Tagged: Juvenile Diabetes Research Foundation

Dear JDCA (Juvenile #Diabetes Care Alliance)… Part 1

hands-talking-1311915-640x480Over the past few weeks, I’ve been seeing infographics produced by the Juvenile Diabetes Care Alliance (JDCA) regarding “cure research” and major diabetes organizations.

The infographic is not flattering, and like everything related to statistics, not entirely truthful. (JDCA even admitted in a post on FB that they made some “judgment calls” in their numbers.)

At first, I ignored the repeated posting in Facebook groups of how JDRF and ADA have not done enough to find a cure for us, but after a while, the bashing became nothing but a “I hate these organizations and I’ll never donate to them again. How dare they take our money and do nothing.

I spoke up and reminded individuals in those groups that there are MANY ways to use the donations raised through walks and rides and other fundraising opportunities, but that ALL of the donations were being used to help people with diabetes, whether it be for research or for support. (And I also reminded them that there was a marked absence in this infographic of where one should be donating…)

My opinion voiced, I went on my merry way, living my life with diabetes, until I got an unsolicited email yesterday from someone claiming to be an employee of JDCA, asking me to promote, on my blog and through social media channels, their petition to the major diabetes non-profits, DEMANDING that JDRF and ADA use 30% of all donations for “practical cure research” through my blog.

Thank you for the invitation, JDCA. I’m going to pass.

Instead, I’m going to take my blog and use it took peek into what your privately funded non-profit, founded by the CEO of Activision Blizzard Entertainment (and a parent of a child diagnosed with Type 1 diabetes at the age of 2) wants us to focus on, rather than telling us what JDRF and ADA isn’t doing.

magnifying-glass-1240025-639x397As I began writing this and hit 2500 words, I realized that this needs to be digested in more than one sitting, so I’m splitting this into 2 blog posts. (Mostly, because no one except masochists read 2500 words of my blog at a time and because I WANT YOU TO READ ALL OF THIS IMPORTANT AND UNBIASED INFORMATION.) Today, I’m covering just the Transplantation “practical cures” and you’ll get the others tomorrow in Part 2.

Juvenile Diabetes Research Alliance

According to a WSJ article, Mr. Kelly’s family foundation, the Brian and Joelle Kelly Family Foundation, has donated $1 million dollars (as of  the 2013 article stated) to JDCA. The goal of JDCA is to help donors “become educated about charities that are focused on a “practical cure” for Type 1 diabetes.

Note: Hey, I have no problem with the fact they have spent $1 million dollars to create a “watchdog” organization. They could have spent it on a boat or a house or funding one of their “practical cure” projects. If you’ve got money, you also have the right to spend it as you see fit. I also believe in watchdog organizations, as long as you provide factual, correct, public-facing information.

“Practical Cure”

The Juvenile Diabetes Care Alliance states that they want a “practical cure” by 2025. For their definition, a “practical cure” meets the following four criteria:

  • Minimal Monitoring (checking BGs less than once per week and a A1C between 5-7%)
  • Being able to sleep without worrying (about hypoglycemia or hyperglycemia)
  • Being able to eat whatever one wants without having to evaluate carbohydrate intake
  • Minimal side effects, understanding that some insignificant side effects are “acceptable”

Sounds reasonable, right? I’m all for that, because that elusive “don’t have to do anything ever again, it’s like magic and you don’t have to think about diabetes for the rest of your life” is a dream.

It then begs the question: What is JDCA’s idea of a practical cure?

JDCA’s Four Ideas of a “practical cure”:

  • Islet cell transplantation
  • A device that mimics the pancreas
  • Glucose-responsive insulin (“smart insulin”)
  • Modification of the immune system (blocking, balancing, and/or retraining)

Again, sounds reasonable, right? Some of these practical cures are beginning to look like they may not make the 2025 timeframe cut-off, but you never know, right?

Every year, JDCA issues a report that tells potential donors which “practical cures” are more likely to pull ahead. Here are the 2014 “Potential Practical Cure Solutions,” found in the JDCA State of the Cure report. (2015 hasn’t been published yet, but expect it in the fall as in previous years) – and I’m going to show you where the funding is coming from. 

JDCA’s 2014 Potential Practical Cure Solutions

These solutions are broken down by type of “practical cure” and gives you the basic info into what it is, where this is in terms of “potential” release into the community and who is funding it. (For my own personal curiosity, I have delved deeper into some than others.) As a reminder, Part 1 is ONLY transplantation. Part 2 is the rest of the “practical cures.”

