Can online information be trusted? The answer, increasingly, is yes. In a study earlier this year, a report in the journal Cancer looked at 343 Web pages about breast cancer that came up in online searches. The researchers found 41 inaccurate statements on 18 sites -- an error rate of 5.2 percent. Sites promoting alternative medicine were 15 times as likely to offer false or misleading health information as those sites that promoted conventional medicine, the study found.
September profile--enjoying success while it lasts
Have you checked out our September 2008 psoriasis patient profile? Lynda has lived with psoriasis for more than 15 years, but is currently enjoying treatment success. She's not sure it will last, but is enjoying it while she can.
She also manages to be a good sport about the indignities many psoriasis patients face. Speaking about the lengthy lotion application sessions she has endured for many years, she jokes: "By the time I got finished I felt like I was a piece of chicken being greased down for the day."
We're sure many of you have "been there, done that" as well!
An experimental psoriasis treatment that could be approved for use in psoriasis patients by the end of 2008 edged out the leading psoriasis biologic in a 12-week head-to-head clinical trial. Ustekinumab (likely brand name, Stelara), made by Johnson & Johnson's Centocor unit, helped more patients achieve 75% and 90% improvements in skin symptoms than did Amgen & Wyeth's Enbrel, which is currently used by more psoriasis patients than all the other biologics combined. As Dow Jones reported:
In the 903-patient trial, participants with moderate to severe psoriasis received one of two dose levels of ustekinumab or Enbrel. The main goal was to track the proportion of patients in each group who achieved at least a 75% reduction in psoriasis at 12 weeks, as measured by an index assessing the surface area and severity of the disease, which causes skin lesions.
J&J said 68% of those taking the lower dose of ustekinumab and 74% taking the higher dose achieved at least a 75% reduction in disease, versus 57% of Enbrel users reaching that mark.
In addition, 36% of patients receiving the lower dose of ustekinumab and 45% of patients receiving the higher dose of ustekinumab achieved a 90% improvement at week 12, compared with 23% of patients receiving Enbrel.
Ustekinumab (Stelara) is also infrequently administered. During the study, patients received just 2 injections of Ustekinumab, and 24 of Enbrel.
This study is important for many reasons, and it points to some of the key issues facing patients seeking a psoriasis treatment.
* These two biologics are among the best psoriasis treatments we've ever had, and yet consider how many people do NOT achieve success with them. 26%, 32% and 43% of patients in the different treatment groups in this study failed to achieve a 75% improvement at week 12. So even if every psoriasis patient with moderate to severe psoriasis could access these expensive treatments, many people are still in need of additional options. (Note: Past studies have shown that some of those who do not reach the 75% improvement mark at week 12, do reach it with continued treatment after 12 weeks.)
*The study duration was 12 weeks. The average psoriasis patient will need psoriasis treatment for 50 YEARS. So while a useful data point, this study does not address whether these treatments can offer lasting relief for a lifelong disease.
* The 12-week duration also means this study does not address long-term safety. "Ustekinumab would be the first of a new class of anti-inflammatory drugs that target proteins called interleukins." It is an anti IL-12/IL-23 agent. Enbrel, meanwhile, is one of a class of biologics that target tumor necrosis factor alpha. These anti-TNFs have been around for more than a decade treating rheumatoid arthritis, psoriasis, Crohn's disease and other diseases. Enbrel has been used in nearly 500,000 patients worldwide over the last 15 years (and won its first U.S. approval, for RA, in 1998). When you add in Humira and Remicade (other anti-TNFs), the anti-TNFs have been used in more than one million people during this time. Ustekinumab, in contrast, has been tested for a year or two, in about 2,000 patients. We simply do not know how the anti-IL12/23 treatments (ustekinumab and another one in development by Abbott called ABT-874) will fare in the long term, either for safety or effectiveness.
* The study did not address psoriatic arthritis, which impacts up to one-third of those with moderate to severe psoriasis. Enbrel and the other anti-TNFs improve psoriatic arthritis and actually impede or stop the progressive damage psoriatic arthritis can cause. Let's hope the anti-IL12/23s also work on arthritis.
