Inadequate Testing of Diabetes Treatments found at FDA

Current FDA approval policy does not require that the side effects, such as increased heart problems, be considered when approving a diabetes drug given that it decreases blood sugar.

"Advisers to the Food and Drug Administration voted 14-2 on Wednesday that all new diabetes drugs should undergo longer studies to assure they don't increase risks of heart problems. The agency currently doesn't screen for heart risks associated with diabetes drugs.

The opinions from diabetes experts, cardiologists and statisticians come less than a year after the FDA was criticized for its handling of heart risks connected with a widely used GlaxoSmithKline pill. The drug was approved in 1999 but the agency didn't add a warning about potential heart risks until last November."

Associated Press, "FDA Panel Urges More Testing for Diabetes Drugs"

FDA Still Hasn't Capped Salmonella Problem

In an attempt to stint the growing salmonella outbreak, the FDA has added new produce to the list of inspection: serrano, jalapeno peppers, and cilantro.

"The 943 reported cases are nationwide, requiring at least 130 hospitalizations since mid-April after the first salmonella illnesses appeared, the FDA said Saturday. That compares with 922 cases two days earlier and 869 reported in the previous week. There have been 225 cases reported since June 1—evidence that the source likely has not been contained."

Chicago Tribune, "Salmonella Outbreak: FDA Looks at Tomatoes, Serrano, Jalapeno Peppers, and Cilantro"

FDA Drug Testing Too Slow for Seriously Ill Patients

Seriously ill patients are often desperate for new drugs to help treat their quickly declining health. However, the Abigail Alliance, led by Steven Walker, claims that the current FDA process for drug approval and regulations on drugs pending approval are detrimental to the livelihood of serious and terminally ill patients.

"Walker, who can barely disguise his contempt for what he calls the FDA's "culture of incompetence," rails against the slow-moving drug testing system where the effectiveness of a cancer drug is measured by how many patients die, not the quality of life. He thinks it's inhumane that trial subjects can receive placebos, rather than potentially effective drugs, in the name of research. And don't try to tell Walker that giving dying patients unproven treatments will just raise false hopes."

"Walker's criticism of the FDA was echoed by the agency's subcommittee on science and technology, which said the outdated evaluation system puts lives at risk. "Today, not only can the agency not lead, it cannot even keep up with the advances in science," the panel said in November."

St. Petersburg Times, "Man Fights FDA's Slow Road to Drug Approval"

FDA too slow to react to warnings of risky painkiller; lawsuit pending

"A prescription painkiller sold under such names as Darvon and Darvocet is too risky to stay on the market, a consumer advocacy group argued Thursday in suing the Food and Drug Administration.

Public Citizen petitioned the FDA two years ago seeking a ban on the drug, calling it no more effective than safer painkillers and citing the accidental deaths of more than 2,000 people since 1981.

Thursday, Public Citizen filed suit in U.S. District Court in Washington arguing that FDA has violated the law by not ruling on its petition within the required six months."

Associated Press, "FDA Sued for Failure to Act on Risky Painkiller"