Studies Conducted at INRA-AgroParisTech Laboratory Under Pr. Daniel Tomé Supervision and Published* in November 2009, in the Official Journal of the International Bone and Mineral Society "Bone", Reveal new Benefits for Peptan(TM) in Osteoporosis Prevention In response to customer concerns regarding long-term bone health, Rousselot has carried out, for several years now, many studies to demonstrate that an oral intake of Peptan(TM) may have a positive impact on osteoporosis.
Bone is a living dynamic metabolic system that relies on a maintained balance between bone formation and bone resorption. Cells called osteoblasts make bone while cells called osteoclasts resorb it. An imbalance
may lead to osteoporosis, a condition where the density and quality of bone is reduced.
Researchers conducted in vitro studies, and highlighted that Peptan(TM) in bone cell culture induced a better differentiation of osteoblasts. Those positive results have then been confirmed in vivo on ovariectomized mice, used to simulate a postmenopausal osteoporosis, which leads to a lower bone mineral density (BMD).
Animals were divided into three groups: a control group (non ovariectomized), a group of ovariectomized mice, both fed with a normal diet and a group of ovariectomized mice that received a diet containing Peptan(TM). After 12 weeks, the BMD of the group fed with Peptan(TM) is not significantly different from the BMD of control group. On the contrary the BMD of ovariectomized mice not fed with Peptan(TM) is lower.
Confirmation of Peptan(TM) benefits on bone health has been obtained by the measures of Carboxy Terminal Telopeptide (CTX), a usual marker of bone resorption. CTX is significantly lower in mice fed with
PeptanTM indicating that bone resorption is reduced.
Researchers conclude that Peptan(TM) may restore bone density in simulated post-menopausal osteoporosis by stimulating osteoblast growth and differentiation. This demonstrates the interest of Peptan(TM) as a bioactive ingredient to help preventing bone loss during aging.
*Hydrolyzed collagen improves bone metabolism and biomechanical parameters in ovariectomized mice: an in vitro and in vivo study. Guillerminet et al. Bone 2009.
Rousselot, http://www.rousselot.com
Part of VION N.V. (N.L.), Rousselot(R) is the worldwide leader in gelatine and hydrolyzed collagen. VION N.V. is an internationally operating food group that produces high-quality foods and ingredients for
humans and animals (Turnover: EUR 9.6 billion - 31,000 employees worldwide)
Wednesday, December 16, 2009
Tuesday, December 15, 2009
Health Care, Telecommunications, And Chemicals Likely Will See More Upgrades Than Other Sectors In 2010, Article Says
Credit quality is slowly beginning to stabilize across nonfinancial industries, though rating activity remains more negative than positive, said an article published today by Standard & Poor's, titled "Three U.S. Industries With The Greatest Potential To Improve Their Credit Quality In 2010 (Premium)." As the economy slowly rebounds in 2010, we expect to see areas of improvement, though upgrades likely will trail downgrades in most sectors.
"After reviewing the distribution of outlooks and CreditWatch listings, ratings trends, the performance of bond spreads, and recent operating results, we identified three sectors that we believe have the potential to see an upturn in creditworthiness next year," said Diane Vazza, head of Standard & Poor's Global Fixed Income Research. "These three are health care, telecommunications, and chemicals."
Health care, which weathered the storm better than most sectors, has a relatively high positive bias (the proportion of issuers with a positive outlook or ratings on CreditWatch positive) and has seen relatively strong operating results.
The telecommunications sector also has fared well during the recession, despite having a number of highly leveraged companies. Improvement in economic and credit market conditions is supportive of continued stabilization and potential improvement in the credit quality of the telecommunications sector.
The chemicals sector has performed much worse than the other two sectors during the recession, though it has begun to show signs of stabilization. Given the cyclical nature of the sector, stronger economic conditions in 2010 could give credit quality a boost.
This article is part of our premium Global Fixed Income Research content, which is available to premium subscribers to RatingsDirect on the Global Credit Portal at www.globalcreditportal.com and to RatingsDirect at www.ratingsdirect.com. Ratings information can also be found on Standard & Poor's public Web site by using the Ratings search box located in the left column at www.standardandpoors.com. Members of the media may request a copy of this report by contacting the media representative provided.
"After reviewing the distribution of outlooks and CreditWatch listings, ratings trends, the performance of bond spreads, and recent operating results, we identified three sectors that we believe have the potential to see an upturn in creditworthiness next year," said Diane Vazza, head of Standard & Poor's Global Fixed Income Research. "These three are health care, telecommunications, and chemicals."
Health care, which weathered the storm better than most sectors, has a relatively high positive bias (the proportion of issuers with a positive outlook or ratings on CreditWatch positive) and has seen relatively strong operating results.
The telecommunications sector also has fared well during the recession, despite having a number of highly leveraged companies. Improvement in economic and credit market conditions is supportive of continued stabilization and potential improvement in the credit quality of the telecommunications sector.
The chemicals sector has performed much worse than the other two sectors during the recession, though it has begun to show signs of stabilization. Given the cyclical nature of the sector, stronger economic conditions in 2010 could give credit quality a boost.
This article is part of our premium Global Fixed Income Research content, which is available to premium subscribers to RatingsDirect on the Global Credit Portal at www.globalcreditportal.com and to RatingsDirect at www.ratingsdirect.com. Ratings information can also be found on Standard & Poor's public Web site by using the Ratings search box located in the left column at www.standardandpoors.com. Members of the media may request a copy of this report by contacting the media representative provided.
Accumetrics Closes 2009 with Positive Outlook
New distribution agreements, favorable clinical data, and significant capital financing position the company for continued growth in 2010 Accumetrics, Inc., developer and marketer of the VerifyNow(R) System, the first rapid and easy-to-use diagnostic system for measuring an individual's response to multiple antiplatelet agents, announced that 2009 included a doubling in the number of international and U.S. distribution agreements, as well as positive medical community support, and significant capital financing
that will take the company into 2011.
In 2009, the company continued its commitment to creating a powerful, worldwide distribution network aimed at gaining adoption of its products at end-user levels. Spanning Europe, Latin America and Asia, Accumetrics currently has partnerships with 20 leading international distributors who provide the company with local representation in over 30 countries. Latest additions to the international distribution network include Keller Medical in Germany, ZAO "Schag" in Russia and VSA Alta Complejidad S.A. in Argentina. Accumetrics continued to strengthen its U.S. presence by partnering with 10 cardiovascular specialty distributors to enhance support to the company's growing base of clinicians in the domestic hospital market. Accumetrics has
also partnered with National Distribution & Contracting, Inc. (NDC), the largest organization of independent medical supply distributors in North America, to expand its distribution network in the physician office lab
marketplace.
Increasing evidence of the clinical value of platelet reactivity testing was demonstrated in several presentations of new clinical studies including the POPular study, presented at the American Heart Association Scientific Sessions in November, and a meta-analysis presented at a symposium during the 2009 Transcatheter Cardiovascular Therapeutics (TCT ) Conference. These data also build upon the anticipation of the results of the GRAVITAS trial, which has now completed 80% enrollment.
"2009 has proven to be an outstanding year of growth for Accumetrics," said Timothy I. Still, CEO and President of Accumetrics. "We look at 2010 as a breakthrough year for the company, and are pleased to be in a position to capitalize on the growing clinical acceptance of platelet reactivity testing."
Accumetrics concluded 2009 with $17.1 million in new capital financing, which will fully support the company into 2011. Proceeds will fund a number of key 2010 milestones including expanded claims for existing products, new product development and continued expansion of commercialization efforts. About Accumetrics (www.accumetrics.com)
Accumetrics is committed to advancing medical understanding of platelet function and enhancing quality of care for patients receiving antiplatelet therapies by providing industry-leading and widely accessible diagnostic tests for rapid platelet function assessment.
Accumetrics' VerifyNow System is the first rapid and easy to use platform for measuring an individual's response to multiple antiplatelet agents. Addressing every major antiplatelet drug, including FDA-cleared products for aspirin, P2Y12 inhibitors (e.g. prasugrel (Effient(TM)) and clopidogrel (Plavix(R))), and the GP IIb/IIIa inhibitors (e.g. ReoPro(R) and Integrilin(R)), the VerifyNow System provides a valuable tool to help
physicians make more informed treatment decisions.
The Accumetrics logo and VerifyNow are registered trademarks of Accumetrics, Inc. ReoPro is a registered trademark of Centocor, Inc. Integrilin is a registered trademark of Millennium Pharmaceuticals. Plavix is a registered trademark of sanofi-aventis. Effient is a trademark of Eli Lilly and Company.
that will take the company into 2011.
In 2009, the company continued its commitment to creating a powerful, worldwide distribution network aimed at gaining adoption of its products at end-user levels. Spanning Europe, Latin America and Asia, Accumetrics currently has partnerships with 20 leading international distributors who provide the company with local representation in over 30 countries. Latest additions to the international distribution network include Keller Medical in Germany, ZAO "Schag" in Russia and VSA Alta Complejidad S.A. in Argentina. Accumetrics continued to strengthen its U.S. presence by partnering with 10 cardiovascular specialty distributors to enhance support to the company's growing base of clinicians in the domestic hospital market. Accumetrics has
also partnered with National Distribution & Contracting, Inc. (NDC), the largest organization of independent medical supply distributors in North America, to expand its distribution network in the physician office lab
marketplace.
Increasing evidence of the clinical value of platelet reactivity testing was demonstrated in several presentations of new clinical studies including the POPular study, presented at the American Heart Association Scientific Sessions in November, and a meta-analysis presented at a symposium during the 2009 Transcatheter Cardiovascular Therapeutics (TCT ) Conference. These data also build upon the anticipation of the results of the GRAVITAS trial, which has now completed 80% enrollment.
"2009 has proven to be an outstanding year of growth for Accumetrics," said Timothy I. Still, CEO and President of Accumetrics. "We look at 2010 as a breakthrough year for the company, and are pleased to be in a position to capitalize on the growing clinical acceptance of platelet reactivity testing."
Accumetrics concluded 2009 with $17.1 million in new capital financing, which will fully support the company into 2011. Proceeds will fund a number of key 2010 milestones including expanded claims for existing products, new product development and continued expansion of commercialization efforts. About Accumetrics (www.accumetrics.com)
Accumetrics is committed to advancing medical understanding of platelet function and enhancing quality of care for patients receiving antiplatelet therapies by providing industry-leading and widely accessible diagnostic tests for rapid platelet function assessment.
Accumetrics' VerifyNow System is the first rapid and easy to use platform for measuring an individual's response to multiple antiplatelet agents. Addressing every major antiplatelet drug, including FDA-cleared products for aspirin, P2Y12 inhibitors (e.g. prasugrel (Effient(TM)) and clopidogrel (Plavix(R))), and the GP IIb/IIIa inhibitors (e.g. ReoPro(R) and Integrilin(R)), the VerifyNow System provides a valuable tool to help
physicians make more informed treatment decisions.
The Accumetrics logo and VerifyNow are registered trademarks of Accumetrics, Inc. ReoPro is a registered trademark of Centocor, Inc. Integrilin is a registered trademark of Millennium Pharmaceuticals. Plavix is a registered trademark of sanofi-aventis. Effient is a trademark of Eli Lilly and Company.
MALARIA PROGRESS REPORT SHOWS THAT DEVELOPMENT AID FOR HEALTH IS WORKING
Significant progress has been made in delivering life saving malaria nets and treatments over the past few years, but the coverage of malaria programmes needs to be stepped up drastically in order to meet the Millennium Development Goals (MDGs), according to a report released today by the World Health Organization (WHO).
The World Malaria Report 2009 found that the increase in international funding commitments (US$ 1.7 billion in 2009 compared to US$ 730 million in 2006) had allowed a dramatic scale up of malaria control interventions in several countries, along with measurable reductions in malaria burden. However, the amounts available still fall short of the US$ 5 billion required annually to ensure high coverage and maximal impact worldwide.
The WHO Director-General, Dr Margaret Chan, described the findings in the report as cause for cautious optimism and said "While much remains to be done, the data presented here clearly suggest that the tremendous increase in funding for malaria control is resulting in the rapid scale up of today's control tools. This, in turn, is having a profound effect on health - especially the health of children in sub-Saharan Africa. In a nutshell, development aid for health is working."
The report found that more life-saving malaria nets and treatments were delivered in 2007 and 2008 compared to 2006.
More African households (31%) own at least one insecticide-treated net (ITN), and more children under 5 years of age used an ITN in 2008 (24%) compared to previous years. These averages are affected by low ITN ownership in several large African countries for which resources for scale-up are only now being made available. Household ITN ownership reached more than 50% in 13 of the 35 highest burden African countries.
Use of artemisinin-based combination therapies (ACTs) is increasing but remains low in most African countries with fewer than 15% of children with fever receiving an ACT.
More than one-third of the 108 malarious countries (9 African countries and 29 outside of Africa) documented reductions in malaria cases of more than 50% in 2008 compared to 2000.
Where scale-up of proven interventions has occurred, and surveillance systems are functioning, remarkable impact has been documented:
In countries and areas that have achieved high coverage with bed nets and treatment programmes (e.g. Eritrea, Rwanda, Sao Tome and Principe, Zambia and Zanzibar, the United Republic of Tanzania) recorded cases and deaths due to malaria have fallen by 50% (target set by World Health Assembly for 2010) suggesting that MDG target for malaria can be achieved if there is adequate coverage of key interventions.
Large decreases in malaria cases and deaths have been mirrored by steep declines in all-cause deaths among children less than 5 years of age suggesting that intensive efforts at malaria control could help many African countries to reach, by 2015, a two-thirds reduction in child mortality as set forth in the MDGs.
High levels of external assistance were shown to be linked to decreases in malaria incidence. However, many external funds are concentrated on smaller countries with lower disease burdens. More attention needs to be given to ensuring success in large countries that account for most malaria cases and deaths.
Parasite resistance to anti-malarial medicines and mosquito resistance to insecticides are major threats to achieving global malaria control. Confirmation of artemisinin resistance was reported in 2009, and WHO is leading a major resistance containment effort in South East Asia. Key elements in the global strategy to prevent the spread of drug resistance include: 1) Rapidly reducing the spread of malaria using malaria preventive tools 2) ensuring that all malaria infections are correctly diagnosed, effectively treated and followed-up to ensure that they do not spread the disease to others 3) halting the marketing and use of oral artemisinin monotherapies and importantly, 4) carefully monitoring the efficacy of medicines to detect early evidence of resistance.
The report noted that there was urgent need for the global community to completely fund the Global Malaria Action Plan in order to sustain early success and achieve the 2015 MDGs. The African Region had the largest increase in funding of all regions, led by investments by the Global Fund, the U.S. President's Malaria Initiative, and other agencies.
The success of malaria control efforts will be in reducing the burden of malaria and improving child survival. Investing in malaria control is not only helping the world to reach the MDGs, but is also helping to build health systems that will ensure that these development gains are sustained.
The World Malaria Report 2009 found that the increase in international funding commitments (US$ 1.7 billion in 2009 compared to US$ 730 million in 2006) had allowed a dramatic scale up of malaria control interventions in several countries, along with measurable reductions in malaria burden. However, the amounts available still fall short of the US$ 5 billion required annually to ensure high coverage and maximal impact worldwide.
The WHO Director-General, Dr Margaret Chan, described the findings in the report as cause for cautious optimism and said "While much remains to be done, the data presented here clearly suggest that the tremendous increase in funding for malaria control is resulting in the rapid scale up of today's control tools. This, in turn, is having a profound effect on health - especially the health of children in sub-Saharan Africa. In a nutshell, development aid for health is working."
The report found that more life-saving malaria nets and treatments were delivered in 2007 and 2008 compared to 2006.
More African households (31%) own at least one insecticide-treated net (ITN), and more children under 5 years of age used an ITN in 2008 (24%) compared to previous years. These averages are affected by low ITN ownership in several large African countries for which resources for scale-up are only now being made available. Household ITN ownership reached more than 50% in 13 of the 35 highest burden African countries.
Use of artemisinin-based combination therapies (ACTs) is increasing but remains low in most African countries with fewer than 15% of children with fever receiving an ACT.
More than one-third of the 108 malarious countries (9 African countries and 29 outside of Africa) documented reductions in malaria cases of more than 50% in 2008 compared to 2000.
Where scale-up of proven interventions has occurred, and surveillance systems are functioning, remarkable impact has been documented:
In countries and areas that have achieved high coverage with bed nets and treatment programmes (e.g. Eritrea, Rwanda, Sao Tome and Principe, Zambia and Zanzibar, the United Republic of Tanzania) recorded cases and deaths due to malaria have fallen by 50% (target set by World Health Assembly for 2010) suggesting that MDG target for malaria can be achieved if there is adequate coverage of key interventions.
Large decreases in malaria cases and deaths have been mirrored by steep declines in all-cause deaths among children less than 5 years of age suggesting that intensive efforts at malaria control could help many African countries to reach, by 2015, a two-thirds reduction in child mortality as set forth in the MDGs.
