StemCell Therapy

Heres another reason to eat your greens.

A powder containing a chemical found in broccoli sprouts is capable of lowering blood sugar levels of persons with type 2 diabetes, according to a study published Wednesday byScience Transitional Medicine.

The powder contains a highly concentrated dose of sulforaphane, according to study co-author Anders Rosengren of the University of Gothenburg in Sweden.

Were very excited about the effects weve seen and are eager to bring the extract to patients, Rosengren toldNew Scientist.We saw a reduction of glucose of about 10 percent, which is sufficient to reduce complications in the eyes, kidneys and blood.

Rosengren and his colleagues conducted a 12-week experiment, with 97 people with type 2 diabetes taking either the sulforaphane powder or a placebo, The Scientist reported. Most of the participants continued to take metformin, a drug used to lower blood sugar levels in diabetics.

Rosengrens team discovered that the broccoli extract was able to reduce the participants blood glucose level by 10 percent compared to those who took the placebo, The Scientist reported.

More research is needed to see if this repurposed drug can be used to treat type 2 diabetes, as it was only tested in a small number of people and only helped a subset of those who are taking it, said Elizabeth Robertson, director of research atDiabetes UK. She told New Scientist thatfor now, we recommend that people continue with the treatment prescribed by their healthcare team.

Read this article:
Study: Broccoli extract lowers blood sugar for type 2 diabetes patients - Atlanta Journal Constitution

Sally Hillerich Galla, Guest Contributor 3:13 p.m. ET June 15, 2017

Measuring blood sugar(Photo: Maya23K, Getty Images/iStockphoto)

It might be old-fashioned, but as a young child growing up in Kentucky, I was taught never to reveal my age. Yet to understand my story, you have to start with a number: Im 65, and Im incredibly fortunate to be alive.

At the age of 24, my doctor gave me six months to live, along with one last hope: an emergency surgery to treat the endometriosis which was threatening my life. Thankfully, that surgery was a success.

But my medical journey was just beginning.

In the weeks after my surgery, I lost 30 pounds, and my vision was getting increasingly blurry. A trip back to my doctor confirmed a new, equally troubling and unrelated diagnosis: Type-1 diabetes. At the time, the outlook for Type-1 patients was grim.

Like every person with Type-1 Diabetes, not a day goes by that I dont spend thinking about and treating my disease. But there are some risk factors beyond our control, notably that Medicare, unlike nearly every private insurance plan, wont pay for some treatments that helpus stay healthy.

To start, it helps to understand that Type-1 Diabetes keeps your pancreas from producing insulin, so those of us living with the disease must inject the right amount of insulin ourselves, using everything from needles to traditional insulin pumps. Youve probably seen these pumps; a patch is connected by tubes to a device clipped to your belt or placed in your pocket.

More: New health bill even worse threat for Kentuckians | Comment

More: Poverty, obesity fuel Ky's diabetes epidemic

More: Help list: Learn to avoid or manage diabetes

Devices like this come with significant drawbacks. They cant get wet, and patients with neuropathy and arthritis have a hard time connecting and re-connecting the tubes multiple times a day. However, they do have one major benefit: theyre covered by Medicare.

The device I use called an Omnipod isnt.

My Omnipod is a wireless pump; a small pod that can be worn nearly anywhere and is connected wirelessly to a device about the size of a cell phone, which doesnt have to be clipped to your clothing. Instead, it just has to be close by.

And this is where that bureaucratic thinking comes in. All other insulin pumps are paid for under Medicare Part B because theyre considered durable medical equipment.

But the Omnipod isnt.

Thats because the Omnipod is different. Each of the pods lasts three days. Once its supply of insulin is used up, you replace it with another. You keep the cell phone-sized transmitter, which connects wirelessly to each new pod. Yet even though it has been approved by the FDA for 12 years, Medicare still wont cover it.

Medicares non-coverage policy is in conflict with Congresss intent, which was to promote medical innovation. Back in 2003, they passed the Medicare Modernization Act, which made it clear: new technologies not covered under Part B should be covered under Part D, which covers medicines. Medicare hasnt used that authority to cover the Omnipod either. But it should.

Because Omnipod isnt covered under Medicare, the Federal government is forcing seniors like me to abandon the treatment we need.

Now Im fortunate: After paying out of pocket since I turned 65, I recently found out that my Express Scripts Medicare Advantage plan has decided to stop mirroring Medicares policy. Thanks to that decision, I will get the coverage I need. But millions of people arent as fortunate they rely on other Medicare and Medicare Advantage plans where Omnipod still isnt covered.

Every major diabetes patient and medical advocacy group agrees: There should be no reason why the Omnipod remains the only FDA-approved insulin pump not covered by Medicare. Theyve urged the Centers for Medicare and Medicaid Services to cover the Omnipod. And Im urging them now, too.

Medicare should cover Omnipod, because it is a critical part of my medical plan. I shouldnt be forced to lose it just because Ive turned 65and neither should any other senior.

A small business owner, Sally Hillerich Galla is a 40-year veteran of the health insurance industry who lives in Eastern Jefferson County with her husband, Patrick.

Read or Share this story: http://www.courier-journal.com/story/opinion/contributors/2017/06/15/expand-coverage-diabetes-treatment-sally-hillerich-galla/399244001/

Excerpt from:
Expand coverage for diabetes treatment | Sally Hillerich Galla - The Courier-Journal

This August, Stephanie and Michael Honig of Honig Vineyard and Winery will host a special party on their property in Rutherford to raise money for a nonprofit diabetes organization called Beyond Type 1.

The party at Honig is just one stop on an epic, 10-week adventure for Team Bike Beyond, a cycling team composed of 20 international riders living with Type 1 diabetes. As they pedal their way from New York City to San Francisco, they will spread the word about Type 1 while showing the world what it means to live Beyond Type 1.

The event, 6 p.m., Wednesday, Aug. 9 at Honig Vineyard and Winery will raise money and awareness for Type 1 Diabetes.

Musician Nick Jonas, Juliet de Baubigny, Sarah Lucas and Sam Talbot founded Beyond Type 1 in 2015, and 100 percent of every dollar raised directly supports the most promising global efforts and programs working to educate, advocate and cure Type 1 diabetes.

Type 1, which affects more than 420 million people globally, is an autoimmune disease that can happen to anyone, can present at any age, and is not related to diet or lifestyle. The Honigs oldest daughter, Sophia, who recently turned 10, was diagnosed with Type 1 at the age of 5, changing the family dynamic forever.

No parent should ever be told that their child has a life-threatening, incurable disease. We will continue to do everything in our power until a cure is found, said Stephanie Honig.

Rep. Mike Thompson said, The Honigs have been tireless advocates for Sophia and the millions of other children and families living with Type 1 diabetes. Their efforts are more important than ever as federal funding for medical research comes under attack.

On the afternoon of the event, the Napa County Sheriffs Office, along with county officials, will escort and welcome the 20 bike riders into Napa County.

There are 11 restaurants hosting food stations: Brasswood, Brix Restaurant, Charlie Palmer, The Cliff Familys Bruschetteria, Crisp Kitchen and Juice, Elaine Bell Catering, Heritage Eats, Model Bakery, Mustards Grill, Oakville Grocery and Prabh Indian Kitchen.

Wine will be provided by Honig Vineyard and Winery, Beran, Dutch Henry, Jordan, Luna, St. Supery and Vineyard 29, with cocktails from Charbay. Music for the event will be provided by Groovetronix Productions. Classic Party Rentals is donating all of the party equipment, furnishing and supplies.

