FOR IMMEDIATE RELEASE: DECEMBER 19, 2018
NEW WHISTLEBLOWER BOOK AGAINST TAKEDA PHARMACEUTICALS
Fraud claims regarding the popular heartburn drug Dexilant
A new book claims potential risk of bone fractures from physicians unknowingly prescribing 60mg instead of the FDA approved 30mg for heartburn. Even with a Warning in the package insert regarding bone fractures, Takeda only sampled and promoted the 60mg dose of Dexilant. The book’s author claims to show that 95% of prescriptions were for 60mg. At issue, is if patients broke bones due to use of 60mg of Dexilant for an extended period of time, or if they would have been able to walk away without a fracture? Takeda claims regardless of how Dexilant was promoted, it is the physician’s responsibility to know how to prescribe the drug.
In order for approval in 2009, the FDA required Takeda to conduct a post-marketing bone fracture study. As of 2018 the FDA webpage on that study still shows “No results posted.” One of the FDA investigators was against Dexilant’s approval due to the bone fracture risk. The Whistleblower’s case went all the way up to the U.S. Supreme Court and then to the Solicitor General of the U.S. The book claims there is a severe Circuit court split on how to interpret a provision of the False Claims Act and is seeking an amendment to clarify the issue.
Heartburn, Broken Bones, and the False Claims Act was just published and is available on Amazon. It is written by the whistleblower, Noah Nathan, the same person who recorded the shooting at the Republican baseball practice in 2017. The book is full of legal documents, court documents, legal articles, medical journals, and information from Takeda Pharmaceuticals. The author is collecting data on patients taking Dexilant with bone fractures at AppleQD.com and more information is also available on the site.
The book claims there are currently around 500,000 Americans on Dexilant, with the majority on 60mg without any medical reason. Dexilant loses patent protection in 2020 and PAR Pharmaceuticals has already secured the first generic manufacturing status, but surprisingly they will only be making a 60mg dose. The author shows an article from the Yale Journal of Biology and Medicine stating that “in persons with GERD symptoms, about 20 percent are found to have erosive esophagitis.” Since only 20 percent are found to have what the 60mg dose is indicated for, why is PAR not making the FDA indicated 30mg dose for GERD (heartburn)? The book claims it is due to the promotion and sampling by Takeda Pharmaceuticals of only the 60mg dose. The author stresses that if a patient has been on Dexilant 60mg for over a year and has broken a bone, to contact their physician and to go to AppleQD.com to document the issue.