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Congressional Testimony
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Written Statement of Michael D. Paranzino,
President, Psoriasis Cure Now,
delivered as part of his live testimony to the U.S. House of Representatives, Committee on Appropriations, Subcommittee on Labor, Health and Human Services,
Education and Related Agencies
April 19, 2005
[Click here for a printable Word version of this document.]
Chairman Regula, Ranking Member Obey and Members of the Subcommittee, thank you for giving the psoriasis community an opportunity to appear before you today. I am Michael Paranzino, from Bethesda, Maryland, president of Psoriasis Cure Now, a nonprofit patient advocacy group that works on behalf of the 6.5 million Americans with psoriasis, or about 15,000 psoriasis patients per Congressional District.
At the outset I would also like to thank you for including Report Language that accompanied the FY 2005 Labor-HHS Appropriations bill, stressing the importance of psoriasis research and urging the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) to conduct additional research to identify the genes implicated in psoriasis and to strengthen clinical research on potential therapies for psoriasis and psoriatic arthritis. Congresswoman Rosa DeLauro and her superb staff deserve special recognition for sponsoring this language, which will help so many people. We appreciate it.
When historians look back on this era’s Congresses 25 or 50 years from now, one of the signature achievements that they will note is the dramatic increases in funding for biomedical research that have been made in recent years. These investments are already helping millions of Americans, and the advances in scientific knowledge that are being made from these investments will continue to improve, and literally save, lives for many years to come. Funding for the National Institutes of Health (NIH), which now exceeds $28 billion annually, has increased 99% since 1995, even after accounting for inflation. This is a bipartisan achievement, and it began right in this Subcommittee. All Americans are surely grateful for this, as I am.
For psoriasis patients, however, the excitement is muted, because the figures point in the opposite direction. Since 1995, funding for psoriasis research at NIAMS has declined 8% after inflation, even including the uptick that occurred in FY 2004. Funding now stands at $6.5 million, or about one dollar per patient annually. If psoriasis research had just kept pace with NIH funding over the last decade, nearly $33 million in additional funds would have been invested in psoriasis research. Simply put, psoriasis research has missed out on the biggest increase in medical research funding in world history. I am here to ask you to change this.
Psoriasis is an incurable, recurring disease of the immune system that can first strike at any age, causing dry, painful skin lesions, and often, arthritic symptoms (known as psoriatic arthritis). Psoriasis is highly heritable, with as many as a dozen or more genes believed to play a role in psoriasis susceptibility. But while it often runs in families, in many cases patients cannot identify a parent or grandparent with the disease. Skin injury and infections—like strep throat—are the most common environmental factors that can trigger psoriasis flares. Diet does not appear to play any meaningful role in the disease.
Psoriatic arthritis is a chronic, progressive and debilitating inflammatory disease that often causes painful joint inflammation, stiffness, tenderness and tiredness, as well as bone damage.
Fortunately, for most people with psoriasis, the disease will start mild and stay mild. That’s the good news. But for millions of Americans, psoriasis is a daily impediment, one that dramatically and negatively impacts their quality of life. A National Institute of Mental Health-sponsored study in the Journal of the American Academy of Dermatology found that “Patients with psoriasis reported reduction in physical functioning and mental functioning comparable to that seen in cancer, arthritis, hypertension, heart disease, diabetes, and depression.” Psoriasis hurts. We have people covered head to toe in psoriasis; people whose skin bleeds when they straighten out their arms or legs; people whose hands are curled in claw-like because of debilitating psoriatic arthritis; people with psoriasis on their hands, feet, face and/or genitals; and people on disability because psoriasis has made them unable to work (a drain on the Treasury when they wish they could be taxpaying members of society).
But what is striking and even less well known is how devastating psoriasis can be emotionally and psychologically. The studies say that psoriasis patients have a higher incidence of depression, and we also, according to the literature, have higher rates of what is called “suicidal ideation.” No wonder. Even today, we still have incidents where people are asked to leave public pools because of their psoriasis—a humiliating and gut-wrenching experience. I met a woman who had a blind date abruptly cancelled because she mentioned to the bum in an email that she had psoriasis.
The visible nature of psoriasis exacerbates its interference with intimacy and one’s sense of self. We are teased in school and stared at in line at the supermarket. People with psoriasis are one of the few groups who can still be mocked – and used as a punch line – in major motion pictures and on network television. In fact, no one in Hollywood wants to admit they have psoriasis. Does this common disease magically avoid Tinseltown, or is psoriasis considered a scarlet letter, a career killer, even shameful?
