June 15, 2010
From the Centers for Disease Control and Prevention: Morbidity and Mortality Weekly Report
1 figure, 2 tables omitted
Liver cancer, primarily hepatocellular carcinoma (HCC), is the third leading cause of death from cancer worldwide and the ninth leading cause of cancer deaths in the United States.1,2 Chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infections account for an estimated 78% of global HCC cases.3 To determine trends in HCC incidence in the United States, CDC analyzed data for the period 2001-2006 (the most recent data available) from CDC's National Program of Cancer Registries (NPCR) and the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) surveillance system. This report summarizes the results of that analysis, which determined that the average annual incidence rate of HCC for 2001-2006 was 3.0 per 100,000 persons and increased significantly from 2.7 per 100,000 persons in 2001 to 3.2 in 2006, with an average annual percentage change in incidence rate (APC) of 3.5%. The largest increases in HCC incidence rates were among whites (APC = 3.8), blacks (APC = 4.8), and persons aged 50-59 years (APC = 9.1). Among states, HCC incidence rates varied widely, ranging from 1.4 per 100,000 in South Dakota to 5.5 in Hawaii. The results demonstrate a continuation of long-term increases in HCC incidence and persistent HCC racial/ethnic disparities. Development of viral hepatitis services, including screening with care referral for persons chronically infected with HBV or HCV, full implementation of vaccine-based strategies to eliminate hepatitis B, and improved public health surveillance are needed to help reverse the trend in HCC.
CDC examined all HCC cases diagnosed during 2001-2006 and reported to NPCR or SEER from 45 cancer registries (covering 90.4% of the U.S. population) that met the criteria for data quality and completeness.* Only microscopically confirmed HCC cases (coded to the liver ICD-O-3 site code C22.0 with ICD-O-3 histology codes 8170-8175) were included. Incidence rates per 100,000 persons were age adjusted to the 2000 U.S. standard population. APCs were calculated using least squares regression. Statistical significance was determined at p<0.05. Data were analyzed by state, sex, race, ethnicity, and age group. Persons categorized as either non-Hispanic or Hispanic might be of any race.
During 2001-2006, a total of 48,596 HCC cases were reported, with an average annual incidence rate of 3.0 per 100,000 persons. Overall, the HCC rate increased from 2.7 per 100,000 persons in 2001 to 3.2 in 2006, with an APC of 3.5%. The median age for diagnosis of HCC was 64 years overall, 62 years for males, and 69 years for females. The highest incidence rate was among persons aged 70-79 years (13.7), followed by persons aged 80 years (10.0), 60-69 years (9.6), 50-59 years (6.8), and 40-49 years (2.1).
The incidence rate for males (5.0 per 100,000 persons) was approximately three times higher than the rate for females (1.3). The HCC rate for males increased from 4.5 in 2001 to 5.4 in 2006, and the rate for females increased from 1.2 to 1.4. During 2001-2006, the APC for males (3.6%) was significantly higher than the APC for females (2.3%).
The HCC incidence rate was highest among Asians/Pacific Islanders (7.8 per 100,000 persons), followed by blacks (4.2), American Indians/Alaska Natives (3.2), and whites (2.6). The incidence rate for Hispanics (5.7 per 100,000 persons) was higher than the rate for non-Hispanics (2.8). From 2001 to 2006, the largest significant increases in HCC incidence rates were among whites (APC = 3.8), blacks (APC = 4.8), and persons aged 50-59 years (9.1). The HCC incidence rate did not increase among Asians/Pacific Islanders.
Among states, HCC incidence rates ranged from 1.4 per 100,000 persons in South Dakota to 5.5 in Hawaii. Eleven states had significant increases in incidence rates, with the highest APCs reported for Oklahoma (11.7), Iowa (9.0), and Georgia (7.4).
S O’Connor, MD, JW Ward, MD, Div of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention; M Watson, MPH, B Momin, MPH, LC Richardson, MD, Div of Cancer Prevention and Control, National Center for Chronic Disease Prevention and Health Promotion, CDC.
