At the same time that a wireless insulin pump for diabetics has been approved for marketing and public use by the U.S. Food and Drug Administration (FDA), its regulators are reconsidering the standards they use to approve diabetes medications.
The FDA began hearing from a panel of outside diabetes experts, cardiologists and statisticians on Tuesday as to whether the agency should require pharmaceutical companies to prove, through extensive long-term clinical research studies, that their drugs reduce heart problems and do not increase risk of death in order to gain FDA approval.
Diabetes is a disease where the body either does not produce or properly use insulin, a hormone that converts food into energy. Prescription drugs used to treat type 2 diabetes - the most common form, where a person's body either produces too little insulin or rejects insulin - are currently evaluated on the basis of whether they are proven to control blood-sugar levels.
The wireless insulin pump that has been approved is known as the OneTouch Ping glucose management system and is produced by Animas Corp., a medical device company from West Chester, that is a subsidiary of Johnson & Johnson Corp. in New Brunswick, N.J. It makes it easier for individuals with diabetes to calculate and inject themselves with the proper dose of insulin.
This reconsideration of regulatory standards is the result of questions that arose last year after an analysis of a popular diabetes drug, Avandia, showed that although taking it lowered blood-sugar levels, its use also increased the risk of heart attack in individuals.
FDA research into the issue yielded no actionable results, and additional trials by Avandia's manufacturer, GlaxoSmithKline, which has operations in the Philadelphia area, will likely not be ready until 2014.
The panel's opinions may influence and affect that approval of both new diabetes drugs and those that are already on the market.
However, there are some scientist even from within the FDA, who are skeptical of the value of tying risk of a side effect (heart attack) to the approval and availability of a drug whose target goal is to treat [low blood sugar and] diabetes.
Still, consumer advocates, lawmakers and diabetes organizations express concern over the risk of possible side effects.
Heather J. Chin can be reached at hchin@thebulletin.us
©The Evening Bulletin 2008
The FDA began hearing from a panel of outside diabetes experts, cardiologists and statisticians on Tuesday as to whether the agency should require pharmaceutical companies to prove, through extensive long-term clinical research studies, that their drugs reduce heart problems and do not increase risk of death in order to gain FDA approval.
Diabetes is a disease where the body either does not produce or properly use insulin, a hormone that converts food into energy. Prescription drugs used to treat type 2 diabetes - the most common form, where a person's body either produces too little insulin or rejects insulin - are currently evaluated on the basis of whether they are proven to control blood-sugar levels.
The wireless insulin pump that has been approved is known as the OneTouch Ping glucose management system and is produced by Animas Corp., a medical device company from West Chester, that is a subsidiary of Johnson & Johnson Corp. in New Brunswick, N.J. It makes it easier for individuals with diabetes to calculate and inject themselves with the proper dose of insulin.
This reconsideration of regulatory standards is the result of questions that arose last year after an analysis of a popular diabetes drug, Avandia, showed that although taking it lowered blood-sugar levels, its use also increased the risk of heart attack in individuals.
FDA research into the issue yielded no actionable results, and additional trials by Avandia's manufacturer, GlaxoSmithKline, which has operations in the Philadelphia area, will likely not be ready until 2014.
The panel's opinions may influence and affect that approval of both new diabetes drugs and those that are already on the market.
However, there are some scientist even from within the FDA, who are skeptical of the value of tying risk of a side effect (heart attack) to the approval and availability of a drug whose target goal is to treat [low blood sugar and] diabetes.
Still, consumer advocates, lawmakers and diabetes organizations express concern over the risk of possible side effects.
Heather J. Chin can be reached at hchin@thebulletin.us
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