Inhalable insulin for diabetes wins FDA approval

imagesThe Food and Drug Administration on Friday approved a long-delayed inhalable diabetes medication to help patients control their blood sugar levels during meals.

The FDA cleared MannKind Corp.’s drug Afrezza, a fast-acting form of insulin, for adults with the most common form of diabetes that affects more than 25 million Americans. The approval decision comes more than three years after the agency first asked MannKind to run additional clinical studies on the drug.

Diabetes is a chronic condition in which the body either does not make enough insulin to break down the sugar in foods or uses insulin inefficiently. It can lead to blindness, strokes, heart disease or death. In Type 2 diabetes, the most common form of the disease, the body does not use insulin properly. Type 1 diabetes is usually diagnosed in children and young adults. In those cases, the body does not produce insulin.

Afrezza, an insulin powder, comes in a single-use cartridge and is designed to be inhaled at the start of a meal or within 20 minutes of starting. MannKind has said patients using the drug can achieve peak insulin levels within 12 to 15 minutes. That compares to a wait time of an hour and a half or more after patients inject insulin.

The FDA said in its approval announcement that Afrezza is not a substitute for long-acting insulin and is a new option for controlling insulin levels during meals.

The FDA approved the drug with a boxed warning — the strongest type — indicating that the drug should not be used in patients with chronic lung diseases, such as asthma, due to reports of breathing spasms.

Demand for diabetes treatments are surging globally as the prevalence of obesity explodes. Roughly 347 million people worldwide have the disease, according to the World Health Organization.

New effort to fight diabetes in Sonoma County

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Sonoma County medical providers are taking aggressive steps to deal with the high rate of patients with diabetes admitted to local hospitals, a trend that is said to be driving up hospital costs.

In Sonoma County, patients with diabetes account for almost 26 percent of all local hospital admissions, according to a recent UCLA analysis of 2011 hospital patient discharge data. That’s a total of 7,459 hospital admissions.

The added cost of hospital care is estimated at $16.4 million, according to the study, which was conducted by the UCLA Center for Health Policy Research with support from the California Center for Public Health Advocacy.

“We are very concerned about the epidemic of diabetes and the toll that it takes on individuals and the system that cares for them,” said Karen Holbrook, the county’s deputy public health officer.

Holbrook said diabetic patients who are admitted to local hospitals pose more medical complications than those who are not diabetic and often require more tests and treatments. Severe diabetes often results in serious medical conditions such as liver disease and kidney failure, she said.

According to the UCLA study, 31 percent of the state’s hospitalized patients 35 years or older, the age group that accounts for most hospitalizations, had diabetes. The study estimated that the added cost to hospitals in California was $1.6 billion. Hospital stays for diabetic patients in the state cost an average of $2,200 more than for non-diabetic patients, according to the study.

The study’s authors pointed out that 75 percent of this care is covered by Medicare and Medi-Cal, the state’s Medicaid program. Medi-Cal alone pays $254 million in added costs for diabetic patients.

The Tour de Cure event hosted by the American Diabetes Association of Northeast Ohio has already raised $250,000 for diabetes research

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CUYAHOGA FALLS — The Tour de Cure event hosted by the American Diabetes Association of Northeast Ohio has already raised $250,000 for diabetes research in the region, according to Melissa Sutton, the event manager.

The annual event leads riders through a bike route as long as 100 miles. However, riders could also bike shorter distances.

The Saturday ride kicked off at the Cuyahoga Valley Christian Academy on Wyoga Lake Rd. in Cuyahoga Falls.

Participants could also enjoy on-site activities geared towards fun and information about diabetes.

Sutton, who has lived with type one diabetes since she was 9-years-old, says she hopes the ride will combat the stigma the disease faces. “My pancreas stopped working and there’s not a darn thing I can do about it,” Sutton tells Channel 3’s Hilary Golston. “It stops working. So I take it particularly personally when people think it’s a lifestyle disease.”