High levels of external assistance were shown to be linked to decreases in malaria incidence. However, many external funds are concentrated on smaller countries with lower disease burdens. More attention needs to be given to ensuring success in large countries that account for most malaria cases and deaths.
Parasite resistance to anti-malarial medicines and mosquito resistance to insecticides are major threats to achieving global malaria control. Confirmation of artemisinin resistance was reported in 2009, and WHO is leading a major resistance containment effort in South East Asia. Key elements in the global strategy to prevent the spread of drug resistance include: 1) Rapidly reducing the spread of malaria using malaria preventive tools 2) ensuring that all malaria infections are correctly diagnosed, effectively treated and followed-up to ensure that they do not spread the disease to others 3) halting the marketing and use of oral artemisinin monotherapies and importantly, 4) carefully monitoring the efficacy of medicines to detect early evidence of resistance.
The report noted that there was urgent need for the global community to completely fund the Global Malaria Action Plan in order to sustain early success and achieve the 2015 MDGs. The African Region had the largest increase in funding of all regions, led by investments by the Global Fund, the U.S. President's Malaria Initiative, and other agencies.
The success of malaria control efforts will be in reducing the burden of malaria and improving child survival. Investing in malaria control is not only helping the world to reach the MDGs, but is also helping to build health systems that will ensure that these development gains are sustained.
Thursday, November 19, 2009
BAXTER RECEIVES EMEA POSITIVE OPINION FOR H1N1 PANDEMIC INFLUENZA VACCINE
Baxter International Inc. (NYSE: BAX) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) granted its “positive opinion” for H1N1 pandemic vaccine using Baxter’s Vero cell technology. This positive opinion confirms the acceptability of Baxter’s regulatory submission to obtain final marketing authorization and licensure of the product.
Baxter H1N1 vaccine is the first cell culture-based and non-adjuvanted vaccine to receive a positive opinion in the European Union. Initial quantities of vaccine have already been delivered to a number of countries, including the UK and Ireland, for use in their national vaccination programs, and are awaiting product release subject to final marketing authorization being granted by the European Commission.
Presently, Baxter is confirming the safety and immunogenicity of Baxter H1N1 vaccine in clinical trials. The company is conducting two randomized trials in 400 healthy adults age 18 and over and in 400 children and adolescents to supplement the licensure post-approval with appropriate clinical data. These trials are evaluating the safety and immunogenicity of the vaccine at dose levels of 7.5ตg and 3.75ตg. Once countries initiate national vaccination programs using H1N1 vaccine, Baxter will also conduct a large-scale observational study with H1N1 vaccine in 9,000 people of different age groups, including children.
Preliminary safety data in adults and the elderly indicate that the vaccine is well tolerated in these age groups. The observed systemic and local reactions are similar to those generally experienced after vaccination with licensed seasonal influenza vaccines. Immunogenicity data from the first vaccination in adults are due later this month. The current dosing schedule, as specified in the EMEA mock-up licensure for H1N1 vaccine using another virus strain, calls for two 7.5 ตg doses of vaccine to be given 21 days apart. Baxter expects the data from the trial of healthy adults to indicate whether a single dose may be possible for H1N1 vaccine. This study will also determine whether a lower dose, 3.75ตg, is sufficient to induce the necessary immune response.
"We are pleased that the regulatory submission and the preliminary clinical trial data uphold the extensive work done by Baxter and the support received from key Ministries of Health in developing a pandemic vaccine,” said Hartmut J. Ehrlich, M.D., vice president of global research and development for Baxter BioScience. “We are looking forward to analyzing the immunogenicity data for our cell culture-derived, non-adjuvanted vaccine to assess the potential of a one dose regimen.”
ABOUT BAXTER’S PANDEMIC VACCINE DEVELOPMENT
Earlier this year, the EMEA granted mock-up licensure for H1N1 vaccine using a different strain with pandemic potential, which was tested in five completed clinical trials worldwide in more than 1,300 people. In addition, more than 3,500 people have been vaccinated using the same strain during an ongoing Phase III study. Mock-up licensure is a regulatory pathway for pandemic vaccines that was created by the EMEA in 2004. This pathway allows for the development, evaluation and licensure of a company’s pandemic candidate vaccine using an available influenza strain that has the potential to cause a pandemic. Once a pandemic is declared and the influenza virus strain causing the pandemic is identified, the mock-up licensure allows for fast track approval of a pandemic vaccine containing the actual pandemic strain.
Baxter received the H1N1 strain for testing and evaluation from the U.S. Centers for Disease Control and Prevention (a WHO Collaborating Center) in early May. The company then undertook pre-production testing and evaluation of the virus strain to assess its growth characteristics in the company’s proprietary Vero cell culture technology.
Baxter initiated commercial production in early June, and made its first commercial product within 12 weeks of receipt of the virus. The company produces bulk H1N1 vaccine at its large-scale commercial facility in Bohumil, Czech Republic, and then sends the vaccine to Vienna, Austria for the final formulation, fill and finish before distribution. Baxter completed production of the first batches of H1N1 vaccine in late July and initiated its first delivery within two weeks. The company continues to deliver vaccine on an ongoing basis to national public health authorities.
Baxter initiated its license application for H1N1 in July based on the EMEA published guidelines for pandemic vaccine marketing authorization. The company conducted rigorous testing of the H1N1 based vaccine and submitted additional data for vaccine development, product quality and manufacturing processes specific to that strain. Other non-E.U. countries may choose to evaluate the company’s EMEA submission and licensure as the basis for their national health authority’s authorization for use of the vaccine.
More information on H1N1 clinical trials is available at http://www.clinicaltrials.gov/ct2/results?term=baxter+h1n1
ABOUT BAXTER INTERNATIONAL INC.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
Baxter H1N1 vaccine is the first cell culture-based and non-adjuvanted vaccine to receive a positive opinion in the European Union. Initial quantities of vaccine have already been delivered to a number of countries, including the UK and Ireland, for use in their national vaccination programs, and are awaiting product release subject to final marketing authorization being granted by the European Commission.
Presently, Baxter is confirming the safety and immunogenicity of Baxter H1N1 vaccine in clinical trials. The company is conducting two randomized trials in 400 healthy adults age 18 and over and in 400 children and adolescents to supplement the licensure post-approval with appropriate clinical data. These trials are evaluating the safety and immunogenicity of the vaccine at dose levels of 7.5ตg and 3.75ตg. Once countries initiate national vaccination programs using H1N1 vaccine, Baxter will also conduct a large-scale observational study with H1N1 vaccine in 9,000 people of different age groups, including children.
Preliminary safety data in adults and the elderly indicate that the vaccine is well tolerated in these age groups. The observed systemic and local reactions are similar to those generally experienced after vaccination with licensed seasonal influenza vaccines. Immunogenicity data from the first vaccination in adults are due later this month. The current dosing schedule, as specified in the EMEA mock-up licensure for H1N1 vaccine using another virus strain, calls for two 7.5 ตg doses of vaccine to be given 21 days apart. Baxter expects the data from the trial of healthy adults to indicate whether a single dose may be possible for H1N1 vaccine. This study will also determine whether a lower dose, 3.75ตg, is sufficient to induce the necessary immune response.
"We are pleased that the regulatory submission and the preliminary clinical trial data uphold the extensive work done by Baxter and the support received from key Ministries of Health in developing a pandemic vaccine,” said Hartmut J. Ehrlich, M.D., vice president of global research and development for Baxter BioScience. “We are looking forward to analyzing the immunogenicity data for our cell culture-derived, non-adjuvanted vaccine to assess the potential of a one dose regimen.”
ABOUT BAXTER’S PANDEMIC VACCINE DEVELOPMENT
Earlier this year, the EMEA granted mock-up licensure for H1N1 vaccine using a different strain with pandemic potential, which was tested in five completed clinical trials worldwide in more than 1,300 people. In addition, more than 3,500 people have been vaccinated using the same strain during an ongoing Phase III study. Mock-up licensure is a regulatory pathway for pandemic vaccines that was created by the EMEA in 2004. This pathway allows for the development, evaluation and licensure of a company’s pandemic candidate vaccine using an available influenza strain that has the potential to cause a pandemic. Once a pandemic is declared and the influenza virus strain causing the pandemic is identified, the mock-up licensure allows for fast track approval of a pandemic vaccine containing the actual pandemic strain.
Baxter received the H1N1 strain for testing and evaluation from the U.S. Centers for Disease Control and Prevention (a WHO Collaborating Center) in early May. The company then undertook pre-production testing and evaluation of the virus strain to assess its growth characteristics in the company’s proprietary Vero cell culture technology.
Baxter initiated commercial production in early June, and made its first commercial product within 12 weeks of receipt of the virus. The company produces bulk H1N1 vaccine at its large-scale commercial facility in Bohumil, Czech Republic, and then sends the vaccine to Vienna, Austria for the final formulation, fill and finish before distribution. Baxter completed production of the first batches of H1N1 vaccine in late July and initiated its first delivery within two weeks. The company continues to deliver vaccine on an ongoing basis to national public health authorities.
Baxter initiated its license application for H1N1 in July based on the EMEA published guidelines for pandemic vaccine marketing authorization. The company conducted rigorous testing of the H1N1 based vaccine and submitted additional data for vaccine development, product quality and manufacturing processes specific to that strain. Other non-E.U. countries may choose to evaluate the company’s EMEA submission and licensure as the basis for their national health authority’s authorization for use of the vaccine.
More information on H1N1 clinical trials is available at http://www.clinicaltrials.gov/ct2/results?term=baxter+h1n1
ABOUT BAXTER INTERNATIONAL INC.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
Thursday, November 12, 2009
Living with KIDNEY DISEASE
Transplants can get patients back to a normal life When Porntip Puang-ngern became easily tired, began to lose weight and was vomiting frequently 10 years ago, she had no idea what was wrong.
Even when the doctor diagnosed her with chronic kidney disease, she remained in the dark about the illness.
"I didn't know much about kidney disease at that time. Information was hard to find, and the illness was so unfamiliar to me," said Ms Porntip, now 60 years old.
However, after similar symptoms appeared in her two sisters a few years later, kidney disease was no longer a stranger to the Puang-ngern family.
Back then, the three sisters were in and out of hospital for treatment which was to change as their illnesses progressed.
Despite oral and injected medication, the disease reached end-stage renal failure so it was necessary to undergo haemodialysis, a treatment which is tiring and time-consuming.
"It took 4-5 hours for each treatment, twice a week, and often I would feel the side effects like weakness and dizziness when I returned home," said Jongkol Puang-ngern, one of Ms Porntip's sisters.
The doctor urged them to register for donated kidneys with the Thai Red Cross Society. Finally, luck was on their side. Just a few years after they registered, the three sisters had successful organ transplants.
"Getting a new kidney and being able to live on with it is like winning the lottery. Now we're happy living life the way we used to. What we need to do is to take better care of ourselves so that our new kidneys can last for a long time," said Ms Jongkol.
Knowing your kidneys
The kidneys are a pair of bean-shaped organs on either side of the spine in your lower-middle back.
Dr Viroon Mavichak, a nephrologist at Praram 9 Hospital, says that the main function of the kidneys is to clean our body by removing waste products and excess water from the blood. All the while our organs such as the heart, lungs and liver are working, waste products are generated from the normal metabolic process. These waste products are released into the blood, and carried to the kidneys, which filter the blood and excrete the waste in the urine.
"If our kidneys function well, all the waste will be excreted, and our bodies will be fresh and clean. But if the kidneys function poorly, our bodies become polluted. Our blood will be dirty and the body dirty. That results in the malfunction of other organs. If both of your kidneys completely fail or someone took them out, you will be dead within seven days," said Dr Viroon.
Chronic and acute kidney disease
The Puang-ngern sisters
Chronic kidney disease happens when one suffers from gradual and usually permanent loss of kidney function. This happens gradually over time, usually months to years. In the end, patients will suffer end-stage renal failure, when there is total or near-total loss of kidney function and patients need dialysis or a transplant to stay alive.
Acute kidney disease, meanwhile, develops rapidly over days or weeks. It is a serious condition, but does not cause permanent damage to the kidneys, and still can be cured in time.
The chronic type, however, is more worrying as the early signs can be very subtle and many people who have the disease don't know it.
What causes chronic kidney disease?
Dr Viroon says there are various causes of kidney disease. Diabetes, high blood pressure, kidney stones, occlusion of blood vessels, gout, and kidney infections can result in chronic kidney disease, while factors such as accidents and severe diarrhoea can result in acute kidney failure.
"Chronic kidney disease that is mostly found in urban people is caused by diabetes. Diabetes can cause arterial occlusive disease which, if it continues for 10-20 years, will lead to damaged kidneys," he said.
In rural areas, however, kidney disease is mostly a result of "glomerulonephritis", a disease causing an autoimmune reaction to kidney tissue.
Who can have a kidney disease?
Dr Viroon says about 10,000 Thai people currently have a kidney disease, with an average of one new patient each day.
He said kidney disease can happen in people of all ages, even infants who are born with a kidney abnormality. But mostly, it happens to people aged 30-50 years old. People with diabetes or high blood pressure are also among the risk groups. In some cases, kidney disease can be genetically transmitted.
Dr Viroon Mavichak
How to know you have chronic kidney disease?
According to Dr Viroon, people with chronic kidney disease normally experience symptoms when their kidneys are about 80% damaged. This is because kidneys can still function normally even though they have started to deteriorate.
"Kidney disease is usually in hiding like an unseen murderer. When your kidneys are slightly damaged, you'll never know it unless you have a blood test. It's like your mobile phone battery. You can use it for 48 hours, then the power is gone and your phone will suddenly switch off," he said.
When the kidneys finally lose their function, patients will experience the following symptoms:
1. Loss of appetite, fatigue, nausea, and vomiting.
2. Swelling in the legs, ankles, feet, face or hands because the kidneys don't remove unwanted fluids in your body.
3. Change in urination. You may urinate more often. Urine may be foamy or bubbly or it may contain blood.
4. Have anaemia problems.
5. Poor function of the brain as it is not getting enough oxygen. This can result in memory problems, trouble with concentration and dizziness. If the symptoms are extreme, patients can be in a comatose state.
6. Shortness of breath and respiratory problems as extra fluid builds up in the lungs.
7. Waste build-up in the blood can result in skin rashes and itching.
8. Reduced immunity causing easy infection from germs.
9. Vomiting blood as a result of waste in the stomach.
10. Women may experience infertility problems.
How to treat chronic kidney disease
Treatment for early stages of chronic kidney disease include oral and injected medication to boost the red blood cell count. When the disease progresses to the end stage, there are normally two major treatment methods. One is haemodialysis. Patients have to spend 4-5 hours per treatment on a kidney machine, two or three times a week, to have their polluted blood filtered and sent back into the body.
"However, note that haemodialysis can only clean your blood, but it cannot replace other functions of the kidneys, such as the production of certain hormones."
The best method, he said, is a kidney transplant. There are two major channels for getting the organs. First is from donors who have died in accidents. Second is donated organs from living people, which Thai law only permits from people in the same family, or husbands and wives who can provide evidence of their relationship. The sale of kidneys is illegal.
After the transplant, patients need to take immune suppressive drugs regularly to stop the body from rejecting the new organ.
"Getting another kidney is like getting a strange object into the body, which will try and fight that object. If that process is not controlled, the transplanted kidney will fail," said the doctor.
The risk of this is especially acute in the first three months. Patients must therefore come for a regular examinations, every one or two months.
The success rate for kidney transplants is 95% if the organs were given from relatives, and 75% from deceased donors. Normally a transplanted kidney can function for 30-40 years.
Even when the doctor diagnosed her with chronic kidney disease, she remained in the dark about the illness.
"I didn't know much about kidney disease at that time. Information was hard to find, and the illness was so unfamiliar to me," said Ms Porntip, now 60 years old.
However, after similar symptoms appeared in her two sisters a few years later, kidney disease was no longer a stranger to the Puang-ngern family.
Back then, the three sisters were in and out of hospital for treatment which was to change as their illnesses progressed.
Despite oral and injected medication, the disease reached end-stage renal failure so it was necessary to undergo haemodialysis, a treatment which is tiring and time-consuming.
"It took 4-5 hours for each treatment, twice a week, and often I would feel the side effects like weakness and dizziness when I returned home," said Jongkol Puang-ngern, one of Ms Porntip's sisters.
The doctor urged them to register for donated kidneys with the Thai Red Cross Society. Finally, luck was on their side. Just a few years after they registered, the three sisters had successful organ transplants.
"Getting a new kidney and being able to live on with it is like winning the lottery. Now we're happy living life the way we used to. What we need to do is to take better care of ourselves so that our new kidneys can last for a long time," said Ms Jongkol.
Knowing your kidneys
The kidneys are a pair of bean-shaped organs on either side of the spine in your lower-middle back.
Dr Viroon Mavichak, a nephrologist at Praram 9 Hospital, says that the main function of the kidneys is to clean our body by removing waste products and excess water from the blood. All the while our organs such as the heart, lungs and liver are working, waste products are generated from the normal metabolic process. These waste products are released into the blood, and carried to the kidneys, which filter the blood and excrete the waste in the urine.
