Electronic Health Record Use by Sex Among Physicians in an Academic Health Care Systemстатья из журнала
Аннотация: high-dose colchicine in the treatment of acute gout. 4 Consistent with the recommendations of the European League Against Rheumatism, low-dose colchicine was found to be equally effective as high-dose drug in the reduction of gouty pain; the rate of gastrointestinal adverse events with lowdose colchicine was one-third that observed with high-dose colchicine.In response to these study findings, the FDA approved Colcrys, which, consequently, became the first colchicine product to ever be approved for the treatment of acute gout.Considering that the Waxman-Hatch Act (https://www.govinfo.gov/content/pkg/STATUTE-98/pdf/STATUTE-98-Pg1585.pdf)resulted in market exclusivity for a newly approved drug, URL Pharma received this benefit.In addition to a period of exclusivity, the manufacturer was able to remove all generic competitors from the market.Upon FDA approval, the manufacturer increased the price of colchicine from what had previously been only a few cents to $5 a tablet.A second colchicine brand-name product (Mitigare) was approved in 2015 at the very conclusion of the 4-year Colcrys monopoly.An additional point considering the study findings 1 is the fact that the potential uses for colchicine currently extend beyond acute gout.The increase in potential indications will likely result in even more demand for this drug.As the authors noted, 1 colchicine has been found to have value in the treatment of pericarditis, as well as prevention of additional cardiovascular complications after myocardial infarction.Currently, the Montreal Heart Institute (NCT04322682) 5 is studying colchicine in the treatment of COVID-19 infection.Early results as of October 2020 suggest that early in-hospital initiation of low-dose colchicine treatment within 3 days of myocardial infarction significantly reduces the risk of future ischemic cardiovascular events.Notably, all the colchicine products used for these indications have been trade products; there have been no approved independent colchicine generics marketed after the approval of Colcrys.Wouters et al 6 estimated the investment required to bring a new medicine to market.The median capitalized research and development investment was estimated to be between $985.3 and $1335.9 million.Such investments inevitably require an appropriate return on investment, which usually translates into a high selling price of the drug.However, such investment and its resultant cost should be associated with potential worth to society.The ideal investment would be a new molecular entity that provides an objective, meaningful improvement in public health.Colchicine does not fit this example.Only a fraction of an investment was required for Colcrys, a product that has provided no increased value and an unnecessary, long-term cost burden to the health care system.The current study findings 1 illustrate that we can never allow such an egregious case to take place again.
Год издания: 2020
Авторы: Sarah Tait, Sachiko M. Oshima, Yi Ren, Alexander Fenn, Mina Boazak, Eugenia R. McPeek Hinz, E. Shelley Hwang
Издательство: American Medical Association
Источник: JAMA Internal Medicine
Ключевые слова: Diversity and Career in Medicine, Sex and Gender in Healthcare, Healthcare Systems and Challenges
Другие ссылки: JAMA Internal Medicine (PDF)
JAMA Internal Medicine (HTML)
PubMed Central (HTML)
PubMed (HTML)
JAMA Internal Medicine (HTML)
PubMed Central (HTML)
PubMed (HTML)
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Том: 181
Выпуск: 2
Страницы: 288–288