According to the ADA, 330,000 people have diabetes in Northeast Ohio. “Red riders” or those living with the disease donned red shirts to denote they have diabetes and are participating in the race.

Riders were asked to raise at least $200 to participate, but some raised much more. 11-year-old Gabe Grizwald was able to rake in $2,000. He’s also living with type one diabetes. “I ride for diabetes because it’s just a horrible disease to have and it’s really just changed my life and I think it helps so much when people ride for us and raise money and it really could lead to a cure,” Grizwald tells Golston.

Brian Travalik is Tour de Cure’s red rider ambassador. Decked out in a tutu for flare, he not only lives with diabetes, but represents the so-called “red riders.” Red riders are those who have diabetes and are also participating in Tour de Cure. “It’s a chance to be honored as a hero,” Travalik said. “To see other people with diabetes, it’s a good feeling to be around that comradery of other people that are dealing with that same disease.”

It’s not too late to donate to the cause. You can head over to http://main.diabetes.org/site/TR?fr_id=9375&pg=pfind to give.

 

Human gut cells turned into insulin producers may treat diabetes

Scientists have converted human gut cells into insulin producers by turning off a single gene in an experiment that suggests a novel way forward in treating diabetes.

Using a miniature model of the human intestine, only a few millimeters in size and made from stem cells, the scientists deactivated a gene in the cells tied to metabolic regulation called FOXO1. Once disabled, the cells began producing insulin.

The method, described Monday in the journal Nature Communications, raises the possibility of replacing insulin- making pancreatic beta cells lost in diabetics by using a drug to retrain patients’ existing cells. While progress has been made in generating beta cells from stem cells, the method hasn’t yet produced ones with all the needed functions, said Domenico Accili, the study’s lead author. Plus, such cells would require transplantation.

“We provided a proof of principle that we can do this in human tissues and are also very excited that there is a single identifiable target to trigger this process,” Accili, professor of medicine at Columbia University’s Naomi Berrie Diabetes Research Center in New York, said in an interview. “This is what the pharmaceutical industry is interested in — make a chemical and do what we did in test tubes to administer to persons with diabetes and teach their gut cells to become beta cells.”

The results build on research two years ago by Accili and his team that first tested the approach in mice, successfully converting gut cells into insulin-making cells. In the human cell experiment, the gut cells started releasing insulin after seven days and only in response to insulin.

Now that Accili and his team have shown it works in human cells, their next step is to develop a drug to test in people. Accili said it’s possible that there could be a compound for clinical trials in a year or two.

Diabetes, which results when the body doesn’t use insulin properly or doesn’t make the hormone, is the seventh-leading cause of death in the U.S. Insulin is a hormone secreted by the pancreas that helps the body control blood sugar.

Destruction of insulin-making beta cells in the pancreas is the central feature of Type 1 and Type 2 diabetes. In Type 1 diabetics, the pancreas are destroyed by the immune system and don’t produce insulin. In Type 2, in which the body doesn’t use insulin properly, beta cells become progressively dysfunctional.

One advantage to this experimental approach is that the gastrointestinal tract is partly protected from attack by the immune system, making gut cells less susceptible to destruction, Accili said.

A treatment for diabetes that doesn’t require daily insulin injections would change the treatment landscape for the 29 million diabetics in the U.S. However, it’s likely that any potential drug would first be evaluated for Type 2 diabetes, because of concerns of testing in Type 1 diabetics going without insulin injections, he said.

“The work is a laser-like focus on turning this into a treatment,” Accili said. “We follow 3,000 patients with Type 1 at the Berrie Center alone. That’s our main goal.”

Collaborations with drugmakers are already under way, Accili said, though he declined to name companies.

British drugmaker AstraZeneca Plc helped fund the research, with the National Institutes of Health, the Manpei Suzuki Diabetes Foundation, the Swedish Society for Medical Research, the Japan Society for the Promotion of Science, the JPB Foundation and the Brehm Coalition.

