We Were All Chefs at the eClinical Forum Meeting

 

This past week, we had the opportunity to attend the Fall meeting of the eClinical Forum. At our meetings and during the year, we are able to share with our friends, colleagues and yes, our competitors, novel technology approaches to solve complex problems in the clinical trial space. This week we also had the opportunity to cook our dinner under supervision of a master chef. A great time was had by all.

 

And yes, OUR TEAM, CHICKEN TUSCANESE, won the chef’s 1st prize.  Congratulations to all, for meals well done.

 

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Our Exalted Team. Working Together ©Target Health Inc. 2016

 

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Chicken Tuscanese. ©Target Health Inc. 2016

 

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.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

Halloween: Appealing to Your Dark Side: True Strange Deaths

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Credit: Toby Ord – Own work, Wikipedia Commons

 

1919: The Great Molasses Flood, also known as the Boston Molasses Disaster or the Great Boston Molasses Flood, occurred in the North End neighborhood of Boston, Massachusetts when a large molasses storage tank burst, and a wave of molasses rushed through the streets at an estimated 35 mph (56 km/h), killing 21 people and injuring an additional 150. The event has entered local folklore, and for decades afterward residents claimed that on hot summer days the area still smelled of molasses.

1923: George Herbert, 5th Earl of Carnarvon, who financed Howard Carter’s search for Tutankhamun, died at age 56 from a mosquito bite on his face, which he later cut while shaving. The bite became seriously infected with erysipelas, leading to blood poisoning and eventually pneumonia. Some attributed his death to the so-called curse of the pharaohs.

1927: Isadora Duncan, world famous dancer, died of a broken neck when her long scarf caught on the wheel of a car in which she was a passenger.

1974: Basil Brown, a 48-year-old health food advocate from Croydon, England, drank himself to death by consuming 10 gallons (38 liters) of carrot juice in ten days, causing him to overdose on vitamin A and suffer severe liver damage.1978: Kurt Godel, the Austrian/American logician and mathematician, died of starvation when his wife was hospitalized. Godel suffered from extreme paranoia and refused to eat food prepared by anyone else.

1982: David Grundman was killed near Lake Pleasant, Arizona, U.S., while shooting at cacti with his shotgun. After he fired several shots at a 26 ft (8 m) tall Saguaro Cactus from extremely close range, a 4 ft. (1.2 m) limb of the cactus detached and fell on him, crushing him.

1993: Garry Hoy, a 38-year-old lawyer in Toronto, Canada, fell to his death on 9 July 1993 after he threw himself against a window on the 24th floor of the Toronto-Dominion Centre in an attempt to prove to a group of visitors that the glass was “unbreakable”, a demonstration he had done many times before. The glass did not break, but popped out of the window frame, and Hoy fell to his death.

1994: Jeremy Brenno, 16, of Gloversville, New York, was killed on a golf course when he struck a bench with a golf club, and the shaft broke, bounced back at him, and pierced his heart.

1997: Karen Wetterhahn, a professor of chemistry at Dartmouth College, died of dimethyl mercury poisoning ten months after a few drops of the substance landed on her protective gloves. Although Wetterhahn had been following the required procedures for handling the chemical, it still permeated her gloves and skin within seconds. As a result of her death, regulations were altered.

2006: Steve Irwin, the international celebrity known as the “Crocodile Hunter”, died from being pierced hundreds of times in a few seconds by the barb of an 8-foot (2.4 m) stingray in chest-deep water, just as he and his cameraman were filming the final shot of the stingray swimming away from them

2010: Mike Edwards, 62, a founding member and cellist for the band Electric Light Orchestra, died when a large round bale of hay rolled down a hill and collided with the van he was driving.

2010: Jimi Heselden was a British entrepreneur, who in 2010 bought Segway Inc., maker of the Segway personal transport system. Heselden died in 2010 from injuries apparently sustained falling from a cliff while riding his own product.

2011: Jose Luis Ochoa, 35, died after being stabbed in the leg at an illegal cockfight in Tulare County, California, U.S., by one of the birds that was holding a knife.

2012: Edward Archbold, 32, of West Palm Beach, Florida, U.S., died after winning a cockroach-eating contest. The cause of death was determined to be accidental choking due to “arthropod body parts.”

