Controversy and response
Following the reports in 2007 that Avandia can significantly increase the risk of heart attacks, the drug has been controversial. A 2010 article in Time uses the Avandia case as evidence of a broken FDA regulatory system that "may prove criminal as well as fatal". It details the disclosure failures, adding, "Congressional reports revealed that GSK sat on early evidence of the heart risks of its drug, and that the FDA knew of the dangers months before it informed the public." It reports, "the FDA is investigating whether GSK broke the law by failing to fully inform the agency of Avandias heart risks", according to deputy FDA commissioner Dr. Joshua Sharfstein. GSK threatened academics who reported adverse research results, and received multiple warning letters from the FDA for deceptive marketing and failure to report clinical data. The maker of the drug, GlaxoSmithKline, has dealt with serious backlash against the company for the drugs controversy. Sales on the drug dropped significantly after the story first broke in 2007, dropping from $2.5 billion in 2006 to less than $408 million in 2009 in the US.In response to the rise in risk of heart attacks, the Indian government ordered GSK to suspend its research study, called TIDE, in 2010.
The expense of such treatment is unwarranted and may divert resources from evidence-based treatment. Critics claim that the symptoms of those with Scotopic Sensitivity Syndrome are related to already known visual perceptual and neurological disorders. According to a statement released by the American Optometric Association in 2004:
There is evidence that the underlying symptoms associated with specifically Meares Irlen Syndrome, are related to identifiable vision anomalies, e.g., accommodative, binocular, and ocular motor dysfunctions, in many patients seeking help from coloured lenses. Furthermore, such conditions return to normal function when appropriately treated with lenses, prisms, or vision therapy. When patients exhibiting Meares Irlen Syndrome were treated with vision therapy, their symptoms were relieved. These patients were no longer classified as exhibiting this syndrome, and therefore did not demonstrate a need for the coloured overlays or tinted lenses. As outlined by Hyatt, Stephenson and Carter (2009):
In 1990, the Journal of Learning Disabilities published a special issue that provided intensive coverage of Irlen lenses. In the preface to the issue, the editor in chief, Wiederholt, noted that each of the studies had serious theoretical, medical/physical, and methodological flaws, but were published along with articles critiquing the studies to provide readers with an overview of the Irlen procedures as well as guidance for conducting quality research studies. He, along with Hoyt (1990), Parker (1990), and Solan (1990), noted that these initial studies by Blaskey et al. (1990), OConnor, Sofo, Kendall, and Olsen (1990), and Robinson and Conway (1990) failed to support the treatment validity of colored overlays.