June 2010

View original article

View original article

WASHINGTON — Federal food regulators took a tentative step Monday toward banning a common use of penicillin and tetracycline in the water and feed given cattle, chickens and pigs in hopes of slowing the growing scourge of killer bacteria.

But the Food and Drug Administration has tried without success for more than three decades to ban such uses. In the past, Congress has stepped in at the urging of agricultural interests and stopped the agency from acting.

In the battle between public health and agriculture, the guys with the cowboy hats generally win.

The F.D.A. released a policy document stating that agricultural uses of antibiotics should be limited to assuring animal health, and that veterinarians should be involved in the drugs’ uses.

While doing nothing to change the present oversight of antibiotics, the document is the first signal in years that the agency intends to rejoin the battle to crack down on agricultural uses of antibiotics that many infectious disease experts oppose.

Dr. Joshua M. Sharfstein, the agency’s principal deputy commissioner, refused at a news conference to give details about when the agency would take more concrete steps.

“We believe this is a public health issue of some urgency,” Dr. Sharfstein said. “We’re looking to see some progress soon.”

About 100,000 people die every year from hospital-acquired infections caused by bacteria that, because of overuse of antibiotics, have developed resistance to the usual remedies and cannot be killed with them. Many others die from superbugs contracted outside hospitals.

How many deaths can be attributed to agricultural uses of antibiotics?

“I don’t think anyone knows that number,” said Dr. James Johnson, a professor of medicine at the University of Minnesota, “but I think it’s substantial.”

Antibiotics are used in agriculture for three reasons: to promote animal growth, prevent illness and treat sickness. How antibiotics in feed and water help to fatten animals is not entirely clear.

The industrialization of animal husbandry has increased processors’ dependence on antibiotics because factory farm animals tend to be sicker and feed-lot diets can encourage bacterial infections.

The Union of Concerned Scientists estimated in 2001 that 84 percent of all antibiotics were used in agriculture and that 70 percent were used simply to promote animal growth, not to treat or prevent illness. The Animal Health Institute, a trade association, estimated that 13 percent of agricultural antibiotics were used to promote growth.

Dave Warner, a spokesman for the National Pork Producers Council, said most agricultural antibiotics were given to healthy animals not to promote growth but to prevent illness.

The distinction is important because F.D.A. officials said they were mostly concerned with the use of antibiotics to promote growth — not to prevent or treat illnesses. If the agency some day bans growth promotion as a use, there is a chance producers would simply relabel such uses as preventative.

Mr. Warner said his organization opposed the F.D.A.’s guidance. “We think this guidance could lead to the elimination or costly review of previously approved animal health products,” he said.

The Animal Health Institute said in a statement that it welcomed the guidance and had “long supported efforts to promote judicious use of antibiotics.”

Representative Louise M. Slaughter, Democrat of New York and chairwoman of the House Rules Committee, said the F.D.A. had “not gone far enough or moved fast enough.” Ms. Slaughter has proposed legislation banning nontherapeutic uses of some classes of antibiotics.

Times Reader 2.0: Daily delivery of The Times – straight to your computer. Subscribe for just $4.62 a week.

Barely two months after the closing of St. Vincent’s Hospital in Greenwich Village, North General Hospital, a potent symbol of the city’s political and philanthropic commitment to Harlem, announced Monday that it was declaring bankruptcy.

The 200-bed North General will close by next week, hospital officials said. But while St. Vincent’s closed abruptly with only the distant promise of an urgent care clinic in its place, the North General building will immediately be occupied by a large government-subsidized walk-in clinic for Harlem residents, state and North General officials said.

The city’s public hospital system will also move two of its facilities, a nursing home and a 200-bed long-term rehabilitation center, to the North General site from Roosevelt Island, officials said.

North General got 36,000 visits a year to its emergency room, but officials said that nearby hospitals and the walk-in clinic would pick up those patients.

The carefully structured deal was hammered out with the help of Gov. David A. Paterson, Mayor Michael R. Bloomberg and Representative Charles B. Rangel of Harlem, hospital officials said.

