Is JDRF A Donor-Centric Organization?

Back in December 2006, JDRF published an interview that Kelly Close conducted with the organization's then-incoming Chief Executive Officer (CEO) Arnold W. Donald. (That interview can be downloaded here.)

I recently re-read that interview because I recalled Mr. Donald making some statements about how he felt that JDRF needed to become more a "donor-centric" organization, and I was looking for the quote. I was also comparing Mr. Donald's view and trying to understand how the new CEO, Alan Lewis will address this issue. I found the quote from former CEO Arnold Donald, and have provided an excerpt from that interview below:

Interview with JDRF CEO Arnold W. Donald, Publish Date: December 2006

KC: Where do you think there is the most potential for improvement in the [JDRF] organization?

AD: Wow. The most potential. I haven't [ranked] it that way ... I come from a continuous improvement orientation, and I see improvement opportunities everywhere. I don't care how good something ism you can always improve, but I would say first and foremost is our ability to live our intent of being donor-centric.

KC: How do you mean?

AD: Every donor or volunteer should feel that they are totally connected to JDRF. They should feel they are proactively communicated with. That their connection to type 1 is understood by JDRF. They should be treated with integrity and caring and know that their opinions count. It doesn't mean we are always going to do exactly what a given volunteer's opinion is, but if they understand why we've done something, even if they would do it differently, it creates the basis of alignment.

KC: Right. But how do you get everyone on the same page?

AD: It requires a lot of components. Number one, it requires orientation of behavior by all of the staff. It requires certain technology, databases, information systems, and what not, that we're working on and we've had some issues with and we're organizing around trying to address. If you don't feel like it's a donor-centric organization when you get the same letter three or four different times, or your name comes and is misspelled, or it comes and it's referencing a child that's not yours, then that's a problem. So having the right information in databases is important.

KC: That counts.

AD. These are little things, but they are symptoms of a more core issue of being truly best in class of being donor-centric. For example, we have tons of communication. I couldn't tell you all the different communications we have. Having said that, I can't tell you how many times I've been told by volunteers, donors, and staff that they don't feel communicated with. So therefore, in that mix somewhere we don't quite have it right, and communication is everything. So we're going to have a difficult time being truly donor-centric of people don't feel like we're communicating effectively with them.

A few months later, in the 2006 State of the Foundation Address, Mr. Donald again spoke about the efforts the organization was making to build it's donor pipeline, especially with it's high-net worth cultivation and stewardship strategy. In his address, Mr. Donald made the following statement:

"We've determined that our donors want information on research that is clear, concise, and targeted to their interests. Information that shows milestones and outcomes on their investment; regular research reports; site visits; and phone conferences with researchers. We're finding that we're engaging both current and prospective donors in an ongoing dialogue that involves them in JDRF's research program in deeper and more committed ways, and motivates them to make new and significant leadership gifts."

Of course, as JDRF's 2008 Annual Report notes that while 2008 was a banner year for JDRF in terms of fundraising and research dollars allocated, the organization expects an extremely tough year in 2009, and is expecting that to continue possibly into 2010.

Now, I certainly do not want to diminish the importance of major donors (who attend some of the organization "galas" to the tune of $500 or $1,000 a plate), and big donors are indeed valuable, but I was curious if everyone in the Diabetes O.C./online donor community feel like JDRF is truly donor-centric, by sharing the latest-and-greatest research news, and presentations with us?

Personally, I've never attended a JDRF gala (frankly, I'm not sure I'd even want to) nor would I spend such an amount to attend a back-tie party, but I have consistently raised a few thousand dollars each year in my walks, yet I get the sense that I'm not a big enough fundraiser to be entitled to get such information. Often, I feel like JDRF is more interested in stupid black-tie parties than in addressing my need to feel like JDRF keeps us as well-informed about different programs the organization funds with the money I help raise.

Case in point: I had to really search out information about Industry Discovery and Development Partnership (IDDP) program and translational research efforts, and most of the information I found came from sources other than JDRF. Is it really so hard to put a Powerpoint presentation on the organization's website? I don't think so.

Well, the great news is that JDRF's New England Chapters (collectively, except for a few chapters in Western Massachusetts and Connecticut) have done an excellent job of addressing this deficit ... with a blog, and that blog has some good stuff you might want to check out. These include presentations, videos, and other information so that anyone can see these things, not a privileged few who managed to attend the original event. Among the items they share is presentation from Todd Zion about the SmartCells program (the bad news: human clinical trials are still quite a way off ... Phase 1a clinical trials are not scheduled to begin until Q2 2010). Also, catch my interview with SmartCells' CEO Todd Zion from back in 2007.

I basically lifted almost all of their content in their update from April 2009, but be sure to catch their archives, too -- they contain some good stuff that should make other JDRF chapters look to replicate! FYI, their blog can be found at http://jdrfne.blogspot.com/, and the specific post I'm referring to can be found here, but also be sure to browse through their archives, too -- there's some good stuff there!

JDRF New England Chapter's Tenth Annual Spring Research Briefing
Wednesday, April 22, 2009

The Tenth Annual Spring Research Briefing was held on Monday, April 6, 2009 at the Boston Marriott Newton. The information shared that night was an inspiration and surely proof that our quest for a cure is closer to reality than ever.

