Date: 10/22/2008 11:30 AM
By RICARDO ALONSO-ZALDIVAR
Associated Press Writer
WASHINGTON (AP) _ A health industry watchdog group reports that a record number of serious problems and deaths linked to medications were reported to the government in the first three months of this year.
An analysis of federal data by the nonprofit Institute for Safe Medication Practices shows that the Food and Drug Administration received nearly 21,000 reports of serious drug reactions, including over 4,800 deaths. The group analyzed quarterly data going back to 2004, and yearly totals dating to the 1990s.
Two drugs accounted for a disproportionately large share of the reports early this year. One was Pfizer’s anti-smoking medication, Chantix, and the other was heparin, the tainted blood thinner from China that caused a safety scandal.
Copyright 2008 The Associated Press.
www.heparin-law.com
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
Misdiagnosis of HIT
One issue that we have been blogging about since the beginning of the heparin catastrophe, is the presumption that doctors have misdiagnosed an overwhelming number of cases of adverse reaction to OSCS contamination, as normal disease processes. The default diagnosis for most heparin related deaths prior to the onset of this crisis is HIT (heparin-induced thrombocytopenia). Initially it was thought that anyone with a HIT diagnosis would clearly not be considered a potential adverse reaction to OSCS. But the more that we have gotten into these files, the more suspicious we are of a HIT diagnosis. Since HIT is the default diagnosis, it may simply mean that the doctors didn’t know what else to call it.
A good example of what we are saying about the overuse of the HIT diagnosis, is the case study below:
In late 2007 after receiving Heparin during cardiac surgery, Mrs. B, age 44, suffered from a severe reaction that caused extremely low blood pressure and required her to be on a breathing ventilator for 15 days. Tests for heparin-induced thrombocytopenia (HIT) came back negative initially, but one week later an additional test came back positive for HIT.
This September, in response to an article published in the New England Journal of Medicine, several medical doctors pointed out that the contaminant recently discovered in the nation’s supply of Heparin manufactured by Baxter International, Inc., may cause symptoms that are indistinguishable from HIT.
After more than three weeks in intensive care, Mrs. B. was discharged, but today suffers from heavy audible wheezing and shortness of breath, severe memory loss, extreme fatigue, and tingling in her extremities.
This information about the heparin catastrophe is provided by Attorney Gordon Johnson, in conjunction with the Nolan Law Group of Chicago, IL. The Johnson Law Office is affiliated with The Nolan Law Group on Heparin litigation. The Nolan Law Group is presently involved in the litigation on behalf of those affected by the distribution of contaminated heparin.
www.heparin-law.com
www.thelegaltimes.net
www.tbilaw.com
http://youtube.com/profile?user=braininjuryattorney
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
A good example of what we are saying about the overuse of the HIT diagnosis, is the case study below:
In late 2007 after receiving Heparin during cardiac surgery, Mrs. B, age 44, suffered from a severe reaction that caused extremely low blood pressure and required her to be on a breathing ventilator for 15 days. Tests for heparin-induced thrombocytopenia (HIT) came back negative initially, but one week later an additional test came back positive for HIT.
This September, in response to an article published in the New England Journal of Medicine, several medical doctors pointed out that the contaminant recently discovered in the nation’s supply of Heparin manufactured by Baxter International, Inc., may cause symptoms that are indistinguishable from HIT.
After more than three weeks in intensive care, Mrs. B. was discharged, but today suffers from heavy audible wheezing and shortness of breath, severe memory loss, extreme fatigue, and tingling in her extremities.
This information about the heparin catastrophe is provided by Attorney Gordon Johnson, in conjunction with the Nolan Law Group of Chicago, IL. The Johnson Law Office is affiliated with The Nolan Law Group on Heparin litigation. The Nolan Law Group is presently involved in the litigation on behalf of those affected by the distribution of contaminated heparin.
www.heparin-law.com
www.thelegaltimes.net
www.tbilaw.com
http://youtube.com/profile?user=braininjuryattorney
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
Heparin-bonded Catheters
Heparin-bonded catheters are used to prolong the patency of central venous catheters in children. According to The Cochrane Collaboration (a database of systematic reviews of world healthcare),
“Central venous catheters are used for prolonged intravenous therapy in the management of critically ill children, for parenteral nutrition, medication and monitoring. Having these catheters in place can cause blood clots in or around the end of the catheter as well as infection, either local or a blood stream infection. As a result, the catheter becomes blocked, eventually to the point that it is occluded and can no longer be used to give fluids. Anticoagulant drugs such as heparin can be given to prolong the usefulness of the catheter or the catheters coated with heparin (heparin-bonded catheters). Heparin can cause side effects such as bleeding, allergic reactions, induced thrombocytopenia (an abnormal drop in the number of platelets in the blood) and osteoporosis with long-term use.”
