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Evidence Regarding Research and Development Investments in Innovative and Non-Innovative Medicines James Love Consumer Project on Technology September 22, 2003

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Evidence Regarding Research and Development Investments in Innovative and Non-Innovative Medicines James Love Consumer Project on Technology September 22, 2003 Evidence Regarding Research and Development Investments in Innovative and Non-Innovative Medicines James Love Consumer Project on Technology September 22, 2003 1. Introduction.......................................................................................................... 3 2. Empirical Estimates of Drug Development Costs........................................... 3 2.1 The Tufts Study ......................................................................................... 3 Table RND 2.1-1: Tufts study estimate of costs of development of self- originated New Chemical Entity .................................................................... 4 2.2 The TB Alliance Study of Drug Development Costs........................................ 6 2.3 Orphan Drug Development ........................................................................ 7 Table 2.3-1: Pre-Tax Cost of Trials for Orphan Products: FDA approvals of Orphan Indications and Orphan NMEs (Millions of USD)............................. 7 2.4 Parexel Analysis of Size of Clinical Trials ................................................. 9 Table RND 2.4-1 : Mean and median number of patents in clinical trials: FDA NME approvals 1998 - 2001 .......................................................................... 9 2.5 October 2001 FDA Study of Clinical Trials. .................................................... 9 2.6 The PERI Survey of development costs ........................................................... 9 Table RND 2.6-1: Average Time and Spending per project..........................10 2.7 R.W. Johnson PRI Estimates of the cost per patient for promotional Media ....10 2.8 Other Per Patient Costs for Trials....................................................................10 BMS oncology trials.........................................................................................10 NIH DCP Cooperative Group Treatment Trials and Funding, 1993 to 1999......10 Table RND 2.8-1: NIH DCP Cooperative Group Treatment Trials and Funding, 1993 to 1999..................................................................................10 Forrester Research ............................................................................................11 Table RND 2.8-2: Forrester Research Estimate of Phase II and III per patient costs, with paper and electronic data collection. ............................................11 Data Edge: Average costs exclusive of central laboratory costs........................11 Data Edge/ CenterWatch: Average fully loaded costs per patient ......................11 Table RND 2.8-3: Fully Loaded Costs Per Patient, Phase I, II and III, across all therapeutic areas, 1992-2000....................................................................12 Mark Hovde, DataEdge: Mean Costs by Phase .................................................12 Table RND 2.8-4: Mean Study Costs by Phase .............................................12 Per Patient Phase III Costs in Europe, Eastern Europe and South Africa ...........12 Table RND 2.8-5: Cost of Phase III trials in the US and Six Eastern and Western European Countries and RSA..........................................................12 2.9 Comparisons of Cost Estimates for New Drug Development.....................13 Table RND 2.9-1 out of Pocket Costs of Clinical Trials Compared ...............13 Table RND 2.9-2 Risk Adjusted Cost of Clinical Trials Compared ...............13 Table RND 2.9-3 Average Per Patient Cost of Clinical Trials Compared ......14 3. Aggregate PhRMA and US IRS data on R&D Outlays ........................................14 Table RND 3.0-1: PhRMA Annual Survey of Member R&D Activities........15 Table RND 3.0-2: US IRS Data on R&D investments in new products .........15 Figure RND 3.0-1: Product Sales and R&D Expenditures on New Products Reported to US IRS ......................................................................................16 4. Priority and Standard US FDA NCE Approvals...................................................16 1 Table RND 4.0-1: Priority and Standard NMEs For Calendar Years 1993-2002 .....................................................................................................................17 Table RND 4.0-2: Number of patients in clinical, Trials cited in FDA approval letters for NCEs, 2000 - 2002........................................................................18 Table RND 4.0-3: Percent of Turnover Invested in Standard and Priority New Products........................................................................................................18 Figure RND 4.0-1: Most Private R&D Invested in Products with No Significant Benefits Over Existing Treatments..............................................19 5. Factors which drive the costs of R&D..................................................................19 5.1 Pharmacoeconomic Analysis in Clinical Research ..........................................20 Seeding Studies ................................................................................................22 5.2 Conflicts of Interest ........................................................................................24 5.3 Haste Makes Waste? / Recruiting Patients......................................................24 6. HIV products.......................................................................................................26 6.1 Duration of HIV Trials...................................................................................26 Table RND 6.1-1: Mean clinical and approval phase times for NCEs approved 1996 to 1998, grouped by therapeutic class ...................................................26 6.2 Researcher Letter to New York Times Regarding Role of US government in supporting R&D for AZT .....................................................................................27 6.3 Expanded Access Programs ..........................................................................28 6.4 Key facts about the particular NMEs use to treat AIDS:.................................29 AZT..............................................................................................................29 3TC ..............................................................................................................29 Nevirapine ....................................................................................................29 7. Choice of Mechanisms to support R&D...............................................................29 7.1 Insufficient R&D for diseases the primarily afflict the poor ...........................30 7.2 The Need to Address Public Health Priorities .................................................31 7.3 New Models for Funding R&D.......................................................................32 2 1. Introduction This report reviews the evidence of the costs of private sector drug development, the nature of private R&D flows, and alternative mechanisms that governments may consider when seeking to support innovation in medicines. 2. Empirical Estimates of Drug Development Costs 2.1 The Tufts Study Major drug manufacturers often cite data from a recent Tufts Center for the Study of Drug Development (CSDD) report as evidence that the costs of drug development are greater than 800 million US dollars. The Tufts report placed the cost of bringing a new drug to market at $802 million. This estimate includes the average cost of both pre-clinical and clinical studies, up to the time of receiving FDA marketing approval. "Out-of-pocket" costs on individual projects are included, as are allowances for failed projects, and the opportunity cost of capital. Roughly half the total -- $399 million -- was allocated to the opportunity cost of capital. Before the report was published in an academic journal, it was presented to the press at a November 30, 2001 briefing organized by Merck, featuring a speech by Raymond V. Gilmartin, the company CEO.1 In 2003, after countless news reports and citations, the study was finally published in an academic journal.2 The authors of the Tufts study were Joseph A. DiMasi of Tufts, Ronald W. Hansen of the University of Rochester, and Henry G. Grabowski of Duke University, three academic researchers that work closely with the research-based pharmaceutical industry. Much of the work at the Tufts CSDD is funded by pharmaceutical industry corporate sponsors,3 and work from the CSDD and the study authors is often used to support industry positions on regulatory, intellectual property and pricing policies. The Tufts Study estimates of the costs of Pre-clinical, human-use Phase I, II and III clinical trials and long-term animal trials are summarized in Table RND 2.1-1. 1 Gardiner Harris, "Health Cost of Developing New Medicine Swelled To $802 Million, Research Study Reports," The Wall Street JournalDATE. "Merck & Co. Chairman and Chief Executive Raymond V. Gilmartin attended the unveiling of the Tufts data at a Philadelphia hotel and said increased clinical costs stem from demands by managed-care buyers that drug companies prove the value of their drugs in larger and longer trials. Dr. DiMasi, lead author of the Tufts Study, has been issuing research-cost estimates for years based upon proprietary surveys of top drug companies. His numbers are routinely cited by industry backers to justify the ever-rising prices of new drugs. Mr. Gilmartin also argued that, given the enormous cost of research, big pharmaceuticals companies, not small biotechnology firms, are essential for
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