"If our kidneys function well, all the waste will be excreted, and our bodies will be fresh and clean. But if the kidneys function poorly, our bodies become polluted. Our blood will be dirty and the body dirty. That results in the malfunction of other organs. If both of your kidneys completely fail or someone took them out, you will be dead within seven days," said Dr Viroon.
Chronic and acute kidney disease
The Puang-ngern sisters
Chronic kidney disease happens when one suffers from gradual and usually permanent loss of kidney function. This happens gradually over time, usually months to years. In the end, patients will suffer end-stage renal failure, when there is total or near-total loss of kidney function and patients need dialysis or a transplant to stay alive.
Acute kidney disease, meanwhile, develops rapidly over days or weeks. It is a serious condition, but does not cause permanent damage to the kidneys, and still can be cured in time.
The chronic type, however, is more worrying as the early signs can be very subtle and many people who have the disease don't know it.
What causes chronic kidney disease?
Dr Viroon says there are various causes of kidney disease. Diabetes, high blood pressure, kidney stones, occlusion of blood vessels, gout, and kidney infections can result in chronic kidney disease, while factors such as accidents and severe diarrhoea can result in acute kidney failure.
"Chronic kidney disease that is mostly found in urban people is caused by diabetes. Diabetes can cause arterial occlusive disease which, if it continues for 10-20 years, will lead to damaged kidneys," he said.
In rural areas, however, kidney disease is mostly a result of "glomerulonephritis", a disease causing an autoimmune reaction to kidney tissue.
Who can have a kidney disease?
Dr Viroon says about 10,000 Thai people currently have a kidney disease, with an average of one new patient each day.
He said kidney disease can happen in people of all ages, even infants who are born with a kidney abnormality. But mostly, it happens to people aged 30-50 years old. People with diabetes or high blood pressure are also among the risk groups. In some cases, kidney disease can be genetically transmitted.
Dr Viroon Mavichak
How to know you have chronic kidney disease?
According to Dr Viroon, people with chronic kidney disease normally experience symptoms when their kidneys are about 80% damaged. This is because kidneys can still function normally even though they have started to deteriorate.
"Kidney disease is usually in hiding like an unseen murderer. When your kidneys are slightly damaged, you'll never know it unless you have a blood test. It's like your mobile phone battery. You can use it for 48 hours, then the power is gone and your phone will suddenly switch off," he said.
When the kidneys finally lose their function, patients will experience the following symptoms:
1. Loss of appetite, fatigue, nausea, and vomiting.
2. Swelling in the legs, ankles, feet, face or hands because the kidneys don't remove unwanted fluids in your body.
3. Change in urination. You may urinate more often. Urine may be foamy or bubbly or it may contain blood.
4. Have anaemia problems.
5. Poor function of the brain as it is not getting enough oxygen. This can result in memory problems, trouble with concentration and dizziness. If the symptoms are extreme, patients can be in a comatose state.
6. Shortness of breath and respiratory problems as extra fluid builds up in the lungs.
7. Waste build-up in the blood can result in skin rashes and itching.
8. Reduced immunity causing easy infection from germs.
9. Vomiting blood as a result of waste in the stomach.
10. Women may experience infertility problems.
How to treat chronic kidney disease
Treatment for early stages of chronic kidney disease include oral and injected medication to boost the red blood cell count. When the disease progresses to the end stage, there are normally two major treatment methods. One is haemodialysis. Patients have to spend 4-5 hours per treatment on a kidney machine, two or three times a week, to have their polluted blood filtered and sent back into the body.
"However, note that haemodialysis can only clean your blood, but it cannot replace other functions of the kidneys, such as the production of certain hormones."
The best method, he said, is a kidney transplant. There are two major channels for getting the organs. First is from donors who have died in accidents. Second is donated organs from living people, which Thai law only permits from people in the same family, or husbands and wives who can provide evidence of their relationship. The sale of kidneys is illegal.
After the transplant, patients need to take immune suppressive drugs regularly to stop the body from rejecting the new organ.
"Getting another kidney is like getting a strange object into the body, which will try and fight that object. If that process is not controlled, the transplanted kidney will fail," said the doctor.
The risk of this is especially acute in the first three months. Patients must therefore come for a regular examinations, every one or two months.
The success rate for kidney transplants is 95% if the organs were given from relatives, and 75% from deceased donors. Normally a transplanted kidney can function for 30-40 years.
Sonova buys cochlear implant maker
Swiss hearing aid firm Sonova Holding AG said yesterday it was buying cochlear implant maker Advanced Bionics Corp,based in California, for $489 million in cash.
Sonova expects the transaction, which is subject to regulatory approval, to be completed within three months.
"Sonova will offer the most comprehensive and innovative product and service portfolio covering any customer need for most types of hearing problems,"Valentin Chapero, Sonova's chief executive, said in a statement.
Privately-held Advanced Bionics was founded in 1993 and is based in Valencia,Los Angeles County. Its majority shareholder is the biotech investor Alfred Mann.
The company, which has 660 employees and sales in over 30 countries,has an 18% share of the global market in cochlear implants.
These electronic devices are surgically implanted inside the ear to stimulate the auditory nerves, allowing deaf people to hear sounds.
Sonova spokesman Holger Schimanke said there was little overlap between Sonova and Advanced Bionics, and consequently there are no plans to restructure the business.
"Advanced Bionics will continue to operate as an independent unit within the Sonova Group," Schimanke told the Associated Press."We aren't talking about any kind of job cuts, definitely not."
He said Advanced Bionics had developed "a great American technology that many people consider to be world leading, but it hasn't really taken off."
"We're going to give them the business and sales expertise to do so," said Schimanke.
Sonova expects the transaction, which is subject to regulatory approval, to be completed within three months.
"Sonova will offer the most comprehensive and innovative product and service portfolio covering any customer need for most types of hearing problems,"Valentin Chapero, Sonova's chief executive, said in a statement.
Privately-held Advanced Bionics was founded in 1993 and is based in Valencia,Los Angeles County. Its majority shareholder is the biotech investor Alfred Mann.
The company, which has 660 employees and sales in over 30 countries,has an 18% share of the global market in cochlear implants.
These electronic devices are surgically implanted inside the ear to stimulate the auditory nerves, allowing deaf people to hear sounds.
Sonova spokesman Holger Schimanke said there was little overlap between Sonova and Advanced Bionics, and consequently there are no plans to restructure the business.
"Advanced Bionics will continue to operate as an independent unit within the Sonova Group," Schimanke told the Associated Press."We aren't talking about any kind of job cuts, definitely not."
He said Advanced Bionics had developed "a great American technology that many people consider to be world leading, but it hasn't really taken off."
"We're going to give them the business and sales expertise to do so," said Schimanke.
Sunday, November 8, 2009
Bigger Merck on the prowl
The new Merck & Co has become the world's second-biggest drugmaker overnight with a huge acquisition, but it still has a fat wallet and plans more wheeling and dealing.
A day after closing its $41.1 billion purchase of longtime joint venture partner Schering-Plough Corp, Merck already "is looking to increase the number of acquisitions and licensing deals it does,"chief executive Richard Clark said on Wednesday.
The company has averaged 50 deals a year since 2003.
"We'll actually do more and maybe even try to double it," he told the Associated Press exclusively.
Clark said Merck was looking to make deals with "biotech companies that have first or best-in-class products that can build our franchises."
It has about $8 billion in cash and investments to spend.
"We've got a tremendous pipeline,with 15 late-stage candidates," Clark said.
Between those drugs and future deals,Merck is focusing on several areas, including its longtime strengths such as cardiovascular disease - with four new drugs in testing - and vaccines, adding Schering-Plough's experimental shot to prevent staph infections to Merck's array of standard child and adult vaccines.
Other targets are osteoporosis medi-cines, such as a Merck drug to replace its pioneering Fosamax, which has lost sales to generic competition, and women's health, as Schering makes contraceptive and fertility drugs.
With the Schering deal, Merck leapfrogged from No.8 to No.2 in the industry by revenue, behind Pfizer Inc - despite Clark insisting he opposed such a megadeal since he took Merck's helm
in 2005.
Merck, based in Whitehouse Station, New Jersey,and New York's Pfizer, which last month bought Wyeth for $68 billion, are now back in the positions they held a decade Clark:'We've got a ago.tremendous pipeline'Merck was the world's top-selling drugmaker in the mid-1990s, but Pfizer took the lead in 1998 when it launched an overnight success, impotence pill Viagra. Repeated mergers among other drugmakers pushed Merck further back in line.
The new Merck will start off with roughly $40 billion in annual sales, operations in more than 140 countries and more than half its sales from foreign countries - an advantage as US sales have stagnated in recent years.
"We're going to be better in emerging markets," Clark said, meaning countries such as China, India and Brazil with people now spending more on health care.
The company also is more diversified,with Schering's animal and consumer health businesses and biotech division.
"It really puts us on a global stage as a health-care leader," Clark said.
Schering-Plough, of Kenilworth, New Jersey, also brings several promising experimental drugs and some big sellers including hepatitis drugs and allergy spray Nasonex.
The companies jointly sell cholesterol drugs Vytorin and Zetia.
About 40% of Schering-Plough's top managers are staying on, but its CEO,Fred Hassan, is leaving with a severance package worth roughly $51 million.
The companies have said they expect to make about 16,000 job cuts out of their now-combined staff of 106,000 people. With no official word on those cuts,many employees are anxious.
Clark said Wednesday it would take time to decide which employees will leave and which facilities will close.
The new company is organised into five divisions, including its manufacturing operations and Merck Research Laboratories.
The others are the prescription drug business and two Schering-Plough businesses, animal health and a consumer health business with well-known brands such as Claritin allergy pills, Miralax laxative, Coppertone sun care items and the Dr Scholl's foot0care line.
A day after closing its $41.1 billion purchase of longtime joint venture partner Schering-Plough Corp, Merck already "is looking to increase the number of acquisitions and licensing deals it does,"chief executive Richard Clark said on Wednesday.
The company has averaged 50 deals a year since 2003.
"We'll actually do more and maybe even try to double it," he told the Associated Press exclusively.
Clark said Merck was looking to make deals with "biotech companies that have first or best-in-class products that can build our franchises."
It has about $8 billion in cash and investments to spend.
"We've got a tremendous pipeline,with 15 late-stage candidates," Clark said.
Between those drugs and future deals,Merck is focusing on several areas, including its longtime strengths such as cardiovascular disease - with four new drugs in testing - and vaccines, adding Schering-Plough's experimental shot to prevent staph infections to Merck's array of standard child and adult vaccines.
Other targets are osteoporosis medi-cines, such as a Merck drug to replace its pioneering Fosamax, which has lost sales to generic competition, and women's health, as Schering makes contraceptive and fertility drugs.
With the Schering deal, Merck leapfrogged from No.8 to No.2 in the industry by revenue, behind Pfizer Inc - despite Clark insisting he opposed such a megadeal since he took Merck's helm
in 2005.
Merck, based in Whitehouse Station, New Jersey,and New York's Pfizer, which last month bought Wyeth for $68 billion, are now back in the positions they held a decade Clark:'We've got a ago.tremendous pipeline'Merck was the world's top-selling drugmaker in the mid-1990s, but Pfizer took the lead in 1998 when it launched an overnight success, impotence pill Viagra. Repeated mergers among other drugmakers pushed Merck further back in line.
The new Merck will start off with roughly $40 billion in annual sales, operations in more than 140 countries and more than half its sales from foreign countries - an advantage as US sales have stagnated in recent years.
"We're going to be better in emerging markets," Clark said, meaning countries such as China, India and Brazil with people now spending more on health care.
The company also is more diversified,with Schering's animal and consumer health businesses and biotech division.
"It really puts us on a global stage as a health-care leader," Clark said.
Schering-Plough, of Kenilworth, New Jersey, also brings several promising experimental drugs and some big sellers including hepatitis drugs and allergy spray Nasonex.
The companies jointly sell cholesterol drugs Vytorin and Zetia.
About 40% of Schering-Plough's top managers are staying on, but its CEO,Fred Hassan, is leaving with a severance package worth roughly $51 million.
The companies have said they expect to make about 16,000 job cuts out of their now-combined staff of 106,000 people. With no official word on those cuts,many employees are anxious.
Clark said Wednesday it would take time to decide which employees will leave and which facilities will close.
The new company is organised into five divisions, including its manufacturing operations and Merck Research Laboratories.
The others are the prescription drug business and two Schering-Plough businesses, animal health and a consumer health business with well-known brands such as Claritin allergy pills, Miralax laxative, Coppertone sun care items and the Dr Scholl's foot0care line.
Wednesday, November 4, 2009
Patients in medical maze need advocates
Two days after surgery to replace both my knees, a social worker employed by the hospital told me that the insurance company would not pay for me to stay any longer. Seeing that I was barely able to get to the bathroom on my own, she told the company I was not ready to enter rehab and insisted that I needed at least another day in the hospital.
She was right, and I was grateful for the intervention; I was in no shape to argue with insurance bureaucrats whose goal is to save money and who had no interest in, nor any way to assess, my well-being.
As health issues go, mine was a relatively minor concern. I now realise that in the complex world of modern medicine, nearly all patients, and especially those who are critically ill, need an advocate, someone to negotiate with medical professionals, insurers and others to ensure that they are receiving optimal care.
David Wayne Smith, a disability specialist at the Arizona Arthritis Centre in Tucson, became an advocate for his 58-year-old son, who had been thrown from a horse and lay near death in a hospital room 800km away. He had several broken ribs,bruised lungs, a fractured clavicle and serious breathing problems, Smith wrote in the September-October issue of Arthritis Self-Management . For three long weeks, during which there were many close calls with death, his son lay in a drug-induced coma, his breathing maintained by a tube in his throat and a respirator.
Steeling himself against profound feelings of helplessness and fear, Smith quickly realised he had to become part of his son's treatment team as a patient advocate.
Smith began by making himself known to the hospital administrator and everyone involved with his son's care. He called the chief of the trauma centre whenever his son took a turn for the worse and got permission for himself and his son's wife to attend daily rounds when doctors discussed the patient's progress.
And when his son was ready to leave the trauma centre, Smith insisted that he be transferred to a rehabilitation centre, not a regular hospital bed.
Thanks in large part to Smith's advocacy, his son made rapid progress in rehab and in two weeks was able to go home, where his father has continued to advocate on his behalf, now to help counter the depression and anxiety that can accompany such a life-changing accident.
"I see patients routinely in this situation, patients in their thirties and forties who've been told by rheumatologists that they can no longer work and must get by on Social Security disability benefits," Smith,83, said in an interview."I work with them to find specialists who can help them improve their situation, and I encourage them to take better care of themselves.
"Many patients with rheumatoid arthritis are reluctant to have the surgery that can enable them to get back to work, or they don't take their medication,or they fail to see the proper specialists."
Smith outlined four situations that call for a patient advocate:
Patients' illnesses or injuries are life-threatening, and they are unable to act on their own behalf.(As with Smith's son, such patients may be unconscious or placed in a drug-induced coma, or otherwise heavily medicated.)
Important decisions must be immediately made regarding treatment,but patients are temporarily unable to act for themselves because of severe physical or emotional trauma.
Although otherwise competent,patients are unaware of their rights, benefits or treatment options, as may happen with patients who have cancer, heart disease or severe arthritis.
Patients lack the mental ability to make rational decisions regarding their rights, treatments and benefits.
The advocate's main role is to serve as a link between patients and their health care providers.
The advocate helps make sure that patients get needed treatments in a timely fashion and can alert doctors when patients fail to follow prescribed remedies.
Perhaps most important, patient advocates assist with continuity of care,
ensuring that critical medical information is given to new providers and helping patients connect with ancillary personnel when employment, financial,legal or other issues arise.
For example, the advocate might negotiate with an employer to adapt work responsibilities that fit the abilities of an ill or injured patient but still benefit the employer.
Sometimes, advocates also have to work with families facing role reversal issues when the family breadwinner becomes disabled.
Smith said that when illness or injury disrupted the family dynamic, communication problems were commonplace.
Smith told of a woman who served as an advocate for her husband, who had been severely injured in a traffic accident.
When the trauma surgeon said the man's leg would have to be amputated, the woman refused to consent to the surgery and instead arranged with his insurance company to have him transferred to a skilled nursing facility,where he could get both physical and occupational therapy.
The wife consulted a plastic surgeon,who repaired injuries to the man's face and sewed his thumb back on. She also closely monitored his pain medication and arranged for a unit that relieves pain through electrical nerve stimulation,arguing with the insurer that this would be a less costly and more effective approach than heavy-duty drugs.
In the end, the man's leg was saved and his face minimally scarred. He could walk without any aid or limp and was able to return to work as a clinical nurse.
An effective advocate, Smith said, has to be "knowledgeable, committed and aggressive - forceful in a positive way and a good listener".