It is not clearly established how much heparin increases the patency of catheters, “There was a trend towards the heparin-bonded catheter reducing the risk of catheter-related thrombosis over the time the catheter was in and a trend towards reduction in the risk of catheter occlusion in the first week after catheter placement.”
Heparin is intended to reduce the risks of catheter-related infections and other problems. Clearly, studies are not based on the incidence of contaminated lots of heparin which introduce risks and risk factors not included in clinical trials. The advantage of using a heparin-bonded catheter over a standard catheter is not a clear advantage, but exposing children to contaminated heparin would not be seen as preferable on any level.
– Baby O. was born March 9, 2007 with choroid plexus carcinoma (brain tumor). He underwent surgery to remove the entire tumor and began chemotherapy in April. To administer his treatment, doctors inserted a broviac catheter that was flushed with heparin twice daily to prevent the catheter from clogging. Until September 2007, Baby O. was responding positively to chemotherapy and was showing signs of improvement. Late that month, however, he suddenly began suffering from respiratory distress, went into renal failure and ultimately passed away on November 19, 2007. Baby O.’s physicians were baffled by the sudden unexplained deterioration in his condition.
On August 26, 2008, Nolan Law Group filed a wrongful death case in the Circuit Court of Cook County, Illinois, located in Chicago, against Baxter International, Inc. and Baxter Healthcare Corporation.
– In January of this year, Little Girl B was diagnosed with a subdural empyema (pus on the brain sometimes caused by sinusitis). Little Girl B underwent surgery with no complications that successfully removed the pus. After the procedure, physicians inserted a Peripherally Inserted Central Catheter (PICC line) for antibiotic medication to prevent post-surgery infection. The PICC line was flushed with heparin to keep the antibiotics free-flowing. Doctors expected Little Girl B to fully recover, but soon after they began administering heparin flushes, Little Girl B. developed a high fever and was re-hospitalized. Blood tests came back negative for infection despite Little Girl B.’s increasing symptoms which included a rash, very low blood pressures, nausea, vomiting and seizures. Little Girl B. passed away on February 9, 2008.
Nolan Law Group filed suit in the Circuit Court of Cook County, Illinois against Baxter International, Inc. and Baxter Healthcare Corporation on October 7, 2008.
Heparin-bonded catheters, on theory, were meant to give a promising edge to children in high risk situations. The results were far less than hoped for when contamination entered into the picture, and tragically, fatal for Baby O and Little Girl B.
This information about the heparin catastrophe is provided by Attorney Gordon Johnson, in conjunction with the Nolan Law Group of Chicago, IL. The Johnson Law Office is affiliated with The Nolan Law Group on Heparin litigation. The Nolan Law Group is presently involved in the litigation on behalf of those affected by the distribution of contaminated heparin.
www.heparin-law.com
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
“Central venous catheters are used for prolonged intravenous therapy in the management of critically ill children, for parenteral nutrition, medication and monitoring. Having these catheters in place can cause blood clots in or around the end of the catheter as well as infection, either local or a blood stream infection. As a result, the catheter becomes blocked, eventually to the point that it is occluded and can no longer be used to give fluids. Anticoagulant drugs such as heparin can be given to prolong the usefulness of the catheter or the catheters coated with heparin (heparin-bonded catheters). Heparin can cause side effects such as bleeding, allergic reactions, induced thrombocytopenia (an abnormal drop in the number of platelets in the blood) and osteoporosis with long-term use.”
It is not clearly established how much heparin increases the patency of catheters, “There was a trend towards the heparin-bonded catheter reducing the risk of catheter-related thrombosis over the time the catheter was in and a trend towards reduction in the risk of catheter occlusion in the first week after catheter placement.”
Heparin is intended to reduce the risks of catheter-related infections and other problems. Clearly, studies are not based on the incidence of contaminated lots of heparin which introduce risks and risk factors not included in clinical trials. The advantage of using a heparin-bonded catheter over a standard catheter is not a clear advantage, but exposing children to contaminated heparin would not be seen as preferable on any level.
