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ed's blog

September, 2009

Tuesday, September 29, 2009

Thursday, September 24, 2009

Tuesday, September 8, 2009

Friday, September 4, 2009

Wednesday, September 2, 2009

Tuesday, September 1, 2009

Tuesday, September 29, 2009 — Stelara™ (ustekinumab)

To Ed: The news is everywhere that Friday FDA finally approved ustekinumab [Stelara] for the treatment of plaque psoriasis. That is, everywhere but at FlakeHQ.  [Are] You asleep at the wheel or just biding your time? -Vance R. (9/28/09)

Thanks, Vance.  I'd tell you if I slept through all the celebrations on Friday, but in fact I didn't. I've been carefully collecting documents off the Internet about Stelara in hopes of scooping everybody else with something, anything overlooked by my P-media colleagues.

But, since you're pressing the point, I will confess that I haven't overturned anything new and sensational.

This new biologic is being billed as "first-in-class," which means it is the first to target a particular aspect of the immune system's response that is believed to cause or contribute to the formation of psoriasis plaques. At the moment, all but one of the other biologics available in the U.S. are TNF Blockers (see September 24ths post in this blog, below). Stelara isn't a TNF Blocker; it is an "interleukin-12 and interleukin-23 inhibitor." It prevents two very specific proteins from binding with immune cells — a process that is otherwise associated with subsequent growth of psoriasis lesions.

It seems important to me to note that the involvement of IL-12 and IL-23 in psoriasis was/is determined to be "abnormal" in people with psoriasis. Why do I think this is important? Stelara is not targeting a product of the immune system that is working normally but happens to result in psoriasis. On the contrary, it's focusing on a very small element in the chain of events that end up being P-lesions, and this very small element is not the same as it is when P is not a consequence.

The older systemics — the ones with so many dreadful and almost certain side effects if these drugs are used too long, specifically methotrexate and cyclosporine — have nowhere near this level of specificity. They blast the immune system with a wide-ranging and powerful suppression. They are like an aerial bombardment whereas the biologics, including Stelara, are a sniper's bullet.

One thing I think my fellow flakers are going to particularly like about Stelara (assuming it works as well as claimed): After starting with two subcutaneous shots in the first month, subsequent injections are only necessary every twelve weeks. (Which may be one reason why, according to Jacquie W. on Psorchat, Stelara costs less than Enbrel in Canada.  I'm hoping that will be true here, too.)

Bad news for now, though: Shots must be administered by a health care professional. Most of you will have to visit your derm to get your injections and I'm sure that will mean an additional charge. Our friend Michael Paranzino, choreographer of all that goes on at Psoriasis Cure Now!, at an FDA hearing prior to Stelara's approval, expressed our dissatisfaction at the administration restriction (needing to get shots from a health care professional). Evidently he didn't change minds at that time. Michael's track record suggests he doesn't give up, so maybe in the future we'll be able to self-inject Stelara at home like we do Enbrel and Humira.

As with the TNF Blockers, the long-term effects of using Stelara are unknown. Unlike Enbrel. Humira and Remicade, which entered the Psoriasis armory only after years of use by rheumatoid arthritis sufferers (and some other conditions), Stelara is brand new. It will come boxed with all the typical warnings we've come to expect from biologics ... increased risk of malignancies, infections, etc. This may dampen entry into the user ranks for some and that's all right. I'm sure Centocor the manufacturer — also maker of Remicade) is in this for the long haul and prepared for a gradual start. At least they should be prepared given all the newly-gun-shy Raptiva survivors.

I've talked to several flakers in the past two years who have been waiting with baited breath for the arrival of ustekinumab. Today I am happy for them. I'm happy to have Stelara on my own list of "try next" things. (For the time being I'm still in love with my TNF blocker, Humira.) 

P.S. It just occurred to me. Lots of us with both psoriasis and psoriatic arthritis have been getting our biologic medicine from a rheumatologist. I haven't had an appointment with my dermatologist for over three years! Stelara is, so far, just approved for plaque psoriasis which means people are more likely to get it from a dermatologist. I sure hope my derm is (a) not retired and (b) still in possession of my file.


