FDA Warns Against the Use of Homeopathic Teething Tablets and Gels
Homeopathic teething tablets and gels are distributed by CVS, Hyland’s, and possibly others, and are sold in retail stores and online.
The FDA is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children and FDA recommends that consumers stop using these products and dispose of any in their possession. Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels. According to the FDA, teething can be managed without prescription or over-the-counter remedies and recommends that parents and caregivers not give homeopathic teething tablets and gels to children and seek advice from their health care professional for safe alternatives.
The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets. The FDA is currently investigating this issue, including testing product samples. The agency will continue to communicate with the public as more information is available. Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy. The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children. The FDA is also encouraging health care professionals and consumers to report adverse events or quality problems experienced with the use of homeopathic teething tablets or gels to the FDA’s MedWatch Adverse Event Reporting program:
Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Holiday Apple Marzipan Cake
Same recipe baked in a deep pie dish. ©Joyce Hays, Target Health Inc.
Baked in the deep pie dish. Moist and luscious. I had to put the brakes on every taste bud, to keep from
having another piece. Jules had many more, but then, he has more lee-way. ©Joyce Hays, Target Health Inc.
Baked in the spring-form pan and equally delicious. ©Joyce Hays, Target Health Inc.
1 teaspoon + butter as needed, to grease the cake pan or dish
1/2 cup almond flour, more for dusting cake pan
1 can 11 ounces, marzipan. If you don’t have it locally, buy it online, here: https://nuts.com/search?q=marzipan
1/2 cup granulated sugar
3/4 cup heavy cream
3/4 cup almond milk
10 to 15 apples, washed, dried, cored and sliced with a mandolin, very thinly, about 3 cups
Pinches of cinnamon over each layer of apples & marzipan
You need a mandolin for this recipe, a few ingredients and the rest is pretty easy. Be careful not to cut
fingers. The mandolin is razor sharp. Young kids probably shouldn’t use it. ©Joyce Hays, Target Health Inc.
I use this almond flour all the time, for practically everything. I get it at FreshDirect and Amazon.
©Joyce Hays, Target Health Inc.
1. Heat oven to 350 degrees. With plenty of butter, smear a cake pan or dish, about 9 x 5 x 2 inches, or a 10-inch round deep pie plate or a spring-form cake pan. If using a spring-form pan, line it first with parchment, then smear it with butter.
2. Next, dust cake pan with flour, rotating pan so flour sticks to all the butter. Next, invert dish to get rid of excess flour.
3. Prepare apples and slice them with mandolin. I took the skin off the first apple, but then I decided to leave the skin on. It’s healthier, so why bother, right?
I peeled the first apple, but then decided to leave the skins on the rest of the apples. ©Joyce Hays, Target Health Inc.
4. In a large bowl, whisk eggs until frothy. Do this by hand, not in the electric mixer. Add granulated sugar and salt and whisk until combined. Add cream and milk and whisk until smooth. Add 1/2 cup flour and stir just to combine, not more. Don’t stir the flour too much.
Mixing the batter, with a gift from a good friend (whisk). ©Joyce Hays, Target Health Inc.
5. Layer the apple slices in the cake pan or dish. Over each layer, sprinkle marzipan (take from the can; crumble it up with your fingers) and a tiny bit of cinnamon. Don’t make stacks of the slices. Distribute the slices all over the bottom of the dish, as one layer. Then do the next layer and so on, until there is a whole lot of apple slices, marzipan, cinnamon. The apple slices should come almost to the top. The thinner the apple slices, the better the dessert will be.
Starting, above, the first layer of thinly sliced apples. ©Joyce Hays, Target Health Inc.
Same recipe, different baking dish. Above is the first layer of apple slices, marzipan and cinnamon.
©Joyce Hays, Target Health Inc.
Using a deep pie dish for this recipe. ©Joyce Hays, Target Health Inc.
First layer of apple slices and marzipan is done. Next will come the cinnamon.
©Joyce Hays, Target Health Inc.
Layers have just about reached the top of the cake pan. ©Joyce Hays, Target Health Inc.
The last layer should only be made up of very thin apple slices. No marzipan on the top layer. ©Joyce Hays, Target Health Inc.
6. Pour the batter over the apple slices, to as close to the top of dish as you can, without the batter dripping over the side. There might be some leftover batter, depending on the size of your pan or dish.
Batter has been poured over the top layer of apple slices. You can be sure it trickles down, just the way it should. J ©Joyce Hays, Target Health Inc.
Going in oven, about to bake. ©Joyce Hays, Target Health Inc.
Later version of this cake, baked in a deep pie dish. ©Joyce Hays, Target Health Inc.
7. Bake for about 40 minutes, or until the top is nicely browned and a knife inserted into it comes out clean. Sift some powdered sugar over it and serve warm or at room temperature. Let it cool down for about an hour, then serve.
8. This dessert does not keep well; serve within a couple of hours of making it.
9. Serve with cool whip or real whipped cream or vanilla ice cream or delicious as is.
Mouth-wateringly good! ©Joyce Hays, Target Health Inc.
Friday night we started our meal with chilled Italian Ceretto which is like a cross between Sauvignon Blanc and a
Chardonnay. We had crudit?s with two dips: a low calorie yogurt/dill dip and hummus. A new warm
cabbage-with-turkey-bacon, recipe followed (will share later) and the apple marzipan cake.
We’ve discovered a new white from the Piedmont district in Northern Italy, that’s affordable and delicious. We were at one of our favorite Italian restaurants, looking to try something new and different. We were presented with two different whites and chose the one above. Ceretto Blange Langhe Ameis 2014. With the first sip, we knew we had made the right choice.. Back home, we ordered more in time to celebrate the beginning of Jules’ birthday month. This gorgeous white, made from the indigenous grape Arneis, is like a Sauvignon Blanc or a non flinty tasting Chardonnay. This full bodied wine offers, subtle fruity flavors with an oaky layer, which is strange, because fermentation takes place in stainless steel barrels. There must be more to learn here. Will keep you posted.
Saturday we went to our first opera of the MetOpera Season, Tristan and Isolde, Wagner’s greatest masterpiece, in my opinion and autobiographical. Part of what makes this opera so special is first, of course, the gorgeous music, second, the libretto, which Wagner also wrote. It reveals Wagner’s philosophy of life, influenced not only by his own life experiences (his mother died giving birth to Wagner) but also by contemporary German philosophers.
