After the past few years of being on the Biological's and having almost totally clear skin, I had forgotten how annoying psoriasis can be.

I've been a lot worse and have had it for years, but the past few years I have been spoiled. I'm going through a bit of a flare up at the moment, mostly on my lower legs but also some on my toes, lips, arm pits, and genital area.

It feels like I have peeled the top layer of my skin off with one of those potato peeler things and then rubbed the wound with stinging nettles and salt.

Must get positive Fred

At 2 weeks after psoriasis patients received their first dose of the investigational interleukin-17 inhibitor ixekizumab, their gene expression pattern resembled that of healthy controls.

At the annual meeting of the Society for Investigative Dermatology, Dr. James G. Krueger presented a translational medicine study aimed at defining the impact that turning off IL-17 signaling has on pathological tissue structures, molecular pathways, and biomarkers.

His conclusion: "I think these data suggest IL-17 is the central cytokine driving pathogenesis in psoriasis," said Dr. Krueger of Rockefeller University in New York.

Eight psoriasis patients received a subcutaneous 150-mg dose of ixekizumab at weeks 0, 2, and 4 and underwent skin biopsies at weeks 0, 2, and 6. He compared their inflammatory gene expression profiles 2 weeks into treatment vs. those obtained from 15 psoriasis patients 2 weeks after beginning treatment with etanercept (at 50 mg twice weekly for 12 weeks).

IL-17 blockade with ixekizumab proved to have a greater impact on the expression of inflammatory genes known to be associated with psoriasis than did tumor necrosis factor inhibition via etanercept. Ixekizumab resulted in greater-than-75% normalization of expression of 643 of these inflammatory genes, compared with 104 with etanercept.

The structural result of IL-17 blockade was reversal by week 6 of the epidermal hyperplasia that is the hallmark of psoriasis, he added.

Two of the eight patients on the ixekizumab 150-mg regimen achieved PASI 75 (that is, a 75% improvement from baseline on the Psoriasis Area and Severity Index) in 2 weeks. That’s remarkably fast improvement, Dr. Krueger noted. By week 6, all eight patients had achieved PASI 75.

Another point in favor of IL-17’s being a central cytokine driving psoriasis is that ixekizumab shut down not only the IL-17A target genes downstream, but also genes controlling the production of key cytokines located upstream, including interferon-gamma and IL-22, he noted.

Phase III trials investigating ixekizumab for psoriasis are underway. The drug is also being investigated for the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

Source: skinandallergynews.com

Context: 
Based on limited data, the live attenuated herpes zoster (HZ) vaccine is contraindicated in patients taking anti–tumor necrosis factor (anti-TNF) therapies or other biologics commonly used to treat immune-mediated diseases. The safety and effectiveness of the vaccine are unclear for these patients.

Objective: 
To examine the association between HZ vaccination and HZ incidence within and beyond 42 days after vaccination in patients with selected immune-mediated diseases and in relation to biologics and other therapies used to treat these conditions.

Design, Setting, and Patients: 
Retrospective cohort study of 463 541 Medicare beneficiaries 60 years and older with rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, or inflammatory bowel disease using Medicare claims data from January 1, 2006, through December 31, 2009.

Main Outcome Measures: 
Herpes zoster incidence rate within 42 days after vaccination (a safety concern) and beyond 42 days; hazard ratios estimated using Cox proportional hazards models for HZ comparing vaccinated vs unvaccinated patients.

Results: 
Median duration of follow-up was 2.0 years (interquartile range, 0.8-3.0); 4.0% of patients received HZ vaccine. The overall crude HZ incidence rate was 7.8 cases per 1000 person-years (95% CI, 3.7-16.5) within 42 days after vaccination. The rate among the unvaccinated was 11.6 cases per 1000 person-years (95% CI, 11.4-11.9). Among 633 patients exposed to biologics at the time of vaccination or within the subsequent 42 days, no case of HZ or varicella occurred. After multivariable adjustment, HZ vaccination was associated with a hazard ratio of 0.61 (95% CI, 0.52-0.71) for HZ risk after 42 days.

Conclusions: 
Receipt of HZ vaccine was not associated with a short-term increase in HZ incidence among Medicare beneficiaries with selected immune-mediated diseases, including those exposed to biologics. The vaccine was associated with a lower HZ incidence over a median of 2 years of follow-up.

Herpes zoster (HZ), caused by the reactivation of latent varicella-zoster virus (VZV), manifests as an acute, painful vesicular rash and is often accompanied by chronic pain or postherpetic neuralgia. In the United States, the incidence rate of HZ in the unvaccinated general population 50 years or older is estimated to be 7.0 cases per 1000 person-years. A live attenuated vaccine reduces HZ risk by 70% and 51% among immunocompetent individuals 50 to 59 years and 60 years and older in 2 randomized blinded trials, respectively. The Advisory Committee on Immunization Practices (ACIP) recommends a single dose of the zoster vaccine for all people 60 years or older.

The risk of HZ is elevated by 1.5 to 2 times in patients with rheumatic and immune-mediated diseases such as rheumatoid arthritis (RA) and Crohn disease. This increase has been attributed to both the underlying disease process and treatments for these conditions. Currently, the Food and Drug Administration (FDA), the ACIP, and the American College of Rheumatology consider the live HZ vaccine to be contraindicated in patients receiving some immunosuppressive medications commonly used to treat these conditions, including all immune-modulating biologic agents; some nonbiologic immunosuppressive medications, such as methotrexate at doses of greater than 0.4 mg per kg per week; and glucocorticoids at prednisone-equivalent doses of 20 mg or more per day. The safety concern is that these individuals may develop varicella infection from the vaccine virus strain. Based on the VZV incubation period, the first 42 days following vaccination was chosen as the primary safety risk window in the Shingles Prevention Study, a randomized blinded trial that preceded the FDA approval of the vaccine.

In light of the uncertainties regarding the safety and effectiveness of zoster vaccine in patients with immune-mediated diseases, we used administrative claims from US Medicare beneficiaries diagnosed with these diseases to evaluate the association between receipt of zoster vaccine and HZ risk within the first 42 days and up to 3.5 years following vaccination.


