How would you like to manage your diabetes by taking your medicine just once a month?

You can’t do that yet. But that prospect is on the horizon.

While I seldom write about news that we can’t use at the moment, I think that this is such big news that many of you will want to know about it right now.

Only once before (if my memory serves me) have I ever written about a diabetes medicine that the U.S. Food and Drug Administration had not yet approved. That was in 2002 when I wrote about something then called Exendin-4 in my article “The Monster Drug.”

That monster drug, renamed exenatide — made from the venom of Gila monsters — became Byetta after the FDA approved it in 2005 as the first of a new class of drugs, GLP-1 agonists. Byetta became a monstrously successful medication for people with diabetes, including this writer. Full disclosure: I own some shares of stock in Amylin Inc., the company that developed Byetta.

When people take Byetta they inject it before breakfast and before dinner. That twice-a-day coverage isn’t quite as convenient as the second GLP-1 agonist, Victoza.

But when and if the FDA approves an extended release form of Byetta called Bydureon, taking it just once a week will be even more convenient.

Today’s news is about an even longer lasting form of exenatide. This is the biggest news announced at the 71st Scientific Sessions of the American Diabetes Association.

The ADA’s annual meeting is always the biggest diabetes gathering in the world. This year more than 17,500 people, including 14,000 scientists, physicians, and other health care professionals — plus a few regular people and some journalists like me — are meeting in San Diego, California, from June 24 to June 28.

The amount of information presented is staggering. I am making my way through more than 2,000 abstracts and more than 1,600 posters. But they seem to save the biggest news for what they call “Late-Breaking Posters,” some 131 in all. These posters got posted today.

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When people with type 2 diabetes could take a pill instead of insulin to help us control our diabetes, smiles must have appeared on many faces. The pill was tolbutamide, and in the mid-1950s it became the first of the sulfonylurea class of drugs.

But that was more than half a century ago. Meanwhile, we now have choices of pills we can use. In fact, we now have nine other classes of oral diabetes medication plus several combinations.

The sulfonylureas force the beta cells in the pancreas to pump out the insulin that our body makes there. That’s why we call these drugs insulin secretagogues. For years many of us have been concerned that they will eventually burn out whatever beta cells we have left.

About a dozen years ago I voiced this suspicion to Edward S. Horton, who was then the director of clinical research at the Joslin Diabetes Center in Boston. In reply he told me that we have no evidence for this belief.

“You are not whipping the beta cells to death,” he said. “There is evidence that the beta cells do fail gradually over time. But there is no evidence that drugs hasten the process. I know that it is a popular conception that people have, but it is not true.”

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Here is a copy of a letter — with the author’s name and other identifying information redacted out — about anecdotal evidence that medical marijuana might help some complications of diabetes.

The person who wrote me has a better memory than I do. I don’t remember corresponding with him before, but he remembers that when I used marijuana I was addicted to it. It got to where I had to be high all my waking hours. My correspondent is also quite correct in writing that I would not be a good candidate for medical marijuana, except as a last resort.

The jist of what he wrote follows:

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Stanley Kim is a practicing physician in Southern California who recently invented the smallest and painless lancets for testing our blood glucose. I wrote about this invention here this August.

At that time Dr. Kim and I hadn’t met. I interviewed him on the phone from my home office in Colorado.

We had to travel all the way to South Korea to meet in person. We are in Busan, Korea’s second largest city with about 3.6 million residents. Specifically, we are both attending the International Diabetes Federation’s Western Pacific Region Congress along with about 3,000 other people who work with diabetes. This congress is taking place in Busan Exhibition and Convention Center (BEXCO) in the most modern part of the city near Haeundae, the most famous and frequented beach in all of South Korea.

As modern as Korea is — particularly in this part of the country — it is naturally quite different from what I normally experience in Colorado. But for Dr. Kim, Busan is quite familiar. He grew up in Busan and has a condo here.

Until I mentioned the meeting during the course of the interview for the article I wrote here in August, Dr. Kim didn’t know that it was happening in his hometown this year. He then arranged to attend the meeting. And at the last minute the conference organizers approved his poster presentation for the tiniBoy lancets. [Read more →]

Greetings from the bottom of my heart and the top of Seoul. I am writing you from South Korea where I am for two weeks at the invitation of one of the largest blood glucose meter and test strip manufacturers in the world.

