Wednesday, June 22, 2011

Health - 2 Unusual Traits Blended in Germany’s E. Coli Strain

Health - 2 Unusual Traits Blended in Germany’s E. Coli Strain

2 Unusual Traits Blended in Germany’s E. Coli Strain

Posted: 22 Jun 2011 12:06 PM PDT

The E. coli bacteria that killed dozens of people in Germany over the past month have a highly unusual combination of two traits and that may be what made the outbreak among the deadliest in recent history, scientists there are reporting.

One trait was a toxin, called Shiga, that causes severe illness, including bloody diarrhea and, in some patients, kidney failure. The other is the ability of this strain to gather on the surface of an intestinal wall in a dense pattern that looks like a stack of bricks, possibly enhancing the bacteria’s ability to pump the toxin into the body.

With the two traits combined in one strain of E. coli bacteria, “now they are highly virulent,” said Dr. Matthew K. Waldor, an infectious-disease expert at Harvard Medical School who was not connected with the new research.

The new findings, by a team led by Helge Karch of the University of Münster, are being published Wednesday in the journal Lancet Infectious Diseases. They result from two days of fevered work to characterize the bacteria causing the illness that raced through Germany in May.

Experts in the United States praised the German scientists’ work. The work and the entire outbreak are “a real game-changer,” said Dr. Philip I. Tarr, a professor of pediatrics and expert in gut infections at Washington University School of Medicine in St. Louis. John Mekalanos of Harvard called the paper “extremely important.”

Other Shiga-producing bacteria adhere to the lining of the gut much less avidly, in diffuse clumps, not bricklike walls, Dr. Tarr said. And other strains of E. coli that do attach tightly to the gut do not make Shiga toxins. The combination of the two traits in one E. coli strain may be what makes this one so lethal.

Microbiologists knew, of course, that E. coli can be deadly; outbreaks in the United States involving tainted hamburger or vegetables have led to kidney failure in 5 to 10 percent of victims. And they knew that the most vulnerable were the very young and the very old.

But the recent outbreak, which has been traced to contaminated bean sprouts grown on a German farm, was different. As of June 20, it had sickened 2,684 people with diarrhea and 810 with kidney failure. Thirty-nine people died. The proportion with kidney failure — 25 percent — was “extraordinary,” Dr. Waldor said.

Moreover, the victims tended to be young and middle-age women.

The hospital in Münster was only mildly affected, compared to others in the north of Germany. Yet Dr. Karch said that even there, “within a few weeks, 20 patients had to be dialyzed.” Now, he added, although the epidemic is dying out, at least 100 people in Germany will need kidney transplants or will have to undergo dialysis for the rest of their lives.

Dr. Karch, a well-known expert in E. coli, infections, got the first stool samples on May 25. Over the next few days, more and more samples flooded his lab, 50 to 100 a day. “You can’t imagine,” he said.

He isolated the strain that was causing the illness and analyzed it to determine that it was strain O104:H4. Then he began investigating the bacteria’s DNA. First he determined what kind of Shiga toxin it made. Then he did adherence tests and found that the bacteria stuck to surfaces in the bricklike pattern. It is an unmistakable phenomenon: “Once you see it you will never forget it,” Dr. Karch said.

He posted the results and provided detailed information so most labs that had a suspicious stool sample could analyze it immediately and see if the stool contained O104:H4 bacteria. Until he posted that information, most labs would be at a loss. The strain is so rare that there are no standard tests to find it.

Dr. Karch also realized that the O104:H4 strain had been seen before in bloody diarrhea and kidney failure, but only on rare occasions — first in Germany in 2001, then sporadically in a few other countries. And in each outbreak, at most a few people were ill.

Why, then, was the German outbreak so widespread and where did the bacteria go between outbreaks?

Many experts assumed the bacteria lived in animals, probably cattle. That is where the strain that usually causes severe illness, E. coli O157:H7, is found. And that is why it has spread all over the world as animals, and their meat, transmit it to humans. In fact, Dr. Karch said, E.coli O157:H7 came to Europe from America, spread by cattle.