Competition by biotech and pharmaceutical companies helps psoriasis patients. This battle to find ever more effective and safer psoriasis treatments offers hope that one day, all psoriasis patients will be able to find and access a treatment that will work for them.
Psoriasis Cure Nowspoke in support of approving ustekinumab at an FDA Advisory Committee hearing in June 2008, because its short-term safety and effectiveness are impressive, and because some of these long-term issues are best observed by having lots of informed patients choosing to use this treatment, so we can see how they fare over time in a real-world setting.
"Short Sleeve Days 2008" has arrived. Even if you have not registered (and you should feel free to still do so), please consider wearing short sleeves at some point this weekend, Sept. 12-14, 2008, and educating your friends, family, colleagues and neighbors about the seriousness of psoriasis.
Rather do something from home? Why not send a note to your email list about the importance of increasing research on psoriasis. Ask them to visit www.psoriasis-cure-now.org and write to Congress. Anything we can do to educate the public about psoriasis will help, throughout the year, and especially during Short Sleeve Days!
Issue of "generic" biologics, or biosimilars, will confront next Congress
Congress is considering several bills that would make it easier for companies to market generic versions of biologic drugs, according to a recent article in the Washington Post. Competition from generics is expected to reduce significantly the cost of expensive biologic medications. The Congressional Budget Office estimates that the availability of biologic generics would save the health care system $200 million by 2013 and $25 billion by 2018. But getting there poses significant challenges.
Generic versions of conventional pharmaceuticals are already commonplace. The 1984 Hatch-Waxman Act established a streamlined procedure for FDA approval of generic drugs. Once the patent on a brand name drug has expired, any company that can demonstrate that its generic is chemically identical to the original can market it without doing any further clinical testing.
Generally speaking, conventional drugs are chemically simple molecules and determining that a generic is identical to the original is straightforward. Biologics, on the other hand, are highly complex protein molecules. They are produced by manipulating cultured cells, a process that has so many variables that it is impossible to prove that one biologic is identical to another. Thus, the generic versions of biologics are known as "biosimilars."
Because biosimilars might be subtly different from the brand name drug they are imitating, some experts believe that biosimilars, unlike conventional generics, should undergo testing for safety and effectiveness before they are approved. Some patient groups are already campaigning to block insurance companies and pharmacies from forcing patients to switch from brand name biologics to biosimilars once they become available, a practice that is common for conventional drugs.
Currently, there is no legal framework in place to get a biosimilar to patients. Three bills outlining modified procedures for approving biosimilars have been introduced in Congress since last year. The major difference between the bills concerns "data exclusivity"--the length of time that must elapse before a generic drug maker is allowed to use the original manufacturer's clinical trial data in support of the generic product. Makers of biosimilars are pushing for five years; makers of brand name biologics are asking for 14 years. Biosimilars are not considered to be identical to the originals, so companies do not have to wait for the brand name drug's patents to expire before marketing an equivalent. That makes the data exclusivity issue that much more important.
A few biosimilars are already available in Europe. In France, about 20% of patients taking growth hormone have switched to a generic version.
For psoriasis patients and advocacy groups, the debate presents its own challenges. If you are taking a biologic successfully and have good insurance, you might not want to risk an untested "biosimilar" just to save your insurer money. Or if you are hoping the next generation of psoriasis treatments will be even better, you might want a profitable and robust biotech sector investing in tomorrow's cures; after all, generic drug companies don't invent anything, they just save the system money. Then again, if you are paying mammoth co-pays or currently cannot afford a biologic, you might be ready to march on Congress to get a generic-style version of psoriasis biologics to market. People might also differ based on how much testing they like to see conducted, and for how long, before they are willing to try a new treatment. Add to that the fact that patient groups receive contributions from biologics manufacturers, and you can imagine the controversy this issue creates.
"We believe it is essential that Congress move toward a legislative framework for approving safe and effective biosimilars," said Michael Paranzino, president of Psoriasis Cure Now. "Too many patients are not able to access biologics today, given their cost and the current state of health insurance. But as with most things, the devil is in the details. How do you ensure safety and effectiveness of a biosimilar? How many patients should test a biosimilar, and for how long, before it is made widely available? And who should decide if a patient should take a biologic or its 'generic' alternative? An insurer? The patient and the patient's doctor? We intend to be part of the dialogue and debate as this important issue is considered next year in Congress."