Thursday, September 24, 2009 — Kids, Cancer & TNF Blockers

The biologic drugs we currently use for plaque psoriasis and/or psoriatic arthritis — Enbrel, Humira, Remicade — are all "tumor necrosis factor blockers," a.k.a. TNF-blockers. (The other currently available biologic, Amevive, is NOT a TNF blocker.) They inhibit the "expression" of a certain kind of immune system cell that combats illness by, in part, stimulating inflammation. We sometimes need to be reminded that "inflammation," though it gets a bad-rap when it runs amok (psoriasis, asthma, arthritis, IBS, Kawasaki disease, uveitis...) is also a natural part of our defense against infection. In its protector role, TNF also helps the body fight cancer. By the time any of these drugs were approved for any type of psoriasis it was already well known that blocking the action of TNF agents could reduce the body's cancer-fighting abilities. No doubt many hours of research time had been spent finding the minimum possible dose to curb inflammatory diseases and, hopefully, NOT increase the same body's chances of getting, and being unable to get rid of, cancer. The success of finding a tolerable "in between" evidently hasn't been total.

In June the FDA stepped forward with a statement that the number of children and teen cancers among users of TNF-blocking biologics was "of concern." They launched a data study and published the results last month. Of around 25,000 kids receiving anti-TNF blockers through biologic agents (over an average 8 year period), 48 cases of malignancy were reported. There are all kinds of factors skewing the reliability of the statistics, including but not limited to different frames of reference (number of years kids were on the drugs, different conditions and diseases, etc.). To get a better handle on the statistics, go to my source article, link at the bottom of this post. Fudging judgment because of the data uncertainties, it is still safe to say less than one-half of one percent of the kids using biologics have contracted cancer and have been reported to the FDA. I don't know how this compares to the number of kids within a given group size who get cancer without taking biologics. I'll assume, until someone straightens me out on this, that the number is higher among those kids taking biologics than it is in the general population. (Otherwise, why would the FDA be specifically alarmed about the association of biologics use and cancer in kids?)

I review all this now because the news reports I've read and heard coming from all kinds of sources have all made the issue sound more alarming. After the Genentech/Raptiva debacle last spring (removal of Raptiva from the market after its association with a fatal brain disease — four cases of PML) I hate to see more panic set in about the use of biologics over all. I know parents of P-kids, if any are reading this, are gritting their teeth right now. Statistics can be sharp or blurry, definitive or loosey-goosey, but when it comes to the safety of one's child there is no room for shades of gray, all decisions are "yes" or "no." Doubt is an arrow pointing directly to "no." Better safe than sorry. And so on.

So, when I see headlines like "Child, Teen Cancers Linked to TNF Blockers" I don't react well. "Linked?" That's too definitive. That implies truths not in evidence.

The following is taken directly from the FDA Alert issued on August 4th:

Considerations for Healthcare Professionals

  • Discuss with patients and families the increased risk of developing cancer in children and adolescents, taking into account the clinical utility of TNF blockers, the risks/benefits of other immunosuppressive therapies, and the risks associated with untreated illness.
  • Be aware of the possibility and monitor for the emergence of malignancies during and after treatment with TNF blockers.
  • Be aware of the possibility and monitor for the emergence or worsening of psoriasis during treatment with TNF blockers, particularly pustular and palmoplantar forms of psoriasis.
  • Understand that some immune-related diseases, such as Crohn’s, have been shown to increase cancer risk independent of treatment with TNF blockers while for others, such as juvenile idiopathic arthritis (JIA), it is unknown whether there is an increased cancer risk.
  • Inform patients, their families, and caregivers of the signs and symptoms of malignancies or psoriasis so they are aware of and able to notify their healthcare professional of any unusual signs or symptoms.

Information for Patients

  • Be aware that taking TNF blockers may increase the risk of developing lymphoma, leukemia, and other cancers. 
  • Be aware that taking TNF blockers may increase the risk of developing psoriasis and may worsen pre-existing psoriasis.
  • Review the Medication Guide that accompanies TNF blockers.
  • Do not stop or change medicines that have been prescribed without first talking with a knowledgeable healthcare professional. 
  • Pay close attention for any signs or symptoms of cancer such as unexplained weight loss or fatigue, swollen lymph nodes in the neck, underarms or groin, or easy bruising or bleeding.  Promptly discuss any signs and symptoms with a healthcare professional.
  • Pay close attention for any signs or symptoms of new onset psoriasis or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.

