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Week Ending: September 24th, 2005
Alan Franciscus
Editor-in-Chief
To download pdf version click here
This Issue:
• 'Hepatitis C' Surgeon Suspended
• Stem Cell Transplant Can Leave Long-Term Health Woes
• New Drug For Hepatitis C Patients
• September is Liver Cancer Awareness Month
• Alcohol Has No Effect pn Hep C Virus Replication
• Aethlon Medical Launches Hepatitis-C Clinical Trial
• Xoma Inks Deal to Make Antibodies
• Morbidity in Live Liver Donors Is Low
• Hepatitis C Co-Infection Diminishes HAART Effectiveness for HIV: Researchers
• Anadys Drug May Become Cornerstone Hepatitis Therapy
• Hepatitis Linked to Body Art
• NIH Establishes National Commission on Digestive Diseases
• Prediction of Survival in Patients with Cirrhosis
• Flamel Technologies Announces Positive Preliminary Results of a Phase I/II Trial of IFN-alpha-XL in Patients with Chronic Hepatitis C Virus Infection
September 16th, 2005
'Hepatitis C' Surgeon Suspended
http://www.dailymail.co.uk
A surgeon who had hepatitis C and put his patients at risk by carrying out invasive procedures has been found guilty of serious professional misconduct and suspended from the medical register for three months.
Dr Mohammad Qamar Sawar-Rana of Kings Heath, Birmingham, had put "his own interests" above the interests and health of his patients.
By continuing to perform operations regardless of the fact that his blood could have infected them, the General Medical Council said.
The surgeon, who acted as a locum at four different hospitals whilst suffering from the virus, had performed more than 18 procedures including several circumcisions and a vasectomy.
The Fitness for Practice panel learned that he had ignored Government guidelines issued in 2002 banning health workers with hepatitis C from carrying out exposure-prone procedures where blood from the worker could get into the patients' tissues.
He had also refused to accept the advice of two consultants who told him he must stop taking part in invasive procedures, the panel added.
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Stem Cell Transplant Can Leave Long-Term Health Woes
SourceURL:http://www.healthscout.com
By Suzanne Rostler
HealthDay Reporter
These effects are non-life-threatening but should be monitored, experts say
FRIDAY, Sept. 16 (HealthDay News) -- Blood cancer patients who undergo stem cell transplantation therapy are likely to suffer more health problems 10 years down the road compared with healthy individuals who've never had this cutting-edge therapy, new research finds.
The study examined the long-term health of blood cancer survivors treated with stem cell transplant against that of healthy "controls" matched for race and age, in most cases a brother or sister.
Researchers tracked patients from before their transplant through the next 10 years, making the study one of the first to report on the long-term health of cancer survivors using this relatively new therapy. The majority of patients had been treated for leukemia or lymphoma and more than three-quarters received donor cells from a relative.
The health problems typically seen in the stem cell recipients were generally not life-threatening, the researcher point out. Rather, most can expect to have some of the problems associated with aging earlier than normal, said study author Karen L. Syrjala, director of behavioral sciences at the Fred Hutchinson Cancer Research Center in Seattle.
For instance, stem cell transplant patients were twice as likely to suffer musculoskeletal problems such as stiffness, cramping and swelling in their joints, compared to individuals without such a medical history. They also had higher rates of hepatitis C and cataract surgery.
Sexual problems were also more common, although rates of divorce, separation and the quality of marriage were similar between the two groups, according to the report in the Sept. 20 issue of the Journal of Clinical Oncology.
And while there were no differences in rates of depression and anxiety, stem cell recipients were more likely to use antidepressants and anti-anxiety medications over the long term compared with individuals who had never received a stem cell transplant. The use of other medications, such as opioids and nonsteroidal anti-inflammatory (NSAID) pain relievers, was found to be similar.
In other areas, stem cell recipients and non-recipients were indistinguishable. There were no differences in eating, smoking or exercise, the researchers report. Rates of hospitalization and outpatient visits were equal, as were rates of disorders such as asthma, diabetes, high blood pressure and high cholesterol.
Rates of osteoporosis and hypothyroidism -- disorders that both tend to be higher in cancer survivors due to the effects of chemotherapy -- were also similar between the two groups, but that may indicate poor diagnosis by doctors, the researchers said.
According to Syrjala, the finding suggests doctors need to improve on screening cancer survivors for these disorders.
"Our finding that only 4 percent of women and 2 percent of men thought they had moderate or severe bone loss is surprising, and makes us worry that bone density is not being checked in these people," she said. "If this is true, we expect that they will have more fractures, weakness and poorer long-term health than we would expect for their age."
