Sweet news for diabetics

Drug companies targeting a huge market keep on finding new treatments, but governments must invest in prevention, says diabetologist Dr. Julio Wainstein.

By
December 6, 2015 03:12
Dr. Julio Wainstein

Dr. Julio Wainstein. (photo credit: Courtesy)

Type II diabetes doesn’t bring only bad news. Although there are some 500,000 Israelis diagnosed and an equal number undiagnosed or with pre-diabetes and predictions that the figure will double to 2,000,000 in a decade, there is hope that many can live a healthy normal life.

That is the hopeful message – after World Diabetes Day was marked on November 14 – of Dr. Julio Wainstein, founder and director of the diabetes unit at Holon’s Wolfson Medical Center and former head of the Israel Diabetes Association (today it is Prof. Ardon Rubinstein).

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Type II diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces.

Insulin is a hormone that regulates blood sugar. Hyperglycaemia, or raised blood sugar, is a common effect of uncontrolled diabetes and over time leads to serious damage to many of the body’s systems, especially the nerves and blood vessels.

The world figure of type II is nine percent of all people over the age of 18. Type I diabetes, which constitutes less than 10% of all cases, is an autoimmune disease that requires regular insulin injections rather than the much-more-common lifestyle form of the disorder.

Better control of blood sugar through advanced medications, technology and even smartphone applications, exercise, proper diet and monitoring of the condition can prevent type II complications even though 5.6% of Israeli deaths are linked to the metabolic disorder. This is an significant figure – the third-highest mortality rate caused by diabetes complications in the Organization of Economic Cooperation and Development, and was topped only by statistics in Turkey and Mexico.

BORN IN Argentina, Wainstein came on aliya with his parents at the age of 16, in 1966.

“I began to study medicine late, at 25,” he told The Jerusalem Post in an interview. “After military service, I decided to study psychology, but then I went on to medical school in Italy, where I had worked at a well-paid job in security.”

But after receiving his MD degree abroad, he decided to do a residency in internal medicine at Wolfson and then to specialize in the treatment of diabetes. Today, he is a leader in its treatment and administration and an active researcher who has participated in over 100 international clinical field trials.

“My own mother developed type II when she was in her 30s, and she died at the age of 93 – and not from diabetes. If you take good care of yourself, you can live well with it. There are always advances in pharmacology, awareness and education of the patient,” Wainstein said.

Statistics on amputation of toes and feet in diabetics with tissue necrosis are down.

A few years ago, there used to be 1,200 cases here a year, but it has declined to 1,000, even though the population and the number of diabetics have grown, said Wainstein, “so this shows that the situation is improving.”

This is due to the wider use of orthopedic shoes, supportive inserts in shoes and the wearing of socks. There is also greater awareness of the need to check the feet and moisturize them every day.

“Some years ago, the Health Ministry director-general issued instructions that every nurse in the country, whether in a hospital or health fund or private clinic, who sees a diabetic patient has to check his or her feet for sores or infections. Nurses do it the best,” said the diabetologist. “Doctors don’t know how to do it or have the time.”

Diabetics often have very dry skin, and neuropathy reduces the senses in the limbs, so if they step on something sharp or if they develop tiny cracks in the skin through which bacteria enter, they can develop a serious infection or necrosis, the death of tissue, and they won’t be aware of it until it’s too late. That can result in amputation and serious disability. The number one rule for diabetics, said Wainstein, is “never walk barefoot, even at home.”

Prof. Itamar Raz, head of the Israel National Diabetes Council and longtime director of the diabetes unit at Hadassah University Medical Center in Jerusalem’s Ein Kerem has invested a great deal of effort in education of patients, said Wainstein.

“This has paid off for prevention of pre-diabetes patients turning into diabetics and of complications in patients.”

A SIGNIFICANT advance is the development of sensors that don’t require painful pricking of a finger to test for blood-sugar levels, said Wainstein.

“Diabetics don’t feel when their blood-sugar level is high [hyperglycemia], although they do feel if it is low [hypoglycemia],” as the symptoms include a rapid heartbeat, confusion, light-headedness or dizziness, hunger and nausea, sweating and chills, irritability and even delirium if seriously low.

Since they are not aware if they are hyperglycemic, they have to check several times a day and keep their sugar under control with diet and exercise. But testing with little needles is unpleasant.

Only about three in five type II patients check their sugar level, yet if they are in public, such as in a restaurant, many prefer to avoid it, he said. Type II patients who take insulin as well as those who are controlled by oral medications have to test themselves.

“If the sugar level is high, such as 200, while eating, a diabetic should avoid eating dessert. If they don’t check, they won’t know. The average sugar level over the previous three-month period – known as HbA1c – is important but doesn’t give a picture of what the current level is; it is only an average.”

There are two new sensors to detect sugar levels in real time, said Wainstein. One is called Libre Flash, from the Abbott pharmaceutical company. A sticker the size of a 10-shekel coin is stuck to the arm. It contains a tiny, microscopic pin. The other part is like a small cellular phone placed in one’s pocket.