Sponsors of this event include Darioush, Trinchero Family Estates, Breakthrough Beverage Group, Chuck Wagner from Caymus Family Wines, David Drucker from Empire Merchants, St Helena Hospital, The Rudd Foundation, American AgCredit, Jelly Belly Candy Company, Jamie Kurtzig and Family, Nomacorc/Vinventions.

For more information, contact stephanie@honigwine.com or visit https://beyondtype1.org/event/bike-beyond-party-napa-valley-california/.

See the original post here:
Honig family planning diabetes fundraiser - Napa Valley Register

Photo: Liveright, Handout

He Calls Me by Lightning: The Life of Caliph Washington and the Forgotten Saga of Jim Crow, Southern Justice, and the Death Penalty

He Calls Me by Lightning: The Life of Caliph Washington and the Forgotten Saga of Jim Crow, Southern Justice, and the Death Penalty

Book World: The brutal blindness of Jim Crow justice in 1957 Alabama

He Calls Me by Lightning: The Life of Caliph Washington and the Forgotten Saga of Jim Crow, Southern Justice, and the Death Penalty

By S. Jonathan Bass

Liveright. 413 pp. $26.95

---

How is it possible in a country that prides itself on having a Bill of Rights, expresses reverence for due process and touts equal protection that a 17-year-old can be arrested, put on trial and sentenced to death, and then spend 13 years being shuttled among death row cellblocks in disgusting jails and prisons with his case under appeal, all for a crime he didn't commit?

The answer contains some simple prerequisites: He had to be black, live in the Jim Crow South and be accused of committing, as one deputy sheriff put it, a "supreme offense, on the same level of a white woman being raped by a black man" - that is, the murder of a white police officer.

Teenager Caliph Washington, a native of Bessemer, Ala., was on the receiving end of all three conditions. And as such, Washington became a sure-fire candidate to suffer the kind of tyrannical law enforcement and rotten jurisprudence that Southern justice reserved for blacks of any age.

In "He Calls Me by Lightning," S. Jonathan Bass, a professor at Alabama's Samford University and a son of Bessemer parents, resurrects the life of Washington, who died in 2001 finally out of prison - but with charges still hanging over his head.

Bass, however, does more than tell Washington's tale, as Washington's widow, Christine, had asked him to do in a phone call. Bass dives deeply into the Bessemer society of 1957 where Washington was accused of shooting white police officer James "Cowboy" Clark on an empty dead-end street near a row of run-down houses on unpaved Exeter Alley.

Bessemer-style justice cannot be known, let alone understood, however, without learning about that neo-hardscrabble town 13 miles southwest of Birmingham.

Bessemer served as home to a sizable black majority, an entrenched white power structure and an all-white police department, consisting at the time of a "ragtag crew of poorly paid, ill-trained, and hot-tempered individuals" who earned less than Bessemer's street and sanitation workers.

Bessemer was a town with its own quaint racial customs, such as forcing black men to "walk in the middle of the downtown streets, not on the sidewalks, after dark - presumably to keep them from any close contact with white women."

Bessemer was a town where in 1944 the police forced black prisoners to participate in an Independence Day watermelon run. White citizens reportedly cheered as firefighters blasted the inmates with high-pressure hoses to make the race more challenging. Winners, it is said, received reduced sentences and the watermelons.

It was in that town that Caliph Washington was born in 1939, the same year of my birth in Washington, D.C.

Bessemer's racial climate was no different the year Washington was accused of killing Cowboy Clark. The town's prevailing attitude on race was captured at the time in a pamphlet distributed by a segregationist group, the Bessemer Citizens' Council. Black Christians, the white citizens' council said, should remain content with being "our brothers in Christ without also wanting to become our brothers-in-law."

If ever there was a place to not get caught "driving while black" - which is what Washington was doing on that fateful night in July 1957 - it was Bessemer. And that night's hazard appeared in the form of Clark and his partner, Thurman Avery, who were cruising the streets in their patrol car looking for whiskey bootleggers.

Washington was not one.

But his color was enough to get him chased, pulled over and told by Clark to "get out, boy."

Washington's color was enough to cause Cowboy to instruct him to place his hands over his head, to get him patted down and escorted to the rear of Cowboy's patrol car, where a tussle ensued following Cowboy's accusation that Washington had whiskey in his car; Washington's denial; Cowboy calling Washington a "smart n-----"; and Cowboy getting so angry that he pulled his weapon and started to strike Washington in the head with the butt of the gun.

Three shots went off in rapid succession - the prosecution said Washington pulled the trigger; Washington's defense said the bullet that ripped through Cowboy resulted from an accidental discharge - that it hit the car, ricocheted and tore into Cowboy.

Both sides agreed on one thing: Washington ran off.

It was a dash compelled by fear and a Southern-bred instinct that no good comes to a black man who defends himself against a white man.

Next, a massive manhunt, arrest in Mississippi, return to Bessemer courthouse, angry cursing white cops, lots of guns, plenty of hate and a jury decidedly not of Washington's peers.

Washington, accused of committing a crime against a white man in Bessemer, Ala., entered a courtroom to face a white prosecutor, a white judge and an all-white jury. To have a black lawyer defend Washington in 1957, Bass observes, would have been seen as an affront to Southern traditions.

Bessemer had only one black lawyer: David Hood Jr., a Howard University Law School graduate. Hood and another black lawyer, a fellow Howard graduate, Orzell Billingsley Jr. of Birmingham, helped prepare Washington's case for trial.

But they knew what Bass would later write in his book: that white supremacy and racial superiority were so deeply ingrained, Bessemer in 1957 was no place or time for a black lawyer to defend a black man. So, to represent Washington, the court appointed a white lawyer, giving him 14 days to prepare for the murder trial.

It was the start of a legal proceeding that stretched more than 13 years - a trek that, along the way, found countless opportunities to celebrate the triumph of racial traditions over justice.

Washington endured police interrogations without counsel; denial of the right to cross-examine witnesses; years of confinement behind bars without trial; more than a dozen scheduled dates with the electric chair, relieved by last-minute reprieves; blatantly discriminatory jury selections; and often languid and lukewarm efforts by the defense bar.

One notable exception in Bass' recitation of Alabama judicial horrors is the role played by Gov. George Wallace. Morally opposed to the death penalty, Wallace granted Washington 13 stays of execution. But Wallace's opposition wasn't enough to stop him from letting other prisoners be put to death, and the governor denied Washington's 14th petition for a reprieve.

I stop short of Bass' sympathetic portrayal of Wallace.

It fell to federal Judge Frank M. Johnson Jr., a law school classmate and onetime friend of Wallace, to render justice. Johnson, not Wallace, stayed Washington's execution. Johnson, not Wallace, recognized errors in the trial that found Washington guilty. Johnson, not Wallace, ordered Washington's conviction and death sentence be set aside. It was Johnson, not the racially demagogic Wallace, who redeemed what little there was left of integrity in Alabama jurisprudence and set Washington free to live what was left of his life. And out of America's sight.

In sharper focus, thanks to Bass' painstaking research, is a picture of how Jim Crow legal systems operated at the local and state levels. Because of his diligent examination of the backgrounds, upbringing and pedigree of those white Southern men and women who enforced Deep South justice, we know more about how courtrooms and jails functioned, and how cops, lawyers, courts and juries combined to degrade the judicial system. Bass provides details, details and more details, to the point, at times, of being overdone.