We heard from two excellent presenters: Dr. Alan Lewis, JDRF's new President & CEO, and Dr. Todd Zion, Co-founder, President & CEO of SmartCells, Inc. Dr. Lewis introduced himself to the JDRF family in the New England area and shared his perspective of diabetes research currently and his vision of where JDRF can help expedite progress toward a cure. Dr. Zion focused on research being done on a product being developed at his company, SmartInsulin, a once-a-day, glucose-regulated, injectable formulation for treating diabetes.

Following you'll find video and slides of the evening's presentations, as well as video of the question and answer session with our presenters. A special thank you to Victoria Bergantino, Greg Ford, Geoffrey McLaughlin, and April Watkins of Bentley University (Bentley is my alma mater!), and to their professor, Mark Frydenberg, for making this possible!


Tuesday, April 21, 2009
Dr. Alan Lewis, President & CEO, JDRF


Presentation from Dr. Alan Lewis

Presentation from Dr. Alan Lewis

View more presentations from BringingTheCureHome.

Dr. Todd Zion, Co-founder, President & CEO, SmartCells, Inc.
Tuesday, April 21, 2009


Presentation from Dr. Todd Zion

Presentation from Dr. Todd Zion

View more presentations from BringingTheCureHome.

Question and Answer Session


Clinical Trial Initiative

Finally, I should also just include the organization's Clinical Trial Public Service Announcement (PSA) which coincides with a new tool they've added to find type 1 clinical trials.

To find a cure, JDRF needs people with type 1 diabetes to consider participation in human clinical trials of experimental new therapies.

The JDRF Type 1 Diabetes Clinical Trials Connection is here to help people with type 1 diabetes better understand what is involved in participating in a clinical trial, and to simplify the process of finding trials that may be of interest to them or to their family members.

The goal of this service is to serve as a resource on the latest research advances, new research studies, and information about opportunities to participate in clinical trials.

Participating in a clinical trial is an important way for people to help to find a cure for type 1 diabetes and its complications. That's particularly true today, when JDRF's nearly 40 years of research leadership has brought us to the point where scientific advances made in the laboratory are being tested in people.

Clinical Trial PSA (YouTube video):



Conclusion? Some JDRF Chapters Are Donor-Centric, Others Have A Lot of Work to Do

I don't know about all of you, but personally, I'd like to see more of these online initiatives from the JDRF National Organization, not simply an innovative local chapter (I don't have great affinity for the New York City chapter anyway, they've been able to coast for years on their location which enables them to have a walk that raises lots of money on a per capita basis, even though the local chapter is dominated by rich "mommies and daddies" who frankly, don't care much beyond their own social circle, but that's a conversation for another day)!

I Do This For Me, Too!

Once again, I've lifted (and slightly altered it) a title for my post today. I've borrowed this one from Chris Bishop, whose blog I've been following for a number of years, and finally got to meet in person last week in Indianapolis.

Chris specifically responded with his feelings to a ... how do I say this ... let's just describe it as a "controversial" post from a blog I've followed for quite some time written by Jenny Ruhl known as Diabetes Update. Jenny's post was entitled "It's Official: I'm Not An Influential Blogger", which was of course, a headline meant to attract readers and it worked pretty well. (FYI, Jenny later followed that post up with another one you can catch here). A number of people who attended the Roche conference were startled by the issues raised in Jenny's first, notably the potential for conflicts of interest within the blogging community, and the subtle (and not-so-subtle) ways that corporate entities (including the pharmaceutical and medical device industries) influence people.

It's no secret this is going on, and in fact, the diabetes industry is a little bit late to the trend ... NPR reported Monday from the BlogHer '09 Conference in Chicago (that several diabetes bloggers also attended, including Allison Blass and Kerri Morrone-Sparling who were also in Indianapolis last week also attended) that Mommy Bloggers at that conference are also struggling with how to deal with "Blog-ola" (the free goodies, products, trips and other perks many marketers are giving to bloggers in hopes of getting favorable publicity or positive reviews). According to NPR, another a hot topic at the BlogHer conference was recent talk by the Federal Trade Commission (FTC) on whether blogs that review products should offer a disclaimer stating whether they are posting paid reviews or are receiving free products in exchange for positive posts.

Until that happens, I'm not going to worry too much, because until the Roche event, I'd only once received any "Blog-ola" ... a meter with some free test-strips from a start-up known as Agamatrix I was asked to try (Roche didn't even give us meters or strips, FYI). In neither case, was I asked to even review the item or reference the event in my blog. But this is certainly a concern, as it is akin to the kind of marketing that has been going on for years (yet is rarely disclosed) with doctors ... the free sample products, the notepads and pens, etc.

Indeed, before I agreed to attend the Roche conference, I thought about whether I too might be potentially corrupted by this subtle influence. But I concluded 2 things: first, unless it becomes a regular issue, I can't worry much about it. If I receive "Blog-Ola" in my mailbox (electronic or snail-mail) on a regular basis, I'll need to reconsider, but as of today, the diabetes industry hasn't noticed me enough to try and buy my influence (I suspect they don't have to; it's doctors who are on their radar screens, and conflicts of interest are a HUGE problem there).

