Revised Post

Diabetes seems to be a topic of discussion in todays society with citizens obtaining this disease from insulin resistance, bad eating, exercise habits, or from large amounts of beta cells loss in the pancreas. As we notice the steady increase in obtaining diabetes, citizens get perplexed about the different concepts of type 1 diabetes and type 2 diabetes. One is curable by exercising and consuming healthier food products, while there is no cure for type 1 diabetics. Their only option to control the disease is by monitoring their glucose blood level to minimize the complications of symptoms that include kidney failure, blindness, nerve damage, heart attack, and an increased rate of stroke.

In a recent article, conducted by the American Diabetes Association, Type 2 diabetes is the most predominant type of diabetes in America. Formerly called adult-onset diabetes this form articulates about 90 to 95% of people in America. Type 2 diabetics pancreas makes the hormone insulin, but their cells don’t use the insulin properly. This form of diabetes is associated with excess weight, physical inactivity, family history of diabetes, and previous history of gestational diabetes. This rarity form of diabetes can occur during pregnancy when the hormones produced during pregnancy increase the amount of insulin needed to have normal blood glucose levels. If their bodies can’t process this increase of insulin, women can develop gestational diabetes during the third term stage. Symptoms that patients might experience align with being diagnosed with type 2 diabetes include: weariness, frequent urination, unusual thirst, weight loss, blurred vision, asymptomatic as signs of warning to take precautions. Diabetics that suffer from type 2 still manage to produce insulin from their pancreas allowing for far less severe symptoms when compared with, type 1 patients who produce little to no insulin from the beta cells that reside in the islets of the Langerhans located in the pancreas.

Type 1 diabetics bodies differ from their counterparts largely due to the immune systems attack that happens within their pancreas. Unaware of what causes this to happen scientists know that the pancreas views the insulin-produced as foreign to the body and destroys them causing a “autoimmune attack”. This immune system attack can occur from anything in the environment, and like a virus your body tells the autoantibodies to go after the pancreas and attack. The autoantibodies attack on the beta cells can also occur from genetic factors; but type 1 diabetes has no connection with diet or lifestyle. Once you are diagnosed as a type 1 diabetic there is no cure just lifelong treatment.

The Juvenile Diabetes Research foundation recently published a report proclaiming that type 1 patients must be careful when they balance their doses of insulin injections(or infusion pumps). Most patients have set time frames that they check themselves with their handheld blood glucose monitoring system to determine if they need to eat, drink some juice, or take extra medicine. How much insulin the patient might need can be determined by the type of insulin available for the patient. There are several types of insulin available on todays market with different purposes,“Rapid-acting starts to work in about 15 minutes. It peaks around 1 hour after you take it and continues to work for 2 to 4 hours. Regular or short-acting gets to work in about 30 minutes. It peaks between 2 and 3 hours and keeps working for 3 to 6 hours. Intermediate-acting wont get into your bloodstream for 2 to 4 hours after injection. It peaks from 4 to 12 hours and works for 12 to 18 hours. Long-acting takes several hours to get into your system and lasts for about 24 hours”(Micheal Dansinger, MD). My father takes a mixture of regular and long-acting insulin that is 70/30 mixture, 70 is the percent regular and 30 is the percent long-acting. He takes this because when he was first diagnosed as being diabetic the doctor offered this combination prescription for its ease of use and insulin mixture. Since then my father has tried taking only the regular option in hopes of going on an insulin pump which offers ease of use, however the switch in insulin mixture resulted in other complications that outweighed changing his prescription.

My father being a type 1 diabetic depends on insulin for the last 30 years of his life, and its the one thing that keeps him alive today. This medical insulin has allowed me to see him everyday. My dad has always been on top of monitoring his blood-glucose level and makes sure that its at the normal range(100-120mg/dl) while not going over this level because he could end up with hyperglycemia which leads to comas if untreated. On the opposite end of the spectrum if your blood sugar level goes below 100 mg/dl you can attract hypoglycemia which can causes seizures or unconsciousness if left unnoticed.

