Sunday, February 22, 2015

People With Diabetes Should Re-Appropriate the Term "Diabetic" (noun)

In December, DiabetesMine ran a post entitled "Using 'Diabetic' vs. 'Person with Diabetes' - Does It Matter?".  It got me to thinking about the term "diabetic" as a noun and how outdated it is, but it also raised the question in my mind as to whether its really worth getting upset over.

Back in 1998, the late Deb Butterfield grappled with the issue of political correctness and the outdated term "diabetic" used as a noun (See http://ow.ly/Jrm66 for the article she wrote).  Deb wrote "... if it's all right with you, may we take it for granted that we are all people and divide by that common denominator? May we describe 'people who have diabetes' as 'diabetics,' 'people who are citizens of the Unites States of America' as 'Americans,' 'people who work for companies' as 'employees,' and 'people who have medical degrees' as 'doctors'?"  That sounded OK, but it missed the broader issue in my opinion.

In no other disease state are people referred to by their conditions, so why is it OK with diabetes?

For example, we don't ever call people with cancer "cancerians" or heart disease patients "cardiovasclarians" (that may be a bit of a mouthful, but it makes my point), so the complaint about diabetes and use of the term "diabetic" (as a noun) to describe people with diabetes is legitimate.  The real issue is from my perspective is the fact that people who use the term really should be more sensitive to using the term "diabetic" (as a noun) yet really don't see anything wrong with it, and patients are the only ones that seem to complain about it; no one from the medical profession, diabetes nonprofits, or even English language teachers bothers to call them on it, so why should an editor know any better?  If a person with diabetes wants to call themselves (or someone else) with diabetes a "diabetic", then I think that's their prerogative - they have every right to use the term AND they are entitled to do so.  Many grew up in an era when that term was used regularly.

But this raises the question:  Should something be done with the outdated noun "diabetic"?  I propose we as people with diabetes re-appropriate the term.  By that, I propose that we as people with diabetes may use the term diabetic as a noun, but if you're a newspaper editor or someone else, tread very, very carefully - you should probably NOT be using the term "diabetic" as a noun, its politically incorrect.  My logic is as follows:

In sociology and cultural studies, there is a term is called "reappropriation" which means the cultural process by which a group reclaims or re-appropriates terms (that were previously used in a disparaging way to describe that group).  Examples include African Americans using terms like "nigger" amongst themselves, or gays and lesbians using terms like "faggot" or "dyke" to describe one another.  The idea is to de-base the negative connotations associated with the terms by reappropriating them.

I propose that we re-appropriate the term "diabetic" as a noun, but that means we need to be vigilant in not permitting non-diabetic (adjective) people from using it, or we fail to reclaim the term.

Thoughts from other PWD's?

Tuesday, January 20, 2015

2014 Observations in Type 1 Diabetes Treatments

Happy 2015! Its no secret that I don’t blog like I once did, and the fact that I'm posting twice this month isn't necessarily a sign that is changing.  It’s not like I’ve disappeared (I still have a very active Twitter feed), but Google tried its best to kill blogs when it shut Google Reader down (that failed; I’m still using a different reader known as G2Reader which I think is a damn close replacement and they have a mobile app for Android, but nothing for Apple, sorry iPhone junkies), but many other people have basically given up on a truly open internet with the likes of RSS readers which paved the way to open communications for companies like Google and Facebook to capture that and try and make it proprietary). Be that as it may, I still blog every so often (at least occasionally). This is one such post. It could have appeared at the end of 2014, but I’m doing it in January 2015.

There were a lot of diabetes related news stories in 2014, yet not every story was in my opinion, really news (or even newsworthy!). However, at least few were at least worth acknowledging. Here are my picks for the biggest news items of 2014:

JDRF Names (Yet) Another New CEO, But Most Recent CEO Appointment Raises Questions About Organization's Internal Politics (Dysfunction?) 

In July 2014, JDRF named Derek Rapp as the organization's new President & CEO. While succession plans would ordinarily not be a big deal, JDRF has taken routine CEO replacement to new levels in recent years. Think about it: over the past decade, JDRF has had 5 new CEO's, which works out to an average of a new CEO every other year! That’s a downright shitty track record, and should be an incredible embarrassment to the organization, yet it keeps happening over and over, again and again.  Was the last CEO really failing?  No.  As I said, it appears that most of it's driven by internal politics among high-ranking board members of the organization, but I've grown tired of routine strategy shifts and the routine change in direction for this organization. Fundraisers and donors are being taken for granted, so I didn't raise any money for the JDRF this year, yet that didn't stop them from trying to mine their advocacy database for fundraising at the end of the year, just like everyone else does. I promptly deposited those emails into my trash bin. Every organization does mass emails at the end of the year so this wasn't innovative, it was just plain annoying.

But more importantly, JDRF needs to go back to a state where its fundraisers and donors are appreciated (one of the things former CEO Arnold Donald tried to do under his short tenure with the organization), because frankly, they've been taken for granted for more than a few years. While I don't agree with a lot of the Juvenile Diabetes Cure Alliance's objectives or conclusions, I do think they wrote one of the best posts of the year about JDRF's internal turmoil. For some reason, hardly anyone dared asked about the internal politics behind the change for reasons that escape me. But this article was well worth a read: http://thejdcablog.org/blog/2014/08/18/jdrfs-abrupt-ceo-transition-raises-questions/ (see also http://www.diabetesmine.com/2014/07/newsflash-ada-and-jdrf-change-leaders.html)

Now, I won’t kid you.

Being CEO sounds nice, but the pay isn't that really great, especially when compared to the private sector. JDRF doesn't pay that badly (for a non-profit), but most CEOs could make a LOT more money elsewhere, usually they’re there because they have a personal stake. That’s a fact. Nonprofits aren’t big-paying gigs, but they are ego boosters. But the CEO shuffle at JDRF? There’s more than meets the eye than we’re being told, and you have the right to ask questions. I don’t know much about Derek Rapp, but I will say that his board members shuffled Jeff Brewer out of office before much had really changed. Was he really doing such a lousy job?  No, someone on the board didn't like him, so instead, they put a guy who worked for Monsanto for years in his place.  Monsanto is a company best known for trying to hide genetically modified organisms from everyday housewives, but who knows, maybe he'll be more cut-throat in negotiations with big pharma and big biotech.  That much the JDRF could use.

By the way, did anyone notice how a few years ago the "State of the Foundation" addresses the JDRF organization once routinely gave suddenly stopped? Why … because its a pain-in-the ass to do? So what? That's why you’re being paid a hundred thousand+ dollars each year. We deserve that much transparency, also your industry partnership program which remains a complete black box for donors with no disclosure of anything (can anyone say how much money the organization has spent on the Artificial Pancreas project?), and don't go blaming industry for that. JDRF agreed to the gag orders, but why not insist on some conditions (milestones) for those gag orders remaining in place?! Just saying.

Sanofi: CEO Shuffle, Acquisition of the Global Rights to Market Mannkind's Afrezza, But Still Not Selling Everything It Could (or Should Be) to Americans 

Sanofi, at least in the U.S., has always been kind of an also-ran in the diabetes space. It is basically a one-trick pony with Lantus and everything else (like Apidra) being pretty minuscule. In spite of getting a lot of news in 2014 for Sanofi buying the rights to selling Mannkind’s new inhalable insulin Afrezza (and the technology for using it on other biotech medicines) globally, that was one of the previous, American-born and based CEO's moves, only now Sanofi has moved back to a France-centric company even though most of its money is made from elsewhere. We can still expect to see Afrezza in 2015, but don't expect it to be getting quite as much marketing attention as it might have under the company’s previous leadership.

Its not that Sanofi doesn't have world-class researchers (it was one of the first three companies along with Novo and Lilly to sell insulin, although it was formerly known by its German name Hoechst which still sells regular and NPH in Germany and Austria under the brand name Insuman), or a lengthy history in the diabetes space. It also is a leader in insulin analogues.  It has a 100-year history but it also has a history of management changes, most recently when the French government coordinated Sanofi's acquisition of Aventis to ensure a global pharmaceutical company remained based on French soil, even though most of its diabetes researchers are actually based in Germany, not France. Sanofi's diabetes business is really big, but consists mainly of a single product whose patents expire in 2015: Lantus (insulin glargine rDNA origin). But Sanofi could be selling old-fashioned Insuman products here today. Are those products going to make Sanofi a fortune? No way, but they might help get Sanofi on some more formularies!

If you're a one-trick-pony, they won't carry Apidra (insulin glulisine rDNA origin), either, and why should they? They are choosing Lilly over Novo nowadays because they’re offering low prices and a nearly complete product suite. Novo offers that too. Sanofi only sells two analogues in the U.S. today, whose patents are due to expire soon. If Sanofi wants to remain relevant, it should consider selling Insuman products here, too.

Fraudulent Research on Diapep 277, But Unless You’re A Hyperion Investor, Who Cares?!

This story was, in my humble opinion, the single biggest diabetes story of 2014.

For years (maybe even decades?) we've been hearing about a potential autoimmunity treatment for type 1 diabetes called Diapep 277. It was at one time owned by Aventis Pharmaceuticals (now known as Sanofi, see preceding paragraph for more on them). I blogged about it when Teva was paying milestone payments on it, but that ended, and now we know why (see my blog post at http://goo.gl/jmiNh for more detailed background).  But Diapep 277 has changed hands many, many, many times over the years. We never really saw much detail on how the product actually worked because it was, after all, proprietary information. A few d-bloggers have been questioning the lack of transparency about it for many years, among them d-blogger Joshua Levy [http://cureresearch4type1diabetes.blogspot.com/].