CDC Editorial Note:
This report provides the most recent population-based estimates of HCC incidence rates and trends in the United States and the first state-specific HCC trends. The findings indicate continued increases in HCC incidence, consistent with earlier reports using different methodology.2,4 However, requiring microscopic confirmation of HCC likely produced more conservative incidence rate estimates than analyses of NPCR/SEER data published previously.2,4
Chronic HBV and HCV infections that persist for decades are major risk factors for HCC. Both infections cause chronic inflammation that can progress to fibrosis, cirrhosis, and eventually malignancy.3 HBV infection also can be directly oncogenic.3 In addition, alcohol consumption, steatohepatitis, and type II diabetes have been linked to HCC2; these risk factors for HCC amplify the effects of viral hepatitis but also might cause HCC in the absence of viral hepatitis.2
The age and race profile of persons with HCC reflects the demographic characteristics of persons with chronic viral hepatitis. During 2001-2006, HCC incidence was highest among Asians/Pacific Islanders, Hispanics (compared with non-Hispanics), blacks, persons aged 50 years, and males. The largest increases occurred among whites, blacks, persons aged 50-59 years, and males. Rates were highest among persons born during 1946-1964 (who are now aged 46-64 years), particularly black males.3,4 In the absence of testing and care, the risk for HCC is expected to increase with aging of the cohort of persons with HCV infection.5
Asians/Pacific Islanders, black adult males, and persons living in the United States who were born in regions where HBV is endemic (e.g., Asia and sub-Saharan Africa) have high rates of both HBV infection and HCC.2,5-8 As shown in this analysis, the rate of HCC did not increase among Asians/Pacific Islanders during 2001-2006. Some reasons for this might be early implementation of hepatitis B vaccination programs, changes in immigration patterns, and the impact of hepatitis B therapy on disease progression.3,4
The findings in this report are subject to at least three limitations. First, misclassification of race and ethnicity in the registries and multiracial status of patients might underestimate HCC rates in certain populations. Second, although some states collect information on specific Asian subgroups, these data are not available at the national level; published reports from selected geographic areas suggest that certain ethnic Asian/Pacific Islander subgroups have greater risk for HCC than other Asian/Pacific Islander subgroups.3 Finally, cancer registries do not routinely collect information on etiologic factors for HCC, including chronic viral hepatitis.
Most cases of HCC are preventable. Prevention of HBV and HCV transmission and progression of chronic viral disease leads to declines in HCC incidence.9 However, new HBV and HCV infections continue to occur.6,7 Populations at greatest risk for new infection include children born to HBV-infected mothers and adults with sexual and drug use risk behaviors. Of the estimated 3.8-5.3 million persons living with chronic viral hepatitis in the United States, most are unaware of their infection.5 Early identification of viral hepatitis with referral to prevention and care services can decrease transmission to others. Treatment of viral hepatitis is cost-effective, and medical management can decrease morbidity.10
In a recent report on prevention of hepatitis and liver cancer, the Institute of Medicine (IOM) called for a national comprehensive approach comprised of interventions to prevent HBV and HCV transmission and interventions to reduce the morbidity associated with chronic HBV and HCV infections.5 IOM recommends improved viral hepatitis surveillance, community education to address health disparities, support for vaccine-based strategies to eliminate HBV transmission, and development of prevention and health services that target key populations (i.e., drug users, foreign-born persons, and persons infected with human immunodeficiency virus), including screening for HBV and HCV infections linked to appropriate medical management.
What is already known on this topic?
Hepatocellular carcinoma (HCC) is a leading cause of cancer deaths in the United States and worldwide; infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) accounts for an estimated 78% of global HCC cases.
What is added by this report?
During 2001-2006, HCC incidence rates increased in the United States, particularly among whites, blacks, and persons aged 50-59 years.
What are the implications for public health practice?
Development of viral hepatitis services, including screening with care referral for persons chronically infected with HBV or HCV, full implementation of vaccine-based strategies to eliminate hepatitis B, and improved public health surveillance are needed to help reverse the trend in HCC.
* Detailed descriptions of the methods used by NCPR and SEER, including data collection and analysis, criteria for data inclusion, and determination of statistical significance are available at http://www.cdc.gov/cancer/npcr and http://seer.cancer.gov/ .
International Classification of Diseases for Oncology, 3rd ed.
Jun 14, 2010
MONDAY, June 14 (HealthDay News) -- A single nucleotide polymorphism (SNP) in the gene encoding for interferon lambda is associated with progression to chronic hepatitis C infection and treatment failure, according to research presented at the annual conference of the European Society of Human Genetics, held from June 12 to 15 in Gothenburg, Sweden.
Zoltan Kutalik, Ph.D., of the University of Lausanne in Switzerland, and colleagues analyzed data from 1,362 patients with hepatitis C infection; 1,015 had chronic hepatitis C and 347 spontaneously cleared the virus. In 465 of the chronic patients, responses to pegylated interferon-alpha and ribavirin were assessed.