When Tristan and Isolde first opened, it was regarded as lewd and much too sexual. In time this great opera greatly influenced future composers. In my limited musical experience, I have never heard a piece of music that has been able to sustain one melody, one theme, successfully for nearly five hours. In short, for many in the Saturday MetOpera audience, this was a transcendental experience.
This opera is almost 5 hours long, but time flew by, because of the glorious music. This was a multi-media, star studded production with the great Sir Simon Rattle conducting, Nina Stemme brilliantly singing Isolde, golden toned, Stuart Skelton singing Tristan and well-loved, Rene Pape as King Marke. These world-famous opera greats, gave the audience 100% what they had come to hear. The ovations were never ending. I stood cheering Brava and Bravo with tears streaming down my face, I love that last aria so much along with the flawless Act 2. Oh what an experience! As we departed this magical source of great pleasure and joy, people were declaring, a once in a life time experience. I concur. It’s probably sold out for the rest of the Season, but try to see this outstanding production.
From Our Table to Yours !
October 6, 2016
University of Wisconsin-Milwaukee
Spring is beginning earlier than its historical average in three-quarters of United States’ national parks studied in new research that employed models created by a climatologist.
Spring is coming earlier in more than 200 U.S. national parks at locations from Alaska to Florida, according to a new study that employed a model created by a UWM climatologist.
The study correlated temperature records with climate change indicators developed by Mark D. Schwartz, UWM distinguished professor of geography. In Schwartz’s model, the start of spring is pegged to the timing of a particular seasonal event — the first leaf of certain plants.
A team of researchers from the National Park Service, the U.S. Geological Survey and three universities, including UWM, found that spring is coming earlier than its historical average in three-quarters of the 276 examined parks.
Results also showed that more than half the parks included in the analysis are experiencing extreme early onsets of spring.
Changes in the timing of seasonal events are ideal indicators of the impact of local and global temperature changes, said Schwartz. “An example would be when plants pump more water into the atmosphere at first-leaf, the temperatures may be quite different than when the plants were dormant.”
The researchers dated the onset of spring in each park, year by year, and then analyzed those trends over the 112-year period in which temperature data were available.
“My model provides the key to knowing when plants are responding to the growing season,” said Schwartz. “Coupling this with temperature data offers a standard way of looking at the park. It tells you what the trends are going to be.”
Results of the study were published Oct. 6 in an article in the journal Ecosphere that commemorates the centennial of the National Park Service.
“The bottom line is not just that parks are susceptible to change. In fact, they have already changed,” said Jake Weltzin, an ecologist with USGS and a co-author on the study. “Many park managers are already managing in an extreme environment.”
Spring’s early and sometimes unpredictable onset can lead to costly management issues. Earlier warm weather often gives a head start to invasive plants, can contribute to wildfires and appear to be disrupting natural relationships such as the peak bloom of wildflowers and the arrival of birds, bees and butterflies.
- Jake Weltzin et al. Climate change is advancing spring onset across the U.S. national park system. Ecosphere, October 2016 DOI: 10.1002/ecs2.1465
Source: University of Wisconsin-Milwaukee. “Spring starting earlier in U.S. national parks, study finds.” ScienceDaily. ScienceDaily, 6 October 2016. <www.sciencedaily.com/releases/2016/10/161006092009.htm>.
October 5, 2016
The 2016 Nobel Prize in Chemistry is being awarded to Jean-Pierre Sauvage, Sir J. Fraser Stoddart, and Bernard L. Feringa “for the design and synthesis of molecular machines.”
The Royal Swedish Academy of Sciences has decided to award the Nobel Prize in Chemistry 2016 to Jean-Pierre Sauvage of the University of Strasbourg, France; Sir J. Fraser Stoddart of Northwestern University, Evanston, IL, USA; and Bernard L. Feringa of the University of Groningen, the Netherlands “for the design and synthesis of molecular machines.”
They developed the world’s smallest machines
A tiny lift, artificial muscles and miniscule motors. The Nobel Prize in Chemistry 2016 is awarded to Jean-Pierre Sauvage, Sir J. Fraser Stoddart and Bernard L. Feringa for their design and production of molecular machines. They have developed molecules with controllable movements, which can perform a task when energy is added.
The development of computing demonstrates how the miniaturisation of technology can lead to a revolution. The 2016 Nobel Laureates in Chemistry have miniaturised machines and taken chemistry to a new dimension.
The first step towards a molecular machine was taken by Jean-Pierre Sauvage in 1983, when he succeeded in linking two ring-shaped molecules together to form a chain, called a catenane. Normally, molecules are joined by strong covalent bonds in which the atoms share electrons, but in the chain they were instead linked by a freer mechanical bond. For a machine to be able to perform a task it must consist of parts that can move relative to each other. The two interlocked rings fulfilled exactly this requirement.
The second step was taken by Fraser Stoddart in 1991, when he developed a rotaxane. He threaded a molecular ring onto a thin molecular axle and demonstrated that the ring was able to move along the axle. Among his developments based on rotaxanes are a molecular lift, a molecular muscle and a molecule-based computer chip.
Bernard Feringa was the first person to develop a molecular motor; in 1999 he got a molecular rotor blade to spin continually in the same direction. Using molecular motors, he has rotated a glass cylinder that is 10,000 times bigger than the motor and also designed a nanocar.
2016’s Nobel Laureates in Chemistry have taken molecular systems out of equilibrium’s stalemate and into energy-filled states in which their movements can be controlled. In terms of development, the molecular motor is at the same stage as the electric motor was in the 1830s, when scientists displayed various spinning cranks and wheels, unaware that they would lead to electric trains, washing machines, fans and food processors. Molecular machines will most likely be used in the development of things such as new materials, sensors and energy storage systems.
Jean-Pierre Sauvage, born 1944 in Paris, France. Ph.D. 1971 from the University of Strasbourg, France. Professor Emeritus at the University of Strasbourg and Director of Research Emeritus at the National Center for Scientific Research (CNRS), France.
Sir J. Fraser Stoddart, born 1942 in Edinburgh, UK. Ph.D. 1966 from Edinburgh University, UK. Board of Trustees Professor of Chemistry at Northwestern University, Evanston, IL, USA.
Bernard L. Feringa, born 1951 in Barger-Compascuum, the Netherlands. Ph.D.1978 from the University of Groningen, the Netherlands. Professor in Organic Chemistry at the University of Groningen, the Netherlands.
Prize amount: 8 million Swedish krona, to be shared equally between the Laureates.
