Transplant helped coach back to the ice

A skating coach who gives group and private lessons for figure skating and hockey, Pitman has been working at Carmel Ice Skadium for 13 years. She also celebrated the two-year anniversary of her liver transplant on July 13.
Now, the effervescent 34-year-old will compete at the World Transplant Games Aug. 25-Sept. 2 in Thailand.
A former competitive figure skater, Pitman was the 1996 National Collegiate Senior Ladies Silver Medalist, a 16-year regional competitor and a six-year sectional competitor. She will compete in swimming (50 meter freestyle and 50 meter breaststroke) and 3K road race at the World Transplant Games, since figure skating is not among sports offered.
Q: How have your health problems affected you? (Pitman has Crohn's disease and ulcerative colitis, collectively known as inflammatory bowel disease.)
A: I was 17 years old when I was diagnosed with bowel problems, but I was 28 when I had my first surgery. They removed my large intestine, and then I had all kinds of reconstructive surgery . . . The liver problem stemmed from the IBD, Crohn's disease, ulcerative colitis . . . Our liver filters everything that goes in our body and it filtered all the drugs, and since I refused to be put on steroids because of skating, because I wouldn't be able to compete, they used a different drug that they think sped up the process. Eventually (my liver) would have failed, but it sped up the process. . .
On Jan. 31, 2005, I became so ill I had to go to the hospital, and they found out that I had spontaneous bacterial peritonitis, which meant the fluid in my abdomen was infected, which meant the liver couldn't filter out what it needed to. Within six weeks I was in the hospital weekly to remove fluid from my abdomen and began the rigorous testing that they put you through for a transplant.
Q: Where did your donated liver come from?
A: I've not been able to meet my donor family . . . Because it's very confidential, I gave a letter to my post-transplant coordinator to send. Hopefully I'll be able to meet them and keep in touch with them because of how they affected by life. I can't thank them enough. I consider them my angels. With the literally horrific situation they were in, to have to make that decision, they gave me a second chance.
Q: How long until you were back at the rink after your transplant?
A: It took me a little longer in the hospital to recover because I had a couple of setbacks, some reactions, but I was out of the hospital in two weeks. Most people are out within seven to 10 days. I didn't have my skates on, but I was back at the rink sitting on the boards coaching after six weeks . . . I was back on the ice in eight weeks. I don't know what I would have done without my job and being around kids.
Q: After going through all that, what will it mean for you to compete in the 2007 World Transplant Games?
A: It's such an honor . . . Of course, everybody wants to win or do well, but it's just the idea that we are able to be there. We are living proof that it works and that organ donation is so important.
Q: What is your advice to athletes who also are transplant recipients interested in competing? (Eleven months out of surgery, Pitman was competing at the 2006 U.S. Transplant Games in Louisville, barely missing a medal.)
A: Becoming active helps your health . . . They said to me, "You would not be able to recover as quickly as you did without being an athlete and having the motivation to go out and do this." We are a special group but we're just like anybody else. If someone is interested in being in any part of the Transplant Games, they don't have to be an athlete, they can contact the National Kidney Foundation in Indiana . . . It's just a fun experience for any transplant recipient because we can do stuff and we can kick people's butts, too.

Source:www.indystar.com

Nausea might mean overmedication

Dear Dr. Gott: I am concerned that my 65-year-old niece, who is a petite 100 pounds, takes 20 pills a day. She has been taking these since she had surgery for a clogged artery on the right side of her neck. The doctor tells her she has to take all of them to live.

She has high blood pressure and when she left the recovery room and went back into her hospital room, they lost her twice. She has only one kidney and only about 60 percent of it is functional.

She is a real estate salesperson and is working, but the pills make her nauseated, and her hands shake, which I feel is due to overmedication. Should she get a second opinion?

Dear Reader: There is a definite possibility that your niece is overmedicated. I urge her to obtain a second opinion.

This can be done appropriately without giving the impression that the family distrusts her present physician.

