Thursday, November 23, 2006
DIABETES ARTICLES - Rookie Is No Novice at Dealing With Diabetes
DIABETES ARTICLES
Rookie Is No Novice at Dealing With Diabetes
After a dismal shooting night, the Charlotte Bobcats rookie Adam Morrison sat in front of his locker, head bowed as he tried to explain a 1-of-8 performance. At his feet was a duffel bag of energy bars and apple juice, reminders of what he has overcome to get this far.
“It’s something I’ve got to work through,” Morrison said of his shooting problems. “I’ve worked through it before and gone through adversity.”
It was not that long ago that Morrison sat in a hospital room, a 14-year-old listening as a doctor told him he was a Type 1 diabetic — a diagnosis he figured would end his N.B.A. dreams. But as the doctor started to rattle off the diabetic athletes who played professionally — the hockey Hall of Famer Bobby Clarke, the nine-time baseball All-Star Ron Santo and the longtime N.B.A. player Chris Dudley — a new goal came into focus.
“Right after that, the nurse came in to give him the second insulin shot and he told her, ‘You better show me how to do this, because I’m going to be doing it for the rest of my life,’ ” recalled his father, John.
Today, the 22-year-old Morrison is the only known diabetic in the N.B.A.. Dudley, the league’s last active player with the disease, hopes that does not become an issue as Morrison struggles to improve a shooting percentage that has not moved above 40 percent and to get quicker as a defender, where he has often been a step slow.
But after going 10 of 43 during a five-game stretch, Morrison rebounded this week to score 21 and 27 points in back-to-back games.
“If he struggles in the midseason, people may talk about his diabetes,” Dudley said. “But every rookie goes through that. Every rookie hits the wall at some point. I hope people don’t blame the guy if he struggles.”
About 21 million Americans have diabetes, which affects the body’s ability to make or properly use insulin. Type 2 diabetes is the most common and involves the destruction of insulin-producing cells, in part because of obesity or poor diet. Morrison has the less-common Type 1. His body cannot make insulin, which it needs to convert sugar from food into energy.
If left untreated, diabetics can experience heart and kidney problems, blindness and even death. They are told to closely monitor their diet and get plenty of rest. Morrison set a daily routine and settled on having the same meal before every game: a steak and baked potato exactly two hours before tip-off.
It worked. Morrison went on to have a stellar high school career in Spokane, Wash., before starring at Gonzaga, where he was the top scorer in college basketball last season at 28.1 points a game. He did it while constantly testing his blood-sugar level, up to four or five times during the day and nearly every timeout during a game.
The Bobcats trainer Joe Sharpe got Morrison’s system down during the preseason and keeps the bench stocked with apple juice and energy bars. There is also insulin on hand should Morrison’s blood sugar get too high.
“I try to make it as quick as possible,” Sharpe said. “I have his kit ready to go. He sits down, pricks his finger and gets his reading. I then give him what he needs.”
Morrison took great care to make sure he would be ready to play at the pro level and deal with the disease. Earlier this year he met with Dudley, who spent 16 seasons in the N.B.A. before retiring in 2003.
“I told him you’re not going to be perfect, but you have to be careful,” Dudley said. “Talking to teams about Adam before the draft, I told them if Adam was the kind of player that you had to worry about being overweight during the summer and all those things, I’d be a lot more worried about him. I’m not worried about that with Adam. He’s the type of guy who knows his body and is going to take care of his body.”
When Dudley first entered the league in 1987, it took 45 seconds to test his blood sugar. The technology has improved. Morrison recently signed an endorsement deal with LifeScan, which makes a device that gives a reading in 5 seconds.
When Morrison’s blood sugar is too high or low, he feels sluggish on the court. But he feels he will be able to adjust to the grind of an 82-game N.B.A. schedule.
“Obviously, you have to take care of your body,” Morrison said. “It’s definitely different than college.”
After signing a rookie contract that pays more than $3 million a season, Morrison has taken advantage of his new wealth. He has hired a full-time chef, had meetings with a nutritionist, and his sister and 5-year-old niece moved to Charlotte, N.C., to help with his off-the-court responsibilities.
That maturity was one of the reasons the Bobcats did not shy away from selecting Morrison with the No. 3 pick in the draft. Dudley, who runs a foundation that helps children deal with diabetes, believes the high-profile Morrison will raise awareness for the disease.
“We all want a cure and we’re trying to get a cure, but in the meantime these kids have to deal with diabetes, and we try to get the message out that they can succeed,” Dudley said.