There is much in "He Calls Me by Lightning" that we needed to know. There is much, almost too much, in this book that is simply nice to know. But we are left, at the last page, with insight into a history of America that can no longer be left unknown.

---

King, winner of the 2003 Pulitzer Prize for commentary, joined the editorial board of The Washington Post in August 1990 and was deputy editorial page editor from January 2000 until his retirement in 2007. He continues to write a weekly column.

See the original post:
Book World: The brutal blindness of Jim Crow justice in 1957 Alabama - Laredo Morning Times

Willful blindness when it comes to the Telephone Consumer Protection Act (TCPA) could cost companies millions in statutory damages and penalties. Dish Network has been ordered in two cases to pay a total of $341 million based on its failure to prevent TCPA violations committed by its marketing agents. The cases illustrate the factors that courts may consider in determining what level of culpability is appropriate for ignoring TCPA violations, even in the absence of direct knowledge.

In Krakauer v. Dish Network LLC, 14-333 (M.D.N.C. May 22, 2017), the court rejected Dish Networks claims that it sufficiently supervised its marketing agent, Satellite Systems Network (SSN), to prevent SSN from making unsolicited calls to consumers. According to the court, treble damages were appropriate because (1) SSN knowingly violated the statute, and (2) Dish Network turned a blind eye to SSNs TCPA violations. The ruling contributes to the uncertainty regarding when courts will find a TCPA violation to be willful and thus subject to treble damages.

In US v. Dish Network, LLC, No. 09-3073 (C.D. Ill. June 5, 2017), the court found that a mathematical calculation of statutory damages would be disproportionate and unreasonable, and therefore did not award treble damages. The court did find, however, that a large civil penalty was appropriate after considering the degree of Dish Networks culpability, its history of prior conduct, its ability to pay and other circumstances.

The TCPA provides for $500 in statutory damages per violation. Courts have discretion to award treble damages for willing or knowing violations. In recent cases, courts have applied varying standards to determine whether conduct is willful and thus subject to treble damages. Some courts have required that the defendant have direct knowledge of calls made and knowledge that the calls violate the TCPA. For example, in Lary v. Trinity Phys. Fin. & Ins. Servs., 780 F.3d 1101 (11th Cir. 2015), the court found that it was not enough to require only that the alleged violator know that it was engaging in the conduct; instead the violator must also know that the conduct violates the TCPA, [otherwise] the statute would have almost no room for violations that are not willful or knowing. The Lary court also noted that the defendants in that case could not be responsible for treble damages under the TCPAs willful and knowing requirement since the defendants had used a third party to send out advertisements, which suggests that [the defendants] might have had no knowledge that [the plaintiff] received a particular fax. See also Harris v. World Fin. Network Natl Bank, 867 F. Supp. 2d 888, 895 (E.D. Mich. 2012) (observing that an overbroad application of willfulness would significantly diminish the statutes distinction between violations that do not require an intent, and those willful and knowing violations that Congress intended to punish more severely.); Brown v. Enter. Recovery Sys., Inc., 2013 WL 4506582, at *9 (Tex. App. Aug. 22, 2013) (But to recover treble damages, the Browns had to show that ERS knew of the TCPAs requirements and that it knew or should have known that its actions violated the Act.).

In some cases, however, courts have stated that treble damages could be awarded where there was only intent to perform the conduct at issue, regardless of whether the defendant knew that the conduct violated the TCPA. In Clark v. Red Rose, Mentor M.C. No. 04CVF-150, 2004 WL 1146679 (May 3, 2004), a consumer brought an action against Red Rose claiming that the company sent her unsolicited fax advertisements. The court awarded treble damages and noted that, as defined in the Federal Communications Act, the term willfully merely means that the defendant acted voluntarily, and under its own free will, and regardless whether the defendant knew that it was acting in violation of the statute. Regarding the knowing standard, the court explained that [k]nowingly may not be held to mean that the defendant must know that its acts were a violation of the law, since this would conflict with the long-established legal principle that ignorance of the law is no excuse. See also American Home Servs., Inc. v. A Fast Sign Co., Inc., 747 S.E.2d 205, 208-209 (Ga. App. 2013) (AHS admitted that it hired Sunbelt to send advertising faxes on its behalf. This is sufficient to make the violation willful within the meaning of the statute.).

Dish Network, a telecommunications service provider, was sued in 2014 in a class action after its marketing agent, SSN, was accused of making more than 50,000 telemarketing calls on Dishs behalf to numbers on the National Do-Not-Call Registry. The lead plaintiff, Dr. Thomas Krakauer, sought injunctive and monetary relief on behalf of himself and others who had allegedly received the calls. Following trial, the jury found Dish Network liable and awarded $20.5 million in damages. The parties then submitted closing arguments to the court on whether the TCPA violations were willful for purposes of treble damages, which was the subject of the courts May 22 opinion.

The court held that Dish Network willfully and knowingly violated the TCPA and trebled the damages award to $61 million. Although SSN made the calls, the court reasoned that Dish, as the principal, was vicariously liable. The court also explained that certain aggravating factors justified the award of treble damages. First, Dish Network failed to monitor SSNs calling practices, ignored SSNs many TCPA violations over the years, and repeatedly looked the other way. Second, and even more damaging, the court was convinced that Dish Network did not care whether SSN complied with the law or not and that Dish Networks TCPA compliance policy was decidedly two-faced, allowing Dish Network to monitor TCPA compliance while Dish Network failed to do so.

Dish Network is expected to appeal the district courts ruling to the US Court of Appeals for the Fourth Circuit, especially considering the inconsistent standards for awarding treble damages and Dish Networks position that the company did all it could to ensure SSN was in compliance with the TCPA. In the meantime, the ruling adds more concern for defendants on the possibility of treble damages and creates another big-dollar TCPA headline.

Unlike the court in Krakauer, the district court judge in US v. Dish Network, LLC, No. 09-3073 (C.D. Ill. June 5, 2017) decided against statutory damages, which the court found unreasonable and disproportionately high given that such damages totaled in the billions of dollars. The court, therefore, did not consider treble damages. Instead, the court awarded a $280 million civil penalty, citing Dishs culpability, its history of prior conduct, its ability to pay and other circumstances. The court found that culpability was significant because the programs were run in a reckless manner. According to the court, Dish [Network] had on-going problems complying with Do-Not-Call Lawsand understood the potential penalties for Do-Not-Call Law violations could be substantial, and yet the problems persisted over many years. Similar to Krakauer, the court was troubled that Dish Network seemed to make little effort to comply with the TCPA, noting, for example, that Dish Network hired Order Entry Retailers based on one factor, the ability to generate activations and that Dish [Network] cared about very little else, including complying with Do-Not-Call laws.

Companies concerned about avoiding potential TCPA exposure should be aware of the factors that some courts have considered in deciding what level of damages and/or penalties are appropriate:

The TCPA continues to create significant litigation risk for any company that communicates with customers or potential customers by phone, text or fax. Although the potential for treble damages and heavy civil penalties heightens the risk, efforts to put strong compliance procedures in place can not only reduce the risk of lawsuits, but also reduce the risk of treble damages in the event of litigation.

Go here to see the original:
Willful Blindness Costs Dish Network $341000000 For TCPA Violations - Lexology (registration)

The American Soybean Association (ASA) submitted comments this week to both the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) regarding regulations in response to advances in genetic engineering.