Short Sleeve Days coming Sept. 12-14: Order your shirt today!
Are you on this map yet? We need you on it. This maps shows current participants in Short Sleeve Days 2008, our national public education event for psoriasis and psoriatic arthritis, on September 12-14, 2008.
Free "Back to School" Resources for Children with Psoriasis
We have expanded our free resources designed to help children with psoriasis, and their parents, as kids head back to school. At www.PsoriasisKids.org, we offer a fact sheet on children's psoriasis that parents can print off the internet and deliver to their child's school teacher; and a podcast interview with a leading pediatric dermatologist discussing how to treat psoriasis in children and how to help them cope with it.
"One of the toughest times for a child with psoriasis can be heading back to school, especially if changing schools," said Michael Paranzino, president of Psoriasis Cure Now and someone whose psoriasis first emerged in high school. "These materials can help ease the transition."
"He escaped while receiving treatment for psoriasis, which is visible on his arms."
He might want to visit our Psoriasis Treatment Section and try to clear those arms fast, before his distinctive skin gives him away and sends him back to the pokey.
Two Grand Prize winners have been named in the 2008 Psoriasis Cure Now Video Contest. John Serpe of Los Angeles, California won the Grand Prize in our Humor track for his video "Playground." TJ Federico of Brooklyn, NY won the Grand Prize in our Serious track for his video "What you would miss." Nine other Finalists won prizes in a 79 video field crowded with excellent submissions.
Here are the Grand Prize winners:
A DVD of the 11 winning videos will be given to every Member of Congress, as well as to television stations nationwide.
Congratulations to all the winners and our heartfelt thanks to all the participants in this fun and important psoriasis video contest.
A European study has confirmed what psoriasis patients whisper about among themselves: a stunning percentage of psoriasis patients do not even fill the prescriptions their doctors prescribe for them. Nearly one-third of dermatology patients do not obtain their prescription medications, found the study from Denmark, and psoriasis patients had the lowest compliance rate--nearly 50% of prescriptions for psoriasis medications went unfilled! The study was published in the July issue of the Journal of the American Academy of Dermatology.
The study's authors followed 322 patients who received a first-time prescription for a skin condition from doctors at a large clinic outside of Copenhagen. Using a nationwide electronic prescription registry, they determined whether patients redeemed their prescription at a pharmacy.
Patients' motivation to follow a prescribed treatment is influenced by their confidence in their doctors and by their previous experience with similar therapies, say the authors. Price is unlikely to be a factor in Denmark, where much of the cost of prescription medications is covered by the public health insurance system. (This raises the question whether compliance is even lower in the U.S.A., where cost is a common problem.)
The authors recommend better communication during office visits, so that doctor and patient can agree on a treatment plan. Also, they propose that doctors follow up about a week after an office visit to ensure that patients have filled their prescriptions and are taking their medications as directed.
"Psoriasis patients and their physicians both have to do better," said Michael Paranzino, president of Psoriasis Cure Now. "Patients have to 'come clean' if they don't plan to fill prescriptions, so the doctor can work with the patient on a treatment plan that meets the patient's needs. At the same time, doctors must take this study to heart: there is a serious disconnect between many doctors and their psoriasis patients, which is impacting patient outcomes."
Do you fill your prescriptions? If not, why not? Click on COMMENTS below and let us know what you think.
Seven Finalists named in 'Humor' track of 2008 Psoriasis Video Contest
Seven Finalists have been named in the 2008 Psoriasis Cure Now Video Contest. Each Finalist has won at least $500, and one of these will win a Grand Prize of $5,000 later this month.
