Legion of Angels News Archive

WASHINGTON (AP) – Adding to tomato confusion, the government is about to start testing numerous other types of fresh produce in the hunt for the source of the nation’s record salmonella outbreak — even as it insists tomatoes remain the leading suspect.

Investigators are mum on exactly what other vegetables are getting tracked.

Items commonly served with fresh tomatoes is the only hint Food and Drug Administration food safety chief Dr. David Acheson would give, calling it “irresponsible” to point a finger until he has more evidence that some other food really deserves the extra scrutiny.

“Tomatoes aren’t off the hook,” he stressed. “It’s just that there is clearly a need to think beyond tomatoes.”

Still, Acheson widened FDA’s probe on Tuesday, activating an emergency network of food laboratories around the country in anticipation of lots of additional samples to test.

The reason is that the outbreak continues, with 869 people now confirmed having taken ill. Most troublesome, at least 179 of them fell ill in June, the latest on June 20. That is more than two months after the first salmonella illnesses appeared, meaning the outbreak is continuing weeks longer than food-poisoning specialists had expected — and suggesting the culprit is still on the market.

Over the weekend, disease detectives with the Centers for Disease Control and Prevention began interviewing people sickened in June to find out what they ate and to compare their diets with those of healthy relatives and neighbors. Officials wouldn’t reveal early findings, except to say they supported the investigation’s new move.

Among the possibilities FDA is exploring is whether tomatoes and other produce are sharing a common packing or shipping site where both might become contaminated, or whether multiple foods might be tainted while being grown on adjoining farms or with common water sources.

Pressure is increasing on the FDA to solve the case, with the tomato industry suffering millions of dollars in losses and pushing for Congress to investigate how the agency handled the outbreak.

But Acheson said Tuesday that there’s a growing misconception in the public that if tomatoes really were to blame, the outbreak would only have lasted six weeks.

That’s just not true, he said, pointing to farms that rotate harvests so as to keep producing tomatoes for months.

Tomatoes first became a suspect because of what are called “case-control” studies rapidly conducted in New Mexico and Texas, the outbreak’s center, CDC food-poisoning specialist Dr. Robert Tauxe said.

Those kinds of studies compare the sick to people who are otherwise similar — in income, lifestyle, where they live — but healthy. In those initial studies, about 80 percent of the ill reported eating certain types of fresh tomatoes, far more than the healthy group did, Tauxe said. Statistically, the association was too strong to think it a coincidence.

Some food-poisoning experts say the CDC missed a key step in not taking those studies a step further and trying to trace why some of the healthy ate tomatoes without harm.

For now, the FDA continues to urge consumers nationwide to avoid raw red plum, red Roma or red round tomatoes unless they were grown in specific states or countries that the agency has cleared of suspicion. Check the FDA’s Web site — http://www.fda.gov — for an updated list. Also safe are grape tomatoes, cherry tomatoes and tomatoes sold with the vine still attached.

That advice is coming under fire too because tomatoes are sent through multiple repacking and distribution sites around the country, even to Mexico and back, regardless of where they’re grown. But Acheson said the advice would be fine-tuned only if new science emerges.

Even Health and Human Services Secretary Michael Leavitt expressed frustration Tuesday that the case isn’t solved.

“Nothing happens fast enough when you have a problem like this,” Leavitt said as he asked Congress for more funds and stronger legal powers for food and consumer safety agencies. Still, “I feel confident we will find the solution to this problem.”

Source — The New York Times

WASHINGTON (AP) – Diabetes drugs should face tougher safety standards that could cost manufacturers millions but protect patients from unforeseen heart risks, a government panel has recommended.

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.

The majority of the panel said drug companies could begin safety testing before they submit drugs to the FDA, and finish the studies after the drugs are on the market. The testing would take an estimated five to seven years to complete, and likely cost tens of millions of dollars.

At least one panelist doubted whether the proposed studies would actually uncover heart risks, and added they could delay important medical breakthroughs.

”If you wait this amount of time for testing you’re going to be preventing certain drugs from getting out there that may be better than what we already have,” said Dr. Eric Felner, a pediatric specialist at Emory University School of Medicine.

The FDA is not required to follow the panel’s advice, though it often does.

GlaxoSmithKline PLC, AstraZeneca and Novartis AG are among the companies developing diabetes treatments to compete in the domestic market, which grew to more than $6 billion last year, according to pharmaceutical research firm IMS Heath.

Takeda Pharmaceuticals’ Actos, GlaxoSmithKline’s Avandia, and Eli Lilly and Amylin Pharmaceutical’s Byetta currently dominate the U.S. market.

Nearly 24 million Americans have Type 2 diabetes, which can lead to kidney failure, blindness and heart disease.

The FDA was pressured to reconsider how it approves diabetes medications after an analysis released last year showed GlaxoSmithKline’s blockbuster drug Avandia may increase patients’ risk of heart attack.

The agency currently approves diabetes drugs based on their ability to lower blood sugar. But Dr. Steven Nissen, who authored the analysis on Avandia, said Tuesday that criterion has little value if drugs also increase heart problems.

Nissen, the chairman of cardiology at the Cleveland Clinic, said the FDA is operating under ”the irrational belief that lowering blood sugar using virtually any pharmacological means will produce” better results for patients.

He recommended the FDA require drug companies to prove their drugs do not have significant heart risks before granting approval.

”The fallacy here is that we will never know everything we’d like to about a drug before it goes on the market,” Dr. Ray Woosley, president of the Critical Path Institute in Tucson, Ariz., said in a phone interview Tuesday. ”If we held up drugs until we did know everything a lot of people would die.”

The institute is a nonprofit partnership with the FDA that aims to speed up the development of new drugs.

Approving drugs based on biological measurements, like blood sugar levels in diabetics, is thought to be a promising method for speeding-up drug development because the results can be gathered relatively quickly. But that approach is under scrutiny, as some lawmakers and medical experts believe the FDA should not approve drugs without evidence they improve more meaningful measures like patients’ life span.

Source — The New York Times