Your niece should call the doctor (or schedule an office visit) to review her concerns, describe her symptoms and ask for a referral to a specialist because she fears that she is reacting adversely to one (or more) of her current medications.

I am particularly concerned about her remaining kidney, which might be unable to excrete the medicines, thereby increasing the possibility of toxicity. Perhaps her kidney specialist could solve this issue.

Dear Dr. Gott: I am a 69-year-old male in good health. Every time I have routine blood work done, I am told that I have high bilirubin. All other blood tests are normal. My doctor tells me this is nothing to worry about. Should I?

Dear Reader: Bilirubin is a byproduct of liver metabolism. Although your elevated levels may simply reflect a genetic tendency, they may indicate liver damage or malfunction.

I assume that you have had appropriate blood tests for common liver diseases, but before reassuring you not to worry, I want to avoid missing an undiagnosed condition.

I encourage you to request a consultation with a liver specialist. You need a diagnosis.

Source:www.nwherald.com

Doctors save child in need of liver

Doctors at Children’s Hospital No. 2 successfully performed a liver transplant yesterday on a one-year old patient who’s organ had failed earlier.

Her mother, the donor, is also out of danger and is awake and aware after the operation.

However, doctors are still cautious about their recovery because they said it was a complex, eight-hour surgery and the little girl could still reject the liver in the next few days.

Professor Tran Dong A, head of the operation team, said at a press briefing also yesterday that Nguyen Anh Kim Tram had been diagnosed with congenial biliary atresia, a disease of the bile ducts, when she was six months old.

However, at that time it was too late to perform a temporary operation that would have replaced her damaged liver ducts with a length of her intestine to act as drain ducts for bile. That procedure would have allowed her to grow until she was strong enough for a new liver.

Doctors decided to go ahead with the transplant after her 29-year-old mother agreed to be the donor.

The girl suffered from multiple organ failure, malnourishment, lung inflammation and a respiratory disorder and faced the constant risk of burst vessels or hemophilia, which could prove fatal.

The bilirubin in her blood was also 675mg per litre, considered too high compared to the permitted level of less than 5mg per litre.

After consulting with Belgian doctors who have worked with Children’s Hospital No.2’s liver transplant programme for the past two years, the hospital decided to conduct the operation.

In the past two years, Professor Dong A’s team at the Children’s Hospital No.2 have successfully performed liver transplants on three children aged less than 2 years old before Tram’s surgery. They are all doing well.

Professor Dong A said that according to the agreement of the joint liver transplant between his hospital and his Belgian counterparts, Vietnamese doctors will begin to operate independently following the completion of six successful transplants with their Belgium partners at their side.

The success of these transplants will be a strong foundation for the hospital to set up a transplant centre for HCM City as per request from the municipal People’s Committee and the Department of Health.

Source:vietnamnews.vnagency.com.vn

Bleeding From the Gallbladder

Although hemorrhage from the gallbladder is not a common event,1 urgent treatment is required. A case is described herein in which the use of contrast-enhanced ultrasonography (CEU) showed the potential to be a first-line modality for a prompt diagnosis of this entity.

A 53-year-old man with right upper abdominal pain was transferred to our emergency department by ambulance. He had a medical history of renal failure and had been receiving chronic hemodialysis for 7 years. He also had a diagnosis of hemophilia A in early childhood. Blood examination showed anemia (hemoglobin level, 8.3 g/dL). Liver enzyme values, including the total bilirubin level, were within normal limits. Ultrasonography showed an enlarged gallbladder with slightly hyperechoic heterogeneous material occupying almost all of the lumen (Figure 1AGo). A power Doppler ultrasonographic study, which was arranged to detect minute vascular structures, depicted only faint flow signals along the gallbladder wall, suggesting the cystic artery (Figure 1BGo). To evaluate detailed hemodynamics of the gallbladder, CEU using the intravenous contrast agent Levovist (SH U 508A; Schering AG, Berlin, Germany) was arranged after informed consent was obtained. The instrument used was a commercially available ultrasonography system (Aplio; Toshiba Medical Systems Co, Ltd, Tokyo, Japan) with a 4-MHz curved linear array transducer. Advanced dynamic flow imaging (wideband Doppler imaging) was conducted with a 1.5-second intermittent scan. Thirty seconds after injection of Levovist, localized enhancement began to emerge inside the lumen at the neck of the gallbladder (Figure 1CGo). Because of progressive enlargement of the gallbladder, surgical treatment was conducted 1 week after CEU. Surgical findings involved bloody ascites in the intraperitoneal cavity and an enlarged gallbladder occupied by a massive amount of blood clots. A ruptured cystic artery was identified after the blood clot was removed at the neck portion of the gallbladder lumen. Pathologic findings of the gallbladder showed gangrenous chronic cholecystitis. There were 2 stones impacted into the neck of the gallbladder.