ASA included in comments to USDA, that biotechnology is an essential tool in farmers quest to produce enough food to meet the needs of 9.7 billion people by 2050, creating the need for a clear, science-based regulatory system in the U.S. as an example and standard for regulatory systems of biotechnology internationally.

While applauding USDAs efforts to reduce the burden on regulated entities, ASA expressed concern that aspects of the rule as proposed will increase the regulatory burden and stifle research and innovation.

Additionally, ASAs comments to FDA cheered USDAs proposal to exclude certain genome-editing techniques from requiring pre-market approvals because they are low risk and could be found in nature or achieved through traditional breeding methods.

ASA concluded its support saying, Technological advancements such as genome editing offer an additional tool to combat threats while also improving sustainability in production agriculture.

Full comments to USDA and FDA can be found here and here, respectively.

Read the original:
ASA Provides Input to USDA, FDA on Advances in Biotechnology - KTIC

(CALIFORNIA)

Thebirthplace of biotechnology is to receive$10 million for a pioneering precision medicine programme.

It was announced this week thatthe California Initiative to Advance Precision Medicine (CIAPM) has been awarded the money from the local governments budget, a decision welcomed by theCalifornia Life Sciences Association (CLSA).

Sara Radcliffe, President & CEO, CLSA, said:California Life Sciences Association (CLSA) applauds Governor Jerry Brown, California State Senate and California Assembly leaders for their strong support of life sciences innovation, as demonstrated again in this years 2017-2018 budget deal which allocates a $10 million investment in precision medicine research. California is the birthplace of biotechnology and today the states life sciences sector employs over 287,200 people working to develop innovative new medicines, technologies and therapies needed to treat and cure patients.

The Californian city of San Diego ishostingtheBIO International Conventionalthe global event for biotechnology next week. It will celebrate the industrys many breakthroughs and on going impact on society.It will take place at the San Diego Convention Center between 19 and 22 June.

BIO International ConventionalCalifornia Initiative to Advance Precision Medicine

Visit link:
$10M for birthplace of biotechnology - Innovators Magazine

As a group of visiting scientists prepared to board a plane in Hawaii that would take them back home to China, U.S. customs agents found rice seeds in their luggage. Those seeds are likely to land at least one scientist in federal prison.

Agriculture today is a high-tech business, but as that technology has developed, so has the temptation to take shortcuts and steal trade secrets that could unlock huge profits. The FBI calls agricultural economic espionage a growing threat and some are worried that biotech piracy can spell big trouble for a dynamic and growing U.S. industry.

Had they succeeded in stealing the gene-spliced rice, the scientists may have been able to reverse-engineer it and ultimately undercut [US company] Ventrias market. [Ventria President and CEO Scott] Deeter says it could have driven his company out of business.

Where the commodity in question is grown in open fields, its sometimes difficult, [Jason] Griess [the assistant U.S. attorney for the Southern District of Iowa] says.

Theft of intellectual property costs the U.S. economy hundreds of billions of dollars each year, according to a recent report from the Commission on the Theft of American Intellectual Property, a Washington, D.C.-based ad-hoc panel formed to study intellectual property theft. China, the authors say, is the biggest offender.

The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post:Spies In The Field: As Farming Goes High-Tech, Espionage Threat Grows

Read more:
FBI says Chinese spying, theft of US agricultural biotechnology is 'a growing threat' - Genetic Literacy Project

June 16, 2017

The results of two studies presented today at the Annual European Congress of Rheumatology (EULAR) 2017 press conference revealed promising data supporting two new drug classes for the treatment of psoriatic arthritis (PsA).

New agents working on different inflammatory aspects of PsA are needed in the treatment of PsA patients living with this chronic immune-mediated disease, which involves both joint and skin symptoms.

In the first study, in patients with active PsA who had not previously been prescribed an anti-TNF treatment, tofacitinib (an oral Janus kinase inhibitor under investigation for the treatment of PsA), was superior to placebo in ACR20 response rates and change from baseline in the HAQ-DI score at 3 months. Tofacitinib demonstrated superiority to placebo as early as week 2, and this was maintained for 12 months. No new safety risks were identified compared to previous studies in other indications.1

In the second study, in patients with active PsA and 3% or more of their body surface area affected by plaque psoriasis despite current or previous treatment with standard-of-care therapies, including anti-TNF treatments, guselkumab demonstrated significant improvement in joint symptoms, physical function, psoriasis, enthesitis , dactylitis and quality of life. Guselkumab, a fully human monoclonal antibody targeting IL-23, in this Phase 2 study for the treatment of PsA, was well tolerated with no unexpected safety findings in this patient population.2 Guselkumab is now being pursued in a Phase 3 development programme for psoriatic arthritis.

Tofacitinib Phase 3 Results positive for treating PsA

At month 3, tofacitinib 5 and 10 mg twice-daily showed a statistically significant improvement compared to placebo as measured by the ACR20 response (p?0.05 and p<0.0001 respectively), and change from baseline in the HAQ-DI score (p?0.05 and p<0.001).

"Despite the differences emerging in the pathophysiology of PsA and rheumatoid arthritis, tofacitinib, which works on many different cytokines, shows efficacy in the treatment of both conditions," said lead author Professor Philip J. Mease from the Swedish-Providence St. Joseph Health Systems and University of Washington School of Medicine, Seattle, US. "Since tofacitinib is a tablet and not an injection, once it receives regulatory approval, it is likely to be popular with both physicians and patients," he added.

Tofacitinib 5 and 10 mg twice-daily was superior to placebo for ACR20 response rates at week 2 (p<0.001 and p<0.0001 respectively) with responses maintained to 12 months. Greater efficacy was also seen for adalimumab vs. placebo.

More than 91% of patients were radiographic non-progressors at 12 months. Safety findings were similar between the treatment groups at 12 months. The most common adverse events were upper respiratory tract infection (7.5-10.6%), nasopharyngitis (7.5-11.5%) and headache (3.8-10.6%).

Eligible patients in this randomised, placebo- and active-controlled, 12-month Phase 3 trial had a PsA diagnosis for at least 6 months, fulfilled CASPAR criteria , had active arthritis (at least 3 tender/painful and at least 3 swollen joints) and active plaque psoriasis at screening, inadequate response to at least 1 csDMARD , and were tumour necrosis factor-inhibitor (TNFi)-nave.

422 patients were randomised 2:2:2:1:1 to tofacitinib 5 or 10 mg twice daily, adalimumab 40 mg subcutaneous injection every 2 weeks, or placebo (advancing to tofacitinib 5 or 10 mg twice-daily at 3 months). Stable treatment with 1 csDMARD was required. 96.9% of patients were white and 53.3% were female; mean age was 47.9 years. 96.2% and 88.4% of patients completed 3 and 12 months respectively.

Guselkumab improved PsA symptoms, physical function and quality of life

In this Phase 2a study, significantly more guselkumab-treated patients achieved ACR 20/50/70 responses and Psoriasis Area Severity Index (PASI) 75/90/100 responses at week 24. Nearly 40% of patients in the active group, vs. 6.3% in the placebo arm, achieved PASI 100 (completely clear skin) at week 24.

"Guselkumab, which targets IL-23, appears to be a promising new treatment of PsA," said lead author Professor Atul Deodhar from Oregon Health & Science University, Portland, US. "Although anti-TNF treatments have revolutionised the management of psoriatic arthritis, new next-generation therapies are needed in the treatment of this disease," he added.