People from i-SENS Inc., a company headquartered in Seoul that designs and manufacturers blood glucose monitoring systems, asked me to visit them this fall. In fact, they originally invited me to come last October. But I had to postpone my visit because I had an emergency operation for twisted small intestines at the beginning of that month, and my surgeon said I couldn’t travel.
For the first few days of my trip I am staying on the top floor of a hotel in the Seongbuk district of Seoul, near the company’s headquarters. With 24.5 million inhabitants Seoul is the world’s second largest metropolitan areas in population (after Tokyo and ahead of Mexico City, New York City, and Mumbai, in that order). Seoul has been Korea’s capital for more than 600 years.
On Friday I left Seoul for the day to visit the new factory that i-SENS built in Wonju city four years ago to make test strips for its blood glucose meters. I went with my friend and hostess, Margaret Leesong. The i-SENS director of international business relations, Margaret visited me in Boulder a couple of years ago, when we had a great hike together in the foothills of the Rockies.

Margaret lived in the States from 1973 to 1978 and then again from 1988 to 1996, when she moved to Australia, remaining there until 2005. After her college years at Seoul National University, she earned a Ph.D. in biophysics from Purdue University in Indiana and then an LLB (law degree) from the University of Sydney. She speaks flawless English.
When Margaret met me at the hotel on Friday morning, we took a taxi to the bus station, where we took a two-hour ride to Wonju, a much smaller city of about 300,000 people in northeastern Korea. From there a staff member who helped us as driver and tour guide from the company picked us up and took us to the factory.

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If you are one of the 600,000 Americans who take Avandia, you need to see your doctor right away. That’s only a small fraction of the 24 million of us here who have diabetes, but anyone who now takes it has an important — and perhaps a life-saving — decision to make.

The U.S. Food and Drug Administration just pulled the major diabetes drug Avandia (rosiglitazone) from the U.S. market — with two exceptions. This government agency responsible for drug safety and efficacy says that people with diabetes who are already on Avandia can keep on using it. But the FDA will let us take it only if we and our doctors swear that they have tried every other diabetes drug and that they and their doctors know how risky Avandia is for their heart.

Vitamin D seems to prevent many of our ills. Some studies show that taking large doses of it will treat just about everything from building strong bones to protecting us from strokes and heart failure to reducing our risk of cancer and on to helping us regulate our immune system and control inflammation, our blood pressure, and even our blood glucose. Higher levels of vitamin D is associated with reduced risks for multiple sclerosis, rheumatoid arthritis, and type 1 diabetes.

Reports of the value of vitamin D for preventing even more conditions continue to appear regularly. Low levels of vitamin D are associated with poor lung function among children with asthma, leading them to use more medication to treat it, as the Journal of Allergy and Clinical Immunology recently reported. Vitamin D might treat or prevent allergy to a common mold that can complicate asthma and frequently affects patients with cystic fibrosis, according to a study that the Journal of Clinical Investigation published a few days ago.

As I wrote here last year we nevertheless might have good reason to wonder if all the current hype over vitamin D is nothing more than a resurgence of snake oil claims.

How could just getting out into the sun more or taking just one inexpensive and tiny pill each day work such magic? It seems to be too good to be true. It doesn’t seem to pass the smell test.

Yet we already had a hint to the solution of this major nutritional puzzle when we learned that what we call “vitamin D” isn’t really a vitamin. When scientists discovered vitamin D in the 1920s and 1930s it seemed to work like a vitamin, so that’s what the called it.

“We have confirmed with our recent research that vitamin D isn’t a vitamin at all,” says Professor Trevor Marshall of the school of biological sciences and biotechnology at Murdoch University in Western Australia. It’s a hormone that is made by the body itself.”

And today the other shoe dropped. Several days ago the Wellcome Trust sent me under embargo the advance word on the latest study that journalists could print this evening. The Wellcome Trust is a global charity headquarters in Britain dedicated to improvements in human and animal health.

The main conclusion of this study goes a long way to explaining why vitamin D seems to work its magic throughout our bodies. The journal Genome Research will publish a study led by Sreeram Ramagopalan and Andreas Heger at the University of Oxford.

Using new DNA sequencing technology, they identified more than 200 genes that vitamin D directly influences and created a map of vitamin D receptor binding across the genome. Vitamin D attaches itself to DNA, thus influencing what proteins we make from our genetic code byactivating this receptor.

The researchers discovered 2,776 binding sites for the vitamin D receptor along the length of the genome. These were unusually concentrated near a number of genes associated with susceptibility to autoimmune conditions and to certain cancers. They also found that vitamin D had a significant effect on the activity of 229 genes including PTPN2, associated with Crohn’s disease and type 1 diabetes.

“Vitamin D status is potentially one of the most powerful selective pressures on the genome in relatively recent times,” says Professor George Ebers of the University of Oxford and one of the senior authors of the paper. “Our study appears to support this interpretation and it may be we have not had enough time to make all the adaptations we have needed to cope with our northern circumstances.”

Seldom does basic science like this make the headlines. But this research certainly warrants that. If vitamin D is snake oil, I’ll drink it.

This is a mirror of one of my articles that Health Central published. You can navigate to that site to find my most recent articles.

