We are (finally) implementing our new website. Please forgive the dead links and other oddities until we get it all worked out. Everything should be working properly and look right by May 1 and we hope you like it!
Psoriasis associated with diabetes and atherosclerosis, aka hardening of the arteries
A new study has found "a higher occurrence of diabetes and atherosclerosis in psoriasis patients compared to patients without psoriasis." But the study did not attempt to take account of the higher rates of smoking and obesity that have been found in psoriasis patients as compared to the general population--differences that could fully explain the higher rates of diabetes and atherosclerosis the researchers found here.
A study that would actually be helpful would compare groups of people as similar as possible in terms of smoking, weight, and other key risk factors for these other ailments, with the only notable difference being that one group would be comprised of people with psoriasis and the other group would exclude anyone with psoriasis. Then we could start to see if psoriasis itself is a risk factor for diabetes, etc.
Last week, an advisory committee to the U.S. Food and Drug Administration (FDA) voted 20-1 to recommend that the FDA not approve a cox-2 inhibitor called Arcoxia (a non-steroidal anti-inflammatory drug, or NSAID, that relieves pain). This Merck drug (also known as etoricoxib), which is already approved in more than 60 other countries, is seen by the company as a successor to Vioxx, which was pulled from the market in 2004 because it has been linked to increased risk of heart attacks.
While Arcoxia might help some patients with psoriatic arthritis (and is probably already being used by some such patients living outside the U.S.), the broader debate that is occurring about Arcoxia and the FDA committee's reasoning could impact everyone with psoriasis and psoriatic arthritis for years to come.
Among the reasons cited for rejecting Arcoxia were claims that it poses an unsafe risk of heart attack and that the data from clinical trials conducted so far is insufficient. We have no opinion on those claims at this time.
But what should be of interest and perhaps concern to the psoriasis community is some of the other reasoning behind the committee's decision. For example, as a critic of the FDA committee's decision noted in the Wall St. Journal:
Asked about Arcoxia, one of FDA's senior officials said "simply having another drug on the market . . . didn't seem to be sufficient reason" for approval. But the fact remains that all drugs that are tweaks on other medicines have different profiles. Sometimes small changes can dramatically impact how a new drug performs. But more often the therapeutic differences are subtler, mattering only for subsets of patients who only respond well to one particular version of a molecule. This is why doctors sometimes cycle a patient through multiple drugs in a "class" of medicines before finding one that works well for that person.
Earlier this week, the FDA staff had concluded that if safer alternatives were available, U.S. regulators should not approve new painkillers in the same class as Vioxx.
While that sounds reasonable, it is not necessarily realistic. What is safer for you may not be what is safer for your neighbor. The millions of permutations of individual health histories and genetic backgrounds is why we have physicians and patients deciding together what makes sense for a particular patient at a particular time. We are wary of any suggestion that FDA officials know today what will be best for millions of psoriasis patients at some future date.
We hear frequently from psoriatic arthritis patients who find pain relief from one drug but not another, and psoriasis patients know all too well that a treatment that works for some may not work at all for them. That is why Psoriasis Cure Now consistently argues for additional treatment options. What some deride as "me-too" treatments that seem too much like existing treatments to us offers hope to patients who have not yet found the treatment that will work for them.
Again, we are not taking a position on Arcoxia--even the Journal commentator wrote that Merck did a poor job defending its drug. But all of us with psoriasis and psoriatic arthritis need to decide if we will really be better off if the FDA continues to block additional treatment options with arguments that patients have plenty of options already.
This is one reason we spoke at the FDA advisory committee that considered Vioxx back in 2005. We feared an overreaction by FDA that would cost the psoriasis community additional treatment choices. Our fears may be coming true. (You can read more here about our FDA testimony at the Vioxx hearing.)
We'll give the final word on this to Dr. Scott Gottlieb, the Journal essayist (and former FDA official) quoted above:
Patients need new drug choices, such as Arcoxia, even when the new drugs reveal the same side effects as the old drugs. Equally important to surfacing side effects is revealing the science that explains why only certain patients will suffer them. The science to do these things is at hand. ...