Similarly, the finding that the cancer survivors were just as likely to use thyroid medications as individuals with no history of cancer raises concerns that some of the other symptoms reported in survivors, such as fatigue, may be the result of undetected thyroid problems, she said.
The good news is that 10 percent of stem cell recipients who suffered a relapse at some point after their transplant were in complete remission at the time of the study.
"Even when a disease like leukemia seems to return after transplant, it is possible with additional treatment to completely eradicate all signs of the disease again and for people to return to living a healthy lifestyle," Syrjala said.
With an increasing number of blood cancer patients being successfully treated with stem cell transplantation worldwide, doctors will need more information on the potential health problems of survivors, so they can monitor and treat them effectively, the researchers noted.
The results of their study are based on the medical records and personal reports of 137 cancer patients treated with hematopoietic cell transplantation (HCT). A hematopoietic stem cell is one from which all red and white blood cells develop.
Those medical outcomes were compared to the medical histories of an equal number of healthy adults (in most cases, a brother or sister of the stem cell recipient) with no history of cancer or stem cell therapy.
Syrjala said her research team will continue to monitor the health of the study patients. In the meantime, more research is needed to find ways to reach stem cell recipients and their doctors long after cancer treatment, to provide information on how to stay healthy and screen for diseases that may not normally be checked.
"As transplant becomes increasingly more common, understanding the long-term needs of these survivors will help to assure the quality of life that we want to offer them along with cure of their disease," she said.
Dr. Marshall Lichtman, executive vice president for research and medical programs at the Leukemia and Lymphoma Society, agreed. He suggested that physicians who provide primary care to patients following transplant receive information from the transplant center highlighting the problems that might develop, along with guidelines for testing.
"It is important for careful long-term follow-up of patients who have had stem cell transplantation," he said.
More information
For more on the history of stem cell transplants, go to National Marrow Donor Program (www.marrow.org ).
SOURCES: Karen L. Syrjala, Ph.D., director, behavioral sciences, Fred Hutchinson Cancer Research Center, Seattle; Marshall Lichtman, M.D., executive vice president, research and medical programs, Leukemia and Lymphoma Society, White Plains, N.Y.; Sept. 20, 2005, Journal of Clinical Oncology
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September 18th, 2005
New Drug For Hepatitis C Patients
SourceURL:http://www.wkyt.com/
He was a champ.but now, retired pro wrestler, Superstar Billy Graham, is fighting his biggest battle outside the ring.
A new drug may help him and millions of other americans with Hepatitis C.
It's called Albuferon, and a study showed the drug is safe and well tolerated by patients.
Right now, more than 100 people are taking the drug.
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September is Liver Cancer Awareness Month
SourceURL:http://www.mb.com.ph
SEPTEMBER has been declared Liver Cancer month to raise public consciousness about this illness that has an unusually high incidence in our country. Liver cancer is only the eighth most common form of cancer worldwide, but in the Philippines, Department of Health (DoH) and Philippine Cancer Society statistics show that it is the third most common form of cancer among men and sixth among women.
Liver cancer is one of the deadliest of all cancers. Most patients die within a year of diagnosis. Without treatment, the five-year survival rate from the disease is less than 5 percent, but if the cancer is diagnosed early and treated aggressively, the five-year survival rate is about 35 percent.
The most important risk factor associated with liver cancer is cirrhosis, a condition that precedes 80 percent of all liver cancers. The most common cause of cirrhosis is chronic hepatitis B, a condition that afflicts about 10-12 percent of all Filipinos. Chronic Hepatitis B is the main reason liver cancer incidence in the Philippines is high. Other possible causes of cirrhosis are hepatitis C infection and alcoholism.
Aside from cirrhosis, the other important risk factors associated with liver cancer are certain toxic substances and chemicals, such as aflatoxin and vinyl chloride which is used in certain industries. Aflatoxin is produced by certain species of fungi that grow in poorly harvested, stored, processed, and handled foodstuff – peanuts, corn, rice, dried fruit, tree nuts, spices, crude vegetable oils, cocoa beans, and copra, as well as milk and milk products from cattle that have consumed contaminated feed. In the Philippines, the high temperature and relative humidity that prevails throughout the year favors the growth of aflatoxin.
Usually, liver cancer presents no symptoms until the tumor has already spread and is in advanced stage. The most common initial symptoms of the disease are abdominal pain and enlargement, feeling of fullness, loss of appetite, weight loss, weakness, and occasionally, vomiting and yellowing (jaundice). There is a vast array of treatment methods for liver. The stage of disease and the availability of facilities and expertise dictate, to a large extent, which treatment method is employed.
