Family Fears the Increasing Cost of Insulin, FDA Blames Congress

The high coast of insulin

Columbia, SC (WLTX) -  About 1.9 million people in the United States live with diabetes, and that number goes up every year.  According to the American Diabetes Association, the medical costs for the disease is $14 billion.  That price tag is due in large part to the cost of insulin that diabetics must have to live.

News 19 looked into the rising cost of this life saving drug that has been around since 1921.

Isabelle Killian, 13, was just 10 years old when she was diagnosed with Type One Diabetes.  

"I was passed out," she remembers about the day she found out. " My eyelids were closed I could hear everything going on like I couldn't come out of it.  I was in a coma stage, it freaked me out." 

Since then, she has learned to take ownership of maintaining her sugar levels.

"Diabetes is when your immune system attacks the pancreas and your pancreas doesn't work anymore. And so when you eat, you ingest all these carbohydrates and sugars and your pancreas usually covers all that. But when it's gone, it can't cover anything and you can't recover and your blood sugar just goes higher and higher and higher and eventually you pass out. It could kill you if you get too high."

The very first time Isabelle went to the hospital, her blood sugar level was over 1,000.  

Because of her diabetes, Isabelle's life has drastically changed. "You really don't want it, because you have to prick your fingers three or four times a day. And it leaves scabs on them."  She checks her blood sugar in the same fingers she uses to play her cello. But no matter what she's doing, at the forefront of everything, is her disease.      

Everyday,  maintaining her blood sugar level is the focus. She says, "I wake up, I would check my blood sugar before eating breakfast, look at the servings I need and I would look at the total carbs. I take those carbs and put them in my pump so if my blood sugar was like lets say 110, it would ask me if I want to lower it since its like in between my range.  And I would usually say yes because I don't want to go too low during the day."

She doesn't want it to get too high either because whether its too low or too high, she could end up in the hospital. That's happened twice. She says, "I actually went at the beginning of August I had a DKA with Acid when my blood sugar was high. I kept throwing up.  I couldn't get it back under control, rapid heart beat, mother checked me with my meter, It just read high so we got to the hospital found out it was like 600 something."

Her insulin pump is what helps her maintain a healthy blood sugar, but Isabelle's mother, Staci Killian,  says the insulin doesn't come cheap. She says, "It's around $45 for two vials and now its gone two to three times more than that."

Like most diabetics, Isabelle has at least two types of Insulin on hand, fast acting and slow acting. Her mom  says if she didn't have insurance, it could cost as much as $500 a vial for each type of insulin. Isabelle needs at least a vial a week of each.               

Staci says, "It really is life or death. It's not a prescription that you cannot do without."

Since the price hike when she changed jobs and her insurance changed, now the worry is about no regulation on the cost. She says she wants Congress to intervene. She says, "We need somebody to go in there and say hey look, we need to control these costs."

Three major drug companies manufacture insulin: Eli Lilly, Sanofi and Novo Nordisk. And there are currently no generic versions of the drug on the market. So we asked Dr. Janet Woodcock  who is the FDA's Director of Drug Evaluation and Research,  "How does this monoploy happen?  She explains, "Protection from compeition on drugs are a matter of law. They are put into place by congress and there are two types.  One is exclusivity that means you are awarded for your innovation for a certain period when no one else is allowed to market. But the second one is patents and they may be more powerful and that may prevent marketing of other products, generic products for even longer time."

In our research we learned that the long lasting insulin, lantus, went up by at least 99% since 2009. The price of the other types of insulin has increased as well, with Aphidra going up as much as 171% in the last 7 years.
Woodcock says, "I've been asked numerous times when I have testified before Congress about these matters and I have told them that the balance between protecting innovation and protecting and encouraging innovation and then affordability is one that they have to make the call." It's those laws that provide drug makers with 20 year patents and FDA exclusivity rights of 3 to 7 years. The laws that reward even small changes to older drugs.  Take insulin, for example.  For years, manufacturers have tweaked formulas and delivery systems just enough.

Dr. David Belk runs a website, the TrueCostofHealthcare.net.  He says he's been concerned about drug costs for about 20 years now and he says the FDA may actually play a roll in keeping prices high. He explains, "Every time a drug company applies for a new indication or applies for exclusivity, they pay the FDA what's called a user fee, a certain amount of money that helps the FDA speed up the process. Now these user fees have amounted,  in recent years, has amounted to 2/3 of their budget for monitoring the pharmaceutical companies, comes from the pharmaceutical companies applying for new indications for their drugs or applying for new reasons for exclusivity. So that might motivate the FDA to grant these somewhat more leniently than better judgement would say."

Staci Killian says that's just not right, and congress needs to do something about it.  She says, "I really think its important to bring this awareness to our lawmakers, congressman, senators, Just over all, this has to be looked at. It has to be looked at.  It has to be regulated in someway shape or form so that everybody can live a normal life.  This is life or death for our people."

It's difficult  now,  but if the price of insulin goes up even more, Killian says she doesn't know what she'll do.  She says, "It scares me to death. It scares me to death that it could be financial ruin for me or other families. You know it shouldn't be a financial ruin."

isabelle knows one day she will face the finances of her disease too. She says, "Hopefully I can pay for it.  That's like my worst nightmare. I hear her talk about the price of insulin and in the back of my mind what happens if I can't pay for it, what am I gonna do?"

What might be good news in all of this is that patents have expired for some of the insulin drugs and according to an article released by "The Week,"  on October 31,  the first biosimilar, or generic, insulin, Basaglar, will hit the market on December 15, 2016. That's 96 years after the first insulin received a patent. It'll finally bring to an end a nearly century long era of government protection.


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