The researchers found that chronic hepatitis C was associated with SNPs in the IL28B locus, which encodes interferon-lambda-3, an antiviral cytokine. The minor allele of the SNP that was the top hit was linked to progression to chronic infection (odds ratio, 2.31). This association was seen in subjects with and without HIV co-infection. This SNP was also linked to failure to respond to therapy (odds ratio, 5.19).
"This disease affects up to 300 million people worldwide. It is insidious, and often individuals are not aware that they are infected until serious liver damage has taken place. Finding better treatments is vital. As well as sparing those who would not react well to current treatment from side effects, we hope that our work may provide pointers to the development of effective therapies for the future," Kutalik said in a statement.
Abstract No. C03.6
Better Clarity on Diagnosis Facilitates the Introduction of Novel Treatments in the Hepatitis C Therapeutics Market in Australia, Finds Frost & Sulliv
Higher efficacy and safety are the most preferred drug attributes. Physicians expect new oral anti-virals (boceprevir and telaprivir) and interferon with improved safety (albuferon) to be launched by 2013 in Australia. According to physicians, prevalence had increased rapidly during the early 2000s. However, the rate had declined over the years, and the pace is likely to slacken in the future owing to a major disruption to the supply of heroin in Australia in 2001.
New analysis from Frost & Sullivan (http://www.pharma.frost.com), Multi Client Study: Opportunities Assessment for the Hepatitis C Therapeutics Market in Australia, finds that the market earned revenues of $2.3 billion in 2007 and this is expected to increase to approximately $4.5 billion by 2017 due to new drug launches occurring after 2010.
"The Australian Government has unleashed Initiatives to address the Hepatitis C virus in the country, allocating $14.3 million (Australian dollar 17 million) for Hepatitis C education and prevention over the 2007-2011 period," says Frost & Sullivan Program Manager Carole Gaffud. "State and territory governments also have substantial budgets for Hepatitis C prevention and education."
The priority action areas identified as part of the National Hepatitis C Strategy are prevention, education, diagnosis, treatment, surveillance, and research. The Government is avidly addressing healthcare workforce development as well as issues surrounding discrimination and stigma.
Although there is a high diagnosis rate in Australia, only a paltry 3 percent of diagnosed patients pursue treatment owing to a lack of understanding about treatment options. According to physicians, one of the main reasons for such a large proportion of diagnosed patients left untreated is that they are predominantly from disadvantaged groups such as illicit drug users, aboriginal people, those serving prison sentences, and some migrant groups, which do not have access to conventional healthcare. Often the reason is real or perceived stigma and discrimination.
Aside from this, there is a great deal of angst about debilitating side effects, frequent dosing, and lackluster efficacy of the existing HCV treatments, especially for those afflicted with genotype 1. Moreover, there is a belief that a liver biopsy is required to receive treatment, which deters patients from undergoing treatment.
To circumvent the challenges clouding the market landscape, companies must offer treatment options that expedite efficiency, have fewer side effects, and are cost efficient. Patients should be made aware of their disease status and encouraged to remain compliant.
"As more improvements are required to educate at risk patients, public and private organizations including pharmaceutical companies must up the ante to spread awareness," says Gaffud. "Greater information outreach will help patients obtain the right mode of treatment and ultimately stem the onslaught of the Hepatitis C virus in Australia.
If you are interested in more information on this study, please send an e-mail to Nicklaus Au, Corporate Communications, at firstname.lastname@example.org, with your full name, company name, title, telephone number, company e-mail address, company website, city, state and country.
Multi Client Study: Opportunities Assessment for the Hepatitis C Therapeutics Market in Australia is part of the Pharmaceutical & Biotechnology Growth Partnership Services program, which also includes research in the following markets: Opportunities Assessment of Hepatitis C Market in Taiwan, Opportunities Assessment of Hepatitis C in Philippines, Opportunities Assessment of Hepatitis C in Indonesia, Opportunities Assessment of Hepatitis C in Singapore, Opportunities Assessment of Hepatitis C in China, Opportunities Assessment of Hepatitis C in Thailand, Opportunities Assessment of Hepatitis C in Hong Kong, Opportunities Assessment of Hepatitis C in India, Opportunities Assessment of Hepatitis C in Korea, and Opportunities Assessment of Hepatitis C in Malaysia. All research services included in subscriptions provide detailed market opportunities and industry trends that have been evaluated following extensive interviews with market participants.