As early as 4 weeks into treatment, 21% in the guselkumab group had a significant treatment effect on ACR20 response, compared to zero in the placebo group (p<0.001). The ACR response in the active arm increased with time, with 58% of subjects reaching a 20% improvement in joint symptoms at week 24, versus 18.4% of those on placebo (p<0.001). Fourteen percent of patients on guselkumab achieved ACR70, versus 2% on placebo, at week 24 (p=0.023).

Resolved enthesitis occurred in 29.0% of those patients with enthesitis at baseline in the placebo group at week 24, versus 56.6% on guselkumab (p=0.012). The percentage resolution from baseline to week 24 for dactylitis (in those patients with dactylitis at baseline) was 17.4% of patients on placebo, versus 55.2% on guselkumab (p<0.001). And the percentage of patients achieving minimal disease activity at week 24 was 2% for placebo compared to 23% in the guselkumab group (p=0.001).

Patients in the active arm also seemed to experience mental benefits, with significantly higher scores on the SF-36 mental component summary (p=0.002), in addition to significantly higher physical component scores (p<0.001).

Guselkumab was well tolerated; through week 24, the proportion of patients with at least 1 adverse event was comparable between the two groups (guselkumab 36.0% vs. placebo 32.7%). Infections were the most common adverse events (guselkumab 17.0% vs. placebo 20.4%). The researchers reported no serious infections, cancer or death during the 24 weeks of the study.

This Phase 2a, randomised, double-blind, placebo-controlled multicentre study included 149 active PsA patients. Patients had psoriasis plaques covering three percent or more of their body surface area, despite standard-of-care treatment, which in some patients included anti-TNF agents. In a 2:1 ratio, patients received either 100 mg guselkumab given subcutaneously, or placebo at baseline and week four; then, every eight weeks through week 44.

Patients in both arms who had less than a 5 percent improvement from baseline in swollen and tender joint counts by week 16 could qualify for early escape and switch to open-label therapy with ustekinumab. All remaining placebo patients crossed over to the guselkumab arm at week 24.

Baseline demographics and ACR component measures were generally similar between the two groups. Four (8.2%) of the patients in the placebo group and 9 (9.0%) of patients in the guselkumab group had been previously exposed to an anti-TNF agent

Explore further: Tofacitinib ups rheumatoid arthritis treatment response

(HealthDay)The addition of tofacitinib to rheumatoid arthritis (RA) treatment regimens improves patient response to non-biologic disease-modifying antirheumatic drugs (DMARDs), according to a study published in the Aug. ...

A Phase 3 clinical trial demonstrates that tofacitinib improves disease activity and inhibits progression of joint damage in rheumatoid arthritis (RA) patients who did not respond to methotrexate (MTX). Results of the 12-month ...

The results of two studies presented today at the Annual European Congress of Rheumatology (EULAR) 2017 press conference have highlighted limitations in the current treatment of patients with Psoriatic Arthritis (PsA).

New data presented today at EULAR 2013, the Annual Congress of the European League Against Rheumatism show that apremilast administered to patients with psoriatic arthritis continues to demonstrate meaningful clinical responses ...

Results of a Phase III study presented today at the EULAR 2011 Annual Congress show that at 6 months, 58.3 percent of patients who had previously not responded to treatment with DMARDs, achieved ACR20 response (a 20 percent ...

In a pivotal phase-3 clinical trial led by a Stanford University School of Medicine investigator, patients with psoriatic arthritis for whom standard-of-care pharmaceutical treatments have provided no lasting relief experienced ...

Stepping up to biologic therapy when methotrexate monotherapy fails offers minimal incremental benefit over using a combination of drugs known as triple therapy, yet incurs large costs for treating rheumatoid arthritis (RA). ...

New research from the University of Liverpool, published today in the journal npj Systems Biology and Applications, has identified 'cell messages' that could help identify the early stages of osteoarthritis (OA).

Osteoarthritis can potentially be prevented with a good diet and regular exercise, a new expert review published in the Nature Reviews Rheumatology reports.

Maintaining the supply of a molecule that helps to nourish cartilage prevented osteoarthritis in animal models of the disease, according to a report published in Nature Communications online May 11.

The results of a study led by Massachusetts General Hospital (MGH) investigators suggest that following a diet known to reduce the risk of hypertension and cardiovascular disease may also reduce the risk of gout. The team's ...

In a preclinical study in mice and human cells, researchers report that selectively removing old or 'senescent' cells from joints could stop and even reverse the progression of osteoarthritis.

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Follow this link:
New effective treatments for psoriatic arthritis patients - Medical Xpress - Medical Xpress

Please enable Javascript to watch this video

KANSAS CITY, Mo. --Charcandrick West, Chiefs running back, teamed up to make a music video with a little girl named Jillian Reid, age 10, because both of them have arthritis.

The music video is meant to raise awareness.

It features Charcandrick singing the song "Body of Steel". You can scroll down to watch and listen to the music video on YouTube.

Some of the lyrics:

We fight every day into the morning light We try to do the impossible. That's right. With every inch of pain, every scar.

One hand Holding onto another hand. One glance Telling me that I can try again and again. I know you got my back if I fall.

We can make it. Just look how far we've come. Everyday is a blessing...

Cause I got a body of steel I'm a fighter

One breath at a time One step at a time

More:
Music video about arthritis features Charcandrick West and 10-year-old singing partner - fox4kc.com

June 16, 2017

The studys primary endpoint was an improvement in arthritis signs and symptoms

Janssenannounced results from the Phase 3 study, GO-VIBRANT, evaluatingSimponi Aria(golimumab) for the treatment of active psoriatic arthritis. The results were presented at the 2017 Annual European Congress of Rheumatology (EULAR) in Madrid, Spain.

GO-VIBRANT, a multicenter, double-blind, placebo-controlled trial, evaluated the safety and efficacy of intravenous Simponi Aria in biologic-nave adult patients withactive psoriatic arthritis. Patients (n=480) were randomized to receive Simponi Aria 2mg/kg at Weeks 0, 4, and every 8 weeks thereafter, or placebo at Weeks 0, 4, 12 and 20 with crossover to Simponi Aria at Week 24. The study's primary endpoint was an improvement in arthritis signs and symptoms as measured by the American College of Rheumatology ACR20 response at Week 14. Other endpoints of the trial included ACR50, ACR75, Psoriasis Area Severity Index (PASI 75) and mean change in HAQ-DI scores.

At Week 14, 75.1% of the treatment group achieved ACR20 vs. 21.8% of the placebo group, demonstrating a statistically significant benefit with Simponi Aria (P<0.001). A greater percentage of patients in the treatment arm compared with placebo achieved ACR50 (43.6% vs. 6.3%, respectively), ACR70 (24.5% vs. 2.1%) and PASI 75 (59.2% vs. 13.6%). The Simponi Aria group also experienced greater improvements in HAQ-DI scores from baseline to Week 14 (0.60) than placebo (0.12). All improvements in secondary endpoints with Simponi Aria were statistically significant withP<0.001.

Additionally, at Week 24, treatment with Simponi Aria showed significant inhibition of joint destruction and damage, joint erosion, and joint space narrowing compared to placebo.

Regarding adverse events, 46.3% of patients receiving Simponi Aria and 40.6% of patients receiving placebo reported at least one adverse event. The most common event was infection, which was seen in 20% of Simponi Aria-treated patients. No events of opportunistic infection or tuberculosis were reported throughout Week 24

Simponi Aria is a fully human anti-TNF-alpha monoclonal antibody that selectively targets TNF-alpha, a protein that causes inflammation and damages cartilage, tissue and bones. By inhibiting both soluble and transmembrane TNF-alpha, Simponi Aria helps control inflammation.

