diabetestalk.net

Insulin Makers

Renegades Join Forces For Affordable Insulin

Renegades Join Forces For Affordable Insulin

Renegades Join Forces for Affordable Insulin But can they manufacture it at scale? Jim Wilkins pulled a test tube from the freezer of his home on San Francisco’s Potrero Hill, stuck it in his pocket, and jumped on his Ducati ST4 motorcycle. He crossed the Bay Bridge to Oakland and pulled up in front of the rambling, two-story Omni Community Center, which once housed a heavy-metal bar and before that a social club for Italian garbage scavengers. Wilkins came bearing a gift. The flask in his pocket contained a special strain of yeast that had been genetically engineered to carry the DNA sequence needed to make human insulin. Inside the Omni, at a DIY biotech facility called Counter Culture Labs, a band of biohackers led by Anthony Di Franco and Yann Huon de Kermadec had been eagerly awaiting their present. De Kermadec and Wilkins went to work, seeding the yeast onto a biological scaffold to start a new colony. Wilkins’s ride across the bay opened a new chapter in an effort with big ambitions — to disrupt the $25 billion insulin market with a cheap, generic version. After two years of work in their Oakland labs, Di Franco, de Kermadec, and other collaborators had managed to engineer E. coli bacteria to produce proinsulin, a precursor to insulin. But E. coli can’t produce mature insulin directly. With additional bioengineering, yeast like what Wilkins delivered may present a more efficient method. If anyone in this cross-bay collaboration ends up producing high-quality generic insulin, it would be a major breakthrough. The three companies that make nearly 90 percent of the insulin sold in the world nearly tripled the price in the U.S. between 2002 and 2013. In sub-Saharan Africa, low access to insulin means children diagnosed with diabetes have a life expectancy of Continue reading >>

Oakland's Open Insulin Project Aims To Disrupt Diabetes | Make:

Oakland's Open Insulin Project Aims To Disrupt Diabetes | Make:

Read articles from the magazine right here on Make: . Dont have a subscription yet? Get one today . Medical patents typically last 20 years, but because of minor yet regular advancements to the insulin production process, these patents have been maintained for nearly a century. Biohackers working on the Open Insulin Project are now working to come up with their own protocol to create the compound that diabetics have relied on since 1922. They plan to make their research available so that a generic drug company can take up their process to produce a low-cost version of the drug. The state of the art in diabetes treatment has changed little in decades, something that I personally am frustrated by along with many others living with diabetes, explains Anthony Di Franco, one of the Open Insulin organizers. Whether directly or indirectly, were hoping our work will improve access to insulin. Di Franco has had Type 1 diabetes since 2005. His initial interest in hacking diabetes was in closed-loop glucose systems and DIY pumps. The idea of making a bioreactor to create insulin seemed like a remote possibility in 2011 when he co-founded Oakland, California-based biohackerspace Counter Culture Labs. Then, in spring of 2015, Di Franco was introduced to Isaac Yonemoto, who has a background working on insulin, and Arcturus BioCloud, a biotech startup that could provide DNA synthesis services. This made Open Insulin seem like an achievable goal. They formed a Meetup group, successfully crowdfunded their experiments, and began the lab work by January of 2016. The main method were looking at [] involves expressing human proinsulin in E. coli and cutting and folding it into insulin using a series of steps involving treatments with enzymes and chemicals that parallel whats done in the bo Continue reading >>

