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Is Your Asthma Drug Doing You More Harm Than Good? Part Two

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By Martha Rosenberg

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? 

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?)

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 askapatient.com 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.

"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!!

In 2009, after 15-year-old Cody Miller of Queensbury, NY was given Singulair for hay fever and took his own life 17 days later, Singulair was given a stronger warning for "neuropsychiatric" side effects. And the next year, Fox TV reported that kids on Singulair are being diagnosed with ADHD, Tourette Syndrome and serious behavioral and neurological conditions. Most are "cured" when they go off the drug. Singulair is no doubt driving other pediatric drugs sales.

Even adults are put on Singulair for minor reasons with major consequences. "I was perfectly healthy prior to taking this drug," reports a 53-year-old woman about Singulair on askapatient.  "Doc noticed I had a little wheeze and prescribed Singulair. I began to have the dreams, insomnia and depression after the first few days," which led to "suicidal thoughts," she says.

Of course, drugs are not tested for a long period of time before they are marketed and  long-term effects can and do emerge later. But even the short-term safety data on which today's blockbuster asthma drugs were approved is under a legal cloud.

One researcher, William H. Ziering, MD was sentenced to six months in prison and lost his medical license for falsification of five drug studies. Ziering conducted trials on salmeterol (the LABA), Flonase and other respiratory drugs and wrote medication-friendly papers like "Allergic rhinitis. Measures to control the misery," and "Diagnosis and treatment of allergic rhinitis and asthma in infancy and childhood."

During the same time period, clinical trials of Singulair and at least five other top asthma drugs conducted at Vivra Asthma & Allergy were also investigated by federal authorities. A "patient mill" was operated at the facility, located in Tucson, to pocket the lucrative compensation paid for each subject, whether or not participants were appropriate, says Robert Davidson, MD, who served as sub-investigator on the trials.

The irregularities at the Vivra facility led to onsite FDA inspections in which witnesses told inspectors they were told to "NOT mention potential risks" to subjects to not "scare them away," and subjects were pressured to participate despite risks to their heath. (One subject was hospitalized from the trials.) Enrolling inappropriate subjects risks both their health and future users of the drug, whose safety was "proved" from their participation.
In one study, conducted at Vivra and elsewhere, more than 40 percent of people on Singulair and salmeterol (the LABA in Advair) had adverse events, two withdrew with--anybody?-- "worsening asthma" and "one died as a result of bronchial asthma!" The drugs were "well tolerated," write the researchers.

There is no evidence that approvals of drugs "tested" by Vivra or Ziering's operation were delayed or revoked nor do the related published papers appear retracted. At least one employee is said to have worked at both facilities.

Among drugs tested at Vivra was the antibiotic Raxar, pulled from the market for fatal heart rhythm abnormalities and the genetically engineered Xolair, which carries a severe anaphylaxis warning and was investigated by the FDA for heart attack and stroke links. Seventy-seven people who took Xolair had life-threatening allergic responses in a year and a half, according to FDA reports.

Genetically engineered drugs like Xolair cost as much as $20,000 a year and cause TB, cancers and super infections because they suppress the immune system. But they seem slated to be the next big thing in asthma.

A study in May says Xolair can provide, "additional clinical benefit" for patients who are "inadequately controlled" on inhaled corticosteroids. That's exactly how Advair, Singulair and the other blockbuster asthma drugs were sold. The study was funded by Xolair's manufacturer and co-written by William Busse, who headed the government's National Asthma Education and Prevention Program Guidelines.

The first part of this series appears here

(Send your news to foodconsumer.org@gmail.com, Foodconsumer.org is part of the Infoplus.com ™ news and information network)

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