The outlook for liver cancer remains poor especially if it is detected late, but the disease is preventable because the risk factors associated with it have already been identified. Vaccination for hepatitis B, avoidance of alcohol, and proper storage of foodstuff are measures that can be taken to significantly reduce the risk of developing the cancer.
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September 19th, 2005
Alcohol Has No Effect on Hep C Virus Replication
SourceURL:http://www.gastrohep.com
The latest issue of Gut reports no association between alcohol use and Hepatitis C viral titres, raising the possibility that the hepatic damage caused by both may be purely additive, involving different mechanisms and pathways.
Patients with chronic Hepatitis C virus infection who consume large quantities of alcohol have more severe liver disease compared with Hepatitis C patients without a history of alcohol consumption.
The mechanism by which alcohol worsens Hepatitis C related liver disease is not properly understood.
A possibility is that alcohol stimulates Hepatitis C replication.
Professor Anand and colleagues from Texas performed a meta-analysis to examine this issue.
The effect of alcohol on viral titres was assessed in 3 ways, firstly by comparing the heaviest drinkers with non-drinkers.
The investigators also considered the effect of graded doses of alcohol, and the effect of abstinence in the same individual.
5 studies showed a positive relationship between alcohol use and Hep C – Gut
The investigative team reported that a total of 14 studies were identified.
The team pooled 3 studies and showed a significant association between patients with the highest alcohol use and viral load.
The investigators observed that 5 studies had a positive direction, while the remaining 4 studies found a negative relationship.
Analysis of the combined results showed no association between alcohol consumption and virus levels.
Assessment of graded doses of alcohol also showed no significant difference between non-drinkers and moderate drinkers, or non-drinkers and heavy drinkers.
The investigators found no difference between graded doses of alcohol and moderate drinkers or heavy drinkers.
In addition, the team reported that 5 studies examined the influence of abstinence on viral titres but none provided sufficient data for statistical analysis.
Professor Anand's team commented, "The present study has failed to show an association between alcohol use and Hepatitis C viral titres."
"These observations raise the possibility that the hepatic damage caused by alcohol and Hepatitis C may be purely additive, involving different mechanisms and pathways."
Gut 2005: 54: 1468-72
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September 20th, 2005
Aethlon Medical Launches Hepatitis-C Clinical Trial
SourceURL:http://www.genengnews.com
Aethlon Medical, Inc. (OTCBB:AEMD) announced today that human clinical trials to treat patients infected with the Hepatitis-C virus (HCV) are now underway at the Apollo Hospital in New Delhi, India. The primary objective of the trial is to demonstrate the safety of Aethlon's Hemopurifier(TM) treatment technology. The secondary objective of the trial will be to obtain preliminary efficacy data related to serologic and virologic markers, including viral load measurements before and after treatment with the Hemopurifier(TM).
Aethlon Chairman and CEO, James A. Joyce, stated, "Five years ago, our vision that a device could capture circulating viruses and toxins was purely conceptual. Today, I thank the researchers, advisors, and shareholders who were instrumental in executing the development phase of our vision." Joyce continued, "As a result, we now have the opportunity to demonstrate the safety and effectiveness of our device in a clinical setting. If successful, we will provide new hope to those afflicted with Hepatitis-C and other infectious diseases."
According to the World Health Organization, Hepatitis-C (HCV) is a global disease with approximately 190 million persons infected. The infected population in India exceeds 12.5 million. In the United States, HCV is the most common blood-born infection with approximately 3.9 million citizens infected. HCV is a leading cause for liver disease and the most common reason for liver transplantation. Unfortunately, only 50% of HCV infected respond to the current standard of Interferon and Ribavirin treatment. Interferon and Ribavirin regimens are expensive and are known to have serious side effects.
Individuals enrolled in the initial trial are HCV-infected patients that require kidney dialysis as a result of End Stage Renal Disease (ESRD). Approximately 30-35% of all ESRD patients are infected with HCV, and as a result of their condition, are unable to endure the toxicity of HCV drug treatment. Follow-on studies are planned to evaluate the ability of the Hemopurifier to improve patient response rates to Interferon and Ribavirin as a conjunctive therapy, and as a stand-alone treatment for patients who are either unable to endure or do not respond to the current standard of care. The trial will also serve as a means to obtain human safety data, which will be submitted in conjunction with planned regulatory initiatives to treat the Human Immunodeficiency Virus (HIV) and drug and vaccine resistant Biological Weapons. Initial safety data and preliminary efficacy observations from the trial are expected to be available within the next sixty days.
