FDA Warns of Fraudulent and Unapproved Flu Products


As part of the FDA’s ongoing efforts to protect consumers from health fraud, the agency is reminding consumers to be wary of unapproved products claiming to prevent, treat or cure influenza, or flu. This year’s severe flu season raises new concerns about the potential for consumers to be lured into buying unproven flu treatments, and even worse, buying counterfeit antivirals online from websites that appear to be legitimate online pharmacies. As the flu continues to make people sick – and even cause deaths – unscrupulous actors may also be taking advantage of unsuspecting consumers by promoting their fraudulent products that have not been reviewed by the FDA to be safe and effective. The FDA is warning consumers to be alert, and try and steer clear of fraudulent flu products, which may be found online or in retail stores. FDA is advising consumers on some of the telltale signs to look for when trying to spot flu products that may be fraudulent. People who are sick with flu-like symptoms and those who are at high risk of serious flu complications should see a health care professional as soon as possible to see if they should be treated with antiviral drugs.


Consumers should be aware that there are no legally marketed over-the-counter (OTC) drugs to prevent or cure the flu. However, there are legal OTC products to reduce fever and to relieve muscle aches, congestion and other symptoms typically associated with the flu. Products sold online are fraudulent if they claim to prevent, treat or cure the flu, and have not been evaluated by the FDA for that intended use. These flu claims may indicate that an OTC product is fraudulent:


– reduces severity and length of the flu;

– boosts your immunity naturally without a flu shot;

– safe and effective alternative to the flu vaccine;

– prevents catching the flu;

– effective treatment for the flu;

– faster recovery from the flu; or

– supports your body’s natural immune defenses to fight off the flu.


Health fraud scams waste money, lead to delays in getting a proper diagnosis and treatment, and may even lead to more serious injuries or death. The FDA routinely warns the public about health scams and has recently taken action against companies promoting and selling unproven treatments for cancer, opioid addiction and other illnesses. However, there are numerous unapproved and potentially unsafe products that continue to be sold directly to consumers in part because companies or individuals can move their marketing operations to new websites. Online pharmacies present another opportunity for scammers to take advantage of unsuspecting consumers. Online pharmacies may claim to sell prescription antiviral drugs, such as Tamiflu, at reduced prices or without a prescription. The FDA advises consumers to avoid purchasing products making such claims. Beware of online pharmacies that:


– allow you to buy prescription medicine without a prescription from your health care provider;

– do not have a U.S. state-licensed pharmacist available to answer your questions;

– offer very low prices that seem too good to be true; or

– are located outside of the U.S. or ship worldwide.


These pharmacies often sell medicines that can be dangerous because they may:


– have too much or too little of the active ingredient you need to treat your disease or condition;

– not contain the right active ingredient; or

– contain wrong or other harmful ingredients.


Legitimate online pharmacies exist, but so do many websites that look like professional and legitimate pharmacies, but are actually fraudulent. The FDA recommends consumers buy prescription drugs from their local pharmacy or only through an online pharmacy that requires a valid prescription from a doctor or other authorized health care professional and is licensed by the state board of pharmacy (or equivalent state agency) where the patient is located.


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Kale and Cheese Stuffed Potatoes

This is a delicious recipe and easy to make. ©Joyce Hays, Target Health Inc.


Kale and Cheese Stuffed Potatoes

(Kale for Brunch, Lunch or Dinner)

3 russet potatoes about 10 oz. each (long and flat)

1 bunch Tuscan kale

Coarse salt

1 Tablespoon olive oil

1 Tablespoon butter

1 large leek

1 cup coarsely grated cheddar, gruyere or comte

3/4 cup sour cream

Pinch black pepper

Pinch cayenne

3 fresh garlic cloves, minced


Get all ingredients together ©Joyce Hays, Target Health Inc.



Heat oven to 400oF.


1. Cook potatoes the first time: Gently scrub potatoes but do not peel. Pierce all over with a fork so that steam escapes. If you don’t poke some holes, you could have a potato explosion followed by a mess. Bake 1 hour to 1 hour 15 minutes or until potatoes are tender when pierced in center. Leave oven on.


2. While potatoes cook, prepare stuffing: Tear kale leaves off the stems, and wash leaves in cold water to remove any dirt. Don’t dry. Tear leaves into large pieces. Heat a pan over medium-high and add the kale and a pinch of salt. Cook in the pan with just the water clinging to the leaves until they wilt down. Remove from pan and transfer to a colander and when cool enough to handle, wring out any extra moisture. I use either paper toweling or a clean kitchen towel. On a cutting board, finely chop greens. There should be about a cup of well-chopped greens; more or less.


3. Trim leek down to the yellow and pale green part. Halve lengthwise and wash in cold water to remove any dirt, then pat dry. Cut leek halves the long way, again, so they’re in quarter-stalks, and thinly slice.


In a bowl, mixing the cooked kale, garlic and leeks ©Joyce Hays, Target Health Inc.


4. Heat a large skillet over medium heat; add butter and oil. When both are warm, add leek and reduce heat to medium-low. Cook until mostly tender and sweet, about 10 to 15 minutes, stirring. Avoid letting it brown. Add the minced garlic and chopped kale back to pan and warm up with leeks, for about 1 minute. Transfer mixture to a bowl.