June 30, 2014 ~ Ginger Vieira, Dealing with Diabetes Burnout

photo2Ginger Vieira

Author of Your Diabetes Science Experiment and Emotional Eating with Diabetes, Ginger Vieira has lived with Type 1 diabetes and Celiac disease since 1999, and fibromyalgia since early 2014. Today, she is an avid freelance writer and motivational speaker with a background as a certified cognitive coach, personal trainer, and Ashtanga yoga instructor specializing in coaching people with diabetes. She creates diabetes video blogs at her YouTube Channel and produces regular freelance content for various diabetes websites including DiabetesDaily.com and ASweetLife.org. In 2009 and 2010, Ginger set 15 records in drug-tested powerlifting with her best lifts including a 308 lb deadlift, 190 lb. bench press, and a 265 lb. squat. Today, she lives in Vermont with three dogs and her fella. Living-in-progress.com

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Listen to the latest broadcast of Diabetes Living Today®:  June 3o, 2014 ~ Ginger Vieira on Dealing with Diabetes Burnout.

 

An Uproar Over a Diabetes Article, With a Back Story

Many Times readers, some of whom have Type 1 diabetes, are upset over an article last Sunday in which Elisabeth Rosenthal explored the often extraordinary expense of treating the disease. It was an installment in her series, “Paying Till It Hurts,” about the high cost of medical care in America.

In emails, on blogs and on Twitter, the readers have harshly criticized what they see as the way the article trivializes the treatments and devices that are crucial to their lives or those of their family members. In response to the article’s mention of “high-priced gadgets and disposable accoutrements,” they are using a Twitter hashtag: #notjustagadget.

Over the past few days, I have read much of the criticism, including that on two blogs: Diabetes Mine and A Sweet Life, both of which make points worth considering. I have reread the article itself, many of the reader comments on it, and spoken to the article’s author and to its main editor, Rebecca Corbett.

I’ve also become aware of the key role that several industry-backed patient-advocacy groups have played in heating up the protests.

These are my observations:

1. The article’s headline — “Even Small Medical Advances Can Mean Big Jumps in Bills” — and a few of its language choices could have been better. The headline’s reference to “small advances” immediately set some on edge, its editor and writer strongly believe. (Ms. Rosenthal told me that she found it “tone deaf” and was afraid that it would mislead readers about the article’s overall point.) Before the article went online, and afterwards, Ms. Rosenthal and Ms. Corbett asked for a headline change, but it was tweaked only slightly. And, within the article, the descriptions of some devices, while accurate, might have been written with more awareness of how they would be received.

2. Over all, the article is not guilty of the crimes it’s being accused of – that is, nowhere does the author make light of the disease or the importance of good and innovative treatment. It is well sourced, and based on conversations with both medical experts and those who have the disease. The focus on cost is no surprise; the series, after all, is about the high cost of medical care. “This was not supposed to be about how hard the life of a Type 1 diabetic is – and it definitely is – but rather about the cost issues,” Ms. Rosenthal told me.

What’s more, the article came about because of reader concern over this very subject, Ms. Corbett told me. More than 200 Times readers identified diabetes care as something they hoped Ms. Rosenthal would look at. And the article states, as early as the second paragraph, that devices such as insulin pumps have changed lives for the better: “Such devices, which tailor insulin dosing more precisely to the body’s needs, have transformed the lives of people with Type I diabetes like Ms. Hayley.”

3. JDRF, formerly known as the Juvenile Diabetes Research Foundation, which gets significant funding from industry players and which provides grants for research and lobbies in Washington, sent an email Monday afternoon to Type I patients across the country. It described the organization’s outrage at the article for having made light of advances in diabetes care and it encouraged patients to comment. Other advocacy groups acted similarly.

And it was effective. The initial response to the article was overwhelmingly positive – both in the comments and in email to Ms. Rosenthal. Reaction became much more negative and accusatory after the advocacy groups emailed their members urging them to write to The Times, to light up Twitter and to otherwise respond negatively to the article, Ms. Corbett said. Research by my office backs this up; the tide turned from positive to negative in the comments on Monday afternoon.

