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How Safe Is Your Asthma Drug--Part Two

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Long acting beta agonists as found in Symbicort, Dulera, Foradil, Advair Diskus and Serevent Diskus, (LABAs) are not the only asthma drugs with questionable safety and effectiveness that have become billion dollar businesses for Pharma. Singulair, a leukotriene receptor antagonist or LTRA, was the nation's seventh most popular drug last year, according to IMS health and earned more than $4 billion . It ranks only two places below Advair in sales. Other LTRAs are Accolate and Zyflo.

Singulair is heavily marketed to kids for allergies, in addition to asthma, and even comes in a cherry-flavored chewable formulation. Marketing included a partnership with Olympic gold-medalist swimmer Peter Vanderkaay, a basketball "skills challenge" for kids 9 to 14 and materials distributed through (and legitimized by) Scholastic and the American Academy of Pediatrics, said published reports.

Sales pieces from Scholastic and Merck (who makes Singulair) called, "Health Ed 101-- Learn to Prevent Asthma Symptoms," told parents, "When your child breathes in an asthma trigger, such as pollen from trees or weeds, the body releases leukotrienes (loo-ko-TRY-eens)" and that Singulair blocks the loo-ko-TRY-eens.

The Scholastic sales piece says Singulair is "steriod-free," implying safety from steroid side effects. But parents are also told that Singulair, "is not a rescue medication. Always carry your child's prescribed rescue inhaler for emergencies or sudden symptoms. If asthma symptoms get worse or your child needs to increase the use of fast-acting medicines, call the doctor at once." Why is a drug that needs to be used with a second drug (like the LABAs Symbicort, Dulera, Advair Diskus) and that may make asthma worse, a bestseller?
But Does It Work? by Martha Rosenberg

Parents are also told that kids on Singulair may experience, "hallucinations (seeing things that are not there), irritability, restlessness, sleepwalking, suicidal thoughts and actions (including suicide), trembling, and trouble sleeping." Hey, it may help runny noses!

A slew of Pharma-backed journal articles support Singulair kids' sales by elevating allergies into a major health problem. One article in Current Opinion in Internal Medicine warns that, "Patients with allergic rhinitis often have a reduced quality of life (QOL) not only due to the symptoms of allergic rhinitis (sneezing, nasal, pruritus, rhinorrhea, and congestion) but also because the pathophysiology of allergic rhinitis can disrupt sleep," which causes, "fatigue, irritability, memory deficits, daytime somnolence, and depression."

But some FDA drug reviewers were agnostic about Singulair's actions in children from the start. In the New England Journal of Medicine, soon after Singulair was approved, FDA reviewers cautioned that adult studies of the drug "may not be predictive of the response," in children. In FDA new drug approval documents in the late 1990s, reviewers note that Singulair levels in adolescents are different from "healthy adults," and that an infant monkey, four weeks old, had to be euthanized because "infants may be more sensitive to the toxicity," of Singulair.   Three out of five guinea pigs also died from "severe anaphylactic responses." (If animal tests do not extrapolate to human safety, why are they done?)

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In Singulair's new drug approval documents, scores of human subjects are reported to have withdrawn from trials because of "worsening" asthma and breathing problems. There's an asthma drug for you!   Reviewers even write that one study, "demonstrates that it is better to leave patients on beclomethasone [Qvar] than to switch them to montelukast [Singulair]." Inhaled corticosteriods like Qvar, Flovent, Pulmicort and Asmanex were the standard asthma treatment until drugs like Advair and Singulair were marketed.

Approval documents include 10 blanked out pages, marked "This section was determined NOT to be releasable," and the frequent phrase, "Portions of this review were excerpted directly from the sponsor's submission," as in we didn't read it but we waved it through.

William Busse, MD, who chaired the expert panel that wrote the government's 2007 National Asthma Education and Prevention Program Guidelines despite his many Pharma financial links listed in the report, was also an investigator in the Singulair approval trials. He was issued an FDA warning letter when an inspection of his facility revealed incorrect consent forms, incorrect patient enrollments and drug inventory and labeling errors, say Singulair's new drug approval documents.

Meanwhile, more than 100 parents on the drug-rating web site report the symptoms the Merck/Scholastic sales piece warns about:   Singulair caused hyperactivity, tantrums, depression, crying, school trouble, facial tics, strange eye movements and self-harm in their children, some as young as one. Many were put on the drug for sniffles, wheezing and early "symptoms" of asthma, in keeping with Pharma's "early treatment" push.

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"Last night was a complete meltdown over every single thing that could have possibly been a minor annoyance, such as not being able to squeeze enough toothpaste out of the tube, which culminated in a 30-minute screaming and crying bonanza," writes the mother of a 7-year-old who has been on Singulair for six months. "I was reading stories to her tonight, and she must have popped her jaw open at least 40 times over the course of two

books (mouth open wide like a yawn in fast-forward). I was keeping an eye on her, and a few times I asked her why she kept doing that and she said she didn't know, and she thought maybe her mouth was 'itchy.'"

"Do NOT recommend this drug to other parents," writes another mother. "4 year olds that suddenly talk about killing themselves are influenced by a DRUG!!

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Martha Rosenberg is an award-winning investigative public health reporter who covers the food, drug and gun industries. Her first book, Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health, is distributed by Random (more...)

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