The Finalists are:
Derek's Dance by Daniel Pouesi Playground - Psoriasis Cure Now 2008 by John Serpe Living With Psoriasis - PSA by Katie Carman Psoriasis is Bad. by Jeff Magni "Ben" by Nate Milton God's Office by Skip Bronkie Help Psoriasis Research Go Farther by Patrick Smith
Before we pick the Grand Prize winner, we need YOUR advice about which video is best. Through August 18th, your comments below will be considered before we judge the videos one last time and select a Grand Prize winner. Remember the mission: create a 15 or 30 second video that uses humor to educate the public about the fact that psoriasis is a serious disease that negatively impacts quality of life. You can watch the seven Finalists right here:
Your comments can be added below. Simply click on the "COMMENT" link and tell us which video should be the Grand Prize winner and why. (Note: we love all these videos, so if your comment is unduly negative about any of the Finalists, we will not post your comment. Constructive criticism is allowed, but better yet, focus on what is good about your favorite Finalist.)
And one last thing. There were 33 other videos in the Humor track, including several EXCELLENT videos that we would have loved to honor. Click here to tell us which videos NOT selected as Finalists should have been!
Thanks for your help. Congratulations to all the Finalists, and good luck to all as we prepare for the Grand Prize selection.
Four Finalists named in 'Serious' track of 2008 Psoriasis Video Contest
Four Finalists have been named in the 2008 Psoriasis Cure Now Video Contest. Each Finalist has won at least $500, and one of these will win a Grand Prize of $5,000 later this month.
The Finalists are:
What Could You Do In 4 Years? by Lamar Crammer Psoriasis_Nana by Michael Rutherford Beach / PsoriasisCureNow '08 Serious Track by Javier Colon Rios What you would miss by TJ Federico
Before we pick the Grand Prize winner, we need YOUR advice about which video is best. Through August 18th, your comments below will be considered before we judge the videos one last time and select a Grand Prize winner. Remember the mission: create a 15 or 30 second video that will educate the public about the startling fact that severe psoriasis has been shown to reduce life expectancy by an average of four years. You can watch the four Finalists right here:
Your comments can be added below. Simply click on the "COMMENT" link and tell us which video should be the Grand Prize winner and why. (Note: we love all these videos, so if your comment is unduly negative about any of the Finalists, we will not post your comment. Constructive criticism is allowed, but better yet, focus on what is good about your favorite Finalist.)
And one last thing. There were 35 other videos in the Serious track, including several EXCELLENT videos that we would have loved to honor. Click here to tell us which videos NOT selected as Finalists should have been!
Thanks for your help. Congratulations to all the Finalists, and good luck to all as we prepare for the Grand Prize selection.
2008 Psoriasis Video Contest: The best of the rest
In addition to the 11 Finalists selected in the 2008 Psoriasis Cure Now Video Contest, there were nearly 70 other videos that we could not give prizes to. Among those are some GREAT videos. So visit the Psoriasis Cure Now groups on YouTube (Humor track and Serious track) to watch these videos, then come back to this page to tell us which ones NOT selected as Finalists should have been. We'll be looking for ways to promote these other videos as well.
Just click on "COMMENTS" below and tell us where we screwed up in the judging!
FDA to take 3 additional months for its review of ustekimumab for psoriasis
The U.S. Food and Drug Administration (FDA), which is reviewing whether to approve the experimental biologic ustekinumab for the treatment of moderate to severe plaque psoriasis, will take an additional three months before it renders its decision. This means we can expect a decision by the FDA near the end of 2008.
Forget your credit score; know your prescription drug score?
The Washington Post reported on August 4 that health and life insurance companies can cheaply and quickly get access to electronic prescription records of insurance applicants. At a cost of about $15 per request, private companies, including Milliman IntelliScript and Ingenix, will compile an insurance applicant's prescription history from databases of past insurance claims. Both companies then analyze the data and generate an estimate of the applicant's risk to the insurer. Applicants who take medication for expensive and/or chronic conditions are labeled high risk.
The compilation and analysis takes just a few minutes. Insurers can then use the information when deciding whether or not to insure a particular patient and at what price. In the past, insurers gathered health information on applicants from physician records, a much slower and more expensive undertaking that might not be comprehensive. In February the Federal Trade Commission ruled that electronic prescription records are subject to the same regulations as financial credit reports under the Fair Credit Reporting Act. Applicants who are denied health or life insurance based on their electronic prescription record must be given access to the record and the opportunity to correct errors.