Big 3 Insulin Makers Sued Over Pricing; Racketeering Alleged

Big 3 Insulin Makers Sued Over Pricing; Racketeering Alleged

The complaint comes on the heels of requests from Congress and the American Diabetes Association for federal agencies to look into why insulin prices are so high. Eleven people with diabetes today filed a class action lawsuit against the world’s 3 largest makers of analog insulin—Novo Nordisk, Sanofi, and Eli Lilly. The suit accuses the 3 for driving up prices in “an organized scheme” that has harmed those who need insulin to stay alive. The suit alleges that in the past 5 years, the 3 companies have raised their benchmark prices for insulin by more than 150%, but that these publicly reported prices differ from the “lower, real price that they offer to certain bulk distributors.” These include large pharmacy benefit managers (PBMs) ExpressScripts, CVS Health, and OptumRx. Publication of these false, misleading prices constitutes violation of the Racketeer Influenced and Corrupt Organizations (RICO) Act said lead attorney Steven Berman, in an interview with The American Journal of Managed Care.® The RICO Act passed in the 1970s to prosecute leaders of organized crime. "We strongly believe these allegations have no merit, and will defend against these claims," said Sanofi spokeswoman Ashleigh Koss in an email to The American Journal of Managed Care.® Novo Nordisk issued a similar statement in media reports, and Lilly said it adhered to high ethical standards. The suit calls current pricing practices an “arms race” as drug makers list ever-increasing benchmark prices as part of a scheme to win favor with PBMs, who collect a percentage of the discount they pass on to their clients, mostly health insurers or large employers. The role of health insurers in the current set-up would be explored as a part of the case, Berman said. “Some may be getting part of Continue reading >>

Insulin Drugmakers Sued For Inflating Prices

Insulin Drugmakers Sued For Inflating Prices

Insulin drugmakers sued for inflating prices A lawsuit filed Monday in Massachusetts district court accused drugmakers Eli Lilly, Novo Nordisk and Sanofi of illegally inflating the list prices for insulin products in a scheme designed to ensure coverage and protect profits. According to the lawsuit , the three drugmakers which together control most of the insulin market have worked in lockstep to push prices up for their insulin products by more than 150% over the last five years. Lawsuit aside, the insulin makers have been under fire for the rising cost of drugs like Humalog (insulin lispro), Novolog(aspart) and Lantus(glargine). At the same time, competition in the U.S. and increasing pressure from payers have crimped the market's growth prospects . The lawsuit, filed on behalf of 11 plaintiffs in U.S. District Court for the District of Massachusetts, alleges the drugmakers violated the Racketeer Influenced and Corrupt Organizations (RICO)Act, along with dozens of other state consumer protection laws. In particular, the suit attacks the relationships between the three drugmakers,insurers and pharmacy benefit managers. Rather than competing for insurance coverage by lowering drug prices, the companies have simultaneously raised list prices as well as the rebates (or discounts) paid to pharmacy benefit managers (PBMs)to lock in coverage. PBMsearn a percentage of this "spread" between list price and net price. The lawsuit claims Eli Lilly, Novo and Sanofimarketed a wider spread to PBMsrather than lower prices a "quid pro quo" that gives PBMshigher profits from a wider spread while preserving a stable net price for the drugmakers. "Insidiously, an arms race in the escalation of reported benchmark pricesand consequently spreadshas ensued between defendants: each defendant Continue reading >>

Heres Why Insulin Is So Expensive And What You Can Do About It

Heres Why Insulin Is So Expensive And What You Can Do About It

The numbers are in: U.S. spending on diabetes drugs increased from $10 billion to $22 billion per year between 2002 and 2012, according to a recent study . And most of that cost was due to skyrocketing prices for one diabetes medication: insulin. Take, for example, Lantus , one of the most popular insulins on the market. The price of a 10-milliliter vial has shot up from under $40 in 2001 to around $275 today. And these costs are hitting more people every year. About 30 million people in the U.S. have diabetes up from 10 million 20 years ago with another 89 million experiencing prediabetes. One study estimates that up to one-third of Americans could have diabetes by 2050. With so many people affected by rising insulin costs, it makes sense to wonder why prices are so high. Today there are two major categories of insulin. Synthetic human insulin was introduced in the early 1980s and appears under brand names like Humulin R and Novolin 70/30 . Genetically modified analog insulin was developed in the 1990s to provide several benefits over human insulin. Analog insulins take effect more quickly, their effects are more consistent and predictable, and they reduce the frequency of low and high blood sugar. Popular analog insulins are Lantus , Humalog , and Novolog . The prices for both types of insulin have risen over the years, but analog insulin is often much more expensive (compare $25 for Novolin 70/30 versus $323 for Humalog 50/50 ). Due to the added convenience and benefits of analog insulin, 96% of insulin prescriptions in the U.S. are now for analogs. However, a growing body of research suggests that synthetic human insulin is just as effective for managing diabetes. Get the best ways to save on your prescriptions delivered to your inbox. Producing insulin is more exp Continue reading >>

