you improve federal research and our public health system to better protect Americans from emerging diseases and other public health threats, such as antibiotic resistant superbugs?
5) Science is essential to many of the laws and policies that keep Americans safe and secure. How would science inform your administration’s decisions to add, modify, or remove federal regulations, and how would you encourage a thriving business sector while protecting Americans vulnerable to public health and environmental threats?
6) Evidence from science is the surest basis for fair and just public policy, but that is predicated on the integrity of the evidence and of the scientific process used to produce it, which must be both transparent and free from political bias and pressure. How will you foster a culture of scientific transparency and accountability in government, while protecting scientists and federal agencies from political interference in their work?
The author seem to want to suggest that the above issues just did not impact science funding, but were of significance to the public at large. I found the paragraph below fascinating:
“Some politicians think science issues are limited to simply things like the budget for NASA or NIH, and they fail to realize that a President’s attitude toward and decisions about science and research affect the public wellbeing, from the growth of our economy, to education, to public health,” Rush Hold, CEO of the American Association for the Advancement of Science, said in a prepared statement. He said that Americans should have the opportunity to know where Presidential candidates stand on these issues.
All issues that are researched from a scientific standpoint are important. Just because the public does not see the ramifications of such research does not disqualify funding. Of course, there are certain areas that are of immediate importance than others.
Science Lessons For Next President
According to a recent article in the Journal "Science" titled "Science lessons for the next president" there are certain issues that need definite support. Here is a short video of the issues stated succinctly (less than 4 minutes in length):
Below are the critical science lessons that are of upmost importance for the next President:
1) "Pathogens Change Faster Than Our Defenses"
Our ability to stay ahead of deadly pathogens relies on our ability to understand how to dismantle a virus or deadly bacteria. I wrote a blog about new research that recently was uncovered in which scientists discovered a site (a part of the molecule) that is responsible for disabling the effectiveness of the antibiotic. Meaning, if a target molecule hits this site, then the antibiotic is rendered ineffective (useless) and will not work.
More money should be devoted toward understanding and developing ways to counter that pathway toward disabling the antibiotic -- which is commonly termed as "Antibiotic Resistance." Additionally, this relies on funding to develop drugs that will be effective and can be tuned to treat evolving pathogens. In a blog post that I wrote recently, there was a short video outlining with an explanation the drug development process which is worth looking at and reading. If you are still not convinced after reading the blogs, then read below the excerpt from the Journal 'Science' on critical issues which offers an alternative explanation of the importance of such research:
Importance:
Why it matters: Evolving pathogens can threaten our food and water supplies, natural resources, and health. In the United States, 2 million people develop antibiotic-resistant infections each year, and 23,000 die. Globally, the World Health Organization estimates that in 2015 there were 580,000 new cases of tuberculosis resistant to the two most powerful drugs used against this disease. Increasing drug resistance in malaria, HIV, and other major diseases threatens to undermine control efforts. And recently emerged threats, such as the Zika and Ebola viruses, are certain to evolve in ways that can be hard to predict. To develop treatments, scientists often must work with the most dangerous pathogens in laboratories, and sometimes even engineer new strains; this creates the possibility of accidental or intentional releases that could have dire consequences.
With the emergence of stories surrounding the spread of diseases throughout the world, research into these diseases is critical. The issues above are due to evolving chemical systems that are natural and are constantly challenging us to keep ahead of the game to fight new pathogens. If we switch gears and look at issues that are brought on by our own actions, we find challenges that definitely need to be addressed immediately. One such issue is 'genetic engineering.' The question is raised below:
What about potential problems brought by our own actions?
