The emergence of commercial genomics: analysis of the rise of a biotechnology subsector during the Human Genome Project, 1990 to 2004.

BackgroundDevelopment of the commercial genomics sector within the biotechnology industry relied heavily on the scientific commons, public funding, and technology transfer between academic and industrial research. This study tracks financial and intellectual property data on genomics firms from 1990 through 2004, thus following these firms as they emerged in the era of the Human Genome Project and through the 2000 to 2001 market bubble.MethodsA database was created based on an early survey of genomics firms, which was expanded using three web-based biotechnology services, scientific journals, and biotechnology trade and technical publications. Financial data for publicly traded firms was collected through the use of four databases specializing in firm financials. Patent searches were conducted using firm names in the US Patent and Trademark Office website search engine and the DNA Patent Database.ResultsA biotechnology subsector of genomics firms emerged in parallel to the publicly funded Human Genome Project. Trends among top firms show that hiring, capital improvement, and research and development expenditures continued to grow after a 2000 to 2001 bubble. The majority of firms are small businesses with great diversity in type of research and development, products, and services provided. Over half the public firms holding patents have the majority of their intellectual property portfolio in DNA-based patents.ConclusionsThese data allow estimates of investment, research and development expenditures, and jobs that paralleled the rise of genomics as a sector within biotechnology between 1990 and 2004

The effects of business practices, licensing, and intellectual property on development and dissemination of the polymerase chain reaction: case study

INTRODUCTION: Polymerase chain reaction (PCR) was a seminal genomic technology discovered, developed, and patented in an industry setting. Since the first of its core patents expired in March, 2005, we are in a position to view the entire lifespan of the patent, examining how the intellectual property rights have impacted its use in the biomedical community. Given its essential role in the world of molecular biology and its commercial success, the technology can serve as a case study for evaluating the effects of patenting biological research tools on biomedical research. CASE DESCRIPTION: Following its discovery, the technique was subjected to two years of in-house development, during which issues of inventorship and publishing/patenting strategies caused friction between members of the development team. Some have feared that this delay impeded subsequent research and may have been due to trade secrecy or the desire for obtaining lucrative intellectual property rights. However, our analysis of the history indicates that the main reasons for the delay were benign and were primarily due to difficulties in perfecting the PCR technique. Following this initial development period, the technology was made widely available, but was subject to strict licensing terms and patent protection, leading to an extensive litigation history. DISCUSSION AND EVALUATION: PCR has earned approximately $2 billion in royalties for the various rights-holders while also becoming an essential research tool. However, using citation trend analysis, we are able to see that PCR's patented status did not preclude it from being adopted in a similar manner as other non-patented genomic research tools (specifically, pBR322 cloning vector and Maxam-Gilbert sequencing). CONCLUSION: Despite the heavy patent protection and rigid licensing schemes, PCR seems to have disseminated so widely because of the practices of the corporate entities which have controlled these patents, namely through the use of business partnerships and broad corporate licensing, adaptive licensing strategies, and a "rational forbearance" from suing researchers for patent infringement. While far from definitive, our analysis seems to suggest that, at least in the case of PCR, patenting of genomic research tools need not impede their dissemination, if the technology is made available through appropriate business practices

No End in Sight: Benzodiazepine Use in Older Adults in the United States

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/135540/1/jgs14379_am.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/135540/2/jgs14379.pd

Prescription Benzodiazepine Use Among Older Adults

ObjectivesDespite evidence for many potential risks, use of benzodiazepines (BZDs) among older adults is common. The authors evaluated the available evidence for BZD effectiveness and tolerability for use in older adults in three psychiatric conditions for which BZDs are commonly prescribed: insomnia, anxiety disorders, and behavioral and psychological symptoms of dementia.DesignElectronic databases, including PubMed/MEDLINE, were searched to identify articles that (1) included patients ≥50 years of age, (2) focused on patients diagnosed with insomnia, anxiety disorders, or behavioral and psychological symptoms of dementia, and (3) were either a randomized, placebo-controlled trial or a randomized trial comparing a BZD with either another psychotropic medication or psychotherapy.ResultsThirty-one studies met the inclusion criteria. Of the three clinical indications evaluated, treatment of insomnia had the greatest available evidence for use of BZDs among older adults, with 21 of 25 trials demonstrating improved sleep outcomes with use of BZDs. Only one trial was found to meet eligibility criteria for BZD use in anxiety disorders, demonstrating benefit over placebo. Five studies for use in behavioral disturbances in dementia were included, of which only one demonstrated improvement over placebo.ConclusionThis systematic review suggests that BZD prescribing to older adults is significantly in excess of what the available evidence suggests is appropriate. Future trials should focus on efforts to reduce both acute and chronic BZD use among older adults while improving access to effective non-pharmacologic treatment alternatives

