Diabetes drug metformin proves useful for other problems
Karen Weintraub
USA TODAY
July 30, 2013
Early research suggests the decades-old diabetes drug metformin can slow cancer, reduce heart disease and perhaps limit the ravages of Alzheimer's. A new study shows it can extend lifespan in mice.
Could metformin, the most widely used diabetes drug in the world, be useful for fighting a number of health problems?
Early research suggests the decades-old drug can slow cancer, reduce heart disease and maybe even limit the ravages of Alzheimer's. Now, a new study in mice finds that it can extend life by a number of weeks — the human equivalent of 3-4 years.
It's far too soon for healthy people to consider taking the drug, researchers say, but the findings are provocative, and suggest science is getting closer to a day when it may be possible to pop a pill to live healthier longer.
Diseases of aging, like cancer, heart disease, type 2 diabetes and dementia are all linked along a biological pathway, researchers say. Eating less food appears to trigger that cascade, significantly extending life in animals, probably by slowing down metabolism.
Metformin is the third drug shown in early research to affect the same pathway, along with rapamycin, a powerful medication used to prevent rejection of transplanted organs; and resveratrol, a compound found in red wine.
"It's clear that we are edging toward developing a pharmaceutical intervention that is going to be able to delay or postpone aging," said Rafael de Cabo, a biogerontologist at the National Institute of Aging, who conducted the new mouse study, published today in Nature Communications. "For how much and how long I have no idea."
Brian Kennedy, CEO of The Buck Institute for Research on Aging in Novato, Calif., said he envisions a day when, instead of giving people drugs after they get sick, healthy people will be able to take pills to avoid illness. Such a pill wouldn't prevent all aging, he said, but by delaying the deadliest diseases for even a few years, it could have a dramatic benefit on an individual's quality of life and the nation's economy.
Despite their optimism, both Kennedy and de Cabo said that healthy people should not be taking metformin at this point. While mice are a good model for diseases, they do not respond exactly as people do; and they live a totally controlled life inside a cage, de Cabo said.
Metformin caused severe kidney problems in mice taking a high dose, suggesting that researchers need to proceed with caution when testing the drug in people, de Cabo said. Even the low dose used in his study left mice with more drug in their bloodstream than diabetics get on their metformin regimen, so it's not yet clear what dose to use in healthy people.
The drug is also known to cause diarrhea, because it affects the metabolism of sugars in the digestive system.
So far, those two side effects have kept researchers from trying the drug on themselves. David Sinclair, a genetics professor at Harvard Medical School who has done extensive research on resveratrol, said he took metformin along with his resveratrol for a short time. He stopped when he saw the toxic effects in this mouse study, which he co-authored. He said he wouldn't take rapamycin because of its side effects.
A new drug will eventually be developed, he predicted, that will amplify the benefits of these drugs and minimize their side effects.
"In terms of history, we're still at the very early stages of understanding how to slow aging in a safe way," said Sinclair.
Even if it turns out not to extend life, metformin has shown powerful results in other areas of research:
• Kevin Struhl, a molecular and cancer biologist at Harvard Medical School, said he has been impressed by early studies showing metformin's effectiveness at treating cancer and stopping cells from turning cancerous in the first place.
• At the University of Pennsylvania, Alzheimer's expert Steven Arnold is studying the drug's ability to slow or prevent mental decline.
• And other work has shown that metformin can help stop pre-diabetes before it turns into type 2 diabetes, said Karin Hehenberger, a molecular biologist, diabetes expert and chief medical officer at Coronado Biosciences, a Massachusetts biotech company focused on autoimmune diseases.
In terms of aging, we already know enough to help people until a pill can be developed, Kennedy said.
"There's a huge secret to (combating) aging right now," he said. "That's eat right and exercise."
Showing posts with label drugs. Show all posts
Showing posts with label drugs. Show all posts
Tuesday, July 30, 2013
Thursday, May 5, 2011
New drugs often marketed ahead of crucial data
Data that could save money and help doctors make smarter treatment decisions are often unavailable at the time new medicines hit the market, according to U.S. researchers.
New drugs often marketed ahead of crucial data
By Frederik Joelving
May 4, 2011
NEW YORK (Reuters Health) - Data that could save money and help doctors make smarter treatment decisions are often unavailable at the time new medicines hit the market, according to U.S. researchers.
In a study out Tuesday, they found nearly a third of new drug approvals from the Food and Drug Administration included no data on how well the medications compare with existing alternatives.
"Even when these things are accessible, it's hugely time-consuming to go through it," said Joshua Gagne, a pharmacist at Harvard Medical School in Boston.
That leaves insurers and healthcare providers at a loss when trying to find the best and cheapest drugs for their patients, Gagne, who led the new work, told Reuters Health.
In 2009, Congress earmarked $1.1 billion to support drug comparison research, which would help doctors choose between various drugs.
But that information is unlikely to appear until years after new medicines reach the market, because drugmakers only need to show their products work better than a sugar pill -- not how they compare to existing treatments.