Potatoes, leeks, kale have been mashed, sour cream and 3/4 grated cheese have been stirred in. Mixture is ready to heap into the baked shells of the potato. ©Joyce Hays, Target Health Inc.


5. Prepare potatoes: When potatoes are cool enough to handle, halve lengthwise and scoop out all but the last 1/4-inch thickness of skin and potato (you want the potato shell to remain strong enough to hold all the stuffing). Now add the potato insides, to bowl with leeks and greens. Arrange the potato shells on a baking sheet. Mash potatoes, leeks and kale together until smooth. Stir in the sour cream, 3/4 of cheese and more salt and pepper (optional). Now, heap the kale/potato mixture into the potato skins. Sprinkle with remaining 1/4 of cheese.


Going in oven for second time ©Joyce Hays, Target Health Inc.


6. Bake potatoes a second time, 20 to 30 minutes, until golden brown and crispy. Serve while still nice and warm


We opened some of this bottled red satin, which we were saving for a special occasion. This is a well-known vineyard putting forth, year after year, only excellent wines. You can’t go wrong drinking it now or investing in futures. ©Joyce Hays, Target Health Inc.


Friday night, we started by toasting with this delicious (from start to finish), full bodied cab, and a salad with fresh ripe tomatoes, cut up avocados, green olives, mini thin-skinned cucumbers, endive and a fresh lemon juice/olive oil dressing. Then came the unbelievably tender center-cut fillet mignon with marsala/mushroom sauce, the (recipe above) kale/cheese stuffed potatoes, some cauliflower fritters with pomegranate arils (will post my recipe soon), some sweet potato/date patties with chopped pistachios (will post another of my recipes soon) and more wine.


Our house guests for a while from LA:  our son and his friend.  We went to the MetOpera to see the gorgeous Anthony Minghella production of Puccini’s Madam Butterfly and enjoyed it immensely. A wonderful weekend was had by all. Here we are dining out at Sardi’s. We look forward to many more visits like the stimulating one we’re in the midst of now.  ©Joyce Hays, Target Health Inc.


Here are two favorite moments from an extraordinary production of Puccini’s Madame Butterfly:


The beautiful Humming Chorus, as the curtain falls on Act 2


Madama Butterfly: “Un bel di” – Maria Callas



Have a great week everyone!


From Our Table to Yours

Bon Appetit!


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March 1, 2018

University of California – San Diego

Science continues to peel away layers of the skin microbiome to reveal its protective properties. Researchers now report on a potential new role for some bacteria on the skin: protecting against cancer.


This is S. epidermidis growing on an agar plate. A strain of S. epidermidis was shown to produce a molecule that kills cancer cells and inhibits the development of skin tumors on mice. UC San Diego Health



Science continues to peel away layers of the skin microbiome to reveal its protective properties. In a study published in Science Advances on February 28, University of California San Diego School of Medicine researchers report a potential new role for some bacteria on the skin: protecting against cancer.

“We have identified a strain of Staphylococcus epidermidis, common on healthy human skin, that exerts a selective ability to inhibit the growth of some cancers,” said Richard Gallo, MD, PhD, Distinguished Professor and chair of the Department of Dermatology at UC San Diego School of Medicine. “This unique strain of skin bacteria produces a chemical that kills several types of cancer cells but does not appear to be toxic to normal cells.”

The team discovered the S. epidermidis strain produces the chemical compound 6-N-hydroxyaminopurine (6-HAP). Mice with S. epidermidis on their skin that did not make 6-HAP had many skin tumors after being exposed to cancer-causing ultraviolet rays (UV), but mice with the S. epidermidis strain producing 6-HAP did not.

6-HAP is a molecule that impairs the creation of DNA, known as DNA synthesis, and prevents the spread of transformed tumor cells as well as the potential to suppress development of UV-induced skin tumors.

Mice that received intravenous injections of 6-HAP every 48 hours over a two-week period experienced no apparent toxic effects, but when transplanted with melanoma cells, their tumor size was suppressed by more than 50 percent compared to controls.

“There is increasing evidence that the skin microbiome is an important element of human health. In fact, we previously reported that some bacteria on our skin produce antimicrobial peptides that defend against pathogenic bacteria such as, Staph aureus,” said Gallo.

In the case of S. epidermidis, it appears to also be adding a layer of protection against some forms of cancer, said Gallo. Further studies are needed to understand how 6-HAP is produced, if it can be used for prevention of cancer or if loss of 6-HAP increases cancer risk, said Gallo.

More than 1 million cases of skin cancer are diagnosed in the United States each year. More than 95 percent of these are non-melanoma skin cancer, which is typically caused by overexposure to the sun’s UV rays. Melanoma is the most serious form of skin cancer that starts in the pigment-producing skin cells, called melanocytes.

Story Source:

Materials provided by University of California – San DiegoNote: Content may be edited for style and length.