Transplantation

VC-01

(ViaCyte – a privately held, for profit company)

-San Diego, CA

What it is (straight from ViaCyte’s website):

ViaCyte’s innovative product is based on the differentiation of stem cells into pancreatic beta cell precursors (PEC-01™), with subcutaneous implantation in a retrievable and immune-protective encapsulation medical device (Encaptra® drug delivery system). Once implanted, the precursor cells mature into endocrine cells that secrete insulin and other hormones in a regulated manner to control blood glucose levels. ViaCyte’s goal is a product that can free patients with type 1 and type 2 diabetes from long-term insulin dependence.

Where it is in the pipeline of “practical cure”:

ViaCyte, Inc. announced in July 2014 that it had filed an Investigational New Drug application (IND) with the United States Food and Drug Administration (FDA) seeking to initiate a Phase 1/2 clinical trial in patients with type 1 diabetes, and in August 2014 the IND was accepted, allowing clinical testing to commence. This first-in-human trial will evaluate the safety and efficacy of ViaCyte’s VC-01™ product candidate, a stem cell-derived, encapsulated cell replacement therapy. ( Viacyte’s website)

They are in Phase I/II clinical trials at two locations, with an expected trial end date of August, 2017 with an estimated enrollment of 40 participants. Note: According to Wikipedia, “The percentage of Phase II trials that proceed to Phase III, as of 2008, is 18%.” Estimated commercialization date is unknown, but safe to say more than five years off.

Who is funding this “practical cure”?

JDCA forgets to include this:

JDRF is a major funder. 

ViaCyte has received substantial financial support from both the California Institute for Regenerative Medicine (CIRM) and JDRF. (Direct from the front page of ViaCyte website.)

Additional funders/partners include: Cellular Dynamics International, Invitrogen, now a part ofLife Technologies, Nestlé Institute of Health Sciences, Seventh Framework Programme, StemCell Technologies, Johnson & Johnson Development Corporation, Sanderling Ventures, Asset Management, BD Ventures LLC, Hospira, Inc., Portage Venture Partners, and The Clayton Foundation.

Note: What happens when/if it becomes commercially available? Janssen has signed an agreement with ViaCyte.

The agreement provides Janssen with a future right to evaluate a transaction related to the VC-01™ combination product that ViaCyte is developing for type 1 diabetes. This right will continue through the initial evaluation of clinical efficacy of VC-01.  ViaCyte received $20 million from Janssen and Johnson & Johnson Development Corporation (JJDC).  The payment included a rights fee and a note convertible into equity at a later date.  JJDC has been a long-standing investor in ViaCyte.


 DIABECELL

(Living Cell Technologies – a multinational for-profit in a joint venture with DOL)

– New Zealand, Japan

What it is:

DIABECELL is an insulin-producing cell product derived from pigs for the treatment of type 1 diabetes. These islet cells are self-regulating and efficiently secrete insulin in the patient’s body.

The treatment involves introducing encapsulated pig cells into the patient’s abdomen in a simple laparoscopic procedure. Living Cell Technologies’ unique proprietary encapsulation technology prevents the islet cells from being attacked by the patient’s immune system. This allows the use of cell therapies without the need for co-treatment with drugs that suppress the immune system, which often have negative side effects.

Where it is in the pipeline of “practical cure”: 

To date, a total of 46 patients have taken part in clinical trials of DIABECELL. The goals of these trials have been to find the optimal dose required for DIABECELL and to obtain early indication of its effectiveness in controlling type I diabetes. These trials showed that DIABECELL has the potential to significantly reduce the number of unaware hypoglycaemic events that people living with Type I diabetes experience, whilst also reducing their insulin dose and not experiencing a rise in HbA1c.

DOL is now preparing for a larger Phase II/III study to more fully determine the frequency and extent of this benefit.(Taken from Diatranz Otsuka Limited (DOL) website.)

The clinical trial results for DIABECELL are located here.

Highlights:

Phase I/IIa safety study (Russia) – Two out of the eight trial patients discontinued insulin injections for up to 32 weeks. (The assumption being that after 32 weeks, they resumed insulin injections.)

According to Seeking Alpha, an investment media company: “Mostly, the results are more modest involving decreased insulin injections and significant reduction in unaware hypoglycemic events.”

There are currently no clinical trials offered through Clinical Trials.gov (a global trial locator). 

Who is funding this “practical cure”?

LCT is an Australian for-profit company with headquarters and operations located in New Zealand. They have a joint venture with Diatranz Otsuka Limited (DOL). In June of 2015, DOL announced:

Diatranz Otsuka Limited (DOL), is to concentrate its research and development activities in supporting the development of DIABECELL® in the United States. As a consequence, research, development and manufacturing of DIABECELL in New Zealand will cease and there will be a reduction of staff at DOL’s headquarters in Auckland.

Otsuka Pharmaceutical Factory, Inc. (OPF), DOL’s 50% shareholder, is full sponsor and funder of the US program, operating under and exclusive license from DOL for US development and commercialisation of DIABECELL. Since securing the license, OPF has made positive progress, establishing a solid partnership framework for the US development.