2013: Takuya Nagaya, 23, from Japan, started to slither on the floor and claim he had become a snake. His mother took this to mean that he had been possessed by a snake, and called for her husband, 53-year-old Katsumi Nagaya. Katsumi spent the next two days head-butting and biting his son “to drive [out] the snake that had possessed him” but instead causing his death.

2013 : Roger Mirro, 56, from the Chicago suburb of Palatine, Illinois, died when he was crushed by a dumpster at the condominium complex where he lived. Mirro was looking for his cellular phone, which he thought he had dropped into a bag of garbage already discarded in the trash compactor, but the dumpster was activated and Mirro died.

2013: An unnamed Belarusian fisherman, 60, was killed by a beaver while attempting to grab the animal to have his picture taken with it. The beaver bit the man, severing a large artery in his leg.

2013: 45-year-old Joao Maria de Souza was crushed by a cow falling through the roof of his home in Caratinga, Brazil (the cow having climbed onto the roof from an adjacent hillside). His wife (who was lying in bed next to him) and the cow were both unharmed. The death was labeled as “bizarre”.

2013: Kendrick Johnson, 17, American student at Lowndes High School, Georgia, was discovered trapped upside down in a rolled-up gym mat in his high school gymnasium. Police had originally ruled that the cause of Johnson’s death was accidental positional asphyxiation after he climbed in to retrieve a shoe and became trapped. The case has since been reopened and investigated as a possible homicide.

2013: Miguel Martinez, 14, from Lubbock, Texas, was impaled through the chest by the horn of a bull statue. He had been playing hide and seek at night in front of the National Ranching Heritage Center.

2014: Peng Fan, a chef in Foshan, Southern China, was bitten by a cobra’s severed head, which he had cut off 20 minutes earlier. Fan had set the head aside while using the body to prepare a soup.  According to investigating police, the case was “highly unusual”. The chef might have had a severe reaction to the bite.

2015: Chelsea Ake-Salvacion, 24, from Henderson, Nevada, U.S., working as a salon employee died when she used a cryotherapy machine alone without assistance. The report states that she did not have the level setting at the proper height, did not get enough oxygen, and suffocated and froze herself to death. The coroner who examined Ake-Salvacion’s body described her death as a “freak accident.”

2015: Robin Wahlgren, 28, a Swedish student at the University of New South Wales and his Swedish friend rode a shopping cart, down a steep road in Randwick, Sydney with a speed limit of 60 km/h (37 mph), reaching speeds of up to 80 km/h (50 mph) before hitting an oncoming car and getting flung out of the trolley. He died at the scene while his friend was seriously injured.  It was labelled as a “freak accident”.

2015: James Shay, 58, from Browns Mills, New Jersey was found partially lodged in the donation bin outside the Country Farms Convenience Store on Pemberton Browns Mills Road. Police said their investigation revealed that he was trying to get items out of the bin when he lost his footing and got trapped in the opening. The Burlington County Medical Examiner ruled the death accidental and determined that the cause of death was compression of the neck.

2015: Ravi Subramanian, an Air India technician, died in an accident during aircraft maintenance at Mumbai airport. He was sucked into one of the aircraft’s jet engines and killed instantly.

2016: V. Kamaraj, a 40-year old Indian bus driver, died from his severe wounds after he and three others were injured by what investigators described as a meteorite which struck the grounds of Bharathidasan Engineering College, in Vellore, Tamil Nadu. Evidence collected from the 2-foot (61 cm) wide crater contained samples of carbonaceous chondrite.

2016: Caitlin Clavette, 35, a Boston-area school teacher driving near the Thomas P. O’Neill Jr. Tunnel, was struck and killed by a dislodged manhole cover, which crashed through the windshield of her car. Massachusetts Governor Charlie Baker called the incident “bizarre.”

2016: Irma Bule, 29, an Indonesian Dangdut singer known for performing with live snakes, died in the middle of a concert after being bitten by a king cobra and refusing treatment.

2016: Anton Yelchin, 27, a Los Angeles actor known for portraying Pavel Chekov in the Star Trek reboot series, and for several other prominent roles, was found pinned between his car and a brick wall. His driveway is on an incline and his car was found still running and in neutral.

2016: Robert Mwaijega, 47, a fisherman in Southern town of Kyela, Mbeya Region in Tanzania, died after one of the live fish that he had caught flip-flopped and jumped into his mouth, squeezing itself down his throat, into his chest and killing him.