“Having gone through what we experienced with St. Vincent’s, we were really happy that we were able through the governor’s leadership to pull together the city, the state and the Department of Health and of course North General to come up with a plan that not only keeps that platform in Harlem devoted to health care but actually expands health care in Harlem,” said Paul Williams, president of the state Dormitory Authority, which helped finance the hospital’s construction, and still holds $117 million of its outstanding debt.

In a joint statement Monday, the governor and the hospital said the hospital planned to file for Chapter 11 bankruptcy.

The Rev. Calvin O. Butts III, pastor of Abyssinian Baptist Church and chairman of the hospital’s board, said Monday that the hospital was about $200 million in debt and had been in debt almost continuously since its inception in 1979. “The hospital opened on borrowed money,” Mr. Butts said. “This just couldn’t go on.”

But the union that represents North General employees, Local 1199 S.E.I.U., lashed out at the plan, saying that the Institute for Family Health, which will operate the new clinic, had told the union it would not be able to hire all the current employees. The union said it had filed unfair labor practice charges with the National Labor Relations Board.

Mr. Butts said he expected that Harlem would gain from the new arrangement. There will be jobs created by the construction of the nursing home, he said. And he said he expected most of the 900 hospital employees to find jobs at other hospitals or with the replacement facilities.

As a so-called federally qualified health care center, the new clinic will receive Medicaid money and other grants to provide primary care, mental health care, dental care and school-based care to 80,000 patients a year, state officials said. Its doctors will also be available to privately insured patients, officials said.

The new clinic is scheduled to open just when North General closes. The Institute for Family Health runs family health centers in the Bronx, Manhattan and the Hudson Valley, and Dr. Neil Calman, the institute’s president, has a reputation as an activist doctor in poor neighborhoods. He got his start in the Bronx about 30 years ago as the first medical director of the Soundview Healthcare Network. He left that organization years ago, however. Dr. Calman did not return a call for comment. Soundview was founded by Pedro Espada Jr., the state senator now accused of looting the clinics of millions of dollars.

Kenneth Raske, president of the Greater New York Hospital Association, a trade group, said, “The death of a hospital is always difficult, but the plans that have been laid out for the re-emergence of health care services in that portion of Harlem is absolutely outstanding.”

The hospital was founded by Randolph Guggenheimer, a Manhattan lawyer, and Eugene McCabe, a management consultant, to replace the Hospital for Joint Diseases when it moved from Madison Avenue and 124th Street in 1979.

Times Reader 2.0: Daily delivery of The Times – straight to your computer. Subscribe for just $4.62 a week.

Bicycling for exercise may help women control their weight during their 30s and 40s, a new study says.

Brisk walking has the same effect for slim, overweight and obese women, researchers found, but slow walking does not.

The findings are based on the second Harvard Nurses’ Health Study, which is tracking 116,608 female nurses who periodically fill out questionnaires about their health, weight, diet and behavior. The new analysis, published in the June 28 issue of Archives of Internal Medicine, looked at weight change and behavior from 1989 (when the nurses were 25 to 42 years old) to 2005; to isolate the effects of exercise, the researchers controlled for other obesity risk factors.

They found that women who increased physical activities like brisk walking and bicycling by 30 minutes a day during the 16-year period maintained their weight and even lost a few pounds, but those whose exercise was slow walking did not lose any weight.

Women who decreased their bicycling time from more than 15 minutes a day to less than 15 minutes gained about four-and-a-half pounds on average.

“This is not suggesting that if you bicycle for five minutes you will immediately go back to the weight you were when you were 18,” said Anne C. Lusk, a research fellow at the Harvard School of Public Health who was an author of the paper. “If that were true, bicycle sales would go through the roof.

“But it’s highly suggestive that bicycling is highly beneficial in women.”

Times Reader 2.0: Daily delivery of The Times – straight to your computer. Subscribe for just $4.62 a week.

People with high blood levels of the amino acid homocysteine are at increased risk for heart disease and strokes. But it has never been clear whether reducing homocysteine will cut the risk, and whether the substance actually causes vascular disease.

