PepsiCo Will Halt Use of Brominated Vegetable Oil in Gatorade

James Edward Bates for The New York TimesSarah Kavanagh, a high school student in Mississippi, started a petition to get PepsiCo to stop using brominated vegetable oil.

PepsiCo announced on Friday that it would no longer use an ingredient in Gatorade after consumers complained.

The ingredient, brominated vegetable oil, which was used in citrus versions of the sports drink to prevent the flavorings from separating, was the object of a petition started on Change.org by Sarah Kavanagh, a 15-year-old from Hattiesburg, Miss., whobecame concerned about the ingredient after reading about it online. Studies have suggested there are possible side effects, including neurological disorders and altered thyroid hormones.

Brominated vegetable oil will be replaced by sucrose acetate isobutyrate, an emulsifier that is “generally recognized as safe” as a food additive by the Food and Drug Administration. The new ingredient will be added to orange, citrus cooler and lemonade Gatorade, as well Gatorade X-Factor orange, Gatorade Xtremo citrus cooler and a powdered form of the drink called “glacier freeze.”

Ms. Carter said consumers would start seeing the new ingredient over the next few months as existing supplies of Gatorade sell out and are replaced.

Health advocates applauded the company’s move. “Kudos to PepsiCo for doing the responsible thing on its own and not waiting for the F.D.A. to force it to,” said Michael Jacobson, executive director of the Center for Science in the Public Interest.

Mr. Jacobson has championed the removal of brominated vegetable oil from foods and beverages for the last several decades, but the F.D.A. has left it in a sort of limbo, citing budgetary constraints that it says keep it from going through the process needed to formally ban the chemical or declare it safe once and for all.

Brominated vegetable oil is banned as a food ingredient in Japan and the European Union. About 10 percent of drinks sold in the United States contain it, including Mountain Dew, which is also made by PepsiCo; some flavors of Powerade and Fresca from Coca-Cola; and Squirt and Sunkist Peach Soda, made by the Dr Pepper Snapple Group.

PepsiCo said it had no plans to remove the ingredient from Mountain Dew and Diet Mountain Dew, both of which generate more than $1 billion in annual sales.

Heather White, executive director at the Environmental Working Group, said of PepsiCo’s decision, “We can only hope that other companies will follow suit.” She added, “We need to overhaul how F.D.A. keeps up with the latest science on food additives to better protect public health.”

Ms. Kavanagh agreed. “I’ve been thinking about ways to take this to the next level, and I’m thinking about taking it to the F.D.A. and asking them why they aren’t doing something about it,” she said. “I’m not sure yet, but I think that’s where I’d like to go with this.”

New Mutations Found in Melanomas May Shed Light on How Cancers Grow

In a leap forward in understanding the basic science of one of the most lethal cancers, two groups of researchers have found mutations in most melanomas that are unlike any they have seen before incancer. The changes are in regions that control genes, not in the genes themselves. The mutations are exactly the type caused by exposure to ultraviolet light, indicating they might be among the first DNA changes in a cell’s path to melanoma.

For years, cancer researchers have searched for mutations in genes, but this time, they looked for — and found — mutations in a region that regulates genes. They did it by examining the entire DNA of multiple tumors, studying not just genes but also what has been called thedark matter, the 99 percent of the DNA that includes regions that control genes.

“You could think of this as one glimmer in what has been called cancer’s dark matter,” said Dr. Levi A. Garraway of the Dana-Farber Cancer Institute and the Broad Instituteof Harvard and M.I.T.

The DNA sequences of 70 malignant melanomas led to the new discovery. A small control region was mutated in 7 out of 10 of the tumors, and also, the investigators found, in liver and bladder cancers. The cancer cells had one of two tiny changes that together were more common than any mutation ever found in the genes of melanoma

Their findings indicate that those who inherit the mutations might be born with cells that have taken a first step toward cancer.

The mutations spur cells to make an enzyme, telomerase, that keeps cells immortal by preventing them from gradually losing the ends of their chromosome, the telomeres. When telomeres erode, a cell dies. But the enzyme also has other, poorly understood functions that are thought to keep cancer cells alive, said Robert Weinberg, an M.I.T. researcher who studies telomerase and cancer and was not involved with the research. “The paradigm that it does nothing but extend telomeres is a gross oversimplification,” he said.