He added that it was important to be cooperative, caring and firm, but not demanding, to foster cooperation and not antagonise the patient's health care providers.
The advocate can be a family member or friend, or a professional patient advocate, who often has a background in medical social work.
Some who work with older people are called geriatric care managers. Many patient advocates are volunteers whose compensation comes from satisfaction in helping someone recover.
It is better to avoid advocates who might have a conflict of interest that could compromise patient care.
Thus, using an advocate employed by the hospital or insurance company may not always serve the patient's best interests.
Some hospitals maintain a roster of patient advocate volunteers.
She was right, and I was grateful for the intervention; I was in no shape to argue with insurance bureaucrats whose goal is to save money and who had no interest in, nor any way to assess, my well-being.
As health issues go, mine was a relatively minor concern. I now realise that in the complex world of modern medicine, nearly all patients, and especially those who are critically ill, need an advocate, someone to negotiate with medical professionals, insurers and others to ensure that they are receiving optimal care.
David Wayne Smith, a disability specialist at the Arizona Arthritis Centre in Tucson, became an advocate for his 58-year-old son, who had been thrown from a horse and lay near death in a hospital room 800km away. He had several broken ribs,bruised lungs, a fractured clavicle and serious breathing problems, Smith wrote in the September-October issue of Arthritis Self-Management . For three long weeks, during which there were many close calls with death, his son lay in a drug-induced coma, his breathing maintained by a tube in his throat and a respirator.
Steeling himself against profound feelings of helplessness and fear, Smith quickly realised he had to become part of his son's treatment team as a patient advocate.
Smith began by making himself known to the hospital administrator and everyone involved with his son's care. He called the chief of the trauma centre whenever his son took a turn for the worse and got permission for himself and his son's wife to attend daily rounds when doctors discussed the patient's progress.
And when his son was ready to leave the trauma centre, Smith insisted that he be transferred to a rehabilitation centre, not a regular hospital bed.
Thanks in large part to Smith's advocacy, his son made rapid progress in rehab and in two weeks was able to go home, where his father has continued to advocate on his behalf, now to help counter the depression and anxiety that can accompany such a life-changing accident.
"I see patients routinely in this situation, patients in their thirties and forties who've been told by rheumatologists that they can no longer work and must get by on Social Security disability benefits," Smith,83, said in an interview."I work with them to find specialists who can help them improve their situation, and I encourage them to take better care of themselves.
"Many patients with rheumatoid arthritis are reluctant to have the surgery that can enable them to get back to work, or they don't take their medication,or they fail to see the proper specialists."
Smith outlined four situations that call for a patient advocate:
Patients' illnesses or injuries are life-threatening, and they are unable to act on their own behalf.(As with Smith's son, such patients may be unconscious or placed in a drug-induced coma, or otherwise heavily medicated.)
Important decisions must be immediately made regarding treatment,but patients are temporarily unable to act for themselves because of severe physical or emotional trauma.
Although otherwise competent,patients are unaware of their rights, benefits or treatment options, as may happen with patients who have cancer, heart disease or severe arthritis.
Patients lack the mental ability to make rational decisions regarding their rights, treatments and benefits.
The advocate's main role is to serve as a link between patients and their health care providers.
The advocate helps make sure that patients get needed treatments in a timely fashion and can alert doctors when patients fail to follow prescribed remedies.
Perhaps most important, patient advocates assist with continuity of care,
ensuring that critical medical information is given to new providers and helping patients connect with ancillary personnel when employment, financial,legal or other issues arise.
For example, the advocate might negotiate with an employer to adapt work responsibilities that fit the abilities of an ill or injured patient but still benefit the employer.
Sometimes, advocates also have to work with families facing role reversal issues when the family breadwinner becomes disabled.
Smith said that when illness or injury disrupted the family dynamic, communication problems were commonplace.
Smith told of a woman who served as an advocate for her husband, who had been severely injured in a traffic accident.
When the trauma surgeon said the man's leg would have to be amputated, the woman refused to consent to the surgery and instead arranged with his insurance company to have him transferred to a skilled nursing facility,where he could get both physical and occupational therapy.
The wife consulted a plastic surgeon,who repaired injuries to the man's face and sewed his thumb back on. She also closely monitored his pain medication and arranged for a unit that relieves pain through electrical nerve stimulation,arguing with the insurer that this would be a less costly and more effective approach than heavy-duty drugs.
In the end, the man's leg was saved and his face minimally scarred. He could walk without any aid or limp and was able to return to work as a clinical nurse.
An effective advocate, Smith said, has to be "knowledgeable, committed and aggressive - forceful in a positive way and a good listener".
He added that it was important to be cooperative, caring and firm, but not demanding, to foster cooperation and not antagonise the patient's health care providers.
The advocate can be a family member or friend, or a professional patient advocate, who often has a background in medical social work.
Some who work with older people are called geriatric care managers. Many patient advocates are volunteers whose compensation comes from satisfaction in helping someone recover.
It is better to avoid advocates who might have a conflict of interest that could compromise patient care.
Thus, using an advocate employed by the hospital or insurance company may not always serve the patient's best interests.
Some hospitals maintain a roster of patient advocate volunteers.
Public health
Remember a couple of weeks ago the government stopped reporting on the H1N1 influenza? Because it had pretty well stopped, and there were no deaths for a week? Yes, well, just kidding.Kamnuan Ungchusak, a Public Health Ministry disease control expert said to stand by for a second wave of swine flu,quite possibly worse than the first wave,which killed 182 people and closed all Bangkok schools for more than a week.The fears stem from a sudden upsurge in H1N1 cases in North America, where children in particular are being struck down by the virus. The weather is cooling,schools are resuming class and (one hopes) the tourist high season is approaching. Also, the long-promised anti-flu vaccine isn't ready, won't be for weeks, oh, make that months. All of these facts are good for flu, bad for humans. Ah, but that's not all. Permanent secretary for public health Paijit Warachit called a meeting of health and livestock officials. He fears that the H5N1 avian flu is set to strike again as well.But big problems loom, potentially political tsunami. In Thailand, in the US -where flu is already an official national emergency - and around the world,authorities have somehow botched the vaccine that would protect tens of millions from the H1N1 pandemic. Thai authorities say tests may begin in midwinter. Despite months of soothing talk and preparation, the Obama administration can't produce enough vaccine to provide shots for President Obama's daughters. The promises of vaccine have proved hollow, and governments may pay for that prevarication if the H1N1 does indeed hit hard, as feared.
Wednesday, October 28, 2009
BOON TURNS TO CHINA AFTER SELLING HOSPITAL STAKE
Property tycoon Boon Vanasin recently unloaded shares in Piyavate Hospital to Red Bull owner Chaleo Yoovidhya so he can focus more on hospital investment in China.
"China will be my latest country for investing in healthcare. I believe revenue from that industry in that country will exceed revenue from all of my businesses in Thailand, both healthcare and property, within five years," Boon said.
He said he spent much of his time in China now, overseeing construction of his hospitals. Despite the opportunities afforded by the world's most populous country, investment in China is quite difficult for foreigners, and so he finds he must be on hand there.
Boon's hospital arm, the Thonburi Hospital Group, sold its entire 40-per-cent stake in Piyavate Hospital, although he maintains his personal 5-per-cent holding and remains a director.
The group generates annual revenue of Bt3 billion from 17 hospitals, while Boon's property business generates about Bt2 billion per annum.
Boon's foreign-investment arm, WJ International Healthcare, is constructing three Chinese hospitals at a combined cost exceeding Bt1 billion, with a different Chinese partner for each one: the military, the Foreign Ministry and the Red Cross Society of China.
Boon plans to open three hospitals a year in China, serving mainly foreigners.
He said the Thonburi Hospital Group agreed to sell its shares in Piyavate Hospital roughly five months ago, obtaining Bt400 million from the deal. The money will go towards the Bt900-million expansion of Thonburi Hospital 1 and Thonburi Hospital 2.
The group will spend Bt400 million to build new outpatient and inpatient buildings at Thonburi Hospital 1, after which capacity will double in the outpatient building to serve 3,000 patients a day, while inpatient beds will increase 25 per cent to 500.
A budget of Bt500 million has been earmarked for a new outpatient building at Thonburi Hospital 2 that can serve 1,500 outpatients daily, up from 800 now.
Boon said another reason for selling the Piyavate shares were his and Chaleo's conflicting opinions on the business's direction. He wanted to embark upon a major Bt2-billion upgrade of Piyavate, in order to make it more competitive with other private hospitals, but Chaleo wants the 16-year-old hospital to grow more slowly.
Boon resigned as Piyavate's chairman but signed an agreement with Chaleo retaining the right to become Piyavate Hospital's major shareholder within three years. If he does return in that capacity, he may let his heirs hold the stake.
Piyavate CEO and president Nithi Mahanonda said Chaleo planned to bring in more doctors from several fields, cut unnecessary costs and make the most beneficial use of the hospital's facilities. After five years of losses, the hospital is expected to post a net profit next year, with revenue increasing 15 per cent.
Nithi expects revenue of Bt1 billion this year, up 25 per cent from last year. The company will book a net loss estimated at Bt60 million, an improvement from last year's Bt300-million loss.
Piyavate expects to take six years to clear its accumulated losses of Bt800 million.
Nithi said with the transaction, Chaleo's children and grandchild now hold 75 per cent of the hospital's registered capital of Bt2.1 billion, while 19 per cent is held physicians.
He said Piyavate had spent nearly Bt200 million on renovating its building and would increase the number of beds from 100 to 150 within six months. It is also adding more full- and part-time physicians to attract more patients, especially foreigners, who are higher margin.
Piyavate plans to become a top-five private hospital in the near future.
"China will be my latest country for investing in healthcare. I believe revenue from that industry in that country will exceed revenue from all of my businesses in Thailand, both healthcare and property, within five years," Boon said.
He said he spent much of his time in China now, overseeing construction of his hospitals. Despite the opportunities afforded by the world's most populous country, investment in China is quite difficult for foreigners, and so he finds he must be on hand there.
Boon's hospital arm, the Thonburi Hospital Group, sold its entire 40-per-cent stake in Piyavate Hospital, although he maintains his personal 5-per-cent holding and remains a director.
The group generates annual revenue of Bt3 billion from 17 hospitals, while Boon's property business generates about Bt2 billion per annum.
Boon's foreign-investment arm, WJ International Healthcare, is constructing three Chinese hospitals at a combined cost exceeding Bt1 billion, with a different Chinese partner for each one: the military, the Foreign Ministry and the Red Cross Society of China.
Boon plans to open three hospitals a year in China, serving mainly foreigners.
He said the Thonburi Hospital Group agreed to sell its shares in Piyavate Hospital roughly five months ago, obtaining Bt400 million from the deal. The money will go towards the Bt900-million expansion of Thonburi Hospital 1 and Thonburi Hospital 2.
The group will spend Bt400 million to build new outpatient and inpatient buildings at Thonburi Hospital 1, after which capacity will double in the outpatient building to serve 3,000 patients a day, while inpatient beds will increase 25 per cent to 500.
A budget of Bt500 million has been earmarked for a new outpatient building at Thonburi Hospital 2 that can serve 1,500 outpatients daily, up from 800 now.
Boon said another reason for selling the Piyavate shares were his and Chaleo's conflicting opinions on the business's direction. He wanted to embark upon a major Bt2-billion upgrade of Piyavate, in order to make it more competitive with other private hospitals, but Chaleo wants the 16-year-old hospital to grow more slowly.
Boon resigned as Piyavate's chairman but signed an agreement with Chaleo retaining the right to become Piyavate Hospital's major shareholder within three years. If he does return in that capacity, he may let his heirs hold the stake.
Piyavate CEO and president Nithi Mahanonda said Chaleo planned to bring in more doctors from several fields, cut unnecessary costs and make the most beneficial use of the hospital's facilities. After five years of losses, the hospital is expected to post a net profit next year, with revenue increasing 15 per cent.
Nithi expects revenue of Bt1 billion this year, up 25 per cent from last year. The company will book a net loss estimated at Bt60 million, an improvement from last year's Bt300-million loss.
Piyavate expects to take six years to clear its accumulated losses of Bt800 million.
Nithi said with the transaction, Chaleo's children and grandchild now hold 75 per cent of the hospital's registered capital of Bt2.1 billion, while 19 per cent is held physicians.
He said Piyavate had spent nearly Bt200 million on renovating its building and would increase the number of beds from 100 to 150 within six months. It is also adding more full- and part-time physicians to attract more patients, especially foreigners, who are higher margin.
Piyavate plans to become a top-five private hospital in the near future.
GE shrinks ultrasound tool
The future of ultrasound technology, as interpreted by General Electric Co, looks a bit like a flip phone crossed with an iPod.
GE chief executive Jeff Immelt unveiled a handheld ultrasound machine at the Web 2.0 Summit in San Francisco on Tuesday called the Vscan, saying it could become the "stethoscope of the 21st century."
The device folds open clamshell-style to reveal a small screen on the top half and a circular button pad on the bottom.A small attached wand can be used to generate a non-invasive scan of a patient's organs or of a fetus.
The Vscan is aimed in part at primary care doctors, who could use it instead of sending patients to get an ultrasound at a specialist's office. It could also be used by doctors in remote regions without access to hospital equipment.
Immelt said that the device, which will be available sometime next year,would be "very digitally capable" but that it would not have Wi-Fi access to wirelessly transmit ultrasound images.
The cost of the device is unknown.During the summit, Immelt declined to elaborate on the possibility that Fairfield, Connecticut-based GE will sell a stake in its NBC Universal entertainment division to cable TV operator Comcast Corp or any other company.
He said that GE "is comfortable" with the division."
GE chief executive Jeff Immelt unveiled a handheld ultrasound machine at the Web 2.0 Summit in San Francisco on Tuesday called the Vscan, saying it could become the "stethoscope of the 21st century."
The device folds open clamshell-style to reveal a small screen on the top half and a circular button pad on the bottom.A small attached wand can be used to generate a non-invasive scan of a patient's organs or of a fetus.
The Vscan is aimed in part at primary care doctors, who could use it instead of sending patients to get an ultrasound at a specialist's office. It could also be used by doctors in remote regions without access to hospital equipment.
Immelt said that the device, which will be available sometime next year,would be "very digitally capable" but that it would not have Wi-Fi access to wirelessly transmit ultrasound images.
The cost of the device is unknown.During the summit, Immelt declined to elaborate on the possibility that Fairfield, Connecticut-based GE will sell a stake in its NBC Universal entertainment division to cable TV operator Comcast Corp or any other company.
He said that GE "is comfortable" with the division."
PREMA LOOKS TO STAUNCH FLOW
Thai pharmaceutical manufacturers are concerned about the sale of counterfeit medication because not only does it affect the industry it also has an adverse effect on consumers, the Pharmaceutical Research & Manufacturers Association (PReMA) said yesterday.
PReMA's CEO Kitima Yuthavong said many members of the group were concerned about the issue, which seems to be increasing in Thailand. PReMa, in its capacity as an alliance of manufacturers, is collaborating with government agencies to solve the problem.
Thavirap Tantiwongse, director of Health System partnerships at PReMA, said though exact figures of the damage inflicted upon the Thai pharmaceutical industry were not available, the World Health Organisation is predicting that the value of counterfeit drugs across the world will hit US$75 billion (Bt2.5 trillion) by next year. At least five nations, including the US, are currently suffering the problem of counterfeit drugs.
He added that fake drugs could be easily bought at ordinary pharmacies, and consumers often buy the counterfeit medication because it is cheaper.
PReMA president Teera Chakajnarodom said the 10,000 or so drug stores across the country face the risk of becoming channels for counterfeit medication.
"Involved government agencies are not able to solve this problem because the penalties are not strong enough. In addition, the business of fake drugs can be very profitable," Thavirap said.
Kitima said PReMA, which is celebrating its 39th anniversary this year, will hold a seminar on October 30 to discuss the issue of counterfeit drugs as well as do case studies on how to cope with the problem and how to educate consumers.
Yoshitaka Koketsu, president of Astellas Pharma (Thailand), a Japanese pharmaceutical manufacturer, said his country ranked 5th globally in terms of counterfeit medication, after China, South Korea, the US and India. In Japan, most of the fake drugs are sold through the Internet, even though most Japanese pharmaceutical companies have unique techniques to stop their drugs being reproduced.
Keketsu said the Japan Pharmaceutical Manufacturers Association (JPMA), which has more experience in combating counterfeit medication, will share its know-how at the PReMa seminar.
PReMA's CEO Kitima Yuthavong said many members of the group were concerned about the issue, which seems to be increasing in Thailand. PReMa, in its capacity as an alliance of manufacturers, is collaborating with government agencies to solve the problem.
Thavirap Tantiwongse, director of Health System partnerships at PReMA, said though exact figures of the damage inflicted upon the Thai pharmaceutical industry were not available, the World Health Organisation is predicting that the value of counterfeit drugs across the world will hit US$75 billion (Bt2.5 trillion) by next year. At least five nations, including the US, are currently suffering the problem of counterfeit drugs.