Journal Reference:

  1. Teruaki Nakatsuji, Tiffany H. Chen, Anna M. Butcher, Lynnie L. Trzoss, Sang-Jip Nam, Karina T. Shirakawa, Wei Zhou, Julia Oh, Michael Otto, William Fenical, Richard L. Gallo. A commensal strain of Staphylococcus epidermidis protects against skin neoplasiaScience Advances, 2018; 4 (2): eaao4502 DOI: 10.1126/sciadv.aao4502


Source: University of California – San Diego. “Beneficial skin bacteria protect against skin cancer.” ScienceDaily. ScienceDaily, 1 March 2018. <www.sciencedaily.com/releases/2018/03/180301103701.htm>.

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February 28, 2018

Brown University

Scientists have long wanted to retrieve rock samples from the Moon’s South Pole-Aitken basin, and a new study could be helpful in locating an ideal landing site.


A new study shows four distinct compositional regions within and around the Moon’s largest impact basin. The findings could help guide future exploration of the basin.
Credit: NASA/Goddard Space Flight Center



A detailed study of a giant impact crater on the Moon’s far side could provide a roadmap for future lunar explorers.

The study, by planetary scientists from Brown University, maps the mineralogy of the South Pole-Aitken (SPA) basin, a gash in the lunar surface with a diameter of approximately 2,500 kilometers (1,550 miles). SPA is thought to be the oldest and largest impact basin on the Moon, and scientists have long had their eyes on it as a target for future lunar landers.

“This is a highly detailed look at the compositional structure of this huge impact basin using modern, cutting-edge data,” said Dan Moriarty, a postdoctoral researcher at NASA’s Goddard Space Flight Center who led the research while a doctoral student at Brown. “Given that it’s such an important target for future exploration and perhaps returning a sample to Earth, we hope this will serve as a framework for more detailed study and landing site selection.”

The study will be published in the Journal of Geophysical Research: Planets.

The impact that created SPA is thought to have blasted all the way through the Moon’s crust and into the mantle, which is part of the reason that scientists are so interested in it. Visiting SPA and grabbing a sample of that exposed mantle material could provide critical clues about the Moon’s origin and evolution. A sample could also help scientists put a firm date on the impact. SPA is thought to be the Moon’s oldest basin, so a firm date would be a key milestone in the timeline of lunar history as well as events affecting early Earth.

But in order to get the right samples, it’s important to know the best spots to find them. That’s what Moriarty and co-author Carlé Pieters, a professor in Brown’s Department of Earth, Environmental and Planetary Sciences, had in mind for this study. They used detailed data from Moon Mineralogy Mapper, a spectrometer that flew aboard India’s Chandrayaan-1 spacecraft for which Pieters is principal investigator.

“Having global access with modern imaging spectrometers from lunar orbit is the next best thing to having a geologist with a rock hammer doing the field work across the surface.” Pieters said. “Ideally, in the future we’ll have both working together.”

The research identified four distinct mineralogical regions that form a bullseye pattern within and around the basin. At the bulleye’s center is a region of what appears to be deposits of volcanic material, a sign that the center of the basin may have been covered by a volcanic flow sometime soon after the SPA impact. That central region is surrounded by a ring of material dominated by magnesium-rich pyroxene, a mineral thought to be plentiful in the lunar mantle. Outside of that is a ring in which pyroxene mixes with the standard crustal rocks of the lunar highlands. Outside of that ring is the basin exterior, where the signatures of impact-related material disappear.

The findings have some interesting implications for SPA exploration, the researchers say. The research suggests, for example, that finding pristine mantle material in the middle of the basin might be a bit tricky because of the large volcanic deposit.

“That’s a little bit counterintuitive,” Moriarty said. “Typically the deepest excavation would be in the middle of the crater. But we show that the middle of SPA has been covered over by what looks like a volcanic flow.”

So if you’re looking for mantle, it might be wise to land in the ring surrounding the center, where what appears to be mantle material is highly concentrated.

But an ideal landing site, Moriarty says, might be a spot that has both mantle and volcanic material, because those volcanics are interesting in their own right. Their composition is a little different than that of other volcanic rocks found on the Moon, which suggests they have a unique origin.

“If these rocks are indeed volcanic, it means that there was a really interesting kind of volcanism happening at SPA,” Moriarty said. “It could be related to the extreme geophysical environment that would have been in place during the formation of the basin. That would be really interesting to look at in more depth.”

With that in mind, Moriarty says a good spot to land might be near the border of the volcanic center and the pyroxene ring. Another strategy could be to look for a spot where the volcanic material has been pierced by a subsequent impact. Moriarty and Pieters found several such craters in the volcanic patch where the pyroxene material has been re-excavated.

“We think going after both mantle and volcanics would make for a richer science return,” Moriarty said.

Moriarty is hopeful that these findings will give mission planners something to think about. China is currently in the process of planning for a mission to SPA. The region has appeared repeatedly on NASA’s “decadal survey” of planetary scientists, which is used to inform the agency’s mission priorities.

“Impacts are the dominant process that drove solar system creation and evolution, and SPA is the largest confirmed impact structure on the Moon, if not the entire solar system,” Moriarty said. “That makes it an important end member in understanding impact processes. We think this work could provide a roadmap for exploring SPA in more detail.”

The research was supported by NASA’s LASER (NNX12AI96G) and SSERVI (NNA14AB01A) programs.

