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August 25, 2016 1

Part 1: Testing And the Lancing Device

Editor's Note: Last month, DTC Perspectives' President & Chief Operating Officer, Scott Ehrlich, was diagnosed with diabetes. Join us in the multi-part series as he shares a first-hand account of his experiences as he moves along his treatment journey.

About a month ago, I went for a blood test and found out my A1C was over 10%. This, combined with an unexplained weight loss of about 30 pounds, led doctors to the obvious conclusion that I had joined the ranks of about 30 million Americans who had diabetes. At this point, the two major questions were which type of diabetes, and how can I treat it? Because it came on suddenly and quite severely, my doctors suspected type 1. I, knowing my diet and physical activity regime over the last 30 years, suspected type 2.

As diabetes is very complex, it's more than just taking medication every day to treat this disease; there is a great deal a patient has to know about diet, exercise, devices, drug interactions, dosing, and testing. As there was so much to take in, I decided to detail my experience as a newly diagnosed diabetic and the challenges I have faced, having spent so much of my time on the marketing side, to now be on the patient side. In this article, I detail with the lancing devices I have had to learn to use. My future articles will deal with the various monitors and medications available, and the overall consumer experience of being a newly diagnosed diabetic.

After going to my GP with my initial blood results, I went to an endocrinologist for a follow-up. After taking a quick and painful finger prick with the lancing device at the office, they quickly confirmed that I had diabetes, with a fasting blood sugar of 273mg/dL at that time. (A normal result for fasting blood glucose ranges from 70-110 mg/dL.) I was also told that the blood work, to determine which type of diabetes I had would take a week. However, because of how high my blood glucose was and that the doctor suspected type 1, he decided an aggressive course of treatment should be tried, well beyond diet and exercise. Being that I was deathly afraid of needles, this was awful news for me. I was told I needed to test my blood sugar at least four times a day and inject insulin into my stomach three times a day on a sliding scale depending on where my glucose was. After a very brief demo, the nurse sent me home with an Accu-Chek meter, a FastClix pen, and 100 units/mL of Humalog fast-acting insulin.

Testing with the Well-Knowns

The first thing to deal with was the testing. I had read, prior to this visit, that FastClix was one of the preferred pens of diabetics as far as reduced pain and ease of use was concerned. The FastClix device was small and came with a cartridge for lancing devices that held six lancets. When pushing the button, you never actually saw the needle, which was good for a needle-phobe like myself. After mustering up the courage to prick myself, I put it on the second lowest depth and proceeded to prick the side of my finger. The button to give the injection is like the button on the back of a pen, except you have to push pretty hard. I kept pushing and pushing, holding my breath, waiting for that stinging pain. Finally, after pushing down a good bit, it finally kicked into action, the lancet pricked me, a little blood bubble was drawn, and I had done my first test.

I was pleasantly surprised to see that this really didn’t hurt. However, I was not happy that it wasn’t comfortable and, the knowledge that I’d have to do this three to four times a day at least, every day, for possible the rest of my life, would leave my fingertips pretty torn up. This was confirmed by the fact that, by the end of the second or third day, and even though I would switch up fingers, they were pretty sore. There’s not a lot of places you can inject on the fingertips and, being useless with my left hand, there is really only one hand I could use for the pen. FastClix also isn’t meant for alternate site testing so I could see my index and middle fingers on my left hand were due for a rough ride. Still, for the price and ease of use, as well as the lack of any real pain (like briefly pricking your fingertip on a thorn at worst), it could have been a lot worse than the FastClix.

Trying an Alternative Device

Still, I was concerned about the frequency of the testing and the accumulated discomfort. Knowing I had to do this a lot, I tried to see if there were any devices that could be better and provide less discomfort or more choices as to where to do the testing. I came across an interesting device called Genteel, developed by an engineer. There weren’t a ton of reviews I could find on it and the price of $129 for a lancing device seemed a bit steep, compared to the $20 or far less most others would cost. Furthermore, most of the positive reviews I could find either came from the site itself or from people given a free sample for testing. The website featured a video of a sleeping child getting tested on their shoulder by a parent and not being woken, which also seemed hard to believe. Still, hating needles more than I hated parting with my money, I decided to order one and give it a try, as it's only available via online order.

When I received it a few days later, it was much bigger than the other device and came with a bunch of highly visible lancets. There are also some attachments you put on top to control the depth of the stick. It is certainly less intuitive than the FastClix, with a lot more moving parts, to start. I put on the one for the smallest stick, which is largely recommended for finger sticks, since body skin may be thicker. I set it up, put it on my shoulder as in the video, and pushed the button. At that point, the plunger pops up and you are supposed to hold the button for a few seconds before taking it off. Aside from the loud pop it makes when you push the button, I didn’t feel anything. No stick, no pressure like with the FastClix. I took it off and figured I’d need to put on the cap for a deeper stick on the arm when I looked down and saw a perfect blood droplet sitting there. I couldn’t believe it.

I tried the same thing on my finger. It wasn’t easy to find a spot on my fingertip that would fit the device at first due to its size, and also it needs a vacuum seal to work properly. However, once I lined it up right and did it, it was much the same result. Painless, and, unlike the FastClix, largely sensationless. You’d also usually draw more blood with each prick, even on the lowest depth, which could be very helpful in machines that require a good amount of blood for each test (more on these in the next article).

One of my only complaints about it is that, for the price, it's not the most durable device. I dropped it on the floor when trying to set the plunger and the back part fell off. While it is removable for cleaning, it was a pain to get back on and even when I did finally get it back on, the device didn’t work properly, either flying off when I tried to test or pricking way too deep leading to real pain. I was able to get it working again, however, in a few hours and I am certainly no engineer when it comes to fixing devices. I was also sent another device immediately after I said something to their customer service rep, who was available to be reached through an online chat, on a Sunday night no less. Their service is superb. My only other issue with this device is that it is a bit bulky compared to others, so carrying it in a pocket or a small carrying case, such as the one provided, along with my other diabetes supplies, isn’t easy. However, it’s a great device and I haven’t used my FastClix since I received it.

Factors Impacting Compliance

Testing is one of the most important things for a new diabetic to learn and compliance with testing is paramount, regardless of the type or severity of the disease. With the FastClix, I didn’t fear testing, but I certainly would not do it more than I had to; I sometimes had to talk myself into it. With Genteel, I had no trouble convincing myself to test. In fact, I was testing so frequently I ran out of my first month’s supply of testing strips in about a week. For someone like me that hates needles, doesn’t do well with pain, and likes to be able to vary their testing sites, Genteel has been a tremendous help in frequent testing, the first step in keeping my blood sugar numbers stable.

However, I am also a consumer that has both means and did a lot of research. Neither my endocrinologist or his assistant had ever heard of it. Most insurances won’t cover it. It doesn’t come with any glucose meter. There is no DTC behind it. It's not sold at pharmacies. So most consumers will be using something like the FastClix or the OneTouch Delica (which came included with my OneTouch Meter). These are good devices and I’m sure much better than what preceded them. They are cost effective (both of them were free for me) and get the job done. They both come with glucose meters, are widely available, and are backed by well-known and respected companies.

If testing was infrequent, cost was a major driver, or the patient was a bit tougher around needles than I was, I think both would be perfectly sufficient. However, if you were like I was, and building up the courage to do each and every single finger prick was a struggle, the Genteel was well worth it. And if my two-year-old son, for example, was the one who had diabetes instead of me, the Genteel is a no brainer. It has been a game changer for me in maintaining testing compliance, and pharma companies would do well to integrate it or a similar lancing device into their treatment packages. Because no matter the diabetes type, no matter the severity, no matter the treatment plan, regular and frequent testing is a necessity. That becomes much harder when the patient has any amount of fear of or dislike for their lancing device.

 

Scott Ehrlich


August 25, 2016 1

JenniferAniston-ShireShire and Digitas Health LifeBrands (the agency of record) announced a new celebrity spokesperson today, partnering with Jennifer Aniston to raise awareness and understanding of chronic dry eye. By sharing her own experiences with the condition, she hopes to “educate and inspire people” to learn and communicate more with their healthcare professional. According to the news release, the educational awareness campaign, eyelove, is “inspired by the wonderful things we can do and see because of our eyes.” As part of the campaign, NYC's High Line will host an “eyelove art project” in October, encouraging visitors to share their own stories and “[create] a unique artistic image of their eye via a customized photo capture. The photo will then be projected onto a large screen, showcasing each person’s one-of-a-kind eyelove art. Participants have the option to share their eyelove art via social media channels. People can also visit www.myeyelove.com to create their own art.”

Another component to the campaign are two unbranded television ads – one with and one without Jennifer Aniston. The ad with their celebrity spokeswoman showcases the actress discussing her own experience with dry eye before she “finally decided to show [her] eyes some love”, followed by a female voice over suggesting consumers talk with their doctors. The non-celebrity TV ad focuses on three different women, each enjoying their favorite activity, or, “the things [they] love to do with their eyes”, as a female voice over states before urging consumers to talk to their doctors.

Click here to read more about Jennifer Aniston's partnership with Shire's disease education launch campaign.

Jennifer Kovack


June 22, 2016 0

The American Society of Health-System Pharmacists (ASHP) has joined the American Medical Association (AMA) in calling for a ban on DTC advertising. Announced during an annual meeting of the ASHP House of Delegates during their Summer Meetings and Exhibition last week, the national pharmacist group approved a new policy calling on Congress to ban all DTC advertising. This action demonstrates a move away from their previous policy – which was first adopted in 1997 and repeatedly refined over the years – that opposed DTC ads unless they met certain criteria.

The organization cited a 2002 Government Accountability Office (GAO) report, which stated that “pharmaceutical companies have increased spending on DTC advertising more rapidly than they have increased spending on research and development … DTC advertising appears to increase drug spending and utilization.” ASHP also opined that despite FDA regulation being “generally effective” over DTC, their “oversight has not prevented the dissemination of misleading advertising by some pharmaceutical companies.” ASHP CEO Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP, stated via the news release, “ASHP believes that medication education provided by pharmacists and other providers as part of a provider-patient relationship is a much more effective way to make patients aware of available therapies, rather than relying on direct-to-consumer advertising.”

While this is just the latest news to put DTC in the crosshairs once again, instituting a ban would ultimately harm knowledge sharing and patient empowerment. DTC not only creates awareness, it also helps educate consumers with accurate information, leading to better doctor discussions, decision-making, and, ultimately, patient outcomes.

Jennifer Kovack


June 22, 2016 0

Following the logic of value-based purchasing, drugs with promise of extending life and treating rare diseases should have a higher purchasing value than those with unclear clinical efficacy results and economic benefits. Sounds reasonable. However, what the healthcare system is lacking is a straightforward method of assessing which drugs are both efficacious and cost-conscious.

To address this need for standardization of the clinical decision making process, The National Pharmaceutical Council is developing “Guiding Practices for Patient-Centered Value Assessment Frameworks”. Leading the pack is Steven Pearson’s Institute for Clinical and Economic Review, known as ICER.

To read more about valuing breakthrough formulas, click here.

Lily Stauffer


April 5, 2016 0

Commonly regarded as an ancient practice, drug compounding may be making a comeback as industry professionals are seeing it as an “essential antidote to spiraling drug prices”. However, high costs of compounding utilization cause a significant financial burden on commercial and government health plans. For this reason, many observers see both positives and negatives. As demand for specially tailored health and medical products continues to increase, compounding has grown to account for the need. When compounding on a large scale, however, there are serious health concerns, such as the meningitis breakout in Massachusetts in 2012.