I’ve seen this happen before. Once contacted by an advocacy group, people who haven’t already formed an opinion about an article are very likely to read it through a particular lens — if they read it at all before reacting.

4. Articles that delve into medical and other scientific topics are always hard to get right, as they attempt to take esoteric information and translate it for the lay reader. Ms. Corbett told me that, prior to publication, she asked a Times reporter who has Type 1 diabetes — as does the reporter’s mother — to read it for tone and accuracy. In addition, Ms. Rosenthal herself is a medical doctor.

The Times’s correction desk has made one factual correction to the article and another to an accompanying graphic; those corrections have been made online and will appear in print on Sunday.

Even some of the harshest critics of the article say they were gratified to see Type 1 diabetes – and the high cost of living with the disease – get front-page attention in The Times.

Was the treatment of the story perfect in every way? No. Was it essentially sound journalism with an important purpose? I think it clearly was.

March 31, 2014 ~ Medtronic Insulin Pump Therapy and CGM with Dr. Francine R. Kaufman

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FRANCINE R. KAUFMAN, M.D.

Chief Medical Officer and Vice President, Global Medical,

Clinical & Health Affairs, Medtronic Diabetes

Emeritus Professor of Pediatrics and Communications at USC

The Center for Diabetes, Endocrinology & Metabolism

Francine Ratner Kaufman, M.D. has had a 30 year distinguished careerin diabetes care, research and advocacy.  In 2009, she stepped down as director of the Comprehensive Childhood Diabetes Center, and head of the Center for Endocrinology, Diabetes and Metabolism at Childrens Hospital Los Angeles to become Chief Medical Officer and VP of Global Clinical, Medical and Health affairs at Medtronic Diabetes (Northridge, CA).

 

Dr. Kaufman is also a Distinguished Professor Emerita of Pediatrics and Communications at the Keck School of Medicine and the Annenberg School of Communications of the University of Southern California, and an attending physician at Childrens Hospital Los Angeles.

Dr. Kaufman has published more than 200 peer-reviewed and invited publications. She is the author of more than 30 books or book chapters. In 2008, she edited the 5th edition of the ADA’s the Medical Management of Type 1 Diabetes.  In 2005 her book, Diabesity, was published by Bantam. Diabesity explores the ravages of the obesity and diabetes epidemics as they spread across the globe. Dr. Kaufman was chair of the National Institutes of Health funded Studies to Treat (the TODAY Trial) and Prevent (the HEALTHY Trial) Type 2 Diabetes in Youth (STOPP-T2). She was a principal investigator of TrialNet, a multinational consortium evaluating ways to prevent type 1 diabetes, funded by the National Institutes of Health (NIH).  She has received many awards and honors, including the LA City Council for promoting youth physical fitness (2004), from the State of California for her role in banning sodas from Los Angeles Unified School District (2003), and from the American Diabetes Association (ADA), Juvenile Diabetes Research Foundation (JDRF), European Association for the Study of Diabetes (EASD), Partners in Care, Starbright Foundation, amongst others.

In 2009, Dr. Kaufman was elected to membership in the Advisory Council of the Diabetes Branch of the NIH. In 2007, she filmed a documentary for Discovery Health on the global diabetes epidemic which was aired around the world on World Diabetes Day, November 14, 2007. Also in 2007, Dr. Kaufman was Co-Chair of the Diabetes Work Group for the Department of Health Services of the State of California to recommend diabetes treatment and prevention strategies for the Medicaid population.  In 2005, she was elected Membership in the Institute of Medicine.  Dr. Kaufman was national president of the American Diabetes Association in 2002-03.  She was elected to AOA Medical Honorary Society. She was also president of Shaping America’s Health, chair of the National Diabetes Education Program, and served as chair of the Youth Consultative Section of the International Diabetes Federation.

Listen to the latest broadcast of Diabetes Living Today®:  March 21, 2014 ~ Medtronic Insulin Pump Therapy and CGM with Dr. Francine R. Kaufman

FDA studies possible pre-cancerous link with diabetes drugs!