– Baby O. was born March 9, 2007 with choroid plexus carcinoma (brain tumor). He underwent surgery to remove the entire tumor and began chemotherapy in April. To administer his treatment, doctors inserted a broviac catheter that was flushed with heparin twice daily to prevent the catheter from clogging. Until September 2007, Baby O. was responding positively to chemotherapy and was showing signs of improvement. Late that month, however, he suddenly began suffering from respiratory distress, went into renal failure and ultimately passed away on November 19, 2007. Baby O.’s physicians were baffled by the sudden unexplained deterioration in his condition.
On August 26, 2008, Nolan Law Group filed a wrongful death case in the Circuit Court of Cook County, Illinois, located in Chicago, against Baxter International, Inc. and Baxter Healthcare Corporation.
– In January of this year, Little Girl B was diagnosed with a subdural empyema (pus on the brain sometimes caused by sinusitis). Little Girl B underwent surgery with no complications that successfully removed the pus. After the procedure, physicians inserted a Peripherally Inserted Central Catheter (PICC line) for antibiotic medication to prevent post-surgery infection. The PICC line was flushed with heparin to keep the antibiotics free-flowing. Doctors expected Little Girl B to fully recover, but soon after they began administering heparin flushes, Little Girl B. developed a high fever and was re-hospitalized. Blood tests came back negative for infection despite Little Girl B.’s increasing symptoms which included a rash, very low blood pressures, nausea, vomiting and seizures. Little Girl B. passed away on February 9, 2008.
Nolan Law Group filed suit in the Circuit Court of Cook County, Illinois against Baxter International, Inc. and Baxter Healthcare Corporation on October 7, 2008.
Heparin-bonded catheters, on theory, were meant to give a promising edge to children in high risk situations. The results were far less than hoped for when contamination entered into the picture, and tragically, fatal for Baby O and Little Girl B.
This information about the heparin catastrophe is provided by Attorney Gordon Johnson, in conjunction with the Nolan Law Group of Chicago, IL. The Johnson Law Office is affiliated with The Nolan Law Group on Heparin litigation. The Nolan Law Group is presently involved in the litigation on behalf of those affected by the distribution of contaminated heparin.
www.heparin-law.com
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
Adverse Heparin Reactions: Symptoms and Side Effects
October 14, 2008
In February, Baxter International Inc. announced that they were proceeding with the voluntary recall of remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products. This followed an initial recall In January. Contaminated heparin has also been found in association with some medical devices, such as certain catheters. Some of these medical devices have been recalled.
Heparin is one of the oldest drugs, having been developed in 1916. It is widely used as an injectible anti-coagulant. It can also be used to form an anti-coagulant surface on various medical devices such as test tubes and dialysis machines.
A serious side-effect of heparin is heparin-induced thrombocytopenia (HIT syndrome). HITS is caused by an immunological reaction that makes platelets a target of immunological response, resulting in the degradation of platelets. This is what causes thrombocytopenia. This condition is usually reversed on discontinuation, and can generally be avoided with the use of synthetic heparins. There is also a benign form of thrombocytopenia associated with early heparin use, which resolves without stopping heparin.
Rarer side-effects include alopecia and osteoporosis with chronic use.
As with many drugs, overdoses of heparin can be fatal. In September 2006, heparin received worldwide publicity when 3 prematurely-born infants died after they were mistakenly given overdoses of heparin at an Indianapolis hospital.
Serious injuries and deaths have been associated with the use of heparin, a blood-thinning drug that contained active pharmaceutical ingredient (API) from China.
Nearly all reported adverse reactions have occurred in three specific areas of product use – renal dialysis, invasive cardiovascular procedures and apheresis procedures. Reported adverse patient reactions have included:
-stomach pain or discomfort,
-nausea,
-vomiting,
-diarrhea,
-decreased or low blood pressure,
-chest pain,
-fast heart rate,
-dizziness,
-fainting,
-unresponsiveness,
-shortness of breath,
-the feeling of a strong or rapid heartbeat,
-drug ineffectiveness,
-burning sensation,
-redness or paleness of skin,
-abnormal sensation of the skin, mouth or lips,
-flushing,
-increased sweating,
-decreased skin sensitivity,
-headache,
-feeling unwell,
-restlessness,
-watery eyes,
-throat swelling,
-thirst,
-bleeding tendencies,
-difficulty opening the mouth,
-those that may resemble the symptoms of Heparin-Induced Thrombocytopenia (HIT), such as a low platelet count, bruising, loss of circulation to the hands and feet, gangrene, bleeding, and blod clots,
-and additional symptoms, including potential long-term effects that have not been identified.