About Frost & Sullivan
Frost & Sullivan, the Growth Partnership Company, enables clients to accelerate growth and achieve best-in-class positions in growth, innovation and leadership. The company's Growth Partnership Service provides the CEO and the CEO's Growth Team with disciplined research and best-practice models to drive the generation, evaluation, and implementation of powerful growth strategies. Frost & Sullivan leverages over 45 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from 40 offices on six continents. To join our Growth Partnership, please visit http://www.frost.com.
Indian Oncologists have performed Treatment of Primary Liver Cancer in India at an Incredible Success Rate
Indian oncologists providing treatment of Primary liver cancer in India has been a pioneer in this field. Indian hospitals are equipped to handle all phases of myeloma problems from the elementary to the latest clinical procedures. The commitment of its surgeons to the prevention and treatment of myeloma has led to the achievement of better outcomes and improved quality of life for thousands of patients. Indian hospitals providing treatment of Primary liver cancer in India ensure that patient’s experience is safe and comfortable, with the highest standards of both medical and non-medical services.
What is Primary Liver Cancer?
Primary liver cancer is one of the less common cancers in Victoria with about 260 people diagnosed each year. It is more common in men and people aged over 65 years. Most primary liver cancers start in liver cells (hepatocellular carcinoma); others start in a bile duct (cholangiocarcinoma). In the Western world, most people who develop Primary liver cancer also have cirrhosis of the liver. This is scarring of the liver due to causes including heavy alcohol drinking over a long period of time. However, only a small number of people who have cirrhosis of the liver develop primary liver cancer. Infection with hepatitis B, C or D can also increase the risk of cirrhosis and, later, Primary liver cancer.
Benefits vs. RisksBenefits:
• Chemoembolization can stop liver tumors from growing or cause them to shrink in 2/3 of cases treated. This benefit, on average, lasts 10-14 months.• Chemoembolization can be used in conjunction with other cancer treatments including tumor ablation, radiation and chemotherapy.
• Most patients don't die from the spread of cancer if it is confined to the liver, but rather from liver failure caused by the tumors growth. Chemoembolization can help prevent the growth of a tumor, preserving liver function and a relatively normal quality of life.
• Two randomized controlled trials published in 2002 showed improved survival in patients with hepatoma (primary liver cancer) after chemoembolization compared to supportive care alone.
• Embolus (tiny particles) can lodge in the wrong place and deprive normal tissue of its blood supply.
• Even if antibiotics are given, there is always a risk of infection after embolization.
• There is a risk of an allergic reaction to the dye used in the angiography x-ray.
• There is a risk of kidney damage in patients with diabetes or other pre-existing kidney disease due to the angiography.
• Nausea, hair loss, decreases in white blood cells and platelets, and anemia may occur due to the chemotherapy drug.
• After 1 in 20 procedures, serious complications occur and typically include liver infection or damage to the liver. Liver failure is usually the cause of the 1 in 100 deaths related to this procedure.
Causes and Risk factors for Primary Liver Cancer
The exact cause of primary liver cancer is still unknown. There are a number of factors, however, that increase your risk of developing it.
These include: -
• Liver cirrhosis: In the Western world, most people who develop hepatoma usually also have a condition called cirrhosis of the liver. This is a fine scarring throughout the liver which is due to a variety of causes including infection and heavy alcohol drinking over a long period of time. However, only a small proportion of people who have cirrhosis of the liver develop Primary liver cancer.
• Infection: Infection with either the hepatitis B or hepatitis C virus can lead to liver cancer. This can also be the cause of cirrhosis, which in turn increases the risk of developing hepatoma. The risk is greater in those that also smoke.
• Inherited conditions: People who have a condition called haemochromatosis, which causes excess deposits of iron in the body, or the condition alpha 1 antitrypsin deficiency, have a higher chance of developing hepatoma.
• Aflatoxin: In Africa and Asia a poison called aflatoxin, found in mouldy peanuts and grain, is a major cause of hepatoma.
Liver cancer is usually diagnosed with a number of different tests, which may include: -
• Blood tests - to check your general health and to check for a chemical usually found in increased levels in people with primary liver cancer.
• Ultrasound - a picture of the liver is taken using sound waves.
• CT scan - a specialised x-ray taken from many different angles to build a three-dimensional (3-D) picture of the body.
• Magnetic resonance imaging (MRI) - similar to a CT scan, but uses magnetism instead of x-rays to build a picture of the body.
• Liver biopsy - a small piece of liver tissue is removed with a needle and examined for cancer cells.
• Laparoscopy - a small cut in the lower abdomen allows a thin mini-telescope (laparoscope) to be inserted to look at the liver and take a sample of the liver tissue.
