Some Asthma Drugs Kill More People Than Asthma: Why Is Big Pharma Allowed to Hawk Deadly Pills?
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Scores of human subjects in the FDA approval documents withdrew from trials because of "worsening" asthma and reviewers even write that one study, "demonstrates that it is better to leave patients on beclomethasone [a corticosteroid] than to switch them to montelukast [Singulair]. There's an asthma drug for you!
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, the guidelines writer, was also an investigator in the Singulair approval trials, though not the most compliant one. 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.
Singulair was heavily marketed for allergies, in addition to asthma, and to kids. 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.
Meanwhile, more than 100 parents on askapatient were reporting that 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.
In 2009, after 15-year-old Cody Miller of Queensbury, NY was given Singulair for hayfever and took his own life 17 days later, the FDA gave Singulair a 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 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.
Could there be any more corruption with asthma drugs? Yes! A sub-investigator who worked at Vivra Asthma & Allergy where clinical trials of Singulair and at least five other top asthma drugs were conducted, says they were riddled with fraud and profiteering. A "patient mill" was operated at the in Tucson facility to pocket the lucrative compensation paid per subject for trials, says Davidson, regardless of the appropriateness of the subjects. (People who participate in drug trials are called subjects, not patients.)
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 "worsening asthma" and "one died as a result of bronchial asthma." The drugs were "well tolerated," write the researchers.
Among drugs tested at Vivra was the antibiotic Raxar, which was withdrawn from the market for fatal heart rhythm abnormalities and the genetically engineered Xolair, which was investigated by the FDA for heart attack and stroke links and carries a severe anaphylaxis warning. Seventy-seven people who took Xolair had life-threatening allergic responses in a year and a half, according to FDA reports.