Source: jamanetwork.com

I am 57 and I've lived with guttate psoriasis since age 22. I used light therapy and ointments off and on for the first 4 or 5 years but have just lived with it for the past 30 or so years for the most part. I have never been completely clear but other than the occasional flareup it hasn't been too bad. Until just recently, I haven't seen a dermatologist since 1996. In 96' Me and my son both had a bad experience with bad food at a local restaurant and that triggered one of the worse psoriasis flareups I've ever had and I made one of my rare doctor appointments to have it looked at. At the time, as well as most of my adult life, I had no health insurance. Thats another thing we learned to live quite well without, but it also helped us to learn to take better care of ourselves and to make the most of home remedies. The prescription I got for my flareup in 96' cost me about $80 US for each refill. Kind of expensive but not terribly so. Just recently, I had another flareup that wound up covering a large area of my body. I have a weak left knee and I injured that knee not long ago and the injury to that knee that must have triggered my psoriasis flareup as I can't think of anything else and the area covered worse by my psoriasis was on my left leg including for the first time below the knee and on the back of my knee. The itching this time was also the worse I've ever experienced. Reluctantly, I finally made an appointment with a dermatologist a couple of weeks ago and was prescribed Clobex spray and Vectical ointment. I've been using them for a week and a half and they have been pretty effective so far, but certainly no more effective than the ointment I used in 1996. . The thing that shocked me was the price of these drugs. At the Walmart pharmacy, 2oz of Clobex was almost $700 US and the tube of Vectical was over $300 - the two together was over $1000 and that is every time I refill them. I believe this is complete medical insanity. Have things really changed THIS much since 1996 ? Here in the US we have just recently had socialized medicine imposed upon us and I can't help but think that this is at-least partially responsible for the ludicrous cost of these two prescriptions. Fortunately for me I am currently employed on a job that provides health insurance and my co-pay part of these drugs cost me a mere $10 but that is not the point. If the insurance I have was not provided and paid for by my employer I could not afford to pay for it myself and would not have any. The new US insurance law also prohibits me from seeing a doctor and paying for the visit myself unless I can prove I have insurance, so I wouldn't have even been able to make the appointment. Now I have found out that even if I could see a doctor and get a prescription, without insurance, the cost of the medication would prohibit me from having it filled. I shudder not for myself, but for everyone that can't afford to buy insurance and there are lot of people that can't. Something has gone terribly wrong. I can't imagine where this will wind up years down the road but no one will ever convince me that anything good will come from this.

Hi everyone

Im new to the forum. Just joined last night. I was on twitter and someone suggested the Psoriasis club to me.

I have had psoriasis almost 33 years, since I was a baby. I have been hospitalized many times with it. I can be in hospital anything from 3 weeks to 2 months at a time. I have just been informed by my dermatologist that I need to be hospitalized again before end of july. I have a young daughter so I am worried about leaving her this time as the last time I was in hospital was in 2007 before she was born.

My flare ups are getting worse and affecting my worklife, home life and self esteem. I never buy tops with short sleeves or short trousers as my limbs are particularly bad. I was put on Methotrexate last November and had serious side effects to it so am no longer on it. For the time being I am using Liquid parafin 50:50 and tar pomade to try and control it until I go back into hospital.

Even though I have had psoriasis for so long I have never come to terms with it. I just hope some day doctors find a cure to help people living with it.

If anyone can give me advice on new treatments, nutrition etc I will be very grateful. Many thanks [/color]

Background:
Tumor necrosis factor inhibitory agents are currently considered to be contraindicated in psoriatic patients with *hepatitis B.

Objective:
We aim to provide guidance to dermatologists on the use of tumor necrosis factor inhibitor therapy in these patients.

Methods:
The current literature was reviewed regarding the use of tumor necrosis factor-alpha inhibitory agents Atanercept (Enbrel), Adalimumab (Humire), and Infliximab (Remicade) in psoriatic patients with particular reference to hepatitis B infection.

Results:
Tumor necrosis factor-alpha inhibitor therapy may result in reactivated hepatitis B in hepatitis B surface antigen-positive patients with psoriasis. This also occurs, although less frequently in patients with an isolated positive hepatitis B core antibody. Thus, all psoriasis patients should be screened for hepatitis B surface antigen plus hepatitis B core antibody prior to the initiation of tumor necrosis factor-alpha inhibitor therapy. Infliximab (Remicade) has been associated with more reactivation cases than the other 2 agents and fatalities have been reported with this agent. Evidence is presented that the risk of reactivation can be greatly minimized or eliminated by early or pre-emptive antiviral therapy.

Limitations:
The data is largely based on small case series that are retrospective in nature.

Conclusions:
Hepatitis B screening is essential prior to the initiation of tumor necrosis factor-alpha inhibitor therapy. Psoriatic patients found to be hepatitis B surface antigen or hepatitis B core antibody-positive should be referred to an appropriate specialist for evaluation and therapy. This would allow for the safe use of tumor necrosis factor-alpha inhibitors in psoriatic patients despite recently published guidelines to the contrary.

Source: eblue.org

*Hepatitis B is an infectious inflammatory illness of the liver and causes liver inflammation, vomiting, jaundice and, rarely, death.

Profiles of *Dental Caries and *Periodontal Disease in Individuals With or Without Psoriasis

Background: Studies of oral health in psoriasis patients are limited. The aim was to assess the experience and risk of caries and periodontal disease in psoriatics and non-psoriatics.

Material and Methods: The material consisted of 89 individuals with mild to moderate chronic plaque psoriasis and 54 non-psoriatics, recruited at the University Hospital in Gothenburg. Psoriasis arthritis was diagnosed in 25 of the psoriatics. All participants answered questionnaires and were subjected to saliva sampling and oral radiological and clinical examinations. Two computer applications were used for illustration of oral disease risk profiles.

Results: Psoriatics had lower salivary pH, fewer remaining teeth, fewer sites with probing pocket depth ≤4 mm and a lower radiographic alveolar bone level than non-psoriatics (p<0.05). Most of the differences remained significant after controlling for confounders. Differences in alveolar bone levels were no longer significant, particularly after introducing “gender” into the regression model. Similar numbers of decayed and filled teeth, sites with deep pockets, sites that bled on probing and risk profiles were observed. Individuals with psoriasis arthritis exhibited a lower stimulated salivary secretion rate than non-psoriatics (p<0.05).