About Aethlon Medical
Aethlon Medical is pioneering the development of immunotherapeutic devices able to mimic the immune response of clearing viruses and viral toxins from circulation. The Company's lead product, the Hemopurifier(TM), converges the established principals of hemodialysis and affinity chromatography with the discovery of compounds that effectively adhere to the surface of a multiple envelope viruses. The Hemopurifier(TM) is targeted to treat acute and chronic infectious diseases, including, drug and vaccine resistant Biological Weapons, the Human Immunodeficiency Virus (HIV), and the Hepatitis-C Virus (HCV). The Company has an experienced management team, which receives support and guidance from globally recognized science and regulatory advisors representing the infectious disease, biowarfare, and dialysis industries. More information on Aethlon Medical and the Hemopurifier(TM) technology can be found at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.
CONTACT:
Aethlon Medical, Inc. Anne Hoversten, 858-459-7800 x300 (Investor Relations) anne@aethlonmedical.com James A. Joyce, jj@aethlonmedical.com
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Xoma Inks Deal to Make Antibodies
SourceURL:http://biz.yahoo.com
Xoma Ltd. said Tuesday it signed a deal to make antibodies for Cubist Pharmaceuticals Inc., which will use them to test a hepatitis B treatment.
Berkeley-based Xoma will develop a new process for making two antibodies used in Cubist's drug HepeX-B. Cubist needs a lot of the antibodies to make enough drugs for Phase III trials of the treatment, which has gotten orphan drug status from the Food and Drug Administration.
Orphan drugs are those the FDA gives seven years of exclusive sales rights in the United States because they treat diseases with small numbers of patients.
Xoma (NASDAQ:XOMA - News) didn't say how much Cubist will pay in the deal.
Cubist (NASDAQ:CBST - News) is based in Lexington, Mass.
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September 21st, 2005
Morbidity in Live Liver Donors Is Low
SourceURL:http://www.gastrohep.com
September's Archives of Surgery finds that most live liver donations have no permanent consequences, and that a standards-based classification framework would allow for a universally applicable method to analyze, and report donor morbidity.
The true extent of morbidity among live liver donors remains poorly understood.
The development of standards for defining and reporting complications would foster a better understanding of the incidence and magnitude of such adverse events.
Dr Christopher Shackleton and colleagues conducted a retrospective review of adverse events among live liver donors.
Of 202 individuals undergoing evaluation for live liver donation, 42 proceeded to surgery.
95% of adverse events occurred in the first postoperative month – Archives of Surgery
The researchers reported that 34 patients underwent a right lobectomy without the middle hepatic vein, and that 3 had a left lateral segmentectomy.
Any event causing a deviation from a patient's ideal course was considered an adverse event and subsequently classified according to a derived framework.
The research team defined morbidity as 1 or more adverse event.
The main outcome measures included incidence, timing, type, severity, and impact of adverse events.
The team reported that no deaths or significant hepatic dysfunction occurred.
In 5 of the 42 donors, the hepatectomy was aborted for anatomic reasons before parenchymal transection.
The researchers found that 8 of the remaining 37 patients experienced 11 adverse events, of which 10 were completely resolved.
The team noted that 1 adverse event resulted in a permanent disability with brachial plexopathy.
The overall incidence of adverse events was 0.3 per case.
The researchers observed that 10 of the 11 adverse events presented within the first postoperative month.
Dr Shackelton's team commented, “Most live liver donations are uncomplicated or do not lead to permanent consequence.”
“The adoption of a standards-based classification framework for adverse events in live liver donors would allow for an inclusive, consistent, and universally applicable method to collect, analyze, and report donor morbidity.”
Arch Surg 2005: 140(9): 888-895
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Hepatitis C Co-Infection Diminishes HAART Effectiveness for HIV: Researchers
SourceURL:http://www.hepatitisneighborhood.com
John C. Martin
Boston researchers say they've found that therapy for HIV infection is not as effective in restoring the immune system in people co-infected with hepatitis C.1 But whether this is detrimental in the long run to these patients or not is still not known.
Clarifying the Confusion
Christopher F. Rowley, MD, with the division of Infectious Diseases at Beth Israel Deaconess Medical Center in Boston and his colleagues wanted to clarify conflicting information about the effectiveness of highly-active anti-retroviral therapy (HAART), a cocktail of medications often prescribed for people with HIV as way to boost their sagging immune systems, when hepatitis C is also present.