Another concern of diabetes is how folks will perceive themselves. In fact my father didn’t let my mother know he was diabetic until a couple of months after they had been dating because he wasn’t sure how she would take the news. The good news is she wasn’t fazed by his diabetes and wanted to learn everything she possibly could about the disease so if anything would happen she would know what to do.

Why is Insulin so expensive?

Manufacturing Insulin

Since the recent price spike of Insulin more scientists and drug companies are using their assets to make a secondary option more plausible. This secondary option opens up the doors for people to decide between the newest product or the original product. As we near closer to FDA’s approval of the new Biosimilar Insulin we try to understand the main reasoning behind this whole altercation for generic Insulin; manufacturing the cost of Insulin.

Over the past couple of years as we have seen vast increases in technology, we can hope for cheaper products and quicker solutions to current day problems. The same can’t be said for the price of Insulin during this technologically advanced period. Pharmaceutical companies are finding ways to play this prescription drug game with its customers over the pricing of Insulin.

The cost of one vial of Insulin is seeing skyrocketing price increases due to direct competition in the market from other competing pharmaceutical companies. These companies input their information into algorithms, formulas, and basic business decisions to arrive at a “reasonable price”. Their resources are determined to justify how they set the price because, “much of how we set price is based on the clinical benefit combined with our-and payers’-understanding about how diabetes can be effectively managed to reduce long-term complications and additional costs those complications place on the health care system”(Allison Tsai).

Inputing information into mathematical equations can see benefits from the increase cost per product but what the calculator doesn’t include is the well being of the patients regarding this price spike. Diabetics feel that the pharmaceutical companies have gained an exponential amount of power when it comes to creating the Insulin price because, “they have a near monopoly on the market”(David Kliff). This may seem over the top but its the truth when you look at the facts from the previous years. Manufactures are using the price increase on everyday drugs, like high blood pleasure medication and Insulin to counter a drop in overall drug sales. The Pharma executives admitted this speculation in 2011, during the Reuters Health Summit. According to a Bloomberg report, US drug spending in 2013 declined by as much as 2% in the first half of the year, giving space for multiple insurance companies to be more lenient with the price spike. These drug companies are generating too much power and allowing a group of them to dictate the pricing for medication needed by patients enabling them to survive.

Companies proclaim that they adjust their prices often due to the competition in the market and set average wholesale prices for that certain drug. The average wholesale price is just a number used by the drug companies to enable negotiations about the exact price with the retailer. These conversations are confidential and only occur between the pharmaceutical company and the middlemen(drug wholesalers and distributors, pharmacy benefit managers, health plans, and sometimes large retail pharmacy chains). During this entire discussion the middlemen take a cut of the profit so they can mark up the drug while not passing along deep price cuts to consumers. The drug companies are allowed to manipulate the Insulin market because, “‘these products are not completely substitutable, and manufactures perceive that, and so they exercise monopoly power over pricing,” said Rena Conti, a health economist at the University of Chicago’(Rebecca Robbins). Based on this companies are allowed to dictate where the price is heading because there will always be a demand for this drug; medicine that people need in order to survive each and every day.

Pharmaceutical companies understand that diabetics need Insulin to survive but are not selling it at reasonable price because they see their incentives as a company more valuable than their customers. Insulin companies use the blaming game whenever there is an arising problem concerning the skyrocketing Insulin prices. These issues are around three facts:

  • First they state that the fierce competition is holding them back from dropping the price of Insulin. (there are only 3 manufactures for all the Insulin used in the United States).
  • Next companies are afraid to take the risk of using Biosimilar Insulin on patients because of potential payment issues and the health of the patient. Biosimilar Insulin has created a healthy competition in the market of brand-name Insulin by allowing the price of Insulin to drop and has offered copayments for diabetics that are having trouble obtaining their medicine.
  • Finally there needs to be some government involvement when it comes to regulating the pricing of insulin. The government isn’t doing a strict enough job enforcing fair pricing for the medication of insulin and their needs to be an outside force that will take care of the drug prices.