Click for Source

Does this sound more reasonable than "Child, Teen Cancers Linked to TNF Blockers"? (I know the FDA's actual language is too dense for a headline, but that's no excuse for the forced sensationalism of "Linked.")

By now it is passe to compare news-induced drug panic with driving an auto; but it seems appropriate to use it again here. One wonders, given the statistics available on cancer cases among kids using biologic drugs, which is more likely to be deadly, using a biologic or letting your 16 year old get a driver's license? (Sorry. It comes to mind because one of my granddaughters recently acquired her learner's permit and she's getting a vehicle when that license gets upgraded in December.)

Article Source: Questions and Answers - TNF Blockers 8/25/2009 (FDA)


Tuesday, September 8, 2009 — Which came first? P or all its comorbidities?

Was rereading that blurb at about the sundry other disorders that have been connected to psoriasis by virtue of above-average numbers of flakers having them (blurb) ... overweight (70%), high blood pressure (33%), diabetes (11%), other autoimmune diseases (28%). In that same article, one of my heroes is quoted:

"This data reinforces what we’ve known all along. Psoriasis is a very serious condition that impacts the body well beyond the skin," said Mark Lebwohl, M.D., professor and chairman of dermatology at the Mount. Sinai School of Medicine and chair of the National Psoriasis Foundation Medical Board.

Now I'm wondering if the study responsible for these new statistics (5,000 psoriatics surveyed) actually indicated that, or if the Foundation picked a poorly worded claim as a Lebwohl quote. It isn't explicit in what Dr. Lebwohl says here, but it is strongly suggested that psoriasis (its "strong impact" on the body) could be responsible for these other problems. Perhaps that is exactly what Dr. Lebwohl intended to convey, and perhaps that is exactly what the research suggests, but it would sure surprise me.

I've fought my weight since I was old enough to care about it.  I have type 1 diabetes, high blood pressure, high cholesterol, heart disease and psoriatic arthritis. That puts me right there in the 30% of flakers who have one or more of these other problems. My grandparents on my mother's side both died of heart conditions, her father's health was further aggravated by diabetes (probably type 2), but neither of them flaked. Both my parents have fought their tendency to be overweight (my mother being more successful than my father), and my father was, late in his life, diagnosed with mild psoriasis in his ears and, occasionally, on his bald pate. The history of the better defined conditions — heart disease, diabetes, hypertension, etc. — in my family, at least, is much more "outspoken" than any prevalence of psoriasis (mild or otherwise). My family history would suggest psoriasis is "just something else" that might come along because of those other problems.

From the point of view of what you and I ought to do about all of this, my argument here is nit-picking; it remains true, whether psoriasis is the "lead condition" or not, that where there is psoriasis there is a higher likelihood of finding these assorted other problems. So we should be on the look-out for them and try to live a healthy lifestyle, etc. (I should be the poster boy for this, but I fail miserably....)

But if you are looking at psoriasis and its comorbidities from a research angle, you might be misdirected if you take Lebwohl 's quote too literally. The immune system — presumed to be at the heart of all this grief — is a complicated process involving many tissue types and virtually every other "system" in the body. First rule out the immune system as the overall bad guy heading up this gang of diseases and disorders. If that isn't possible, if the immune system steadfastly shows up behind all of these agonies, then why focus on psoriasis — one relatively minor minion in the overall membership of woe?

Comment from Jason G., September 19, 2009; Re: 9/8 Which came first?...

I fit the 70% overweight group. Not because P has caused me to be overweight, but rather, P has caused me to retreat from society, leading to a sedentary lifestyle. Which of course leads to obesity.

I believe if the P were gone, I'd be much more involved socially (ie; active) and much less overweight.

I don't think scientists should make chatter about indirect connections. It causes too much scare and worry.