Morrison said he realizes the influence he can have, and spent time this summer on a promotional tour for the company that makes his blood sugar meter. Could the day come when, instead of being asked to autograph a shirt or a ball, a child with diabetes hands Morrison his blood-sugar meter to sign?
“That would be pretty wild, but you know, I think it would be cool if it could happen,” Morrison said. “I’ll try to give back and be a role model to kids and even adults.”
by The Assosiated Press at The New York Times, published on Nov 19, 2006
Rookie Is No Novice at Dealing With Diabetes
After a dismal shooting night, the Charlotte Bobcats rookie Adam Morrison sat in front of his locker, head bowed as he tried to explain a 1-of-8 performance. At his feet was a duffel bag of energy bars and apple juice, reminders of what he has overcome to get this far.
“It’s something I’ve got to work through,” Morrison said of his shooting problems. “I’ve worked through it before and gone through adversity.”
It was not that long ago that Morrison sat in a hospital room, a 14-year-old listening as a doctor told him he was a Type 1 diabetic — a diagnosis he figured would end his N.B.A. dreams. But as the doctor started to rattle off the diabetic athletes who played professionally — the hockey Hall of Famer Bobby Clarke, the nine-time baseball All-Star Ron Santo and the longtime N.B.A. player Chris Dudley — a new goal came into focus.
“Right after that, the nurse came in to give him the second insulin shot and he told her, ‘You better show me how to do this, because I’m going to be doing it for the rest of my life,’ ” recalled his father, John.
Today, the 22-year-old Morrison is the only known diabetic in the N.B.A.. Dudley, the league’s last active player with the disease, hopes that does not become an issue as Morrison struggles to improve a shooting percentage that has not moved above 40 percent and to get quicker as a defender, where he has often been a step slow.
But after going 10 of 43 during a five-game stretch, Morrison rebounded this week to score 21 and 27 points in back-to-back games.
“If he struggles in the midseason, people may talk about his diabetes,” Dudley said. “But every rookie goes through that. Every rookie hits the wall at some point. I hope people don’t blame the guy if he struggles.”
About 21 million Americans have diabetes, which affects the body’s ability to make or properly use insulin. Type 2 diabetes is the most common and involves the destruction of insulin-producing cells, in part because of obesity or poor diet. Morrison has the less-common Type 1. His body cannot make insulin, which it needs to convert sugar from food into energy.
If left untreated, diabetics can experience heart and kidney problems, blindness and even death. They are told to closely monitor their diet and get plenty of rest. Morrison set a daily routine and settled on having the same meal before every game: a steak and baked potato exactly two hours before tip-off.
It worked. Morrison went on to have a stellar high school career in Spokane, Wash., before starring at Gonzaga, where he was the top scorer in college basketball last season at 28.1 points a game. He did it while constantly testing his blood-sugar level, up to four or five times during the day and nearly every timeout during a game.
The Bobcats trainer Joe Sharpe got Morrison’s system down during the preseason and keeps the bench stocked with apple juice and energy bars. There is also insulin on hand should Morrison’s blood sugar get too high.
“I try to make it as quick as possible,” Sharpe said. “I have his kit ready to go. He sits down, pricks his finger and gets his reading. I then give him what he needs.”
Morrison took great care to make sure he would be ready to play at the pro level and deal with the disease. Earlier this year he met with Dudley, who spent 16 seasons in the N.B.A. before retiring in 2003.
“I told him you’re not going to be perfect, but you have to be careful,” Dudley said. “Talking to teams about Adam before the draft, I told them if Adam was the kind of player that you had to worry about being overweight during the summer and all those things, I’d be a lot more worried about him. I’m not worried about that with Adam. He’s the type of guy who knows his body and is going to take care of his body.”
When Dudley first entered the league in 1987, it took 45 seconds to test his blood sugar. The technology has improved. Morrison recently signed an endorsement deal with LifeScan, which makes a device that gives a reading in 5 seconds.
When Morrison’s blood sugar is too high or low, he feels sluggish on the court. But he feels he will be able to adjust to the grind of an 82-game N.B.A. schedule.
“Obviously, you have to take care of your body,” Morrison said. “It’s definitely different than college.”
After signing a rookie contract that pays more than $3 million a season, Morrison has taken advantage of his new wealth. He has hired a full-time chef, had meetings with a nutritionist, and his sister and 5-year-old niece moved to Charlotte, N.C., to help with his off-the-court responsibilities.