Source:www.jultrasoundmed.org

Cancer Patient Shares Amazing Survival Story

A Maryland man and his wife are calling what happened to them at Monongahela Valley Hospital nothing short of a miracle.

The wife had been given only six months to live but a news segment and a cancer surgeon changed all of that.

Cindy Russell says every hospital she went to, every doctor she spoke with gave her a death sentence.

At one point, she prepared to mail her Christmas cards early thinking she would not be around for the holidays but now Cindy and her husband Neil are looking ahead to the future.

It's been a long and frightening road for Neill Russell and his wife Cindy.

They call it their journey.

Back in march, 52-year old Cindy was diagnosed with liver cancer.

Doctors from some of the nation's best cancer centers, including Johns Hopkins and the Mayo Clinic told Cindy her cancer was terminal and that she only had six months to live.

But, the Russells never gave up hope.

Cindy related what happened next: "My mother-in-law was watching KDKA-TV 2 and that's when she found Doctor Canady," she recalled. "So, we contacted Doctor Canady and that very night he called us back and he wanted to see me."

Cindy's mother-in-law was watching a story KDKA did back in April.

Clinton Rhodes, 78, a liver cancer patient was also told there was no hope.

It turns out Cindy's mother-in-law knew Rhodes.

"I've know him for years and also he lives a quarter of a mile from me," said Selma Russell. "Right after that program… I'll back up. He said that Doctor Canady saved his life. He had liver cancer. They told him the same thing they my daughter-in law -- go home and die. So anyhow I called him immediately and I spoke with him and his wife and within ten minutes Doctor Canady called me."

"He looked at me and said 'Cindy, I can do something for you' and that's when I started crying because he finally gave me hope when there was no hope and I love him," said Cindy. "I really love that man."

"Every patient that I get a call from, and I get them from all over the country, I am their last resort," said Dr. Jerome Canady. "They have already been operated on two or three times."

Cancer had taken over 75-percent of Cindy's liver.

Doctor Gene Manzetti worked right along side Doctor Canady.

During Cindy's surgery, Doctor Canady used one of the instruments he invented.

He completed his fellowship at Yale University and UPMC under Doctor Thomas Starzl.

He has also studied in Japan and Germany.

He says what he does with 3D imaging and digital mapping is the wave of the future.

"Currently she is cancer free," said Dr. Canady. "Her liver function tests, her bilirubin, they are all normal and they were abnormal when she came to us."

"There is nothing worse than not having hope," said Cindy's husband Neill. "We found hope at this little hospital and in a man named Dr. Canady and I just want people to know who are searching like we did… because it's horrible. There is a hospital and there is a doctor in this little valley who can save lives."

Eight days after surgery Cindy was released from Monongahela Valley Hospital.

"God brought that doctor to her. He knew just what doctor to bring and I am thankful for him," said Cindy's mother Olive Pulaski.