"There are conflicting data in the medical literature regarding the degree of immune restoration in patients who commence highly active antiretroviral therapy (HAART) when coinfected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV), compared with those with HIV infection alone," Rowley's team wrote.
Therapy Cocktail Against HIV
HAART was invented as a way to prevent HIV from becoming resistant to any one drug designed to suppress the virus. While this combination of drugs cannot suppress HIV completely, it can lower viral levels significantly, thereby slowing the progression of opportunistic infections that can occur in people with AIDS due to impaired immune systems. Thus, HAART provides a way for the immune system to remain intact and effective in these patients.2
But is HAART's ability to restore the immune system in those co-infected with hepatitis C and HIV impaired? To try and clear up the confusion, Rowley and his team from the National Cancer Institute conducted a review of previous clinical trials involving a collective total of more than 6,200 patients. The research team compared immune system restoration in co-infected people using HAART to that of people using the drug cocktail who were only infected with HIV.
Co-Infected Patients Had Less Immune Restoration
In all, the results of eight previously published trials were analyzed for this study. It was found that after beginning HAART therapy, people co-infected with HCV and HIV in these studies had an average increase in CD4 cells (a type of immune system cell) that was lower than those with HIV monoinfection taking the medication cocktail. All patients had been taking HAART for 48 weeks.
"The results of the meta-analysis [analysis of many previous studies] were independent of any one study, and were not influenced by the year in which HAART was started," Rowley's group wrote.
About HIV/HCV Coinfection
One shared factor associated with both hepatitis C and HIV infection is injection drug use. In fact, it's the main way that HIV patients can become infected with HCV. Estimates are that up to 90 percent of HIV-infected injection drug users are co-infected.
HCV infection is more serious in those also infected with HIV, leading to liver damage more quickly. Symptoms are often hidden in people who are coinfected. So, one of the best ways to determine whether you have both infections is to undergo a blood test.
According to the study researchers, nearly one-third of those with HIV also have hepatitis C infection.
This study wasn't able to determine if the blunted immune system restoration in co-infected individuals on HAART may be detrimental or not. Because of that, "future research should examine whether an impaired immunologic response corresponds with meaningful virologic and clinical outcomes," wrote Rowley and his team.
1. Miller MF, Haley C, Koziel MJ, Rowley CF. Impact of hepatitis C virus on immune restoration in HIV-infected patients who start highly active antiretroviral therapy: a meta-analysis. Clin Infect Dis 2005 Sep 1;41(5):713-20. Epub 2005 Jul 22.
2. National Institute of Allergy and Infectious Diseases. National Institutes of Health (NIH). Treatment of HIV Infection. Available at: http://www.niaid.nih.gov/factsheets/treat-hiv.htm. Accessed September 14, 2005.
John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include overseeing health news coverage for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.
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September 22nd, 2005
Anadys Drug May Become Cornerstone Hepatitis Therapy
SourceURL:http://www.forbes.com/
Peter Kang
Credit Suisse First Boston initiated coverage on Anadys Pharmaceuticals (nasdaq: ANDS - news - people ) with an "outperform" rating and said the company's experimental drug ANA975 has the potential to become a "cornerstone therapy" for hepatitis C.
Anadys is a development-stage biotech focused on toll-like receptor (TLR)-based therapeutics and structure-based drug design, according to CSFB. "ANA975, an oral TLR 7 agonist, has peak sales potential in excess of $1 billion in hepatitis C," said CSFB. "ANA975 could be a cornerstone therapy replacing interferon alfa and complementing direct antiviral small molecule drugs in combination regimens."
The research firm said it predicts an approval and launch in 2011 and values the drug at $12 per share. "ANA975 for hepatitis C is the clear value driver in our Anadys model and valuation analysis. We assign it a 33% probability of success in hepatitis C," it said. "Should the next round of clinical studies continue to validate ANA975 development, significant stock upside could exist, based on anticipated probability adjustments."
CSFB projects peak sales potential of $300 million for Anadys' other drug candidate, ANA380, currently in Phase II testing for hepatitis B.
The research firm placed a $19 price target on the stock. "At its current $350 million market capitalization, Anadys trades at a 65% to 80% discount to Idenix Pharmaceuticals (nasdaq: IDIX - news - people ) and Vertex Pharmaceuticals (nasdaq: VRTX - news - people ), despite having established proof of concept with its two lead drug candidates and technology validation from a major corporate partnership."