That maturity was one of the reasons the Bobcats did not shy away from selecting Morrison with the No. 3 pick in the draft. Dudley, who runs a foundation that helps children deal with diabetes, believes the high-profile Morrison will raise awareness for the disease.
“We all want a cure and we’re trying to get a cure, but in the meantime these kids have to deal with diabetes, and we try to get the message out that they can succeed,” Dudley said.
Morrison said he realizes the influence he can have, and spent time this summer on a promotional tour for the company that makes his blood sugar meter. Could the day come when, instead of being asked to autograph a shirt or a ball, a child with diabetes hands Morrison his blood-sugar meter to sign?
“That would be pretty wild, but you know, I think it would be cool if it could happen,” Morrison said. “I’ll try to give back and be a role model to kids and even adults.”
by The Assosiated Press at The New York Times, published on Nov 19, 2006
Thursday, November 16, 2006
DIABETES ARTICLES - When Advice on Diabetes Is Sound, but Ignored
DIABETES ARTICLES
When Advice on Diabetes Is Sound, but Ignored
Ask any diabetes specialist whether people can protect themselves from Type 2 diabetes through diet and exercise and the answer will be a resounding yes. It has been shown three times, in studies in three countries, one of them the United States.
Weight loss and exercise can do more than just stave off diabetes, diabetes specialists will tell you. They can result in lower blood pressure, lower levels of cholesterol, less sleep apnea, more vigor and, in general, a better life.
But if you ask how likely it is that people at high risk of diabetes will follow the advice to diet and exercise, or about using a drug instead, you will get a different sort of answer.
It is a classic conundrum in medicine: if doctors know that patients can help themselves without taking drugs, but they also know that patients are not likely to follow this advice, what should they do?
Should diabetes specialists even bother to advise patients to try helping themselves through diet and exercise first, before prescribing drugs?
A large federal study, completed several years ago, seemed to make a compelling case that they should. A third of its 3,234 participants were assigned to a low-fat, low-calorie diet and told to exercise for 150 minutes a week. The others were given a placebo or were given metformin, a diabetes drug available as an inexpensive generic.
After an average of three years, just 14.1 percent of those in the diet and exercise group had developed diabetes. In contrast, 28.9 percent of participants taking the placebo had diabetes, and 21.7 percent of those taking metformin.
But the diet and exercise program was nothing like what an ordinary person might expect. The participants got extensive individual counseling and group support, at a cost of $1,356 a person the first year and $672 in each subsequent year. Even so, they shed only about 12 pounds after four years, or 4 percent of their initial weight. Most were continuing with their exercise program, though. If a large health plan decided to offer the same program for its members at risk for diabetes, the plan’s price for every member would rise by 1 percent, said Dr. David Eddy, the medical director of Archimedes Inc., a health care consulting company. Over 30 years, 61 percent of the people at risk would develop diabetes, as compared with 72 percent if no such program were instituted.
Last month, another study showed that a newer diabetes drug, rosiglitazone, might be more effective than either metformin or diet and exercise. Over three years, it reduced the risk of developing diabetes by 60 percent in people with elevated blood sugar levels.
Both drugs are relatively safe. Patients may lose about five pounds if they take metformin; other than that its major side effect is gastrointestinal disturbances, like a sense of fullness or soft bowel movements. Patients may gain about five pounds with rosiglitazone, about half of which is from fluid retention. That increases the risk of heart failure in people with heart disease.
But with the drugs’ effectiveness in preventing diabetes, maybe, some specialists say, doctors will soon view blood sugar as they do blood pressure or cholesterol. As soon as they spot an abnormally high level, they will whip out their prescription pads.
Already, health authorities have ventured along that path. International treatment guidelines once said that the first step for patients with full spectrum Type 2 diabetes was to exercise and lose weight. Only after patients had tried that and utterly failed were doctors to prescribe drugs.
As of August, however, the guidelines have changed.
“We recommend starting patients on metformin immediately,” said Dr. David M. Nathan, who directs the diabetes center at Massachusetts General Hospital and is a member of the group that formulated the new guidelines. “Don’t start with lifestyle alone, even for newly diagnosed people. Most end up failing the lifestyle recommendations.”
He added: “What classically happened was that the patients would take three months and try to diet. It wouldn’t work. Then they joined a health club. It didn’t work. Then they take another three months and try some more. By the time they were on effective therapy, they had had diabetes for years and years.”
In developing the new guidelines, the group reasoned that the consequences of untreated diabetes — which can include heart attacks, strokes, kidney failure, blindness and amputations — are too dire to allow high blood sugar levels to persist.