Some of these reactions, particularly profound and refractory hypotension, may be severe or life-threatening.
On the web:
http://en.wikipedia.org/wiki/Heparin
http://www.fda.gov/cder/drug/infopage/heparin/
This information about the heparin catastrophe is provided by Attorney Gordon Johnson, in conjunction with the Nolan Law Group of Chicago, IL. The Johnson Law Office is affiliated with The Nolan Law Group on Heparin litigation. The Nolan Law Group is presently involved in the litigation on behalf of those affected by the distribution of contaminated heparin.
www.heparin-law.com
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
In February, Baxter International Inc. announced that they were proceeding with the voluntary recall of remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products. This followed an initial recall In January. Contaminated heparin has also been found in association with some medical devices, such as certain catheters. Some of these medical devices have been recalled.
Heparin is one of the oldest drugs, having been developed in 1916. It is widely used as an injectible anti-coagulant. It can also be used to form an anti-coagulant surface on various medical devices such as test tubes and dialysis machines.
A serious side-effect of heparin is heparin-induced thrombocytopenia (HIT syndrome). HITS is caused by an immunological reaction that makes platelets a target of immunological response, resulting in the degradation of platelets. This is what causes thrombocytopenia. This condition is usually reversed on discontinuation, and can generally be avoided with the use of synthetic heparins. There is also a benign form of thrombocytopenia associated with early heparin use, which resolves without stopping heparin.
Rarer side-effects include alopecia and osteoporosis with chronic use.
As with many drugs, overdoses of heparin can be fatal. In September 2006, heparin received worldwide publicity when 3 prematurely-born infants died after they were mistakenly given overdoses of heparin at an Indianapolis hospital.
Serious injuries and deaths have been associated with the use of heparin, a blood-thinning drug that contained active pharmaceutical ingredient (API) from China.
Nearly all reported adverse reactions have occurred in three specific areas of product use – renal dialysis, invasive cardiovascular procedures and apheresis procedures. Reported adverse patient reactions have included:
-stomach pain or discomfort,
-nausea,
-vomiting,
-diarrhea,
-decreased or low blood pressure,
-chest pain,
-fast heart rate,
-dizziness,
-fainting,
-unresponsiveness,
-shortness of breath,
-the feeling of a strong or rapid heartbeat,
-drug ineffectiveness,
-burning sensation,
-redness or paleness of skin,
-abnormal sensation of the skin, mouth or lips,
-flushing,
-increased sweating,
-decreased skin sensitivity,
-headache,
-feeling unwell,
-restlessness,
-watery eyes,
-throat swelling,
-thirst,
-bleeding tendencies,
-difficulty opening the mouth,
-those that may resemble the symptoms of Heparin-Induced Thrombocytopenia (HIT), such as a low platelet count, bruising, loss of circulation to the hands and feet, gangrene, bleeding, and blod clots,
-and additional symptoms, including potential long-term effects that have not been identified.
Some of these reactions, particularly profound and refractory hypotension, may be severe or life-threatening.
On the web:
http://en.wikipedia.org/wiki/Heparin
http://www.fda.gov/cder/drug/infopage/heparin/
This information about the heparin catastrophe is provided by Attorney Gordon Johnson, in conjunction with the Nolan Law Group of Chicago, IL. The Johnson Law Office is affiliated with The Nolan Law Group on Heparin litigation. The Nolan Law Group is presently involved in the litigation on behalf of those affected by the distribution of contaminated heparin.
www.heparin-law.com
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
Therapy helps hard-to-transplant get a new kidney
Date: 10/13/2008 4:33 PM
By LAURAN NEERGAARD
AP Medical Writer
WASHINGTON (AP) _ Nearly one in three patients who need a kidney transplant may never get one because their bodies are abnormally primed to attack a donated organ.
Now doctors are trying new ways to outwit the immune system and save more of those so-called “highly sensitized” patients — often with kidneys donated by living donors, considered the optimal kind.