Since psoriasis is chronic and often expensive to treat, especially for those who take biologics, psoriasis patients are likely to fare poorly in these electronic assessments of cost (which ignore the benefits of treatment entirely), making it even more difficult for self-employed psoriasis patients and others in the individual insurance market to secure affordable health insurance. Then again, insurers have always had methods for gathering pertinent health information about applicants; the new electronic services just make the process cheaper, faster, and easier. It remains to be seen how much effect the new methods will have on psoriasis patients who are seeking health insurance coverage. But it's another troubling sign (like the emergence of Tier 4 Insurance Pricing) that insurance, which used to be about spreading risk among large groups of individuals, could one day be a place where only the healthy need apply.
The U.S. Senate's powerful Appropriations Committee recently included Report language urging the National Institutes of Health (NIH) to increase funding for and attention to psoriasis research. While it does not have the force of law, this language is closely watched by NIH and other key decision-makers as they allocate a whopping $30 billion annually in taxpayer funds for biomedical research. Last year, for the first time ever, psoriasis research passed $10 million in annual funding. It looks like your letters and Congressional visits are having an impact! Wait--you say you have not written your lawmakers about psoriasis research? Take two minutes and do it right now!
Experimental psoriasis treatment PTH (1-34) fails in clinical trial
Parathyroid Hormone (1-34) [PTH (1-34)], a topical cream that showed promise as a new treatment for psoriasis, failed to significantly reduce psoriasis symptoms in a Phase II clinical study, the company reported on July 31, 2008.
Manhattan Pharmaceuticals, the company sponsoring the study, compared two dosages of PTH (1-34) to placebo in more than 50 patients with mild-to-moderate plaque psoriasis. Patients using the drug did not experience an overall decrease in the severity of their psoriasis, nor did they see improvement in specific symptoms such as redness, scaling, plaque thickness, and itch. On the positive side, PTH (1-34) appeared to be safe (no serious side effects were reported) and well tolerated by patients. Manhattan is planning to further analyze the data from the trial before deciding how to proceed.
An earlier study of 15 patients, published in the British Journal of Dermatology in 2003, had indicated that PTH (1-34) was effective. Patients applying the drug experienced a 67% reduction in psoriasis severity as compared to an 18% reduction for patients using a placebo.
Drug research is expensive and difficult, as this experience shows. And there's no guarantee that a potential treatment that shows promise in initial tests will prove to be both safe and effective when facing the scrutiny of longer clinical trials. We're always disappointed to see a hoped-for psoriasis treatment not pan out, but glad that the psoriasis and psoriatic arthritis drug pipeline remains robust and promising.
Eighty Videos Submitted in 2008 Psoriasis Video Contest
The videos are all in, and now the judging begins. An impressive collection of 80 videos has been created for the 2008 Psoriasis Cure Now Video Contest. Unfortunately, only 10 will win prizes.
On August 11th, we'll announce the 10 Finalists. Then we'll need your input on which two should win the $5,000 Grand Prizes.
The deadline for entries in the 2008 Psoriasis Cure Now Video Contest is this Saturday night, August 2, 2008. We expect an avalanche of last-minute entries, just like last year. Want to view some of the videos? Here is a good place to start.
Our latest calendar profile is up, of two Psoriasis Cure Now volunteers with psoriasis. The twist? These two are in (one just finished) ELEMENTARY SCHOOL. Too often, psoriasis is treated as a disease of adults. But it strikes ALL ages. Check it out.
Psoriasis Video Contest 'Early Bird' Winners Announced
We have selected Early Bird winners in the 2008 Psoriasis Cure Now Video Contest. The Early Bird winner in the 'Humor' track was John Serpe of Los Angeles, California, for his video "Playground - Psoriasis Cure Now 2008."
The Early Bird winner in the 'Serious' track was Lamar Crammer of Beachwood, New Jersey, for his video "What Could You Do In 4 Years?"
The video contest submission period runs through August 2, 2008, with TWO $5,000 Grand Prizes still among those to be awarded in late August.