My take has always been I cannot question something I have little or no data on, so I took the company at their word (indeed, I still listed DiaPep 277 as a potential autoimmunity treatment a few years ago (see HERE). At the time, I thought it looked promising because Teva was still backing it, but the company never met Teva's milestones, so Teva was paid nothing and backed out, but Andomeda was undeterred and found a new sucker buyer in Silicon Valley. As it turns out, their word wasn't worth much, either, yet they still managed to sell their fraud to a less-than-careful Silicon Valley biotech company known as Hyperion Therapeutics, which had acquired DiaPep277 developer Andromeda Biotech in June 2014. I wanted to believe that there was some secret information Hyperion had access to, but as it turns out, it was all a load of crap, fraudulent from the very beginning, with made-up research results and studies. Not a good omen.

Frankly, I would expect Hyperion to have done much, much better due diligence, but apparently not. Andromeda played them like a harp. More than a few people should be fired for this at both companies (forthcoming lawsuits aren't going to be cheap.). Apparently, they (Hyperion) were fools. Big Fools. My opinion on this is that its yet another failed autoimmunity treatment, as ALL of them have been so, NOT ONE has succeeded so far, which should have you worrying about how seriously anyone is taking the idea of a biological cure for type 1 diabetes. Sure, there's still Tolerion, Inc. (formerly Bayhill Therapeutics) but they no longer have backing from Roche's Genentech unit, which in my opinion isn't necessarily a bad thing, since Genentech avoided spending a dime on it anyway, blaming things like "resource constraints"), and Macrogenics still thinks its treatment can work in certain people, but we don't have any imminent success stories on the autoimmunity front.

Author P.S., Feb. 17, 2014:  There was news in the Israeli business press today that the two companies have come to some kind of agreement, suggesting that outright fraud may be a bit of an overstatement (see http://iglob.es/?en1010763 for details).  Maybe, but I personally don't have much confidence in this as a potential Type 1 diabetes treatment anytime soon largely because the actual data has been kept hidden from the public.  Only time will tell, but this isn't the first failed autoimmunity treatment to make news, in fact, all have failed so far.

It's upsetting, but at least there wasn't any money (unless you're a Hyperion investor) from the likes of JDRF or the DRI or even ADA at stake here. But it also means we haven't witnessed a single autoimmunity treatment for type 1 diabetes that's made it to commercialization yet, either. This is yet another one in a long line of failures.

Rather than continuing to fund even more incremental treatment improvements, perhaps we should insist on more collaboration with other autoimmune disease foundations or institutes?

NIDDK won't even send the same person to Autoimmune Coordinating Committee within the NIH each meeting.

Never.

In spite of The Special Statutory Funding Program for Type 1 Diabetes Research, one might think NIDDK would consider it important enough to have dedicated resources they allocate to this cross-NIH program, but you'd be wrong. A different person, assuming NIDDK even bothers sending someone (sometimes they haven't), has showed up to every single meeting.

The Institute doesn't even acknowledge being a member. The real question we should be asking is why not? I've been bitching about this for over 5 years, and no one seems to care. Maybe they will when there's some success in disease states like Rheumatoid Arthritis? The leader of NIDDK is not even a specialist in endocrinology or nephrology, he's a hematologist.  That's fine if we're looking for a cure for lymphoma, but we want to cure diabetes.  Why the hell are we allowing this man to continue running the NIDDK … for years and years?  He stepped in as a temporary replacement, but never left the job.  Do we really need a hematologist making decisions for us? Not to be too cynical, but we'd be just as well off having a gynecologist run the show, frankly, they have just as much relevant training.

Yet I've been the only person questioning this choice of leadership. 

Maybe 2015 will be different?

Maybe patient advocates will raise the issue with our lawmakers?

Patient Advocates Increase FDA Presence (Some Staff Actually Know Us Now!!) 

Aside from these, there were of course, the incremental improvements, a whole lot of cost increases, but nothing really new. There's was news last week (from the J.P. Morgan Healthcare Conference) that Medtronic's Minimed 640G (with low glucose suspend) will finally be sold in the U.S. by April 2016, and the company is saying that overnight closed loop could be ready for sale by April 2017.

That's a impressive, but no offense to Aaron Kowalski at JDRF who was recently promoted to JDRF's Chief Strategy Officer, I've been hearing this fucking promise since 1978, and he wasn't even at the organization back then, but my parents were, along with others like Lee Ducat and Carol Lurie (who is now passed).

The artificial pancreas has had a gestation period longer than any diabetes treatment in history, so JDRF and others don't deserve to call it big progress, because that's an exaggeration. This means its only taken you 38 years to deliver on this device. I could jokingly say that’s still incredible in biomedical research, but I'd be lying completely.

I realize Medtronic can only do so much by itself, and in that regard, patient advocacy with FDA was very important in advancing this. But we only have FDA involved in the device side of the FDA, on drugs and biologics, they still aren't truly considering patient input yet as best I can tell (though occasionally they do vote in ways that are in the best interest of patients).

Unless, of course, you count the progress FDA has made in its interactions with patients. That was THE BIGGEST success so far. It still leaves much room for improvement, of course, but its still a very big deal in my opinion. Now if only we can get Janet Woodcock at CDER and her colleagues in CBER on board. Never fear. The explosion of nonprofits in diabetes with at least one saying this is their direction, so we can see what (if any) progress is made on this.

But its time for someone with more time and resources to do something on this; I've been plugging away since before 2005, and after a decade of effort on my part, these days, I'm a bit more focused on other parts of my life. Like planning for retirement with my spouse, buying a house, that kind of stuff. Make no mistake, I'm more than willing to assist where I can help, but I'm not driving this initiative unless someone asks me.

Monday, January 19, 2015

When All Else Fails, Call the CEO's Office at Your Insurance Co.

I make no secret about it: I test my blood sugar a LOT.  Hypoglycemia unawareness is a big reason for this, but its also how my HbA1c's are as excellent as they are.  Insurance companies would like to limit how many you can use because its a big expense line for them.  But I look at it this way: one trip to the Emergency Room for a hypo I couldn't tell was happening would erase any savings they got for denial of a few test strips.  Over the years, I've had a number of different insurance companies, including United Healthcare, Wellpoint/Anthem, EmblemHealth of New York and Aetna.  I cannot say enough bad things about Anthem.  They suck, and bad service to patients is part of the company's DNA.  They simply don't give a shit about patients, only the employers who buy their services.  United Healthcare has, in my opinion, consistently been better at service.  They have their own unique differences, but nothing insurmountable.

I never had Aetna before last year, I migrated from United Healthcare (whom I was relatively pleased with) because my employer switched PEOs and with that came a new healthplan.  For the most part, I've had no major issues with Aetna.  Sure, their formularies are slightly different and I had to switch meter brands yet again, but the policies themselves work in a similar manner and were relatively straightforward.

Shortly after Thanksgiving 2014, I placed a refill order for my testing supplies.  I had one refill remaining, but my endo was submitting a new script in December so I didn't anticipate any issues.  True, on December 1, 2014, we had a new "plan year" and there were some minor modifications to the formulary (some items required pre-certification that did not require them previously), but I wasn't expecting a major change, and I had all of the things I needed to do ready, including the order, pre-certification, payment, etc.

As of Thursday, January 15, 2014 and I still haven't received my fucking test strips.  Not only that, by my supply is now dwindling.  Throughout the last month, I've spent more than a few hours on the phone with Aetna, Aetna Rx Home Delivery, Appeals and others.  I was most pissed off when Aetna Rx Home Delivery told me to speak to appeals, transferred me there, and then appeals told me I had to speak to Aetna Rx Home Delivery, who had just transferred me to them.

Last Friday, I'd had enough.

I was doing everything I was supposed to, going through the proper channels, I'd provided everything I needed to, yet no decisions, no denials, no explanation of benefits, no answers and no test strips.  I think placing an order 2 months ago was more than enough time, so I did something I'd heard about but never had a reason to try it: I called Aetna's corporate headquarters number in Connecticut (I've driven by there a hundred times so I know where they're located) and I told the receptionist that I needed to speak to the President.  When she asked who was calling I gave her my name and the reason I was calling.

Within a minute or two, I was speaking with a department by the name of Corporate Office Complaints.  They handle calls when people call the CEO and try and reach that person, and they are often much better trained than a typical call center employee is.  The person I spoke with had heard it all before, and she was very pleasant.  She took all of my information including everything I had experienced and explained to every department at Aetna, then gave me a complaint number to save just in case I needed it again and her direct line.  Because it was Friday afternoon, I didn't expect much to happen.

However, this morning, I received an email that my Aetna Rx Home Delivery order for test strips was being shipped today.  Not "in process" or "pending" but "shipped".

After two months of an endless back-and-forth, my situation (at least for this order) had been resolved.  The lesson I would impart you with is that people who call the President and/or CEO's office usually get taken care of.  These departments are set up so the CEO never hears about the crap that goes on underneath him.  But these executive office complaints can save you lots of hassle and get things done that should otherwise be working but somehow aren't.  Make no mistake: you need to have done everything you're supposed to or they can't help you.  If you didn't get a precertification from your doctor, they really can't help you, as you need to get that stuff first and make sure you don't have anything outstanding on your end.  But they can make things happen when no one else in the company wants or is willing to assist.

Update, January 20, 2015: My order arrived today (finally).  See the picture below!