Simponi Aria is currently approved for the treatment of adults with moderately to severely active rheumatoid arthritis in combination with methotrexate. It is available as single-use vials containing 50mg golimumab per 4mL of solution.

For more information visit SimponiAria.com.

Read the original here:
Golimumab Significantly Improves Psoriatic Arthritis Symptoms - Monthly Prescribing Reference (registration)

June 16, 2017

The trial included 363 patients with psoriatic arthritis

Eli Lilly reported that Taltz (ixekizumab) achieved primary and secondary endpoints in SPIRIT-P2, a Phase 3 clinical trial evaluating the treatment in psoriatic arthritis (PsA). These results were announced in the Annual European Congress of Rheumatology (EULAR) 2017 in Madrid, Spain.

SPIRIT-P2, a randomized, double-blind, placebo-controlled study, evaluated the efficacy of Taltz in patients (n=363) with psoriatic arthritis who either exhibited inadequate response to one or two TNF inhibitors or were intolerant to TNF inhibitors. Patients were randomized to two treatment groups of Taltz or placebo for 24 weeks. The dosing regimens for Taltz treatment arms consisted of starting doses of subcutaneous (SC) Taltz 160mg then either 80mg SC once every 2 weeks or once every 4 weeks.

The primary endpoint of the study was the percentage of patients achieving at least a 20% reduction in disease activity as defined by the American College of Rheumatology (ACR20). Secondary endpoints measured included ACR50, ACR70, skin clearance defined by the Psoriasis Area Severity Index (PASI), and physical function assessed as change in HAQ-DI scores.

Both Taltz treatment arms showed significant superiority to placebo in achieving the primary endpoint of ACR20 (53% in patients treated every 4 weeks vs. 48% in patients treated every 2 weeks vs. 19% placebo;P<0.0001). Similar results of superiority were seen in comparison of ACR50 (35% and 33% vs. 5%, respectively;P<0.0001) and ACR70 (22% and 12% vs. 0%, respectively;P<0.0001).

Additionally, both Taltz regimens demonstrated significant improvements in skin clearance and HAQ-DI scores at Week 12 and Week 24 compared with placebo.

Treatment with Taltz resulted in greater treatment-emergent adverse events, which included injection site reaction, upper respiratory infection, nasopharyngitis and sinusitis. Other common adverse reactions established in previous trials were nausea and tinea infections.

Ixekizumab is a monoclonal antibody that selectively inhibits interleukin 17A (IL-17A), a cytokine responsible for inflammatory and immune responses. By inhibiting IL-17A, ixekizumab helps control excess inflammation.

Many patients with psoriatic arthritis have tried a variety of therapies and have either lost response over time, had an inadequate response or been intolerant of therapy, stated lead author of the study, Peter Nash, Associate Professor of the University of Queensland. If approved, ixekizumab may provide physicians with a new option in this difficult-to-treat patient population.

Taltz is filed under a supplemental Biologics License Application for the treatment of active PsA in adults. It is currently approved for the treatment of moderate to severeplaque psoriasisin patients who are eligible for systemic therapy or phototherapy.

The SPIRIT-P2 trial will continue to evaluate long-term efficacy and safety of Taltz in PsA for up to 3 years.

For more information visit Taltz.com.

View post:
Ixekizumab Effective in Psoriatic Arthritis After Inadequate TNFi Response - Monthly Prescribing Reference (registration)

June 16, 2017

The ORAL Strategy also compared tofacitinib alone vs. tofacitinib in combination with methotrexate

Pfizerannounced findings from the head-to-head Phase 3b/4 study comparingXeljanz (tofacitinib citrate; Pfizer) with or without methotrexate vs.Humira (adalimumab;AbbVie) with methotrexate for the treatment of moderate to severe rheumatoid arthritis. The ORAL Strategy also compared Xeljanz alone vs. Xeljanz in combination with methotrexate. Full findings were published in The Lancetand presented during the Annual European Congress of Rheumatology (EULAR) 2017 in Madrid, Spain.

The non-inferiority study found that ACR50 response, the primary efficacy endpoint, was achieved in 46% of the Xeljanz 5mg twice daily + methotrexate group, 38.3% of the Xeljanz 5mg twice daily group, and in 43.8% of the Humira 40mg every other week + methotrexate group.

Study author, Dr. Roy Fleischmann, stated, "Although Xeljanz monotherapy did not demonstrate non-inferiority to either combination arm, the clinical responses observed are reflective of those in the Phase 3 clinical program and affirm our understanding that Xeljanz is an important option both in combination with methotrexate and as monotherapy for patients who do not respond to or are intolerant to methotrexate.

Regarding safety data, the most commonly reported adverse events for each study arm were upper respiratory tract infections, alanine aminotransferase elevation, nasopharyngitis, urinary tract infections, and nausea. Between treatment arms, the overall rate of adverse events were similar.

Adverse events were seen in 61.4% of the Xeljanz 5mg twice daily + methotrexate group, 58.9% of the Xeljanz 5mg twice daily group, and in 65.5% of Humira 40mg every other week + methotrexate group. Serious adverse events were noted in 7.2% of the Xeljanz 5mg twice daily + methotrexate group, 9.1% of the Xeljanz 5mg twice daily group, and in 6.2% of Humira 40mg every other week + methotrexate group.

Xeljanz andXeljanz XRare Janus kinase (JAK) inhibitors indicated to treat moderately to severely active rheumatoid arthritis when methotrexate therapy is inadequate. Xeljanz and Xeljanz XR may be used alone or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs).

For more information visitXeljanz.com.

Read more:
Tofacitinib Goes Head-to-Head with Adalimumab in Rheumatoid Arthritis Study - Monthly Prescribing Reference (registration)

MIRI SCHROETER AND KAROLINE TUCKEY

Last updated17:56, June 11 2017

Warwick Smith

Accountancy student Megan Hislop, 19, was suffering headaches and fatigue from long hours studying, but found a big improvement after getting glasses especially for monitor use.

Almost 50 per cent of a group of 70 Massey Universitystudents were found to have eyesight problems, according to a study.

The EssilorVisionFoundation, a charity that tests students' eyesight nationwide, found that45 per cent of those in the study had previously undiagnosed eye issues.

VisiqueEye Spy optometristMaileTarsau, whocarriedout the free checks at Massey, said daily use of digital devices contributed to the problem.

Warwick Smith

An optometrist firm did free tests of students eyesight on Massey campus. Megan Hislop (pictured), who did the free test and was found to have eye issues as a result of lots of device use.

"Alot of [students'] work can be based online these daysand then they are online on their social media every day."

Many students spent up to 12 hours a day looking at screens without realising that it affected their eyes, Tarsau said.

"Commonly people come in saying they've got headaches, or it takes a little while for their eyes to focus, delayed focus, sometimes their eyes are watery, gritty or scratchy, or even itchy.

"People don't always put two and two together, that it might be related to their eyes.They know they've been under the pump and stressedand think they are just tired."

Massey accounting studentMegan Hislop, 19, realised after taking part in the study that her tiredness was partially a result of using a computer every day.

"I didn't really think it was anything at the time, but when looking at screens I found it took longer to focus.

"Some days I got headaches from it, because I'd been straining my eyes so much."