Second, I started this blog to share items I felt the diabetes community (especially the type 1 community) should either be aware of or be concerned about, and perhaps share news. Along the way, I've found it to be personally very therapeutic express things (even if no one reads them). I'm not looking to be the #1 blogger or attract advertising dollars, and I don't worry about statistics. If someone stumbles about something I read and thinks twice about it, I've gotten something from it. But I think the biggest thing I've gotten from blogging is meeting others who also had this invisible disease, and dealt with the same crappy, never-ending treatment demands.

Which brings me to the reason I started this post. I never sought to influence others when I began writing this blog -- if that happens, great. Already, I've met others who are dealing with the same B.S. day after day and struggle with the same crap, so I've gotten what I came to the blogosphere for. I do this for me -- it's a selfish motive, but if I can help someone along the way, I'm a happy man.

The Scam of U.S. Healthcare Reform (Circa 2009)

This week, NPR reported that one of the most powerful players in health care is PhRMA, which as I've noted before, stands for the Pharmaceutical Research and Manufacturers of America. PhRMA is a trade organization that represents some 32 brand-name drug companies, and NPR also reported that this organization now has so much influence in Washington, that when Congress passes a bill, PhRMA almost ALWAYS gets its way, and we're all picking up the tab (except, perhaps, for big pharma's shareholders). Listen to the story here:



PhRMA Lobbying Efforts Lead to Costly Corporate Welfare

We need look no further to the Medicare Drug Bill, which was one of the biggest pieces of corporate welfare to emerge in the U.S. since the great depression (and without serious efforts to reform to this over the long-run, it COULD potentially make the current Troubled Asset Relief Program [TARP] given to banks look comparatively cheap by comparison). A quick refresher on the Medicare Drug program: On January 1, 2006, Congress passed a bill and then-President Bush signed into law new legislation that authorized the government-run healthcare plan for senior citizens known as Medicare to provide an new optional prescription drug benefit. While the merits of that law bill are well known, the cost is an effective sinkhole (growing rapidly with a massive baby boom now entering retirement), and to make matters worse, Medicare cannot negotiate for lower prescription drug prices directly with prescription drug manufacturers!

To cite an example under the U.S. Government umbrella that proves that the current Medicare drug program is corporate welfare, we need look no further to the U.S. Veteran's Administration (VA) for a lesson. The VA has negotiated drug prices that are 20% to 30% lower than the price of drugs available through the 50 or so private plans that currently provide Medicare Part D coverage, and yet no one from the industry is crying they cannot make any money as a result of of the VA's move. The current system is pure corporate welfare. Governments around the world already negotiating prices, but in the U.S., Medicare can't do the same thing. The current system keeps the profit model going for all groups involved (except U.S. taxpayers, of course), including insurance companies, pharmacies, pharmacy benefits managers (PBMs), drug wholesalers just to name a few of the groups who skims a profit from the current system.

Bills have been introduced repeatedly for the past few years to try and address this "little" issue with the law, yet somehow never seem to make it out of committee, let alone be voted on. The drug industry argues that changing the current system would lead to government price fixing, cost shifting and eventual drug rationing, yet these arguments are fictitious without any real evidence to back them. Countries with nationalized healthcare systems routinely negotiate drug prices, yet I've never heard of a shortage of a blockbuster drug like Lipitor which lead to rationing of that drug anywhere on earth.

Former President Bill Clinton was somewhat more diplomatic about it, but he argues that the U.S. effectively subsidizes the rest of the world's drug prices. In an an interview with Larry King earlier this year, the former President said:

"... We have made a bargain with our pharmaceutical companies. We've said to them for decades now, we love having you in America. We're proud of you. We know you have to spend a lot of money on research and then you market the drugs and all.

So we will eat your research and development costs in American prices so that you can sell exactly the same drugs you sell to us for less money in Canada and Europe.

Even our -- for example, our AIDS clinic down the street here in Harlem, the taxpayers pay $10,000 a year to treat people with the big pharmaceutical companies' AIDS medicine. That medicine costs about $3,500 a year in Canada and Europe -- countries with per capita incomes as high as America."

If the Congress is talking healthcare REFORM, we MUST change that business model, but as I'll demonstrate, that isn't happening thanks to groups like PhRMA.

PhRMA Diabetes Industry Players

Among the better-known members of PhRMA in the diabetes industry include: Abbott, Amylin Pharmaceuticals, Bayer HealthCare, Johnson & Johnson, Eli Lilly & Co., Sanofi-Aventis U.S., and Novo Nordisk Inc., as well as most of the largest drug companies (Pfizer, Merck, Bristol Myers-Squibb, Novartis, etc.). Recently, Roche decided to leave PhRMA to another trade group known as the Biotechnology Industry Organization ("BIO"), which is a biotechnology industry trade group with more than 1,200 members worldwide (see here for details). I have similar view of both PhRMA and BIO, and more often than not, BIO and PhRMA seek the same things from Congress. Of note is the fact that many diabetes companies, including Abbott, Bayer Healthcare, Johnson & Johnson, Eli Lilly & Co., Sanofi-Aventis, Novo Nordisk, Pfizer, Merck just to name a few are actually members of BOTH organizations.

In any event, according to the Center for Responsible Politics, PhRMA is the 6th largest lobbyist in Washington based on total dollars spent over the past decade. As I've reported in the past, the Center for Responsible Politics also rates the Pharmaceutical/Health Products industry (including efforts from both PhRMA AND BIO) as the single biggest lobbying group based on total dollars spent among all of 121 different industry and interest group categories the organization profiles, spending a whopping $1,629,694,750 on K-Street lobbying activity between 1998 and 2009.