#insulin4all Protests Target Insulin Makers Over Skyrocketing Prices

#insulin4all Protests Target Insulin Makers Over Skyrocketing Prices

#Insulin4all Protests Target Insulin Makers Over Skyrocketing Prices Written by Mike Hoskins on September 6, 2017 In just a few days, I'll be part of a group standing outside Eli Lilly headquarters in Indianapolis raising my voice to protest outrageously high insulin prices. Yes, we'll be chanting, and carrying signs marked with the #insulin4all rally cry and phrases like "Insulin = Life," "Insulin's Not Advil, It's Oxygen, and of course "Lower Insulin Prices! -- to underscore the Diabetes Communitys call for more transparency from the insulin makers, who play a big role in setting prices for this vital medication. Because the struggle is real, and the stats don't lie: Retail prices now exceed $300 for a single vial of insulin, and more than half of those whose lives depend on this drug are exposed to these crazy-high pricetags at some point, even with insurance coverage. In the 21 years since Humalog first hit the market, its gone up roughly 1123% (!) compared to a 56% overall inflation rate during that same timeframe. The protest is happening on the afternoon of Saturday (Sept. 9) in downtown Indy. On the day prior, Friday (Sept. 8), theres also an online day of action aimed at calling on Congress to address the insulin pricing issue; that one is aimed at all three big insulin makers. These efforts are spearheaded by the grassroots group T1International , a UK-based non-profit that created the #insulin4all hashtag and mantra just a few short years ago in 2014. Living up to its name, this group is truly international and has been expanding its US efforts over the past several months -- which I'm proud to be part of in some small way. Ill be contacting lawmakers on Friday and then on Saturday will be present in Indy, sharing the story of my own challenges to afford ins Continue reading >>

Lawsuit Accuses Drug Makers Of Conspiring To Hike Insulin Prices

Lawsuit Accuses Drug Makers Of Conspiring To Hike Insulin Prices

More than 29 million Americans live with diabetes, and for some six million of them, insulin is a life or death medication. Between 2002 and 2013, the price of insulin more than tripled, to more than $700 per patient. A federal lawsuit accuses the three insulin manufacturers of conspiring to raise their prices. The drug makers deny the allegations. Those high prices, combined with rising insurance deductibles, mean many people who rely on insulin are feeling sticker shock. Even doctors say without a way to pay, some patients are left facing impossible choices, reports CBS News correspondent Anna Werner. Contact us about this issue or other consumer problems you think we should look into at [email protected] A cell phone video shows Dr. Claresa Levetan talking to her patient Shawna Thompson back in the hospital because she couldn’t pay for her insulin. “One vial of insulin costs how much for you?” Levetan asked. “One hundred and seventy-eight dollars,” Thompson responded. It was the fourth time in just over a year that Thompson had to be treated for a life-threatening diabetic coma. “Patients come in and say I can’t afford to take it, so I’m not,” Levetan said. She said it’s common for her now to hand out free drug company samples of insulin, just so patients can stay on their lifesaving medication. “Patients are begging for samples because they can’t afford the insulin,” Levetan said. “Not asking, you’re saying, begging,” Werner said. “Begging,” Levetan said. Like 74-year-old Kathleen Washington. Some months, her insulin runs over $300 a month – more than she can afford. “I must pay my mortgage,” Washington said. If it’s a choice between the mortgage and the insulin, “It’s going to be the mortgage,” she said. Investm Continue reading >>