What are the treatment options for Liver Cancer?
The treatment options for Primary liver cancers are dictated by the stage of liver cancer and the overall condition of the patient. The only proven cure for liver cancer is liver transplantation for a solitary, small (<3cm) tumor. Now, many physicians may dispute this statement. They may argue that a small tumor can be surgically removed (partial hepatic resection) without the need for a liver transplantation. Moreover, they may claim that the one and three year survival rates for resection are perhaps comparable to those for liver transplantation. Why India? Treatment of Primary liver cancer in India is done under best medical supervision. The reason India is a favorable destination is because of its infrastructure and technology which is in par with developed countries. India has some of the best hospitals and treatment centers in the world with the best facilities. India has state of the art Hospitals and the best qualified doctors. With the best infrastructure, the best possible Medical facilities, accompanied with the most competitive prices, you can get the treatment done in India at the lowest charges. For further details on the treatment of Primary liver cancer in India, visit us at : http://www.forerunnershealthcare.com/ . Call us at: +91-9371136499, +91- 9860755000 (International) / + 1-415-599-2537 (USA) / +44-20-8133-2571 (UK)
Please Send Queries On: www.forerunnershealthcare.com/enquiry_form.php
Watch International Patient Videos: www.forerunnershealthcare.com/International-patient-videos.html
Prediction of prognostic biomarkers for Interferon-based therapy to Hepatitis C Virus patients : a metaanalysis of the NS5A protein in subtypes 1a, 1b
We implement a novel approach for extracting features including informative markers from mutations in the non-structural 5A protein (NS5A), specifically its ISDR and V3 regions, and use a novel bioinformatics approach for pattern recognition on the NS5A protein and its motifs to find biomarkers for response prediction using class association rules (CARs) and comparing the predictability of the different features.
Results: A total of 58 sequences from sustained responders and 94 from non-responders were downloaded from the HCV LANL database. Site-specific signatures for response prediction from the NS5A protein were extracted from the alignments.
CARs were generated (e.g.: sustained response is associated with position A2368T in subtype 1a (support 100% and confidence 52.19%); in subtype 1b, response is associated with E2356G/D/K (support 76.3% and confidence 67.3%).
Conclusion: The V3 region was a more accurate biomarker than the ISDR region. Subtype-specific CARs gave better support and confidence than hidden Markov models HMMs scores, genetic distances (GDs) or number of variable sites (NVS), and would thus aid in the prediction of prognostic biomarkers and improve the accuracy of prognosis.
Sites-specific CARs in the V3 region of the NS5A protein have given the best support and confidence.
Author: Mahmoud ElHefnawiSuher ZadaIman El-AzabCredits/Source: Virology Journal 2010, 7:130
Published on: 2010-06-15
NVHR Launches Targeted Print Advertising Campaign Urging Swift Congressional Action on Secret Epidemic of Chronic Viral Hepatitis
NVHR is a coalition of more than 175 public, private, and voluntary organizations dedicated to reducing the incidence of infection, morbidity, and mortality from chronic viral hepatitis that afflicts more than 5 million Americans. www.nvhr.org
"NVHR's new advertising initiative is a timely reminder to Congress, the Administration, and all stakeholders that federal action is desperately needed this year to help combat this insidious disease that affects over 5 million Americans and their loved ones," said Ms. Lorren Sandt, Chair of the National Viral Hepatitis Roundtable (NVHR) and Executive Director of Caring Ambassadors Program, based in Portland, OR. "Six months ago, the Institute of Medicine issued nearly two-dozen expert recommendations for improving the federal government's response to the viral hepatitis epidemic. The pressing challenge now before Congress and the Administration is to provide federal funding to translate the IOM report into swift and decisive action."
Under the banner of "Mission: Possible," NVHR's new advertisement highlights the IOM report and urges action on HR 3974. The advertisement also features the tagline "If Congress gets on the case now, the leading cause of liver cancer won't stand a chance."
Thursday's hearing before the House Oversight & Government Reform Committee is an important step forward in this fight. An estimated 5.3 million Americans have been infected with chronic viral hepatitis B or C – and with most unaware of their infection, millions are at risk of developing life-threatening complications, especially African Americans and Asian Americans. Without detection and treatment, chronic viral hepatitis leads to liver cancer, cirrhosis, or liver failure. In the absence of federal leadership, the research firm Milliman estimates that public and private payers' cost of treating chronic viral hepatitis C alone will more than triple by 2024 to $85 billion annually. Medicare and Medicaid would absorb a disproportionate share of these added costs.