The influence of an industry trade organization isn't the only way these companies are influencing government policy, or in the U.S. healthcare reform debate for that matter. In fact, many of big Pharma's biggest names (Pfizer, GlaxoSmithKline, Eli Lilly & Co. and Bristol-Myers Squibb) are also each named among the top 200 all-time donors in political contributions.

As I've written previously, pharmaceutical companies are best described as "fair-weather" friends to whichever party is in power at a given time, readily switching their loyalties (and dollars) between Republican and Democratic candidates with almost no hesitation.

Addressing the Cost of Home Diagnostics?

No doubt, my readers heard that there was a bit of conflict when Roche was confronted about the high costs of testing supplies. In essence, the company executive said he was not at liberty to discuss the issue. While participant Kelly Close did note that her own business estimates that the profit margins on testing supplies were declining (she didn't say this, but I can tell you that this is mainly because managed care providers are demanding - and getting - price cuts from the industry). For a box of 100 test strips, while the low-price retail cost is somewhere around $90 to $100, but by some estimates, insurance companies are probably now paying anywhere from $38 to $60 for these items, depending on how much of a volume-based discount the companies can get. But whether the markup is 900% or only 100%, whether they cost a mere $0.10, $0.60 or even $0.75/strip to make, there is little doubt that this business is one hell of a cash-cow.

As a number of diabetes bloggers have written, when Roche Diabetes was confronted by some patient advocates about the cost of test strips, the company evaded the issue. I, for one, was surprised they didn't have a prepared statement to address that issue. Roche claimed they were not at liberty to disclose that information (although truth be told, the U.S. Food and Drug Administration has little to do with their unwillingness to discuss profit margins; this is a business decision not to disclose this information). It should also be noted that Roche's investors might find this information to be valuable to help assess and determine whether the business is healthy. Which raises the question:

Just Who Owns and Controls Roche?

I couldn't find all of details, but it is known cross-town rival Novartis tried to seek a merger with Roche back in 2004 (according to Bloomberg, Novartis AG owns a 33% stake in the company) -- a move that the descendants of company founder Fritz Hoffman-La Roche did not approve. Apparently, in January 2009, the family agreed to keep its stake in a single voting pool for an unlimited period (their voting pact was to have expired at the end of 2009). The family members' agreement includes provisions on the pool's use of its voting rights and restrictions on the sale of its bearer shares -- which is important because sometimes wealthy families bicker and disagree on how to vote. On January 28, 2009, Bruno Dallo, the family representative at Scobag Privatbank AG, said in a statement that the family pool owns slightly more than 50% of the bearer shares in the Basel-based company. Collectively, this amounts around 84% of the company's shares.

This means that any push for more disclosure on the diabetes business would have to be presented and approved to these two very important shareholder groups, which seems highly unlikely unless there is collective pressure to sell this portion of the business, and given its cash-cow status (albiet the business which is not growing as much as it could in the U.S., but its certainly profitable), so it seem unlikely that a movement to influence the key shareholder groups would yield much in terms of disclosure here.

By comparison, other companies such as Abbott or Johnson & Johnson are largely controlled by big institutional investors (for example, in the case of J&J, State Street Global Advisors US is the biggest institutional shareholder, followed more distantly by Barclays Global Investors, Vanguard Group, Fidelity Management & Research, and State Farm Insurance Companies to name a few of the biggies, while Abbott is controlled by State Street Global Advisors US, Barclays Global Investors, Vanguard Group, Fidelity Management & Research and State Farm Insurance Companies -- although these institutional investors' shares are more even in size than JNJ's are).

Disclosure My Personal Holdings

Now, if you really want to know, a bit more than half of my personal investments are largely in the form of mutual funds, which consist of American Funds New Perspective Fund Class A shares, as well as American Funds Investment Company of America Fund Class A shares, and American Funds New Economy Fund Class A shares. The specific stocks these particular funds hold is a matter of public record if you really care to know. These funds do own a chunk of Novo Nordisk (one of the larger holdings, FYI), Teva, Lilly, GlaxoSmithKline and yes, even Roche, but I would hardly consider this a conflict-of-interest. Also, aside from my recent trip to Indianapolis, I've never received any form of compensation and am not about to change my opinion of the pharmaceutical industry's behavior because of a single event.

Ted Kennedy: A Lifelong Passion? Maybe (Not)

Ironically, in a recent essay in Newsweek, Massachusetts Senator Ted Kennedy, who says he has championed health care reform for much of his long career, writes:

"I believe the [healthcare reform] bill will pass, and we will end the disgrace of America as the only major industrialized nation in the world that doesn't guarantee health care for all of its people - And I am resolved to see to it this year that we create a system to ensure that someday, when there is a cure for the disease I now have, no American who needs it will be denied it."

But as the NPR story I shared suggests, there are legitimate questions about what exectly will come out of Congress.

It is a known fact that the healthcare industry, consisting of countless players including drug companies, insurance companies, pharmacy benefits managers, hospitals, doctors and nurse associations, even individuals who do medical billing and coding for work, have a strong interest in preserving the status quo.

Their livelihoods are at stake.