Story Source:

Materials provided by Brown UniversityNote: Content may be edited for style and length.

Journal Reference:

  1. D. P. Moriarty, C. M. Pieters. The Character of South Pole – Aitken Basin: Patterns of Surface and Sub-Surface CompositionJournal of Geophysical Research: Planets, 2018; DOI: 10.1002/2017JE005364


Source: Brown University. “Mineralogy of potential lunar exploration site.” ScienceDaily. ScienceDaily, 28 February 2018. <www.sciencedaily.com/releases/2018/02/180228153013.htm>.

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Investment in greater storage, transmission capabilities needed

February 27, 2018

University of California – Irvine

The United States could reliably meet about 80 percent of its electricity demand with solar and wind power generation, according to scientists.


Solar panels cover the roof of UCI’s Student Center Parking Structure. A new study co-authored by Steven Davis, associate professor of Earth system science, shows that the U.S. can meet 80 percent of its electricity demand with renewable solar and wind resources.
Credit: Steve Zylius / UCI



The United States could reliably meet about 80 percent of its electricity demand with solar and wind power generation, according to scientists at the University of California, Irvine; the California Institute of Technology; and the Carnegie Institution for Science.

However, meeting 100 percent of electricity demand with only solar and wind energy would require storing several weeks’ worth of electricity to compensate for the natural variability of these two resources, the researchers said.

“The sun sets, and the wind doesn’t always blow,” noted Steven Davis, UCI associate professor of Earth system science and co-author of a renewable energy study published today in the journal Energy & Environmental Science. “If we want a reliable power system based on these resources, how do we deal with their daily and seasonal changes?”

The team analyzed 36 years of hourly U.S. weather data (1980 to 2015) to understand the fundamental geophysical barriers to supplying electricity with only solar and wind energy.

“We looked at the variability of solar and wind energy over both time and space and compared that to U.S. electricity demand,” Davis said. “What we found is that we could reliably get around 80 percent of our electricity from these sources by building either a continental-scale transmission network or facilities that could store 12 hours’ worth of the nation’s electricity demand.”

The researchers said that such expansion of transmission or storage capabilities would mean very substantial — but not inconceivable — investments. They estimated that the cost of the new transmission lines required, for example, could be hundreds of billions of dollars. In comparison, storing that much electricity with today’s cheapest batteries would likely cost more than a trillion dollars, although prices are falling.

Other forms of energy stockpiling, such as pumping water uphill to later flow back down through hydropower generators, are attractive but limited in scope. The U.S. has a lot of water in the East but not much elevation, with the opposite arrangement in the West.

Fossil fuel-based electricity production is responsible for about 38 percent of U.S. carbon dioxide emissions — CO2 pollution being the major cause of global climate change. Davis said he is heartened by the progress that has been made and the prospects for the future.

“The fact that we could get 80 percent of our power from wind and solar alone is really encouraging,” he said. “Five years ago, many people doubted that these resources could account for more than 20 or 30 percent.”

But beyond the 80 percent mark, the amount of energy storage required to overcome seasonal and weather variabilities increases rapidly. “Our work indicates that low-carbon-emission power sources will be needed to complement what we can harvest from the wind and sun until storage and transmission capabilities are up to the job,” said co-author Ken Caldeira of the Carnegie Institution for Science. “Options could include nuclear and hydroelectric power generation, as well as managing demand.”

Story Source:

Materials provided by University of California – IrvineNote: Content may be edited for style and length.

Journal Reference:

  1. Matthew R. Shaner, Steven J. Davis, Nathan S. Lewis, Ken Caldeira. Geophysical constraints on the reliability of solar and wind power in the United StatesEnergy & Environmental Science, 2018; DOI: 10.1039/c7ee03029k


Source: University of California – Irvine. “Wind and solar power could meet four-fifths of US electricity demand, study finds: Investment in greater storage, transmission capabilities needed.” ScienceDaily. ScienceDaily, 27 February 2018. <www.sciencedaily.com/releases/2018/02/180227111639.htm>.

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Microorganisms rebounded after decades without water

February 26, 2018

Washington State University

For the first time, researchers have seen life rebounding in the world’s driest desert, demonstrating that it could also be lurking in the soils of Mars.


The hyperarid core of the Atacama Desert.
Credit: Dirk Schulze-Makuch



For the first time, researchers have seen life rebounding in the world’s driest desert, demonstrating that it could also be lurking in the soils of Mars.

Led by Washington State University planetary scientist Dirk Schulze-Makuch, an international team studied the driest corner of South America’s Atacama Desert, where decades pass without any rain.

Scientists have long wondered whether microbes in the soil of this hyperarid environment, the most similar place on Earth to the Martian surface, are permanent residents or merely dying vestiges of life, blown in by the weather.

In a new study published in the Proceedings of the National Academy of Sciences, Schulze-Makuch and his collaborators reveal that even the hyper-arid Atacama Desert can provide a habitable environment for microorganisms.

The researchers found that specialized bacteria are able to live in the soil, going dormant for decades, without water and then reactivating and reproducing when it rains.