He added that fake drugs could be easily bought at ordinary pharmacies, and consumers often buy the counterfeit medication because it is cheaper.
PReMA president Teera Chakajnarodom said the 10,000 or so drug stores across the country face the risk of becoming channels for counterfeit medication.
"Involved government agencies are not able to solve this problem because the penalties are not strong enough. In addition, the business of fake drugs can be very profitable," Thavirap said.
Kitima said PReMA, which is celebrating its 39th anniversary this year, will hold a seminar on October 30 to discuss the issue of counterfeit drugs as well as do case studies on how to cope with the problem and how to educate consumers.
Yoshitaka Koketsu, president of Astellas Pharma (Thailand), a Japanese pharmaceutical manufacturer, said his country ranked 5th globally in terms of counterfeit medication, after China, South Korea, the US and India. In Japan, most of the fake drugs are sold through the Internet, even though most Japanese pharmaceutical companies have unique techniques to stop their drugs being reproduced.
Keketsu said the Japan Pharmaceutical Manufacturers Association (JPMA), which has more experience in combating counterfeit medication, will share its know-how at the PReMa seminar.
Tuesday, October 20, 2009
Obama eases pressure on medical marijuana
In a sharp policy shift, the Obama administration told federal attorneys not to prosecute patients who use marijuana for medical reasons or dispensaries in states where it has been legalised.
A Justice Department official said the formal guidelines were issued on Monday to reflect President Barack Obama's views. The Bush administration had said it could enforce the federal law against marijuana and that it trumped state laws.
The decision was praised by activists in California, the first state to legalise medical marijuana in 1996. But concern remains among some medical and law enforcement authorities about hundreds of clinics distributing marijuana under the protection of state law and without regard to health.
During his presidential campaign last year, Mr Obama said he intended to halt raids of medical marijuana facilities operating legally under state laws.
On Monday a White House spokesman repeated Mr Obama's view that "federal resources should not be used to circumvent state laws".
A Justice Department official said the formal guidelines were issued on Monday to reflect President Barack Obama's views. The Bush administration had said it could enforce the federal law against marijuana and that it trumped state laws.
The decision was praised by activists in California, the first state to legalise medical marijuana in 1996. But concern remains among some medical and law enforcement authorities about hundreds of clinics distributing marijuana under the protection of state law and without regard to health.
During his presidential campaign last year, Mr Obama said he intended to halt raids of medical marijuana facilities operating legally under state laws.
On Monday a White House spokesman repeated Mr Obama's view that "federal resources should not be used to circumvent state laws".
Wednesday, October 14, 2009
Dental Implant
What is Dental Implant?
A dental implant is an artificaial tooth root replacement and is used in prosthetic dentistry to support restorations that resemble a tooth or group of teeth.
What are the Advantages of Dental Implants?
- Improved appearance. Dental implants look and feel lide your own teeth. And because they are designe4d to fuse with bone, they become permanent.
- Improved speech.
with poor-fitting dentures, the teeth can slip within the mouth causing you to mumble or slur your worlds. Dental implants allow you to speak without the worry that your denture might slip.
- Improved comfort. Because they become part of you, implants eliminate the discomfort of removable dentures being displaced.
- Easier eating. Sliding dentures can make chewing difficult.
Dental implants function like your own teeth allowing you to eat you favourite foods with confidence and without pain.
- Improved self-esteem. Dental implants can give you back your natural smile, and help you feel better about yourself.
- Improved oral health. Dental implants don't require reducing other teeth, as a tooth-supported bridge does. Because nearby teeth are not altered to support the bridge, more of your own teeth are left intact, improving your long-term oral health. Individual implants also allow easier access between teeth, improving oral hygiene.
- Durability. Implants are very durable and will ast many years. With good care, many implants last a lifetime.
- Convenience. Removable dentures are just that; removable. Dental implants eliminate the embarrassing inconvenience of removing your dentures, as well as the need for messy adhesives to keep your dentures in place.
Detailed Procedural Steps are as follows:
Preparation of the Jaw for Implantation: A dental implant is commonly composed of a titanium material screw and a crown. A small-diameter hole (pilot hole) is drilled at edentulous (where there is no tooth) jaw sites in order to guide the titanium screw that is a dental implant in place. to avoid damaging vital jaw and fae structures like the inferior alveolar nerve in the mandible (lower jaw), a dentist must use great skill and expertise when boring the pilot hole and sizing the jaw bone.
Placement of the Implant: After the initial pilot hole has been drilled into the appropriate jaw site, it is slowly widened to allow for placement of the implant body. Following this placement, a protective cover screw is placed on top to allow the implant site to heal and the dental implant to anchor (Osseo integration). After several months, the portective cover is removed ans a temporary healing is placed on top of the dental implant. The temporary abutment serves as a template around which the gum grows and shapes itself in a natural way. The process is completed when the temporary abutment is replaced with a permanent crown.
How Painful are Dental Implants?
Most people who have received dental implants say that there is very little discomfort involved in the procedure. Local anesthesia can be used durint the procedure, and most patients report that implants cause less pain than a tooth extraction.
After the dental implant, mild soreness can be treated with over-the-counter pain medications, such as Tylenol.
How Do I Care for My Implant?
Dental implants require the same care as real teeth, including;
Brushing after meals of at least twice a day.
Cleaning with cholhexidine mouth wash after meal in case of unable to do brushing.
Applying dental flossing after meals or at least once daily before bed time.
Avoiding rigid or hard chewing food to prevent broken of the teeth.
Undergoing regular dental check-ups.
De. Jaran Busagonruangrat
Docter of Dental Surgery
Dental Center Bangpakok 9 Internnational Hospital
Can Anyone Get Dental Implant?
In most cases, anyone healthy enough to undergo a routine dental extraction or oral surgery can be considered for an implant procedure. Patients should have healthy gums and enough bone to hole the implant. They also m ust be committed to good oral hygiene and regular dental visits. Heavy smokers, people suffering from uncontrolled chronic disorders-such as diabetes or heart disease-or patients who have had radiation therapy to the head/neck area need to be evaluated on an individual basis. If yoy are considering implants, talk to your dentist to see if they are right for you.
A dental implant is an artificaial tooth root replacement and is used in prosthetic dentistry to support restorations that resemble a tooth or group of teeth.
What are the Advantages of Dental Implants?
- Improved appearance. Dental implants look and feel lide your own teeth. And because they are designe4d to fuse with bone, they become permanent.
- Improved speech.
with poor-fitting dentures, the teeth can slip within the mouth causing you to mumble or slur your worlds. Dental implants allow you to speak without the worry that your denture might slip.
- Improved comfort. Because they become part of you, implants eliminate the discomfort of removable dentures being displaced.
- Easier eating. Sliding dentures can make chewing difficult.
Dental implants function like your own teeth allowing you to eat you favourite foods with confidence and without pain.
- Improved self-esteem. Dental implants can give you back your natural smile, and help you feel better about yourself.
- Improved oral health. Dental implants don't require reducing other teeth, as a tooth-supported bridge does. Because nearby teeth are not altered to support the bridge, more of your own teeth are left intact, improving your long-term oral health. Individual implants also allow easier access between teeth, improving oral hygiene.
- Durability. Implants are very durable and will ast many years. With good care, many implants last a lifetime.
- Convenience. Removable dentures are just that; removable. Dental implants eliminate the embarrassing inconvenience of removing your dentures, as well as the need for messy adhesives to keep your dentures in place.
Detailed Procedural Steps are as follows:
Preparation of the Jaw for Implantation: A dental implant is commonly composed of a titanium material screw and a crown. A small-diameter hole (pilot hole) is drilled at edentulous (where there is no tooth) jaw sites in order to guide the titanium screw that is a dental implant in place. to avoid damaging vital jaw and fae structures like the inferior alveolar nerve in the mandible (lower jaw), a dentist must use great skill and expertise when boring the pilot hole and sizing the jaw bone.
Placement of the Implant: After the initial pilot hole has been drilled into the appropriate jaw site, it is slowly widened to allow for placement of the implant body. Following this placement, a protective cover screw is placed on top to allow the implant site to heal and the dental implant to anchor (Osseo integration). After several months, the portective cover is removed ans a temporary healing is placed on top of the dental implant. The temporary abutment serves as a template around which the gum grows and shapes itself in a natural way. The process is completed when the temporary abutment is replaced with a permanent crown.
How Painful are Dental Implants?
Most people who have received dental implants say that there is very little discomfort involved in the procedure. Local anesthesia can be used durint the procedure, and most patients report that implants cause less pain than a tooth extraction.
After the dental implant, mild soreness can be treated with over-the-counter pain medications, such as Tylenol.
How Do I Care for My Implant?
Dental implants require the same care as real teeth, including;
Brushing after meals of at least twice a day.
Cleaning with cholhexidine mouth wash after meal in case of unable to do brushing.
Applying dental flossing after meals or at least once daily before bed time.
Avoiding rigid or hard chewing food to prevent broken of the teeth.
Undergoing regular dental check-ups.
De. Jaran Busagonruangrat
Docter of Dental Surgery
Dental Center Bangpakok 9 Internnational Hospital
Can Anyone Get Dental Implant?
In most cases, anyone healthy enough to undergo a routine dental extraction or oral surgery can be considered for an implant procedure. Patients should have healthy gums and enough bone to hole the implant. They also m ust be committed to good oral hygiene and regular dental visits. Heavy smokers, people suffering from uncontrolled chronic disorders-such as diabetes or heart disease-or patients who have had radiation therapy to the head/neck area need to be evaluated on an individual basis. If yoy are considering implants, talk to your dentist to see if they are right for you.
Tuesday, October 13, 2009
Cancer cure still far off
Politicians and researchers have predicted for nearly four decades that a cure for cancer is near, but cancer death rates have hardly budged and most new cancer drugs cost a fortune while giving patients few, if any, added weeks of life. For this collective failure,the man atop the United States' regulatory agency for new cancer drugs increasingly - and supporters say unfairly - gets the blame: Dr Richard Pazdur.
Patient advocates have called Dr Pazdur, director of the Food and Drug Administration's cancer drug office, a murderer, conservative pundits have vilified him as an obstructionist bureaucrat, and guards are now posted at the agency's public cancer advisory meetings to protect him and other committee members.
"The industry is not producing that many good drugs, so now they're looking for scapegoats in Rick Pazdur and the FDA," said Ira S. Loss,who follows the drug industry for Washington Analysis, a service for investors.
In 10 years at the Food and Drug Administration, Dr Pazdur,57, has helped to loosen approval standards for cancer medicines and made it easier for dying patients to get experimental drugs. But he demands that drug makers prove with near certainty that their products are beneficial, a requirement that he repeated at a public advisory hearing on September 1 in the slow,loud tones of someone disciplining a dog. After he spoke, the committee of experts voted to reject both drugs.
Critics say that Dr Pazdur's resolve has cost thousands of lives and set back the pace of discoveries."Patients are right to be angry and frustrated with Richard Pazdur," said Steven Walker, co-founder of the Abigail Alliance, a patient-advocacy group."He is a dinosaur."
But neither the controversies swirling about him nor his years as an oncologist treating terminal patients have dented Pazdur's naturally sunny disposition. He laughs like Charles Nelson Reilly,eats like Gandhi and likens his tenure at the drug administration to that of a Roman Catholic priest from the 1960s who had to translate the Latin liturgy into plain language.
"You can't win in this job," Dr Pazdur said in an interview in his office."If you approve a drug,they accuse you of lowering standards. And if you don't approve it, you're the worst thing since the Nazi death camps and should be killed."
Whether Dr Pazdur has struck the right balance between hope and certainty has enormous consequences for patients and industry. Cancer is the second-leading cause of death in the US;more than 562,000 people are expected to die of it this year.
Pharmaceutical and biotechnology companies are testing more than 860 new cancer medicines - more than in any other disease category,according to manufacturers. Because patients are desperate and insurers are often forced by law to pay, prices are soaring, making cancer medicines among the best ways for drug makers to make money. But cancer has proven difficult to crack, leading to frustration among executives and advocates who wonder why the FDA is not approving more drugs.
No cancer medicines can be sold to or even tested on people without the imprimatur of Dr Pazdur and his staff of about 150 oncologists,toxicologists and other specialists. But pressure from advocacy groups and cancer researchers frustrated with failure have led the agency to abandon many of the usual approval requirements.
Federal law requires that the agency demand two "well controlled" trials before approving a drug; in cancer, the FDA is often satisfied with just one. With many experimental drugs, the agency demands trials with thousands of patients,while for cancer, it has accepted studies with a few dozen.
Before Dr Pazdur's arrival, the agency largely insisted that drug makers prove that their products extended life. Companies did this by giving the drug to one group of patients, providing a placebo or an older drug to another group and then seeing which group lived longer. But some cancers take a long time to kill, making survival trials lengthy and expensive. So the drug administration under Dr Pazdur's leadership increasingly allowed some studies to track a drug's effect with X-rays.If scans showed that tumours grew less rapidly,the drug could be approved.
Dr Pazdur pressed for the changes because,he said, the growing number of approved cancer medicines made determining whether any one delayed death increasingly difficult. Many patients now cycle through several medicines before dying.And some drugs that have not been proven to extend life may delay more serious symptoms and medical interventions, he said.
For instance, the drug administration initially rejected oxaliplatin because no trial at the time proved that it delayed death. But the agency finally relented in 2002- years after the drug's approval in Europe - because scans showed that it postponed tumour growth. Oxaliplatin is now commonly used to combat colorectal cancer.
Some patient advocates - mostly from older,more established organisations - bemoan these changes because even if a drug shrinks tumours,it may do nothing to delay death or improve patients' last days. And because so many cancer medicines have toxic side effects and high prices,drugs that have no proven benefit may actually be harmful to patients' health and economic well-being.
These advocates point to mistakes like toxic chemotherapy with bone marrow transplants in breast cancer, which in the 1980s and 1990s increased the suffering of nearly 30,000 women before studies finally showed that it was ineffective.When in doubt, the drug administration should not approve, they say.
"We want drugs that prolong survival, not drugs that just improve a test result," said Frances M. Visco, president of the National Breast Cancer Coalition.
To others - mostly newer, more aggressive patient organisations - the FDA's cancer group under Dr Pazdur's leadership has not lowered standards or sped approvals nearly enough. If there is any hint that a drug works, dying patients -many of whom have run out of other options - should be allowed to buy them, they said.
And some cancer specialists say that Dr Pazdur,after pushing for years to lower approval standards,has toughened them recently after being criticised for approving drugs that were later shown to have few benefits.
"I'm worried there's been a change in his thinking that could be adverse for the field,"said Dr Bruce A. Chabner, clinical director of the Massachusetts General Hospital Cancer Center and a member of the board of directors of PharmaMar, a Spanish biotech company whose drug Yondelis is approved in Europe but was rejected in July by the FDA's cancer advisory board after a critical introduction by Dr Pazdur.
Little of this controversy surrounding Dr Pazdur affects the development of truly powerful medicines. In 2001, his agency took just 11 weeks to approve Gleevec, which has miraculous effects on a form of leukaemia. But when drugs have marginal benefits, figuring out whether they work is controversial and time consuming.
Many of the recent rejects have come from small biotechnology companies for which a single FDA approval can be the difference between fiscal calamity and vast profits. On September 1,tiny Vion Pharmaceuticals brought its leukaemia drug Onrigin to an FDA advisory committee for consideration.
One clinical trial found that Onrigin increased deaths three-fold compared with a placebo. The drug administration told the company in meetings in 2004 and 2006 that another trial was so poorly designed that it was unlikely to pass muster.Vion persisted.
During the company's presentation to the advisory committee, Dr Pazdur seemed at times visibly pained - grimacing or shaking his head.When patients brought to the meeting by Vion spoke about Onrigin's benefits, he turned away ("Only patients who benefit from the drugs are brought to the meetings, not those who are harmed or get nothing," he explained later.) He reminded the committee,"We only have one randomised trial here which shows an increase in death."
The committee voted 13 to 0 to require a new study. Vion executives would not comment.
Some small companies seeking approval of a drug have waged public campaigns with the help of investors and advocacy groups that sometimes lead to vicious attacks on Dr Pazdur. Take the case of Xcytrin, a brain cancer medicine made by Pharmacyclics of Sunnyvale, California.After a key study failed to show that the drug worked, the company's chief executive at the time, Dr Richard Miller, blamed doctors at a hospital in France.
"They got a very negative result there, and it really skewed the data," Dr Miller said in an interview.
He lobbied top FDA officials to approve the drug anyway. They refused. He became a prominent agency critic, writing four opinion columns in The Wall Street Journal in 2007 arguing that the agency was keeping vital treatments from dying patients.
Dr Miller did not make public the drug agency's reasons for rejecting Xcytrin and, because the law prevents the agency from discussing drug rejections, Dr Pazdur remained mum.
A year ago, Dr Miller was replaced as chief executive at Pharmacyclics by Robert W. Duggan.In an interview, Duggan said that the Xcytrin study was flawed, and that the drug administration was right to reject the drug.