2016: A seven-year-old girl died after being struck by a stone thrown by an elephant from its enclosure at Rabat Zoo in Morocco.

 

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A traditional Irish turnip Jack-o’-lantern from the early 20th century. Photographed at the Museum of Country Life, Ireland by Rannphairti Anaithnid of English Wikipedia

 

Speaking of Halloween: One of History’s First Serial Killers

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Poster of Fritz Lang’s 1931 film M; Credit: Wikipedia Commons

 

 

A Real Case of Macabre Mentality: Fritz Haarmann (1879-1925)

 

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Friedrich Heinrich Karl Haarmann; Alias: Fritz The Butcher of Hanover;

The Vampire of Hanover; The Wolf Man; The Werewolf

 

 

“Often, after I had killed, I pleaded to be put away in a military asylum, but not a madhouse. If [Hans] Grans had really loved me he would have been able to save me. Believe me, I’m not ill ? it’s only that I occasionally have funny turns. I want to be beheaded. It’ll only take a moment, then I’ll be at peace.“

 

One of history’s first serial killers, Friedrich Heinrich Karl Haarmann, better known by his nickname of Fritz Haarmann and also referred to as “The Butcher of Hanover“ or “The Vampire of Hanover“, was a German serial killer responsible for at least 24 murders of young males. Born in Hanover on October 25, 1879, during the German Empire, Fritz was the sixth child of a poor couple, Ollie and Johanna. He was motivated by his sickly mother to play with his sisters’ dolls instead of boys’ activities. As a result, Fritz seemed to have a bit of a feminine personality; he also had sadistic tendencies in which he would tie up his sisters and also tap windows during the nighttime to cause rumors of supernatural creatures that roam about in the middle of the night. He also harbored a dislike for his father, whom he would threaten to throw in jail as Ollie supposedly murdered a train driver. Performing terribly in school, Fritz was sent to attend a military academy at Neu Breisach. Though he did well, Fritz was eventually discharged for medical reasons after having a series of seizures. Returning to Hanover, he found employment at a local cigar factory. Sometime in 1898, he was arrested for molesting several children, but was deemed psychologically unfit to stand trial and was sentenced to a mental institution. Six months into his stay, Fritz escaped and sought shelter in Switzerland before returning to Germany at the age of 20. Around 1900, he was able to seduce and marry a woman named Erna Loewert, later impregnating her with their child. Fritz then abandoned Erna in favor of a life in the military. While becoming a soldier, Fritz, much like the serial killer William Burke, led a successful life under the occupation. However, on October of 1901, all of that abruptly ended when he collapsed during an exercise and was diagnosed as having an unspecified mental deficiency. As a result, he was discharged and sent back to live with his family. His father Ollie made at least one attempt at putting Fritz in an asylum, but the local doctors merely deemed him as “morally inferior“. Fritz attempted to open up a small business of his own, but it went bankrupt immediately and was closed down. Sometime after this, he started a series of petty burglaries and con jobs to easily gain money and spent about one-third of the following two decades being incarcerated for such crimes. Because of his frequent arrests, he became well-known with the Hanover police, even becoming one of their informers after his latest release in 1918, just to redirect police attention from himself. Simultaneously, World War 1 began and he was hit hard by the inflicted national poverty. Fritz also started a number of misdemeanor sexual offenses that went unnoticed by authorities mostly because his partners were too ashamed to file reports.

 

“I never intended to hurt those youngsters, but I knew that if I got going something would happen and that made me cry. I would throw myself on top of those boys and bite through the Adam’s apple, throttling them at the same time.

 

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Some of the many bones of Haarmann’s victims that were recovered from the Leine River. Credit: Wikipedia Commons

 