Insulin Prices Have Skyrocketed, Putting Drug Makers On The Defensive

Insulin Prices Have Skyrocketed, Putting Drug Makers On The Defensive

Here’s a sticking point for diabetics: the cost of insulin more than tripled — from $231 to $736 a year per patient — between 2002 and 2013, according to a new analysis. The increase reflected rising prices for a milliliter of insulin, which climbed 197 percent from $4.34 per to $12.92 during the same period. Meanwhile, the amount of money spent by each patient on other diabetes medications fell 16 percent, to $502 from $600, according to a research letter published Tuesday in the Journal of the American Medical Association. “Insulin is a life-saving medication,” said Dr. William Herman, a coauthor of the analysis and a professor of medicine and epidemiology at the University of Michigan School of Public Health. “There are people with type 1 diabetes who will die without insulin. And while there have been incremental benefits in insulin products, prices have been rising. So there are people who can’t afford them. It’s a real problem.” The analysis also found that the cost of various widely used oral diabetes drugs either dropped in price or did not rise nearly as significantly as insulin. Metformin, for instance, which is available as a generic, fell to 31 cents in 2013 from $1.24 per tablet in 2002. And the newer class of diabetes drugs known as DPP-4 inhibitors rose 34 percent since becoming available in 2006. The researchers analyzed data from nearly 28,000 diabetes patients found in the Medical Expenditure Panel, a database on health care costs maintained by the US Department of Health and Human Services. About 1 in 4 people used insulin and two-thirds took a pill. Toward the end of the study period, a small percentage began taking new injectable medicines that are designed to complement pills. There have been previous efforts to track insulin pric Continue reading >>

Patient Assistance Program

Patient Assistance Program

Even though NovoLog® is covered by most health insurance and Medicare plans,a we know that sometimes things can get in the way of filling your prescription: Having a hard time getting the prescription coverage you need Money issues that make it difficult to pay for your insulin If you have questions about insurance reimbursement for NovoLog®, you can contact our call center at 1-866-310-7549. Please have your insurance information with you when you call. This includes your managed care plan name and your group number, which should be on your insurance card. If you can’t afford the cost of your insulin, we may be able to help. Making our products available to people who need them but cannot afford them is part of Novo Nordisk's commitment to helping people with diabetes. Anyone with diabetes who meets the eligibility requirements for the Patient Assistance Program (PAP) can receive NovoLog®, or any other Novo Nordisk product free of charge as long as they stay eligible. aFormulary data are provided by Fingertip Formulary® and are current as of January 2015. Because formularies do change and many health plans offer more than one formulary, please check directly with the health plan to confirm coverage. Continue reading >>

Good Lord. Even The Price Of Insulin Is Skyrocketing.

Good Lord. Even The Price Of Insulin Is Skyrocketing.

Reuters At this point, it’s getting hard to keep track of all the stories of drug companies jacking up the prices of prescription medications to nauseating heights for little identifiable reason other than the fact that, unlike in other developed countries, the U.S. government lets them. At the moment, Congress is getting exercised over EpiPens, the fast-acting epinephrine injectors made by Mylan that are used to stop potentially deadly allergy attacks. (I carry one myself, because bees.) Mylan has upped EpiPen prices by 400 percent since it bought the decades-old device from Merck in 2007. The company says the moves are justified by “product improvements,” a line that presumably even they couldn’t possibly believe. Sen. Chuck Grassley has some questions. On Wednesday I noticed yet another disturbing story about drug prices—one that, despite some coverage in the New York Times and elsewhere, hasn’t become a national scandal quite on the order of the EpiPen or the adventures of Martin Shkreli. It turns out that the cost of insulin, which diabetics rely on to stabilize their blood sugar, has been going through the roof. A study published by the Journal of the American Medical Association in April found that between 2002 and 2013, insulin's cost had leapt by more than 200 percent, from $231 to $736 per patient annually. “Insulin is a life-saving medication,” William Herman, one of the study's authors and a professor of medicine and epidemiology at the University of Michigan School of Public Health, told Stat at the time. “There are people with type 1 diabetes who will die without insulin. And while there have been incremental benefits in insulin products, prices have been rising. So there are people who can’t afford them. It’s a real problem.” Drugm Continue reading >>