Be Well, Do Good Work, and Keep In Touch. -Jason G

Thanks, Jason. I think sometimes it is the news medias'
reportage that creates the problems. Out of the scientific
context those "indirect connections" can be made
dramatically more scary. -Ed


Comment from Griff, Sept 9, 2009; Re: 9/8 Which came first?...

That was a little dense, Dewky. (As I’ve suggested on more than one occasion, you might want to have fewer cups of coffee before you sit down to compose your thoughts for this new blog-thing.) If I get it – and that’s very iffy – you are saying psoriasis is probably not a cause of these other health problems; rather, along with all of them it is caused by some overriding immune system problem. Is this correct? (I won’t get into how some people might react to having their severe psoriasis called “one relatively minor minion in the overall membership of woe.” What did you put  in that coffee?) Keep pedaling. Everybody falls off the bike a few times at first. -Griff

You interpreted correctly. Thanks, Griff. -Ed


Friday, September 4, 2009 — Addressing Psoriasis: the Big Moment  Here you can watch the video made at the September 2nd Addressing Psoriasis Fashion Show in NYC, meet the "most inspirational story" winner, browse a photo gallery of 8 beautiful flaky people and in other ways share this multi-sponsor extravaganza. In many ways the whole event — from the initial nationwide contest for "models" to the final 8 walking the NYC runway in clothes designed just for them — was to be a climax to a year-long theme that, consciously or not, has pervaded the U.S. psoriasis community since last Fall: Don't Hide!

For me, the importance of this theme to furthering research toward a cure for psoriasis was first driven home by Michael Paranzino, proprietor of Psoriasis Cure Now!, starting with his debut "Short Sleeve Day" (September, 2007). The point is pretty straightforward, but it goes against the typical psoriatic's tendency to withdraw and live "unnoticed." If no one knows about the seriousness of psoriasis and the large numbers of people affected by it, the disease isn't going to get the political attention it needs to spurn funding for more research and greater access to treatments and medicines.

The National Psoriasis Foundation has been intensely behind the theme since its incorporation of CariDee English (America's Next Top Model...) and, more recently, CW singer LeAnn Rimes as spokesfolks for the cause. Their celebrity helps a lot, but the NYC Addressing Psoriasis fashion show does a lot, too. Read the winners' stories, watch them walk the runway on the video, participate in their experience through the photo gallery ... as the circus showman would say, "Goooooooood promotion!"

My only nagging question: Where was Fred Finkelstein during all this? Our notable producer/star of the blazing documentary My Skin's On Fire, has been struggling to raise money for a new documentary about children with psoriasis, but someone should have given him three tickets to New York. One for himself, a second for his videographer, and a third for their gear and a carton of blank videocassettes. I have this horrible sinking feeling that these eight beautiful people are going to disappear back where they came from, like baseball players fading into the corn on the fringes of the Field of Dreams. Hell No Don't Let Them Go! They are us — much more than the celebrities, these eight people have longer stories to tell and those deserve fuller treatment. Paranzino likes to leave DVD's with legislators; everybody wants to have video links on their web pages. Here is the best fodder for this stuff we've had in ages. Eight beautiful success stories. The third act of the Addressing Psoriasis drama hasn't played, yet. I hope it will.

Comment from Fred Finkelstein; September 15, 2009; Re: "...the Big Moment"

I'm right here, Ed — sitting in front of my computer in my apartment searching for creative ways to find completion funding for I'm Just Like You, our follow-up piece to My Skin's on Fire.

In an act of shameless self-promotion I appeal to all your loyal readers to consider contributing to our project so we may continue to spread the messages of hope and empowerment that are fundamental in dealing with the challenges of both psoriasis and psoriatic arthritis.

And in terms of those eight brave souls who walked the runway in NY — they have already done all of us a great service simply by showing up. Their courage in 'walking the walk' will enable others to step forward and share their stories ... and it will continue.... -Fred Finkelstein


Wednesday, September 2, 2009 — A Delightfully Scary New Concept for Health Care Reform

I think most flakers with moderate to serious psoriasis are probably paying more than typical attention to the health care reform debates. I've no doubt those of us using $1500+-per-month prescriptions are watching the news about this. The link above will take you to an article in this Month's Atlantic magazine: How American Health Care Killed My Father, by David Goldhill. It is a very provocative assay of U.S. health care's current condition, what's wrong with proposed reform plans, and another approach to reform.