“It has always fascinated me to go to the places where people don’t think anything could possibly survive and discover that life has somehow found a way to make it work,” Schulze-Makuch said. “Jurassic Park references aside, our research tell us that if life can persist in Earth’s driest environment there is a good chance it could be hanging in there on Mars in a similar fashion.”

The dry limit of life

When Schulze-Makuch and his collaborators went to the Atacama for the first time in 2015 to study how organisms survive in the soil of Earth’s driest environment, the craziest of things happened.

It rained.

After the extremely rare shower, the researchers detected an explosion of biological activity in the Atacama soil.

They used sterilized spoons and other delicate instrumentation to scoop soil samples from various depths and then performed genomic analyses to identify the different microbial communities that were reproducing in the samples. The researchers found several indigenous species of microbial life that had adapted to live in the harsh environment.

The researchers returned to the Atacama in 2016 and 2017 to follow up on their initial sampling and found that the same microbial communities in the soil were gradually reverting to a dormant state as the moisture went away.

“In the past researchers have found dying organisms near the surface and remnants of DNA but this is really the first time that anyone has been able to identify a persistent form of life living in the soil of the Atacama Desert,” Schulze-Makuch said. “We believe these microbial communities can lay dormant for hundreds or even thousands of years in conditions very similar to what you would find on a planet like Mars and then come back to life when it rains.”

Implications for life on Mars

While life in the driest regions of Earth is tough, the Martian surface is an even harsher environment.

It is akin to a drier and much colder version of the Atacama Desert. However it wasn’t always this way.

Billions of years ago, Mars had small oceans and lakes where early lifeforms may have thrived. As the planet dried up and grew colder, these organisms could have evolved many of the adaptations lifeforms in the Atacama soil use to survive on Earth, Schulze-Makuch said.

“We know there is water frozen in the Martian soil and recent research strongly suggests nightly snowfalls and other increased moisture events near the surface,” he said. “If life ever evolved on Mars, our research suggests it could have found a subsurface niche beneath today’s severely hyper-arid surface.”

Next Steps

On March 15, Schulze-Makuch is returning to the Atacama for two weeks to investigate how the Atacama’s native inhabitants have adapted to survive. He said his research team also would like to look for lifeforms in the Don Juan Pond in Antarctica, a very shallow lake that is so salty it remains liquid even at temperatures as low as -58 degrees Fahrenheit.

“There are only a few places left on Earth to go looking for new lifeforms that survive in the kind of environments you would find on Mars,” Schulze-Makuch said. “Our goal is to understand how they are able to do it so we will know what to look for on the Martian surface.”

Story Source:

Materials provided by Washington State University. Original written by Will Ferguson, College of Arts and Sciences. Note: Content may be edited for style and length.

Journal Reference:

  1. Dirk Schulze-Makuch, Dirk Wagner, Samuel P. Kounaves, Kai Mangelsdorf, Kevin G. Devine, Jean-Pierre de Vera, Philippe Schmitt-Kopplin, Hans-Peter Grossart, Victor Parro, Martin Kaupenjohann, Albert Galy, Beate Schneider, Alessandro Airo, Jan Frösler, Alfonso F. Davila, Felix L. Arens, Luis Cáceres, Francisco Solís Cornejo, Daniel Carrizo, Lewis Dartnell, Jocelyne DiRuggiero, Markus Flury, Lars Ganzert, Mark O. Gessner, Peter Grathwohl, Lisa Guan, Jacob Heinz, Matthias Hess, Frank Keppler, Deborah Maus, Christopher P. McKay, Rainer U. Meckenstock, Wren Montgomery, Elizabeth A. Oberlin, Alexander J. Probst, Johan S. Sáenz, Tobias Sattler, Janosch Schirmack, Mark A. Sephton, Michael Schloter, Jenny Uhl, Bernardita Valenzuela, Gisle Vestergaard, Lars Wörmer, Pedro Zamorano. Transitory microbial habitat in the hyperarid Atacama DesertProceedings of the National Academy of Sciences, 2018; 201714341 DOI: 10.1073/pnas.1714341115


Washington State University. “Life in world’s driest desert seen as sign of potential life on Mars: Microorganisms rebounded after decades without water.” ScienceDaily. ScienceDaily, 26 February 2018. <www.sciencedaily.com/releases/2018/02/180226152634.htm>.

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Rare and Orphan Diseases at Target Health Inc.


One of Target Health’s expertise is in the area of rare and orphan diseases. Our expertise is not just in obtaining Orphan Drug Designations in multiple areas, but also the regulatory strategy to optimize the path to the market. For one program, we worked with our client to propose to FDA to go directly from Phase 1 in normal volunteers to a pivotal trial with 30 patients with just 2 doses of the drug and no placebo arm. The drug was approved and the company saved at least 2 years by not having to do a phase 2 study. In additional, the NDA was a rolling submission, so that when the last patient visit occurred in September, the final NDA was submitted in December, just 3 months later. Of course, the planning of the submission started a year in advance which made for a smooth transition. A recent Orphan Drug Designation was approved for a rare epilepsy in children and a Fast Track Designation cleared for a metabolic disease.


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. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.


Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor


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Cell Signaling

Notch-mediated juxtacrine signal between adjacent cells.