"There is a gap between the time the drug hits the market and the time this information is generated," Gagne said.
With his colleagues, he went through public FDA data for 197 drugs approved between 2000 and 2010.
After excluding medications for diseases with no alternative treatments, 70 percent of the FDA approval packages contained some data on how the new products compared to existing ones.
Experts who spoke with Reuters Health were split in their reaction to the new study, published in the Journal of the American Medical Association.
Dr. Robert Temple, who directs FDA's Office of Medical Policy at the Center for Drug Evaluation and Research, said he was surprised by how many drugmakers had provided some comparative data, despite not being required to do so.
"Considering that there is absolutely no requirement, it is pretty impressive," he said in a phone interview.
Another expert took the opposite view.
"A third of new drugs that are approved have no comparative data at all," said Dr. Alec B. O'Connor of the University of Rochester School of Medicine and Dentistry in New York. "I think we'd all say that is sad."
He said he believes new drugs should always be tested against those already approved to treat a given disease.
In an earlier study, O'Connor had tried to compare the cost-effectiveness of different painkillers. But that turned out to be next to impossible, because almost no researchers had tested the drugs head-to-head.
"When a new drug becomes available, if it's not compared with a drug we already use, we don't know if it is better or worse -- we're just guessing. If you're a patient, I don't think you would want your doctor to be guessing," he told Reuters Health.
"You could save a lot of money if you had better comparative data at the time of approval," he added. "It's a win-win for patients, for doctors and for societal costs."
Meanwhile, Gagne and his team say the comparative FDA data, when it exists, should be made more accessible.
But according to an e-mail from Temple, of the FDA, that is not without problems.
"Comparative data are often too limited to allow a firm conclusion about comparative effectiveness (the size of studies that would be needed to rule out a small difference is usually daunting)," he told Reuters Health. "FDA would not want to suggest that a small study showing no difference between two treatments 'proves' equivalence, when the data fall well short of such proof."
SOURCE: bit.ly/j8dJ7p Journal of the American Medical Association, May 4, 2011.
New drugs often marketed ahead of crucial data
By Frederik Joelving
May 4, 2011
NEW YORK (Reuters Health) - Data that could save money and help doctors make smarter treatment decisions are often unavailable at the time new medicines hit the market, according to U.S. researchers.
In a study out Tuesday, they found nearly a third of new drug approvals from the Food and Drug Administration included no data on how well the medications compare with existing alternatives.
"Even when these things are accessible, it's hugely time-consuming to go through it," said Joshua Gagne, a pharmacist at Harvard Medical School in Boston.
That leaves insurers and healthcare providers at a loss when trying to find the best and cheapest drugs for their patients, Gagne, who led the new work, told Reuters Health.
In 2009, Congress earmarked $1.1 billion to support drug comparison research, which would help doctors choose between various drugs.
But that information is unlikely to appear until years after new medicines reach the market, because drugmakers only need to show their products work better than a sugar pill -- not how they compare to existing treatments.
"There is a gap between the time the drug hits the market and the time this information is generated," Gagne said.
With his colleagues, he went through public FDA data for 197 drugs approved between 2000 and 2010.
After excluding medications for diseases with no alternative treatments, 70 percent of the FDA approval packages contained some data on how the new products compared to existing ones.
Experts who spoke with Reuters Health were split in their reaction to the new study, published in the Journal of the American Medical Association.
Dr. Robert Temple, who directs FDA's Office of Medical Policy at the Center for Drug Evaluation and Research, said he was surprised by how many drugmakers had provided some comparative data, despite not being required to do so.
"Considering that there is absolutely no requirement, it is pretty impressive," he said in a phone interview.
Another expert took the opposite view.
"A third of new drugs that are approved have no comparative data at all," said Dr. Alec B. O'Connor of the University of Rochester School of Medicine and Dentistry in New York. "I think we'd all say that is sad."
He said he believes new drugs should always be tested against those already approved to treat a given disease.
In an earlier study, O'Connor had tried to compare the cost-effectiveness of different painkillers. But that turned out to be next to impossible, because almost no researchers had tested the drugs head-to-head.
"When a new drug becomes available, if it's not compared with a drug we already use, we don't know if it is better or worse -- we're just guessing. If you're a patient, I don't think you would want your doctor to be guessing," he told Reuters Health.
"You could save a lot of money if you had better comparative data at the time of approval," he added. "It's a win-win for patients, for doctors and for societal costs."
Meanwhile, Gagne and his team say the comparative FDA data, when it exists, should be made more accessible.
But according to an e-mail from Temple, of the FDA, that is not without problems.
"Comparative data are often too limited to allow a firm conclusion about comparative effectiveness (the size of studies that would be needed to rule out a small difference is usually daunting)," he told Reuters Health. "FDA would not want to suggest that a small study showing no difference between two treatments 'proves' equivalence, when the data fall well short of such proof."
SOURCE: bit.ly/j8dJ7p Journal of the American Medical Association, May 4, 2011.
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