Insulin manufacturing companies at the end of the day look at their benefits as a company over benefiting the people they supply to. There needs to be a strict regulation from the FDA that breaks up the power that these three Insulin companies in the United States have gained over the past decade. If we are able to break up the tightly knit Insulin leaders and introduce Bisomilar Insulin,we will see a significant change in treating diabetics through the newly updated process. This will allow patients the freedom to decide if they want to try out new products that are experiencing incredible success in Europe since the approval.

Biosimilar Insulin

Increase in insulin prices has caused diabetics to look for alternative ways to receive their medication. In a recent article by the American Diabetes Association, its been proclaimed that since the change of the calendar year we have noticed a potential  solution to the insulin spike through biosimilar insulin. Lilly/ BI have recently just announced their FDA approval of its long awaited biosimilar insulin, glargine, basaglar, for type 1 and type 2.

Biosimilar insulin is a copy of a biological molecule, generated via microorganism(bacteria or yeast), that is already approved in the pharmaceutical market. This approved biological molecule can reduce the price of diabetes treatment costs, which increases the accessibility to receive insulin treatment, and expands the number of drug companies that produce insulin. When creating biosimilar insulin it is impossible to make identical proteins.  Normally when something likes this occurs, “even if the primary amino acid sequence is identical, it doesn’t mean that the secondary and tertiary structure of the insulin molecule is as well”. Recent studies have shown that its possible to make manufactured insulin at a reduced cost through the production of recombinant proteins. Thus, although a biosmiliar and its reference insulin product may have similar amino acid seqeuence, they may differ slightly in their more subtle molecular characteristics and clinical profiles.

Deepti Narayan, a healthcare specialist, wrote a report report on the effects of biosimilar insulin and how its becoming a predominant, promising figure in the insulin industry. Some diabetics are wary about this biological molecule insisting that the sensitivity of the biosimilars is high, meaning that they would need to distribute it through a cold chain network. Cold chain networking causes the drug to have a shorter life overall, which increases the cost of complexity of distribution. The cost of developing biosimilar insulin would be significantly higher; it would require, capital investment in property, plant, and equipment and the costs of manufacturing will be much higher for biosimilars than for generic drugs.

Citizens are skeptical over biosimilar insulin because it lacks a, pharmacopoeia monograph that contains directions for the identification of compound medicines, and is published by the authority of a government or medical or pharmaceutical society. Since there are no pharmacopoeia monographs that can be abided by the appropriate monograph, some citizens are cautious about risking their health over speculations, while others want change and see convenience from biosimilar insulin.

A copy of a biological molecule seems most notably appealing to diabetics due to the increase in supplies which will drag the price of the insulin product down, about a 15-30% reduction. This reduction doesn’t seem significant but what also makes biosimilar insulin attractive is that if patients are struggling to buy this product then the manufactures provide copay assistance directly to the patient. No matter which route manufactures of biosimilar insulin partake in, “a certain level of cost savings may need to be associated with biosimilars. It could be worthwhile in future studies to explore just how much cost drives patients to switch to biosimilars, and how much of a discount compared to the reference product is required before patients will consider such a switch”. Overall improving the acceptance of the drug and generating loyalty with the patient. Biopharmaceutical products are the fastest-growing segments in the pharmacy industry, and with the patent of original product expiring soon it opens opportunity for generic versions(biosimilar insulin). This openness gives the patient the option to choose from an increased range of treatment options, as well the choice of delivery devices.

My father is one of these people that deems this innovation as a success in the diabetic community and wants to see the FDA approve biosimilar insulin so instead of choosing one pricey vial of insulin you have more options to choose from. He understands that people are cautious about switching from a product thats been around their entire life to a newer product they know nothing about. The most crucial idea from opening up a new form of insulin is to give the patients the ability to change to the newer product if they find the newer product to be more beneficial. My dad designs heart valves for Edwards Lifesciences and his company  came up with this new product for heart valves called the Transcatheter Heart Valve (THV). This product makes the surgeons life easier, by decreasing the length of heart surgery from 8 to 2 hours. As time passed, competing companies made replicas of Edwards’ products. The newer products made by a competing company showed signs of benefits to certain patients that Edwards products didn’t. Diabetics, like patients who need heart surgery, should have the option to decide if they want to take the generic insulin or the new biosimilar entrant.