The patient can place it near the sticker to read the sugar level. You can check it as many times as you want.

“There is an arrow that automatically shows the current level and whether it has risen or dropped or is stable.”

This device is not in the basket of health services, so its cost is not covered by the health fund. Its accuracy is regarded as close to 100%.

“The digital part costs NIS 400 and lasts for three years, while the stickers cost NIS 245 a month. If it were in the basket, it would be cheaper. But as there are so many diabetics, not everyone can have it. We endorsed the Libre Flash to the 2016 public committee that recommends additions to the basket for type II diabetics who get injected insulin.”

Raz did a study on the device and found that regular checking of sugar levels with the device reduces HbA1c levels by 1.4%, which is more than by taking a diabetes pill like Januvia (sitagliptin), which reduced it by only 0.8%.

It is sold in private pharmacies, but there was such a demand that the supply quickly ran out. Now it is being exclusively imported by Gefen Medical.

The other new type of sensor, Glucotrack, has an Israeli patent. It includes a tiny earring- like device attached to the ear lobe that is connected to a device held in the pocket.

“It ‘broadcasts’ blood-sugar levels to the device without pricking the skin. But while no disposable equipment is involved, said Wainstein, the system costs a one-time NIS 9,000 and is available for private purchase.

AS FOR new prescription drugs for diabetes, there seems to be a steady stream of them from pharmaceutical companies, as the disease is chronic and of global epidemic proportions, and thus is very profitable.

“There as a drug called Avandia, but as it caused heart attacks in diabetics, it was taken off the market by the FDA ,” said Wainstein.

“If the FDA approves a new diabetes drug, it isn’t enough just to lower sugar levels. It must also be proven as being good for the heart and not raising the risk for strokes. It must show its ‘non-inferiority’ – meaning that it doesn’t have a negative effect larger than that of a placebo or active control.”

In September, two new diabetes drugs that astounded doctors in the field were introduced at the annual meeting of the European Association for the Study of Diabetes (EASD) in Stockholm. The first was Jardiance (empaglifozin), shown to be the only diabetes medication to show a significant reduction in both cardiovascular risk and cardiovascular death and of strokes in a dedicated outcome trial. The results were published in The New England Journal of Medicine. The drug is produced by Boehringer Ingelheim (Germany) and Eli Lilly. As diabetics are at significantly higher risk of death due to heart attacks and stroke, the 38% decline in cardiovascular deaths was very significant, Wainstein said. In addition, treatment with the oral pill resulted in a lower risk of allcause mortality (32% reduction) and hospitalization for heart failure (35% reduction).

It also reduces blood pressure and weight.

“These results are both novel and exciting for the millions of people living with type II diabetes at risk for cardiovascular disease,” said lead investigator of the trial Dr. Bernard Zinman, who is director of the diabetes center at New York’s Mount Sinai Hospital.

Empagliflozin works by helping the kidneys get rid of glucose from your bloodstream and should be used together with diet and exercise to treat type II diabetes. Jardiance is not for treating type I diabetes or taken if the patient has severe kidney disease.

The second drug is Astrazeneca’s Forxiga, oral tablets given to type II diabetics 18 years or older to improve their glycaemic control when diet and exercise alone are not adequate or as an add-on therapy in combination with other drugs.

“It is not yet in the basket, because research is still going on,” said Wainstein. “It was presented to the basket committee but was not yet among those drugs at the top of the list because there isn’t enough money to add to the basket,” he said. It costs NIS 280 per month when purchased privately. It works according to a different mechanism than Jardiance, said Wainstein.

“It may, but not necessarily, be dangerous for people over age 65 because it causes abnormal urination that could lead to possibly dangerous dehydration.”

In addition to pills, he said that a new injectable drug named Trulicity was approved by the FDA in September. It is administered once a week, helping the body to release its own insulin – and not being insulin itself. Made by Eli Lilly, it comes in an easy-to-use, single-dose pen, it can help improve HbA1c and blood-sugar numbers.

Asked about Oramed, the Jerusalem-based company headed by Dr. Miriam Kidron that has for years been working on an oral insulin pill, Wainstein said it “still has a way to go.”

There is also an inhaled insulin from Sanofi Aventis called Afrezza that was approved two years ago by the FDA , but issues such as cost, fear for lung safety and the small number of studies in patients with underlying respiratory disease has prevented its widespread use.

As for non-medical treatment for diabetes, bariatric (stomach-shortening) surgery has been found to cure diabetes in many obese patients whose metabolism is “confused” and even in some of those with normal weight – although this is legal only in Brazil – but any surgery presents some risks.

“We are getting better all the time in treating diabetes,” concluded Wainstein, but as the number of patients rises all the time, in addition to treating patients, we have to invest more money in preventing it. Drug companies want to treat diabetes and invest a lot of money in it, but governments should invest in preventing it because no one else will do it.”


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