ISLAMABAD: Babies who taken even just one course of antibiotics during the first year of their life may face an elevated risk of developing childhood asthma, according to a new Canadian study published in the April issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians (ACCP).

Asthma is a chronic respiratory disease characterized by episodes or attacks of inflammation and narrowing of small airways in response to asthma “triggers.” Asthma attacks can vary from mild to life-threatening and involve shortness of breath, cough, wheezing, chest pain or tightness, or a combination of these symptoms.

The study found those who were exposed to antibiotics in the first year of life were twice as likely as those who were untreated to develop asthma in childhood. In addition, there was a dose-response relationship between the risk and the number of courses of antibiotics.

“Antibiotic use in children has been found to coincide with an increased incidence of childhood asthma,” said lead author Carlo Marra, Pharm D, PhD, University of British Columbia, Vancouver, BC, Canada. “Although the causal nature between antibiotics and asthma is still unclear, our overall results show that treatment with at least one antibiotic as an infant appears to be associated with the development of childhood asthma.”

To examine the association between antibiotic exposure during infancy and the risk of developing childhood asthma, researchers from the University of British Columbia meta-analyzed results of seven studies involving 12,082 children among whom 1,817 cases of childhood asthma were recorded.

Overall, infants exposed to at least one course of antibiotics in the first year were twice as likely as those who were untreated to develop childhood asthma. The effect of antibiotics was more significant in the retrospective studies than the prospective studies.

Researchers also conducted a dose-response analysis of 27,167 children among whom 3,392 asthma cases were documented in five studies.

They found for each additional course of antibiotics taken during the first year of life, the risk increased by 16 percent compared with those who were not exposed to antibiotics. The effect of antibiotics was more significant in retrospective studies than prospective studies.

The antibiotic-asthma association did not seem significant in infants born with high risk factors such as a family history of the condition or a genetic tendency to develop allergies, the study found.

“Asthma is one of the most common chronic childhood diseases, affecting millions of children in the United States,” said W. Michael Alberts, MD, FCCP, President of the American College of Chest Physicians. Asthma is diagnosed in about 30 million people in the US during their lifetime - 22 million adults and 8 million children age 0 to 17 years. In the US, asthma results in about 4,500 deaths every year - about 200 deaths in children.

“By identifying potential risk factors for asthma and educating patients and families about risk factors, we may begin to see a reduction in the overall incidence of asthma,” said Alberts.

The researchers question the rational behind the current recommendation on use of antibiotics in young children. “In children, antibiotics are commonly used to treat ear infections, upper respiratory tract infections, and bronchitis, but not every childhood infection requires an antibiotic,” said the study’s co-author Fawziah Marra, MD, University of British Columbia.

“Current guidelines recommend that children under age 2 receive an antibiotic for diagnosed ear infection. However, the majority of upper respiratory tract infections and bronchitis is viral for which antibiotics are ineffective.”

The use of antibiotics would kill beneficial bacteria in the body and promote growth of molds and or parasites, which in turn make the immune system hyper sensitive to pollen, dust and other harmless substances.

The studies were carried out based on the survey data, not medical records. Because of this, possible errors and bias make the studies used in the meta-analysis less reliable. Although the association was statistically significant, the results of previous studies and the current meta-analysis did not mean use of antibiotics definitely causes asthma.

Further, some cases of asthma may not be identified before antibiotic exposure, which could make the results less reliable, researchers noted.

One possible explanation for the antibiotic-asthma link is that those infants who received antibiotics may be more susceptible to asthma in the first place.

Does the world’s bestselling asthma drug sometimes kill the patients it is supposed to help?

Frank A. Dittig was recovering from a nasty bout of pneumonia in the spring of 2004 when he developed a wheeze that wouldn’t go away. For this his doctor prescribed Advair, the hot- selling asthma inhaler, though Dittig didn’t have asthma and never had.

 He used it and immediately began to feel worse. “When I sucked it in, it felt like I was collapsing my lungs,” he recalls. He complained but says his doctor told him the drug couldn’t possibly be making him worse. Soon, the wheezing was so bad he couldn’t walk. Against his doctor’s advice, he stopped taking Advair after a week and recovered. Dittig, who runs his father’s office supply business near Pittsburgh, Pa., says his 14-year-old son has asthma and had problems on Advair, too, as did Dittig’s father.