But that does not necessarily mean that drugs should be the first choice for people with so-called prediabetes, who have elevated blood sugar levels but have not yet developed the disease.
Or so says Rena Wing, a professor of psychiatry and human behavior at Brown University Medical School. Dr. Wing helped develop the diet and exercise program for the federal study of prediabetes.
Drugs, she said, should be a last resort for people with prediabetes. The answer to the problem of poor compliance with diet and exercise programs is to develop better ways of encouraging people to follow them, she said.
“If you have a problem that can be solved with a lifestyle change, you have to work on how to do that, how to bring it to people,” Dr. Wing said. “We have to change the system.”
For example, she said, there could be lists of effective programs for weight loss and exercise so doctors would stop telling patients to simply “lose weight” and say instead, “Join this program.”
Yet, if people know that a drug can solve their problem, how much incentive is there to change their diet and exercise patterns?
“The behaviorists say that if you have a medication available, you can hang up the idea that the patients will try lifestyle,” Dr. Nathan said.
Still, he said, “as a realist, it seems to me that the truth is that whatever your thoughts are on the importance of self-control and willpower and profligacy, and that we shouldn’t be such pigs, that we should exercise more, the truth is that we are what we are.”
Dr. Nathan added, “We have recognized that although lifestyle can be miraculously effective, it often isn’t, because people won’t change.”
by Gina Kolata at The New York Times, published on Oct 17 2006
When Advice on Diabetes Is Sound, but Ignored
Ask any diabetes specialist whether people can protect themselves from Type 2 diabetes through diet and exercise and the answer will be a resounding yes. It has been shown three times, in studies in three countries, one of them the United States.
Weight loss and exercise can do more than just stave off diabetes, diabetes specialists will tell you. They can result in lower blood pressure, lower levels of cholesterol, less sleep apnea, more vigor and, in general, a better life.
But if you ask how likely it is that people at high risk of diabetes will follow the advice to diet and exercise, or about using a drug instead, you will get a different sort of answer.
It is a classic conundrum in medicine: if doctors know that patients can help themselves without taking drugs, but they also know that patients are not likely to follow this advice, what should they do?
Should diabetes specialists even bother to advise patients to try helping themselves through diet and exercise first, before prescribing drugs?
A large federal study, completed several years ago, seemed to make a compelling case that they should. A third of its 3,234 participants were assigned to a low-fat, low-calorie diet and told to exercise for 150 minutes a week. The others were given a placebo or were given metformin, a diabetes drug available as an inexpensive generic.
After an average of three years, just 14.1 percent of those in the diet and exercise group had developed diabetes. In contrast, 28.9 percent of participants taking the placebo had diabetes, and 21.7 percent of those taking metformin.
But the diet and exercise program was nothing like what an ordinary person might expect. The participants got extensive individual counseling and group support, at a cost of $1,356 a person the first year and $672 in each subsequent year. Even so, they shed only about 12 pounds after four years, or 4 percent of their initial weight. Most were continuing with their exercise program, though. If a large health plan decided to offer the same program for its members at risk for diabetes, the plan’s price for every member would rise by 1 percent, said Dr. David Eddy, the medical director of Archimedes Inc., a health care consulting company. Over 30 years, 61 percent of the people at risk would develop diabetes, as compared with 72 percent if no such program were instituted.
Last month, another study showed that a newer diabetes drug, rosiglitazone, might be more effective than either metformin or diet and exercise. Over three years, it reduced the risk of developing diabetes by 60 percent in people with elevated blood sugar levels.
Both drugs are relatively safe. Patients may lose about five pounds if they take metformin; other than that its major side effect is gastrointestinal disturbances, like a sense of fullness or soft bowel movements. Patients may gain about five pounds with rosiglitazone, about half of which is from fluid retention. That increases the risk of heart failure in people with heart disease.
But with the drugs’ effectiveness in preventing diabetes, maybe, some specialists say, doctors will soon view blood sugar as they do blood pressure or cholesterol. As soon as they spot an abnormally high level, they will whip out their prescription pads.
Already, health authorities have ventured along that path. International treatment guidelines once said that the first step for patients with full spectrum Type 2 diabetes was to exercise and lose weight. Only after patients had tried that and utterly failed were doctors to prescribe drugs.
As of August, however, the guidelines have changed.
“We recommend starting patients on metformin immediately,” said Dr. David M. Nathan, who directs the diabetes center at Massachusetts General Hospital and is a member of the group that formulated the new guidelines. “Don’t start with lifestyle alone, even for newly diagnosed people. Most end up failing the lifestyle recommendations.”