Conclusions: There were no differences in profiles of caries and periodontal disease experience and risk between individuals with and without psoriasis. Fewer remaining teeth were observed in psoriatics. However, the exact reason for tooth loss could not be identified. Meanwhile, the reduced salivary pH in psoriatics and salivary secretion in psoriasis arthritis individuals, may pose a risk for future caries.



*Dental caries, also known as tooth decay or a cavity, is an infection, usually bacterial in origin, that causes demineralization of the hard tissues (enamel, dentin and cementum) and destruction of the organic matter of the tooth.

*Periodontal disease is a type of disease that affects one or more of the periodontal tissues that both surround and support the teeth.

Hybrigenics bio-pharmaceutical company, with a focus on research and development of new treatments against proliferative diseases, announces the first results of the placebo-controlled double-blind clinical Phase II efficacy study of oral inecalcitol at the single dose of 4 mg per day in moderate to severe psoriasis.

Of the total 60 enrolled patients, 57 (20 placebo and 37 inecalcitol) have completed their treatment for at least 10 weeks and up to 16 weeks. One early study withdrawal was due to grade 3 hypercalcemia caused by inecalcitol within the first week of treatment. Of the 37 patients treated with oral inecalcitol, 24 patients (65%) showed a PASI 50 response and, among them, 10 patients (27%) had a PASI 75 clinical improvement. However, these results were not statistically different from the placebo group, in which women had an unexpectedly strong improvement of their disease with a PASI 75 rate of 63% vs. 17% observed in placebo-treated men, which is more in line with usual values from the literature on psoriasis studies of similar duration.

Blood levels of inflammatory biomarkers such as IL-4, IL-10, IL-12, IL-17, interferongamma (IFN-γ) and tumor necrosis factor alpha (TNF-α) are currently being assayed in samples from all patients, as well as the levels of vitamin D receptor in white blood cells. Biopsies of skin lesions have been taken in subsets of patients and their histopathological examination is also ongoing.

This additional data will be available in the coming weeks and may shed some light on the reasons for the strong placebo effect observed in women, and why there weren’t more PASI 50 responders progressing to PASI 75 clinical improvement.

During the entire treatment period (16 weeks) and still one month later, after the follow-up period, the PTH levels of each of the 20 patients on placebo changed by less than 50% from their initial value and remained within the normal range. By contrast, the PTH levels of each of the 37 patients receiving inecalcitol decreased by more than 50% during the treatment.

PTH levels were decreased below the normal range in 34 inecalcitol-treated patients (92%) and below LoQ in 24 of them (65%). This PTH lowering effect was highly statistically significant as compared with placebo at all times during treatment (p< 0.001), even as soon as week 4, the earliest time point measured. This pharmacological effect of inecalcitol was totally and rapidly reversible because all PTH levels were back within the normal range after the one-month followup period.

“Two-thirds of inecalcitol-treated psoriasis patients showed some degree of response (PASI 50) but only one fourth had a clinically-relevant improvement (PASI 75) at week 12 or at week 16. A hypothesis could be that a longer duration of treatment might be necessary for inecalcitol to fully improve all the responders”, commented Dr Jean- François Dufour-Lamartinie, Hybrigenics’ Head of clinical R&D. He added: “the confirmation of inhibition of normal PTH secretion by inecalcitol, a fast, strong and straightforward effect observed in all treated patients, without any placebo effect, deserves further clinical investigation in chronic kidney disease patients who suffer from pathologically elevated PTH levels”.

Source: hybrigenics.com

An international team of scientists led by principal investigator Richard L. Gallo, M.D., Ph.D., professor of medicine and chief of UC San Diego’s Division of Dermatology, analyzed skin biopsies of patients with and without psoriasis, as well as the skin of mice with psoriasis and with wounds on their backs. They discovered that a molecule called regenerating islet-derived protein 3-alpha (REG3A) is highly expressed in skin cells during psoriasis and wound-healing, but not under normal skin conditions.

In tests on mice, researchers found that inhibiting REG3A slowed wound-healing but cleared up psoriasis, which is commonly characterized by patches of inflammation and white, scaly skin.

The scientists also noted that REG3A acts in concert with interleukin-17 (IL-17), an immune system protein involved in the signaling cascade which prompts skin cells to multiply in excess numbers. “IL-17 binds to receptors on skin cells and causes REG3A to be expressed, which then binds to another protein inside the cells that promotes cell growth,” said first author Yuping Lai, Ph.D., professor of microbiology and immunity at East China Normal University in Shanghai.

Gallo said the discovery of REG3A’s dual roles provides a new target for different therapies.

“A drug that inhibits the expression of REG3A could represent a more targeted way to treat psoriasis without the systemic immunosuppression problems of current treatments. Conversely, a drug that stimulates or mimics REG3A could boost cell growth and improve wound healing.”

Source: universityofcalifornia.edu

The Medical College of Wisconsin received a two-year, $200,000 grant from the National Psoriasis Foundation to study the pathogenesis of psoriasis and to identify new drugs that may benefit patients.

Sam Hwang, MD, PhD, and Thomas J. Russell Family/Milwaukee Community Dermatologists Chair and professor of dermatology, is the principal investigator for the grant.

Approximately 7.5 million Americans are living with psoriasis, an autoimmune disease in which dead skin cells accumulate and cause irritation that appears as itchy scales or dry patches. Symptoms can be treated, but there is no cure, and the severity of the disease ranges from mild discomfort to complete disability. Complications include arthritis, ischemic heart disease, and depression. Dr. Hwang’s lab identified two proteins (a chemokine receptor called CCR6 and it binding protein) in prior studies of psoriasis development that appear to have significant involvement in the disease.  In this study, Dr. Hwang will investigate these proteins further to better understand how they impact the pathogenesis of psoriasis.  Dr. Hwang will also use computer modeling to discover drugs that may block the actions of these proteins and thus, potentially, improve therapy for patients with this disease.

This study may verify a pathway for psoriasis and provide new information about its cause. The project may also identify new treatments for psoriasis and other diseases influenced by the proteins Dr. Hwang is investigating.

This special award is called the Lutto Translational Grant in honour of Seymour and Rebecca Lutto, who made this research possible with a gift to the National Psoriasis Foundation. They sought to memorialise their son Lawrence Lutto by advancing scientific knowledge regarding the cause and treatment of psoriasis.