Source: Nobel Foundation. “Nobel Prize in Chemistry 2016: Making the world’s smallest machines.” ScienceDaily. ScienceDaily, 5 October 2016. <www.sciencedaily.com/releases/2016/10/161005071227.htm>.
October 3, 2016
Texas Tech University
A researcher is working to advance research to develop secure user authentication methods, by looking at using brain waves as individual identifiers. However, those brain waves can tell more about a person than just his or her identity, warns this expert.
Cyber security and authentication have been under attack in recent months as, seemingly every other day, a new report of hackers gaining access to private or sensitive information comes to light. Just recently, more than 500 million passwords were stolen when Yahoo revealed its security was compromised.
Securing systems has gone beyond simply coming up with a clever password that could prevent nefarious computer experts from hacking into your Facebook account. The more sophisticated the system, or the more critical, private information that system holds, the more advanced the identification system protecting it becomes.
Fingerprint scans and iris identification are just two types of authentication methods, once thought of as science fiction, that are in wide use by the most secure systems. But fingerprints can be stolen and iris scans can be replicated. Nothing has proven foolproof from being subject to computer hackers.
“The principal argument for behavioral, biometric authentication is that standard modes of authentication, like a password, authenticates you once before you access the service,” said Abdul Serwadda a cybersecurity expert and assistant professor in the Department of Computer Science at Texas Tech University.
“Now, once you’ve accessed the service, there is no other way for the system to still know it is you. The system is blind as to who is using the service. So the area of behavioral authentication looks at other user-identifying patterns that can keep the system aware of the person who is using it. Through such patterns, the system can keep track of some confidence metric about who might be using it and immediately prompt for reentry of the password whenever the confidence metric falls below a certain threshold.”
One of those patterns that is growing in popularity within the research community is the use of brain waves obtained from an electroencephalogram, or EEG. Several research groups around the country have recently showcased systems which use EEG to authenticate users with very high accuracy.
However, those brain waves can tell more about a person than just his or her identity. It could reveal medical, behavioral or emotional aspects of a person that, if brought to light, could be embarrassing or damaging to that person. And with EEG devices becoming much more affordable, accurate and portable and applications being designed that allows people to more readily read an EEG scan, the likelihood of that happening is dangerously high.
“The EEG has become a commodity application. For $100 you can buy an EEG device that fits on your head just like a pair of headphones,” Serwadda said. “Now there are apps on the market, brain-sensing apps where you can buy the gadget, download the app on your phone and begin to interact with the app using your brain signals. That led us to think; now we have these brain signals that were traditionally accessed only by doctors being handled by regular people. Now anyone who can write an app can get access to users’ brain signals and try to manipulate them to discover what is going on.”
That’s where Serwadda and graduate student Richard Matovu focused their attention: attempting to see if certain traits could be gleaned from a person’s brain waves. They presented their findings recently to the Institute of Electrical and Electronics Engineers (IEEE) International Conference on Biometrics.
Brain waves and cybersecurity
Serwadda said the technology is still evolving in terms of being able to use a person’s brain waves for authentication purposes. But it is a heavily researched field that has drawn the attention of several federal organizations. The National Science Foundation (NSF), funds a three-year project on which Serwadda and others from Syracuse University and the University of Alabama-Birmingham are exploring how several behavioral modalities, including EEG brain patterns, could be leveraged to augment traditional user authentication mechanisms.
“There are no installations yet, but a lot of research is going on to see if EEG patterns could be incorporated into standard behavioral authentication procedures,” Serwadda said
Assuming a system uses EEG as the modality for user authentication, typically for such a system, all variables have been optimized to maximize authentication accuracy. A selection of such variables would include:
• The features used to build user templates.
• The signal frequency ranges from which features are extracted.
• The regions of the brain on which the electrodes are placed, among other variables.
Under this assumption of a finely tuned authentication system, Serwadda and his colleagues tackled the following questions: • If a malicious entity were to somehow access templates from this authentication-optimized system, would he or she be able to exploit these templates to infer non-authentication-centric information about the users with high accuracy? • In the event that such inferences are possible, which attributes of template design could reduce or increase the threat?
Turns out, they indeed found EEG authentication systems to give away non-authentication-centric information. Using an authentication system from UC-Berkeley and a variant of another from a team at Binghamton University and the University of Buffalo, Serwadda and Matovu tested their hypothesis, using alcoholism as the sensitive private information which an adversary might want to infer from EEG authentication templates.
In a study involving 25 formally diagnosed alcoholics and 25 non-alcoholic subjects, the lowest error rate obtained when identifying alcoholics was 25 percent, meaning a classification accuracy of approximately 75 percent.
When they tweaked the system and changed several variables, they found that the ability to detect alcoholic behavior could be tremendously reduced at the cost of slightly reducing the performance of the EEG authentication system.
Motivation for discovery
Serwadda’s motivation for proving brain waves could be used to reveal potentially harmful personal information wasn’t to improve the methods for obtaining that information. It’s to prevent it.
To illustrate, he gives an analogy using fingerprint identification at an airport. Fingerprint scans read ridges and valleys on the finger to determine a person’s unique identity, and that’s it.
In a hypothetical scenario where such systems could only function accurately if the user’s finger was pricked and some blood drawn from it, this would be problematic because the blood drawn by the prick could be used to infer things other than the user’s identity, such as whether a person suffers from certain diseases, such as diabetes.
Given the amount of extra information that EEG authentication systems are able glean about the user, current EEG systems could be likened to the hypothetical fingerprint reader that pricks the user’s finger. Serwadda wants to drive research that develops EEG authentication systems that perform the intended purpose while revealing minimal information about traits other than the user’s identity in authentication terms.
Currently, in the vast majority of studies on the EEG authentication problem, researchers primarily seek to outdo each other in terms of the system error rates. They work with the central objective of designing a system having error rates which are much lower than the state-of-the-art. Whenever a research group develops or publishes an EEG authentication system that attains the lowest error rates, such a system is immediately installed as the reference point.
A critical question that has not seen much attention up to this point is how certain design attributes of these systems, in other words the kinds of features used to formulate the user template, might relate to their potential to leak sensitive personal information. If, for example, a system with the lowest authentication error rates comes with the added baggage of leaking a significantly higher amount of private information, then such a system might, in practice, not be as useful as its low error rates suggest. Users would only accept, and get the full utility of the system, if the potential privacy breaches associated with the system are well understood and appropriate mitigations undertaken.