Given the sheer size of trials Merck ran, few pain pills in Arcoxia's class will be as closely examined and clearly understood. Yet in today's political environment, precautionary principles will keep the FDA from letting patients choose if this pill is right for them. All drugs have risks that patients must weigh against the benefits. Limiting choices patients can make in seeking relief won't change that. But patients would be better off if the FDA focused on unearthing information to help doctors determine which pills will perform the best for each individual patient.
Stay tuned in coming days for exciting changes to our website. The new look and expanded content will help us reach more people with our important message about the seriousness of psoriasis.
Please also forgive some dust--and maybe a few dead links--as we transition over to the new design.
A father urges all immune disease groups to work together
We don't typically link to blogs, but we have come to know the author of this blog through his emails to us. We are moved by his sense of urgency for his son--who has devastating psoriatic arthritis--even though we disagree with some of the tone and messaging of these writings.
But despite some differences, we certainly agree that we must speed the delivery of new treatments to patients, and that all immune disease groups should try to band together, as the evidence keeps building that we are all in this together.
Most new treatments for psoriasis for more than 100 years have been discovered through serendipity and not through scientific design. ... We contest that the art of medicine is the prime innovator for radical new therapeutic advances, whereas the science of medicine is responsible for slow incremental change. ...
Dermatology is not alone in its reliance on serendipity for advancement of treatments, this can broadly be said of all medical science. Surely the greatest advancement in medicine in the twentieth century was the discovery of antibiotics, that would not have occurred if Fleming had been more meticulous in laboratory cleanliness. That is not to underestimate the genius of many of medicine's forefathers but to celebrate their exploitation of serendipity. In the future should we invest in specific drug development programs or just give the money to various scientists and clinicians to allow them to satisfy their own curiosity. History would suggest that the latter option may be more rewarding!
In a bizarre twist, psoriasis has found its way into the story surrounding the pet food recall. (First, our hearts go out to all the pet owners who have lost pets or who are filled with anxiety because of this pet food recall.)
During the period Aminopterin was marketed, the agent was used off-label to safely treat over 4,000 patients with psoriasis in the United States, producing dramatic clearing of lesions. The National Institutes of Health (NIH) has recently awarded Syntrix Biosystems $800,000 to support the clinical testing of Aminopterin in psoriasis.
Old scientific papers actually refer to aminopterin as a precursor or predecessor to methotrexate, the Korean War-era psoriasis treatment that is still widely used today.
So what's old may be new again. Syntrix may bring aminopterin back to market, giving us psoriasis patients a chance to tell our friends we take "rat poison" to alleviate our psoriasis symptoms. (Syntrix does not believe aminopterin is actually used as a rodenticide.)
For most people, itching is only a mild annoyance, relieved by a quick scratch or maybe some skin cream. For others, the itch stays, stays -- and stays.
"It starts like any other itch, like you've been bitten or something," said David Hayes, a Los Angeles computer technician who has psoriasis, a noncontagious disease that causes skin inflammation, probably due to an overactive immune system. "But then it keeps on going. You've got to scratch it, and you've got to keep scratching until you're almost bleeding before it stops."
For people like Hayes with psoriasis, or for others with the skin allergy eczema, the sensation can be unbearable. "Itching is the worst thing," says Susan Lipworth of Bloomfield Hills, Mich., who has had eczema for 13 years. "It never stops -- it never stops -- it wears you down." ...
Such itches can erode a person's mental health, experts now say.
Many studies have found that people with severe itching from psoriasis, eczema and kidney dialysis are more likely to be depressed than others. In a 1998 study published in the British Journal of Dermatology, for example, researchers from the University of Western Ontario in Canada reported that almost 10% of 217 patients with psoriasis had had suicidal thoughts.*
For many people, the itchiness also prevents them from sleeping. In a study in 2002, Yosipovitch found that 84% of 102 eczema patients had trouble falling asleep due to itching. ...
Lack of sleep due to itching can affect people's physical health, Yosipovitch says.
[* Of course, it is not just itch that can make someone with psoriasis depressed.] The article then suggests a theory to add to the woes of every itchy person: scratching can make it worse.
But in 1997, Schmelz discovered distinct nerve cells in the skin that respond to itchy stimuli, and itch researchers revised their theories. They now believe that the sensations of itch and pain travel along separate pathways.