Graphic credit: Fred the Oysteri. The source code of this SVG is valid. This vector graphics image was created with Adobe Illustrator. – Graphic: National Institute of Health. U.S. http://ccr.cancer.gov/staff/images/1372_Fortini_178.gif, Public Domain, https://commons.wikimedia.org/w/index.php?curid=36238400


In 1999 Dr. Gunter Blobel of the Rockefeller University in New York received the Nobel Laureate in Medicine or Physiology for his discovery of this protein signal system of “ZIP codes.“


ZIP code, protein is an informal name for a molecular cell biology system of signals or “address tags“ that guide the movement of a protein within a cell. In more technical terms, protein ZIP codes** are molecular signals that direct the 1) ___ from the endoplasmic reticulum, where it is assembled, to the cytoplasm of the cell and into other cellular compartments such as the nucleus of the cell. Mutations in this molecular system of protein “ZIP codes“ have been found to cause several human genetic (hereditary) disorders, including cystic fibrosis and hyperoxaluria (a disorder that causes a special type of stone to form in the urine beginning in childhood). It is well-known that the body’s immune response depends on proper direction of cells through the bloodstream and into the tissues that need them. But exactly how this cell trafficking occurred was unknown. Studies have shown that just as ZIP codes direct mail to particular communities, special molecules that sit on cell surfaces guide the cells through the bloodstream to their tissue destinations. However, before it can slip into the target tissue, a cell exiting the bloodstream must first adhere to the vessel wall. Blood cells contain more than 100 adhesion molecules, yet only a handful of these form bonds that can admit the cell into the surrounding tissue. These so-called Goldilocks molecules possess very specific chemical and mechanical properties that enable the formation of bonds of a particular strength and duration. Adhesion cannot be too tight, or the cells will bind to the vessel 2) ___ and never let go. It also can’t be too weak, or the blood cell will just pass on by. To study this phenomenon, computer simulations we used to explore the adhesion between a blood-borne cell and a surface akin to a vessel wall. Interestingly, this technique could one day be used to design 3) ___ with tailored mechanical properties.


Cell signaling is part of any communication process that governs basic activities of cells and coordinates all cell actions. The ability of cells to perceive and correctly respond to their microenvironment is the basis of development, tissue repair, and immunity, as well as normal tissue homeostasis. Errors in signaling interactions and cellular information processing are responsible for diseases such as cancer, autoimmunity, and diabetes. By understanding cell 4) ___, diseases may be treated more effectively and, theoretically, artificial tissues may be created. Traditional work in biology has focused on studying individual parts of cell signaling pathways. Systems biology research helps us to understand the underlying structure of cell signaling networks and how changes in these networks may affect the transmission and flow of information (signal transduction). Such 5) ___ are complex systems in their organization and may exhibit a number of emergent properties including bi-stability and ultrasensitivity. Cell signaling has been most extensively studied in the context of human diseases and signaling between cells of a single organism. However, cell signaling may also occur between the cells of two different organisms. In many mammals, early embryo cells exchange signals with cells of the uterus. In the human gastrointestinal tract, bacteria exchange signals with each other and with human epithelial and immune system cells.


During mating of the yeast Saccharomyces cerevisiae, some cells send a peptide signal (mating factor pheromones) into their environment. The mating factor peptide may bind to a cell surface receptor on other 6)___ cells and induce them to prepare for mating. Cell signaling can be classified to be mechanical and biochemical based on the type of the signal. Mechanical signals are the forces exerted on the cell and the forces produced by the cell. These forces can both be sensed and responded by the cells. Biochemical signals are the biochemical molecules such as proteins, lipids, ions and gases. These signals can be categorized based on the distance between signaling and responder cells. Signaling within, between, and among cells is subdivided into the following classifications:


Intracrine signals are produced by the target cell that stay within the target cell.

Autocrine signals are produced by the target cell, are secreted, and affect the target cell itself via receptors. Sometimes autocrine cells can target cells close by if they are the same type of cell as the emitting cell. An example of this are immune cells.

Juxtacrine signals target adjacent (touching) cells. These signals are transmitted along cell membranes via protein or lipid components integral to the membrane and are capable of affecting either the emitting cell or cells immediately adjacent.

Paracrine signals target cells in the vicinity of the emitting cell. Neurotransmitters represent an example.

Endocrine signals target distant cells. Endocrine cells produce hormones that travel through the blood to reach all parts of the body.


Cells communicate with each other via direct contact (juxtacrine signaling), over short distances (paracrine signaling), or over large distances and/or scales (endocrine signaling). Some cell-cell communication requires direct cell-cell contact. Some cells can form gap junctions that connect their cytoplasm to the cytoplasm of adjacent cells. In cardiac muscle, gap junctions between adjacent cells allows for action potential propagation from the cardiac pacemaker region of the heart to spread and coordinately cause contraction of the 7) ___. The notch signaling mechanism is an example of juxtacrine signaling (also known as contact-dependent signaling) in which two adjacent cells must make physical contact in order to communicate. This requirement for direct contact allows for very precise control of cell differentiation during embryonic development.