2) "CRISPR Raises Tough Ethical Issues"
Recently, the field of 'genetic modification' has been getting alot of attention and rightly so. The prospect of changing an organisms "genetic code" seems strange and straight out of a science fiction book. Although, if I were to tell you that certain foods you eat have been genetically modified and you still love them -- what would you do? Furthermore, if the so called 'genetic modification' was to help the crop avoid destruction -- i.e., preserve a given crop in order to provide you food, would your opinion change? The current benchmark (among other methods) is the rising CRISPR-Cas9 method. You can read more about the method on the 'Wikipedia' page if you wish. In order to understand the importance of funding such research along with the potential implications, lets turn to the same article from the Journal 'Science' with the following explanation shown below:
Importance:
Why it matters: A powerful tool for basic research, CRISPR could also lead to new treatments for genetic disease in humans, pest-resistant crops with higher yields, and disease-resistant livestock. But uses of CRISPR could also raise profound ethical and regulatory concerns. It could allow the creation of human embryos with modified genes in their germ line—eggs and sperm—meaning the changes would be passed on to future generations. And, in an approach known as gene drive, CRISPR could be used to permanently alter the genome of an entire species in ways that could shift its evolutionary path and ecological role, or even wipe it off Earth. In principle, gene drive could give an endangered species a boost, wreck the genetic defenses that allow some weeds to resist herbicides, or drive a disease-carrying mosquito to extinction.
The promises are huge as well as the payoffs if the CRISPR method is perfected. And I say "perfected" -- why? Because, according to a certain part of the science community, the method does not work "perfectly." Professor Karmella Haynes at Arizona State University is performing research that investigates which environments where the CRISPR method works well. The method does not work well in human embryo cells. The DNA is coiled differently (slightly as a defense mechanism) which presents a large challenge. Of course, in the popular science news, positive results are published rather than discouraging results. Nonetheless, the method is still a strong method.
As an example, here is a short video of a reporter trying to perform the CRISPR method and failing shown below:
The above video shows the extent to which science is a profession of tireless effort. Time is put into get results and verify the methodology of a given experiment. Often, people think that scientists have an easy job -- but in fact, the development of research that is reproducible and clear to the public is a difficult task which takes time and money.
Certain areas require more time than others to delve into a given research inquiry. How about the atmosphere? The time scale of global warming is seemingly long. Although, according to current reports, action is needed immediately. The danger associated with the lack of immediate action is catastrophic. I find the fact that certain politicians are in denial a terrible observation and can only exacerbate the problem and solution.
3) "Sea Levels Rising"
As a nation, the United States public has been engulfed by the current chatter on the television along with the myriad devices that each of us carry around. Not too long ago, their were three presidential debates. Did you watch the debates? Were you able to watch the debates? Why do I ask such questions?
Because, while some were watching the debates, other East Coast residents were in the midst of cleaning up their lives which were ripped apart by Hurricane Matthew. The depth of the destruction along with the cost of the damage to the U.S. has not yet been realized. What is realized is that there have been some crazy weather patterns lately. Further, the seas have been rising. Both situations are not good indicators for the future. The amount of rain that dropped during Hurricane Matthew was insane compared to other large storms around the globe. You can read about the comparison here.
In order to fully understand the importance of such rising sea levels, lets turn to the article (series) we have been citing about the six lessons for the next president. Here is the "importance" stated below:
Importance:
Why it matters: Nearly 40% of the U.S. population lives near the coast, and shorelines host extensive infrastructure—including roads, rail lines, ports, military bases, and energy, water, and sewer plants—that will cost billions of dollars to protect or replace. Already, shorefront communities in hot spots of sea level rise, such as Hampton Roads, Virginia, and Miami Beach, Florida, are seeing tidal floods—even on sunny days—that clog traffic, poison lawns, and corrode utilities. Key ecosystems are also at risk of inundation, such as wetlands and aquatic grass beds that help protect coastlines from storms and provide important nursery grounds for economically important fish. This rising stage also allows stormwaters to surge deeper and higher inland, exacerbating their damage.
Based on the destruction that we have seen this year in the United States as a result of a rising sea level (flooding rain), there is no question that the above research is vitally important. One candidate (Donald Trump) would like to take funds away from research concerning global warming and fight ISIS. Ask yourself if this is a good idea? Is that where you want your money spent? Money is already available for the Department of Defense for such adventures. If any money should be diverted toward research in defense, then how about toward mental health for veterans returning from war with invisible wounds?
4) "Brain Health Should Be Top Of Mind"
Dr. James Watson once posed the following question regarding the human brain:
Can the brain understand itself?
The above question at first sight appears to be quite simple. Yet, over the decades that have past coupled with the advancing digital age, science still appears to be in the dark age to an extent. At the other end of this logic, the computational power needed to understand the brain is said to not yet exist. If the second statement is correct, then we need not stop funding research just yet.