But the strain that caused the German outbreak does not seem to live in animals.

“I think it is human-specific,” Dr. Karch said. And that increases the mystery of where it goes between outbreaks.

Dr. Karch thinks it smoldered in human populations, causing mild illnesses in most and occasionally causing severe disease. Then, somehow, it was passed to the bean sprouts by someone who harbored the bacteria. And since sprouts are eaten raw, they were highly infectious.

The strain is so rare, Dr. Karch says, that those infected had no immunity. An epidemic caught fire.

Women may have been the primary victims, Dr. Karch speculates, because they are more likely to eat sprouts.

He himself does not like sprouts, he says, though his wife does. Aware that sprouts have always been “a high-risk food” for bacterial illnesses, he will not touch them unless they have been cooked.

Senators Seek Information on Side Effects of Medtronic Bone-Growth Product

Posted: 21 Jun 2011 09:55 PM PDT

Two senators on Tuesday expanded an investigation of the medical device maker Medtronic, demanding that the company turn over records involving millions of dollars in payments to researchers and internal correspondence with doctors who had published its research on a controversial bone-growth product.

Senator Max Baucus, Democrat of Montana and chairman of the Senate Finance Committee, and Senator Charles E. Grassley, Republican of Iowa, wrote to Omar Ishrak, Medtronic’s recently named chairman and chief executive, seeking extensive documents related to its bone-growth product, Infuse.

“Reports that doctors conducting medical trials while on Medtronic’s payroll may have hidden serious side effects for patients are deeply troubling,” Senator Baucus said in a statement. “We need to do everything we can to ensure companies aren’t concealing serious medical complications from patients just to increase profits,” he added.

Medtronic, in a statement late Tuesday, said it would respond to the senators’ request. The company did not comment specifically on the accusations of unreported complications and financial bias in research, but said it routinely reported all adverse events to the Food and Drug Administration “irrespective of any financial relationship between the company and the clinical investigator or study author.”

Marybeth Thorsgaard, a spokeswoman for Medtronic, said three specific complications listed in the letter — abnormal bone growth, swelling in the neck and throat, and a form of sterility — were all listed as side-effect warnings on the Infuse product label.

The senators’ query was prompted in part by a forthcoming spinal journal article saying some of the 13 Medtronic-sponsored studies of Infuse had failed to properly disclose complications.

The Justice Department has been investigating the marketing of Infuse, according to Securities and Exchange Commission filings by Medtronic since late 2008, and to people who have been contacted more recently by federal investigators.

And in May, Senator Baucus wrote to the company to ask why it had canceled contracts with Novation, a group-purchasing organization. The senator said he was concerned that patients or hospitals could end up paying more for Medtronic products. Senate staff is reviewing Medtronic’s confidential reply.

The senators set a July 11 deadline for Medtronic to respond, saying that they wanted the company to furnish “all documents and communications” with researchers, medical journals, the F.D.A., advisory board members and other Medtronic consultants, concerning adverse events or complications from the product.

Infuse is a bioengineered protein used instead of real bone in many graft operations. The F.D.A. has warned of serious problems for some spinal surgery patients. Infuse, approved by the F.D.A. for limited purposes in 2002, is widely used for broader purposes, as doctors are allowed to do.

Medtronic had $15.9 billion in sales and $3.1 billion in profit last year. The company does not break out sales by products, but Infuse has been one of its best sellers.

Well: To Stretch or Not to Stretch

Posted: 21 Jun 2011 09:01 PM PDT

Well: Cholesterol Drugs Linked With Diabetes Risk

Posted: 21 Jun 2011 02:08 PM PDT

The New Old Age: A Health Care Proxy

Posted: 22 Jun 2011 10:19 AM PDT

Program Offering Waivers for Health Law Is Ending

Posted: 17 Jun 2011 10:30 PM PDT

WASHINGTON — The Obama administration said Friday that it was shutting down a program that had provided exemptions from the new health care law for many employers and labor unions offering bare-bones insurance coverage to workers.

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No more applications will be accepted after Sept. 22, federal health officials said.