He added: “What classically happened was that the patients would take three months and try to diet. It wouldn’t work. Then they joined a health club. It didn’t work. Then they take another three months and try some more. By the time they were on effective therapy, they had had diabetes for years and years.”
In developing the new guidelines, the group reasoned that the consequences of untreated diabetes — which can include heart attacks, strokes, kidney failure, blindness and amputations — are too dire to allow high blood sugar levels to persist.
But that does not necessarily mean that drugs should be the first choice for people with so-called prediabetes, who have elevated blood sugar levels but have not yet developed the disease.
Or so says Rena Wing, a professor of psychiatry and human behavior at Brown University Medical School. Dr. Wing helped develop the diet and exercise program for the federal study of prediabetes.
Drugs, she said, should be a last resort for people with prediabetes. The answer to the problem of poor compliance with diet and exercise programs is to develop better ways of encouraging people to follow them, she said.
“If you have a problem that can be solved with a lifestyle change, you have to work on how to do that, how to bring it to people,” Dr. Wing said. “We have to change the system.”
For example, she said, there could be lists of effective programs for weight loss and exercise so doctors would stop telling patients to simply “lose weight” and say instead, “Join this program.”
Yet, if people know that a drug can solve their problem, how much incentive is there to change their diet and exercise patterns?
“The behaviorists say that if you have a medication available, you can hang up the idea that the patients will try lifestyle,” Dr. Nathan said.
Still, he said, “as a realist, it seems to me that the truth is that whatever your thoughts are on the importance of self-control and willpower and profligacy, and that we shouldn’t be such pigs, that we should exercise more, the truth is that we are what we are.”
Dr. Nathan added, “We have recognized that although lifestyle can be miraculously effective, it often isn’t, because people won’t change.”
by Gina Kolata at The New York Times, published on Oct 17 2006
Thursday, November 09, 2006
DIABETES ARTICLES - Merck Wins U.S. Approval for a New Diabetes Drug
DIABETES ARTICLES
Merck Wins U.S. Approval for a New Diabetes Drug
Federal drug regulators yesterday approved a new diabetes medicine from Merck that is expected to become a blockbuster treatment used by millions of people worldwide.
Skip to next paragraph
Merck
Januvia, the new medicine, is a once-daily pill that has fewer severe side effects than existing diabetes medications and does not cause weight gain, according to clinical trials. The Food and Drug Administration said Januvia could be prescribed either on its own or in addition to other medicines.
It is aimed at Type 2 diabetes, the most common form, which affects nearly 21 million Americans — 7 percent of the population — and more than 200 million people globally.
Merck said Januvia would cost just under $5 a day, or about $145 a month, comparable to existing treatments. Merck shares rose slightly after the approval was announced yesterday morning, which had been expected.
Many doctors say they believe Januvia — and Galvus, a similar drug from Novartis that is expected to be approved later this year — will be valuable for many patients with diabetes, most of whom have dangerously high levels of blood sugar despite existing treatments.
“I can’t wait to put people on the drug,” Dr. James Underberg, a clinical assistant professor at New York University medical school who participated in a clinical trial of Januvia. Januvia is the third major new diabetes drug approved since the summer of 2005, and potentially the most important, analysts and doctors say. The drug works in a different way than existing treatments, and its pill form makes it more convenient than Byetta, a treatment approved last year that has some of the same benefits as Januvia but must be taken by injection.
Analysts predict that Januvia, either as a stand-alone treatment or in combination with an existing diabetes drug called metformin, will have worldwide sales of nearly $2 billion by 2010. Merck hopes to win approval for that combined drug early next year.
Optimism about Januvia has helped push Merck shares up 38 percent this year, compared with an 11 percent gain for the average large drug stock. Merck shares closed yesterday at $43.96, up 20 cents — at their highest level since the company withdrew its arthritis drug Vioxx in September 2004 after a study linked Vioxx to heart attacks and strokes.
Executives at Merck declined to comment on their plans for advertising Januvia to consumers. Unlike several other major drug makers, Merck has not committed to waiting at least six months before advertising new drugs so that doctors have a chance to learn about new therapies before patients begin asking for them.
But physicians like Dr. Underberg are already enthusiastic. “It doesn’t cause weight gain, it doesn’t cause episodes of hypoglycemia, and the side effects otherwise are pretty moderate,” he said.