The emergence of commercial genomics: analysis of the rise of a biotechnology subsector during the Human Genome Project, 1990 to 2004.

BackgroundDevelopment of the commercial genomics sector within the biotechnology industry relied heavily on the scientific commons, public funding, and technology transfer between academic and industrial research. This study tracks financial and intellectual property data on genomics firms from 1990 through 2004, thus following these firms as they emerged in the era of the Human Genome Project and through the 2000 to 2001 market bubble.MethodsA database was created based on an early survey of genomics firms, which was expanded using three web-based biotechnology services, scientific journals, and biotechnology trade and technical publications. Financial data for publicly traded firms was collected through the use of four databases specializing in firm financials. Patent searches were conducted using firm names in the US Patent and Trademark Office website search engine and the DNA Patent Database.ResultsA biotechnology subsector of genomics firms emerged in parallel to the publicly funded Human Genome Project. Trends among top firms show that hiring, capital improvement, and research and development expenditures continued to grow after a 2000 to 2001 bubble. The majority of firms are small businesses with great diversity in type of research and development, products, and services provided. Over half the public firms holding patents have the majority of their intellectual property portfolio in DNA-based patents.ConclusionsThese data allow estimates of investment, research and development expenditures, and jobs that paralleled the rise of genomics as a sector within biotechnology between 1990 and 2004

National Trends in Antidepressant, Benzodiazepine, and Other Sedative-Hypnotic Treatment of Older Adults in Psychiatric and Primary Care.

ObjectiveTo describe how use of antidepressants, benzodiazepines, and other anxiolytic/sedative-hypnotics among older adults (age ≥ 65 years) has changed over time among visits to primary care providers and psychiatrists.MethodsData were from the National Ambulatory Medical Care Survey (years 2003-2005 and 2010-2012), a nationally representative cross-section of outpatient physician visits. Analysis focused on visits to primary care providers (n = 14,282) and psychiatrists (n = 1,095) at which an antidepressant, benzodiazepine, or other anxiolytic/sedative-hypnotic was prescribed, which were stratified by demographic and clinical characteristic (including ICD-9-CM diagnosis) and compared across study intervals. Odds of medication use were calculated for each stratum, adjusting for demographic and clinical characteristics.ResultsThe visit rate by older adults to primary care providers where any of the medications were prescribed rose from 16.4% to 21.8% (adjusted odds ratio [AOR] = 1.43, P < .001) while remaining steady among psychiatrists (75.4% vs 68.5%; AOR = 0.69, P = .11). Primary care visits rose for antidepressants (9.9% to 12.3%; AOR = 1.28, P = .01) and other anxiolytic/sedative-hypnotics (3.4% to 4.7%; AOR = 1.39, P = .01), but the largest growth was among benzodiazepines (5.6% to 8.7%; AOR = 1.62, P < .001). Among patients in primary care, increases primarily occurred among men, non-Hispanic white patients, and those with pain diagnoses as well as those with no mental health or pain diagnoses.ConclusionsFrom 2003 to 2012, use of the most common psychotropic medications among older adults seen in primary care increased, with concentration among patients with no mental health or pain diagnosis. As the population of older adults grows and receives mental health treatment in primary care, it is critical to examine the appropriateness of psychotropic use

Benzodiazepine Use among Medicare, Commercially Insured, and Veteran Older Adults, 2013–2017

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/166215/1/jgs16825.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/166215/2/jgs16825-sup-0001-Tables.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/166215/3/jgs16825_am.pd