Source:kdka.com

Type 2 Diabetes Drug Avandia Should Be Pulled, PC Testifies

Diabetes Drug Avandia Should Be Removed From the Market, Public Citizen Tells FDA Advisory Committee

Popular Drug Associated With Risks to Multiple Organ Systems Has No Benefit Over Older, Safer Type 2 Diabetes Drugs

WASHINGTON, July 30, 2007 – The popular type 2 diabetes drug Avandia should be removed from the U.S. market, according to testimony delivered today by Public Citizen before a Food and Drug Administration (FDA) advisory committee panel investigating the medication.

Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, testified about the risks of Avandia (rosiglitazone), detailing pre-approval and post-approval evidence of cardiac toxicity, liver toxicity and anemia. Wolfe also discussed post-approval evidence of increased bone fractures in women and damage to patients’ vision associated with the drug.

“Does the overall risk-benefit profile of Avandia support its continued marketing in the United States?” said Wolfe. “The answer is clearly no.”

According to Wolfe’s testimony, in FDA adverse reaction reports filed since marketing began for the drug in 1999 through the end of last year, there was a 15.2 times higher adjusted rate of heart failure reported with Avandia than for the older diabetes drug Glucotrol. The adjusted rate of liver toxicity with Avandia was 9.5 times higher, and 14.8 times higher for liver failure.

In addition, the adjusted rate of post-approval adverse reaction reports for anemia in patients was 13.3 times higher for Avandia than with Glucotrol. In patients already damaged by heart failure or other cardiac risks associated with the drug, the addition of anemia could significantly worsen their clinical condition, Wolfe warned. Wolfe also cited in his testimony a recently completed study finding statistically significant increases in bone fractures in women using Avandia compared to those using another diabetes drug.

Vision impairment, a major complication of diabetes, is also made worse by Avandia, Wolfe said. A mechanism related to heart failure and fluid accumulation has produced macular edema – a swelling in the retina – in many patients, causing usually reversible damage to vision. The adjusted reporting rate for macular edema was 35.3 times higher for Avandia than for Glucotrol.

“There is no evidence of any uniquely beneficial clinical outcome for Avandia and growing evidence of unique risks in multiple organ systems,” concluded Wolfe. “If Avandia were up for approval today, based on what is now known, it would be summarily rejected. There should not be a double standard for removing it from the market.”

Because of the dangers associated with the drug that are not present in older, safer diabetes medications, Public Citizen is preparing a petition to the FDA to remove Avandia from the market.


Testimony Before the FDA Advisory Committee Meeting on Rosiglitazone (HRG Publication #1820)

FDA Endocrine Metabolic Drugs Advisory Committee Meeting on Rosiglitazone: July 30, 2007

Testimony of Sidney Wolfe M.D., Elizabeth Barbehenn Ph.D. and Ben Wolpaw, Health Research Group of Public Citizen



I will focus on the fourth question to the committee: Does the overall risk-benefit profile of rosiglitazone (Avandia) support its continued marketing in the US?

The evidence presented today concerning the increased risk of ischemic heart disease including myocardial infarctions appears to justify the removal of this drug from the market, but due to the ubiquitous nature of PPAR gamma receptor sites in so many parts of the body, it is hardly surprising that there are many other significant kinds of damage this drug is causing to patients.

Preclinical (Pre-Approval) and Post-Approval Evidence of Cardiac Toxicity

In a 1999 FDA pharmacology review of animal toxicity, "rosiglitazone produced various toxicities such as left atrial thrombosis, hydrothorax, cardio hypertrophy and elevations of hepatic enzymes in the high dose group. In this reviewer's opinion, it is not possible to anticipate potential human toxicities" and stated that "these findings appear as long term clinical concern." The final recommendation states "Pharmacology recommends not to approve rosiglitazone for the proposed indication for long-term human use."

In dogs, at doses only 1.2 times higher than the human dose, there was evidence of significant cardiac hypertrophy after 26 weeks.