"It's not just one hospital mishandling the data. That's false," said Duggan, who described the trial's results as a "dog's breakfast" of confusing signals. Biotech executives often blame the drug administration for their own failures so they can continue to raise money from investors, Duggan said.
Dr Miller, who is raising money for a new company, responded:"I think Mr Duggan is making nice to the FDA."
Tony Fiorino, president and chief executive of EnzymeRx, in Paramus, New Jersey, said that biotech executives were often former scientists who believed so deeply in their products that "it's an ecstatic experience". When the drug administration rejects their application, these executives have every incentive, he said, to "go ballistic on the agency".
"You're going to pull out all the stops," Fiorino said."This is your one lottery ticket."
And it is not just executives behind the attacks.Melvin Flores, an oxygen technician from Lowell,Arkansas, sent several email messages last year to Pazdur, one of which said,"You've murdered enough innocent people already - enough is enough."
Flores invested in a company whose cancer medicine did not get approved, pummelling its shares and depriving patients of a lifesaver, he said in an interview."It's a Holocaust that has happened," he said.
Besides singling out Dr Pazdur's email box,advocates have put his name on advertisements on city buses in the Washington area, sued him and shouted his name at protests. But Dr Pazdur said he and his family had endured far worse.
His grandfather, a Polish immigrant, was crushed to death under a railroad car in the Great Depression while sweeping up loose corn kernels to feed his family. With six children, his grandmother remarried, had three more children and was widowed again several years later when her second husband died in a construction accident.
His mother married her first husband two weeks before he shipped out for the Second World War; he was killed in the war. Dr Pazdur's father, a factory worker for Standard Oil of Indiana,went blind from glaucoma when Dr Pazdur was a young teenager, impoverishing his family anew.
An avid gym cyclist who is greyhound-thin,Dr Pazdur does not eat meat because he believes a vegetarian diet will help protect him from cancer, although the supporting evidence is as thin as vegetable broth. His wife, Mary, said that when he travels, she buys herself a nice steak.
Dr Pazdur became intrigued with the FDA while overseeing drug trials at the University of Texas M.D. Anderson Cancer Centre. When the cancer job became available, he applied. On his first day, he was struck by how much the agency resembled the Catholic church of his childhood.
"We had a door in our old office that was controlled electronically, so someone had to buzz you in," Dr Pazdur said."We had that same door in my grade school separating the convent from the school. It was such a secretive world here."
He set about changing that by reaching out to cancer advocacy and medical groups. He has held cancer advisory meetings at the annual meeting of the American Society of Clinical Oncology, the world's largest body of cancer scientists.And he began, in conjunction with others, an annual training programme for cancer researchers.
The result is that Dr Pazdur "has a lot of support within the mainstream cancer community", said Dr Otis W. Brawley, chief medical officer of the American Cancer Society. In May,the oncologists' society gave him a special recognition award for "his outstanding service to the oncology community".
Dr William John, a cancer researcher at Eli Lilly, described Dr Pazdur as knowledgeable and fair. But Walker, the patient advocate, said that Dr Pazdur's close ties with the oncology community showed the corruption of the entire clinical trial system.
Pazdur said that blaming the FDA for the dearth of new cancer medicines was "like blaming the failures of American education on the SAT test".
"We just do the assessments," he said.
Patient advocates have called Dr Pazdur, director of the Food and Drug Administration's cancer drug office, a murderer, conservative pundits have vilified him as an obstructionist bureaucrat, and guards are now posted at the agency's public cancer advisory meetings to protect him and other committee members.
"The industry is not producing that many good drugs, so now they're looking for scapegoats in Rick Pazdur and the FDA," said Ira S. Loss,who follows the drug industry for Washington Analysis, a service for investors.
In 10 years at the Food and Drug Administration, Dr Pazdur,57, has helped to loosen approval standards for cancer medicines and made it easier for dying patients to get experimental drugs. But he demands that drug makers prove with near certainty that their products are beneficial, a requirement that he repeated at a public advisory hearing on September 1 in the slow,loud tones of someone disciplining a dog. After he spoke, the committee of experts voted to reject both drugs.
Critics say that Dr Pazdur's resolve has cost thousands of lives and set back the pace of discoveries."Patients are right to be angry and frustrated with Richard Pazdur," said Steven Walker, co-founder of the Abigail Alliance, a patient-advocacy group."He is a dinosaur."
But neither the controversies swirling about him nor his years as an oncologist treating terminal patients have dented Pazdur's naturally sunny disposition. He laughs like Charles Nelson Reilly,eats like Gandhi and likens his tenure at the drug administration to that of a Roman Catholic priest from the 1960s who had to translate the Latin liturgy into plain language.
"You can't win in this job," Dr Pazdur said in an interview in his office."If you approve a drug,they accuse you of lowering standards. And if you don't approve it, you're the worst thing since the Nazi death camps and should be killed."
Whether Dr Pazdur has struck the right balance between hope and certainty has enormous consequences for patients and industry. Cancer is the second-leading cause of death in the US;more than 562,000 people are expected to die of it this year.
Pharmaceutical and biotechnology companies are testing more than 860 new cancer medicines - more than in any other disease category,according to manufacturers. Because patients are desperate and insurers are often forced by law to pay, prices are soaring, making cancer medicines among the best ways for drug makers to make money. But cancer has proven difficult to crack, leading to frustration among executives and advocates who wonder why the FDA is not approving more drugs.
No cancer medicines can be sold to or even tested on people without the imprimatur of Dr Pazdur and his staff of about 150 oncologists,toxicologists and other specialists. But pressure from advocacy groups and cancer researchers frustrated with failure have led the agency to abandon many of the usual approval requirements.
Federal law requires that the agency demand two "well controlled" trials before approving a drug; in cancer, the FDA is often satisfied with just one. With many experimental drugs, the agency demands trials with thousands of patients,while for cancer, it has accepted studies with a few dozen.
Before Dr Pazdur's arrival, the agency largely insisted that drug makers prove that their products extended life. Companies did this by giving the drug to one group of patients, providing a placebo or an older drug to another group and then seeing which group lived longer. But some cancers take a long time to kill, making survival trials lengthy and expensive. So the drug administration under Dr Pazdur's leadership increasingly allowed some studies to track a drug's effect with X-rays.If scans showed that tumours grew less rapidly,the drug could be approved.
Dr Pazdur pressed for the changes because,he said, the growing number of approved cancer medicines made determining whether any one delayed death increasingly difficult. Many patients now cycle through several medicines before dying.And some drugs that have not been proven to extend life may delay more serious symptoms and medical interventions, he said.
For instance, the drug administration initially rejected oxaliplatin because no trial at the time proved that it delayed death. But the agency finally relented in 2002- years after the drug's approval in Europe - because scans showed that it postponed tumour growth. Oxaliplatin is now commonly used to combat colorectal cancer.
Some patient advocates - mostly from older,more established organisations - bemoan these changes because even if a drug shrinks tumours,it may do nothing to delay death or improve patients' last days. And because so many cancer medicines have toxic side effects and high prices,drugs that have no proven benefit may actually be harmful to patients' health and economic well-being.
These advocates point to mistakes like toxic chemotherapy with bone marrow transplants in breast cancer, which in the 1980s and 1990s increased the suffering of nearly 30,000 women before studies finally showed that it was ineffective.When in doubt, the drug administration should not approve, they say.
"We want drugs that prolong survival, not drugs that just improve a test result," said Frances M. Visco, president of the National Breast Cancer Coalition.
To others - mostly newer, more aggressive patient organisations - the FDA's cancer group under Dr Pazdur's leadership has not lowered standards or sped approvals nearly enough. If there is any hint that a drug works, dying patients -many of whom have run out of other options - should be allowed to buy them, they said.
And some cancer specialists say that Dr Pazdur,after pushing for years to lower approval standards,has toughened them recently after being criticised for approving drugs that were later shown to have few benefits.
"I'm worried there's been a change in his thinking that could be adverse for the field,"said Dr Bruce A. Chabner, clinical director of the Massachusetts General Hospital Cancer Center and a member of the board of directors of PharmaMar, a Spanish biotech company whose drug Yondelis is approved in Europe but was rejected in July by the FDA's cancer advisory board after a critical introduction by Dr Pazdur.
Little of this controversy surrounding Dr Pazdur affects the development of truly powerful medicines. In 2001, his agency took just 11 weeks to approve Gleevec, which has miraculous effects on a form of leukaemia. But when drugs have marginal benefits, figuring out whether they work is controversial and time consuming.
Many of the recent rejects have come from small biotechnology companies for which a single FDA approval can be the difference between fiscal calamity and vast profits. On September 1,tiny Vion Pharmaceuticals brought its leukaemia drug Onrigin to an FDA advisory committee for consideration.
One clinical trial found that Onrigin increased deaths three-fold compared with a placebo. The drug administration told the company in meetings in 2004 and 2006 that another trial was so poorly designed that it was unlikely to pass muster.Vion persisted.
During the company's presentation to the advisory committee, Dr Pazdur seemed at times visibly pained - grimacing or shaking his head.When patients brought to the meeting by Vion spoke about Onrigin's benefits, he turned away ("Only patients who benefit from the drugs are brought to the meetings, not those who are harmed or get nothing," he explained later.) He reminded the committee,"We only have one randomised trial here which shows an increase in death."
The committee voted 13 to 0 to require a new study. Vion executives would not comment.
Some small companies seeking approval of a drug have waged public campaigns with the help of investors and advocacy groups that sometimes lead to vicious attacks on Dr Pazdur. Take the case of Xcytrin, a brain cancer medicine made by Pharmacyclics of Sunnyvale, California.After a key study failed to show that the drug worked, the company's chief executive at the time, Dr Richard Miller, blamed doctors at a hospital in France.
"They got a very negative result there, and it really skewed the data," Dr Miller said in an interview.
He lobbied top FDA officials to approve the drug anyway. They refused. He became a prominent agency critic, writing four opinion columns in The Wall Street Journal in 2007 arguing that the agency was keeping vital treatments from dying patients.
Dr Miller did not make public the drug agency's reasons for rejecting Xcytrin and, because the law prevents the agency from discussing drug rejections, Dr Pazdur remained mum.
A year ago, Dr Miller was replaced as chief executive at Pharmacyclics by Robert W. Duggan.In an interview, Duggan said that the Xcytrin study was flawed, and that the drug administration was right to reject the drug.
"It's not just one hospital mishandling the data. That's false," said Duggan, who described the trial's results as a "dog's breakfast" of confusing signals. Biotech executives often blame the drug administration for their own failures so they can continue to raise money from investors, Duggan said.
Dr Miller, who is raising money for a new company, responded:"I think Mr Duggan is making nice to the FDA."
Tony Fiorino, president and chief executive of EnzymeRx, in Paramus, New Jersey, said that biotech executives were often former scientists who believed so deeply in their products that "it's an ecstatic experience". When the drug administration rejects their application, these executives have every incentive, he said, to "go ballistic on the agency".
"You're going to pull out all the stops," Fiorino said."This is your one lottery ticket."
And it is not just executives behind the attacks.Melvin Flores, an oxygen technician from Lowell,Arkansas, sent several email messages last year to Pazdur, one of which said,"You've murdered enough innocent people already - enough is enough."
Flores invested in a company whose cancer medicine did not get approved, pummelling its shares and depriving patients of a lifesaver, he said in an interview."It's a Holocaust that has happened," he said.
Besides singling out Dr Pazdur's email box,advocates have put his name on advertisements on city buses in the Washington area, sued him and shouted his name at protests. But Dr Pazdur said he and his family had endured far worse.
His grandfather, a Polish immigrant, was crushed to death under a railroad car in the Great Depression while sweeping up loose corn kernels to feed his family. With six children, his grandmother remarried, had three more children and was widowed again several years later when her second husband died in a construction accident.
His mother married her first husband two weeks before he shipped out for the Second World War; he was killed in the war. Dr Pazdur's father, a factory worker for Standard Oil of Indiana,went blind from glaucoma when Dr Pazdur was a young teenager, impoverishing his family anew.
An avid gym cyclist who is greyhound-thin,Dr Pazdur does not eat meat because he believes a vegetarian diet will help protect him from cancer, although the supporting evidence is as thin as vegetable broth. His wife, Mary, said that when he travels, she buys herself a nice steak.
Dr Pazdur became intrigued with the FDA while overseeing drug trials at the University of Texas M.D. Anderson Cancer Centre. When the cancer job became available, he applied. On his first day, he was struck by how much the agency resembled the Catholic church of his childhood.
"We had a door in our old office that was controlled electronically, so someone had to buzz you in," Dr Pazdur said."We had that same door in my grade school separating the convent from the school. It was such a secretive world here."
He set about changing that by reaching out to cancer advocacy and medical groups. He has held cancer advisory meetings at the annual meeting of the American Society of Clinical Oncology, the world's largest body of cancer scientists.And he began, in conjunction with others, an annual training programme for cancer researchers.
The result is that Dr Pazdur "has a lot of support within the mainstream cancer community", said Dr Otis W. Brawley, chief medical officer of the American Cancer Society. In May,the oncologists' society gave him a special recognition award for "his outstanding service to the oncology community".
Dr William John, a cancer researcher at Eli Lilly, described Dr Pazdur as knowledgeable and fair. But Walker, the patient advocate, said that Dr Pazdur's close ties with the oncology community showed the corruption of the entire clinical trial system.
Pazdur said that blaming the FDA for the dearth of new cancer medicines was "like blaming the failures of American education on the SAT test".
"We just do the assessments," he said.
Sunday, October 11, 2009
Graft inquiry shows we're serious- PM
Inquiries into alleged irregularities under the economic stimulus package at the Public Health Ministry would show how determined the government is in fighting corruption, Prime Minister Abhisit Vejjajiva says.
"Authorities were told from the beginning that they need to be extra careful when a scheme of this scale and enormous budget is involved as it will be prone to corruption," Mr Abhisit said during his weekly television and radio address yesterday.
The prime minister has instructed Public Health Minister Witthaya Kaewparadai to speed up the investigations into the graft allegations.
"I want to prove to the people that my government is determined to make state projects corruption-free," he said.
Mr Abhisit's assurances come just days after his meeting with the president of the Rural Doctors Society, Kriangsak Vacharanukulkiat, who raised the alleged irregularities under the 86 billion baht medical supplies and equipment procurement programme.
Dr Kriangsak also revealed the names of politicians he claimed were involved in the irregularities, Mr Abhisit said.
The prime minister has agreed to consider calls to change the make up of the inquiry panels to ensure the investigations remain free of political meddling.
The investigations focus on two areas,Mr Abhisit said: the unusually high cost of constructing buildings, and the list of medical supplies which does not match the needs of hospitals.
The unwanted medical items had been included on the list upon a request from members of the public health minister's advisory team, the doctor claimed.
Mr Witthaya said he would push ahead with the scheme.
Speaking at a meeting in Songkhla yesterday, the embattled minister called on health officials not to let down the public.
"The scheme must go ahead and it's the duty of public health officials to prove that it is corruption-free and is beneficial to the people," he said.
"Authorities were told from the beginning that they need to be extra careful when a scheme of this scale and enormous budget is involved as it will be prone to corruption," Mr Abhisit said during his weekly television and radio address yesterday.
The prime minister has instructed Public Health Minister Witthaya Kaewparadai to speed up the investigations into the graft allegations.
"I want to prove to the people that my government is determined to make state projects corruption-free," he said.
Mr Abhisit's assurances come just days after his meeting with the president of the Rural Doctors Society, Kriangsak Vacharanukulkiat, who raised the alleged irregularities under the 86 billion baht medical supplies and equipment procurement programme.
Dr Kriangsak also revealed the names of politicians he claimed were involved in the irregularities, Mr Abhisit said.
The prime minister has agreed to consider calls to change the make up of the inquiry panels to ensure the investigations remain free of political meddling.
The investigations focus on two areas,Mr Abhisit said: the unusually high cost of constructing buildings, and the list of medical supplies which does not match the needs of hospitals.
The unwanted medical items had been included on the list upon a request from members of the public health minister's advisory team, the doctor claimed.
Mr Witthaya said he would push ahead with the scheme.
Speaking at a meeting in Songkhla yesterday, the embattled minister called on health officials not to let down the public.
"The scheme must go ahead and it's the duty of public health officials to prove that it is corruption-free and is beneficial to the people," he said.
Saturday, October 10, 2009
Democrats to eradicate loopholes
The Democrat Party has pledged to eradicate loopholes in the Thai Kem Kaeng economic stimulus project by learning a lesson from alleged irregularities in the Public Health Ministry's procurement of medical supplies.
The Rural Doctors Society has accused the ministry of spending money on unnecessary and overpriced medical items for hospitals.
Democrat spokesman Buranaj Smutharaks said the case would be considered in the cabinet meeting on Tuesday when Prime Minister Abhisit Vejjajiva and his ministers are scheduled to discuss the budget for a second economic stimulus project.
The ministry has been given 86.6 billion baht under the Thai Kem Kaeng project, which is part of a huge budget of 1.44 trillion baht.