 Marcus Faulk of Louisville, Ala. also had a bad reaction to Advair or to Serevent, one of the two drugs it comprises. He started out on Serevent and “said that every time he took the medicine it made him feel worse,” says his aunt, Annette Glanton. A few weeks after Faulk tried Advair, he collapsed on the floor of a relative’s home, late on the night of Jan. 6, 2003. Just 20 years old, he was dead by the time the ambulance pulled up to the hospital, his Serevent inhaler still clutched in one hand. Three years later his father, Earl Faulk, a truck driver, still can’t talk about it without breaking down and sobbing. He has sued Advair’s maker, GlaxoSmithkline. It says the drugs’ benefits outweigh their risks, and, in court filings, denies the charges.
Advair is the fourth-best-selling drug in the world, with $5.6 billion in sales, up 19% in 2005, and 21.1 million U.S. prescriptions. Many patients swear by it. It also is one of the most heavily advertised drugs: GlaxoSmithkline spent $137 million on Advair ads last year, says TNS Media Intelligence. Thanks to that and Advair’s nifty delivery system–a plastic purple puck that is easy to use–the drug has moved far beyond a narrow audience of severe asthma patients to reach those with mild cases and nonasthmatics who simply have a bad bronchial cough.

 Now growing evidence suggests that a small percentage of patients–perhaps 4,000 people a year, by one doctor’s estimate–may be dying because of Advair or its Serevent component. This highlights a tough dilemma in drug safety: what to do about drugs that help many but harm a few. It could mark the start of the next great drug-liability war, and already the drama seems all too familiar: scared patients, contradictory studies, a company that calls the evidence “inconclusive” and is accused of skewing clinical data–and lawyers looking at whether there’s enough damage here to cash in.

 “If we got these drugs off the market, we could prevent 4,000 deaths a year,” argues Shelley Salpeter, a clinical professor of medicine at Stanford University who says both Advair and Serevent should be recalled. She pored over the results of 19 previous trials of Serevent-style drugs and found that patients have twice the rate of asthma hospitalizations, twice the rate of life-threatening asthma and four times as many deaths as patients who aren’t on those drugs. She believes Advair and Serevent cause four of every five asthma-related deaths each year. “These drugs make asthma worse,” she says. By some estimates, asthma kills roughly 5,000 Americans a year.
“Every death is a potential lawsuit that Glaxo will have to face, and rightly so,” says trial lawyer W. Chad Cook. Adding to the risk, some of these deaths are children and young adults such as Marcus Faulk. Cook’s law firm, Beasley Allen in Montgomery, Ala., filed the Faulk lawsuit and three others and is reviewing hundreds of potential cases. “We have people calling us literally every day who have had adverse reactions on these drugs,” he says.