Hypoglycemia is a potentially dangerous condition in which blood sugar levels drop too fast. In severe instances, it can cause fainting or even coma. Several older diabetes drugs can cause hypoglycemia by pushing the pancreas to produce large amounts insulin quickly.
In contrast, Januvia and Galvus are the first in a newer class of drugs called DPP-IV inhibitors, which work by enhancing levels of a natural protein called GLP-1. The protein stimulates the pancreas to produce insulin and discourages the liver from making glucose. But the DPP-IV inhibitors work only when blood sugar levels are already elevated, such as after a meal, sharply lowering the risk for hypoglycemia.
“The approval of Januvia marks an important advance in the fight against diabetes,” Dr. Steven Galson, director of the F.D.A.’s center for drug evaluation and research, said in a statement. “We now have another new option that treats the disease in an entirely new way.”
Diabetes is a disease in which blood sugar rises uncontrollably from a lack of, or resistance to, insulin, a hormone normally produced in the pancreas. In Type 1 diabetes, the pancreas is unable to produce insulin.
Type 2 diabetes is linked to obesity and inactivity. Typically, the disease progresses over several years as the pancreas gradually loses the ability to produce insulin, and drug treatments lose their effectiveness. Eventually, many patients wind up injecting themselves with insulin to control their blood sugar. Severe, late-stage diabetes sharply raises the risks of many medical problems, including heart attacks, strokes, kidney disease and blindness.
Jay Galeota, general manager of Merck’s global diabetes division, said Merck planned to ship Januvia to pharmacies and offer samples to doctors’ offices quickly. The company expects to market Januvia to both doctors and patients almost immediately, he said.
“We’re confident that we’re going to communicate the science of Januvia in a very wide way,” he said. “We’re expecting very rapid uptake right away.”
While there are several major classes of diabetes medicines already on the market, many have side effects that discourage patients from taking them, including weight gain and nausea. As a result, the market is ripe for new treatments, doctors and analysts say.
In clinical trials that examined Januvia in 2,719 patients, the most common side effects were sore throat, diarrhea and colds, the F.D.A. said.
Richard Evans, an analyst at Sanford C. Bernstein & Company, said he expected Januvia and Galvus to rapidly replace an older class of drugs called sulfonylureas. The newer drugs are similarly effective but much less likely to cause weight gain and hypoglycemia, he said.
“Everybody knows that sulfonylureas are kind of a losing game,” he said. While Galvus and Januvia are very similar, Januvia may have an edge because it clearly works as a once-a-day pill, while Galvus was initially formulated to be taken twice daily, Mr. Evans said. Novartis, the manufacturer of Galvus, now claims that its drug is effective when taken once daily, but doctors may be skeptical of that claim, he said.
Tony Butler, an industry analyst at Lehman Brothers, said he expected that Januvia would have sales of $271 million next year, rising to $1.1 billion by 2010. Mr. Butler said sales of the Januvia-metformin combination pill would be $500 million more in 2010.
by Alex Berenson at The New York Times, Published: October 18, 2006
Merck Wins U.S. Approval for a New Diabetes Drug
Federal drug regulators yesterday approved a new diabetes medicine from Merck that is expected to become a blockbuster treatment used by millions of people worldwide.
Skip to next paragraph
Merck
Januvia, the new medicine, is a once-daily pill that has fewer severe side effects than existing diabetes medications and does not cause weight gain, according to clinical trials. The Food and Drug Administration said Januvia could be prescribed either on its own or in addition to other medicines.
It is aimed at Type 2 diabetes, the most common form, which affects nearly 21 million Americans — 7 percent of the population — and more than 200 million people globally.
Merck said Januvia would cost just under $5 a day, or about $145 a month, comparable to existing treatments. Merck shares rose slightly after the approval was announced yesterday morning, which had been expected.
Many doctors say they believe Januvia — and Galvus, a similar drug from Novartis that is expected to be approved later this year — will be valuable for many patients with diabetes, most of whom have dangerously high levels of blood sugar despite existing treatments.
“I can’t wait to put people on the drug,” Dr. James Underberg, a clinical assistant professor at New York University medical school who participated in a clinical trial of Januvia. Januvia is the third major new diabetes drug approved since the summer of 2005, and potentially the most important, analysts and doctors say. The drug works in a different way than existing treatments, and its pill form makes it more convenient than Byetta, a treatment approved last year that has some of the same benefits as Januvia but must be taken by injection.
Analysts predict that Januvia, either as a stand-alone treatment or in combination with an existing diabetes drug called metformin, will have worldwide sales of nearly $2 billion by 2010. Merck hopes to win approval for that combined drug early next year.