Avandia1c



In her review of animal and human evidence of cardiac toxicity of PPAR gamma agonists such as rosiglitazone last year, former FDA Pharmacologist Dr. Jeri El-Hage stated:

* There was fluid accumulation in all species (mouse, rat, dog, rabbit, monkey, human).
* Fluid accumulation leads to weight gain, edema, cardiac hypertrophy with resultant heart failure in all species.
* Drug-induced heart failure and death were observed with chronic treatment (>6 months in animals and man).
* In people, the longer a patient was on a PPAR gamma, the lower the dose needed to produce edema or CHF.

In a recently published meta-analysis of randomized trials with rosiglitazone (2 trials) and pioglitazone (1 trial) co-authored by Dr. Curt Furberg, the increased risk of heart failure compared to placebo was 2.1 (95% CI of 1.08-4.08)

Finally, in FDA adverse reaction reports filed since marketing began through the end of last year, there were 698 cases of heart failure reported with Avandia compared with 39 for the older diabetes drug, Glucotrol. Adjusting for differences in the number of prescriptions for the two drugs, the rate of heart failure reports for Avandia compared with Glucotrol was 15.2 times higher.



Avandia2



Preclinical (Pre-Approval) and Post-Approval Evidence of Liver Toxicity

In the pre-clinical 1999 FDA pharmacology review, evidence of liver toxicity was seen in dogs at a dose only 1.2 times higher than the human dose that included ALT, AST and LDH in males that increased to being statistically significant in males and females (ALT only) by 25 weeks in the next higher dose.

In eight published case reports of rosiglitazone-caused liver toxicity, with human exposures ranging from two weeks to 15 months, for the seven patients for whom follow-up data was available, five recovered within two weeks to four months after the drug was stopped. Two of the patients died. Bilirubin levels in these patients, consistent with the similar hepatocellular toxicity seen with troglitazone (Rezulin), ranged from 2.9 to 22.3 with an average of 10.5.



Avandia3



Finally, in FDA adverse reaction reports filed since marketing began through the end of last year, there were 594 cases of hepatic toxicity (including 122 cases of liver failure) reported with Avandia compared with 53 cases of toxicity (and only seven cases of liver failure) for Glucotrol. Adjusting for differences in the number of prescriptions for the two drugs, the increased adjusted rate of reports for Avandia compared with Glucotrol was 9.5 times higher than Glucotrol for all reports of hepatic toxicity and 14.8 times higher for hepatic failure.

There were 46 reports of deaths from hepatic failure with Avandia, and six with Glucotrol, for an adjusted rate of 6.5 times higher with Avandia.

Avandia4

Avandia5



Post Approval Evidence of Increased Bone Fractures in Women

The recently completed ADOPT study found statistically significant increases in total and lower limb fractures in women using Avandia compared to those using either glyburide or metformin.

Avandia6

Avandia7



Pre-Approval and Post-Approval Clinical Evidence of Anemia

* In pre-approval clinical trials, anemia was reported in 1.9% of patients receiving Avandia as monotherapy compared to 0.7% on placebo.
* Severe anemia (male: Hct less than 31; female: Hct less than 28) was seen in clinical trials in 9/2,121 patients on rosiglitazone, 0/485 patients given placebo. A lesser degree of anemia was seen in many more patients.
* Anemia was seen most commonly in combination therapy with rosiglitazone plus metformin (7.1%) compared to those receiving placebo plus metformin (2.2%).

Post-approval adverse reaction reports included 407 cases of anemia in patients using Avandia and 26 in patients using Glucotrol for an adjusted reporting rate of 13.3 times higher for Avandia.

In patients already damaged by heart failure or other cardiac risks of this drug, the addition of anemia can significantly worsen their clinical condition.

Macular Edema

Although one of the major worries as far as microvascular complications of diabetes is visual impairment, not only does Avandia lack evidence of improving this situation but, through a mechanism related to heart failure and fluid accumulation, many patients have developed macular edema—swelling in the critical macular portion of the retina—with Avandia with concomitant, usually reversible, damage to their vision.

Post-approval adverse reaction reports included 83 cases of macular edema in patients using Avandia and two in patients using Glucotrol, for an adjusted reporting rate of 35.3 times higher for Avandia.