Goldhill's proposal isn't going to stop the momentum toward a more public reform plan (he readily admits this), and some of the things in those other plans may help temporarily, but he (rather convincingly) points out things will still get worse and, perhaps, next round we'll come to our senses....

Whether you agree or not, it wouldn't be right for you to go to bed tonight without at least knowing this "new idea" has bobbed to the surface.


Tuesday, September 1, 2009 — Changes and So Forth

Welcome to the "new"! Actually, about 98% of the site isn't new. Once you start reading mail, articles, creative contributions and archived correspondence everything is the same as it's always been. It is the main pages — those listed in the navigation bar on the left — that now sport this new layout. Other changes that are most important (but also subtle) are as follows:

  • The search bar is now available on every main page (top right, instead of just on the home page). Every search bar is the same and will scan ALL TEXT AT FLAKEHQ for the key words you insert.
  • The concept of regularly scheduled updates, every other month, has been replaced with the new (to FlakeHQ) concept of a "blog."  The way you will know if material has been added to the site is no longer looking for "September-October 2009" above the links in the home page nav bar. Now you will look at the month right beneath "ed's blog" on this page (the home page), and then the date of the first entry beneath that little caricature of me perusing a newspaper. There's also a hyperlinked list of contents adjacent to the caricature which grows with the month and you can get to any story fast by clicking on its headline in this list. New material will be announced in my blog entries. I will make as many blog entries as appropriate every month. At the end of a month I will archive the month's contents (like I used to archive Briefings) and start a new blog for the next month. All monthly blogs will be key word searchable.
  • For the time being, you'll have to check the home page to see if new material has been added, or you may use one of those services that checks for you and emails you if anything has changed. (These are on their way out....) Eventually, I will add an RSS feed to FlakeHQ (RSS stands for Real Simple Syndication). Simply put, that means you can sign up for the feed using Internet Explorer, or Microsoft Outlook, or some dedicated RSS reader and short announcements about new material at FlakeHQ will show up in your reader.

As always, the "new" FlakeHQ is bound to have rough spots and oversights. Please help me clean these up by emailing me when you encounter them. (This transformation has been accomplished as a direct denial of the old axiom that you can't teach an old dog new tricks!)

Stroke Risk and Psoriasis — Fred Finkelstein (creator of the documentary My Skin's On Fire) emailed me a blurb from the Journal of Investigative Dermatology (21 May 2009) about a statistical study of stroke patients in England. The results suggested 1 in 4,115 stroke patients per year also had mild psoriasis; 1 in 530 stroke patients per year also had severe psoriasis. On the surface that sounds alarming, but consider this: the researchers defined "severe psoriasis" as "Any patient with a diagnostic code of psoriasis and a history of systemic therapy consistent with severe psoriasis" [underscore mine]. I ask myself, "How can they rule out the effect of the systemics as a risk creator in-and-of themselves?" There's probably an answer to that question and if anyone knows what it is, please share it with me. We know what systemic therapies are: methotrexate, cyclosporine, Soriatane, sulfasalazine, and all the biologics. All but the biologics are known to be toxic, which means assorted risks go along with the benefits. Would it be so surprising if stroke were one of those risks? Here's the link Fred sent me:

Steven Feldman's Compartments  First thing I'm going to do is keep you from feeling like an idiot after you've bought this book and realize it's not at all what you thought it would be. Study the cover. The entire thesis of the book is captured by the illustration on the cover. Now, what I'm NOT going to do is write an expositive review of the book. I was becoming surprised and a little perplexed as I read further and further into the book. By the final chapters.... Well, the final chapters are the whole point, and a worthwhile point. The surprise was so important to the purpose of the book — and was so masterfully played out throughout —  it would be criminal to deny you a similar experience. But I get ahead of myself.