Optimism about Januvia has helped push Merck shares up 38 percent this year, compared with an 11 percent gain for the average large drug stock. Merck shares closed yesterday at $43.96, up 20 cents — at their highest level since the company withdrew its arthritis drug Vioxx in September 2004 after a study linked Vioxx to heart attacks and strokes.
Executives at Merck declined to comment on their plans for advertising Januvia to consumers. Unlike several other major drug makers, Merck has not committed to waiting at least six months before advertising new drugs so that doctors have a chance to learn about new therapies before patients begin asking for them.
But physicians like Dr. Underberg are already enthusiastic. “It doesn’t cause weight gain, it doesn’t cause episodes of hypoglycemia, and the side effects otherwise are pretty moderate,” he said.
Hypoglycemia is a potentially dangerous condition in which blood sugar levels drop too fast. In severe instances, it can cause fainting or even coma. Several older diabetes drugs can cause hypoglycemia by pushing the pancreas to produce large amounts insulin quickly.
In contrast, Januvia and Galvus are the first in a newer class of drugs called DPP-IV inhibitors, which work by enhancing levels of a natural protein called GLP-1. The protein stimulates the pancreas to produce insulin and discourages the liver from making glucose. But the DPP-IV inhibitors work only when blood sugar levels are already elevated, such as after a meal, sharply lowering the risk for hypoglycemia.
“The approval of Januvia marks an important advance in the fight against diabetes,” Dr. Steven Galson, director of the F.D.A.’s center for drug evaluation and research, said in a statement. “We now have another new option that treats the disease in an entirely new way.”
Diabetes is a disease in which blood sugar rises uncontrollably from a lack of, or resistance to, insulin, a hormone normally produced in the pancreas. In Type 1 diabetes, the pancreas is unable to produce insulin.
Type 2 diabetes is linked to obesity and inactivity. Typically, the disease progresses over several years as the pancreas gradually loses the ability to produce insulin, and drug treatments lose their effectiveness. Eventually, many patients wind up injecting themselves with insulin to control their blood sugar. Severe, late-stage diabetes sharply raises the risks of many medical problems, including heart attacks, strokes, kidney disease and blindness.
Jay Galeota, general manager of Merck’s global diabetes division, said Merck planned to ship Januvia to pharmacies and offer samples to doctors’ offices quickly. The company expects to market Januvia to both doctors and patients almost immediately, he said.
“We’re confident that we’re going to communicate the science of Januvia in a very wide way,” he said. “We’re expecting very rapid uptake right away.”
While there are several major classes of diabetes medicines already on the market, many have side effects that discourage patients from taking them, including weight gain and nausea. As a result, the market is ripe for new treatments, doctors and analysts say.
In clinical trials that examined Januvia in 2,719 patients, the most common side effects were sore throat, diarrhea and colds, the F.D.A. said.
Richard Evans, an analyst at Sanford C. Bernstein & Company, said he expected Januvia and Galvus to rapidly replace an older class of drugs called sulfonylureas. The newer drugs are similarly effective but much less likely to cause weight gain and hypoglycemia, he said.
“Everybody knows that sulfonylureas are kind of a losing game,” he said. While Galvus and Januvia are very similar, Januvia may have an edge because it clearly works as a once-a-day pill, while Galvus was initially formulated to be taken twice daily, Mr. Evans said. Novartis, the manufacturer of Galvus, now claims that its drug is effective when taken once daily, but doctors may be skeptical of that claim, he said.
Tony Butler, an industry analyst at Lehman Brothers, said he expected that Januvia would have sales of $271 million next year, rising to $1.1 billion by 2010. Mr. Butler said sales of the Januvia-metformin combination pill would be $500 million more in 2010.
by Alex Berenson at The New York Times, Published: October 18, 2006
Thursday, November 02, 2006
DIABETES ARTICLES - Firm Reports Stem Cell Use for Making of Insulin
DIABETES ARTICLES
Firm Reports Stem Cell Use for Making of Insulin
Scientists at a small California biotechnology company reported yesterday that they had developed a process to turn human embryonic stem cells into pancreatic cells that can produce insulin and other hormones.
The work by the company, Novocell, based in San Diego, is a step toward using embryonic stem cells to replace the insulin-producing cells that are destroyed by the body’s immune system in people with Type 1, or juvenile, diabetes. Years of research remain, however, before a therapy developed from this approach can be put to use.