A paper published in The Journal of the American Medical Association says it does not.

The paper is based on a large, randomized, controlled clinical trial in Britain from 1998 to 2008. More than 12,000 heart-attack survivors were randomly assigned to take either a combination of folic acid and vitamin B 12, which reduce homocysteine levels, or a placebo.

After seven years, patients who were taking the vitamins had lowered their homocysteine, butdid not reduce their risk of heart attack or stroke. They had the same rates of heart attack and death from vascular causes as those taking placebos, the study found.

The research “conclusively shows that these vitamins do not prevent heart attack and strokes as we had previously hoped they might,” Dr. Jane Armitage, professor of clinical trials and epidemiology at the University of Oxford, and one of the authors of the paper, said in an e-mail message. The study was financed by Merck, which makes both cholesterol-lowering drugs and vitamins; Merck supplied the vitamins used in the trial.

Times Reader 2.0: Daily delivery of The Times – straight to your computer. Subscribe for just $4.62 a week.

Toddlers who get a vaccine that combines the measles-mumps-rubella and chickenpox immunizations are at twice the usual risk for fevers that lead to convulsions, a new study reports.

The risk for a so-called febrile seizure after any measles vaccination is less than 1 seizure per 1,000 vaccinations; but among children who received the combined vaccine, there is 1 additional seizure for every 2,300 vaccinated, said Dr. Nicola Klein, the study’s lead investigator and director of the Kaiser Permanente Vaccine Study Center.

The reactions, which occur a week to 10 days after vaccination, are not life-threatening and usually resolve on their own. The fever-related convulsions can be frightening, but they are brief and not linked to any long-term complications or seizure disorders.

To do the analysis, published this week in the journal Pediatrics, Kaiser Permanente researchers used the government’s Vaccine Safety Datalink, a safety surveillance system that compiles data on nine million members of eight managed-care organizations.

They compared seizure and fever reactions among 83,107 1-year-olds who had combined M.M.R. and chickenpox vaccinations with reactions of 376,354 toddlers who received separate vaccines.

“Unless parents have a strong preference for the combination vaccine, providers should use a separate vaccine,” Dr. Klein said.

Times Reader 2.0: Daily delivery of The Times – straight to your computer. Subscribe for just $4.62 a week.

For her first appointment with Dr. Daniel Simon, Neelima Raval showed up with a rolling file cabinet full of documents. She had downloaded every word written by or about Dr. Paolo Zamboni, a vascular surgeon from Italy with a most unorthodox theory about multiple sclerosis.

Share your thoughts on this column at the Well blog.

Go to Well »

A LOOK INSIDE Neelima Raval had her veins tested by Dr. Daniel Simon, top, to see if they were narrow.

Dr. Zamboni believes that the disease, which damages the nervous system, may be caused by narrowed veins in the neck and chest that block the drainage of blood from the brain. He has reported in medical journals that opening those veins with the kind of balloons used to treat blocked heart arteries—an experimental treatment he calls the “liberation procedure”— can relieve symptoms.

The idea is a radical departure from the conventional belief that multiple sclerosis is caused by a malfunctioning immune system and inflammation.

The new theory has taken off on the Internet, inspiring hope among patients, interest from some researchers and scorn from others. Supporters consider it an outside-the-box idea that could transform the treatment of the disease. Critics call it an outlandish notion that will probably waste time and money, and may harm patients.

These critics warn that multiple sclerosis has unpredictable attacks and remissions that make it devilishly hard to know whether treatments are working — leaving patients vulnerable to purported “cures” that do not work.

The controversy has exposed the deep frustration of many people with this incurable, disabling disease, who feel that research has let them down. It is a case study in the power of the Internet to inform and unite angry patients—which may be a double-edged sword. Pressure from activists helped persuade the Multiple Sclerosis Society to pay for studies of Dr. Zamboni’s theory, but the Internet buzz has also created an avid market for a therapy that is still unproved.