However, CSFB projects Vertex and Idenix to launch their lead drugs two to three years ahead of Anadys. Anadys forged an agreement with Novartis (nyse: NVS - news - people ) last June to commercialize ANA975. The deal is potentially worth up to $570 million, with an upfront payment of $20 million and milestone payments of up to $550 million.
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Hepatitis Linked to Body Art
SourceURL:http://www.smudailycampus.com
By Erica Lovett, Chief Copy Editor, elovett@smu.edu
A shamrock on the ankle or an anchor on the bicep might seem like a harmless personal expression to some, but tattoos also pose a serious health concern, according to Dr. Robert Fischer, who lectured to a small group of pre-med students in the Dedman Life Sciences Building on Wednesday at 5 p.m.
Fischer, an internist and principal owner of the Dallas Internal Medicine Group, said that infection from needles and other tattoo instruments accounts for 41 percent of hepatitis C infections.
He became interested in the study after finding several cases of hepatitis C in a span of a few months while working in an orthopedic clinic that treated patients with back pain.
"My hair stood on end when I found that third case," he said. "I knew this wasn't random."
He teamed up with Dr. Robert Haley, the chief of epidemiology at University of Texas. Together, they began a study to identify the various causes of hepatitis C.
One of the potential causes they were considering were tattoos.
I had noticed there were a lot of tattoos in my back pain clinic, he said.
Fischer and Haley studied 629 patients, conducting interviews and having the patients fill out questionnaires about their lifestyles, habits and medical histories.
They narrowed down potential factors to intravenous drug use, tattoos, heavy drinking, working in health care, blood transfusions and having 10 or more sexual partners in one year.
After ruling out several of the factors because of a lack of direct causality, Fischer and Haley arrived at the conclusion that getting tattoos put people at a higher risk for hepatitis C.
Fischer then said that receiving a tattoo from a tattoo parlor doesn't reduce the risk.
You would think at a tattoo parlor it would be safest, he said. "That's the exact opposite. No one is checking the tattoo parlors."
Fischer said that some tattoo artists test the needles on themselves first to make sure they work. In addition, some tattoo artists may not clean the tattoo gun, and microscopic drops of blood from other customers may collect in the barrel when the needle goes up and down.
Fischer and Haley faced some opposition to their findings when they were first revealed. "It's gradually being accepted," Fischer said.
Christine Buchanan, the faculty advisor of Alpha Epsilon Delta, the pre-med honors society that held the lecture, said she admired the initiative that Fischer took to do the study. "It's kind of unusual that a person in private practice would follow through on that kind of observation," she said. "It's impressive."
Fischer also took initiative to fund his education. He decided to join the Air Force after he realized he couldn't afford medical school on his own.
"I was married, I had no money and my family would not and could not support me," he said.
Fischer got his master's degree in organic chemistry from the Georgia Institute of Technology and did his medical residency at Wright-Patterson Air Force Base before completing three years of service at the Tinker Air Force Base Hospital in Oklahoma City.
However, he said students should not use the military to finance their education unless they have no other option.
"I wouldn't do it if you could avoid it," he said. "You might end up dead."
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September 23rd, 2005
NIH Establishes National Commission on Digestive Diseases
SourceURL:http://www.gastrohep.com
The National Institutes of Health (NIH) announced this week the establishment of the National Commission on Digestive Diseases, which will work to improve the health of the nation through digestive diseases research.
Dr Elias Zerhouni, Director of the National Institutes of Health (NIH) announced an overview of the state-of-the science in the field of digestive diseases research.
A 10-year, long-range plan for digestive diseases research consistent with the research mission of the NIH will be developed.
The Commission will report directly to the Director of the NIH.
Dr Zerhouni commented, “Digestive diseases take a terrible toll on the health and well-being of Americans.”
“With more than 70 million people affected and 1.4 million disabled, now is the time to examine the state of digestive diseases research.”
The Commission plans scientific overview of NIH-funded research in digestive diseases - National Institute of Health
“We need to develop a plan to most effectively take advantage of advances in the field.”
The Commission will conduct a scientific overview of NIH-funded research and research-related activities in digestive diseases.
Recent research advances and new and emerging opportunities for future research will be identified.
The Commission will also develop a 10-year plan to address important goals for research in digestive diseases and make recommendations to the NIH Director.
The Charter for the Commission will expire in 2 years, unless renewed by appropriate action prior to its expiration.
The Commission will be composed of 16 members, appointed for the life of the Commission by the Director of the NIH.
The members will represent a broad diversity of scientific and professional experience in the field of digestive diseases.