Psoriasis patients routinely take medications that can destroy their livers, kidneys, and increase cancer rates, because the alternative, unchecked psoriasis, is felt to be even worse. Psoriasis patients are so desperate for relief that Sunday newspaper inserts and the internet are filled with phony “cures” being sold by rip-off artists — and they actually find customers. I have met psoriasis patients who told me they decided not to have children specifically because they did not dare risk imposing this on a child. As a father of two, I obviously made a different decision, but I launched Psoriasis Cure Now because of how disturbing it is for me to see psoriasis in my 4 and 8 year-old nieces. The 8 year-old is about to hit the age when the teasing could begin. And my nieces are not alone. Every day, roughly 50 children age 10 and under are newly diagnosed with psoriasis.
People with psoriasis have three times the rate of lymphoma cancers as the rest of the population. Finding effective psoriasis treatments for women who are or may want one day to be pregnant is particularly challenging. And a study out earlier this year found that of 40 autoimmune diseases studied in mothers, only one had an association with autism: moms with psoriasis had a 50% increased incidence of children with autism, disturbing news to the roughly 3 million American women of child-bearing age who have psoriasis.
As I asked psoriasis patients in recent days what they wanted me to tell Congress, the response was disheartening. There is a frustration, and even despair, among many patients with serious psoriasis. “Please make them understand how awful it is to live with this disease,” is what one person replied in a typical response. “We’re suffering. We need help,” another said. It’s difficult to articulate the trauma of having skin that bleeds and itches, every day, not for weeks, but for decades. Or of being stared at because you look like you have a contagious disease. But if you imagine it for a moment, you will start to understand how we feel.
Given these challenges and the huge economic impact of psoriasis — several billions of dollars per year spent treating the disease and in work missed because of it — the relatively small amount of research funding is particularly distressing. But let me be clear — in significant respects, we psoriasis patients have ourselves to blame. For many, many years, psoriasis patients were completely absent from our nation’s Capital. In the nearly five years I worked as a Congressional staffer here in the House of Representatives in the late 1990s, the word “psoriasis” never crossed my desk.
How can we expect our lawmakers, or NIH, for that matter, to protect our interests when we did not even attempt to make our case before you? But those days are over, and the psoriasis community is now finding its voice. I founded this group, in part, to push psoriasis patients to stop compounding our problems by suffering in silence. Psoriasis Cure Now launched the first-ever web-based psoriasis advocacy center on April 3, and with apologies to you and your staffs — who are busy enough already — we are energizing your constituents across the country to write to you, to visit you in Washington, DC and in your Districts, and in every case to speak to you from the heart about how psoriasis affects them and their families.
You can rest assured that if you go to bat for us, that we will not disappear again the way we were absent for so long previously. Psoriasis Cure Now and the 6.5 million Americans with psoriasis will now be a fixture in this town, taking our place proudly alongside so many other groups of Americans also exercising their Constitutional rights. This is representative government at its best. So while today’s testimony is in some ways a culmination of our recent efforts, in fact it is actually just the beginning of a new relationship between the psoriasis community and you, our lawmakers.
There is other good news for psoriasis patients. In the past few years, we have seen several new “biologic” drugs come to market — and these drugs are helping many psoriasis patients find the best relief they have had in years. But these medications are too new to know how they will fare in terms of long-term safety, and as immune system suppressors, they could theoretically pose long-term safety concerns. Also, with prices for these new treatments reaching $15,000 per year, they are out of reach for many Americans. (While this may be beyond the scope of this Hearing, there is a wide disparity in how insurers reimburse patients who require the new, more expensive psoriasis and psoriatic arthritis treatments. While some insurers are covering these treatments commendably, many others are putting up unfair roadblocks and even flatly denying coverage for these treatments that are, in many cases, the last, best hope for these patients. Congress may want to take a closer look at this subset of insurers who are suddenly going AWOL when their customers need them.)
Because funding is relatively scarce for psoriasis research, many promising research areas are not currently being pursued. In my final section of these remarks, I would like to touch on several of these areas. For example, let’s return to that troubling link I mentioned earlier between mothers with psoriasis and their significantly increased likelihood of bearing a child with autism. This study raised many more questions than it answered. For example, does the increased risk of autism come from certain psoriasis treatments or from having psoriasis itself? Do women with mild psoriasis have the same rate of children with autism as mothers with severe psoriasis? And do fathers with psoriasis also produce a higher rate of children with autism than fathers without psoriasis? Further study in this area might help us discover the root causes of both psoriasis and autism.