Embryonic stem cells can potentially be turned into any type of tissue in the body, and scientists are trying to figure out how to form various types.
Other researchers have previously reported turning various types of human or animal stem cells into cells that produce insulin. But the new work, published online yesterday by the journal Nature Biotechnology, represents a significant advance, some experts said.
“It provides some very strong evidence that it will be possible to make insulin-producing pancreatic beta cells from human E.S. cells in a culture dish,” Dr. Mark A. Magnuson, a professor at Vanderbilt University, wrote in an e-mail message. He said the scientists at Novocell had achieved an efficiency of cell conversion and insulin production in “orders of magnitude higher than anything previously accomplished.”
Dr. Magnuson, however, also said that in laboratory experiments the cells had not varied their insulin production much in response to the level of glucose, a key requirement for a beta cell. So more work is needed.
Emmanuel Baetge, the chief scientific officer at Novocell and the senior author of the paper, said the cells were “not fully mature” but rather seemed similar to the beta cells in a human fetus. Those cells also do not respond to glucose, a capability gained after the baby is born.
He said the insulin-producing cells had been derived by taking the embryonic stem cells and adding and subtracting various growth factors in a series of stages that mimicked the process that cells in an embryo go through to become a pancreatic cell. The process takes 16 to 20 days, he said.
Dr. Baetge said that the company hoped to begin testing its cells in animals in 2008 and that if all went well to begin clinical trials in human patients in 2009. Such timeline projections by companies often prove overly optimistic.
Doctors are already experimenting with transplanting cells from the pancreases of deceased organ donors into people with Type 1 diabetes. In some cases, the transplants relieve the recipients of the need to give themselves daily injections of insulin. But the effect wears off for most patients by two years.
Donated pancreases are scarce, so scientists hope to use stem cells to create insulin-producing cells. People with Type 1 diabetes and their families were among the biggest backers of the effort to create a $3 billion program of stem cell research in California. The program’s chairman, the real estate developer Robert N. Klein, has a son with diabetes.
by Andrew Pollack at New York Times
Firm Reports Stem Cell Use for Making of Insulin
Scientists at a small California biotechnology company reported yesterday that they had developed a process to turn human embryonic stem cells into pancreatic cells that can produce insulin and other hormones.
The work by the company, Novocell, based in San Diego, is a step toward using embryonic stem cells to replace the insulin-producing cells that are destroyed by the body’s immune system in people with Type 1, or juvenile, diabetes. Years of research remain, however, before a therapy developed from this approach can be put to use.
Embryonic stem cells can potentially be turned into any type of tissue in the body, and scientists are trying to figure out how to form various types.
Other researchers have previously reported turning various types of human or animal stem cells into cells that produce insulin. But the new work, published online yesterday by the journal Nature Biotechnology, represents a significant advance, some experts said.
“It provides some very strong evidence that it will be possible to make insulin-producing pancreatic beta cells from human E.S. cells in a culture dish,” Dr. Mark A. Magnuson, a professor at Vanderbilt University, wrote in an e-mail message. He said the scientists at Novocell had achieved an efficiency of cell conversion and insulin production in “orders of magnitude higher than anything previously accomplished.”
Dr. Magnuson, however, also said that in laboratory experiments the cells had not varied their insulin production much in response to the level of glucose, a key requirement for a beta cell. So more work is needed.
Emmanuel Baetge, the chief scientific officer at Novocell and the senior author of the paper, said the cells were “not fully mature” but rather seemed similar to the beta cells in a human fetus. Those cells also do not respond to glucose, a capability gained after the baby is born.
He said the insulin-producing cells had been derived by taking the embryonic stem cells and adding and subtracting various growth factors in a series of stages that mimicked the process that cells in an embryo go through to become a pancreatic cell. The process takes 16 to 20 days, he said.
Dr. Baetge said that the company hoped to begin testing its cells in animals in 2008 and that if all went well to begin clinical trials in human patients in 2009. Such timeline projections by companies often prove overly optimistic.
Doctors are already experimenting with transplanting cells from the pancreases of deceased organ donors into people with Type 1 diabetes. In some cases, the transplants relieve the recipients of the need to give themselves daily injections of insulin. But the effect wears off for most patients by two years.
Donated pancreases are scarce, so scientists hope to use stem cells to create insulin-producing cells. People with Type 1 diabetes and their families were among the biggest backers of the effort to create a $3 billion program of stem cell research in California. The program’s chairman, the real estate developer Robert N. Klein, has a son with diabetes.
by Andrew Pollack at New York Times