Abundant telomerase is so important to cancers that it occurs in 90 percent of them, said Immaculata De Vivo, a Harvard Medical School researcher who studies telomerase and cancer and directs a DNA sequencing program. She, too, was not involved with the research.

The results of the two studies presented in the papers “are like a court of law — it’s the preponderance of the evidence,” she said. “We all knew telomerase was important for cancer, but now we are finding the mechanisms, the machinery.”

Scientists were surprised that the mutations in the dark matter of melanoma tumors were so commonplace. Dr. Garraway and his colleagues had the entire DNA sequences for a collection of melanomas — genes as well as the rest of the DNA, including areas that turn genes on and off.

“We said, ‘Let’s just take a look and see if there are any mutations in a regulatory region,’ ” Dr. Garraway said.

At first, they looked at the DNA sequences of 19 tumors. They were amazed to find one or the other of the two mutations in 17 of them. So the researchers decided to look at 51 additional melanomas and a handful of bladder and liver cancers. The mutations popped up again.

“It was really quite striking,” Dr. Garraway said.

Research to Resume on Modified, Deadlier Bird Flu

Experiments with a deadly flu virus, suspended last year after a fierce global debate over safety, will start up again in some laboratories, probably within the next few weeks, scientists say.

The research touched off a firestorm in 2011 when it became known that two groups, one in the Netherlands and another in the United States, had genetically altered a dangerous bird flu virus to make it more contagious in mammals. Some scientists warned that a deadly pandemic could break out if the mutant virus leaked out of the lab accidentally or if terrorists stole it or made it themselves, using articles in scientific journals for the recipe.

The outcry led scientists conducting the experiments to declare avoluntary moratorium a year ago, in part to let research organizations and governments decide what safety rules to require.

Now, flu researchers say, the moratorium should end because most countries have rules in place. A letter from 40 scientists — the same ones who called the moratorium last year — was published on Wednesday in the journals Science and Nature, saying it is time for the work to begin again in countries ready to allow it.

But the United States, which pays for much of the flu research both at home and abroad, has not yet released new guidelines. So scientists here will not be able to resume experiments yet, nor will those in other countries who depend on grant money from the United States.

During a telephone news conference on Wednesday, Ron Fouchier, a virologist who conducted some of the flu experiments at Erasmus Medical Center in the Netherlands, said the scientists were lifting the moratorium without waiting for guidelines from the United States.

“How long do you want us to wait?” Dr. Fouchier asked. “If this was the Netherlands, would the U.S. wait? Should all countries really wait for the U.S., and why?”

He said his laboratory would resume research within a few weeks. Although he receives research money from the National Institutes of Health in the United States, funding from other sources will allow him to go ahead, he said. Other researchers in the European Union will be free to pick up the research if they have funding that does not come from the United States government, he said. Laboratories in China and Canada may be ready to start up, but Japan, like the United States, is still working on new guidelines, researchers said during the teleconference.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the Department of Health and Human Services was reviewing new guidelines, and that he expected them to be approved in weeks. The guidelines will specify the laboratory conditions under which this type of research is permitted and require that experiments have a potential benefit for public health.

The work is usually done in laboratories with several layers of barriers to keep viruses from leaking out, and the workers wear protective suits and receive vaccinations to prevent infection, Dr. Fouchier said.

But some scientists still have reservations. Michael T. Osterholm, director of the Minnesota Center of Excellence for Influenza Research and Surveillance at the University of Minnesota and a member of a United States biosecurity board, said that he thought the research should go on, but that details should not be published for fear others would try to replicate it without safety precautions.

“The work they’re doing is really important,” he said, “but I don’t see it as work I want in the hands of every potential gene jockey out there.”

The experiments involve a bird flu virus called H5N1. It does not often infect people, but appears unusually deadly when it does. Of 610 known cases in people since 1997, slightly more than half have been fatal. But the real death rate is not known and could be lower than half because some mild cases may go uncounted.