Monday, October 20, 2014

Upcoming 11/3/2014 FDA-DOC Meeting; Concerns About FDA Biosimilar Guidance(s)

At this point, I don't think its really necessary for me to repeat too much of the content that is already circulating within the diabetes online community of blogs about the forthcoming Monday, November 3, 2014 meeting  from 1:00 pm-4:00 pm ET with the U.S. Food and Drug Administration (FDA).  But I WILL say that collectively, over the past year, the diabetes patient community was able to accomplish something truly quite extraordinary.  You should know about that, and even better, you also have a chance to participate in that!

Specifically, in 2013, the diabetes online community started a petition (see http://www.change.org/p/us-food-and-drug-administration-sponsor-a-patient-meeting-on-diabetes), which asked the FDA to devote one of its planned public meetings to diabetes.  For those who don't recall or never heard the sordid history, the short story is that back in 2012, FDA announced that over the next five years, it would be conducting at least 20 meetings on various conditions ranging from Chronic Fatigue Syndrome to Narcolepsy to Irritable Bowel Syndrome.  FDA pre-selected the diseases it would address in the first half of those meetings, yet miraculously, FDA did NOT originally plan to hold a patient meetings to discuss diabetes.  There were only four remaining slots open, and that's where we as a patient community came in.  The basic idea is that such a meeting would help to identify what barriers still exist that prevent the most effective treatments, and what the FDA can do to solve these problems.

I find it interesting that for all the lip service public health officials, including FDA and others, give to diabetes as an epidemic, complete with threatening stats such as more than one in five total U.S. healthcare dollars being spent to care for people with diabetes, and estimated costs of diagnosed cases of diabetes now totaling more than $245 billion (and growing).  Yet apparently, FDA thought it already knew what people with diabetes need and want.  (In fact, I have written in the past that FDA relies almost exclusively on the "surrogate endpoint" of HbA1c, catch my 2007 blog post at http://goo.gl/PSO3qJ), often disregarding everything else, as long as a treatment reduced someone's HbA1c.  But it was the diabetes patient community which felt that FDA excluding diabetes (all types) was a big oversight, and the online petition collected over 7,000 signatures!  That, combined with our increased activism in recent years, including commenting on draft guidance documents, attending review meetings, etc., and I guess that FDA agreed that diabetes activists should be entitled to a meeting with them.

I should add that FDA hasn't really been overwhelmingly in favor of the idea (truth be told, they're used to working with industry [indeed, many FDA staffers are former industry people], but not very used to working with actual patients, so we ARE a bit scary to a group of people used to talking with and amongst themselves), but they're under tremendous pressure from the U.S. Department of Health and Human Services which manages FDA to become more "open" in the ways it does business.  Truth be told, I think the patient-led "Strip Safely" [http://www.stripsafely.com/] initiative kind of scared the crap out of FDA.

Having said that, it does seem that the medical device division within FDA appears to be the most receptive to this particular patient meeting, as the drug and biotech divisions don't yet seem to be completely onboard, with some rumors circulating that one of them actually cancelled its participation in the November 3, 2014 meeting.  But if the first meeting goes well, that may convince the laggard divisions to join in for future patient discussions.

A while back (in July 2014, diaTribe first wrote [http://diatribe.org/issues/66/new-now-next/1] about the upcoming November 2014 meeting, and even offered patients an opportunity to email them with thoughts, see the aforementioned link for details).  As is my nature, I emailed them with two of my biggest concerns.

The first comment I submitted was about FDA's lackluster (which is putting things mildly) follow-up on post-marketing analysis and asked if patients might play a role in that, such as by filing Citizen's Petitions.  For the record, on that issue, several major medical journals show that something like only about half of all post-marketing analysis studies are even submitted as the law requires (and sometimes only because state court challenges mandates it), and even then, it often takes biotech, pharma and medical device companies nearly a decade to do what they agreed to when they received conditional approval for the drugs or devices.  Post-marketing analysis has come to be viewed by industry as a de-facto approval, and FDA's lack of follow-thru and enforcement has helped to create that situation.  There are examples where post-marketing analysis have been submitted (think of type 2 diabetes drugs like Avandia and Actos) which have revealed some truly frightening results and led FDA to add warning labels after they were already being marketed, but even that only happened after doctors like Steven Nissen at the Cleveland Clinic really pushed the issue.

Beyond that, I also wrote about some major concerns I have with the FDA and their biosimilar guidance.  FDA is required, in accordance with details outlined in the Affordable Care Act, to outline guidance for industry on biosimilars.  They did release initial draft guidance (three documents, no less), but a year after the comment period ended, they did something totally unprecedented.  Rather than issuing final guidance, they released yet another guidance document!  That was really confusing for me, and I don't think I'm a stupid person.  How did the new draft guidance document relate to the other three draft guidance document FDA already released?  What would they do next?

My second question was more of a concern.  My readers may recall that I have long been pushing the idea of follow-on biopharmaceuticals or biosimilars.  I first blogged about it in January 2007 asking why the hell we still didn't have generic insulin (see http://goo.gl/QGcSi) for details, and subsequently blogged about the various delays and issues related to that).  Last year, we finally got the original draft guidance FDA released on biosimilars (or "follow-on" biopharmaceuticals as FDA calls them and I submitted a laundry list of concerns, not the least of which was lack of clarity on biopharmaceuticals such as insulin which is governed by the Food Drug and Cosmetics Act, not the Public Health Services Act which governs most other biopharmaceuticals, which they went out of their way to note was only applicable to drugs governed by the Public Health Services Act but did provide some guidance as to FDA's thinking about biosimilars overall.  In my original comments on the first biosimilar draft guidance, I said that FDA needed much more clarity on which instances a biosimilar would be considered bioequivalent to the original molecule (a true generic).  I don't think they can ever really be considered a true generic, as master cell banks and process controls are different with each manufacturer, but unless the FDA spells that out, they've got room for issues, and insulin, which is among the most widely-used biotech products, is likely to see the results first, so I argued that was kind of big deal FDA needed to address.

Lilly's Lantus Biosimilar Has More Hypoglycemia in Patients With Type 1 Diabetes

Right now, because its grandfathered under the Food Drug and Cosmetics Act, insulin is still considered a "small molecule" drug and manufacturers can use several regulatory pathways [including the the 505(b)(2) pathway, which is not available to manufacturers of other biopharmaceutical products like vaccines].  Indeed, Eli Lilly and Company and partner Boehringer Ingelheim already have a biosimilar to Sanofi's Lantus (insulin glargine rDNA origin) which FDA already granted tentative approval.  Lilly is calling it Basaglar (peglispro rDNA origin).  But here's the thing: Lilly will be competing with Sanofi on price, which will likely win them coverage on a number of insurance company formularies.  Normally, that's a good thing, BUT … peglispro is not glargine, and the trial results have already revealed some troubling differences.  FierceBiotech, which was reporting on Lilly's press release how their biosimilar version of Lantus was supposed to be "better" than Sanofi's, this not-so-little tidbit was revealed (see http://www.fiercebiotech.com/story/lilly-claims-another-head-head-victory-over-lantus-phiii-diabetes-showdown/2014-09-04 for the article):

Just to quickly re-summarize:


Lilly also was forced to concede that in one of the two Phase III trials [specifically, the leg on patients with Type 1 diabetes] there was a statistically significant increase in daytime hypoglycemic events, an important safety measure, compared to Lantus. Even with an approval, any safety issues could carve out market value from a new diabetes treatment in this hotly competitive space.

The results from the two Phase III studies IMAGINE-1 and IMAGINE-3 in type I diabetes completes the trials planned for peglispro, and leaves Eli Lilly on track to file for an approval in the first quarter of next year.



Holy shit!  This is kind of very big deal, especially for insulin-sensitive type 1 patients with impaired hypoglycemia awareness.  Yet Lilly is busy saying how much better peglispro is to glargine (its not, its merely the same, unless you think that a statistically significant increase in hypoglycemia isn't a big deal).  Do you want your insurance company to switch you to this because its cheaper for them, but is more likely to increase your liklihood to have hypos?  I don't!  I expect to express my concerns to FDA!

Back to FDA-DOC Meeting

Back to my comments to diaTribe/Close Concerns about the November 3, 2014 FDA patient meeting.  Following the FDA's draft guidance for biosimilar guidance, FDA then did something unprecedented.  Rather than releasing final guidance on biosimilars, it instead released yet another guidance document.  I must admit that FDA move confused me a lot.  How did the new guidance relate to the original draft guidance?  What is/was supposed to happen next?  If I don't understand it, should other patients be expected to?!

I admit that I was totally confused by this FDA move, but I suspect many others were, too, because FDA has yet to release any final guidance on biosimilars even though it is obligated under the Affordable Care Act to do so.  My question for FDA is if industry and doctors don't even understand what FDA did, how are laypersons in the patient community supposed to?

To be sure, I think I could speak to FDA by myself for a long time with a long list of questions, but I like to think of this move as a first step in actual patient engagement.  Remember, FDA works for U.S. taxpayers to keep patients safe, they do NOT work for industry.

That meeting is scheduled for November 3, 2014 from 1:00 pm-4:00 pm ET.  One area that would help is to take a short, 5-minute survey to help the folks at diaTribe/Close Concerns summarize what areas of concerns matter to people with diabetes, and all you need to do is visit http://diaTribe.org/survey to take that survey.