Finally, Fritz suddenly snapped and murdered a 17-year-old youth named Friedel Rothe on September 25, 1918. Following from eyewitness accounts provided by Rothe’s friends and the pressure from Rothe’s family, authorities raided Fritz’s residence and found him with a teenage boy in bed, having been seduced by him for about nine months. Fritz was arrested for sexual assault, but the police, for some unknown reason, never searched his house and, as a result, he was cleared of any suspicion of Rothe’s murder. Eventually released, Fritz later met Hans Grans at the Hanover central station, and the two became fast friends and, eventually, lovers. In early 1922, they moved to an apartment, number 27 Cellerstrasse, which was located in the “haunted area“ of Hanover. Fritz then started murdering young men again, this time by luring them in by pretending to be a police officer. Hans became his accomplice after unexpectedly returning home to witness Fritz murder his second victim, 17-year-old Fritz Franke. In the following nine months, twelve men were murdered this way, with their dismembered remains being dumped in the Leine River and their valuables used to provide Fritz and Hans with money. The killings went unnoticed, until in May 1924, when over 500 human bones belonging to Fritz’s victims started washing up downstream in the Leine River. Sheer terror gripped Hanover and citizens dubbed the killer as The Butcher of Hanover.

 

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Haarmann’s Apartment. Credit: Wikipedia Commons

 

 

Fritz’s last murdered victim was 17-year-old Erich de Vries; at this time, police had begun an enormous manhunt for the serial killer. Suspicion quickly fell on him due to knowledge of his 1898 molestation crimes and the disappearance of Friedel Rothe years ago. Police silently observed Fritz, and on June 22, they apprehended him after he attempted to lure in a would-be victim, Karl Fromm, from Hanover’s central station; Fromm had spent several days in Fritz’s apartment before, during which he was assaulted by him. Fritz would later confess to his intention of killing Fromm, marking the first time that he was guided by moral principles, although it ironically proved to be his downfall. Police searched Fritz’s home and found the walls sporting bloodstains, with Fritz alleging it to be an unhandy result of the illegal meat-trade business he ran there. However, officers found clothing and belongings of his victims and arrested him on suspicion of the Hanover murders. Fritz quickly confessed to being the perpetrator and claimed that the amount of lives he took ranged from “somewhere between 50 and 70“, though police made it official that the true body count was measured to 24-27 victims. He then aided officers in finding undiscovered parts of his victims and the dump sites at the Leine River. He proved overall to become extremely cooperative in the investigation, save for instances in which he was confronted by families of his victims or conversing about decapitation, to which he would become withdrawn.

 

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Haarmann (middle) with police detectives.

Credit: By Bundesarchiv, Bild; Wikipedia Commons

 

Fritz’s trial began on December 4, 1924, and was conducted at the Hannover Assizes. As the term “serial killer“ had not been coined yet, there were no words to describe Fritz other than “werewolf“ or “vampire“. Hoping to take Hans with him to execution, he resorted to accusing him of some of the murders, which the court actually came to believe. A notable aspect of the case was the shock that came to the public after the discovery that Fritz was a police informant, and therefore, the police never came to suspect him of the murders even though witnesses pointed him out as being with his last victims. Fritz’s trial lasted for two weeks and required 200 witnesses to explain their accounts. He was found guilty of murdering all but three of the victims tied to him and sentenced to death by guillotine. On April 15, 1925, he was beheaded by guillotine, but not before he said as his last words, “I repent, but I do not fear death.“ The remains of his victims were buried together in a grave at Stockener Cemetery months before his execution, with a large, granite, triptych-style memorial inscribed with the victims’ names and ages being erected on April 1928. Fritz’s head was preserved in a jar by scientists, who used it in their studies to examine the structure of his brain. It was being kept at the Gottingen medical school until 2014, when it was cremated.

 

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Haarmann (seated in front of chalkboard sketch of his apartment), during his trial in 1924.

Credit: Bundesarchiv_Bild; Wikipedia Commons

 

 

Hans Grans spent his early years as a petty thief before running away from his home, making his living by selling old clothes. He soon met Fritz Haarmann at Hanover’s central station after offering to prostitute himself in exchange for money. The two soon became friends, and then lovers. From March 1920 to December of the same year, Hans traveled through Germany, committing petty robberies before returning to Hanover and reuniting with Fritz on Christmas, later moving into a new apartment, number 27 Cellerstrasse, with him. On February 12, 1923, he returned home unexpectedly to find Fritz murdering his second victim, 17-year-old Fritz Franke. Condoning the act, he soon became Fritz’s accomplice and live-in partner. Hans even chose two of Fritz’s victims for him, one of them 17-year-old Adolf Hannappel, who was murdered on November 11, 1923. Hans was arrested on July 8, 1924, and initially found guilty to enticement to the murder of Hannappel. Fritz and eyewitnesses verified that Hans picked Hannappel out for the former and as a result, Hans was sentenced to death. However, he was cleared and the sentence was reduced after a letter written by Fritz that declared Hans’s innocence was discovered. Instead, Hans served twelve years in prison and was eventually released. He continued to live in Hanover until his death in 1975, from natural causes.

