 | |
| Formation | 2015 |
|---|---|
| Founder | Anthony Di Franco |
| Headquarters | Counter Culture Labs |
| Location |
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| Website | openinsulin |
The Open Insulin Project is a community of researchers and advocates working to develop an open-source protocol for producing insulin that is affordable, has transparent pricing, and is community-owned. [1] [2] [3] [4]
The Open Insulin Project was started in 2015 by Anthony Di Franco, himself a type 1 diabetic. [5] He started the project in response to the unreasonably high prices of insulin in the US. The project has been housed in Counter Culture Labs, a community laboratory and maker space in the Bay Area. [6] Other collaborators include ReaGent, BioCurious and BioFoundry.
The project aims to develop both the methodology and hardware to allow communities and individuals to produce medical-grade insulin for the treatment of diabetes. [7] These methods will be low-cost in order to combat the high price of insulin in places like the US. There is also potential for small-scale distributed production that may allow for improved insulin access in places with poor availability infrastructure. Access to insulin remains so insufficient around the globe that "Half of all people who need insulin lack the financial or logistical means to obtain adequate supplies". [8]
Researcher Frederick Banting famously [9] refused to put his name on the patent after discovering insulin in 1923. The original patent for insulin was later sold by his collaborators for just $1 to the University of Toronto in an effort to make it as available as possible. [10] Despite this, for various reasons, [11] there remains no generic version of insulin available in the US. Insulin remains controlled by a small number of large pharmaceutical companies and sold at prices unaffordable to many who rely on it to live, particularly those without insurance. This lack of availability has led to fatalities, such as Alec Smith, who died in 2017 due to lack of insulin. [12] The Open Insulin Project is motivated by the urgent need to protect the health of those with diabetes regardless of their economic or employment status by developing low-cost methods for insulin production available for anyone to use.
The project has genetically engineered microorganisms to produce long-acting (glargine) and short-acting (lispro) insulin analogs using standard techniques in biotechnology and according to their December 2018 release the "first major milestone ― the production of insulin at lab scale ― is almost complete". [13]
The cost to produce insulin via Open Insulin methods is estimated by the project to be such that "roughly $10,000 should be enough to get a group started with the equipment needed to produce enough insulin for 10,000 people". [1]
A more recent estimate (May 2020) by the Open Insulin Foundation states that it will cost $200,000 (one-time price, per patient of $7-$20) for used equipment and up to $1,000,000 (one-time price, per patient of $73) for new equipment. The average price per vial was estimated to be $7 with each patient needing two vials per month. [14]
Hypoglycemia, also called low blood sugar, is a fall in blood sugar to levels below normal, typically below 70 mg/dL (3.9 mmol/L). Whipple's triad is used to properly identify hypoglycemic episodes. It is defined as blood glucose below 70 mg/dL (3.9 mmol/L), symptoms associated with hypoglycemia, and resolution of symptoms when blood sugar returns to normal. Hypoglycemia may result in headache, tiredness, clumsiness, trouble talking, confusion, fast heart rate, sweating, shakiness, nervousness, hunger, loss of consciousness, seizures, or death. Symptoms typically come on quickly.
Diabetic ketoacidosis (DKA) is a potentially life-threatening complication of diabetes mellitus. Signs and symptoms may include vomiting, abdominal pain, deep gasping breathing, increased urination, weakness, confusion and occasionally loss of consciousness. A person's breath may develop a specific "fruity" smell. The onset of symptoms is usually rapid. People without a previous diagnosis of diabetes may develop DKA as the first obvious symptom.
Blood glucose monitoring is the use of a glucose meter for testing the concentration of glucose in the blood (glycemia). Particularly important in diabetes management, a blood glucose test is typically performed by piercing the skin to draw blood, then applying the blood to a chemically active disposable 'test-strip'. The other main option is continuous glucose monitoring (CGM). Different manufacturers use different technology, but most systems measure an electrical characteristic and use this to determine the glucose level in the blood. Skin-prick methods measure capillary blood glucose, whereas CGM correlates interstitial fluid glucose level to blood glucose level. Measurements may occur after fasting or at random nonfasting intervals, each of which informs diagnosis or monitoring in different ways.
Hyperglycemia is a condition in which an excessive amount of glucose circulates in the blood plasma. This is generally a blood sugar level higher than 11.1 mmol/L (200 mg/dL), but symptoms may not start to become noticeable until even higher values such as 13.9–16.7 mmol/L (~250–300 mg/dL). A subject with a consistent range between ~5.6 and ~7 mmol/L is considered slightly hyperglycemic, and above 7 mmol/L is generally held to have diabetes. For diabetics, glucose levels that are considered to be too hyperglycemic can vary from person to person, mainly due to the person's renal threshold of glucose and overall glucose tolerance. On average, however, chronic levels above 10–12 mmol/L (180–216 mg/dL) can produce noticeable organ damage over time.
Drugs used in diabetes treat diabetes mellitus by altering the glucose level in the blood. With the exception of insulin, most GLP receptor agonists, and pramlintide, all are administered orally and are thus also called oral hypoglycemic agents or oral antihyperglycemic agents. There are different classes of anti-diabetic drugs, and their selection depends on the nature of diabetes, age, and situation of the person, as well as other factors.
Novo Nordisk A/S is a Danish multinational pharmaceutical company headquartered in Bagsværd, Denmark, with production facilities in nine countries and affiliates or offices in five countries. Novo Nordisk is controlled by majority shareholder Novo Holdings A/S which holds approximately 28% of its shares and a Majority (77%) of its voting shares.