But, Serwadda said, while the EEG is still being studied, the next wave of invention is already beginning.
“In light of the privacy challenges seen with the EEG, it is noteworthy that the next wave of technology after the EEG is already being developed,” Serwadda said. “One of those technologies is functional near-infrared spectroscopy (fNIRS), which has a much higher signal-to-noise ratio than an EEG. It gives a more accurate picture of brain activity given its ability to focus on a particular region of the brain.”
The good news, for now, is fNIRS technology is still quite expensive; however there is every likelihood that the prices will drop over time, potentially leading to a civilian application to this technology. Thanks to the efforts of researchers like Serwadda, minimizing the leakage of sensitive personal information through these technologies is beginning to gain attention in the research community.
“The basic idea behind this research is to motivate a direction of research which selects design parameters in such a way that we not only care about recognizing users very accurately but also care about minimizing the amount of sensitive personal information it can read,” Serwadda said.
Source: Texas Tech University. “Brain waves can be used to detect potentially harmful personal information.” ScienceDaily. ScienceDaily, 3 October 2016. <www.sciencedaily.com/releases/2016/10/161003130904.htm>.
October 3, 2016
For the past 100 years, scientists have understood that different areas of the brain serve unique purposes. Only recently have they realized that the organization isn’t static. Rather than having strictly defined routes of communication between different areas, the level of coordination between different parts of the brain seems to ebb and flow. Now, by analyzing the brains of a large number of people at rest or carrying out complex tasks, researchers at have learned that the integration between those brain regions also fluctuates. When the brain is more integrated, people do better on complex tasks.
For the past 100 years, scientists have understood that different areas of the brain serve unique purposes. Only recently have they realized that the organization isn’t static. Rather than having strictly defined routes of communication between different areas, the level of coordination between different parts of the brain seems to ebb and flow.
Now, by analyzing the brains of a large number of people at rest or carrying out complex tasks, researchers at Stanford University have learned that the integration between those brain regions also fluctuates. When the brain is more integrated people do better on complex tasks. The research was published in Neuron.
“The brain is stunning in its complexity and I feel like, in a way, we’ve been able to describe some of its beauty in this story,” said study lead author Mac Shine, a postdoctoral researcher in the lab of Russell Poldrack, a professor of psychology “We’ve been able to say, ‘Here’s this underlying structure that you would never have guessed was there, that might help us explain the mystery of why the brain is organized in the way that it is.'”
Brain connections at rest and at work
In a three-part project, the researchers used open source data from the Human Connectome Project to examine how separate areas of the brain coordinate their activity over time, both while people are at rest and while they are attempting a challenging mental task. They then tested a potential neurobiological mechanism to explain these findings.
For the resting state condition, the researchers used a novel analysis technique to examine functional magnetic resonance imaging (fMRI) data — which shows in real time which areas of the brain are active — of people who weren’t doing any particular task. The analysis estimates the amount of blood flow in pairs of brain regions and then uses the mathematics of graph theory to summarize the way that the whole network of the brain is organized. They found that even without any intentional stimulation, the brain network fluctuates between periods of higher and lower coordinated blood flow in the different areas of the brain.
To determine whether these fluctuations were relevant for the function of the brain, the researchers used fMRI data from people who had successfully performed a challenging memory test.
The researchers found that the brains of participants were more integrated while working on this complicated task than they were during quiet rest. Scientists have previously shown that the brain is inherently dynamic but further statistical analysis in this study revealed that the brain was most interconnected in people who performed the test fastest and with the greatest accuracy.
“My background is in cognitive psychology and cognitive neuroscience, and stories about how the brain works that don’t relate back to behavior don’t really do much for me,” said co-author Poldrack. “But this research shows these really clear relationships between how the brain is functioning at a network level and how the person’s actually performing on these psychological tasks.”
Amplifying brain interconnectedness
As a final step in their study, the researchers measured pupil size to try and tease out how the brain coordinates this change in connectivity. Pupil size is an indirect measure of the activity of a small region in the brainstem called the locus coeruleus that is thought to amplify or mute signals across the entire brain. Up to a certain point, increases in pupil size likely indicate greater amplification of strong signals and greater muting of weak signals across the brain.
The researchers found that pupil size roughly tracked with changes in brain connectivity during rest, in that larger pupils were associated with greater connectedness. This suggests that the noradrenaline coming from the locus coeruleus might be what drives the brain to become more integrated during highly complicated cognitive tasks, allowing a person to perform well on that task.
The value of curiosity-driven science
The researchers plan to further investigate the connection between neural gain and integration in the brain. They also want to figure out how universal these findings are to other behaviors, such as attention and memory. This research may also eventually help us better understand cognitive disorders, such as Alzheimer’s disease or Parkinson’s disease, but Shine stressed that this was a curiosity-driven investigation, fueled by the passion to simply know more about the brain.
“I think we were really lucky here, in that we had an exploratory question that bore fruit,” said Shine. “Now, we’re in a position where we can ask new questions that will hopefully help us to make progress in understanding the brain.”
- James M. Shine, Patrick G. Bissett, Peter T. Bell, Oluwasanmi Koyejo, Joshua H. Balsters, Krzysztof J. Gorgolewski, Craig A. Moodie, Russell A. Poldrack. The Dynamics of Functional Brain Networks: Integrated Network States during Cognitive Task Performance.Neuron, 2016; DOI: 10.1016/j.neuron.2016.09.018
Source: Stanford University. “How a fluctuating brain network may make us better thinkers.” ScienceDaily. ScienceDaily, 3 October 2016. <www.sciencedaily.com/releases/2016/10/161003131352.htm>.
CBI’s Risk-based Monitoring Meeting – Philadelphia November 3-4, 2016
Please join us on November 3-4, 2016 at CBI’s RBM 2016 being held in Philadelphia at the Doubletree by Hilton Center City. At a session entitled Leverage Real-Time Trial Data to Optimize Process and System Interoperability, Dr. Jules Mitchel, President of Target Health Inc., will share Target Health’s extensive clinical trials experience using eSource and Risk-Based Monitoring, including one FDA approval, as well as the results of regulatory inspections of Target Health and 8 clinical sites. The title of his presentation is Learn to Monitor Clinical Trials with Real-Time Data.
The Isle of Dreams
On Friday, Glen Park and Jules Mitchel visited a client in Jersey City. Not only is the project really interesting, but we had a spectacular view of lower Manhattan. Photo shot by Jules Mitchel with iPhone6.
