December 18, 2008
Stricter Diabetes Drug Trials
Twenty-three million Americans suffer from Type 2 diabetes, and the FDA says it will now strictly screen the drugs created to treat the epidemic.
Some believe the Food and Drug Administration's policy change will provide greater assurance of safety to doctors and patients, but it will make it more costly and time-consuming for companies to develop drugs that lower blood sugars.
"I think the FDA got this one right," said Dr. Steven Nissen, a Cleveland Clinic cardiologist who raised the diabetes safety concern two years ago with a study indicating a popular new drug increased the risk of heart attacks.
People with diabetes are unable to properly break down carbohydrates, either because their bodies do not produce enough insulin or because of resistance to insulin.
Those who suffer from diabetes are at higher risk for heart attacks, kidney problems, blindness, and other serious complications.
Dr. Mary Parks, head of the FDA division that oversees diabetes drugs, said the policy is intended to remove the uncertainty about new diabetes drugs.
"The more we know about the safety profile, the better it is for physicians to make decisions," Parks said.
Experts say the new policy enforces stricter standards for testing diabetes drugs.
According to the new FDA policy, drug companies will have to test drugs on greater numbers of high-risk patients, like the elderly instead of young people. They will also study those with advanced diabetes and those with kidney problems.
"What you have to do, for the first time, is study these drugs in patients who have cardiovascular risks," Nissen said.
The policy also calls for independent committees to monitor the rates of heart attacks, strokes, and heart-related deaths and hospitalizations linked to diabetes drugs in development.
But the FDA says one thing will remain steady throughout the influx of changes: Diabetes drugs still will be judged on how well they lower blood sugars.
The FDA says its stance on new drugs allows for discretion in approving diabetes medications.
"The idea is not to create such a high barrier that you will stifle innovation in developing new drugs, but to make sure clinicians have the information they need," said Nissen. "This will raise the level of evidence available, and that is good for patients."
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