HR 3974, "The Viral Hepatitis and Liver Cancer Control and Prevention Act," is sponsored by Representatives Mike Honda (D-Calif.), Charles Dent (R-Pa.) and 49 other House Members and would help turn the tide. The Honda-Dent legislation would increase the ability of the CDC to support state health departments in their prevention, immunization and surveillance, and referral to care efforts. Much of the Honda-Dent legislation tracks with the IOM's recommendations.
SOURCE National Viral Hepatitis Roundtable
-FDA posted the linked warning letter regarding unjustified HIV and hepatitis claims by a natural products supplier-
Healthy World Distributing
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Seattle DistrictPacific Region22201 23rd Drive SE
Bothell, WA 98021-4421
May 11, 2010
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 10-22
Dr. Leonard G. Horowitz
Healthy World Distributing, LLC
206 North 4th Avenue, Suite #147
Sandpoint, Idaho 83864
Jacqueline G. LindenBach
Healing Celebrations, LLC
217 Cedar Street, #326
Sandpoint, Idaho 83864
Dear Dr. Horowitz, Ms. LindenBach and Ms. Johnson:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your integrated system of promotional websites and labeling for your "Oxysilver," "PrimoLife," "ZeoLife," "Green Harvest," "ElectrOEnyzmes," "OxySilver Immune Support Hydrosol Concentrate," "GI Flora Pro," "OxyAdvantage," and "Love Minerals" products. We have reviewed the internet addresses where these products are sold, www.oxysilver.com, www.healthyworldambassadors.com and www.healthyworldstore.com. and have determined that they are promoted for conditions that cause them to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)].
The therapeutic claims on your websites establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease, and/or in the case of your products marketed for topical use, because they are intended to affect the structure or function of the human body. The marketing of your products with these claims violates section 505(a) of the Act [21 U.S.C. § 355(a)]. In addition, your products Oxysilver, Green Harvest, ElectrOEnzymes, and OxySilver Immune Support Hydrosol Concentrate fail to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
In addition, your websites listed below automatically redirect to http://www.oxysilver.com/ :
Also, your websites listed below promote Oxysilver with "buy" links or a graphic representation of Oxysilver that links directly to http://www.oxysilver.com/:
In addition, your websites listed below automatically redirect to the opening page of http://www.healthyworldstore.com/:
1. Claims on www.oxysilver.com
The website address http://www.oxysilver.com/ appears on your Oxysilver product label.
Examples of some of the claims observed on your http://www.oxysilver.com/ website include:
The following are claims that stream at the top of your www.oxysilver.com home page:
• "Destroy Viruses, Bacteria, and Fungi"
• "Eliminate the need for harmful vaccines and anti-biotics[sic]"
Additional claims found on your www.oxysilver.com home page include:
• "Silver hydrosols, in general, are superior powerful broad spectrum anti-microbials."
• "[Silver hydrosols are] alternatives to ...poisonous antibiotics, and risky vaccinations."
• "Can you Imagine a world free of infectious diseases, viral cancers, and AIDS? Some people can't imagine this, including the major corporations producing risky expensive antibiotics and intoxicating vaccines (i.e., Oxysilver's competition)."
The following claims are found on the page that opens from the "Technology" tab on the http://www.oxysilver.com/ home page:
• . "[S]ilver hydrosols, in general destroy pathogens safer and better than anything. They pioneered silver hydrosols effective against disease forming bacteria; viruses, and fungi."
• "OXYSILVERTM serves as the world's first nutraceutical alternative to risky vaccinationsand immunizations... "
• "[T]hese solutions are safe and effective adjuncts and alternatives to risky antibiotics and chemotherapeutics. This breakthrough evolutionizes disease prevention, germ elimination... "
• "Substantial scientific research proves silver hydrosols destroy pathogens-disease forming bacteria, viruses, and fungi-in your body... "
• "Take the burden off your immune system with OXYSILVERTM...developed to strengthen natural immunity against infectious diseases and common chronic ailments largely attributable to weakened immune systems."
Your http://www.oxysilver.com/ website also contains disease claims in the form of personal testimonials. These testimonials are examples of those found on the page that opens from the "Validation" tab on your home page:
• "I wanted to let you know how well the OxySilver has worked for me. I have had trouble with recurring bladder and kidney infections and interstitial cystitis. My pains hurt so bad that it was hard to sit down at times. Within two days of taking OxySilver at the recommended dosage as per the bottle, I was able to go to the bathroom without burning anymore. This is much better than other treatments which did nothing for me."