Isle of Dreams – Foggy Day in the Big Apple ©Target Health Inc.
For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website, and if you like the weekly newsletter, ON TARGET, you’ll love the Blog.
Joyce Hays, Founder and Editor in Chief of On Target
Jules Mitchel, Editor
‘Sixth Sense’ May be More Than Just a Feeling
Early parapsychological research employed the use of Zener cards in experiments designed to test for the existence of telepathic communication, or clairvoyant or precognitive perception. Source: Wikipedia Commons
The sixth sense is another term for extrasensory 1) ___. Extrasensory perception (ESP) would involve the reception of information not gained through the recognized senses and not internally originated. The expression sixth sense is a misnomer that falsely suggests that there is only one additional sense besides the traditional five senses of sight, hearing, touch, smell, and taste, a classification attributed to Aristotle. Humans have at least five additional senses that include: nociception (pain); equilibrioception (balance); proprioception and kinaesthesia (joint motion and acceleration); sense of time; thermoception (temperature differences); and possibly an additional weak magnetoception(direction). There is no firm agreement among neurologists as to the number of senses because of differing definitions of what constitutes a 2) ___. The senses and their operation, classification, and theory are overlapping topics studied by a variety of fields, most notably Neuroscience, cognitive psychology, and philosophy of perception. The nervous system has a specific sensory system, or organ, that manages each sense. One categorization for human senses is as follows: chemoreception; photoreception; mechanoreception; and thermoception. This categorization has been criticized as too restrictive, however, as it does not include categories for accepted senses such as the sense of time and sense of pain. Some non-human animals possess senses that are absent in humans, such as electroreception and detection of polarized light.
Study of rare genetic disorder reveals importance of touch and body awareness. With the help of two young patients with a unique neurological disorder, scientists have discovered that a 3) ___ called PIEZO2 controls specific aspects of human touch and proprioception, a sixth sense describing awareness of one’s body in space. Mutations in the gene caused the two to have movement and balance problems and the loss of some forms of touch. Despite their difficulties, they both appeared to cope with these challenges by relying heavily on vision and other senses.
Unlocking the mysteries of our senses: An NIH Study shows that two young patients with a mutation in the PIEZO2 have problems with touch and proprioception, or body awareness. Credit: Bonnemann Lab, NIH/NINDS, Bethesda, MD
Our study highlights the critical importance of PIEZO2 and the senses it controls in our daily lives, said Carsten G. Bonnemann, M.D., senior investigator at the NIH’s National Institute of Neurological Disorders and Stroke (NINDS) and a co-leader of the study published in the New England Journal of Medicine. The results establish that PIEZO2 is a touch and proprioception gene in 4) ___. Understanding its role in these senses may provide clues to a variety of neurological disorders. Dr. Bonnemann’s team uses cutting edge genetic techniques to help diagnose children around the world who have disorders that are difficult to characterize. The two patients in this study are unrelated, one nine and the other 19 years old. They have difficulties walking; hip, finger and foot deformities; and abnormally curved 5) ___ diagnosed as progressive scoliosis. Working with the laboratory of Alexander T. Chesler, Ph.D., investigator at NIH’s National Center for Complementary and Integrative Health (NCCIH), the researchers discovered that the patients have mutations in the PIEZO2 gene that appear to block the normal production or activity of Piezo2 proteins in their cells. Piezo2 is what scientists call a mechanosensitive protein because it generates electrical 6) ___ signals in response to changes in cell shape, such as when skin cells and neurons of the hand are pressed against a table. Studies in mice suggest that Piezo2 is found in the neurons that control touch and proprioception. As someone who studies Piezo2 in mice, working with these patients was humbling, said Dr. Chesler. Our results suggest they are touch-blind. The patient’s version of Piezo2 may not work, so their neurons cannot detect touch or limb movements. Further examinations at the NIH Clinical Center suggested the young patients lack body awareness. Blindfolding them made walking extremely difficult, causing them to stagger and stumble from side to side while assistants prevented them from falling. When the researchers compared the two patients with unaffected volunteers, they found that blindfolding the young patients made it harder for them to reliably reach for an object in front of their faces than it was for the volunteers. Without looking, the patients could not guess the direction their joints were being moved as well as the control subjects could. The patients were also less sensitive to certain forms of touch. They could not feel vibrations from a buzzing tuning 7) ___ as well as the control subjects could. Nor could they tell the difference between one or two small ends of a caliper pressed firmly against their palms. Brain scans of one patient showed no response when the palm of her hand was brushed. Nevertheless, the patients could feel other forms of touch. Stroking or brushing hairy skin is normally perceived as pleasant. Although they both felt the brushing of hairy skin, one claimed it felt prickly instead of the pleasant sensation reported by unaffected volunteers. 8) ___ scans showed different activity patterns in response to brushing between unaffected volunteers and the patient who felt prickliness. Despite these differences, the patients’ nervous systems appeared to be developing normally. They were able to feel pain, itch, and temperature normally; the nerves in their limbs conducted electricity rapidly; and their brains and cognitive abilities were similar to the control subjects of their age. What’s remarkable about these patients is how much their nervous systems compensate for their lack of touch and body awareness, said Dr. Bonnemann. It suggests the nervous system may have several alternate pathways that we can tap into when designing new therapies.
Previous studies found that mutations in PIEZO2 may have various effects on the Piezo2 protein that may result in genetic musculoskeletal disorders, including distal arthrogryposis type 5, Gordon Syndrome, and Marden-Walker Syndrome. Drs. Bonnemann and Chesler concluded that the scoliosis and joint problems of the patients in this study suggest that Piezo2 is either directly required for the normal growth and alignment of the skeletal system or that touch and proprioception indirectly guide 9) ___ development. Our study demonstrates that bench and bedside research are connected by a two-way street, said Dr. Chesler. Results from basic laboratory research guided our examination of the children. Now we can take that knowledge back to the lab and use it to design future experiments investigating the role of PIEZO2 in nervous 10) ___ and musculoskeletal development. This work was supported by the NCCIH and NINDS intramural research programs.
ANSWERS: 1) perception; 2) sense; 3) gene; 4) humans; 5) spines; 6) nerve; 7) fork; 8) Brain; 9) skeletal; 10) system
John Locke, Philosopher and Physician
Portrait of John Locke, by Godfrey Kneller, National Portrait Gallery, London
Editor’s note: We’re including, in History of Medicine, the well-known philosopher, John Locke, in this edition of the newsletter, because we didn’t realize (and readers might like to know), that this great thinker was also a physician.