Around 60% of the ministry's spending goes to build public health buildings while the rest is used to buy medical equipment for hospitals.
However, the Rural Doctors Society has alleged hospitals did not participate in the procurement and many bought items which were unnecessary and unusually expensive.
The allegations have forced the advisory team of minister Witthaya Kaewparadai to resign. Doctors on Friday also demanded Mr Witthaya and his deputy Manit Nopamornbodee step down to make way for a transparent inquiry.
Dr Buranaj yesterday defended the ministers, saying they did not have to resign now as there was no evidence of their involvement in the alleged scandal.
However, he said the government has agreed to investigate the case and even cancel the acquisition of some medical supplies.
He urged the society to directly tell Mr Abhisit if it had evidence showing ministers have been involved in corrupt acts.
The society's head Kriengsak Watcharanukulkiat conceded that it was difficult to get "the bills" to prove the alleged irregularities.
However, he had the documents showing the average prices of medical equipment and construction projects under the Thailand: Investing from Strength to Strength scheme were much higher than the figures used in normal projects.
For example, Phu Kradueng Hospital built a 24-room nurse dormitory at a cost of 6.8 million baht in December last year, but a building of the same type cost as much as 9.57 million baht under the Thai Kem Kaeng scheme.
A doctor's residence normally costs 760,000 baht, but the budget jumped to 1.89 million baht under the project.
"This should be sufficient evidence to show that there is something fishy in this mega-spending scheme," Dr Kriengsak said.
He called on public health officials,particularly the management of rural hospitals who were forced to follow the politicians' orders, to speak up.
"Without information from state officials, it will be difficult to unmask politicians implicated in the alleged corruption," he said.
The Rural Doctors Society has accused the ministry of spending money on unnecessary and overpriced medical items for hospitals.
Democrat spokesman Buranaj Smutharaks said the case would be considered in the cabinet meeting on Tuesday when Prime Minister Abhisit Vejjajiva and his ministers are scheduled to discuss the budget for a second economic stimulus project.
The ministry has been given 86.6 billion baht under the Thai Kem Kaeng project, which is part of a huge budget of 1.44 trillion baht.
Around 60% of the ministry's spending goes to build public health buildings while the rest is used to buy medical equipment for hospitals.
However, the Rural Doctors Society has alleged hospitals did not participate in the procurement and many bought items which were unnecessary and unusually expensive.
The allegations have forced the advisory team of minister Witthaya Kaewparadai to resign. Doctors on Friday also demanded Mr Witthaya and his deputy Manit Nopamornbodee step down to make way for a transparent inquiry.
Dr Buranaj yesterday defended the ministers, saying they did not have to resign now as there was no evidence of their involvement in the alleged scandal.
However, he said the government has agreed to investigate the case and even cancel the acquisition of some medical supplies.
He urged the society to directly tell Mr Abhisit if it had evidence showing ministers have been involved in corrupt acts.
The society's head Kriengsak Watcharanukulkiat conceded that it was difficult to get "the bills" to prove the alleged irregularities.
However, he had the documents showing the average prices of medical equipment and construction projects under the Thailand: Investing from Strength to Strength scheme were much higher than the figures used in normal projects.
For example, Phu Kradueng Hospital built a 24-room nurse dormitory at a cost of 6.8 million baht in December last year, but a building of the same type cost as much as 9.57 million baht under the Thai Kem Kaeng scheme.
A doctor's residence normally costs 760,000 baht, but the budget jumped to 1.89 million baht under the project.
"This should be sufficient evidence to show that there is something fishy in this mega-spending scheme," Dr Kriengsak said.
He called on public health officials,particularly the management of rural hospitals who were forced to follow the politicians' orders, to speak up.
"Without information from state officials, it will be difficult to unmask politicians implicated in the alleged corruption," he said.
Friday, October 9, 2009
Fake drugs swamping region
Fake malaria drugs from China are breeding resistance to life-saving medications in Thailand and Cambodia, threatening to derail global efforts to eradicate the disease, a study funded by the Bill and Melinda Gates Foundation found.
Among more than 700 packets of pills sold at private drugstores in Cambodia and Thailand,60% were found to be substandard or counterfeit around the border, compared with less than 5% in other areas in Thailand, said Patrick Lukulay, director of drug quality and information for US Pharmacopeia,a Rockville, Maryland-based organisation that tracks fake drugs. Previous studies have suggested about one-third of malaria drugs in western Cambodia are fake, Mr Lukulay said. Substandard treatments are contributing to growing resistance to genuine medicines in the area, he added. That threatens to unravel progress made against the disease in Africa, which has 90% of the world's malaria cases, if the resistant strain spreads there, researchers have warned.
"We did not expect a worsening of the situation," Mr Lukulay said in Phnom Penh yesterday."We thought that by now things would have improved, but in fact they have not. The border areas are still notorious for having poor quality medicines."
Malaria strikes about 250 million people each year and kills more than 880,000, mostly children under five,according to the World Health Organisation. Its the world's third-deadliest infectious disease, behind Aids, which results in about 2 million deaths each year, and tuberculosis, which kills 1.6 million people annually.
The disease is caused by a tiny parasite called Plasmodium, carried in the saliva of female mosquitoes. When an infected insect bites a person, the bugs travel to the liver, multiply and enter the bloodstream. There they invade red cells,leading to fever, chills, nausea and diarrhoea. Unchecked, they cause red cells to stick to the walls of capillaries,slowing blood flow. Sufferers can die from organ failure without treatment.
The pills tested in the $350,000(11.7 million baht) Gates-funded study were mostly from China and touted to contain artesunate, part of a family of drugs called artemisinins that are the most potent weapons against malaria, Mr Lukulay said. In reality, the study completed last week found that some had no active ingredient, while others contained small amounts, which fuel resistance by aiding the survival of the hardiest parasites, he said.
Treatments derived from artemisinin are taking almost twice as long to clear the parasites in patients in western Cambodia than in northwestern Thailand,showing the drugs are losing their potency against the disease, a study published in July in the New England Journal Of Medicine showed."This is a very, very large problem potentially for the whole world," said Nick White, director of the Bangkokbased Mahidol Oxford Tropical Medicine Research Unit, which is studying drug-resistant malaria in the areas around the Thai-Cambodia border."The scale and the speed of the response have been unfortunately too small."
Researchers are still trying to understand why counterfeit malaria drugs are so abundant there, Mr Lukulay said.
The WHO, which also participated in the drug-quality study, is trying to eliminate the resistant strain from that region with a mass screening and treatment programme backed by $23 million from the Seattle-based Gates Foundation.
Among more than 700 packets of pills sold at private drugstores in Cambodia and Thailand,60% were found to be substandard or counterfeit around the border, compared with less than 5% in other areas in Thailand, said Patrick Lukulay, director of drug quality and information for US Pharmacopeia,a Rockville, Maryland-based organisation that tracks fake drugs. Previous studies have suggested about one-third of malaria drugs in western Cambodia are fake, Mr Lukulay said. Substandard treatments are contributing to growing resistance to genuine medicines in the area, he added. That threatens to unravel progress made against the disease in Africa, which has 90% of the world's malaria cases, if the resistant strain spreads there, researchers have warned.
"We did not expect a worsening of the situation," Mr Lukulay said in Phnom Penh yesterday."We thought that by now things would have improved, but in fact they have not. The border areas are still notorious for having poor quality medicines."
Malaria strikes about 250 million people each year and kills more than 880,000, mostly children under five,according to the World Health Organisation. Its the world's third-deadliest infectious disease, behind Aids, which results in about 2 million deaths each year, and tuberculosis, which kills 1.6 million people annually.
The disease is caused by a tiny parasite called Plasmodium, carried in the saliva of female mosquitoes. When an infected insect bites a person, the bugs travel to the liver, multiply and enter the bloodstream. There they invade red cells,leading to fever, chills, nausea and diarrhoea. Unchecked, they cause red cells to stick to the walls of capillaries,slowing blood flow. Sufferers can die from organ failure without treatment.
The pills tested in the $350,000(11.7 million baht) Gates-funded study were mostly from China and touted to contain artesunate, part of a family of drugs called artemisinins that are the most potent weapons against malaria, Mr Lukulay said. In reality, the study completed last week found that some had no active ingredient, while others contained small amounts, which fuel resistance by aiding the survival of the hardiest parasites, he said.
Treatments derived from artemisinin are taking almost twice as long to clear the parasites in patients in western Cambodia than in northwestern Thailand,showing the drugs are losing their potency against the disease, a study published in July in the New England Journal Of Medicine showed."This is a very, very large problem potentially for the whole world," said Nick White, director of the Bangkokbased Mahidol Oxford Tropical Medicine Research Unit, which is studying drug-resistant malaria in the areas around the Thai-Cambodia border."The scale and the speed of the response have been unfortunately too small."
Researchers are still trying to understand why counterfeit malaria drugs are so abundant there, Mr Lukulay said.
The WHO, which also participated in the drug-quality study, is trying to eliminate the resistant strain from that region with a mass screening and treatment programme backed by $23 million from the Seattle-based Gates Foundation.
Wednesday, October 7, 2009
THONGLOR PET HOSPITAL TO LIST ON SET
Thonglor Pet Hospital plans to list on the Stock Exchange of Thailand next year to raise funds for expansion.
Managing director Boonchu Thongcharoenpoonporn yesterday said the company wanted to make the institution the country's pet-hospital leader within three years.
The listing plan should help the company to achieve the target.
The company plans to increase its number of hospitals from the current five branches to eight in the next three years. Each branch requires a budget of about Bt100 million, he said.
After listing on the SET, the company will grow by 30 per cent during the three-year plan, he added.
Thonglor Pet Hospital plans to develop into a specialist medical centre for pets. It has already purchased medical equipment worth more than Bt30 million and will install computers and tele-medicine to exchange information on treatment between the main hospital and provincial branches.
There are 1,400 pet hospitals nationwide with an overall growth rate of 10 per cent a year, according to the company.
Thonglor Pet Hospital projects revenue growth of 30 per cent this year.
The pet market is valued at Bt10 billion, which covers pet services, food, clothing, fashion and shampoos.
Managing director Boonchu Thongcharoenpoonporn yesterday said the company wanted to make the institution the country's pet-hospital leader within three years.
The listing plan should help the company to achieve the target.
The company plans to increase its number of hospitals from the current five branches to eight in the next three years. Each branch requires a budget of about Bt100 million, he said.
After listing on the SET, the company will grow by 30 per cent during the three-year plan, he added.
Thonglor Pet Hospital plans to develop into a specialist medical centre for pets. It has already purchased medical equipment worth more than Bt30 million and will install computers and tele-medicine to exchange information on treatment between the main hospital and provincial branches.
There are 1,400 pet hospitals nationwide with an overall growth rate of 10 per cent a year, according to the company.
Thonglor Pet Hospital projects revenue growth of 30 per cent this year.
The pet market is valued at Bt10 billion, which covers pet services, food, clothing, fashion and shampoos.
Friday, October 2, 2009
Health procurement projects put on hold
All Public Health Ministry procurement projects under the government's stimulus programme have been halted due to corruption allegations.
Acting permanent secretary for public health Paijit Warachit yesterday shelved all procurement projects for medical equipment and ambulances to be funded under the "Thailand: Investing from Strength to Strength" scheme.
The order came only a day after he ordered the purchase of UV sanitisers at community hospitals be delayed.
"All procurement projects have to be deferred for transparency reasons until the two committees have completed their findings," he said.
"Any procurement project found to have irregularities or to be unnecessary will be cancelled."
Dr Paijit appointed public health inspector Seri Hongyok to chair a committee investigating the purchase of UV sanitisers.
Another panel will scrutinise other health related procurement proposals.
The preliminary findings should be released by Oct 8, Dr Paijit said.
The freeze came after the Rural Doctors Society revealed irregularities in the planned purchase of equipment at community hospitals. An 86.6 billion baht budget had been allocated for local public health authorities to make the purchases.
For the first time in several years, the government has allocated a massive budget to the Public Health Ministry.
The doctors' group said the funding,50 times larger than the annual health budget, could be skimmed by politicians and officials.
UV sanitisers, for example, had been added to the procurement list for community hospitals without their request.
The quoted price was 40,000 baht for each machine, compared with a market price of only 6,000 baht.
Kriangsak Vatcharanukulkiat, director of Phu Kradueng Hospital and president of the Rural Doctors Society, said the plan to purchase flagpoles for small community hospitals should be reviewed as the quoted price of 495,000 baht for each pole was inflated.
Suppakit Sirilak, director of the ministry's Bureau of Policy and Strategy responsible for projects under the government's stimulus package scheme, said he would seek advice from the Budget Bureau to ensure transparency in the procurement process.
Acting permanent secretary for public health Paijit Warachit yesterday shelved all procurement projects for medical equipment and ambulances to be funded under the "Thailand: Investing from Strength to Strength" scheme.
The order came only a day after he ordered the purchase of UV sanitisers at community hospitals be delayed.
"All procurement projects have to be deferred for transparency reasons until the two committees have completed their findings," he said.
"Any procurement project found to have irregularities or to be unnecessary will be cancelled."
Dr Paijit appointed public health inspector Seri Hongyok to chair a committee investigating the purchase of UV sanitisers.
Another panel will scrutinise other health related procurement proposals.
The preliminary findings should be released by Oct 8, Dr Paijit said.
The freeze came after the Rural Doctors Society revealed irregularities in the planned purchase of equipment at community hospitals. An 86.6 billion baht budget had been allocated for local public health authorities to make the purchases.
For the first time in several years, the government has allocated a massive budget to the Public Health Ministry.
The doctors' group said the funding,50 times larger than the annual health budget, could be skimmed by politicians and officials.
UV sanitisers, for example, had been added to the procurement list for community hospitals without their request.
The quoted price was 40,000 baht for each machine, compared with a market price of only 6,000 baht.
Kriangsak Vatcharanukulkiat, director of Phu Kradueng Hospital and president of the Rural Doctors Society, said the plan to purchase flagpoles for small community hospitals should be reviewed as the quoted price of 495,000 baht for each pole was inflated.
Suppakit Sirilak, director of the ministry's Bureau of Policy and Strategy responsible for projects under the government's stimulus package scheme, said he would seek advice from the Budget Bureau to ensure transparency in the procurement process.
Vitallife to launch blood testing for anti-ageing
Vitallife, operator of Vitallife Wellness Centre, a leading anti-ageing medicine provider, will launch VitechPro in mid-December.
It will be the first advanced wellness lab for anti-ageing and preventive medicine in Southeast Asia. The new unit is part of company plans to expand its client base from individuals to companies.
CEO Anthony Jude Tan yesterday said Vitallife, a subsidiary of Bumrungrad Hospital, where it is located, had spent Bt30 million to set up VitechPro.
Of that, Bt22 million was used to import an LCMS-MS machine, an advanced diagnostic lab tool to test blood in the course of anti-ageing and preventive treatment. Once the blood is tested, VitechPro can customise n8utraceuticals for patients in its affiliated clinics and other wellness centres throughout Southeast Asia.
This method has become standard in wellness centres and is gaining in popularity among health-conscious consumers. At present, centres must send blood samples to the US or Europe and wait roughly four weeks for the results.
But with this new service, Vitallife can complete blood tests within a week, which will be much more convenient. VitechPro's blood test will also save 20-30 per cent on the cost.
VitechPro, a pioneer in anti-ageing and preventive medicine, will also provide short courses for its affiliated clinics, so they can have a comprehensive knowledge of the field. Courses will cost US$20,000 (Bt671,000) for clinics outside of Thailand and $15,000 for local clinics.
VitechPro has already secured contracts with wellness centres in Indonesia, Singapore and the Philippines to be its affiliates.
Tan said many clinics throughout Southeast Asia were approaching VitechPro about doing their blood tests. It expects to have 10 corporate clients in the region next year along with eight local ones.
Vitallife expects the new business to generate Bt40 million next year, with revenue growth of 8-10 per cent per annum.
Tan said the global economic turmoil had not affected Vitallife Wellness Centre as much as it had its competitors. Its revenue is up 10 per cent year on year so far, and the company has targeted full-year revenue of Bt110 million.
Vitallife this year has appointed representatives in eight markets, including Russia, Malaysia, Portugal and Hong Kong. That number is expected to reach 13 by year-end, including the US and Germany.
"We expect Vitallife's revenue to grow 15 per cent next year with these new representatives," he said.
It will be the first advanced wellness lab for anti-ageing and preventive medicine in Southeast Asia. The new unit is part of company plans to expand its client base from individuals to companies.
CEO Anthony Jude Tan yesterday said Vitallife, a subsidiary of Bumrungrad Hospital, where it is located, had spent Bt30 million to set up VitechPro.
Of that, Bt22 million was used to import an LCMS-MS machine, an advanced diagnostic lab tool to test blood in the course of anti-ageing and preventive treatment. Once the blood is tested, VitechPro can customise n8utraceuticals for patients in its affiliated clinics and other wellness centres throughout Southeast Asia.