The slow entry of biosimilars into the insulin market may alter diabetics decision of whether or not they should give this new product a chance. While some of them view this product as optimistic due to missing credentials in the market (regulatory, commercial, and competitive fronts), others view this product as a significant change for the insulin landscape in the forth coming years. Lilly and Boehringer Ingelheim’s biosimilar insulin glargine product was approved in the European Union on September 10, 2014. Glargine has similar efficiency and safety compared to the currently marketed insulin glargine products for people with type 1 and 2 diabetes. As biosimilar insulin starts to get more exposure we ask ourselves, why is insulin so expensive?

Insulin Price Spike

As mentioned in my previous blog, the expansion of technology has enabled scientists to find a testable hypothesis for them to work on and figure out if its null or not. This scientific hypothesis that was once tested to find a viable cure to prevent diabetes has been inching closer to a final result. These hypotheses have led to new age machines like the MiniMed 670G that can self-regulate blood sugar levels. Harvard and MIT are also figuring out that they can use embryonic stem cells to produce equivalent human insulin-producing cells to mimic the functionality of normal cells.

In the past couple of years, as we loom closer to finding a viable cure for diabetes, most of our attention has been focused on finding a cure. What we don’t notice is the skyrocketing prices of insulin over the past couple of months versus the past couple of years. In a recent excerpt, Matt Smith compares the insulin price hikes to the price hikes of the EpiPens, which drew great controversy about our governments health care plan. Over the past couple of years we have noticed that Novo Nordisk, Eli Lilly, and Sanofi, the three companies that produce insulin in America, have increased their wholesale acquisition cost price by over 200 percent! To be exact, since 2004 Novo Nordisk’s insulin Novolog is up 381 percent, Eli Lilly’s Homolog is up 380 percent and Sanofi’s Lantus is up 400 percent. That means the price of insulin a month is around $2,500 for someone that has no assistance from the United States government. You may say that’s not that much money for someone with no health care plan, but you are wrong. The price for a vial of insulin in Canada is $35, the price of a vial of insulin in Europe $35, the price of a vial of insulin in Mexico $35.

Pharmaceutical companies are making outrageous profits from the price influx of insulin while diabetics struggle to pay for something their body needs to stay alive. Millions depend on insulin, making the three companies profitable no matter what because there is no second solution to insulin. While citizens hurt drug companies profits, drug companies proclaim that, “the spread of high-deductible health insurance policies since the Affordable Care Act passed has left consumers exposed to higher prices that might have been covered by previous plans.” Companies are also defending their price increases due to the strong competition in the marketplace; they also claim that they are using their profits to develop “innovative medicines” for diabetics. Companies are trying to find excuses as to why they are not helping out their patients, when their primary goal is to benefit the consumer (diabetics). In the eyes of companies, the incentive of driving up the price of insulin is more appealing than the incentive of an 8-year-old girl receiving her required medication.

The future for diabetics is looking promising but todays diabetics are suffering with the outrageous increase of insulin prices over the last couple of years. Diabetics like my father are dependent on insulin and can’t go a day without insulin or serious consequences will occur. These repercussions can lead to my father in the hospital because he fainted due to his blood sugar dropping to an alarming rate. Or even worse, he doesn’t wake up from going unconscious. This scenario is scary to think about but the likeness of this happening will continue to increase if the drug companies continue to spike up their insulin prices. The insulin price influx has caused lower-income families to struggle obtaining the correct medication. With the insulin price epidemic more diabetics are looking to venture into alternative ways to receive insulin like biosimilar insulin.

 

The Future of Diabetes

Diabetes is an autoimmune disease that has no viable cure, just medicine to reduce the severity of the disease. Becoming diabetic applies a lot of pressure on the person that is diagnosed; you need to monitor what you eat, how much you eat, as well as how much insulin you need to have after a meal. Diabetics are dependent on insulin; they consistently check themselves about 5-6 times a day because there is no machine that will self evaluate your blood sugar level while you are at home, in the office or anywhere else for that matter. Over the last couple of years the FDA has been working diligently to figure out a way to make the pancreas of a diabetic to reproduce insulin. They’ve also been working on ways to have the pancreas recognize the insulin being produced as friendly and not foreign.