John Locke FRS (1632-1704) was an English philosopher and physician, widely regarded as one of the most influential of Enlightenment thinkers and commonly known as the Father of Liberalism. Considered one of the first of the British empiricists, following the tradition of Sir Francis Bacon, he is equally important to social contract theory. His work greatly affected the development of epistemology and political philosophy. His writings influenced Voltaire and Rousseau, many Scottish Enlightenment thinkers, as well as the American revolutionaries. His contributions to classical republicanism and liberal theory are reflected in the United States Declaration of Independence. Locke’s theory of mind is often cited as the origin of modern conceptions of identity and the self, figuring prominently in the work of later philosophers such as Hume, Rousseau, and Kant. Locke was the first to define the self through a continuity of consciousness. He postulated that, at birth, the mind was a blank slate or tabula rasa. Contrary to Cartesian philosophy based on pre-existing concepts, he maintained that we are born without innate ideas, and that knowledge is instead determined only by experience derived from sense perception.
Locke was born on 29 August 1632, in a small thatched cottage by the church in Wrington, Somerset, about 12 miles from Bristol. He was baptized the same day. Soon after Locke’s birth, the family moved to the market town of Pensford, about seven miles south of Bristol, where Locke grew up in a rural Tudor house in Belluton. Locke’s father, also called John, was a country lawyer and clerk to the Justices of the Peace in Chew Magna, who had served as a captain of cavalry for the Parliamentarian forces during the early part of the English Civil War. His mother was Agnes Keene. Both parents were Puritans. In 1647, Locke was sent to the prestigious Westminster School in London under the sponsorship of Alexander Popham, a member of Parliament and his father’s former commander. After completing studies there, he was admitted to Christ Church, Oxford, in the autumn of 1652 at the age of twenty. The dean of the college at the time was John Owen, vice-chancellor of the university. Although a capable student, Locke was irritated by the undergraduate curriculum of the time. He found the works of modern philosophers, such as Rene Descartes, more interesting than the classical material taught at the university. Through his friend Richard Lower, whom he knew from the Westminster School, Locke was introduced to medicine and the experimental philosophy being pursued at other universities and in the Royal Society, of which he eventually became a member. Locke was awarded a bachelor’s degree in February 1656 and a master’s degree in June 1658. He obtained a bachelor of medicine in February 1675, having studied medicine extensively during his time at Oxford and worked with such noted scientists and thinkers as Robert Boyle, Thomas Willis, Robert Hooke and Richard Lower. In 1666, he met Lord Anthony Ashley Cooper, 1st Earl of Shaftesbury, who had come to Oxford seeking treatment for a liver infection. Cooper was impressed with Locke and persuaded him to become part of his retinue.
Locke had been looking for a career and in 1667 moved into Shaftesbury’s home at Exeter House in London, to serve as Lord Ashley’s personal physician. In London, Locke resumed his medical studies under the tutelage of Thomas Sydenham. Sydenham had a major effect on Locke’s natural philosophical thinking – an effect that would become evident in An Essay Concerning Human Understanding. Locke’s medical knowledge was put to the test when Shaftesbury’s liver infection became life-threatening. Locke coordinated the advice of several physicians and was probably instrumental in persuading Shaftesbury to undergo surgery (then life-threatening itself) to remove the cyst. Shaftesbury survived and prospered, crediting Locke with saving his life. During this time, Locke served as Secretary of the Board of Trade and Plantations and Secretary to the Lords Proprietor of Carolina, which helped to shape his ideas on international trade and economics.
Shaftesbury, as a founder of the Whig movement, exerted great influence on Locke’s political ideas. Locke became involved in politics when Shaftesbury became Lord Chancellor in 1672. Following Shaftesbury’s fall from favor in 1675, Locke spent some time travelling across France as tutor and medical attendant to Caleb Banks. He returned to England in 1679 when Shaftesbury’s political fortunes took a brief positive turn. Around this time, most likely at Shaftesbury’s prompting, Locke composed the bulk of the Two Treatises of Government. While it was once thought that Locke wrote the Treatises to defend the Glorious Revolution of 1688, recent scholarship has shown that the work was composed well before this date. The work is now viewed as a more general argument against absolute monarchy (particularly as espoused by Robert Filmer and Thomas Hobbes) and for individual consent as the basis of political legitimacy. Although Locke was associated with the influential Whigs, his ideas about natural rights and government are today considered quite revolutionary for that period in English history.
Locke fled to the Netherlands in 1683, under strong suspicion of involvement in the Rye House Plot, although there is little evidence to suggest that he was directly involved in the scheme. The philosopher and novelist Rebecca Newberger Goldstein argues that during his five years in Holland, Locke chose his friends from among the same freethinking members of dissenting Protestant groups as Spinoza’s small group of loyal confidants. Locke almost certainly met men in Amsterdam who spoke of the ideas of that renegade Jew who insisted on identifying himself through his religion of reason alone. While she says that Locke’s strong empiricist tendencies would have disinclined him to read a grandly metaphysical work such as Spinoza’s Ethics, in other ways he was deeply receptive to Spinoza’s ideas, most particularly to the rationalist’s well thought out argument for political and religious tolerance and the necessity of the separation of church and state. In the Netherlands, Locke had time to return to his writing, spending a great deal of time re-working the Essay and composing the Letter on Toleration. Locke did not return home until after the Glorious Revolution. Locke accompanied William of Orange’s wife back to England in 1688. The bulk of Locke’s publishing took place upon his return from exile – his aforementioned Essay Concerning Human Understanding, the Two Treatises of Civil Government and A Letter Concerning Toleration all appearing in quick succession.
Locke’s close friend Lady Masham invited him to join her at the Mashams’ country house in Essex. Although his time there was marked by variable health from asthma attacks, he nevertheless became an intellectual hero of the Whigs. During this period he discussed matters with such figures as John Dryden and Isaac Newton. Locke died on 28 October 1704, and is buried in the churchyard of the village of High Laver, east of Harlow in Essex, where he had lived in the household of Sir Francis Masham since 1691. Locke never married nor had children.
Events that happened during Locke’s lifetime include the English Restoration, the Great Plague of London and the Great Fire of London. He did not quite see the Act of Union of 1707, though the thrones of England and Scotland were held in personal union throughout his lifetime. Constitutional monarchy and parliamentary democracy were in their infancy during Locke’s time.