Source: mcw.edu

Objective: 
To assess the risk of incident diabetes mellitus (DM) in patients with psoriasis and to evaluate DM treatment patterns among patients with psoriasis and incident DM.

Design: 
Population-based cohort study.

Setting: 
United Kingdom–based electronic medical records.

Patients: 
We matched 108 132 patients with psoriasis aged 18 to 90 years with 430 716 unexposed patients based on practice and time of visit. For our nested study, only patients who developed incident DM during our study time were included.

Main Outcome Measures: 
Incident DM and adjusted risk of pharmacotherapy among those with incident DM.

Results: 
The fully adjusted hazard ratios (95% CIs) for incident DM were 1.14 (95% CI, 1.10-1.18), 1.11 (95% CI, 1.07-1.15), and 1.46 (95% CI, 1.30-1.65) in the overall, mild, and severe psoriasis groups, respectively. Among those with incident DM and severe psoriasis, the adjusted risk for receiving DM pharmacotherapy was 1.55 (95% CI, 1.15-2.10).

Conclusions:
Our results suggest that psoriasis is an independent risk factor for the development of type *2 DM in a dose-dependent manner, and that patients with severe psoriasis who develop DM are more likely to receive systemic diabetic therapies in comparison with patients with DM but without psoriasis.

Source: archderm.jamanetwork.com

* Diabetes mellitus type 2 is a metabolic disorder that is characterized by high blood glucose in the context of insulin resistance and relative insulin deficiency. This is in contrast to diabetes mellitus type 1 in which there is an absolute insulin deficiency due to destruction of islet cells in the pancreas. The classic symptoms are excess thirst, frequent urination, and constant hunger. Type 2 diabetes is initially managed by increasing exercise and dietary modification. If blood glucose levels are not adequately lowered by these measures, medications such as metformin or insulin may be needed.

Hiya just found this on my weekly psoriasis google, has anyone ever heard of it before?  I don't like buying things unless I've had a recommendation. Although I am getting to the point where I will try anything.



Ossie gold soap bars

Hello everyone

I have just joined and thought I would tell you a little about myself. I'm Tamsin in 25 and was diagnosed with psoriasis when I was 18. I used to have it very badly and all over includin my face, but since getting older it has become milder. I now tend to get it on my elbows, legs and scalp but in small patches.

I'm sure you have heard it all before but I've found it really hard to cope with psoriasis and have generally quite low self esteem. I don't like to go out wearing clothes that show my spots of psoriasis. I have learned to cope with the fact I have it but still find showing it in public quite hard. And hence my single status, being worried about what men will say has put me off dating at the moment! Lol sounds rediculous now I'm telling someone!

Apart from that I'm generally a happy, healthy person and I enjoy jogging and eating healthily. I have a job that I love although it is a renowned professional for its stressful nature haha the big old STRESS word we all hate!

I hope to make some friends here, it's always nice to talk to people who understand what it's like

Well that's me, please feel free to reply

Hi my names lesley.i used to be a member here.i do remember some if you especially you fred.i cant remember my old user name.anyway I was on twitter and I found you all again.im from glasgow have had psorisis for over 4 years now but its under control with MTX.hope everyone on here is good hope I can get online a bit and chat to you all.much love lesley x

Summary Background: 
Psoriasis is a Th1 immune-mediated, inflammatory disease, in which skin lesions appear many years before the related metabolic and cardiovascular comorbidities, according to the theory of the ‘psoriatic march’. Inducible nitric oxide synthetase (iNOS), tumour necrosis factor (TNF)-α and vascular endothelial growth factor (VEGF) are directly implicated in determining both skin lesions and systemic involvement in psoriasis. Reactive oxygen species actively promote the secretion of inflammatory Th1 cytokines directly involved in the pathogenesis of psoriasis.

Objectives: 
Evaluation of VEGF expression and production, nitric oxide (NO) production, iNOS expression, and the antioxidant response of mesenchymal stem cells (MSCs), both before and after 12 weeks of treatment with the TNF-α inhibitors adalimumab or etanercept.

Methods: 
Biochemical, morphological and immunohistochemical analyses were performed in MSCs isolated from nonlesional, perilesional and lesional skin of patients with psoriasis, before and after treatment.

Results: 
The treatments were able to reduce the expression and production of VEGF, the expression of iNOS and the production of NO in MSCs of patients with psoriasis. TNF-α inhibitors also reduced the oxidative damage in MSC membrane and proteins, several antioxidant systems responded to treatments with a general inhibition of activities (glutathione S-transferase and catalase) and these effects were also supported by a general decrease of total oxyradical scavenging capacity towards hydroxyl radicals and peroxynitrite.

Conclusions: 
TNF-α inhibitors are able to change the physiopathological pathway of psoriasis, and our results suggest their therapeutic effects already take place at the level of MSCs, which probably represent the cells primarily involved in the ‘psoriatic march’.

Source: onlinelibrary.wiley.com

Obese patients with psoriatic arthritis demonstrate a worse response when starting anti–tumor necrosis factor therapy than do normal weight patients, but achievement of minimal disease activity can be improved by weight loss, based on two studies by Dr. Giovanni Di Minno, lead investigator on both.

The first study investigated the influence of obesity and the second, the influence of weight loss on response to starting anti–tumor necrosis factor (TNF) therapy.

The study on the effect of obesity on response to anti-TNF therapy in psoriatic arthritis (PsA) involved 135 psoriatic arthritis patients with a body mass index (BMI) over 30 kg/m2and 135 normal weight controls. Dr. Di Minno and his coinvestigators found that the two groups did not differ significantly in terms of disease activity and vascular risk factors including swollen and tender joint counts, levels of C-reactive protein, erythrocyte sedimentation rates, and psoriasis area severity index scores. They found that patients with a BMI over 30 had a higher prevalence of hypercholesterolemia and hypertriglyceridemia.

Dr. Di Minno and his associates in the department of clinical and experimental medicine, Federico II University, Naples, Italy, found that at 12 months’ follow-up, 98 of the 270 patients (36.3%) had achieved minimal disease activity (MDA). The prevalence of obesity was higher in those not achieving MDA than in those achieving it (64% vs. 25.5%, P less than .001).