 

“I’d make two cuts in the abdomen and put the intestines in a bucket, then soak up the blood and crush the bones until the shoulders broke. Now I could get the heart, lungs and kidneys and chop them up and put them in my bucket. I’d take the flesh off the bones and put it in my waxcloth bag. It would take me five or six trips to take everything and throw it down the toilet or into the river. I always hated doing this, but I couldn’t help it – my passion was so much stronger than the horror of the cutting and chopping.“

In the wake of his killings, Fritz has inspired three films to date. The first, a 1931 German drama-thriller named M, is well-known and has also been inspired by two other serial killers, Peter Kurten and Carl Grossmann. The second, The Tenderness of the Wolves (Die Zartlichkeit der Wolfe), was released on July 1973 and is directly based upon Fritz’s murders. And finally, the most recent is Der Totmacher (The Deathmaker), which was released on 1995 and, like the previous film, is based on Fritz’s murders. Fritz has also been mentioned in several novels, a subject of focus in a song called “Fritz Haarmann [sic] der Metzger“ (“Fritz Haarmann the butcher“) by the band Macabre, and has even been used as a company logo for Beton Kopf Media, a record label.

 

Though Fritz wasn’t mentioned or referenced in Lucky, Floyd Feylinn Ferell’s habit of dismembering his victims post-mortem and selling them as meat to unsuspecting customers appears to be an allusion to a rumor that Fritz did the exact same thing. Fritz was mentioned in Magnum Opus, when the BAU compared his sloppy method of drawing blood from his victims (by biting) with that of the prominent unsub, who was more organized, using a tube instead. A scene where Wallace Hines feeds the pieces of a victim’s head to unsuspecting restaurant customers in The Inspiration is also a possible allusion to the aforementioned rumor.

 

The New York Times clebrated Halloween with an article entitled: Victorian Cocktails and Medical Curiosities in (Where Else?) Brooklyn

 

Gene Therapy for Niemann-Pick Disease, Type C1 (NPC1)

 

Niemann-Pick disease is a rare and fatal disorder of the central nervous system (the brain and spinal cord) that has no cure. The disease occurs when a faulty housekeeping gene fails to remove cell waste, like lipids and cholesterol. The accumulation of waste in the spleen, liver and brain causes progressive deterioration in intellectual and motor functions. It also shortens patient’s lives, as people with Niemann-Pick disease typically die in their teens. There are several types of Niemann-Pick disease; this study focused on mice that had been bred with a faulty NPC1 gene to model Niemann-Pick disease, type C1.

 

According to an article published online in the journal Human Molecular Genetics (26 October 2016), for the first time, it has been demonstrated in mice that gene therapy may be the best method for correcting the single faulty gene that causes Niemann-Pick disease, type C1 (NPC1). The gene therapy involved inserting a functional copy of the NPC1 gene into mice with the disease; the treated animals were then found to have less severe NPC1 symptoms. The study was led by researchers at NIH’s National Human Genome Research Institute (NHGRI) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

 

The researchers’ goal was to correct the faulty NPC1 gene in as many cells and organs as possible, with a strong focus on the brain. To do this, they used a non-disease-causing virus called the adeno-associated virus serotype 9 (AAV9) to transfer functioning NPC1 to the cells. The AAV9 containing a functioning NPC1 gene successfully crossed the blood-brain barrier, reaching cells in the brain and elsewhere. Once inside cells, the normal NPC1 gene was then able to make the functional NPC1 protein to correct the cell defects. With a single injection, mice showed improvements in motor coordination, weight gain and longevity compared to those without this gene therapy. The effect of gene therapy equaled that of a drug called VTS-270, which has been evaluated in preclinical and clinical studies at numerous academic labs. However, to be effective, the VTS-270 compound has to be given three times a week for the life of the mouse and does not provide a true cure. The team is now investigating if a combination of the two therapies will improve results.