To participate in the actual November 3, 2014 FDA meeting's webcast, you first must register at http://www.cvent.com/d/z4qgt1/1Q.  Once you're registered, FDA will send you all the relevant information on how to join from 1-4 on November 3, 2014.

Friday, January 31, 2014

Hors d'oeuvres Suitable for the Super Bowl

I've never been a big sports fan, in part, because the ticket prices to attend virtually any professional sporting event is beyond ridiculous.  I remember attending my first professional baseball game with my Dad at Fenway Park when I was a kid.  That event remains one of the most memorable events I spent with my father when I was growing up.  But the prices to attend games like that are now simply out-of-reach for many families, and a lot has to do with the salaries for players, although the leagues can afford that with the costly TV broadcasting rights deals they sign for the games.  Its little wonder that minor league sports leagues of all varieties (including the Brooklyn Cyclones baseball team, which has consistently enjoyed sold-out audiences more so than any of the major league games do in New York, including the New York Yankees or the New York Mets) are on a roll.

There's also the not-so-little issue of the NFL still clinging to nonprofit status (exempting the NFL from paying Federal taxes) even though its CEO is better-paid than the CEOs for than many, many for-profit entities (the CEO for the NFL makes $30 million per year, more than both the CEOs for Coca Cola and Walmart earn).  What charitable function does the NFL serve?  Also, Major League Baseball (MLB) dropped its own nonprofit status over a decade ago when a similar complaint came up and has been paying taxes (and wasn't ruined as a result), so why won't the NFL do the right thing?  It's beyond reprehensible, but at this point, unless U.S. lawmakers revoke its nonprofit status, that will continue, and I don't expect that to happen anytime soon.   U.S. Congress finished 2013 as the least productive Congress in American history (see http://ow.ly/t4w6T for more background).  By the way, there's currently a petition on Change.org to revoke NFL's nonprofit status at http://www.change.org/NFLnonprofit if you'd like to see that change.  They've aligned themselves with another organization with a very similar goal at http://www.sacknfltaxbreaks.org/.  You won't be hurting the NFL, but you might get rid of taxpayer giveaways to an organization that clearly doesn't need them.

My personal indifference to major league sports aside, this Sunday is the Super Bowl, which is arguably one of the biggest live events in the U.S. each year.  It also happens to be taking place in New York, rather than some sunbelt location raising the possibility they might consider other locations in the future.  The teams this year come from smaller NFL markets, notably Seattle and Denver (both Washington and Colorado legalized recreational marijuana in the 2012 elections, prompting some nickname this one the "Stoner Bowl" ... indeed, a pro pot-legalization organization has rented several huge billboards outside of the Meadowlands in New Jersey to make that very point, see http://ow.ly/t4xzS for details).  Most of us won't be getting stoned, but a lot of us will be watching the game with family and friends.  Which brings me to today's topic: the food.

Traditionally, Super Bowl Sunday is a day with lots of food, little of which is very healthy food.  If the data is correct, Americans will spend nearly than $1 billion dollars (or more) on Super Bowl snacks alone.  Yet even seemingly healthy appetizers are caloric, with cheese being a very common ingredient (and the calories add up fast), salt, etc.

Rather than turn this post into a lecture about what should or should not be served (after all, I'm guilty of indulging, too!), I thought it might be useful to offer a few alternatives, so when you're munching the deep-fried tortilla chips with some kind of dip (salsa may be OK, but the queso dip, probably not so good), you don't have to regret all of it later.

To be sure, I am always a big fan of Crudité (better known as raw veggies, and they're so easy to prepare, in many cases the supermarket sells them already prepared, but you really should toss the Ranch dressing that comes with the veggies into the trash, more on that in a second).  You can do some cool things with presentation.  This photo shows how a hollowed-out red pepper was used as the bowl for the accompanying dip, so there's no clean up necessary, and it looks good, too.






















Roasted or grilled veggies are also great.  I prefer to prepare my own crudité, but I don't want anyone to spend more time than they have to in the kitchen.

Ranch dressing is an easy and popular accompaniment to go with veggies, but I suggest skipping the Hidden Valley Ranch variety and consider grabbing a bottle of Bolthouse Farms Ranch dressing instead.

Its typically sold in the refrigerated produce aisle of most supermarkets, rather than on the shelf with the shelf-stable bottled salad dressings.  They've (Bolthouse Farms, a wholly-owned subsidiary of Campbell Soup Company since 2012, see http://bloom.bg/1exd18r for the news) taken an American classic (ranch dressing), but instead of using lots of fattening and highly-caloric mayonnaise and cream, they've substituted yogurt instead.  The calorie count for a serving is less than half of what typical varieties of ranch dressing contain (45 calories vs. 140 for a serving of Hidden Valley Ranch dressing), so you won't do quite as much damage, and I think it tastes the same.  I would guess your fellow Super Bowl watchers probably won't even notice the switch.


However, there are other things you can do, depending on how creative you want to get.  Since many people spend the Super Bowl with friends and/or family, they may be asked to bring a hors d'oeuvre to the party.  Aside from crudité and lower-calorie ranch dressing, consider a re-imagined version of a classic appetizer recipe instead, as well the following easy ideas as well.

One recipe that I've tried and rather like I found in the newspaper a few years ago (in 2012).  This one is the most complicated (not that its especially difficult or complex) of the hors d'oeuvres I will share in this post, the others require little effort and can be prepared in minutes.

An Associated Press journalist named Alison Ladman re-imagined a seemingly healthy appetizer whose ingredients aren't nearly as as virtuous as the name implies: Spinach and Artichoke Dip.  Her original article can be found online (the Salt Lake [City] Tribune has it on its website at http://bit.ly/1d8tSxe), but I think the opening paragraphs say it all:

"Spinach and artichoke dip sounds like it should be a virtuous treat. After all, it's loaded with vegetables.

Trouble is, it's usually more mayonnaise and cheese than spinach and artichoke. So we decided to see if we could come up with a version that isn't so out-of-sync with healthy eating."

This recipe takes a bit of prep-work but the crudité will save you time, and I'll offer another easy recipe to accompany this, so you can bring a few tasty and interesting items to your Super Bowl gathering.

Below is the article text (its short) for this recipe remake.  A downloadable version which I found online follows.


Spinach and Artichoke Dip
By Alison Ladman, Associated Press
First Published: April 12, 2012

Spinach and artichoke dip sounds like it should be a virtuous treat. After all, it's loaded with vegetables.

Trouble is, it's usually more mayonnaise and cheese than spinach and artichoke. So we decided to see if we could come up with a version that isn't so out-of-sync with healthy eating.

First order of business was to nix the mayonnaise. But, of course, we wanted something that had a great creamy texture and that could be heated. Greek style yogurt blended with low-fat cream cheese (Neufchatel) worked beautifully. It even added a subtle tang, which we enhanced with some lemon zest for a nice spring flavor profile. Some fresh herbs took it ever further.

Next up, dealing with the cheese. We handled the inner gooey-ness with the aforementioned cream cheese. But often there also is a pile of cheese or bread crumbs (or both) on the top. After it's broiled, we wanted that textural contrast and the toastiness that comes with it.

We found that crushed and seasoned whole-grain crackers worked well. Just note that different varieties of crackers can have widely varying nutrition. So be sure to read the labels carefully to select a whole-grain cracker with modest amounts of fat and calories. Aim for around 100 to 120 calories and 4 grams of fat per serving. You'll also want about 3 to 4 grams each of protein and fiber.

Lastly — and most importantly — was upping the amount of spinach and artichoke. We went with canned artichokes for ease. They also are available frozen. Either way, be sure to get the variety in water, not oil. Fresh baby spinach got a quick saute with onion and garlic before being added. Serve the warm dip with whole-wheat pita chips, baked tortilla chips or veggie sticks.

Spinach and Artichoke Dip
Makes 8 servings

Ingredients:

  • Cooking spray
  • 1 ounce (1 serving) whole-grain crackers, crushed
  • 1/4 teaspoon garlic powder
  • 1/4 teaspoon onion powder
  • 2 tablespoons Parmesan cheese, grated
  • 6 ounces plain nonfat Greek yogurt
  • 4 ounces low-fat cream cheese (Neufchatel)
  • 1 teaspoon lemon zest
  • 2 teaspoons fresh oregano, minced
  • 2 teaspoons fresh mint, minced
  • 1/2 teaspoon salt
  • 1/2 teaspoon ground black pepper
  • 1 tablespoon olive oil
  • 1 small yellow onion, diced
  • 1 clove garlic, minced
  • 1 (5-ounce) package fresh baby spinach
  • 1 (14-ounce) can artichoke hearts, lightly chopped
Heat the oven to 400 degrees. Coat a small casserole or gratin dish with cooking spray.

In a small bowl, combine the cracker crumbs, garlic powder, onion powder and Parmesan. Set aside.

In a food processor, combine the yogurt, cream cheese, lemon zest, oregano, mint, salt and pepper. Pulse until smooth.

In a large skillet over medium-high, heat the oil. Add the onion and garlic and saute until soft, about 5 minutes. Add the spinach and cook until soft and any liquid has evaporated, about another 5 minutes. Remove from the heat and stir in the artichokes and the yogurt mixture. Spoon into the prepared dish.

Sprinkle the cracker crumb mixture over the dip and bake for 10 to 15 minutes, or until hot. Serve warm.

Approximate nutrients per serving: 120 calories, 5 g fat, 2 g saturated; 10 mg cholesterol; 560 mg sodium; 3 g fiber.

Copyright 2012 Associated Press. All rights reserved.