"A BMI of over 30 was shown to be a strong predictor [of not achieving MDA] with a hazard ratio of 4.90 (95%CI: 3.04-7.87; P less than .001)," according to Cox regression analysis findings, reported Dr. Di Minno.

At 24 months, 17.3% of those who achieved MDA a year earlier relapsed, and 82.7% maintained their MDA. "A BMI greater than 30 was associated with a higher risk of disease relapse, with a hazard ratio of 2.04 [95% CI: 1.02-3.61; P = .014]," he said at the annual European Congress of Rheumatology.

Dr. Di Minno also noted that there was no difference found between the three anti-TNF blockers (infliximab, etanercept, and adalimumab) used in the study.

Session moderator Dr. Laura Coates said that the study was valuable because patients with PsA were prone to being overweight, and there was an established link between excess weight, metabolic syndrome, and psoriasis. "Until this study, there were no data to support the concept that weight loss could alter people’s outcome in terms of their arthritis response.

"This provides evidence of an immediate improvement to people’s health with weight loss, in terms of a better response to the anti-TNF therapies," said Dr. Coates of the division of rheumatic and musculoskeletal disease at Chapel Allerton Hospital in Leeds, England.

Furthermore, Dr. Coates noted that there was also a known association between psoriasis/PsA and cardiovascular morbidity related to the metabolic syndrome. "Controlling weight is very important for these patients in the long term as well," she said.

Introducing his second study, which investigated the effect of weight loss in obese patients, Dr Di Minno noted that prior studies had shown that restricting calorie intake reduced obesity-related inflammation.

The study specifically investigated the impact of changes in body weight on the achievement of MDA in PsA patients starting treatment on anti-TNF therapy.

A total of 126 obese (BMI greater than 30) patients with active PsA, who had not responded to traditional disease-modifying antirheumaic drugs were randomized to either a diet of 1,300 calories per day (n = 63), or an unrestricted diet (n = 63), with the advice to eat more vegetables, fish, and fresh fruits and no more than 2 tablespoons of olive oil per day. All patients were encouraged to exercise five times a week, and all started on anti-TNF therapy immediately.

"The intervention diet was the traditional Mediterranean diet rich in fibers, with a careful balance of sugar, proteins, and lipids, similar to the diet used by diabetics," explained Dr. Di Minno. The Mediterranean diet has been shown to lessen inflammation because it is rich in mono- and polyunsaturated fatty acids, antioxidants, dietary fiber, and phytochemicals.

At the 6-month follow-up, the researchers found a 5%-10% weight loss was achieved by 47.6% of patients on the hypocaloric diet versus 28.6% on the unrestricted diet. Only 41.3% of patients on the hypocaloric diet lost more than 10% of their body weight.

Furthermore, patients on the hypocaloric diet had more significant reductions in triglycerides and cholesterol compared with those on the unrestricted diet (29.1% vs. 10% for triglycerides. and 23.7% vs. 8.1% for cholesterol, for hypocaloric and unrestricted diets, respectively).

"To our surprise we found that the Mediterranean diet was not much better than the other diet in terms of MDA achievement [42.9% on the hypocaloric diet vs. 34.9% on the free diet; P = .465]," reported Dr. Di Minno.

MDA was achieved more frequently by patients who achieved a greater than 5% weight loss compared with those who did not [50% vs. 23.1%]. Furthermore, as weight loss increased so did the achievement of MDA, with 16.7%, 42.9%, and 59.5% MDA achievement for a weight loss of less than 5%, 5%-10%, and more than 10%, respectively.

The data strongly support the need for the control of body weight and cardiometabolic parameters in PsA subjects starting anti-TNF treatment, Dr. Di Minno said. "This may result in a better achievement of minimal disease activity in these patients."

Source: skinandallergynews.com

The Food and Drug Administration USA has issued a warning letter to The Himalayan Institute, Buffalo, New York. after an inspection of their liquid dietary supplement manufacturing facility. The letter also mentions their Himalayan Triphala Oil webpage which states “Ayuredic practitioners have traditionally used ‘medicated’ or treated oils topically to assist with conditions such as . . . eczema, psoriasis, and dermatitis . . . .”

Here is a copy of the letter:

Quote:

---

Mr. Rolf Sovik, President
Himalayan Institute of Buffalo
841 Delaware Avenue
Buffalo, New York 14209

Dear Mr. Sovik:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your liquid dietary supplement manufacturing facility, located at 952 Bethany Turnpike, Honesdale, PA, from January 4, 2012 through January 18, 2012. The inspection found that your facility has serious violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111).  These violations cause your dietary supplement products identified below to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that the products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.

In addition, we have reviewed the labeling for your products and your website at [web]www.himalayaninstitute.org.[/web] Based on our review, we have concluded that your products identified below are in violation of sections 403, 505(a), and/or 502(f)(1) of the Act [21 U.S.C. §§ 343, 355(a), and/or 352(f)(1)] and the regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and FDA regulations through links on FDA’s home page at [web]www.fda.gov.[/web]

Dietary Supplement CGMP Violations

1)    You have not prepared and followed a written master manufacturing record (MMR) for each batch size of dietary supplement that you manufacture, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically,


    You use blank “Formulations Logs” that contain pre-determined multiplication factors for each ingredient used in a particular product as your MMR. Before a new batch of product is manufactured, employees use this multiplication factor to determine the amounts of each ingredient that must be used based on the total batch volume that is needed. These amounts are then handwritten on the “Formulation Log.” Our review of each MMR for your products Elixir 29, Immuno-Stim, Sweet Dreams, Safe Travel, and Sages Treasure revealed that the same MMR was used for multiple batch sizes.
    You did not follow the MMRs for the following batches of product:


i)    Elixir 29 Lot # (b)(4) and (b)(4)-You substituted (b)(4) for blue vervain leaf. You used many spagyric ingredients in place of herbal extracts. A 2 oz. bottle of product contains 59 ml instead of the prescribed 60 ml.

ii)    Sweet Dreams Lot # (b)(4)-You substituted (b)(4) and (b)(4) for skullcap herb.  You used many spagyric ingredients in place of herbal extracts. A 2 oz. bottle of product contains 59 ml instead of the prescribed 60 ml.

iii)    Safe Travel Lot # (b)(4)-You substituted (b)(4) for goldenseal root. You used many spagyric ingredients in place of herbal extracts. A 2 oz. bottle of product contains 59 ml instead of the prescribed 60 ml.

iv)    Safe Travel Lot # (b)(4)- You added extra licorice and calamus to make up for a shortage in wood betony herb. You used many spagyric ingredients in place of herbal extracts.