 

According to the authors, their work in NPC1 mice may help lead to human clinical trials and eventually FDA approval for gene therapy as a treatment for NPC1 disease, and that for NPC1 patients, gene therapy could halt progression of the disease, improve the quality of their lives and, hopefully, increase the patient’s life span. The authors added that their work on gene therapy for NPC1 also has the potential to treat genetic disorders with some similar features, including mucolipidosis IV, Batten disease and Danon disease.

 

Skin Patch to Treat Peanut Allergy Shows Benefit in Children

 

According to an article published online in the Journal of Allergy and Clinical Immunology (26 October 2016), a wearable patch that delivers small amounts of peanut protein through the skin showed promise for treating children and young adults with peanut allergy, with greater benefits for younger children. According to the article, the treatment, called epicutaneous immunotherapy or EPIT, was found safe and well-tolerated, and nearly all participants used the skin patch daily as directed.

 

According to the NIH, to avoid potentially life-threatening allergic reactions, people with peanut allergy must be vigilant about the foods they eat and the environments they enter, which can be very stressful. Therefore, one goal of experimental approaches such as epicutaneous immunotherapy is to reduce this burden by training the immune system to tolerate enough peanut to protect against accidental ingestion or exposure.

 

The study, which was performed at 5 clinical research sites, randomly assigned 74 peanut-allergic volunteers aged 4 to 25 years to treatment with either a high-dose (250 micrograms peanut protein), low-dose (100 micrograms peanut protein), or placebo patch. The investigators assessed peanut allergy at the beginning of the study with a supervised, oral food challenge with peanut-containing food. The patches were developed and provided by the biopharmaceutical company DBV Technologies under the trade name Viaskin. Each day, study participants applied a new patch to their arm or between their shoulder blades.

 

After one year, the team assessed each participant’s ability to consume at least 10 times more peanut protein than he or she was able to consume before starting EPIT. The low-dose and high-dose regimens offered similar benefits, with 46% of the low-dose group and 48%of the high-dose group achieving treatment success, compared with 12% of the placebo group. In addition, the peanut patches induced immune responses similar to those seen with other investigational forms of immunotherapy for food allergy. Investigators observed greater treatment effects among children aged 4 to 11 years, with significantly less effect in participants aged 12 years and older.

 

Nearly all of the study participants followed the EPIT regimen as directed. None reported serious reactions to the patch, although most experienced mild skin reactions, such as itching or rash, at the site of patch application. Additional studies in larger groups of children are needed before the therapy could be approved for wider use. The study continues to assess the long-term safety and effectiveness of peanut EPIT. After the first year, all participants began receiving high-dose daily patches, and they will continue in the study for a total of two and a half years of EPIT.

 

FDA is Working with Hospitals to Modernize Data Collection About Medical Devices

 

Extracted from FDA Voice by Jeffrey Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health

 

Throughout their work day, hospital staff use a variety of medical devices: imaging machines, EKGs and in vitro tests to make diagnoses; infusion pumps, ventilators and robotics to provide treatment, and an array of implants to replace diseased joints and organs. And, as the nation’s hubs for real-time health care data, hospitals are uniquely positioned to help identify new safety problems with devices  as well as changes in the frequency of already known safety problems. The reason is that hospitals use these technologies in the real-world setting of clinical practice, outside of the more controlled setting of a clinical trial. FDA is looking to improve the way we work with hospitals to modernize and streamline data collection about medical devices.

 

FDA’s evaluation of medical device safety presents unique challenges not seen with drugs and biologics, given: 1) the greater diversity and complexity of medical devices today; 2) the rapid technological advances and iterative nature of medical device product development; 3) the interface between the technology and the user; and, 4) in some cases, a relatively short product life cycle that can be measured in months, not years. Therefore, assuring the safety of medical devices depends on many factors and should a problem arise, it could be due to a variety of causes.

 

At the time of premarket evaluation, however, it is not feasible to identify all possible risks or to have absolute certainty regarding a technology’s benefit-risk profile. The reaon is that  studies required to do so would likely be prohibitively large in order to capture less frequent and more unpredictable effects or consequences. In addition, such larger studies still may not reflect the true benefit-risk profile of the device. Once a device is on the market, for example, doctors may use it beyond the FDA cleared intended use. In addition, subsequent modifications to the device or changes in how the device is used in practice can result in new safety risks or greater frequency of known risks.