Diabetes UK is a British-based patient, healthcare professional and research charity that has been described as "one of the foremost diabetes charities in the UK". The charity campaigns for improvements in the care and treatment of people with diabetes.
Diabetic hypoglycemia is a low blood glucose level occurring in a person with diabetes mellitus. It is one of the most common types of hypoglycemia seen in emergency departments and hospitals. According to the National Electronic Injury Surveillance System-All Injury Program (NEISS-AIP), and based on a sample examined between 2004 and 2005, an estimated 55,819 cases involved insulin, and severe hypoglycemia is likely the single most common event.
Tolbutamide is a first-generation potassium channel blocker, sulfonylurea oral hypoglycemic medication. This drug may be used in the management of type 2 diabetes if diet alone is not effective. Tolbutamide stimulates the secretion of insulin by the pancreas.
Type 1 diabetes (T1D), formerly known as juvenile diabetes, is an autoimmune disease that originates when cells that make insulin are destroyed by the immune system. Insulin is a hormone required for the cells to use blood sugar for energy and it helps regulate glucose levels in the bloodstream. Before treatment this results in high blood sugar levels in the body. The common symptoms of this elevated blood sugar are frequent urination, increased thirst, increased hunger, weight loss, and other serious complications. Additional symptoms may include blurry vision, tiredness, and slow wound healing. Symptoms typically develop over a short period of time, often a matter of weeks.
The term diabetes includes several different metabolic disorders that all, if left untreated, result in abnormally high concentrations of a sugar called glucose in the blood. Diabetes mellitus type 1 results when the pancreas no longer produces significant amounts of the hormone insulin, usually owing to the autoimmune destruction of the insulin-producing beta cells of the pancreas. Diabetes mellitus type 2, in contrast, is now thought to result from autoimmune attacks on the pancreas and/or insulin resistance. The pancreas of a person with type 2 diabetes may be producing normal or even abnormally large amounts of insulin. Other forms of diabetes mellitus, such as the various forms of maturity-onset diabetes of the young, may represent some combination of insufficient insulin production and insulin resistance. Some degree of insulin resistance may also be present in a person with type 1 diabetes.
Automated insulin delivery systems are automated systems designed to assist people with insulin-requiring diabetes, by automatically adjusting insulin delivery in response to blood glucose levels. Currently available systems can only deliver a single hormone—insulin. Other systems currently in development aim to improve on current systems by adding one or more additional hormones that can be delivered as needed, providing something closer to the endocrine functionality of the pancreas.
Insulin lispro, sold under the brand name Humalog among others, is a modified type of medical insulin used to treat type 1 and type 2 diabetes. It is used by injection under the skin or within an insulin pump. Onset of effects typically occurs within 30 minutes and lasts about 5 hours. Often a longer-acting insulin like insulin NPH is also needed.
Frederick Madison Allen was a physician who is best remembered for his carbohydrate-restricted low-calorie diet for sufferers of diabetes mellitus. He was known for pioneering the "starvation diet".
As a medication, insulin is any pharmaceutical preparation of the protein hormone insulin that is used to treat high blood glucose. Such conditions include type 1 diabetes, type 2 diabetes, gestational diabetes, and complications of diabetes such as diabetic ketoacidosis and hyperosmolar hyperglycemic states. Insulin is also used along with glucose to treat hyperkalemia. Typically it is given by injection under the skin, but some forms may also be used by injection into a vein or muscle. There are various types of insulin, suitable for various time spans. The types are often all called insulin in the broad sense, although in a more precise sense, insulin is identical to the naturally occurring molecule whereas insulin analogues have slightly different molecules that allow for modified time of action. It is on the World Health Organization's List of Essential Medicines. In 2020, regular human insulin was the 307th most commonly prescribed medication in the United States, with more than 1 million prescriptions.
Do-it-yourself biology is a biotechnological social movement in which individuals, communities, and small organizations study biology and life science using the same methods as traditional research institutions. DIY biology is primarily undertaken by individuals with limited research training from academia or corporations, who then mentor and oversee other DIY biologists with little or no formal training. This may be done as a hobby, as a not-for-profit endeavor for community learning and open-science innovation, or for profit, to start a business.
Diabetes mellitus, often known simply as diabetes, is a group of common endocrine diseases characterized by sustained high blood sugar levels. Diabetes is due to either the pancreas not producing enough insulin, or the cells of the body becoming unresponsive to the hormone's effects. Classic symptoms include thirst, polyuria, weight loss, and blurred vision. If left untreated, the disease can lead to various health complications, including disorders of the cardiovascular system, eye, kidney, and nerves. Untreated or poorly treated diabetes accounts for approximately 1.5 million deaths every year.
The Connaught Medical Research Laboratories was a non-commercial public health entity established by Dr. John G. FitzGerald in 1914 in Toronto to produce the diphtheria antitoxin. Contemporaneously, the institution was likened to the Pasteur Institutes in France and Belgium and the Lister Institute in London. It expanded significantly after the discovery of insulin at the University of Toronto in 1921, manufacturing and distributing insulin at cost in Canada and overseas. Its non-commercial mandate mediated commercial interests and kept the medication accessible. In the 1930s, methodological advances at Connaught updated the international standard for insulin production.
An injector pen is a device used for injecting medication under the skin. First introduced in the 1980s, injector pens are designed to make injectable medication easier and more convenient to use, thus increasing patient adherence. The primary difference between injector pens and traditional vial and syringe administration is the easier use of an injector pen by people with low dexterity, poor vision, or who need portability to administer medicine on time. Injector pens also decrease the fear or adversity towards self-injection of medications, which increases the likelihood that a person takes the medication.