In the worm Caenorhabditis elegans, two cells of the developing gonad each have an equal chance of terminally differentiating or becoming a uterine precursor cell that continues to divide. The choice of which cell continues to divide is controlled by competition of cell surface signals. One cell will happen to produce more of a cell surface protein that activates the Notch receptor on the adjacent cell. This activates a feedback loop or system that reduces Notch expression in the cell that will differentiate and that increases Notch on the surface of the cell that continues as a stem cell.


Hormones are produced by endocrine cells and they travel through the blood to reach all parts of the body. Specificity of signaling can be controlled if only some cells can respond to a particular hormone. Paracrine signals such as retinoic acid target only cells in the vicinity of the emitting cell. Neurotransmitters represent another example of a paracrine signal. Some signaling molecules can function as both a hormone and a neurotransmitter. For example, epinephrine and norepinephrine can function as hormones when released from the adrenal gland and are transported to the heart by way of the blood stream. Norepinephrine can also be produced by neurons to function as a neurotransmitter within the brain. Estrogen can be released by the ovary and function as a 8) ___ or act locally via paracrine or autocrine signaling. Active species of oxygen and nitric oxide can also act as cellular messengers. This process is dubbed redox signaling.


In a multicellular organism, signaling between cells occurs either through release into the extracellular space, divided in paracrine signaling (over short distances) and endocrine signaling (over long distances), or by direct contact, known as juxtacrine signaling. Autocrine signaling is a special case of paracrine signaling where the secreting cell has the ability to respond to the secreted signaling molecule. Synaptic signaling is a special case of paracrine signaling (for chemical synapses) or juxtacrine signaling (for electrical synapses) between neurons and target cells. Signaling molecules interact with a target cell as a ligand to cell surface receptors, and/or by entering into the cell through its membrane or endocytosis for intracrine signaling. This generally results in the activation of second messengers, leading to various physiological effects. Neurotransmitters are signaling molecules of the nervous system, also including neuropeptides and neuromodulators. Neurotransmitters like the catecholamines are also secreted by the endocrine system into the systemic circulation. Cytokines are signaling molecules of the immune system, with a primary paracrine or juxtacrine role, though they can during significant immune responses have a strong presence in the circulation, with systemic effect (altering iron metabolism or body temperature). Growth factors can be considered as cytokines or a different class.


Signaling molecules can belong to several chemical classes: lipids, phospholipids, amino acids, monoamines, proteins, glycoproteins, or gases. Signaling molecules binding surface receptors are generally large and hydrophilic (e.g. TRH, vasopressin, acetylcholine), while those entering the cell are generally small and hydrophobic (e.g. glucocorticoids, thyroid hormones, cholecalciferol, retinoic acid), but important exceptions to both are numerous, and a same molecule can act both via surface receptor or in an intracrine manner to different effects. In intracrine signaling, once inside the 9) ___, a signaling molecule can bind to intracellular receptors, other elements, or stimulate enzyme activity (e.g. gasses). Hydrogen sulfide is produced in small amounts by some cells of the human body and has a number of biological signaling functions. Only two other such gases are currently known to act as signaling molecules in the human body: nitric oxide and carbon monoxide.


Cells receive information from their neighbors through a class of proteins known as receptors. Notch is a cell surface protein that functions as a 10) ___. Animals have a small set of genes that code for signaling proteins that interact specifically with Notch receptors and stimulate a response in cells that express Notch on their surface. Molecules that activate (or, in some cases, inhibit) receptors can be classified as hormones, neurotransmitters, cytokines, and growth factors, in general called receptor ligands. Ligand receptor interactions such as that of the Notch receptor interaction, are known to be the main interactions responsible for cell signaling mechanisms and communication.


** For the benefit of readers, not familiar with the United States mail system, the term “ZIP code“ refers to address codes of the U.S. Postal Service used to sort mail into geographic regions.

Sources: Scientific American; Wikipedia


ANSWERS: 1) protein; 2) wall; 3) bonds; 4) signaling; 5) networks; 6) yeast; 7) heart; 8) hormone; 9) cell; 10) receptor


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Gunter Blobel MD, PhD (1936 – 2018) Redefined Cell Biology

Gunter Blobel: Died a few days ago, on 18 February 2018 (aged 81): From Wikimedia Commons, the free media repository


Gunter Blobel (May 21, 1936 – February 18, 2018 was a Silesian German and American biologist and 1999 Nobel Prize laureate in Physiology for the discovery that proteins have intrinsic signals that govern their transport and localization in the cell. Blobel was born in Waltersdorf in the Prussian Province of Lower Silesia, now a part of Poland. In January 1945 his family fled from native Silesia from the advancing Red Army. After the war Blobel grew up and attended gymnasium in the Saxon town of Freiberg. He graduated at the University of Tubingen in 1960 with MD and received his Ph.D. from the University of Wisconsin-Madison in 1967. Blobel joined the Rockefeller University faculty 51 years ago where he was the John D. Rockefeller Jr. Professor. He was also a Howard Hughes Medical Institute Investigator since 1986.