“I feel very lucky. Our son saved my life,” said Cynthia Preloh of Arlington, Va., after an unusual combination of blood cleansing and a cancer drug allowed her to receive a kidney from her son that her body otherwise would have destroyed.
It’s promising work that comes as the nation’s kidney distribution system is beginning a major overhaul. Together, the two efforts aim to make a long-needed dent in the years of waiting it can take to get a kidney transplant.
That’s crucial, because “your chance of getting successfully transplanted decreases with time,” says Dr. Keith Melancon of Georgetown University Hospital, Preloh’s surgeon and a leader in the small but growing field of incompatible kidney transplants.
More than 77,000 people are on the national waiting list to receive a kidney from a deceased donor. Yet fewer than 17,000 transplants a year are performed, about 10,500 of them from deceased donors and just over 6,000 from living donors, relatives or friends who offer to help a specific patient. The wait can stretch four to five years, and more than 4,000 patients die on the waiting list each year.
The United Network for Organ Sharing is considering some big changes to the system. There’s no formal proposal yet, but there are options under discussion:
—Wait times might be defined by kidney function deterioration rather than how early someone gets on the transplant list, to level the field for patients who don’t see a specialist right away.
—In addition to wait time, matches may weigh recipient and kidney age and medical conditions to maximize what’s “life years from transplant.” One kidney might last longer in an older person without diabetes than in a younger diabetic, explains Dr. Kenneth Andreoni of Ohio State Medical Center and vice chair of the UNOS kidney committee.
“It’s trying to get the balance between having a person live longer because they have the transplant over dialysis, and also looking at how many years in total they would live,” he says.
—Ranking the quality of donated kidneys in a way that would let patients choose one of lesser quality if it means a shorter wait, or try to hold out longer for a better one.
Such changes wouldn’t increase available kidneys. Hence the need for the new kidney match-making called desensitization aimed at patients like Preloh who otherwise might not get a chance at a new organ.
A transplant starts by matching patient and donor kidney according to blood and tissue type. Today’s anti-rejection drugs are so good that tissue-typing can be far from perfect.
A different threat is what’s called antibody-mediated rejection, where patients increasingly are “sensitized” — their bodies produce antibodies that are super-vigilant at attacking most available kidneys. What causes that? Pregnancy, blood transfusions, a previous transplant, increased time on dialysis. So longer transplant wait times are fueling sensitization, a vicious cycle.
The more antibodies, the harder it is to find a compatible kidney. So the quest is to rid patients of antibodies targeted to a specific donated kidney, and keep them from making more.
One method: Filtering a patient’s blood, called plasma pheresis, before transplant. Another is intravenous immune globulin, or IVIG, a mix of infection-fighting antibodies that basically crowd out the bad kidney kind with run-of-the-mill types. They’re treatments pioneered at a few hospitals — including Los Angeles’ Cedars-Sinai Medical Center and Baltimore’s Johns Hopkins University — and now slowly spreading.
But that’s not strong enough for many super-sensitized patients, so a new experiment is testing the lymphoma drug Rituxan, which fights the immune-system cancer by killing certain antibody-producing cells. Cedars-Sinai researchers reported the first preliminary but promising evidence in the New England Journal of Medicine this summer: Rituxan helped slash antibody levels enough that 16 of 20 patients could be transplanted, and all but one of the new kidneys was working a year later.
Back at Georgetown, Cynthia Preloh, 50, had been told to expect a seven-year wait for a donated kidney when diabetes destroyed her own. Diabetics have particularly poor survival on dialysis and her son offered a faster living donation, but Preloh had too many antibodies that would attack his tissue.
Melancon — who moved from Hopkins to Georgetown in the nation’s capital to spread this work — hoped Rituxan would give Preloh enough extra desensitization to try the transplant. Her new kidney started working on the operating table, “which was the best thing you could hope to hear,” she said last week as she recovered.
___
EDITOR’s NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.
Copyright 2008 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
By LAURAN NEERGAARD
AP Medical Writer
WASHINGTON (AP) _ Nearly one in three patients who need a kidney transplant may never get one because their bodies are abnormally primed to attack a donated organ.
Now doctors are trying new ways to outwit the immune system and save more of those so-called “highly sensitized” patients — often with kidneys donated by living donors, considered the optimal kind.
“I feel very lucky. Our son saved my life,” said Cynthia Preloh of Arlington, Va., after an unusual combination of blood cleansing and a cancer drug allowed her to receive a kidney from her son that her body otherwise would have destroyed.