• "DIABETES SYMPTOMS RELIEVED 'I have been a diabetic for most of my life. As I have gotten older I have gradually been taking more and more insulin. After just one week on OxySilver for the first time I can remember I am actually taking less insulin. I have also noticed that my blood sugar levels have stabilized considerably. I would highly recommend the use of OxySilver to anyone suffering from any level of diabetes. '"
• "RELIEF FROM SINUS HEADACHES 'I have suffered from chronic sinus headaches for most of my adult life; I'm 50 years old now. Miraculously since I've begun taking OXYSLIVER [sic], I've had many days and nights now of no pain at all. I can honestly tell you, nothing I have ever done has had nearly the positive effect on my Sinus condition and I seem to be continuously improving.'"
• "BRONCHITIS SYMPTOMS GONE 'I had the fortunate experience of a personal visit of a member of your executive staff to my home. After much convincing by him, I agreed to try some Oxysilver as a potential remedy for my chronic bronchitis. I'm very pleased to report that not only is my bronchitis completely gone, but I am feeling better than I can ever recall feeling after 20 years of continuous bronchitis.'"
• "RELIEF FROM KNEE PAIN DUE TO HEPATITIS VACCINATIONS 'As a result of several hepatitis vaccinations I ... started experiencing joint pains especially in my left knee. The pain became so severe I couldn't walk a quarter of a mile on level ground. After taking OXYSLIVER [sic] for approximately one month, my knee pain has almost completely disappeared.'''
• "GULF WAR SYNDROME SYMPTOMS GONE 'In late 1999, I was in and out of the VA Hospital suffering from Gulf War Syndrome. I had aches and pains and zero energy. I was introduced to Oxysilver by some close friends. After taking the mineral solution for several months, I now have no symptoms and I'm as healthy as ever."
• "HIGH FEVERS IN TODDLERS RELIEVED 'I had to take my 18 month & 28 month old daughters to the emergency Medi-Center one Sunday morning last winter with 103 degree temperatures. I avoid taking them because my husband and I want to minimize the number of drugs our children receive. My husband came home from church with Oxysilver for the girls. I hadn't filled the prescriptions yet - I wanted to believe in this new mineral solution so decided to give it (the mineral solution) 24 hrs. Before filling the prescriptions, I gave the girls 1 oz. three times during that afternoon and evening. The next morning their fevers had broken - and within 2-3 days they were fine.'
• "RELIEF FROM LUPUS SYMPTOMS OF PAIN AND FATIGUE 'In fall 1998, I went to the doctor with symptoms such as joint pains and chronic fatigue. They performed a blood test and the results came back positive with Lupus. ... A friend asked me to try Oxysilver and see if it would help relieve the symptoms. I started drinking a quart a day for two weeks, and I started to feel better. I could finally sleep throughout the night, and my mornings were much easier now that I was able to get out of bed. After eight months of using Oxysilver, I went back to the doctor for a blood test, and this time there was no sign of Lupus in the blood work. The doctor states that it is in remission, Oxysilver did what no prescribed medication or diet could accomplish, and that was relieve my pain and fatigue."
• "HEPATITIS C SYMPTOMS RELIEVED 'Thanks again for the opportunity to try Oxysilver. Hepatitis C had my life in such a state of affairs. '" My liver enzymes were at their worst and my viral load was dangerously high. Now my liver is normal and the viral load is coming down.'"
The claims quoted above are supplemented by the metatags used to bring consumers to your http://www.oxysilver.com/ website through Internet searches. The metatags include:
• "hep b, hep c, hepatitis b, hepatitis c, rnrsa, fibromyalgia, Cancers, HIV, AIDS ... virus, viruses, germs, bacteria ... Vaccine ... antibiotics ... flu ... infectious .. : high fevers, lupus, typhus infection ... fungus, fungi ... pathogens, disease forming bacteria ... anaerobic germs, germicides ...."
In addition, the following claims in the form of personal testimonials marketing the OxySilver™ product for topical uses were found on the page that opens from the "Validation" tab on your http://www.oxysilver.com/ website:
• "I developed an infection in my right eye. ... I got an eye dropper that I had in my kitchen and filled it with OXYSILVER and dropped two drops in my eye. When I woke up the next morning and looked at my eye. The puss and redness and swelling were gone and I was amazed!"
• "QUICK RELIEF FROM TYPHUS INFECTION AND PAIN IN LEG ... 'I was suffering from typhus in my left leg. I wrapped gauze around my leg and poured Oxysilver onto the wrapping. Within 2 to 3 hours, the pain was gone, and that same day the infection was also gone.'"