 Glaxo says its detractors are exaggerating the risks. “The data we have are inconclusive,” says Kathy A. Rickard, a Glaxo vice president, echoing early responses by Wyeth (nyse: WYE - news - people ) about its Redux diet drug and Merck (nyse: MRK - news - people ) & Co. about its Vioxx painkiller. Both drugs were pulled from the market, with Wyeth now paying $22 billion in damages and Merck facing lawsuits that Wall Street expects will cost it billions (its market value is off by $22 billion since Vioxx was recalled).
Advair, approved by federal regulators in 2000, was more a miracle of marketing than of science. The purple puck delivers a blast of two Glaxo medicines that won approval years before: Serevent, a “beta agonist” that was cleared in England in 1990 and in the U.S. in 1994, and Flovent, an inhaled steroid that won U.S. approval in 1996. Advair’s one-two punch seemed ideal: Serevent to expand constricted airways, Flovent to ease inflammation. Glaxo touted it as “the first and only” drug to treat both underlying components of asthma at once and bragged that it yielded “nearly twice as many symptom-free days.”
But Serevent had been under suspicion from the start, and earlier beta agonists had stirred doubts for decades. In 1948 one study of 2,200 asthma patients found a fivefold-higher death rate for patients who inhaled epinephrine, a beta drug, versus those who hadn’t. In the late 1970s asthma deaths in New Zealand soared after a beta agonist called fenoterol hit the market.
In 1993, a year before Serevent made its debut, a Glaxo study found 12 asthma deaths among almost 17,000 patients on Serevent for four months, three times the death rate in an equivalent control group of asthma patients. But this difference was deemed statistically insignificant.
Serevent was introduced in 1994, touted as longer lasting than older beta agonists like albuterol (12 hours versus 4 to 6 hours). Soon after, the Food & Drug Administration received reports of several deaths. A letter to the New England Journal of Medicine described two elderly patients who had died while still clutching their Serevent inhalers. Glaxo added warnings on proper use (it doesn’t work instantly, so don’t take it to quell a new attack) but denied any problem: “No patient is known to have died as a direct result of taking Serevent,” it said at the time.
But in response to the worries, Glaxo set up an even bigger study in 1996, ultimately aiming to track a massive 60,000 patients on Serevent. It wouldn’t report any results for several years, and by that time Advair was on the market and roaring. It debuted in 2001 and soon after had largely replaced Serevent-only prescriptions. Last year Advair’s 21 million prescriptions dwarfed the 1.7 million for Serevent, according to IMS Health.
Glaxo promoted the new brand heavily. It also ran an ad featuring “the Bus,” former Pittsburgh Steelers running back Jerome Bettis, hailing new hope for controlling asthma. It encouraged people to take a five-question “asthma control test.”
“A large number of patients are being treated uselessly,” says Fernando Martinez, professor of pediatrics at the University of Arizona. “We have to target these medicines to those that need them. What’s happening now is many patients get the combination straight away.”
Yet a Glaxo study in 2004 found that 60% of asthma patients could control their disease with just the inhaled steroid Flovent, the other half of Advair. Compared with steroids alone, using Advair helped only an extra 15% of patients.
The rampant prescribing of Advair grew a bit more alarming in 2003 when results were released from Glaxo’s big safety trial of Serevent. Though it had hoped to track 60,000 patients in the effort that began in 1996, Glaxo got up to only 26,000. The six-month study, when extrapolated, suggested one extra death for every 700 patients on Serevent for one year. The company put out a warning to doctors; then it ended the trial because of difficulties in signing up more patients.
In that trial Glaxo found a total of 13 people on Serevent had died of asthma, while only 3 people had died in the placebo inhaler group (everyone was allowed albuterol). But Glaxo’s Kathy Rickard says, “We cannot tell whether it is due to pharmacology or socioeconomic status or patients who don’t take their medicines or whether it is a genetic predisposition.” Why? Because the trial “wasn’t designed to test those issues,” she says.
Nationally, asthma deaths have eased recently, even as use of long-acting beta agonists has risen, Rickard notes, inconsistent with an epidemic of drug-induced deaths. With Advair, “patients get control of their asthma faster,” she maintains. People died clutching their inhalers long before Serevent came along.
It may be that the presence of the second drug in Advair, the steroid Flovent, quells any threat posed by Serevent (the beta agonist) in many patients. Yet GlaxoSmithkline never has expressly studied whether Advair, too, might cause a higher death rate in a giant trial. And it has no plans for such a trial. Instead, it is conducting a 460-patient trial looking at Advair versus Flovent in black patients; a 540-patient study looking at whether genetic variations influence response to Serevent and Advair; and an “observational study” using Medicaid data.
Some doctors defend Glaxo and Advair. George Washington University internist Matthew Mintz says the safety issue “has been blown way out of proportion” and that the bigger threat is underuse, not overprescribing. Doctors who bash the drug are “irresponsible,” because they may scare away patients who would do well on Advair, he adds. (Mintz is a consultant to GlaxoSmithkline; Advair critic Martinez has consulted to Merck, which makes an Advair rival; and Advair foe Salpeter of Stanford has consulted to trial lawyers on the matter.)
The FDA has strengthened label warnings for Serevent and Advair three times amid wrangling with the company over how to interpret trial data. Last July an FDA advisory panel, which included Martinez of Arizona, voted unanimously in favor of keeping both Advair and Serevent on the market, although the FDA now says Serevent should never be used on its own. In November the FDA warned that Advair should be used only after other drugs had failed; Glaxo objected and the final label, released in March, was softened a bit.
A recalcitrant company, a suspect drug, young patients dying–and lawyers smelling blood. This could get very ugly.