Hislop has been using glasses for about three weeks and has noticed that her eyes don't feel as tired.

"It's a huge advantage.I can process information faster."

Previous studies on primary school children showed that30 per cent of low decile school pupilshad eyesight issues, Tarsau said.

Ongoing use of digital devices throughoutschooling and then at university contributed to the problem, she said.

Massey University education lecturerJulia Buddsaid uncorrected vision could affect behaviour and learning.

Budd was currentlycompleting a studyto see what the affects are and whatimprovementscould be made, such as providing regular testing for childrensimilar to dental checks theyreceivedduringtheir schooling.

Massey University associate professor Alison Kearney, who is working on the project with Budd, said it was estimated that up to 80 per cent of learning was done through visual means.

Shannon School principal Murray Powellsaid some pupils used devicesup to 80 per cent of the day at school.

Because they used them heavily at school, Powell advised pupils to minimise screen time at home.

Awahou school principal Matt Schmidtsaid teachers tried to limit screen time and when the weather permits pupils were not allowed inside on devices.

They were encouraged to play outsideto limit screen time and to increasesocial interaction, Schmidt said.

-Stuff

Read more:
Almost 50 per cent of Massey University students in vision test have eyesight issues - Stuff.co.nz

MEDFORD (CBS) After 20 years of darkness, there is light.

It seems like science fiction, but a bionic eye implant is bringing a kind of sight to the blind.

Its not what you and I see, but for a small number of people, its making all the difference.

Its not actual vision. Its what they call artificial vision, says Anthony Andreotolla,one of the first people to ever receive a bionic eye.

Every day he puts on his gear, leaves his Medford home and rides the MBTA to his job in Downtown Crossing.

Anthony Andreotolla wearing bionic eye (WBZ-TV)

Andreotolla has retinitis pigmentosa. He began to lose his vision in his teens. By his 30s he couldnt see a thing.

Once everything is black, for many, many years, that was it, he said.

For 20 years he lived in that blackness until he became one of the first to receive a bionic eye.

How does it work?

A tiny camera in his glasses sends images to a wearable computer. The images are processed and sent wirelessly to an implant in his eye.

Anthony Andreotolla wearing bionic eye (WBZ-TV)

I dont see things the way other people do. I see everything in different flashes, lights, shapes, Andreotolla explained.

Its more of a cloudy, black and white vision.

I can tell the difference between a car or a bus or a truck. I cant tell you what make the car is, he said.

That vision helps him navigate life more safely.

And after his journey, he arrives at his job as a substance abuse counselor at St. Anthonys Shrine.

I have my hope back. Once I lost my sight I was resigned to be blind for the rest of my life. Im not resigned to that anymore. I believe if I can live long enough, Ill be able to see a lot of beautiful things, Andreotolla said.

The developer of the bionic eye is Second Sight, and theyre already working on the next generation with faster processing and sharper images. Andreotolla had to go to Johns Hopkins in Baltimore for his surgery, but it will be available soon at at least one Boston hospital.

Follow Paula on Twitter Award-winning journalist Paula Ebben co-anchors WBZ-TV News at 5:30PM and WBZ-TV 8PM News on myTV38 with co-anchor Liam Martin. Ebben also reports across WBZ-TVs newscasts including WBZ-TV News Eye on Educatio...

Go here to read the rest:
Medford Man Receives Bionic Eye - CBS Boston / WBZ

Island Packet (blog)

Hilton Head waitress who inspired the nation gets her eyesight back Island Packet (blog) He called to suggest the local Lions Clubs might be able to help resolve Webber's eyesight problem. Lions Clubs International, now celebrating its ... Conventional glasses cannot compensate for the loss of vision. And even with glasses, Webber has been ...

View post:
Hilton Head waitress who inspired the nation gets her eyesight back - Island Packet (blog)

A chemical called sulforaphane could be a new option for people with Type 2 diabetes who need help managing their blood sugar.

In a studyjust published inScience Translational Medicine, researchers randomized 97 people diagnosed with Type 2 diabetes to take a concentrated broccoli sprout extract containingsulforaphane once a day for 12 weeks or a placebo with the same regimen. All but three of the participants were taking metformin, a standard treatment for controlling blood sugar.

Broccoli at a market in Vienna. A new study shows yet another health benefit for the vegetable: A chemical it contains could help people with Type 2 diabetes manage blood sugar. Leonhard Foeger/Reuters

Tech & Science Emails and Alerts- Get the best of Newsweek Tech & Science delivered to your inbox

Glucose production was reduced among patients taking the ultraconcentrated sulforaphane. The compound improved fasting glucose and glycated hemoglobin, or HbA1c, an indicatorof blood sugar levels in obese patients with dysregulated Type 2 diabetes. And sulforaphane also showed a protective effect against some complications linked to diabetes, such as neuropathy and kidney failure.

How did the researchers light upon sulforaphane as a blood sugar manager? Genetics and math. Led by Annika Axelsson, of Lund University Diabetes Centre in Sweden, the scientists created a genetic profile for Type 2 diabetes based on 50 key genes, alterations of which are associated with the disease. They then screened 3,852 different compounds to find any that might reverse that genetic signature. Sulforaphane stood out.

Before studying the compound in humans, Axelsson and colleagues first gave sulforaphane to animals.In rats with diabetes, the compound, which occurs naturally in cruciferous vegetables, had the intended effect, reversing the genetic signature in the animals livers. The chemical also controlled blood sugar at a level comparable to metformin.

The human study that followed indicated that concentrated sulforaphane could be a viable treatment for Type 2 diabetes. Because up to 15 percent of the 300 million people with Type 2 diabetes worldwide cannot take metformin due to the risk of kidney damage, new ways to help patients manage blood sugar are needed. The researchers emphasize that high doses of sulforaphane cannot yet be recommended to patients as a drug treatment, the study results are a clear sign that the approach is worth pursuing.

The rest is here:
Sulforaphane, a Chemical in Broccoli, May Help Diabetics Control Blood Sugar - Newsweek

Here are some data to file under Drugs do things that we dont expect. The SGLT-2 inhibitors are a class of diabetes medications that work by inhibiting the sodium/glucose transporter 2 protein in the kidneys. That keeps glucose from being reabsorbed there; instead, more of it is removed in the urine, and that lowers circulating glucose levels. One side effect, as you might imagine, is an increased risk of urinary tract infections, but overall, the class seems to have a lot of beneficial effects.

Too many beneficial effects, actually. One of the major drugs in this category, Jardiance (empagliflozin) from Boehringer and Lilly (NYSE:LLY), has recently been the subject of a big outcomes trial by the two companies. And the results were good the drug reduced cardiovascular mortality, all-causes mortality, and hospitalizations from heart failure. Good news! But when the team dug further into the data, things got weird. Youd think that these benefits would be due to reductions in glycosylated hemoglobin (HbA1c), lower LDL cholesterol, lower blood pressure, etc. But when they corrected for all these factors, the effects persisted.

Its quite clear that the results that we see from the drugmakers Empa-Reg Outcome studyincluding the 38% reduction in the risk of cardiovascular deathreally is not explained through these classical risk factors we have all been aware of for some decades now, Thomas Seck, Boehringers VP of clinical development and medical affairs for its primary care unit, said in an interview.

So what the heck is it explained by? At this point, no one knows. This is reminiscent of the situation with statins, whose good outcomes are not completely explained by their reduction of LDL levels. This should serve as a reminder that (1) there are a lot of biochemical mechanisms that we dont know about yet and (2) the ones that we know about arent necessarily as important as weve made them out to be.