2)    You failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required by 21 CFR 111.75(a)(1)(i). Specifically, you verbally confirmed to our investigator that you did not test or verify the identities of any dietary ingredients used in the following batches of product:


    Elixir 29 - Lot #: (b)(4)
    Immuno-Stim – Lot #: (b)(4)
    Sweet Dreams – Lot #: (b)(4)
    Safe Travel – Lot #: (b)(4)
    Sages Treasure – Lot #: (b)(4)


Before using a component that is a dietary ingredient, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you petition FDA under 21 CFR 111.75(a)(1)(ii) and FDA exempts you from such testing. Your firm has not petitioned FDA for such an exemption.

3)    Your firm failed to qualify a supplier of a component by establishing the reliability of the supplier’s certificate of analysis (COA) through confirmation of the results of their tests or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A). Your firm verbally confirmed that you did not establish the reliability of your suppliers’ certificates of analysis.

While you must conduct, at minimum, one test or examination to verify the identity of any component that is a dietary ingredient, you may, if desired, rely on a COA for other specifications for those ingredients, and to confirm the identity of other components that are not dietary ingredients. However, you may only rely on a COA if you have met the requirements of 21 CFR 111.75(a)(2)(ii), which include qualifying the supplier.

4)    You failed to establish specifications for any of your dietary supplement products, such as Elixir 29, Immuno-Stim, Sweet Dreams, Safe Travel, and Sages Treasure, as required by 21 CFR 111.70. Specifically:


    You failed to establish specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR, as required by 21 CFR 111.70(a).
    You failed to establish component specifications, as required by 21 CFR 111.70(b).
    You failed to establish specifications for dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications) as required by 21 CFR 111.70(d).
    You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of each dietary supplement that you manufacture, and for limits on those types of contamination that may adulterate, or that may lead to the adulteration of, the finished batch, as required by 21 CFR 111.70(e).


We also note that once you have established the above specifications, you must determine whether the specifications have been met, as required by 21 CFR 111.73.

5)    You failed to quarantine components before you used them in the manufacture of a dietary supplement, as required by 21 CFR 111.155©. For example, the dietary supplement components used to manufacture the finished batches noted in item no. 2 above, were used without being quarantined. Your firm verbally confirmed to our investigator, that you do not quarantine components before they are used in the manufacturing of a dietary supplement. Prior to using components in the manufacture of a dietary supplement, you must quarantine the components until all of the requirements of 21 CFR 111.155©(1), ©(2), and ©(3) have been met.

6)    You failed to include required information in your MMRs for your Elixir 29, Immuno-Stim, Sweet Dreams, Safe Travel, and Sages Treasure products, as required by 21 CFR 111.210. Specifically:


    Your MMR must include the identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the ingredients list of the dietary supplement [21 CFR 111.210(d)]. However, your MMRs do not contain water and the weight or measure of grain alcohol although they are declared on the labels for these products.
    Your MMR must include a statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made [21 CFR 111.210(f)]. However, your MMRs for these products do not include this information.
    Your MMR must include a description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)]. However, your MMRs for these products do not contain this.
    Your MMR must include written instructions, including the following: specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR; procedures for sampling and a cross-reference to procedures for tests or examinations; specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR; and, corrective action plans for use when a specification is not met [21 CFR 111.210(h)(1)-(3),(5)]. However, your MMRs for these products do not include this information.


7)    You failed to include required information in your batch production records (BPRs) for your Elixir 29 (Lot #: (b)(4)), Immuno-Stim (Lot #: (b)(4)), Sweet Dreams (Lot #: (b)(4)), Safe Travel (Lot #: (b)(4)), and Sages Treasure (Lot #: (b)(4)) products, as required by 21 CFR 111.260. Specifically:


    Your BPR must include the identity of the equipment and processing lines used in producing the batch [21 CFR 111.260(b)].  However, your BPRs for these products do not include this information.
    Your BPR must include the date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained [21 CFR 111.260©]. However, your BPRs for these products do not include this information.
    Your BPR must include the identity and weight or measure of each component used [21 CFR 111.260(e)]. However, the BPRs for these products do not include water, which is declared on your product labels.
    Your BPR must include a statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)]. However, your BPRs for these products lack this information.
    Your BPR must include documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR 111.70(e) and (g) [21 CFR 111.260(i)]. However, your BPRs for these products lack this information. As is discussed above in item no. 4, you have not established any specifications for these dietary supplement products.
    Your BPR must include documentation, at the time of performance, of the manufacture of the batch, including the initials of the person responsible for weighing or measuring each component used in the batch, the initials of the person responsible for verifying the weight or measure of each component used in the batch, the initials of the person responsible for adding the component to the batch, and the initials of the person responsible for verifying the addition of components to the batch [21 CFR 111.260(j)(2)]. However, your BPRs for these products do not include any of this information.
    Your BPR must include documentation, at the time of performance, of packaging and labeling operations including the unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels; an actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the MMR; and the results of any tests or examinations conducted on packaged and labeled dietary supplements (including repackaged or relabeled dietary supplements), or a cross-reference to the physical location of such results [21 CFR 111.260(k)]. However, your BPRs for these products do not include this information.
    Your BPR must include documentation at the time of performance that quality control personnel reviewed the BPR; approved or rejected any reprocessing or repackaging; approved and released, or rejected, the batch for distribution, including any reprocessed batch; and approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement [21 CFR 111.260(l)]. However, your BPRs for these products do not include this information. Your BPRs for these products do not include any documentation of review by quality control personnel.
    Your BPR must include documentation at the time of performance of any required material review and disposition decision [21 CFR 111.260(m)]. However, several of your BPRs, for example, Elixir 29 Lot #(b)(4), Sweet Dreams Lot #(b)(4), and Safe Travel Lot #(b)(4), show deviations from the MMR in that ingredients other than the ones specified are used, but there is no documentation that you conducted a material review or made a disposition decision. As required by 21 CFR 111.113(a)(2), quality control personnel must conduct a material review and make a disposition decision if a batch deviates from the MMR, including when any step established in the MMR is not completed and including any deviation from specifications.