Allergies Can Affect Your Budget and Quality

of Life

Have you ever considered how much your allergies cost you? Whether you are suffering from inhalant allergies or food allergies, your life has been impacted not only physically and emotionally, but financially.The April 2002 issue of “Annals of Allergy, Asthma, and Immunology” contains a study from Emory University that addresses the high cost of allergies. By reviewing past studies, the research team, led by Stanley Fineman, M.D., discovered allergies not only caused a financial burden but also affected a person’s quality of life.

“Because allergic rhinitis influences many aspects of daily living, it is important to be diagnosed and treated properly. Physicians’ and patients’ education will increase their awareness and signs and symptoms of allergic rhinitis,” Fineman concludes from the findings.

Financial Burden
The cost of medications and preventative measures puts a strain on any household budget. Stop to think how much you spend on ways to help reduce your reactions. Listed here are items that can destroy anyone’s budget.

Medical care — Doctors visits, allergy tests, over-the-counter medications, prescription medications, vitamins, supplements, and facial tissues. 

• Preventative measures — bedding encasements, air purifiers, air filters, replacing carpet with other flooring, specialty foods, fragrance free products, and the list could go on forever. 

Quality of Life
Allergies affect everyone differently, but all who suffer from allergies have their quality of life impacted in one or more ways. Allergies have been known to affect people’s: 

• Cognitive functions
• Decision making abilities
• General productivity
• Learning abilities
• Quality of work
• Self esteem
• Stamina

The Buteyko method is a great help for reducing sensitivity to allergens. It consists of simple breathing exercises and lifestyle guidelines aimed at promoting good health. Nasal breathing is the first step.

Asthma patients could soon be able to measure their breathing problems with a new testing device. It allows the condition to be checked while they breath normally - unlike existing peak flow meters, which ask patients to blow as hard as possible.

Peak flow meters do not work for children under seven, and can also be difficult for some adults to use.

Asthma Alert was devised by scientists at Brunel University, who say it is so simple even toddlers will be able to use it.

They say the hand-held device, which is still in development, could be commercially available within 18 months.

It uses a technique known as capnography to measure the rate of change in the concentration of exhaled carbon dioxide against time with normal breathing.

Its makers say it is easy for patients to interpret results and then alter their medication if necessary.

More than 50m people are being treated for asthma across the world, and it kills more than 1,500 people in the UK each year.

One in eight children have the condition.

Diagnosis difficulties

Dr Deryk Williams, who worked on the device, said: “It’s simplicity, reliability and low cost will make it ideal for patients to monitor their own asthma and be in control of the disease.

“It will also be of immense benefit to GPs, who will now be able to diagnose asthma far more accurately.”

Asthma Alert Ltd recently won the Smart Award from the Department of Trade and Industry’s Small Business Service, which encourages innovation.

A spokeswoman for the National Asthma Campaign told BBC News Online: “There is no single test for asthma and this can make diagnosis difficult, especially in young children.

“We do need better diagnostic tests for asthma and we need to ensure that once asthma is diagnosed, people are on the minimum medication required to manage their condition.”

Asthma patients could soon be able to measure their breathing problems with a new testing device. It allows the condition to be checked while they breath normally - unlike existing peak flow meters, which ask patients to blow as hard as possible.

Peak flow meters do not work for children under seven, and can also be difficult for some adults to use.

Asthma Alert was devised by scientists at Brunel University, who say it is so simple even toddlers will be able to use it.

They say the hand-held device, which is still in development, could be commercially available within 18 months.

It uses a technique known as capnography to measure the rate of change in the concentration of exhaled carbon dioxide against time with normal breathing.

Its makers say it is easy for patients to interpret results and then alter their medication if necessary.

More than 50m people are being treated for asthma across the world, and it kills more than 1,500 people in the UK each year.

One in eight children have the condition.

Diagnosis difficulties

Dr Deryk Williams, who worked on the device, said: “It’s simplicity, reliability and low cost will make it ideal for patients to monitor their own asthma and be in control of the disease.

“It will also be of immense benefit to GPs, who will now be able to diagnose asthma far more accurately.”

Asthma Alert Ltd recently won the Smart Award from the Department of Trade and Industry’s Small Business Service, which encourages innovation.

A spokeswoman for the National Asthma Campaign told BBC News Online: “There is no single test for asthma and this can make diagnosis difficult, especially in young children.

“We do need better diagnostic tests for asthma and we need to ensure that once asthma is diagnosed, people are on the minimum medication required to manage their condition.”