In a recent study, Medtronic’s got the approval from the U.S. Food and Drug Administration for their first automated insulin delivery system that is labeled as an “artificial pancreas” for type 1 diabetics. The artificial pancreas is not a replica organ; it is an automated insulin system designed to mimic a healthy person’s glucose-regulating function. Serena Gordon, a writer for CBS news, talks about how Medtronic is revolutionizing the initial push in finding the cure for type 1 diabetes. The MiniMed 670G is a small device, about the size of your palm, that continuously monitors your blood sugar and excretes the right amount of insulin doses. The sophisticated computer figures out if your blood sugar is too low or too high and adjusts accordingly via the small catheter inserted beneath the skin and attached to a tube connected to an insulin pump. However this device isn’t fully an artificial pancreas, as patients still need to monitor their carbohydrate intake from their food and enter the information into the system. Medtronic has done clinical trials to back up their experiment on the automated insulin device and the people who participated in the experiment proclaimed that they attained better overall control of their blood sugar. Allowing diabetics, like my father, to gain control over their sugar level will give them instant relief because they wont have to be worrying about checking on themselves every couple of hours. Sometimes my dad gets sidetracked by work and forgets if he has taken his medicine or not, which leads to an increase in the possibility of him taking double medicine for when he only needs single use. Not only will it help my father with monitoring his sugar level, but it also leads to patients experiencing relief of sleeping through the night and waking up in the morning with blood glucose level within the norm.

Medtronic isn’t the only company trying to revolutionize type 1 diabetes. Sarah Knapton, a science editor for The Telegraph, stated in a recent report that Harvard and MIT are closing in to find a cure for type 1 diabetes and overall end daily insulin injections that are required by the patient. The Harvard team has been working with embryonic stem cells to produce equivalent human insulin-producing cells to have them mimic the functionality of the normal cells. These embryonic stem cells, which give the scientists the ability to produce mass quantities of insulin producing cells, were implanted into mice. Almost immediately after these cells were placed into mice, the mice began producing insulin in response to their blood glucose level. The mice were also able to maintain a healthy blood glucose level of 100 for a range of 174 days. These therapies can establish long-term insulin independence and eliminate the burden for managing the disease for months, possibly years at a time without the need for immune suppression. At an early age it was hard watching my father always prick his finger and shoot insulin into the side of his stomach just so he could eat dinner with us. I hate seeing my father, to this day, injecting himself with insulin. I’ve always wanted this new innovation to come out or this break through with the cure for diabetes, but nothing. Not until this recent study that is making the cure for diabetes more plausible by mimicking insulin produced cells through embryonic cells, giving the person with diabetes a more stable blood glucose level. With the technology to figure out that embryonic cells are identical to insulin produce cells and that we can use them to eliminate the disease for months and possibly years just shows the progressive push we can make for this disease. And that in the near future I wont have to consider my dad as a type 1 diabetic, I can consider him a type 1 survivor.

With the increase in technology and the possibility of finding a cure to diabetes also becoming plausible, my father told me that he will give one of these experiments a try. That is after they fully get approved by the FDA because at this moment a majority of the experiments are being done through animals, but still show tremendous success in the diagnose chart. Next year in 2017 the artificial pancreas will get approved by the FDA. With the accession in technology and the continuous money being placed into research, I believe we are close to finding a cure for type 1 diabetes. I’m hoping that sometime in my life I can sit down and enjoy a nice ice cream sundae with my father and not have to pester him to check himself so he can either take more insulin or eat a small snack.

Preventing Type 1 Diabetes

Diabetes drastically changed my dads life and completely altered his day to day routine that he had prior to getting diagnosed. As a diabetic, my dad always needs to make sure his blood sugar level is around the norm (100), as well as monitor the amount of insulin his body needs to alter his sugar level efficiently. From reading the past two blogs you probably have a good idea that as of right now type 1 diabetes is not curable but manageable. Ongoing studies are exploring various ways to prevent diabetes with those most suitable for the disease. First-degree relatives that are diabetic are more easily to get diagnosed by genetic factors. Having a first-degree relative with type 1 diabetes increase your chances from 1 in 300, the general percentage, to 6 in 100 chance of developing type 1.