You can download an Adobe Acrobat (PDF) version of this recipe HERE.

The next two appetizer ideas were courtesy of Health magazine (see http://tinyurl.com/o3nba7u for these and others), but they were so quick and easy that they were definitely worth trying at your next party, whether its for the Super Bowl or some other occasion.  Of course, nice photos are always a selling point!

Med Coast-Bites
66 calories, 2g fat

Spread 8 ounces hummus evenly onto baked pita chips (12-ounce bag). Shred 1 large carrot; distribute evenly over chips. Zest rind of 2 lemons; place a few pieces atop carrot.

I've added some of my own feedback on this recipe one because this is a recipe that lends itself to some creativity IMHO.

Alternatives to the lemon zest (for variety and flavor) include various dried herbs and spices.  To make things easy, I've found it easy to use Mrs. Dash seasoning blend varieties that you like (see http://www.mrsdash.com/products/seasoning-blends).  I'm personally quite fond of the Onion & Herb Seasoning Blend (although my local supermarket no longer carries it) as well as the Lemon Pepper Seasoning Blend, but as I said, the selection is yours.  More creative alternatives include using ingredients like powdered wasabi, which I personally really like (it can usually be found in Asian supermarkets).  A blend with salt is great (I use 2 tbs. or wasabi and 2 tsp. of salt, though I would skip the salt for this particular recipe because its really not needed here.  The trick is to use these ingredients to enhance the flavor, just don't use too much.  Remember, there's already flavorful hummus in this recipe (and even there, you can use varieties other than plain tahini-flavored hummus, although there's nothing wrong with that).  Mix things up and make a couple different versions, just be sure your Super Bowl guests or friends know what each is.

Caprese skewer
46 calories, 4g fat

Using 2 pints cherry or grape tomatoes, 1 pound bocconcini (fresh mozzarella), and 1 bunch fresh basil, thread ingredients onto skewers. My personal preference is the yellow and orange tomatoes because the red ones are rather flavorless.  Sprinkle each skewer with sea salt and black pepper; drizzle with extra-virgin olive oil.

So these are my contribution to Super Bowl Super Bowl XLVIII hors d'oeuvres menu.  Any other suggestions?  Feel free to add them to the comments.

Monday, January 27, 2014

Recent FDA Moves Suggests Agency Is Again Taking Its Role of "Protecting Public Health" Seriously

As a patient with type 1 diabetes, I have found myself at odds with the U.S. Food and Drug Administration (FDA) on a number of things the agency has done in recent years (actually since the 1980s), and perhaps even more so in recent years.  In fact, I once joked (only halfheartedly) that the acronym "FDA" stood for Fatal Drug Administration.  Indeed, for a number of years (under the leadership of chief Dr. Andrew von Eschenbach especially, he pushed for FDA to serve what he called its "clients", meaning the companies that the FDA regulates, rather than protecting public safety).  Staff in areas for brand new drugs exploded, while the queue of unapproved applications in generics also grew, yet the FDA never asked Congress for user fee authorization in generics during that time.  However, at the end of 2013, the FDA took two very important moves that might just give me reason to reconsider my belief that the FDA was looking out more for industry than it was for patient safety.  Both relate to the "Food" responsibilities at FDA, but given that cardiovascular disease is the #1 killer of people with diabetes, the first one is especially relevant, while the second one relates to big agribusiness routine abuse of medicines and has resulted in a rise of antibiotic-resistant viruses.

Item #1: Obituary for Twinkie the Kid?

On November 16, 2012, Huffington Post featured an article entitled "Twinkie The Kid, Dead At 85" (see http://huff.to/1dINwQt).  The article, of course, was a parody of the then-current news that Hostess, the manufacturer of Twinkies had filed for liquidation in a bankruptcy filing.  The maker of Twinkies cakes had flirted with death several times in recent years, and in 2012, when the parent company, Hostess (which had various names over the years, including Continental Baking Company and Interstate Bakeries) had finally filed for bankruptcy after failing to reach an agreement with the company's unions.  Unlike a bankruptcy reorganization, this one was a liquidation, which meant the company and all of its brands were dismantled.  But as author Mark Twain once wrote: "The reports of my death are greatly exaggerated", and so too was the reported death of the über-processed, junky snack food known as Twinkies.  Indeed, the Twinkie re-emerged to much fanfare under new ownership a year later (in 2013).  But the obituary for the Twinkie in Huffington Post may have been a premonition, only this time, it won't be finances or unions that kill it - it will be the recipe for Twinkies itself.

That's because the Twinkie (and virtually all Hostess cakes) is made primarily from hydrogenated fats.  It has a bunch of other highly-processed ingredients, some of which are mined, and an entire book entitled "Twinkie, Deconstructed" [http://www.twinkiedeconstructed.com/] by Steve Ettlinger was written to try and explain the ingredients in Twinkies.  (That book, incidentally, is highly-entertaining reading!)  Indeed, the creamy filling is pure hydrogenated fat and sugar.  The cake itself also has a lot of sugar and hydrogenated fat, which explains why they seemingly never spoil.  But the new nemesis of the Twinkie may be the U.S. Food and Drug Administration (FDA), and unless the company suddenly gets creative, because all of the Hostess cakes (including the namesake Twinkie, as well as Ding Dongs, Ho Hos, Chocodiles and others depicted in the commercial featured in the Huffington Post article) will cease to exist.  Nostalgia won't save them from using a banned ingredient, namely hydrogenated fat.

That's because in early November 2013, FDA did something doctors and nutritionists had been advocating for decades: it finally took steps to remove artificial trans fats (hydrogenated or partially hydrogenated oils) from the U.S. food supply.  See the news in the Federal Register at http://1.usa.gov/1aY5Ubk and a separate, more user-friendly article about the announcement from the FDA at http://1.usa.gov/1bsRrRy.

About Trans Fats

Trans fats are created when hydrogen is added to vegetable oils to make them more solid (vegetable shortening, a.k.a. "Crisco" is the usual result).  The result is an artificial product said to accumulate as plaque in the arteries.  If the FDA's decision is finalized, partially hydrogenated oils (trans fats) will soon be classified as food additives that can no longer be used without prior FDA approval.  A  final ruling by the FDA won't come until after a 60-day comment period, but Dr. Margaret Hamburg and the FDA's top food official, Michael Taylor, left little doubt that the agency's goal was to completely remove trans fat from the U.S. food supply.  The FDA and CDC jointly estimate that totally eliminating trans fats from the U.S. food supply could prevent 20,000 heart attacks and 7,000 deaths due to heart disease each year.

Its hard to believe it now, but once upon a time, trans fats were actually claimed by their promoters to be healthier than the lard, butter and the saturated animal fats they often replaced.  However, mountains of data since proven they are actually even worse for us than saturated fats are when it comes to heart disease, which is a major U.S. killer.  In 2006, after a campaign by public health advocates, the FDA finally started requiring food companies to add trans fats to food labels.  (On a related issue, there was news recently, see http://ow.ly/t2mG6 for details, that the FDA would likely be revising food labels in the near future.  The FDA won't say exactly when the changes will come, or what the new labels will include. But we're likely to see changes that make it easier to see calorie counts, more up-to-date serving sizes [right now, serving sizes are a joke] and more detailed information on added sugars including high fructose corn syrup.)  That was a good start, but the FDA's latest move may actually be the impetus to end routine use of these toxic ingredients in the U.S. industrial food supply found in your local supermarkets.  Indeed, trans fats would become an ingredient "not generally recognized as safe" and would need special permission from the FDA to be used.  The commercial food industry, especially commercial bakeries such as Nabisco (part of Kraft) will need to do some serious soul searching to find practical alternatives which are in bread, cookies and various other products including cake frosting sold in supermarkets.

Trans fats are very common in highly-processed foods, although they are also very common in commercial baked goods like biscuits, pie crusts, and frostings that aren't hand-made.  The FDA once estimated that in the late 1990s, 95% of prepared cookies, 100% of crackers, and 80% of frozen breakfast products sold in the U.S. contained trans fats.  The frying oils used in restaurants were also rich in them at that time, but the use of trans fats in frying foods (at places like McDonalds) has indeed declined significantly in recent years so that they’re relatively uncommon in fried foods sold in fast food joints today.  According more recent data from the FDA, trans fat intake among Americans declined from 4.6 grams per day in 2003 to around 1 gram in 2012.  Michael Jacobson, executive director of the Center for Science in the Public Interest, estimates that today, 75% of the trans fats is already is gone from the nation's food supply.  But, they still remain in things like Twinkies, so the FDA move is a good move.

The scientific evidence against these staples in processed foods is pretty overwhelming, namely that they provide absolutely no nutritional value at all, yet are implicated in the prevalence of heart disease (trans fats aren't the only factor, but it's a notable one).  That's why the FDA's announcement on November 7, 2013 that for the first time, it believes that trans fat can no longer be considered "generally considered as safe" drew a lot of praise from doctors.  Trans fats are made by adding hydrogen to vegetable oil (most commonly, genetically modified soybean oil) in a process that is hardly new.  In fact, in what was perhaps a great irony, Paul Sabatier won the 1912 Nobel Prize in Chemistry for discovering the hydrogenation method that activists are now fighting to remove from our food today. His research detailed the way nickel could be used as a catalyst to create chemical reactions between hydrogen molecules and other compounds, which laid the groundwork for the creation of hydrogenated oils.