So far, H5N1 has rarely spread from person to person. People who fall ill have nearly always caught it from poultry. But flu viruses mutate a lot, and the fear has been that H5N1 will somehow become more contagious in humans.

The debated experiments, by Dr. Fouchier and Dr. Yoshihiro Kawaoka, at the University of Wisconsin-Madison, involved ferrets, which react to the virus in much the way people do. Researchers can infect ferrets with H5N1 by squirting the virus into their noses or lungs, but then the animals normally do not infect one another. However, by genetically manipulating the virus, researchers created a form that became airborne and spread from ferret to ferret. Its transmissibility set off alarms.

Advocates of the research insist it can be done safely. And they say it is necessary so scientists can recognize changes in naturally occurring viruses that are dangerous and signal the need to eradicate infected animal populations. Understanding the viruses better should also help researchers develop more effective vaccines and antiviral drugs, Dr. Fouchier said.

He said other scientists could be given samples of the mutant virus for research only with the permission of Erasmus Medical Center, the National Institutes of Health and virus experts at the Mount Sinai Medical Center in Manhattan.

NEJM

SPECIAL ARTICLE

21st-Century Hazards of Smoking and Benefits of Cessation in the United States

Figure 2. Survival Probabilities for Current Smokers and for Those Who Never Smoked among Men and Women 25 to 80 Years of Age.

The overall mortality among smokers of both sexes in the United States is about three times as high as that among otherwise similar persons who never smoked, and the smokers lose, on average, at least a decade of life. The women in this cohort represent the first generation of women in the United States in which those who smoked began early in life and smoked for decades, and the risks of death for these women are about 50% greater than the risks reported in the 1980s studies.4,5 For both female and male smokers, the tripling of the relative risk of death and the reduction in survival by at least a decade are similar to the risks in four other studies: a study of male British doctors born between 1900 and 1930,17,18 the large U.K. study of women born between 1930 and 1950,19 a meta-analysis of several other U.S. cohort studies,20 and a study in Japan of people born between 1920 and 1945.21 Although the relative risks were similarly tripled across the studies, the absolute death rates (for both current smokers and those who had never smoked) were much higher in our study than in other U.S. studies,20 since the NHIS is more representative of the general U.S. population. Thus, in the NHIS, the large absolute differences in risk between current smokers and those who never smoked, as well as the gains in years of life for those who quit smoking, are likely to be true for the U.S. population as a whole. The hazards associated with smoking are substantial, even though in recent decades, most smokers in the United States have smoked cigarettes with relatively low levels of tar, as measured by machine testing, as compared with the cigarettes smoked in earlier decades.22

Figure 3. Effect of Smoking Cessation on Survival to 80 Years of Age, According to Age at the Time of Quitting.

Egypt: Polio Virus Is Found in Cairo’s Sewers

The polio virus has been found in the sewers of Cairo, and it appears to have come from Pakistan, the World Health Organization said Wednesday. Egypt has not had a case of polio since 2004. A vaccination drive is being planned for Feb. 25, and health workers are canvassing the neighborhoods where the sewage samples were taken, looking for children or adults who may have recently been paralyzed, said Sona Bari, a spokeswoman for the W.H.O.  Pakistan has said it will post teams at its international airports vaccinating all outward-bound passengers under age 5. Last month, at least nine Pakistani volunteers in an internationally supported polio vaccination drive were killed by militants across Pakistan in a campaign of intimidation that has hurt efforts to eradicate the disease there. Pakistan is one of the last three countries, with Afghanistan and Nigeria, with indigenous polio.

Drug Agency Recommends Lower Doses of Sleep Aids for Women

For two decades, millions of Americans have taken Ambien to help them sleep at night. But for years, the Food and Drug Administration has gotten complaints that people felt drowsy the morning after taking the medicine or its successors, and sometimes got into car accidents.

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About 60 million prescriptions for sleep aids were dispensed in 2011, up about 20 percent since 2006.

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On Thursday the agency said that women should be taking half as much, after laboratory studies and driving tests confirming the risks ofdrowsiness.