The emergence of the new biologic medications also opens up exiting research possibilities. For example, biologics slow the progression of psoriatic arthritis by reducing levels of tumor necrosis factor (TNF), but would early TNF blockade prevent psoriatic arthritis? If we could intervene earlier in psoriatic arthritis patients, and thus prevent irreversible joint damage, this would be a major health advance. Similarly, biologics clear psoriasis in some patients, and have virtually no effect on others. In addition, one biologic may have no effect on a patient, but a different biologic may provide significant relief. What is it about a particular patient’s genes or other factors that accounts for whether a medication will work? By linking our advances in genetic understanding of the disease with clinical studies monitoring actual patients on biologics, we might figure out how to predict which biologic agents would work for which patients, bringing patients improvement much more quickly and potentially saving Medicare, Medicaid and private insurers tens of millions of dollars annually in trial-and-error treatments.
On the other end of the cost spectrum, we have older therapies that are mainstays of psoriasis treatment, even though they have troubling side-effects or limited efficacy. There is no reason a private company would fund expensive clinical trials in generic prednisone, methotrexate, or topical steroids for psoriasis patients. And yet, hundreds of thousands of patients are using at least one of these treatments annually. NIH should sponsor clinical trials on these treatments, with an eye to improving their efficacy while reducing the impact of their harmful side effects.
Test tube research is important, but there needs to be greater emphasis on clinical research. There are clinical studies sent to NIH now that are receiving outstanding scores on scientific merit but are not funded because insufficient priority is given to psoriasis research and clinical trials. For example, one study on factors that determine the efficacy of topical psoriasis treatments had an outstanding scientific merit score but was not funded. This type of clinical research is reportedly frowned upon in some quarters of the medical research establishment, but clinical research could help your constituents immensely.
Another potentially powerful place for NIH to step in would be in creating long-term safety databases for the range of psoriasis treatments. The typical psoriasis patient will live with his or her disease for 40 or 50 years, and even longer in many cases. What is the cumulative effect of these medications over the long haul? Does long-term use of some treatments create dangerous or expensive long-term consequences? No one is looking at these issues. Again, we might be able to improve patient outcomes and reduce later health care costs through improving our understanding of these older, ‘workhorse’ treatments.
Another recently published study found that psoriasis among African-Americans is twice as common as previously believed. However, this study found that psoriasis is still twice as common among Caucasians (rather than four times as common, as previously believed). The study also hinted at the possibility that there may be disparities in psoriasis severity between whites and African-Americans, with Blacks reporting more extensive psoriasis than Caucasians. These possible differences, if they show up in larger studies, could be due to genetic differences, to a difference in access to health care, or to other causes. But whatever the cause or causes, the answer is important. If there are genetic differences that account for this, this could help us further pinpoint genes that give rise to psoriasis susceptibility. If the differences, instead, are shown to be due to differences in access to health care, this would be important to know for ongoing public policy debates about insurance coverage, Medicaid and related issues.
Last and certainly not least, continued work on the genetic underpinnings of psoriasis will certainly pay great dividends in the years ahead.
We are grateful for the top-notch research on psoriasis that NIAMS is currently funding, including in or near the Congressional Districts of several of you on this Subcommittee, including at Case Western Reserve University in Ohio; at Johns Hopkins University in Maryland; and at the University of Rochester in New York. Leaders in the psoriasis scientific and medical communities are also working at the University of Oklahoma, Baylor University, and universities in New Jersey, New York, California, Michigan, Pennsylvania, Illinois, Missouri, North Carolina, and elsewhere. Many of these scientists and physicians could accelerate their research if more NIH funds were available to them.
Thank you again for this wonderful opportunity to appear today. Psoriasis is a serious, painful, debilitating disease, and millions of Americans will directly benefit from additional investments in psoriasis and psoriatic arthritis research; investments that are well justified on grounds of economics, scientific promise and, of course, in human terms. I urge you to direct the NIH to significantly increase funding for research on psoriasis and psoriatic arthritis, including at NIAMS and NIAID, so we can get answers to these important questions, and alleviate the suffering of so many people.
I would be happy to answer your questions.
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