But the money being spent by PhRMA is obscene, and has already shifted the focus away from actually reforming the healthcare "system" (a term I use loosely) to merely one of covering more people. The healthcare industry stands to benefit handsomely from this part of the equation, which explains why they are suddenly willing to "negotiate" as part of this discussion. With this money, some of the old players are back, like Harry and Louise, that nice middle-class couple that was invented by the health insurance industry to dismember the Clinton plan back in the 1990's. Only this time around, Harry and Louise have switched sides and now sound optimistic about an overhaul that provides "good coverage that people can afford."

NPR reports that Harry and Louise still have deep-pocketed friends in the healthcare industry. The ad is jointly sponsored by Families USA, a pro-reform group, and ... surprise ... by PhRMA! Together, they're spending about $4 million. But as my conversation on this subject at the Roche summit demonstrated (and Roche admitted), so far, there is really no discussion of true "reform" going on in Congress. Its all about covering more people. To be sure, that's important, but it's not reforming what doesn't work with the current arrangement.

Ted Kennedy can easily afford the best medical care on earth. He went to North Carolina to have brain surgery from one of the best. But even if he wasn't sitting on a family fortune, he'd still have what some are now calling "gold-plated" healthcare plans, because Congressmen and women are covered by one of the best plans available anywhere, and for the rest of their lives, no less. They'll never have to live within the laws they're considering now because they've exempted themselves from it.

Some in Congress ARE trying to address this issue. For example, Republican U.S. Representative John Fleming from Louisiana (who is a physician, by the way), is fighting to introduce a resolution that would require members of Congress and the Senate to accept the same healthcare regime that they mandate for the public. Fleming has also placed a petition on his website, http://www.fleming.house.gov/.

Fleming's website has a short narrative explaining his resolution on his home page, and a link to the actual resolution. It's brief and easy to understand. While Fleming makes condescending jabs at the idea of a government-run healthcare plan, at least his bill would mandate that our Congressmen and women live by the same rules they're proposing to mandate on everyone else. At the very least, his simple bill deserves consideration, but so far, most of Congress isn't running to co-sponsor the bill (any ideas why?).

Buying Influence to Preserve the Status Quo

As the NPR story previously noted details, Jerry Avorn, a professor at Harvard Medical School and author of the book about drugs and health care called "Powerful Medicines" says just look at what's NOT on the table during the healthcare reform debate if you want to know what PhRMA is getting:

- Drug re-importation from Canada? Off the table.

- Government-negotiated drug prices? Off the table.

"A lot of those seem to have been resolved even before the public discussion begins," says Avorn. "And usually, as with the other interest groups involved, they seem to have been resolved in favor of the interest groups, rather than in favor of the public."

Real healthcare reform ... Off the table?

So far, all that is being talked about is how to insure and get more people into the system. There is little (if any) real conversation about reform.

Having said this, we need to start someplace. Congress has failed to do anything about the many problems our healthcare "system" faces, and we can always start someplace and then worry about revising it later. But we need to speak about REFORM, not simply how to make more companies with vested interests even richer on an already broken system.

My "Spin" on the Roche Summit

I pretty much lifted the title from Kelly Kunik's Diabetesaliciousness, but I hope she won't mind! I'm pretty late in posting my take on the Diabetes Social Media Summit sponsored by the Swiss pharmaceutical giant Roche at their U.S. Diabetes Care HQ in Indianapolis. That's because I had real work to do on Friday (and into Saturday afternoon), so blogging took a back seat. Because of my delinquency on that, I have the distinct luxury of linking to almost everyone else's review posts on this particular topic! So here's the photo (catch it on Facebook, too!):


(Thanks to Manny Hernandez of "TuDiabetes" for the photo legend)
In the photo above:

1. Riva Greenberg "Diabetes Stories"

2. Ginger Vieira "MyDiabetesCentral.com"

3. Kelly Kunik "Diabetesaliciousness"

4. Fran Carpentier "Parade magazine's Diabetes Daily blog"

5. Crystal Lane "Calpumper"

6. Kitty Castellini "Diabetes Living Today"

7. Sandra Miller "A Shot In The Dark"

8. Christel Marchand

9. David Edelman "Diabetes Daily"

10. Brandy Barnes "DiabetesSisters"

11. Bennet Dunlap "YDMV a.k.a. Your Diabetes May Vary"

12. Lee Ann Thill "The Butter Compartment"

13. Allison Blass "Lemonade Life"

14. Gina Capone "DiabetesTalkFest" AND The Diabetes O.C. (FYI, O.C. stands for "online community")

15. Jeff Hitchcock "Children With Diabetes"

16. Kerri Morrone-Sparlin "Six Until Me" (see here for her photos)

17. Manny Hernandez "TuDiabetes"

18. Chris Bishop "The Big D"

19. Amy Tenderich "Diabetes Mine"

20. Kelly Close of Close Concerns, Inc. and "diaTribe"

21. Christopher Thomas "DiabeticRockStar"

22. Scott King "Diabetes Health" magazine and his editorials "My Own Injection" (see also here)

23. Bernard Farrell "Diabetes Technology Blog" and the Diabetes Search Engine

24. Scott Strumello (Yours Truly, no introductions necessary)

25. George Simmons "The B.A.D. Blog"

26. Scott K. Johnson "Scott's Diabetes Journal"

27. William "Wil", Lee, or Liam Dubois "Life After Diagnosis"

28. David (a.k.a. "Rick") Mendosa and "MyDiabetesCentral.com"

29. Charlie Cherry "Diabetes Power Show"

To be sure myself and a very limited number of diabetes social media people (a total of 29, to be exact) were selected and invited to attend this event, and apparently, the hosts at Roche had to work really hard to "sell" the idea of even having such a risky event to the company's conservative executives, so they deserve a big thumbs up for that.