Steven B. Larsen, director of the federal Center for Consumer Information and Insurance Oversight, said employers and labor unions had until that date to seek exemptions or request the extension of waivers already granted.

The new health care law generally requires employers to provide at least $750,000 in coverage to each person in their health insurance plans this year. Many restaurants, retailers and small businesses do not meet the standard. Some provide “mini-med” coverage with annual limits that may be as low as $10,000.

“Mini-med plans do not provide comprehensive health coverage, but unfortunately they are the only insurance options some consumers have today,” Mr. Larsen said.

The minimum amount of coverage will increase. Federal rules require health plans to provide at least $1.25 million in coverage next year and $2 million in 2013. In 2014, annual limits for new health plans will be banned. In that year, individuals and small businesses will be able to buy comprehensive coverage through state-supervised insurance exchanges.

Waivers granted or renewed in the next three months will run through 2013. To date, the administration has granted waivers to 1,433 health plans covering 3.2 million people.

On Friday, the administration disclosed that it had denied 100 applications and then approved nearly one-third of them after reconsidering the evidence.

To obtain waivers, employers and health plans must show that compliance with the federal requirements would cause a significant increase in premiums or a significant decrease in access to benefits. Without waivers, some employers said, they would have increased premiums or dropped coverage this year because they could not afford to provide higher health benefits.

Republicans have seized on the waivers as evidence that the law is fundamentally flawed.

“If the law is so good, why are more and more employers begging for a waiver to get relief from its burdensome mandates?” asked Senator John Barrasso, Republican of Wyoming. “Americans need waivers from the president’s law because it causes health premiums to go up.”

The policy announced Friday may eliminate the waivers as an issue in the 2012 election year. Under the policy, the administration said, employers and insurers with annual coverage limits below $2 million will have “a reasonable opportunity” to apply for waivers in the next three months.

Republicans have repeatedly asserted that the administration was giving preferential treatment to its political allies by granting waivers to health plans sponsored by labor unions that had supported the legislation. But in a study this week, the Government Accountability Office, an investigative arm of Congress, said health officials had used objective criteria in deciding whether to grant waivers.

E. Neil Trautwein, a vice president of the National Retail Federation, a trade group, said that ending the waivers was “a wise, appropriate step for the administration to take.”

“This step will avoid unnecessary politics and furor over the waivers,” Mr. Trautwein said.

Recipes for Health: Asparagus Rolled in Herb Crêpes

Posted: 21 Jun 2011 01:40 PM PDT

A simple and elegant way to serve asparagus, this dish makes a great main course for a vegetarian dinner party. It can be assembled ahead of time and baked just before serving.

Recipes for Health

Martha Rose Shulman presents food that is vibrant and light, full of nutrients but by no means ascetic, fun to cook and to eat.

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12 herb crêpes

2 pounds asparagus

Salt and freshly ground pepper

1/2 cup (2 ounces) grated gruyère cheese

2 tablespoons chopped chives

2 tablespoons extra virgin olive oil

3 tablespoons freshly grated Parmesan

1. Preheat the oven to 375 degrees. Butter or oil two baking dishes. Steam the asparagus until tender, about five minutes. Divide into 12 portions, and place a portion on each crêpe. Sprinkle with salt, pepper, gruyère and chives. Roll up and place in the prepared baking dishes.

2. Sprinkle the Parmesan over the crêpes, and drizzle on the olive oil. Bake 15 to 20 minutes until bubbling; the edges of the crêpes should be just beginning to crisp. Serve hot.

Yield: Serves six.

Advance preparation: You can store the crêpes in the refrigerator or the freezer for a couple of days. Stack them between pieces of parchment or wax paper so they don’t stick together. The assembled crêpes can be refrigerated for up to a day.

Nutritional information per serving (six servings): 288 calories; 4 grams saturated fat; 3 grams polyunsaturated fat; 10 grams monounsaturated fat; 76 milligrams cholesterol; 22 grams carbohydrates; 5 grams dietary fiber; 303 milligrams sodium (does not include salt to taste); 12 grams protein

Martha Rose Shulman is the author of "The Very Best of Recipes for Health."

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