| My day job more or less consists of analyzing data for a variety of clients. If I am lucky I can also have a voice and develop content and a narrative to help contextualize the numbers and make sure that statistical rigor is employed. Originally my thoughts about this project involved a linear arc reaching back in time and extending to modern day with little "mile-posts" along the way. Unfortunately my mind doesn't always work that way and little nuggets attract my attention and won't go away until I can explore and find a revelation or at least articulate a question for discussion. In reviewing the ProPublica prescriber data I noticed the 9th highest drug related to cost, Namenda. It is 48th in the number of prescriptions filled totaling $1,301,134,518 resulting from 5,328,808 claims. It is indicated for memory loss and mental changes although several studies report inconclusive evidence that it impacts activity of daily living or that it should be included in evidence-based care for patients "diagnosed" with Alzheimer's Disease. Findings may be dose-related and further studies are suggested although the relationship between clinical studies, industry and the FDA are certainly worthy of an arched eyebrow. |  Source: L. E. Hebert et aL. Arch. Neurol. 69, 670–671 (2012) |
Congress enacted the Prescription Drug User Fee Act (PDUFA) in 1992 to provide a mechanism to charge fees to industry on each new drug application (NDA) filed. The revenues from these “user fees” were used to hire 600 new drug reviewers and support staff. These new medical officers, chemists, pharmacologists, and other experts were tasked with clearing the backlog of NDAs awaiting approval. Consequently, the FDA was able to reduce review times of NDAs to 12 months for standard NDAs and to 6 months for priority applications that involved significant advances over existing treatment. As a result of PDUFA, the timing of U.S. drug approvals began to mirror that of the rest of the world. Congress clearly likes PDUFA as the act has been renewed five times since 1992. PDUFA-V was approved in 2012. Undoubtedly, this legislation helps to support the FDA and fuel needed growth. In 1995, The actual user fee charged to each company filing an NDA in 1995 was $208,000. In 2014, the user fee will be $2,169,100. If you assume that as many as 50 NDAs are filed in a year, Congress is passing on $100 million of FDA funding costs to the industry.--Forbes
Of the top ten leading causes of death in the United States, Alzheimer’s disease — which ranks sixth — is particularly devastating in that there is no cure, no way to prevent it and no proven way to slow its progression. And with at least 11 million Americans expected to have the disease by the middle of the century (see ‘Degeneration generation’ figure) — boosting the annual costs of health care to more than US$1 trillion — the US government is anxiously looking to researchers to improve the prognosis.--Forbes
The complexity of debates around what constitutes Alzheimer's Disease are of interest because there is a lack of consensus regarding the clinical and neuropathic determinants. Are the behavioral and cognitive manifestations a disease entity in and of themselves or just a natural complication of aging? These issues continue to resonate and influence the development of elusive effective treatments. Perhaps the futility of attempting to find a cure is muted due to the substantial investment in funding.