Now, I have to admit that I have some degree of new-found fondness (that some of my peers may not) for Roche for being the pharma company that happened to end the life of the biotech company Genentech. Even though I lived in the Bay Area for most of the 1990's, IMHO, Genentech was kind of a sleazy company that pretty much shafted countless people with diabetes with their pushing biotech synthetic insulin that caused well-documented problems [see here for more] with hypoglycemia unawareness for countless patients without any undisputed conclusive evidence of benefits over the stuff it replaced. You can catch my review of the book "Invisible Frontiers" by Stephen Hall, to get some idea of why I'm glad Roche is kind of dismantling that company!

Anyway, having said all of this, I do think Roche received as much from this even as those of us who actually attended did. To some extent, the entire social media space (defined as bloggers, social networking communities such as Facebook, LinkedIn, and Twitter as well as more specialized social networking communities focused specifically on diabetes including TuDiabetes, DiabetesTalkFest, DiabetesRockStar, DiabetesFriends.net and others) was/is a bit like stepping into the dangerous, untested waters. Their move was certainly not risk-free, and hopefully they learned some valuable lessons that can help them avoid the missteps some that their competitors (including Johnson & Johnson and insulin manufacturer Novo Nordisk) have made in the social media space which made those companies look pretty stupid. But beyond that, I also believe that Roche received a healthy dosage of patient candor from their customers that corporations are far too often shielded from -- both good and bad, even if these were tangential to the social media aspect, these are lessons that the company should learn.

For example, a while back I
wrote about my encounter with a Madison Avenue advertising person who worked in marketing pharmaceuticals and how their job was making sure the client was happy, which does not necessarily mean selling more products for the client (although it's supposed to be).

The event began Weds., and I believe Gina Capone (of DTF) and I were the first two to arrive at the Sheraton in Indianapolis where we all stayed (on Roche's dime, no less). After we both checked in, we decided to walk across the street to the Fashion Mall and we dared to eat food court grub because we were pretty hungry by then. We had only an hour or so to hang out until the next group of participants started trickling in, so we waited at the hotel bar!

As Scott K. Johnson aptly described these meet-ups, it was kind of like "sensory overload" (at least initially). Without providing every gory detail (you might be bored), I can say that my response was mostly due to seeing all of these people I've really come to know over the past few years via the blogosphere but had yet to meet in person, and that was and always is an incredible experience! Let's just say that I think we can conclude that the seeds have been sewn for some kind of semi-regular meeting (Allison Blass is working on that), hopefully expanded to include many of the people we felt were left out of this particular opportunity.

The first evening, we attended a dinner hosted by Roche, and a few executives gave some speeches. As Wil (a.k.a. Liam, Lee, or Printcrafter among a few of his better known aliases) Dubois wrote (and a pretty good overview of the company):

"Roche's stated purpose for hosting the Summit could be summed up (in my words, not theirs), as follows. Hmmmmm….These D-bloggers are a powerful force. We watched Novo step on their own dicks with the Twitter Debacle and J&J with their YouTube mess. These people shape decisions. We want on in that. But we don't want it to blow up in our faces. We want to know what your sacred cows are. What is holy ground. Where are the mine fields?

They want a seat at the table, and rather than just barge in and sit where ever they pleased, they are asking the maître'd if there are any seats available.

They were, I felt, pretty up front. They promised this would not be a day-long Roche add. They kept their promise. Beyond keeping their word, they treated us well. They paid our airfare. They put us up in suites at the Sheraton. They fed us, with high regard for our varied dietary needs. They treated us with respect. All they asked us for was honesty. And boy, did they get an earful of that!"

Were Roche's questions on social media addressed?

I think to some extent, but it's a work in progress, folks, so the answers aren't necessarily clear-cut. But they took a bold step which will be remembered by those of us who attended this first meeting, and I hope we gave them a perspective they may not have appreciated before! I don't necessarily think that the discussion about pricing of test strips was necessarily out-of-place here, and I was frankly a bit surprised that the company's President didn't have a well-rehearsed answer to that question.

I am looking forward to hearing Roche's perspective on this conference!

Happy D-Anniversary to Me

You may recall that back in May, I shared my experience with what passed as children's diabetes literature circa 1976, the year I was diagnosed (BTW, my 33rd anniversary is Friday, July 24), and I'll be headed back from the Diabetes Social Media Summit hosted by Roche, a perfect way to mark the occasion!

Anyway, considering Mr. Hypo(dermic) was supposed to be my new "friend", I felt like commenting on that ... with a comic which about summarizes how I felt as a 7-year old kid when the nurse at the hospital handed that booklet sponsored by Bayer (then known as Miles Laboratories):



Cheers to anniversaries and social media, but let's face facts, diabetes sucks, no matter how you try to "spin" it. Any 7-year old kid can tell you that!