8)    You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, your firm verbally confirmed to our investigator, that no written procedures exist at your facility for the responsibilities of the quality control operations.

9)    You firm failed to make and keep records of written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met, as required by 21 CFR 111.325(b)(1). Specifically, your firm verbally confirmed to our investigator that you did not have written procedures for laboratory operations and were not aware that these procedures had to be written.

10)    You failed to establish written procedures to fulfill the requirements of 21 CFR 111.560 relating to the review and investigation of product complaints, as required by 21 CFR 111.553. Specifically, your firm verbally confirmed to our investigator that there is no formal system in place to address product complaints.

11)    You failed to establish and follow written procedures to fulfill the requirements of 21 CFR Part 111, Subpart N for handling returned dietary supplements, as required by 21 CFR 111.503. Specifically, you have not established written procedures to ensure the proper disposition of returned dietary supplements. Additionally, your firm verbally confirmed to our investigator that products were returned to your facility and that there were no records available which document the final disposition of these returned dietary supplements as required by 21 CFR 111.535(b)(2).   

12)    You failed to routinely calibrate, inspect, or check the automated, mechanical, or electronic equipment that you use to manufacture, package, label, or hold a dietary supplement, to ensure proper performance, as required by 21 CFR 111.30©. Specifically, your firm verbally confirmed to our investigator, that the equipment noted below was used to manufacture dietary supplements and was not calibrated:


    The scale, manufactured by (b)(4), which is used to weigh all herbal ingredients; and
    The specific gravity meter which is used to measure fine % alcohol concentration in the finished products.


13)    You failed to make and keep records of your written procedures for calibrating, inspecting, and checking automated, mechanical, and electronic equipment; and maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements, as required by 21 CFR 111.35(b)(1)(ii) and (iii). You also failed to make and keep written records of calibrations, inspections, and checks of automated, mechanical, and electronic equipment, as required by 21 CFR 111.35(b)(4). Specifically:


    You verbally informed our investigator that the UV Water System, manufactured by (b)(4) was inspected by your firm (b)(4); however, you stated that there are no written procedures for this inspection, nor do you maintain any records of these inspections.
    You verbally informed our investigator that there are no written procedures in place that outline the cleaning process for the lab/processing area and equipment.


Unapproved New Drugs:

Your product labels and website, [web]www.himalayaninstitute.org,[/web] promote your products for conditions that cause the products identified below to be drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your product labels and website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Examples of the claims found on your product labels and website include:

Inflam-away label


    The name of your product implies that your product reduces inflammation


Himalayan Triphala Oil webpage:


    “Ayuredic practitioners have traditionally used ‘medicated’ or treated oils topically to assist with conditions such as . . . eczema, psoriasis, and dermatitis . . . .”
    “Sesame oil [ingredient in the product] . . . is considered to be effective in treating the pain and swelling of rheumatoid arthritis . . . .”
    “Due to this lecithin content it is believed to . . . alleviate . . . depression . . . .”
    “It may also be used as a mouthwash (called oil pulling) for problem gums and inflammation.”


Namastea Black webpage


    “[B]lack tea may protect against certain types of heart disease while having a favorable influence on blood lipid levels.”
    “[T]hese compound [antioxidants] are helpful in supporting the body’s immune function in preventing cancer . . . .”


Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)].  A new drug may not be legally marketed in the United States without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

Further, your Himalayan Triphala Oil and Namastea Black products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these products safely for their intended uses. Thus, the labeling fails to bear adequate directions for the products’ intended uses, causing the products to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction of misbranded drugs into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].

Misbranded Food

Under section 403®(1)(A) of the Act [21 U.S.C. § 343®(1)(A)], a claim made in the label or labeling of a food that characterizes the level of any nutrient which is of the type required to be in the label or labeling of the food (a “nutrient content claim”) must be made in accordance with regulations promulgated by the Secretary (or, by delegation, FDA). The use of a term, not defined by regulation, in food labeling to characterize the level of a nutrient misbrands a product under section 403®(2)(A)(i) of the Act [21 U.S.C. § 343®(2)(A)(i)].

Nutrient content claims that characterize the level of antioxidant nutrients present in a food must also comply with the specific requirements listed in 21 CFR 101.54(g). These requirements state, in part, that for a product to bear such a claim, an RDI must have been established for each of the nutrients that are the subject of the claim (21 CFR 101.54(g)(1)), and these nutrients must have recognized antioxidant activity (21 CFR 101.54(g)(2)). The level of each nutrient that is the subject of the claim must also be sufficient to qualify for the claim under 21 CFR 101.54(b), ©, or (e) (21 CFR 101.54(g)(3)). For example, to bear the claim "high in antioxidant vitamin C," the product must contain 20 percent or more of the RDI for vitamin C. Such a claim must also include the names of the nutrients that are the subject of the claim as part of the claim or, alternatively, the term "antioxidant" or "antioxidants" when used as part of a nutrient content claim such as “high in antioxidants” may be linked by a symbol (e.g., an asterisk) that refers to the same symbol that appears elsewhere on the same panel of the product label, followed by the name or names of the nutrients with recognized antioxidant activity (21 CFR 101.54(g)(4)). The use of a nutrient content claim that uses the term "antioxidant" but does not comply with the requirements of 21 CFR 101.54(g) misbrands a product under section 403®(1)(A) of the Act.

Your webpage entitled "Namastea Black (225g Bag)" at [web]www.himalayaninstitute.org[/web] includes the claims, "Black tea is recognized for its rich concentration in antioxidant polyphenols such as EGC, EGCG, and other flavonols . . . .”  and “Loaded with protective antioxidant polyphenols.” The terms "rich concentration” and “[l]oaded with” characterize the level of antioxidant nutrients in the product and, therefore, these claims are nutrient content claims (see section 403®(1)(A) of the Act and 21 CFR 101.13(b)). Even if we determined that the terms "rich concentration" or “[l]oaded with” could be considered synonyms for terms defined by regulation (e.g., "high" or "good source"), nutrient content claims that use the term "antioxidant" must meet the requirements of 21 CFR 101.54(g). These claims do not comply with 21 CFR 101.54(g)(1) because no RDI has been established for polyphenols, EGC, EGCG, or flavonols. Thus, these unauthorized nutrient content claims cause your product to be misbranded under section 403®(1)(A) of the Act.