“It’s eye-opening the way this group of patients has grabbed hold of the social-networking technology,” said Dr. Simon, an interventional radiologist at JFK Medical Center in Edison, N.J. “They’ve taken this to a level I’ve not seen in other patients. Patients used to read an article or two. Now, they’re actually seeing procedures on YouTube. Is this the future of medicine?”

Scientifically, the jury is out: Dr. Zamboni’s hypothesis is being studied. It is not known whether narrowed veins are more common in people with multiple sclerosis than in others, and even if they are, whether the narrowings are a cause, or an effect, of the disease. There is no solid proof that opening the veins can help. There have been no studies with control groups — the only way to find out whether a treatment works.

“In my view the evidence is quite scanty and the biological plausibility is low,” said Dr. Stephen L. Hauser, the chairman of neurology at the University of California, San Francisco. Many neurologists agree. Dr. Hauser said there was much stronger evidence that the disease arose from genetic variations affecting the immune system.

But Dr. Adnan H. Siddiqui, part of a team at the University at Buffalo that has been studying Dr. Zamboni’s theory, said that it made sense and that the data from Italy was encouraging. Still, he emphasized that more study was needed, and that patients should not be treated until the research was done.

In Demand

Despite the lack of proof, many patients are captivated by the idea that multiple sclerosis might turn out to be a vascular disease. They want to believe it can fixed with a relatively simply procedure, and they want to be tested and treated. Now.

These patients say they cannot afford to wait for research results because they will wind up in wheelchairs before the studies are done. Their only option so far has been a lifelong course of drugs with limited benefits and harsh side effects. To some, balloon treatment seems no riskier than those drugs.

Dr. Zamboni himself has said that the procedure should not yet be done outside of studies. He said in an interview that he was conducting research only and had turned down thousands of requests from people wanting to go to his clinic at the University of Ferrara.

But other doctors have set up shop. A clinic in India with a toll-free American phone number has an online advertisement for a “liberation package.” Patients are posting testimonial videos and trading tips on clinics in Bulgaria, Poland and Jordan.

In the United States, where many hospitals forbid experimental treatments outside of studies, a “back alley” network of doctors willing to perform the procedure has begun to develop, said Dr. Salvatore J. A. Sclafani, chairman of radiology at Downstate Medical Center in Brooklyn. He said he knew of about a dozen. The doctors try to stay under the radar, and patients quietly pass their names to one another.

“It reminds me of abortion in 1968,” Dr. Sclafani said.

He said he had treated about 20 patients at Kings County Hospital before the hospital ordered him to stop in early April. He said he had a waiting list of 300 to 400 patients..

Times Reader 2.0: Daily delivery of The Times – straight to your computer. Subscribe for just $4.62 a week.

GlaxoSmithKline, Merck and Novartis have taken the top three spots again on the Access to Medicine Index, which ranks pharmaceutical companies on how readily they make their products available to the world’s poor.

It was the second time the rankings, which were created in 2008, have been issued. This time, 95 percent of the brand-name companies approached by the Dutch foundation that started the index agreed to provide information; two years ago, only about half did.

European companies slightly edged out American companies in the rankings, while the four Japanese companies ranked were at or near the bottom.

The companies are graded on many factors, including whether they offer lower prices or donate drugs in poor countries, whether they license generic versions of their products or fight to prevent them, whether they donate expertise or money to struggling health systems and whether they do research on neglected diseases.

Gilead Sciences and Pfizer rose several ranks from 2008.

Those falling in rank were Novo Nordisk, Bayer, Bristol-Meyers Squibb and Merck KGaA (a German company no longer connected to the Merck based in New Jersey).

The index, which is supported by the Bill and Melinda Gates Foundation, the Dutch and British governments, Oxfam and other donors, also issued detailed “report cards” on 20 companies.

For the first time, generic drug makers were ranked separately. Three Indian companies, Ranbaxy Laboratories, Cipla and Dr. Reddy’s, took the top three spots.

Times Reader 2.0: Daily delivery of The Times – straight to your computer. Subscribe for just $4.62 a week.