In cases of chronic itching, though, things go wrong. Some of the nerves that would normally transmit pain start to send itch signals instead. A 2004 study led by Schmelz, for example, found that people with eczema perceived pinpricks and electric shocks as itchy, not painful.
"The nerves are acting wacky," Yosipovitch says.
In such cases, scratching doesn't make the itch go away -- in fact, over the long run it can make people even more sensitive to itchy sensations. Repeated damage to the skin makes it grow thicker and sprout even more itch nerves.
Yet it's hard to avoid scratching in response to an itch -- even when you know you're doing yourself no favors. "I consider it almost an addiction," said Diana Cordio, a human resources assistant in San Mateo, who has psoriasis. "Scratching the itch -- you know that it's not helping you in any way. But there were some times I would have to break down, and get [finger]nails to skin, or whatever was handy, like a hairbrush."
Of course, as our understanding of a medical phenomenon increases, so does the likelihood of effective treatments:
One now-common treatment for people who itch because of liver disease is to prevent the body's own itch-promoting opioids from working, using drugs such as naloxone or naltrexone (also used to treat morphine overdose and alcoholism). Patients experience less itch -- the downside is they also experience more pain. They often find this preferable. ...
Other opioid-linked drugs are in the works. Last year, Yosipovitch tested one called butorphanol that is known to decrease sensitivity to itch-promoting opioids and increase sensitivity to itch-reducing ones. ...
In yet another opioid-related approach, Japanese researchers at Toray Industries Inc., in Kanagawa, developed a drug called TRK-820 that mimics the action of itch-reducing opioids. They have found that TRK-820 is effective in reducing scratching in mice with eczema. ... In the U.S., Phase III clinical trials are expected to begin later this year. ...
[Dr. Sonja Stander, who runs the Clinic for Neurodermatology in Munster, Germany] has used some pain drugs, including gabapentin (originally used to treat epilepsy), which seems to reduce the excitability of itch nerves. She's also treated patients with capsaicin, the same substance that makes chile peppers spicy.
Initially, capsaicin cream burns when it's smeared on the skin, but in fact it can help in a number of itchy conditions, Stander says, including psoriasis and the itching that often accompanies kidney dialysis. It does so by lowering levels of a chemical called "substance P" that allows sensory nerves in the skin to communicate with the brain. (The nerves detect the itch but can't send the message to the brain.)
Stander's itch clinic has been successfully treating some patients with another drug called aprepitant (Emend) that blocks substance P directly. And sometimes, she says, low doses of antidepressants such as paroxetine (Paxil) or mirtazapine (Remeron) can help.
No one knows quite why, but two pilot studies in the last five years have found that mirtazapine can relieve some people's itching, particularly at night -- even in people who aren't depressed. ...
Treating the itch itself is good, but it would be better to keep the itch-scratch cycle from spiraling out of control in the first place.
People with eczema, for example, sprout extra nerve endings where their skin is inflamed, making them more and more sensitive to itch as the years go by. A substance called nerve growth factor drives the nerves to sprout. It may be one key to stopping the runaway itching.
The article closes with a reminder that reducing the psoriasis on the skin can be the best way to address the incessant, relentless itch that often comes with the disease:
Cordio, whose psoriasis was diagnosed in 1998, has finally managed to clear up most of her skin. She had rough periods in the past: "I've been as much as 90% covered. Let me tell you, that's not a fun way to be."
She's tried a variety of different medications, none of which were particularly effective. Recently, she's started a new drug -- efalizumab (Raptiva), which interferes with the immune cells responsible for skin inflammation. "This was my lucky ticket," she says. "This is the first time in all the years that I've had psoriasis that I've had this significant a clearing."
There's always a worry that her skin will flare up again. "I have a tendency to live in a cautious joy," she says, "but I never know when [the itch] is going to come back."
For now, though, "It's a kind of freedom. There's a freedom from the flare; there's freedom from that constant burden of scratching.
"It is liberating," she says, "when the itch is not there."
If itch is a problem for you, tell your doctor. There are many ways to reduce itch, from Sarna lotion and other moisturizers to antihistamines and other over-the-counter and prescription treatments. And if you scratch, don't beat yourself up over it. Just try to be gentle, and keep looking for ways to reduce the itch in the first place.