Why Industrial Food Producers Loved Trans-Fats

Trans fats became very popular because of their versatility in industrialized food production which dominates U.S. supermarket shelves.  Trans fats make processed foods "shelf-stable," able to stay on supermarket shelves for months without going bad.  Fast food restaurants also liked trans fats because they could be used repeatedly in commercial deep fryers without having to be replaced, according to the American Heart Association.  As already noted, that industry largely abandoned trans fats nearly a decade ago.

Kantha Shelke, a scientist with the Institute of Food Technologists in Chicago, told NPR that the the use of trans fats in things like cookies or doughnuts means the products don't leave a ring of oil behind on a paper towel and don't start tasting rancid after a few weeks.  Also, this type of fat doesn't have a strong taste of its own so you can use lots of it without ruining the flavor.

"It's really absolutely perfect [for industrial food production], and it's also perfect for the American style of shopping: You buy boxes and boxes of crackers, put them in your pantry," says Shelke. "You open this box six months or eight months or a year later, and it would still taste and smell just as good as it was on the day you bought it!"

The use of these fats really exploded as the food system in the U.S. became increasingly industrialized, but so did the adverse the health effects.  However, since the FDA started requiring labeling of trans fats separate from other fats, much of the food industry has already started to migrate to more traditional oils, and trans fat usage has declined as food manufacturers and processors found alternatives.  In a statement, the Grocery Manufacturers of America said that since that 2005 food manufacturers have already lowered trans fats in products by more than 73%.  However, the FDA says that today, 12% of all packaged foods still contains a partially hydrogenated oil, the formal name for trans fats, which is why the FDA feels the time is right now to eliminate them completely.

U.S. Not Alone in Efforts to Get Rid of Trans-Fats, WHO Also Advances the Issue

The U.S. is hardly alone in the move to try and eliminate these industrial fats from its food supply food.  In 2004, Denmark made it illegal (see http://ow.ly/sZQto for more) for any food to have more than 2% trans fats. Offenders risk hefty fines or even prison terms.  Other countries are also working to reduce trans fat in their food supplies. Policies in Brazil, Costa Rica, the Netherlands and South Korea have proven effective over the past two decades (showing that countries from Latin America to Europe to Asia are dealing with the issue), the World Health Organization says. The WHO has also called for completely eliminating trans fat from the global food supply, though the WHO lacks any enforcement capability.

Giant food-processor Cargill Inc., which now sells partially hydrogenated shortening to commercial customers, said it will help them switch to alternatives.  Another big maker, Archer Daniels Midland Co., said it [trans fats] is a steadily declining business and that it sells low- and zero-trans-fat oils.  These big industrial food suppliers are now working with clients to find suitable alternatives.

Junk Foods That Are Ahead of the Curve?

Pepsico's Frito-Lay snack unit saw the handwriting on the wall nearly a decade ago and did take a lead in product reformulation when it began selling "zero trans fat" snacks before all packaged foods were required to list the amount of trans fat on the nutrition labels.

Nevertheless, some of the company's snacks, now cooked in corn, canola and/or sunflower oil, still fall into the 0.0 to 0.5 gram range, a spokesman said.  That's because the FDA permits them, if there's less than half a gram of trans fats per serving, to list the amount of trans fats in their products as zero.

Other food categories may require modification.  They remain staples in things like boxed cake mixes and frostings, as well as such mundane categories as breakfast cereals (for example, Post Fruity Pebbles sugary breakfast cereal relies on trans fats).

Food processors should not be surprised; the moves to eliminate trans fats in restaurants (notably, New York City banned them for use in restaurants in 2004 and other big cities including San Francisco did the same) has been growing and the industry has (for the most part) found suitable alternatives, including non-hydrogenated, genetically modified soybean or canola oil that is used for deep fat frying many foods.  Fast food chains have already eliminated trans fats from much of their menus (except for their baked goods, such as hamburger buns, which come from third-party suppliers who rely heavily on trans fats in their production and so the products will stay fresher, longer) a number of years ago, and no one's french fries or chicken nuggets suddenly disappeared as a result.

The evidence has been mounting against trans fats over the past few decades after numerous studies linked trans fat to higher LDL, or bad cholesterol, as well as to heart attacks and strokes. The Institute of Medicine said in a widely-cited 2002 report that "there is no safe level" of the ingredient (see http://1.usa.gov/1hF26wQ for reference).  As I noted, the turning point really came in 2006 when the FDA mandated that processed food makers must disclose the presence of trans fat on their nutrition labels, at which point food manufacturers began (in earnest) switching to more traditional oils rather than have the negatively-perceived ingredient show up on their "Nutrition Facts" labels.

Microwave Popcorn, Commercial Baked Goods Still Loaded With Trans-Fats

Aside from the products already mentioned, certain food products are still heavily dependent on trans fats.  For example,  things like microwave popcorn, frozen pies and all kinds of mass-produced baked goods. Often, food companies use just a little bit, but the new rules would require them to reformulate their recipes.  A complete ban on trans fats would be a bigger deal for food manufacturers, according to Ms. Shelke. She says food companies can drop the trans fats, but their products won't be quite the same.

"They have to go back to re-educating consumers that cookies don't last forever," says Shelke.

Although the packaged baked goods might have a shorter shelf life, the FDA is hoping consumers' lives will be be longer as a result.

The FDA move seemed to have few opponents, even among residents of states generally opposed to big government.  One Houston resident, when asked about whether the move was too "nanny state", wasn't opposed to the FDA move.  He rationalized his response as follows:

"I think the government should have control over things that we create, just like any drug," the man said. "I don't want the government telling me I can't eat duck fat. But telling me I can't eat crude oil that's been refined and turned back into something that resembles margarine I have no problem whatsoever with. That isn't something you're getting out of an animal. You cannot make trans fats in your home kitchen. So why the hell should a company be able to sell them to you when they know it's bad for you?"

The FDA press release on the announcement can be found at http://1.usa.gov/1dIVusV and the announcement in the Federal Register with information such as the docket number and whom to send comments to can be found at http://1.usa.gov/1fhYdhA.  Comments to the FDA were due on January 7, 2014, although U.S. law permits public comments on any guidance at any time, even if the practical impact may result in the agency giving late comments less consideration (if any at all).  As to whether “Twinkie the Kid” can cheat this particular death round remains to be seen.

Item #2:  Routine Use of Antibiotics in U.S. Industrial Meat Production

Separately, on December 11, 2013, the FDA took steps that are within the agency's authority to crack down on widespread use of antibiotics in the nation's food supply.  See coverage in the New York Times at http://nyti.ms/1bXhYeO) and the FDA’s announcement at http://1.usa.gov/1cASPF0.

As the Los Angeles Times reported (see http://lat.ms/Mljay8) at the beginning of 2012, only 20% of the antibiotics sold in the U.S. are actually given to people who are sick with bacterial infections, such as ear and urinary tract infections or pneumonia.  In fact, most of the penicillin, tetracycline and other antibiotic drugs used in the U.S. today are given to livestock -- and to make matters even worse, most of the livestock given these antibiotics are aren't even sick.


"We feed antibiotics to sick animals, which is completely appropriate, but we also put antibiotics in their feed and in their water to help them grow faster and to compensate for unhygienic conditions. said Dr. Gail Hansen, a veterinarian and senior officer for the Pew Campaign on Human Health and Industrial Farming, a project aimed at phasing out overuse of antibiotics in food production, who added "If you have to keep the animals healthy with drugs, I would argue you need to re-examine the system. You don't take antibiotics preventively when you go out into the world."

The FDA's latest move is (at this point) voluntary and will be phased in over a three year period because the FDA believes that's actually the fastest and most effective way to achieve its goal.  The FDA told Reuters that approximately 25 to 27 companies would be affected by the voluntary three-year phase-out of the use of antibiotics in the raising of animals for food production.  William Flynn, deputy director for science policy at the Center for Veterinary Medicine at the FDA, said during a call with reporters that Zoetis Inc. and Eli Lilly & Co.'s Elanco unit sell a large percentage of those products and it has already started speaking with those companies about compliance with the phase-out.

As might be expected, the big meat processors like Smithfield Farms, as well as others like Tyson Foods, Inc., Hormel Foods Corp. and others all claimed that the FDA move was a huge mistake, but don’t believe them.  Critics say they need to clean up their act, although their response (so far) has been to push for so-called “Ag-gag” bills, which is already the law in Utah, Iowa, Missouri.  Similar legislation has been appearing, and reappearing in almost a dozen other states, including Nebraska, Indiana, Wyoming, Arkansas, North Carolina, Minnesota, Pennsylvania and New Hampshire, which basically makes it a criminal offense to even photograph industrial "farms" (see http://wny.cc/1esvu5W for an interesting discussion on that) that’s now routine in modern American farming.  Many of these bills are reportedly efforts to combat terrorism, eco-terrorism or otherwise (at least if one believes the bills’ sponsors in the legislature), and yet, the real outcome seems to be criminalizing information.

However, the FDA's move on antibiotic use was actually precipitated by a number of true citizen's petitions which the FDA basically ignored, followed by lawsuits which the FDA lost.  In other words, the FDA was sued and lost, hence it had to do something on the matter, and finally moved in 2013 to actually do so.  Some of the petitions and lawsuits go back to 2009 or even before.  More recently, on March 23, 2012, the FDA lost a lawsuit filed by the Natural Resources Defense Council, Center for Science in the Public Interest (CSPI), Food Animal Concerns Trust (FACT), Public Citizen, and Union of Concerned Scientists (UCS).  One Court noted the issue in its 2012 decision: "Research has shown that the use of antibiotics in livestock leads to the development of antibiotic-resistant bacteria that can be--and has been--transferred from animals to humans through direct contact, environmental exposure, and the consumption and handling of contaminated meat and poultry products."