In the late 17th and early 18th centuries, Locke’s Two Treatises were rarely cited. Historian Julian Hoppit said of the book, except among some Whigs, even as a contribution to the intense debate of the 1690s it made little impression and was generally ignored until 1703 (though in Oxford in 1695 it was reported to have made ‘a great noise’). John Kenyon, in his study of British political debate from 1689 to 1720, has remarked that Locke’s theories were mentioned so rarely in the early stages of the [Glorious] Revolution, up to 1692, and even less thereafter, unless it was to heap abuse on them and that no one, including most Whigs, [were] ready for the idea of a notional or abstract contract of the kind adumbrated by Locke. In contrast, Kenyon adds that Algernon Sidney’s Discourses Concerning Government were certainly much more influential than Locke’s Two Treatises. In the 50 years after Queen Anne’s death in 1714, the Two Treatises were reprinted only once (except in the collected works of Locke). However, with the rise of American resistance to British taxation, the Second Treatise gained a new readership; it was frequently cited in the debates in both America and Britain. The first American printing occurred in 1773 in Boston.
Locke exercised a profound influence on political philosophy, in particular on modern liberalism. Michael Zuckert has argued that Locke launched liberalism by tempering Hobbesian absolutism and clearly separating the realms of Church and State. He had a strong influence on Voltaire who called him le sage Locke. His arguments concerning liberty and the social contract later influenced the written works of Alexander Hamilton, James Madison, Thomas Jefferson, and other Founding Fathers of the United States. In fact, one passage from the Second Treatise is reproduced verbatim in the Declaration of Independence, the reference to a long train of abuses. Such was Locke’s influence that Thomas Jefferson wrote: Bacon, Locke and Newton – I consider them as the three greatest men that have ever lived, without any exception, and as having laid the foundation of those superstructures which have been raised in the Physical and Moral sciences. But Locke’s influence may have been even more profound in the realm of epistemology. Locke redefined subjectivity, or self, and intellectual historians such as Charles Taylor and Jerrold Seigel argue that Locke’s An Essay Concerning Human Understanding (1690) marks the beginning of the modern Western conception of the self. Locke, writing his Letters Concerning Toleration (1689-92) in the aftermath of the European wars of religion, formulated a classic reasoning for religious tolerance. Three arguments are central: (1) Earthly judges, the state in particular, and human beings generally, cannot dependably evaluate the truth-claims of competing religious standpoints; (2) Even if they could, enforcing a single true religion would not have the desired effect, because belief cannot be compelled by violence; (3) Coercing religious uniformity would lead to more social disorder than allowing diversity. With regard to his position on religious tolerance, Locke was influenced by Baptist theologians like John Smyth and Thomas Helwys, who had published tracts demanding freedom of conscience in the early 17th century. Baptist theologian Roger Williams founded the colony Rhode Island in 1636, where he combined a democratic constitution with unlimited religious freedom. His tract The Bloody Tenent of Persecution for Cause of Conscience (1644), which was widely read in the mother country, was a passionate plea for absolute religious freedom and the total separation of church and state. Freedom of conscience had had high priority on the theological, philosophical and political agenda, since Martin Luther refused to recant his beliefs before the Diet of the Holy Roman Empire at Worms in 1521, unless he would be proved false by the Bible.
Appraisals of Locke have often been tied to appraisals of liberalism in general, and to appraisals of the United States. Detractors note that in 1671 he was a major investor in the English slave-trade through the Royal African Company. In addition, he participated in drafting the Fundamental Constitutions of Carolina while Shaftesbury’s secretary, which established a feudal aristocracy and gave a master absolute power over his slaves. For example, Martin Cohen notes that Locke, as a secretary to the Council of Trade and Plantations (1673-4) and a member of the Board of Trade (1696-1700), was in fact, one of just half a dozen men who created and supervised both the colonies and their iniquitous systems of servitude. Some see his statements on unenclosed property as having been intended to justify the displacement of the Native Americans. Because of his opposition to aristocracy and slavery in his major writings, he is accused of hypocrisy and racism, or of caring only for the liberty of English capitalists. Locke also drafted implementing instructions for the Carolina colonists designed to ensure that settlement and development was consistent with the Fundamental Constitutions. Collectively, these documents are known as the Grand Model for the Province of Carolina. Locke uses the word property in both broad and narrow senses. In a broad sense, it covers a wide range of human interests and aspirations; more narrowly, it refers to material goods. He argues that property is a natural right and it is derived from labor. In Chapter V of his Second Treatise, Locke argues that the individual ownership of goods and property is justified by the labor exerted to produce those goods or utilize property to produce goods beneficial to human society. Locke stated his belief, in his Second Treatise, that nature on its own provides little of value to society, implying that the labor expended in the creation of goods gives them their value. This position can be seen as a labor theory of value. From this premise, Locke developed a labor theory of property, namely that ownership of property is created by the application of labor. In addition, he believed that property precedes government and government cannot dispose of the estates of the subjects arbitrarily. Karl Marx later critiqued Locke’s theory of property in his own social theory.
Locke’s political theory was founded on social contract theory. Unlike Thomas Hobbes, Locke believed that human nature is characterized by reason and tolerance. Like Hobbes, Locke believed that human nature allowed people to be selfish. This is apparent with the introduction of currency. In a natural state all people were equal and independent, and everyone had a natural right to defend his Life, health, Liberty, or Possessions. Most scholars trace the phrase life, liberty, and the pursuit of happiness, in the American Declaration of Independence, to Locke’s theory of rights, though other origins have been suggested. Like Hobbes, Locke assumed that the sole right to defend in the state of nature was not enough, so people established a civil society to resolve conflicts in a civil way with help from government in a state of society. However, Locke never refers to Hobbes by name and may instead have been responding to other writers of the day. Locke also advocated governmental separation of powers and believed that revolution is not only a right but an obligation in some circumstances. These ideas would come to have profound influence on the Declaration of Independence and the Constitution of the United States. According to Locke, unused property is wasteful and an offence against nature, but, with the introduction of durable goods, men could exchange their excessive perishable goods for goods that would last longer and thus not offend the natural law. In his view, the introduction of money marks the culmination of this process, making possible the unlimited accumulation of property without causing waste through spoilage. He also includes gold or silver as money because they may be hoarded up without injury to anyone, since they do not spoil or decay in the hands of the possessor. In his view, the introduction of money eliminates the limits of accumulation. Locke stresses that inequality has come about by tacit agreement on the use of money, not by the social contract establishing civil society or the law of land regulating property. Locke is aware of a problem posed by unlimited accumulation but does not consider it his task. He just implies that government would function to moderate the conflict between the unlimited accumulation of property and a more nearly equal distribution of wealth; he does not identify which principles that government should apply to solve this problem. However, not all elements of his thought form a consistent whole. For example, labor theory of value of the Two Treatises of Government stands side by side with the demand-and-supply theory developed in a letter he wrote titled Some Considerations on the Consequences of the Lowering of Interest and the Raising of the Value of Money. Moreover, Locke anchors property in labor but in the end upholds the unlimited accumulation of wealth.