A type 1 diabetic develops an autoimmune disease which defends your body against disease; in this case your body thinks that the insulin being produced is foreign creating your body to attack itself. While doing research to figure out if there was a possibility with today’s technology to avert type 1 diabetes from occurring, The Association of Diabetes posted this article that described the process of conducting a study to target the autoimmune response to prevent type 1 diabetes. Dr. Piganelli is searching for a way to prevent type 1 diabetes by interrupting the autoimmune process. Piganelli has found that antioxidant molecules that reduce the spread of inflammation increases the expression of a factor found on immune cells that weaken their ability to deteriorate someones healthy cells. By having the number of factors on immune cells, Dr. Piganelli was able to keep the immune cells in check and keep them from spreading in an animal model. Dr. Piganelli has found this antioxidant molecule that inhibits autoimmune response leading to type 1 diabetes. The antioxidant that blocks the cellular growth in the immune cells and metabolic pathways are produced for energy production. These studies have opened up new avenues for the development of therapies to treat autoimmune disease like type 1 diabetes.

If scientists can figure out a solution to autoimmune disease, it can put an end to the body producing antibodies that attack its own tissue. The body can then notice its own tissue and stop attacking the immune system causing an end to any autoimmune disease; examples include: lupus, thyroiditis, rheumatoid arthritis. Not only can this help people by determining if they have the possibility to have an autoimmune disease before it occurs. It can also benefit people that have the disease by minimizing the severeness of the symptoms for the patient. For diabetics it can help the body to acknowledge the insulin thats being produced as not antibodies and alter the process of insulin ultimately leading to the body to slowly trust the insulin being produced.

With beta cell loss being a big component of someone becoming a type 1 diabetic, scientists want to figure out a way to detect beta cell loss so they can act immediately and hopefully halt the spread of type 1 diabetes. Martin Hessner, a director at the Max Magee National Research Center for Juvenile Diabetes, proclaimed in this report that scientists are in currently conducting a study to detect type 1 diabetes before any beta cells are lost. People that are diagnosed with type 1 diabetes don’t know they’re diabetic because the symptoms progress for several years before the patient is considered diabetic. During these crucial years your beta cells are getting destroyed. The disease isn’t detected until a significant amount of beta cells are lost leaving you with noticeable symptoms. Dr. Hessner is investigating “biomarkers”, which are components in measuring blood or tissue samples that can predict which individuals are more likely to develop type 1 diabetes symptoms. Hessner was also able to show that family members of people who have type 1 diabetes have a larger inflammatory state that is regulated differently during aging between high genetic risk siblings. Dr. Hessner is working to refine biomarkers that can be used to identify individuals that are most likely to develop this disease. If redeemed a success, these blood samples could help people identify who would benefit from drug therapies to protect their beta cells from the autoimmune attack, reducing the diabetic complications and possibly delaying or preventing type 1 diabetes.

The issue with becoming diabetic is that you don’t notice the symptoms until months from the first beta cell loss. By the time someone is notified they have type 1 diabetes, they may have lost 70-80% of their beta cells. But with the possibility of “biomarkers” that can predict which individuals are most vulnerable to get diagnosed, we can cut the notification notice in half. This can also help future people who have speculation of becoming diabetic by measuring blood or sample tissue to determine the likeliness of them being diagnosed. From this diagnostic they can work accordingly and visit their doctor to figure out what steps they need to take to help their fight against the disease.

My father, who is a type 1 diabetic, has looked into various ways to help his fight against this disease and has came across some promising studies but not any breakthrough studies. Over the past couple of years studies have been done where biomarkers have been placed into normal pigs to see the effects it has on their welfare and general productive performance. Over time the scientist noticed that the stress level of the animals started to increase exponentially in social environments. These physio-pathological changes that were associated with stress had negative effects on pig production. With studies being done to animals and showing negative effects, there is no timetable to determine when we can stop cells from attacking the insulin thats produced.