Each and every one of us has either experienced or been touched by a person with a mental health issue. Even if we did not realize it at the time. Mental health is an extremely complicated issue that plagues parts of the entire population from the homeless to the ultra rich. Mental Illness is blind to income and wealth. With the new initiative to study the brain put forth by President Obama, we are headed in the correct direction. He has the BRAIN initiative - which can be understood in greater detail by reading more about here. Why is the health of the brain so important? Here is an excerpt from the article in 'Science' below:
Importance:
Why it matters: Brain health touches us from cradle to grave, and when brain disease strikes, the costs—personal and budgetary—are staggering. By 2025, at least 7 million Americans are expected to suffer from Alzheimer's disease, which causes memory loss, personality changes, impaired reasoning, and, eventually, death. This year alone, treating and caring for Americans with Alzheimer's and other less common dementias cost $236 billion, with government health programs shouldering two-thirds of the cost. At the other end of life, the prevalence of autism, a disorder of language and social communication, rose by 123% between 2002 and 2012. That year, one in 68 U.S. children was affected; costs to each affected family are estimated at about $60,000 annually.
Other brain health issues abound. Learning disabilities are a big issue in classrooms; mental illness is common in the homeless, in addicts, and in prison inmates; and concussions have become a major concern in sports. The military faces the burden of treating traumatic brain injuries and the psychological aftereffects of combat. Effective diagnostics and treatments could make a huge difference.
As I mentioned above, the amount of computational power needed to fully understand the brain is just being realized. Think about current research just published which shed light on the way proteins behave in their natural environment -- inside a human cell. If research carried out at the current level sheds light on the onset of diseases, then imagine the requirement to understand diseases inside the entire brain (different parts of the brain acting together). The point is that research into the disease causing aspects of the brain as well as our ability to comprehend the world around us is extremely important.
With the rise of the machine in understanding the world around us come other advances of the same technology. Artificial intelligence has been speculated to be around and supposedly proposed to play a large role in our lives in the coming decades. For now, what about simple machines -- drones? self driving cars, etc?
5) "Machines Are Getting Much, Much Smarter"
Elon Musk has been in the news lately for a variety of reasons. His space initiative has cost the private sector of the space industry a pretty penny. He has shown a complete lack of regard for the loss of life in his Tesla cars while operating on autopilot. How? He cannot admit that his technology is not nearly where technology needs to be at in order to let everyone have an autonomous car. I write about this here. In order to have completely autonomous cars, advancements in artificial intelligence will have to be taken toward a whole new level. Currently, we are not there yet. Science can shed light on potential issues that prevent us from proceeding to 'go' just yet -- which are shown below:
Importance:
Why it matters: Although experts say we are still decades away from machines that truly think like humans, narrower applications of AI are already having an impact on society. Products and services from self-driving cars to systems that guide medical care and treatment could bring major benefits, including increased labor productivity, lucrative new markets, and fewer deaths from traffic accidents and medical mistakes. But AI brings worries, too. It will enable employers to automate more tasks and displace workers, and economists predict that some low-wage jobs will be among the first to be eliminated, possibly increasing economic inequality. Letting machines make their own decisions also raises profound ethical, legal, and regulatory questions. Who is responsible if an autonomous car crashes, a piece of software wrecks an investment portfolio, or a sensor switches a stoplight to green at the wrong time? The stakes are even higher on the battlefield, where the military is exploring the possibility of fielding autonomous lethal weapons that would make their own decisions about when to fire.
Advancing forward, a fair amount of research needs to be conducted. From the machine programming and execution standpoint, current research is quite advanced. Just this week, research about a world record was set for NASA surrounding the precision of a satellite with GPS technology. A satellite traveling at a distance of 43,500 miles travels the slowest, whereas at a distance of just under 5 miles from Planet Earth -- the satellite can travel at speeds of 22,000 miles per hour. The precision offered in orbit has allowed very precise 3-dimensional images of different aspects of Earth. This is just one of many reasons why space funding is extremely important. Better precision, better time, new technologies.