Locke’s general theory of value and price is a supply and demand theory, which was set out in a letter to a Member of Parliament in 1691, titled Some Considerations on the Consequences of the Lowering of Interest and the Raising of the Value of Money. He refers to supply as quantity and demand as rent. The price of any commodity rises or falls by the proportion of the number of buyer and sellers, and that which regulates the price… [of goods] is nothing else but their quantity in proportion to their rent. The quantity theory of money forms a special case of this general theory. His idea is based on money answers all things (Ecclesiastes) or rent of money is always sufficient, or more than enough, and varies very little. Locke concludes that as far as money is concerned, the demand is exclusively regulated by its quantity, regardless of whether the demand for money is unlimited or constant. He also investigates the determinants of demand and supply. For supply, he explains the value of goods as based on their scarcity and ability to be exchanged and consumed. He explains demand for goods as based on their ability to yield a flow of income. Locke develops an early theory of capitalization, such as land, which has value because by its constant production of saleable commodities it brings in a certain yearly income. He considers the demand for money as almost the same as demand for goods or land; it depends on whether money is wanted as medium of exchange. As a medium of exchange, he states that money is capable by exchange to procure us the necessaries or conveniences of life, and for loanable funds, it comes to be of the same nature with land by yielding a certain yearly income or interest. Locke distinguishes two functions of money, as a counter to measure value, and as a pledge to lay claim to goods. He believes that silver and gold, as opposed to paper money, are the appropriate currency for international transactions. Silver and gold, he says, are treated to have equal value by all of humanity and can thus be treated as a pledge by anyone, while the value of paper money is only valid under the government which issues it.
Locke argues that a country should seek a favorable balance of trade, lest it fall behind other countries and suffer a loss in its trade. Since the world money stock grows constantly, a country must constantly seek to enlarge its own stock. Locke develops his theory of foreign exchanges, in addition to commodity movements, there are also movements in country stock of money, and movements of capital determine exchange rates. He considers the latter less significant and less volatile than commodity movements. As for a country’s money stock, if it is large relative to that of other countries, he says it will cause the country’s exchange to rise above par, as an export balance would do. He also prepares estimates of the cash requirements for different economic groups (landholders, laborers and brokers). In each group he posits that the cash requirements are closely related to the length of the pay period. He argues the brokers – middlemen – whose activities enlarge the monetary circuit and whose profits eat into the earnings of laborers and landholders, have a negative influence on both personal and the public economy to which they supposedly contribute. Locke defines the self as that conscious thinking thing, (whatever substance, made up of whether spiritual, or material, simple, or compounded, it matters not) which is sensible, or conscious of pleasure and pain, capable of happiness or misery, and so is concerned for itself, as far as that consciousness extends. He does not, however, ignore substance, writing that the body too goes to the making the man.
In his Essay, Locke explains the gradual unfolding of this conscious mind. Arguing against both the Augustinian view of man as originally sinful and the Cartesian position, which holds that man innately knows basic logical propositions, Locke posits an empty mind, a tabula rasa, which is shaped by experience; sensations and reflections being the two sources of all our ideas. Locke’s Some Thoughts Concerning Education is an outline on how to educate this mind: he expresses the belief that education maketh the man, or, more fundamentally, that the mind is an empty cabinet, with the statement, I think I may say that of all the men we meet with, nine parts of ten are what they are, good or evil, useful or not, by their education. Locke also wrote that the little and almost insensible impressions on our tender infancies have very important and lasting consequences. He argued that the associations of ideas that one makes when young are more important than those made later because they are the foundation of the self: they are, put differently, what first mark the tabula rasa. In his Essay, in which both these concepts are introduced, Locke warns against, for example, letting a foolish maid convince a child that goblins and sprites are associated with the night for darkness shall ever afterwards bring with it those frightful ideas, and they shall be so joined, that he can no more bear the one than the other. This theory came to be called associationism, and it strongly influenced 18th-century thought, particularly educational theory, as nearly every educational writer warned parents not to allow their children to develop negative associations. It also led to the development of psychology and other new disciplines with David Hartley’s attempt to discover a biological mechanism for associationism in his Observations on Man (1749).
Drug to Treat Alcoholism Shows Promise
According to a study published online in the journal Neuropsychopharmacology (September 2016), a new medication that targets part of the brain’s stress system may help reduce alcohol use in people with alcohol use disorder (AUD). The investigation was a 12-week, randomized clinical trial that recruited 144 alcohol-dependent adult men and women. The investigational product, called ABT-436, was designed to block the effects of vasopressin, a neuropeptide produced in the hypothalamus of the brain. Vasopressin helps to regulate the pituitary adrenal axis and other brain circuits involved in emotion. As a result, it plays a role in regulating stress, anxiety, and their interaction with AUD.”
During the 28-day baseline period, female participants consumed at least 28 drinks per week, while male participants consumed at least 35 drinks per week. Participants were then randomized to receive either placebo tablets or ones containing ABT-436. During the study participants’ alcohol consumption was monitored, as well as their mood changes and smoking habits, as these are known to co-vary with alcohol consumption.
Results showed that participants receiving ABT-436 experienced more days of alcohol abstinence than those receiving the placebo. In particular, participants who reported high levels of stress appeared to respond better to ABT-436, in that both the frequency of their drinking and the number of heavy drinking days they experienced decreased. The authors suggested that potential future studies with drugs targeting vasopressin blockade should focus on populations of people with AUD who also report high levels of stress. Smokers may be another population that could benefit from ABT-436. In addition to its effects on alcohol consumption, study participants receiving the ABT-436 experienced a reduction in smoking. The authors suspected that ABT-436 might be targeting the same areas in the brain that relate to withdrawal and stress, and, in the process, influencing both tobacco and alcohol use disorders. Additional research is needed to determine if that is the case.