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.
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