(insulin Glargine Injection) 100 Units/ml

(insulin Glargine Injection) 100 Units/ml

Do not take Lantus® during episodes of low blood sugar or if you are allergic to insulin or any of the inactive ingredients in Lantus®. Do not share needles, insulin pens, or syringes with others. Do NOT reuse needles. Before starting Lantus®, tell your doctor about all your medical conditions, including if you have liver or kidney problems, if you are pregnant or planning to become pregnant or if you are breast-feeding or planning to breast-feed. Heart failure can occur if you are taking insulin together with certain medicines called TZDs (thiazolidinediones), even if you have never had heart failure or other heart problems. If you already have heart failure, it may get worse while you take TZDs with Lantus®. Your treatment with TZDs and Lantus® may need to be changed or stopped by your doctor if you have new or worsening heart failure. Tell your doctor if you have any new or worsening symptoms of heart failure, including: Sudden weight gain Tell your doctor about all the medications you take, including OTC medicines, vitamins, and supplements, including herbal supplements. Lantus® should be taken once a day at the same time every day. Test your blood sugar levels while using insulin, such as Lantus®. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made cautiously and only under medical supervision. Do NOT dilute or mix Lantus® with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. Lantus® must only be used if the solution is clear and colorless with no particles visible. Always make sure you have the correct insulin before each injection. While using Lantus®, do not drive or operate heavy machinery until Continue reading >>

Rising Insulin Prices Forcing Hoosiers With Diabetes To Make Tough Choices

Rising Insulin Prices Forcing Hoosiers With Diabetes To Make Tough Choices

INDIANAPOLIS (Statehouse File) – For six years, Erin Roberts worked two jobs in order to afford the life-saving medication her son depends on. “It was really hard,” she said. “I feel like I missed a lot of family life because I was working as a registered nurse, and so I would work five 12-hour shifts a week.” When he was 2 years old, Roberts’ son was diagnosed with Type 1 diabetes, a disease that occurs when the body does not properly process the food it needs for energy. The pancreas, an organ that lies near the stomach, makes a hormone called insulin, which is needed to transform the sugar from foods into energy. Without it, the body’s glucose levels can rise dangerously, resulting in potentially life-threatening situations. But while necessary for survival, families across the country are finding it increasingly difficult to afford their diabetes medication. Roberts, who requested her name be changed for the purpose of this article, said she didn’t want her son to feel like his diabetes was a burden on their family. “I try not to let our son know how his disease affects our family financially,” she said. “I know he’s somewhat aware, but I don’t want that to be something he feels bad about.” As a nurse practitioner, Roberts works with disadvantaged diabetic Hoosiers, many of whom are at a loss for how they way pay for their insulin. The price of an order of insulin per patient increased from roughly $230 in 2002 to more than $700 in 2013, according to an analysis published in 2016 for the Journal of the American Medical Association. An order can last for weeks or months, depending on the patient. “My patients are still struggling,” she said. “If they go to the pharmacy, I know it’s going to be hundreds of dollars for their insulin, Continue reading >>