On June 4, 2012, the courts ruled that the FDA had been dragging its feet for years and ordered the FDA to take action in order to protect public health from the overuse of antibiotics in animal feed by instructing FDA to reconsider two previous citizen petitions which urged the agency to revoke approvals for all non-therapeutic uses of antibiotics in livestock production.  For years, scientists, health care organizations, and government agencies had warned that the widespread use of antibiotics to hasten animal growth and compensate for unsanitary and over-crowded feedlots resulted in diminishing effectiveness of these essential medicines to treat infections in people.  The term antibiotic resistance has become more common in recent years.

"The Court's order pushes the agency one step closer to meaningful action to curb the dangerous overuse of antibiotics in animal feed," said Avinash Kar, NRDC health attorney. "The Court calls out FDA's protracted foot-dragging on the problem of antibiotic resistance and requires the agency do its job to protect our food, our health and our families."

In recent years, some pathogens have evolved to withstand the drugs (antibiotics) that previously was used to kill them.  The World Health Organization sees this threat as dire. "A post-antibiotic era, in which common infections and minor injuries can kill, far from being an apocalyptic fantasy, is instead a very real possibility for the 21st century," the organization notes.

Urinary tract infections caused by drug-resistant E. coli are increasingly common, as are infections caused by methicillin-resistant Staphylococcus aureus (MRSA) — rates of which doubled at academic hospitals between 2003 and 2008.  The WHO also notes that gonorrhea, which used to respond well to common antibiotics, "may soon become untreatable as no vaccines or new drugs are in development."

However, the most recent move by the FDA was greeted more favorably by the meat industry but decidedly less so by critics.  The Natural Resources Defense Council, a non-profit environmental advocacy group that was among the organizations that sued the FDA for changes bashed the FDA's plan, saying it fails to require any change in the use of antibiotics."

FDA's policy is an early holiday gift to industry," NRDC health attorney Avinash Kar said in a statement. "It is a hollow gesture that does little to tackle a widely-recognized threat to human health. FDA has essentially followed a voluntary approach for more than 35 years, but use of these drugs to raise animals has increased."

The Center for Science in the Public Interest noted in a statement the proposal "requires the drug companies who profit from sales of their drugs to initiate the process. The good news is the agency has pledged to evaluate levels of compliance and inform the public after 90 days if the drug industry is cooperating with the relabeling effort."

Having said this, even this move (however late and toothless) is still a much-needed step in the right direction, although its one which some would say the U.S. Department of Agriculture (USDA) kind of promoted (at least unofficially) to address downright filthy feedlots routinely used in industrial meat production.  To give you an illustration of just what this means, animals are fed antibiotic-laced food and stand in 1-2 inches of feces.  The runoff pollutes waterways around these "farms".  According to Iowa Citizens for Community Improvement, a group that is trying to fight factory farming in Iowa, using data from the state's Department of Natural Resources, the number of "impaired waterways" in the state over the past decade, although all of that degradation can't be laid at the feet of livestock farms — Iowa also has massive amounts of corn farming, which also results in leaching of algae-causing nitrogen and phosphorus. However, farming hogs has scaled up over the same time frame (see http://bit.ly/1ekYwF5 for more details).  On the latter issue, I should note that the Chinese seem very eager to copy U.S. industrial food production methods to feed its billion people inexpensive meat.  China has been on a meat-eating binge, having doubled its consumption in the last two decades of economic growth.

In September 2013, Virginia-based pork producer Smithfield Foods Inc. was acquired by Shuanghui International Holdings Ltd., but the company legally changed its name on January 21, 2014 to the less-distinctively Chinese WH Group Ltd., in a $4.7 billion acquisition deal, meaning the company sold at a 31% premium.  The deal made Smithfield shareholders very happy, and also passed the Justice Department's requirements.  China itself has been plagued by routine food processing scandals at home (does anyone remember the poisoned infant formula incident that made world headlines in 2008?), so the Chinese government viewed the Smithfield acquisition as a way of helping the country produce meat more cheaply at home using methods that are now already widely-deployed in the United States.

China seems to want to emulate U.S. food industrialization, regardless of the health consequences.  I suppose its marginally better than what they have presently, but one could hardly call it an “advancement”, but they’ll have to deal with the longer-term health consequences down the road, something the U.S. has been slow to do itself.

On the issue of industrial meat production, a relatively new documentary released on December 10, 2013 in cooperation with Rolling Stone magazine (see http://rol.st/ID5xs3) gives a closer look at what American "farming" looks like today.  I'll give you a hint: images of animals grazing happily on open fields is a big myth.  The reality, as documented to some extent in the film I addressed a few years ago "Food, Inc." (see my post at http://goo.gl/X0iiun for details), is very different.  Although the Rolling Stone film focuses more on the issue of animal cruelty which is an eye-opener by itself, the conditions (which China now wants to adopt) have certainly become a major health threat that has grown exponentially over time.

In the end, these two recent FDA moves, regardless of what prompted them, does suggest (to me, at least), that the era of the FDA serving "clients" it is tasked with regulating, is less important today than is the goal of public safety.  That certainly doesn't mean things are perfect at FDA.  There's still a revolving door between senior executives in the drug and biotech companies into the management roles at the FDA (and USDA) which is a significant conflict-of-interest that still hasn't been resolved, but it IS a step in the right direction.

Tuesday, December 31, 2013

Little-Noticed Diabetes Care Developments of 2013

As we approach the new year (2014!), although I haven't blogged as much as I did a number of years ago, there were a few things which, in my opinion, deserve acknowledgement as they relate to diabetes care.  One of the biggest (perhaps), yet less acknowledged, developments was mergers and acquisitions in the diabetes care space.  Although I follow this stuff, sometimes even I lose track of who acquired who and what their new names are (when they change the name of the company).

Bristol Myers Squibb: In Again, Out Again (... Of Diabetes Care, That Is).  Novo's Danish Delusions.

My readers may recall that last year (see http://on.wsj.com/Kh9xic for details), San Diego-based Amylin Pharmaceuticals was acquired by the pharma giant Bristol Myers Squibb (BMY), a company that was (after Eli Lilly & Co.) once the second-largest American drug company to sell insulin in the U.S. (in those days, it was sold under the E.R. Squibb & Sons, Inc. brand name and did so until the mid-1970s).  Various mergers and acquisitions (including Squibb's being acquired by Bristol Myers in 1989) over the years and production problems led the company to turn to a largely unknown (to Americans and Canadians) Danish company known as Novo Nordisk A/S to supply insulin through a joint venture which relied on Squibb's American salespeople to merchandise the product, and Novo's manufacturing sold by a joint venture known as Squibb/Novo, Inc. until 1989, at which point, Bristol Myers Squibb executives sold the company's share of the joint venture to Novo Nordisk outright and exited the U.S. insulin market completely.  I should note that 1989 was also the year that two separate, Danish rival insulin manufacturers merged to form Novo Nordisk A/S, previously Novo and Nordisk were independent entities.  Novo did see sales grow with the joint venture, hence the acquisition established the company as a viable competitor in the U.S. insulin market whereas the company was almost completely unknown to North Americans prior to the 1980s.  However, insulin pens didn't propel the company to become a major player as it did in Europe, its ability to navigate the managed care environment and sell itself to the formulary managers did.  Ironically, Diabetic Investor David Kliff thinks Novo Nordisk management is naïve to think its products are immune from competition (see http://onforb.es/JIsWbo for his write-up).  I will say that in addition to losing Express Scripts and Kaiser Permanente this year, the company has also seen a newly-aggressive Lilly grab more market share during the past few years, whereas Lilly had let its diabetes business slide previously.

Novo Nordisk followed a somewhat similar strategy in Canada.  The Canadian government under Prime Minister Brian Mulroney liquidated the birthplace of insulin, Connaught Laboratories, Ltd. around the same time, although I believe it was sold to what was then Aventis (now Sanofi) because by that time, Novo had already established its own manufacturing facility in Canada.  BMY, on the other hand, had pretty much avoided diabetes treatments (for type 1 or type 2) until more than a decade later when it bought Amylin.

In any event, BMY re-emerged as a player in the diabetes space when it acquired Amylin.  I should note that the company's CEO left the company to run Israel-based drug giant Teva (best known for generics) for a bigger paycheck, only to leave a few months later after a disagreement with someone on the board of directors.  He and the rest of Teva's management team see opportunity in proprietary, patent-protected drugs rather than simply competing with low-price generics companies (several from India) as well as others like Perrigo (headquartered in Michigan, more on them later) which just closed on Elan, a big Ireland-based generics manufacturer (see http://prn.to/1bQBMOh for details).  Rival BMY moved in a different direction when it comes to diabetes.

AstraZeneca: A Newer Player In Diabetes Care, But Now A Pretty Big One

Without getting too far off-topic, the irony is that BMY had decided less than a year after acquiring Amylin, to sell its diabetes business as a whole to AstraZeneca (a.k.a. "AZ", which was a joint venture partner to market products like Symlin and Byetta in Europe) which seemed a tad like deja vu for long-timers who remember the days when Novo Nordisk had absolutely no brand recognition in the U.S.  AZ is kind of unknown in the U.S. diabetes market, much as Novo Nordisk was in the 1980s, but it cannot be discounted.