 

FDA has several tools for watching devices once they are on the market, all of which have inherent limitations. For one thing, FDA can require that a manufacturer conduct a post-approval or postmarket surveillance study that focuses on identifying potential longer-term issues noted at the time of clearance or approval or specific safety concerns that may arise after clearance or approval. However, conducting studies on a product after it’s already on the market can be challenging because patients often have little incentive to enroll in a study when the device is already available to them. Likely the most well-known of FDA’s postmarket surveillance tools is medical device reporting, which FDA requires from certain entities, including device manufacturers and device user facilities, such as hospitals.

 

Federal law requires hospitals and other user facilities to report when they become aware of information reasonably suggesting that a medical device has or may have caused or contributed to a death or serious injury to a patient. These facilities must report these medical device-related deaths to both FDA and the manufacturer, if known; and device-related serious injuries to the manufacturer, or to FDA, if the manufacturer is not known. Such passive surveillance has important limitations because it relies on people to identify that a harm occurred or a risk is present, recognize that the harm or risk is associated with the use of a particular device, and take the time to report it.

 

Congress mandated this reporting by user facilities in 1990 to complement similar adverse event reporting by manufacturers. But then, in 1997, Congress required that FDA establish a reporting program that could limit user facility reporting to a subset of representative user facilities. As part of our efforts to develop this reporting program, FDA set up a large-scale network of about 300 hospitals, called MedSun (the Medical Product Safety Network), with whom FDA works interactively to better understand and report on device use in the real-world environment. Even with MedSun, all hospitals were required to continue reporting until FDA implements by regulation a program limiting user facility reporting to a subset of facilities. Although FDA has recognized that requiring all hospitals and other user facilities to report may provide limited added value and could entail unnecessary costs that take away from patient care, FDA has not yet established the program limiting reporting to a subset of user facilities. In the past, FDA has also not enforced universal reporting requirements for hospitals and other user facilities. In light of several high-profile device safety issues occurring in hospitals, FDA, in December 2015, initiated inspections at 17 hospitals, chosen because there were reports of events at these facilities related to the spread of uterine cancer from the use of morcellators or the spread of infections associated with contaminated duodenoscopes. While these events appeared to be the kind that would have fallen under our current medical device reporting requirements, FDA did not see corresponding adverse event reports in its adverse event (MAUDE) database. From those inspections, FDA learned three important lessons:

 

First, some hospitals didn’t submit required reports for deaths or serious injuries related to devices used at their facilities, and in some cases, they did not have adequate procedures in place for reporting device-related death or serious injury events to FDA or to the manufacturers. Based on the number of user facilities in the United States and the number of reports FDA receives, FDA believes that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers at some hospitals. FDA wants to work with all hospitals to address these issues.

Second, hospital staff often were not aware of nor trained to comply with all of FDA’s medical device reporting requirements.

Third, FDA feelsthat there is a better way to work with hospitals to get the real-world information it needs.

Fourth, FDA should work with the hospital community to find that right path, especially in light of developments in the creation and evaluation of electronic health information.

In order to effectively address these issues, FDA will work with the hospital community on what role they should play in assuring the safe use of medical devices. This work will include how they can effectively participate in the National Evaluation System for health Technology (NEST), and whether or not current reporting requirements should remain, be modified, or eliminated in light of more effective modern tools, such as software tools to conduct active surveillance of electronic health information that contain unique device identifiers. In many cases, FDA inspections of these 17 hospitals turned up violations of FDA’s medical device reporting regulation. For some hospitals with significant violations of the regulation, FDA received a response that FDA determined was not adequate to address those violations, and FDA engaged with these facilities to facilitate an effective path to compliance. These hospitals indicated their willingness to work with FDA and address the violations, and at this time, FDA does not believe any additional action with regard to these hospitals is necessary. Some hospitals also expressed willingness to work with FDA on more efficient and effective ways to collect the information FDA needs.

 

On December 5, FDA will hold a public workshop to solicit input and advice on improving hospital-based surveillance systems, and the broader role of using hospitals to evaluate how well devices work in the clinical setting. FDA is encouraging all hospital stakeholders – from clinicians to IT system managers – to attend and discuss current hospital-based surveillance efforts, the role of hospitals in evidence generation and future opportunities for hospital-based surveillance. FDA would also like input on the incorporation of unique device identifiers (UDIs) into electronic health records to aid in the future development of evidence generation efforts, including the support of better device development, surveillance and health care delivery. FDA is already working directly with the Association of American Medical Colleges and the American Hospital Association to prepare for this workshop and help develop improvements to FDA systems.