Meanwhile, at the same ADA meeting where these results where released, J&J presented data on their own SGLT-2 inhibitor, Invokana (canaglifozin). And with this one, too, patients were notably less likely to suffer cardiovascular events, which is good news. But there was also an unexpected increased in the risk of amputation (which is already a risk in advanced Type II diabetes patients). This is not something thats turned up with the other SGLT-2 compounds so far, and is also a mystery.

We do not know what a new drug is going to do, not really, until its gone into a large patient population. And that means, most of the time, until its made it to the market. Clinical trials are absolutely necessary to clear out the biggest, most noteworthy problems, and will show you the biggest, most noteworthy benefits that can be shown in the time it takes to run the trial. But the longer, more subtle things (or the ones that happen in very low incidence) will only appear once the drug is out there in the real world, being taken by a large number of people under all kinds of conditions.

Disclosure: None.

Originally posted here:
2 Diabetes Drug Mysteries - Seeking Alpha

For about a week, Griffin Kyes will get to be a normal child at summer camp. He'll do all the traditional camp activities: running through the woods, swimming, watching skits and playing in the GaGa ball pit his favorite.

Along the way, Kyes will also master how to control his Type 1 diabetes.

"I've learned that you need to control your diabetes or else your body could get really harmed," said the soon-to-be fifth-grader at Pioneer Elementary School in Bismarck.

This will be Kyes third time at Camp Sioux, which is for children ages 8 to 15 who have diabetes. It's the only camp like it in the state, located in Park River, just northwest of Grand Forks.

Camp Sioux is sponsored by various organizations, including several Lions Clubs, such as the one in Mandan. The American Diabetes Association runs the camp, according to Carol Holten, associate manager of community health strategies for the Midwest Division of the ADA.

"We just want them to be normal kids and know that their diabetes won't hold them back," Holten said.

The kids do this while also learning independence. There aren't any formal educational sessions or classes, but instead "teachable moments," Holten said.

There will be dietitians to help count carbs. Some of the children will learn to take an insulin shot for the first time.

Kyes was diagnosed with Type 1 diabetes when he was 4 years old. His mother, Lisa Rask, said the chronic disease doesn't run in the family, and she began noticing Kyes' symptoms, such as being constantly thirsty, weak and wetting the bed,when he was younger.

It was super hard to drop him off the first year when a kid is diabetic you cant just let them go to a party or sleepover, it doesnt work like that," she said. "When you walk into camp, you have a parent meeting and they line up all the nurses and doctors, and you just feel better."

Behavioral Risk Factor Surveillance System, 2014

In 2014, about 49,000 adults in North Dakota were living with diagnosed diabetes, and an estimated 37 percent of the population, or more than 202,000 people, had prediabetes.

There are two types of diabetes: Type 1 is most common in people under age 20, and it occurs when insulin-producing cells of the pancreas are damaged. In this instance, little or no insulin is produced, and patients need insulin injections to control their blood sugar.

Type 2 diabetes is diagnosed in people who produce insulin, but not enough. This type can be managed by controlling a person's weight, diet, regular exercise or by taking oral medicine or insulin injections.

There are some serious complications associated with diabetes, including lower limb amputation, blindness, kidney failure and cardiovascular disease.

Holten said 150 children plan to attend Camp Sioux this year, which will be held Saturday through next Thursday. This year's registration is up from 134 in 2016. She said the increase in children attending the camp can be attributed to a general rising trend in the number of children with diabetes, but also to more doctors getting the word out to newly diagnosed patients.

Such gatherings aim to help children control the disease while also helping them meet others who are experiencing the same things. Many of the camp counselors are former campers.

"Many of the younger kids aspire to (become a counselor), and the older kids love being able to be in that staff position," Holten said.

KateyNick, a nurse and diabetes educator at Sanford Health in Bismarck, was diagnosed with Type 1 diabetes at age 3.

"I don't remember it any other way," said Nick, 26, who has gone to Camp Sioux on and off since she was 8 years old.

Nick has been a camper, counselor and, this year, she'll go back as a nurse.

"Growing up, I didn't really want to take care of myself. I wanted to be a normal teenager; eat what I wanted," said Nick, who struggled to control her diabetes.

But the camp helped her feel normal, and she's made some lifelong friends along the way.

"It helps kids really learn that they're not so different. They have this chronic disease, but it's manageable," Nick said.

See the original post:
Children with diabetes find comfort at camp - Bismarck Tribune

From left, Rebecca Merriman (Medtronic), Melissa Louis (Medtronic), Shelley Blonheim (Insulin Pump User), Laura Cameron (Medtronic), Linda Hepner (Surrey Mayor), Neil Fraser (Medtronic) cut the ribbon to officially open a new Medtronic diabetes resource centre in Surrey. (Submitted photo)

Fraser Health says Surrey and Abbotsford have the largest proportion of diabetics in the region

SURREY Canadas first Medtronic Resource Centre for patients with diabetes held its grand opening in Surrey this Wednesday (June 14).

Located on the main floor of the City Centre 1 building across the street from Surrey Memorial Hospital, the new centre will serve as a one-stop shop for those with diabetes.

Its intended to be able to provide support in between clinic visits, explained Laura Cameron director of Medtronic Canadas Diabetes Group. To allow them to better utilize their technology so that they can have better support in managing their diabetes. We hope it will provide additional support to the clinics who will be doing some of the less-basic things with them. Well take care of some of the stuff in between.

The goal, she noted, is to elevate their ability to manage their disease and as a result, have better outcomes and fewer complications, thus, improving lives.

The new centre will offer insulin pump classes, lessons on CGM (continuous glucose monitoring) and educate patients on carb counting and best travel practices.

The centre, within the Innovation Boulevard health tech district, will also provide networking opportunities and one-on-one time with certified insulin pump trainers.

Cameron said Surrey was chosen as the location for their centre because of the high prevalence of diabetes in the city, and all of Fraser Health.

Its estimated that 29 per cent of British Columbians (or 1.5 million people) have either diabetes or pre-diabetes. Over the last decade, the province has seem a 74 per cent spike in the number of people diagnosed with diabetes and by 2027, its projected to grow by another 44 per cent.

According to Fraser Health, Surrey and Abbotsford have the largest proportion of diabetics within its region, which the health authority says may be due to the large South Asian populations living there.

Surrey diabetes specialist Dr. Chris Mahony said the centre has been much anticipated as a real-world solution to a real-world problem, offering post-marketing care of our clients on an intensive insulin regimen using Medtronic insulin pump technology.

He said the centre will raise the bar to a new level of support.

Jodie Steen has been living with Type 1 Diabetes for 31 years and started on her first insulin pump almost 17 years ago.

It has given me so much freedom and better blood sugar control than multiple daily injections, she aid. More recently, I have been wearing CGM on a regular basis which has resulted in the best A1C I have had in years.

Steen said she looks forward to having the access to experts at her convenience.

Cameron said thats why she does what she does to help people live better lives.

We hear stories about parents who had their first good night sleep since their child was diagnosed, as a result of being able to trust the pump, said Cameron. Thats why were so passionate. Its very rewarding.

The new Medtronics Resource Centre is located in the City Centre 1 building, located at 13737 96th Ave.

amy.reid@surreynowleader.com

Excerpt from:
Canada's first Medtronic diabetes resource centre opens in Surrey - Surrey Now-Leader