AstraZeneca, itself the result of a 1993 merger between Sweden's Astra Pharmaceuticals and the larger UK rival Zeneca Group plc, is kind of struggling these days with a number of patent expirations, and relatively few likely drug prospects in its own development pipeline.  The acquisition gives it sales and a few likely drug approvals in the coming years.  AZ had an autoimmunity treatment (which it was working with a Cambridge, MA startup known as Tolerx) for type 1 diabetes in its pipeline which failed in clinical trials (see the news at http://bit.ly/1fWjexj), and many of the company's other products are no longer patent protected.  It has seen its share in the Type 2 GLP-1 receptor agonists, which mimic the effect of glucagonlike peptide- 1 space (Byetta) shrink as Novo's Victoza has grabbed a bigger slice, but there are expectations that its extended release version to be known as Bydureon could reverse that in the not-too-distant future.  Also, Novo Nordisk lost the massive Express Scripts PBM account, which may favor AZ.  AZ needed the diabetes business more than BMY did, although I question whether the company can effectively manage the business, though it certainly has every incentive to make it work.

Teva Could Emerge As a Bigger Player in Diabetes than AstraZeneca in the Future

Teva already sells a number of type 2 generics, but its also one of the few (aside from Novartis' Sandoz unit) companies that could emerge as a major biosimilar manufacturer (although Lilly is already discussing a new-and-improved version of Sanofi's Lantus whose patent is due to expire in a about a year).  Aside from that, the company has licensed the rights to one of the few autoimmunity treatments that hasn't [yet] failed in clinical trials (Diapep 277), which its licensed from another Israeli company known as Andromeda (see my post HERE for background).  Of note is the fact that on December 18, 2013, Andromeda announced that the first patient had been dosed with DiaPep277 for the treatment of type 1 diabetes in its Extension Study to the Phase 3 Clinical Trial known as DIA-AID 2.  The 24-month extension study is designed to evaluate long-term safety, tolerability, and the effect of DiaPep277 on the ability of patients to maintain glycemic control for 2 additional years following the completion of the DIA-AID 2 confirmatory study. DIA-AID 2 is scheduled to be completed at the end of 2014, and is being conducted in medical centers in the USA, Europe, and Israel.  Catch my Tweet on that below, or HERE.

Nipro Diabetes Care: You May Not Know Them, But You May Know Them Soon (or at least you'll know their products)

My readers may recall that a few years ago, I wrote about Nipro Diabetes Care (see my post HERE).  In hindsight, my write-up wasn't terribly flattering (to Nipro), but my perspective was that Walmart Stores, Inc. was getting big price breaks from its new supplier (Nipro), but wasn't passing the savings on to consumers.  However, on my most recent visit to Walmart, the company had cut the prices for its liquid glucose products by $0.20.  Thanks Walmart, better late than never, especially for a company whose Q4 2013 sales are likely to disappoint institutional investors, and you wonder why?  In any event, a Nipro made a little-noticed but pretty big move that deserves to be acknowledged here.  My readers may recall that in January 2013, Perrigo acquired CanAm Care (see the press release at http://prn.to/1doc59j).  They are a big supplier of store-branded lancets and glucose tablets, although it also sells glucose tablets and liquids under the Dex4 brand name.  In any event, my longtime readers may recall that I disclosed that CanAm care relied upon a small, privately-held New Hampshire based company known as P.J. Noyes Company (I wrote about it HERE) to make its glucose tablets and bottle its Dex4 Liquid Blast liquid glucose treatments.  As it turns out, in August 2013, rival Nipro Diabetes Care acquired P.J. Noyes (see the Businesswire press release of the acquisition at http://bit.ly/1dodRai) the contract manufacturing company CanAm users to make these things.

Not only did Nipro snag the massive Walmart account from Perrigo, but it also acquired the very company that contract-manufactures its glucose tablets and liquids!  This undoubtedly puts Perrigo's CanAm Care unit in a rather uncomfortable position.  As part of a bigger drug manufacturer, CanAm can theoretically bring production in-house, but it may not have the ability to do everything right now, and the company is very busy digesting its big Elan acquisition (the company which is headquartered in Michigan, but is now legally based in Ireland thanks to tax benefits), so the company to watch in this space is (for the moment), Nipro, although as I wrote way back in 2006 (see my post HERE) there are other players such as New Jersey-based Raritan Pharmaceuticals which might step in given the change-in-hands seen at P.J. Noyes.

Time will tell.

However, we have seen Nipro make some subtle changes (a number for the better), such as removing less popular flavors from the bottles of glucose tablets that patients aren't complaining about, removing the inner seal to the glucose liquids to make them easier to open, so this development could be an interesting one.  I would expect to see Perrigo to be more aggressive to try and retain its share of the lucrative private-label business (sold under the pharmacies' brand names), but whether this translates to savings for patients remains to be seen.  However, Nipro did switch to shorter bottles for its glucose liquids that resemble energy (caffeine) shots so as to be less conspicuous.  They also lack an inner seal making them easier to open (good news if your hands are shaking from hypoglycemia), so it seems CEO Scott Verner is bringing innovation to what had largely become a commodity market.  The Orlando Sun-Sentinel had a fascinating article about some of the things Nipro has done under Mr. Verner's leadership (see the article at http://ow.ly/sbqVu) which you might want to have a look at.

Beyond this, 2013 brought several other changes.

Without question, the Affordable Care Act (a.k.a. "Obamacare") will profoundly impact people with diabetes in 2014, and ways that have yet to be appreciated.  While some segments of the population and the media outlets that cater to those viewpoints have been only too quick to declare it a failure before it began, the reality is this law was the first fundamental change to overtly discriminatory practices which enabled healthcare insurance companies to basically cherry-pick the youngest and most healthy individuals, while simultaneously enabling them to refuse to sell (at any price) policies to people with so-called pre-existing conditions (a list so long that virtually any ailment renders a person ineligible and can therefore be excluded from the market; this incidentally, is one of the law's most popular provisions).  To be sure, there are parts of this enormous reform legislation that will undoubtedly need to be retooled, but the impact will be that the U.S. could possibly climb in the rankings to be closer to other advanced, industrialized societies, whereas the U.S. ranks lower than most in spite of our spending more on a per capita basis (catch my 2008 post HERE for details).

Medtronic Low Glucose Suspend Feature FINALLY Approved by FDA

Aside from that, we saw some long-overdue progress in some areas of treatment, although certainly not as soon as we should have.  Most notably, the Medtronic Low Glucose Suspend feature (in the Medtronic 530G/Veo) finally received FDA approval after Europeans and Australians (even Brazilians) have had access for years already.  Less discussed was the fact that the FDA's approval happened due in no small part to patient involvement and activism.  JDRF led the charge for this particular issue, and it was ultimately our patient testimonies and letters that convinced the FDA why this feature was so badly needed.

FDA Is Realizing that Patient Involvement Here To Stay

Patient involvement, led by patient groups including the JDRF, Diabetes Advocates and Diabetes Hands Foundation and several others has fundamentally changed how the FDA does business.  Although the FDA is required by law to consider input from the American public (which includes everyone, not just doctors and industry), in practice, patients have seldom had direct representation.  But a number of years ago (catch my push in 2010 HERE for more), I started urging patients to participate on accuracy, and I believe the FDA was a bit overwhelmed with how many patients submitted comments.  Since then, patients have pushed the agenda.  To be sure, another branch of the U.S. Government, specifically Medicare, in a move that got little public attention until it was implemented, has simultaneously managed to undermine this with its so-called competitive bidding (see my post HERE) process for mail orders.

However, my friend Bennet [http://www.ydmv.net/] has really done a lot more in that regardthan I have in recent years, with a campaign called StripSafely [http://www.stripsafely.com/] which has pushed the message home to the FDA that accuracy is important.  He has also attended several FDA meetings during the past year, putting a patient face and perspective on meetings that were once routinely regarded as "industry only" meetings.  The team at Close Concerns called attention to the fact that the FDA will hold a series of 20 patient meetings (effectively meeting with patients to discuss their concerns) for a number of different disease areas, yet miraculously, diabetes did not make the initial list of 16 planned meetings, which means there are only four meetings have not been determined, and diabetes should be on the list.  Why the FDA chose to effectively ignore the voices of one of the largest patient groups in the U.S. is unclear, but Close Concerns has a petition to encourage the FDA to put diabetes on the agenda with a Patient Conference for this group of diseases (see their writeup at http://ow.ly/sbrch).  People with diabetes are viewed by regulators and industry as pioneers in this regard, but other groups, including those with autoimmune rhematoid arthritis (RA) which differs from osteoarthritis common in the elderly, have seen what people with diabetes have accomplished and are following our lead to some extent.  In the future, there's a possibility of collaborating with them on issues that impacts both diseases on issues that affect us both, ranging from FDA guidance on biosimilars, to NIH funding.

Anyway, this is my list of some pretty noteworthy events in the diabetes care front for 2013.  I think there are positive signs for 2014, but patients and their caregivers cannot become complacent.  We have only begun to make our presence known with entities such as the FDA, but there are other areas (I'm thinking of the NIH's NIDDK which does not even have a permanent representative it sends to the NIH Autoimmune Diseases Coordinating Committee (ADCC), see http://1.usa.gov/1amQmtQ for more background.

Hello?

The Special Diabetes Program spends billions on type 1 research, yet the NIDDK doesn't have a permanent representative on a committee that could help?!  Yes, that's an area that needs attention, too.  I'm putting it on my New Years Resolutions list.  Maybe we can change that, too!