The Food and Drug Administration is studying unconfirmed reports that a widely used class of diabetes drugs, which includes Merck & Co’s Januvia, may cause inflammation of the pancreas and pre-cancerous changes to the pancreas.

The agency, in a notice on its website on Thursday, said this is the first time it has communicated potential pre-cancerous links to the medicines, known as incretin mimetics.

The drugs for type 2 diabetes also include Victoza from Danish drugmaker Novo Nordisk and Onglyza from Bristol-Myers Squibb Co and AstraZeneca Plc.

Patients should continue taking their medicines as directed until speaking with healthcare professionals, the agency said. The FDA said it is investigating findings from academic researchers that highlighted the potential risk.

“These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes,” the agency said.

The FDA has asked the researchers to explain how they collected and studied the specimens and to provide tissue samples so the agency can further assess any possible risks.

In the meantime, the FDA said it has not reached any new conclusions about safety risks of the class of drugs.

The agency noted it has previously warned the public about acute pancreatitis, including fatal and nonfatal cases, seen with the medicines. Package insert labels for the class of drugs already warn about risk of the potentially dangerous inflammation.

“It’s too early to tell, but we’ll keep an eye on it,” Edward Jones analyst Judson Clark said, when asked about the significance of the potential safety issues in Thursday’s FDA advisory.

But Clark said he did not expect any immediate changes in prescribing habits for the drugs because the pancreatitis risk is already noted on the drug labels.

The class of medicines, which mimic a natural hormone called incretin, prompt the pancreas to release insulin when blood sugar is rising. They are approved to treat type 2 diabetes, the most common form of diabetes which usually develops in adulthood and is closely linked to obesity.

Merck’s Januvia and its related drug, Janumet, had combined sales last year of almost $6 billion, making them by far the company’s biggest product franchise. Onglyza and a related drug called Kombiglyze had sales last year of $709 million.

Shares of Merck were down 1.1 percent at $44.08, while Bristol-Myers shares were down 0.8 percent at $38.18 on Thursday afternoon on the New York Stock Exchange. Shares of AstraZeneca were up 1 percent at $46.31, also on the NYSE. Novo Nordisk shares closed down 1 percent in Copenhagen.

Merck, Bristol Diabetes Drugs Linked to Pancreatitis Risk

Diabetes drugs sold by Merck & Co. (MRK) and Bristol-Myers Squibb Co. (BMY) may double a user’s risk of developing an inflammation of the pancreas linked to cancer and kidney failure, an analysis of insurance records shows.

Patients hospitalized with pancreatitis were twice as likely to be taking Januvia, Merck’s top-selling drug, or using Bristol-Myers’s Byetta, than a control group of diabetics who didn’t have pancreatitis, according to the analysis today in the journal JAMA Internal Medicine. Both drugs increase GLP-1, a hormone that stimulates insulin production from the pancreas.

Doctors have been concerned that this category of diabetes treatments may damage the pancreas since the U.S. Food and Drug Administration said in 2007 it received a high number of reports of pancreatitis in patients taking Byetta. The agency issued a similar alert for Januvia in 2009. The study, which analyzed data from 2005 to 2008, showed a doubling in pancreatitis cases.

“This is the first real study to give an estimate of what the risk is, until now we just had a few case reports,” said Sonal Singh, the study’s author and an assistant professor of medicine at Johns Hopkins University in Baltimore. “These drugs are effective in lower glucose, but we should also consider the risk of pancreatitis and balance the risk versus the benefit.”

Merck, the second-largest U.S. drugmaker, reported $4 billion in sales, or about 9 percent of total revenue, from Januvia last year. The daily pill blocks an enzyme that breaks down GLP-1. Janumet, which combines Januvia with the older diabetes drug metformin, generated $1.7 billion in sales last year for Whitehouse Station, New Jersey-based Merck.