Steven Feldman is Steven Feldman, MD, PhD, Dermatologist, Professor ... a stalwart member (on the professional side) of the National Psoriasis Foundation, frequent contributor to Foundation activities and a FlakeHQ Interviewee. (Titles are one kind of compartment, by the way.)

Is Compartments about dermatology? About Psoriasis? Not really, though there's some of that in the text. The book's subtitle reads "How the Brightest, Best Trained, and Most Caring People can Make Judgments That are Completely & Utterly Wrong." Kind of draws you in; no? To be honest I bought the book anticipating a dermatologist's take on psoriasis, or at least skin disorders generally — perhaps a somewhat stern look at how patients are their own worst enemies (non-compliance with prescription instructions) — but also self-effacing criticism of derms. Feldman dispatched those issues in the first couple of chapters. In the end, the book is a lot LARGER than skin disorders and some readers are going to like this and others are going to object — depending on the compartment they're reading in and their perceptions about the compartment from which Feldman is writing.

Sound a little off-putting? If so that's my fault, not Feldman's. One of the remarkable things Feldman has managed to accomplish in this little book (189 pages plus references and index) is illustrate his argument through the language and organization of the argument itself. A very crafty (and difficult) thing to do.

I recommend Compartments without reservation ... knowing full-well a lot of you are not going to be comfortable with it. I know the book is going to affect me for a long, long time — hopefully for the rest of my life —  but I'm not quite sure what metaphor is most appropriate. Is it a new set of eye glasses that is going to make my vision much better? Is it a philosophy or a moral code? Is it simply old wisdom in new clothes? ... Help me out here. If you read Compartments, let me know what YOU think.

Compartments at
Compartments at Barnes & Noble

New at FlakeHQ — Neil P. Flanagan give us "Psoriasis Hell," a new poem. It's like looking in a mirror, but with rhythm and rhyme. Visit flaker creativity or go direct to the poem.  FlakeHQ's Poet Laureate Sherry Sheehan has created "A Solipsistic Souliloquy," in which she asks all the ponderous questions flakers ask — and which are, of course, unanswerable. But only Sheehan can ask those questions and make us grin at the same time. Visit the Sherry Sheehan page, or go direct to the poem.

Interesting Mail over the summer: Another report about good luck with low-dose naltrexone. (Naltrexone has been used for some time to curb addict cravings for heroin and opium. Used at much lower doses, there are significant but anecdotal reports that it improves some immune system issues including psoriasis.) ... Double dosing a biologic with another systemic is a prescription practice that seems to be growing. One fellow writes about being prescribed cyclosporine and Enbrel at the same time.... A positive report about Amevive!... Emails exchanged over the summer as one unfortunate suffers the removal of Raptiva from the market (and herself).... And a wonderful rant about the fact that no treatment for psoriasis works forever.

Been awhile since we've had new additions for Flaker's Jargon, but two good ones came in from Adam G. in August. They're at the top of the list.

Tim Gunn's "Addressing Psoriasis" Fashion Show Happens Tomorrow (Sept. 2, 2009) — I wanted to attend this. At first I didn't know what to think about it. (Maybe a little silly?) But as the year unfolded the theme of showing your psoriasis emerged lots of different ways: videos and appearances by CariDee English and LeAnn Rimes and other campaigns by the National Psoriasis Foundation, Short Sleeves Day, a very snazzy calendar and home-grown public service TV spots by Psoriasis-Cure-Now!, and walks ... walks EVERYWHERE people are walking, trotting, tottering and jogging to support the cause. After all of this, the Addressing Psoriasis fashion show — which has really been an unfolding series of events — is coming off like icing on the cake. Eight finalists are going to have the time of their lives in New York as well as a no doubt interesting experience cavorting with fashion dandy Tim Gunn.

The good news is we're going to get to see the exciting parts. That's right, the august assembly of sponsors for this confab are videotaping the fashion show and releasing it in ways we can ALL enjoy. Probably right from the Addressing Psoriasis web site. The minute something is available I'll let you know. Meanwhile, visit the site, check out the 8 finalists. Oh, if you are going to this, how about sharing your experience with us in words to keep at FlakeHQ?


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