Price-fixing Alleged In Lawsuit Against Insulin Makers

Price-fixing Alleged In Lawsuit Against Insulin Makers

Read Sanders, Cummings Ask Justice Department to Investigate Insulin Prices. Whereas many price-fixing schemes involve discounts to corner the market, the Massachusetts complaint against the insulin manufacturers is built upon a novel legal analysis of the pharmaceutical industry that transcends standard antitrust price-fixing allegations. Its being claimed here that the manipulation of manufacturers sales discounts and rebates, as well as exclusions of brands from pharmacy formularies have caused the true prices of diabetes medications to be hidden from customers, and the prices at the counter to become unfairly inflated. This amounts to racketeering, the complaining parties argue, and the lawsuit alleges that the actions caused harm to the plaintiffs. One named plaintiff alleges, for example, that he had to abandon a branded medication he uses for Type 2 treatment, and move to the Walmart ReliOn brand of the equivalent product because of high insulin prices. Express Scripts, CVS Caremark, and OptumRx, are named in the complaint as participants in the unfair pricing of insulin. Incorporating possible violations of state consumer protection laws lends another dimension to the case. Many jurisdictions which have such laws on the books require notice to the states attorney general of private action seeking enforcement; that has been done with this case. Its not possible at the moment to know if state attorneys general plan to join in the RICO complaint or join together in a separate case, as often has been done in various enforcement proceedings against businesses operating nationwide. What we can most likely predict, however, is that it will take some time before this complaint is resolved in court or settled. The deadlines just for serving the complaint and for respons Continue reading >>

Diabetes Patients Sue Insulin Makers For ‘pricing Fraud’

Diabetes Patients Sue Insulin Makers For ‘pricing Fraud’

A group of diabetes patients filed a lawsuit Monday against three drug companies for systematically increasing the list prices of insulin for years in an alleged fraudulent-pricing scheme that saddled patients with “crushing out-of-pocket expenses,” according to the filing. The insulin market is dominated by an oligopoly of companies that sell many billions of dollars worth of insulin each year — and have steadily raised the list prices of their drugs. A version of insulin called Humalog launched two decades ago with a sticker price of $21 a vial and has increased to $255 a vial. Meanwhile, competition has appeared to work in a perverse way, with list prices of competing insulins often rising in concert. Last year, Sen. Bernie Sanders (I-Vt.) and Rep. Elijah E. Cummings (D-Md.) asked for a federal investigation into “possible collusion” on insulin prices. The lawsuit, filed by 11 patients in U.S. District Court in Massachusetts, focuses on a common practice in the pharmaceutical industry: Drug companies compete for insurers' business by offering secret rebates on their drugs. Companies that negotiate drug prices for insurers, called pharmacy benefit managers, can place drugs on tiers that determine how much consumers pay for them — decisions that may be influenced by the size of the discount granted by the drug companies. The lawsuit claims that drug companies have been increasing the list price of insulin in order to expand their discounts without lowering the overall price tag. The people stuck paying the balance: patients, particularly those without insurance or with high-deductible plans. The lawsuit alleges those actions violate the Racketeer Influenced and Corrupt Organizations Act and state consumer protection laws. “I think that publishing a price Continue reading >>

Gov. Sandoval To Decide Whether To Force Insulin Price Disclosure

Gov. Sandoval To Decide Whether To Force Insulin Price Disclosure

CARSON CITY, Nev. (AP) - Nevada Gov. Brian Sandoval will decide whether to impose the nation's strictest disclosure rules on pharmaceutical companies with a bill focused on make public the price, profits and middlemen surrounding insulin sold in America. Supporters say transparency could prompt manufacturers to lower prices, and would allow diabetes patients to push back against soaring costs at the pharmacy counter. The Democratic-controlled Legislature on Thursday gave final approval to the proposal aiming to force insulin makers to publish their sticker prices. The companies would also have to disclose discounts they give market middlemen and profits they make on the life-sustaining diabetes treatment. All drugmakers would have to register sales representatives who market their prescription drugs in Nevada. Additionally, the proposal would mandate that certain nonprofit organizations report donations from drugmakers and insurers. (Copyright 2017 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.) Continue reading >>

More in insulin