Your Adapt-a-gem product is misbranded within the meaning of section 403(u) of the Act [21 U.S.C. 343(u)] in that it is represented as containing ginseng, but the purported ginseng ingredient is not from a plant classified within the genus Panax. The ingredient statement for your product lists Siberian Ginseng (Eleutherococcus senticosus). Section 10806(b)(1) of the Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171) provides that the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Therefore, Eleutherococcus senticosus may not be declared under a name that includes the term "ginseng."

Your Adapt-a-gem and Cholesta-low products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the label fails to bear nutrition labeling (“Supplement Facts” panel) as required by 21 CFR 101.36. In addition, should you decide to change the name of your Inflam-away product so that it no longer promotes it as an unapproved new drug, as stated on page seven (7) of this letter, it  would then become a misbranded dietary supplement within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)], in that the label fails to bear nutrition labeling (“Supplement Facts” panel) as required by 21 CFR 101.36.

Your Cholesta-low product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2] in that the ingredients statement does not list the ingredient He Shou Wu root by the common or usual name. In accordance with 21 CFR 101.4(h), the common or usual name of ingredients of dietary supplements that are botanicals shall be consistent with the names standardized in Herbs of Commerce, 1992 edition. The common name for He Shou Wu in Herbs of Commerce is Fo-Ti.

The above violations are not intended to be an all-inclusive list of violations at your facility and with your products, labels, and labeling. It is your responsibility to ensure that your products are in compliance with all applicable statutes and regulations, including the Act, the CGMP regulations for dietary supplements, and FDA’s food labeling regulations.

You should take prompt action to correct the violations described in this letter. Failure to take appropriate corrective action may result in FDA taking regulatory action without further notice, such as injunction or seizure.

Further, Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility.  The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.

In addition to the above violations, we also have the following concerns:


    You were unable to provide any documentation to indicate that you have performed training of your personnel. Our investigator was informed that most of the training is done on-the-job; however the firm does not document this training. Under 21 CFR 111.14(b)(2), you must make and keep documentation of training, including the date of the training, the type of training, and the person(s) trained.
    You have not formally identified personnel to be responsible for your quality control operations. Specifically, you verbally confirmed to our investigator that while there is an employee who has been informally filling the role of quality control, no one has been formally designated for this position. Under 21 CFR 111.12(b), you must identify who is responsible for your quality control operations. Each person who is identified to perform quality control operations must be qualified to do so and have distinct and separate responsibilities related to performing such operations from those responsibilities that the person otherwise has when not performing such operations.
    As noted above, your batch production records indicate several instances where ingredients listed in the master manufacturing records were replaced with other ingredients. Under section 403(s)(2)(A)(i) of the Act [21 U.S.C. §343(s)(2)(A)(i)], a dietary supplement is misbranded if its label or labeling fails to list the name of each ingredient of the supplement that is described in section 321(ff) of the Act [21 U.S.C. § 201(ff)]. 


You should notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps that you have taken to correct the violations listed in this letter and to prevent their recurrence. Your response should include documentation of the corrective actions that you have taken or that you plan to take to correct these violations, including the specifics of what methods and controls you have implemented or plan to implement to prevent the recurrence of the violations. If corrective actions cannot be completed within fifteen (15) working days of receiving this letter, please state the reason for the delay and include a timetable for the implementation of the remaining corrections.

A new treatment being developed for bowel disease could also help relieve the suffering of arthritis patients, experts believe.

The as yet unnamed drug will become the first to be tested at Wales’ only arthritis treatment research centre – called CREATE – which has been designed to develop new treatments to stop inflammatory arthritis.

Based at Cardiff University’s School of Medicine, the first trial is expected to involve about 50 patients from across South Wales.

Professor Ernest Choy, professor of rheumatology at Cardiff University, said: “The aim is to develop novel and more effective treatments for patients with inflammatory arthritis.

“Unlike the more common forms like osteoarthritis, patients with these forms of inflammatory arthritis – rheumatoid and psoriatic arthritis – have much higher rates of mortality because the inflammation can spread through the body.

“As a result they have more complicated and severe disease and survival rates subsequently decrease compared to the general population.

“These are aggressive conditions and we know that a key factor in improving outcomes is to keep the inflammation to a minimum.

“Over the last 20 years there have been some new and effective treatments which have improved the condition significantly.

“But the number of patients who get to persistent remission remains low – at less than 30%. Our aim is to try and develop new treatments which are more effective and put more patients into remission.”

The new centre – the Arthritis Research UK Experimental Arthritis Treatment Centre (Create) – which has been backed with £115,000 of start-up funding from Arthritis Research UK over the next three years and additional funding from National Institute for Social Care and Health Research (NISCHR) and Cardiff University, will also develop new laboratory tests that will determine the most appropriate therapies for individual patients.

One of the first pieces of work for the new centre will be to examine whether a new and unlicensed treatment for inflammatory bowel disease will also be effective for patients with rheumatoid and psoriatic arthritis – experts are hopeful the treatment will be effective in addressing the inflammatory response and symptoms in arthritic patients.

Prof Choy added: “For the last few years, the opportunity for patients in Wales to get access to innovative treatments has been rather limited. Having this centre will open up the opportunities for better treatment.

“And it will also allow us to look across the horizon and see whether there are treatment examples from other diseases that could help arthritis.”

Source: walesonline

Thank you for welcoming me Fred. I found this site while browsing on the web for someone to publish what I had written. I decided to write down how Psoriasis had and still has made me a very insecure person and just wanted to let others know that the old saying "Ignorance is Bliss" is wrong. I only wrote a couple of pages but it just summed up how little matters had affected me and wanted others to know that they are not alone. Susan x

G'day guys I'm new to this forum I've had psoriasis since I was 18 I'm 35 now it's been on and off but at he moment it's the worst it's ever been so Im intersted if there is any new treatment my doc wants to try mega iv dose's of vitamin c and zinc , has any one tried this