Evergreening Does Not Refer to Trees

When most of us think of evergreen, usually images of Christmas trees come to mind (or perhaps Barbra Streisand's sappy 1977 tune "A Star Is Born", a.k.a. "Evergreen"). The term evergreen is derived from perennially green trees that retain their rich, green colors even through the coldest winters in places like Alaska, the Canadian Northwest Territories, Siberia, the Scandinavian Lapland or anywhere else these hearty trees happen to call home.

But the term "evergreen" has come to mean something else, especially when it comes to the debate over how to manage healthcare costs. In effect, the term has become a euphemism used by the pharmaceutical, biotechnology, home diagnostics, and medical device industries as a means to perpetually extend the lives of their patent protection by making marginal modifications to the product design (or, a derogatory term if you're a critic). Critics argue companies are abusing the patent and regulatory systems to delay the legitimate entry of generic competition. In effect, these are a low-risk way to extend the exclusivity protection of established products, without bringing much genuine health benefit, although it does delay generics from entering the market.

In pills, for example, the phrase "incrementally modified" drugs is sometimes used by the pharma industry staffers to describe variations on existing pharmaceutical products, such as new formulations (extended release versions, for example, or different dosages which require fewer pills), liquid capsule forms, transdermal patches, etc., of the established, brand-name product) to effectively entitle the brand-name manufacturer to enjoy more time under effective monopoly of patent protection even though the changes made to the core medicine do little to fundamentally change the product. Sometimes, there are pretty standard modifications that can be made which are known at the time the drug is first developed and patented but are subsequently promoted as "innovations" even when the core product remains essentially unchanged.

In 2002, the U.S. Federal Trade Commission (FTC) conducted a study which was scathing of the pharmaceutical industry practice known as evergreening that finally gave some much-needed regulator and lawmaker attention to these industry practices (and abuses). The study also prompted the FTC to issue recommendations for legislative changes to Hatch-Waxman Act to maintain incentives to innovate and facilitate the entry of generic drugs. So far, however, Congress has been agonizing slow to reform this in a very meaningful way (some argue that Washington lobbyists are responsible for that).

Examples of Evergreening in Diabetes Care

One of the most obvious examples of "evergreening" occurs in home diagnostics business, notably with blood glucose testing supplies. As guest-writer David Lazurus fairly recently wrote on Amy Tenderich's blog Diabetes Mine, "the pricing of test strips — a roughly 900% markup over the manufacturing cost, as best as I can tell" adding that "the global market for glucose meters and test strips was estimated at $6.3 billion as of 2005. It undoubtedly tops $7 billion now." This topic alone subsequently prompted a lively discussion on the social networking site TuDiabetes.

Ironically, however, there is not a single generic test strip sold in the U.S. market. It seems pretty clear that we can thank evergreening for that. For example, the companies might reduce the blood sample size required for a test, or modify the type of plastic used to manufacture them, or maybe change the electronic contacts inside the meter, but none of these are what could really be billed as "innovations" to the core product, but nevertheless, entitles them to more time under the protection of U.S. patent law.

The companies who dominate this industry, Johnson & Johnson, Abbott, Roche, Bayer and a handful of others, are for the most part, well-seasoned in the various intricacies of pharmaceutical evergreening, and have arguably used it to effectively preclude any sort of meaningful generic competition in the home diagnostics market. Thus, we have 900% markup on test strips and I haven't seen generic test strips in a good 15 years or more.

My own opinion is that as long as healthcare providers (e.g. insurance companies) continue to tolerate this practice, we are unlikely to see any meaningful reform short of lawmakers addressing the practice via legislation. But when we discuss the costs of managing chronic diseases in the context of healthcare reforms, these practices undoubtedly should be part of the debate, but so far, have not been. However, to reduce the influence of industry and special-interest lobbyists, we as patients need to make our voices heard by contacting our legislators!

Some also say the effective extension of patents on biosynthetic human insulin is also an example of evergreening. Although I disagree on that point (there is no need to evergreen when there is no way for generics makers to seek approvals from the FDA). Nevertheless, last month, the Pharmaceutical Care Management Association (PCMA) released an advertisement lambasting our lawmakers for their failure to move (download the ad directly here).

Whether this is evergreening or not is irrelevant. The main issue is that Congress has consistently debated the topic, but has failed to act. How can they have meaningful healthcare reform when they can't even get their $#!t together to actually vote on a bill that even former President George W. Bush said he would sign?

Evergreening Follow-On Biopharmaceuticals?

In January 2007, with my ground-breaking article (see here for that article) I shared that that the patents on Eli Lilly & Company's Humulin insulin products had expired in 2001, and Novo Nordisk's Novolin insulin product patents had expired in 2002, and yet, in spite of no law preventing generic insulin, we still don't have it several years later (2009).

The FDA has continually delayed outlining procedures for generic manufacturers to apply for and obtain approvals of therapeutically equivalent versions of insulin, making excuses that Congress needs to tell them what to do or saying they want to publish broad guidelines applicable to ALL biopharmaceuticals.

In effect, the Congressional and FDA's failure to act on this extends the life of the original patent, costing taxpayers and our healthcare providers millions of dollars each year. In 2006, Sen. Orrin Hatch (who co-authored the Hatch-Waxman Act permitting generic drugs back in the mid-1980s) admitted that the absence of having a comparable approval path for biotechnology drugs, "essentially acts as a second patent to keep off-patent biological products off the market."