When intended for topical use, Oxysilver is not a dietary supplement because the Act defines the term "dietary supplement" in 201(ff)(2)(A)(i) of the Food Drug and Cosmetic Act (21 U.S.C. § 321(ff)(2)(A)(i)), as a product that is "intended for ingestion." Topical products and products intended to enter the body directly through the skin or mucosal tissues are not dietary supplements. The above testimonials suggesting that consumers use Oxysilver topically subject the product to regulation as a drug. Thus, Oxysilver is a drug under 201(g)(1)(B)/(C) of the Act (21 U.S.C. §321(g)(1)(B)/(C)), because it is intended to affect the structure or function of the human body and/or to prevent, treat or cure disease conditions.
2. Claims on www.healthyworldambassadors.com
Examples of some of the claims observed on your www.healthyworldambassadors.com website include:
• "This mineral water electrocutes germs safely and powerfully!"
• "It promotes vaccine-free natural nutritional immunity against infectious diseases without immunization toxicity."
• "OXYSILVERTM is ... developed to strengthen natural immunity against infectious diseases and common chronic ailments largely attributable to weakened immune systems.
3. Claims on www.healthyworldstore.com
Examples of some of the claims observed on your website http://www.healthyworldstore.com/ include the following:
• "PrimoLife... possesses the secrets of living disease-free ... enhance your immune system's ability to identify and destroy germs and diseased cells."
2009 Flu Package Special (includes PrimoLife, Oxysilver, Zeolife, GI Flora Pro, OxyAdvantage, and Love Minerals)
• The hyperlink "Don't be fooled by the H1N1 Swine Flu Scam. The Vaccine is Deadly. Get this kit and Save" links to a webpage titled "2009 Flu Package Special," which states, "This package contains assorted immunity boosters and health enhancers that, when you are using responsibly, guarantee you will stay healthy, no matter who or what kind of animal around you gets sick."
• "Green Harvest contains ingredients helping people beat cancer. .. "
• "[ElectrOEnzymes is] also for those who have used antibiotics that have killed natural gut flora."
• "Here is what ElectrOEnyzmes can do for you: Gastrointestinal repair ... Reduces allergies ... Reduces build-up of arterial plaque"
Oxysilver Immune Support Hydrosol Concentrate
• "Oxysilver is an effective alternative to risky vaccinations and deadly antibiotics. It promotes vaccine-free natural nutritional immunity against infectious diseases without immunization toxicity."
• "OXYSILVER is ... developed to strengthen natural immunity against infectious diseases and common chronic ailments largely attributable to weakened immune systems."
• "This product destroys pathogens-disease forming bacteria, viruses, and fungi .... "
• "What's entirely unique about this product [Oxysilver Immune Support Hydrosol Concentrate] is that theoretically it can prevent and cure any disease affected by oxygen, which is the vast majority of ailments from colds to cancers."
The claims quoted above are supplemented by the metatags used to bring consumers to your http://www.healthvworldstore.com/ website through Internet searches. The metatags include:
• "anti-microbiaL .. autism ... cancer. .. virus, viruses infection... antibiotics... flu, Cancer Cure... Flu Formula... H1N1, pandemic ... swine flu emerging viruses."
Your products OxySilver, PrimoLife, ZeoLife, Green Harvest, ElectrOEnzymes, OxySilver Immune Support Hydrosol Concentrate, GI Flora Pro, OxyAdvantage, and Love Minerals 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)]. Under section 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. The introduction into interstate commerce of unapproved new drugs without approved applications violates these provisions of the Act.
Furthermore, because your Oxysilver, Green Harvest, ElectrOEnyzmes, and OxySilver Immune Support Hydrosol Concentrate, products are offered for conditions that are not amenable to self diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layperson can use the products safely for their intended uses. Thus, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of § 301(a) of the Act [21 U.S.C. § 331(a)].
The violations cited in this letter are not meant to be an all-inclusive list of violations that exist in connection with your products and their labeling. While reviewing your website, we noticed that you were promoting other products for disease treatment and/or prevention. The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. Sections 302 and 304 of the Act authorize the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be directed to: Lisa Althar, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington, 98021-4421. If you have any questions regarding any issues in this letter, please contact Ms. Althar at (425) 483-4906.
Roberta F. Wagner
Office of Compliance
Center for Food Safety and Applied Nutrition
Office of Compliance
Center for Drug Evaluation and Research
Charles M. Breen C.
Seattle District Office