 

FDA has made it very clear that hospitals are our partners in building the infrastructure for NEST. Together all stakeholders can build a state-of-the-art system that not only quickly identifies life-threatening problems caused by medical devices but also expedites patient access to crucial life-saving devices. Armed with such information, health care providers can help patients make more informed medical decisions that improve their health.

 

The October Julz

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When the weather outside is cold, and you start to shiver, come inside and create liquid fire, down your throat; feel it spread to your neck and beyond. This is effect of The October Julz, an original birthday gift to my beloved husband, Jules Mitchel. This is fire, you won’t ever want to put out. ©Joyce Hays, Target Health Inc.

 

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This is NOT a summer cocktail. ©Joyce Hays, Target Health Inc.

 

 

Ingredients (for 2 people)

 

2 jiggers of your best Bourbon

2 jiggers Apricot Brandy

2 jiggers Orange Curacao or Cointreau

1/2-1 jigger Amaretto liqueur

2 Cinnamon sticks (1 per glass)

1 Orange, for the peels

1 Lime, for the peels

Candied orange peels, for garnish

Luxardo cherries, for garnish

 

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All the liquor and liqueur were purchased from Sherry-Lehmann, a reliable and amazing resource, for decades. ©Joyce Hays, Target Health Inc.

 

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Sturdy glasses for this substantial cocktail. Good for some spiked cider, as well as this recipe. ©Joyce Hays, Target Health Inc.

 

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Besides glasses, you need a jigger and a container to pour the ingredients into. You don’t need the strainer, shown, above. ©Joyce Hays, Target Health Inc.

 

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You’ll need a small cutting board, a Y peeler, a paring knife if you prefer. Cut long orange peels and thick lime peels, one each, for each drink you make. ©Joyce Hays, Target Health Inc.

 

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Cut a long slit in each lime peel. Fold the long orange peel, and slip it through the slit in the lime peel. ©Joyce Hays, Target Health Inc.

 

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Into each glass, put the orange/lime peels, a cherry, a cinnamon stick and a candied orange peel (if you can find it), stuck onto the rim of each glass. ©Joyce Hays, Target Health Inc.

 

 

Next step is to stir, not shake, all the ingredients, in a cocktail shaker or tall glass cocktail pitcher. Use a long cocktail stirrer, then pour the cocktail into each glass. You can serve this cocktail over ice cubes or straight up, neat. Our recommendation is not to use ice, as it will soon dilute a drink that needs no diluting.

 

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Cinnamon stick adds to the flavor. ©Joyce Hays, Target Health Inc.

 

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Using cinnamon sticks with this cocktail adds an autumn touch. ©Joyce Hays, Target Health Inc.

 

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This is a very smooth bourbon. ©Joyce Hays, Target Health Inc.

 

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A delicious but powerful addition. Use only 1/2 jigger for each drink or its flavor will take over. ©Joyce Hays, Target Health Inc.

 

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Apricot brandy was the first ingredient to come to mind for creating this cocktail from scratch. ©Joyce Hays, Target Health Inc.

 

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A favorite everywhere! ©Joyce Hays, Target Health Inc.

 

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Added just the right touch. ©Joyce Hays, Target Health Inc.

 

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The fruit adds nuance to this warm mellow October Julz cocktail. ©Joyce Hays, Target Health Inc.

 

 

I knew I wanted to create a brand new cocktail, that I would name after Jules, as a birthday present; however, together, over a period of about two or three weeks, I put together dozens of combinations of ingredients, trying to get the exact flavor and color that I had in mind. We tried, orange juice, mango puree, champagne, Proseco, Campari, Aperol, seltzer water, Sprite, and many other liquors and liqueurs. It turned out to be a fun filled, drawn out experiment, that ended up with what we think is a new great cocktail, the October Julz

 

We hope you’ll try it and let us know how you liked it, and if it warmed you.

 

This was a Halloween birthday weekend to remember! Below are two birthday desserts for two separate birthday dinners.

 

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Boo! ©Joyce Hays, Target Health Inc.

 

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Moist chocolate layer cake with pumpkin ice cream. ©Joyce Hays, Target Health Inc.

 

 

From Our Table to Yours !

 

Bon Appetit!