It’s promising work that comes as the nation’s kidney distribution system is beginning a major overhaul. Together, the two efforts aim to make a long-needed dent in the years of waiting it can take to get a kidney transplant.
That’s crucial, because “your chance of getting successfully transplanted decreases with time,” says Dr. Keith Melancon of Georgetown University Hospital, Preloh’s surgeon and a leader in the small but growing field of incompatible kidney transplants.
More than 77,000 people are on the national waiting list to receive a kidney from a deceased donor. Yet fewer than 17,000 transplants a year are performed, about 10,500 of them from deceased donors and just over 6,000 from living donors, relatives or friends who offer to help a specific patient. The wait can stretch four to five years, and more than 4,000 patients die on the waiting list each year.
The United Network for Organ Sharing is considering some big changes to the system. There’s no formal proposal yet, but there are options under discussion:
—Wait times might be defined by kidney function deterioration rather than how early someone gets on the transplant list, to level the field for patients who don’t see a specialist right away.
—In addition to wait time, matches may weigh recipient and kidney age and medical conditions to maximize what’s “life years from transplant.” One kidney might last longer in an older person without diabetes than in a younger diabetic, explains Dr. Kenneth Andreoni of Ohio State Medical Center and vice chair of the UNOS kidney committee.
“It’s trying to get the balance between having a person live longer because they have the transplant over dialysis, and also looking at how many years in total they would live,” he says.
—Ranking the quality of donated kidneys in a way that would let patients choose one of lesser quality if it means a shorter wait, or try to hold out longer for a better one.
Such changes wouldn’t increase available kidneys. Hence the need for the new kidney match-making called desensitization aimed at patients like Preloh who otherwise might not get a chance at a new organ.
A transplant starts by matching patient and donor kidney according to blood and tissue type. Today’s anti-rejection drugs are so good that tissue-typing can be far from perfect.
A different threat is what’s called antibody-mediated rejection, where patients increasingly are “sensitized” — their bodies produce antibodies that are super-vigilant at attacking most available kidneys. What causes that? Pregnancy, blood transfusions, a previous transplant, increased time on dialysis. So longer transplant wait times are fueling sensitization, a vicious cycle.
The more antibodies, the harder it is to find a compatible kidney. So the quest is to rid patients of antibodies targeted to a specific donated kidney, and keep them from making more.
One method: Filtering a patient’s blood, called plasma pheresis, before transplant. Another is intravenous immune globulin, or IVIG, a mix of infection-fighting antibodies that basically crowd out the bad kidney kind with run-of-the-mill types. They’re treatments pioneered at a few hospitals — including Los Angeles’ Cedars-Sinai Medical Center and Baltimore’s Johns Hopkins University — and now slowly spreading.
But that’s not strong enough for many super-sensitized patients, so a new experiment is testing the lymphoma drug Rituxan, which fights the immune-system cancer by killing certain antibody-producing cells. Cedars-Sinai researchers reported the first preliminary but promising evidence in the New England Journal of Medicine this summer: Rituxan helped slash antibody levels enough that 16 of 20 patients could be transplanted, and all but one of the new kidneys was working a year later.
Back at Georgetown, Cynthia Preloh, 50, had been told to expect a seven-year wait for a donated kidney when diabetes destroyed her own. Diabetics have particularly poor survival on dialysis and her son offered a faster living donation, but Preloh had too many antibodies that would attack his tissue.
Melancon — who moved from Hopkins to Georgetown in the nation’s capital to spread this work — hoped Rituxan would give Preloh enough extra desensitization to try the transplant. Her new kidney started working on the operating table, “which was the best thing you could hope to hear,” she said last week as she recovered.
___
EDITOR’s NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.
Copyright 2008 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
Drug stayed on hospital shelves despite recall
10/02/2008 06:25:19 PM PDT
By SHAYA TAYEFE MOHAJER Associated Press Writer
LOS ANGELES—Nearly 100 pharmacists and the hospitals they work for face fines for failing to remove a blood thinner from their shelves after a federal recall last winter, a state agency said Thursday.
The recalled drug heparin was found 94 times in inspections of all 533 hospitals in California, and at least 16 hospitals administered the drug to patients, according to the state Board of Pharmacy. Fines range from $2,500 to $5,000.
“This was really an alert that the recall system doesn’t work,” Virginia Herold, head of the state’s pharmacy board, told The Associated Press.
