Dr. Victor Gura began creating the initial models for his Wearable Artificial Kidney (WAK), in an exam room in his Beverly Hills medical offices 10 years ago. He is a kidney specialist and an Associate Clinical Professor at UCLA, specifically working with patients on dialysis. His goal was to create a Wearable dialysis machine, so patients would not have to be tied down for many hours to a big machine, and would get more dialysis time but feel much better as they could walk around with a miniaturized battery operated machine worn as a belt.

Earlier this month, Gura’s WAK was one of three projects accepted into the Federal Drug Administration End Stage Renal Disease (ESRD) Innovation Challenge. The ESRD Challenge is an accelerated program to assist new projects in dialysis treatments, in getting fast approval from the FDA to make it available to the public in the US.

Over 2 million people throughout the world are on dialysis, and in the US about 20 percent of dialysis patients die every year.

“When the kidneys fail, the poisons accumulate in the body,” Gura said. “The vast majority of the patients who need a transplant will die before they get it. So, dialysis is the main solution, and consists of running the patients blood through a large machine connected by two thick needles to cleanse the blood.

Patients on dialysis have a better quality of life if they are able to undertake dialysis every day, but that requires many more hours of care, that doctors and nurses can’t offer in beds they don’t have. If not, toxins build up in their blood, and life becomes uncomfortable and limited.

“Society doesn’t have the financial resources to pay for daily dialysis,” Gura said. “I need to improve the quality of life for my patients.”

The WAK is the first miniaturized dialysis machine of its kind in the world. It is battery operated and uses very little water as compared to the currently used machines. Gura said that in the past some Nephrology specialists have been skeptical of the WAK, but that now his concept has gained world wide acceptance.

“We can’t continue doing business as usual because too many people suffer too much, and the high mortality is unacceptably high ,” Gura said. “We had to come up with something better for them. The only reason you become a doctor is either to alleviate suffering or save lives. This is like being a doctor on steroids because now I hope to be saving a lot of lives through the device.”

Gura said the WAK has been tested in the lab, on pigs, and in two successful human trials in Italy and the United Kindgdom. Now, it will undergo trials across the country, in different facilities including the University of Washington, Downstate New York, UCSD and Vanderbilt, for different periods of time. He said he is hoping the trials will be completed in less than two years.

“We have definite estimates of what the pathway should be, but now that the FDA is involved we are much more confident that collaborating with their team may help us do things better and faster” Gura said. “I’m elated to work with the FDA. The FDA has been demonized but [from] what I encountered, they are a wonderful group of people, modest, knowledgeable, smart and trying to do good.”

http://bhcourier.com/article/Local/Local/Beverly_Hills_Doctor_On_Fast_Track_To_FDA_Approval_For_WAK/87992

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Over the counter medications like Advil, Tylenol, and other pain relieving drugs are found in many households, and are generally considered safe when used properly.

Even the safest drugs have risks. Using too much of a common pain relieving drug may cause a variety of problems.

For example, while it's perfectly safe at normal doses, Tylenol is the leading cause of non-alcoholic liver failure in adults.

A recent study concluded that years of daily use of non-steroidal anti-inflammatory drugs (NSAIDs), in the same family as Advil (ibuprofen), slightly increases the risk for developing renal cell (kidney) cancer. Risk increased slightly the longer the medication had been taken, up to three times the normal lifetime risk. 

Aspirin and Tylenol (acetaminophen) were also studied, but did not demonstrate the same increase in cancer risk.

This development provides an interesting counterpoint to previous theories that long term use of anti-inflammatory drugs, including statins (drugs used to lower cholesterol), may lower the risk of developing certain types of cancer. 

Data was taken from two studies, the 1990 Nurses' Health Study and the 1986 Health Professionals Follow-up Study. Together, twenty years of patient records were analyzed for a combined total of 333 cases of renal cell cancer out of the 126,928 people.

Renal cell cancer (RCC) accounts for 85 percent of all kidney cancers. 

The study analyzed the theory that these drugs may be involved with some minor damage to the kidneys, due to both their direct removal by the kidney, as well as the effects of the drugs on blood flow.

The cancer risk changed from the normal risk of 1.5 percent during a person's lifetime, to 2.9 percent if non-aspirin NSAID drugs were used daily for more than ten years.