This method has become standard in wellness centres and is gaining in popularity among health-conscious consumers. At present, centres must send blood samples to the US or Europe and wait roughly four weeks for the results.
But with this new service, Vitallife can complete blood tests within a week, which will be much more convenient. VitechPro's blood test will also save 20-30 per cent on the cost.
VitechPro, a pioneer in anti-ageing and preventive medicine, will also provide short courses for its affiliated clinics, so they can have a comprehensive knowledge of the field. Courses will cost US$20,000 (Bt671,000) for clinics outside of Thailand and $15,000 for local clinics.
VitechPro has already secured contracts with wellness centres in Indonesia, Singapore and the Philippines to be its affiliates.
Tan said many clinics throughout Southeast Asia were approaching VitechPro about doing their blood tests. It expects to have 10 corporate clients in the region next year along with eight local ones.
Vitallife expects the new business to generate Bt40 million next year, with revenue growth of 8-10 per cent per annum.
Tan said the global economic turmoil had not affected Vitallife Wellness Centre as much as it had its competitors. Its revenue is up 10 per cent year on year so far, and the company has targeted full-year revenue of Bt110 million.
Vitallife this year has appointed representatives in eight markets, including Russia, Malaysia, Portugal and Hong Kong. That number is expected to reach 13 by year-end, including the US and Germany.
"We expect Vitallife's revenue to grow 15 per cent next year with these new representatives," he said.
Flood-affected people to get medical help
The Public Health Ministry yesterday sent medical supplies to aid flood victims in the northern and northeastern areas hit by tropical depression "Ketsana".
Public Health Minister Witthaya Kaewparadai said 70,000 medical sets were dispatched to 15 flooded provinces for distribution to local mobile medical units giving preliminary help to flood affected people.
The 15 provinces include Ubon Ratchathani, Nong Khai, Nakhon Phanom, Mukdahan, Si Sa Ket, Roi Et, Yasothon, Buri Ram, Chiang Rai, Mae Hong Son, Nan, Uttaradit, Lampang, Chiang Mai and Tak.
In addition, the ministry has stockpiled around one million sets of medical supplies for emergency distribution to the inundated areas.
Over 100 residents of Ubon Ratchathani are reported suffering from floodrelated diseases.
Provincial health offices have been instructed to send medical workers to treat victims as well as educate them on basic treatment for such diseases, said Mr Witthaya.
The ministry has launched floodrelated Hotline 1699 to help stranded victims contact medical emergency teams.
According to the Meteorological Department, tropical depression Ketsana has been downgraded to active low pressure cell status, covering the Northeast. It is expected to move slowly along a low pressure trough passing through Nakhon Ratchasima and Thailand's central regions.
Public Health Minister Witthaya Kaewparadai said 70,000 medical sets were dispatched to 15 flooded provinces for distribution to local mobile medical units giving preliminary help to flood affected people.
The 15 provinces include Ubon Ratchathani, Nong Khai, Nakhon Phanom, Mukdahan, Si Sa Ket, Roi Et, Yasothon, Buri Ram, Chiang Rai, Mae Hong Son, Nan, Uttaradit, Lampang, Chiang Mai and Tak.
In addition, the ministry has stockpiled around one million sets of medical supplies for emergency distribution to the inundated areas.
Over 100 residents of Ubon Ratchathani are reported suffering from floodrelated diseases.
Provincial health offices have been instructed to send medical workers to treat victims as well as educate them on basic treatment for such diseases, said Mr Witthaya.
The ministry has launched floodrelated Hotline 1699 to help stranded victims contact medical emergency teams.
According to the Meteorological Department, tropical depression Ketsana has been downgraded to active low pressure cell status, covering the Northeast. It is expected to move slowly along a low pressure trough passing through Nakhon Ratchasima and Thailand's central regions.
Ministry halts UV sanitiser purchase plan
The Public Health Ministry has ordered its offices across the Kingdom to halt the funding of UV sanitisers purchased under the government's economic stimulus scheme.
The freeze follows complaints from the Rural Doctors Society about alleged corruption in the purchase of the equipment and other facilities involving the ministry's spending of an 86.6 billion baht fund under the Thailand: Investing from Strength to Strength scheme.
The Rural Doctors Society last week claimed there were irregularities in the ministry's spending under the scheme,saying some projects called for the purchase of medical equipment at inflated prices and some facilities were not necessary.
It cited the approved budget of over 300 million baht for UV sanitisers for use at community hospitals nationwide.The machines are not needed. Also,the price quoted was 40,000 baht each when the market price is only 6,000 baht.
Acting permanent secretary for public health Paijit Warachit yesterday said a letter had been sent to provincial public health offices calling a temporary halt to all purchases of UV sanitisers until the situation had been investigated.
Dr Paijit said two committees had been set up to look into the corruption allegations.
One chaired by public health inspector Seri Hongyok would consider if the purchases were needed.
A deputy permanent secretary would head the other panel looking into the transparency of other medical equipment and facility purchases under the scheme.
Preliminary results of the need for UV sanitisers for community hospitals should be completed within a week,Dr Paijit said.
The president of the Rural Doctors Society, Kriangsak Vatcharanukulkiat,said the Ubon Ratchathani provincial health office and other provinces had announced the terms of reference for the UV sanitiser procurement.
Meanwhile, the house committee on public health yesterday invited Dr Kriangsak to provide details of the alleged irregularities.
Dr Kriangsak told the committee the prices of medical supplies quoted under the scheme were up to 30%above market prices in some cases.
He also told the committee two politicians had spoken with two car companies about the zoning of the bidding for the ambulance supply contract.
Dr Kriangsak asked for a review of the procurement plan.
The freeze follows complaints from the Rural Doctors Society about alleged corruption in the purchase of the equipment and other facilities involving the ministry's spending of an 86.6 billion baht fund under the Thailand: Investing from Strength to Strength scheme.
The Rural Doctors Society last week claimed there were irregularities in the ministry's spending under the scheme,saying some projects called for the purchase of medical equipment at inflated prices and some facilities were not necessary.
It cited the approved budget of over 300 million baht for UV sanitisers for use at community hospitals nationwide.The machines are not needed. Also,the price quoted was 40,000 baht each when the market price is only 6,000 baht.
Acting permanent secretary for public health Paijit Warachit yesterday said a letter had been sent to provincial public health offices calling a temporary halt to all purchases of UV sanitisers until the situation had been investigated.
Dr Paijit said two committees had been set up to look into the corruption allegations.
One chaired by public health inspector Seri Hongyok would consider if the purchases were needed.
A deputy permanent secretary would head the other panel looking into the transparency of other medical equipment and facility purchases under the scheme.
Preliminary results of the need for UV sanitisers for community hospitals should be completed within a week,Dr Paijit said.
The president of the Rural Doctors Society, Kriangsak Vatcharanukulkiat,said the Ubon Ratchathani provincial health office and other provinces had announced the terms of reference for the UV sanitiser procurement.
Meanwhile, the house committee on public health yesterday invited Dr Kriangsak to provide details of the alleged irregularities.
Dr Kriangsak told the committee the prices of medical supplies quoted under the scheme were up to 30%above market prices in some cases.
He also told the committee two politicians had spoken with two car companies about the zoning of the bidding for the ambulance supply contract.
Dr Kriangsak asked for a review of the procurement plan.
HIV VACCINE TRIAL SUCCESS REPRESENTS A RAY OF HOPE
Following last week's announcement by the Public Health Ministry and other agencies of a modest but historic breakthrough in HIV vaccine development, the question is now: What's the next step in the fight against the spread of HIV/Aids? In this interview with The Nation, director of the Thai Phase III HIV vaccine clinical trial, Dr Suppachai Rerks-Hgarm, discusses this and other related issues.
Q: What is your feeling now the world's largest HIV vaccine trial, involving 16,402 volunteers, is complete?
A: I am relieved as we have done a great job and come up with quality information to be analysed, despite world pessimism over development of an HIV vaccine. But I am still worried because my ultimate goal is to have a vaccine to prevent the spread of HIV/Aids, particularly in Thailand. We have not reached this goal, meaning an important mission still awaits us.
Q: The researchers announced at the Public Health Ministry's Department of Disease Control press conference that the vaccine was 31.2 per cent effective in reducing the risk of HIV infection. Would you explain further.
A: The result of this experiment meant people who received this vaccine had a 31.2 per cent lower risk of HIV infection than people who did not. We found only 51 out of 8,201 volunteers who received the prime boost combination of vaccine were infected with HIV, while 74 out of 8,201 volunteers who received the placebo vaccine were infected with the HIV virus. However, we compared the efficacy of the vaccine among volunteers who used a condom when they had sex and those who did not. The result showed there was no difference among both groups. We also found that most volunteers had reduced sexual risk behaviour, including reduced sexual partners, and were using more condoms after receiving the vaccine.
Q: What was done to follow up on the volunteers and provide treatment for those infected with HIV?
A: Volunteers could still access health services under their benefits provided by the government. Those 125 volunteers infected with HIV will receive free anti-retroviral drugs and treatment.
Q: How do you explain the deaths of two volunteers during the trial?
A: Two volunteers who died were infected with HIV but they received a placebo vaccine. One of them had been abroad and did not receive treatment there, fearing repatriation. This volunteer had decided to come back to Thailand to receive medication when the disease became severe. The other volunteer disappeared from the trial after receiving the vaccine. We could not track their records about symptoms and cause of death. But we can conclude that the vaccine was safe because it was produced from the synthetic HIV virus. There was no chance of getting HIV from injecting vaccine.
Q: How will you develop this research for the next vaccine generation?
A: We can do more studies in detail from the information and blood samples we collected from volunteers. This will help us understand [the vaccine] from different angles and provide important clues for development of the next generation vaccine. We also need opinions from local and international researchers. In the long term, we hope the next generation of vaccine will be more effective. Thanks to [what we learned from] the failure of the previous HIV vaccine trial, we have improved our methods. Now we have seen the world's first achievement in developing an HIV vaccine and we know exactly what we are going to do for the next generation of vaccine.
Q: Will you release to the public the remaining information about the HIV vaccine trial?
A: Of course. We need to inform people and listen to opinions from scientists and researchers to help us check and reconfirm information we did not get from the experiment. But the right to publish this study in academic journals is the research team's privilege. We made agreements with the HIV vaccine-makers - who own a licence to produce a vaccine - to reduce the price of their product if the vaccine is effective. But now we have to restart negotiations with them, as the trial's efficacy was not high enough for [its general] use. This does not mean we have no ray of hope. The success of this trial reflects that developing countries have the capacity to be partners with developed countries to discover a vaccine. So we are trying to change our position from buyer to co-developer. And for those countries not participating in the trial, the World Health Organisation and other non-profit organisations will help them negotiate with the vaccine-makers to reduce the price of the product. From now on, the project will invite the volunteers to hear their individual results and to know what kind of vaccine they received.
Background to the vaccine trial
The Thai Phase III HIV vaccine clinical trial, also known as RV144, tested the "prime-boost" combination of two vaccines: ALVAC HIV vaccine (the prime) produced by Sanofi-Pasteur, and AIDS VAX B/E vaccine (the boost) produced by Global Solutions for Infectious Diseases. This vaccine combination was based on an HIV strain common in Thailand. The RV144 was designed to test the vaccine strategy's ability to prevent HIV infection, as well as its ability to reduce the amount of HIV in the blood (viral load) of those who became infected after they enrolled in the study.
The Ministry of Public Health conducted the study, together with Mahidol University and the US Armed Forces Research Institute of Medical Science, operating out of Thailand. It was sponsored with funds of Bt3.5 billion from the US Army Surgeon General.
The Phase III vaccine study was launched in 2003 involving 500 Thai researchers and 16,402 non-infected volunteers - aged between 18 to 30 - with an average risk of HIV infection; half received the prime boost combination of vaccine and half received a placebo.
The vaccinations ended in July 2006, and volunteers received an HIV test every six months for three years. They received counselling on how to prevent becoming infected with HIV at the beginning of the study, and every six months after the start of the trial, for a total of three and a half years.
Before agreeing to participate, all volunteers were informed of and consented to the potential risks associated with receiving the experimental vaccine combination. Meanwhile, the International Data and Safety Monitoring Board did not identify any safety concerns after eight meetings following the trial's initiation.
The study vaccines did not cause HIV infection because they are not made from and do not contain the entire virus, either live or killed.
Q: What is your feeling now the world's largest HIV vaccine trial, involving 16,402 volunteers, is complete?
A: I am relieved as we have done a great job and come up with quality information to be analysed, despite world pessimism over development of an HIV vaccine. But I am still worried because my ultimate goal is to have a vaccine to prevent the spread of HIV/Aids, particularly in Thailand. We have not reached this goal, meaning an important mission still awaits us.
Q: The researchers announced at the Public Health Ministry's Department of Disease Control press conference that the vaccine was 31.2 per cent effective in reducing the risk of HIV infection. Would you explain further.
A: The result of this experiment meant people who received this vaccine had a 31.2 per cent lower risk of HIV infection than people who did not. We found only 51 out of 8,201 volunteers who received the prime boost combination of vaccine were infected with HIV, while 74 out of 8,201 volunteers who received the placebo vaccine were infected with the HIV virus. However, we compared the efficacy of the vaccine among volunteers who used a condom when they had sex and those who did not. The result showed there was no difference among both groups. We also found that most volunteers had reduced sexual risk behaviour, including reduced sexual partners, and were using more condoms after receiving the vaccine.
Q: What was done to follow up on the volunteers and provide treatment for those infected with HIV?
A: Volunteers could still access health services under their benefits provided by the government. Those 125 volunteers infected with HIV will receive free anti-retroviral drugs and treatment.
Q: How do you explain the deaths of two volunteers during the trial?
A: Two volunteers who died were infected with HIV but they received a placebo vaccine. One of them had been abroad and did not receive treatment there, fearing repatriation. This volunteer had decided to come back to Thailand to receive medication when the disease became severe. The other volunteer disappeared from the trial after receiving the vaccine. We could not track their records about symptoms and cause of death. But we can conclude that the vaccine was safe because it was produced from the synthetic HIV virus. There was no chance of getting HIV from injecting vaccine.
Q: How will you develop this research for the next vaccine generation?
A: We can do more studies in detail from the information and blood samples we collected from volunteers. This will help us understand [the vaccine] from different angles and provide important clues for development of the next generation vaccine. We also need opinions from local and international researchers. In the long term, we hope the next generation of vaccine will be more effective. Thanks to [what we learned from] the failure of the previous HIV vaccine trial, we have improved our methods. Now we have seen the world's first achievement in developing an HIV vaccine and we know exactly what we are going to do for the next generation of vaccine.
Q: Will you release to the public the remaining information about the HIV vaccine trial?
A: Of course. We need to inform people and listen to opinions from scientists and researchers to help us check and reconfirm information we did not get from the experiment. But the right to publish this study in academic journals is the research team's privilege. We made agreements with the HIV vaccine-makers - who own a licence to produce a vaccine - to reduce the price of their product if the vaccine is effective. But now we have to restart negotiations with them, as the trial's efficacy was not high enough for [its general] use. This does not mean we have no ray of hope. The success of this trial reflects that developing countries have the capacity to be partners with developed countries to discover a vaccine. So we are trying to change our position from buyer to co-developer. And for those countries not participating in the trial, the World Health Organisation and other non-profit organisations will help them negotiate with the vaccine-makers to reduce the price of the product. From now on, the project will invite the volunteers to hear their individual results and to know what kind of vaccine they received.
Background to the vaccine trial
The Thai Phase III HIV vaccine clinical trial, also known as RV144, tested the "prime-boost" combination of two vaccines: ALVAC HIV vaccine (the prime) produced by Sanofi-Pasteur, and AIDS VAX B/E vaccine (the boost) produced by Global Solutions for Infectious Diseases. This vaccine combination was based on an HIV strain common in Thailand. The RV144 was designed to test the vaccine strategy's ability to prevent HIV infection, as well as its ability to reduce the amount of HIV in the blood (viral load) of those who became infected after they enrolled in the study.
The Ministry of Public Health conducted the study, together with Mahidol University and the US Armed Forces Research Institute of Medical Science, operating out of Thailand. It was sponsored with funds of Bt3.5 billion from the US Army Surgeon General.
The Phase III vaccine study was launched in 2003 involving 500 Thai researchers and 16,402 non-infected volunteers - aged between 18 to 30 - with an average risk of HIV infection; half received the prime boost combination of vaccine and half received a placebo.
The vaccinations ended in July 2006, and volunteers received an HIV test every six months for three years. They received counselling on how to prevent becoming infected with HIV at the beginning of the study, and every six months after the start of the trial, for a total of three and a half years.
Before agreeing to participate, all volunteers were informed of and consented to the potential risks associated with receiving the experimental vaccine combination. Meanwhile, the International Data and Safety Monitoring Board did not identify any safety concerns after eight meetings following the trial's initiation.
The study vaccines did not cause HIV infection because they are not made from and do not contain the entire virus, either live or killed.
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