DOL’s know-how, research to date and clinical experience in pig islet transplantation will be actively combined with OPF’s global drug development expertise and these partnerships to further strengthen and expedite the US development program.

This alignment of DOL’s expertise with the US program is part of DOL’s previously announced commitment to focus on the US development and FDA approval of DIABECELL. Once registered in the US, DOL retains a royalty free right to commercialise the FDA approved product in the rest of the world.

And of greater interest, Seeking Alpha says of DOL:

Otsuka is a formidable Japanese company with an established presence for its products in the US. Most notably its Abilify antipsychotic drug (shared with Bristol-Myers Squibb (NYSE:BMY)) generated $6.5 billion in US sales in 2013 (a top 10 US drug). To show it is no shrinking violet, Otsuka is involved in a fight to keep out generic versions of Abilify by suing the FDA!

Here is the press release from OPF.

None of these companies are non-profits and expressly state that they will sell and commercialize this product. They have not requested funding for cure research from the public. 


 

ßAir Bio-Artifical Pancreas

Beta-O2 Technologies

– Tel Aviv, Israel

What it is:

The ßAir Bio-artificial Pancreas is a macrocapsule that contains islets of Langerhans, cells from pancreatic regions of the body that contain hormone-producing beta-cells. The macrocapsule provides a fully isolated environment for the islets to thrive. The islets in the bio-artificial pancreas replace the function of the endocrine part of the pancreas; i.e., the sensing of the level of glucose in the blood and the regulation of the production of insulin and glucagon as needed.

ßAir has the potential to ‘normalize’ the lives of people living today with type 1 diabetes. How? Of greatest importance, the ßAir bio-artificial pancreas eliminates the need for frequent glucose testing and insulin injections. Immunosuppressive therapy, which has many side effects, is also not required.

Note: as the ßAir device contains ‘living’ cells, the patient must commit to keeping them healthy. Once every 24 hours, the patient needs to refill the air in the device using a replenishing device which includes a dedicated injector. This guarantees that the cells will have the requisite oxygen supply to thrive and perform their insulin and glucagon production role.

Replenishing the device is performed by injecting oxygen into one of two ports implanted under the skin. The replenishing device is very user friendly, requires minimal technical skills for operation, and has very few possibilities for incorrect operation. The replenishing procedure takes just about two minutes. An alarm will trigger if something has gone wrong. (Beta O2 Website)

Where it is in the pipeline of “practical cure”:

Phase I/II clinical trial being conducted in Sweden. Last verified in December, 2014 with a study completion date of March, 2016. 8 people are to be enrolled in this study. No results have been reported.

Who is funding this “practical cure”?

JDCA forgets to include this:

JDRF funded this company in 2014 to help get this clinical trial going.

Here’s the list of additional investors. As of this time, there has been no appeal to the general public for donations.


 

My Conclusion from Part 1:

For all the talk about JDRF not helping to fund a “practical cure,” I’m here to show you that JDRF is helping. Perhaps not to the extent that JDCA deems acceptable.

Who is JDCA to determine how much is acceptable?

Their “survey” of 1,000 donors in 2014, conducted by a third party (but where did they get their donor responses? Ask yourself that as they didn’t publicly state it in their report) claims that 88% of donors want their donations to go to “cure research.” The questions were targeted to invoke “cure” responses.

And before you jump on me saying that I’m a shill for JDRF (or ADA, who hasn’t been mentioned by me yet)… be very aware of this fact:

I donate to one of the “practical cures” that JDCA touts.

I’ve asked others for their help in funding this “practical cure.” I also donate to other diabetes non-profits, some big and some small, because I know (from my own thirty-two years of T1 diabetes) that while

I would sell everything I own to have a cure, crawl across a minefield strewn with broken glass to not have this horrible disease haunt me

in the meantime, we need support and research for the complications from this disease.

Every time a parent complains about a school issue in the US, every time a child gets a T1 peer or mentor, every time a teenager goes to a summer camp where diabetes is the norm, every time a family member views their loved one’s BG graph on a device from miles away… those donations matter, too. 

Conclusion: DO. YOUR. OWN. RESEARCH. 

More information is coming in Part 2, including JDCA’s practical cure solutions: devices (1) and immune system modifications(4).

Don’t be surprised. Or disappointed.

I was told in 1983 there would be a cure in five years. I’ve waited this long. We’ll all be waiting a little longer.

* I have chosen not to link to JDCA’s website. On purpose. They’re easy to Google if you want to see what I did. I’ve linked to the deep dive stuff.


 

Got Twitter? Simply click this link to share this post. 

If only everything was that easy.