And as then-Kansas Governor (now U.S. Secretary of Health and Human Services, who now has a much more vested interest in controlling healthcare costs in her new role) wrote in the petition she signed back in 2006: "The FDA's delay in informing manufacturers of the requirements for obtaining approval of therapeutically equivalent versions of insulin and HGH has cost the states and other health-care providers hundreds of millions of dollars."

Concerns About Follow-On Biopharmaceuticals Legislation Needs to Address

I have long been a supporter of legislation that would enable follow-on biopharmaceuticals to emerge, but my support for legislation does not mean I support a free-for-all for generics makers or branded drug companies.

As the political debate on U.S. healthcare turns to cost-savings, there will be growing pressure on lawmakers to do something about so-called generic biopharmaceuticals (they aren't exactly the same, therefore the FDA refers to them as "follow-on" biopharmaceuticals, while regulators in Europe sometimes refer to them as "biosimilars"). Contrary to what the biotechnology industry would have us (and their Congressmen/women) believe, the real concern in this debate is not about balancing the needs of the industry by allowing a longer period with patent protection. The real issue is about enabling competition at an appropriate time while also protecting patients as well.

1. Say NO to Interchangeability

First, we need legislation that will clearly specify that follow-ons are NOT considered interchangeable with the brand-name product, because they aren't. This would mean that no pharmacy could simply give us a "generic" insulin without asking our permission as they can with pills. Anyone who has ever switched insulin brands knows that just because they are both "regular" insulin doesn't mean they work exactly the same way.

The FDA has already suggested that what they call "follow-ons" would not be considered interchangeable. A follow-on is not interchangeable, and we cannot have pharmacies automatically switching us to follow-on versions without our knowledge or consent. The FDA has already suggested this might be the case anyway, although it's up to Congress to specify this in the law.

2. Demand Full Disclosure of the Manufacturer and Ensure Continued Availability from Pharmacies/PBMs

We also need to take this a step further and demand that our legislators let us know more about the manufacturers, and that we will be able to attain the exact same product be from the same manufacturer (not a manufacturer chosen by Medco Health, CVS Caremark, or Express Scripts) based on the simple economics of their business.

We are entitled to know not only who makes the follow-on, but also that we can continue using that particular follow-on if we switch pharmacies (especially mail-order pharmacies who typically provide 90-day supplies). Keep in mind that pharmacy benefits managers (PBMs) make millions of dollars on generics, but they can switch suppliers without telling patients because the FDA says that small-molecule drugs are interchangeable.

Consider the following potential real-life scenario:

Let's say you buy your medicines from Medco Health Solutions (they're the #1 PBM, so many of you already do). Medco may have a deal with Barr (now owned by Teva), but Medco can switch suppliers if they get a better deal from someone else. But if Medco decides to switch from Barr/Teva to say Watson, Mylan, Sandoz or Hospira (... or Dr. Reddy's or anyone else, for that matter), while its usually a non-issue in terms of bioequivalency in small-molecule (chemical) drugs, it is a very big deal in terms of biopharmaceuticals because the unique cell culture used in making these medicines can make for a very different product.

Your insulin dosage with Novo's Novolin R may be 1 unit per 15 grams of carbohydrate consumption, while your dosage of Lilly's Humulin R may be 1 unit for 13 grams of carbohydrate. The difference is real, but if you can't be sure to get the biopharmaceutical from the exact same manufacturer, you could have a dosage management nightmare on your hands every time you order it, thanks to lack of thought by our legislators.

Hyper and/or hypoglycemia might be the rule every time you refill your script if you can't ensure continuity in suppliers. The pharmacy benefits managers (PBMs) aren't expecting biosimilars to result in the same kind of mass-switching that normally occurs when a generic comes on the market. In the article I recently featured on this topic, the CFO of Medco Health Solutions spoke more on the subject of follow-on biopharmaceuticals.

In Q2 interview with Investor's Business Daily, Richard Rubino, Medco's Chief Financial Officer (CFO), admitted that follow-on biopharmaceuticals wouldn't necessarily be the gravy train PBMs saw with prescriptions for Prozac, Zocor and other small-molecule drugs. He said that Medco understands follow-on biopharmaceuticals are not likely to be exact duplicates, as is the case with small-molecule drugs, which are considered interchangeable without patient or doctor permission unless specifically designated "Dispense As Written" by the doctor on the prescription itself.

Rubino said "You won't see the mass switching of a [as we observed with generic] Zocor. That's because the disease states are hypersensitive. They're matters of life and death.

The molecules will not necessarily be identical. They'll be similar but not necessarily identical. So if you are diagnosed with a disease, you will start on the biosimilar. If that works then you'll stay on it."

Rubino's last sentence is especially important to my point about knowing who makes the product, and ensuring access to continued availability of that biosimilar from Pharmacies/PBMs such as Medco, CVS/Caremark or Express Scripts. But unless Congress mandates in the law that biosimilar manufacturers must be clearly disclosed, and that the supplier will guarantee continued availability from the same manufacturer, people with diabetes are lacking simple protections that any "Access to Lifesaving Medicines" legislation need to address -- so share this with your lawmakers and make the issues known to him or her!