"In these large prospective studies of women and men, we found that use of non-aspirin NSAIDs was associated with an elevated risk of RCC, especially among those who took them for a long duration," write the authors, who add that aspirin and acetaminophen were not associated with RCC risk.

"Risks and benefits should be considered in deciding whether to use analgesics; if our findings are confirmed, an increased risk of RCC should also be considered."

Results were published in the journal Archives of Internal Medicine.

No conflicts of interest were disclosed by researchers.

The study was supported by research grants from the National Institutes of Health, the Kidney Center Association and the Dana-Farber/Harvard Cancer Center.

Recent figures show that about 55,000 people in the United States are diagnosed with kidney cancer each year, and the figure is rising. There are many different types of kidney cancer, but the most common by far is renal cell carcinoma, a tumor which arises from the proximal tubule in the kidney, part of the body's filtration process.

It occurs more often in men than in women, and usually after age 50. The most significant risk factors are smoking and obesity, and high blood pressure and family history are strong risk factors as well. Patients on dialysis from polycystic kidney disease are have a thirty times greater risk of developing RCC.

Symptoms are not very specific, as most cases are discovered incidentally in patients when they are undergoing imaging for a different cause. If undetected, common symptoms will include blood in the urine, flank pain, and an abdominal mass. Abdominal pain and back pain are also common, along with unintentional weight loss. Less common symptoms include cold intolerance, constipation, pallor, and excessive hair growth in women. Utlimately, diagnosis will be made by ultrasound and CT scan of the kidneys.

Treatment is usually surgical removal of the kidney, and removal of the bladder and surrounding lymph nodes may be needed as well. Chemotherapy and radiation are often ineffective, so newer immunotherapies such as Nexavar, Sutent, Torisel, and Avastin have been used with some success. RCC confined to only the kidney has a 90% five-year survival rate, but as metastasis progresses, the survival rate unfortunately decreases precipitously.

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Pneumonia and pulmonary edema commonly occur among HD patients. Chest X-rays are used routinely in clinical practice to assist with the differential diagnosis, but their reliability has not been evaluated in this patient population, the researchers explained.

Nephrology fellow Eric K. Judd, MD, and colleagues at the University of Alabama at Birmingham identified 122 HD patients admitted with a diagnosis of pneumonia from the emergency department of a large university hospital during a one-year period. The investigators excluded 54 subjects because of missing dialysis records and other reasons, leaving 68 patients in the study. Two experienced radiologists blinded to patients' clinical course and subsequent imaging studies independently interpreted the admission chest X-rays for the presence of pneumonia or pulmonary edema. Two internal-medicine trained physicians independently determined the presence of pneumonia and pulmonary edema after reviewing patients' entire hospitalization records. Dr. Judd's group assessed the level of agreement among the observers.

The investigators concluded that there is substantial disagreement between experienced radiologists on the radiologic diagnosis of pneumonia and pulmonary edema in HD patients, perhaps reflecting uncertainty about the etiology of the pulmonary infiltrate in this population. Clinicians more frequently agreed on the diagnosis of pulmonary edema than of pneumonia, suggesting that pneumonia is more difficult to diagnose clinically. 

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Gay Martin has been caring on and off for renal patient Peter Morrison since 1975. Picture: Dean Martin Source: The Advertiser

FRESH out of school, Gay Martin embarked in her life's work as a nurse. More than 40 years later, she is still doing the job she loves.

Ms Martin, 56, who works at Royal Adelaide Hospital, is one of the millions of nurses being celebrated today as part of International Nurses Day.

After training at Queen Elizabeth Hospital, Ms Martin started in the renal ward.

In her late 30s, she travelled the world for two years - to Singapore, Malaysia, New Zealand, and Indonesia - using her renal nursing skills to set up dialysis centres in those countries.

In Adelaide, she's had many nursing roles, from training patients for dialysis to organising transplants for people.

But one role that has stood out from the others caring for renal patient Peter Morrison, 51.

Ms Martin has been his nurse since 1975, when at 14, he was first admitted to hospital for renal failure. Since then, he has been in and out of hospital, had two kidney transplants and will receive a third in June.

"Gay always goes that little bit extra," Mr Morrison said.

Ms Martin said: "It's very rewarding to see someone who faces the ups and downs, to see them get a transplant, become well and resume a healthy life."

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