To read more about the pros and cons of drug compounding, click here.

Lily Stauffer


March 30, 2016 0

home theater

The significant majority of pharma budgets are often spent on TV media due to its wide reach and being a great starting connection with consumers.

In a recent study by TiVo, which was not pharma specific but rather covered a broader TV industry perspective, found that reducing TV ad spend led to a loss in ROI for 11 of 15 brands studied. Conducted in partnership with consultancy engagement firm 84.51° (a wholly-owned subsidiary of The Kroger Co.), TiVo research discovered that “for every dollar decline in ad spend, the 11 brands lost 3x that amount in return.” The white paper was sponsored by media companies such as A+E Networks and Turner.

To read more about the TiVo report, “Independent Study Confirms That Decreased TV Advertising Spend Hurts Sales,” click here.

Jennifer Kovack


March 28, 2016 0

The FDA has recently noted that there appears to be a trend of serious adverse events among those taking anticoagulants, which may be linked to faulty performance of blood clotting monitors. Senior FDA official Dr. Alberto Gutierrez recognizes this trend, but explains how it is difficult to measure how often these deaths are directly due to device malfunctions. This is because many people taking drugs such as Warfarin are prone to fatal events such as strokes and irregular bleeding. All factors considered, the FDA estimates eighteen deaths in the past two years were linked to erroneous readings. One theory, proposed by Sidney M. Wolfe, Senior Advisor to Public Citizen Health Research Group, suggests that the faulty devices can be attributed to the lack of proper FDA approval process. He continued by explaining how the FDA pushes these products through quickly because they only require that companies prove their device are substantially equivalent to one currently on the market.

Research on this topic has only scratched the surface, and industry professionals such as Wolfe believe that the FDA should continue their investigation into such devices.

To read more from WSJ, click here.

Lily Stauffer


March 28, 2016 0

As a result of the sudden Zika virus outbreak, both big pharma companies and non-profits alike are diving head first into vaccine research in hopes of halting this life-threatening virus. First to the table was Sanofi Pasteur, announcing that they “would lead the way against Zika”. Following their successful launch of the dengue fever vaccine, Sanofi is confident they can tackle Zika as the two viruses are similar in nature. Apart from Sanofi’s progress, the WHO has announced that fifteen other groups, both government agencies and big pharma are also working on a vaccine formulation.

To read more about progress on the Zika vaccine, click here.

 

Lily Stauffer


March 18, 2016 0

This year’s DTC Perspectives Top 25 Marketers of the Year list includes ad campaigns both old and new. In addition to the long-advertised household names such as Viagra from Pfizer and Crestor from AstraZeneca, brand managers for some up-and-coming drugs made the cut as well. Such campaigns include Jardiance from Eli Lilly, Belsomra from Merck, and Entyvio from Takeda. Jennifer Kovack, Director of Publishing and Awards at DTC was quoted saying, “the mix of young and old drug campaigns is relatively new to the awards, partly because of the way the industry is changing and adopting more patient-centric marketing methods”.

To read the full article from Fierce PharmaMarketing, click here.

For the complete Top 25 Marketers list, click here.

Lily Stauffer


March 18, 2016 0

Despite pressure from all angles for stricter limits on prescription drug ads, the industry continues to expend billions on their campaigns. Sky-high spending has been continuously increasing over the past few years; surpassing the $5 billion mark this year. It is estimated that one quarter of this $5.2B came from five campaigns: Humira, Lyrica, Eliquis, Cialis, and Xeljanz. According to DTC Perspectives CEO and Chairman Bob Ehrlich, “there’s no doubt that [direct-to-consumer advertising] is now seen as almost a must-do for a drug that wants to be big”.

To read more about the controversy over pharmaceutical advertising, click here.

Lily Stauffer