Of the 16 appointed members, 12 will be members of the academic or medical research and practice communities.
Of the 16 member, 4 will be from patient-oriented organizations or will have close personal or family experience with digestive diseases.
In addition to the 16 appointed members, the Commission will include 18 nonvoting ex officio members from the NIH.
The Commission will also include other federal government agencies involved in digestive diseases research.
The Chair of the Commission will be the Director, Division of Digestive Diseases and Nutrition at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
The other ex officio members will be senior representatives from several government organizations.
“This is an incredible opportunity to move the field of digestive diseases research in a direction that could lead to significant advances over the next 10 years,” said Dr Stephen James, Director of the Division of Digestive Diseases and Nutrition at the NIDDK.
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Prediction of Survival in Patients with Cirrhosis
SourceURL:http://www.gastrohep.com
Hepatic venous pressure gradient has an independent effect on survival in addition to the MELD score, and improves the calibrative ability of MELD, finds the latest issue of Hepatology.
Measurements of portal pressure, usually obtained via the hepatic venous pressure gradient may be a prognostic marker in cirrhosis.
Dr Rafael Bañares from Spain examined the inclusion of hepatic venous pressure gradient with Model for End-Stage Liver Disease (MELD) variables.
The researchers therefore evaluated whether this combination improves survival in patients with cirrhosis, as well as the models prognostic ability.
Retrospective analyses of all patients who had hepatic venous pressure gradient measurements between 1998 and 2002 were considered.
The research team developed proportional hazards Cox models, and evaluated prognostic calibrative and discriminative ability of the model.
1-mmHg increase in hepatic venous pressure gradient had a 3% increase in death risk – Hepatology
In this period, 693 patients had a hepatic hemodynamic study, and the team included 393 patients.
The researchers found that survival was significantly worse in those patients with greater hepatic venous pressure gradient value.
Hepatic venous pressure gradient remained as an independent variable in a model adjusted by MELD, ascites, encephalopathy, and age.
The research team observed that so that each 1-mmHg increase in hepatic venous pressure gradient had a 3% increase in death risk.
The team noted that hepatic venous pressure gradient significantly contributes to the calibrative predictive capacity of the prognostic model.
In addition, MELD score variables and age, were found to significantly contributes to the calibrative predictive capacity of the prognostic model.
However, discriminative ability improved only slightly.
Dr Bañares' team concluded, "Hepatic venous pressure gradient has an independent effect on survival in addition to the MELD score."
"Although inclusion of hepatic venous pressure gradient and age in a survival predicting model would improve the calibrative ability of MELD, its discriminative ability is not significantly improved."
Hepatol 2005: 42(4): 793-801
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Flamel Technologies Announces Positive Preliminary Results of a Phase I/II Trial of IFN-alpha-XL in Patients with Chronic Hepatitis C Virus Infection
SourceURL:http://home.businesswire.com
LYON, France--(BUSINESS WIRE)--Sept. 23, 2005--Flamel Technologies (NASDAQ:FLML) today announced positive preliminary Phase I/II data from a trial demonstrating the safety, tolerability, and long-acting activity of IFN-alpha-XL in patients with chronic hepatitis C virus (HCV) infection. Data also show that IFN-alpha-XL had positive effects on viral load and interferon activity biomarkers. IFN-alpha-XL utilizes Flamel's proprietary Medusa(R) nanoparticle technology to provide a long-acting formulation of interferon alpha that may have enhanced efficacy and reduced toxicity compared with unmodified or PEG-modified interferon formulations. Flamel plans to present the full data at a medical conference.
The lead investigator of the study, Professor Christian Trepo (Hotel Dieu Hospital-Lyon), remarked, "Interferon therapy is a cornerstone in the treatment of chronic hepatitis C infection, but today its use is limited by the significant side effects associated with approved formulations of Interferon-alpha. These side effects are debilitating and treatment limiting. The results of this first study of IFN-alpha-XL are very promising, and suggest that this novel formulation of interferon alpha may provide equivalent and possibly better therapeutic benefit with fewer side effects in comparison to existing interferon-alpha therapies. This would be a significant advance in the treatment of a disease that has reached pandemic proportions in the United States and around the world."
The dose-escalating study was conducted in 53 subjects with chronic hepatitis C. Thirty-nine participants were assigned to receive a single subcutaneous injection of one of three escalating doses of IFN-alpha-XL (12 - 14 patients per dose). The three IFN-alpha-XL groups received an injection of 9 million international units (MIU), 18 MIU, and 27 MIU, respectively. A cohort of 14 patients received three subcutaneous injections of a standard dose of Viraferon(R) (3 MIU) over one week as a comparator. All patients completed the study, and no serious adverse events were reported.