Summary

In a recent editorial in the New England Journal of Medicine, Dr. David Nathan, a diabetes expert from the Mass General Hospital wrote:

In theory, newer classes of antidiabetes medications might be welcome additions to the existing armamentarium; however, those that have been developed recently are generally no more potent, and often less effective in lowering glycemia, than the three oldest classes (insulin, the sulfonylureas, and the biguanides), all of which are more than 50 years old.

Moreover, the newer classes are uniformly more expensive and are associated with adverse effects — some that are shared by the older drugs, but others that are new.

He added that “The failure of clinicians and their patients with diabetes to implement currently available interventions aggressively and effectively is, I suspect, the major barrier to good care. This problem will not be fixed by making more medications available.”

Our answer to the question, "Does the overall risk-benefit profile of Avandia support its continued marketing in the US?" is clearly no.

There is no evidence of any uniquely beneficial clinical outcome for Avandia and growing evidence in multiple organ systems (cardiac, liver, bone, bone marrow) of unique risks. If this drug were up for approval today, based on what is now known, it would be summarily rejected. There should not be a double standard for removing it from the market.

Source:www.pharmalive.com

Child wins huge damages over medical care

A Glendale Superior Court civil jury has awarded an estimated $96 million in future damages in the case of a child who developed a rare but serious neurological disorder caused by untreated jaundice shortly after his birth four years ago at Verdugo Hills Hospital.

The jury's 9-3 verdict, which came late Monday, is calculated in two ways. The current value of the award is $15 million, but it is expected to reach $96 million over the course of medical care for the boy during his lifetime, said attorneys for Aidan Ming-Ho Leung. That would make it one of the largest jury awards in recent California court history, according to a website that tracks the top jury awards.

Michael Thomas, a lawyer for the nonprofit hospital, said the award would be appealed. Thomas also said he would seek a mistrial based on what he said were jury deliberation irregularities and other problems involving the court's receipt of evidence. He declined to elaborate.

Aidan was born March 24, 2003, at Verdugo Hills Hospital under the care of Dr. Steven Wayne Nishibayashi, who also was listed as a defendant in the case.

According to the lawsuit, Aidan exhibited several risk factors for kernicterus, a neurological disorder that can cause mental retardation, cerebral palsy and hearing loss, when he developed jaundice shortly after birth. The jaundice was a sign of the buildup of bilirubin, a yellow bile pigment, produced in greater quantities than a baby's liver can excrete.

The hospital and the doctor, the plaintiff's attorneys argued, should have been alert to that possibility and given him appropriate medical treatment to reduce the bilirubin buildup.

Aidan's parents were concerned just days after his birth because he became lethargic and was barely feeding, said Aidan's attorney, Luan K. Phan, but they were told that the jaundice would go away by itself. Phan said the hospital gave the parents a pamphlet that said jaundice did not produce a serious medical risk. Instead, Phan said, Aidan wound up in an emergency room at another hospital, where two attempts to remove the buildup through blood transfusions failed.

Aidan's condition "was never on the radar of the doctors and nurses" at Verdugo Hills Hospital, Phan said.

The hospital presented a dramatically different version of events. Thomas said that Aidan was born healthy and that his mother requested a discharge from the hospital while he was still in excellent health. When she left with Aidan, the baby was then beyond the hospital's responsibility, Thomas said.

"It's the hospital's position that they did nothing wrong and that all follow-up care was out of their hands," Thomas said.

Aidan, now 4, requires constant medical attention, said Phan, whose firm employs Aidan's father.

"He has normal intelligence, but he can't walk. He can't talk, can't feed himself. He can't control a single muscle and it was all preventable," Phan said.

Lawyers USA Online, which covers court decisions, legislation and litigation trends, said the largest California verdict last year was a $106-million award to the family of a murder victim seeking to prevent a defendant from profiting from book or movie deals. That award was reduced to $16 million and is on appeal.

Source:www.latimes.com