The new recommendation applies to drugs containing the active ingredient zolpidem, by far the most widely used sleep aid. Using lower doses means less of the drug will remain in the blood in the morning hours, and will reduce the risk that people who use it will be impaired while driving.

Sleeping pills have boomed in popularity with the increasingly frantic pace of modern American life. According to IMS, a health care information and technology company, about 60 million prescriptions were dispensed in 2011, up about 20 percent since 2006. About 40 million were for products containing zolpidem.

The agency’s announcement was focused on women because they take longer to metabolize the drug than men. An estimated 10 percent to 15 percent of women will have a level of zolpidem in their blood that could impair driving eight hours after taking the pill, while only about 3 percent of men do, said Dr. Robert Temple, an official in the agency’s Center for Drug Evaluation and Research.

Reports of aftereffects from sleeping pills have circulated for years, and some doctors questioned why the drug agency took so long to act. Mishaps with sleepy driving — and even strange acts of texting, eating or having sex in the night without any memory of it in the morning — have long been familiar to the medical community.

“In this case, the F.D.A. may be behind the eight ball,” said Daniel Carlat, an associate clinical professor of psychiatry at Tufts University, referring to residual drowsiness. “Few doctors will be surprised hearing about this. They’ll say, ‘Oh yeah, we’ve already seen this in our patients.’ ”

He added that Thursday’s announcement “will be good for public health because it will get patients to ask their doctors about the appropriate dosage.”

Agency officials acknowledged that they had received about 700 reports of driving mishaps with people on zolpidem over the years, with a spike in 2007 after a change in labeling caused more people to call in complaints. But they said it was not easy to draw a direct connection between the reports and the drug. Patients often did not remember what time they took the pill. Sometimes they had been drinking.

It was not until the drug agency reviewed driving simulation studies from controlled trials of the drug Intermezzo, which was approved in 2011 for middle-of-the-night waking, that a more complete picture of the risks emerged. The agency linked the driving simulation information with data from manufacturers on the amount of zolpidem in patients’ blood and determined that levels above about 50 nanograms per milliliter increased the risk of crashing while driving, said Dr. Ellis Unger, an official at the agency’s Center for Drug Evaluation and Research.

Dr. Unger said that all makers of new sleeping drugs would now be asked to conduct driving trials; a spokeswoman clarified that it would not be required.

“A lot of people are wondering about the elephant in the room,” Dr. Unger said. “Why did this take so long? This is science, and our thinking evolves over time.”

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Zolpidem has also been known to cause sleepwalking incidents, and Dr. Unger said there was evidence that the lower dose might ease such events, though it is weaker than the evidence about next-morning drowsiness. Dr. Carlat said one of his patients discovered that her weight gain while on the drug was from midnight trips to the kitchen that she did not even remember taking.

Dr. Daniel Kripke, professor emeritus of psychiatry at the University of California, San Diego, and a leading critic of sleeping pills, welcomed the move but said the agency was still not doing enough to investigate other possible side effects.

“It’s a very small step in the right direction,” he said. He added that sleeping medications like zolpidem might increase total sleep time by 20 minutes a night, but that most studies suggest that the use of sleeping pills impairs a person’s performance the next day.

Critics of the drug agency said the label on Intermezzo, which very clearly denotes the risks for women, indicates that the agency was aware of these problems earlier.

But Thomas Roth, director of the sleep center at Henry Ford Hospital in Detroit who has been a consultant to sleeping pill makers, said that the drug agency had always been concerned about the potential risks with driving, “but they care about it more now.” He said he believed the lower dose would still be effective for many patients.

Agency officials say all patients are unique and doses will need to be tailored. They say the drugs should be prescribed at the lowest dose required to treat a patient’s insomnia.

Dr. Daniel J. Buysse, professor of psychiatry at the University of Pittsburgh School of Medicine, says he already prescribes the lower dose when he feels it is necessary, by telling patients to cut a tablet in half along the score.

“This just tells me, maybe be a little bit more cautious,” said Dr. Buysse, who has been a consultant for drug companies including the maker of Ambien. “But I do not think it will have a big effect on what I do.”