Novo’s Victoza

Bristol-Myers, based in New York, acquired Byetta when it bought Amylin Pharmaceuticals last year for about $5 billion. Byetta, which mimics GLP-1, had sales of $148 million for Bristol-Myers last year, and $159 million for Indianapolis-based Eli Lilly & Co. (LLY), which ended its marketing partnership with Amylin in 2011.

“Bristol-Myers Squibb and AstraZeneca are confident in the positive benefit-risk profile of Byetta and Bydureon as demonstrated by extensive clinical trial data and safety surveillance data,” Ken Dominski, a Bristol-Myers spokesman, said in an e-mail. The companies “will continue to carefully monitor any post-marketing reports of acute pancreatitis.”

AstraZeneca Plc (AZN), based in London, has a partnership with Bristol-Myers on diabetes treatments. Bydureon is a longer acting version of Byetta.

Other drugs that increase the level of GLP-1 in the body include Bristol-Myers’s Onglyza and Novo Nordisk A/S (NOVOB)’s Victoza. The analysis only looked at Januvia and Byetta because the other treatments weren’t on the market during the study period. Januvia was approved in the U.S. in 2006, and Byetta in 2005.

Pancreatic Cancer

Singh said long-term studies should be done to determine if GLP-1 therapies also increase the risk of pancreatic cancer.

“We really need to know more about these drugs as pancreatitis is on the pathway to pancreatic cancer,” he said.

Merck said it has thoroughly reviewed preclinical, clinical and post-marketing safety data and found “no compelling evidence of a causal relationship between” the active ingredient in Januvia and pancreatitis or pancreatic cancer.

“Nothing is more important to Merck than the safety of our medicines and vaccines and the patients who use them,” Pam Eisele, a company spokeswoman, said in a statement.

Diabetes Patients

In diabetics, pancreatitis occurs in about 3 in 1,000 patients. A doubling of that risk, such as that seen in the study, would drive that number to 6 in 1,000 for patients taking Byetta or Januvia, Singh said. About 8.6 percent of Americans, or 25 million people, had diabetes in 2010, according to data compiled by Bloomberg. The number may rise to more than 34 million by 2020.

The study looked at 1,268 diabetics who had been hospitalized with pancreatitis and compared them to the same number of patients who didn’t have the condition. Among those with pancreatitis, 87 had filled a prescription for Byetta or Januvia compared with 58 in the control group. When adjusting for variables that can make a patient more likely to develop pancreatitis, the researchers determined there was a doubling of risk, Singh said.

The study was funded by grants from Johns Hopkins, the National Center for Research Resources, and the National Institutes of Health Roadmap for Medical Research.

To contact the reporter on this story: Shannon Pettypiece in New York at spettypiece@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

“Merry Christmas” There is a Santa Claus and a God!

My Christmas Gift Came, I Am Out Of Rejection!

As many of you may know I have been battling rejection Since June of 2010.  Under going aggressive treatments that has taken a major toll on my body!  The past year and a half has been a real roller coaster ride to say the least.  With many medicine changes, oodles of trips to the lab for blood work, traveling and working with my transplant team, Dr. Nasser I. Youssef, Transplant Surgeon at Our Lady of Lourdes Medical Center (my rock)  and world renowned research scientist from Virgina Eastern Medical School (Dr. Aaron I. Vinik)  to Miami, a big thanks to my family at The Diabetes Research Institute, My friend Gary Kleiman and  Dr. Camillo Ricordi.  Also The University of Maryland Medical Center ~ Transplantation.   The support of my loving family and friends.  I am happy to share with you that this week, I beat my battle with rejection!  I am now out of rejection and my pancreas is working beautiful!  I’ve always said it and will say it again, I was blessed with an awesome donor.  May he enjoy his Christmas in the arms of Jesus and know how much his gift of life has been appreciated!

I will celebrated my Christmas with my close family and friends and start to rebuild my strength.  I thank everyone of you who prayed for me during this time, your spirits will always shine on in my heart!

Our motto at Diabetes Living Today® has always been:  May Kindness Always Be Our Guide! We wish all of you a very Happy Holiday filled with peace and joy!