Blobel was awarded the 1999 Nobel Prize in Physiology or Medicine for the discovery of signal peptides. Signal peptides form an integral part of protein targeting, a mechanism for cells to direct newly synthesized protein molecules to their proper location by means of an “address tag“ (i.e. a signal peptide) within the molecule. Proteins that are manufactured within cells must be transported to the sites where they are needed. Blobel discovered a system of intrinsic signals that explain how cells are able to accurately distribute billions of such proteins within a cell each day. Along with his colleagues, Blobel learned that sequences in proteins were responsible for directing traffic, matching up these “zip codes“ with transport machinery in the cell that facilitate targeting to the proper cellular membranes. This connection results in the proteins either passing through the membranes or becoming embedded within them. His observations were central to uniting the fields of molecular biology, which deals primarily with proteins and nucleic acids, and cell biology, which is focused on the structures inside cells, called organelles. In addition, he found that the same system plays a role across all eukaryotes, ranging from yeast to humans.


Blobel became well known for his direct and active support for the rebuilding of Dresden in Germany, becoming, in 1994, the founder and president of the nonprofit “Friends of Dresden, Inc.“ He donated all of the Nobel award money to the restoration of Dresden, in particular for the rebuilding of the Frauenkirche (completed in 2005) and the building of a new synagogue. In Leipzig he pursued a rebuilding of the Paulinerkirche, the university church of the University of Leipzig, which had been blown up by the communist regime of East Germany in 1968, arguing “this is a shrine of German cultural history, connected to the most important names in German cultural history.“ In addition to his research at the Rockefeller University in New York City from 1968 to 2018, Blobel lived in Manhattan’s Upper East Side with his wife, Laura Maioglio (owner of Barbetta Restaurant in Manhattan). He was on the board of directors for Nestle and the Board of Scientific Governors at The Scripps Research Institute. Furthermore, he was Co-Founder and Chairman of the Scientific Advisory Board for Chromocell Corporation. He sat on the Selection Committee for Life Science and Medicine which chooses winners of the Shaw Prize.


Excellent video about the work of Dr. Gunter Blobel


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Hospitals Testing Therapies to Prevent 2 Common Bacterial Infections


The World Health Organization recently included P. aeruginosa and S. aureus on a list of antibiotic-resistant bacteria that pose the greatest risk to human health. People in healthcare settings with weakened immune systems, especially those on breathing machines or with catheters, face an increased risk of becoming seriously ill from these infections. The Centers for Disease Control and Prevention has also clearly indicated that Staphylococcus bacteria are a leading cause of healthcare-associated infections, such as pneumonia, bacteremia, and heart valve and bone infections. In 2011, methicillin-resistant S. aureus (MRSA) caused more than 80,000 serious infections and 11,285 related deaths in the United States, according to the CDC. P. aeruginosa can cause bloodstream infections and pneumonia that can be fatal. Approximately 51,000 healthcare-associated P. aeruginosa infections occur each year in the United States, and about 6,700 of these are drug-resistant, leading to more than 400 deaths annually, according to CDC estimates based on a 2011 survey.


The mission of the Antibacterial Resistance Leadership Group (ARLG), is to prioritize, design and execute clinical research that will reduce the public health threat of antibacterial resistance. The ALRG has combined with a large international consortium of international trials supported by MedImmune, the global biologics research and development arm of AstraZeneca, and the Brussels-based Innovative Medicines Initiative Joint Undertaking and the Combatting Antimicrobial Resistance in Europe (COMBACTE) consortium, to enroll 30 adult patients from 15 intensive care units in the US.


One trial, called EVADE, is evaluating the safety of the investigational medicine MEDI3902 (developed by MedImmune) and its ability to prevent pneumonia caused by Pseudomonas aeruginosa. The other trial, called SAATELLITE, is testing the safety of another investigational MedImmune medicine, suvratoxumab (previously known as MEDI4893), and its ability to prevent disease caused by Staphylococcus aureus. Both trials are randomized, placebo-controlled, and double-blind, meaning neither the participants nor the investigators will know who receives a placebo.


MEDI3902 and suvratoxumab are both monoclonal antibodies being investigated as preventive therapies. The medicines are not antibiotics but can be administered alongside standard antibiotic therapy. Monoclonal antibodies have been developed for use against diseases such as cancer, Ebola and respiratory syncytial virus, but rarely have been used to target bacterial pathogens.


All participants in both the EVADE and SAATELLITE trials will be on mechanical ventilation in the intensive care unit at the time of enrollment. Trial investigators will provide information about the purpose and possible risks and benefits of the study so that patients can ask questions before they agree to participate. If a patient is unconscious or otherwise unable to consent during the screening process, a legally authorized representative can provide initial consent. Participants in the EVADE trial must be colonized with P. aeruginosa bacteria in the lower respiratory tract but display no signs of pneumonia. They will be randomly assigned to receive either one intravenous (IV) infusion of MEDI3902 or placebo. Investigators will check for incident pneumonia caused by P. aeruginosa for 21 days, and will monitor participants for 49 days total. Similarly, participants in the SAATELLITE trial must be colonized with S. aureus in the lower respiratory tract but free of S. aureus-related disease. They will be randomly assigned to receive either one IV infusion of suvratoxumab or a placebo. Investigators will evaluate the incidence of S. aureus-related pneumonia for 30 days, and monitor participants for 190 days total. Participants in both the EVADE and SAATELLITE trials will be regularly evaluated for any treatment-related safety issues.


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