Although, with space research comes risk. Over the decades, risk has been studied and worked on by scientists over various scales within various problems. From the small scale - quantum error correction to the enormous scale of space flight - risk remains a crucial area of need to study in greater detail.
6) "We Aren't So Great At Assessing Risk"
Communicating risk to the public without posing great fear is extremely complicated. In many areas of research, communication of results is equated with great fear surrounding the research which leads to reductions in funding and possible cancellations of investigations all together. This highlights the demand to understand how to greater understand risk and the ability to convey risk to the greater public. Two areas seem to be polarized with regard to risk: 'genetic engineering' and 'climate change'. These two areas stand at opposite ends of the spectrum, but are equally important. In the area of 'genetic engineering' - the scare lies in the unknown product and effect toward civilization. Whereas in the other area -- climate science, the scare lies in the incomprehensible. Thinking on the global scale couple with temperatures rising to the point of civilization not being able to occupy the Earth is unfathomable and science fiction -- as far as some are concerned.
Therefore, understanding how to communicate and assess risk is crucial. Science says:
Importance:
Why it matters: Misperception of risk can push a president to overreact to lesser threats and underreact to greater problems, or to embrace policies that may make people feel good but end up being costly and ineffective—or even counterproductive. And how a president communicates with the public about risk can mean the difference between sowing panic and maintaining calm. Talking realistically about risks in advance—as opposed to promising absolute protection—may help prepare people for the inevitable disasters and minimize calls for a policy response that's out of proportion to the actual threat. To do this effectively, the president will have to maintain the public's trust, which is much harder to earn than it is to lose. Understanding the basic psychology of risk can help avoid missteps.
Again, transmitting the unfathomable to the public is complicated. The best hope is that the communicator is a good communicator (patient, humble, and intelligent) with a great audience (patient, humble, and intelligent). Yes, each of us need to do our part to achieve transmission of information (i.e. communication) between one another. Hollywood does this quite well. Science is a work in progress.
Celebrities Elevate STEM and Voting!
Beyonce (the singer) recently promoted the presidential candidate Hillary Clinton along with her husband Jay Z. With good reason. It has taken over a hundred years to achieve equality (and we are still fighting for it) - a work in progress. Having the first female president would be a major step in the right direction. Furthermore, this would reinforce the idea that any woman can go as far as she is willing to work to go. My wife is a scientist and I encourage her to be the best she can be -- break all barriers.
Although, the fields -- Science Technology, Engineering, and Mathematics (STEM) still need more women and minorities engaging in them for careers. Each of us is smart in our own unique way. There are plenty of women and minorities out there to help take science and society to the next advanced level. Having celebrities elevate science is critical. Science usually gets a bad rap. Why? Movie portrayals (such as "The Accountant") portray scientists as strange with disorders but super smart. Not all are strange. I promise.
Recently, the actor Leonardo DiCaprio became the 'Messenger of Peace' for the United Nations -- an honor he holds dearly and sincerely. He speaks about the role in a documentary he recently released investigating the state of global warming and explored all possible solutions. We need more people like him with the unparalleled ability to communicate to a large audience the importance of research and world problems. Here is the video below (just over an hour and a half in length) - but worth watching before or after the election:
I think that I have provided you (the reader) with an eyeball full of information to think about before you hit the voting polls. Get out and vote. Listen to the stars, listen to your family, just be sure to vote. Exercise your place in our democratic society. Yes, your vote does count.
Conclusion ...
Science funding impacts all areas of our lives. If you do not believe me, just try to think of an area which has nothing to do with science. Leave the answer in the comments below and I will try to provide a rebuttal to your answer. There is no rebuttal for the issues that can be solved with science but lack funding. We need all of the help that is possible to educate the public about the importance of science. How do you help?
The most important learning begins at home. What about science do you not understand? Why don't you care? What kind of world are you leaving to your children? These questions do have answers. The unknown is centered around how those answers will surface in the days and years to come. Whether we find out the answers through your vote, your children, your family, the answers will become apparent. Why not educate yourself and others on critical issues for a better society?
I hope that each of you go out and vote tomorrow. Further, I hope that each of you are inspired to educate yourself more after reading this post. Until next time, Have a great day!!!
