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.
Thursday, November 19, 2009
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.
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