Adverse events were similar to what has been reported in other studies of interferon therapy and were transient in duration and mild to moderate in severity. Patients receiving IFN-alpha-XL appeared to have fewer adverse events than patients receiving Viraferon, which is marketed in the U.S. as Intron(R) A, even when the weekly dosage of IFN-alpha-XL was at its highest level. Pharmacokinetic data demonstrate that the Medusa formulation provides sustained release of IFN-alpha-XL over one week. Significantly, post-injection serum concentrations (Cmax) of IFN-alpha-XL were lower or equivalent than those observed for Viraferon. This is important in maintaining a concentration that provides therapeutic benefit while reducing side effects.
Dr. R. Kravtzoff, Director of preclinical and clinical development of Flamel Technologies, said: "We are very pleased with the preliminary results of this first clinical study of our long-acting Interferon alpha formulation, IFN-alpha-XL. The data demonstrate that IFN-alpha-XL was well tolerated and did not exhibit the toxicity typically observed with Interferon alpha 2b, even at the highest dose evaluated. The results indicate that reduction in viral load in these high-dose patients, including traditionally hard-to-treat genotype 1 cases, was at least equivalent to that observed in the control group. We are looking forward to sharing these results in greater detail at an upcoming medical conference."
Dr. Kravtzoff continued, "Patients with hepatitis C have significant unmet medical need, with only about half of patients treated with the current standard of care achieving a sustained, meaningful virologic response. We believe that IFN-alpha-XL may provide a new therapeutic option that would provide improved tolerance and patient compliance, leading to improved clinical outcomes."
Based on these clinical results Flamel Technologies is preparing a Phase IIa study in hepatitis C patients, while meeting with large pharmaceutical companies to explore partnership for this important program. A Phase IIa study would be designed to investigate the safety, duration of release and clinical efficacy of IFN-alpha-XL following repeated weekly administration in hepatitis C patients, compared with weekly administration of pegylated interferon alpha.
About IFN-alpha-XL
IFN-alpha-XL is a new formulation of recombinant Interferon alpha-2b based on Flamel's proprietary Medusa(R) nanoparticle delivery system. Medusa(R) is a versatile protein carrier for the development of novel and second-generation long-acting native protein drugs. IFN-alpha-XL is designed to provide patients with a longer acting and more tolerable approach to interferon therapy compared with approved interferon regimens.
About Hepatitis C
Hepatitis C virus is a blood-borne pathogen that causes inflammation of the liver. According to the U.S. Centers for Disease Control and Prevention (CDC) hepatitis C virus (HCV), more than 75 percent of people infected with HCV will develop chronic infections; and 60 to 70 percent of these people will subsequently develop chronic hepatitis. HCV infection is the most common blood-borne viral infection in the United States. Approximately 4 million people in the United States are infected with HCV and the World Health Organization estimates that 170 million people worldwide - 3 percent of the world's population - are infected with HCV.
Current treatment regimens require frequent administration of Interferon-alpha for periods of several months to a year or longer. Thus, frequent dosing of Interferon-alpha has been considered necessary for sustained efficacy. Furthermore, treatment with Interferon-alpha is associated with dose-dependent adverse events that can be classified as either acute or of later onset. The typical acute toxicity profile tends to occur after every injection and thus causes difficulties for repeated administration. The decrease of Interferon-alpha side effects, especially long-term side effects such as psychological depression and myelosuppression, the decrease of frequency of administration, and the improvement of clinical efficiency, are thus major issues for Interferon-alpha based therapy.
Flamel Technologies, S.A. is a biopharmaceutical company principally engaged in the development of two unique polymer-based delivery technologies for medical applications. Micropump(R) is a controlled release and taste- masking technology for the oral administration of small molecule drugs. Flamel's Medusa(R) technology is designed to deliver controlled-release formulations of therapeutic proteins.
This document contains a number of matters, particularly as related to the status of various research projects and technology platforms, that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
This document reflects the current view of management with respect to future events and is subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements.
These risks include risks that products in the development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements, uncertainties regarding market acceptance of products in development, the impact of competitive products and pricing, and the risks associated with Flamel's reliance on outside parties and key strategic alliances.
These and other risks are described more fully in Flamel's Annual Report on the Securities and Exchange Commission Form 20-F for the year ended December 31, 2004.
Viraferon(R) and Intron(R) A are registered trademarks of Schering-Plough Corporation.
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