 

The Flu Shot & The Porcelain God

It's cute and orange, but I still don't want to pray to it.
It’s cute and orange, but I still don’t want to pray to it.

I hate to puke.

Whatever you call it: technicolor yawn, tossing your cookies, ralphing, or my favorite… “praying to the porcelain god”, I try to avoid doing it at all costs.

I don’t think there is anyone who thinks it’s something fun to do. (Please correct me if I’m wrong.)

“What’cha up to?”

“Not much. I’m bored, so I’m just going to puke my brains out. Want to come over and watch?” 

I get a flu shot every year now, because I have zero desire to lose my lunch (or dinner or breakfast) or feel like a freight train has run over me due to the inability of other people to wash their hands or cover their mouths.

A fellow T1 asked in a FB status about flu shots and I was surprised to see the myriad of responses. Some were positive, some were negative, and some left me scratching my head, wondering where they got their info.

I realize that if you’re reading my blog, you’ve got at least a few brain cells to rub together. (Take that compliment and run with it.) You may already have an opinion on flu shots, so let me give you some facts. (And then I’ll give you my opinion, because… well, it’s my blog.)

Here’s what the CDC has to say:

Over a period of 31 seasons between 1976 and 2007, estimates of flu-associated deaths in the United States range from a low of about 3,000 to a high of about 49,000 people. During a regular flu season, about 90 percent of deaths occur in people 65 years and older. The “seasonal flu season” in the United States can begin as early as October and last as late as May.

During this time, flu viruses are circulating in the population. An annual seasonal flu vaccine (either the flu shot or the nasal-spray flu vaccine) is the best way to reduce the chances that you will get seasonal flu and spread it to others. When more people get vaccinated against the flu, less flu can spread through that community.

So, read that last sentence again. Go ahead. I’ll wait.

Sometimes it’s not about you. It’s about the people around you. It’s about the woman ahead of you in line at the grocery store with the premature son at home. It’s about the guy next to you on the subway who takes care of his elderly parents. It’s the schoolteacher. The bus driver. The retail store employee who can’t take a week off because the paycheck pays the rent.

And the CDC page about the flu continues on to say who should definitely get a flu shot:

  • People who have certain medical conditions including asthma, diabetes, and chronic lung disease.
  • Household contacts and caregivers of people with certain medical conditions including asthma, diabetes, and chronic lung disease.

Look! We’re on the list! Hooray for us! And wait… those people around you? Yep. They’re on the list.

Getting a flu shot may not prevent you from getting the flu. As they say, nothing in life is guaranteed except death and taxes. But the likelihood of death by flu is diminished by getting a flu shot, which can prevent flu-related complications, per the CDC.

“But the flu vaccine has live viruses in it! No way am I taking something like that! I’ll just get the flu!”

That would be a no. No, a flu vaccine cannot cause you to get the flu. If you have a flu shot, you get a vaccine with viruses that have been ‘inactivated’ and are not infectious, or with no flu vaccine viruses at all.  If you get the vaccine through a nasal spray, while it does contain live viruses, the viruses are so weakened that the CDC claims it cannot cause the flu.

Influenza is a respiratory illness, but for some (like me), we get additional symptoms for free – like fertilizing the lawn or your floor or the inside of your wastebasket. For those who do get the flu, you’ll recover in a few days (up to two weeks). For others, it can progress to pneumonia, bronchitis, ear infections, sinus infections….or worse. I don’t want to be the “worse”. Hospitalization is worse. Death is worse.

(And healthy kids who die from influenza and didn’t get a flu shot? I can’t keep quiet about the need for everyone to get one. Check out Families Fighting Flu.)

You may have your reasons for not getting a flu shot. I’d love to hear them. Seriously.

If you haven’t gotten your flu shot, but plan on doing so, you can help the Juvenile Diabetes Research Foundation raise money by going to Walgreen’s or Duane Reade by October 31st and give them this coupon. The pharmacy will donate $1 for every flu shot, up to $100,00. I call that a win-win.

Now, onto my opinion.

I used to avoid getting a flu shot, down to flat out lying to my parents about getting one when I was younger. I’m petrified of needles and intramuscular injections. Seriously. What changed my mind? The realization that if I got sick, someone would have to take care of me and I would be putting them at risk and forcing them to take time off from work or taking them away from their own families. Financially? Being stuck in a hospital isn’t as bad as being stuck with a huge bill afterwards that could have been avoided.

Last year, we all got flu shots. And yes, when the flu came round, we did all get sick. ONE. DAY. EACH. Round robin style. I knew people who did not get a flu shot who spent weeks being sick – and then more weeks tending to other family members who got sick.

So, now I pull up my big girl pants, turn my face away and close my eyes while the nice medical person jabs me.

And the porcelain god in my house will hopefully have no one to pray in front of it.

Amen.