Yesterday Medco Health Solutions presented a study at the Scientific Sessions of the American Diabetes Association. The study found that, contrary to warnings from the Food and Drug Administration, neither Byetta or Januvia increase the risk of acute pancreatitis.

Byetta and Januvia are two of the most important medications for type 2 diabetes, since they reduce blood glucose without increasing weight, which all the other diabetes drugs (except metformin, Victoza, and Symlin) do. In fact, Byetta is proven to reduce weight, and that’s why I wrote a book about it, Losing Weight with Your Diabetes Medication.

Due to reported cases of acute pancreatitis, several years ago the FDA added warnings to the labels for Byetta and Januvia.

However, Medco’s study indicates that patients taking either of these medications were no more likely to develop acute pancreatitis than patients taking other drugs to control diabetes. The study indicates there is an increased risk of acute pancreatitis for people with diabetes. But that it is not associated with the particular diabetic medication the patients are using.

“While cases of acute pancreatitis have been reported in patients using Byetta and Januvia, diabetic patients who are not taking these drugs also have been reported to have an increased risk for pancreatitis,” says Merri Pendergrass, MD, PhD, national practice leader of the Medco Therapeutic Resource Center for Diabetes, who conducted the study. “The major question has been are these medications causing the pancreatitis or are they innocent bystanders? Our findings are reassuring in that they did not reveal any increased risk of acute pancreatitis with Byetta and Januvia.”

Medco released even more good news for people taking Byetta. Another one of its studies presented at the ADA’s Scientific Sessions found that, despite FDA warnings, Byetta is not associated with an increased risk of acute renal failure in people with type 2 diabetes. This Medco analysis indicated that while there is an increased risk of acute renal failure in people with diabetes, the diabetes drug they are taking does not appear to impact that risk.

Medco Health Solutions Inc. conducted the study in association with the Medco Research Institute and the University of Texas Southwestern Medical School. Medco Health Solutions is a major pharmacy, ranking 35th on the Fortune 500. The study analyzed Medco’s pharmacy and medical claims data for more than 786,000 adult patients between January 2007 and June 2009.

They divided the people with diabetes into three groups based on whether they were taking Byetta, Januvia, or other diabetes drugs. A group of people without diabetes served as the control.

While the risk for acute pancreatitis was essentially the same among the three groups of people with diabetes, the average risk for all the diabetes groups was higher than that for the control group. Medco used comparable methodology and study parameters in the two studies.

The lack of increased risk of renal failure was news to me. But I’ve known for years that Byetta doesn’t pose an additional risk of pancreatitis, and I wrote about it here in October 2007. Now it’s time for the FDA to catch up.

This is a mirror of one of my articles that Health Central published. You can navigate to that site to find my most recent articles.

Sometimes it’s superior to be short. Especially if it’s a needle.

Now, the company that makes some of the highest quality needles and lancets has gone even further. Becton, Dickson and Company, which many of us know simply as BD, announced a few days ago that it has produced a pen needle that is even smaller and thinner than anything available before.

BD says that it BD Ultra-Fine Nano is the “world’s smallest pen needle” and is proven to be as effective as longer needles for anyone — big or small, thin or fat. These new needles promise to be less painful for any one of the 5 million Americans who inject insulin or GLP-1 to manage their diabetes.

Please catch the reference to GLP-1. This means that not only insulin users but also those of us who use Byetta or Victoza. These are the newest class of diabetes drugs that people with type 2 diabetes can use to reduce their A1C and their weight at the same time.

This shorter needle is just 4 mm long and has a thin 32 gauge. It provided equivalent glycemic control compared to 31 gauge needles that are 5 mm or 8 mm long and had “reduced pain, no difference in insulin leakage and was preferred by patients,” according to a study reported in Current Medical Research and Opinion. While five of the seven authors of this study work for BD, which raises a red flag, two of them are independent researchers. And one of them, Timothy Bailey, M.D., the director of the AMCR Institute in San Diego, I greatly respect and know personally.

Even though this needle is only 4 mm long, it reaches the subcutaneous tissue — the layer of fat that all of us have below our skin — that is the recommended site for injections of insulin and GLP-1s. And it’s not too long to mean a risk of injecting into muscle, where we can absorb insulin too fast, increasing the risk of hypos. So this new needle promises better glycemic control.

With this needle we don’t have to pinch-up the skin. And it fits all of the insulin pens and dosers sold here.

As I writer, I don’t like to admit that pictures can sometimes be superior to words. Even photos that I have taken myself, like this one. They seldom are, but this is an exception.

Here is one of those new needles mounted on a saline pen. You can see for yourself how short it really is.

A BD Ultra-Fine Nano Pen Needle on a Saline Pen

This is a mirror of one of my articles that Health Central published. You can navigate to that site to find my most recent articles.