Regulators have not released the full list of hospitals involved. However, documents obtained by the Daily Journal show newborns were allegedly given heparin at the University of California San Francisco Medical Center and Children’s Hospital of Central California in Madera. Both hospitals are appealing the charges.
Heparin, which is often used in premature children to prevent blood clots, has come under scrutiny because of accidental life-threatening overdoses given to babies, including actor Dennis Quaid’s newborn twins at a Los Angeles hospital last November. Fourteen other babies received accidental heparin overdoses in July at a hospital in Corpus Christi, Texas.
The Federal Drug Administration issued a drug recall in February because “a higher than usual number” of patients reported adverse effects to heparin, which include chest pain, dizziness and headache.
The state’s Department of Public Health has also launched an investigation to determine whether recalled heparin, Digitex and Procrit caused harm to any patients.
No link has been found, though a state health official said the state will try to ensure recalled drugs are taken out of hospitals.
“Our actions are to act as both a partner and an enforcer to look at what kinds of system breakdowns are taking place, to make sure we don’t have a reoccurrence of this in the future,” Kathleen Billingsley, deputy director of the state’s Center for Healthcare Quality, told the AP.
In March, the state Board of Pharmacy voted 12-0 to give drug makers, wholesalers and pharmacies until Jan. 1, 2011, to start electronically tracking drugs from factory to patient. The electronic tracking system has been delayed a number of times since 2004, when a recall of 175,000 bottles of fake Lipitor, the cholesterol drug, led state regulators to require tracking.
Herold said although it’s unclear whether the tracking system would have prevented this incident, it will give pharmacists a better idea of what is on their shelves.
Last week the Oakbrook Terrace, Ill.-based Joint Commission, an independent, not-for-profit organization health quality group, issued a safety alert asking hospitals nationwide to adopt stricter measures to prevent errors involving blood thinners, including heparin.
Copyright 2008 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
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By SHAYA TAYEFE MOHAJER Associated Press Writer
LOS ANGELES—Nearly 100 pharmacists and the hospitals they work for face fines for failing to remove a blood thinner from their shelves after a federal recall last winter, a state agency said Thursday.
The recalled drug heparin was found 94 times in inspections of all 533 hospitals in California, and at least 16 hospitals administered the drug to patients, according to the state Board of Pharmacy. Fines range from $2,500 to $5,000.
“This was really an alert that the recall system doesn’t work,” Virginia Herold, head of the state’s pharmacy board, told The Associated Press.
Regulators have not released the full list of hospitals involved. However, documents obtained by the Daily Journal show newborns were allegedly given heparin at the University of California San Francisco Medical Center and Children’s Hospital of Central California in Madera. Both hospitals are appealing the charges.
Heparin, which is often used in premature children to prevent blood clots, has come under scrutiny because of accidental life-threatening overdoses given to babies, including actor Dennis Quaid’s newborn twins at a Los Angeles hospital last November. Fourteen other babies received accidental heparin overdoses in July at a hospital in Corpus Christi, Texas.
The Federal Drug Administration issued a drug recall in February because “a higher than usual number” of patients reported adverse effects to heparin, which include chest pain, dizziness and headache.
The state’s Department of Public Health has also launched an investigation to determine whether recalled heparin, Digitex and Procrit caused harm to any patients.
No link has been found, though a state health official said the state will try to ensure recalled drugs are taken out of hospitals.
“Our actions are to act as both a partner and an enforcer to look at what kinds of system breakdowns are taking place, to make sure we don’t have a reoccurrence of this in the future,” Kathleen Billingsley, deputy director of the state’s Center for Healthcare Quality, told the AP.
In March, the state Board of Pharmacy voted 12-0 to give drug makers, wholesalers and pharmacies until Jan. 1, 2011, to start electronically tracking drugs from factory to patient. The electronic tracking system has been delayed a number of times since 2004, when a recall of 175,000 bottles of fake Lipitor, the cholesterol drug, led state regulators to require tracking.
Herold said although it’s unclear whether the tracking system would have prevented this incident, it will give pharmacists a better idea of what is on their shelves.
Last week the Oakbrook Terrace, Ill.-based Joint Commission, an independent, not-for-profit organization health quality group, issued a safety alert asking hospitals nationwide to adopt stricter measures to prevent errors involving blood thinners, including heparin.
Copyright 2008 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney